Man vs. machine: A fair match when it comes to cardiac ablation

Whether guided by robotic navigation (RN) or the hands of a physician, catheter ablations demonstrated comparable results in a study of 258 patients treated for atrial fibrillation (AFib). The RN procedures took, on average, 11 minutes longer.

Two high-volume ablation centers in Germany and one in Texas participated in the trial, which randomized the patient population and designated each individual for RN or manual circumferential pulmonary vein isolation (PVI). Physicians treated 131 patients via the RN method and 127 manually, with both groups sharing similar baseline characteristics.

The research team, led by Andreas Rillig of the cardiology department at Asklepios Klinik St. Georg in Hamburg, Germany, attempted to eliminate learning curve issues by using sites that had already performed at least 50 RN-guided PVIs. Results were published in JACC: Clinical Electrophysiology.

Among the 247 patients who completed the one-year follow-up, recurrence rates were 23.6 percent in the RN group and 20.2 percent in the manual group, a level of significance for noninferiority. The incidence of procedure-related major complications didn’t differ significantly between the two groups, although one patient from the RN group developed a fatal atrioesophageal fistula.

Rillig and colleagues noted a limitation of their study: It only included patients with paroxysmal AFib or persistent AFib not lasting longer than two months, therefore excluding patients at higher risk for recurrence.

“This randomized multicenter study confirms that the success rate using RNS is noninferior to a manual ablation approach in experienced centers after a 12-month FU (follow-up) period,” Rillig et al. wrote. “Advances in catheter ablation are needed to further improve success rate in atrial fibrillation treatment. According to our findings, robotic navigation might be an opportunity to optimize atrial fibrillation ablation in the future.”

A Cleveland Clinic doctor remains skeptical. Simply being “noninferior” shouldn’t be enough to move the needle, Bruce D. Lindsay, MD, wrote in an accompanying editorial.

“In an era that demands cost-effective delivery of health care, it is difficult to justify the purchase or continued use of a system that adds to the cost of care without improving outcomes or saving time,” wrote Lindsay, who specializes in cardiac electrophysiology and pacing. “Although there are legitimate reasons why trials are designed to demonstrate noninferiority, the real objective of new and expensive technologies is to be superior. Why else would you buy them?”