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; Ottó Árkossy; Stefano Stuard; Wiebke Duettmann; Friedrich Koehler; Sebastian Winkler

doi:10.3389/fmed.2022.917466

July 11, 2022Frontiers in MedicineOpen Access

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

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Why the study?

Following the TIM-HF2 trial showing reduced mortality and hospitalizations with remote patient management in heart failure, the effects across prespecified eGFR subgroups needed reporting.

Does remote patient management reduce the percentage of days lost due to unplanned cardiovascular hospitalizations or death in patients with stable heart failure?

Structured PICO

Does remote patient management reduce the percentage of days lost due to unplanned cardiovascular hospitalizations or death in patients with stable heart failure?

P

Population

1,538 patients with stable heart failure, enrolled in Germany from 2013 to 2017, analyzed by prespecified eGFR subgroups (<60 and ≥60 ml/min/1.73 m²).

I

Intervention

Remote patient management (RPM) added to usual care, involving daily transmission of vital parameters and telemedical center review cooperating with the patient's General Practitioner and cardiologist.

C

Comparator

Usual care (UC) by General Practitioners or cardiologists applying current guidelines for HF management.

O

Outcome

Percentage of days lost due to unplanned cardiovascular hospitalizations or death.composite

Remote patient management did not significantly reduce days lost to CV hospitalization or death across eGFR subgroups, but may improve 1-year survival and reduce recurrent HF hospitalizations in stable HF patients with eGFR <60 ml/min/1.73 m².

Implication

RPM does not reduce days lost to CV hospitalization or death in HF by eGFR subgroup; leaves open survival benefit in eGFR<60.

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 m 2 : 40.9% vs. 43.6%, p = 0.1, ≥60 ml/min/1.73 m 2 26.5 vs. 29.3%, p = 0.36). In patients with eGFR < 60 ml/min/1.73 m 2 , 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 m 2 : IRR 0.70, p = 0.02; ≥60 ml/min/1.73 m 2 : 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 m 2 . 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.