Surgeons interested in learning and performing minimally invasive aortic valve replacement must have expertise in conventional aortic valve replacement at centers with adequate case volumes. A team approach that coordinates efforts of the surgeon, anesthesiologist, perfusionist, and nurses is required to achieve the best clinical outcomes. By first developing fundamental minimally invasive skills using specialized cannulation techniques, neck lines, and long-shafted instruments in the setting of conventional full sternotomy, the safest operative environment is afforded to patients.

OBJECTIVESWe assessed the safety, effectiveness and haemodynamic performance of a new bovine stented aortic valve bioprosthesis (Avalus™).METHODSThe PERIGON Pivotal Trial is a prospective, non-randomized, multicentre study. Subjects had symptomatic moderate or severe aortic stenosis or chronic, severe aortic regurgitation. Death, valve-related adverse events (AEs), functional recovery and haemodynamic performance were assessed at discharge, 3–6 months and 1 year. The primary analysis compared ‘late’ (>30 days post-implant) linearized rates of valve-related thromboembolism, thrombosis, all and major haemorrhage, all and major paravalvular leak (PVL) and endocarditis after implantation with objective performance criteria (OPC) for AEs, in accordance with EN ISO 5840:2009. We hypothesized that the upper 95% confidence bounds of the true linearized AE rates would be ≥ 2 × OPC; rejection of the null hypothesis would demonstrate that these rates were below acceptable rates. The analysis was required to include at least 150 patients followed to 1 year and 400 valve-years. Kaplan–Meier survival analysis was also performed.RESULTSTotal number of valve-years was 459.5 (n = 686). Linearized rates were <2 × OPC for death and valve-related thromboembolism, valve thrombosis, all and major PVL, and endocarditis, but ≥2 × OPC for all and major haemorrhage. Survival at 1 year (n = 270) was 96.4%. Patients showed good functional recovery, and haemodynamic performance was within expected range.CONCLUSIONSThis analysis demonstrated a good safety profile and clinical effectiveness of the Avalus valve except for bleeding rates. The linearized rates of all and major haemorrhage may be related to long-term anticoagulation for non-valvular indications and the length of follow-up of this cohort.Trial registrationNCT02088554 (www.clinicaltrials.gov).

This analysis of a new stented bovine pericardial aortic valve demonstrated low overall mortality and valve-related adverse events, and hemodynamic performance comparable to that of other surgical aortic valves.

No abstract

Objectives: We performed a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption to assess safety and efficacy of Perceval, a sutureless bovine pericardial aortic valve representing the initial US experience.Methods: From June 2013 to January 2015, 300 patients (mean age 76.7 AE 7.7 years, 54.3% men, 37.3% !80 years, median Society of Thoracic Surgeons Predicted Risk of Mortality 2.8%), underwent Perceval valve implantation at 18 centers across the United States. Twenty patients (6.7%) had a bicuspid aortic valve and 5 (1.7%) patients had previous aortic valve replacement. A minimally invasive approach was used in 80 (26.7%) and concomitant procedures were performed in 113 (37.8%) patients.Results: Two hundred eighty-nine patients (96.3%) were successfully implanted. Operative mortality ( 30 days) was 1.3% (n ¼ 4) (observed to expected ratio of 0.40). One-year results included all-cause mortality in 5.2% (n ¼ 15), stroke in 1% (n ¼ 3), and endocarditis in 1.7% (n ¼ 5). New permanent periprocedural pacemaker rate was 10.7% (n ¼ 30/281); 2.5% (n ¼ 7/281) resulted from third-degree atrioventricular block. One-year valve-related reoperation was 2.1% (n ¼ 6). At 1-year follow-up, 98% of patients were in New York Heart Association class I/II, left ventricular mass index decreased from 103.5 AE 30.1 g/m 2 at discharge to 95.8 AE 27.1 g/m 2 (P ¼ .001), and 3 (1.3%) moderate paravalvular leaks were identified. Health-related quality of life score increased from 62.7 AE 21.8 before surgery to 85.5 AE 17.8 at 1 year (P <.001).Conclusions: These results confirm the safety and effectiveness of the Perceval sutureless aortic valve replacement in study patients with lower mortality than Perceval Sutureless aortic valve. Central MessageThe results of the initial US experience for Perceval in a prospective, single-arm clinical trial confirm safety and efficacy outcomes both in isolated and combined procedures regardless of surgical approach. PerspectiveThere is an extensive medical literature for Perceval from centers outside of the United States; this initial US experience further confirms sutureless aortic valve replacement is a safe and effective therapy for patients with aortic valve stenosis. The device may be used in isolated and combined procedures via open or minimally invasive approaches.