A Comparative Study of Aortic Valve Neocuspidization Techniques: Formula vs. Template Methods of Neocusp Formation.

Introduction: The template method (TM), pioneered by Ozaki for aortic valve neocuspidization (AVNeo), has been widely adopted for aortic valve replacement, though it requires specialized instruments. This study introduces a novel formula method (FM), which uses the diameter of the aortic valve fibrous ring (AV-D) to determine the dimensions of the neocusps to be trimmed from autologous without the need for templates, potentially reducing costs and complexity. We aimed to compare the clinical outcomes of the FM with the established TM in patients undergoing AVNeo.
Methods: A retrospective and prospective study was conducted on 31 patients who underwent isolated AVNeo between January 21, 2019 and December 15, 2022. Patients were divided into two groups: FM (n = 17) and TM (n = 14). The formula for the cusp free margin horizontal length is L1 = AV-D + 10 mm, cusp height is H = AV-D, cusp suture margin is L2 is a parabola that joins L1 and H, and cusp wings to be secured to aortic sinus = 3mm. The primary endpoints were major adverse valve-related events, including cardiac death, reoperation, and infective endocarditis. Secondary endpoints included significant aortic regurgitation, peak pressure gradients, aortic valve area, and New York Heart Association (NYHA) functional class. Intraoperative times, early postoperative outcomes, and mid-term hemodynamic performance were evaluated for both techniques.
Results: Both the FM and TM demonstrated comparable intraoperative and postoperative outcomes. The cardiopulmonary bypass time, myocardial ischemia time, and blood loss were similar between the groups. Mid-term outcomes also showed no significant differences in valve function or hemodynamic parameters, with both groups exhibiting substantial reverse left ventricular remodeling. The FM group had a peak pressure gradient of 14.1 ± 4.3 mmHg compared to 18.4 ± 12.0 mmHg in the TM group (p = 0.219). The aortic valve area was 2.43 ± 0.3 cm² in the FM and 2.4 ± 0.2 cm² in the TM (p = 0.890). No significant differences were observed in freedom from reoperation or adverse events.
Conclusion:  Both techniques showed excellent mid-term hemodynamic performance and comparable intraoperative and postoperative outcomes. The FM for AVNeo provides a cost-effective and practical alternative to the TM, offering similar clinical outcomes without the need for expensive templates; it has the potential to improve the accessibility of AVNeo, particularly in resource-limited settings. However, further research with larger cohorts and long-term follow-up is needed to fully assess the durability and long-term benefits of the FM.
Competing Interests: Human subjects: Consent for treatment and open access publication was obtained or waived by all participants in this study. I.M. Sechenov First Moscow State Medical University IRB issued approval N/A. The study was conducted in compliance with the ethical requirements of the Ministry of Health of the Russian Federation Order No. 922n, dated November 15, 2012, "On the approval of the Procedure for providing medical care to the adult population in the field of 'surgery'." The study was also approved by the Institutional Review Board of I.M. Sechenov First Moscow State Medical University. Patients were informed of the procedure and were required to sign informed consent for surgery. Individual written consent to publish their study data was also obtained. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.
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