Transcatheter valve replacement curbs tricuspid regurgitation in many

Reuters Health - 26/11/2020 - Patients at high surgical risk with severe, symptomatic functional tricuspid regurgitation (TR) treated with a first-generation transcatheter tricuspid-valve implantation (TTVI) system show significant clinical improvement, according to a multicenter report of compassionate use.

"Further refinement of the implantation algorithm may reduce malpositioning of the device, leading to better TR reduction," Dr. Rebecca T. Hahn of New York-Presbyterian Hospital, in New York City, told Reuters Health by email. "Device iteration towards reduced invasiveness and improved patient-selection criteria are needed to improve procedural safety, along with larger prospective studies to assess the impact on long-term clinical outcomes."

Isolated TR surgery is associated with high in-hospital mortality, Dr. Hahn and her colleagues note in JACC: Cardiovascular Interventions. To evaluate the feasibility and safety of TTVI in patients at "extreme" surgical risk, the researchers examined data on 30 patients from 10 institutions.

The patients had severe or greater TR and reduced baseline right ventricular function, and 86% of them had New York Heart Association (NYHA) functional class III or IV.

All were on antiplatelet or anticoagulant agents and had multiple comorbidities including chronic kidney disease seen in 63%. More than half (57%) had had prior hospitalizations for right heart failure and 90% were in atrial fibrillation or flutter.

Technical success was achieved in 26 of the patients but device malpositioning in the remaining four led to open-heart surgery in two (5%). All who received the device had reductions in TR of at least one grade and 75% experienced reductions of two or more grades.

At mean follow-up of more than three months, four patients had died but 62% of the remainder were NYHA functional class I or II, with no late device-related adverse events.

"I think the advantages of the transcatheter tricuspid valve replacement devices are that these devices can treat many different etiologies (primary leaflet disease, as well as functional disease due to annular dilatation or ventricular dilatation) and can treat a wide range of tricuspid regurgitation (severe, massive or torrential) with likely equal efficacy," Dr. Hahn said.

However, she added, "We will need to determine the optimal patients for these devices, the post-device management issues and the long-term clinical outcomes."

In an accompanying editorial, Drs. Joerg Hausleiter and Nicole Karam of University Clinic, in Munich, Germany, agree, pointing out, "As it is always the case in the beginning of a new and promising era, such encouraging reports raise a number of questions, which need to be addressed in the future: The central question is, which patient will be the ideal candidate for TTVI?"

The system used in the study was produced by NaviGate Cardiac Structures. Dr. Hahn and other authors have relationships with the company.

SOURCE: https://bit.ly/3nugOy6 and https://bit.ly/3puleHl JACC: Cardiovascular Interventions, online November 9, 2020.

By David Douglas



Posted on 26 November, 20204 December, 2020