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Clinical Trial
. 2023 Jul;29(7):1046-1055.
doi: 10.1016/j.cardfail.2023.03.003. Epub 2023 Mar 22.

Transcatheter Left Ventricular Restoration in Patients With Heart Failure

Nadira Hamid  1 , Ulrich P Jorde  2 , Mark Reisman  3 , Azeem Latib  2 , D Scott Lim  4 , Susan M Joseph  5 , Alena Kurlianskaya  6 , Oleg Polonetsky  6 , Petr Neuzil  7 , Vivek Reddy  8 , Jason Foerst  9 , Hemal Gada  10 , Kendra J Grubb  11 , Guilherme Silva  12 , Dean Kereiakes  13 , Satya Shreenivas  13 , Sean Pinney  14 , Giedrius Davidavicius  15 , Paul Sorajja  16 , John P Boehmer  17 , Franz X Kleber  18 , Patrick Perier  19 , Nicolas M VAN Mieghem  20 , Nicolas Dumonteil  21 , Martin B Leon  1 , Daniel Burkhoff  22
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Free article
Clinical Trial

Transcatheter Left Ventricular Restoration in Patients With Heart Failure

Nadira Hamid et al. J Card Fail. 2023 Jul.
Free article

Abstract

Background: Left ventricular (LV) volume reshaping reduces myocardial wall stress and may induce reverse remodeling in patients with heart failure with reduced ejection fraction. The AccuCinch Transcatheter Left Ventricular Restoration system consists of a series of anchors connected by a cable implanted along the LV base that is cinched to the basal free wall radius. We evaluated the echocardiographic and clinical outcomes following transcatheter left ventricular restoration.

Methods and results: We analyzed 51 heart failure patients with a left ventricular ejection fraction between 20% and 40%, with no more than 2+ mitral regurgitation treated with optimal medical therapy, who subsequently underwent transcatheter left ventricular restoration. Serial echocardiograms, Kansas City Cardiomyopathy Questionnaire scores, and 6-minute walk test distances were measured at baseline through 12 months. Primary analysis end point was change in end-diastolic volume at 12 months compared with baseline. Patients (n = 51) were predominantly male (86%) with a mean age of 56.3 ± 13.1 years. Fluoroscopy showed LV free wall radius decreased by a median of 9.2 mm amounting to a 29.6% decrease in the free wall arc length. At 12 months, the LV end-diastolic volume decreased by 33.6 ± 34.8 mL (P < .01), with comparable decreases in the LV end-systolic volume. These decreases were associated with significant improvements in the overall Kansas City Cardiomyopathy Questionnaire score (16.4 ± 18.7 points; P < .01) and 6-minute hall walk test distance (45.9 ± 83.9 m; P < .01). There were no periprocedural deaths; through the 1-year follow-up, 1 patient died (day 280) and 1 patient received a left ventricular assist device (day 13).

Conclusions: In patients with heart failure with reduced ejection fraction without significant mitral regurgitation receiving optimal medical therapy, the AccuCinch System resulted in decreases of LV volume, as well as improved quality of life and exercise endurance. A randomized trial is ongoing (NCT04331769).

Keywords: Transcatheter; heart failure; left ventricle.

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Conflict of interest statement

Conflicts of Interest Nadira Hamid reports Institutional grant support. Ulrich Jorde reports travel support from Ancora Heart. Mark Reisman reports travel support from Ancora Heart. Azeem Latib has nothing to declare. D. Scott Lim has nothing to declare. Susan Joseph has nothing to declare. Alena Kurlianskaya has nothing to declare. Oleg Polonetsky, MD, reports consultancy fees from Ancora Heart, and consultancy or proctoring fees from Edwards Lifesciences and Medtronic. Petr Neuzil has nothing to declare. Vivek Reddy has nothing to declare. Jason Foerst has nothing to declare. Hemal Gada has nothing to declare. Kendra J. Grubb reports advisory board and consulting fees for Medtronic, Boston Scientific, Abbott, Ancora, 4C Medical, and honorarium for Edwards Lifesciences. Guilherme Silva has nothing to declare. Dean Kereiakes has nothing to declare. Satya Shreenivas has nothing to declare. Sean Pinney reports consulting fees from Abbott, CareDx, Medtronic, Procyrion, and Transmedics. Giedrius Davidavicius is a consultant to Ancora Heart. Paul Sorajja has nothing to declare. John Boehmer has nothing to declare. Franz X. Kleber is a consultant to Ancora Heart. Patrick Perier has nothing to declare. Nicolas M. Van Mieghem reports research grant support from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, PulseCath BV, Abiomed, Siemens, and Daiichi Sankyo. Nicolas Dumonteil reports consultancy fees from Ancora Heart, is the co-PI of the CorCinch European study; and reports consultancy and proctoring fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. Martin B. Leon reports institutional clinical research grants from Abbott, Abiomed, Ancora, Boston Scientific, Edwards, and Medtronic. Daniel Burkhoff reports institutional grant support from Ancora Heart to the Cardiovascular Research Foundation.

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