Pledgeted versus nonpledgeted sutures in aortic valve replacement: Insights from a prospective multicenter trial

Bart J J Velders; Michiel D Vriesendorp; Joseph F Sabik 3rd; Francois Dagenais; Louis Labrousse; Vinayak Bapat; Gabriel S Aldea; Anelechi C Anyanwu; Yaping Cai; Robert J M Klautz

doi:10.1016/j.xjtc.2022.10.016

Pledgeted versus nonpledgeted sutures in aortic valve replacement: Insights from a prospective multicenter trial

JTCVS Tech. 2022 Nov 5:17:23-46. doi: 10.1016/j.xjtc.2022.10.016. eCollection 2023 Feb.

Affiliations

¹ Department of Cardiothoracic Surgery, Leiden University Medical Centre, Leiden, the Netherlands.
² Department of Surgery, University Hospitals, Case Western Reserve University School of Medicine, Cleveland, Ohio.
³ Division of Cardiac Surgery, Quebec Heart and Lung Institute, Quebec, Quebec, Canada.
⁴ Medico-Surgical Department of Valvulopathies, Bordeaux Heart University Hospital, Bourdeaux-Pessac, France.
⁵ Department of Cardiothoracic Surgery, NHS Foundation Trust-St Thomas' Hospital, London, United Kingdom.
⁶ Department of Cardiothoracic Surgery, University of Washington School of Medicine, Seattle, Wash.
⁷ Department of Cardiovascular Surgery, Icahn School of Medicine at Mount Sinai, New York, NY.
⁸ Core Clinical Solutions, Medtronic, Mounds View, Minn.

Abstract

Objective: The objective of this study was to compare short- and midterm clinical and echocardiographic outcomes according to the use of pledgeted sutures during aortic valve replacement.

Methods: Patients with aortic stenosis or regurgitation requiring aortic valve replacement were enrolled in a prospective cohort study to evaluate the safety of a new stented bioprosthesis. Outcomes were analyzed according to the use of pledgets (pledgeted group) or no pledgets (nonpledgeted group). The primary outcome was a composite of thromboembolism, endocarditis, and major paravalvular leak at 5 years of follow-up. Secondary outcomes included multiple clinical endpoints and hemodynamic outcomes. Propensity score matching was performed to adjust for prognostic factors, and subanalyses with small valve sizes (<23 mm) and suturing techniques were performed.

Results: The pledgeted group comprised 640 patients (59%), and the nonpledgeted group 442 (41%), with baseline discrepancies in demographic characteristics, comorbidities, and stenosis severity. There were no differences between groups in any outcome. After propensity score matching, the primary outcome occurred in 41 (11.7%) patients in the pledgeted and 36 (9.8%) in the nonpledgeted group (P = .51). The effective orifice area was smaller in the pledgeted group (P = .045), whereas no difference was observed for the mean or peak pressure gradient. Separate subanalyses with small valve sizes and suturing techniques did not show relevant differences.

Conclusions: In this large propensity score-matched cohort, comprehensive clinical outcomes were comparable between patients who underwent aortic valve replacement with pledgeted and nonpledgeted sutures up to 5 years of follow-up, but pledgets might lead to a slightly smaller effective orifice area in the long run.

Keywords: AVR, aortic valve replacement; BMI, body mass index; BSA, body surface area; EOA, effective orifice area; EOAi, effective orifice area indexed; LVOT, left ventricular outflow tract; PERIGON, PERIcardial SurGical AOrtic Valve ReplacemeNt; PPM, prosthesis–patient mismatch; PVL, paravalvular leak; STS, Society of Thoracic Surgeons; endocarditis; paravalvular leak; pledgets; surgical aortic valve replacement; suturing technique; thromboembolism.