Sameer A Hirji1, Edward D Percy2, Siobhan McGurk2, Alexandra Malarczyk2, Morgan T Harloff2, Farhang Yazdchi2, Ashraf A Sabe2, Vinayak N Bapat3, Gilbert H L Tang4, Deepak L Bhatt5, Vinod H Thourani6, Martin B Leon7, Patrick O'Gara8, Pinak B Shah9, Tsuyoshi Kaneko10. 1. Division of Cardiac Surgery, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: https://twitter.com/Hirji1987. 2. Division of Cardiac Surgery, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. 3. Department of Cardiac Surgery, Columbia University Medical Center, New York, New York. 4. Department of Cardiovascular Surgery, Mount Sinai Medical Center, New York, New York. Electronic address: https://twitter.com/GilbertTangMD. 5. Division of Cardiology, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: https://twitter.com/DLBHATTMD. 6. Department of Cardiovascular Surgery, Marcus Valve Center, Piedmont Heart Institute, Atlanta, Georgia. 7. Columbia University Medical Center/New York-Presbyterian Hospital and Cardiovascular Research Foundation, New York, New York. 8. Division of Cardiology, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. 9. Division of Cardiology, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: https://twitter.com/PinakShahMD. 10. Division of Cardiac Surgery, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: tkaneko2@partners.org.
Abstract
BACKGROUND: Currently, there is a paucity of information on surgical explantation after transcatheter aortic valve replacement (TAVR). OBJECTIVES: The purpose of this study was to examine the incidence, patient characteristics, predictors, and outcomes of surgical explantation after TAVR using a population-based, nationally representative database. METHODS: We analyzed the Medicare Provider profile to include all U.S. patients undergoing TAVR from 2012 to 2017. Time to surgical explant was calculated from the index TAVR discharge to surgical explantation. Post-operative survival was assessed using time-dependent Cox proportional hazard regression analysis and landmark analysis. RESULTS: The incidence of surgical explantation was 0.2% (227 of 132,633 patients), and was 0.28% and 0.14% in the early and newer TAVR era, respectively. The median time to surgical explant was 212 days, whereas 8.8% and 70.9% underwent surgical explantation within 30 days and 1 year, respectively. The primary indication for reintervention was bioprosthetic failure (79.3%). Compared with the no-explant cohort, the explant cohort was significantly younger (mean age 73.7 years vs. 81.7 years), with a lower prevalence of heart failure (55.9% vs. 65.8%) but more likely a lower-risk profile cohort (15% vs. 2.4%; all p < 0.05). The 30-day and 1-year mortality rates were 13.2% and 22.9%, respectively, and did not vary by either time to surgical explant or TAVR era, or between patients with versus without endocarditis (all p > 0.05). The time-dependent Cox regression analysis demonstrated a higher mortality in those with surgical explantation (hazard ratio: 4.03 vs. no-explant group; 95% confidence interval: 1.81 to 8.98). Indication, time-to-surgical-explant, and year of surgical explantation were not associated with worse post-explantation survival (all p > 0.05). CONCLUSIONS: The present study provides updated evidence on the incidence, timing, and outcomes of surgical explantation of a TAVR prosthesis. Although the overall incidence was low, short-term mortality was high. These findings stress the importance of future mechanistic studies on TAVR explantation and may have implications on lifetime management of aortic stenosis, particularly in younger patients.
BACKGROUND: Currently, there is a paucity of information on surgical explantation after transcatheter aortic valve replacement (TAVR). OBJECTIVES: The purpose of this study was to examine the incidence, patient characteristics, predictors, and outcomes of surgical explantation after TAVR using a population-based, nationally representative database. METHODS: We analyzed the Medicare Provider profile to include all U.S. patients undergoing TAVR from 2012 to 2017. Time to surgical explant was calculated from the index TAVR discharge to surgical explantation. Post-operative survival was assessed using time-dependent Cox proportional hazard regression analysis and landmark analysis. RESULTS: The incidence of surgical explantation was 0.2% (227 of 132,633 patients), and was 0.28% and 0.14% in the early and newer TAVR era, respectively. The median time to surgical explant was 212 days, whereas 8.8% and 70.9% underwent surgical explantation within 30 days and 1 year, respectively. The primary indication for reintervention was bioprosthetic failure (79.3%). Compared with the no-explant cohort, the explant cohort was significantly younger (mean age 73.7 years vs. 81.7 years), with a lower prevalence of heart failure (55.9% vs. 65.8%) but more likely a lower-risk profile cohort (15% vs. 2.4%; all p < 0.05). The 30-day and 1-year mortality rates were 13.2% and 22.9%, respectively, and did not vary by either time to surgical explant or TAVR era, or between patients with versus without endocarditis (all p > 0.05). The time-dependent Cox regression analysis demonstrated a higher mortality in those with surgical explantation (hazard ratio: 4.03 vs. no-explant group; 95% confidence interval: 1.81 to 8.98). Indication, time-to-surgical-explant, and year of surgical explantation were not associated with worse post-explantation survival (all p > 0.05). CONCLUSIONS: The present study provides updated evidence on the incidence, timing, and outcomes of surgical explantation of a TAVR prosthesis. Although the overall incidence was low, short-term mortality was high. These findings stress the importance of future mechanistic studies on TAVR explantation and may have implications on lifetime management of aortic stenosis, particularly in younger patients.
Authors: Alexander A Brescia; G Michael Deeb; Stephane Leung Wai Sang; Daizo Tanaka; P Michael Grossman; Devraj Sukul; Chang He; Patricia F Theurer; Melissa Clark; Francis L Shannon; Stanley J Chetcuti; Shinichi Fukuhara Journal: Circ Cardiovasc Interv Date: 2021-03-15 Impact factor: 6.546