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Multicenter Study
. 2021 Sep 27;14(18):1978-1991.
doi: 10.1016/j.jcin.2021.07.015.

Surgical Explantation After TAVR Failure: Mid-Term Outcomes From the EXPLANT-TAVR International Registry

Vinayak N Bapat  1 , Syed Zaid  2 , Shinichi Fukuhara  3 , Shekhar Saha  4 , Keti Vitanova  5 , Philipp Kiefer  6 , John J Squiers  7 , Pierre Voisine  8 , Luigi Pirelli  9 , Moritz Wyler von Ballmoos  10 , Michael W A Chu  11 , Josep Rodés-Cabau  8 , J Michael DiMaio  7 , Michael A Borger  6 , Rudiger Lange  5 , Christian Hagl  4 , Paolo Denti  12 , Thomas Modine  13 , Tsuyoshi Kaneko  14 , Gilbert H L Tang  15 ; EXPLANT-TAVR Investigators
Collaborators, Affiliations
Free article
Multicenter Study

Surgical Explantation After TAVR Failure: Mid-Term Outcomes From the EXPLANT-TAVR International Registry

Vinayak N Bapat et al. JACC Cardiovasc Interv. .
Free article

Abstract

Objectives: The aim of this study was to evaluate clinical characteristics, mechanisms of failure, and outcomes of transcatheter aortic valve replacement (TAVR) explantation.

Background: Surgical explantation following TAVR may be required for structural valve degeneration, paravalvular leak, infection, or other reasons. However, in-depth data on indications and outcomes are lacking.

Methods: Data from a multicenter, international registry (EXPLANT-TAVR) of patients who underwent TAVR explantation were reviewed retrospectively. Explantations performed during the same admission as initial TAVR were excluded. Clinical and echocardiographic outcomes were evaluated. Median follow-up duration was 6.7 months (interquartile range [IQR]: 1.0-18.8 months) after TAVR explantation and was 97.7% complete at 30 days and 86.1% complete at 1 year.

Results: From November 2009 to September 2020, 269 patients across 42 centers with a mean age of 72.7 ± 10.4 years underwent TAVR explantation. About one quarter (25.9%) were deemed low surgical risk at index TAVR, and median Society of Thoracic Surgeons risk at TAVR explantation was 5.6% (IQR: 3.2%-9.6%). The median time to explantation was 11.5 months (IQR: 4.0-32.4 months). Balloon-expandable and self-expanding or mechanically expandable valves accounted for 50.9% and 49.1%, respectively. Indications for explantation included endocarditis (43.1%), structural valve degeneration (20.1%), paravalvular leak (18.2%), and prosthesis-patient mismatch (10.8%). Redo TAVR was not feasible because of unfavorable anatomy in 26.8% of patients. Urgent or emergency cases were performed in 53.1% of patients, aortic root replacement in 13.4%, and 54.6% had concomitant cardiac procedures. Overall survival at last follow-up was 76.1%. In-hospital, 30-day, and 1-year mortality rates were 11.9%, 13.1%, and 28.5%, respectively, and stroke rates were 5.9%, 8.6%, and 18.7%, respectively.

Conclusions: The EXPLANT-TAVR registry reveals that surgical risks associated with TAVR explantation are not negligible and should be taken into consideration in the lifetime management of aortic stenosis.

Keywords: TAVR explantation; TAVR failure; surgical aortic valve replacement; transcatheter aortic valve replacement.

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Conflict of interest statement

Funding Support and Author Disclosures Dr Bapat has served as a consultant for Medtronic, Edwards Lifesciences, 4C Medical, and Boston Scientific. Dr Fukuhara is a consultant for Terumo Aortic. Dr Pirelli is a physician proctor for and has received speaker honoraria from Edwards Lifesciences; and is a consultant for Medtronic. Dr Wyler von Ballmoos has served as a consultant for LivaNova, Medtronic, and Boston Scientific. Dr Chu has received speaker honoraria from Medtronic, Edwards Lifesciences, and Terumo Aortic. Dr Rodés-Cabau has received institutional research grants from and is a consultant for Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Borger has reported that his hospital receives speaker honoraria and/or consulting fees on his behalf from Edwards Lifesciences, Medtronic, Abbott, and CryoLife. Dr Lange is a consultant for Medtronic. Dr Hagl has received speaker honoraria from Edwards Lifesciences. Dr Denti has received speaker honoraria from Abbott and Edwards Lifesciences; and is a consultant for InnovHeart. Dr Modine is a physician proctor and consultant for Medtronic, Edwards Lifesciences, and Abbott. Dr Kaneko is a speaker for Edwards Lifesciences, Medtronic, Abbott, and Baylis Medical; and is a consultant for 4C Medical. Dr Tang is a physician proctor for Medtronic; is a consultant for Medtronic, Abbott, and NeoChord; and is an advisory board member for Abbott and JenaValve. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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