Initial clinical experience with the BioValsalva aortic valve-conduit as full root replacement in high-risk patients

Objective: The BioValsalva™ aortic valve implant (Vascutek) is a prefabricated porcine tissue-valved conduit designed for aortic root replacement. We report the operative outcome and early clinical results in a series of high-risk patients.

Methods: Between March 2008 and September 2011, a total of 65 valve-conduits were implanted in a consecutive cohort of high-risk patients (log. EuroSCORE 18.9±16.3%, 77% males, mean age 69.5±8.0 years, LVEF 54.8±9.6%) due to: aortic aneurysm with aortic stenosis (n=60) or acute Type A dissection (n=5). Eight of the procedures were re-operations. Concomitant procedures included coronary artery bypass grafting (n=18, 28%), aortic arch replacement with circulatory arrest (n=17, 26%) and other valve procedures.

Results: Mean valve-conduit size was 25.4±1.6mm (21mm:1; 23mm:12; 25mm:25; 27mm:27). Mean cardiopulmonary bypass and cross-clamp times were 170±67.9min and 120.8±44.8min respectively, with a mean procedure time of 289.6±92.5min. 14 patients required repeat-thoracotomy due to bleeding. Postoperatively, 3 patients (5%) received a permanent pacemaker. The stroke rate was 5% (n=3). Mean length of hospital stay was 12.8±8.7 days. Discharge transthoracic echo revealed a mean trans-valvular gradient of 12.5±5.0mmHg. Moderate patients-prosthesis mismatch (iEOA<0.85cm²/m²) was present in only 3% of patients (n=2) and severe mismatch in none. The 30-day mortality was n=5 (7.7%) (n=2 myocardial failure, n=1 mediastinitis, n=2 sepsis followed by multi-organ failure). Clinical follow-up extends up to 1085 days (mean 294.4±308.3 days). None of the patients required a valve-related re-operation. During the follow up, one patient died due to unclear reasons.

Conclusions: Our initial clinical experience with the BioValsalva™ valve-conduit as a full-root replacement in high-risk patients suggests good valve performance and good overall clinical outcome.