Surgical Explantation of Transcatheter Aortic Bioprostheses
2020; Lippincott Williams & Wilkins; Volume: 142; Issue: 23 Linguagem: Inglês
10.1161/circulationaha.120.050499
ISSN1524-4539
AutoresShinichi Fukuhara, Alexander A. Brescia, G. Michael Deeb,
Tópico(s)Aortic Disease and Treatment Approaches
ResumoHomeCirculationVol. 142, No. 23Surgical Explantation of Transcatheter Aortic Bioprostheses Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toSupplemental MaterialFree AccessLetterPDF/EPUBSurgical Explantation of Transcatheter Aortic BioprosthesesAn Analysis From the Society of Thoracic Surgeons Database Shinichi Fukuhara, MD, Alexander A. Brescia, MD, MSc and G. Michael Deeb, MD Shinichi FukuharaShinichi Fukuhara Shinichi Fukuhara, MD, 1500 E Medical Center Drive, Ann Arbor, MI 48109. Email E-mail Address: [email protected] https://orcid.org/0000-0002-7898-5159 Department of Cardiac Surgery, University of Michigan, Ann Arbor. , Alexander A. BresciaAlexander A. Brescia https://orcid.org/0000-0002-6988-7987 Department of Cardiac Surgery, University of Michigan, Ann Arbor. and G. Michael DeebG. Michael Deeb Department of Cardiac Surgery, University of Michigan, Ann Arbor. Originally published7 Dec 2020https://doi.org/10.1161/CIRCULATIONAHA.120.050499Circulation. 2020;142:2285–2287Transcatheter aortic valve replacement (TAVR) is an established alternative to surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis.1,2 TAVR use has increased greatly, but the clinical impact and outcomes of surgical TAVR valve explantation and SAVR (TAVR explant) are not well understood.3 Despite the feasibility of a repeat TAVR procedure, there has been an increasing need for TAVR explant as the number of TAVR implants has increased. There are reports of TAVR valves causing neoendothelialization between the device and contacting native tissue (Figure, A and B), making device explantation a more morbid procedure than originally thought.3 The difficulty of SAVR after TAVR may be another consideration for the initial choice of TAVR versus SAVR in younger patients. This study was undertaken to review registry TAVR explant data to better understand the challenges and outcomes of surgical TAVR explant procedures.Download figureDownload PowerPointFigure. Summary of the present investigation. A, Intraoperative photograph showing distinct technical challenges of surgical transcatheter bioprosthesis explant. Neoendothelialization formed between the sinotubular junction and self-expandable device (arrow). B, Explanted self-expandable transcatheter bioprosthesis with denuded aortic intima remnants attached to the stent cage. C, Trend of surgical transcatheter aortic prosthesis explant total case numbers (orange bars), case numbers with simultaneous procedures (blue bars), and patient median age (red line) by year. D, Overview of the study cohort, the frequency of simultaneous other procedures, and clinical outcomes. CABG indicates coronary artery bypass grafting; O/E, observed to expected; SAVR, surgical aortic valve replacement; and TAVR, transcatheter aortic valve replacement.This study was approved by the Society of Thoracic Surgeons (STS) and the University of Michigan institutional review board. The data were provided by the STS National Database Participant User File Research program. The data are available from the corresponding author on reasonable request. TAVR explant was defined as a non–same-day surgical TAVR valve explant with SAVR performed in patients who had undergone TAVR. Between 2011 and 2018, 782 patients with TAVR explant were identified. The STS predicted risk of mortality score was available in patients with isolated SAVR. Where available, the observed-to-expected 30-day mortality ratio is reported.The TAVR explant procedures were performed by 483 surgeons (median, 1.0 case per surgeon [interquartile range (IQR), 1.0–2.0]) from 313 centers (median, 1.0 case per center [IQR, 1.0–3.0]) across the nation. Figure, C shows the annual number of patients with TAVR explant with and without simultaneous cardiac procedures. The case number increased over time from 4 in 2011 to 260 in 2018. The annual number of patients requiring simultaneous other procedures also increased each year. The median age was 74.0 years (IQR, 67.0–81.0), which trended down over the study period from 80.0 (IQR, 70.8–87.0) to 73.0 (IQR, 66.3–80.0). A total of 39% were female and 55.1% demonstrated New York Heart Association Class III or IV symptoms. More than 60% had previous cardiac surgeries. The leading indication for TAVR explant was failed repair/positioning/sizing issue (27%), followed by aortic insufficiency/paravalvular leak (21.5%), stenosis (20.2%), endocarditis (17.7%), and structural valve degeneration (6.5%).Among those with simultaneous procedures (n=437; 55.9%), aortic repair was the most frequent procedure (n=200; 45.8%), which comprises aortic root (76.0%) or ascending aortic replacement (48.5%), or both. Mitral procedure was the second most common (n=165; 37.8%), followed by coronary artery bypass grafting (n=122; 27.9%), tricuspid procedure (n=46; 10.5%; Figure, D), and ventricular septal defect repair (n=20; 4.6%). A quarter of the patients received ≥2 additional procedures. The overall 30-day mortality was 19.4%. The 30-day mortality in patients with isolated SAVR versus SAVR with simultaneous procedure was 14.8 and 23.8% (P=0.002), respectively. Of the 283 patients with isolated SAVR with available STS predicted risk of mortality, the mortality was 13.1% and the observed-to-expected 30-day mortality ratio was 1.54. Patients with simultaneous procedures demonstrated more frequent hospital readmission (18.3 versus 11.1%; P=0.011), prolonged mechanical ventilation (43.3 versus 29.9%; P 50% of the aortic repair