D-AB05-01 - Device-device Communication Stability Of Leadless Anti-tachycardia Pacemaker And Subcutaneous Implantable Cardioverter Defibrillator Over 18 Months (ID 760)
Background: A 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).
Objective: To investigate long-term DDC performance of linked S-ICD to LP (mCRM System) and factors that impact DDC performance.
Methods: The mCRM System (Boston Scientific) 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 8 subjects. Communication thresholds (CTs) were measured in three postures up to 18 months (mo). LP percent tissue encapsulation (PTE) was measured at necropsy and ranged 6% - 100% (mean: 62%). CTs at 0 vs. 3 days (d) were evaluated using a t-test and 3 d through 18 mo using a linear regression analysis. A repeated measures generalized linear model (GLM) was used to evaluate if test posture, PTE or pouch use were significant predictors of CT performance.
Results: DDC was successful for each tested posture and time point for all subjects (n=37; n=355 tests in left lateral, n=371 tests in dorsal, n=355 tests in right lateral). CTs decreased 0 vs. 3 d (left lateral p<0.01, dorsal p<0.01, right lateral p<0.05) and did not change significantly 3d through 18 mo. The GLM showed that there is no significant difference in CTs for test posture (p=0.24 left lateral vs. dorsal, p=0.24 right lateral vs. dorsal), pouch use (p=0.62) or PTE (p=0.63).
Conclusion: Longitudinal studies demonstrate low and stable communication thresholds over time for all three tested postures, regardless of factors such as LP encapsulation or pouch use.