A new water-resistant patch, designed as a wearable cardioverter-defibrillator (P-WCD), has been proven safe and effective for people at risk of sudden cardiac arrest. This information comes from a study published in the August 6 issue of the Journal of the American College of Cardiology.
The study, led by Dr. John Hummel from The Ohio State University, examined the safety and effectiveness of this innovative P-WCD. Involving 290 patients who were at risk of sudden cardiac arrest due to serious heart rhythm problems but were not suitable for or did not want an implanted defibrillator, the study yielded promising results.
The study found that only 2.30 percent of the patients experienced mild skin problems from the device, with no severe adverse effects reported. Importantly, there were no deaths or serious issues caused by the device. The rate of inappropriate shocks was very low, at 0.36 per 100 patient-months. Nine patients received 11 shocks, and nine of these were deemed appropriate. Eight out of nine appropriate shocks successfully restored normal heart rhythm with just one shock. Patients wore the device for a median of 23.5 hours per day, showing high compliance.
The authors emphasized, “There were no patient deaths or missed episodes requiring external rescue, and high patient compliance enabled a high number of successful life-saving conversions.”
Several authors of the study disclosed financial ties to medical device companies, including Element Science, the manufacturer of the P-WCD, which also funded the trial.
Sudden Cardiac Arrest (SCA) occurs when the heart suddenly stops beating due to an electrical malfunction. This condition is life-threatening because it stops blood flow to the brain and other vital organs. Causes include heart disease, heart attack, or other heart conditions. Symptoms include sudden collapse, no pulse, no breathing, and loss of consciousness. Immediate treatment involves CPR and defibrillation, which can be provided by devices like the P-WCD. Long-term management includes medications, lifestyle changes, and devices like implantable cardioverter-defibrillators (ICDs).
Key Insights:
- The P-WCD is effective in preventing sudden cardiac arrest in high-risk patients.
- The device caused minimal adverse skin reactions.
- High patient compliance was observed, with an average wear time of 23.5 hours per day.
- The device delivered successful life-saving shocks in most appropriate cases.
- No serious adverse effects or device-related deaths occurred.
Source:
Journal of the American College of Cardiology