Vinod H Thourani1, Isaac George2, Kestutis Rucinskas3, Gintaras Kalinauskas3, Vilius Janusauskas3, Diana Zakarkaite3, Gorav Ailawadi4, Robert Smith5, Michael J Mack5. 1. Department of Cardiovascular Surgery, Marcus Valve Center, Piedmont Heart Institute, Atlanta, Ga. Electronic address: Vinod.thourani@piedmont.org. 2. Division of Cardiothoracic Surgery, New York Presbyterian Hospital-Columbia University Medical Center, New York, NY. 3. Vilnius University Clinic of Cardiac and Vascular Diseases, Vilnius, Lithuania. 4. Division of Cardiothoracic Surgery, University of Virginia, Charlottesville, Va. 5. Baylor Scott & White Heart and Vascular Hospital, Plano, Tex.
Abstract
OBJECTIVE: We describe a novel, off-pump, epicardial implant that is intended to reshape both the mitral valve annulus and the left ventricle (LV) in those with secondary mitral regurgitation (MR). METHODS: Five patients underwent an epicardial implant with the Mitral Touch device (Mitre Medical Corp, Morgan Hill, Calif), during concomitant off-pump coronary artery bypass for secondary MR. The median age was 71.2 years; 4 patients had severe MR and 1 moderate. Patients were followed for 1 year with transthoracic echocardiography and computed tomography. Safety, cardiac remodeling, and MR were assessed by an independent core laboratory. RESULTS: One patient died within 30 days from nondevice-related organ failure and the remaining 4 survived through 1-year follow-up. Implant technical success was 100% and took an average of 52 minutes. Paired computed tomography showed mean left ventricular end-systolic volume remodeling at 1 and 12 months of -35% and -31%, respectively. They averaged left atrial end-systolic volume remodeling of -12% and -15% at 1 and 12 months. Right ventricular end-systolic volume changes of -19% and -8% and right atrial end-systolic volume remodeling of -5% and 1%, at the 1- and 12-month time points were noted. Regurgitant volume by transthoracic echocardiography decreased by 46% and 44% and the ejection fraction from 34.6% to 32.1% and 39.5%, at 1 and 12 months, respectively. There were no device-related complications reported to 1 year. CONCLUSIONS: The Epicardial Mitral Touch System for Mitral Regurgitation (ENRAPT-MR) study demonstrates a first-in-man, off-pump, epicardial repair of secondary MR. Procedural safety and geometric correction of the mitral valve apparatus and LV was achieved. Further studies in the United States are underway.
OBJECTIVE: We describe a novel, off-pump, epicardial implant that is intended to reshape both the mitral valve annulus and the left ventricle (LV) in those with secondary mitral regurgitation (MR). METHODS: Five patients underwent an epicardial implant with the Mitral Touch device (Mitre Medical Corp, Morgan Hill, Calif), during concomitant off-pump coronary artery bypass for secondary MR. The median age was 71.2 years; 4 patients had severe MR and 1 moderate. Patients were followed for 1 year with transthoracic echocardiography and computed tomography. Safety, cardiac remodeling, and MR were assessed by an independent core laboratory. RESULTS: One patient died within 30 days from nondevice-related organ failure and the remaining 4 survived through 1-year follow-up. Implant technical success was 100% and took an average of 52 minutes. Paired computed tomography showed mean left ventricular end-systolic volume remodeling at 1 and 12 months of -35% and -31%, respectively. They averaged left atrial end-systolic volume remodeling of -12% and -15% at 1 and 12 months. Right ventricular end-systolic volume changes of -19% and -8% and right atrial end-systolic volume remodeling of -5% and 1%, at the 1- and 12-month time points were noted. Regurgitant volume by transthoracic echocardiography decreased by 46% and 44% and the ejection fraction from 34.6% to 32.1% and 39.5%, at 1 and 12 months, respectively. There were no device-related complications reported to 1 year. CONCLUSIONS: The Epicardial Mitral Touch System for Mitral Regurgitation (ENRAPT-MR) study demonstrates a first-in-man, off-pump, epicardial repair of secondary MR. Procedural safety and geometric correction of the mitral valve apparatus and LV was achieved. Further studies in the United States are underway.
Authors: Bo Jiang; Ji-Wei Gu; Yan-Yan Song; Lei Bai; Xu-Dong Liu; Yu-Jing Zhang; Ming-Liang Li; Jian Yang; Li Liu; Yun Wang Journal: Int J Gen Med Date: 2021-05-26