MINI-STERNOTOMY FOR AVR · HISTORY I •A right parasternal incision is made, extending from the...

21
MINI-STERNOTOMY FOR AVR Γ. ΔΡΟΣΟΣ Θ.ΚΑΡΑΙΣΚΟΣ ΧΕΙΡΟΥΡΓΙΚΗ ΚΛΙΝΙΚΗ ΘΩΡΑΚΟΣ ΚΑΡΔΙΑΣ ΝΟΣ. ΠΑΠΑΝΙΚΟΛΑΟΥ

Transcript of MINI-STERNOTOMY FOR AVR · HISTORY I •A right parasternal incision is made, extending from the...

Page 1: MINI-STERNOTOMY FOR AVR · HISTORY I •A right parasternal incision is made, extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal

MINI-STERNOTOMY FOR AVR

Γ ΔΡΟΣΟΣ ΘΚΑΡΑΙΣΚΟΣ

ΧΕΙΡΟΥΡΓΙΚΗ ΚΛΙΝΙΚΗ ΘΩΡΑΚΟΣ ΚΑΡΔΙΑΣ

ΝΟΣ ΠΑΠΑΝΙΚΟΛΑΟΥ

HISTORY I

Minimally Invasive Approach for Aortic Valve Operations

Delos M Cosgrove III MD and Joseph F Sabik MD

Department of Thoracic and Cardiovascular Surgery

The Cleveland Clinic Foundation Cleveland Ohio

A minimally invasive procedure for performing repair or replacement of the aortic valve has been developed that simplifies the technique and reduces surgical trauma

Ann Thorac Surg 199662596-7

HISTORY I

bull A right parasternal incision is made extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal cartilage The pectoralis major muscle is divided exposing the second third and fourth intercostal spaces and the third and fourth costal cartilages The third and fourth costal cartilages are totally excised The right internal thoracic artery is ligated just below the second costal cartilage and just above the fifth costal cartilage Intercostal muscles and pleura are incised lateral to the edge of the sternum entering the right pleural cavity The pericardium is incised exposing the ascending aorta and right atrium and a tangential incision is made in the aorta exiting into the noncoronary sinus

bull A common femoral artery and vein are exposed and after heparinization are cannulated Adequate venous drainage is obtained by placing a long venous cannula so that the tip of the cannula passes through the right atrium and lies in the superior vena cava A centrifugal pump is attached to the venous line to actively drain the right side of the heart Alternatively a cannula may be placed in the right atrial appendage After cardiopulmonary bypass is established the aorta is encircled with umbilical tape and the aorta cross-clamped with a right-angled clamp A suture is then placed just above each commissure and clamped to the surrounding drape under tension This elevates the aortic root into the operative field When isolated aortic stenosis is present cardioplegia is administered into the ascending aorta in the presence of aortic insufficiency cardioplegia is given directly into the coronary ostia after the aortotomy is performed The aortic valve is either repaired or replaced A suction catheter is placed into the left ventricle through the aortic annulus as needed At the completion of the repair or replacement the aortotomy is closed and air is removed from the heart through the aortic incision with the assistance of the transesophagealechocardiography probe Atrial and ventricular pacing wires are placed and the cross-clamp is removed

HISTORY I

From January to April 1996 this approach was em- ployed in 25 patients with isolated aortic valve disease Repairs of the aortic valve were carried out in 6 patients Nineteen patients had valve replacement 10 Carpentier- Edwards pericardial valves 8 aortic homografts and 1 St Jude valve There were no deaths reoperations for bleeding strokes or wound infections

History II

bull Minimally invasive cardiac valve surgery improves patient satisfaction while reducing costs of cardiac valve replacement and repair

bull L H Cohn D H Adams G S Couper D P Bichell D M Rosborough S P Sears and S F Aranki

bull From the Division of Cardiac Surgery Brigham and Womens Hospital Department of Surgery Harvard Medical School Boston Massachusetts

bull Ann Surg 1997 Oct 226(4) 421ndash428

History II

History II

bull Of the 84 patients there were 2 operative mortalities both in class IV aortic patients from multisystem organ failure There was no operative mortality in the patients undergoing mitral valve replacement or repair The operations were carried out with the same accuracy and attention to detail as with the conventional operation There was minimal postoperative bleeding cerebral vascular accidents or other major morbidity Groin cannulation complications primarily were related to atherosclerotic femoral arteries

Minimally Invasive and Conventional Aortic Valve ReplacementA Propensity Score Analysis

Department of Adult Cardiac Surgery Daniyar Gilmanov G Pasquinucci Heart Hospital Massa Italy

Methods

bull This is a retrospective observational cohort study of prospectively collected data on 709 patients undergoing isolated primary aortic valve replacement between 2004 and 2011 Of these 338

were performed through either right anterior minithoracotomy or upper ministernotomy With propensity score matching 182 patients (minimally invasive group) were compared with 182

patients in conventional sternotomy (control group)

Conclusions

bull Our experience shows that mini-access isolated aortic valve surgery is a reproducible safe and effective procedure and reduces assisted ventilation duration the need for blood product

transfusion and incidence of post-surgery atrial fibrillation

(Ann Thorac Surg 201396837ndash43)

Introduction

bull The approaches taken under the umbrella of minimally-invasive surgical aortic valve replacement (MICS SAVR) essentially consist of a variety of access options to the aortic valve using smaller incisions

bull Importantly there is no convention or consensus as to what size incision qualifies as a minimally-invasive procedure

bull Furthermore lsquominimally-invasiversquo cardiac surgery (MICS) arguably is somewhat of a misnomer certainly in comparison interventions such as TAVR because the most invasive portions of the surgery including cross-clamping of the aorta ischemic cardiac arrest the use of cardiopulmonary bypass and opening of the aorta with introduction of air into the heart chambers all remain the same

Mahesh K Ramchandani MDAnnals of Thoracic Surgery ( in press)

ΜΙΝΙ

ν=28

ΥΠΟΛΟΙΠΟΙ

ν=131Ηλικία 722plusmn84 704plusmn98Γυναίκες(n) 10 (357) 58(442)Euro score 227plusmn2 18plusmn19ΜΕΘ μέρες 196plusmn06 198plusmn11Μέρες νοσηλείας 6plusmn218 57plusmn18Νοσηλεία lt5

μέρες

14(50) 37(517)

Μετάγγιση

RBC UNITS

12plusmn09 15plusmn13

CPB min 1124plusmn37 933plusmn33Μηχανικός

αερισμός (ώρες)

86plusmn45 104plusmn13

ΜΙΝΙ Στερνοτομές 2018Μεμονωμένη αντικατάσταση αορτικής βαλβίδας 2018

Σύνολο 159- ΜΙΝΙ 28 (176)

Χαρακτηριστικά ασθενών Επιπλοκές

ΜΙΝΙ

ν=28

ΥΠΟΛΟΙΠΟΙ

ν=131

P value

LCOS(n) 1 (36) 3(23) 069

Επαναδιάνοιξη(n) 0 4(31) 035

Λοιμώξεις

στερνοτομής(n)

1 (36) 3(23) 069

Stroke 0 2(15) 051

NIV 1 (36) 6(46) 081

Επαναδιασωλήνωση 0 3(23) 042

AKI(n) 3(107) 12(92) 079

Κολπική μαρμαρυγή 7(25) 40(305) 056

Θάνατος 0 3(23) 042

Minimally Invasive Approaches to Surgical Aortic Valve Replacement

A Meta-Analysis

Carolyn Chang BS Sajjad Raza MD Salah E Altarabsheh MD Sarah Delozier PhD Umesh M Sharma MD MBA Aisha Zia MD Muhammad Shahzeb Khan MD Mandy Neudecker MS Alan H Markowitz MD Joseph F Sabik III MD and Salil V Deo MD

Cleveland Ohio

(Ann Thorac Surg 20181061881ndash9)

Minimally Invasive Approaches to Surgical Aortic Valve ReplacementA Meta-Analysis

The outcomes of the 2 minimally invasive aortic valve replacement (AVR) strategiesmdashmini-sternotomy (AVR-st) and right anterior thoracotomy (AVR-th) with each other and with conventional AVR (cAVR)

Searched Medline PubMed Embase and Web of Science in December 2017 for studies comparing AVR-st AVR-th and cAVR Endpoints studied included hospital mortality stroke atrial fibrillation cardiopulmonary bypass (CPB) time and length of stay

A total of 19 studies (gt10000 pooled patients) met the inclusion criteria

bull Mortality (p [ 006) and stroke (p [ 015) were comparable between minimally invasive and conventional AVR

bull CPB times were longer with AVR-th versus cAVR (124 minutes [range 5 to 19] p lt 001) In the AVR-th cohort CPB duration was weakly inversely related to study size (p [ 006)

bull Atrial fibrillation was much less after AVR-th (odds ratio 047 [035 to 063] p lt 0001)

bull Hospital stay was significantly lower after minimally invasive surgery (08 [04 to 13] days p lt 001

Minimally invasive approaches to AVR yield excellent outcomes in high-volume centers They reduce hospital stay and incidence of postoperative atrial fibrillation and therefore should be considered in patients undergoing AVR The operative approach should be selected according to surgeonrsquos technical expertise and what is best for specific patient profile

(Ann Thorac Surg 20181061881ndash9)

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

Elisa Mikus MD Simone Calvi MD Gianluca Campo MD Rita Pavasini MD Marco Paris MD Eliana Raviola MD Marco Panzavolta MD Alberto Tripodi MD Roberto Ferrari MD PhD and Mauro Del Giglio MD PhD

Cardiothoracic and Vascular Department Maria Cecilia Hospital GVM Care amp Research Cotignola (RA) Cardiovascular Institute Azienda Ospedaliero-Universitaria di Ferrara Cona (FE) and Cardiovascular Department Istituto Clinico San Rocco Ome (BS) Italy

(Ann Thorac Surg 20181061782ndash8)

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

bull The study included all 1907 consecutive patients hospitalized at the Maria Cecilia Hospital (Cotignola RA Italy) between January 2010 and March 2017 undergoing isolated AVR through PUH RAT or MS The choice of the approach was left to surgeonrsquos preference To adjust for differences in baseline characteristics between the study groups a propensity score matching was performed Linear and logistic regression analyses were performed

bull Results Partial upper hemisternotomy was performed in 820 patients (43) right anterior minithoracotomy in 488 (26) and median sternotomy in 599 (31) After propensity score matching three groups of 377 patients were obtained Cardiopulmonary bypass and crossclamptimes were shorter in the right anterior minithoracotomy group than in the median sternotomy and partial upper hemisternotomy groups (p lt 0001) No significant differences in in-hospital mortality were observed (p [ 09) Renal failure (odds ratio 54 95 confidence interval 23 to 114 p lt 00001) extracardiac arteriopathy (odds ratio 29 95 confidence interval 11 to 67 p [ 0017) and left ventricular ejection fraction (odds ratio 096 95 confidence interval 093 to 099 p [ 0009) emerged as independent predictors of in hospital mortality

bull Conclusions Minimal-access isolated aortic valve surgery is a reproducible safe and effective procedure with similar outcomes and operating times compared with conventional sternotomy

Ann Thorac Surg 20181061782ndash8

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement

Sukumaran K Nair FRCS(CTh) et al

bull From the a Department of Cardiothoracic Surgery PapworthHospital Cambridge United Kingdom Freeman Hospital Newcastle upon Tyne United Kingdom Leeds Institute of Clinical Trials Research University of Leeds Leeds United Kingdom Health Economics Research Group Brunel University London London United Kingdom and London School of Hygiene and Tropical Medicine Keppel Street London United Kingdom

J Thorac Cardiovasc Surg 20181562124-32

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacement

bull Methods This RCT compared MS with FS for first-time isolated AVR in 2 United Kingdom National Health Service hospitals Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR analyzed in the intent-to-treat population

bull Results In this RCT 222 patients were recruited and randomized (n frac14 118 in the MS group n frac14 104 in the FS group) Compared with the FS group the MS group had a longer hospital length of stay (mean 95 days vs 86 days) and took longer to achieve fitness for discharge home (mean 85 days vs 75 days) Adjusting for valve type sex and surgeon hazard ratios (HRs) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR 0874 95 confidence interval [CI] 0668-1143 P frac14 3246) or time to fitness for discharge (HR 0907 95 CI 0688-1197 P value frac14 4914) During a mean follow-up of 760 days (745 days for the MS group and 777 days for the FS group) 12 patients (10) in the MS group and 7 patients (7) in the FS group died (HR 1871 95 CI 0723-4844 P frac14 1966) Average extra cost for MS was pound1714 during the first 12 months

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacementCentral Message

In the United Kingdomrsquos National Health Service compared with a conventional median sternotomy approach for surgical aortic valve replacement mini-sternotomy did not hasten recovery or hospital discharge and was not cost-effective

Measuring What Matters

Having lived through the growth of percutaneous coronary intervention and now seeing the expansion of transcatheter aortic valve replacement I find myself asking the somewhat existential question ldquoAre we measuring what matters to patientsrdquo

Thoralf M Sundt MD Division of Cardiac Surgery

Massachusetts General Hospital Boston Massachusetts

Ann Thorac Surg 20181061602

Measuring What Matters

In a study performed at Dartmouth-Hitchcock

elderly patients prioritized ability to pursue activities maintaining independence and reducing symptoms

over

mortality benefit

Coleywright M et al Patients defined goals for the treatment of sever AVS a qualitative analysis

Health Expect 2016 191036-43

Measuring What Matters

These sorts of ldquosoftrdquo outcome variables are challenging to us We think of ourselvesmdashat least I domdashas medical scientists interested in ldquohardrdquo endpoints

But our patients are challenging us to consider what they value most not what we can measure easily Irsquod say it is time for us to broaden our horizons and revisit how we can better measure what matters

Ann Thorac Surg 20181061602

Page 2: MINI-STERNOTOMY FOR AVR · HISTORY I •A right parasternal incision is made, extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal

HISTORY I

Minimally Invasive Approach for Aortic Valve Operations

Delos M Cosgrove III MD and Joseph F Sabik MD

Department of Thoracic and Cardiovascular Surgery

The Cleveland Clinic Foundation Cleveland Ohio

A minimally invasive procedure for performing repair or replacement of the aortic valve has been developed that simplifies the technique and reduces surgical trauma

Ann Thorac Surg 199662596-7

HISTORY I

bull A right parasternal incision is made extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal cartilage The pectoralis major muscle is divided exposing the second third and fourth intercostal spaces and the third and fourth costal cartilages The third and fourth costal cartilages are totally excised The right internal thoracic artery is ligated just below the second costal cartilage and just above the fifth costal cartilage Intercostal muscles and pleura are incised lateral to the edge of the sternum entering the right pleural cavity The pericardium is incised exposing the ascending aorta and right atrium and a tangential incision is made in the aorta exiting into the noncoronary sinus

bull A common femoral artery and vein are exposed and after heparinization are cannulated Adequate venous drainage is obtained by placing a long venous cannula so that the tip of the cannula passes through the right atrium and lies in the superior vena cava A centrifugal pump is attached to the venous line to actively drain the right side of the heart Alternatively a cannula may be placed in the right atrial appendage After cardiopulmonary bypass is established the aorta is encircled with umbilical tape and the aorta cross-clamped with a right-angled clamp A suture is then placed just above each commissure and clamped to the surrounding drape under tension This elevates the aortic root into the operative field When isolated aortic stenosis is present cardioplegia is administered into the ascending aorta in the presence of aortic insufficiency cardioplegia is given directly into the coronary ostia after the aortotomy is performed The aortic valve is either repaired or replaced A suction catheter is placed into the left ventricle through the aortic annulus as needed At the completion of the repair or replacement the aortotomy is closed and air is removed from the heart through the aortic incision with the assistance of the transesophagealechocardiography probe Atrial and ventricular pacing wires are placed and the cross-clamp is removed

HISTORY I

From January to April 1996 this approach was em- ployed in 25 patients with isolated aortic valve disease Repairs of the aortic valve were carried out in 6 patients Nineteen patients had valve replacement 10 Carpentier- Edwards pericardial valves 8 aortic homografts and 1 St Jude valve There were no deaths reoperations for bleeding strokes or wound infections

History II

bull Minimally invasive cardiac valve surgery improves patient satisfaction while reducing costs of cardiac valve replacement and repair

bull L H Cohn D H Adams G S Couper D P Bichell D M Rosborough S P Sears and S F Aranki

bull From the Division of Cardiac Surgery Brigham and Womens Hospital Department of Surgery Harvard Medical School Boston Massachusetts

bull Ann Surg 1997 Oct 226(4) 421ndash428

History II

History II

bull Of the 84 patients there were 2 operative mortalities both in class IV aortic patients from multisystem organ failure There was no operative mortality in the patients undergoing mitral valve replacement or repair The operations were carried out with the same accuracy and attention to detail as with the conventional operation There was minimal postoperative bleeding cerebral vascular accidents or other major morbidity Groin cannulation complications primarily were related to atherosclerotic femoral arteries

Minimally Invasive and Conventional Aortic Valve ReplacementA Propensity Score Analysis

Department of Adult Cardiac Surgery Daniyar Gilmanov G Pasquinucci Heart Hospital Massa Italy

