Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis

Abstract

OBJECTIVES Long-term durability of bioprosthetic valves is predominantly limited by structural valve deterioration. RESILIA™ tissue has exhibited reduced calcification in pre-clinical and early clinical studies. This study evaluated the 5-year clinical and haemodynamic outcomes of an aortic valve with this tissue. METHODS This was a prospective, non-randomized, single-arm study of 133 patients implanted with a RESILIA aortic bioprosthesis between July 2011 and February 2013 at 2 sites in Poland. Clinical outcomes and haemodynamic performance were assessed annually for 5 years post-implant. Safety events were adjudicated by a Clinical Events Committee and echocardiographic data were assessed by an independent core laboratory. RESULTS Mean patient age was 65.3 ± 13.5 years, with 34 patients (25.6%) ≤60. The mean follow-up was 4.2 ± 1.5 years. Early (≤30 days) and late (>30 days) all-cause mortality were 2.3% (N = 3) and 3.2%/late patients-years (N = 18) respectively. Early events included thromboembolism in 3 patients (2.3%). Late valve-related events included endocarditis in 1 patient, which led to explant, and valve thrombosis in another patient. There were no events of structural valve deterioration throughout the study. At 5 years, mean gradient was 14.8 ± 7.6 mmHg and effective orifice area was 1.4 ± 0.5 cm2, a marked improvement over baseline values. All New York Heart Association class III patients and most class II patients at baseline had improved classifications at 5 years. CONCLUSIONS The bioprosthesis with RESILIA tissue demonstrated a good safety profile with excellent haemodynamic performance over 5 years of follow-up. These encouraging outcomes warrant additional investigation of this novel tissue. Clinical trial registration number NCT01651052

Serial echocardiographic evaluation of the Perimount Magna Ease prosthesis

“…In our series, the incidence of SVD ≥ stage 2 at 10-year follow-up was more frequent due to the lower mean age (by 5 years) of our study population and due to our continuous echocardiographic follow-up. New generation heart valves made with tissue designed to reduce calcification, such as the RESILIA (bovine pericardial, Edwards Lifesciences, Irvine, CA, USA) prosthesis, showed no SVD up to 5 years of implantation (16,17). When comparing this valve to the PME, equal rates of SVD 5 years post implantation were seen, and the potential longterm advantage of the RESILIA prosthesis still needs to be proven.…”

Long-Term Outcome of Mechanical and Biological Prostheses in Patients with Left-Side Infective Endocarditis: A Systematic Review and Meta-Analysis

“…This is in favor of the increased use of biological prostheses even in patients under 60 years of age. In addition, the latest generation of biological prostheses with novel preservation technology to protect against valve degeneration [ 38 ] and other prosthesis predisposed to future valve-in-valve therapy [ 39 ] are being used in clinical practice with the aim of eliminating long-life anticoagulant therapy. In addition, some last generation mechanical prostheses with lower thromboembolism incidence would allow for less anticoagulation and therefore have a wider use in patients >60 years old [ 40 ].…”

Prognostic influence of objective nutritional indexes on mortality after surgical aortic valve replacement in elderly patients with severe aortic stenosis (from the nutrition‐SAVR trial)

“…Severe aortic stenosis (AS) is a common heart valve disease, especially in the elderly population 1,2 . Considering the increase in the rate of elderly patients in the world population, especially in Europe, the prevalence of degenerative severe AS probably will increase in the near future 3,4 . The most common treatment method used in these patients is surgical aortic valve replacement (SAVR), but the rate of transcatheter aortic valve replacement (TAVR) is increasing rapidly especially in the elder population.…”