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

JTCVS Techniques, vol. 17, pp. 23–46

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.

Authors 9

1. Bart J.J. Velders corresponding Aachen Department of Cardiothoracic Surgery

   Leiden University · Leiden University Medical Center

   Affiliation as printed

   Department of Cardiothoracic Surgery, Leiden University Medical Centre, Leiden, the Netherlands

2. Michiel D. Vriesendorp Aachen Department of Cardiothoracic Surgery

   Leiden University · Leiden University Medical Center

   Affiliation as printed

   Department of Cardiothoracic Surgery, Leiden University Medical Centre, Leiden, the Netherlands

3. Joseph F. Sabik

   University Hospitals of Cleveland · Case Western Reserve University

   Affiliation as printed

   Department of Surgery, University Hospitals, Case Western Reserve University School of Medicine, Cleveland, Ohio

4. François Dagenais

   Institut universitaire de cardiologie et de pneumologie de Québec

   Affiliation as printed

   Division of Cardiac Surgery, Quebec Heart and Lung Institute, Quebec, Quebec, Canada

5. Louis Labrousse
   Affiliation as printed

   Medico-Surgical Department of Valvulopathies, Bordeaux Heart University Hospital, Bourdeaux-Pessac, France

6. Vinayak Bapat

   St Thomas' Hospital

   Affiliation as printed

   Department of Cardiothoracic Surgery, NHS Foundation Trust-St Thomas' Hospital, London, United Kingdom

   Department of Cardiothoracic Surgery, NHS Foundation Trust–St Thomas' Hospital, London, United Kingdom

7. Gabriel S. Aldea

   University of Washington

   Affiliation as printed

   Department of Cardiothoracic Surgery, University of Washington School of Medicine, Seattle, Wash

8. Anelechi Anyanwu

   Icahn School of Medicine at Mount Sinai

   Affiliation as printed

   Department of Cardiovascular Surgery, Icahn School of Medicine at Mount Sinai, New York, NY

9. Robert J.M. Klautz Aachen Department of Cardiothoracic Surgery

   Leiden University · Leiden University Medical Center

   Affiliation as printed

   Department of Cardiothoracic Surgery, Leiden University Medical Centre, Leiden, the Netherlands