OBJECTIVES: The purpose of this study was to evaluate potential interference between the Pill-cam video-capsule and implanted cardio-defibrillators (ICD) in both in vitro and in vivo test environments. METHODS: Phase I consisted of in vitro testing utilized 6 ICD models. Each was placed in a saline gel bath in conjunction with a tool designed to emit the same wave length as the Pill-Cam (the Test Cap). Tests were performed at both the manufacturer's nominal and most sensitive settings with the test probe placed at 1, 5, 10, and 15 cm from three different points. There were emissions of 10-, 30-, and 60- second duration at each location. Phase II was the in vivo study utilizing patients with implanted ICDs for standard clinical reasons who were undergoing evaluation with the Test Cap. RESULTS: In Phase I, 864 tests were performed involving the 6 ICDs. There was totally normal behavior in 5 of the devices. The Biotronik Belos (Berlin, Germany) demonstrated oversensing and delivery of inappropriate therapy. In phase II, 6 patients underwent a total number of 288 tests (48 in each patient). There were 4 men and 2 women, mean age 61 (33-77) and none demonstrated any adverse interactions. CONCLUSIONS: In patients with devices identical to those evaluated that showed no interference, the use of the Pill-Cam is safe. However, in patients with a Biotronik Belos ICD (or any other nontested ICD) the use of the Pill-Cam should be done only in-hospital, after suspended ICD therapy and in conjunction with close monitoring.
OBJECTIVES: The purpose of this study was to evaluate potential interference between the Pill-cam video-capsule and implanted cardio-defibrillators (ICD) in both in vitro and in vivo test environments. METHODS: Phase I consisted of in vitro testing utilized 6 ICD models. Each was placed in a saline gel bath in conjunction with a tool designed to emit the same wave length as the Pill-Cam (the Test Cap). Tests were performed at both the manufacturer's nominal and most sensitive settings with the test probe placed at 1, 5, 10, and 15 cm from three different points. There were emissions of 10-, 30-, and 60- second duration at each location. Phase II was the in vivo study utilizing patients with implanted ICDs for standard clinical reasons who were undergoing evaluation with the Test Cap. RESULTS: In Phase I, 864 tests were performed involving the 6 ICDs. There was totally normal behavior in 5 of the devices. The Biotronik Belos (Berlin, Germany) demonstrated oversensing and delivery of inappropriate therapy. In phase II, 6 patients underwent a total number of 288 tests (48 in each patient). There were 4 men and 2 women, mean age 61 (33-77) and none demonstrated any adverse interactions. CONCLUSIONS: In patients with devices identical to those evaluated that showed no interference, the use of the Pill-Cam is safe. However, in patients with a Biotronik Belos ICD (or any other nontested ICD) the use of the Pill-Cam should be done only in-hospital, after suspended ICD therapy and in conjunction with close monitoring.