Original article
Adult cardiac
A European Multicenter Study of 616 Patients Receiving the Freedom Solo Stentless Bioprosthesis

https://doi.org/10.1016/j.athoracsur.2015.06.096Get rights and content

Background

The purpose of this study was to evaluate the safety and performance of the Freedom Solo valve in aortic valve replacement by clinical and hemodynamic outcomes.

Methods

Six hundred sixteen patients underwent aortic valve replacement in 18 European centers; mean age was 74.5 ± 5.9 years, 54.1% of the patients were male, and concomitant procedures were performed in 43.2% of the patients. The majority (69%) of the implanted sizes were 23 mm and 25 mm.

Results

At 1 year, overall survival was 94.0%, whereas freedom from valve-related death was 98.6%. There were 9 (1.5%) early (≤30 days) and 27 (4.4%) late (>30 days) deaths. Early and late valve-related mortality was 0.3% (n = 2) and 1.1% (n = 7), respectively. Freedom from explant was 97.6%; 10 valves were explanted for endocarditis and 4 for paravalvular leak. There were 10 (1.6%) early and 5 (0.8%) late strokes. Atrioventricular block requiring pacemaker implant occurred in 8 (1.3%) and 1 (0.2%) patients in the early and late postoperative period, respectively. Thrombocytopenia was seen in 27 cases (4.4%) in the early postoperative period. Preoperatively, 93.8% of patients were in New York Heart Association functional classes II through IV, whereas at 1 year 96.9% of patients were in New York Heart Association functional classes I and II. At 1-year follow-up, mean and peak pressure gradients were 7.2 and 14.6 mm Hg, respectively. Indexed left ventricular mass decreased by 12% from 138 g/m2 at discharge to 122 g/m2 at 1 year.

Conclusions

At 1-year follow-up after Freedom Solo implantation, we found acceptable clinical results with low mortality and morbidity and good hemodynamic performance, confirming safety and effectiveness in this multicenter experience.

Section snippets

Study Design

This prospective, multicenter, nonrandomized trial included 18 centers from 8 European countries, and was registered with the US National Institutes of Health (NCT00876525, www.clinicaltrials.org). Patients were enrolled as part of a US Food and Drug Administration study.

Inclusion and Exclusion Criteria

Patients were referred for native or prosthetic aortic valve replacement and had to be at least 18 years old and capable of providing written informed consent. Patients with previously implanted mitral or tricuspid prostheses,

Operative Data

Table 2 provides the operative results. Approximately 50% of this cohort received a 23-mm valve or smaller. One or more concomitant procedures were required in 43.2% of patients, with coronary artery bypass grafting being the most common (91.4%). Mean aortic cross-clamp time was 64 minutes for isolated aortic valve replacement and greater than 71 minutes when additional procedures were required.

Mortality

There were 9 deaths during the first 30 days after surgery (30-day mortality, 1.5%). All of them were

Comment

Historically, tissue heart valves were anticipated to last for 10 to 15 years before calcific degeneration required their replacement. Subsequent improvements in valve design and biologic materials have further reduced the rate of valve calcification and reoperation, with particular relevance in the elderly population, in which prolonged durability of bioprosthetic valves has been broadly reported 15, 19.

Stentless valves were introduced into clinical practice in the early 1990s with the goal of

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