Clinical Equivalence of Trubond® and Ethibond® Braided Polyester Sutures for Valvular Prosthesis Fixation During Aortic or Mitral Valve Replacement: A Single-Blind Randomized Controlled Trial

Neelam B Desai; P S Seetharama Bhat; Chandra Sena M; Siddharth S; C H Praveen; Ashok K Moharana; Deepak Ts

doi:10.7759/cureus.41117

Clinical Equivalence of Trubond® and Ethibond® Braided Polyester Sutures for Valvular Prosthesis Fixation During Aortic or Mitral Valve Replacement: A Single-Blind Randomized Controlled Trial

Cureus. 2023 Jun 28;15(6):e41117. doi: 10.7759/cureus.41117. eCollection 2023 Jun.

Authors

Neelam B Desai¹, P S Seetharama Bhat², Chandra Sena M², Siddharth S¹, C H Praveen¹, Ashok K Moharana³, Deepak Ts³

Affiliations

¹ Cardio Vascular and Thoracic Surgery, Sri Sathya Sai Institute of Higher Medical Sciences, Puttaparthi, IND.
² Cardio Vascular and Thoracic Surgery, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bengaluru, IND.
³ Clinical Affairs, Healthium Medtech Limited, Bengaluru, IND.

Abstract

Background Paravalvular leak (PVL) following valve replacement is a serious cardiovascular complication that increases morbidity and mortality. Valve replacement with the interrupted suture technique using polyester suture provides adequate tensile strength and reduces the probability of tissue reaction. This study compared the clinical equivalence of Trubond®(Healthium) and Ethibond® (Ethicon, Johnson & Johnson) braided polyester sutures for valvular prosthesis fixation using interrupted suturing, with respect to the proportion of subjects having PVL after aortic valve (AV) or mitral valve (MV) replacement. Methodology Patients undergoing AV/MV replacement were enrolled and randomized in this study. The primary endpoint of this prospective, multicentric, two-arm, randomized (1:1), parallel-group, single-blind study (December 2020-October 2022) was the presence of PVL in Trubond® (n = 40) and Ethibond® (n = 42) groups within 26 weeks of surgery. The secondary endpoints included event rate of all-cause mortality, cardiac death, stroke, myocardial infarction, re-hospitalization, re-intervention, wound infection, operative time, intraoperative suture parameters, postoperative hospital stay, time to resume normal activities and work, quality of life, patient satisfaction, and adverse events in both groups. Results Patients who underwent AV/MV replacement and were followed up until 26 weeks had no incidence of PVL or other postoperative complications. No requirement for readmission or re-intervention was noted in both groups. Intraoperative suture handling characteristics, operative time, and hospital stay were also comparable between the groups. With each follow-up, subjects in both groups exhibited improved postoperative functional abilities, quality of life, and health status. Conclusions Trubond® braided polyester suture is clinically equivalent to Ethibond® braided polyester suture. Trubond® suture is safe and effective for valvular prosthesis fixation in patients undergoing AV or MV replacement.

Keywords: aortic valve; mitral valve; paravalvular leak; polyester suture; valvular prosthesis.

Grants and funding

Authors Ashok Kumar Moharana and Deepak TS are employees of Healthium Medtech Limited, India who are manufacturers of the Trubond suture. Authors Neelam B Desai, P.S. Seetharama Bhat, Chandra Sena M, Siddharth S, and CH Praveen declare no conflict of interest.