Methods

bull This is a retrospective observational cohort study of prospectively collected data on 709 patients undergoing isolated primary aortic valve replacement between 2004 and 2011 Of these 338

were performed through either right anterior minithoracotomy or upper ministernotomy With propensity score matching 182 patients (minimally invasive group) were compared with 182

patients in conventional sternotomy (control group)

Conclusions

bull Our experience shows that mini-access isolated aortic valve surgery is a reproducible safe and effective procedure and reduces assisted ventilation duration the need for blood product

transfusion and incidence of post-surgery atrial fibrillation

(Ann Thorac Surg 201396837ndash43)

Introduction

bull The approaches taken under the umbrella of minimally-invasive surgical aortic valve replacement (MICS SAVR) essentially consist of a variety of access options to the aortic valve using smaller incisions

bull Importantly there is no convention or consensus as to what size incision qualifies as a minimally-invasive procedure

bull Furthermore lsquominimally-invasiversquo cardiac surgery (MICS) arguably is somewhat of a misnomer certainly in comparison interventions such as TAVR because the most invasive portions of the surgery including cross-clamping of the aorta ischemic cardiac arrest the use of cardiopulmonary bypass and opening of the aorta with introduction of air into the heart chambers all remain the same

Mahesh K Ramchandani MDAnnals of Thoracic Surgery ( in press)

ΜΙΝΙ

ν=28

ΥΠΟΛΟΙΠΟΙ

ν=131Ηλικία 722plusmn84 704plusmn98Γυναίκες(n) 10 (357) 58(442)Euro score 227plusmn2 18plusmn19ΜΕΘ μέρες 196plusmn06 198plusmn11Μέρες νοσηλείας 6plusmn218 57plusmn18Νοσηλεία lt5

μέρες

14(50) 37(517)

Μετάγγιση

RBC UNITS

12plusmn09 15plusmn13

CPB min 1124plusmn37 933plusmn33Μηχανικός

αερισμός (ώρες)

86plusmn45 104plusmn13

ΜΙΝΙ Στερνοτομές 2018Μεμονωμένη αντικατάσταση αορτικής βαλβίδας 2018

Σύνολο 159- ΜΙΝΙ 28 (176)

Χαρακτηριστικά ασθενών Επιπλοκές

ΜΙΝΙ

ν=28

ΥΠΟΛΟΙΠΟΙ

ν=131

P value

LCOS(n) 1 (36) 3(23) 069

Επαναδιάνοιξη(n) 0 4(31) 035

Λοιμώξεις

στερνοτομής(n)

1 (36) 3(23) 069

Stroke 0 2(15) 051

NIV 1 (36) 6(46) 081

Επαναδιασωλήνωση 0 3(23) 042

AKI(n) 3(107) 12(92) 079

Κολπική μαρμαρυγή 7(25) 40(305) 056

Θάνατος 0 3(23) 042

Minimally Invasive Approaches to Surgical Aortic Valve Replacement

A Meta-Analysis

Carolyn Chang BS Sajjad Raza MD Salah E Altarabsheh MD Sarah Delozier PhD Umesh M Sharma MD MBA Aisha Zia MD Muhammad Shahzeb Khan MD Mandy Neudecker MS Alan H Markowitz MD Joseph F Sabik III MD and Salil V Deo MD

Cleveland Ohio

(Ann Thorac Surg 20181061881ndash9)

Minimally Invasive Approaches to Surgical Aortic Valve ReplacementA Meta-Analysis

The outcomes of the 2 minimally invasive aortic valve replacement (AVR) strategiesmdashmini-sternotomy (AVR-st) and right anterior thoracotomy (AVR-th) with each other and with conventional AVR (cAVR)

Searched Medline PubMed Embase and Web of Science in December 2017 for studies comparing AVR-st AVR-th and cAVR Endpoints studied included hospital mortality stroke atrial fibrillation cardiopulmonary bypass (CPB) time and length of stay

A total of 19 studies (gt10000 pooled patients) met the inclusion criteria

bull Mortality (p [ 006) and stroke (p [ 015) were comparable between minimally invasive and conventional AVR

bull CPB times were longer with AVR-th versus cAVR (124 minutes [range 5 to 19] p lt 001) In the AVR-th cohort CPB duration was weakly inversely related to study size (p [ 006)

bull Atrial fibrillation was much less after AVR-th (odds ratio 047 [035 to 063] p lt 0001)

bull Hospital stay was significantly lower after minimally invasive surgery (08 [04 to 13] days p lt 001

Minimally invasive approaches to AVR yield excellent outcomes in high-volume centers They reduce hospital stay and incidence of postoperative atrial fibrillation and therefore should be considered in patients undergoing AVR The operative approach should be selected according to surgeonrsquos technical expertise and what is best for specific patient profile

(Ann Thorac Surg 20181061881ndash9)

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

Elisa Mikus MD Simone Calvi MD Gianluca Campo MD Rita Pavasini MD Marco Paris MD Eliana Raviola MD Marco Panzavolta MD Alberto Tripodi MD Roberto Ferrari MD PhD and Mauro Del Giglio MD PhD

Cardiothoracic and Vascular Department Maria Cecilia Hospital GVM Care amp Research Cotignola (RA) Cardiovascular Institute Azienda Ospedaliero-Universitaria di Ferrara Cona (FE) and Cardiovascular Department Istituto Clinico San Rocco Ome (BS) Italy

(Ann Thorac Surg 20181061782ndash8)

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

bull The study included all 1907 consecutive patients hospitalized at the Maria Cecilia Hospital (Cotignola RA Italy) between January 2010 and March 2017 undergoing isolated AVR through PUH RAT or MS The choice of the approach was left to surgeonrsquos preference To adjust for differences in baseline characteristics between the study groups a propensity score matching was performed Linear and logistic regression analyses were performed

bull Results Partial upper hemisternotomy was performed in 820 patients (43) right anterior minithoracotomy in 488 (26) and median sternotomy in 599 (31) After propensity score matching three groups of 377 patients were obtained Cardiopulmonary bypass and crossclamptimes were shorter in the right anterior minithoracotomy group than in the median sternotomy and partial upper hemisternotomy groups (p lt 0001) No significant differences in in-hospital mortality were observed (p [ 09) Renal failure (odds ratio 54 95 confidence interval 23 to 114 p lt 00001) extracardiac arteriopathy (odds ratio 29 95 confidence interval 11 to 67 p [ 0017) and left ventricular ejection fraction (odds ratio 096 95 confidence interval 093 to 099 p [ 0009) emerged as independent predictors of in hospital mortality

bull Conclusions Minimal-access isolated aortic valve surgery is a reproducible safe and effective procedure with similar outcomes and operating times compared with conventional sternotomy

Ann Thorac Surg 20181061782ndash8

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement

Sukumaran K Nair FRCS(CTh) et al

bull From the a Department of Cardiothoracic Surgery PapworthHospital Cambridge United Kingdom Freeman Hospital Newcastle upon Tyne United Kingdom Leeds Institute of Clinical Trials Research University of Leeds Leeds United Kingdom Health Economics Research Group Brunel University London London United Kingdom and London School of Hygiene and Tropical Medicine Keppel Street London United Kingdom

J Thorac Cardiovasc Surg 20181562124-32

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacement

bull Methods This RCT compared MS with FS for first-time isolated AVR in 2 United Kingdom National Health Service hospitals Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR analyzed in the intent-to-treat population

bull Results In this RCT 222 patients were recruited and randomized (n frac14 118 in the MS group n frac14 104 in the FS group) Compared with the FS group the MS group had a longer hospital length of stay (mean 95 days vs 86 days) and took longer to achieve fitness for discharge home (mean 85 days vs 75 days) Adjusting for valve type sex and surgeon hazard ratios (HRs) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR 0874 95 confidence interval [CI] 0668-1143 P frac14 3246) or time to fitness for discharge (HR 0907 95 CI 0688-1197 P value frac14 4914) During a mean follow-up of 760 days (745 days for the MS group and 777 days for the FS group) 12 patients (10) in the MS group and 7 patients (7) in the FS group died (HR 1871 95 CI 0723-4844 P frac14 1966) Average extra cost for MS was pound1714 during the first 12 months

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacementCentral Message

In the United Kingdomrsquos National Health Service compared with a conventional median sternotomy approach for surgical aortic valve replacement mini-sternotomy did not hasten recovery or hospital discharge and was not cost-effective

Measuring What Matters

Having lived through the growth of percutaneous coronary intervention and now seeing the expansion of transcatheter aortic valve replacement I find myself asking the somewhat existential question ldquoAre we measuring what matters to patientsrdquo

Thoralf M Sundt MD Division of Cardiac Surgery

Massachusetts General Hospital Boston Massachusetts

Ann Thorac Surg 20181061602

Measuring What Matters

In a study performed at Dartmouth-Hitchcock

elderly patients prioritized ability to pursue activities maintaining independence and reducing symptoms

over

mortality benefit

Coleywright M et al Patients defined goals for the treatment of sever AVS a qualitative analysis

Health Expect 2016 191036-43

Measuring What Matters

These sorts of ldquosoftrdquo outcome variables are challenging to us We think of ourselvesmdashat least I domdashas medical scientists interested in ldquohardrdquo endpoints

But our patients are challenging us to consider what they value most not what we can measure easily Irsquod say it is time for us to broaden our horizons and revisit how we can better measure what matters

Ann Thorac Surg 20181061602

Page 3: MINI-STERNOTOMY FOR AVR · HISTORY I •A right parasternal incision is made, extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal

HISTORY I

bull A right parasternal incision is made extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal cartilage The pectoralis major muscle is divided exposing the second third and fourth intercostal spaces and the third and fourth costal cartilages The third and fourth costal cartilages are totally excised The right internal thoracic artery is ligated just below the second costal cartilage and just above the fifth costal cartilage Intercostal muscles and pleura are incised lateral to the edge of the sternum entering the right pleural cavity The pericardium is incised exposing the ascending aorta and right atrium and a tangential incision is made in the aorta exiting into the noncoronary sinus

bull A common femoral artery and vein are exposed and after heparinization are cannulated Adequate venous drainage is obtained by placing a long venous cannula so that the tip of the cannula passes through the right atrium and lies in the superior vena cava A centrifugal pump is attached to the venous line to actively drain the right side of the heart Alternatively a cannula may be placed in the right atrial appendage After cardiopulmonary bypass is established the aorta is encircled with umbilical tape and the aorta cross-clamped with a right-angled clamp A suture is then placed just above each commissure and clamped to the surrounding drape under tension This elevates the aortic root into the operative field When isolated aortic stenosis is present cardioplegia is administered into the ascending aorta in the presence of aortic insufficiency cardioplegia is given directly into the coronary ostia after the aortotomy is performed The aortic valve is either repaired or replaced A suction catheter is placed into the left ventricle through the aortic annulus as needed At the completion of the repair or replacement the aortotomy is closed and air is removed from the heart through the aortic incision with the assistance of the transesophagealechocardiography probe Atrial and ventricular pacing wires are placed and the cross-clamp is removed

HISTORY I

From January to April 1996 this approach was em- ployed in 25 patients with isolated aortic valve disease Repairs of the aortic valve were carried out in 6 patients Nineteen patients had valve replacement 10 Carpentier- Edwards pericardial valves 8 aortic homografts and 1 St Jude valve There were no deaths reoperations for bleeding strokes or wound infections

History II

bull Minimally invasive cardiac valve surgery improves patient satisfaction while reducing costs of cardiac valve replacement and repair

bull L H Cohn D H Adams G S Couper D P Bichell D M Rosborough S P Sears and S F Aranki

bull From the Division of Cardiac Surgery Brigham and Womens Hospital Department of Surgery Harvard Medical School Boston Massachusetts

bull Ann Surg 1997 Oct 226(4) 421ndash428

History II

History II

bull Of the 84 patients there were 2 operative mortalities both in class IV aortic patients from multisystem organ failure There was no operative mortality in the patients undergoing mitral valve replacement or repair The operations were carried out with the same accuracy and attention to detail as with the conventional operation There was minimal postoperative bleeding cerebral vascular accidents or other major morbidity Groin cannulation complications primarily were related to atherosclerotic femoral arteries

Minimally Invasive and Conventional Aortic Valve ReplacementA Propensity Score Analysis

Department of Adult Cardiac Surgery Daniyar Gilmanov G Pasquinucci Heart Hospital Massa Italy

Methods

bull This is a retrospective observational cohort study of prospectively collected data on 709 patients undergoing isolated primary aortic valve replacement between 2004 and 2011 Of these 338

were performed through either right anterior minithoracotomy or upper ministernotomy With propensity score matching 182 patients (minimally invasive group) were compared with 182

patients in conventional sternotomy (control group)

Conclusions

bull Our experience shows that mini-access isolated aortic valve surgery is a reproducible safe and effective procedure and reduces assisted ventilation duration the need for blood product

transfusion and incidence of post-surgery atrial fibrillation

(Ann Thorac Surg 201396837ndash43)

Introduction

bull The approaches taken under the umbrella of minimally-invasive surgical aortic valve replacement (MICS SAVR) essentially consist of a variety of access options to the aortic valve using smaller incisions

bull Importantly there is no convention or consensus as to what size incision qualifies as a minimally-invasive procedure

bull Furthermore lsquominimally-invasiversquo cardiac surgery (MICS) arguably is somewhat of a misnomer certainly in comparison interventions such as TAVR because the most invasive portions of the surgery including cross-clamping of the aorta ischemic cardiac arrest the use of cardiopulmonary bypass and opening of the aorta with introduction of air into the heart chambers all remain the same

Mahesh K Ramchandani MDAnnals of Thoracic Surgery ( in press)

ΜΙΝΙ

ν=28

ΥΠΟΛΟΙΠΟΙ

ν=131Ηλικία 722plusmn84 704plusmn98Γυναίκες(n) 10 (357) 58(442)Euro score 227plusmn2 18plusmn19ΜΕΘ μέρες 196plusmn06 198plusmn11Μέρες νοσηλείας 6plusmn218 57plusmn18Νοσηλεία lt5

μέρες

14(50) 37(517)

Μετάγγιση

RBC UNITS

12plusmn09 15plusmn13

CPB min 1124plusmn37 933plusmn33Μηχανικός

αερισμός (ώρες)

86plusmn45 104plusmn13

ΜΙΝΙ Στερνοτομές 2018Μεμονωμένη αντικατάσταση αορτικής βαλβίδας 2018

Σύνολο 159- ΜΙΝΙ 28 (176)

Χαρακτηριστικά ασθενών Επιπλοκές

ΜΙΝΙ

ν=28

ΥΠΟΛΟΙΠΟΙ

ν=131

P value

LCOS(n) 1 (36) 3(23) 069

Επαναδιάνοιξη(n) 0 4(31) 035

Λοιμώξεις

στερνοτομής(n)

1 (36) 3(23) 069

Stroke 0 2(15) 051

NIV 1 (36) 6(46) 081

Επαναδιασωλήνωση 0 3(23) 042

AKI(n) 3(107) 12(92) 079

Κολπική μαρμαρυγή 7(25) 40(305) 056

Θάνατος 0 3(23) 042

Minimally Invasive Approaches to Surgical Aortic Valve Replacement

A Meta-Analysis

Carolyn Chang BS Sajjad Raza MD Salah E Altarabsheh MD Sarah Delozier PhD Umesh M Sharma MD MBA Aisha Zia MD Muhammad Shahzeb Khan MD Mandy Neudecker MS Alan H Markowitz MD Joseph F Sabik III MD and Salil V Deo MD

Cleveland Ohio

(Ann Thorac Surg 20181061881ndash9)

Minimally Invasive Approaches to Surgical Aortic Valve ReplacementA Meta-Analysis

The outcomes of the 2 minimally invasive aortic valve replacement (AVR) strategiesmdashmini-sternotomy (AVR-st) and right anterior thoracotomy (AVR-th) with each other and with conventional AVR (cAVR)

Searched Medline PubMed Embase and Web of Science in December 2017 for studies comparing AVR-st AVR-th and cAVR Endpoints studied included hospital mortality stroke atrial fibrillation cardiopulmonary bypass (CPB) time and length of stay

A total of 19 studies (gt10000 pooled patients) met the inclusion criteria

bull Mortality (p [ 006) and stroke (p [ 015) were comparable between minimally invasive and conventional AVR

bull CPB times were longer with AVR-th versus cAVR (124 minutes [range 5 to 19] p lt 001) In the AVR-th cohort CPB duration was weakly inversely related to study size (p [ 006)

bull Atrial fibrillation was much less after AVR-th (odds ratio 047 [035 to 063] p lt 0001)

bull Hospital stay was significantly lower after minimally invasive surgery (08 [04 to 13] days p lt 001

Minimally invasive approaches to AVR yield excellent outcomes in high-volume centers They reduce hospital stay and incidence of postoperative atrial fibrillation and therefore should be considered in patients undergoing AVR The operative approach should be selected according to surgeonrsquos technical expertise and what is best for specific patient profile

(Ann Thorac Surg 20181061881ndash9)

