F V Y Tjong1, T F Brouwer2, L Smeding2, K M Kooiman2, J R de Groot2, D Ligon3, R Sanghera4, M J Schalij5, A A M Wilde2, R E Knops2. 1. AMC Heart Center, Department of Clinical and Experimental Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, Amsterdam 1105 AZ, The Netherlands f.v.tjong@amc.uva.nl. 2. AMC Heart Center, Department of Clinical and Experimental Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, Amsterdam 1105 AZ, The Netherlands. 3. St Jude Medical, Sunnyvale, CA, USA. 4. Boston Scientific Corporation, St Paul, MN, USA. 5. Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
Abstract
AIMS: The subcutaneous implantable cardioverter-defibrillator (S-ICD) and leadless pacemaker (LP) are evolving technologies that do not require intracardiac leads. However, interactions between these two devices are unexplored. We investigated the feasibility, safety, and performance of combined LP and S-ICD therapy, considering (i) simultaneous device-programmer communication, (ii) S-ICD rhythm discrimination during LP communication and pacing, and (iii) post-shock LP performance. METHODS AND RESULTS: The study consists of two parts. Animal experiments: Two sheep were implanted with both an S-ICD and LP (Nanostim, SJM), and the objectives above were tested. Human experience: Follow-up of one S-ICD patient with bilateral subclavian occlusion who received an LP and two LP (all Nanostim, SJM) patients (without S-ICD) who received electrical cardioversion (ECV) are presented. Animal experiments : Simultaneous device-programmer communication was successful, but LP-programmer communication telemetry was temporarily lost (2 ± 2 s) during ventricular fibrillation (VF) induction and 4/54 shocks. Leadless pacemaker communication and pacing did not interfere with S-ICD rhythm discrimination. Additionally, all VF episodes (n = 12/12), including during simultaneous LP pacing, were detected and treated by the S-ICD. Post-shock LP performance was unaltered, and no post-shock device resets or dislodgements were observed (24 S-ICD and 30 external shocks). Human experience : The S-ICD/LP patient showed adequate S-ICD sensing during intrinsic rhythm, nominal, and high-output LP pacing. Two LP patients (without S-ICD) received ECV during follow-up. No impact on performance or LP dislodgements were observed. CONCLUSION: Combined LP and S-ICD therapy appears feasible in all animal experiments (n = 2) and in one human subject. No interference in sensing and pacing during intrinsic and paced rhythm was noted in both animal and human subjects. However, induced arrhythmia testing was not performed in the patient. Defibrillation therapy did not seem to affect LP function. More data on safety and performance are needed. Published on behalf of the European Society of Cardiology. All rights reserved.
AIMS: The subcutaneous implantable cardioverter-defibrillator (S-ICD) and leadless pacemaker (LP) are evolving technologies that do not require intracardiac leads. However, interactions between these two devices are unexplored. We investigated the feasibility, safety, and performance of combined LP and S-ICD therapy, considering (i) simultaneous device-programmer communication, (ii) S-ICD rhythm discrimination during LP communication and pacing, and (iii) post-shock LP performance. METHODS AND RESULTS: The study consists of two parts. Animal experiments: Two sheep were implanted with both an S-ICD and LP (Nanostim, SJM), and the objectives above were tested. Human experience: Follow-up of one S-ICD patient with bilateral subclavian occlusion who received an LP and two LP (all Nanostim, SJM) patients (without S-ICD) who received electrical cardioversion (ECV) are presented. Animal experiments : Simultaneous device-programmer communication was successful, but LP-programmer communication telemetry was temporarily lost (2 ± 2 s) during ventricular fibrillation (VF) induction and 4/54 shocks. Leadless pacemaker communication and pacing did not interfere with S-ICD rhythm discrimination. Additionally, all VF episodes (n = 12/12), including during simultaneous LP pacing, were detected and treated by the S-ICD. Post-shock LP performance was unaltered, and no post-shock device resets or dislodgements were observed (24 S-ICD and 30 external shocks). Human experience : The S-ICD/LPpatient showed adequate S-ICD sensing during intrinsic rhythm, nominal, and high-output LP pacing. Two LPpatients (without S-ICD) received ECV during follow-up. No impact on performance or LP dislodgements were observed. CONCLUSION: Combined LP and S-ICD therapy appears feasible in all animal experiments (n = 2) and in one human subject. No interference in sensing and pacing during intrinsic and paced rhythm was noted in both animal and human subjects. However, induced arrhythmia testing was not performed in the patient. Defibrillation therapy did not seem to affect LP function. More data on safety and performance are needed. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Vincent C Thomas; Mark Peterson; Martin McDaniel; Humberto Restrepo; Abraham Rothman; Amit Jain Journal: Pediatr Cardiol Date: 2017-05-22 Impact factor: 1.655
Authors: Daniel Kiblboeck; Christian Reiter; Juergen Kammler; Pierre Schmit; Hermann Blessberger; Joerg Kellermair; Franz Fellner; Clemens Steinwender Journal: J Cardiovasc Magn Reson Date: 2018-07-05 Impact factor: 5.364