Heart failure patients with atrial fibrillation benefit from remote patient management: insights from the TIM‐HF2 trial

Stegmann, T; Koehler, Kerstin; Wachter, Rolf; Moeller, Volker; Zeynalova, Samira; Koehler, Friedrich; Laufs, Ulrich

doi:10.1002/ehf2.12819

Cited by 14 publications

(17 citation statements)

References 32 publications

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“…The present exploratory analyses of prespecified eGFR-subgroups from the TIM-HF2 trial investigate the clinical effects of RPM in an HF population with impaired renal function. Other high-risk groups within the TIM-HF2 study cohort have been investigated and also showed better outcomes in the RPM group ( 31 – 33 ). Thus our paper extends this observation to patients with impaired vs. better renal function.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2022

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BackgroundRemote 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.MethodsTIM-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.ResultsOur 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.ConclusionRPM 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.

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Section: Discussionmentioning

confidence: 99%

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

et al. 2022

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“…These effects were less prominent in the sinus rhythm group (P = 0.45 and P = 0.16, respectively). 41 The discussion on telemonitoring will certainly continue. This is in view of the recently published results of OSICAT (Optimization of the Ambulatory Monitoring for Patients With Heart Failure by Tele-cardiology) trial, 42 in which remote intervention was again ineffective for the primary endpoints (all-cause mortality and unplanned HF hospitalizations).…”

Section: Greenmentioning

confidence: 99%

Rationale and design of the AMULET study: A new Model of telemedical care in patients with heart failure

et al. 2021

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Aims Heart failure (HF) is characterized by high mortality and hospital readmission rates. Limited access to cardiologists restricts the application of guideline-directed, patient-tailored medical therapy. Some telemedicine solutions and novel non-invasive diagnostic tools may facilitate real-time detection of early HF decompensation symptoms, prompt initiation of appropriate treatment, and optimal management of medical resources. We describe the rationale and design of the AMULET trial, which investigates the effect of comprehensive outpatient intervention, based on individualized haemodynamic assessment and teleconsultations, on cardiovascular mortality and unplanned hospitalizations in HF patients. Methods and resultsThe AMULET trial is a multicentre, prospective, randomized, open-label, and controlled parallel group trial (ClinicalTrials.gov Identifier: NCT03476590). Six hundred and five eligible patients with HF (left ventricular ejection fraction ≤49%, at least one hospitalization due to acute HF decompensation within 6 months prior to enrolment) were randomly assigned in a 1:1 ratio to either an intervention group or a standard care group. The planned follow-up is 12 months. The AM-ULET interventions are performed in ambulatory care points operated by nurses, with the remote support of cardiologists. The comprehensive clinical evaluation comprises measurements of heart rate, blood pressure, body mass, thoracic fluid content, and total body water. A recommendation support module based on these objective parameters is implemented in remote therapeutic decision-making. The primary complex endpoints are cardiovascular mortality and unplanned HF hospitalization. Conclusions The AMULET trial will provide a prospective assessment of the effect of comprehensive ambulatory intervention, based on telemedicine and haemodynamically guided therapy, on mortality and readmissions in HF patients.

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“…▪ G-BA-Beschluss: Erstmalig wird (europaweit) eine digi- Neben der Versorgung bei HI ermöglicht eine telemedizinische Mitbetreuung auch die Betreuung von Komorbiditäten [10]. So kann durch eine frühzeitige Rhythmuskontrolle zur Detektion von Vorhofflimmern das Letalitäts-und Morbiditätsrisiko bei HI-Patient*innen deutlich reduziert werden [11]. Die intensive telemedizinische Mitbetreuung in der TIM-HF-Studie hatte zudem positiven Einfluss auf die depressive Symptomatik bei Patient*innen [12].…”

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Telemedizin bei Herzinsuffizienz – Translation von klinischen Studien in die Regelversorgung

Hiddemann

Prescher

Koehler

et al. 2021

Aktuelle Kardiologie

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ZusammenfassungFür telemedizinische Mitbetreuung von Patient*innen mit chronischer Herzinsuffizienz besteht Evidenz bezüglich der Senkung von Letalität und kardiovaskulärer Morbidität. Nach aktuellem Beschluss des Gemeinsamen Bundesausschusses (G-BA) wird erstmals eine digitale Methode in die Regelversorgung überführt. Hochrisikopatient*innen mit reduzierter linksventrikulärer Ejektionsfraktion haben künftig einen Leistungsanspruch, entweder mittels aktiver Implantate (ICD, CRT-P und CRT-D) oder mittels telemedizinischer Heimmessgeräte betreut zu werden. Die Indikation zum Telemonitoring stellt der/die primär behandelnde Arzt/Ärztin (PBA). Der tägliche Vitaldatentransfer erfolgt an ein kardiologisch geführtes Telemedizinzentrum (TMZ), welches den/die PBA bei auffälligen Befunden zeitnah benachrichtigt. Der/die PBA entscheidet im Einzelfall über den Bedarf einer telemedizinischen 24/7-Mitbetreuung. Ein/e kardiologische/r PBA mit einer TMZ-Infrastruktur kann die telemedizinische Mitbetreuung der eigenen Patient*innen übernehmen.

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Heart failure patients with atrial fibrillation benefit from remote patient management: insights from the TIM‐HF2 trial

Cited by 14 publications

References 32 publications

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

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

Rationale and design of the AMULET study: A new Model of telemedical care in patients with heart failure

Telemedizin bei Herzinsuffizienz – Translation von klinischen Studien in die Regelversorgung

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