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

Prospective, Randomized, Cost-utility Analysis of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Brazil

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Stenosis
• Intervention / Treatment: Procedure: TAVR - Transcatheter aortic valve replacement; Procedure: Surgical aortic valve replacement

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.

• Study Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dimytri A Siqueira, MD, PhD; Phone Number: +5511994516856; Email: dimytrisiqueira@gmail.com
• Study Contact Backup: Name: Flavia Kojima; Phone Number: 8226 +551130536611; Email: fkojima@hcor.com.br

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 04005-000
      • Hospital do Coracao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Surgical aortic valve replacement	Procedure: Surgical aortic valve replacement; Surgical aortic valve replacement; Other Names: SAVR
Experimental: TAVR - Transcatheter aortic valve replacement; TAVR - Transcatheter aortic valve replacement with Acurate Neo bioprosthesis (Boston Scientific) using minimalist approach	Procedure: TAVR - Transcatheter aortic valve replacement; TAVR - Transcatheter aortic valve replacement with Acurate Neo bioprosthesis (Boston Scientific) using minimalist approach; Other Names: TAVR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-utility of minimalist TAVR as compared to SAVR	Quality-adjusted life-years (QALYs). Quality of life will be assessed by EuroQol 5D.	1 year
Cost-utility of minimalist TAVR as compared to SAVR	Incremental cost-effectiveness ratio (ICER)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcomes	All-cause mortality, cardiovascular mortality, disabling stroke, acute renal failure, bleeding, major vascular complications, atrial fibrillation and permanent pacemaker implantation	30 days and 1 year

Collaborators and Investigators

• Sponsor: Hospital do Coracao
• Investigators: Study Chair: Alexandre A Abizaid, MD, PhD, Hospital do Coracao; Study Chair: Fabio Jatene, MD, PhD, Hospital do Coracao; Principal Investigator: Dimytri A Siqueira, MD PhD, Hospital do Coracao; Study Chair: Paulo P Fernandes, Md, PhD, Hospital do Coracao

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2018
• Primary Completion (Anticipated): September 13, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 11, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: aortic stenosis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: TEAm-BR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Reproducible Research Statement:We will share the database containing de-identified individual participant data, data dictionary documentation, statistical analysis plan, and analysis code.

Beginning 6 months and ending 24 months following article publication, the trial steering committee will evaluate proposals of studies accompanied by a statistical analysis plan and may grant access to the data for approved proposals. After 24 months, the database and accompanying documents will be publicly available in an institutional data repository (http://www.hcor.com.br).

• IPD Sharing Time Frame: Beginning 6 months and ending 24 months following article publication, the trial steering committee will evaluate proposals of studies accompanied by a statistical analysis plan and may grant access to the data for approved proposals. After 24 months, the database and accompanying documents will be publicly available in an institutional data repository (http://www.hcor.com.br).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No