@article{a4d238f000714d1ab047348a7aefe11c,
title = "Durability and Clinical Outcomes of Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses",
abstract = "Background: Valve-in-valve transcatheter aortic valve replacement (TAVR) is an option when a surgical valve demonstrates deterioration and dysfunction. This study reports 3-year results following valve-in-valve with self-expanding TAVR. Methods: The CoreValve US Expanded Use Study is a prospective, nonrandomized, single-arm study that evaluates safety and effectiveness of TAVR in extreme risk patients with symptomatic failed surgical biologic aortic valves. Study end points include all-cause mortality, need for valve reintervention, hemodynamic changes over time, and quality of life through 3 years. Patients were stratified by presence of preexisting surgical valve prosthesis-patient mismatch. Results: From March 2013 to May 2015, 226 patients deemed extreme risk (STS-PROM [Society of Thoracic Surgeons Predicted Risk of Mortality] 9.0±7%) had attempted valve-in-valve TAVR. Preexisting surgical valve prosthesis-patient mismatch was present in 47.2% of the cohort. At 3 years, all-cause mortality or major stroke was 28.6%, and 93% of patients were in New York Heart Association I or II heart failure. Valve performance was maintained over 3 years with low valve reintervention rates (4.4%), an improvement in effective orifice area over time and a 2.7% rate of severe structural valve deterioration. Preexisting severe prosthesis-patient mismatch was not associated with 3-year mortality but was associated with significantly less improvement in quality of life at 3-year follow-up (P=0.01). Conclusions: Self-expanding TAVR in patients with failed surgical bioprostheses at extreme risk for surgery was associated with durable hemodynamics and excellent clinical outcomes. Preexisting surgical valve prosthesis-patient mismatch was not associated with mortality but did limit patient improvement in quality of life over 3-year follow-up. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01675440.",
keywords = "aortic valve, aortic valve stenosis, bioprosthesis, transcatheter aortic valve replacement",
author = "Dauerman, {Harold L.} and Deeb, {G. Michael} and O'Hair, {Daniel P.} and Ron Waksman and Yakubov, {Steven J.} and Kleiman, {Neal S.} and Chetcuti, {Stanley J.} and Hermiller, {James B.} and Tanvir Bajwa and Kamal Khabbaz and {De Marchena}, Eduardo and Tomas Salerno and Dries-Devlin, {Jessica L.} and Shuzhen Li and Popma, {Jeffrey J.} and Reardon, {Michael J.}",
note = "Funding Information: Dr Dauerman is a consultant to Medtronic and Boston Scientific; Data Safety and Monitoring Board member for HCRI, Recor Medical and CRF (multiple trials), research grants from Medtronic and Boston Scientific. Dr O{\textquoteright}Hair receives research support from Aurora Healthcare; proctor and consultant for Medtronic; consultant for Edwards LifeSciences. Dr Waksman is a member of the advisory board for Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc, Medtronic, Philips Volcano, Pi-Cardia Ltd; as a Consultant for Abbott Vascular, Amgen, Biosensors, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc, Medtronic, Philips Volcano, Pi-Cardia Ltd; receives grant support from Abbott Vascular, AstraZeneca, Biosensors, Biotronik, Boston Scientific, Chiesi; serves on the Speakers Bureau for AstraZeneca and Chiesi; and is an investor in MedAlliance. Dr Yakubov has received grant support, personal fees, and proctor for Medtronic. Dr Kleiman is an investigator for Medtronic. Dr Chetcuti has been a consultant and proctor for Medtronic, research support from Medtronic, Gore, Boston Scientific, Edwards Lifescience, and JenaValve. Dr Hermiller is a consultant for Medtronic. Dr Bajwa is a proctor and consultant for Medtronic. Dr de Marchena received research grants from Medtronic and Rox Medical; stockholder and advisory board member for Tendyne and Abbott; investor and advisory board member for Aegis Medical; investor and consultant for Argoresearch; founder and medical director for SyftSynch LLC; and investor and advisory board member for Vdyne Medical. Drs Dries-Devlin and Li served as employees and shareholders of Medtronic. Dr Popma has received grants from Medtronic and Abbott Vascular; grants and personal fees from Edwards Lifesciences and Boston Scientific; Dr Reardon serves on an advisory board for Medtronic with fees paid to his institution. The other authors report no conflicts. Funding Information: This study was supported by Medtronic; Minneapolis, MN. Publisher Copyright: {\textcopyright} 2019 Lippincott Williams and Wilkins. All rights reserved.",
year = "2019",
month = oct,
day = "1",
doi = "10.1161/CIRCINTERVENTIONS.119.008155",
language = "English (US)",
volume = "12",
journal = "Circulation: Cardiovascular Interventions",
issn = "1941-7640",
publisher = "Lippincott Williams and Wilkins",
number = "10",
}