Five-year results from a prospective, single-arm European trial on decellularized allografts for aortic valve replacement-the ARISE Study and ARISE Registry Data.

OBJECTIVES: Decellularized aortic homografts (DAH) were introduced as a new option for aortic valve replacement for young patients. METHODS: A prospective, EU-funded, single-arm, multicentre study in 8 centres evaluating non-cryopreserved DAH for aortic valve replacement. RESULTS: A total of 144 patients (99 male) were prospectively enrolled in the ARISE Trial between October 2015 and October 2018 with a median age of 30.4 years [interquartile range (IQR) 15.9-55.1]; 45% had undergone previous cardiac operations, with 19% having 2 or more previous procedures. The mean implanted DAH diameter was 22.6 mm (standard deviation 2.4). The median operation duration was 312 min (IQR 234-417), the median cardiopulmonary bypass time was 154 min (IQR 118-212) and the median cross-clamp time 121 min (IQR 93-150). No postoperative bypass grafting or renal replacement therapy were required. Two early deaths occurred, 1 due to a LCA thrombus on day 3 and 1 due ventricular arrhythmia 5 h postoperation. There were 3 late deaths, 1 death due to endocarditis 4 months postoperatively and 2 unrelated deaths after 5 and 7 years due to cancer and Morbus Wegener resulting in a total mortality of 3.47%. After a median follow-up of 5.9 years [IQR 5.1-6.4, mean 5.5 years. (standard deviation 1.3) max. 7.6 years], the primary efficacy end-points peak gradient with median 11.0 mmHg (IQR 7.8-17.6) and regurgitation of median 0.5 (IQR 0-0.5) of grade 0-3 were excellent. At 5 years, freedom from death/reoperation/endocarditis/bleeding/thromboembolism were 97.9%/93.5%/96.4%/99.2%/99.3%, respectively. CONCLUSIONS: The 5-year results of the prospective multicentre ARISE trial continue to show DAH to be safe for aortic valve replacement with excellent haemodynamics.

Mid-term single-center outcomes of BioIntegral compared to Freestyle aortic conduit implantation.

BACKGROUND: Full aortic root replacement with biological conduit has limited options. This non-randomized cohort study aims to compare mid-term clinical and hemodynamic results of the BioIntegral (BI) composite biological versus the stentless Freestyle (FS) conduits in patients undergoing full aortic root replacement. METHODS: From February 2013 to July 2017, 265 patients underwent aortic root replacement at a single institution (202 BI, 65 FS). Preoperative, intraoperative and postoperative parameters, complications including stroke, myocardial infarction (MI), endocarditis and reoperation were studied. Hemodynamic performance of both conduits was analyzed by echocardiography. Target endpoints were 30-day mortality, two-year survival, two-year freedom from major adverse valve-related and cardiovascular events. RESULTS: Wider BI conduits were used (BI 27±2 vs. FS 25±2 mm, P<0.0001). The BI group had shorter cardiopulmonary bypass (BI 165±67 vs. FS 200±78 min, P<0.0001) and cross-clamp (BI 102±36 vs. FS 122±40 min, P=0.001) times. Thirty-day mortality was similar in both groups. There were fewer conduit-related reoperations in the BI group (BI 0% vs. FS 3%, P=0.012) but higher postoperative atrial fibrillation (BI 31% vs. FS 17%, P=0.025). No significant differences were observed for stroke (BI 5% vs. FS 10%, P=0.947), MI (BI 3% vs. FS 4%, P=0.583), or infective endocarditis (BI 0% vs. FS 2%, P=0.077). No significant hemodynamic differences were evident on follow-up echocardiography while an improved overall survival trend was seen in the BI group (P=0.062). CONCLUSIONS: FS and BI provide comparable clinical mid-term results and hemodynamic parameters. Simplified implantation technique providing shorter cardiopulmonary bypass and operation times are advantageous for BI.