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First-in-Man Experience of a Novel Transcatheter Repair System for Treating Severe Tricuspid Regurgitation.

Abstract：

BACKGROUND:Isolated tricuspid valve surgery is associated with high morbidity and mortality, especially in patients with prior cardiac surgery. The transcatheter Forma Repair System (Edwards Lifesciences, Irvine, California) is designed to provide a surface for native leaflet coaptation to reduce tricuspid regurgitation (TR) by occupying the regurgitant orifice area. OBJECTIVES:This study sought to evaluate the feasibility and exploratory efficacy with this transcatheter repair system for the treatment of severe TR. METHODS:Seven high-risk patients with severe TR and clinical signs of heart failure were declined for surgery and offered transcatheter treatment with this device. All procedures were performed within a cardiac catheterization laboratory or hybrid operating room under general anesthesia with transesophageal echocardiographic guidance. Vascular access was via the left axillary vein. Baseline characteristics, procedural and in-hospital outcomes, as well as 30-day follow-up were prospectively collected. RESULTS:All patients had severe TR and New York Heart Association (NYHA) functional class II to IV (mean age 76 ± 13 years; mean logistic EuroSCORE 25.7 ± 17.4%), and underwent device implantation to improve tricuspid leaflet coaptation, thereby reducing TR. Device implantation was successful without procedural complications in all patients, with significant reductions in TR severity (moderate in 3 patients and mild in 4 patients). Median hospital length of stay was 4 days. At 30-day follow-up, all patients but 1 demonstrated improvements in NYHA functional status (to class II) with pronounced reductions in the presence and severity of peripheral edema. TR severity was assessed as being moderate at 30-day transthoracic echocardiography follow-up in all patients. No complications related to the device or vascular access were observed during follow-up. CONCLUSIONS:A transcatheter-based treatment option for severe TR appears safe and feasible with this repair system. Improvements in TR severity were documented in all patients, which were accompanied by improvements in peripheral edema and functional status.

journal_name

J Am Coll Cardiol

journal_title

Journal of the American College of Cardiology

authors

Campelo-Parada F,Perlman G,Philippon F,Ye J,Thompson C,Bédard E,Abdul-Jawad Altisent O,Del Trigo M,Leipsic J,Blanke P,Dvir D,Puri R,Webb JG,Rodés-Cabau J

doi

10.1016/j.jacc.2015.09.068

subject

Has Abstract

pub_date

2015-12-08 00:00:00

pages

2475-83

issue

eissn

0735-1097

issn

1558-3597

pii

S0735-1097(15)06686-3

journal_volume

pub_type

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First-in-Man Experience of a Novel Transcatheter Repair System for Treating Severe Tricuspid Regurgitation.