Επιδιόρθωση Μιτροειδούς με MitraClip

M. Chrissoheris

From the Department of Transcatheter Heart Valves

HYGEIA Hospital Athens

Disclosures

-Proctoring activities for Abbott Vascular, Edwards Lifesciences

I and the HYGEIA Hospital «Heart Team» have receivedresearch and/or travel grants and/or lecture fees from:- ABBOTT Vascular, Europe, Edwards Lifesciences, Medtronic

HYGEIA Hospital Heart Team

Cardiologists: G. Kourkoveli, K Papadopoulos, A Halapas, M Chrissoheris, N.

Georgakopoulos, K Spargias

CT Surgeons: G. Pattakos, N Bouboulis, S Skardoutsos, A Tsolakis, S Pattakos

Anesthesiologist: N.Papanikolaou, I Nikolaou

Pediatric and Adult Congenital Cardiology: A Tzifa

Vascular Surgeons: I Belos, S Kaliafas

Radiologists: F Laspas, C Mourmouris

Electrophysiology: L Papavassiliou, S. Kourouklis, G Zervopoulos, T Apostolopoulos

Research Nurse: E. Dafnomyli

Need for Transcatheter Mitral Valve Repair

The Prototype of Mitral Valve Repair: The MitraClip Device

• Implant made of cobalt chromium

• Polyester-covered to promote healing

• MRI Safe to 3 Tesla

• Real-time positioning during procedure

• Surgically removable when required

• Single size available

1 EH 4 0566 01 11/2010

Advantages of the MitraClip

• Transvenous procedure

– Low risk of vascular complications

– Low stroke risk

• Repositionable – Removable

• Echocardiographic guided procedure

– Low risk of arrhythmias

– Low risk of cardiac perforation

Goals of Mitraclip Therapy

• Reduction in severity of mitral regurgitation to ≤2+

In order to achieve this we need

• Adequate leaflet capture at the site of maximum mitral regurgitation to ensure permanent coaptation, without causing stenosis or other complications

Contemporary Cardiology: Valvular Heart Disease Chapter 10:221-246

Modern Classification of MR

MitraClip Timeline

October 2011

Global MitraClip Procedures

Data on file at Abbott Vascular as of 12/31/2014

Organic / Primary Mitral Regurgitation

Degenerative / Primary Mitral Regurgitation: Guidelines for

MitraClip

Transcatheter mitral valve repair maybe considered for severelysymptomatic patients (NYHA class III toIV) with chronic severe primary MR(stage D) who have favorable anatomyfor the repair procedure and areasonable life expectancy but whohave a prohibitive surgical risk becauseof severe comorbidities and remainseverely symptomatic despite optimalGDMT for HF (Level of Evidence: B)

MitraClip in an Octogenarian with DMR

• 83 year-old female

• NYHA-III dyspnea, despite optimal HF therapy

• EF 65%

• MR 4+ due to P2 prolapse (fibroelastic deficiency, ruptured chord)

• Pulmonary HTN (sPAP 80 mmHg)

• Chronic Atrial Fibrillation

• STS risk 3.3% Intermediate risk patient

Live 3-D Zoom: Mitral Valve Surgeon’s View

X-Plane with Color Flow Doppler

X-Plane: Post Mitra Clip Deployment

Double Orifice Mitral Valve post Mitra Clip Deployment

MitraClip in a patient with degenerative MR treated with 1 MitraClip:

5 years later

Clinically doing well, ambulatory, no heart failure readmissions, mainly geriatrics issues

MitraClip in Degenerative Mitral Regurgitation: The US Experience

MitraClip in Degenerative Mitral Regurgitation: The US Experience

MitraClip in Degenerative Mitral Regurgitation: The US Experience - Outcomes

MitraClip in Degenerative Mitral Regurgitation: The US Experience- Outcomes

MitraClip Registries

Functional MR: Severe Ischemic Cardiomyopathy

Severe Functional MR affects Survival

Heart 2011;97:1675e1680.

MitraClip in Functional MR

• Cardiomyopathy is the reason for mitral valve

dysfunction and determines overall prognosis

• Before MitraClip

– Optimal medical therapy?

– Revascularization candidate?

– Need for resynchronization?

Bleeker G B et al. Heart 2007;93:1339-1350

Cardiac Resynchronization and Functional MR

• CRT effects

– Improved dp/dt

– Reverse

remodelling

– More coordinated

activation of

papillary muscles

BASELINE

6 MONTHS

Heart Failure Patient with Significant Ischemic MR

• 56 year old male• NYHA III-ΙV dyspnea • 11/2016 AMI, primary PCI in LCx• Staged LAD PCI with multiple stents• Gradually developing SOB symptoms

together with MR (initially mild)• ECHO MR 4/4, ERO 50mm2, RV 66ml,

LVEF 30-35%, PAP 60mmHg• Paroxysmal AF, TIAs (most recent 3m

ago)• HEART TEAM decision: MitraClip

TEE X-plane

3MR: Live 3D color

MitraClip: alignment

2 Clip bridge

Stages of Secondary Mitral Regurgitation

Circulation. 2017;DOI: 10.1161/CIR.0000000000000503

Change in severe fMR criteria

…the recommended definition of severe secondary MR is now the same

as for primary MR (effective regurgitant orifice ≥0.4 cm2 and regurgitant

volume ≥60 mL), with the understanding that effective regurgitant

orifice cutoff of >0.2 cm2 is more sensitive and >0.4cm2 is more

specific for severe MR.

Circulation. 2017;DOI: 10.1161/CIR.0000000000000503

Is “moderate” MR acceptable in patients with severe heart failure?

• 89 year old female, NYHA IV

• Acute anterior MI 1o PCI

• Ischemic cardiomyopathy

– EF 35%, LVEDD 62mm, LVESD 56mm

• Multiple hospitalizations for acute

pulmonary edema

• “Moderate mitral regurgitation”

• RVOL34ml, RF 45%, EROA 20mm2

• Patient hospital course uneventful

• At 12 months, no readmissions for heart failure, NYHA class I-II

• Sustained mitral regurgitation reduction on follow up

• “Moderate” MR should be considered as a therapeutic target in patients with severe heart failure symptoms

• Stress echo by supine bicycle, or simply raising the blood pressure may uncover the true significance of MR in the patient

Is “moderate” MR acceptable in patients with severe heart failure?

• N=628 patients w severe MR (FMR 72%)

– 25 centers, 1/2011-12/2012

• NYHA class ≥3 in 85%, log. Euroscore 20%

• Acute Procedural Success 95.4%

• At 1-year, persistent reduction in the degree of mitral regurgitation

J A C C V OL . 6 4 , N O . 9 , 2 0 1 4 : 8 7 5 – 8 4

Sentinel Registry: Mitral Regurgitation Grade at follow up

J A C C V OL . 6 4 , N O . 9 , 2 0 1 4 : 8 7 5 – 8 4

Sentinel Registry: NYHA class during 12-month follow up

J A C C V OL . 6 4 , N O . 9 , 2 0 1 4 : 8 7 5 – 8 4

Sentinel Registry: Echocardiographic follow up to 12-months

J A C C V OL . 6 4 , N O . 9 , 2 0 1 4 : 8 7 5 – 8 4

• N=139 pts MitraClip– FMR 77%

Compared with:

• N=53 surgical MVR– FMR 59%

• N=59 conservative Rx– FMR 81%

JACC: Cardiovascular Interventions. 2014;7(8):875-881.

MitraClip: Initial Inclusion Criteria (EVEREST studies)

• Valve geometry features:

– Coaptation length ≥2 mm, coaptation

depth <11 mm,

– Flail gap <10 mm, flail width <15 mm

• Ventricle function/ geometry:

– Ejection fraction [EF] >25%,

– LV end-systolic diameter ≤55mm

MitraClip Anatomic Evaluation: Basic Requirements

• Ability to approximate leaflets

• Adequate mitral valve orifice area (to avoid iatrogenic

mitral stenosis)

• Adequate transesophageal imaging to guide the

procedure

• Expanding indications to non-EVEREST anatomies

Optimal TEE Imaging

• Patient / anatomical factors

– Adequate imaging in majority of patients

– In rare patients, impossible to obtain adequate TEE imaging planes for steering

• Technical factors

– Image degradation after prolonged procedure

– Need for breath holding during grasping of leaflets to ensure stable imaging

Defining Mitral Regurgitant Jet(s)

• 3-Dimensional with Color Flow Imaging

• Vena contracta area assessment (area of the narrowest point of the mitral regurgitant jet)

– Marker of severity

• In addition to evaluation of MV inflow, pulmonary vein flow, ERO calculations, chamber size, degree of pulmonary hypertension

3-D Mitral Valve

Modelling of Mitral Valve - MVQ

3D Color to Assess Extent and Location of Regurgitant Flow

Prolapse / flail of the P2

Prolapse / flail P2 seen in 3D zoom (anatomically oriented)

