Remote Patient Management May Reduce All-Cause Mortality in Patients With Heart-Failure and Renal Impairment

Marcel G Naik; Klemens Budde; Kerstin Koehler; Eik Vettorazzi; Mareen Pigorsch; Otto Arkossy; Stefano Stuard; Wiebke Duettmann; Friedrich Koehler; Sebastian Winkler

doi:10.3389/fmed.2022.917466

Remote Patient Management May Reduce All-Cause Mortality in Patients With Heart-Failure and Renal Impairment

Front Med (Lausanne). 2022 Jul 11:9:917466. doi: 10.3389/fmed.2022.917466. eCollection 2022.

Authors

Marcel G Naik^{1

2}, Klemens Budde¹, Kerstin Koehler³, Eik Vettorazzi⁴, Mareen Pigorsch⁵, Otto Arkossy⁶, Stefano Stuard⁶, Wiebke Duettmann^{1

2}, Friedrich Koehler^{3

7}, Sebastian Winkler^{3

7

8}

Affiliations

¹ Charité-Universitätsmedizin Berlin, Department of Nephrology and Medical Intensive Care, Charité University Medicine Berlin, Berlin, Germany.
² Berlin Institute of Health, Charité Medical University of Berlin, Berlin, Germany.
³ Charité-Universitätsmedizin Berlin, Medical Department, Division of Cardiology and Angiology, Centre for Cardiovascular Telemedicine, Berlin, Germany.
⁴ University Medical Center Hamburg-Eppendorf, Institute of Medical Biometry and Epidemiology, Hamburg, Germany.
⁵ Charité-Universitätsmedizin Berlin, Institute of Biometry and Clinical Epidemiology, Berlin, Germany.
⁶ Global Medical Office, Clinical and Therapeutical Governance Europe Middle East Asia, Fresenius Medical Care, Bad Homburg, Germany.
⁷ German Center for Cardiovascular Research (DZHK), Gottingen, Germany.
⁸ Unfallkrankenhaus Berlin, Department of Internal Medicine, Berlin, Germany.

Abstract

Background: Remote patient management (RPM) in heart failure (HF) patients has been investigated in several prospective randomized trials. The Telemedical Interventional Management in Heart Failure II (TIM-HF2)-trial showed reduced all-cause mortality and hospitalizations in heart failure (HF) patients using remote patient management (RPM) vs. usual care (UC). We report the trial's results for prespecified eGFR-subgroups.

Methods: TIM-HF2 was a prospective, randomized, controlled, parallel-group, unmasked (with randomization concealment), multicenter trial. A total of 1,538 patients with stable HF were enrolled in Germany from 2013 to 2017 and randomized to RPM (+UC) or UC. Using CKD-EPI-formula at baseline, prespecified subgroups were defined. In RPM, patients transmitted their vital parameters daily. The telemedical center reviewed and co-operated with the patient's General Practitioner (GP) and cardiologist. In UC, patients were treated by their GPs or cardiologist applying the current guidelines for HF management and treatment. The primary endpoint was the percentage of days lost due to unplanned cardiovascular hospitalizations or death, secondary outcomes included hospitalizations, all-cause, and cardiovascular mortality.

Results: Our sub analysis showed no difference between RPM and UC in both eGFR-subgroups for the primary endpoint (<60 ml/min/1.73 m²: 40.9% vs. 43.6%, p = 0.1, ≥60 ml/min/1.73 m² 26.5 vs. 29.3%, p = 0.36). In patients with eGFR < 60 ml/min/1.73 m², 1-year-survival was higher in RPM than UC (89.4 vs. 84.6%, p = 0.02) with an incident rate ratio (IRR) 0.67 (p = 0.03). In the recurrent event analysis, HF hospitalizations and all-cause death were lower in RPM than UC in both eGFR-subgroups (<60 ml/min/1.73 m²: IRR 0.70, p = 0.02; ≥60 ml/min/1.73 m²: IRR 0.64, p = 0.04). In a cox regression analysis, age, NT-pro BNP, eGFR, and BMI were associated with all-cause mortality.

Conclusion: RPM may reduce all-cause mortality and HF hospitalizations in patients with HF and eGFR < 60 ml/min/1.73 m². HF hospitalizations and all-cause death were lower in RPM in both eGFR-subgroups in the recurrent event analysis. Further studies are needed to investigate and confirm this finding.

Keywords: cardiovascular disease; chronic kidney disease; heart failure; randomized controlled trial; remote patient management.