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Nutzenbewertung des strukturierten Telemonitorings mithilfe von aktiven Herzrhythmusimplantaten

Appraisal of structured remote monitoring by active cardiac implantable electrical devices

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Zusammenfassung

Das implantatbasierte Telemonitoring bei Patienten mit erhöhtem Risiko für plötzlichen Herztod und bei Herzinsuffizienz ermöglicht im Vergleich zur konventionellen Nachsorge die frühere Erkennung technischer und klinischer Konstellationen, durch welche Patienten in Lebensqualität und Überleben gefährdet sein können. Unterschiedliche Methoden der Datenakquisition und variable Definitionen von therapeutischen Reaktionen auf Befunde aus dem Telemonitoring wurden in bisherigen Studien zur Evaluation des Telemonitorings angewandt. Zur Analyse der Wirksamkeit des implantatbasierten Telemonitorings erscheinen die Gesamtsterblichkeit und die kardiovaskuläre Sterblichkeit als adäquate Endpunkte. Die Hospitalisation als Endpunkt ist weniger geeignet, da sich in diesem Parameter Krankenhausbehandlungen als erforderliche Reaktion auf früh detektierte Dekompensationen und Hospitalisationen aufgrund klinischer Verschlechterung in schwer zu differenzierender Weise mischen. Die modifizierte Analyse und Metaanalyse der vom IQWiG zur Bewertung des Telemonitorings herangezogenen Studien zeigt, dass bei zeitlich engmaschiger und umfangreicher Datenakquisition und strukturierter verbindlicher Vorgabe von Behandlungskonsequenzen aus spezifischen Befundkonstellationen das implantatbasierte Telemonitoring die Gesamtsterblichkeit und kardiovaskuläre Sterblichkeit relevant und signifikant mindert. Dagegen ist die reine Datenakquisition ohne strukturierte Konsequenz nicht wirksam. Die pauschale Negation eines Zusatznutzens durch das implantatbasierte Telemonitoring im deutschen Gesundheitswesen würde Patienten in Deutschland eine international geforderte innovative Methode zur verbesserten Versorgung vorenthalten. Zusätzlich wären gravierende juristische Folgen zu erwarten, wenn das implantatbasierte Telemonitoring generell disqualifiziert würde. Stattdessen sollte Telemonitoring in sinnvoller und wirksamer Weise gemeinsam breit etabliert werden.

Abstract

Remote monitoring by active cardiac implantable electrical devices to prevent sudden cardiac death and/or to improve care of patients with heart failure, enables the early detection of technical and clinical issues that are threatening the patients’ life or quality of life. Different methods of remote data acquisition and varying definitions of therapeutic interventions responding to specific remotely detected parameter patterns have been applied in studies evaluating clinical effectiveness of remote monitoring. Total mortality and cardiovascular mortality appear to be appropriate endpoints in the evaluation of device-based remote monitoring. Hospitalization appears to be less useful as an endpoint, because this parameter is likely to be confounded by hospitalizations appropriately reacting to early detected technical or clinical problems and urgent hospital admissions due to apparent clinical patient impairment. An analysis and meta-analysis of studies evaluating the clinical effectiveness of remote monitoring has been performed according to the strategy of data acquisition and the specification of compulsive treatment interventions responding to defined parameter patterns. The analyses show that device-based remote monitoring strategies specifying close-meshed comprehensive data acquisition and defined treatment interventions are able to relevantly and significantly reduce total mortality and cardiovascular mortality, whereas remote data acquisition alone without specified treatment interventions appears to be ineffective. The global negation of added benefit by device-based remote monitoring, as recently suggested by the German health authorities, denies German heart failure patients an internationally required innovative method of improved care. In addition, important medicolegal consequences would have to be expected if device-based remote monitoring was generally disqualified. Instead, remote monitoring should be widely established in a reasonable and effective manner.

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Correspondence to M. Stockburger.

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M. Stockburger, T.M. Helms, C.A. Perings, T. Deneke, F. Köhler, V. Leonhardt, A. Müller, C. Piorkowski, K. Rybak und S. Sack geben an, dass kein Interessenkonflikt besteht.

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Stockburger, M., Helms, T.M., Perings, C.A. et al. Nutzenbewertung des strukturierten Telemonitorings mithilfe von aktiven Herzrhythmusimplantaten. Kardiologe 11, 452–459 (2017). https://doi.org/10.1007/s12181-017-0203-8

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  • DOI: https://doi.org/10.1007/s12181-017-0203-8

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