Mid-term outcomes of the COMMENCE trial investigating mitral valve replacement using a bioprosthesis with a novel tissueCentral MessagePerspective
David A. Heimansohn, MD,
Craig Baker, MD,
Evelio Rodriguez, MD,
Hiroo Takayama, MD, PhD,
Francois Dagenais, MD,
David S. Talton, MD,
Mubashir A. Mumtaz, MD,
Philippe Pibarot, DMV, PhD,
John D. Puskas, MD
Affiliations
David A. Heimansohn, MD
St Vincent The Heart Center of Indiana, Indianapolis, Ind; Address for reprints: David A. Heimansohn, MD, St Vincent The Heart Center of Indiana, 10590 North Meridian St, Suite 105, Indianapolis, IN 46290.
Craig Baker, MD
Depertament of Cardiothoracic Surgery, Cardiovascular Thoracic Institute, University of Southern California, Los Angeles, Calif
Evelio Rodriguez, MD
Ascension Saint Thomas Heart, Nashville, Tenn
Hiroo Takayama, MD, PhD
Columbia University Irving Medical Center, New York Presbyterian Hospital, Division of Cardiothoracic and Vascular Surgery, New York, NY
Francois Dagenais, MD
North Mississippi Medical Center, Tupelo, Miss
David S. Talton, MD
Institut Universitaire de Cardiology et Pneumologie de Quebec, Quebec, Canada
Mubashir A. Mumtaz, MD
Department of Cardiovascular and Thoracic Surgery, UPMC Central Pennsylvania, Harrisburg, Pa
Philippe Pibarot, DMV, PhD
Department of Cardiology, Québec Heart and Lung Institute, Laval University, Quebec, Canada
John D. Puskas, MD
Department of Cardiovascular Surgery, Mount Sinai Morningside, New York, NY
Objective: Novel tissue leaflets (RESILIA tissue) may improve durability of bioprosthetic heart valves. The COMMENCE trial is an ongoing prospective study to evaluate valve replacement using RESILIA tissue. This report describes mid-term outcomes in the mitral cohort of COMMENCE. Methods: Adult patients requiring mitral valve replacement were enrolled in a prospective, single-arm trial at 17 sites in the United States and Canada. An independent clinical events committee adjudicated safety events using definitions from established guidelines, and hemodynamic performance was evaluated by an independent echocardiographic core laboratory. Results: Eighty-two patients (median age 70 years) successfully underwent mitral valve replacement with the study valve. Five-year event-free probabilities for all-cause mortality, structural valve deterioration, and reoperation were 79.9%, 98.7%, and 97.1%, respectively. Hemodynamic valve function measurements were stable through the 5-year follow-up period; valvular leaks were infrequently observed and primarily clinically insignificant/mild. Conclusions: Mitral valve replacement patients implanted with a RESILIA tissue bioprosthesis had a good safety profile and clinically stable hemodynamic performance.
