| Autor: |
Taborsky, Milos, Skala, Tomas, Aiglova, Renata, Fedorco, Marian, Kautzner, Josef, Jandik, Tomas, Vancura, Vlastimil, Linhart, Ales, Valek, Martin, Novak, Miloslav, Kala, Petr, Polasek, Rostislav, Roubicek, Tomas, Schee, Alexandr, Hindricks, Gerhard, Dagres, Nikolaos, Hatala, Robert, Jarkovsky, Jiri |
| Zdroj: |
Biomedical Papers of the Medical Faculty of Palacky University in Olomouc; Jun2022, Vol. 166 Issue 2, p173-179, 7p |
| Abstrakt: |
Background. Primary preventive implantation of implantable defibrillator (ICD) is according to current guidelines indicated in patients with heart failure NYHA (New York Heart Association) class II/III and LVEF <35%. Thanks to advances in heart failure pharmacotherapy, a decrease in mortality could render a benefit of ICD insufficient to justify its implantation in some patients. Methods. Study design: multicenter, prospective, randomized, controlled trial evaluating the benefit of implantation of Cardiac Resynchronization and Defibrillator Therapy (CRT-D) or CRT Alone (CRT-P) in non-ischemic patients with reduced left ventricle ejection fraction (LVEF) and optimal pharmacotherapy without significant mid-wall myocardial fibrosis detected by cardiac magnetic resonance (CMR). The primary end-point: Re-hospitalization for heart failure, ventricular tachycardia, major adverse cardiac events (MACE). The secondary end-points: Sudden cardiac death, cardiovascular death, resuscitated cardiac arrest or sustained ventricular tachycardia, device-related complications, and change in quality of life. Course of the study: After a pharmacotherapy is optimized and significant mid-wall myocardial fibrosis excluded, patients will be randomized 1:1 to CRT-P or CRT-D implantation. Discussion. If our hypothesis is confirmed, this could provide evidence for the management of these patients with a significant impact on common daily praxis and health care expenditures. Trial registration. ClinicalTrials.gov, NCT04139460 [ABSTRACT FROM AUTHOR] |
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