MVQ Analysis and 3D Color Flow

Clin Res Cardiol (2014) 103:85–96

Clin Res Cardiol (2014) 103:85–96

Optimal Anatomy for MitraClip

HYGEIA Hospital Heart Team

Clin Res Cardiol (2014) 103:85–96

Conditionally Suitable Anatomy for MitraClip

Clin Res Cardiol (2014) 103:85–96

Conditionally Suitable Anatomy for MitraClip

Clin Res Cardiol (2014) 103:85–96

Conditionally Suitable Anatomy for MitraClip

Clin Res Cardiol (2014) 103:85–96

Conditionally Suitable Anatomy for MitraClip

Clin Res Cardiol (2014) 103:85–96

Conditionally Suitable Anatomy for MitraClip

Clin Res Cardiol (2014) 103:85–96

Conditionally Suitable Anatomy for MitraClip

Clin Res Cardiol (2014) 103:85–96

Conditionally Suitable Anatomy for MitraClip

Clin Res Cardiol (2014) 103:85–96

Conditionally Suitable Anatomy for MitraClip

Clin Res Cardiol (2014) 103:85–96

Conditionally Suitable Anatomy for MitraClip

Clin Res Cardiol (2014) 103:85–96

Unsuitable Valve Morphology for MitraClip

Severely degenerated mitral valve in 3D-Zoom

SYSTOLE

A3

P3

MITRAL VALVE FROM LV SIDE MITRAL VALVE FROM LV SIDE

MITRAL VALVE FROM LA SIDE

A3

P3

Degenerative MR

Short posterior leaflet (<7mm) not suitable for MitraCLip

Mixed Mitral Valve Disease

• 75 year old female, NYHA III, atrial fibrillation, mixed mitral valve disease (MVA 1.3cm2), moderate MR, pulmonary hypertension

MitraClip in 2018

• Larger flail gaps and widths

• Commissural jets

• Multiple jets

• Diminutive posterior leaflet

• Post surgical repair

• Bridge to transplant

• Acute MI mechanical complications

MitraClip as a Bridge to Heart Transplant

The Annals of Thoracic Surgery , Volume 99 , Issue 5 , 1796 - 1799

Clin Res Cardiol (2011) 100:719–721

MitraClip in a Patient with Advanced Heart Failure

BaselineFinal

55 year old male with dilated cardiomyopathy, NYHA IVa on maximal medical Rx, BIV-AICD, paroxysmal atrial fibrillation, BNP 2210,Post MitraClip, clinical stabilization x12months , eventual cardiac transplantation

Acute Heart Failure Complicating Myocardial Infarction

• 85 year-old female

• Subacute dyspnea on exertion

• Delayed presentation anterior myocardial infarction

• Coronary angiography: PCI stent to large ramus intermedius

• LVEF ~40%

• Initial improvement and response to medical Rx

• Clinical deterioration

• Acute pulmonary edema despite high doses of iv Lasix

Emerging Novel MitraClip Application:In Hypertrophic Obstructive Cardiomyopathy

What are the limits for MitraClip

• N=300 patients (FMR 68%) treated with MitraClip– N=32 unsuccessful outcome (MR>2+ @discharge)

• Clip failure in 21 patients• Aborted procedure in 11 patients

• Independent predictors of overall failure– Effective Regurgitant Orifice Area (>78mm2)– Mitral Valve Orifice Area (≤3.0cm2)– Mean Transmitral Pressure Gradient (≥4mmHg)

J A C C : C A RD I O V A S C U L A R I N T E R V E NT I O N S , V OL . 7 , N O . 4 , 2 0 1 4: 3 9 4 – 4 0 2

Echocardiographic Parameters and MitraClip Outcomes

J A C C : C A RD I O V A S C U L A R I N T E R V E NT I O N S , V OL . 7 , N O . 4 , 2 0 1 4: 3 9 4 – 4 0 2

MitraClip in a patient with dilated cardiomyopathy

Baseline Final

76 year old male with dilated cardiomyopathy EF 25%, significant FMR (ERO 38mm2 ) NYHA IV, CRT-AICD, stage IV CKDDifficult Mitraclip procedure (4 hours duration, 100min fluoroscopy), moderate reduction in MR grade

Redo MitraClip, 18 months later…

Baseline Final

Recurrent admissions for heart failure decompensation, despite maximal heart failure treatment, decision for redo MitraClipProcedure less complicated, fluro time 25:14, further reduction of MR grade to <2+

Clinical benefit of MitraClip procedure depends on effective reduction of MR grade

• N=100

• FMR 62%

• NYHA III-IV 82%

• Acute procedural success in 85%

MitraClip acute procedural success and impact on survival @ 12 months

MR grade at discharge correlates withlong-term survival

Reduction of MR grade ≤ 2 leads to reverse left ventricular remodeling

LV End Diastolic Volume LV End Systolic Volume

Mitral Regurgitation Grade and Long Term Outcomes after MitraClip Therapy

Circulation. 2013;128:1667-1674

Edwards PASCAL Repair System:Designed to reduce mitral regurgitation

• Spacer is clasped between both Mitral Valve Leaflets

• Independent leaflet clasping

• Simple “Commander-like” delivery system

• Conventional transfemoral/ transeptal approach

Edwards PASCAL Repair System:Designed to reduce mitral regurgitation

• N=23 patients

• Functional MR 12 (57%), Degenerative MR 6 (26%), Mixed 5 (22%)

