(HealthDay News) — A novel, water-resistant patch-wearable cardioverter-defibrillator (P-WCD) is safe and effective for patients at risk for sudden cardiac arrest, according to a study published in the Aug. 6 issue of the Journal of the American College of Cardiology.
John Hummel, MD, from The Ohio State University in Columbus, and colleagues assessed the safety and clinical effectiveness of a novel P-WCD. The analysis included 290 patients at risk for sudden cardiac arrest due to ventricular tachycardia/ventricular fibrillation who were not candidates for or refused an implantable defibrillator.
The researchers found that the clinically significant cutaneous adverse device effect rate was 2.30%, with no severe adverse effects. There were no device-related deaths or serious adverse events reported. The inappropriate shock rate was 0.36 per 100 patient-months. Nine patients received 11 shocks, of which nine shocks were adjudicated to be appropriate. Eight of nine appropriate shocks were successful with a single shock. Median wear time compliance was 23.5 hours per day.
“There were no patient deaths or missed episodes requiring external rescue, and high patient compliance enabled a high number of successful life-saving conversions,” the authors write.
Several authors disclosed ties to medical device companies, including Element Science, which manufactures the studied P-WCD and funded the trial.
