Key result
Stentless Pericarbon Freedom aortic prostheses show similar 10-year mortality to stented Perimount prostheses.
Why the study?
Stentless aortic valves show superior hemodynamics and faster left ventricular mass regression than stented bioprostheses, but controversies exist regarding their durability.
Does the stentless LivaNova-Sorin Pericarbon Freedom aortic bioprosthesis improve long-term clinical outcomes and hemodynamics compared to the stented Carpentier-Edwards Perimount prosthesis in patients undergoing aortic valve replacement?
Cohort (n=110)
No
Does the stentless LivaNova-Sorin Pericarbon Freedom aortic bioprosthesis improve long-term clinical outcomes and hemodynamics compared to the stented Carpentier-Edwards Perimount prosthesis in patients undergoing aortic valve replacement?
Stentless aortic bioprostheses offer superior long-term hemodynamic performance compared to stented valves, with comparable rates of late mortality, structural valve degeneration, and reintervention.
Comparable late mortality in this cohort does not support preferential stentless use; leaves open hemodynamic or other advantages for randomized trials.
Objective Stentless aortic valves have shown superior hemodynamic performance and faster left ventricular mass regression compared to stented bioprostheses. Yet, controversies exist concerning the durability of stentless valves. This case-matched study compared short- and long-term clinical outcomes of stentless LivaNova-Sorin Pericarbon Freedom™ (SPF) and stented Carpentier-Edwards Perimount (CEP) aortic prostheses. Methods From 2003 through 2006, 134 consecutive patients received aortic valve replacement with SPF at our institution. This cohort was matched, according to 20 preoperative clinical parameters, with a control group of 390 patients who received CEP prosthesis during the same time. The resulting 55 + 55 matched patients were analyzed for perioperative results and long-term clinical outcomes. Results Early mortality was 0% for both groups. Lower transvalvular gradients were found in the SPF group (10.6 ± 2.9 versus 15.7 ± 3.1 mmHg, P < 0.001). Overall late mortality (mean follow-up: 10.03 years) was similar for both groups (50.1% versus 42.8%, P = 0.96). Freedom from structural valve degeneration (SVD) at 13 years was similar for both groups (SPF = 92.3%, CEP = 73.9%, P = 0.06). Freedom from aortic valve reinterventions did not differ (SPF = 92.3%, CEP = 93.5%, P = 0.55). Gradients at 13-year follow-up remained significantly lower in SPF group (10.0 ± 4.5 versus 16.2 ± 9.5 mmHg, P < 0.001). Incidence of acute bacterial endocarditis (ABE) and major adverse cardiovascular and cerebrovascular events (MACCE) was similar. Conclusions SPF and CEP demonstrated comparable long-term outcomes related to late mortality, SVD, aortic valve reinterventions, and incidence of ABE and MACCE. Superior hemodynamic performance of SPF over time can make this valve a suitable choice in patients with small aortic root and large body surface area.
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Stefanelli et al. (2020) conducted a cohort in Aortic valve replacement (n=110). Stentless LivaNova-Sorin Pericarbon Freedom (SPF) aortic prosthesis vs. Stented Carpentier-Edwards Perimount (CEP) aortic prosthesis was evaluated on Overall late mortality (p=0.96). Stentless Pericarbon Freedom aortic prostheses demonstrated similar overall late mortality compared to stented Perimount prostheses (50.1% vs 42.8%, P=0.96) over a mean follow-up of 10 years.
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