At the beginning of August 2017, the French National Authority for Health (HAS) published a health technology assessment of systems for remote monitoring for implantable cardioverter defibrillators (ICD). The aim of this assessment was an update and clarification of arrangements for the provision of implantable cardioverter defibrillator systems (ICDS) to improve the quality of care for patients with ICD and to promote the deployment of effective solutions in the country.
A systematic literature search of evidence for the application of remote monitoring of ICD was performed. A total of 7 RCTs and a meta-analysis for ICDS were identified. The results of these studies were transposable from one system to another due to the technical similarity between systems. Outcomes of remote monitoring systems were evaluated in relation to reduction in the time required to transmit information, inadequate shocks and the total number of consultations. However, the impact of the application of ICDS on patient morbidity and mortality is still difficult to interpret because of divergent results on this type of criterion and differences in the management and intensity of follow-up related to patient management in accordance with clinical studies. It was emphasized that the specific interest of remote monitoring of the parameters measured by the ICDS for the monitoring of heart failure is also to be determined in their ability to predict and anticipate episodes of cardiac decompensation.
The CNEDiMTS confirms the medical value of a follow-up of ICDS using a remote monitoring. However, it considered that the interest of medical surveillance of ICD depended on the modalities of its implementation. The Commission has therefore specified minimum requirements implementation of remote monitoring systems for ICD following in three main areas:
- On the technical level: the CNEDiMTS formulated requirements for the modalities of automatic data transfer, the type of data to be transmitted, the parameters monitored that could trigger an alert, the accommodation of the transmitted data and provision of data to doctors and patients
- In relation to medical activity: The Commission has defined the level of competence, qualifications, and experience required for healthcare professionals involved in medical surveillance; procedures for initiating of remote monitoring; telephone communication with the patient; reports
- On the organizational level: The Commission described the modalities for setting up and implementing the necessary telemonitoring at the level of the ICD patient follow-up centers. It also specified requirements for training and coordination of follow-up of these patients
Within the health technology assessment process all remote monitoring systems for ICDS that had been already approved for inclusion in LPPR with ASA level V (absence of improvement) (CARELINK, HOME MONITORING, LATITUDE NXT, MERLIN.NET, SMARTVIEW) were reassessed as part of their renewal of the LPPR registration. Following devices were approved by CNEDiMTS for renewal for registration with appropriate LPPR codes:
- St Jude Medical
- MERLIN.NET System of remote monitoring for ICDS single-chamber (LPPR code: 3464579)
- MERLIN.NET System of remote monitoring for ICDS dual-chamber (LPPR code: 3474164)
- MERLIN.NET System of remote monitoring for ICDS three chamber (CRT-D) (LPPR code: 3435017)
- Biotronik
- HOME MONITORING system of remote monitoring for ICDS single-chamber (LPPR code: 3499030)
- HOME MONITORING system of remote monitoring for ICDS dual-chamber (LPPR code: 3491091)
- HOME MONITORING system of remote monitoring for ICDS three chamber (CRT-D) (LPPR code: 3433314)
- LivaNova
- SMARTVIEW remote monitoring System for ICDS single-chamber (LPPR code: 3447925)
- SMARTVIEW remote monitoring System for ICDS dual-chamber (LPPR code: 3495440)
- SMARTVIEW remote monitoring System for DAI three chamber (CRT-D) (LPPR code: 3483826)
- Medtronic
- CARELINK remote monitoring system for ICDS single-chamber (LPPR code: 3492564)
- CARELINK remote monitoring system for ICDS dual-chamber (LPPR code: 3499780)
- CARELINK remote monitoring system for DAI three chamber (CRT-D) (LPPR code: 3456628)
- Boston Scientific
- LATITUDE NXT remote monitoring System for ICDS single-chamber (LPPR code: 3407713)
- LATITUDE NXT remote monitoring System for ICDS dual-chamber (LPPR code: 3427822)
- LATITUDE NXT remote monitoring System for DAI three chamber (CRT-D) (LPPR code: 3414541)
Additionally, estimation of the annual target population for ICDS remote monitoring was performed for each type of ICD:
- Single-chamber – from 4,200 to 6,300 patients per year
- Dual chamber – from 3,150 to 4,725 patients per year
- Three chamber (CRT-D) – from 20,750 to 41,500 patients per year
See HAS’ report in French here.
See decree of telemedicine °2010-1229 of 19th October 2010.
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