eine retrospektive Analyse der randomisierten, kontrollierten Studien TIM-HF und TIM-HF2

Hintergrund: In der Betreuung von Herzinsuffizienzpatienten werden zunehmend telemedizinische Anwendungen eingesetzt. Das Telemonitoring bildet dabei eine Teilkomponente innerhalb eines holistischen Betreuungskonzeptes (Remote Patient Management), das die ambulante Präsenzbetreuung und Patientenschulung ergänzt. Die Rationale der telemedizinischen Mitbetreuung besteht insbesondere in der Früherkennung kardialer Funktionsverschlechterungen und daraus abgeleiteter frühzeitiger Intervention, um Hospitalisierungen zu vermeiden und Mortalität zu senken. In den vergangenen 15 Jahren wurden mehrere randomisierte, klinische Telemedizinstudien mit sehr uneinheitlichen Ergebnissen durchgeführt. Als eine der Hauptursachen wird die Adhärenz angesehen. Methode: Die eigenen Adhärenzuntersuchungen beziehen sich auf zwei randomisierte, klinische, nicht-invasive Telemedizinstudien mit Herzinsuffizienzpatienten im Stadium NYHA II/III. In den Jahren 2008 bis 2010 wurde die TIM-HF-Studie (Telemedical Interventional Monitoring in Heart Failure) mit 710 Patienten durchgeführt. Zwischen 2013 und 2018 wurde die TIM-HF2-Studie (Telemedical Interventional Management in Heart Failure II) mit 1.538 Patienten nach einem stationären Aufenthalt wegen hydropischer Dekompensation durchgeführt. Die primären Endpunkte waren in TIM-HF „Tod jeder Genese“ und in TIM-HF2 „Verlorene Tage wegen ungeplanter kardiovaskulärer Krankhausaufenthalte und durch Tod jeder Genese im einjährigen Follow-up“. In beiden Studien sollten die Patienten der Interventionsgruppe täglich Vitalwerte mittels einer Waage, eines Blutdruckmessgeräts und eines EKG-Geräts messen sowie eine Selbsteinschätzung zum körperlichen Befinden an das Telemedizinzentrum (TMZ) übermitteln. Post-hoc wurde die Adhärenz zu den Messungen erhoben und zwischen täglicher Messung mindestens eines Vitalwertes (relative Adhärenz) und aller Vitalwerte (absolute Adhärenz) unter-schieden. Anschließend wurden die Adhärenzeinflussfaktoren gemäß WHO-Definition anhand der Studiendaten sowie Fragebögen zur Patientenzufriedenheit untersucht. Ergebnisse: Es zeigten sich sehr hohe Adhärenzwerte (TIM-HF: absolute Adhärenz 81,8 ± 22,8 %, relative Adhärenz 88,9 ± 21,5 %; TIM-HF2: absolute Adhärenz 89,1 ± 14,1 %, relative Adhärenz 94,6 ± 10,1 %), die im Studienverlauf konstant hoch waren. Es gab keine signifikanten Adhärenzunterschiede zwischen der Nutzung der Messgeräte zur Messung der Vitalparameter. Bei der Analyse der WHO-Einflussfaktoren - sozioökonomische Faktoren sowie Art und Schwere der Erkrankung - ließen sich keine spezifischen Ursachen für die hohe Adhärenz sichern. Die beiden Post-hoc-Befragungen deuten darauf hin, dass die Adhärenz von einfacher Messgerätebedienbarkeit, regelmäßigen Telefonkontakten mit dem TMZ so-wie einem guten Zusammenwirken zwischen TMZ und primär behandelnden Haus- und Fachärzten abhängt. Weiterhin sind die Erwartung des Patienten an einen individuellen und unmittelbaren medizinischen Nutzen sowie die enge Verbindung zum primär betreuenden Arzt relevant (WHO-Faktoren „Gesundheitssystem“, „Patient“ sowie „Therapiekomplexität“). Schlussfolgerung: Bei vergleichbar hoher Adhärenz in beiden Studien wurde nur in der TIM-HF2-Studie ein positiver primärer Endpunkt erreicht. Die Adhärenz zur täglichen Vitaldatenmessung ist deshalb eine notwendige, aber nicht hinreichende Bedingung für das klinische Interventionsergebnis.Background: Telemedical applications are increasingly being used in medical care for heart failure (HF) patients. Telemonitoring is one aspect within a holistic care concept (Remote Patient Management/RPM) that completes outpatient care and patient training. The rationale of RPM is the early detection of cardiac deterioration and intervention derived therefrom to avoid hospitalization and reduce mortality. Over the past 15 years, several randomized controlled trials (RCT) have been conducted with very inconsistent results. The lack of adherence is considered as one of the main reasons. Methods: The adherence analysis relates to two RCTs in non-invasive telemedicine with HF patients. In 2008-2010, the TIM-HF (Telemedical Interventional Monitoring in Heart Failure) trial was performed with 710 HF patients. Between 2013 and 2018, the TIM-HF2 trial (Telemedical Interventional Management in Heart Failure II) was performed with 1,538 HF patients. The primary endpoint in TIM-HF was "all-cause death“ and in TIM-HF2 "days lost due to unplanned cardiovascular hospital admissions and all-cause death“. In both studies, RPM-patients were instructed to measure and transmit vital signs daily using a scale, a blood pressure monitor, an ECG device, and to report a self-rated health status to the telemedicine centre (TMC). The adherence to the measurements was determined post-hoc, distinguishing between daily measurement of at least one (relative adherence) and all vital parameters (absolute adherence). Subsequently, the adherence factors according to the WHO-definition were examined based on the study data as well as from post-hoc surveys on patient satisfaction received. Results: Both studies showed very high adherence rates (TIM-HF: absolute adherence 81.8 ± 22.8 %, relative adherence 88.9 ± 21.5 %, TIM-HF2: absolute adherence 89.1 ± 14.1 %, relative adherence 94.6 ± 10.1 %), which were consistently high during the study course. There were no significant differences between the adherence of the various vital signs. The WHO factors analysis - socioeconomic, type and severity of the disease -) did not identify specific causes for high adherence. Two post-hoc surveys suggest that adherence is strongly dependent on ease of device usability, regular phone contact with the TMC, and good interaction between TMC and primary care physicians. Furthermore, the patient expectation on individual and immediate physical benefit is relevant (WHO factors "health system“, ”patient" and "therapy complexity"). Conclusion: Despite of high adherence rates in both telemedical studies, only TIM-HF2 achieved a positive primary endpoint. Adherence to daily telemonitoring is therefore a necessary but not sufficient requirement regarding the clinical outcome of the intervention

