Incidence and Outcomes of Infective Endocarditis After Transcatheter or Surgical Aortic Valve Replacement

Jonas Lanz, Michael J Reardon, Thomas Pilgrim, Stefan Stortecky, G Michael Deeb, Stanley Chetcuti, Steven J Yakubov, Thomas G Gleason, Jian Huang, Stephan Windecker, Jonas Lanz, Michael J Reardon, Thomas Pilgrim, Stefan Stortecky, G Michael Deeb, Stanley Chetcuti, Steven J Yakubov, Thomas G Gleason, Jian Huang, Stephan Windecker

Abstract

Background Data comparing the frequency and outcomes of infective endocarditis (IE) after transcatheter (TAVR) to surgical aortic valve replacement (SAVR) are scarce. The objective of this study is to compare the incidence and outcomes of IE after TAVR using a supra-annular, self-expanding platform (CoreValve and Evolut) to SAVR. Methods and Results Data of 3 randomized clinical trials comparing TAVR to SAVR and a prospective continued TAVR access study were pooled. IE was defined on the basis of the modified Duke criteria. The cumulative incidence of IE was determined by modeling the cause-specific hazard. Estimates of all-cause mortality were calculated by means of the Kaplan-Meier method. Outcomes are reported for the valve-implant cohort. During a mean follow-up time of 2.17±1.51 years, 12 (0.5%) of 2249 patients undergoing TAVR and 21 (1.1%) of 1828 patients undergoing SAVR developed IE. Patients with IE more frequently had diabetes mellitus than those without (57.6% versus 34.2%; P=0.005). The cumulative incidence of IE was 1.01% (95% CI, 0.47%-1.96%) after TAVR and 1.58% (95% CI, 0.97%-2.46%) after SAVR (P=0.047) at 5 years. Among patients with IE, the rate of all-cause mortality was 27.3% (95% CI, 1.0%-53.6%) in the TAVR and 51.8% (95% CI, 28.2%-75.3%) in the SAVR group at 1 year (log-rank P=0.15). Conclusions Pooled prospectively collected data comparing TAVR with a supra-annular, self-expanding device to SAVR showed a low cumulative risk of IE irrespective of treatment modality, although the risk was lower in the TAVR implant group. Once IE occurred, mortality was high. Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01240902, NCT01586910, NCT02701283.

Keywords: SAVR; TAVR; endocarditis; incidence; mortality.

Conflict of interest statement

Dr Reardon reports fees for educational services from Medtronic. Dr Pilgrim reports research grants to the institution from Edwards Lifesciences, Boston Scientific, and Biotronik; personal fees from Biotronik and Boston Scientific; and other from HighLife SAS. Dr Stortecky has received research grants to the institution from Edwards Lifesciences, Medtronic, Abbott Vascular, and Boston Scientific; serves as consultant for BTG and Teleflex; and has received speaker fees from BTG and Boston Scientific. Dr Chetcuti reports grant support, fees for proctoring, and consulting fees from Medtronic and JenaValve Technology Inc. Dr Yakubov reports research grant support and fees for proctoring services from Medtronic. Dr Gleason reports grant support paid to his institution from Medtronic and Boston Scientific and serves as an advisor to Abbott. Dr Huang is an employee of Medtronic. Dr Windecker reports research and educational grants to the institution from Abbott, Amgen, BMS, Bayer, Boston Scientific, Biotronik, Cardinal Health, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Johnson & Johnson, Medtronic, Querbet, Polares, Sanofi, Terumo, and Sinomed. The remaining authors have no disclosures to report.

Figures

Figure 1. Flowchart depicting the patient flow…
Figure 1. Flowchart depicting the patient flow from the intention‐to‐treat to the as‐treated and valve‐implanted cohorts in the randomized trials and the SURTAVI continued access study.
FU indicates follow‐up; SAVR, surgical aortic valve replacement; SURTAVI, Surgical Replacement and Transcatheter Aortic Valve Implantation; and TAVR, transcatheter aortic valve replacement.
Figure 2. Cumulative incidence of endocarditis taking…
Figure 2. Cumulative incidence of endocarditis taking into account the competing risk of death in the SAVR group amounted to 0.66% (95% CI, 0.35%–1.15%) at 1 year, and 1.58% (95% CI, 0.97%–2.46%) at 5 years, in the TAVR group to 0.23% (95% CI, 0.12%–0.61%) at 1 year and 1.01% (95% CI, 0.47%–1.96%) at 5 years.
SAVR indicates surgical aortic valve replacement; and TAVR, transcatheter aortic valve replacement.
Figure 3. Kaplan–Meier curves depicting all‐cause mortality…
Figure 3. Kaplan–Meier curves depicting all‐cause mortality after endocarditis stratified by mode of valve replacement.
In the TAVR cohort, 1‐year all‐cause mortality was 27.3% (95% CI, 1.0%–53.6%) and in the SAVR group 51.8% (95% CI, 28.2%–75.3%). SAVR indicates surgical aortic valve replacement; and TAVR, transcatheter aortic valve replacement.

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