Single-center experience in the treatment of severe aortic stenosis with XcorTM transcatheter aortic valve replacement system: 1-year follow-up results.
10.3724/zdxbyxb-2024-0487
- Author:
Shengwen WANG
1
,
2
;
Haozhong LIU
3
;
Haijiang GUO
3
;
Tong TAN
4
;
Hanxiang XIE
3
;
Xiang LIU
3
;
Hailong QIU
3
;
Jimei CHEN
3
;
Huiming GUO
3
;
Jian LIU
5
Author Information
1. Guangdong Cardiovascular Institute, Guangzhou 510080, China. wshengwen2023@
2. com.
3. Section of Heart Valve & Coronary Artery Surgery, Guangdong Provincial People's Hospital, Guangzhou 510080, China.
4. Structural Heart Disease Surgical Center, Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China.
5. Section of Heart Valve & Coronary Artery Surgery, Guangdong Provincial People's Hospital, Guangzhou 510080, China. jameslau1984@sina.com.
- Publication Type:Clinical Trial
- Keywords:
Aortic stenosis;
Prospective study;
Therapeutic efficacy;
Transcatheter aortic valve replacement;
Xcor TM transcatheter aortic valve replacement system
- MeSH:
Humans;
Male;
Female;
Aortic Valve Stenosis/surgery*;
Transcatheter Aortic Valve Replacement/methods*;
Aged;
Follow-Up Studies;
Prospective Studies;
Treatment Outcome;
Aged, 80 and over;
Heart Valve Prosthesis;
Middle Aged
- From:
Journal of Zhejiang University. Medical sciences
2025;54(2):141-148
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVES:To analyze the early clinical outcomes of the XcorTM transcatheter aortic valve replacement (TAVR) system in treating severe aortic stenosis. This study has been registered at Chinese Clinical Trial Registry (ChiCTR2200065593).
METHODS: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. 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 (70.9±4.3) years old and a Society of Thoracic Surgeons (STS) score of 6.45% (6.07%, 7.28%). 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%. Mean aortic valve gradient decreased from (55.21±23.17) mmHg (1 mmHg=0.133 kPa) to (8.45±5.30) mmHg, peak aortic jet velocity decreased from (4.66±0.85) m/s to (1.99±0.48) m/s, aortic valve area increased from (0.66±0.21) cm² to (2.09±0.67) cm² (all 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 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.
