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

Published:December 14, 2020DOI:https://doi.org/10.1016/j.jtcvs.2020.11.169

      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.

      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?
        The Journal of Thoracic and Cardiovascular Surgery
        • Preview
          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.
        • Full-Text
        • PDF
      • Commentary: A device for the whole mitral valve apparatus
        The Journal of Thoracic and Cardiovascular SurgeryVol. 161Issue 3
        • Preview
          Ischemic mitral regurgitation (IMR) is complex disease caused by an alteration of the left ventricular (LV) geometry that distorts the whole mitral valve (MV) apparatus.1 Valve dysfunction is mainly related to posterior and lateral displacement of papillary muscles, which leads to apical leaflets tethering and lack of coaptation.2 In addition, the dilatation of septal lateral mitral annulus and the loss of systolic shortening of interpapillary muscle distance, with consequent slackness in the marginal and secondary chordae, alter the mitral force balance and contribute to IMR.
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        • PDF
      • Commentary: Old problem, new solution: Epicardial annuloplasty with left ventricular support for functional mitral regurgitation
        The Journal of Thoracic and Cardiovascular Surgery
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          Functional mitral regurgitation (FMR) remains a challenging problem for surgeons. The optimal surgical treatment is still a matter of significant debate. Over the last decade, surgeons have come to appreciate the pathophysiology of this disease process as a complex interplay between the mitral valve, including its subannular structures, and the left ventricle. In addition, recent surgical and transcatheter trials and subsequent post hoc analyses have suggested that there are in fact multiple phenotypes of FMR (ie, proportionate vs disproportionate) that respond differently to intervention directed at various components of the mitral–ventricular complex.
        • Full-Text
        • PDF