The study aimed to evaluate the efficacy and safety of transcatheter aortic valve replacement (TAVR) in patients with severe native valve aortic insufficiency. It is a multicentre, observational cohort study. The primary endpoint consisted of a composite of all-cause death, disabling stroke, or rehospitalization for heart failure at 12 months postoperatively. According to previous research results and opinions of expert groups, the sample size was expected to be 76 cases.
Study Type
OBSERVATIONAL
Enrollment
76
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGall-cause mortality
Death caused by any reason
Time frame: 12 months
Disabling stroke
Stroke that results in a disabled state
Time frame: 12 months
Rehospitalization for heart failure
Rehospitalization for heart failure
Time frame: 12 months
Device success
Absence of procedural mortality AND Correct positioning of a single prosthetic heart valve into the proper anatomical location AND Intended performance of the prosthetic heart valve (no prosthesis- patient mismatch and mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s, AND no moderate or severe prosthetic valve regurgitation)
Time frame: intraoperative
Perioperative complications
Perioperative complications conclude Life-threatening bleeding, Acute kidney injury-Stage 2 or 3 (including renal replacement therapy), Coronary artery obstruction requiring intervention, Major vascular complications, and Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)
Time frame: up to 1 week
New permanent pacemaker implantation(PPI)
New PPI indications: 1. persistent high-degree AV block 2. sick sinus syndrome
Time frame: up to 1 week
New complete left bundle branch block(CLBBB)
Diagnostic criteria are defined as follows: 1. Rhythm must be of super-ventricular origin (EG: ventricular activation coming from atrial or AV nodal activation) 2. QRS Duration greater than 120 ms 3. Lead V1 should have either a QS or a small r wave with large S wave 4. Lead V6 should have a notched R wave and no Q wave.
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Time frame: up to 1 week
Valve-related dysfunction
Mean aortic valve gradient ≥20 mmHg, EOA ≤0.9-1.1 cm and DVI \<0.35 m/s, and/or moderate or severe prosthetic valve regurgitation, and/or Prosthetic valve endocarditis, and/or Prosthetic valve thrombosis
Time frame: 12 months
NYHA class Ill or IV
The New York Heart Association (NYHA) class Ill or IV
Time frame: 12 months