Feasibility of SAPIEN 3 20-mm Transcatheter Heart Valve Implantation in Aortic Stenosis Patients with a Small Aortic Annulus

• Published in: Journal of Transcatheter Valve Therapies Vol. 3; no. 1; pp. 7 - 13
• Main Authors: Amano, Tetsuya, Mukai, Kentaro, Sugiyama, Kayo, Matsuyama, Katsuhiko, Suzuki, Mayu, Watanabe, Atsushi
• Format: Journal Article
• Language: English
• Published: Japan Transcatheter Valve Therapies 2021
• Subjects: effective orifice area; prosthesis–patient mismatch; transcatheter aortic valve implantation
• ISSN: 2434-4532; 2434-4532
• DOI: 10.33290/jtvt.oa.20-0004

Objective: Transcatheter aortic valve implantation (TAVI) is an effective therapeutic procedure for treating severe aortic valve stenosis (AS) in inoperable or high-risk surgical patients. Prosthesis–patient mismatch (PPM) after TAVI or surgical aortic valve replacement (SAVR) is a critical determinant for mortality and morbidity related to the procedure. TAVI could be advantageous over SAVR regarding the reduction of risks of PPM. However, few reports have focused on outcomes for SAPIEN 3 20-mm transcatheter heart valve (THV) implantation, which is associated with higher incidence of PPM than a larger size of THV. This study aimed to compare pre- and post-procedural hemodynamic and clinical data including PPM between 20-mm and 23- or 26-mm SAPIEN 3 THVs, taking into an account for the feasibility of smaller size of THV.Methods: This retrospective single-center observational study included data from the cardiac catheter database of Aichi Medical University between April 2017 and April 2020. The study evaluated 43 consecutive patients with severe AS who successfully underwent TAVI with balloon-expandable Edwards SAPIEN 3 prosthesis. Patients were divided into two groups: patients with 20mm THV (8 patients), and 23- or 26-mm THV (35 patients). Pre- and post-procedural hemodynamic and clinical data were assessed. PPM is defined based on the indexed prosthetic valve effective orifice area (EOA) to the patient’s body surface area (BSA), and PPM is considered moderate when indexed EOA (EOAI) is between 0.65 and 0.85 cm2/m2 and severe when <0.65 cm2/m2. The primary endpoint was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization due to heart failure, and reintervention for implanted valve failure assessed for up to 39 months of follow-up.Results: There were no significant differences in baseline characteristics and assessed hemodynamic data except for the preoperative aortic valve area, postoperative mean pressure gradient, EOAI, and incidence of moderate PPM. All procedures were successfully performed, and the 30-day mortality rate was 0%. Although moderate PPM was more frequently observed in the 20-mm THV than in the 23- or 26-mm THV patients, severe PPM was not detected in all subjects. Major adverse cardiovascular events (MACE) only occurred in 23-mm THV patients. Moderate PPM was observed in 50% of patients with 20-mm THV, which was not associated with adverse outcomes.Conclusions: Although this result cannot be applied to long-term results, the implantation of a 20-mm THV seems to be feasible in patients with a small aortic annulus. Long-term careful clinical follow-up is necessary after 20-mm SAPIEN 3 THV implantation.