News: PVI outperforms sham procedures in new AF study

A new study published in JAMA Open Network suggests that pulmonary vein isolation (PVI) procedures result in “significant and clinically important” decreases in symptomatic atrial fibrillation (AF) patients, according to Medscape.

The study conducted a randomized trial of 126 patients with symptomatic AF, seeking to determine whether PVI procedures are “more effective than […] sham procedure[s]” for improving clinical outcomes.

The report concluded by arguing that “[p]ulmonary vein isolation resulted in a statistically significant and clinically important decrease[s] in atrial fibrillation burden at 6 months, with substantial improvements in symptoms and quality of life, compared with a sham procedure.”

Despite the relative successes of the study, there remain some unanswered questions. Among them, for instance, are questions related to the proper introduction of placebos, patient selection, and the choice of sham procedure types for comparison.

“The SHAM-PVI investigators and patients deserve our respect. Doing this experiment more than 20 years into our AF ablation experience, and in the face of great enthusiasm to increase the number of these lucrative procedures, was bold and brave,” according to Medscape. “They have shown that, indeed, there is a placebo-resistant effect of PVI. But the nuances of this trial leave important questions.”

Editor’s note: To read the Medscape coverage, click here. To read the JAMA Open Network study, click here.