Treatment of Aortic Stenosis in Brazil: Cost-Utility Analysis of TAVI vs SAVR (TEAm-BR)

This is an interventional treatment trial for Aortic Stenosis focused on measuring aortic stenosis Read More

Inclusion Criteria:

• Age > 70 years;
• Symptoms of heart failure NYHA class > II;
• Severe aortic stenosis (as defined by echocardiography: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s or an initial aortic valve area of < 1.0 cm2)
• Heart team (including examining cardiac surgeon) agree on eligibility including assessment that TAVR or SAVR is appropriate;
• The study patient or the study patient's legal representative informed of the nature of the study, agreed to its provisions and provided written informed consent as approved by the Institutional Review Board (IRB) center;
• The study patient agreed to comply with all required post-procedure follow-up visits including visits through 1 month and 1 year;
• Heart team agreed (a priori) on treatment strategy for concomitant coronary disease (if present);
• Patient agreed to undergo surgical aortic valve replacement (SAVR) if randomized to control treatment.

Exclusion Criteria:

• Heart Team assessment of inoperability (including examining cardiac surgeon);
• Hostile chest
• Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)];
• Concomitant severe valvular disease (mitral, tricuspid or pulmonic) requiring surgical intervention;
• Preexisting mechanical or bioprosthetic aortic valve with dysfunction;
• Complex coronary artery disease: unprotected left main coronary artery, Syntax score > 32 (in the absence of prior revascularization);
• Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker is not an exclusion criteria;
• Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), thrombocytopenia (Plt < 50,000 cell/mL);
• Hypertrophic cardiomyopathy with or without obstruction (HOCM);
• Severe ventricular dysfunction with LVEF < 20%;
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
• Active upper GI bleeding within 3 months (90 days) prior to procedure;
• A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure;
• Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 6 months (180 days) of the procedure;
• Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy at the time of screening;
• Estimated life expectancy < 24 months (730 days) due to carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease;
• Currently participating in an investigational drug or another device study;
• Active bacterial endocarditis within 6 months (180 days) of procedure;
• Patient refuses surgery for aortic valve replacement.