Background: CLOSE-guided atrial fibrillation (AF) ablation is based on contiguous (intertag distance ≤6 mm), optimized (Ablation Index >550 anteriorly and >400 posteriorly) point-by-point radiofrequency lesions. The optimal radiofrequency power remains unknown. Methods: The POWER-AF study is a prospective, randomized controlled monocentric study including patients with paroxysmal AF, planned for first CLOSE-guided pulmonary vein isolation using a contact force radiofrequency catheter (Thermocool SmartTouch, Biosense Webster, Inc, Irvine, CA). A total of 100 patients were randomized into 2 groups (1:1). The control group received AF ablation using the standard CLOSE protocol (35 W), whereas in the experimental group, pulmonary vein isolation was performed using high power (45 W). Endoscopic evaluation was performed in patients with intraesophageal temperature rise >38.5 °C. Results: The resulting sample size was 96 (48+48) patients. In the high power group, shorter procedure time (80 versus 102 minutes, P <0.001), shorter total radiofrequency application time (16 versus 26 minutes, P <0.001), and radiofrequency time per application (26 versus 37 s anteriorly, P <0.001 and 13 versus 17 s posteriorly, P <0.001) were observed. Endoscopic evaluation (performed in 19/48 versus 25/48 patients respectively, P =0.31) showed an ulcerative perforation in a high power group patient (treated by endoscopic stenting and normalization after ≈4 months) and a superficial ulcerative lesion in a control group patient (conservative treatment). Both occurred following excessive Ablation Index applications (up to 460 and 480, respectively) with excessive contact force (30 g on average, with peaks up to 50 g). Six-months AF recurrence was not significantly different (10% in high power versus 8% in control, P =0.74). Conclusions: This randomized controlled study shows that a 45 W radiofrequency power CLOSE protocol in patients with paroxysmal AF significantly increases the global procedural efficiency with similar midterm efficacy. However, our study showed a narrower safety margin and a limited increased efficiency at the posterior wall using high power. This advocates against the use of high power in the region neighboring the esophagus.
Aims: "CLOSE"-guided pulmonary vein isolation (PVI) is based on contiguous (≤6 mm) and optimized radiofrequency (RF) ablation lesions (ablation index[AI] ≥ 400 posteriorly and ≥ 550 anteriorly]. However, the optimal RF power to reach the desired AI is unknown. Therefore we evaluated the efficiency of an ablation strategy using higher power (40 W) during a first "CLOSE"-guided PVI.Methods: Eighty consecutive patients undergoing "CLOSE"-guided PVI for symptomatic paroxysmal atrial fibrillation were ablated with 40 W (group A). Results were compared with 105 consecutive patients enrolled in the "CLOSE to CURE"-study and were ablated using the same protocol with 35 W (group B). Results:In group A, ablation was associated with shorter ablation procedure time (91 vs 111 minutes; P < .001), shorter fluoroscopy time (5 vs 11 minutes; P < .001), shorter PVI time (48 vs 64 minutes; P < .001), shorter RF time (20 vs 28 minutes; P < .001), lower RF time per application (22 vs 29 seconds; P < .001), less RF applications (52 vs 58; P < .001), and less catheter dislocations (1 vs 2; P = .002). The impedance drop (12 vs 13 Ω; P = .192), first-pass isolation rate (99% vs 93%; P = .141) and acute reconnection rate (6% vs 4%; P > .733) were similar in both groups (groups A and B, respectively). No complications occurred. In group A, a gastroscopy-performed in five patients with esophageal temperature rise more than 42°C-did not reveal any esophageal lesion. Postprocedural recurrence of atrial tachyarrhythmia at 1 year was not significantly different between both groups.Conclusions: Using the "CLOSE"-protocol, increased power increases the efficiency of PVI without compromising patients' safety. K E Y W O R D S atrial fibrillation, contact force, high power ablation, pulmonary vein isolation Maria Kyriakopoulou and Jean-Yves Wielandts contributed equally to this study. a Adenosine test performed in 97 out of 105 patients. F I G U R E 1 Two representative examples of "CLOSE"-guided encirclement of the pulmonary veins (PV) and the radiofrequency parameters (median/median value) of all VISITAG points in one patient from group A (40 W; A) and one patient from group B (35 W; B). Posteroanterior view. Red VISITAG points with ablation index (AI) > 550 and pink VISITAG points with AI > 400. Asterisk (*) on two dislocation points in group B (35 W) 1094 | KYRIAKOPOULOU ET AL.
