Clinical efficacy and safety of transcatheter aortic valve replacement for patients with severe pure native aortic regurgitation.

Objectives: To evaluate the early clinical efficacy and safety of trans-catheter aortic valve replacement (TAVR) for patients with severe pure native aortic regurgitation (PNAR).

Methods: A retrospective analysis was conducted on 48 PNAR patients who underwent TAVR at the Department of Cardiac Surgery, the First Affiliated Hospital of Sun Yat-sen University between March 2019 and February 2025, including 25 cases with transfemoral approach (TF-TAVR group) and 23 cases with transapical approach (TA-TAVR group). Efficacy and safety were assessed by analyzing baseline characteristics, all-cause mortality, and procedure-related complications.

Results: Compared with the TA-TAVR group, the TF-TAVR group exhibited significantly smaller aortic annulus circumference and diameter, left ventricular outflow tract circumference and diameter, diameters of the left, right, and non-coronary sinuses, and sinotubular junction (STJ) diameter, with a shorter distance from the STJ to the aortic valve basal ring plane (all P<0.01). Additionally, the TF-TAVR group had a smaller annulus angle (P<0.05), and showed a deeper prosthesis implantation depth relative to the aortic valve basal ring plane (P<0.01). Post-TAVR, both groups demonstrated significant improvement in left ventricular end-diastolic diameter (both P<0.05), but only the TA-TAVR group showed significant reduction in left ventricular end-systolic diameter (P<0.05). The overall technical success rate was 91.67%, and device success rate was 83.33%. For primary outcomes, in-hospital mortality occurred in 2 patients (4.17%). No additional deaths were reported at 60 d or 90 d after surgery. During 90-180 d after surgery, one patient in the TF-TAVR group (4.76%) died of sudden cardiac death, and one in the TA-TAVR group (6.25%) died of gastrointestinal bleeding. During 180 d-1 year after surgery, one patient in the TF-TAVR group (9.09%) died of low cardiac output syndrome. No statistically significant differences were observed in 1-year Kaplan-Meier survival curves between two groups (P>0.05). No conduction block events occurred in TA-TAVR group, while high-grade atrioventricular block, left bundle branch block, permanent pacemaker implantation occurred in TF-TAVR group during hospitalization or 1-year follow-up (12.00%, 4.00%, and 12.00%, respectively).

Conclusions: TAVR demonstrates high success rates and acceptable safety for severe PNAR patients who are unable to undergo traditional surgical procedures. Although TF-TAVR may face more challenges in certain complex cases than TA-TAVR, the overall outcomes are promising.