Background/objective: The Canadian Heart Rhythm Society (CHRS) Device Advisory Committee was commissioned in 2006 to develop a mechanism for responding to advisories regarding cardiac rhythm device and lead performance.
Methods: In the event of an advisory, the Chair classifies the advisory as urgent, semi-urgent, or routine based on the nature of the threat to the patient and the number of patients affected. The Chair uses an e-mail network with the committee members to disseminate advisory information and to assemble a consensus recommendation. Committee membership is broadly representative of the Canadian device community, including both academic and nonacademic centers, adult and pediatric specialists, and includes balanced regional representation. Recommendations are approved by the CHRS executive and made available to all implant and follow-up centers on the CHRS website.
Results: With the Medtronic Fidelis lead advisory of October 15, 2007, the Chair classified the advisory as semi-urgent and initiated an e-mail discussion and preliminary survey of all Canadian implantable cardioverter-defibrillator (ICD) centers within 3 hours of advisory announcement. A CHRS membership statement was issued within 48 hours. Within 5 working days, sample letters to physicians and patients were posted for local adaptation and distribution. Complete data collection was obtained from all Canadian defibrillator centers. Analyses at 20, 25, 30, and 32 months suggest an accelerating course of failures (3.91% at 32 months, P <.0001), with a reduced likelihood of presentation with inappropriate shocks (from 56% to 21%, P = .0003).
Conclusion: A collaborative approach using an e-mail network provides a mechanism for a rapid national response to device advisories. The network allows collection of focused data on implanted device system performance and facilitates timely reporting of clinically relevant data to patients and clinicians.