EVEREST 2 5 YEAR OUTCOMES NISHITH PATEL WAIKATO

EVEREST 2 5 YEAR OUTCOMES NISHITH PATEL WAIKATO CARDIOTHORACIC UNIT

INTRODUCTION

BACKGROUND (NO MORE THAN 7 SLIDES) • MITRACLIP (ABBOT VASCULAR) DEVLOPED AS A PERCUTANEOUS ALTERNATIVE TO REDUCE MR. • IT APPROXIMATES THE MITRAL VALVE LEAFLETS • MODELLED ON THE ALFIERI DOUBLE ORIFICE TECHNIQUE FOR SURGICAL MV REPAIR; • 1 -YEAR OUTCOMES OF EVEREST II • SURGERY MORE EFFECTIVE FOR REDUCING MR • PERCUTANEOUS APPROACH SAFER THAN SURGERY https: //youtu. be/GDx. XTZ 1 I 12 s

OBJECTIVE • GIVEN THE INCREASED PREVALENCE OF MR AND LACK OF ANNULOPLASTY WITH PERC REPAIR, • WHAT IS THE DURABILITY OF PERC REPAIR COMPARED TO SURGERY • WHAT IS THE IMPACT OF EITHER TECHNIQUE ON LONG-TERM SURVIVAL, SYMPTOMS, AND LV REMODELLING

METHODOLOGY

METHODS – STUDY DESIGN • MULTICENTRE, RANDOMISED, NON-BLINDED TRIAL OF MITRACLIP VS CONVENTIAL SURGERY FOR THE TREATMENT OF MR • PRE-SPECIFIED 5 -YEAR FOLLOW-UP • RANDOMISED IN A 2: 1 RATIO (MITRACLIP TO SURGERY) • 37 STUDY CENTRES IN NORTH AMERICA BETWEEN 2005 AND 2008. • INCLUSION CRITERIA: • MODERATE TO SEVERE (3+) OR SEVERE (4+) CHRONIC MR • SYMPTOMATIC WITH LVEF >25% AND LV ESD <55 MM OR • ASYMPTOMATIC WITH 1 OR MORE OF THE FOLLOWING: • LVEF 25 -60% • LV ESD >40 MM • NEW-ONSET AF • PASP >50 MMHG AT REST OR 60 MMHG DURING EXERCISE • PRIMARY REGURGITANT JET ORIGINATED FROM MALCOAPTATION OF A 2 AND P 2 SCALLOPS • BOTH FUNCTIONAL AND DEGENERATIVE MR WERE ELIGIBLE.

METHODS – SURGICAL DETAILS • BASELINE AND FOLLOW-UP ECHOS ASSESSED BY INDEPENDENT ECHO CORE LAB – UNIVERSITY OF SAN FRANCISCO • TRIAL DESIGNED BY ABBOTT • HARVARD CLINICAL RESEARCH INSTITUTE CONTRACTED BY ABBOTT TO PERFORM DATA MANAGEMENT, ANALYSIS AND CLINICAL EVENT ADJUDICATION.

METHODS • MITRACLIP • UNDER GA • USING TOE AND FLUOROSCOPY IN CARDIAC CATH LAB • 2 ND MITRACLIP DEPLOYED IF FIRST DID NOT RESULT IN ADEQUATE REDUCTION IN MR • PATIENTS GIVEN ASPIRIN 325 MGOD FOR 6 MONTHS AND CLOPIDOGREL 75 MG OD FOR 30 DAYS. • SURGERY • DISCRETION OF THE SURGEON

METHODS – ENDPOINTS AT 5 YEARS • FREEDOM FROM DEATH, SURGERY FOR MV DYSFUNCTION, AND 3+ OR 4+ MR • FREEDOM FROM DEATH • FREEDOM FROM SURGERY FOR MV DYSFUNCTION • FREEDOM FROM DEATH AND SURGERY FOR MY DYSFUNCTION • ADDITIONAL PRE-SPECIFIED ENDPOINTS: • CHANGE IN LV DIMENSIONS AND VOLUMES • NYHA CLASS • QUALITY OF LIFE

