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

To analyze the early clinical outcomes of the XcorTM transcatheter aortic valve replacement (TAVR) system in treating severe aortic stenosis. This single-arm, prospective clinical trial enrolled patients with severe aortic stenosis treated with the XcorTM 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. 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 XcorTM 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. The XcorTM 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.