@article{80c716c9102c4eb39622147313f25705,
title = "Stratification of outcomes after transcatheter aortic valve replacement according to surgical inoperability for technical versus clinical reasons",
abstract = "Objectives The goal of this study was to examine the impact of reasons for surgical inoperability on outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). Background Patients with severe aortic stenosis may be deemed inoperable due to technical or clinical reasons. The relative impact of each designation on early and late outcomes after TAVR is unclear. Methods Patients were studied from the inoperable arm (cohort B) of the randomized PARTNER (Placement of Aortic Transcatheter Valve) trial and the nonrandomized continued access registry. Patients were classified according to whether they were classified as technically inoperable (TI) or clinically inoperable (CLI). Reasons for TI included porcelain aorta, previous mediastinal radiation, chest wall deformity, and potential for injury to previous bypass graft on sternal re-entry. Reasons for CLI were systemic factors that were deemed to make survival unlikely. Results Of the 369 patients, 23.0% were considered inoperable for technical reasons alone; the remaining were judged to be CLI. For TI, the most common cause was a porcelain aorta (42%); for CLI, it was multiple comorbidities (48%) and frailty (31%). Quality of life and 2-year mortality were significantly better among TI patients compared with CLI patients (mortality 23.3% vs. 43.8%; p < 0.001). Nonetheless, TAVR led to substantial survival benefits compared with standard therapy in both inoperable cohorts. Conclusions Patients undergoing TAVR based solely on TI have better survival and quality of life improvements than those who are inoperable due to clinical comorbidities. Both TI and CLI TAVR have significant survival benefit in the context of standard therapy. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).",
keywords = "inoperable, risk, TAVI, TAVR, transcatheter aortic valve",
author = "Makkar, {Raj R.} and Hasan Jilaihawi and Michael Mack and Tarun Chakravarty and Cohen, {David J.} and Wen Cheng and Fontana, {Gregory P.} and Bavaria, {Joseph E.} and Thourani, {Vinod H.} and Herrmann, {Howard C.} and Augusto Pichard and Samir Kapadia and Vasilis Babaliaros and Whisenant, {Brian K.} and Kodali, {Susheel K.} and Mathew Williams and Alfredo Trento and Smith, {Craig R.} and Teirstein, {Paul S.} and Cohen, {Mauricio G.} and Ke Xu and Tuzcu, {E. Murat} and Webb, {John G.} and Leon, {Martin B.}",
note = "Funding Information: Dr. Makkar has received grant support from Edwards Lifesciences Corporation and St. Jude Medical ; is a consultant for Abbott Vascular, Cordis, and Medtronic; and holds equity in Entourage Medical. Dr. Jilaihawi is a consultant for Edwards Lifesciences Corporation, St. Jude Medical, and Venus MedTech. Dr. Cohen has received grant support from Edwards Lifesciences Corporation, Medtronic, Abbott Vascular, Boston Scientific, Eli Lilly and Company, Daiichi Sankyo, AstraZeneca, and Biomet ; and is a consultant for Medtronic, Eli Lilly and Company, Gilead Sciences, AstraZeneca, and Abbott Vascular. Dr. Fontana has received grant support from Medtronic and St. Jude Medical ; and is a consultant for Edwards Lifesciences Corporation. Dr. Bavaria is a consultant for Edwards Lifesciences Corporation. Dr. Thourani has received grant support from Edwards Lifesciences Corporation ; is a consultant for St. Jude Medical and Sorin Medical; and holds equity in Apica Cardiovascular. Dr. Herrmann has received grant support from Abbott Vascular, Edwards Lifesciences Corporation, Medtronic, Gore, Siemens Medical, and St. Jude Medical ; is a consultant for St. Jude Medical, Siemens Medical, and Micro Interventional Devices; and holds equity and intellectual property in Micro Interventional Devices. Dr. Pichard is a consultant for Edwards Lifesciences Corporation. Dr. Babaliaros is a consultant for Direct Flow Medical. Dr. Whisenant has received grant support from Gore ; is a consultant for Edwards Lifesciences Corporation, Boston Scientific, and Medtronic; and has ownership/partnership in Coherex Medical. Dr. Kodali is a consultant for Edwards Lifesciences Corporation and St. Jude Medical; and is a member of the scientific advisory board for Thubrikar Aortic Valve, Inc. Dr. Williams is a consultant for Edwards Lifesciences Corporation and Medtronic. Dr. Teirstein is a consultant for Abbott Vascular, Boston Scientific, and Medtronic; and holds equity in Shepherd Scientific. Dr. Webb is a consultant for Edwards Lifesciences Corporation and St. Jude Medical. Drs. Smith, Tuzcu, Mack, and Leon have received travel reimbursements from Edwards Lifesciences Corporation for activities related to their positions as unpaid members of the PARTNER Trial Executive Committee. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. ",
year = "2014",
month = mar,
day = "11",
doi = "10.1016/j.jacc.2013.08.1641",
language = "English (US)",
volume = "63",
pages = "901--911",
journal = "Journal of the American College of Cardiology",
issn = "0735-1097",
publisher = "Elsevier USA",
number = "9",
}