Prospective US investigational device exemption trial of a sutureless aortic bioprosthesis: One-year outcomes

Abstract

Objectives: We performed a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption to assess safety and efficacy of Perceval, a sutureless bovine pericardial aortic valve representing the initial US experience.Methods: From June 2013 to January 2015, 300 patients (mean age 76.7 AE 7.7 years, 54.3% men, 37.3% !80 years, median Society of Thoracic Surgeons Predicted Risk of Mortality 2.8%), underwent Perceval valve implantation at 18 centers across the United States. Twenty patients (6.7%) had a bicuspid aortic valve and 5 (1.7%) patients had previous aortic valve replacement. A minimally invasive approach was used in 80 (26.7%) and concomitant procedures were performed in 113 (37.8%) patients.Results: Two hundred eighty-nine patients (96.3%) were successfully implanted. Operative mortality ( 30 days) was 1.3% (n ¼ 4) (observed to expected ratio of 0.40). One-year results included all-cause mortality in 5.2% (n ¼ 15), stroke in 1% (n ¼ 3), and endocarditis in 1.7% (n ¼ 5). New permanent periprocedural pacemaker rate was 10.7% (n ¼ 30/281); 2.5% (n ¼ 7/281) resulted from third-degree atrioventricular block. One-year valve-related reoperation was 2.1% (n ¼ 6). At 1-year follow-up, 98% of patients were in New York Heart Association class I/II, left ventricular mass index decreased from 103.5 AE 30.1 g/m 2 at discharge to 95.8 AE 27.1 g/m 2 (P ¼ .001), and 3 (1.3%) moderate paravalvular leaks were identified. Health-related quality of life score increased from 62.7 AE 21.8 before surgery to 85.5 AE 17.8 at 1 year (P <.001).Conclusions: These results confirm the safety and effectiveness of the Perceval sutureless aortic valve replacement in study patients with lower mortality than Perceval Sutureless aortic valve. Central MessageThe results of the initial US experience for Perceval in a prospective, single-arm clinical trial confirm safety and efficacy outcomes both in isolated and combined procedures regardless of surgical approach. PerspectiveThere is an extensive medical literature for Perceval from centers outside of the United States; this initial US experience further confirms sutureless aortic valve replacement is a safe and effective therapy for patients with aortic valve stenosis. The device may be used in isolated and combined procedures via open or minimally invasive approaches.

Perceval or Trifecta to Prevent Patient–Prosthesis Mismatch

“…Very few studies have investigated the prevalence of PPM using the sutureless valves, specifically the Perceval aortic prosthesis. In a recent multicenter prospective study, Suri et al reported very high rates of severe PPM using the Perceval [ 8 ]. So, for the size S, the rate of severe PPM was 40%; for M and L, the rate was 30%, and for XL, it was 25%.…”

“…Few studies have evaluated the hemodynamic performance of the Perceval [ 8 , 9 , 10 , 11 ]; even fewer have evaluated the prevalence of PPM using this prosthesis [ 8 ], which is a really important measure for outcomes, and no study has compared the prevalence of this complication with the Trifecta aortic valve.…”

Commentary: Age is just an element of the quality of life puzzle following aortic valve replacement

“…A recent US investigational device exemption trial of a sutureless aortic bioprosthesis corroborates significant HRQL benefits at 1 year with the sutureless approach. 4 Minimally invasive approaches (mini-sternotomy or right thoracotomy) proved the same. 5 Finally, HRQL is impacted by postoperative complications, and SAVR-related complications, such as perioperative bleeding, postoperative acute kidney injury, atrial fibrillation, and stroke, are all associated with worse quality of life after open heart surgery.…”

A case of challenging percutaneous coronary intervention following surgical aortic valve replacement with a sutureless aortic bioprosthesis

“…Hence, SAVR is still considered as the standard treatment. Use of Perceval (LivaNova, London, UK), a sutureless bioprosthesis with a self-expanding open-cell designed nitinol frame (SL-AVR), is feasible because it reduces the duration of cardio-pulmonary bypass [2]. There are various options for the treatment of AS and the advantages and disadvantages of each option need to be considered before deciding the treatment strategy.…”