Pulmonary vein isolation using ablation index vs. CLOSE protocol with a surround flow ablation catheter

EP Europace ◽  
2019 ◽  
Vol 22 (1) ◽  
pp. 84-89 ◽  
Author(s):  
Benjamin Berte ◽  
Gabriella Hilfiker ◽  
Federico Moccetti ◽  
Thomas Schefer ◽  
Vanessa Weberndörfer ◽  
...  

Abstract Aims Pulmonary vein isolation (PVI) using ablation index (AI) incorporates stability, contact force (CF), time, and power. The CLOSE protocol combines AI and ≤6 mm interlesion distance. Safety concerns are raised about surround flow ablation catheters (STSF). To compare safety and effectiveness of an atrial fibrillation (AF) ablation strategy using AI vs. CLOSE protocol using STSF. Methods and results First cluster was treated using AI and second cluster using CLOSE. Procedural data, safety, and recurrence of any atrial tachycardia (AT) or AF >30 s were collected prospectively. All Classes 1c and III anti-arrhythmic drugs (AAD) were stopped after the blanking period. In total, all 215 consecutive patients [AI: 121 (paroxysmal: n = 97), CLOSE: n = 94 (paroxysmal: n = 74)] were included. Pulmonary vein isolation was reached in all in similar procedure duration (CLOSE: 107 ± 25 vs. AI: 102 ± 24 min; P = 0.1) and similar radiofrequency time (CLOSE: 36 ± 11 vs. AI: 37 ± 8 min; P = 0.4) but first pass isolation was higher in CLOSE vs. AI [left veins: 90% vs. 80%; P < 0.05 and right veins: 84% vs. 73%; P < 0.05]. Twelve-month off-AAD freedom of AF/AT was higher in CLOSE vs. AI [79% (paroxysmal: 85%) vs. 64% (paroxysmal: 68%); P < 0.05]. Only four patients (2%) without recurrence were on AAD during follow-up. Major complications were similar (CLOSE: 2.1% vs. AI: 2.5%; P = 0.87). Conclusion The CLOSE protocol is more effective than a PVI approach solely using AI, especially in paroxysmal AF. In this off-AAD study, 79% of patients were free from AF/AT during 12-month follow-up. The STSF catheter appears to be safe using conventional CLOSE targets.

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
D De Campos ◽  
L Puga ◽  
P Sousa ◽  
N Antonio ◽  
L Elvas

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Ablation Index (AI) software has been associated with better freedom from atrial arrhythmias after pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (AF). There is conflicting data regarding the relationship between high sensitivity cardiac Troponin I (Hs-cTnI) and arrhythmia recurrence. The objective was to evaluate the impact of AI on Hs-cTnI level and on ablation effectiveness quotient (AEQ) and to assess if these markers are predictors of arrhythmia recurrence.  Methods Prospective observational study of consecutive patients referred for PVI for paroxysmal AF ablation from October 2017 to June 2018 according to a pre-specified AI protocol. Procedural endpoints and 2-year follow-up outcomes were assessed and compared to a retrospective cohort of conventional PVI contact-force-guided group .  Results A total of 56 patients were included: 29 patients the AI group and 27 patients in the control group. The mean age was 60.5 ± 10.3 years, 48% males. Left ventricular ejection fraction (60 ± 6 % AI vs 61 ± 5 % control, P = 0.07) and left atrium diameter (43 ± 7 mm AI vs 44 ± 6 mm control, P = 0.58) were comparable between groups. First-pass isolation was shown to be higher in the AI group (79% AI vs 44%, p= 0.01). Mean number of radiofrequency applications was lower in the AI group (93 ± 24 vs 111 ± 30, P = 0.02). Average contact-force was similar between groups (17.6 ± 4.1 g vs 22.6 ± 10.7 g, P =0.166). Patients that performed PVI guided by the AI had lower Hs-cTnI (1815 ± 1146 ng/L vs 3274 ± 1696 ng/L, p < 0.001) and lower AEQ (1.01 ± 0.7 ng/L/s vs 1.51 ± 0.7 ng/L/s, P = 0.011) compared to patients in the control group. During a mean follow-up of 26 ± 11 months, AF recurrence was documented in 10.3% of patients in the AI group and 22.2% in the control group (P = 0.223). Neither Hs-cTnI nor AEQ levels were predictors of arrhythmia recurrence.  Conclusions These data suggest that AI-guided catheter ablation is associated with reduced levels of of Hs-cTnI and AEQ. Neither Hs-cTnI and AEQ should be used to predict arrhythmia recurrence. Abstract Figure.


