Cardiac shockwave therapy in addition to coronary bypass surgery improves myocardial function in ischaemic heart failure: the CAST-HF trial.

Autor: Holfeld J; University Clinic of Cardiac Surgery, Medical University of Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria., Nägele F; University Clinic of Cardiac Surgery, Medical University of Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria.; Center for Cardiovascular Regeneration, Houston Methodist Research Institute, Houston, TX, USA., Pölzl L; University Clinic of Cardiac Surgery, Medical University of Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria., Engler C; University Clinic of Cardiac Surgery, Medical University of Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria., Graber M; University Clinic of Cardiac Surgery, Medical University of Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria.; Center for Cardiovascular Regeneration, Houston Methodist Research Institute, Houston, TX, USA., Hirsch J; University Clinic of Cardiac Surgery, Medical University of Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria., Schmidt S; University Clinic of Cardiac Surgery, Medical University of Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria., Mayr A; Department of Radiology, Medical University of Innsbruck, Innsbruck, Austria., Troger F; Department of Radiology, Medical University of Innsbruck, Innsbruck, Austria., Pamminger M; Department of Radiology, Medical University of Innsbruck, Innsbruck, Austria., Theurl M; Department of Internal Medicine III, Medical University of Innsbruck, Innsbruck, Austria., Schreinlechner M; Department of Internal Medicine III, Medical University of Innsbruck, Innsbruck, Austria., Sappler N; Department of Internal Medicine III, Medical University of Innsbruck, Innsbruck, Austria., Ruttmann-Ulmer E; University Clinic of Cardiac Surgery, Medical University of Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria., Schaden W; The Research Center in Cooperation with AUVA, Ludwig Boltzmann Institute for Traumatology, Vienna, Austria.; International Medical Director of SoftWave Tissue Regeneration Technologies, Kennesaw, GA, USA., Cooke JP; Center for Cardiovascular Regeneration, Houston Methodist Research Institute, Houston, TX, USA., Ulmer H; Institute of Medical Statistics and Informatics, Medical University of Innsbruck, Innsbruck, Austria., Bauer A; Department of Internal Medicine III, Medical University of Innsbruck, Innsbruck, Austria., Gollmann-Tepeköylü C; University Clinic of Cardiac Surgery, Medical University of Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria., Grimm M; University Clinic of Cardiac Surgery, Medical University of Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria.
Jazyk: angličtina
Zdroj: European heart journal [Eur Heart J] 2024 Aug 03; Vol. 45 (29), pp. 2634-2643.
DOI: 10.1093/eurheartj/ehae341
Abstrakt: Background and Aims: In chronic ischaemic heart failure, revascularisation strategies control symptoms but are less effective in improving left ventricular ejection fraction (LVEF). The aim of this trial is to investigate the safety of cardiac shockwave therapy (SWT) as a novel treatment option and its efficacy in increasing cardiac function by inducing angiogenesis and regeneration in hibernating myocardium.
Methods: In this single-blind, parallel-group, sham-controlled trial (cardiac shockwave therapy for ischemic heart failure, CAST-HF; NCT03859466) patients with LVEF ≤40% requiring surgical revascularisation were enrolled. Patients were randomly assigned to undergo direct cardiac SWT or sham treatment in addition to coronary bypass surgery. The primary efficacy endpoint was the improvement in LVEF measured by cardiac magnetic resonance imaging from baseline to 360 days.
Results: Overall, 63 patients were randomized, out of which 30 patients of the SWT group and 28 patients of the Sham group attained 1-year follow-up of the primary endpoint. Greater improvement in LVEF was observed in the SWT group (Δ from baseline to 360 days: SWT 11.3%, SD 8.8; Sham 6.3%, SD 7.4, P = .0146). Secondary endpoints included the 6-minute walking test, where patients randomized in the SWT group showed a greater Δ from baseline to 360 days (127.5 m, SD 110.6) than patients in the Sham group (43.6 m, SD 172.1) (P = .028) and Minnesota Living with Heart Failure Questionnaire score on day 360, which was 11.0 points (SD 19.1) for the SWT group and 17.3 points (SD 15.1) for the Sham group (P = .15). Two patients in the treatment group died for non-device-related reasons.
Conclusions: In conclusion, the CAST-HF trial indicates that direct cardiac SWT, in addition to coronary bypass surgery improves LVEF and physical capacity in patients with ischaemic heart failure.
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Databáze: MEDLINE