Procedural efficacy and safety of standardized, ablation index guided fixed 50 W high‐power short‐duration pulmonary vein isolation and substrate modification using the CLOSE protocol

Abstract

Introduction Ablation index (AI)‐guided ablation according to the CLOSE protocol is very effective in terms of chronic pulmonary vein isolation (PVI). However, the optimal radiofrequency (RF) power remains controversial. Here, we thought to investigate the efficiency and safety of an AI‐guided fixed circumferential 50 W high‐power short‐duration (HPSD) PVI using the CLOSE protocol. Methods and Results In a single‐center trial, 40 patients underwent randomized PVI using AI‐guided ablation without esophageal temperature monitoring. In 20 patients a CLOSE protocol guided fixed 50 W HPSD was followed irrespective of the anatomical localization. Twenty subjects were treated according to the CLOSE protocol with standard power settings (20 W posterior and 40 W roof and anterior wall). In addition, 80 consecutive patients were treated according to the HPSD protocol to gather additional safety data. All patients underwent postprocedural esophagogastroduodenoscopy to reveal esophageal lesions (EDELs). The mean total procedural time was 80.3 ± 22.5 in HPSD compared to control 109.1 ± 27.4 min (p < .001). The total RF‐time was significantly lower in HPSD with 1379 ± 505 s versus control 2374 ± 619 s (p < .001). There were no differences in periprocedural complications. EDEL occurred in 13% in the HPSD and 10% in the control group. EDEL occurring in the 50 W HSDP patients were smaller, more superficial, and had a faster healing tendency. Conclusion A fixed 50 W HPSD circumferential PVI relying on the AI and CLOSE protocol reduce the total procedure time and the total RF time, without increasing the complication rates. The incidence of EDELs was similar using 50 W at the posterior atrial wall.

Comparison between High-Power Short-Duration and Conventional Ablation Strategy in Atrial Fibrillation: An Updated Meta-Analysis

“…Esophageal injuries correlated with PVI RFA occurred in 3 studies [ 21 , 32 , 37 ], while other 7 studies did not report any PVI-related esophageal injury during or after surgery [ 7 , 8 , 20 , 22 , 25 , 30 , 34 ]. The overall effect did not show statistically differences between HPSD and conventional ablation setting groups on esophageal injuries (RR = 0.99, 95% CI: 0.31-3.13, I 2 = 0%, and P = 0.98) ( Figure 4(a) ).…”

“…Major complications other than esophageal injury were reported in 12 studies [ 7 , 8 , 19 – 23 , 25 , 30 , 32 , 35 , 37 ]. RFA-related major complications in this study were defined as phrenic nerve paralysis, CVA, TIA, cardiac perforations, pericardial tamponade, pericardial effusion, and death during periprocedural period and were clearly attributed to the radiofrequency ablation.…”

Reconnection patterns after CLOSE‐guided 50 W high‐power‐short‐duration circumferential pulmonary vein isolation and substrate modification—PV reconnection might no longer be an issue

“…As shown in our previous works, thermal esophageal lesions (EDELs) occurred in 13% of patients after CLOSE‐guided HPSD (50 W) PVI. EDEL occurring after HPSD ablation were smaller, more superficial, and had a faster healing tendency in comparison to the EDEL revealed in the standard CLOSE group 6 . Predictors for progression of EDEL towards atrio‐esophageal fistula are mostly unknown.…”

“…AF ablations were performed by a standardized approach as previously described 6 : Patients underwent the procedure in deep analgo‐sedation. A single transseptal puncture was guided by fluoroscopy using Abbott Agilis medium curve sheaths and an Abbott BRK needle, followed by ACT‐guided heparin treatment.…”

“…Recently, we have published our own approach for treating both paroxysmal and persistent AF with a fixed 50W-CLOSE-guided ablation. 6 Here, we report patterns of reconnection in patients requiring repeat-ablation for AF, atrial flutter (AFL), or other atrial tachycardia (AT) after previous fixed 50W-HPSD circumferential PVI and additional substrate-tailored left-atrial ablation.…”