Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation: a Prospective, Multicenter, Randomized Study
Prospective, multicenter, randomized trial.
• Procedural indications: symptomatic severe aortic regurgitation; no symptom plus left ventricular ejection fraction ≤ 55% or left ventricular end-diastolic dimension (LVEDD) \> 65mm or left ventricular end-systolic dimension (LVESD) \> 50mm;
• Severe aortic valve regurgitation, and mean pressure gradient \< 20mmHg; Annular perimeter ≤ 85 mm;
• The ratio of the perimeter of the left ventricular outflow tract 4mm to the perimeter of the valve annulus is 0.95-1.05;
• STS score ≥8 or moderate to severe frailty or refused surgical valve replacement or presence of any of the following factors judged to be difficult to perform the surgical valve replacement:
‣ Severe aorta calcification or active ascending aorta atherosclerotic plaque
⁃ History of mediastinum radiotherapy
⁃ Past mediastinitis
⁃ Presence of unobstructed coronary bypass implants
⁃ Previous more than two cardiothoracic surgeries
⁃ Liver cirrhosis
⁃ Other surgical risk factors