TY - JOUR
T1 - Pledgeted versus nonpledgeted sutures in aortic valve replacement
T2 - Insights from a prospective multicenter trial
AU - Velders, Bart J. J.
AU - Vriesendorp, Michiel D.
AU - Sabik, Joseph F.
AU - Dagenais, Francois
AU - Labrousse, Louis
AU - Bapat, Vinayak
AU - Aldea, Gabriel S.
AU - Anyanwu, Anelechi C.
AU - Cai, Yaping
AU - Klautz, Robert J. M.
N1 - Funding Information: The PERIGON Pivotal Trial was funded by Medtronic . Publisher Copyright: © 2022 The Author(s)
PY - 2022
Y1 - 2022
N2 - 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.
AB - 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.
KW - endocarditis
KW - paravalvular leak
KW - pledgets
KW - surgical aortic valve replacement
KW - suturing technique
KW - thromboembolism
UR - http://www.scopus.com/inward/record.url?scp=85143914744&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.xjtc.2022.10.016
DO - https://doi.org/10.1016/j.xjtc.2022.10.016
M3 - Article
C2 - 36820352
SN - 2666-2507
JO - JTCVS Techniques
JF - JTCVS Techniques
ER -