RESULTS
A total of 63 patients underwent PVI using the DT catheter and system. The mean age of the patients was 60.3 ± 11.4 years; 60% male (Table 1). The mean CHA2DS2-VASc score of the subjects was 1,8 ± 1,2. A total of 77.1% of patients were on oral anticoagulation, 6.3% on ASA, and 9.5% did not take any medication at baseline, for details see Table 2.
The procedural characteristics are shown in Table 3. Mean fluoroscopy and procedure times were 9.6 ± 6.6 min and 155 ± 47 min, respectively. The mean number of RF applications per patient was 66.6 ± 24.0 with a mean duration of 17.5 ± 2.4 sec per RF application. A total of 59 PVs were targeted in the 63 patients. Seven patients (10%) underwent additional ablation in addition to PVI (four ablation of cavotricuspid isthmus for typical atrial flutter, two ablation of atypical left atrial flutter and one typical atrio-ventricular nodal tachycardia ablation). The primary effectiveness endpoint of acute PVI was achieved in 100% of targeted PVs. The primary safety endpoint of SAEs or SADEs within 7 days of the procedure occurred in two (2.9%) patients. One patient developed a delayed pericardial effusion 8 h after the procedure which was successfully drained and the patient was discharged. A few weeks later, the same patient returned with recurrent pericardial effusion that was again drained. No further accumulation occurred, and the patient did well in follow-up. The exact etiology of this effusion was unclear. During the procedure, there were no instances of audible pops, and at the end of the procedure, the intracardiac echocardiography catheter was used to document the absence of any pericardial effusion. One patient developed after the procedure, a transient ischemic attack (impairment of vision) with complete resolution and no finding on CT of the brain. Seven patients developed AEs, six pseudoaneurysm of femoral vein, one patient had single orthostatic syncope day after procedure. During follow-up, two patients suffered from back pain with complete resolution, see Table 4. Two months following the ablation procedure, 1 patient died; a post-mortem examination indicated that the cause of death was systolic heart failure related to coronary artery disease. This was adjudicated to be unrelated to either the procedure or study catheter.
As previously reported, subgroup of 23 patients from one center were scheduled for a second PV remapping procedure at ~3 months. Out of those, 8 patients underwent reisolation of PVs due to reconnections (15). These eight reablated patients were excluded from the evaluation of 12-month efficacy. In the surviving 62 patients (without one deceased patient) the freedom from AF at 12 months was 74.2%. Of the whole group of 62 patients 29 patients were totally without antiarrhytmic therapy and 18 were remaining on class I or class III AADs. A total of 25 patients used betablocker, for details see Table 2.