Prospective observational study on the efficacy and safety of Hydra transcatheter aortic valve - AIIMS Hydra Registry

简要总结

主要结局

次要结局

• Acute kidney injury(30 days)
• All-cause mortality (cardiovascular mortality, valve-related mortality, and non-cardiovascular mortality)(30 days, 1, 3, and 5 years)
• All stroke(30 days, 1, 3, and 5 years)
• Disabling stroke(30 days, 1, 3, and 5 years)
• Myocardial infarction(30 days, 1, 3, and 5 years)
• Life threatening bleeding(30 days)
• Major vascular complication(30 days)
• New permanent pacemaker implantation due to procedure related conduction abnormalities(30 days, 1, 3, and 5 years)
• Coronary artery obstruction requiring intervention(30 days, 1, 3, and 5 years)
• Re-hospitalization for procedure- or valve-related causes(30 days, 1, 3, and 5 years)
• Mean aortic valve gradient(30 days, 1, 3, and 5 years)
• Effective Orifice Area (EOA)(30 days, 1, 3, and 5 years)
• Paravalvular leak(30 days, 1, 3, and 5 years)
• New York Heart Association (NYHA) functional class(30 days, 1, 3, and 5 years)
• Quality-of-life evaluation(30 days, 1, 3, and 5 years)
• Bioprosthetic Valve Failure (BVF), defined as valve-related mortality or aortic valve re-operation/re-intervention, or stage 3 haemodynamic severe structural valve deterioration(30 days, 1, 3, and 5 years)
• Bioprosthetic valve dysfunction (BVD), defined as structural valve deterioration, non-structural valve deterioration, clinical valve thrombosis, infective endocarditis(30 days, 1, 3, and 5 years)
• Stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies)(30 days, 1, 3, and 5 years)
• VARC-3 Type 2–4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents used specifically for valve-related concerns (e.g., clinically apparent leaflet thrombosis)(30 days, 1, 3, and 5 years)