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

Elisa Mikus MD Simone Calvi MD Gianluca Campo MD Rita Pavasini MD Marco Paris MD Eliana Raviola MD Marco Panzavolta MD Alberto Tripodi MD Roberto Ferrari MD PhD and Mauro Del Giglio MD PhD

Cardiothoracic and Vascular Department Maria Cecilia Hospital GVM Care amp Research Cotignola (RA) Cardiovascular Institute Azienda Ospedaliero-Universitaria di Ferrara Cona (FE) and Cardiovascular Department Istituto Clinico San Rocco Ome (BS) Italy

(Ann Thorac Surg 20181061782ndash8)

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

bull The study included all 1907 consecutive patients hospitalized at the Maria Cecilia Hospital (Cotignola RA Italy) between January 2010 and March 2017 undergoing isolated AVR through PUH RAT or MS The choice of the approach was left to surgeonrsquos preference To adjust for differences in baseline characteristics between the study groups a propensity score matching was performed Linear and logistic regression analyses were performed

bull Results Partial upper hemisternotomy was performed in 820 patients (43) right anterior minithoracotomy in 488 (26) and median sternotomy in 599 (31) After propensity score matching three groups of 377 patients were obtained Cardiopulmonary bypass and crossclamptimes were shorter in the right anterior minithoracotomy group than in the median sternotomy and partial upper hemisternotomy groups (p lt 0001) No significant differences in in-hospital mortality were observed (p [ 09) Renal failure (odds ratio 54 95 confidence interval 23 to 114 p lt 00001) extracardiac arteriopathy (odds ratio 29 95 confidence interval 11 to 67 p [ 0017) and left ventricular ejection fraction (odds ratio 096 95 confidence interval 093 to 099 p [ 0009) emerged as independent predictors of in hospital mortality

bull Conclusions Minimal-access isolated aortic valve surgery is a reproducible safe and effective procedure with similar outcomes and operating times compared with conventional sternotomy

Ann Thorac Surg 20181061782ndash8

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement

Sukumaran K Nair FRCS(CTh) et al

bull From the a Department of Cardiothoracic Surgery PapworthHospital Cambridge United Kingdom Freeman Hospital Newcastle upon Tyne United Kingdom Leeds Institute of Clinical Trials Research University of Leeds Leeds United Kingdom Health Economics Research Group Brunel University London London United Kingdom and London School of Hygiene and Tropical Medicine Keppel Street London United Kingdom

J Thorac Cardiovasc Surg 20181562124-32

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacement

bull Methods This RCT compared MS with FS for first-time isolated AVR in 2 United Kingdom National Health Service hospitals Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR analyzed in the intent-to-treat population

bull Results In this RCT 222 patients were recruited and randomized (n frac14 118 in the MS group n frac14 104 in the FS group) Compared with the FS group the MS group had a longer hospital length of stay (mean 95 days vs 86 days) and took longer to achieve fitness for discharge home (mean 85 days vs 75 days) Adjusting for valve type sex and surgeon hazard ratios (HRs) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR 0874 95 confidence interval [CI] 0668-1143 P frac14 3246) or time to fitness for discharge (HR 0907 95 CI 0688-1197 P value frac14 4914) During a mean follow-up of 760 days (745 days for the MS group and 777 days for the FS group) 12 patients (10) in the MS group and 7 patients (7) in the FS group died (HR 1871 95 CI 0723-4844 P frac14 1966) Average extra cost for MS was pound1714 during the first 12 months

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacementCentral Message

In the United Kingdomrsquos National Health Service compared with a conventional median sternotomy approach for surgical aortic valve replacement mini-sternotomy did not hasten recovery or hospital discharge and was not cost-effective

Measuring What Matters

Having lived through the growth of percutaneous coronary intervention and now seeing the expansion of transcatheter aortic valve replacement I find myself asking the somewhat existential question ldquoAre we measuring what matters to patientsrdquo

Thoralf M Sundt MD Division of Cardiac Surgery

Massachusetts General Hospital Boston Massachusetts

Ann Thorac Surg 20181061602

Measuring What Matters

In a study performed at Dartmouth-Hitchcock

elderly patients prioritized ability to pursue activities maintaining independence and reducing symptoms

over

mortality benefit

Coleywright M et al Patients defined goals for the treatment of sever AVS a qualitative analysis

Health Expect 2016 191036-43

Measuring What Matters

These sorts of ldquosoftrdquo outcome variables are challenging to us We think of ourselvesmdashat least I domdashas medical scientists interested in ldquohardrdquo endpoints

But our patients are challenging us to consider what they value most not what we can measure easily Irsquod say it is time for us to broaden our horizons and revisit how we can better measure what matters

Ann Thorac Surg 20181061602

Page 4: MINI-STERNOTOMY FOR AVR · HISTORY I •A right parasternal incision is made, extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal

HISTORY I

From January to April 1996 this approach was em- ployed in 25 patients with isolated aortic valve disease Repairs of the aortic valve were carried out in 6 patients Nineteen patients had valve replacement 10 Carpentier- Edwards pericardial valves 8 aortic homografts and 1 St Jude valve There were no deaths reoperations for bleeding strokes or wound infections

History II

bull Minimally invasive cardiac valve surgery improves patient satisfaction while reducing costs of cardiac valve replacement and repair

bull L H Cohn D H Adams G S Couper D P Bichell D M Rosborough S P Sears and S F Aranki

bull From the Division of Cardiac Surgery Brigham and Womens Hospital Department of Surgery Harvard Medical School Boston Massachusetts

bull Ann Surg 1997 Oct 226(4) 421ndash428

History II

History II

bull Of the 84 patients there were 2 operative mortalities both in class IV aortic patients from multisystem organ failure There was no operative mortality in the patients undergoing mitral valve replacement or repair The operations were carried out with the same accuracy and attention to detail as with the conventional operation There was minimal postoperative bleeding cerebral vascular accidents or other major morbidity Groin cannulation complications primarily were related to atherosclerotic femoral arteries

Minimally Invasive and Conventional Aortic Valve ReplacementA Propensity Score Analysis

Department of Adult Cardiac Surgery Daniyar Gilmanov G Pasquinucci Heart Hospital Massa Italy

Methods

bull This is a retrospective observational cohort study of prospectively collected data on 709 patients undergoing isolated primary aortic valve replacement between 2004 and 2011 Of these 338

were performed through either right anterior minithoracotomy or upper ministernotomy With propensity score matching 182 patients (minimally invasive group) were compared with 182

patients in conventional sternotomy (control group)

Conclusions

bull Our experience shows that mini-access isolated aortic valve surgery is a reproducible safe and effective procedure and reduces assisted ventilation duration the need for blood product

transfusion and incidence of post-surgery atrial fibrillation

(Ann Thorac Surg 201396837ndash43)

Introduction

bull The approaches taken under the umbrella of minimally-invasive surgical aortic valve replacement (MICS SAVR) essentially consist of a variety of access options to the aortic valve using smaller incisions

bull Importantly there is no convention or consensus as to what size incision qualifies as a minimally-invasive procedure

bull Furthermore lsquominimally-invasiversquo cardiac surgery (MICS) arguably is somewhat of a misnomer certainly in comparison interventions such as TAVR because the most invasive portions of the surgery including cross-clamping of the aorta ischemic cardiac arrest the use of cardiopulmonary bypass and opening of the aorta with introduction of air into the heart chambers all remain the same

Mahesh K Ramchandani MDAnnals of Thoracic Surgery ( in press)

ΜΙΝΙ

ν=28

ΥΠΟΛΟΙΠΟΙ

ν=131Ηλικία 722plusmn84 704plusmn98Γυναίκες(n) 10 (357) 58(442)Euro score 227plusmn2 18plusmn19ΜΕΘ μέρες 196plusmn06 198plusmn11Μέρες νοσηλείας 6plusmn218 57plusmn18Νοσηλεία lt5

μέρες

14(50) 37(517)

Μετάγγιση

RBC UNITS

12plusmn09 15plusmn13

CPB min 1124plusmn37 933plusmn33Μηχανικός

αερισμός (ώρες)

86plusmn45 104plusmn13

ΜΙΝΙ Στερνοτομές 2018Μεμονωμένη αντικατάσταση αορτικής βαλβίδας 2018

Σύνολο 159- ΜΙΝΙ 28 (176)

Χαρακτηριστικά ασθενών Επιπλοκές

ΜΙΝΙ

ν=28

ΥΠΟΛΟΙΠΟΙ

ν=131

P value

LCOS(n) 1 (36) 3(23) 069

Επαναδιάνοιξη(n) 0 4(31) 035

Λοιμώξεις

στερνοτομής(n)

1 (36) 3(23) 069

Stroke 0 2(15) 051

NIV 1 (36) 6(46) 081

Επαναδιασωλήνωση 0 3(23) 042

AKI(n) 3(107) 12(92) 079

Κολπική μαρμαρυγή 7(25) 40(305) 056

Θάνατος 0 3(23) 042

Minimally Invasive Approaches to Surgical Aortic Valve Replacement

A Meta-Analysis

Carolyn Chang BS Sajjad Raza MD Salah E Altarabsheh MD Sarah Delozier PhD Umesh M Sharma MD MBA Aisha Zia MD Muhammad Shahzeb Khan MD Mandy Neudecker MS Alan H Markowitz MD Joseph F Sabik III MD and Salil V Deo MD

Cleveland Ohio

(Ann Thorac Surg 20181061881ndash9)

Minimally Invasive Approaches to Surgical Aortic Valve ReplacementA Meta-Analysis

The outcomes of the 2 minimally invasive aortic valve replacement (AVR) strategiesmdashmini-sternotomy (AVR-st) and right anterior thoracotomy (AVR-th) with each other and with conventional AVR (cAVR)

Searched Medline PubMed Embase and Web of Science in December 2017 for studies comparing AVR-st AVR-th and cAVR Endpoints studied included hospital mortality stroke atrial fibrillation cardiopulmonary bypass (CPB) time and length of stay

A total of 19 studies (gt10000 pooled patients) met the inclusion criteria

bull Mortality (p [ 006) and stroke (p [ 015) were comparable between minimally invasive and conventional AVR

bull CPB times were longer with AVR-th versus cAVR (124 minutes [range 5 to 19] p lt 001) In the AVR-th cohort CPB duration was weakly inversely related to study size (p [ 006)

bull Atrial fibrillation was much less after AVR-th (odds ratio 047 [035 to 063] p lt 0001)

bull Hospital stay was significantly lower after minimally invasive surgery (08 [04 to 13] days p lt 001

Minimally invasive approaches to AVR yield excellent outcomes in high-volume centers They reduce hospital stay and incidence of postoperative atrial fibrillation and therefore should be considered in patients undergoing AVR The operative approach should be selected according to surgeonrsquos technical expertise and what is best for specific patient profile

(Ann Thorac Surg 20181061881ndash9)

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

Elisa Mikus MD Simone Calvi MD Gianluca Campo MD Rita Pavasini MD Marco Paris MD Eliana Raviola MD Marco Panzavolta MD Alberto Tripodi MD Roberto Ferrari MD PhD and Mauro Del Giglio MD PhD

Cardiothoracic and Vascular Department Maria Cecilia Hospital GVM Care amp Research Cotignola (RA) Cardiovascular Institute Azienda Ospedaliero-Universitaria di Ferrara Cona (FE) and Cardiovascular Department Istituto Clinico San Rocco Ome (BS) Italy

(Ann Thorac Surg 20181061782ndash8)

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

bull The study included all 1907 consecutive patients hospitalized at the Maria Cecilia Hospital (Cotignola RA Italy) between January 2010 and March 2017 undergoing isolated AVR through PUH RAT or MS The choice of the approach was left to surgeonrsquos preference To adjust for differences in baseline characteristics between the study groups a propensity score matching was performed Linear and logistic regression analyses were performed

bull Results Partial upper hemisternotomy was performed in 820 patients (43) right anterior minithoracotomy in 488 (26) and median sternotomy in 599 (31) After propensity score matching three groups of 377 patients were obtained Cardiopulmonary bypass and crossclamptimes were shorter in the right anterior minithoracotomy group than in the median sternotomy and partial upper hemisternotomy groups (p lt 0001) No significant differences in in-hospital mortality were observed (p [ 09) Renal failure (odds ratio 54 95 confidence interval 23 to 114 p lt 00001) extracardiac arteriopathy (odds ratio 29 95 confidence interval 11 to 67 p [ 0017) and left ventricular ejection fraction (odds ratio 096 95 confidence interval 093 to 099 p [ 0009) emerged as independent predictors of in hospital mortality

bull Conclusions Minimal-access isolated aortic valve surgery is a reproducible safe and effective procedure with similar outcomes and operating times compared with conventional sternotomy

Ann Thorac Surg 20181061782ndash8

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement

Sukumaran K Nair FRCS(CTh) et al

bull From the a Department of Cardiothoracic Surgery PapworthHospital Cambridge United Kingdom Freeman Hospital Newcastle upon Tyne United Kingdom Leeds Institute of Clinical Trials Research University of Leeds Leeds United Kingdom Health Economics Research Group Brunel University London London United Kingdom and London School of Hygiene and Tropical Medicine Keppel Street London United Kingdom

J Thorac Cardiovasc Surg 20181562124-32

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacement

bull Methods This RCT compared MS with FS for first-time isolated AVR in 2 United Kingdom National Health Service hospitals Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR analyzed in the intent-to-treat population

bull Results In this RCT 222 patients were recruited and randomized (n frac14 118 in the MS group n frac14 104 in the FS group) Compared with the FS group the MS group had a longer hospital length of stay (mean 95 days vs 86 days) and took longer to achieve fitness for discharge home (mean 85 days vs 75 days) Adjusting for valve type sex and surgeon hazard ratios (HRs) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR 0874 95 confidence interval [CI] 0668-1143 P frac14 3246) or time to fitness for discharge (HR 0907 95 CI 0688-1197 P value frac14 4914) During a mean follow-up of 760 days (745 days for the MS group and 777 days for the FS group) 12 patients (10) in the MS group and 7 patients (7) in the FS group died (HR 1871 95 CI 0723-4844 P frac14 1966) Average extra cost for MS was pound1714 during the first 12 months

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacementCentral Message

In the United Kingdomrsquos National Health Service compared with a conventional median sternotomy approach for surgical aortic valve replacement mini-sternotomy did not hasten recovery or hospital discharge and was not cost-effective

Measuring What Matters

Having lived through the growth of percutaneous coronary intervention and now seeing the expansion of transcatheter aortic valve replacement I find myself asking the somewhat existential question ldquoAre we measuring what matters to patientsrdquo

Thoralf M Sundt MD Division of Cardiac Surgery

Massachusetts General Hospital Boston Massachusetts

Ann Thorac Surg 20181061602

Measuring What Matters

In a study performed at Dartmouth-Hitchcock

elderly patients prioritized ability to pursue activities maintaining independence and reducing symptoms

over

mortality benefit

Coleywright M et al Patients defined goals for the treatment of sever AVS a qualitative analysis

Health Expect 2016 191036-43

Measuring What Matters

These sorts of ldquosoftrdquo outcome variables are challenging to us We think of ourselvesmdashat least I domdashas medical scientists interested in ldquohardrdquo endpoints

But our patients are challenging us to consider what they value most not what we can measure easily Irsquod say it is time for us to broaden our horizons and revisit how we can better measure what matters

Ann Thorac Surg 20181061602

Page 5: MINI-STERNOTOMY FOR AVR · HISTORY I •A right parasternal incision is made, extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal

History II

bull Minimally invasive cardiac valve surgery improves patient satisfaction while reducing costs of cardiac valve replacement and repair

bull L H Cohn D H Adams G S Couper D P Bichell D M Rosborough S P Sears and S F Aranki

bull From the Division of Cardiac Surgery Brigham and Womens Hospital Department of Surgery Harvard Medical School Boston Massachusetts

bull Ann Surg 1997 Oct 226(4) 421ndash428

History II

History II

bull Of the 84 patients there were 2 operative mortalities both in class IV aortic patients from multisystem organ failure There was no operative mortality in the patients undergoing mitral valve replacement or repair The operations were carried out with the same accuracy and attention to detail as with the conventional operation There was minimal postoperative bleeding cerebral vascular accidents or other major morbidity Groin cannulation complications primarily were related to atherosclerotic femoral arteries

Minimally Invasive and Conventional Aortic Valve ReplacementA Propensity Score Analysis

Department of Adult Cardiac Surgery Daniyar Gilmanov G Pasquinucci Heart Hospital Massa Italy

Methods

bull This is a retrospective observational cohort study of prospectively collected data on 709 patients undergoing isolated primary aortic valve replacement between 2004 and 2011 Of these 338

were performed through either right anterior minithoracotomy or upper ministernotomy With propensity score matching 182 patients (minimally invasive group) were compared with 182

patients in conventional sternotomy (control group)

Conclusions

bull Our experience shows that mini-access isolated aortic valve surgery is a reproducible safe and effective procedure and reduces assisted ventilation duration the need for blood product

transfusion and incidence of post-surgery atrial fibrillation

(Ann Thorac Surg 201396837ndash43)

