Clinical trials in valvular surgery: a 2018 update.

PURPOSE OF REVIEW: There is a growing emphasis on the conduct of large-scale, multicenter randomized controlled trials (RCTs) to guide decision-making in cardiac surgery. Here we review recent landmark RCTs in cardiac valvular surgery.

RECENT FINDINGS: RCTs are the gold-standard level of data in medicine. However, there are unique challenges of conducting large-scale surgical trials including funding, blinding, generalizability, nonstandardization of the surgical technique, crossover, among others. Thus, the vast majority of clinical outcomes data in cardiac surgery are mainly from observational studies and most prospective data are small, single-center trials. The Cardiothoracic Surgery Network is the largest platform focused on the conduct of high-quality, multicenter cardiac surgical trials, which has already produced several seminal guideline-changing and practice-changing contributions to the surgical approach to functional mitral regurgitation, aortic stenosis, atrial fibrillation, and neuroprotective surgical adjuncts.

SUMMARY: There continues to be great interest in the conduct of high-quality, RCTs to help guide surgical management of patients with valvular heart disease.