METHODS – STATISTICAL ANALYSIS • ANALYSED AS THE ALL-TREATED COHORT FOR 5 -YEAR ANALYSIS • EXCLUDES PATIENTS RANDOMISED BUT NOT TREATED • TIME-TO EVENT ANALYSES USING KAPLEIN MEIER CURVES, LOG-RANK TEST AND COXPROPORTIONAL HAZARDS REGRESSION ANALYSIS • SUB-GROUP ANALYSIS: AGE, MR AETIOLOGY, LV FUNCTION

RESULTS

RESULTS (STUDY FLOW)

RESULTS (BASELINE CHARACTERISTICS)

RESULTS: EFFICACY ENDPOINTS AT 5 -YEARS

RESULTS: 5 -YEAR CLINICAL OUTCOMES

RESULTS: SEVERITY OF MR AND SYMPTOMS

RESULTS: SUBGROUP ANALYSES

RESULTS: PREDICTORS OF 5 -YEAR MORTALITY

AUTHOR’S CONCLUSION • 5 -YEAR RESULTS OF EVEREST II SUPPORT THE SUPERIORITY OF SURGERY IN REDUCING MR • BUT IT ALSO SUPPORTS THE LONG-TERM SAFETY OF MITRACLIP AND THE DURABILITY OF MR REDUCTION AFTER PERCUTANEOUS REPAIR • BEYOND 1 YEAR, WORSENING MR AND SURGERY FOR MV DYSFUNCTION OCCURRED RARELY AFTER EITHER SURGERY OR PERC REPAIR. • SIMILARLY IMPROVEMENTS IN SYMPTOMS AND LV DIMENSIONS REMAINED STABLE THROUGH 5 -YEAR FOLLOW-UP, MITIGATING CONCERNS THAT RESIDUAL MR AFTER DEVICE PLACEMENT AND THE ABSENCE OF AN ANNULOPLASTY RING WOULD RESULT IN WORSENING MR AND LV DYSFUNCTION. • DESPITE REDUCTION IN MR, FUNCTIONAL MR INCREASED RISK OF LONG-TERM MORTALITY.

DISCUSSION

STRENGTHS OF THE STUDY • FIRST RCT OF PERC REPAIR VERSUS SURGERY • INDEPENDENT ECHO CORE LAB • INDEPENDENT ADJUDICATION COMMITTEE

LIMITATIONS OF THE STUDY • HETEROGENEOUS STUDY POPULATIONS: FUNCTIONAL AND DEGENERATIVE MR • INCLUSION CRITERIA: 3+ REGURGITATION • ONLY 24% HAD 4+S(EVERE) REGURGITATION • NEEDS TO MIRROR CLINICAL PRACTICE • 5% OF PATIENTS HAD MILD-MODERATE MR • USE OF CORE LAB BEFORE RECRUITMENT • QUALITY OF CENTRES: • BREAKDOWN OF CENTRES NOT PROVIDED • MEAN NUMBER MITRACLIP/CENTRE WAS 5 AND SURGERY/CENTRE 2. 5 • HIGH PROPORTION OF SURGEONS IN TRIAL PERFORMED <15 MV REPAIRS PER YEAR • 14% OF PATIENTS IN SURGICAL ARM HAD MV REPLACEMENT

LIMITATIONS • PATIENT COMPLIANCE • HIGH PERCENTAGE OF WITHDRAWAL • ITT VS TREATED COHORT • ANAESTHETISE AFTER INDUCTION ? • INCLUSION OF LOW-RISK ASYMPTOMATIC PATIENTS • HIGH RATE OF VALVE REPLACEMENT • TEST ON HIGH RISK PATIENTS

IMPACT OF THE STUDY

HOW HAS THE STUDY IMPACTED ON PRACTICE • ROLE FOR PERCUTAENOUS MITRAL VALVE REPAIR • INOPERABLE OR HIGH RISK PATIENTS • FUNCTIONAL MR PATIENTS