Stereotaxis this week announced positive outcomes of an independent study assessing its robotic cardiac ablation system in pediatric patients.
The St. Louis-based company’s robotic technology demonstrated superior safety and efficacy in treating atrioventricular reentry tachycardia (AVRT) and atrioventricular nodal reentry tachycardia (AVNRT) in pediatric patients who had heart rhythm disease.
The independent study enrolled 223 patients and was conducted at Erasmus Medical Center in Rotterdam, the Netherlands. It compared robotic magnetic navigation (RMN) guided cardiac ablation to manual radiofrequency (RF) ablation and manual cryoablation.
“We are excited to share data from this large long-term comparative study,” study author Anne-Marie Noten said in a news release. “It builds upon the significant body of evidence supporting the clinical value of robotics for arrhythmia patients, particularly the most vulnerable patients with complex disease.”
AV(N)RTs can cause abnormally fast heartbeats and are the most common supraventricular tachyarrhythmias (SVT) in children without structural heart disease. The primary endpoint of the study was long-term freedom from arrhythmia recurrence with a mean follow-up time of 5.5 years.
The median age of study participants was 14 years. Patients treated with RMN had 94.4% freedom from arrhythmia recurrence through long-term follow-up. In comparison, patients treated with manual RF ablation or cryoablation had 85.5% and 59% freedom, respectively.
“Particularly in small hearts, the flexibility and versatility of a magnetic catheter with Stereotaxis allows us to perform cardiac ablation without being limited to fixed, pre-defined curves,” Dr. Tamas Szili-Torok, cardiac electrophysiologist and associate professor at Erasmus Medical Center, said in the news release. “The stability and precision of robotics enables us to provide the best care for our patients. We are proud to advance the frontiers of patient care and the scientific knowledge in electrophysiology, particularly when we can improve the health of children we are entrusted to treat.”
Results were published in the International Journal of Cardiology: Heart & Vascular.