Authors' objectives:

This report aims to assess the use of biventricular pacemakers at the McGill University Health Centre.

Authors' results and conclusions: In addition to high mortality, congestive heart failure is characterized by high morbidity, repeated hospitalizations, and reduced exercise tolerance. Several pharmacologic and non-pharmacologic interventions have been shown to reduce both mortality and morbidity. A recent technologic intervention is biventricular pacing, also known as cardiac resynchronization therapy (CRT). The rationale of this approach is to diminish ventricular asynchrony and thus improve ventricular function in those cases in which intraventricular conduction is prolonged. Several randomized studies have been performed. No study has demonstrated improved survival with isolated CRT or CRT combined with an implantable cardiac defibrillator (ICD) versus CRT. The studies suggest improvements in the patients quality of life, but there was no consistent evidence of reduced hospitalizations with biventricular pacing with or without ICD compared to ICDs. Approximately 10% of installations cant be successfully completed. The cost of implantation of the CRT-ICD is $34,677 per patient, compared to $24,704 for an ICD alone. In terms of opportunity costs given the fixed budget of the cardiology (pacemaker) department, this additional expense means that for every 2 combined CRT-ICD devices installed, there will be a budget reduction corresponding approximately to 1 fewer ICD being available. While CRTs have no demonstrated mortality benefit, ICDs have been shown to improve survival in very similar patients. If there were 6 combined CRT-ICD installations over the next 12 months, the additional $60,000 would likely have to be offset by the installation of 3 fewer ICD devices. Based on the lack of clinically meaningful differences consistently identified to date, including the difficulty in predicting responders, the current state of clinical equipoise and the consequent existence of ongoing research projects, the difficulties in installation and the increased costs, TAU does not at this time recommend the routine approval of combined CRT/ICD technology at the MUHC. Despite this recommendation, it should not be concluded that there is no role for this technology at the MUHC as TAU firmly encourages the participation of the MUHC in the Canadian Institute of Health Research funded Raft trial to further clarify the risks and benefits of this therapy. TAU recognizes that unique cases may arise whereby there is a strong clinical suspicion that a patient, ineligible for the current research project, may be thought to greatly benefit from this technology. For these exceptions, the evidence cited in this present document, which summarizes which patients are most likely to obtain maximum benefit, will be useful. A decision to initiate the CRT-ICD therapy in these exceptional cases should only be made after formal approval by a committee of the Division of Cardiology.

Authors' recommendations: Based on the lack of mortality benefits, the marginal impact on quality of life, the lack of long term results at this time, the presence of ongoing research designed to establish the benefit of this therapy, and the considerable opportunity costs, the TAU does not recommend routine use of biventricular pacemakers with ICD at the MUHC. TAU encourages the active participation of the MUHC in the CIHR funded trial that is further examining this technology. At present, TAU does not expect annually that more than a maximum of 5 or 6 exceptional cases would require biventricular pacing outside the context of the funded research trial.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.mcgill.ca/tau/publications/2004

Year Published: 2004

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Canada

Organisation Name: Technology Assessment Unit of the McGill University Health Centre (MUHC)

Contact Address: Technology Assessment Unit of the MUHC, Centre for Outcomes Research and Evaluation (CORE), Research Institute of the McGill University Health Centre, 5252 boul. de Maisonneuve, Bureau 3F.50, Montreal, Quebec H4A 3S5

Contact Name: nandini.dendukuri@mcgill.ca

Contact Email: nandini.dendukuri@mcgill.ca

Copyright: Technology Assessment Unit of the McGill University Health Centre (MUHC)