Lisa-Maria Rosenthal, Oliver Miera, Annemarie Krauss, Friederike Danne, Felix Berger, Peter Kramer
{"title":"Initial clinical experience with dapagliflozin in addition to optimized medical therapy in paediatric heart failure patients.","authors":"Lisa-Maria Rosenthal, Oliver Miera, Annemarie Krauss, Friederike Danne, Felix Berger, Peter Kramer","doi":"10.1002/ehf2.15386","DOIUrl":"https://doi.org/10.1002/ehf2.15386","url":null,"abstract":"<p><strong>Aims: </strong>Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has shown clinical benefits in adults with heart failure (HF), improving cardiac function, reducing HF-related hospitalizations and enhancing survival rates. While extensively studied in adult HF, data on its efficacy and safety in paediatric HF patients remain limited. We aimed to evaluate the use of dapagliflozin in addition to optimized therapy in paediatric HF patients regarding safety, clinical outcomes and adverse events.</p><p><strong>Methods and results: </strong>We conducted a single-centre retrospective analysis of 37 paediatric HF patients (median age 9.0 years, range 0.2-17.1 years) treated with dapagliflozin at our institution between April 2022 and February 2025. Clinical outcomes, left ventricular ejection fraction (LVEF), global longitudinal strain (GLS), NT-proBNP levels and estimated glomerular filtration rate (eGFR) were analysed at baseline, 3-6 months and the latest follow-up. The most frequent diagnoses among paediatric HF patients treated with dapagliflozin were dilated cardiomyopathy (43.2%, 56% of those with acute myocarditis), heart transplant recipients (18.9%) and single ventricle heart defects (16.2%). The median duration of dapagliflozin treatment was 189 days (Q1, Q3: 381, 596). Dapagliflozin was well tolerated, with no severe adverse effects observed. During follow-up, four patients required ventricular assist device (VAD) implantation, five underwent heart transplantation and one patient died. In six patients, the VAD could be explanted due to myocardial recovery. Overall, LVEF significantly improved from 40% at baseline to 51% at 3-6 months and further to 57% at latest follow-up (P = 0.016). GLS significantly improved from -9.2% to -14.7% from baseline to latest follow-up (P = 0.023). Heart failure classification significantly improved from baseline to latest follow-up (P = 0.004). NT-proBNP levels decreased during follow-up, without reaching statistical significance.</p><p><strong>Conclusions: </strong>Dapagliflozin in addition to optimized HF therapy was safe and well tolerated in paediatric HF patients, with improvements in functional class, left ventricular contractility and heart failure symptoms. The study's limitations, including its small sample size and retrospective design, highlight the need for larger, multicentre, prospective trials to confirm these findings.</p>","PeriodicalId":11864,"journal":{"name":"ESC Heart Failure","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144682173","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Christoph Knosalla, Gloria Färber, Andreas J Rieth, Rolf Wachter, Marius Placzek, Wolfgang Albert, Gerd Hasenfuß, Volkmar Falk, Tim Friede
{"title":"Rationale and design of the randomized 'early ventricular assist device'-Trial (VAD-DZHK3).","authors":"Christoph Knosalla, Gloria Färber, Andreas J Rieth, Rolf Wachter, Marius Placzek, Wolfgang Albert, Gerd Hasenfuß, Volkmar Falk, Tim Friede","doi":"10.1002/ehf2.15376","DOIUrl":"https://doi.org/10.1002/ehf2.15376","url":null,"abstract":"<p><strong>Aims: </strong>Bridge to transplantation (BTT) with durable, continuous-flow left ventricular assist devices (LVAD) of patients is a well-established treatment concept in patients awaiting heart transplantation (HTx). However, the role of elective LVAD implantation in patients with less advanced HF, but increased risk of decompensation remains uncertain.