Comparison of Sutureless Bioprosthetic Valve With Surgical or TAVR for Severe Aortic Stenosis

Ho Jin Kim, Do-Yoon Kang, Hanbit Park, Jung-Min Ahn, Joon Bum Kim, Seon-Ok Kim, You Jung Ok, Seung Hun Lee, Won Kyung Pyo, Euihong Ko, Seung-Ah Lee, Dae-Hee Kim, Seung-Jung Park, Duk-Woo Park, Suk Jung Choo, Ho Jin Kim, Do-Yoon Kang, Hanbit Park, Jung-Min Ahn, Joon Bum Kim, Seon-Ok Kim, You Jung Ok, Seung Hun Lee, Won Kyung Pyo, Euihong Ko, Seung-Ah Lee, Dae-Hee Kim, Seung-Jung Park, Duk-Woo Park, Suk Jung Choo

Abstract

Background: Clinical advantages of sutureless rapid-deployment (RD) aortic valve replacement (AVR) for severe aortic valve stenosis (AS) have not been elucidated compared with surgical (SAVR) or transcatheter (TAVR) aortic valve replacement.

Objectives: This study sought to investigate comparative effectiveness and safety of RD-AVR compared with SAVR and TAVR in a prospective cohort of patients with severe AS.

Methods: The primary outcome was a composite of death, stroke, or rehospitalization at 12 months. Propensity score matching was used to assemble a cohort of patients with similar baseline characteristics.

Results: Among 1,020 eligible patients, 107 (10.5%) underwent RD-AVR, 437 (42.8%) underwent SAVR, and 476 (46.7%) underwent TAVR. In the matched cohorts of RD-AVR and SAVR (n = 107), the incidence of primary composite outcome at 12 months was similar between the 2 groups (8.0% vs 10.8%, respectively; hazard ratio [HR]: 0.74; 95% confidence interval [CI]: 0.30-1.84; P = 0.52). In the matched cohorts of RD and TAVR (n = 58), the incidence of primary composite outcome at 12 months did not statistically differ between the 2 groups (9.4% vs 16.2%, respectively; HR: 0.53; 95% CI: 0.18-1.57; P = 0.25).

Conclusions: In this propensity-matched cohort of patients who underwent AVR for severe AS, we did not detect significant differences in the rates of the primary composite of death, stroke, or rehospitalization at 12 months when comparing RD-AVR with SAVR and TAVR. Because the study was underpowered, the results should be considered as hypothesis generating highlighting the need for further research. (ASAN Medical Center Aortic Valve Replacement Registry [ASAN-AVR]; NCT03298178).

Keywords: AS, aortic valve stenosis; ASAN-AVR, ASAN Medical Center Aortic Valve Replacement; AVR, aortic valve replacement; GARY, German Aortic Valve Registry; RCT, randomized clinical trial; RD, rapid deployment; SAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement; heart valves; mortality; surgery; transcatheter aortic valve replacement.

Conflict of interest statement

This study was partly supported by the CardioVascular Research Foundation (Seoul, South Korea) and the grant (2017IT1205) from the Asan Institute for Life Sciences, Asan Medical Center (Seoul, South Korea). The sponsor had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

© 2021 The Authors.

Figures

Graphical abstract
Graphical abstract
Figure 1
Figure 1
Study Flow Chart AS = aortic valve stenosis; ASAN-AVR = ASAN Medical Center Aortic Valve Replacement; CABG = coronary artery bypass grafting; PCI = percutaneous coronary intervention; SAVR = surgical aortic-valve replacement; TAVR = transcatheter aortic-valve replacement.
Figure 2
Figure 2
Unadjusted Cumulative Risks of the Study Outcomes Event rates are shown with the use of Kaplan-Meier estimates of the rates of (A) the primary composite end point and the individual components of the primary end point, ie, (B) death from any cause, (C) stroke, and (D) rehospitalization, in patients who underwent rapid-deployment aortic-valve replacement (Sutureless/RD-AVR), surgical aortic valve replacement (SAVR), and transcatheter aortic valve replacement (TAVR).
Figure 3
Figure 3
Cumulative Risks of the Study Outcomes in the Matched Cohorts of Sutureless/RD-AVR and SAVR Event rates are shown with the use of Kaplan-Meier estimates of the rates of (A) the primary composite end point and the individual components of the primary end point, ie, (B) death from any cause, (C) stroke, and (D) rehospitalization, in patients who underwent sutureless/AD-AVR and those who underwent SAVR. CI = confidence interval; HR = hazard ratio; other abbreviations as in Figure 1.
Figure 4
Figure 4
Cumulative Risks of the Study Outcomes in the Matched Cohorts of Sutureless/RD-AVR and TAVR Event rates were shown by use of Kaplan-Meier estimates of the rates of (A)the primary composite end point and the individual components of the primary end point, ie, (B) death from any cause, (C) stroke, and (D) rehospitalization), in patients who underwent rapid deployment aortic-valve replacement (Sutureless/RD-AVR) and those who underwent transaortic aortic-valve replacement (SAVR). Abbreviations as in Figures 1 and 2.
Central Illustration
Central Illustration
Comparison of Sutureless/RD-AVR with SAVR or TAVR Adjusted HRs (95% CIs) were derived from the propensity score–matched cohorts of RD-AVR with SAVR or TAVR. AVR = aortic valve replacement; RD = rapid-deployment; MICS = minimally invasive cardiac surgery; PPM = permanent pacemaker; PVL = paravalvular leak; SAVR = surgical aortic valve replacement; TAVR = transcatheter aortic valve replacement.

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