Perceval valve intermediate outcomes: a systematic review and meta-analysis at 5-year follow-up

Abstract

Abstract Objectives New technologies for the treatment of Aortic Stenosis are evolving to minimize risk and treat an increasingly comorbid population. The Sutureless Perceval Valve is one such alternative. Whilst short-term data is promising, limited mid-term outcomes exist, until now. This is the first systematic review and meta-analysis to evaluate mid-term outcomes in the Perceval Valve in isolation. Methods A systematic literature review of 5 databases was performed. Articles included evaluated echocardiographic and mortality outcomes beyond 5 years in patients who had undergone Perceval Valve AVR. Two reviewers extracted and reviewed the articles. Weighted estimates were performed for all post-operative and mid-term data. Aggregated Kaplan Meier curves were reconstructed from digitised images to evaluate long-term survival. Results Seven observational studies were identified, with a total number of 3196 patients analysed. 30-day mortality was 2.5%. Aggregated survival at 1, 2, 3, 4 and 5 years was 93.4%, 89.4%, 84.9%, 82% and 79.5% respectively. Permanent pacemaker implantation (7.9%), severe paravalvular leak (1.6%), structural valve deterioration (1.5%), stroke (4.4%), endocarditis (1.6%) and valve explant (2.3%) were acceptable at up to mid-term follow up. Haemodynamics were also acceptable at up mid-term with mean-valve gradient (range 9–13.6 mmHg), peak-valve gradient (17.8–22.3 mmHg) and effective orifice area (1.5–1.8 cm2) across all valve sizes. Cardiopulmonary bypass (78 min) and Aortic cross clamp times (52 min) were also favourable. Conclusion To our knowledge, this represents the first meta-analysis to date evaluating mid-term outcomes in the Perceval Valve in isolation and demonstrates good 5-year mortality, haemodynamic and morbidity outcomes. Key question What are the mid-term outcomes at up to 5 years follow up in Perceval Valve Aortic Valve Replacement? Key findings Perceval Valve AVR achieves 80% freedom from mortality at 5 years with low valve gradients and minimal morbidity. Key outcomes Perceval Valve Aortic Valve Replacement has acceptable mid-term mortality, durability and haemodynamic outcomes.