Trend towards better outcomes with sutureless valve for high-risk patients


Antonio Miceli (Istituto Clinico Sant’Ambrogio, University and Research Hospitals, Gruppo Ospedaliero SanDonato, Milan, Italy) and others report in the European Journal of Cardio-Thoracic Surgery that surgical aortic valve replacement using the right anterior minithoracomy approach and a sutureless valve (Perceval, Sorin) is associated with a trend towards better postoperative outcomes than those with transcatheter aortic valve implantation (TAVI) using the Sapien device (Edwards Lifesciences).

Miceli et al note that while TAVI is an alternative treatment to surgical aortic valve replacement in high-risk patients with severe aortic stenosis, “controversies still exist” regarding its effect on postoperative outcomes. They add that a subanalysis of randomised trials indicated that TAVI is associated with a higher incidence of neurological events, vascular complications, permanent pacemaker implantation, and aortic regurgitation than is surgical aortic valve replacement.

Furthermore, the authors state that surgical aortic valve replacement using the minimally invasive right anterior minithoracomy approach and the Perceval device is potentially “the real alternative” to traditional surgery for high-risk patients because it is associated with “excellent surgical results” and reduced procedural times (compared with traditional surgery). In this retrospective, observation, cohort study, Miceli et al compared early and midterm outcomes with surgical valve replacement (using the right anterior minithoracomy approach) with the Perceval S with those of TAVI using the Sapien valve.

Reviewing data for 269 high-risk patients who underwent isolated aortic valve replacement at their institution, the authors identified 178 who underwent surgery with the Perceval device and 91 who underwent TAVI with the Sapien device through the either the transfemoral approach (47) or the transapical approach (44). From this patient cohort, the authors identified 37 matched pairs.

There were no significant differences between groups in terms of the in-hospital mortality rate, stroke rate, or the rate of conversion to sternotomy. However, these events were all numerically higher in the TAVI group: death—0 for surgery vs. 3 for TAVI; stroke—0 vs 2, respectively; conversion to sternotomy—0 vs. 2. Furthermore, the rates of mild and moderate paravalvular leak were significant higher in the TAVI group (37.8% and 27% vs. 2.7% and 0% for surgery; p=0.1). “Although not statistically significant, the one- and two- year survival rates were higher in patients undergoing right anterior minithoracomy with the sutureless Perceval valve compared with those undergoing TAVI: 91.6% vs. 78.6% and 91.6% vs. 66.2%, respectively; p=0.1”, Miceli et al report.

They conclude: “Minimally invasive aortic valve replacement with sutureless Perceval valves through right anterior minithoracomy is associated with a trend towards better early outcomes and midterm survival compared with TAVI. A prospective randomised trial with a larger sample size is required to confirm our data.”

Miceli told Cardiovascular News: “I strongly believe that a multicentre randomised trial is required to evaluate the risk and benefit of these procedures in a high-intermediate risk population. However, the latest generation of TAVI technology is required to perform a well-designed trial.