Impact of clinical factors and surgical techniques on early outcome of patients treated with frozen elephant trunk technique by using EVITA open stent-graft: Results of a multicentre study

OBJECTIVES: The treatment of patients with extensive thoracic aortic disease involving the arch and descending aorta is often performed, using the frozen elephant trunk (FET) technique. We retrospectively analysed early outcomes with this technique, using a prospective database. METHODS: A total of 509 patients (mean age: 61 \ub1 11 years) were registered between January 2005 and January 2014 in a multicentre database after FET surgery. Acute or chronic aortic dissection (AD) was the indication for surgery in 350 (68.8%) patients and degenerative or atherosclerotic aneurysm (DA) accounted for 159 (31.2%) patients. A logistic regression model was created to identify independent predictors of in-hospital mortality and neurological complications. RESULTS: The average in-hospital mortality was 15.9% (n = 81) with 17.1% for AD patients and 13.2% for DA patients (P = 0.2). Independent predictors of in-hospital mortality were haemodynamic instability [odds ratio (OR): 2.7, P = 0.005], peripheral vascular disease (OR: 2.6, P = 0.002), diabetes (OR: 2.1, P = 0.05) and selective cerebral perfusion time >60 min (OR: 2.2, P = 0.005). Patients under 60 years of age and the use of guide wire during FET implantation were protective for early survival. Stroke occurred in 7.7% (n = 39) of patients. Paraplegia or paraparesis occurred in 7.5% (n = 38) of patients. A distal landing zone lower than T10 was an independent predictor for spinal cord injury (OR: 2.3, P = 0.03). CONCLUSIONS: Techniques for faster arch replacement and controlled FET placement should be considered in order to reduce the early mortality and neurological complications after FET surgery. For distal aortic lesions, a two-staged approach is suggested, rather than the FET landing lower than T10

Sutureless versus conventional bioprostheses for aortic valve replacement in severe symptomatic aortic valve stenosis

Objective: Sutureless aortic valves are a novel option for aortic valve replacement. We sought to demonstrate noninferiority of sutureless versus standard bioprostheses in severe symptomatic aortic stenosis. Methods: The Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement is a prospective, randomized, adaptive, open-label trial. Patients were randomized (March 2016 to September 2018) to aortic valve replacement with a sutureless or stented valve using conventional or minimally invasive approach. Primary outcome was freedom from major adverse cerebral and cardiovascular events (composite of all-cause death, myocardial infarction, stroke, or valve reintervention) at 1 year. Results: At 47 centers (12 countries), 910 patients were randomized to sutureless (n = 453) or conventional stented (n = 457) valves; mean ages were 75.4 ± 5.6 and 75.0 ± 6.1 years, and 50.1% and 44.9% were female, respectively. Mean ± standard deviation Society of Thoracic Surgeons scores were 2.4 ± 1.7 and 2.1 ± 1.3, and a ministernotomy approach was used in 50.4% and 47.3%, respectively. Concomitant procedures were performed with similar rates in both groups. Noninferiority was demonstrated for major adverse cerebral and cardiovascular events at 1 year, whereas aortic valve hemodynamics improved equally in both groups. Use of sutureless valves significantly reduced surgical times (mean extracorporeal circulation times: 71.0 ± 34.1 minutes vs 87.8 ± 33.9 minutes; mean crossclamp times: 48.5 ± 24.7 vs 65.2 ± 23.6; both P <.0001), but resulted in a higher rate of pacemaker implantation (11.1% vs 3.6% at 1 year). Incidences of perivalvular and central leak were similar. Conclusions: Sutureless valves were noninferior to stented valves with respect to major adverse cerebral and cardiovascular events at 1 year in patients undergoing aortic valve replacement (alone or with coronary artery bypass grafting). This suggests that sutureless valves should be considered as part of a comprehensive valve program