Mid-term Outcomes And Durability Of Transcatheter Aortic Valve Replacement At A Federal Facility
Rachel S. Yang1, Vimala Ponna2, Joshua Gustafson2, Kendrick A. Shunk2, Jeffrey M. Zimmet2, Liang Ge2, Elaine E. Tseng2.
1University of California San Francisco, San Francisco, CA, USA, 2San Francisco Veterans Affairs Medical Center, San Francisco, CA, USA.
BACKGROUND: Transcatheter aortic valve replacement (TAVR) is the predominant treatment for patients with severe aortic stenosis of any surgical risk. Veterans Affairs Medical Centers (VAMC) are not required to submit TAVR outcomes to the Society of Thoracic Surgeons Transcatheter Valve Therapy registry, but instead report to VA databases for surgery and interventional cardiology. Therefore, limited TAVR durability data is available from VAMC. Using standardized definitions of structural valve degeneration (SVD) and bioprosthetic valve failure (BVF), our objective was to evaluate short and mid-term outcomes of TAVR at a VA facility. METHODS: We retrospectively evaluated our first 253 TAVR patients from November 2013 to May 2019 for short and mid-term clinical outcomes. Standardized criteria of SVD and other endpoints were used from the European Association of Percutaneous Cardiovascular Interventions and Valve Academic Research Consortium-2 consensus statements. RESULTS: 253 patients (age 78.1±8.7 years) underwent TAVR with 77 self-expanding, and 176 balloon-expandable devices. Overall device success was 97.6%. Survival at 30-days was 98.8%, 1-year was 89.5%, 3-years was 72.1%, and 5-years was 58.8%. Short-term 30-day procedural outcomes included (n,%): permanent pacemaker (26, 10.3%), bleeding (12, 4.7%), cerebrovascular accident (8, 3.2%), vascular injury (6, 2.4%), cardiac tamponade (3, 1.2%), temporary hemodialysis (1, 0.4%), and acute kidney injury (1, 0.4%). Mid-term outcomes included (n,%): SVD (12, 4.7%), thromboembolism (12, 4.7%), bioprosthetic valve failure (3, 1.2%), and endocarditis (2, 0.8%). TAVR SVD was categorized by: moderate hemodynamic SVD (10, 4.0%), severe hemodynamic SVD (1, 0.4%), or morphological SVD with leaflet integrity abnormality (1, 0.4%). Patients with SVD consistently had mean transprosthetic gradients >20mmHg, with the exception of one patient who spontaneously resolved to normal gradients. One patient underwent aortic reintervention, and one patient underwent paravalvular leak repair.
Figure: Kaplan-Meier cumulative incidence of SVD. Freedom from SVD at 1-year was 97.5%, 3-years was 94.6%, and 5-years was 83.7%.
CONCLUSIONS: We demonstrated excellent short and mid-term TAVR outcomes at a VA facility. SVD was evident at a low but detectable rate in the first 6 years. Further understanding of TAVR biomechanics will be essential for informing patient-specific risk of SVD over time, particularly for low-risk younger patients.
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