Rationale and design of the Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure (TAVR UNLOAD) trial
| Autor: | Ori Ben-Yehuda, Martin B. Leon, Jean-Michel Paradis, Gerrit-Anne van Es, Philippe Pibarot, William N. Anderson, Mathew S. Maurer, Jan Tijssen, Tamim Nazif, Ernest Spitzer, Susheel Kodali, Josep Rodés-Cabau, Nicolas M. Van Mieghem, Faouzi Kallel, Rebecca T. Hahn, Arie-Pieter Kappetein |
|---|---|
| Přispěvatelé: | Cardiology, Cardiothoracic Surgery |
| Rok vydání: | 2016 |
| Předmět: |
Male
Cardiac Catheterization medicine.medical_specialty medicine.medical_treatment 030204 cardiovascular system & hematology Severity of Illness Index Transcatheter Aortic Valve Replacement 03 medical and health sciences 0302 clinical medicine Valve replacement Afterload Internal medicine medicine Humans 030212 general & internal medicine Heart valve Aged Heart Failure Ejection fraction business.industry Stroke Volume Aortic Valve Stenosis Stroke volume medicine.disease Surgery Stenosis Outcome and Process Assessment Health Care medicine.anatomical_structure Ventricle Heart failure Cardiology Female Cardiology and Cardiovascular Medicine business Echocardiography Stress |
| Zdroj: | American Heart Journal, 182, 80-88. Mosby Inc. |
| ISSN: | 0002-8703 |
| Popis: | Background Coexistence of moderate aortic stenosis (AS) in patients with heart failure (HF) with reduced ejection fraction is not uncommon. Moderate AS increases afterload, whereas pharmacologic reduction of afterload is a pillar of contemporary HF management. Hypothesis Unloading the left ventricle by reducing the transaortic gradient with transfemoral transcatheter aortic valve replacement (TAVR) may improve clinical outcomes in patients with moderate AS and HF with reduced ejection fraction. Study design The TAVR UNLOAD (NCT02661451) is an international, multicenter, randomized, open-label, clinical trial comparing the efficacy and safety of TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve in addition to optimal heart failure therapy (OHFT) vs OHFT alone in patients with moderate AS (defined by a mean transaortic gradient ≥20 mm Hg and 1.0 cm 2 and ≤1.5 cm 2 at rest or after dobutamine stress echocardiography) and reduced ejection fraction. A total of 600 patients will be randomized in a 1:1 fashion. Clinical follow-up is scheduled at 1, 6, and 12 months, and 2 years after randomization. The primary end point is the hierarchical occurrence of all-cause death, disabling stroke, hospitalizations related to HF, symptomatic aortic valve disease or nondisabling stroke, and the change in the Kansas City Cardiomyopathy Questionnaire at 1 year. Secondary end points capture effects on clinical outcome, biomarkers, echocardiographic parameters, and quality of life. Summary The TAVR UNLOAD trial aims to test the hypothesis that TAVR on top of OHFT improves clinical outcomes in patients with moderate AS and HF with reduced ejection fraction. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect