Διαδερμική θεραπεία

πνευμονικής βαλβίδας

- Αντίλογος -Dr Γιώργος Κρασόπουλος MD, PhD, MRCS(Eng), FRCS-CTh(Eng)Καρδιοχειρουργός

www.καρδιοχειρουργός.gr

“Δεν μπορώ να διδάξω τίποτα και σε κανένα, το μόνο που μπορώ είναι να τους κάνω να

σκεφτούν.”Σωκράτης, 470-399πχ

Σύντομη αναδρομή

• Surgical pulmonary valve replacement: >30 years,

>5000 papers

• Trans-femoral pulmonary valve implantation

• Melody – Medtronic: 9-10 years of experience, <40 papers

• SAPIEN – Edwards: 2-3 years of experience, <<10 papers

• Trans-ventricular pulmonary valve implantation:

<1year, <<5 papers

Indications

Cost

Effectiveness

Indications for Use: The Melody TPV is indicated for use as an adjunct to surgery in the management of pediatric and adult patients with the following clinical conditions: • Existence of a full (circumferential) RVOT conduit

that was equal to or greater than 16 mm in diameter when originally implanted and

• Dysfunctional RVOT conduits with a clinical indication for intervention, and either: • regurgitation: ≥ moderate regurgitation, or• stenosis: mean RVOT gradient ≥ 35 mm Hg

Contraindications: None known.

Indications for Use: The Melody TPV is indicated for use as an adjunct to surgery in the management of pediatric and adult patients with the following clinical conditions: • Existence of a full (circumferential) RVOT conduit

that was equal to or greater than 16 mm in diameter when originally implanted and

• Dysfunctional RVOT conduits with a clinical indication for intervention, and either: • regurgitation: ≥ moderate regurgitation, or• stenosis: mean RVOT gradient ≥ 35 mm Hg

Contraindications: None known.

Very specific indicatio

ns

Indications for Use: The Melody TPV is indicated for use as an adjunct to surgery in the management of pediatric and adult patients with the following clinical conditions: • Existence of a full (circumferential) RVOT conduit

that was equal to or greater than 16 mm in diameter when originally implanted and

• Dysfunctional RVOT conduits with a clinical indication for intervention, and either: • regurgitation: ≥ moderate regurgitation, or• stenosis: mean RVOT gradient ≥ 35 mm Hg

Contraindications: None known.

Everything else is “off la

bel”

&

it should be tr

eated as such!

Very specific indicatio

ns

Cost comparison: Melody versus Surgery

Surgery Melody

Need for pre-op angiogram No Yes

Radiation No Yes

Valve cost (without VAT) 3-5.000 Euro 22.900 Euro

Time usage of theatre or angio suite 4-6 hours 2-5 hours

Hospital stay 5-7 days (min) 2-3 days (min)

MortalityPVR:1%

RVOT Redo: >10%

1%

MorbidityPVR: 2%

RVOT Redo: >15%

5,5%

Structural failure at 3 years (re-intervention?) Maybe 1% 40±1%

Estimated cost 10-15.000 Euro 30-50.000 Euro…

Patient follow up or life long, costly anxiety?

Policlinico San Donato

Patient follow up or life long, costly anxiety?

Post implantation cost for the first

year well over 4000 Euros for Melody

&

Just two ECHOs for surgery!

Policlinico San Donato

Potential device-related adverse events

• Stent fracture resulting in recurrent obstruction• Endocarditis• Embolization or migration of the

device• Valvular dysfunction (stenosis or

regurgitation)• Paravalvular leak• Valvular thrombosis• Pulmonary thromboembolism• Haemolysis• Conduit-induced distortion of the initial

implant

Early results from Melody & Sapien

No of patient

s

Follow-up

time (month

s)

Stent fractur

e

Regurg. >2+

Migration

Compli-

cations

Re-occ. of

stenosis

needing new valve

Melody

30 6 30% 10% 10%

Sapien

36 6 3% 10% 10%

J Am Coll Cardiol. 2009 Oct 27;54(18):1722-9.J Am Coll Cardiol. 2011 Nov 15;58(21):2248-56.

Different portions of the RVOT may be more distensible than others and

the whole structure deforming unevenly during the cardiac cycle.

Eur Radiol 2011; 21:36-45

From the experimental point of view, the pressure pulse to which the stent-graft is subjected when deployed into

the cylinder is very large.

Different portions of the RVOT may be more distensible than others and

the whole structure deforming unevenly during the cardiac cycle.

Eur Radiol 2011; 21:36-45

From the experimental point of view, the pressure pulse to which the stent-graft is subjected when deployed into

the cylinder is very large.

Conventional in-vitro testing for fatigue assessment, where the PPVI

device was placed in a straight, distensible cylindrical tube, and tested with cyclic pressures over millions of cycles, did not predict stent fractures

…but they do occur!

Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu 2009; 12:112-7

Conventional in-vitro testing for fatigue assessment, where the PPVI

device was placed in a straight, distensible cylindrical tube, and tested with cyclic pressures over millions of cycles, did not predict stent fractures

…but they do occur!

Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu 2009; 12:112-7

«If a stent fracture is detected, continued monitoring of the stent

should be performed in conjunction with clinically appropriate

hemodynamic assessment. In patients with stent fracture and significant

associated RVOT obstruction or regurgitation, reintervention should

be considered in accordance with usual clinical practice.»

«If a stent fracture is detected, continued monitoring of the stent

should be performed in conjunction with clinically appropriate

hemodynamic assessment. In patients with stent fracture and significant

associated RVOT obstruction or regurgitation, reintervention should

be considered in accordance with usual clinical practice.»

When does it stop!

Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: patient-related and procedural risk factors in the US Melody Valve Trial.McElhinney DB, Cheatham JP, Jones TK, Lock JE, Vincent JA, Zahn EM, Hellenbrand WE.

• 150 patients• Freedom from a diagnosis of metal stent fracture was:

• 77±4% at 14 months (after the 1-year evaluation window) and • 60±9% at 39 months (3-year window).

• Among patients with a MSF, freedom from RVOT re-intervention after metal stent fracture diagnosis was 49±10% at 2 years.

• New prestent, or bioprosthetic valve (combined variable) was associated with longer freedom from MSF (P<0.001).

• Valve compression (P=0.01) and apposition to the anterior chest wall (P=0.02) were associated with shorter freedom from MSF.

Circ Cardiovasc Interv. 2011 Dec 1;4(6):602-14. Epub 2011 Nov 9.

Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: patient-related and procedural risk factors in the US Melody Valve Trial.McElhinney DB, Cheatham JP, Jones TK, Lock JE, Vincent JA, Zahn EM, Hellenbrand WE.

• 150 patients• Freedom from a diagnosis of metal stent fracture was:

• 77±4% at 14 months (after the 1-year evaluation window) and • 60±9% at 39 months (3-year window).

• Among patients with a MSF, freedom from RVOT re-intervention after metal stent fracture diagnosis was 49±10% at 2 years.

• New prestent, or bioprosthetic valve (combined variable) was associated with longer freedom from MSF (P<0.001).

• Valve compression (P=0.01) and apposition to the anterior chest wall (P=0.02) were associated with shorter freedom from MSF.

Circ Cardiovasc Interv. 2011 Dec 1;4(6):602-14. Epub 2011 Nov 9.

Big problem that gets

bigger with time!

Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: patient-related and procedural risk factors in the US Melody Valve Trial.McElhinney DB, Cheatham JP, Jones TK, Lock JE, Vincent JA, Zahn EM, Hellenbrand WE.

• 150 patients• Freedom from a diagnosis of metal stent fracture was:

• 77±4% at 14 months (after the 1-year evaluation window) and • 60±9% at 39 months (3-year window).

• Among patients with a MSF, freedom from RVOT re-intervention after metal stent fracture diagnosis was 49±10% at 2 years.

• New prestent, or bioprosthetic valve (combined variable) was associated with longer freedom from MSF (P<0.001).

• Valve compression (P=0.01) and apposition to the anterior chest wall (P=0.02) were associated with shorter freedom from MSF.

Circ Cardiovasc Interv. 2011 Dec 1;4(6):602-14. Epub 2011 Nov 9.

Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: patient-related and procedural risk factors in the US Melody Valve Trial.McElhinney DB, Cheatham JP, Jones TK, Lock JE, Vincent JA, Zahn EM, Hellenbrand WE.

• 150 patients• Freedom from a diagnosis of metal stent fracture was:

• 77±4% at 14 months (after the 1-year evaluation window) and • 60±9% at 39 months (3-year window).

• Among patients with a MSF, freedom from RVOT re-intervention after metal stent fracture diagnosis was 49±10% at 2 years.

• New prestent, or bioprosthetic valve (combined variable) was associated with longer freedom from MSF (P<0.001).

