Original Title: Informe sobre el Holter insertable con monitorización remota

Authors' objectives: • To review, systematically, all available evidence on the safety, effectiveness, cost and cost-effectiveness of the insertable Holter. • To estimate the budget impact of the introduction of the insertable Holter versus implantable Holter from the perspective of the National Health System. The ultimate goal is to inform the deliberations of the working group on surgical implants organized by the Ministry of Health to review the portfolio of services of the National Health System.

Authors' results and conclusions: RESULTS: SYSTEMATIC REVIEW: Two trials registered in ClinicalTrials.gov were identified. One of the studies has released preliminary results at conferences. No scientific studies have been published in peer review scientific journal evaluating safety, yield or diagnostic validity of the insertable Holter, however, one study is under review in a scientific journal. No economic evaluations have been identified neither, however, a cost analysis presented by Medtronic at a scientific conference was found. This analysis compares the insertable and implantable Holter costs from the hospital perspective. It shows that the insertable Holter is associated with an average cost saving of € 534 which mainly comes from the insertion procedure and consequently, from the no need of hospitalization and the absence of a specialist medical visit just after the intervention. Preliminary safety, yield or diagnostic validity results presented at conferences show that the implantation were successfully produced in 100% of cases and that the amplitude of the R- waves was stable at the time of implantation and one month later. However, a high body mass index associated with a decrease of the R-waves at the time of implantation and one month later in both sexes, but always over the recommended value of amplitude. Only in a study of 151 patients a case of explant occurred due to a tear in the skin. This same study evaluated the indicators related to the implantation procedure. Most insertable Holter were implanted in the recommended area under local anaesthesia (97.4%), even though there was a moderate bleeding at implantation in 4.6% of patients. COST ANALYSIS AND BUDGET IMPACT ANALYSIS: The insertable Holter per patient for 3 years would cost € 2,961.20 in scenario 1 and € 2,901.57 in scenario 2. In turn, the implantable Holter would cost € 3,142.72 in both scenarios. The budget impact analysis shows that the introduction of the insertable Holter would yield savings for the National Health System between € 345,801 and € 832,939 in five years.

Authors' recommendations: Despite the potential cost savings, there is no enough evidence on the comparative effectiveness and safety on the insertable Holter that allows to make a categorical recommendation on the introduction into the National Health System as an alternative to implantable Holter. This recommendation may change in the short or medium term when results of the studies were currently underway and cost-effectiveness studies are published.

Authors' methods: SYSTEMATIC REVIEW: Systematic searching in Google Scholar, MEDLINE and PreMEDLINE, EMBASE, IEEE Xplore and ClinicalTrials.gov were performed in October 2014. Since the technology is new, neither language, dates nor types of studies filters were used. References manually identified and material provided by Medtronic were also reviewed. Inclusion criteria for studies were slightly restrictive. Two reviewers independently selected studies; when there were doubts or discrepancies, they were resolved by consensus or with the help of a third reviewer. Due to the impossibility to carry out a meta-analysis because of the absence of studies, a narrative synthesis of the characteristics and results of studies was conducted. COST ANALYSIS AND BUDGET IMPACT: A cost analysis for the first three years and a budget impact analysis for the first five years were performed, comparing the insertable and implantable Holter costs from the National Health System perspective. Only direct medical costs were included. The comparator was the implantable Holter Reveal XT. Due to variability in clinical practice, two hypothetical scenarios are considered, either if the insertable Holter is implemented under minor surgery (scenario 1) or in consultation (scenario 2).

Project Status: Completed

Year Published: 2014

URL for published report: https://sescs.es/informe-sobre-el-holter-insertable-con-monitorizacion-remota/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Canary Health Service

Contact Address: Dirección del Servicio. Servicio Canario de la Salud, Camino Candelaria 44, 1ª planta, 38109 El Rosario, Santa Cruz de Tenerife

Contact Name: sescs@sescs.es

Contact Email: sescs@sescs.es