Introduction

bull The approaches taken under the umbrella of minimally-invasive surgical aortic valve replacement (MICS SAVR) essentially consist of a variety of access options to the aortic valve using smaller incisions

bull Importantly there is no convention or consensus as to what size incision qualifies as a minimally-invasive procedure

bull Furthermore lsquominimally-invasiversquo cardiac surgery (MICS) arguably is somewhat of a misnomer certainly in comparison interventions such as TAVR because the most invasive portions of the surgery including cross-clamping of the aorta ischemic cardiac arrest the use of cardiopulmonary bypass and opening of the aorta with introduction of air into the heart chambers all remain the same

Mahesh K Ramchandani MDAnnals of Thoracic Surgery ( in press)

ΜΙΝΙ

ν=28

ΥΠΟΛΟΙΠΟΙ

ν=131Ηλικία 722plusmn84 704plusmn98Γυναίκες(n) 10 (357) 58(442)Euro score 227plusmn2 18plusmn19ΜΕΘ μέρες 196plusmn06 198plusmn11Μέρες νοσηλείας 6plusmn218 57plusmn18Νοσηλεία lt5

μέρες

14(50) 37(517)

Μετάγγιση

RBC UNITS

12plusmn09 15plusmn13

CPB min 1124plusmn37 933plusmn33Μηχανικός

αερισμός (ώρες)

86plusmn45 104plusmn13

ΜΙΝΙ Στερνοτομές 2018Μεμονωμένη αντικατάσταση αορτικής βαλβίδας 2018

Σύνολο 159- ΜΙΝΙ 28 (176)

Χαρακτηριστικά ασθενών Επιπλοκές

ΜΙΝΙ

ν=28

ΥΠΟΛΟΙΠΟΙ

ν=131

P value

LCOS(n) 1 (36) 3(23) 069

Επαναδιάνοιξη(n) 0 4(31) 035

Λοιμώξεις

στερνοτομής(n)

1 (36) 3(23) 069

Stroke 0 2(15) 051

NIV 1 (36) 6(46) 081

Επαναδιασωλήνωση 0 3(23) 042

AKI(n) 3(107) 12(92) 079

Κολπική μαρμαρυγή 7(25) 40(305) 056

Θάνατος 0 3(23) 042

Minimally Invasive Approaches to Surgical Aortic Valve Replacement

A Meta-Analysis

Carolyn Chang BS Sajjad Raza MD Salah E Altarabsheh MD Sarah Delozier PhD Umesh M Sharma MD MBA Aisha Zia MD Muhammad Shahzeb Khan MD Mandy Neudecker MS Alan H Markowitz MD Joseph F Sabik III MD and Salil V Deo MD

Cleveland Ohio

(Ann Thorac Surg 20181061881ndash9)

Minimally Invasive Approaches to Surgical Aortic Valve ReplacementA Meta-Analysis

The outcomes of the 2 minimally invasive aortic valve replacement (AVR) strategiesmdashmini-sternotomy (AVR-st) and right anterior thoracotomy (AVR-th) with each other and with conventional AVR (cAVR)

Searched Medline PubMed Embase and Web of Science in December 2017 for studies comparing AVR-st AVR-th and cAVR Endpoints studied included hospital mortality stroke atrial fibrillation cardiopulmonary bypass (CPB) time and length of stay

A total of 19 studies (gt10000 pooled patients) met the inclusion criteria

bull Mortality (p [ 006) and stroke (p [ 015) were comparable between minimally invasive and conventional AVR

bull CPB times were longer with AVR-th versus cAVR (124 minutes [range 5 to 19] p lt 001) In the AVR-th cohort CPB duration was weakly inversely related to study size (p [ 006)

bull Atrial fibrillation was much less after AVR-th (odds ratio 047 [035 to 063] p lt 0001)

bull Hospital stay was significantly lower after minimally invasive surgery (08 [04 to 13] days p lt 001

Minimally invasive approaches to AVR yield excellent outcomes in high-volume centers They reduce hospital stay and incidence of postoperative atrial fibrillation and therefore should be considered in patients undergoing AVR The operative approach should be selected according to surgeonrsquos technical expertise and what is best for specific patient profile

(Ann Thorac Surg 20181061881ndash9)

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

Elisa Mikus MD Simone Calvi MD Gianluca Campo MD Rita Pavasini MD Marco Paris MD Eliana Raviola MD Marco Panzavolta MD Alberto Tripodi MD Roberto Ferrari MD PhD and Mauro Del Giglio MD PhD

Cardiothoracic and Vascular Department Maria Cecilia Hospital GVM Care amp Research Cotignola (RA) Cardiovascular Institute Azienda Ospedaliero-Universitaria di Ferrara Cona (FE) and Cardiovascular Department Istituto Clinico San Rocco Ome (BS) Italy

(Ann Thorac Surg 20181061782ndash8)

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

bull The study included all 1907 consecutive patients hospitalized at the Maria Cecilia Hospital (Cotignola RA Italy) between January 2010 and March 2017 undergoing isolated AVR through PUH RAT or MS The choice of the approach was left to surgeonrsquos preference To adjust for differences in baseline characteristics between the study groups a propensity score matching was performed Linear and logistic regression analyses were performed

bull Results Partial upper hemisternotomy was performed in 820 patients (43) right anterior minithoracotomy in 488 (26) and median sternotomy in 599 (31) After propensity score matching three groups of 377 patients were obtained Cardiopulmonary bypass and crossclamptimes were shorter in the right anterior minithoracotomy group than in the median sternotomy and partial upper hemisternotomy groups (p lt 0001) No significant differences in in-hospital mortality were observed (p [ 09) Renal failure (odds ratio 54 95 confidence interval 23 to 114 p lt 00001) extracardiac arteriopathy (odds ratio 29 95 confidence interval 11 to 67 p [ 0017) and left ventricular ejection fraction (odds ratio 096 95 confidence interval 093 to 099 p [ 0009) emerged as independent predictors of in hospital mortality

bull Conclusions Minimal-access isolated aortic valve surgery is a reproducible safe and effective procedure with similar outcomes and operating times compared with conventional sternotomy

Ann Thorac Surg 20181061782ndash8

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement

Sukumaran K Nair FRCS(CTh) et al

bull From the a Department of Cardiothoracic Surgery PapworthHospital Cambridge United Kingdom Freeman Hospital Newcastle upon Tyne United Kingdom Leeds Institute of Clinical Trials Research University of Leeds Leeds United Kingdom Health Economics Research Group Brunel University London London United Kingdom and London School of Hygiene and Tropical Medicine Keppel Street London United Kingdom

J Thorac Cardiovasc Surg 20181562124-32

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacement

bull Methods This RCT compared MS with FS for first-time isolated AVR in 2 United Kingdom National Health Service hospitals Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR analyzed in the intent-to-treat population

bull Results In this RCT 222 patients were recruited and randomized (n frac14 118 in the MS group n frac14 104 in the FS group) Compared with the FS group the MS group had a longer hospital length of stay (mean 95 days vs 86 days) and took longer to achieve fitness for discharge home (mean 85 days vs 75 days) Adjusting for valve type sex and surgeon hazard ratios (HRs) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR 0874 95 confidence interval [CI] 0668-1143 P frac14 3246) or time to fitness for discharge (HR 0907 95 CI 0688-1197 P value frac14 4914) During a mean follow-up of 760 days (745 days for the MS group and 777 days for the FS group) 12 patients (10) in the MS group and 7 patients (7) in the FS group died (HR 1871 95 CI 0723-4844 P frac14 1966) Average extra cost for MS was pound1714 during the first 12 months

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacementCentral Message

In the United Kingdomrsquos National Health Service compared with a conventional median sternotomy approach for surgical aortic valve replacement mini-sternotomy did not hasten recovery or hospital discharge and was not cost-effective

Measuring What Matters

Having lived through the growth of percutaneous coronary intervention and now seeing the expansion of transcatheter aortic valve replacement I find myself asking the somewhat existential question ldquoAre we measuring what matters to patientsrdquo

Thoralf M Sundt MD Division of Cardiac Surgery

Massachusetts General Hospital Boston Massachusetts

Ann Thorac Surg 20181061602

Measuring What Matters

In a study performed at Dartmouth-Hitchcock

elderly patients prioritized ability to pursue activities maintaining independence and reducing symptoms

over

mortality benefit

Coleywright M et al Patients defined goals for the treatment of sever AVS a qualitative analysis

Health Expect 2016 191036-43

Measuring What Matters

These sorts of ldquosoftrdquo outcome variables are challenging to us We think of ourselvesmdashat least I domdashas medical scientists interested in ldquohardrdquo endpoints

But our patients are challenging us to consider what they value most not what we can measure easily Irsquod say it is time for us to broaden our horizons and revisit how we can better measure what matters

Ann Thorac Surg 20181061602

Page 6: MINI-STERNOTOMY FOR AVR · HISTORY I •A right parasternal incision is made, extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal

History II

History II

bull Of the 84 patients there were 2 operative mortalities both in class IV aortic patients from multisystem organ failure There was no operative mortality in the patients undergoing mitral valve replacement or repair The operations were carried out with the same accuracy and attention to detail as with the conventional operation There was minimal postoperative bleeding cerebral vascular accidents or other major morbidity Groin cannulation complications primarily were related to atherosclerotic femoral arteries

Minimally Invasive and Conventional Aortic Valve ReplacementA Propensity Score Analysis

Department of Adult Cardiac Surgery Daniyar Gilmanov G Pasquinucci Heart Hospital Massa Italy

Methods

bull This is a retrospective observational cohort study of prospectively collected data on 709 patients undergoing isolated primary aortic valve replacement between 2004 and 2011 Of these 338

were performed through either right anterior minithoracotomy or upper ministernotomy With propensity score matching 182 patients (minimally invasive group) were compared with 182

patients in conventional sternotomy (control group)

Conclusions

bull Our experience shows that mini-access isolated aortic valve surgery is a reproducible safe and effective procedure and reduces assisted ventilation duration the need for blood product

transfusion and incidence of post-surgery atrial fibrillation

(Ann Thorac Surg 201396837ndash43)

Introduction

bull The approaches taken under the umbrella of minimally-invasive surgical aortic valve replacement (MICS SAVR) essentially consist of a variety of access options to the aortic valve using smaller incisions

bull Importantly there is no convention or consensus as to what size incision qualifies as a minimally-invasive procedure

bull Furthermore lsquominimally-invasiversquo cardiac surgery (MICS) arguably is somewhat of a misnomer certainly in comparison interventions such as TAVR because the most invasive portions of the surgery including cross-clamping of the aorta ischemic cardiac arrest the use of cardiopulmonary bypass and opening of the aorta with introduction of air into the heart chambers all remain the same

Mahesh K Ramchandani MDAnnals of Thoracic Surgery ( in press)

ΜΙΝΙ

ν=28

ΥΠΟΛΟΙΠΟΙ

ν=131Ηλικία 722plusmn84 704plusmn98Γυναίκες(n) 10 (357) 58(442)Euro score 227plusmn2 18plusmn19ΜΕΘ μέρες 196plusmn06 198plusmn11Μέρες νοσηλείας 6plusmn218 57plusmn18Νοσηλεία lt5

μέρες

14(50) 37(517)

Μετάγγιση

RBC UNITS

12plusmn09 15plusmn13

CPB min 1124plusmn37 933plusmn33Μηχανικός

αερισμός (ώρες)

86plusmn45 104plusmn13

ΜΙΝΙ Στερνοτομές 2018Μεμονωμένη αντικατάσταση αορτικής βαλβίδας 2018

Σύνολο 159- ΜΙΝΙ 28 (176)

Χαρακτηριστικά ασθενών Επιπλοκές

ΜΙΝΙ

ν=28

ΥΠΟΛΟΙΠΟΙ

ν=131

P value

LCOS(n) 1 (36) 3(23) 069

Επαναδιάνοιξη(n) 0 4(31) 035

Λοιμώξεις

στερνοτομής(n)

1 (36) 3(23) 069

Stroke 0 2(15) 051

NIV 1 (36) 6(46) 081

Επαναδιασωλήνωση 0 3(23) 042

AKI(n) 3(107) 12(92) 079

Κολπική μαρμαρυγή 7(25) 40(305) 056

Θάνατος 0 3(23) 042

Minimally Invasive Approaches to Surgical Aortic Valve Replacement

A Meta-Analysis

Carolyn Chang BS Sajjad Raza MD Salah E Altarabsheh MD Sarah Delozier PhD Umesh M Sharma MD MBA Aisha Zia MD Muhammad Shahzeb Khan MD Mandy Neudecker MS Alan H Markowitz MD Joseph F Sabik III MD and Salil V Deo MD

Cleveland Ohio

(Ann Thorac Surg 20181061881ndash9)

Minimally Invasive Approaches to Surgical Aortic Valve ReplacementA Meta-Analysis

The outcomes of the 2 minimally invasive aortic valve replacement (AVR) strategiesmdashmini-sternotomy (AVR-st) and right anterior thoracotomy (AVR-th) with each other and with conventional AVR (cAVR)

Searched Medline PubMed Embase and Web of Science in December 2017 for studies comparing AVR-st AVR-th and cAVR Endpoints studied included hospital mortality stroke atrial fibrillation cardiopulmonary bypass (CPB) time and length of stay

A total of 19 studies (gt10000 pooled patients) met the inclusion criteria

bull Mortality (p [ 006) and stroke (p [ 015) were comparable between minimally invasive and conventional AVR

bull CPB times were longer with AVR-th versus cAVR (124 minutes [range 5 to 19] p lt 001) In the AVR-th cohort CPB duration was weakly inversely related to study size (p [ 006)

bull Atrial fibrillation was much less after AVR-th (odds ratio 047 [035 to 063] p lt 0001)

bull Hospital stay was significantly lower after minimally invasive surgery (08 [04 to 13] days p lt 001

Minimally invasive approaches to AVR yield excellent outcomes in high-volume centers They reduce hospital stay and incidence of postoperative atrial fibrillation and therefore should be considered in patients undergoing AVR The operative approach should be selected according to surgeonrsquos technical expertise and what is best for specific patient profile

(Ann Thorac Surg 20181061881ndash9)

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

Elisa Mikus MD Simone Calvi MD Gianluca Campo MD Rita Pavasini MD Marco Paris MD Eliana Raviola MD Marco Panzavolta MD Alberto Tripodi MD Roberto Ferrari MD PhD and Mauro Del Giglio MD PhD

Cardiothoracic and Vascular Department Maria Cecilia Hospital GVM Care amp Research Cotignola (RA) Cardiovascular Institute Azienda Ospedaliero-Universitaria di Ferrara Cona (FE) and Cardiovascular Department Istituto Clinico San Rocco Ome (BS) Italy

(Ann Thorac Surg 20181061782ndash8)

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

bull The study included all 1907 consecutive patients hospitalized at the Maria Cecilia Hospital (Cotignola RA Italy) between January 2010 and March 2017 undergoing isolated AVR through PUH RAT or MS The choice of the approach was left to surgeonrsquos preference To adjust for differences in baseline characteristics between the study groups a propensity score matching was performed Linear and logistic regression analyses were performed

bull Results Partial upper hemisternotomy was performed in 820 patients (43) right anterior minithoracotomy in 488 (26) and median sternotomy in 599 (31) After propensity score matching three groups of 377 patients were obtained Cardiopulmonary bypass and crossclamptimes were shorter in the right anterior minithoracotomy group than in the median sternotomy and partial upper hemisternotomy groups (p lt 0001) No significant differences in in-hospital mortality were observed (p [ 09) Renal failure (odds ratio 54 95 confidence interval 23 to 114 p lt 00001) extracardiac arteriopathy (odds ratio 29 95 confidence interval 11 to 67 p [ 0017) and left ventricular ejection fraction (odds ratio 096 95 confidence interval 093 to 099 p [ 0009) emerged as independent predictors of in hospital mortality

bull Conclusions Minimal-access isolated aortic valve surgery is a reproducible safe and effective procedure with similar outcomes and operating times compared with conventional sternotomy

Ann Thorac Surg 20181061782ndash8

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement

Sukumaran K Nair FRCS(CTh) et al

bull From the a Department of Cardiothoracic Surgery PapworthHospital Cambridge United Kingdom Freeman Hospital Newcastle upon Tyne United Kingdom Leeds Institute of Clinical Trials Research University of Leeds Leeds United Kingdom Health Economics Research Group Brunel University London London United Kingdom and London School of Hygiene and Tropical Medicine Keppel Street London United Kingdom

J Thorac Cardiovasc Surg 20181562124-32

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacement

bull Methods This RCT compared MS with FS for first-time isolated AVR in 2 United Kingdom National Health Service hospitals Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR analyzed in the intent-to-treat population

bull Results In this RCT 222 patients were recruited and randomized (n frac14 118 in the MS group n frac14 104 in the FS group) Compared with the FS group the MS group had a longer hospital length of stay (mean 95 days vs 86 days) and took longer to achieve fitness for discharge home (mean 85 days vs 75 days) Adjusting for valve type sex and surgeon hazard ratios (HRs) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR 0874 95 confidence interval [CI] 0668-1143 P frac14 3246) or time to fitness for discharge (HR 0907 95 CI 0688-1197 P value frac14 4914) During a mean follow-up of 760 days (745 days for the MS group and 777 days for the FS group) 12 patients (10) in the MS group and 7 patients (7) in the FS group died (HR 1871 95 CI 0723-4844 P frac14 1966) Average extra cost for MS was pound1714 during the first 12 months

