Safety and Performance of the Subcutaneous Implantable Cardioverter Defibrillator Detection Algorithm INSIGHTTM in Pacemaker Patients

BACKGROUND: The use of the S-ICD is limited by its inability to provide backup pacing. Combined use of the S-ICD with a pacemaker may be a good choice in certain situations, yet current experience concerning the compatibility is limited. The goal of this study was to determine the safety and efficacy of the S-ICD in patients with a pacemaker. METHODS: A total of 74 consecutive patients with a bipolar pacemaker were prospectively enrolled. First, surface rhythm strips were recorded in all possible pacemaker stimulation modes, to screen for T-wave oversensing (TWOS). Second, a S-ICD functional dummy was placed epicutaneously on the patient in the typical implant position. The same standardized pacing protocol was used as mentioned above, and every stimulation mode was recorded via S-ECG in all vectors. RESULTS: In 16 patients (21.6%), programmed stimulation would have led to VT/VF detection. Triggered episodes were due to counting of the pacing spike(s), QRS complex, premature ventricular contractions, and/or additional TWOS. Three cases triggered in the bipolar stimulation mode. Oversensing was associated with lung emphysema and a reduced QRS amplitude in the S-ECG. CONCLUSION: The combination of an S-ICD and a pacemaker may lead to inadequate shock delivery due to oversensing, even under programmed bipolar stimulation. Oversensing cannot be sufficiently predicted by the screening tool in pacemaker patients. Testing with an epicutaneous S-ICD dummy in all vectors and stimulation settings is recommended in patients with pre-existing pacemakers.