Author + information
- Received March 4, 2011
- Revision received June 20, 2011
- Accepted June 24, 2011
- Published online November 15, 2011.
- Angelo Auricchio, MD, PhD⁎,⁎ (, )
- Wolfgang Schillinger, MD†,
- Sven Meyer, MD‡,
- Francesco Maisano, MD§,
- Rainer Hoffmann, MD∥,
- Gian Paolo Ussia, MD¶,
- Giovanni B. Pedrazzini, MD⁎,
- Jan van der Heyden, MD#,
- Simona Fratini, MD, PhD⁎⁎,
- Catherine Klersy, MD, MSc††,
- Jan Komtebedde, DVM⁎,
- Olaf Franzen, MD‡,
- PERMIT-CARE Investigators
- ↵⁎Reprint requests and correspondence:
Dr. Angelo Auricchio, Division of Cardiology, Fondazione Cardiocentro Ticino, Via Tesserete 48, CH-6900 Lugano, Switzerland
Objectives This study evaluated the safety, efficacy, and effect of MitraClip treatment on symptoms and left ventricular (LV) remodeling in nonresponders to cardiac resynchronization therapy (CRT).
Background Moderate to severe functional mitral regurgitation (FMR) frequently persists after CRT, contributing to reduced or no response to CRT. Percutaneous repair with the MitraClip has been proposed as an additional therapeutic option in select patients with significant FMR.
Methods Fifty-one severely symptomatic CRT nonresponders with significant FMR (grade ≥2, 100%) underwent MitraClip treatment. Changes in New York Heart Association functional class, degree of FMR, LV ejection fraction (EF), and LV end-diastolic/end-systolic volumes (EDV/ESV) before and after (3, 6, and 12 months) MitraClip implantation were recorded. Mortality data, including cause of death, were collected.
Results MC treatment was feasible in all patients (49% 1 clip, 46% 2 clips). There were 2 periprocedural deaths. Median follow-up was 14 months (25th to 75th percentile: 8 to 17 months). New York Heart Association functional class improved acutely at discharge (73%) and continued to improve progressively during follow-up (regression model, p < 0.001). The proportion of patients with significant residual FMR (grade ≥2) progressively decreased during follow-up (regression model, p < 0.001). Reverse LV remodeling and improved LVEF were detected at 6 months, with further improvement at 12 months (regression model, p = 0.001, p = 0.008, and p = 0.031 for ESV, EDV, and LVEF, respectively). Overall 30-day mortality was 4.2%. Overall mortality during follow-up was 19.9 per 100 person-years (95% confidence interval: 10.3 to 38.3). Nonsurvivors had more compromised clinical baseline conditions, longer QRS duration, and a more dilated heart.
Conclusions FMR treatment with the MitraClip in CRT nonresponders was feasible, safe, and demonstrated improved functional class, increased LVEF, and reduced ventricular volumes in about 70% of these study patients.
Dr. Auricchio is a consultant to Medtronic, Biotronik, Sorin, BDS-Cordis, EBR System, Merck, Abbott Laboratories, and Philips; and received speaker fees from Medtronic, Biotronik, Sorin, Merck, Abbott Laboratories, and Philips. Dr. Schillinger has received speaker honoraria, reimbursement for travel expenses, is a proctor, and is a consultant for Abbott Vascular. Dr. Fratini is a consultant to Abbott Vascular. Dr. Maisano is a consultant to Abbott Vascular, Valtech Cardio, Medtronic, Edwards Lifesciences, St. Jude, and Apica. Dr. Hoffmann is a consultant to GE Ultrasound; and received speaker fees from Novartis, Abbott Laboratories, GE Ultrasound, and Daiichi-Sankyo. Dr. van der Heyden is a proctor for Abbott/Evalve. Dr. Komtebedde was previously employed by Abbott Laboratories. Dr. Franzen has received royalties from and has served as a proctor and on the advisory board of Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received March 4, 2011.
- Revision received June 20, 2011.
- Accepted June 24, 2011.
- American College of Cardiology Foundation