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacementCentral Message

In the United Kingdomrsquos National Health Service compared with a conventional median sternotomy approach for surgical aortic valve replacement mini-sternotomy did not hasten recovery or hospital discharge and was not cost-effective

Measuring What Matters

Having lived through the growth of percutaneous coronary intervention and now seeing the expansion of transcatheter aortic valve replacement I find myself asking the somewhat existential question ldquoAre we measuring what matters to patientsrdquo

Thoralf M Sundt MD Division of Cardiac Surgery

Massachusetts General Hospital Boston Massachusetts

Ann Thorac Surg 20181061602

Measuring What Matters

In a study performed at Dartmouth-Hitchcock

elderly patients prioritized ability to pursue activities maintaining independence and reducing symptoms

over

mortality benefit

Coleywright M et al Patients defined goals for the treatment of sever AVS a qualitative analysis

Health Expect 2016 191036-43

Measuring What Matters

These sorts of ldquosoftrdquo outcome variables are challenging to us We think of ourselvesmdashat least I domdashas medical scientists interested in ldquohardrdquo endpoints

But our patients are challenging us to consider what they value most not what we can measure easily Irsquod say it is time for us to broaden our horizons and revisit how we can better measure what matters

Ann Thorac Surg 20181061602

Page 7: MINI-STERNOTOMY FOR AVR · HISTORY I •A right parasternal incision is made, extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal

History II

bull Of the 84 patients there were 2 operative mortalities both in class IV aortic patients from multisystem organ failure There was no operative mortality in the patients undergoing mitral valve replacement or repair The operations were carried out with the same accuracy and attention to detail as with the conventional operation There was minimal postoperative bleeding cerebral vascular accidents or other major morbidity Groin cannulation complications primarily were related to atherosclerotic femoral arteries

Minimally Invasive and Conventional Aortic Valve ReplacementA Propensity Score Analysis

Department of Adult Cardiac Surgery Daniyar Gilmanov G Pasquinucci Heart Hospital Massa Italy

Methods

bull This is a retrospective observational cohort study of prospectively collected data on 709 patients undergoing isolated primary aortic valve replacement between 2004 and 2011 Of these 338

were performed through either right anterior minithoracotomy or upper ministernotomy With propensity score matching 182 patients (minimally invasive group) were compared with 182

patients in conventional sternotomy (control group)

Conclusions

bull Our experience shows that mini-access isolated aortic valve surgery is a reproducible safe and effective procedure and reduces assisted ventilation duration the need for blood product

transfusion and incidence of post-surgery atrial fibrillation

(Ann Thorac Surg 201396837ndash43)

Introduction

bull The approaches taken under the umbrella of minimally-invasive surgical aortic valve replacement (MICS SAVR) essentially consist of a variety of access options to the aortic valve using smaller incisions

bull Importantly there is no convention or consensus as to what size incision qualifies as a minimally-invasive procedure

bull Furthermore lsquominimally-invasiversquo cardiac surgery (MICS) arguably is somewhat of a misnomer certainly in comparison interventions such as TAVR because the most invasive portions of the surgery including cross-clamping of the aorta ischemic cardiac arrest the use of cardiopulmonary bypass and opening of the aorta with introduction of air into the heart chambers all remain the same

Mahesh K Ramchandani MDAnnals of Thoracic Surgery ( in press)

ΜΙΝΙ

ν=28

ΥΠΟΛΟΙΠΟΙ

ν=131Ηλικία 722plusmn84 704plusmn98Γυναίκες(n) 10 (357) 58(442)Euro score 227plusmn2 18plusmn19ΜΕΘ μέρες 196plusmn06 198plusmn11Μέρες νοσηλείας 6plusmn218 57plusmn18Νοσηλεία lt5

μέρες

14(50) 37(517)

Μετάγγιση

RBC UNITS

12plusmn09 15plusmn13

CPB min 1124plusmn37 933plusmn33Μηχανικός

αερισμός (ώρες)

86plusmn45 104plusmn13

ΜΙΝΙ Στερνοτομές 2018Μεμονωμένη αντικατάσταση αορτικής βαλβίδας 2018

Σύνολο 159- ΜΙΝΙ 28 (176)

Χαρακτηριστικά ασθενών Επιπλοκές

ΜΙΝΙ

ν=28

ΥΠΟΛΟΙΠΟΙ

ν=131

P value

LCOS(n) 1 (36) 3(23) 069

Επαναδιάνοιξη(n) 0 4(31) 035

Λοιμώξεις

στερνοτομής(n)

1 (36) 3(23) 069

Stroke 0 2(15) 051

NIV 1 (36) 6(46) 081

Επαναδιασωλήνωση 0 3(23) 042

AKI(n) 3(107) 12(92) 079

Κολπική μαρμαρυγή 7(25) 40(305) 056

Θάνατος 0 3(23) 042

Minimally Invasive Approaches to Surgical Aortic Valve Replacement

A Meta-Analysis

Carolyn Chang BS Sajjad Raza MD Salah E Altarabsheh MD Sarah Delozier PhD Umesh M Sharma MD MBA Aisha Zia MD Muhammad Shahzeb Khan MD Mandy Neudecker MS Alan H Markowitz MD Joseph F Sabik III MD and Salil V Deo MD

Cleveland Ohio

(Ann Thorac Surg 20181061881ndash9)

Minimally Invasive Approaches to Surgical Aortic Valve ReplacementA Meta-Analysis

The outcomes of the 2 minimally invasive aortic valve replacement (AVR) strategiesmdashmini-sternotomy (AVR-st) and right anterior thoracotomy (AVR-th) with each other and with conventional AVR (cAVR)

Searched Medline PubMed Embase and Web of Science in December 2017 for studies comparing AVR-st AVR-th and cAVR Endpoints studied included hospital mortality stroke atrial fibrillation cardiopulmonary bypass (CPB) time and length of stay

A total of 19 studies (gt10000 pooled patients) met the inclusion criteria

bull Mortality (p [ 006) and stroke (p [ 015) were comparable between minimally invasive and conventional AVR

bull CPB times were longer with AVR-th versus cAVR (124 minutes [range 5 to 19] p lt 001) In the AVR-th cohort CPB duration was weakly inversely related to study size (p [ 006)

bull Atrial fibrillation was much less after AVR-th (odds ratio 047 [035 to 063] p lt 0001)

bull Hospital stay was significantly lower after minimally invasive surgery (08 [04 to 13] days p lt 001

Minimally invasive approaches to AVR yield excellent outcomes in high-volume centers They reduce hospital stay and incidence of postoperative atrial fibrillation and therefore should be considered in patients undergoing AVR The operative approach should be selected according to surgeonrsquos technical expertise and what is best for specific patient profile

(Ann Thorac Surg 20181061881ndash9)

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

Elisa Mikus MD Simone Calvi MD Gianluca Campo MD Rita Pavasini MD Marco Paris MD Eliana Raviola MD Marco Panzavolta MD Alberto Tripodi MD Roberto Ferrari MD PhD and Mauro Del Giglio MD PhD

Cardiothoracic and Vascular Department Maria Cecilia Hospital GVM Care amp Research Cotignola (RA) Cardiovascular Institute Azienda Ospedaliero-Universitaria di Ferrara Cona (FE) and Cardiovascular Department Istituto Clinico San Rocco Ome (BS) Italy

(Ann Thorac Surg 20181061782ndash8)

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

bull The study included all 1907 consecutive patients hospitalized at the Maria Cecilia Hospital (Cotignola RA Italy) between January 2010 and March 2017 undergoing isolated AVR through PUH RAT or MS The choice of the approach was left to surgeonrsquos preference To adjust for differences in baseline characteristics between the study groups a propensity score matching was performed Linear and logistic regression analyses were performed

bull Results Partial upper hemisternotomy was performed in 820 patients (43) right anterior minithoracotomy in 488 (26) and median sternotomy in 599 (31) After propensity score matching three groups of 377 patients were obtained Cardiopulmonary bypass and crossclamptimes were shorter in the right anterior minithoracotomy group than in the median sternotomy and partial upper hemisternotomy groups (p lt 0001) No significant differences in in-hospital mortality were observed (p [ 09) Renal failure (odds ratio 54 95 confidence interval 23 to 114 p lt 00001) extracardiac arteriopathy (odds ratio 29 95 confidence interval 11 to 67 p [ 0017) and left ventricular ejection fraction (odds ratio 096 95 confidence interval 093 to 099 p [ 0009) emerged as independent predictors of in hospital mortality

bull Conclusions Minimal-access isolated aortic valve surgery is a reproducible safe and effective procedure with similar outcomes and operating times compared with conventional sternotomy

Ann Thorac Surg 20181061782ndash8

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement

Sukumaran K Nair FRCS(CTh) et al

bull From the a Department of Cardiothoracic Surgery PapworthHospital Cambridge United Kingdom Freeman Hospital Newcastle upon Tyne United Kingdom Leeds Institute of Clinical Trials Research University of Leeds Leeds United Kingdom Health Economics Research Group Brunel University London London United Kingdom and London School of Hygiene and Tropical Medicine Keppel Street London United Kingdom

J Thorac Cardiovasc Surg 20181562124-32

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacement

bull Methods This RCT compared MS with FS for first-time isolated AVR in 2 United Kingdom National Health Service hospitals Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR analyzed in the intent-to-treat population

bull Results In this RCT 222 patients were recruited and randomized (n frac14 118 in the MS group n frac14 104 in the FS group) Compared with the FS group the MS group had a longer hospital length of stay (mean 95 days vs 86 days) and took longer to achieve fitness for discharge home (mean 85 days vs 75 days) Adjusting for valve type sex and surgeon hazard ratios (HRs) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR 0874 95 confidence interval [CI] 0668-1143 P frac14 3246) or time to fitness for discharge (HR 0907 95 CI 0688-1197 P value frac14 4914) During a mean follow-up of 760 days (745 days for the MS group and 777 days for the FS group) 12 patients (10) in the MS group and 7 patients (7) in the FS group died (HR 1871 95 CI 0723-4844 P frac14 1966) Average extra cost for MS was pound1714 during the first 12 months

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacementCentral Message

In the United Kingdomrsquos National Health Service compared with a conventional median sternotomy approach for surgical aortic valve replacement mini-sternotomy did not hasten recovery or hospital discharge and was not cost-effective

Measuring What Matters

Having lived through the growth of percutaneous coronary intervention and now seeing the expansion of transcatheter aortic valve replacement I find myself asking the somewhat existential question ldquoAre we measuring what matters to patientsrdquo

Thoralf M Sundt MD Division of Cardiac Surgery

Massachusetts General Hospital Boston Massachusetts

Ann Thorac Surg 20181061602

Measuring What Matters

In a study performed at Dartmouth-Hitchcock

elderly patients prioritized ability to pursue activities maintaining independence and reducing symptoms

over

mortality benefit

Coleywright M et al Patients defined goals for the treatment of sever AVS a qualitative analysis

Health Expect 2016 191036-43

Measuring What Matters

These sorts of ldquosoftrdquo outcome variables are challenging to us We think of ourselvesmdashat least I domdashas medical scientists interested in ldquohardrdquo endpoints

But our patients are challenging us to consider what they value most not what we can measure easily Irsquod say it is time for us to broaden our horizons and revisit how we can better measure what matters

Ann Thorac Surg 20181061602

Page 8: MINI-STERNOTOMY FOR AVR · HISTORY I •A right parasternal incision is made, extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal

Minimally Invasive and Conventional Aortic Valve ReplacementA Propensity Score Analysis

Department of Adult Cardiac Surgery Daniyar Gilmanov G Pasquinucci Heart Hospital Massa Italy

Methods

bull This is a retrospective observational cohort study of prospectively collected data on 709 patients undergoing isolated primary aortic valve replacement between 2004 and 2011 Of these 338

were performed through either right anterior minithoracotomy or upper ministernotomy With propensity score matching 182 patients (minimally invasive group) were compared with 182

patients in conventional sternotomy (control group)

Conclusions

bull Our experience shows that mini-access isolated aortic valve surgery is a reproducible safe and effective procedure and reduces assisted ventilation duration the need for blood product

transfusion and incidence of post-surgery atrial fibrillation

(Ann Thorac Surg 201396837ndash43)

Introduction

bull The approaches taken under the umbrella of minimally-invasive surgical aortic valve replacement (MICS SAVR) essentially consist of a variety of access options to the aortic valve using smaller incisions

bull Importantly there is no convention or consensus as to what size incision qualifies as a minimally-invasive procedure

bull Furthermore lsquominimally-invasiversquo cardiac surgery (MICS) arguably is somewhat of a misnomer certainly in comparison interventions such as TAVR because the most invasive portions of the surgery including cross-clamping of the aorta ischemic cardiac arrest the use of cardiopulmonary bypass and opening of the aorta with introduction of air into the heart chambers all remain the same

Mahesh K Ramchandani MDAnnals of Thoracic Surgery ( in press)

ΜΙΝΙ

ν=28

ΥΠΟΛΟΙΠΟΙ

ν=131Ηλικία 722plusmn84 704plusmn98Γυναίκες(n) 10 (357) 58(442)Euro score 227plusmn2 18plusmn19ΜΕΘ μέρες 196plusmn06 198plusmn11Μέρες νοσηλείας 6plusmn218 57plusmn18Νοσηλεία lt5

μέρες

14(50) 37(517)

Μετάγγιση

RBC UNITS

12plusmn09 15plusmn13

CPB min 1124plusmn37 933plusmn33Μηχανικός

αερισμός (ώρες)

86plusmn45 104plusmn13

ΜΙΝΙ Στερνοτομές 2018Μεμονωμένη αντικατάσταση αορτικής βαλβίδας 2018

Σύνολο 159- ΜΙΝΙ 28 (176)

Χαρακτηριστικά ασθενών Επιπλοκές

ΜΙΝΙ

ν=28

ΥΠΟΛΟΙΠΟΙ

ν=131

P value

LCOS(n) 1 (36) 3(23) 069

Επαναδιάνοιξη(n) 0 4(31) 035

Λοιμώξεις

στερνοτομής(n)

1 (36) 3(23) 069

Stroke 0 2(15) 051

NIV 1 (36) 6(46) 081

Επαναδιασωλήνωση 0 3(23) 042

AKI(n) 3(107) 12(92) 079

Κολπική μαρμαρυγή 7(25) 40(305) 056

Θάνατος 0 3(23) 042

Minimally Invasive Approaches to Surgical Aortic Valve Replacement

A Meta-Analysis

Carolyn Chang BS Sajjad Raza MD Salah E Altarabsheh MD Sarah Delozier PhD Umesh M Sharma MD MBA Aisha Zia MD Muhammad Shahzeb Khan MD Mandy Neudecker MS Alan H Markowitz MD Joseph F Sabik III MD and Salil V Deo MD

Cleveland Ohio

(Ann Thorac Surg 20181061881ndash9)

Minimally Invasive Approaches to Surgical Aortic Valve ReplacementA Meta-Analysis

The outcomes of the 2 minimally invasive aortic valve replacement (AVR) strategiesmdashmini-sternotomy (AVR-st) and right anterior thoracotomy (AVR-th) with each other and with conventional AVR (cAVR)

Searched Medline PubMed Embase and Web of Science in December 2017 for studies comparing AVR-st AVR-th and cAVR Endpoints studied included hospital mortality stroke atrial fibrillation cardiopulmonary bypass (CPB) time and length of stay

A total of 19 studies (gt10000 pooled patients) met the inclusion criteria

bull Mortality (p [ 006) and stroke (p [ 015) were comparable between minimally invasive and conventional AVR

bull CPB times were longer with AVR-th versus cAVR (124 minutes [range 5 to 19] p lt 001) In the AVR-th cohort CPB duration was weakly inversely related to study size (p [ 006)

bull Atrial fibrillation was much less after AVR-th (odds ratio 047 [035 to 063] p lt 0001)

bull Hospital stay was significantly lower after minimally invasive surgery (08 [04 to 13] days p lt 001

Minimally invasive approaches to AVR yield excellent outcomes in high-volume centers They reduce hospital stay and incidence of postoperative atrial fibrillation and therefore should be considered in patients undergoing AVR The operative approach should be selected according to surgeonrsquos technical expertise and what is best for specific patient profile

(Ann Thorac Surg 20181061881ndash9)

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

Elisa Mikus MD Simone Calvi MD Gianluca Campo MD Rita Pavasini MD Marco Paris MD Eliana Raviola MD Marco Panzavolta MD Alberto Tripodi MD Roberto Ferrari MD PhD and Mauro Del Giglio MD PhD

Cardiothoracic and Vascular Department Maria Cecilia Hospital GVM Care amp Research Cotignola (RA) Cardiovascular Institute Azienda Ospedaliero-Universitaria di Ferrara Cona (FE) and Cardiovascular Department Istituto Clinico San Rocco Ome (BS) Italy

(Ann Thorac Surg 20181061782ndash8)

