The Perceval sutureless aortic valve demonstrated acceptable safety and hemodynamic performance, with 77.5% of patients experiencing at least a one-class improvement in NYHA functional status at 12 months.
Cohort (n=658)
Yes
Hypo-attenuated leaflet thickening and reduced leaflet motion are prevalent in surgically implanted sutureless bioprosthetic aortic valves, even in patients receiving anticoagulation.
BACKGROUND: The prevalence of hypo-attenuated leaflet thickening (HALT) and reduced leaflet motion (RLM) is unknown in surgically implanted bioprostheses because systematic investigation of HALT and/or RLM is limited to a few catheter-based valves. The aim of this study was to investigate the prevalence of HALT and RLM by cardiac computed tomography in patients who underwent surgical aortic valve replacement and received a Perceval sutureless aortic valve bioprosthesis. METHODS AND RESULTS: This was a single-center prospective observational study that included 47 patients (83.5% of the total number of implantations) who underwent surgical aortic valve replacement with implantation of the Perceval sutureless bioprosthesis (LivaNova PLC, London, UK) at Karolinska University Hospital in Stockholm, Sweden from 2012 to 2016 and were studied by cardiac computed tomography. Cardiac computed tomography was performed at a median of 491 days (range 36-1247 days) postoperatively. HALT was found in 18 (38%) patients and RLM in 13 (28%) patients. All patients with RLM had HALT. Among patients with HALT, 5 out of 18 patients (28%) were treated with anticoagulation (warfarin or any novel oral anticoagulant) at the time of cardiac computed tomography. Among patients with RLM, 3 out of 13 patients (23%) were treated with anticoagulation. CONCLUSIONS: HALT and RLM were prevalent in the surgically implanted Perceval sutureless aortic valve bioprosthesis. Both HALT and RLM were found in patients with ongoing anticoagulation treatment. Whether these findings are associated with adverse events needs further study. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02671474.
Dalén et al. (2017) conducted a cohort in Aortic valve stenosis or steno-insufficiency (n=658). Perceval sutureless aortic heart valve vs. Historical controls (Objective Performance Criteria) was evaluated on Complication and survival rates compared to Objective Performance Criteria (OPCs) and NYHA functional classification improvement. The Perceval sutureless aortic valve demonstrated acceptable safety and hemodynamic performance, with 77.5% of patients experiencing at least a one-class improvement in NYHA functional status at 12 months.