1. Time-to-isolation-guided cryoballoon ablation reduces oesophageal and mediastinal alterations detected by endoscopic ultrasound: results of the MADE-PVI trial.
- Author
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Cordes F, Ellermann C, Dechering DG, Frommeyer G, Kochhäuser S, Lange PS, Pott C, Lenze F, Schmidt H, Ullerich H, and Eckardt L
- Subjects
- Adult, Aged, Aged, 80 and over, Atrial Fibrillation physiopathology, Edema diagnostic imaging, Edema epidemiology, Endoscopy, Digestive System, Endosonography, Esophageal Diseases diagnostic imaging, Esophageal Fistula, Female, Heart Atria, Heart Diseases, Humans, Male, Mediastinal Diseases diagnostic imaging, Middle Aged, Postoperative Complications diagnostic imaging, Pulmonary Veins physiopathology, Time Factors, Ulcer diagnostic imaging, Ulcer epidemiology, Atrial Fibrillation surgery, Cryosurgery methods, Esophageal Diseases epidemiology, Mediastinal Diseases epidemiology, Postoperative Complications epidemiology, Pulmonary Veins surgery
- Abstract
Aims: Cryoballoon ablation is safe and efficient for achieving pulmonary vein isolation (PVI) in atrial fibrillation. Structural oesophago-mediastinal lesions, which seem to be associated with an increased risk of the lethal complication of an atrio-oesophageal fistula, have been described. MADE-PVI (Mediastino-oesophageal Alterations Detected by Endosonography after PVI) aimed at evaluating safety of cryoballoon PVI in relation to two different freeze protocols. As time-to-isolation-(TTI)-guided protocol has been reported to be as effective as conventional 'two freeze protocol', we hypothesized a TTI-guided protocol causes less oesophago-mediastinal lesions., Methods and Results: Seventy consecutive patients were scheduled for cryoballoon (2nd generation) PVI employing either a conventional protocol (n = 35: 2 × 180 s per vein) or a TTI-guided approach (n = 35: TTI + 120 s per vein or 1 × 180 s in case TTI could not be measured). Oesophagogastroduodenoscopy and endoscopic ultrasound, assessing oesophago-mediastinal alterations (e.g. ulceration, oedema) were performed blinded prior and post-ablation. Post-interventional mediastinal oedematous alterations were detected in 70% with a mean diameter of 14 mm (±0.9 mm), while only 15% revealed large mediastinal oedema >20 mm. Oesophageal lesions due to PVI occurred in 5%. Freeze protocols had a distinct impact on oesophago-mediastinal alterations as mean diameter and frequency of large oedema were significantly increased in patients after conventional protocol PVI (17 mm vs. 11 mm; 26% vs. 6%). Furthermore, every oesophageal lesion was detected in patients with conventional protocol (9%). No major complication occurred in either group., Conclusion: The present prospective study demonstrates a significant impact of freeze protocol on oesophago-mediastinal alterations. A TTI-guided protocol reduces mediastino-oesophageal lesions and may reduce short- and long-term complications of cryoballoon PVI., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)
- Published
- 2019
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