Is 24/7 remote patient management in heart failure necessary? Results of the telemedical emergency service used in the TIM‐HF and in the TIM‐HF2 trials

Aims: Telemedical emergency services for heart failure (HF) patients are usually provided during business hours. However, many emergencies occur outside of business hours. This study evaluates if a 24/7 telemedical emergency service is needed for the remote management of high-risk HF patients. Methods: and results The study included 1119 patients merged from the TIM-HF and TIM-HF2 trials [age 69 +/- 11, 73% male, left ventricular ejection fraction 37% +/- 13, 557 New York Heart Association (NYHA) II/562 NYHA III]. Patients received a 24/7 physician-guided emergency service provided by the telemedical centre (TMC) in addition to remote management within business hours. During emergency calls, patient status, symptoms, electronic patient record, and instant telemonitoring data were evaluated by the TMC physician. Following diagnosis, patients were referred for hospital admission or instructed to stay at home. Apart from the TMC, patients could place a call to the public emergency service at any time. Seven hundred sixty-eight emergency calls were placed over 1383 patient years (0.56 calls/patient year). Five hundred twenty-six calls (69%) occurred outside business hours. There were 146 (19%) emergency calls for worsening HF, 297 (39%) other cardiovascular, and 325 (42%) non-cardiac causes, with a similar pattern inside and outside business hours. Of the 1119 patients, 417 (37%) placed at least one emergency call. Patients with NYHA Class III, higher N-terminal prohormone of brain natriuretic peptide (>1.400 pg/mL) levels, ischaemic aetiology of HF, implanted defibrillator, and impaired renal function had a higher probability of placing emergency calls. During study follow-up, patients who made an emergency call had a higher all-cause mortality (22% vs. 11%, P = 0.007 in TIM-HF; 16% vs. 4%, P < 0.001 in TIM-HF2) and more unplanned hospitalizations (324 vs. 162, P < 0.001 in TIM-HF; 545 vs. 180, P < 0.001 in TIM-HF2). Of the total 1,211 unplanned hospital admissions, 492 (41%) were initiated by a patient emergency call. Three hundred seventy-nine calls (49%) were placed to the TMC, whereas 389 calls (51%) were made to the public emergency service. Three hundred twenty-six (84%) of the calls to the public emergency service resulted in acute hospitalizations. The TMC initiated 202 (53%) hospital admissions; 177 (47%) patients were advised to stay at home. All patients that remained at home were alive during a prespecified safety period of 7 days post-call. Diagnoses made by the TMC physician were confirmed in 83% of cases by the hospital. Conclusion: A telemedical emergency service for high-risk HF patients is safe and should operate 24/7 to reduce unplanned hospitalizations. Emergency calls could be considered as a marker for higher morbidity and mortality

I walk along the river without me fine tooth saw

Song about the lumberman's life - working in the woods, eating Johnny cake and boiling up tea in an old tin can

Cost-effectiveness of noninvasive telemedical interventional management in patients with heart failure: health economic analysis of the TIM-HF2 trial

10.1007/s00392-021-01980-2Clinical Research in Cardiolog