Author(s):  
Subbarao Choudry ◽  
Moussa Mansour ◽  
Sri Sundaram ◽  
Duy T. Nguyen ◽  
Srinivas R. Dukkipati ◽  
...  

Background: Pulmonary vein isolation is insufficient to treat all patients with persistent atrial fibrillation (AF), and effective adjunctive ablation strategies are needed. Ablation of AF drivers holds promise, but current technologies to identify drivers are limited by spatial resolution. In a single-arm, first-in-human, investigator-initiated Food and Drug Administration Investigational Device Exemption study, we used a novel system for real-time, high-resolution identification of AF drivers in persistent AF. Methods: Patients with persistent or long-standing persistent AF underwent ablation using the RADAR (Real-Time Electrogram Analysis for Drivers of Atrial Fibrillation) system in conjunction with a standard electroanatomical mapping system. After pulmonary vein isolation, electrogram and spatial information was streamed to the RADAR system and analyzed to identify driver domains to target for ablation. Results: Across 4 centers, 64 subjects were enrolled: 73% male, age, 64.7±9.5 years; body mass index, 31.7±6.0 kg/m 2 ; left atrium size, 54±10 mm, with persistent/long-standing persistent AF in 53 (83%)/11 (17%), prior AF ablation (re-do group) in 26 (41%). After 12.6±0.8 months follow-up, 68% remained AF-free off all antiarrhythmics; 74% remained AF-free and 66% remained AF/atrial tachycardia/atrial flutter-free on or off AADs (antiarrhythmic drugs). AF terminated with ablation in 35 patients (55%) overall and in 23/38 (61%) of de novo ablation patients. For patients with AF termination during ablation, 82% remained AF-free and 74% AF/atrial tachycardia/atrial flutter-free during follow-up on or off AADs. Patients undergoing first-time ablation generally had higher rates of freedom from AF than the re-do group. Conclusions: This novel technology for panoramic mapping of AF drivers showed promising results in a persistent/long-standing persistent AF population. These data provide the scientific basis for a randomized trial. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03263702; IDE#G170049.


Heart Rhythm ◽  
2021 ◽  
Vol 18 (8) ◽  
pp. S125-S126
Author(s):  
Takashi Yamasaki ◽  
Tetsuhisa Hattori Keisuke Ohta ◽  
Nobuyuki Miyai, Reo Nakamura ◽  
Takayoshi Sawanishi Noriyuki Kinosita ◽  
Ken Kakita

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Di Cori ◽  
L Segreti ◽  
G Zucchelli ◽  
S Viani ◽  
F Tarasco ◽  
...  

Abstract Background Contact force catheter ablation is the gold standard for treatment of atrial fibrillation (AF). Local tissue impedance (LI) evaluation has been recently studied to evaluate lesion formation during radiofrequency ablation. Purpose Aim of the study was to assess the outcomes of an irrigated catether with LI alghorithm compared to contact force (CF)-sensing catheters in the treatment of symptomatic AF. Methods A prospective, single-center, nonrandomized study was conducted, to compare outcomes between CF-AF ablation (Group 1) and LI-AF ablation (Group 2). For Group 1 ablation was performed using the Carto 3© System with the SmartTouch SF catheter and, as ablation target, an ablation index value of 500 anterior and 400 posterior. For Group 2, ablation was performed using the Rhythmia™ System with novel ablation catheter with a dedicated algorithm (DirectSense) used to measure LI at the distal electrode of this catheter. An absolute impedance drop greater than 20Ω was used at each targeted. According to the Close Protocol, ablation included a point by point pulmonary vein isolation (PVI) with an Inter-lesion space ≤5 mm in both Groups. Procedural endpoint was PVI, with confirmed bidirectional block. Results A total of 116 patients were enrolled, 59 patients in Group 1 (CF) and 57 in Group 2 (LI), 65 (63%) with a paroxismal AF and 36 (37%) with a persistent AF. Baseline patients features were not different between groups (P=ns). LI-Group showed a comparable procedural time (180±89 vs 180±56, P=0.59) but with a longer fluoroscopy time (20±12 vs 13±9 min, P=0.002). Wide antral isolation was more often observed in CF-Group (95% vs 80%, P=0.022), while LI-Group 2 required frequently additional right or left carina ablation (28% vs 14%, P=0.013). The mean LI was 106±14Ω prior to ablation and 92.5±11Ω after ablation (mean LI drop of 13.5±8Ω) during a median RF time of 26 [19–34] sec for each ablation spot. No steam pops or complications during the procedures were reported. The acute procedural success was 100%, with all PVs successfully isolated in all study patients. Regarding safety, only minor vascular complications were observed (5%), without differences between groups (p=0.97). During follow up, 9-month freedom from atrial fibrillation/atrial flutter/atrial tachycardia recurrence was 86% in Group 1 and 75% in Group 2 (P=0.2). Conclusions An LI-guided PV ablation strategy seems to be safe and effective, with acute and mid-term outcomes comparable to the current contact force strategy. LI monitoring could be a promising complementary parameter to evaluate not only wall contact but also lesion formation during power delivery. Procedural Outcomes Funding Acknowledgement Type of funding source: None


