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

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. 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. 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 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.

© 2023 The Author(s).

Dr Malaisrie reported research grants, consulting fees, and honoraria from 10.13039/100006520Edwards Lifesciences, 10.13039/100004374Medtronic, Artivion, and Terumo Aortic. Dr Mumtaz reported consulting fees, honoraria, and research grants from 10.13039/100006520Edwards Lifesciences, 10.13039/100004374Medtronic, 10.13039/100007330AtriCure, 10.13039/100024655Teleflex, and 10.13039/100000046Abbott. Dr Barnhart reported consulting for Articure and Artivion. Dr Chitwood reported consulting for NeoChord and Edwards Lifesciences. Dr Accola reported consulting fees and honoraria from Edwards Lifesciences. Dr Dewey reported serving as a speaker for Abbott as well as a speaker, proctor, and consultant for Edwards Lifesciences. Dr Koulogiannis reported consulting for Edwards Lifesciences and Abbott. Dr Grossi reported intellectual property and royalties from Medtronic for valve repair devices and intellectual property and royalties from Edwards Lifesciences. Drs Ryan, Patel, Woo, and Dorsey reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest.