Ratika Parkash1, Bernard Thibault2, Francois Philippon3, Raymond Yee4, Elizabeth Stephenson5, Jeff Healey6, Andrew Krahn7, Derek Exner8, Christopher Simpson9, Eugene Crystal10, Pablo Nery11, Vidal Essebag12, Laurence Sterns13, Anthony Tang4, George Wells14. 1. Department of Medicine, Division of Cardiology, QEII Health Sciences Center, Halifax, Nova Scotia, Canada. Electronic address: Ratika.parkash@nshealth.ca. 2. Division of Cardiology, Montréal Heart Institute, Montréal, Québec, Canada. 3. Division of Cardiology, Université de Laval, Québec City, Québec, Canada. 4. Division of Cardiology, London Health Sciences Center, London, Ontario, Canada. 5. Division of Cardiology, Hospital for Sick Children, Toronto, Ontario, Canada. 6. Division of Cardiology, Hamilton Health Sciences Center, Hamilton, Ontario, Canada. 7. Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada. 8. Division of Cardiology, Libin Cardiovascular Institute, Calgary, Alberta, Canada. 9. Division of Cardiology, Kingston General Hospital, Kingston, Ontario, Canada. 10. Division of Cardiology, Sunnybrook Health Sciences Center, Toronto, Ontario, Canada. 11. Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada. 12. Divisions of Cardiology, McGill University and Hôpital de Sacre Coeur, Montréal, Québec, Canada. 13. Division of Cardiology, Royal Jubilee Hospital, Victoria, British Columbia, Canada. 14. Cardiovascular Research Methods Center, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
Abstract
BACKGROUND: Cardiac implantable electrical devices (CIEDs) are subject to advisories and complications that can result in morbidity and mortality for patients; there is currently no system in Canada to track these. METHODS: This was a multicenter, prospective cohort study conducted at 5 centers to determine feasibility. Patients with a de novo high-voltage (HV) lead implantation were included and followed for a minimum of 1 year. RESULTS: There were 611 leads enrolled into the registry over 18 months. The mean age was 62.4 ± 12.8 years; 144 (23.6%) women were enrolled. The indication for lead implantation was for primary prevention in 65.5%. There were 497 (82.1%) de novo devices (single chamber: 54.5%, dual chamber: 20.5%, cardiac resynchronization therapy [CRT] 25.0%); the remainder of the procedures was a system revision for either upgrade (8.1%) or lead revision (9.8%). The lead revision rate at 1 year was 3.4%, with the primary reason being lead dislodgements. Mortality rate was 3.8% at 1 year. The rate of any device-related complication was 2.0% at 30 days, with the highest rate in CRT implants (4.9%, P = 0.0105). At 1 year, the complication rate was 4.5%, with no significant difference among device types. CONCLUSIONS: This study demonstrates that device surveillance is feasible and highlights (1) the need for CIED surveillance to track device-related complications, (2) the scope of this should be larger, and (3) mandatory participation should be considered. This system could predict CIEDs that may be susceptible to higher than usual rates of failure, mitigating adverse outcomes in patients.
BACKGROUND: Cardiac implantable electrical devices (CIEDs) are subject to advisories and complications that can result in morbidity and mortality for patients; there is currently no system in Canada to track these. METHODS: This was a multicenter, prospective cohort study conducted at 5 centers to determine feasibility. Patients with a de novo high-voltage (HV) lead implantation were included and followed for a minimum of 1 year. RESULTS: There were 611 leads enrolled into the registry over 18 months. The mean age was 62.4 ± 12.8 years; 144 (23.6%) women were enrolled. The indication for lead implantation was for primary prevention in 65.5%. There were 497 (82.1%) de novo devices (single chamber: 54.5%, dual chamber: 20.5%, cardiac resynchronization therapy [CRT] 25.0%); the remainder of the procedures was a system revision for either upgrade (8.1%) or lead revision (9.8%). The lead revision rate at 1 year was 3.4%, with the primary reason being lead dislodgements. Mortality rate was 3.8% at 1 year. The rate of any device-related complication was 2.0% at 30 days, with the highest rate in CRT implants (4.9%, P = 0.0105). At 1 year, the complication rate was 4.5%, with no significant difference among device types. CONCLUSIONS: This study demonstrates that device surveillance is feasible and highlights (1) the need for CIED surveillance to track device-related complications, (2) the scope of this should be larger, and (3) mandatory participation should be considered. This system could predict CIEDs that may be susceptible to higher than usual rates of failure, mitigating adverse outcomes in patients.
Authors: Fadila Zerka; Samir Barakat; Sean Walsh; Marta Bogowicz; Ralph T H Leijenaar; Arthur Jochems; Benjamin Miraglio; David Townend; Philippe Lambin Journal: JCO Clin Cancer Inform Date: 2020-03