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

bull The study included all 1907 consecutive patients hospitalized at the Maria Cecilia Hospital (Cotignola RA Italy) between January 2010 and March 2017 undergoing isolated AVR through PUH RAT or MS The choice of the approach was left to surgeonrsquos preference To adjust for differences in baseline characteristics between the study groups a propensity score matching was performed Linear and logistic regression analyses were performed

bull Results Partial upper hemisternotomy was performed in 820 patients (43) right anterior minithoracotomy in 488 (26) and median sternotomy in 599 (31) After propensity score matching three groups of 377 patients were obtained Cardiopulmonary bypass and crossclamptimes were shorter in the right anterior minithoracotomy group than in the median sternotomy and partial upper hemisternotomy groups (p lt 0001) No significant differences in in-hospital mortality were observed (p [ 09) Renal failure (odds ratio 54 95 confidence interval 23 to 114 p lt 00001) extracardiac arteriopathy (odds ratio 29 95 confidence interval 11 to 67 p [ 0017) and left ventricular ejection fraction (odds ratio 096 95 confidence interval 093 to 099 p [ 0009) emerged as independent predictors of in hospital mortality

bull Conclusions Minimal-access isolated aortic valve surgery is a reproducible safe and effective procedure with similar outcomes and operating times compared with conventional sternotomy

Ann Thorac Surg 20181061782ndash8

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement

Sukumaran K Nair FRCS(CTh) et al

bull From the a Department of Cardiothoracic Surgery PapworthHospital Cambridge United Kingdom Freeman Hospital Newcastle upon Tyne United Kingdom Leeds Institute of Clinical Trials Research University of Leeds Leeds United Kingdom Health Economics Research Group Brunel University London London United Kingdom and London School of Hygiene and Tropical Medicine Keppel Street London United Kingdom

J Thorac Cardiovasc Surg 20181562124-32

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacement

bull Methods This RCT compared MS with FS for first-time isolated AVR in 2 United Kingdom National Health Service hospitals Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR analyzed in the intent-to-treat population

bull Results In this RCT 222 patients were recruited and randomized (n frac14 118 in the MS group n frac14 104 in the FS group) Compared with the FS group the MS group had a longer hospital length of stay (mean 95 days vs 86 days) and took longer to achieve fitness for discharge home (mean 85 days vs 75 days) Adjusting for valve type sex and surgeon hazard ratios (HRs) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR 0874 95 confidence interval [CI] 0668-1143 P frac14 3246) or time to fitness for discharge (HR 0907 95 CI 0688-1197 P value frac14 4914) During a mean follow-up of 760 days (745 days for the MS group and 777 days for the FS group) 12 patients (10) in the MS group and 7 patients (7) in the FS group died (HR 1871 95 CI 0723-4844 P frac14 1966) Average extra cost for MS was pound1714 during the first 12 months

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacementCentral Message

In the United Kingdomrsquos National Health Service compared with a conventional median sternotomy approach for surgical aortic valve replacement mini-sternotomy did not hasten recovery or hospital discharge and was not cost-effective

Measuring What Matters

Having lived through the growth of percutaneous coronary intervention and now seeing the expansion of transcatheter aortic valve replacement I find myself asking the somewhat existential question ldquoAre we measuring what matters to patientsrdquo

Thoralf M Sundt MD Division of Cardiac Surgery

Massachusetts General Hospital Boston Massachusetts

Ann Thorac Surg 20181061602

Measuring What Matters

In a study performed at Dartmouth-Hitchcock

elderly patients prioritized ability to pursue activities maintaining independence and reducing symptoms

over

mortality benefit

Coleywright M et al Patients defined goals for the treatment of sever AVS a qualitative analysis

Health Expect 2016 191036-43

Measuring What Matters

These sorts of ldquosoftrdquo outcome variables are challenging to us We think of ourselvesmdashat least I domdashas medical scientists interested in ldquohardrdquo endpoints

But our patients are challenging us to consider what they value most not what we can measure easily Irsquod say it is time for us to broaden our horizons and revisit how we can better measure what matters

Ann Thorac Surg 20181061602

Page 9: MINI-STERNOTOMY FOR AVR · HISTORY I •A right parasternal incision is made, extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal

Introduction

bull The approaches taken under the umbrella of minimally-invasive surgical aortic valve replacement (MICS SAVR) essentially consist of a variety of access options to the aortic valve using smaller incisions

bull Importantly there is no convention or consensus as to what size incision qualifies as a minimally-invasive procedure

bull Furthermore lsquominimally-invasiversquo cardiac surgery (MICS) arguably is somewhat of a misnomer certainly in comparison interventions such as TAVR because the most invasive portions of the surgery including cross-clamping of the aorta ischemic cardiac arrest the use of cardiopulmonary bypass and opening of the aorta with introduction of air into the heart chambers all remain the same

Mahesh K Ramchandani MDAnnals of Thoracic Surgery ( in press)

ΜΙΝΙ

ν=28

ΥΠΟΛΟΙΠΟΙ

ν=131Ηλικία 722plusmn84 704plusmn98Γυναίκες(n) 10 (357) 58(442)Euro score 227plusmn2 18plusmn19ΜΕΘ μέρες 196plusmn06 198plusmn11Μέρες νοσηλείας 6plusmn218 57plusmn18Νοσηλεία lt5

μέρες

14(50) 37(517)

Μετάγγιση

RBC UNITS

12plusmn09 15plusmn13

CPB min 1124plusmn37 933plusmn33Μηχανικός

αερισμός (ώρες)

86plusmn45 104plusmn13

ΜΙΝΙ Στερνοτομές 2018Μεμονωμένη αντικατάσταση αορτικής βαλβίδας 2018

Σύνολο 159- ΜΙΝΙ 28 (176)

Χαρακτηριστικά ασθενών Επιπλοκές

ΜΙΝΙ

ν=28

ΥΠΟΛΟΙΠΟΙ

ν=131

P value

LCOS(n) 1 (36) 3(23) 069

Επαναδιάνοιξη(n) 0 4(31) 035

Λοιμώξεις

στερνοτομής(n)

1 (36) 3(23) 069

Stroke 0 2(15) 051

NIV 1 (36) 6(46) 081

Επαναδιασωλήνωση 0 3(23) 042

AKI(n) 3(107) 12(92) 079

Κολπική μαρμαρυγή 7(25) 40(305) 056

Θάνατος 0 3(23) 042

Minimally Invasive Approaches to Surgical Aortic Valve Replacement

A Meta-Analysis

Carolyn Chang BS Sajjad Raza MD Salah E Altarabsheh MD Sarah Delozier PhD Umesh M Sharma MD MBA Aisha Zia MD Muhammad Shahzeb Khan MD Mandy Neudecker MS Alan H Markowitz MD Joseph F Sabik III MD and Salil V Deo MD

Cleveland Ohio

(Ann Thorac Surg 20181061881ndash9)

Minimally Invasive Approaches to Surgical Aortic Valve ReplacementA Meta-Analysis

The outcomes of the 2 minimally invasive aortic valve replacement (AVR) strategiesmdashmini-sternotomy (AVR-st) and right anterior thoracotomy (AVR-th) with each other and with conventional AVR (cAVR)

Searched Medline PubMed Embase and Web of Science in December 2017 for studies comparing AVR-st AVR-th and cAVR Endpoints studied included hospital mortality stroke atrial fibrillation cardiopulmonary bypass (CPB) time and length of stay

A total of 19 studies (gt10000 pooled patients) met the inclusion criteria

bull Mortality (p [ 006) and stroke (p [ 015) were comparable between minimally invasive and conventional AVR

bull CPB times were longer with AVR-th versus cAVR (124 minutes [range 5 to 19] p lt 001) In the AVR-th cohort CPB duration was weakly inversely related to study size (p [ 006)

bull Atrial fibrillation was much less after AVR-th (odds ratio 047 [035 to 063] p lt 0001)

bull Hospital stay was significantly lower after minimally invasive surgery (08 [04 to 13] days p lt 001

Minimally invasive approaches to AVR yield excellent outcomes in high-volume centers They reduce hospital stay and incidence of postoperative atrial fibrillation and therefore should be considered in patients undergoing AVR The operative approach should be selected according to surgeonrsquos technical expertise and what is best for specific patient profile

(Ann Thorac Surg 20181061881ndash9)

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

Elisa Mikus MD Simone Calvi MD Gianluca Campo MD Rita Pavasini MD Marco Paris MD Eliana Raviola MD Marco Panzavolta MD Alberto Tripodi MD Roberto Ferrari MD PhD and Mauro Del Giglio MD PhD

Cardiothoracic and Vascular Department Maria Cecilia Hospital GVM Care amp Research Cotignola (RA) Cardiovascular Institute Azienda Ospedaliero-Universitaria di Ferrara Cona (FE) and Cardiovascular Department Istituto Clinico San Rocco Ome (BS) Italy

(Ann Thorac Surg 20181061782ndash8)

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

bull The study included all 1907 consecutive patients hospitalized at the Maria Cecilia Hospital (Cotignola RA Italy) between January 2010 and March 2017 undergoing isolated AVR through PUH RAT or MS The choice of the approach was left to surgeonrsquos preference To adjust for differences in baseline characteristics between the study groups a propensity score matching was performed Linear and logistic regression analyses were performed

bull Results Partial upper hemisternotomy was performed in 820 patients (43) right anterior minithoracotomy in 488 (26) and median sternotomy in 599 (31) After propensity score matching three groups of 377 patients were obtained Cardiopulmonary bypass and crossclamptimes were shorter in the right anterior minithoracotomy group than in the median sternotomy and partial upper hemisternotomy groups (p lt 0001) No significant differences in in-hospital mortality were observed (p [ 09) Renal failure (odds ratio 54 95 confidence interval 23 to 114 p lt 00001) extracardiac arteriopathy (odds ratio 29 95 confidence interval 11 to 67 p [ 0017) and left ventricular ejection fraction (odds ratio 096 95 confidence interval 093 to 099 p [ 0009) emerged as independent predictors of in hospital mortality

bull Conclusions Minimal-access isolated aortic valve surgery is a reproducible safe and effective procedure with similar outcomes and operating times compared with conventional sternotomy

Ann Thorac Surg 20181061782ndash8

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement

Sukumaran K Nair FRCS(CTh) et al

bull From the a Department of Cardiothoracic Surgery PapworthHospital Cambridge United Kingdom Freeman Hospital Newcastle upon Tyne United Kingdom Leeds Institute of Clinical Trials Research University of Leeds Leeds United Kingdom Health Economics Research Group Brunel University London London United Kingdom and London School of Hygiene and Tropical Medicine Keppel Street London United Kingdom

J Thorac Cardiovasc Surg 20181562124-32

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacement

bull Methods This RCT compared MS with FS for first-time isolated AVR in 2 United Kingdom National Health Service hospitals Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR analyzed in the intent-to-treat population

bull Results In this RCT 222 patients were recruited and randomized (n frac14 118 in the MS group n frac14 104 in the FS group) Compared with the FS group the MS group had a longer hospital length of stay (mean 95 days vs 86 days) and took longer to achieve fitness for discharge home (mean 85 days vs 75 days) Adjusting for valve type sex and surgeon hazard ratios (HRs) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR 0874 95 confidence interval [CI] 0668-1143 P frac14 3246) or time to fitness for discharge (HR 0907 95 CI 0688-1197 P value frac14 4914) During a mean follow-up of 760 days (745 days for the MS group and 777 days for the FS group) 12 patients (10) in the MS group and 7 patients (7) in the FS group died (HR 1871 95 CI 0723-4844 P frac14 1966) Average extra cost for MS was pound1714 during the first 12 months

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacementCentral Message

In the United Kingdomrsquos National Health Service compared with a conventional median sternotomy approach for surgical aortic valve replacement mini-sternotomy did not hasten recovery or hospital discharge and was not cost-effective

Measuring What Matters

Having lived through the growth of percutaneous coronary intervention and now seeing the expansion of transcatheter aortic valve replacement I find myself asking the somewhat existential question ldquoAre we measuring what matters to patientsrdquo

Thoralf M Sundt MD Division of Cardiac Surgery

Massachusetts General Hospital Boston Massachusetts

Ann Thorac Surg 20181061602

Measuring What Matters

In a study performed at Dartmouth-Hitchcock

elderly patients prioritized ability to pursue activities maintaining independence and reducing symptoms

over

mortality benefit

Coleywright M et al Patients defined goals for the treatment of sever AVS a qualitative analysis

Health Expect 2016 191036-43

Measuring What Matters

These sorts of ldquosoftrdquo outcome variables are challenging to us We think of ourselvesmdashat least I domdashas medical scientists interested in ldquohardrdquo endpoints

But our patients are challenging us to consider what they value most not what we can measure easily Irsquod say it is time for us to broaden our horizons and revisit how we can better measure what matters

Ann Thorac Surg 20181061602

Page 10: MINI-STERNOTOMY FOR AVR · HISTORY I •A right parasternal incision is made, extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal

ΜΙΝΙ

ν=28

ΥΠΟΛΟΙΠΟΙ

ν=131Ηλικία 722plusmn84 704plusmn98Γυναίκες(n) 10 (357) 58(442)Euro score 227plusmn2 18plusmn19ΜΕΘ μέρες 196plusmn06 198plusmn11Μέρες νοσηλείας 6plusmn218 57plusmn18Νοσηλεία lt5

μέρες

14(50) 37(517)

Μετάγγιση

RBC UNITS

12plusmn09 15plusmn13

CPB min 1124plusmn37 933plusmn33Μηχανικός

αερισμός (ώρες)

86plusmn45 104plusmn13

ΜΙΝΙ Στερνοτομές 2018Μεμονωμένη αντικατάσταση αορτικής βαλβίδας 2018

Σύνολο 159- ΜΙΝΙ 28 (176)

Χαρακτηριστικά ασθενών Επιπλοκές

ΜΙΝΙ

ν=28

ΥΠΟΛΟΙΠΟΙ

ν=131

P value

LCOS(n) 1 (36) 3(23) 069

Επαναδιάνοιξη(n) 0 4(31) 035

Λοιμώξεις

στερνοτομής(n)

1 (36) 3(23) 069

Stroke 0 2(15) 051

NIV 1 (36) 6(46) 081

Επαναδιασωλήνωση 0 3(23) 042

AKI(n) 3(107) 12(92) 079

Κολπική μαρμαρυγή 7(25) 40(305) 056

Θάνατος 0 3(23) 042

Minimally Invasive Approaches to Surgical Aortic Valve Replacement

A Meta-Analysis

Carolyn Chang BS Sajjad Raza MD Salah E Altarabsheh MD Sarah Delozier PhD Umesh M Sharma MD MBA Aisha Zia MD Muhammad Shahzeb Khan MD Mandy Neudecker MS Alan H Markowitz MD Joseph F Sabik III MD and Salil V Deo MD

Cleveland Ohio

(Ann Thorac Surg 20181061881ndash9)

Minimally Invasive Approaches to Surgical Aortic Valve ReplacementA Meta-Analysis

The outcomes of the 2 minimally invasive aortic valve replacement (AVR) strategiesmdashmini-sternotomy (AVR-st) and right anterior thoracotomy (AVR-th) with each other and with conventional AVR (cAVR)

Searched Medline PubMed Embase and Web of Science in December 2017 for studies comparing AVR-st AVR-th and cAVR Endpoints studied included hospital mortality stroke atrial fibrillation cardiopulmonary bypass (CPB) time and length of stay

A total of 19 studies (gt10000 pooled patients) met the inclusion criteria

bull Mortality (p [ 006) and stroke (p [ 015) were comparable between minimally invasive and conventional AVR

bull CPB times were longer with AVR-th versus cAVR (124 minutes [range 5 to 19] p lt 001) In the AVR-th cohort CPB duration was weakly inversely related to study size (p [ 006)

bull Atrial fibrillation was much less after AVR-th (odds ratio 047 [035 to 063] p lt 0001)

bull Hospital stay was significantly lower after minimally invasive surgery (08 [04 to 13] days p lt 001

Minimally invasive approaches to AVR yield excellent outcomes in high-volume centers They reduce hospital stay and incidence of postoperative atrial fibrillation and therefore should be considered in patients undergoing AVR The operative approach should be selected according to surgeonrsquos technical expertise and what is best for specific patient profile

(Ann Thorac Surg 20181061881ndash9)

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

Elisa Mikus MD Simone Calvi MD Gianluca Campo MD Rita Pavasini MD Marco Paris MD Eliana Raviola MD Marco Panzavolta MD Alberto Tripodi MD Roberto Ferrari MD PhD and Mauro Del Giglio MD PhD

Cardiothoracic and Vascular Department Maria Cecilia Hospital GVM Care amp Research Cotignola (RA) Cardiovascular Institute Azienda Ospedaliero-Universitaria di Ferrara Cona (FE) and Cardiovascular Department Istituto Clinico San Rocco Ome (BS) Italy

(Ann Thorac Surg 20181061782ndash8)

