Midterm outcomes of aortic valve replacement using a rapid-deployment valve for aortic stenosis: TRANSFORM trial.

Publication Title

JTCVS Open

Authors

S Chris Malaisrie
Mubashir A Mumtaz
Glenn R Barnhart, Swedish Heart and Vascular Institute, Structural Heart Program, Seattle, Washington.Follow
Randolph Chitwood
William H Ryan
Kevin D Accola
Himanshu J Patel
Y Joseph Woo
Todd M Dewey
Konstantinos Koulogiannis
Michael P Dorsey
Eugene A Grossi

Document Type

Article

Publication Date

2-1-2024

Keywords

washington; swedish; swedish heart

Abstract

BACKGROUND: The use of rapid-deployment valves (RDVs) has been shown to reduce the operative time for surgical aortic valve replacement (AVR). Long-term core laboratory-adjudicated data are scarce, however. Here we report final 7-year data on RDV use.

METHODS: TRANSFORM was a prospective, nonrandomized, multicenter, single-arm trial implanting a stented bovine pericardial valve with an incorporated balloon-expandable sealing frame. A prior published 1-year analysis included 839 patients from 29 centers. An additional 46 patients were enrolled and implanted, for a total of 885 patients. Annual clinical and core laboratory-adjudicated echocardiographic outcomes were collected through 8 years. Primary endpoints were structural valve deterioration (SVD), all-cause reintervention, all-cause valve explantation, and all-cause mortality. Secondary endpoints included hemodynamic performance assessed by echocardiography. The mean duration of follow-up was 5.0 ± 2.0 years.

RESULTS: The mean patient age was 73.3 ± 8.2 years. Isolated AVR was performed in 62.1% of the patients, and AVR with concomitant procedures was performed in 37.9%. Freedom from all-cause mortality at 7 years was 76.0% for isolated AVR and 68.2% for concomitant AVR. Freedom from SVD, all-cause reintervention, and valve explantation at 7 years was 97.5%, 95.7%, and 97.8%, respectively. The mean gradient and effective orifice area at 7 years were 11.1 ± 5.3 mm Hg and 1.6 ± 0.3 cm

CONCLUSIONS: AVR for aortic stenosis using an RDV is associated with low rates of late adverse events. This surgical pericardial tissue platform provides excellent and stable hemodynamic performance through 7 years.

Clinical Institute

Cardiovascular (Heart)

Specialty/Research Institute

Cardiology

Specialty/Research Institute

Surgery

DOI

10.1016/j.xjon.2023.10.034