2011 ◽  
Vol 141 (6) ◽  
pp. 1455-1460 ◽  
Author(s):  
Yoshiharu Soga ◽  
Hitoshi Okabayashi ◽  
Yoshio Arai ◽  
Takuya Nomoto ◽  
Jota Nakano ◽  
...  

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
B Schmidt ◽  
S Tohoku ◽  
S Bordignon ◽  
S Chen ◽  
S Zanchi ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): CardioFocus Background The endoscopic ablation system (EAS) is an established ablation device for pulmonary vein isolation (PVI) in patients with paroxysmal and persistent atrial fibrillation (AF). In randomized studies, however, point-by-point laser ablation resulted in longer procedure times. The novel X3 EAS is now equipped with a motor driven laser generator that sweeps the diode laser beam around the individual PV ostium at a pre-defined speed (2.25°/sec) thus allowing for contiguous circumferential ablation (RAPID mode).  Purpose To determine the feasibility of single sweep ablation using the new X3 EAS. Methods Consecutive AF patients were enrolled. After single transseptal puncture selective PV angiographies were performed. A 3D enabled circular mapping catheter was used to record PV potentials and to create a 3D map of the left atrium. Then, the transseptal sheath was exchanged for the 12F EAS delivery sheath. The EAS was inflated to obtain optimal circumferential contact to the PV ostium. Before ablation, the laser generator was retracted to ensure optimal contact behind the catheter shaft (blind spot). Ideally, RAPID mode ablation was employed at 13-15W. In case of esophageal heating >39°C or suboptimal tissue exposure point-by-point ablation (5.5-12W for 20-30 secs) was used instead. During ablation at the septal PVs phrenic nerve pacing was performed via a diagnostic catheter in the superior vena cava. Single sweep ablation was defined as one single RAPID energy application per PV to complete the singular, circular lesion set. PV conduction was re-assessed after all PVs had been treated. In case of residual PV conduction, gap mapping followed by EAS guided ablation was performed. If EAS failed to achieve complete PVI, touch up ablation was allowed at the discretion of the operator. Hemostasis was achieved by means of a figure of 8 suture.  Procedure time was defined as initial groin puncture to groin closure.  Follow-up included office visits at 3, 6 and 12 months including 72 h Holter monitoring. Results One-hundred AF patients (56% male, mean age 6810 years, 66% PAF) with normal LV ejection fraction (mean 60 ± 10%) and normal LA size (41 ± 6mm) underwent X3 EAS ablation. Of 382 PVs 378 (99%) were isolated with the X3 EAS. In 214 PVs (56%) single sweep isolation was achieved. First pass isolation and RAPID mode only PVI was achieved in 362 (95%) and 357 (94%), respectively. Single sweep isolation rates varied across PVs from 46% at LIPV to 64% at RSPV.  The mean total procedure and fluoroscopy times were 43 ± 10 and 4 ± 2 mins, respectively. Safety data and the complete follow-up will be reported. Conclusion The new X3 EAS equipped with a motor driven laser generator allows for single sweep PVI in 56% of PVs. Almost all PVs (94%) may be isolated with RAPID mode only leading to a very high first pass isolation rate. Altogether, this leads to substantially faster procedure times compared to the predecessor EAS.


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