Dr. Martin C. Burke
There were 18 suspected or confirmed infections, 14 of which were superficial or incisional infections successfully managed with antibiotics in 13 and sternal wound revision in 1, and 4 cases in which explantation of the device was required.
Inappropriate shocks occurred in 38 patients, 15 with supraventricular tachycardia in the shock-only zone, and 24 patients from oversensing (1 patient had multiple events). No patient had a shock caused by a discrimination error in the conditional shock zone.
Inappropriate shocks were reduced with dual-zone programming, Dr. Burke noted.
The device is currently approved for marketing in Europe (CE Marking) but has not received the Food and Drug Administration’s approval.
The study was funded by Cameron Health, maker of the device. Dr. Burke and his colleagues have received consulting fees, honoraria, and/or research grants from the company. Dr. Calkins reported having no relevant financial disclosures.