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

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.

Sutureless Perceval Valve: Size Matters

“…The Perceval valve can simplify surgical aortic valve replacement by shortening cardiopulmonary bypass and cross-clamp times and providing excellent hemodynamic outcomes. 1,2,4,14,27 Nonetheless, sizing and selection of the appropriate prosthesis remains a challenge that still requires the conversion of several nuanced inputs such as “feel,” tactile feedback, and visual assessment. The incorporation of cardiac CT for more standardized preoperative planning and to complement intraoperative obturator sizing is currently under investigation and is an important area of future study.…”

“…Even when using the small Perceval valve, the resulting transvalvular gradients are as low as single digits, and the hemodynamics are excellent. 1,[6][7][8][9][10]14 This is because the low profile of the valve frame is such that when the leaflets open, they are essentially opening to the dimensions of the aortic root.…”

“…Correct or "right" sizing of Perceval valves is important if one is to reap the benefits of the superior hemodynamic performance, shorter operative times, and excellent clinical outcomes that this valve offers. [1][2][3][4][5][6][7] The Perceval valve has a nitinol frame and bovine pericardial leaflets. Nitinol has 2 distinct properties: shape memory and superelasticity.…”

“…Correct or “right” sizing of Perceval valves is important if one is to reap the benefits of the superior hemodynamic performance, shorter operative times, and excellent clinical outcomes that this valve offers. 1–7…”

The Perceval Sutureless Bioprosthetic Aortic Valve: Evolution of Surgical Valve Technology

“…69 A recent meta-analysis of midterm outcomes indicates a mortality rate of 6.6%, 11.6%, 15.1%, and 21.5% at 1, 2, 3, and 5 years, respectively. 71 Stroke. Overall rates of stroke range from 0.5% to 6%.…”