Sylvain Ploux1,2, Charles D Swerdlow3, Marc Strik1,4, Nicolas Welte1, Nicolas Klotz1, Philippe Ritter1,2, Michel Haïssaguerre1,2, Pierre Bordachar1,2. 1. IHU Liryc, Electrophysiology and Heart Modeling Institute, Fondation Bordeaux Université, F-33600, Pessac- Bordeaux, France. 2. Bordeaux University Hospital (CHU), Cardio-Thoracic Unit, F-33600, Pessac, France. 3. Cedars-Sinai Heart Center, Cedars Sinai Medical Center, Los Angeles, CA, USA. 4. Physiology and Cardiology Department, Maastricht University Medical Center, Cardiovascular Research Institute Maastricht, Maastricht, the Netherlands.
Abstract
INTRODUCTION: Recognition of implantable cardioverter defibrillator (ICD) lead malfunction before occurrence of life threatening complications is crucial. We aimed to assess the effectiveness of remote monitoring associated or not with a lead noise alert for early detection of ICD lead failure. METHODS: From October 2013 to April 2017, a median of 1,224 (578-1,958) ICD patients were remotely monitored with comprehensive analysis of all transmitted materials. ICD lead failure and subsequent device interventions were prospectively collected in patients with (RMLN) and without (RM) a lead noise alert (Abbott Secure Sense™ or Medtronic Lead Integrity Alert™) in their remote monitoring system. RESULTS: During a follow-up of 4,457 patient years, 64 lead failures were diagnosed. Sixty-one (95%) of the diagnoses were made before any clinical complication occurred. Inappropriate shocks were delivered in only one patient of each group (3%), with an annual rate of 0.04%. All high voltage conductor failures were identified remotely by a dedicated impedance alert in 10 patients. Pace-sense component failures were correctly identified by a dedicated alert in 77% (17 of 22) of the RMLN group versus 25% (8 of 32) of the RM group (P = 0.002). The absence of a lead noise alert was associated with a 16-fold increase in the likelihood of initiating either a shock or ATP (OR: 16.0, 95% CI 1.8-143.3; P = 0.01). CONCLUSION: ICD remote monitoring with systematic review of all transmitted data is associated with a very low rate of inappropriate shocks related to lead failure. Dedicated noise alerts further reduce inappropriate detection of ventricular arrhythmias.
INTRODUCTION: Recognition of implantable cardioverter defibrillator (ICD) lead malfunction before occurrence of life threatening complications is crucial. We aimed to assess the effectiveness of remote monitoring associated or not with a lead noise alert for early detection of ICD lead failure. METHODS: From October 2013 to April 2017, a median of 1,224 (578-1,958) ICDpatients were remotely monitored with comprehensive analysis of all transmitted materials. ICD lead failure and subsequent device interventions were prospectively collected in patients with (RMLN) and without (RM) a lead noise alert (Abbott Secure Sense™ or Medtronic Lead Integrity Alert™) in their remote monitoring system. RESULTS: During a follow-up of 4,457 patient years, 64 lead failures were diagnosed. Sixty-one (95%) of the diagnoses were made before any clinical complication occurred. Inappropriate shocks were delivered in only one patient of each group (3%), with an annual rate of 0.04%. All high voltage conductor failures were identified remotely by a dedicated impedance alert in 10 patients. Pace-sense component failures were correctly identified by a dedicated alert in 77% (17 of 22) of the RMLN group versus 25% (8 of 32) of the RM group (P = 0.002). The absence of a lead noise alert was associated with a 16-fold increase in the likelihood of initiating either a shock or ATP (OR: 16.0, 95% CI 1.8-143.3; P = 0.01). CONCLUSION:ICD remote monitoring with systematic review of all transmitted data is associated with a very low rate of inappropriate shocks related to lead failure. Dedicated noise alerts further reduce inappropriate detection of ventricular arrhythmias.