1. Nishith Patel Waikato Cardiothoracic Unit
Everest 2
5 year outcomes
Nishith Patel
Waikato Cardiothoracic Unit

3. INTRODUCTION

4. 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

5. 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

6. Methodology

7. 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 and 2008.
Inclusion criteria:
Moderate to severe (3+) or severe (4+) chronic mr
Symptomatic with LVEF >25% and LV ESD <55mm or
Asymptomatic with 1 or more of the following:
LVEF 25-60%
LV ESD >40mm
New-onset AF
PASP >50mmhg at rest or 60mmhg during exercise
Primary regurgitant jet originated from malcoaptation of a2 and p2 scallops
Both functional and degenerative mr were eligible.

8. 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.

9. methods Mitraclip Surgery Under ga
Using toe and fluoroscopy in cardiac cath lab
2nd mitraclip deployed if first did not result in adequate reduction in mr
Patients given aspirin 325mg OD for 6 months and clopidogrel 75mg od for 30 days.
Surgery
Discretion of the surgeon

10. 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

11. 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 cox- proportional hazards regression analysis
Sub-group analysis: age, mr aetiology, lv function

12. Results

13. Results (STUDY FLOW)
Study Flow: All-Treated Group Data are shown for patients in the all-treated cohort evaluated for the 5-year efficacy endpoint. Because the primary endpoint required echocardiographic assessment of mitral regurgitation (MR), patients with missing MR grade at 5-year follow-up were excluded from the analysis.

14. Results (Baseline Characteristics)

15. Results: EFFICACY ENDPOINTS AT 5-YEARS

16. ResultS: 5-YEAR CLINICAL OUTCOMES
5-Year Clinical Outcomes: Percutaneous Repair and Surgery for Mitral Regurgitation Kaplan-Meier curves depict (A) freedom from the composite of death, mitral valve (MV) surgery, or reoperation, (B) freedom from death, (C) freedom from MV surgery or reoperation, and (D) landmark analysis of freedom from MV surgery or reoperation beyond 6 months after percutaneous repair or surgery. Although patients undergoing percutaneous repair more commonly required surgery for residual mitral regurgitation during the first year after treatment, comparably low rates of surgery for MV dysfunction with either percutaneous or surgical therapy were seen between 1- and 5-year follow-up. RCT = randomized clinical trial.

17. Results: SEVERITY OF MR AND SYMPTOMS
Severity of MR and Heart Failure Symptoms Post-Treatment For patients who survived to 5 years and had pertinent data reported at each time point, comparisons are seen for (A) echocardiographic severity of MR in 101 and 40 patients in the device and surgery arms, respectively, and (B) New York Heart Association functional class in 105 and 40 patients in the device and surgery arms, respectively. MR = mitral regurgitation.

18. Results: SUBGROUP ANALYSES

19. Results: PREDICTORS OF 5-YEAR MORTALITY

20. 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.

21. Discussion

22. Strengths of the study First rct of perc repair versus surgery
Independent echo core lab
Independent adjudication committee

23. Limitations of the study
Heterogeneous study populations: functional and degenerative mr
Inclusion criteria: 3+ regurgitation
Only 24% had 4+ (Severe) 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

24. 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

25. Impact of the study

26. How has the study impacted on practice
Role for percutaenous mitral valve repair
Inoperable or high risk patients
Functional mr patients