Propensity-Matched 1-Year Outcomes Following Transcatheter Aortic Valve Replacement in Low-Risk Bicuspid and Tricuspid Patients.

OBJECTIVES: The aim of this study was to compare 1-year outcomes after transcatheter aortic valve replacement (TAVR) in low surgical risk patients with bicuspid aortic stenosis to patients with tricuspid aortic stenosis. BACKGROUND: The pivotal TAVR trials excluded patients with bicuspid aortic valves. The Low Risk Bicuspid Study 30-day primary endpoint of death or disabling stroke was 1.3%. METHODS: The Low Risk Bicuspid Study is a prospective, single-arm, TAVR trial that enrolled patients from 25 U.S. sites. A screening committee confirmed bicuspid anatomy and valve classification on computed tomography using the Sievers classification. Valve sizing was by annular measurements. An independent clinical events committee adjudicated all serious adverse events, and an independent core laboratory assessed all echocardiograms. The 150 patients from the Low Risk Bicuspid Study were propensity matched to the TAVR patients in the randomized Evolut Low Risk Trial using the 1:1 5- to-1-digit greedy method, resulting in 145 pairs. RESULTS: All-cause mortality or disabling stroke at 1 year was 1.4% in the bicuspid and 2.8% in the tricuspid group (P = 0.413). A pacemaker was implanted in 16.6% of bicuspid and 17.9% of tricuspid patients (P = 0.741). The effective orifice area was similar between groups at 1 year (2.2 ± 0.7 cm2 vs 2.3 ± 0.6 cm2, P = 0.677) as was the mean gradient (8.7 ± 3.9 mm Hg vs 8.5 ± 3.1 mm Hg, P = 0.754). Fewer patients in the bicuspid group had mild or worse paravalvular leak (21.3% vs 42.6%, P < 0.001). CONCLUSIONS: There were no significant differences in clinical or forward flow hemodynamic outcomes between the propensity-matched groups at 1 year.

Achieving and Sustaining Zero: Preventing Surgical Site Infections After Isolated Coronary Artery Bypass With Saphenous Vein Harvest Site Through Implementation of a Staff-Driven Quality Improvement Process.

BACKGROUND: Surgical site infections (SSI) increase morbidity and mortality, hospital costs, length of stay, readmissions, and risk of litigation and may impact a facility's reputation. METHODS: Through implementation of a Six Sigma, interdisciplinary team process and the Contextual Model for change engaged all stakeholders. A total of 44 perioperative processes were evaluated, with 15 processes ultimately altered. Revisions involved identifying inconsistent implementation of procedures and standardizing processes, as well as utilizing new suture techniques and products including disposable electrocardiogram leads and pacing wires, antibiotic-coated sutures, and silver-impregnated midsternal dressings. RESULTS: In isolated coronary artery bypass grafting with donor-site procedures, an incidence of 3.74 per 100 procedures was reduced to 0.7 and ultimately to 0. No patients who underwent coronary artery bypass grafting developed a deep sternal wound infection in over 30 months and 590 procedures, resulting in an estimated cost savings of more than $600 000, from May 2012 through December 2014. CONCLUSIONS: A significant reduction in deep sternal wound infections was achieved by working at all levels of the organization through a multidisciplinary approach to create sustained change. Using real-time observations for current practices, areas for improvement were identified. By engaging frontline staff in the process, ownership of the outcomes and adherence to practice change were promoted. The result was a dramatic, rapid, and sustainable improvement in the prevention of deep sternal wound infection.