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

bull The study included all 1907 consecutive patients hospitalized at the Maria Cecilia Hospital (Cotignola RA Italy) between January 2010 and March 2017 undergoing isolated AVR through PUH RAT or MS The choice of the approach was left to surgeonrsquos preference To adjust for differences in baseline characteristics between the study groups a propensity score matching was performed Linear and logistic regression analyses were performed

bull Results Partial upper hemisternotomy was performed in 820 patients (43) right anterior minithoracotomy in 488 (26) and median sternotomy in 599 (31) After propensity score matching three groups of 377 patients were obtained Cardiopulmonary bypass and crossclamptimes were shorter in the right anterior minithoracotomy group than in the median sternotomy and partial upper hemisternotomy groups (p lt 0001) No significant differences in in-hospital mortality were observed (p [ 09) Renal failure (odds ratio 54 95 confidence interval 23 to 114 p lt 00001) extracardiac arteriopathy (odds ratio 29 95 confidence interval 11 to 67 p [ 0017) and left ventricular ejection fraction (odds ratio 096 95 confidence interval 093 to 099 p [ 0009) emerged as independent predictors of in hospital mortality

bull Conclusions Minimal-access isolated aortic valve surgery is a reproducible safe and effective procedure with similar outcomes and operating times compared with conventional sternotomy

Ann Thorac Surg 20181061782ndash8

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement

Sukumaran K Nair FRCS(CTh) et al

bull From the a Department of Cardiothoracic Surgery PapworthHospital Cambridge United Kingdom Freeman Hospital Newcastle upon Tyne United Kingdom Leeds Institute of Clinical Trials Research University of Leeds Leeds United Kingdom Health Economics Research Group Brunel University London London United Kingdom and London School of Hygiene and Tropical Medicine Keppel Street London United Kingdom

J Thorac Cardiovasc Surg 20181562124-32

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacement

bull Methods This RCT compared MS with FS for first-time isolated AVR in 2 United Kingdom National Health Service hospitals Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR analyzed in the intent-to-treat population

bull Results In this RCT 222 patients were recruited and randomized (n frac14 118 in the MS group n frac14 104 in the FS group) Compared with the FS group the MS group had a longer hospital length of stay (mean 95 days vs 86 days) and took longer to achieve fitness for discharge home (mean 85 days vs 75 days) Adjusting for valve type sex and surgeon hazard ratios (HRs) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR 0874 95 confidence interval [CI] 0668-1143 P frac14 3246) or time to fitness for discharge (HR 0907 95 CI 0688-1197 P value frac14 4914) During a mean follow-up of 760 days (745 days for the MS group and 777 days for the FS group) 12 patients (10) in the MS group and 7 patients (7) in the FS group died (HR 1871 95 CI 0723-4844 P frac14 1966) Average extra cost for MS was pound1714 during the first 12 months

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacementCentral Message

In the United Kingdomrsquos National Health Service compared with a conventional median sternotomy approach for surgical aortic valve replacement mini-sternotomy did not hasten recovery or hospital discharge and was not cost-effective

Measuring What Matters

Having lived through the growth of percutaneous coronary intervention and now seeing the expansion of transcatheter aortic valve replacement I find myself asking the somewhat existential question ldquoAre we measuring what matters to patientsrdquo

Thoralf M Sundt MD Division of Cardiac Surgery

Massachusetts General Hospital Boston Massachusetts

Ann Thorac Surg 20181061602

Measuring What Matters

In a study performed at Dartmouth-Hitchcock

elderly patients prioritized ability to pursue activities maintaining independence and reducing symptoms

over

mortality benefit

Coleywright M et al Patients defined goals for the treatment of sever AVS a qualitative analysis

Health Expect 2016 191036-43

Measuring What Matters

These sorts of ldquosoftrdquo outcome variables are challenging to us We think of ourselvesmdashat least I domdashas medical scientists interested in ldquohardrdquo endpoints

But our patients are challenging us to consider what they value most not what we can measure easily Irsquod say it is time for us to broaden our horizons and revisit how we can better measure what matters

Ann Thorac Surg 20181061602

Page 11: MINI-STERNOTOMY FOR AVR · HISTORY I •A right parasternal incision is made, extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal

Minimally Invasive Approaches to Surgical Aortic Valve Replacement

A Meta-Analysis

Carolyn Chang BS Sajjad Raza MD Salah E Altarabsheh MD Sarah Delozier PhD Umesh M Sharma MD MBA Aisha Zia MD Muhammad Shahzeb Khan MD Mandy Neudecker MS Alan H Markowitz MD Joseph F Sabik III MD and Salil V Deo MD

Cleveland Ohio

(Ann Thorac Surg 20181061881ndash9)

Minimally Invasive Approaches to Surgical Aortic Valve ReplacementA Meta-Analysis

The outcomes of the 2 minimally invasive aortic valve replacement (AVR) strategiesmdashmini-sternotomy (AVR-st) and right anterior thoracotomy (AVR-th) with each other and with conventional AVR (cAVR)

Searched Medline PubMed Embase and Web of Science in December 2017 for studies comparing AVR-st AVR-th and cAVR Endpoints studied included hospital mortality stroke atrial fibrillation cardiopulmonary bypass (CPB) time and length of stay

A total of 19 studies (gt10000 pooled patients) met the inclusion criteria

bull Mortality (p [ 006) and stroke (p [ 015) were comparable between minimally invasive and conventional AVR

bull CPB times were longer with AVR-th versus cAVR (124 minutes [range 5 to 19] p lt 001) In the AVR-th cohort CPB duration was weakly inversely related to study size (p [ 006)

bull Atrial fibrillation was much less after AVR-th (odds ratio 047 [035 to 063] p lt 0001)

bull Hospital stay was significantly lower after minimally invasive surgery (08 [04 to 13] days p lt 001

Minimally invasive approaches to AVR yield excellent outcomes in high-volume centers They reduce hospital stay and incidence of postoperative atrial fibrillation and therefore should be considered in patients undergoing AVR The operative approach should be selected according to surgeonrsquos technical expertise and what is best for specific patient profile

(Ann Thorac Surg 20181061881ndash9)

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

Elisa Mikus MD Simone Calvi MD Gianluca Campo MD Rita Pavasini MD Marco Paris MD Eliana Raviola MD Marco Panzavolta MD Alberto Tripodi MD Roberto Ferrari MD PhD and Mauro Del Giglio MD PhD

Cardiothoracic and Vascular Department Maria Cecilia Hospital GVM Care amp Research Cotignola (RA) Cardiovascular Institute Azienda Ospedaliero-Universitaria di Ferrara Cona (FE) and Cardiovascular Department Istituto Clinico San Rocco Ome (BS) Italy

(Ann Thorac Surg 20181061782ndash8)

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

bull The study included all 1907 consecutive patients hospitalized at the Maria Cecilia Hospital (Cotignola RA Italy) between January 2010 and March 2017 undergoing isolated AVR through PUH RAT or MS The choice of the approach was left to surgeonrsquos preference To adjust for differences in baseline characteristics between the study groups a propensity score matching was performed Linear and logistic regression analyses were performed

bull Results Partial upper hemisternotomy was performed in 820 patients (43) right anterior minithoracotomy in 488 (26) and median sternotomy in 599 (31) After propensity score matching three groups of 377 patients were obtained Cardiopulmonary bypass and crossclamptimes were shorter in the right anterior minithoracotomy group than in the median sternotomy and partial upper hemisternotomy groups (p lt 0001) No significant differences in in-hospital mortality were observed (p [ 09) Renal failure (odds ratio 54 95 confidence interval 23 to 114 p lt 00001) extracardiac arteriopathy (odds ratio 29 95 confidence interval 11 to 67 p [ 0017) and left ventricular ejection fraction (odds ratio 096 95 confidence interval 093 to 099 p [ 0009) emerged as independent predictors of in hospital mortality

bull Conclusions Minimal-access isolated aortic valve surgery is a reproducible safe and effective procedure with similar outcomes and operating times compared with conventional sternotomy

Ann Thorac Surg 20181061782ndash8

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement

Sukumaran K Nair FRCS(CTh) et al

bull From the a Department of Cardiothoracic Surgery PapworthHospital Cambridge United Kingdom Freeman Hospital Newcastle upon Tyne United Kingdom Leeds Institute of Clinical Trials Research University of Leeds Leeds United Kingdom Health Economics Research Group Brunel University London London United Kingdom and London School of Hygiene and Tropical Medicine Keppel Street London United Kingdom

J Thorac Cardiovasc Surg 20181562124-32

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacement

bull Methods This RCT compared MS with FS for first-time isolated AVR in 2 United Kingdom National Health Service hospitals Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR analyzed in the intent-to-treat population

bull Results In this RCT 222 patients were recruited and randomized (n frac14 118 in the MS group n frac14 104 in the FS group) Compared with the FS group the MS group had a longer hospital length of stay (mean 95 days vs 86 days) and took longer to achieve fitness for discharge home (mean 85 days vs 75 days) Adjusting for valve type sex and surgeon hazard ratios (HRs) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR 0874 95 confidence interval [CI] 0668-1143 P frac14 3246) or time to fitness for discharge (HR 0907 95 CI 0688-1197 P value frac14 4914) During a mean follow-up of 760 days (745 days for the MS group and 777 days for the FS group) 12 patients (10) in the MS group and 7 patients (7) in the FS group died (HR 1871 95 CI 0723-4844 P frac14 1966) Average extra cost for MS was pound1714 during the first 12 months

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacementCentral Message

In the United Kingdomrsquos National Health Service compared with a conventional median sternotomy approach for surgical aortic valve replacement mini-sternotomy did not hasten recovery or hospital discharge and was not cost-effective

Measuring What Matters

Having lived through the growth of percutaneous coronary intervention and now seeing the expansion of transcatheter aortic valve replacement I find myself asking the somewhat existential question ldquoAre we measuring what matters to patientsrdquo

Thoralf M Sundt MD Division of Cardiac Surgery

Massachusetts General Hospital Boston Massachusetts

Ann Thorac Surg 20181061602

Measuring What Matters

In a study performed at Dartmouth-Hitchcock

elderly patients prioritized ability to pursue activities maintaining independence and reducing symptoms

over

mortality benefit

Coleywright M et al Patients defined goals for the treatment of sever AVS a qualitative analysis

Health Expect 2016 191036-43

Measuring What Matters

These sorts of ldquosoftrdquo outcome variables are challenging to us We think of ourselvesmdashat least I domdashas medical scientists interested in ldquohardrdquo endpoints

But our patients are challenging us to consider what they value most not what we can measure easily Irsquod say it is time for us to broaden our horizons and revisit how we can better measure what matters

Ann Thorac Surg 20181061602

Page 12: MINI-STERNOTOMY FOR AVR · HISTORY I •A right parasternal incision is made, extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal

Minimally Invasive Approaches to Surgical Aortic Valve ReplacementA Meta-Analysis

The outcomes of the 2 minimally invasive aortic valve replacement (AVR) strategiesmdashmini-sternotomy (AVR-st) and right anterior thoracotomy (AVR-th) with each other and with conventional AVR (cAVR)

Searched Medline PubMed Embase and Web of Science in December 2017 for studies comparing AVR-st AVR-th and cAVR Endpoints studied included hospital mortality stroke atrial fibrillation cardiopulmonary bypass (CPB) time and length of stay

A total of 19 studies (gt10000 pooled patients) met the inclusion criteria

bull Mortality (p [ 006) and stroke (p [ 015) were comparable between minimally invasive and conventional AVR

bull CPB times were longer with AVR-th versus cAVR (124 minutes [range 5 to 19] p lt 001) In the AVR-th cohort CPB duration was weakly inversely related to study size (p [ 006)

bull Atrial fibrillation was much less after AVR-th (odds ratio 047 [035 to 063] p lt 0001)

bull Hospital stay was significantly lower after minimally invasive surgery (08 [04 to 13] days p lt 001

Minimally invasive approaches to AVR yield excellent outcomes in high-volume centers They reduce hospital stay and incidence of postoperative atrial fibrillation and therefore should be considered in patients undergoing AVR The operative approach should be selected according to surgeonrsquos technical expertise and what is best for specific patient profile

(Ann Thorac Surg 20181061881ndash9)

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

Elisa Mikus MD Simone Calvi MD Gianluca Campo MD Rita Pavasini MD Marco Paris MD Eliana Raviola MD Marco Panzavolta MD Alberto Tripodi MD Roberto Ferrari MD PhD and Mauro Del Giglio MD PhD

Cardiothoracic and Vascular Department Maria Cecilia Hospital GVM Care amp Research Cotignola (RA) Cardiovascular Institute Azienda Ospedaliero-Universitaria di Ferrara Cona (FE) and Cardiovascular Department Istituto Clinico San Rocco Ome (BS) Italy

(Ann Thorac Surg 20181061782ndash8)

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

bull The study included all 1907 consecutive patients hospitalized at the Maria Cecilia Hospital (Cotignola RA Italy) between January 2010 and March 2017 undergoing isolated AVR through PUH RAT or MS The choice of the approach was left to surgeonrsquos preference To adjust for differences in baseline characteristics between the study groups a propensity score matching was performed Linear and logistic regression analyses were performed

bull Results Partial upper hemisternotomy was performed in 820 patients (43) right anterior minithoracotomy in 488 (26) and median sternotomy in 599 (31) After propensity score matching three groups of 377 patients were obtained Cardiopulmonary bypass and crossclamptimes were shorter in the right anterior minithoracotomy group than in the median sternotomy and partial upper hemisternotomy groups (p lt 0001) No significant differences in in-hospital mortality were observed (p [ 09) Renal failure (odds ratio 54 95 confidence interval 23 to 114 p lt 00001) extracardiac arteriopathy (odds ratio 29 95 confidence interval 11 to 67 p [ 0017) and left ventricular ejection fraction (odds ratio 096 95 confidence interval 093 to 099 p [ 0009) emerged as independent predictors of in hospital mortality

bull Conclusions Minimal-access isolated aortic valve surgery is a reproducible safe and effective procedure with similar outcomes and operating times compared with conventional sternotomy

Ann Thorac Surg 20181061782ndash8

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement

Sukumaran K Nair FRCS(CTh) et al

bull From the a Department of Cardiothoracic Surgery PapworthHospital Cambridge United Kingdom Freeman Hospital Newcastle upon Tyne United Kingdom Leeds Institute of Clinical Trials Research University of Leeds Leeds United Kingdom Health Economics Research Group Brunel University London London United Kingdom and London School of Hygiene and Tropical Medicine Keppel Street London United Kingdom

J Thorac Cardiovasc Surg 20181562124-32

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacement

bull Methods This RCT compared MS with FS for first-time isolated AVR in 2 United Kingdom National Health Service hospitals Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR analyzed in the intent-to-treat population

bull Results In this RCT 222 patients were recruited and randomized (n frac14 118 in the MS group n frac14 104 in the FS group) Compared with the FS group the MS group had a longer hospital length of stay (mean 95 days vs 86 days) and took longer to achieve fitness for discharge home (mean 85 days vs 75 days) Adjusting for valve type sex and surgeon hazard ratios (HRs) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR 0874 95 confidence interval [CI] 0668-1143 P frac14 3246) or time to fitness for discharge (HR 0907 95 CI 0688-1197 P value frac14 4914) During a mean follow-up of 760 days (745 days for the MS group and 777 days for the FS group) 12 patients (10) in the MS group and 7 patients (7) in the FS group died (HR 1871 95 CI 0723-4844 P frac14 1966) Average extra cost for MS was pound1714 during the first 12 months

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacementCentral Message

In the United Kingdomrsquos National Health Service compared with a conventional median sternotomy approach for surgical aortic valve replacement mini-sternotomy did not hasten recovery or hospital discharge and was not cost-effective

Measuring What Matters

Having lived through the growth of percutaneous coronary intervention and now seeing the expansion of transcatheter aortic valve replacement I find myself asking the somewhat existential question ldquoAre we measuring what matters to patientsrdquo

Thoralf M Sundt MD Division of Cardiac Surgery

Massachusetts General Hospital Boston Massachusetts

Ann Thorac Surg 20181061602

Measuring What Matters

In a study performed at Dartmouth-Hitchcock

elderly patients prioritized ability to pursue activities maintaining independence and reducing symptoms

over

mortality benefit

Coleywright M et al Patients defined goals for the treatment of sever AVS a qualitative analysis

Health Expect 2016 191036-43

Measuring What Matters

These sorts of ldquosoftrdquo outcome variables are challenging to us We think of ourselvesmdashat least I domdashas medical scientists interested in ldquohardrdquo endpoints

But our patients are challenging us to consider what they value most not what we can measure easily Irsquod say it is time for us to broaden our horizons and revisit how we can better measure what matters

Ann Thorac Surg 20181061602

Page 13: MINI-STERNOTOMY FOR AVR · HISTORY I •A right parasternal incision is made, extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

Elisa Mikus MD Simone Calvi MD Gianluca Campo MD Rita Pavasini MD Marco Paris MD Eliana Raviola MD Marco Panzavolta MD Alberto Tripodi MD Roberto Ferrari MD PhD and Mauro Del Giglio MD PhD

Cardiothoracic and Vascular Department Maria Cecilia Hospital GVM Care amp Research Cotignola (RA) Cardiovascular Institute Azienda Ospedaliero-Universitaria di Ferrara Cona (FE) and Cardiovascular Department Istituto Clinico San Rocco Ome (BS) Italy

