Key result
Transapical aortic valve implantation using the Apica ASC device with second-generation valves achieved device success and complete apical hemostasis in all 3 patients without major adverse events.
Why the study?
Is the use of a left ventricular apical access and closure device safe and feasible for second-generation transapical aortic valve implantation in high-risk patients with aortic stenosis?
Case Report (n=3)
Is the use of a left ventricular apical access and closure device safe and feasible for second-generation transapical aortic valve implantation in high-risk patients with aortic stenosis?
The use of a novel apical access and closure device for transapical TAVI is safe and feasible, potentially reducing surgical trauma.
Answers are grounded in this paper and cite their sources.
Apical closure success in 3 cases is hypothesis-generating; leaves open safety, efficacy, and trauma reduction in larger transapical TAVI cohorts.
BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become routine for the treatment of high-risk patients with aortic stenosis. We assessed safety and feasibility of a left ventricular apical access and closure device combined with second-generation transapical (TA) TAVI transcatheter heart valves (THV). METHODS AND RESULTS: Three elderly, comorbid patients (logEuroSCORE I 13.0-31.1%) received transapical aortic valve implantation (TA-AVI) via the Apica ASC device (Apica Cardiovascular Ltd., Galway, Ireland) using second-generation THV (Medtronic Engager [Medtronic 3F Therapeutics, Santa Ana, California, United States], JenaValve [JenaValve Technology GmbH, Munich, Germany], Symetis Acurate [Symetis S.A., Ecublens, Switzerland]). Access was gained using a non-rib-spreading technique and a novel access and closure device. THV deployment was successful with excellent hemodynamic outcome (no PVL, n = 2; trace PVL, n = 1; mean transvalvular gradients, 5-19 mm Hg) and complete apical hemostasis. No periprocedural major adverse events occurred and Valve Academic Research Consortium-2-defined composite end point of device success was met in all cases. CONCLUSION: Safety and feasibility of TA-AVI using the ASC device with second-generation THV was demonstrated. Combining latest available technology is a major step toward improved functional outcome and decreased surgical trauma in TA-AVI. Potentially, technical enhancements may eventually pave the way toward a fully percutaneous TA-AVI procedure.
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Seiffert et al. (2014) conducted a case report in aortic stenosis (n=3). Apica ASC device with second-generation transcatheter heart valves was evaluated on Valve Academic Research Consortium-2-defined composite end point of device success. Transapical aortic valve implantation using the Apica ASC device with second-generation valves achieved device success and complete apical hemostasis in all 3 patients without major adverse events.
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