EVOLUTION: Clinical EValuation Of the Edwards Lifesciences percUTaneous mItral annulOplasty system for the treatment of mitral regurgitatioN  

	Presenter
	Presenter | see Discussant report
Harnek, Jan (Sweden)

List of Authors:

Abstract

Introduction

3-Year Interim Results of the Percutaneous MONARC™ System for the Treatment of Functional Mitral Regurgitation
Functional mitral regurgitation (FMR) is frequently observed in heart failure pts with ischemic or dilated cardiomyopathy and associated with poor prognosis. The aim of the prospective, multicenter, non randomized feasibility study was to assess the safety and efficacy of a percutaneous coronary sinus approach, with the MONARC system to reduce FMR up to 3-years. Primary objective of the study is to evaluate the acute safety (30d, 90d) of the MONARC system in treating functional mitral regurgitation in heart failure patients. Secondary objective of the study is reduction in MR by at least one grade at 90 days.  

Inclusion / Exclusion Criteria

 
INCLUSION

• Functional mitral valve regurgitation : dilated or ischemic cardiomyopathy
• MR grade 2+ to 4+ on a scale of 4+
• Coronary Sinus Dimensions – Target Area is ≥ 14 cm and ≤ 18 cm in length, – Distal section of Target Area, the AIV is ≥ 3 mm in diameter

EXCLUSION

• Organic mitral regurgitation
• Ischemia requiring cardiac revascularization within 3 months prior to or planned after the implant procedure
• Implanted cardiac defibrillator (ICD) or pacing leads within the coronary sinus
• Ejection Fraction < 25%
• Moderate to severe mitral annulus calcification

THE DEVICE
The device is delivered within the coronary sinus via a jugular venous approach The device is composed of 3 components: Self expanding distal anchor, Self expanding proximal anchor and Bridge connecting the anchors.
A biodegradable suture is wound on the bridge and acts as a temporary spacer to hold the spring open in an elongated state. Over about 6 weeks, the suture material dissolves, and the bridge compresses, shortening the coronary sinus

Methods and Results

• 72 patients with FMR grade II to IV were enrolled in the study. Age 70 +/- 10 Years. 72% male gender. 68% had coronary artery disease. 57% previous Mi, 47% CABG, and 40% PCI. NYHA classes: I: 4%, II: 42%, III 50% and IV: 4%. Congestive heart failure 57%.
• In 59 (82%) patients the MONARC, an annular reduction implant was positioned in the coronary sinus/great cardiac vein with a jugular approach in local anaesthesia. In 13 (18%) patients the device was not implanted due to torturous anatomy or size outside the offered rage.
• Clinical evaluation and echocardiography was performed pre-procedure, at day 1, and at 3, 6 months and yearly up to 3 years.
• Coronary angiography and CT scans was performed pre-procedure and at 3 months.
• Core-labs evaluated all examinations.
• Breakdown of matched patients at 3 years: Subjects enrolled n=72. Not implanted n=13. Expired n=16. Study exit n=14. Missing base-line TTE n=7. BiV pacing-leads implant n=3. Image not obtained n=6. Ending up with 13 matched patient were TTE were included in analysis.
• Cumulative safety defined as device migration, death, MI, embolization, cardiac tamponade, coronary sinus thrombosis or pulmonary embolism: 83% at 6 months, 81% at one year, 72 % at 2 years and 64% at 3 years. (19 matched patients)
• NYHA class long-term follow up: at 3 years 83% were in NYHA class I or II, and 16% in NYHA class III, none were in class IV. (12 matched patients)
• MR severity long-term follow up: 38% were in grade 1, 46 grade II and 15% in grade III. None were in grade IV. (13 matched patients)
• Five pts had bi-ventricular pacemaker leads implanted at day 109,149,170,222, and 357.
• 7 pts had subsequently mitral valve surgery at day 70,110, 164, 222, 232, 426 and 430.
• There were 9 non-procedure or device related deaths at day 22, 24, 51, 52, 61, 96, 141, 280, 421 One death was adjudicated device relate at day 551.
• The coronary sinus crossed over the coronary arteries in 56% of cases.
• Compression of a marginal branch was seen in 10 cases. 3 had a clinical event. One was successfully stented. One case resolved itself. One patient died at day 551 in cardiogenic shock after successfully, but late (>1 day) reopening of the artery.

Conclusion

Implantation of the MONARC system is feasible, easy and reproducible. The 3-years data shows 64% of patients are event free compared to baseline. And encouraging 36-months results compared to baseline in respect to MR reduction and clinical functional NYHA class reduction.
EVOLUTION I is solely a safety study. It has a small 3-year sample size and no control group which gave limited insight to clinical benefit.
EVOLUTION II is underway taking into account the lessons learned from EVOLUTION I including a prospective control group, MR and hemodynamic responses and clinical outcomes measuring NYHA class, 6MWT and QoL.

	Discussant
	Discussant | see Presenter abstract
Antunes, Manuel J (Portugal)