Aims The aim of this study was to compare procedural efficacy and safety, including 1-year freedom from AF recurrence, between the novel cryoballoon system PolarX (Boston Scientific) and the Arctic Front Advance Pro (AFA-Pro) (Medtronic), in patients with paroxysmal AF undergoing PVI. Methods and results This multicentre prospective observational study included 267 consecutive patients undergoing a first cryoablation procedure for paroxysmal AF (137 PolarX, 130 AFA-Pro). KM curves with the log-rank test was used to compare the 1-year freedom from AF recurrence between both groups. Multivariate Cox model was performed to evaluate whether the type of procedure (PolarX vs. AFA-Pro) had an impact on the occurrence of AF recurrences after adjustment on potentially confounding factors. The PolarX reaches lower temperatures than the AFA-Pro (LSPV 52 ± 5, vs. 59 ± 6; LIPV 49 ± 6 vs. 56 ± 6; right superior pulmonary vein: 49 ± 6 vs. 57 ± 7; right inferior pulmonary vein: 52 ± 6 vs. 59 ± 6; P < 0.0001). A higher rate of transient phrenic nerve palsy was found in patients treated with the PolarX system (15% vs. 7%, P = 0.05). After a mean follow-up of 15 ± 5 months, 20 patients (15%) had recurrences in AFA-Pro group and 27 patients (19%) in PolarX group (P = 0.35). Based on survival analysis, no significant difference was observed between both groups with a 12-month free of recurrence survival of 91.2% (85.1–95.4%) vs. 83.7% (76.0%–89.1%) (log-rank test P = 0.11). In multivariate Cox model hazard ratio of recurrence for PolarX vs. AFA-Pro was not significant [HR = 1.6 (0.9–2.8), P = 0.12]. Conclusion PolarX and AFA-Pro have comparable efficacy and safety profiles for pulmonary veins isolation in paroxysmal atrial fibrillation.
Aims Oesophageal fistula represents a rare but dreadful complication of atrial fibrillation catheter ablation. Data on its incidence, management and outcome are sparse. Methods and results This international multicenter registry investigates the characteristics of oesophageal fistulae after treatment of atrial fibrillation by catheter ablation. A total of 553,729 catheter ablation procedures (radiofrequency: 62.9%, cryoballoon: 36.2%, other modalities: 0.9%) were performed at 214 centers in 35 countries. In 78 centers 138 patients (0.025%, radiofrequency: 0.038%, cryoballoon: 0.0015% (p<0.0001)) were diagnosed with an oesophageal fistula. Periprocedural data were available for 118 patients (85.5%). Following catheter ablation, the median time to symptoms and the median time to diagnosis were 18 (7.75, 25; range: 0-60) days and 21 (15, 29.5; range: 2-63) days, respectively. The median time from symptom onset to oesophageal fistula diagnosis was 3 (1, 9; range: 0-42) days. The most common initial symptom was fever (59.3%). The diagnosis was established by chest computed tomography in 80.2% of patients. Oesophageal surgery was performed in 47.4% and direct endoscopic treatment in 19.8%, and conservative treatment in 32.8% of patients. The overall mortality was 65.8%. Mortality following surgical (51.9%) or endoscopic treatment (56.5%) was significantly lower as compared to conservative management (89.5%) (odds ratio 7.463 (2.414, 23.072) p<0.001). Conclusions Oesophageal fistula after catheter ablation of atrial fibrillation is rare and occurs mostly with the use of radiofrequency energy rather than cryoenergy. Mortality without surgical or endoscopic intervention is exceedingly high.
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