</p><p><strong>Methods and results: </strong>The VAD-DZHK3 trial is an investigator-initiated, randomized controlled trial designed to assess whether an early strategy of elective LVAD implantation improves outcomes compared with a conventional approach involving optimal medical therapy and delayed device implantation only after clinical deterioration. Eligible patients are those with end-stage HF listed for cardiac transplantation. This is an event-driven study, that is, the study is completed once 120 events of the primary composite endpoint have been observed and all patients have at least 1 year of follow-up unless they died earlier. Patients meeting inclusion criteria who decline randomization are enrolled in a parallel observational registry reflecting standard care. The primary efficacy endpoint is survival free from high urgent cardiac transplantation, disabling stroke and HF hospitalizations (including emergency room HF visits >6 h).</p><p><strong>Conclusions: </strong>The VAD-DZHK3 trial will provide guidance on the optimal timing and patient selection for LVAD implantation in heart transplant candidates, potentially redefining current standards of care.</p>","PeriodicalId":11864,"journal":{"name":"ESC Heart Failure","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144674122","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Refractory anaemia in a patient with end-stage heart failure secondary to aortic stenosis.","authors":"Jiayu Liang, Suxin Luo, Bi Huang","doi":"10.1002/ehf2.15388","DOIUrl":"https://doi.org/10.1002/ehf2.15388","url":null,"abstract":"","PeriodicalId":11864,"journal":{"name":"ESC Heart Failure","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144658762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lisa D Rathman, Samuel F Sears, Marie-Elena Brett, John D Henderson, Natalie R Castillo, Philip B Adamson, Lynne W Stevenson
{"title":"Patients report increased control and decreased impact of heart failure during pulmonary pressure-guided management.","authors":"Lisa D Rathman, Samuel F Sears, Marie-Elena Brett, John D Henderson, Natalie R Castillo, Philip B Adamson, Lynne W Stevenson","doi":"10.1002/ehf2.15364","DOIUrl":"https://doi.org/10.1002/ehf2.15364","url":null,"abstract":"<p><strong>Aims: </strong>This study investigated Class III heart failure patient experience with pulmonary artery pressure (PAP) monitoring over 24 months including (1) changes in reported quality of life (QoL), (2) changes in HF illness perception and sense of control (control), (3) patient evaluation of PAP-guided therapy as a modality and (4) behavioural adherence to remote monitoring.</p><p><strong>Methods and results: </strong>A 272 patient subgroup from the N = 1200 patient CardioMEMS™ Post-Approval Study completed 3 questionnaires including HF-related QoL, illness perception and control, and PAP therapy evaluation. Patient measurement frequency was also collected as a behavioural adherence index. Patient perception of illness was assessed via a general linear mixed model to account for all data available at all time points (n = 272). A paired analysis of patients with 24-month questionnaires (n = 135) was performed to further evaluate patients who completed follow-up. Patients reported significant improvement in overall QoL scores from baseline (44.5 ± 24.0) to 6 months (58.8 ± 25.2) which was maintained through 2 years (all P < 0.0001). Patients described their sense of control as strong (4.3 ± 0.9, 5 is strongly agree), positively evaluated PAP-guided therapy (4.1 ± 1.0, 5 is strongly agree), and 90% actively transmitted device data weekly with a significant reduction in patient perceived illness throughout 2 years of follow-up.</p><p><strong>Conclusions: </strong>Two-year follow up of the patient experience of PAP-guided therapy indicated that patients reported increased QoL, perceptions of control, device acceptability and continued remote monitoring over the 24 month follow-up. These results suggest that knowledge of PA pressures is associated with positive patient experience and engagement in HF care.</p>","PeriodicalId":11864,"journal":{"name":"ESC Heart Failure","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144658761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Laura A Rechsteiner, Lukas Weber, Philipp K Haager, Johannes Rigger, Joannis Chronis, Peter Ammann, Roman Brenner, Martin O Schmiady, Hans Rickli, Micha T Maeder
