Key result
Intrabody communication between a subcutaneous ICD and leadless pacemaker was 100% successful in canine models despite a less favorable median device angle of 29°, while human subjects showed a more favorable median angle of 56°.
Observational (n=195)
No
Intrabody conductive communication between a leadless pacemaker and S-ICD is feasible and successful in canine models, with human radiographic data suggesting even more favorable anatomical device orientation for this modular therapy.
Supports preclinical feasibility of modular S-ICD and leadless pacemaker therapy; leaves open human translation pending prospective trials.
Aims: The development of communicating modular cardiac rhythm management systems relies on effective intrabody communication between a subcutaneous implantable cardioverter-defibrillator (S-ICD) and a leadless pacemaker (LP), using conducted communication. Communication success is affected by the LP and S-ICD orientation. This study is designed to evaluate the orientation of the LP and S-ICD in canine subjects and measure success and threshold of intrabody communication. To gain more human insights, we will explore device orientation in LP and S-ICD patients. Methods and results: Canine subjects implanted with a prototype S-ICD and LP (both Boston Scientific, MA, USA) with anterior-posterior fluoroscopy images were included in this analysis. For comparison, a retrospective analysis of human S-ICD and LP patients was performed. The angle of the long axis of the LP towards the vertical axis of 0°, and distance between the coil and LP were measured. Twenty-three canine subjects were analysed. Median angle of the LP was 29° and median distance of the S-ICD coil to LP was 0.8 cm. All canine subjects had successful communication. The median communicating threshold was 2.5 V. In the human retrospective analysis, 72 LP patients and 100 S-ICD patients were included. The mean angle of the LP was 56° and the median distance between the S-ICD coil and LP was 4.6 cm. Conclusion: Despite the less favourable LP orientation in canine subjects, all communication attempts were successful. In the human subjects, we observed a greater and in theory more favourable LP angle towards the communication vector. These data suggests suitability of human anatomy for conductive intrabody communication.
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Quast et al. (2018) conducted an observational in Patients with a leadless pacemaker or subcutaneous implantable cardioverter-defibrillator (n=195). Leadless pacemaker and subcutaneous implantable cardioverter-defibrillator was evaluated on Angle of the long axis of the leadless pacemaker towards the communication vector and communication success. Intrabody communication between a subcutaneous ICD and leadless pacemaker was 100% successful in canine models despite a less favorable median device angle of 29°, while human subjects showed a more favorable median angle of 56°.
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