The ALSYNC system consists of a deflectable catheter, a preshaped inner catheter, and radiofrequency-powered transseptal puncture guidewire/dilator, enabling a subclavian approach and targeted LVE lead delivery. The primary study objective was to show that the complication rates were less than 30% at 6 months in patients with an implant attempt.
Dr. John M. Morgan
The mean age of the patients in the study was 68 years, 78% were male, and 40% had ischemic disease. Dr. Morgan, a cardiologist at the University of Southampton (England), reported that, at 6 months’ follow-up, LVE pacing was successful in 118 out of 133 (89%) implant attempts. The study objective was met with an observed complication rate of 17.7%, which is comparable to the complication rates of conventional CRT implants, he said.
Based on the study results to date, "there is no unexpected adverse complication rate that bothers us about the procedure in clinical terms," Dr. Morgan said.
Concerns about stroke risk "are unfounded as long as our patients are anticoagulated in order to reduce thromboembolic risk. The ALSYNC study offers the potential for us to use this new tool and this new set of technologies to give cardiac resynchronization to patients who either don’t respond or who are not able to have conventional coronary sinus-placed pacing, and thereby should extend the reach and the benefit of cardiac resynchronization therapy to many patients," he said.
The learning curve for the ALSYNC system, he estimated, is "a few cases" for clinicians who have experience with transeptal puncture procedures. "Most interventional electrophysiologists will have that experience," Dr. Morgan said, but "doctors who implant devices may not. We do have some suggestion from the trial data that the higher-volume implanting centers in the trial were getting faster procedure times."
The study was funded by Medtronic. Dr. Morgan disclosed that he is a paid consultant to the company.