{"title":"The pulmonary artery pulsatility index in patients with severe aortic stenosis undergoing valve replacement.","authors":"Laura A Rechsteiner, Lukas Weber, Philipp K Haager, Johannes Rigger, Joannis Chronis, Peter Ammann, Roman Brenner, Martin O Schmiady, Hans Rickli, Micha T Maeder","doi":"10.1002/ehf2.15378","DOIUrl":"https://doi.org/10.1002/ehf2.15378","url":null,"abstract":"<p><strong>Background and aims: </strong>The pulmonary artery pulsatility index (PAPi), that is, the pulmonary artery pulse pressure (PAPP) divided by the mean right atrial pressure (mRAP), is an increasingly used invasive index of right ventricular function. We sought to assess the prognostic impact of the PAPi in unselected patients with aortic stenosis (AS) undergoing aortic valve replacement (AVR).</p><p><strong>Methods: </strong>We studied consecutive patients with severe AS (n = 487, 74 ± 10 years, 58% males) undergoing right heart catheterization prior to AVR with post-AVR follow-up of several years.</p><p><strong>Results: </strong>The mean PAPi was 4.7 ± 3.3, and the mean values in the four PAPi quartiles were 2.1 ± 0.5, 3.2 ± 0.3, 4.5 ± 0.5 and 8.9 ± 4.2. Patients in the lowest PAPi quartile had similar AS severity, symptoms, B-type natriuretic peptide and surgical risk compared with patients in higher quartiles. The lowest PAPi quartile had the lowest PAPP and the highest mRAP and only a slightly reduced stroke volume index (SVI) but the highest pulmonary artery capacitance (PAC). After a median post-AVR follow-up of 45 months mortality did not differ across PAPi quartiles (log rank P = 0.50), which was independent of the AVR mode. However, all contributors of the PAPi equation, that is, higher PAPP, lower PAC (i.e., stroke volume divided by PAPP), lower SVI and higher mRAP were associated with increased mortality.</p><p><strong>Conclusions: </strong>In unselected patients with severe AS, the PAPi did not predict post-AVR mortality. This may be explained by the fact that the low PAPP in those with low PAPi was mainly a reflection of a high PAC rather than a low SVI.</p>","PeriodicalId":11864,"journal":{"name":"ESC Heart Failure","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144658763","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Amit Gruber, Aharon Ronnie Abbo, Ina Volis, Doron Aronson, Nicolas Girerd, Søren Lund Kristensen, Robert Zukermann, Natalia Alberkant, Elena Sitnitsky, Anton Kruger, Polina Khasis, Evgeny Bravo, Boaz Elad, Ludmila Helmer Levin, Oren Caspi
{"title":"Efficacy of ambulatory intravenous diuresis for chronic heart failure patients: Insights from the DEA-HF trial.","authors":"Amit Gruber, Aharon Ronnie Abbo, Ina Volis, Doron Aronson, Nicolas Girerd, Søren Lund Kristensen, Robert Zukermann, Natalia Alberkant, Elena Sitnitsky, Anton Kruger, Polina Khasis, Evgeny Bravo, Boaz Elad, Ludmila Helmer Levin, Oren Caspi","doi":"10.1002/ehf2.15358","DOIUrl":"https://doi.org/10.1002/ehf2.15358","url":null,"abstract":"<p><strong>Aims: </strong>Oral diuretic treatment has limited efficacy in managing chronic heart failure (HF) patients. Novel strategies are needed to manage patients with refractory congestion despite optimal HF therapy and high-dose oral diuretic treatment. In the present study, we prospectively quantified the efficacy and safety of an ambulatory, weekly, high-dose parenteral diuresis strategy.