Janusz Lipiecki1, David M Kaye2, Klaus K Witte3, Michael Haude4, Samir Kapadia5, Horst Sievert6, Steven L Goldberg7, Wayne C Levy8, Tomasz Siminiak9. 1. Centre de Cardiologie Interventionnelle, Elsan, Pôle Santé République, Clermont-Ferrand, France. Electronic address: jlipiecki@polesanterepublique.com. 2. Department of Cardiology, Alfred Hospital, Melbourne, Australia. 3. Leeds Institute for Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, United Kingdom. 4. Medical Clinic I Städtische Kliniken Neuss Lukaskrankenhaus, Neuss, Germany. 5. Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, United States of America. 6. CardioVascular Center Sankt Katharinen, Frankfurt, Germany; Anglia Ruskin University, Chelmsford, United Kingdom. 7. Tyler Heart Institute at Community Hospital of the Monterey Peninsula, Monterey, CA, United States of America; Cardiac Dimensions, Kirkland, WA, United States of America. 8. Advanced Heart Failure, Division of Cardiology, University of Washington Heart Institute, Seattle, WA, United States of America. 9. Poznan University of Medical Sciences, HCP Medical Center, Poznan, Poland.
Abstract
PURPOSE: To report long-term survival and to identify potential determinants of survival among patients receiving treatment for functional mitral regurgitation (FMR) with the Carillon device. METHODS: This was a post hoc analysis in which we pooled prospectively collected data from three studies of the Carillon device with available long-term vital status data. Patient eligibility in these trials specified symptomatic congestive heart failure despite guideline-directed medical therapy, grade 2 to 4 FMR, left ventricular enlargement, and reduced ejection fraction. Echocardiographic parameters were available through the 12-month visit and vital status was available through 5 years. The association of patient characteristics and changes in echocardiographic parameters at 6 and 12 months with long-term survival was analyzed using Cox proportional hazards regression. RESULTS: A total of 74 patients (mean age 67 years, 72% male, 59% MR grade 3 or 4) were treated with the Carillon device. Over 1 year of follow-up, the New York Heart Association (NYHA) class decreased in 64% of patients, distance on the 6-minute walk test increased, and echocardiographic measures indicated significant decreases in MR grade and favorable left ventricular remodeling. The Kaplan-Meier survival rate was 83.6% at 1 year, 73.1% at 2 years, 67.9% at 3 years, and 56.2% at 4 and 5 years of follow-up. Primary determinants of long-term survival were a decrease in NYHA class, an increase in 6-minute walk test distance, and a decrease in regurgitant volume during the first year of follow-up. CONCLUSIONS: Among patients with congestive heart failure and grade 2 to 4 FMR who were symptomatic despite guideline-directed medical therapy, transcatheter mitral valve repair with the Carillon device resulted in a favorable 5-year survival rate. The survival benefit was greatest among patients with improvement in clinical and hemodynamic parameters during the first year of follow-up.
PURPOSE: To report long-term survival and to identify potential determinants of survival among patients receiving treatment for functional mitral regurgitation (FMR) with the Carillon device. METHODS: This was a post hoc analysis in which we pooled prospectively collected data from three studies of the Carillon device with available long-term vital status data. Patient eligibility in these trials specified symptomatic congestive heart failure despite guideline-directed medical therapy, grade 2 to 4 FMR, left ventricular enlargement, and reduced ejection fraction. Echocardiographic parameters were available through the 12-month visit and vital status was available through 5 years. The association of patient characteristics and changes in echocardiographic parameters at 6 and 12 months with long-term survival was analyzed using Cox proportional hazards regression. RESULTS: A total of 74 patients (mean age 67 years, 72% male, 59% MR grade 3 or 4) were treated with the Carillon device. Over 1 year of follow-up, the New York Heart Association (NYHA) class decreased in 64% of patients, distance on the 6-minute walk test increased, and echocardiographic measures indicated significant decreases in MR grade and favorable left ventricular remodeling. The Kaplan-Meier survival rate was 83.6% at 1 year, 73.1% at 2 years, 67.9% at 3 years, and 56.2% at 4 and 5 years of follow-up. Primary determinants of long-term survival were a decrease in NYHA class, an increase in 6-minute walk test distance, and a decrease in regurgitant volume during the first year of follow-up. CONCLUSIONS: Among patients with congestive heart failure and grade 2 to 4 FMR who were symptomatic despite guideline-directed medical therapy, transcatheter mitral valve repair with the Carillon device resulted in a favorable 5-year survival rate. The survival benefit was greatest among patients with improvement in clinical and hemodynamic parameters during the first year of follow-up.
Authors: Janusz Lipiecki; Hicham Fahrat; Séverine Monzy; Nicolat Caillot; Tomasz Siminiak; Tim Johnson; Suzanne Vogt; Matthew A Stark; Steven L Goldberg Journal: ESC Heart Fail Date: 2020-10-13