Background: Transfemoral transcatheter aortic valve replacement (TAVR) was superior to surgical aortic valve replacement (SAVR) in the placement of aortic transcatheter valves (PARTNER) 2A trial (P2). The generalizability of the trial results to the broader population of patients with intermediate surgical risk remains unknown. Objective: To compare the outcomes of SAVR and TAVR among patients with intermediate surgical risk treated in the VA Healthcare System. Methods: We retrospectively analyzed the clinical characteristics and outcomes on all SAVR (1987–2014) and TAVR procedures (2015–2017) performed at the Minneapolis VA Healthcare System. Patients were divided into three groups based on their estimated 30-day mortality risk. The primary outcome was a composite of death or stroke at 30-days. Results: A total of 1,049 patients underwent SAVR with (n = 468, 45%) or without CABG (n = 581, 55%) and 110 underwent TAVR during the study period. Intermediate-risk patients represented 29.4% and 40% of patients undergoing SAVR and TAVR, respectively. The predicted 30-day mortality risk of intermediate-risk patients was 5.5% for the SAVR group and 5.2% for the TAVR group (P = 0.54). The observed combined rate of stroke or death at 30-days for intermediate-risk patients treated with SAVR and TAVR was 11% and 2.2%, respectively (P = 0.05). The results for SAVR and TAVR at the VA were comparable to the P2 trial and STS database (all P = NS). The results did not change when the analysis was restricted to a more contemporary (2005–2014) surgical cohort or isolated SAVR. The number needed to treat to prevent one death/stroke with TAVR was 10. Conclusions: Adoption of TAVR as the preferred treatment modality in intermediate-risk patients may result in significant improvements in morbidity and mortality.
Bibliographical noteFunding Information:
Sponsor: The study was supported by Edwards Lifesciences through an investigator-initiated grant to the Minnesota Veterans Research Foundation. The sponsor had no role in the design of the study or writing of the manuscript.
Dr. Garcia is a consultant for Surmodics, Medtronic, Boston Scientific and Osprey Medical. Research support from Edwards Lifescien-ces, MN Veterans Research Foundation and the VA Office of Research and Development. Dr. Yannopoulos is the PI and co-PI for the following NIH (NHLBI) grants: R01 HL123227, 1R01HL126092 201, R01HL1223231, R43HL123194-01 1R43HL110517-01A1, R43HL115937-01. Dr. Yannopoulos also received funds for the Minnesota Resuscitation Consortium from the Medtronic Foundation. The other authors have no conflicts to report related to this manuscript.
- aortic valve disease (AVD)
- surgery valvular (SVAL)
- transcatheter valve implantation (TVI)