Midterm outcomes of aortic valve replacement using a rapid-deployment valve for aortic stenosis: TRANSFORM trial.
Document Type
Article
Publication Date
2-1-2024
Publication Title
JTCVS Open
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
Cardiology
Specialty
Surgery
Recommended Citation
Malaisrie, S Chris; Mumtaz, Mubashir A; Barnhart, Glenn R; Chitwood, Randolph; Ryan, William H; Accola, Kevin D; Patel, Himanshu J; Woo, Y Joseph; Dewey, Todd M; Koulogiannis, Konstantinos; Dorsey, Michael P; and Grossi, Eugene A, "Midterm outcomes of aortic valve replacement using a rapid-deployment valve for aortic stenosis: TRANSFORM trial." (2024). Articles, Abstracts, and Reports. 8660.
https://digitalcommons.providence.org/publications/8660
