Original Title: Marcapasos compatible con resonancia magnética

Authors' objectives: To assess the effectiveness and possible benefits and adverse effects of magnetic resonance-compatible pacemakers.

Authors' results and conclusions: In light of the studies included for evaluation, this summary shows that the use of EnRhythm™ MR-compatible pacemakers is safe in patients undergoing magnetic resonance examinations at 1.5 Tesla and that EnRhythm™ functions are at least as effective as conventional pacemakers. It should be noted that these findings are limited to MR scans performed using a 1.5 Tesla scanner and therefore that this technology is limited to safe use with such scanners. Smaller implantable devices containing fewer ferromagnetic materials provide greater protection against the external magnetic field to which they are exposed. The contraindication for magnetic resonance in patients with implantable devices is currently being reconsidered. Various reports have shown 1.5 T MR to be safe in patients with implantable pacemakers or defibrillators provided the technique is applied in a professionally supervised setting. However, although a few studies (12,13,14) have considered 3 T MR and the application thereof in these patients, no conclusive results as regards the safety of these devices at such doses of electromagnetic radiation have been obtained. New concepts such as «MR-conditional pacemakers» are currently being introduced, although the majority of devices are still not «MR-safe». MR should only be performed when absolutely necessary and when no other diagnostic technique can replace it. The risks and benefits of MT must be weighed and the patient must provide consent prior to the examination. Conclusions Magnetic resonance is a risky procedure in patients with implanted cardiac prostheses. Consequently, MR must only be performed in such patients if it is the only technique that can aid diagnosis. Moreover, the benefits of diagnosis must clearly outweigh the risks. Current evidence suggests that the use of MR-compatible pacemakers at a radiation dose of 1.5 T appears to be feasible and safe. According to the FDA, there are currently no «MR-safe» devices.

Authors' methods: A time-unrestricted search of the scientific literature in databases that collect primary, secondary and applied research studies, namely the Medline, CRD (INAHTA, NHS EED, DARE), Cochrane Collaboration, National Guidelines ClearingHouse (NGC), EuroScan and ECRI databases, in order to locate systematic reviews, clinical practice guidelines or clinical trials that analyse the technique under study.

Project Status: Completed

Year Published: 2014

URL for published report: https://www.euskadi.eus/contenidos/informacion/2014_osteba_publicacion/es_def/adjuntos/marcapasoscomp.pdf

English language abstract: An English language summary is available

Publication Type: Rapid Review

Country: Spain

Organisation Name: Basque Office for Health Technology Assessment

Contact Address: C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz

Contact Name: Lorea Galnares-Cordero

Contact Email: lgalnares@bioef.eus

Copyright: Osteba (Basque Office for Health Technology Assessment) Health Department of the Basque Government