New Research Paper
Structural
Explant vs Redo-TAVR After Transcatheter Valve Failure: Mid-Term Outcomes From the EXPLANTORREDO-TAVR International Registry

https://doi.org/10.1016/j.jcin.2023.01.376Get rights and content

Abstract

Background

Valve reintervention after transcatheter aortic valve replacement (TAVR) failure has not been studied in detail.

Objectives

The authors sought to determine outcomes of TAVR surgical explantation (TAVR-explant) vs redo-TAVR because they are largely unknown.

Methods

From May 2009 to February 2022, 396 patients in the international EXPLANTORREDO-TAVR registry underwent TAVR-explant (181, 46.4%) or redo-TAVR (215, 54.3%) for transcatheter heart valve (THV) failure during a separate admission from the initial TAVR. Outcomes were reported at 30 days and 1 year.

Results

The incidence of reintervention after THV failure was 0.59% with increasing volume during the study period. Median time from index-TAVR to reintervention was shorter in TAVR-explant vs redo-TAVR (17.6 months [IQR: 5.0-40.7 months] vs 45.7 months [IQR: 10.6-75.6 months]; P < 0.001], respectively. TAVR-explant had more prosthesis–patient mismatch (17.1% vs 0.5%; P < 0.001) as the indication for reintervention, whereas redo-TAVR had more structural valve degeneration (63.7% vs 51.9%; P = 0.023), with a similar incidence of ≥moderate paravalvular leak between groups (28.7% vs 32.8% in redo-TAVR; P = 0.44). There was a similar proportion of balloon-expandable THV failures (39.8% TAVR-explant vs 40.5% redo-TAVR; P = 0.92). Median follow-up was 11.3 (IQR: 1.6-27.1 months) after reintervention. Compared with redo-TAVR, TAVR-explant had higher mortality at 30 days (13.6% vs 3.4%; P < 0.001) and 1 year (32.4% vs 15.4%; P = 0.001), with similar stroke rates between groups. On landmark analysis, mortality was similar between groups after 30 days (P = 0.91).

Conclusions

In this first report of the EXPLANTORREDO-TAVR global registry, TAVR-explant had a shorter median time to reintervention, with less structural valve degeneration, more prosthesis–patient mismatch, and similar paravalvular leak rates compared with redo-TAVR. TAVR-explant had higher mortality at 30 days and 1 year, but similar rates on landmark analysis after 30 days.

Section snippets

Data Source

The EXPLANTORREDO-TAVR registry is a multicenter, international registry of patients who underwent TAVR-explant or redo-TAVR for THV failure. This registry included 29 centers performing both surgical and transcatheter reintervention for THV failure, between May 2009 and February 2022. Initial TAVR was performed between June 2007 and November 2021, and was not limited to only our participating centers, given a proportion of patients who underwent reintervention at our centers had TAVR at

Baseline Clinical Characteristics at Index TAVR

Among 66,760 patients undergoing TAVR at the sites participating in the EXPLANTORREDO-TAVR registry during the study period, a total of 396 (0.59%) patients underwent reintervention for THV failure, per the inclusion criteria. Baseline clinical characteristics at the index-TAVR procedure are summarized in Table 1. Mean age was 75.5 ± 9.3 years, 40.9% were female, and 14.3% of patients were deemed low surgical risk by the local heart team. At index-TAVR, 38.4% of patients had previous cardiac

Discussion

This multicenter, international EXPLANTORREDO-TAVR registry is the first study to report the incidence, characteristics, and mid-term outcomes of TAVR-explant and redo-TAVR across the same centers. This is the largest and most comprehensive in-depth evaluation to date comparing the 2 treatment strategies for THV failure. The incidence of AV reintervention after THV failure was 0.59%. Our study has several key findings (Central Illustration): First, the incidence of reintervention after THV

Conclusions

This first report of the multicenter, international EXPLANTORREDO-TAVR registry provides a timely longitudinal review of the incidence, characteristics, and mid-term outcomes of redo-TAVR vs TAVR-explant across the same centers. Although TAVR-explant was riskier, with earlier reintervention and higher 30-day mortality, long-term prognosis remained similar to redo-TAVR patients. Our study provides valuable insights on lifetime management of patients with THV failure, and for further research to

Funding Support and Author Disclosures

Dr Meier is supported by the Swiss National Science Foundation (grant P2LAP3_199561). Dr Tang has been a proctor for Medtronic; a consultant for Medtronic and Abbott Structural Heart; and an advisory board member for Abbott Structural Heart and JenaValve. Dr Kleiman has been a local principal investigator in trials sponsored by Boston Scientific, Medtronic, Abbott, and Edwards Lifesciences. Dr Fukuhara has been a consultant for Medtronic, Artiviion, and Terumo Aortic. Dr Mohamed Abdel-Wahab has

Acknowledgments

The authors thank all the coinvestigators for their participation and involvement in the EXPLANTORREDO-TAVR registry.

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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 Author Center.

Drs Tang and Zaid contributed equally to this work.

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