</p><p><strong>Methods and results: </strong>Data from the prospective, randomized, cross-over controlled study for comparisons of diuresis efficacy in HF patients (DEA-HF) were analysed. Chronic HF patients with congestion despite guideline-directed medical therapy were enrolled to receive three high-intensity diuretic regimens, once a week, in a randomized order: intravenous (IV) furosemide 250 mg; IV furosemide 250 mg + oral metolazone 5 mg; and IV furosemide 250 mg + IV acetazolamide 500 mg. The primary outcome compared the total sodium excretion following each diuretic regimen. Here, all regimens were pooled to assess the effect of weekly intensive diuresis approach on congestion parameters. The study population included 42 patients, 40% females, with a mean age of 72 ± 9 years. Following three consecutive weekly treatments, the mean body weight was decreased from 85.5 kg [95% confidence interval (CI): 79.7-91.2] to 83.1 kg (95% CI: 77.4-88.9. P = 0.0005), accompanied by a significant decrease in congestion score, N-terminal-pro-brain natriuretic peptide levels and lung ultrasound B-line count. Serum creatinine mildly but significantly increased from 1.81 mg/dL (95% CI: 1.62-2.01) to 2.01 mg/dL (95% CI: 1.81-2.21. P < 0.001), and no hospitalizations due to acute kidney injury occurred.</p><p><strong>Conclusions: </strong>In patients with congestion-refractory HF, an ambulatory strategy utilizing high-intensity weekly IV diuretic therapy achieved effective decongestion without major safety concerns. This escalated strategy may improve clinical outcomes and prevent hospitalizations of chronic HF patients who require diuresis intensification.</p>","PeriodicalId":11864,"journal":{"name":"ESC Heart Failure","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144636513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Clinical impact of tricuspid regurgitation in patients with acute myocardial infarction.","authors":"Shun Nishino, Chiharu Nishino, Michikazu Nakai, Kensaku Nishihira, Nehiro Kuriyama, Yoshisato Shibata","doi":"10.1002/ehf2.15375","DOIUrl":"https://doi.org/10.1002/ehf2.15375","url":null,"abstract":"<p><strong>Aims: </strong>The clinical impact of tricuspid regurgitation (TR) in patients after acute myocardial infarction (AMI) is largely unknown. The aim of this study was to clarify the prevalence and prognostic impact of TR in post-AMI patients treated with appropriate primary percutaneous coronary intervention (PCI).</p><p><strong>Methods and results: </strong>Three hundred fifty-one consecutive patients with first-onset AMI who underwent successful primary PCI from July 2014 to December 2018 were retrospectively examined. Standard two- and three-dimensional echocardiography were performed at discharge. Based on the presence or absence of mild or greater TR, patients were divided into TR (+) and TR (-) groups, respectively. The primary outcome was the incidence of major adverse cardiac events (MACE), defined as the composite of death, re-hospitalization for congestive heart failure and recurrent MI. Seventy-eight (22.2%) patients had mild or greater TR. Kaplan-Meier analysis showed that the cumulative 6-year incidence of MACE was significantly higher in the TR (+) group (hazard ratio, 2.56 [95% confidence interval, 1.48-4.44]; P < 0.001). In the analysis of the severity of TR, the prognosis of patients with mild TR was significantly worse than that of patients without TR (P = 0.026). Multivariable analysis identified the left anterior descending coronary artery as the culprit vessel, left atrial dilation (>34 mL/m<sup>2</sup>), reduced left ventricular ejection fraction (<50%) and the presence of significant (≥mild) ischaemic mitral regurgitation as independent predictors of mild or greater residual TR after primary PCI for AMI at discharge. Following adjustment for significant clinical parameters, mild or greater TR at discharge was still associated with a significant hazard ratio for the occurrence of MACE (1.87, [95% confidence interval, 1.01-3.48]; P = 0.048).</p><p><strong>Conclusions: </strong>The presence of mild or greater TR at discharge may serve as a poor prognostic marker in patients with first-onset AMI. In addition to traditional clinical risk factors, it is important to pay more attention to TR and to manage it appropriately.</p>","PeriodicalId":11864,"journal":{"name":"ESC Heart Failure","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144636512","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Giorgia D'Italia, Daniëlle M Coenen, Titus P Lemmens, Lloyd Brandts, Simone J H Wielders, Magdolna Nagy, Sanne G J Mourmans, Anouk Achten, Ahmad Al-Abadi, Jerremy Weerts, Arantxa Barandiaran Aizpurua, Vanessa van Empel, Blanche Schroen, Judith M E M Cosemans
