Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis†

Abstract

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).

Clinical outcomes and hemodynamic performance of Dafodil™ aortic and mitral pericardial bioprosthesis: 1-year results from Dafodil-1 first-in-human trial

“…In the present study, none of the patients having Dafodil pericardial bioprosthesis for AVR died at 12-month follow-up. The 30-day mortality of patients receiving Dafodil pericardial bioprosthesis for AVR is similar to that of reported by the studies of other valves [3,[14][15][16]. Reported 30-days mortality rate of Trifecta (St. Jude Medical Inc., MN, USA), and Carpentier-Edwards Perimount Magna Ease (Edwards Lifesciences, Irvine, CA) bioprostheses was 0 and 2%, respectively [15].…”

Open heart mitral valve replacement using the Edwards-Sapien 3 for severe mitral annular calcification prevents left ventricular outflow tract obstruction

“…While weaning from cardiopulmonary bypass, we temporarily stopped the bypass flow and checked the PG between the LV (109/12 mmHg) (needle through the ventricular wall) and the ascending aorta (94/56 mmHg). Because the direct pressure is higher than the pressure measured by echocardiography, and the mean gradient measured by echocardiography after AV replacement using AVALUS is between 10 and 15 mmHg, this maximum PG was acceptable 4 . Transthoracic echocardiography 3 month post-operatively showed no PVL at the mitral prosthesis and confirmed no significant LVOT obstruction.…”

Commentary: Do old rules apply to new valves?

“…Within this segment of the market, the Avalus bioprosthetic valve (Medtronic, Minneapolis, Minn) is a novel low-profile, stented bovine pericardial valve, the safety and efficacy of which has been investigated in the PERIGON trial (PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial). Early results, previously reported, 4,5 included favorable hemodynamics and acceptable rates of death, paravalvular leak, thromboembolism, and endocarditis. The rate of bleeding events, however, has been higher than expected.…”

“…These included concomitant antithrombotic therapy for comorbidities and the suggestion that early bleeding is more likely and therefore skews the linearized projections. 4,5 In this edition of the Journal, Klautz and colleagues 6 address the topic of elevated bleeding risk associated with the Avalus valve more directly and report on midterm data regarding valvular deterioration. Included are 1115 patients, now with 3-year follow-up.…”