Safety and efficacy of exclusive remote monitoring of pacemaker (TELEPACE study)
J Gourraud, L Jesel, P Mabo, B Degand, F Anselme, B Guyomarch, I Hebia, J L Pasquie, J M Dupuis, D Klug, P Maury, D Babuty, M De Guillebon, J Mansourati, V ProbstAbstract
Background
Monitoring pacemakers requires significant and increasing healthcare resources despite limited availability. However technological progress of remote monitoring may allow to reduce such impact without modifying the safety. The aim of this study is to compare exclusive remote monitoring of pacemaker with standard care.
Methods
A multicentric (15 centers) French study was design with randomization of follow up after pacemaker implantation between exclusive remote monitoring and standard care. Cardiac resynchronistaion therapy and defibrillator were excluded from the study. Patients were all follow with Biotronik home monitoring system but data were masked in the standard care follow up.
Results
A total of 620 patients (mean age 76 [26-95] years; 31% female) were enrolled. A patient withdrew consent before the start of follow-up. Pacemker implanation was mainly performed for atrioventricular block with a dual chamber pacemaker ( 564 patients, 95%). Thirty (4,9%) patients presented PM implantation complication including 17 (2,8%) with new intervention.
After a mean follow up longer than 2 years in all patients, data from remote monitoring system, in site follow up and health care data base are currently being analyzed and expected in the next month.
Conclusion
We here described the first randomized study to assess the value of exclusive telecardiology monitoring of pacemakers.