Focus on Aortic Regurgitation and Transcatheter Aortic Valve Replacement
New Research Paper: Structural
Transcatheter Treatment of Native Aortic Valve Regurgitation: The North American Experience With a Novel Device

https://doi.org/10.1016/j.jcin.2023.05.018Get rights and content

Abstract

Background

Transcatheter treatment of patients with native aortic valve regurgitation (AR) has been limited by anatomical factors. No transcatheter device has received U.S. regulatory approval for the treatment of patients with AR.

Objectives

The aim of this study was to describe the compassionate-use experience in North America with a dedicated transcatheter device (J-Valve).

Methods

A multicenter, observational registry was assembled of compassionate-use cases of J-Valve implantation for the treatment of patients with severe symptomatic AR and elevated surgical risk in North America. The J-Valve consists of a self-expanding Nitinol frame, bovine pericardial leaflets, and a valve-locating feature. The available size matrix (5 sizes) can treat a wide range of anatomies (minimum and maximum annular perimeters 57-104 mm).

Results

A total of 27 patients (median age 81 years [IQR: 72-85 years], 81% at high surgical risk, 96% in NYHA functional class III or IV) with native valve AR were treated with the J-Valve during the study period (2018-2022). Procedural success (J-Valve delivered to the intended location without the need for surgical conversion or a second transcatheter heart valve) was 81% (22 of 27 cases) in the overall experience and 100% in the last 15 cases. Two cases required conversion to surgery in the early experience, leading to changes in valve design. At 30 days, there was 1 death, 1 stroke, and 3 new pacemakers (13%), and 88% of patients were in NYHA functional class I or II. No patient had residual AR of moderate or greater degree at 30 days.

Conclusions

The J-Valve appears to provide a safe and effective alternative to surgery in patients with pure AR and elevated or prohibitive surgical risk.

Section snippets

Study design and patients

The compassionate-use study is an investigator-initiated, multicenter, North American observational registry designed to capture the early clinical experience with J-Valve for the treatment of patients with symptomatic, severe, pure AR from May 2018 to October 2022. A total of 5 sites were included in the present analysis: 1) The Christ Hospital (Cincinnati, Ohio); 2) St. Paul’s Hospital (Vancouver, British Columbia, Canada); 3) Houston Methodist (Houston, Texas); 4) Henry Ford Hospital

Results

The baseline characteristics of the study cohort are presented in Table 1. A total of 27 patients with native valve AR were treated with J-Valve during the study period. Consistent with the compassionate-use intent of the protocol, the study cohort was composed of elderly patients (median age 81 years; range: 72-85 years) at either high (81%) or extreme or prohibitive (8%) surgical risk (median Society of Thoracic Surgeons score 4.3; range: 2.6-5.3). Most patients exhibited advanced heart

Discussion

This 5-year (2018-2022) compassionate-use experience with a dedicated THV designed to treat severe native AR in patients at high or prohibitive surgical risk provides several important observations (Central Illustration). First, overall procedural success was 81%, with all complications requiring surgery or urgent placement of a second valve occurring during the first 2 years of the experience with the first generation of the device. Root-cause analyses of these cases led to modifications in

Conclusions

The early North American compassionate-use experience with the J-Valve for the treatment of patients with native AR is characterized by increasingly higher procedural success, few complications, marked reductions in heart failure symptoms, and improvements in valve hemodynamic status. Transcatheter treatment of patients with AR is rapidly evolving, and device enhancements will likely result in expansion of this therapy in the near future.

Funding Support and Author Disclosures

This study was supported by a JC Medical grant to the data coordinating center at the Lindner Center for Research and Education. Dr Garcia has received institutional grant support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Vascular; serves as a proctor and steering committee member for Edwards Lifesciences; and serves on advisory boards for Boston Scientific and Medtronic. Dr Kereiakes is a consultant for JC Medical and JenaValve; and is a member of the ALIGN-AR trial

Cited by (7)

View all citing articles on Scopus

The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the Author Center.

View full text