• Valve compression (P=0.01) and apposition to the anterior chest wall (P=0.02) were associated with shorter freedom from MSF.

Circ Cardiovasc Interv. 2011 Dec 1;4(6):602-14. Epub 2011 Nov 9.

Big problem that gets bigger with

time!&

We have to do it again!

Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: patient-related and procedural risk factors in the US Melody Valve Trial.McElhinney DB, Cheatham JP, Jones TK, Lock JE, Vincent JA, Zahn EM, Hellenbrand WE.

• 150 patients• Freedom from a diagnosis of metal stent fracture was:

• 77±4% at 14 months (after the 1-year evaluation window) and • 60±9% at 39 months (3-year window).

• Among patients with a MSF, freedom from RVOT re-intervention after metal stent fracture diagnosis was 49±10% at 2 years.

• New prestent, or bioprosthetic valve (combined variable) was associated with longer freedom from MSF (P<0.001).

• Valve compression (P=0.01) and apposition to the anterior chest wall (P=0.02) were associated with shorter freedom from MSF.

Circ Cardiovasc Interv. 2011 Dec 1;4(6):602-14. Epub 2011 Nov 9.

Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: patient-related and procedural risk factors in the US Melody Valve Trial.McElhinney DB, Cheatham JP, Jones TK, Lock JE, Vincent JA, Zahn EM, Hellenbrand WE.

• 150 patients• Freedom from a diagnosis of metal stent fracture was:

• 77±4% at 14 months (after the 1-year evaluation window) and • 60±9% at 39 months (3-year window).

• Among patients with a MSF, freedom from RVOT re-intervention after metal stent fracture diagnosis was 49±10% at 2 years.

• New prestent, or bioprosthetic valve (combined variable) was associated with longer freedom from MSF (P<0.001).

• Valve compression (P=0.01) and apposition to the anterior chest wall (P=0.02) were associated with shorter freedom from MSF.

Circ Cardiovasc Interv. 2011 Dec 1;4(6):602-14. Epub 2011 Nov 9.

Big problem that gets bigger with

time!&

We have to do it again!

&It works better if we put a bioprosthesis

first!

Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: patient-related and procedural risk factors in the US Melody Valve Trial.McElhinney DB, Cheatham JP, Jones TK, Lock JE, Vincent JA, Zahn EM, Hellenbrand WE.

• 150 patients• Freedom from a diagnosis of metal stent fracture was:

• 77±4% at 14 months (after the 1-year evaluation window) and • 60±9% at 39 months (3-year window).

• Among patients with a MSF, freedom from RVOT re-intervention after metal stent fracture diagnosis was 49±10% at 2 years.

• New prestent, or bioprosthetic valve (combined variable) was associated with longer freedom from MSF (P<0.001).

• Valve compression (P=0.01) and apposition to the anterior chest wall (P=0.02) were associated with shorter freedom from MSF.

Circ Cardiovasc Interv. 2011 Dec 1;4(6):602-14. Epub 2011 Nov 9.

Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: patient-related and procedural risk factors in the US Melody Valve Trial.McElhinney DB, Cheatham JP, Jones TK, Lock JE, Vincent JA, Zahn EM, Hellenbrand WE.

• 150 patients• Freedom from a diagnosis of metal stent fracture was:

• 77±4% at 14 months (after the 1-year evaluation window) and • 60±9% at 39 months (3-year window).

• Among patients with a MSF, freedom from RVOT re-intervention after metal stent fracture diagnosis was 49±10% at 2 years.

• New prestent, or bioprosthetic valve (combined variable) was associated with longer freedom from MSF (P<0.001).

• Valve compression (P=0.01) and apposition to the anterior chest wall (P=0.02) were associated with shorter freedom from MSF.

Circ Cardiovasc Interv. 2011 Dec 1;4(6):602-14. Epub 2011 Nov 9.

Big problem that gets bigger with time!

&We have to do it again!

&It works better if we put a

bioprosthesis first!&

We need a specialist team approach!

