Periprocedural complications other than thermal oesophageal lesions (secondary safety endpoints)
Secondary safety endpoints are shown in table 3. Pericardial tamponade or vascular/groin complications did not occur in any of the therapy groups. One patient within the high-power group reported a transient episode of facial palsy, which resolved within minutes, and did not had any correlations in MR imaging. Discrete pericardial effusion was reported in two patients in the fixed HPSD group. One of these subjects developed Dressler’s syndrome with polyserositis after extensive left-atrial ablation including extensive additional substrate modification with a resulting total RF-delivery-time of 2300 seconds. The symptoms and effusions resolved after 5 days on antiphlogistic treatment. These findings were statistically non-significant.
No steam pops occurred in the delivery of 1706 standard energy and 7462 high-power ablation lesions.
Chest pain was reported frequently after HPSD ablation, mostly described as breath dependant, starting 1-2 days after the procedure, lasting for 1-2 days in most patients. Some of these patients required antiphlogistic medication.