Adult: Mitral Valve
First in human experience with an epicardial beating heart device for secondary mitral regurgitation

Read at the 100th Annual Meeting of The American Association for Thoracic Surgery: A Virtual Learning Experience, May 22-23, 2020.
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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.

Key Words

mitral regurgitation
mitral repair
mitral valve
beating heart mitral repair
epicardial repair
minimally invasive mitral surgery

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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Supported by Mitre Medical Corp.