Extravascular Implantable Cardioverter-Defibrillator Efficacy and Safety
Budget: $12 – $30 USD
Abstract: Extravascular Implantable Cardioverter-Defibrillator Efficacy and Safety
A single lead implanted substernally serves as the extravascular implantable cardioverter-defibrillator (ICD) and allows for the same pause-prevention pacing, antitachycardia pacing, and defibrillation energy as transvenous ICDs. Extravascular ICDs' effectiveness and safety are still unknown.
METHODS All of the patients in our prospective, single-group, nonrandomized, premarket global clinical research received an extravascular ICD system and had a class I or IIa indication for an ICD. Successful defibrillation at implantation served as the major efficacy end goal. If the lower bound of the one-sided 97.5% confidence interval for the proportion of patients who successfully underwent defibrillation was more than 88%, the efficacy objective would have been achieved.
A single lead implanted substernally serves as the extravascular implantable cardioverter-defibrillator (ICD) and allows for the same pause-prevention pacing, antitachycardia pacing, and defibrillation energy as transvenous ICDs. Extravascular ICDs' effectiveness and safety are still unknown.
METHODS All of the patients in our prospective, single-group, nonrandomized, premarket global clinical research received an extravascular ICD system and had a class I or IIa indication for an ICD. Successful defibrillation at implantation served as the major efficacy end goal. If the lower bound of the one-sided 97.5% confidence interval for the proportion of patients who successfully underwent defibrillation was more than 88%, the efficacy objective would have been achieved.