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ALSYNC: Alternate site benefited patients with HF needing CRT
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SAN FRANCISCO — Some patients unable to receive or benefit from traditional cardiac resynchronization therapy achieved successful left ventricular endocardial pacing delivered via a novel atrial transseptal system, according to findings presented at the Heart Rhythm Society Annual Scientific Sessions.
Approximately 10% of patients with HF indicated for CRT pacing fail the implantation procedures because of issues related to the coronary sinus, and approximately one-third of those who receive the implant fail to respond, John M. Morgan, MD, from the University of Southampton, United Kingdom, said at a press conference.
“The difficulty with conventional coronary sinus pacing is that we are limited, and always will be, by coronary sinus anatomy,” Morgan said. “But with the ability to get to the inside of the left ventricle, we have the landscape of the left ventricle to choose the most appropriate pacing site. The downside of this technique is that it is perhaps technically more challenging, so we need good tools to do that.”
Researchers enrolled 138 patients in ALSYNC, a nonrandomized, prospective study that evaluated the safety and efficacy of LV endocardial pacing using a Model 3830 lead delivered using a novel atrial transseptal system (Alsync, Medtronic). Seventy-eight percent of patients had experienced a failed prior implant and 22% did not respond to the implant. The primary objective for 6-month follow-up was a complication rate <30%; follow-up will continue to 12 months.
Potential risks of the procedure include LV clots and impedance of the mitral valve, Morgan said, but 6-month results “suggest that those concerns are so far unfounded, as long as our patients are anticoagulated in order to reduce thromboembolic risk.”
The procedure was successful in 89% of patients, and 82% were free from events at 6 months, Morgan said. There were two strokes, one of which the researchers attributed to suboptimal anticoagulation, four transient ischemic attacks, and 10 deaths, nine of which were unrelated to the implant procedure.
Clinical benefits at 6 months included a ≥15% relative reduction in LV end-systolic volume in 55% of patients, a ≥5% absolute increase in LV ejection fraction in 64% of patients and improvement in NYHA class in 60% of patients, Morgan said.
“The ALSYNC study offers us the potential to use this new set of technologies to give cardiac resynchronization therapy for patients who either don’t respond or were unable to have coronary sinus-based pacing, and thereby should extend the reach and the benefit of cardiac resynchronization therapy to many patients and indications,” he said. – by Erik Swain
For more information:
Morgan JM. LB02-05. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 7-10, 2014; San Francisco.
Disclosure: The study was funded by Medtronic. Morgan reports consulting for Medtronic, speaking for Boston Scientific and Soren Group, receiving research grants from Boston Scientific, Medtronic and St. Jude Medical, and receiving fellowship support from Medtronic.
Perspective
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Andrea M. Russo, MD, FACC, FHRS
This device is another way to provide cardiac resynchronization therapy in patients who had failed coronary sinus lead placement or had a prior poor response to CRT therapy. Perhaps these patients did not have a good branch in the coronary sinus or the effort was otherwise limited by coronary sinus anatomy: there may be one branch that was too small to allow insertion of a coronary sinus lead, or perhaps the branch wasn't in a good location. This new technology gives you another option to treat patients with refractory congestive HF by putting a lead into the left ventricular endocardium. It is currently unclear whether or not an LV endocardial lead will perform as well, or even better in the long term than a coronary sinus lead, and we'll need more data to determine this in the future.
The new data looks reasonably good according to this preliminary investigation. However, we need to have more long-term information on complication rates and clinical benefits. With these technologies, you need to make sure that the implanting centers have good training to reduce risks for procedural complications.
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