Key result
An esophageal temperature-guided safety algorithm for high-intensity focused ultrasound failed to prevent lethal complications, including one atrial-to-esophageal fistula and one unexplained death.
Why the study?
Does an esophageal temperature-guided safety algorithm prevent severe complications during high-intensity focused ultrasound for pulmonary vein isolation in patients with atrial fibrillation?
Observational (n=28)
Does an esophageal temperature-guided safety algorithm prevent severe complications during high-intensity focused ultrasound for pulmonary vein isolation in patients with atrial fibrillation?
An esophageal temperature-guided safety algorithm failed to prevent lethal complications during HIFU for PVI, indicating the technology currently does not meet safety standards for AF treatment.
Esophageal temperature monitoring may not avert fatal HIFU complications; leaves open whether alternative energies or protocols can achieve safe PVI.
BACKGROUND: High-intensity focused ultrasound (HIFU) can achieve pulmonary vein isolation (PVI), but there are safety concerns after severe complications. Therefore, we evaluated an esophageal temperature (ET)-guided safety algorithm to apply HIFU safely. METHODS AND RESULTS: After standard left atrial access, HIFU was repeatedly applied until PVI was complete. A safety algorithm was used: <or=3 complete ablations per pulmonary vein (PV), early abortion when no effect after 50%of programmed time or when ET was >or=40.0 degrees C, use of power modulation (PM) at ET 39.0 degrees C: to reduce ablation temperature in surrounding tissue, acoustic power is switched on/off at 1 Hz; in all first ablations, use of PM after 50% of programmed time. Touch-up radiofrequency ablation was used when PVI failed. Periprocedural ET monitoring and endoscopy 2 days after ablation were performed. Twenty-eight patients (18 males; mean age at enrollment, 63 years), with paroxysmal atrial fibrillation (AF; n=19) and persistent AF (n=9) were included. In 84 of 109 PV (9 of 25 patients), PVI was achieved using HIFU only. In 9 of 109 PV, HIFU was aborted because of high ET. Mean ET at the end of the ablations with and without use of PM were 38.1+/-2.0 degrees C and 37.4+/-1.0 degrees C (P=0.0002). During endoscopy in 2 of 26 patients, a small thermal lesion was found. Other complications included 2 persistent phrenic nerve palsies, 1 ischemic stroke, 1 pericardial effusion 48 days after ablation, 1 unexplained death 49 days after ablation, and 1 lethal atrial-to-esophageal fistula 31 days after ablation. CONCLUSIONS: The safety algorithm failed to prevent lethal complications. Currently HIFU does not meet the safety standards required for treatment of atrial fibrillation.
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Neven et al. (2010) conducted an observational in Atrial fibrillation (n=28). High-intensity focused ultrasound (HIFU) with esophageal temperature-guided safety algorithm was evaluated on Safety and complications. An esophageal temperature-guided safety algorithm for high-intensity focused ultrasound failed to prevent lethal complications, including one atrial-to-esophageal fistula and one unexplained death.
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