No Follow up

(Years)

Homo-graft

Other valve

Mortality

Freedom from re-do

@ 5 years

Freedom from re-do

@ 10

years

Freedom from valve

related compli-cations

@ 5 years

Freedom from valve

related compli-cations @ 10 years

Risk factors of valve failure

1 181 7.3 yes 94% 52% 92% 20%

YoungPulmonary atresia with

VSDStentless

2 331 3.8 yes 82% 80% Young

3 1095 10.9 yes yes 3.7% 55%

YoungHomograft

TGASmall conduit

1. J Thorac Cardiovasc Surg. 2011 Aug;142(2):351-8. Epub 2011 Feb 1.

2. J Thorac Cardiovasc Surg. 1999 Jan;117(1):141-6; discussion 46-7.3. Ann Thorac Surg. 2003 Feb;75(2):399-410; discussion 410-1.

Surgery for pulmonary valve: results (rounded)

No Follow up

(Years)

Homo-graft

Other valve

Mortality

Freedom from re-do

@ 5 years

Freedom from re-do

@ 10

years

Freedom from valve

related compli-cations

@ 5 years

Freedom from valve

related compli-cations @ 10 years

Risk factors of valve failure

1 181 7.3 yes 94% 52% 92% 20%

YoungPulmonary atresia with

VSDStentless

2 331 3.8 yes 82% 80% Young

3 1095 10.9 yes yes 3.7% 55%

YoungHomograft

TGASmall conduit

1. J Thorac Cardiovasc Surg. 2011 Aug;142(2):351-8. Epub 2011 Feb 1.

2. J Thorac Cardiovasc Surg. 1999 Jan;117(1):141-6; discussion 46-7.3. Ann Thorac Surg. 2003 Feb;75(2):399-410; discussion 410-1.

Surgery for pulmonary valve: results (rounded)

No Follow up

(Years)

Homo-graft

Other valve

Mortality

Freedom from re-do

@ 5 years

Freedom from re-do

@ 10

years

Freedom from valve

related compli-cations

@ 5 years

Freedom from valve

related compli-cations @ 10 years

Risk factors of valve failure

1 181 7.3 yes 94% 52% 92% 20%

YoungPulmonary atresia with

VSDStentless

2 331 3.8 yes 82% 80% Young

3 1095 10.9 yes yes 3.7% 55%

YoungHomograft

TGASmall conduit

1. J Thorac Cardiovasc Surg. 2011 Aug;142(2):351-8. Epub 2011 Feb 1.

2. J Thorac Cardiovasc Surg. 1999 Jan;117(1):141-6; discussion 46-7.3. Ann Thorac Surg. 2003 Feb;75(2):399-410; discussion 410-1.

Surgery for pulmonary valve: results (rounded)

Conclusions• Surgery is the gold standard technique for pulmonary

valve replacement.• Percutaneous valve implantation: • Has only, very specific indications• It is very expensive• It has a very high percentage of “complications”

• For some patients the percutaneous option can be the only option.

• The decision making on, which technique to deploy to which patient should be a matter of:• Specialist centres only• Properly trained subspecialists• Team work (multidisciplinary meetings)• Recorded results which are regularly put under auditing

& peer review

Conclusions• Surgery is the gold standard technique for pulmonary

valve replacement.• Percutaneous valve implantation: • Has only, very specific indications• It is very expensive• It has a very high percentage of “complications”

• For some patients the percutaneous option can be the only option.

• The decision making on, which technique to deploy to which patient should be a matter of:• Specialist centres only• Properly trained subspecialists• Team work (multidisciplinary meetings)• Recorded results which are regularly put under auditing

& peer review

Conclusions• Surgery is the gold standard technique for pulmonary

valve replacement.• Percutaneous valve implantation: • Has only, very specific indications• It is very expensive• It has a very high percentage of “complications”

• For some patients the percutaneous option can be the only option.

• The decision making on, which technique to deploy to which patient should be a matter of:• Specialist centres only• Properly trained subspecialists• Team work (multidisciplinary meetings)• Recorded results which are regularly put under auditing

& peer review

Conclusions• Surgery is the gold standard technique for pulmonary

valve replacement.• Percutaneous valve implantation: • Has only, very specific indications• It is very expensive• It has a very high percentage of “complications”

• For some patients the percutaneous option can be the only option.

• The decision making on, which technique to deploy to which patient should be a matter of:• Specialist centres only• Properly trained subspecialists• Team work (multidisciplinary meetings)• Recorded results which are regularly put under auditing

& peer review

Ευχαριστώ πολύ για την προσοχή σας.

www.καρδιοχειρουργός.gr

“Το πραγματικό ταξίδι της ανακάλυψης δεν συνίσταται στο να αναζητάς νέους τόπους

αλλά, στο να κοιτάς με νέα μάτια”Marcel Proust