Robert Sheldon1, Mario Talajic2, Anthony Tang3, Giuliano Becker4, Vidal Essebag5, Omar Sultan6, Adrian Baranchuk7, Debbie Ritchie8, Carlos Morillo8, Andrew Krahn9, Michele Brignole10, Braden Manns8, Connor Maxey8, Satish R Raj8. 1. Libin Cardiovascular Institute of Alberta, University of Calgary, Calgary, Alberta, Canada. Electronic address: sheldon@ucalgary.ca. 2. Montreal Heart Institute, Montreal, Quebec, Canada. 3. University of Western Ontario, London, Ontario, Canada. 4. Hopital Sacre Couer, Montreal, Quebec, Canada. 5. McGill University, Montreal, Quebec, Canada. 6. Regina General Hospital, Regina, Saskatchewan, Canada. 7. Queen's University, Kingston, Ontario, Canada. 8. Libin Cardiovascular Institute of Alberta, University of Calgary, Calgary, Alberta, Canada. 9. University of British Columbia, Vancouver, British Columbia, Canada. 10. Ospedali Del Tigullio, Lavagna, Italy.
Abstract
OBJECTIVES: In this study, the authors tested whether a strategy of empiric permanent pacing reduces major composite events more effectively than acting on the results of an implantable cardiac monitor (ICM). BACKGROUND: Syncope may be caused by intermittent complete heart block in patients with bifascicular heart block, but competing diagnoses coexist. Whether empiric permanent pacing or acting on investigative results provides best care is unknown. METHODS: This was a multinational, randomized, pragmatic clinical trial of patients ≥50 years of age with bifascicular block, preserved left ventricular function, and ≥1 syncope in the preceding year. The primary composite outcome measure comprised cardiovascular death, syncope, bradycardia resulting in pacemaker insertion, and device complications. RESULTS: There were 57 and 58 subjects randomized to receive a pacemaker or ICM. A total of 41 patients had left bundle branch block and 74 had right bundle branch block and a left fascicular block. Patients were followed for a median 33 months. There were fewer composite primary outcomes in patients randomized to pacemaker compared with ICM, respectively (20 [35%] vs 44 [76%]; chi square P < 0.0001), with lower actuarial probabilities of a primary outcome (0.45 and 1.00; P < 0.001). Syncope was as likely in the groups randomized to receive a pacemaker or ICM (29% vs 26%, chi-square P = 0.95). CONCLUSIONS: Empiric permanent pacing compared with ICM reduced major adverse events but not syncope in older patients with bifascicular block and recent syncope. There remains a substantial likelihood of syncope recurrence in patients who receive a permanent pacemaker likely caused by vasodepressor syncope. (Syncope: Pacing or Recording in the Later Years [SPRITELY]; NCT01423994).
OBJECTIVES: In this study, the authors tested whether a strategy of empiric permanent pacing reduces major composite events more effectively than acting on the results of an implantable cardiac monitor (ICM). BACKGROUND: Syncope may be caused by intermittent complete heart block in patients with bifascicular heart block, but competing diagnoses coexist. Whether empiric permanent pacing or acting on investigative results provides best care is unknown. METHODS: This was a multinational, randomized, pragmatic clinical trial of patients ≥50 years of age with bifascicular block, preserved left ventricular function, and ≥1 syncope in the preceding year. The primary composite outcome measure comprised cardiovascular death, syncope, bradycardia resulting in pacemaker insertion, and device complications. RESULTS: There were 57 and 58 subjects randomized to receive a pacemaker or ICM. A total of 41 patients had left bundle branch block and 74 had right bundle branch block and a left fascicular block. Patients were followed for a median 33 months. There were fewer composite primary outcomes in patients randomized to pacemaker compared with ICM, respectively (20 [35%] vs 44 [76%]; chi square P < 0.0001), with lower actuarial probabilities of a primary outcome (0.45 and 1.00; P < 0.001). Syncope was as likely in the groups randomized to receive a pacemaker or ICM (29% vs 26%, chi-square P = 0.95). CONCLUSIONS: Empiric permanent pacing compared with ICM reduced major adverse events but not syncope in older patients with bifascicular block and recent syncope. There remains a substantial likelihood of syncope recurrence in patients who receive a permanent pacemaker likely caused by vasodepressor syncope. (Syncope: Pacing or Recording in the Later Years [SPRITELY]; NCT01423994).
Authors: Mark Hofmeister; Robert S Sheldon; Eldon Spackman; Satish R Raj; Mario Talajic; Giuliano Becker; Vidal Essebag; Deborah Ritchie; Carlos A Morillo; Andrew Krahn; Shahana Safdar; Connor Maxey; Fiona Clement Journal: CJC Open Date: 2022-03-29