Clinical, Physiologic, and Anatomic Outcomes of a Novel Bioprosthetic Aortic Valved Conduit

Background: In 2020, the first pre-assembled bioprosthetic aortic valved conduit (AVC) was approved in the United States. This study compares its anatomic and functional outcomes to traditional hand-sewn composite conduits in patients undergoing aortic root replacement. Methods: This retrospective study compared 118 patients receiving the pre-assembled AVC (2021-2023) versus 66 patients with hand-sewn conduits (2012-2020) after elective bio-Bentall procedures. Primary outcomes were post-operative mortality and complication rates. Secondary outcomes included anatomic and hemodynamic changes. Graft dimensions were obtained from post-operative computed tomography (CT). Echocardiographic parameters were collected at early and late follow-up. Between-group differences and longitudinal changes were assessed using linear mixed-effects models. Results: Groups were comparable in age (pre-assembled 63 ± 11 vs. hand-sewn 64 ± 11 years) and predominantly male. Despite significantly higher concomitant hemiarch rates in pre-assembled conduits (91.5% vs. 28.8%, p < 0.001), 30-day mortality, stroke, and reoperation for bleeding were comparable between groups. Pre-assembled conduits demonstrated superior hemodynamics with lower baseline peak gradients (Δ 9.1 mmHg, p < 0.001), lower mean gradients (Δ 5.3 mmHg, p < 0.001), and larger indexed effective orifice area (Δ 0.27 cm²/m², p = 0.018). Annual rates of hemodynamic and dimensional change were minimal and comparable between groups. Kaplan-Meier analysis showed no survival difference at 3 years. Conclusions: The pre-assembled AVC demonstrates equivalent safety and superior early hemodynamic performance compared to hand-sewn conduits, with stable mid-term anatomic and functional outcomes.