The Lancet, Vol 390 / Issue 10096, pg773-780

Increase in Referrals for MitraClip

BASELINE DEMOGRAPHICS – CLINICAL CHARACTERISTICS Ν=117 ACCESS N=566

AGE (±SD) 73±11 74±10

MALE (%) 73 64

HISTORY OF CHF (%) 100

CORONARY ARTERY DISEASE (%) 68 63

PREVIOUS CABG (%) 35 37

ATRIAL FIBRILLATION (%) 59 68

COPD (%) 25

CHRONIC RENAL FAILURE (GFR<60ml/min) (%) 53 42

DIABETES (%) 34

EUROSCORE (%) mean 27 23

STS mortality (%) / Morbidity (%) 6.3 / 32

MitraClip: Patient Characteristics

CLINICAL CHARACTERISTICS (CONTINUED) N=117 ACCESS N=566

DEGENERATIVE MR ETIOLOGY (%) 31 23

FUNCTIONAL MR ETIOLOGY (%) 67 77

NYHA CLASS III/IV (%) 96 85

MR GRADE ≥3 (%) 100 98%

ERO (mm2) 33±11 NA

EJECTION FRACTION MEAN (%) 39±15 NA

SYSTOLIC PULMONARY ARTERY PRESSURE, mmHg 59±14 NA

Clinical and Echocardiographic Characteristics

Functional 67%

Degenerative 31%

Mixed 2%

Etiology of Mitral Regurgitation

BASELINE DEMOGRAPHICS – CLINICAL

CHARACTERISTICS

FMR

Ν=78

DMR

Ν=39

AGE (±SD), Years 70 ± 10 79 ± 11

MALE GENDER (%) 77 65

LVEF, Left Ventricular Ejection Fraction, mean(%) 30 56

CORONARY ARTERY DISEASE (%) 75 53

PREVIOUS CABG (%) 42 23

ATRIAL FIBRILLATION (%) 49 75

COPD (%) 19 65

CHRONIC RENAL FAILURE (%) 62 36

DIABETES (%) 42 21

EUROSCORE (%) mean 27±13 27±15

STS MORTALITY (%) mean 6.3±5.5 6.4±4.4

MitraClip Patient Characteristics:Functional vs. Degenerative MR

PROCEDURE – POST PROCEDURE RESULTS N=117 ACCESS

N=566

SUCCESFULL IMPLANTATION (%) 98 99.6

NUMBER OF CLIPS DEPLOYED: 0 / 1/ >1 (%) 0.9 /54.5 /44.6 0.4 /60/39.6

Total number of clips 172

FLUOROSCOPY TIME (MEAN) 0:37:57 NA

EXTUBATION TIME IN ICU, hours 9.7±5.2

ICU / TOTAL HOSPITAL STAY (DAYS, MEAN) 1.1 / 4.8 2.5 / 7.7

DISCHARGE HOME, (%) 99% 79.6%

Procedural Characteristics

Single or Multiple MitraClips

More than one MitraClip in ~44% DMR patients more consistently require more than one MitraClip

Procedural Time: More efficient over time

Procedure Time: Similar for DMR and FMR

Reduction in Mitral Regurgitation

MITRACLIP: Perioperative and 30-day Events

30-Day Events HYGEIA Cohort (N=117) ACCESS EU (N=567)

Death, (%) 0 3.4

Stroke, (%) 0 0.7

Myocardial Infarction, (%) 0 0.7

Partial Leaflet Detachment, (%) 0.9

Renal Failure, (%) 6.8 4.8

Respiratory Failure, (%) 2 0.7

Need for Resuscitation, (%) 0 1.8

Cardiac Tamponade, (%) 0 1.1

Red cell transfusion, (%) 9.7 3.9

Major Vascular Complications 0 NA

MITRACLIP: Clinical Outcomes at 30-Days

HYGEIA Cohort (N=117)

ΝΥΗΑ ≤2 (%) 93.5%

Mean MV Gradient, (mmHg) 3.1±1.3

MV area, (cm2) 2.8±0.9

MR grade (+) 1.4±0.8

In Summary

• MitraClip is an important (but can not be the only one)

transcatheter option for selected high risk patients with severe MR

(degenerative or functional)

• Good understanding of anatomy critical for success

• In the near future, availability of other modalities (transcatheter

mitral valves) will greatly enhance our ability to treat high risk

patients with variable mitral valve pathologies

Ευχαριστώ!