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

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(2), respectively. Paravalvular leak at 7 years was none/trace in 88.6% and mild in 11.4%. In patients undergoing isolated AVR, the cumulative probability of pacemaker implantation was 13.9% at 30 days, 15.5% at 1 year, and 21.8% at 7 years. 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.