First in human experience with an epicardial beating heart device for secondary mitral regurgitation

Published:December 14, 2020DOI:



      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).


      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.


      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.


      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.

      Graphical abstract

      Key Words

      Abbreviations and Acronyms:

      AV (atrioventricular), CABG (coronary artery bypass grafting), CT (computed tomography), CTSN (Cardiothoracic Surgical Trials Network), EROA (effective regurgitant orifice area), HF (heart failure), LV (left ventricle), LVEDD (left ventricular end-diastolic diameter), LVEDV (left ventricular end-diastolic volume), LVESV (left ventricular end-systolic volume), MR (mitral regurgitation), MV (mitral valve), SMR (secondary mitral regurgitation), SL (septal-lateral), TEE (transesophageal echocardiography), TTE (transthoracic echocardiography)
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      Linked Article

      • Commentary: Another epicardial device for secondary mitral regurgitation: Is this one different?
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          Thourani and colleagues1 describe a novel, off-pump, epicardial implant intended to reshape the mitral valve and remodel the left ventricle, and they report outcomes after implantation of this device for treatment of secondary mitral regurgitation (MR) in 5 patients undergoing concomitant off-pump coronary artery bypass grafting. The authors should be commended on the first-in-human experience with the Mitral Touch (Mitre Medical Corp, Morgan Hill, Calif) device and implanting it with technical success and favorable outcomes at 1 year.
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