Device-device communication stability of leadless anti-tachycardia pacemaker and subcutaneous implantable cardioverter defibrillator over 18 months

Abstract

Abstract Background A novel modular cardiac rhythm management (mCRM) therapy approach is evaluated in this study: the performance of an anti-tachycardia pacing enabled leadless pacemaker (LP) commanded by a subcutaneous-ICD (S-ICD) via wireless, intra-body, device-device communication (DDC). Objectives To investigate long-term DDC performance of linked S-ICD to LP (mCRM System) and factors that impact DDC performance. Methods The mCRM System was implanted in 37 canine subjects: 33 with an S-ICD and an LP; 4 with an S-ICD and 2 LPs. The S-ICD was implanted using a Parsonnet pouch in the first 8 subjects. Communication thresholds were measured in three postures up to 18 months. Percent tissue encapsulation of the LP was measured at necropsy and ranged from 6% to 100% (mean: 62%). S-ICD system migration was evaluated radiographically at implant vs. at necropsy in two planes (anterior-posterior and left lateral) and evaluated 0–3 scale: none, minimal, moderate, significant. Communication thresholds were evaluated at 0 vs. 3 days using a t-test and 3 days through 18 months using a linear regression analysis. A repeated measures generalized linear model (GLM) was used to evaluate if test posture, percent tissue encapsulation of the LP, Parsonnet pouch use, or S-ICD system migration (no/ minimal migration vs. moderate/significant migration) were significant predictors of DDC performance at the subject's termination time point. Results DDC was successful for each tested posture and time point for all subjects (n=37), with 355 tests in Left Lateral (LL), 371 tests in Dorsal (D), and 355 tests in Right Lateral (RL). Follow up data are available up to 18 months for 19 subjects at the time of this abstract; additional follow-up data will be added to the analysis for presentation. Communication thresholds decreased between 0 days and 3 days (LL P<0.01, D P<0.01, RL P<0.05) and did not change significantly from 3 days through 18 months (LL P=0.90, D P=0.83, RL P=0.83). The GLM showed that there is no significant difference in communication thresholds for test posture (P=0.24 LL vs. D, P=0.24 RL vs. D), percent tissue encapsulation of the LP (P=0.63), Parsonnet pouch use (P=0.65), or S-ICD system migration (P=0.95). Conclusion Longitudinal studies demonstrate low and stable communication thresholds of a novel mCRM system over time for all three tested postures, regardless of factors such as LP encapsulation, Parsonnet pouch use, or S-ICD system migration. Device Communication Threshold Stability Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Boston Scientific