Cardiovascular Implantable Electronic Devices -> Bradycardia Devices: -> Device Technology D-AB05 - Leadless Pacing: What's Up? (ID 17) Abstract Plus

D-AB05-06 - Safety And Feasibility Of Leadless Pacemaker For Cardio Inhibitory Vasovagal Syncope (ID 763)


Background: Single chamber leadless pacemakers (LP) have been shown to be an effective alternative to conventional transvenous pacemakers (CTP), but their benefit within the context of cardioinhibitory vasovagal syncope (CI-VVS) is unknown.
Objective: To assess the safety and feasibility of LP compared with CTP for CI-VVS
Methods: We conducted a multicenter, retrospective study of patients who received LP or dual-chamber-CTP for CI-VVS between January 1, 2014 and October 31, 2018. CI-VVS was diagnosed clinically supported by cardiac monitoring (Holter/event/implantable loop recorders) and tilt table testing. The primary efficacy end points were acceptable sensing (R-wave amplitude ≥5.0 mV) and pacing thresholds (≤2.0V@0.4 ms) at follow up. Safety endpoints included device-related major (early ≤1 month, late >1 month) and minor adverse events (AE).
Results: A total of 72 patients (LP=24 vs CTP=48) with age 32±5.5 years, 90% female and frequency of syncope of 7.6±3.4/year were included. 91.6% (22/24) of the LP-group and 97.9% (47/48) of the CTP-group met primary efficacy endpoint (p=0.4). Early major AE occurred in 2/24 (loss of pacing/sensing) in the LP-group and 3/48 (1-lead dislodgement, 1-pneumothorax, 1-pocket hematoma) in the CTP-group (P=0.4). Late major AE occurred in 0/24 and 2/48 (upper extremity DVT) in the LP and CTP groups (p=1.0). Minor AE was noted in 1 (groin hematoma) in LP-group and 3 (≥moderate TR) in the CTP-group. At 1-year, mean pacing % was 1.9±0.86 vs 1.9±0.87 (p=1.0) and 91% (22/24) and 93.7% (43/48) were free of symptoms in the LP and CTP groups.
Conclusion: Our results demonstrate the feasibility and safety of LP as a treatment option of cardioinhibitory vasovagal syncope.