Aortic Stenosis
Conditions
Keywords
aortic stenosis
Brief summary
TEAM-Br is a randomized, prospective, cost-utility study comparing transcatheter aortic valve implantation (TAVI) versus surgical aortic vale replacement in Brazil. The study is sponsored by the national Minister of Health, through PROADI-SUS (Programa de Apoio ao Desenvolvimento Institucional do SUS).
Detailed description
Transcatheter aortic valve implantation has been shown to be non-inferior to surgical aortic valve replacement in patients with severe aortic stenosis at high, intermediate and low surgical risk. In recent years, a concept of a simplified and optimized TAVR procedure (known as minimalist approach) has led experienced centers to perform the majority of these procedures using conscious sedation and local anesthesia only. From a clinical perspective, this approach is associated with better and faster recovery and mobilization, reduced need for a prolonged intensive care unit (ICU) stay and faster hospital discharge, as compared to general anesthesia. The cost-effectiveness of minimalist TAVR strategy - as compared to surgery - in Brazil is uncertain. Our objective is to conduct a cost-utility analysis comparing minimalist transcatheter aortic valve implantation with surgical aortic valve replacement in patients with severe aortic stenosis.
Interventions
PROCEDURETAVR - Transcatheter aortic valve replacement
TAVR - Transcatheter aortic valve replacement with Acurate Neo bioprosthesis (Boston Scientific) using minimalist approach
PROCEDURESurgical aortic valve replacement
Surgical aortic valve replacement
Sponsors
Hospital do Coracao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cost-utility of minimalist TAVR as compared to SAVR | 1 year | Quality-adjusted life-years (QALYs). Quality of life will be assessed by EuroQol 5D. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcomes | 30 days and 1 year | All-cause mortality, cardiovascular mortality, disabling stroke, acute renal failure, bleeding, major vascular complications, atrial fibrillation and permanent pacemaker implantation |
Countries
Brazil
Outcome results
None listed