Pulmonary vein isolation benefits patients with atrial fibrillation vs. sham procedure
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Key takeaways:
- Compared with a sham procedure, pulmonary vein isolation reduced atrial fibrillation burden at 6 months.
- Pulmonary vein isolation was also linked to improved symptoms and quality of life.
Pulmonary vein isolation was associated with genuine improvements in patients with atrial fibrillation at 6 months that cannot be attributed to a placebo effect, researchers reported at the European Society of Cardiology Congress.
“There are an estimated 50,000 AF ablations a year in Europe and 75,000 in the U.S.; however, there are concerns that pulmonary vein isolation, which is a cornerstone for atrial fibrillation ablation, may have a profound placebo effect,” Rajdip Dulai, BSc (Hons), MBBS, MRCP, from the cardiology research department, Eastbourne District General Hospital, East Sussex Hospitals NHS Trust, Saint Leonards-on-Sea, East Sussex, U.K., and the Institute of Cardiovascular Science, University College London, said during a press conference. “Thus, we performed a double-blind, randomized, sham-controlled study in symptomatic AF patients.”
For the investigator-initiated SHAM-PVI trial, simultaneously published in JAMA, Dulai and colleagues randomly assigned 126 patients with symptomatic paroxysmal or persistent AF (mean age, 67 years; 71% men; 20.63% with paroxysmal AF) to pulmonary vein isolation with cryoablation (Arctic Front family of products, Medtronic) or a sham procedure with phrenic nerve pacing.
The primary outcome was AF burden at 6 months, excluding a 3-month blanking period. To assess it, all patients had an implantable loop recorder (Reveal LINQ, Medtronic) inserted at enrollment if they did not have one already.
The absolute mean AF burden change at 6 months was 60.31% in the pulmonary vein isolation and 35% in the sham group (geometric mean difference, 0.25; 95% CI, 0.15-0.42; P < .001), Dulai and colleagues found.
At 6 months, improvement in the overall Atrial Fibrillation Effect on Quality of Life score favored the pulmonary vein isolation group (estimated difference, 18.39 points; 95% CI, 11.38-25.3), as did improvement in the SF-36 general health score (estimated difference, 9.27 points; 95% CI, 3.78-14.76), according to the researchers.
In addition, the Mayo AF‐Specific Symptom Inventory frequency score favored the pulmonary vein isolation group for both frequency and severity of symptoms at 3 and 6 months, Dulai said.
“The results show that pulmonary vein isolation results in a statistically significant and clinically important decrease in AF burden, with substantial improvements in symptoms and quality of life, when compared to a sham procedure,” Dulai said during the press conference. “At 6 months follow-up, the SHAM-PVI study has demonstrated no clinically relevant placebo effect with pulmonary vein isolation.”
Reference:
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Dulai R, et al. Hot line 10. Presented at: European Society of Cardiology Congress; Aug. 30-Sept. 2, 2024; London (hybrid meeting).
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