(Ann Thorac Surg 20181061782ndash8)

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

bull The study included all 1907 consecutive patients hospitalized at the Maria Cecilia Hospital (Cotignola RA Italy) between January 2010 and March 2017 undergoing isolated AVR through PUH RAT or MS The choice of the approach was left to surgeonrsquos preference To adjust for differences in baseline characteristics between the study groups a propensity score matching was performed Linear and logistic regression analyses were performed

bull Results Partial upper hemisternotomy was performed in 820 patients (43) right anterior minithoracotomy in 488 (26) and median sternotomy in 599 (31) After propensity score matching three groups of 377 patients were obtained Cardiopulmonary bypass and crossclamptimes were shorter in the right anterior minithoracotomy group than in the median sternotomy and partial upper hemisternotomy groups (p lt 0001) No significant differences in in-hospital mortality were observed (p [ 09) Renal failure (odds ratio 54 95 confidence interval 23 to 114 p lt 00001) extracardiac arteriopathy (odds ratio 29 95 confidence interval 11 to 67 p [ 0017) and left ventricular ejection fraction (odds ratio 096 95 confidence interval 093 to 099 p [ 0009) emerged as independent predictors of in hospital mortality

bull Conclusions Minimal-access isolated aortic valve surgery is a reproducible safe and effective procedure with similar outcomes and operating times compared with conventional sternotomy

Ann Thorac Surg 20181061782ndash8

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement

Sukumaran K Nair FRCS(CTh) et al

bull From the a Department of Cardiothoracic Surgery PapworthHospital Cambridge United Kingdom Freeman Hospital Newcastle upon Tyne United Kingdom Leeds Institute of Clinical Trials Research University of Leeds Leeds United Kingdom Health Economics Research Group Brunel University London London United Kingdom and London School of Hygiene and Tropical Medicine Keppel Street London United Kingdom

J Thorac Cardiovasc Surg 20181562124-32

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacement

bull Methods This RCT compared MS with FS for first-time isolated AVR in 2 United Kingdom National Health Service hospitals Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR analyzed in the intent-to-treat population

bull Results In this RCT 222 patients were recruited and randomized (n frac14 118 in the MS group n frac14 104 in the FS group) Compared with the FS group the MS group had a longer hospital length of stay (mean 95 days vs 86 days) and took longer to achieve fitness for discharge home (mean 85 days vs 75 days) Adjusting for valve type sex and surgeon hazard ratios (HRs) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR 0874 95 confidence interval [CI] 0668-1143 P frac14 3246) or time to fitness for discharge (HR 0907 95 CI 0688-1197 P value frac14 4914) During a mean follow-up of 760 days (745 days for the MS group and 777 days for the FS group) 12 patients (10) in the MS group and 7 patients (7) in the FS group died (HR 1871 95 CI 0723-4844 P frac14 1966) Average extra cost for MS was pound1714 during the first 12 months

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacementCentral Message

In the United Kingdomrsquos National Health Service compared with a conventional median sternotomy approach for surgical aortic valve replacement mini-sternotomy did not hasten recovery or hospital discharge and was not cost-effective

Measuring What Matters

Having lived through the growth of percutaneous coronary intervention and now seeing the expansion of transcatheter aortic valve replacement I find myself asking the somewhat existential question ldquoAre we measuring what matters to patientsrdquo

Thoralf M Sundt MD Division of Cardiac Surgery

Massachusetts General Hospital Boston Massachusetts

Ann Thorac Surg 20181061602

Measuring What Matters

In a study performed at Dartmouth-Hitchcock

elderly patients prioritized ability to pursue activities maintaining independence and reducing symptoms

over

mortality benefit

Coleywright M et al Patients defined goals for the treatment of sever AVS a qualitative analysis

Health Expect 2016 191036-43

Measuring What Matters

These sorts of ldquosoftrdquo outcome variables are challenging to us We think of ourselvesmdashat least I domdashas medical scientists interested in ldquohardrdquo endpoints

But our patients are challenging us to consider what they value most not what we can measure easily Irsquod say it is time for us to broaden our horizons and revisit how we can better measure what matters

Ann Thorac Surg 20181061602

Page 14: MINI-STERNOTOMY FOR AVR · HISTORY I •A right parasternal incision is made, extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal

Full Sternotomy Hemisternotomy and Minithoracotomyfor Aortic Valve Surgery Is There a Difference

bull The study included all 1907 consecutive patients hospitalized at the Maria Cecilia Hospital (Cotignola RA Italy) between January 2010 and March 2017 undergoing isolated AVR through PUH RAT or MS The choice of the approach was left to surgeonrsquos preference To adjust for differences in baseline characteristics between the study groups a propensity score matching was performed Linear and logistic regression analyses were performed

bull Results Partial upper hemisternotomy was performed in 820 patients (43) right anterior minithoracotomy in 488 (26) and median sternotomy in 599 (31) After propensity score matching three groups of 377 patients were obtained Cardiopulmonary bypass and crossclamptimes were shorter in the right anterior minithoracotomy group than in the median sternotomy and partial upper hemisternotomy groups (p lt 0001) No significant differences in in-hospital mortality were observed (p [ 09) Renal failure (odds ratio 54 95 confidence interval 23 to 114 p lt 00001) extracardiac arteriopathy (odds ratio 29 95 confidence interval 11 to 67 p [ 0017) and left ventricular ejection fraction (odds ratio 096 95 confidence interval 093 to 099 p [ 0009) emerged as independent predictors of in hospital mortality

bull Conclusions Minimal-access isolated aortic valve surgery is a reproducible safe and effective procedure with similar outcomes and operating times compared with conventional sternotomy

Ann Thorac Surg 20181061782ndash8

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement

Sukumaran K Nair FRCS(CTh) et al

bull From the a Department of Cardiothoracic Surgery PapworthHospital Cambridge United Kingdom Freeman Hospital Newcastle upon Tyne United Kingdom Leeds Institute of Clinical Trials Research University of Leeds Leeds United Kingdom Health Economics Research Group Brunel University London London United Kingdom and London School of Hygiene and Tropical Medicine Keppel Street London United Kingdom

J Thorac Cardiovasc Surg 20181562124-32

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacement

bull Methods This RCT compared MS with FS for first-time isolated AVR in 2 United Kingdom National Health Service hospitals Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR analyzed in the intent-to-treat population

bull Results In this RCT 222 patients were recruited and randomized (n frac14 118 in the MS group n frac14 104 in the FS group) Compared with the FS group the MS group had a longer hospital length of stay (mean 95 days vs 86 days) and took longer to achieve fitness for discharge home (mean 85 days vs 75 days) Adjusting for valve type sex and surgeon hazard ratios (HRs) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR 0874 95 confidence interval [CI] 0668-1143 P frac14 3246) or time to fitness for discharge (HR 0907 95 CI 0688-1197 P value frac14 4914) During a mean follow-up of 760 days (745 days for the MS group and 777 days for the FS group) 12 patients (10) in the MS group and 7 patients (7) in the FS group died (HR 1871 95 CI 0723-4844 P frac14 1966) Average extra cost for MS was pound1714 during the first 12 months

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacementCentral Message

In the United Kingdomrsquos National Health Service compared with a conventional median sternotomy approach for surgical aortic valve replacement mini-sternotomy did not hasten recovery or hospital discharge and was not cost-effective

Measuring What Matters

Having lived through the growth of percutaneous coronary intervention and now seeing the expansion of transcatheter aortic valve replacement I find myself asking the somewhat existential question ldquoAre we measuring what matters to patientsrdquo

Thoralf M Sundt MD Division of Cardiac Surgery

Massachusetts General Hospital Boston Massachusetts

Ann Thorac Surg 20181061602

Measuring What Matters

In a study performed at Dartmouth-Hitchcock

elderly patients prioritized ability to pursue activities maintaining independence and reducing symptoms

over

mortality benefit

Coleywright M et al Patients defined goals for the treatment of sever AVS a qualitative analysis

Health Expect 2016 191036-43

Measuring What Matters

These sorts of ldquosoftrdquo outcome variables are challenging to us We think of ourselvesmdashat least I domdashas medical scientists interested in ldquohardrdquo endpoints

But our patients are challenging us to consider what they value most not what we can measure easily Irsquod say it is time for us to broaden our horizons and revisit how we can better measure what matters

Ann Thorac Surg 20181061602

Page 15: MINI-STERNOTOMY FOR AVR · HISTORY I •A right parasternal incision is made, extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement

Sukumaran K Nair FRCS(CTh) et al

bull From the a Department of Cardiothoracic Surgery PapworthHospital Cambridge United Kingdom Freeman Hospital Newcastle upon Tyne United Kingdom Leeds Institute of Clinical Trials Research University of Leeds Leeds United Kingdom Health Economics Research Group Brunel University London London United Kingdom and London School of Hygiene and Tropical Medicine Keppel Street London United Kingdom

J Thorac Cardiovasc Surg 20181562124-32

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacement

bull Methods This RCT compared MS with FS for first-time isolated AVR in 2 United Kingdom National Health Service hospitals Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR analyzed in the intent-to-treat population

bull Results In this RCT 222 patients were recruited and randomized (n frac14 118 in the MS group n frac14 104 in the FS group) Compared with the FS group the MS group had a longer hospital length of stay (mean 95 days vs 86 days) and took longer to achieve fitness for discharge home (mean 85 days vs 75 days) Adjusting for valve type sex and surgeon hazard ratios (HRs) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR 0874 95 confidence interval [CI] 0668-1143 P frac14 3246) or time to fitness for discharge (HR 0907 95 CI 0688-1197 P value frac14 4914) During a mean follow-up of 760 days (745 days for the MS group and 777 days for the FS group) 12 patients (10) in the MS group and 7 patients (7) in the FS group died (HR 1871 95 CI 0723-4844 P frac14 1966) Average extra cost for MS was pound1714 during the first 12 months

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacementCentral Message

In the United Kingdomrsquos National Health Service compared with a conventional median sternotomy approach for surgical aortic valve replacement mini-sternotomy did not hasten recovery or hospital discharge and was not cost-effective

Measuring What Matters

Having lived through the growth of percutaneous coronary intervention and now seeing the expansion of transcatheter aortic valve replacement I find myself asking the somewhat existential question ldquoAre we measuring what matters to patientsrdquo

Thoralf M Sundt MD Division of Cardiac Surgery

Massachusetts General Hospital Boston Massachusetts

Ann Thorac Surg 20181061602

Measuring What Matters

In a study performed at Dartmouth-Hitchcock

elderly patients prioritized ability to pursue activities maintaining independence and reducing symptoms

over

mortality benefit

Coleywright M et al Patients defined goals for the treatment of sever AVS a qualitative analysis

Health Expect 2016 191036-43

Measuring What Matters

These sorts of ldquosoftrdquo outcome variables are challenging to us We think of ourselvesmdashat least I domdashas medical scientists interested in ldquohardrdquo endpoints

But our patients are challenging us to consider what they value most not what we can measure easily Irsquod say it is time for us to broaden our horizons and revisit how we can better measure what matters

Ann Thorac Surg 20181061602

Page 16: MINI-STERNOTOMY FOR AVR · HISTORY I •A right parasternal incision is made, extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacement

bull Methods This RCT compared MS with FS for first-time isolated AVR in 2 United Kingdom National Health Service hospitals Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR analyzed in the intent-to-treat population

bull Results In this RCT 222 patients were recruited and randomized (n frac14 118 in the MS group n frac14 104 in the FS group) Compared with the FS group the MS group had a longer hospital length of stay (mean 95 days vs 86 days) and took longer to achieve fitness for discharge home (mean 85 days vs 75 days) Adjusting for valve type sex and surgeon hazard ratios (HRs) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR 0874 95 confidence interval [CI] 0668-1143 P frac14 3246) or time to fitness for discharge (HR 0907 95 CI 0688-1197 P value frac14 4914) During a mean follow-up of 760 days (745 days for the MS group and 777 days for the FS group) 12 patients (10) in the MS group and 7 patients (7) in the FS group died (HR 1871 95 CI 0723-4844 P frac14 1966) Average extra cost for MS was pound1714 during the first 12 months

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacementCentral Message

In the United Kingdomrsquos National Health Service compared with a conventional median sternotomy approach for surgical aortic valve replacement mini-sternotomy did not hasten recovery or hospital discharge and was not cost-effective

Measuring What Matters

Having lived through the growth of percutaneous coronary intervention and now seeing the expansion of transcatheter aortic valve replacement I find myself asking the somewhat existential question ldquoAre we measuring what matters to patientsrdquo

Thoralf M Sundt MD Division of Cardiac Surgery

Massachusetts General Hospital Boston Massachusetts

Ann Thorac Surg 20181061602

Measuring What Matters

In a study performed at Dartmouth-Hitchcock

elderly patients prioritized ability to pursue activities maintaining independence and reducing symptoms

over

mortality benefit

Coleywright M et al Patients defined goals for the treatment of sever AVS a qualitative analysis

Health Expect 2016 191036-43

Measuring What Matters

These sorts of ldquosoftrdquo outcome variables are challenging to us We think of ourselvesmdashat least I domdashas medical scientists interested in ldquohardrdquo endpoints

But our patients are challenging us to consider what they value most not what we can measure easily Irsquod say it is time for us to broaden our horizons and revisit how we can better measure what matters

Ann Thorac Surg 20181061602

Page 17: MINI-STERNOTOMY FOR AVR · HISTORY I •A right parasternal incision is made, extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal

Mini-Stern TrialA randomized trial comparing mini-sternotomy to full

median sternotomy for aortic valve replacementCentral Message

In the United Kingdomrsquos National Health Service compared with a conventional median sternotomy approach for surgical aortic valve replacement mini-sternotomy did not hasten recovery or hospital discharge and was not cost-effective

Measuring What Matters

Having lived through the growth of percutaneous coronary intervention and now seeing the expansion of transcatheter aortic valve replacement I find myself asking the somewhat existential question ldquoAre we measuring what matters to patientsrdquo

Thoralf M Sundt MD Division of Cardiac Surgery

Massachusetts General Hospital Boston Massachusetts

Ann Thorac Surg 20181061602

Measuring What Matters

In a study performed at Dartmouth-Hitchcock

elderly patients prioritized ability to pursue activities maintaining independence and reducing symptoms

over

mortality benefit

Coleywright M et al Patients defined goals for the treatment of sever AVS a qualitative analysis

Health Expect 2016 191036-43

Measuring What Matters

These sorts of ldquosoftrdquo outcome variables are challenging to us We think of ourselvesmdashat least I domdashas medical scientists interested in ldquohardrdquo endpoints

But our patients are challenging us to consider what they value most not what we can measure easily Irsquod say it is time for us to broaden our horizons and revisit how we can better measure what matters

Ann Thorac Surg 20181061602

Page 18: MINI-STERNOTOMY FOR AVR · HISTORY I •A right parasternal incision is made, extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal

Measuring What Matters

Having lived through the growth of percutaneous coronary intervention and now seeing the expansion of transcatheter aortic valve replacement I find myself asking the somewhat existential question ldquoAre we measuring what matters to patientsrdquo

Thoralf M Sundt MD Division of Cardiac Surgery

Massachusetts General Hospital Boston Massachusetts

Ann Thorac Surg 20181061602

Measuring What Matters

In a study performed at Dartmouth-Hitchcock

elderly patients prioritized ability to pursue activities maintaining independence and reducing symptoms

over

mortality benefit

Coleywright M et al Patients defined goals for the treatment of sever AVS a qualitative analysis

Health Expect 2016 191036-43

Measuring What Matters

These sorts of ldquosoftrdquo outcome variables are challenging to us We think of ourselvesmdashat least I domdashas medical scientists interested in ldquohardrdquo endpoints

But our patients are challenging us to consider what they value most not what we can measure easily Irsquod say it is time for us to broaden our horizons and revisit how we can better measure what matters

Ann Thorac Surg 20181061602

Page 19: MINI-STERNOTOMY FOR AVR · HISTORY I •A right parasternal incision is made, extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal

Measuring What Matters

In a study performed at Dartmouth-Hitchcock

elderly patients prioritized ability to pursue activities maintaining independence and reducing symptoms

over

mortality benefit

Coleywright M et al Patients defined goals for the treatment of sever AVS a qualitative analysis

Health Expect 2016 191036-43

Measuring What Matters

These sorts of ldquosoftrdquo outcome variables are challenging to us We think of ourselvesmdashat least I domdashas medical scientists interested in ldquohardrdquo endpoints

But our patients are challenging us to consider what they value most not what we can measure easily Irsquod say it is time for us to broaden our horizons and revisit how we can better measure what matters

Ann Thorac Surg 20181061602

Page 20: MINI-STERNOTOMY FOR AVR · HISTORY I •A right parasternal incision is made, extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal

Measuring What Matters

These sorts of ldquosoftrdquo outcome variables are challenging to us We think of ourselvesmdashat least I domdashas medical scientists interested in ldquohardrdquo endpoints

But our patients are challenging us to consider what they value most not what we can measure easily Irsquod say it is time for us to broaden our horizons and revisit how we can better measure what matters

Ann Thorac Surg 20181061602