{"title":"Immuno-haemostatic dysregulation in heart failure with preserved ejection fraction.","authors":"Giorgia D'Italia, Daniëlle M Coenen, Titus P Lemmens, Lloyd Brandts, Simone J H Wielders, Magdolna Nagy, Sanne G J Mourmans, Anouk Achten, Ahmad Al-Abadi, Jerremy Weerts, Arantxa Barandiaran Aizpurua, Vanessa van Empel, Blanche Schroen, Judith M E M Cosemans","doi":"10.1002/ehf2.15361","DOIUrl":"https://doi.org/10.1002/ehf2.15361","url":null,"abstract":"<p><strong>Aims: </strong>Heart failure with preserved ejection fraction (HFpEF) is a complex condition with partially unclear pathophysiology, in which systemic inflammation is a central contributor to changes in cardiac structure and function. The contribution of non-traditional immune effectors-such as platelets and coagulation-remains underexplored in HFpEF. We characterized platelet function, as well as coagulation and neutrophil activation, in patients with HFpEF.</p><p><strong>Methods: </strong>The in vivo activation of platelets, neutrophils, endothelial cells and coagulation was measured in plasma from patients with HFpEF (n = 103), age- and sex-matched controls (n = 40) and pooled plasma from a healthy reference cohort. Flow cytometric and microfluidic assays were performed to investigate platelet function ex vivo.</p><p><strong>Results: </strong>Compared with matched controls, patients with HFpEF exhibited reduced platelet reactivity, characterized by alterations in platelet integrin activation and granule release, and an overall decrease in thrombus activation, contraction and fibrin formation. In vivo platelet activation markers β-TG and CXCL4 were increased in plasma from patients with HFpEF and matched controls compared with the healthy reference cohort (β-TG: 923.01 and 822.25 vs. 335.06 ng/mL; CXCL4: 660.16 and 603.63 vs. 458.34 ng/mL). Linear regression analyses showed an association between platelet aberrant activation and function and the presence of HFpEF, independent of comorbidities or medications [e.g., thrombus characteristics (size, contraction, height): P values<sub>Fully adjusted model</sub> = <0.001; <0.001; <0.001]. Patients with HFpEF showed higher levels of the neutrophil activation markers MPO and S100A8/A9 compared with matched controls (MPO: P value = 0.0152; S100A8/A9: P value = 0.0041). Levels of endothelial markers ICAM-1 and VCAM-1 were unaltered between groups. Coagulation was found elevated in patients with HFpEF, particularly in patients not on anticoagulant (AC) medications, showing increased plasma levels of plasma kallikrein, factor XI, factor IX, thrombin and D-dimer (kallikrein: P value = 0.0415; AC excluded: FXIa:C1inh: P value = 0.0110; FIXa:AT: P value = 0.0095; T:AT: 4.46 vs. reference 4 μg/L; D-dimer: 0.65 vs. reference 0.5 mg/L).</p><p><strong>Conclusions: </strong>Patients with HFpEF present with dysfunctional platelets, a procoagulant state and neutrophil activation. The association of immuno-haemostatic processes including aberrant platelet function with the presence of HFpEF, independent of comorbidities or medications, suggests that platelet dysfunction is an intrinsic feature of HFpEF.</p>","PeriodicalId":11864,"journal":{"name":"ESC Heart Failure","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144607857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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":"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 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":"https://doi.org/10.1002/ehf2.15369","url":null,"abstract":"<p><strong>Aims: </strong>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><p><strong>Methods: </strong>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><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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>","PeriodicalId":11864,"journal":{"name":"ESC Heart Failure","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144599769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}