Martin Möckel1, Kerstin Koehler2, Stefan D Anker3, Jörn Vollert4, Volker Moeller2, Magdalena Koehler5, Stefan Gehrig4, Jan C Wiemer4, Stephan von Haehling6, Friedrich Koehler2. 1. Division of Emergency and Acute Medicine, Cardiovascular Process Research, Campus Mitte and Virchow, Charité - Universitätsmedizin Berlin, Berlin, Germany. 2. Centre for Cardiovascular Telemedicine, Department of Cardiology and Angiology, Campus Mitte, Charité - Universitätsmedizin Berlin, Berlin, Germany. 3. Department of Cardiology (CVK) and Berlin Institute of Health, Center for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) partner site Berlin Charité - Universitätsmedizin Berlin, Berlin, Germany. 4. Clinical Diagnostics, Thermo Fisher Scientific, Hennigsdorf, Germany. 5. Technical University Munich, Department of Prevention, Rehabilitation and Sports Medicine, Ludwig-Maximilians-Universität, Munich, Germany. 6. Department of Cardiology and Pneumology, Universitätsmedizin Göttingen, Göttingen, Germany.
Abstract
AIMS: The TIM-HF2 study showed less days lost due to unplanned cardiovascular hospitalization or all-cause death and improved survival in patients randomly assigned to remote patient management (RPM) instead of standard of care. METHODS AND RESULTS: This substudy explored whether the biomarkers mid-regional pro-adrenomedullin (MR-proADM) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) could be used to identify low-risk patients unlikely to benefit from RPM, thereby allowing more efficient allocation of the intervention. For 1538 patients of the trial (median age 73 years, interquartile range 64-78 years, 30% female), baseline biomarkers were used to select subpopulations recommended for RPM with various safety endpoints (100%, 98%, 95% sensitivity), and efficacy of RPM was assessed. Both biomarkers were strongly associated with events. The primary endpoint of lost days increased from 1.0% (1.4%) in the lowest to 17.3% (17.6%) in the highest quintile of NT-proBNP (MR-proADM). After combining biomarkers to identify patients recommended for RPM with 95% sensitivity, in the most efficient scenario (excluding 27% of patients; NT-proBNP < 413.7 pg/mL and MR-proADM < 0.75 nmol/L), the effect of RPM on patients was highly similar to the original trial (ratio of lost days: 0.78, hazard ratio for all-cause death: 0.68). Number needed to treat for all-cause death was lowered from 28 to 21. Rates of emergencies and telemedical efforts were significantly lower among patients not recommended for RPM. Biomarker guidance would have saved about 150 h effort/year per 100 patients of the eligible population. CONCLUSIONS: The combined use of MR-proADM and NT-proBNP may allow safe, more precise, effective and cost-saving allocation of patients with heart failure to RPM and warrants further prospective studies.
RCT Entities:
AIMS: The TIM-HF2 study showed less days lost due to unplanned cardiovascular hospitalization or all-cause death and improved survival in patients randomly assigned to remote patient management (RPM) instead of standard of care. METHODS AND RESULTS: This substudy explored whether the biomarkers mid-regional pro-adrenomedullin (MR-proADM) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) could be used to identify low-risk patients unlikely to benefit from RPM, thereby allowing more efficient allocation of the intervention. For 1538 patients of the trial (median age 73 years, interquartile range 64-78 years, 30% female), baseline biomarkers were used to select subpopulations recommended for RPM with various safety endpoints (100%, 98%, 95% sensitivity), and efficacy of RPM was assessed. Both biomarkers were strongly associated with events. The primary endpoint of lost days increased from 1.0% (1.4%) in the lowest to 17.3% (17.6%) in the highest quintile of NT-proBNP (MR-proADM). After combining biomarkers to identify patients recommended for RPM with 95% sensitivity, in the most efficient scenario (excluding 27% of patients; NT-proBNP < 413.7 pg/mL and MR-proADM < 0.75 nmol/L), the effect of RPM on patients was highly similar to the original trial (ratio of lost days: 0.78, hazard ratio for all-cause death: 0.68). Number needed to treat for all-cause death was lowered from 28 to 21. Rates of emergencies and telemedical efforts were significantly lower among patients not recommended for RPM. Biomarker guidance would have saved about 150 h effort/year per 100 patients of the eligible population. CONCLUSIONS: The combined use of MR-proADM and NT-proBNP may allow safe, more precise, effective and cost-saving allocation of patients with heart failure to RPM and warrants further prospective studies.
Authors: Piero Pollesello; Tuvia Ben Gal; Dominique Bettex; Vladimir Cerny; Josep Comin-Colet; Alexandr A Eremenko; Dimitrios Farmakis; Francesco Fedele; Cândida Fonseca; Veli-Pekka Harjola; Antoine Herpain; Matthias Heringlake; Leo Heunks; Trygve Husebye; Visnja Ivancan; Kristian Karason; Sundeep Kaul; Jacek Kubica; Alexandre Mebazaa; Henning Mølgaard; John Parissis; Alexander Parkhomenko; Pentti Põder; Gerhard Pölzl; Bojan Vrtovec; Mehmet B Yilmaz; Zoltan Papp Journal: J Clin Med Date: 2019-11-01 Impact factor: 4.241
Authors: Marcel G Naik; Klemens Budde; Kerstin Koehler; Eik Vettorazzi; Mareen Pigorsch; Otto Arkossy; Stefano Stuard; Wiebke Duettmann; Friedrich Koehler; Sebastian Winkler Journal: Front Med (Lausanne) Date: 2022-07-11