The research name of this project is: A prospective, multicenter and observational study on the safety and effectiveness of emergency transcatheter aortic valve replacement (TAVR) in the treatment of patients with severe aortic stenosis. It is a prospective, multi-center clinical study, and 35 cases are planned to be enrolled and followed up for 12 months (before discharge, 30 days, 6 months and 12 months). The research instruments used are VitaFlow Liberty® transcatheter aortic valve and recoverable delivery system. The purpose of this study is to evaluate the safety and effectiveness of emergency TAVR in patients with severe aortic stenosis. The main end point is the cumulative all-cause mortality 12 months after operation, and the secondary end points mainly include adverse cerebrovascular events (MACCE), acute renal injury, implantation rate of permanent pacemaker and valve function.
Patients with severe aortic stenosis diagnosed at the clinic: peak transvalvular flow velocity ≥4.0m/s, or mean transvalvular pressure difference ≥40mmHg(1 mmHg=0.133kPa), or aortic valve orifice area < <0.8cm2 (or effective aortic valve orifice area index < 0.5 cm2/m2);
Aortic root anatomy and lesions are not suitable for prosthetic valve implantation;
Anatomic morphology or vascular diseases affecting the instrument approach;
Left ventricular outflow tract obstruction;
Primary dilated cardiomyopathy;
1\. Severe aortic stenosis 2, high risk of surgery, or surgical taboo, is not suitable for conventional surgery valve replacement; 3, anatomically suitable for TAVI/TAVR
Case-only
Prospective
Transcatheter aortic valve and recyclable delivery system
DeviceIn this study, the transcatheter aortic valve and its recycling delivery system were VitaFlow Liberty®, a TAVR product independently developed by Shanghai Minimally Invasive Cardiovascular Treatment Co., Ltd. (approved and marketed by NMPA). This product is equipment/consumables routinely purchased by hospitals. For routine clinical use, it is designed for transcatheter aortic valve implantation. The valve is delivered to the intended implantation site via the peripheral artery by retrograde flow through the delivery system, realizing the delivery, positioning and release of the valve. Under the supervision of medical imaging equipment, the valve is delivered to the lesion site of the aortic valve, and marked by the diseased aortic annulus, to release the valve and relieve the stenosis at the lesion site, thereby ensuring smooth aortic flow, improving cardiac function and achieving therapeutic purposes.
Cumulative all-cause mortality at 12 months postoperatively
All-cause death includes cardiac death and non-cardiac death
Incidence of major adverse cardiovascular events
Incidence of major adverse cardiovascular events (MACCE including mortality, disabling stroke, myocardial infarction, reoperation) calculated as number of occurrences/total number of occurrences
Incidence of acute kidney injury
Incidence of acute kidney injury (AKIN Grade 2 or 3, or renal replacement therapy (RRT: hemodialysis, intraperitoneal dialysis, hemofiltration)) calculated as: Occurred/Total
Incidence of permanent pacemaker implantation
Incidence of permanent pacemaker implantation, calculated as: Cases Occurred/Total Cases
Incidence of severe vascular complications
Incidence of severe vascular complications, calculated as: number of cases/total number of cases
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