Dragana B. Kosevic, Una Radak, Petar Vukovic, Jan D. Schmitto, Kersten Brandes, Peter Goettel, Hans-Dirk Duengen, Elvis Tahirovic, Marija Zdravkovic, Johannes Mueller, Faouzi Kallel, Marat Fudim, Stefan D. Anker, Jesus Eduardo Rame, Miodrag Peric
{"title":"心脏微电流装置治疗慢性心力衰竭的两年疗效:首次人体先导研究","authors":"Dragana B. Kosevic, Una Radak, Petar Vukovic, Jan D. Schmitto, Kersten Brandes, Peter Goettel, Hans-Dirk Duengen, Elvis Tahirovic, Marija Zdravkovic, Johannes Mueller, Faouzi Kallel, Marat Fudim, Stefan D. Anker, Jesus Eduardo Rame, Miodrag Peric","doi":"10.1002/ehf2.15369","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Aims</h3>\n \n <p>In heart failure patients, altered myocardial electrical fields linked to oedema may impair left ventricular function. While short-term use of implanted microcurrent generators (C-MIC) has shown promise, long-term effects remain unclear. This study assessed the safety and efficacy of C-MIC use beyond the initial 6 month pilot period.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>Patients from the initial C-MIC pilot study who were alive at 6 months were screened for 2 year follow-up. The primary endpoint included rates of all-cause, cardiac- and device-related mortality, all-cause, cardiac and device related hospitalizations, along with adverse events, device malfunctions and exchanges. Secondary endpoints evaluated device performance via left ventricular ejection fraction (LVEF), 6 min walk distance, New York Heart Association (NYHA) class and SF-36 quality-of-life scores and the need for prolonged therapy.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Of the 10 patients enrolled in the initial study, 7 were enrolled in follow-up (mean age 52.4 ± 7.6 years, NYHA Class III and mean LVEF 31.7 ± 3.7%). No device-related adverse events occurred. One non-cardiac, non-device related death was reported at 18 months. Improvement in LVEF of 11.60% [95% confidence interval (CI): 5.64–17.56, <i>P</i> < 0.001] from baseline to 6 months was maintained at 2 years post-C-MIC deactivation, with a sustained increase of 12.56% from baseline (95% CI: 4.67–20.45, <i>P</i> = 0.002). Similarly, the 6 min walk distance improved by 206.35 m at 6 months (95% CI: 161.32–251.39, <i>P</i> < 0.0001) and remained at 191 m above baseline at 2 years (95% CI: 131.83–250.99, <i>P</i> < 0.0001). Improvements in NYHA functional class and SF-36 quality-of-life scores observed at 6 months were also preserved throughout the 2 year follow-up. One patient required C-MIC reactivation.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>Long-term use of the C-MIC device appears safe with sustained improvements in NYHA class, LVEF, 6 min walk distance and quality of life, supporting the long-term therapeutic potential of microcurrent therapy.</p>\n </section>\n </div>","PeriodicalId":11864,"journal":{"name":"ESC Heart Failure","volume":"12 5","pages":"3264-3275"},"PeriodicalIF":3.7000,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/ehf2.15369","citationCount":"0","resultStr":"{\"title\":\"Two-year outcomes of a cardiac microcurrent device in chronic heart failure: A first-in-human pilot study\",\"authors\":\"Dragana B. Kosevic, Una Radak, Petar Vukovic, Jan D. 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The primary endpoint included rates of all-cause, cardiac- and device-related mortality, all-cause, cardiac and device related hospitalizations, along with adverse events, device malfunctions and exchanges. Secondary endpoints evaluated device performance via left ventricular ejection fraction (LVEF), 6 min walk distance, New York Heart Association (NYHA) class and SF-36 quality-of-life scores and the need for prolonged therapy.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>Of the 10 patients enrolled in the initial study, 7 were enrolled in follow-up (mean age 52.4 ± 7.6 years, NYHA Class III and mean LVEF 31.7 ± 3.7%). No device-related adverse events occurred. One non-cardiac, non-device related death was reported at 18 months. Improvement in LVEF of 11.60% [95% confidence interval (CI): 5.64–17.56, <i>P</i> < 0.001] from baseline to 6 months was maintained at 2 years post-C-MIC deactivation, with a sustained increase of 12.56% from baseline (95% CI: 4.67–20.45, <i>P</i> = 0.002). Similarly, the 6 min walk distance improved by 206.35 m at 6 months (95% CI: 161.32–251.39, <i>P</i> < 0.0001) and remained at 191 m above baseline at 2 years (95% CI: 131.83–250.99, <i>P</i> < 0.0001). Improvements in NYHA functional class and SF-36 quality-of-life scores observed at 6 months were also preserved throughout the 2 year follow-up. 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Two-year outcomes of a cardiac microcurrent device in chronic heart failure: A first-in-human pilot study
Aims
In heart failure patients, altered myocardial electrical fields linked to oedema may impair left ventricular function. While short-term use of implanted microcurrent generators (C-MIC) has shown promise, long-term effects remain unclear. This study assessed the safety and efficacy of C-MIC use beyond the initial 6 month pilot period.
Methods
Patients from the initial C-MIC pilot study who were alive at 6 months were screened for 2 year follow-up. The primary endpoint included rates of all-cause, cardiac- and device-related mortality, all-cause, cardiac and device related hospitalizations, along with adverse events, device malfunctions and exchanges. Secondary endpoints evaluated device performance via left ventricular ejection fraction (LVEF), 6 min walk distance, New York Heart Association (NYHA) class and SF-36 quality-of-life scores and the need for prolonged therapy.
Results
Of the 10 patients enrolled in the initial study, 7 were enrolled in follow-up (mean age 52.4 ± 7.6 years, NYHA Class III and mean LVEF 31.7 ± 3.7%). No device-related adverse events occurred. One non-cardiac, non-device related death was reported at 18 months. Improvement in LVEF of 11.60% [95% confidence interval (CI): 5.64–17.56, P < 0.001] from baseline to 6 months was maintained at 2 years post-C-MIC deactivation, with a sustained increase of 12.56% from baseline (95% CI: 4.67–20.45, P = 0.002). Similarly, the 6 min walk distance improved by 206.35 m at 6 months (95% CI: 161.32–251.39, P < 0.0001) and remained at 191 m above baseline at 2 years (95% CI: 131.83–250.99, P < 0.0001). Improvements in NYHA functional class and SF-36 quality-of-life scores observed at 6 months were also preserved throughout the 2 year follow-up. One patient required C-MIC reactivation.
Conclusions
Long-term use of the C-MIC device appears safe with sustained improvements in NYHA class, LVEF, 6 min walk distance and quality of life, supporting the long-term therapeutic potential of microcurrent therapy.
期刊介绍:
ESC Heart Failure is the open access journal of the Heart Failure Association of the European Society of Cardiology dedicated to the advancement of knowledge in the field of heart failure. The journal aims to improve the understanding, prevention, investigation and treatment of heart failure. Molecular and cellular biology, pathology, physiology, electrophysiology, pharmacology, as well as the clinical, social and population sciences all form part of the discipline that is heart failure. Accordingly, submission of manuscripts on basic, translational, clinical and population sciences is invited. Original contributions on nursing, care of the elderly, primary care, health economics and other specialist fields related to heart failure are also welcome, as are case reports that highlight interesting aspects of heart failure care and treatment.