A Bicentric, International, Retrospective Study to Assess Steelex Sternum Set for Sternal Closure in Cardiac Surgery – STERCCAS a Cohort Study

Abstract

Sternal fixation with steel wires or cerclages, is the gold standard for closing a midline sternotomy, the standard incision in cardiac surgery. Rare wound complications can occur following a sternotomy wire closure. The objective of this study is to establish that the clinical efficacy of the Steelex Sternum Set is equivalent to the results documented in existing literature. The cohorts of the previously conducted OPTICABG and PREMIVALVE studies served as a foundation for the design of this retrospective, bicentric, international, single-arm study. The purpose of the study was to evaluate the clinical performance of the Steelex Sternum Set for sternal closure after coronary artery bypass grafting or cardiac valve replacement/reconstruction surgery. The primary endpoint was the incidence of a composite consisting of sternum instability, sternum dehiscence, superficial and deep sternal wound infection up to six months after surgery. A quantitative summary of the available clinical literature has been conducted for comparison purposes. There were 229 patients in total (89 PREMIVALVE and 140 OPTICABG). The combined rate of surgical site infection and sternal dehiscence/instability was 3.49%, compared to 1.5 - 20% described in the literature. Severe complications such as mortality, stroke, myocardial infarction, and mediastinitis occurred in about 0.8 - 2% of cases. The Steelex Sternum Set is a safe and appropriate method for sternal closure in a diverse patient population undergoing cardiac valve replacement and/or reconstruction, as well as coronary artery bypass graft surgery, in routine clinical settings.