rates. A subgroup analysis among the 395 patients with documented explanted TAVR valve type, comprising 80.5% balloon expandable and 19.5% self-expandable devices, showed comparable mortality (20.8% versus 19.8%; P=0.85). Patients with a self-expandable device underwent more frequent ascending aortic replacement than those with a balloon-expandable device (18.2 versus 8.2%; P=0.009), whereas the aortic root replacement rate was similar (22.1 versus 18.9%; P=0.52). Ascending aortic repair alone was rare (2.8%) in the balloon-expandable group.This study represents the largest series describing TAVR explant using a national database to provide insight into the incidence and clinical implications of TAVR explants. The primary findings include the frequent combined cardiac procedure rate and high mortality along with the high observed-to-expected 30-day mortality ratios for TAVR explants. A major limitation is the lack of the actual number of TAVR implants, or denominator, for these reported TAVR explant procedures. Based on the STS/American College of Cardiology Transcatheter Valve Therapy data, the incidence of TAVR explant is estimated at ≈0.4% (782/200 000 TAVR procedures between 2011 and 20184,5). Other limitations include the absence of clarity regarding interval after TAVR and precise indications for the TAVR explant. As the role of TAVR continues to expand in the treatment of lower-risk patients, an increase in TAVR explant procedures is expected in the next decade. Optimal management of patients requiring TAVR explant may require treatment in high-volume aortic surgery centers.AcknowledgmentsThe data for this research were provided by The Society of Thoracic Surgeons' National Database Participant User File Research Program. Data analysis was performed at the investigators' institution. The authors thank Dr Robert Habib, Director of the Society of Thoracic Surgeons Research Center, and Kristin Mathis, senior coordinator of the Society of Thoracic Surgeons Research Center, for their support in data acquisition and organization.DisclosuresDr Fukuhara serves as a consultant and research investigator for Terumo Aortic. Dr Deeb serves on an advisory board and as a proctor for Medtronic, as a consultant and research investigator for Edwards Lifesciences, as a consultant and proctor for Terumo, and as a research investigator for Gore Medical, with all fees paid to his institution. Dr Brescia is supported by the National Research Service Award postdoctoral fellowship (5T32HL076123).FootnotesThe podcast and transcript are available as a Data Supplement at https://www.ahajournals.org/doi/suppl/10.1161/CIRCULATIONAHA.120.050499.https://www.ahajournals.org/journal/circShinichi Fukuhara, MD, 1500 E Medical Center Drive, Ann Arbor, MI 48109. Email [email protected]umich.eduReferences1. Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, et al; PARTNER 3 Investigators. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients.N Engl J Med. 2019; 380:1695–1705. doi: 10.1056/NEJMoa1814052CrossrefMedlineGoogle Scholar2. Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, et al; Evolut Low Risk Trial Investigators. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients.N Engl J Med. 2019; 380:1706–1715. doi: 10.1056/NEJMoa1816885CrossrefMedlineGoogle Scholar3. Fukuhara S, Brescia AA, Shiomi S, Rosati CM, Yang B, Kim KM, Deeb GM. Surgical explantation of transcatheter aortic bioprostheses: results and clinical implications [published online January 12, 2020].J Thorac Cardiovasc Surg. doi: 10.1016/j.jtcvs.2019.11.139 https://www.jtcvs.org/article/S0022-5223(20)30061-1/fulltextGoogle Scholar4. Huded CP, Tuzcu EM, Krishnaswamy A, Mick SL, Kleiman NS, Svensson LG, Carroll J, Thourani VH, Kirtane AJ, Manandhar P, et al. Association between transcatheter aortic valve replacement and early postprocedural stroke.JAMA. 2019; 321:2306–2315. doi: 10.1001/jama.2019.7525CrossrefMedlineGoogle Scholar5. Bavaria JE. TAVR Update: New Insights and Perspectives from the US National STS/ACC TVT Registry.https://www.sts.org/sites/default/files/102419%201645.%20Bavaria.%20TVT.pdf. Published 2019. Accessed March 23, 2020Google Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited ByRusso G, Tang G, Sangiorgi G, Pedicino D, Enriquez-Sarano M, Maisano F and Taramasso M (2022) Lifetime Management of Aortic Stenosis: Transcatheter Versus Surgical Treatment for Young and Low-Risk Patients, Circulation: Cardiovascular Interventions, 15:11, (915-927), Online publication date: 1-Nov-2022. Gerdisch M, Sathyamoorthy M and Michelena H (2022) The role of mechanical valves in the aortic position in the era of bioprostheses and TAVR: Evidence-based appraisal and focus on the On-X valve, Progress in Cardiovascular Diseases, 10.1016/j.pcad.2022.06.001, 72, (31-40), Online publication date: 1-May-2022. 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Ailawadi G (2021) Time for a More Sophisticated Approach for Young Aortic Stenosis Patients, Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery, 10.1177/1556984521991529, 16:1, (22-23), Online publication date: 1-Jan-2021. Woods R (2021) Commentary: Can Kicking and Rip Currents, Seminars in Thoracic and Cardiovascular Surgery, 10.1053/j.semtcvs.2021.06.031, 33:4, (1093-1094), Online publication date: 1-Dec-2022. December 8, 2020Vol 142, Issue 23 Advertisement Article InformationMetrics © 2020 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.120.050499PMID: 33284653 Originally publishedDecember 7, 2020 Keywordsaortic valve stenosisheart diseasesthoracic surgeryPDF download Advertisement SubjectsAortic Valve Replacement/Transcatheter Aortic Valve ImplantationCardiovascular SurgeryMortality/SurvivalValvular Heart Disease
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