A prospective, international, bicentric study to evaluate PremiCron suture material for cardiac valve surgery – PREMIVALVE a cohort study

Abstract

Introduction: The most common age-related heart valve diseases include aortic valve stenosis and mitral valve insufficiency. The suture material is not the focus of most studies. The aim of the study was to assess the performance of PremiCron suture material for cardiac valve reconstruction and/or replacement under clinical routine. Performance was evaluated using the incidence of major adverse cardiac and cerebrovascular events (MACCE) combined with endocarditis. Materials and methods: The study was designed as an international, prospective, bicentric, observational, single-arm study to evaluate the PremiCron suture material in cardiac valve surgery and compare the outcome with literature data regarding postoperative complications. The primary endpoint was a composite of MACCE acquired in the hospital, combined with endocarditis occurring up to 6 months postoperatively. The secondary parameters were intraoperative handling of the suture, incidence of MACCE and other relevant complications and quality of life up to 6 months after surgery. Patients were examined at discharge, 30 days, and 6 months postoperatively. Results: A total of 198 patients were enrolled in two centers in Europe. The cumulative primary endpoint event rate was 5.0%, lower than the reference value of 8.2% from the literature. Comparison of the incidence of individual MACCE until discharge and endocarditis rate 6 months postoperatively also showed that our data were within the range of the published rates. Quality of life significantly increased from preoperatively to 6 months after surgery. Ease of handling of the suture material was rated as very good. Conclusion: The PremiCron suture material is safe and very eligible for cardiac valve replacement and/or cardiac valve reconstruction in a broad patient population with a cardiac valve disorder treated under daily clinical practice.