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Central Surgical Association

49th Annual Meeting

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Pledgeted Versus Non-Pledgeted Sutures in Aortic Valve Replacement: Insights From a Large Prospective Multicenter Trial
Bart Velders1, Michiel Vriesendorp1, Joseph Sabik2, Francois Dagenais3, Louis Labrousse3, Vinayak Bapat4, *Gabriel Aldea5, Yaping Cai6, Robert Klautz1
1Department of Cardio-Thoracic Surgery, Leiden University Medical Centre, The Hague, Netherlands, 2Department of Surgery, University Hospitals, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA, Cleveland, Ohio, United States, 3Division of Cardiac Surgery, Quebec Heart and Lung Institute, Quebec, Quebec, Canada, Quebec, Quebec, Canada, 4Department of Cardiothoracic Surgery, NHS Foundation Trust - St Thomas' Hospital, London, UK, London, United Kingdom, 5Department of Cardiothoracic Surgery, University of Washington School of Medicine, Seattle, Washington, United States, 6Department of Biostatistics, Medtronic, Minneapolis, Minnesota, United States

Objective:
Whether to use pledgeted sutures in surgical aortic valve replacement is an ongoing debate among surgeons. While some argue that use of pledgeted sutures leads to decreased paravalvular leakage, others believe it might increase postoperative pressure gradients and endocarditis or thromboembolism rates due to extra foreign material in the left ventricular outflow tract. As previous studies have shown conflicting results, we compared short- and mid-term clinical and echocardiographic outcomes according to the use of pledgeted sutures in a prospective multicenter setting.

Methods:
Patients with aortic stenosis or regurgitation requiring aortic valve replacement were enrolled at 38 sites in the United States, Canada, and Europe. While all patients received the same stented bioprosthesis, the implantation technique was left to the discretion of the surgeon. For this analysis, patients were stratified to either pledgets (pledgeted group) or everted mattress, non-everted mattress, continuous, Cor-knot, or simple interrupted sutures without pledgets (non-pledgeted group). Death and valve-related adverse events were adjudicated by an independent clinical events committee, and echocardiographic evaluation was performed by a core laboratory. The primary outcome was a composite of thromboembolism, endocarditis, and major paravalvular leakage at 5 years of follow-up. Secondary outcomes consisted of multiple clinical endpoints and hemodynamical outcomes. Clinical endpoints were reported as Kaplan-Meier rates and compared with the log-rank test.

Results:
The pledgeted group comprised 645 patients (59%), and the non-pledgeted group 447 (41%). The pledgeted group had, on average, lower age, higher body mass index, lower Society of Thoracic Surgeons risk score, and larger aortic valve area at baseline (Table 1). Furthermore, concomitant coronary artery bypass grafting was performed more often in the pledgeted group. There were no significant differences between groups in the individual and composite outcomes (Figure 1) of thromboembolism, endocarditis, and major paravalvular leakage, nor were there significant differences in other adverse events or hemodynamic performance at 5 years of follow-up. The presentation will include additional results of propensity score matching and subanalyses within the non-pledgeted group to compare different suturing techniques and valve sizes below 23 mm.

Conclusions:
At 5 years, clinical outcomes and hemodynamic performance were comparable between patients undergoing surgical aortic valve replacement with and without pledgeted sutures. Even the endocarditis and thromboembolism rates were comparable despite the use of extra foreign material in pledgeted sutures. The lack of pledgeted sutures did not lead to increased paravalvular leakage in this study.

Figure 1. Five-year outcomes according to the use of pledgets. Shown are unadjusted Kaplan-Meier event rates with 95% confidence intervals (CIs) for (A) the composite endpoint of thromboembolism, endocarditis, and major paravalvular leak; (B) thromboembolism; (C) endocarditis; and (D) major paravalvular leak. NA: not available.

Table 1. Overview of baseline characteristics, procedural details, and five-year outcomes according to the use of pledgets in aortic valve replacement.Values are n (%) or mean ± standard deviation unless otherwise stated. * Five-year outcomes are reported as Kaplan-Meier rates (95% CI) for all clinical adverse events. BMI = Body mass index; CABG = Coronary artery bypass graft; NYHA = New York Heart Association; STS = Society of Thoracic Surgeons.


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