Predictors for efficacy of percutaneous mitral valve repair using the MitraClip system: the results of the MitraSwiss registry

Abstract

BACKGROUND: Percutaneous mitral valve repair (MVR) using the MitraClip system has become a valid alternative for patients with severe mitral regurgitation (MR) and high operative risk. OBJECTIVE: To identify clinical and periprocedural factors that may have an impact on clinical outcome. DESIGN: Multi-centre longitudinal cohort study. SETTING: Tertiary referral centres. PATIENTS: Here we report on the first 100 consecutive patients treated with percutaneous MVR in Switzerland between March 2009 and April 2011. All of them had moderate-severe (3+) or severe (4+) MR, and 62% had functional MR. 82% of the patients were in New York Heart Association (NYHA) class III/IV, mean left ventricular ejection fraction was 48% and the median European System for Cardiac Operative Risk Evaluation was 16.9%. INTERVENTIONS: MitraClip implantation performed under echocardiographic and fluoroscopic guidance in general anaesthesia. MAIN OUTCOME MEASURES: Clinical, echocardiographic and procedural data were prospectively collected. RESULTS: Acute procedural success (APS, defined as successful clip implantation with residual MR grade 2+) was achieved in 85% of patients. Overall survival at 6 and 12 months was 89.9% (95% CI 81.8 to 94.6) and 84.6% (95% CI 74.7 to 91.0), respectively. Univariate Cox regression analysis identified APS (p=0.0069) and discharge MR grade (p=0.03) as significant predictors of survival. CONCLUSIONS: In our consecutive cohort of patients, APS was achieved in 85%. APS and residual discharge MR grade are important predictors of mid-term survival after percutaneous MVR.

The MitraClip System: A Systematic Review of Indications, Procedural Requirements, and Guidelines

“…In the early postoperative course, the MAE Multimorbidity, high-risk patient, contraindication for oMVS: log EuroScore > 20% and/or STS-Score >10% 11,13,14,19,21,24,26,31,35,42,43,48,49 AHA/ASC/ESC criteria for oMVS fulfilled [10][11][12]20,21,38,40,43,45,47,50 Previous cardiac surgery 13,14,20,26,40,45 Echocardiographic criteria for treatment with MitraClip system fulfilled 8,9,19,32,33 Chest radiation/porcelain aorta 8,9,16,26,45,51 Possible indications…”

Almanac 2013: novel non-coronary cardiac interventions

“…Ureaj MitraClip je dobio CE odobrenje i veÊ se koristi kod tisuÊe bolesnika diljem svijeta. 25,26 Dok se ne ishodi odobrenje od FDA, "kvaËica" je dostupna u SAD samo sudjelovanjem u REALISM registru otvorenog tipa. Pacijenti ukljuËeni u ovaj kliniËki registar uvrπteni su u skupinu visokoriziËnih ili skupinu bolesnika bez visokog rizika.…”

“…Analiza prvih 100 bolesnika u πvicarskom MitraSwiss registru je pokazala da su kongestivno zatajivanje srca i prethodna operacija premoπtenja koronarnih arterija (CABG) prije implantacije bili prediktori loπeg ishoda s MitraClip sustavom. 26 Smanjenje MR na ≤2+ tijekom postupka i niski stupanj MR kod otpusta su bili prediktori boljeg srednjoroË-nog preaeivljavanja. Gaemperli i sur.…”

“…An analysis of the first 100 patients in the MitraSwiss register from Switzerland showed that congestive heart failure before clip implantation and previous coronary artery bypass grafting (CABG) were predictors of poor outcome with the MitraClip procedure. 26 A reduction of MR to ≤2+ during the procedure and a low grade MR at discharge predicted better mid-term survival. Gaemperli et al 30 documented an improvement in the haemodynamic profile immediately after the procedure.…”

“…25,26 Until approval is obtained from the FDA, the clip is available only through the REALISM continued access registry in the USA. Patients enrolled into this 'real-world' registry are assigned to either the high risk arm or the non-high risk arm.…”