2017 Buyer’s Guide

This buyer’s guide offers a searchable, comprehensive listing of the FDA-approved interventional devices available in the United States.

Patient Characteristics Evaluated in International, Multicenter TriValve Registry

 

October 3, 2017—An evaluation of patients undergoing transcatheter tricuspid repair was published by Maurizio Taramasso, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2017;10:1982–1990).

As explained in JACC: Cardiovascular Interventions, several transcatheter tricuspid valve therapies are emerging as therapeutic options for patients with severe symptomatic tricuspid regurgitation, which is generally a high-risk surgical population. The investigators sought to develop the large, multicenter, international TriValve registry to evaluate the diffusion of these approaches and investigate patient characteristics and initial clinical results.

The TriValve registry included 106 high-risk patients with severe tricuspid regurgitation (76 ± 9 years of age; 60.4% women; European System for Cardiac Operative Risk Evaluation II, 7.6 % ± 5.7%) from 11 cardiac centers.

The investigators reported that 35% of the patients had previous left heart valve intervention (surgical in 29 of 106 patients and transcatheter in 8 of 106 patients). Right ventricular dysfunction (tricuspid annular plane systolic excursion < 17 mm) was present in 56.3% of the patients; 95% of the patients were New York Heart Association functional class III to IV. The etiology of tricuspid regurgitation was functional in 95.2%, and the mean tricuspid annulus was 45.4 ± 11 mm.

In 76.9% of the patients, the main location of the regurgitant jet was central, preprocedural systolic pulmonary artery pressure was 39.7 ± 13.8 mm Hg, and the inferior vena cava was severely dilated in most of the patients (27.4 ± 6.8 mm).

Implanted devices included MitraClip (Abbott Vascular; n = 58), Trialign (Mitralign; n = 17), TriCinch (4Tech Inc.; n = 15), Forma (Edwards Lifesciences; n = 7), Cardioband (Edwards Lifesciences; n = 5), and caval valve implantation (n = 3). One case had combined Trialign and MitraClip devices. Patients were similar in terms of European System for Cardiac Operative Risk Evaluation II and degree of right ventricular dysfunction.

Tricuspid intervention was performed as an isolated procedure in 68% of the cases. Procedural success was achieved in 62% of cases. At 30-day follow-up, all-cause mortality was 3.7%, with an overall incidence of major adverse cardiac and cerebrovascular events of 26%, and 58% of the patients were New York Heart Association functional class I or II.

The investigators concluded that patients currently undergoing transcatheter tricuspid valve therapy are mostly high risk, with a functional etiology and very severe central regurgitation, and do not have severely impaired right ventricular function. Initial results suggest that transcatheter tricuspid valve therapy is feasible with different techniques, but clinical efficacy requires further investigation, stated the investigators in JACC: Cardiovascular Interventions.

 

Contact Info

For advertising rates and opportunities, contact:
Craig McChesney
484-581-1816
cmcchesney@bmctoday.com

Stephen Hoerst
484-581-1817
shoerst@bmctoday.com

Charles Philip
484-581-1873
cphillip@bmctoday.com

About Cardiac Interventions Today

Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.