Author + information
- Received May 7, 2020
- Revision received August 19, 2020
- Accepted August 19, 2020
- Published online October 12, 2020.
- Sameer A. Hirji, MD, MPHa@Hirji1987,
- Edward D. Percy, MDa,
- Siobhan McGurk, BSa,
- Alexandra Malarczyk, BSa,
- Morgan T. Harloff, MDa,
- Farhang Yazdchi, MD, MSa,
- Ashraf A. Sabe, MDa,
- Vinayak N. Bapat, MBBSb,
- Gilbert H.L. Tang, MD, MSc, MBAc@GilbertTangMD,
- Deepak L. Bhatt, MD, MPHd@DLBHATTMD,
- Vinod H. Thourani, MDe,
- Martin B. Leon, MDf,
- Patrick O’Gara, MDd,
- Pinak B. Shah, MDd@PinakShahMD and
- Tsuyoshi Kaneko, MDa,∗ (, )@TsuyoshiKaneko1
- aDivision of Cardiac Surgery, Department of Surgery, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
- bDepartment of Cardiac Surgery, Columbia University Medical Center, New York, New York
- cDepartment of Cardiovascular Surgery, Mount Sinai Medical Center, New York, New York
- dDivision of Cardiology, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
- eDepartment of Cardiovascular Surgery, Marcus Valve Center, Piedmont Heart Institute, Atlanta, Georgia
- fColumbia University Medical Center/New York-Presbyterian Hospital and Cardiovascular Research Foundation, New York, New York
- ↵∗Address for correspondence:
Dr. Tsuyoshi Kaneko, Division of Cardiac Surgery, Brigham and Women’s Hospital, 15 Francis Street, Boston, Massachusetts 02115.
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.
This work was supported by Levinger gift funds from Brigham and Women’s Hospital, Harvard Medical School. Dr. Tang has served as a physician proctor for Medtronic; and has served as a consultant for Medtronic, W. L. Gore and Associates, and Abbott Structural Heart. Dr. Bapat has served as a consultant for Medtronic, Edwards Lifesciences, 4C Medical, and Boston Scientific. Dr. O’Gara has served as a consultant to Medtronic and Edwards Lifesciences. Dr. Kaneko has served as a speaker for Edwards Lifesciences, Medtronic, Abbott, and Baylis Medical; and has served as a consultant for 4C Medical. Dr. Bhatt has served on the Advisory Board for Cardax, Cereno Scientific, Elsevier Practice Update Cardiology, Medscape Cardiology, PhaseBio, PLx Pharma, and Regado Biosciences; has served on the Board of Directors of Boston VA Research Institute, Society of Cardiovascular Patient Care, and TobeSoft; has served as chair of the American Heart Association Quality Oversight Committee, NCDR-ACTION Registry Steering Committee, and VA CART Research and Publications Committee; has served on data monitoring committees for Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi-Sankyo), and the Population Health Research Institute; has received honoraria from American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Vice-Chair, ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor-in-Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor-in-Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), Medtelligence/ReachMD (CME steering committees), Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), and WebMD (CME steering committees); has served as Deputy Editor of Clinical Cardiology; has received research funding from Abbott, Afimmune, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Chiesi, CSL Behring, Eisai, Ethicon, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Idorsia, Ironwood, Ischemix, Lexicon, Lilly, Medtronic, PhaseBio, Pfizer, PLx Pharma, Regeneron, Roche, Sanofi, Synaptic, and The Medicines Company; has received royalties from Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease); has served as site co-investigator for Biotronik, Boston Scientific, CSI, St. Jude Medical (now Abbott), and Svelte; has served as a Trustee of the American College of Cardiology; and has performed unfunded research for FlowCo, Merck, Novo Nordisk, and Takeda. Dr. Thourani has served as an advisor and performed research for Abbott Vascular, Boston Scientific, Edwards Lifesciences, Gore Vascular, and Jenavalve. Dr. Leon has served as a consultant for Abbott, Boston Scientific, and Medtronic; and has received research grants from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. P.K. Shah, MD, served as Guest Editor-in-Chief for this paper.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC author instructions page.
- Received May 7, 2020.
- Revision received August 19, 2020.
- Accepted August 19, 2020.
- 2020 American College of Cardiology Foundation
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