Single-center experience in the treatment of severe aortic stenosis with XcorTM transcatheter aortic valve replacement system: 1-year follow-up results.

Abstract

Objectives: To analyze the early clinical outcomes of the Xcor^TM transcatheter aortic valve replacement (TAVR) system in treating severe aortic stenosis.

Methods: This single-arm, prospective clinical trial enrolled patients with severe aortic stenosis treated with the Xcor^TM TAVR system at the Section of Heart Valve&Coronary Artery Surgery, Guangdong Provincial People's Hospital. Perioperative and follow-up parameters were compared to evaluate differences in hemodynamic outcomes. Adverse events including all-cause mortality, aortic regurgitation, paravalvular leakage, cerebrovascular events, and reoperation were analyzed.

Results: Thirty-two patients with severe aortic stenosis were included (20 males, 12 females), with a mean age of (70.9±4.3) years and a Society of Thoracic Surgeons (STS) score of (7.0±3.2)%. Notably, 87.5% of patients had New York Heart Association (NYHA) class≥Ⅲ. All patients underwent successful Xcor^TM bioprosthesis implantation, achieving an immediate technical success rate of 100.0% and device success rate of 96.9%. Post-procedural metrics demonstrated significant improvements: mean aortic valve gradient decreased from (55.21±23.17) mmHg (1 mmHg=0.133 kPa) to (8.45±5.30) mmHg (P<0.01), peak aortic jet velocity was reduced from (4.66±0.85) m/s to (1.99±0.48) m/s (P<0.01), aortic valve area increased from (0.66±0.21) cm² to (2.09±0.67) cm² (P<0.01). Intraoperative ventricular fibrillation occurred in one patient, while one case exhibited moderate prosthetic valve regurgitation and paravalvular leakage post-procedure. At 12-month follow-up, sustained improvements were observed in cardiac function, left ventricular ejection fraction, hemodynamic parameters, and SF-12 quality-of-life scores (all P<0.01). All-cause mortality was 12.5% (4/32), with 13.8% (4/29) developing moderate paravalvular leakage.

Conclusions: The Xcor^TM TAVR system demonstrated favorable early outcomes in severe aortic stenosis patients, significantly improving symptoms and hemodynamics while exhibiting excellent performance in preventing malignant arrhythmias and coronary obstruction.