664Local catheter impedance drop during pulmonary vein isolation predicts conduction block in patients with paroxysmal atrial fibrillation: initial results of the LOCALIZE clinical trial

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
M Das ◽  
A Luik ◽  
E Shepherd ◽  
M Sulkin ◽  
J Laughner ◽  
...  

Abstract Funding Acknowledgements Boston Scientific Background Radiofrequency (RF) catheter ablation for pulmonary vein isolation (PVI) requires resistively heating cardiac tissue to create conduction block. Creation of an RF lesion results in an impedance drop and the magnitude of this drop depends on the temperature and amount of myocardium being heated. Pre-clinical and clinical evaluation of an advanced local impedance (LI) metric found that greater LI drops were indicative of more effective lesion formation. Purpose To evaluate whether LI drop is associated with conduction block after first pass encirclement of the PVs in patients with paroxysmal AF. Methods LOCALIZE is an ongoing, single-arm, multi-center clinical trial (clinicaltrials.gov NCT03232645). LOCALIZE consists of an index PVI procedure (results presented here) and a 3-month follow-up mapping procedure. In the index procedure, electroanatomical maps of the left atrium were created and ipsilateral PVs were divided into 8 anatomical segments (n = 16 per patient). PVI was performed using point-by-point ablation with blinding of operators to LI. Following initial encirclement and a 20-minute wait period, coronary sinus-paced electroanatomical maps were created to identify gaps within anatomical segments. Gaps were annotated on the map and subsequently ablated. Mean LI drop within each segment was calculated offline as an estimate of regional RF energy delivery (Figure - Left). The diagnostic accuracy of LI drop for predicting segment block was assessed using receiver operating characteristic (ROC) analysis in segments with inter-lesion spacing ≤6mm. Results Forty-seven patients with paroxysmal AF underwent PVI at 5 centers (age 62 ± 11 years, male 55.3%). All patients left the index procedure with all PVs isolated. When blinded to LI (n = 3,064 ablations), median baseline LI was 106 (IQR: 97-115) Ω and median LI drop was 18.4 (12.7-24.9) Ω. After first pass encirclement, blocked segments had a significantly larger LI drop (20.2 [14.6-26.0] Ω) than segments with gaps (10.6 [6.9-15.1] Ω, p < 0.01, Figure - Right). The association between LI drop and block was further evaluated along anatomical anterior/posterior wall thickness differences. Anterior block segments were found to have significantly larger LI drops (21.0 [15.9-27.2] Ω) than posterior block segments (16.6 [12.7-23.7] Ω, p < 0.01). ROC analysis of segments with inter-lesion spacing ≤6mm identified optimal LI cut-off values of 16Ω in anterior segments and 11Ω posteriorly, which had positive predictive values for conduction block of 95.6% and 96.7%, respectively. Conclusions The magnitude of LI drop is predictive of acute PVI segment conduction block in patients with paroxysmal AF. The thinner posterior wall required smaller LI drops for block compared to the thicker anterior wall. With inter-lesion spacing of ≤6mm, reaching a LI drop of ≥16Ω anteriorly and ≥11Ω posteriorly was highly predictive of acute segment block in de novo PVI. Abstract Figure. Local impedance drop in de novo PVI

EP Europace ◽  
2020 ◽  
Vol 22 (11) ◽  
pp. 1645-1652
Author(s):  
Mattias Duytschaever ◽  
Johan Vijgen ◽  
Tom De Potter ◽  
Daniel Scherr ◽  
Hugo Van Herendael ◽  
...  

Abstract Aims To evaluate the safety and effectiveness of pulmonary vein isolation in paroxysmal atrial fibrillation (PAF) using a standardized workflow aiming to enclose the veins with contiguous and optimized radiofrequency lesions. Methods and results This multicentre, prospective, non-randomized study was conducted at 17 European sites. Pulmonary vein isolation was guided by VISITAG SURPOINT (VS target ≥550 on the anterior wall; ≥400 on the posterior wall) and intertag distance (≤6 mm). Atrial arrhythmia recurrence was stringently monitored with weekly and symptom-driven transtelephonic monitoring on top of standard-of-care monitoring (24-h Holter and 12-lead electrocardiogram at 3, 6, and 12 months follow-up). Three hundred and forty participants with drug refractory PAF were enrolled. Acute effectiveness (first-pass isolation proof to a 30-min wait period and adenosine challenge) was 82.4% [95% confidence interval (CI) 77.4–86.7%]. At 12-month follow-up, the rate of freedom from any documented atrial arrhythmia was 78.3% (95% CI 73.8–82.8%), while freedom from atrial arrhythmia by standard-of-care monitoring was 89.4% (95% CI 78.8–87.0%). Freedom fromrepeat ablations by the Kaplan–Meier analysis was 90.4% during 12 months of follow-up. Of the 34 patients with repeat ablations, 14 (41.2%) demonstrated full isolation of all pulmonary vein circles. Primary adverse event (PAE) rate was 3.6% (95% CI 1.9–6.3%). Conclusions The VISTAX trial demonstrated that a standardized PAF ablation workflow aiming for contiguous lesions leads to low rates of PAEs, high acute first-pass isolation rates, and 12-month freedom from arrhythmias approaching 80%. Further research is needed to improve the reproducibility of the outcomes across a wider range of centres. Clinical trial registration: ClinicalTrials.gov, number NCT03062046, https://clinicaltrials.gov/ct2/show/NCT03062046.


2020 ◽  
Vol 11 ◽  
Author(s):  
Lohit Garg ◽  
Naga Venkata K. Pothineni ◽  
J. Michael Daw ◽  
Matthew C. Hyman ◽  
Jeffrey Arkles ◽  
...  

BackgroundFirst pass pulmonary vein isolation (PVI) is associated with durable isolation and reduced recurrence of atrial fibrillation (AF).ObjectiveWe sought to investigate the relationship between left atrial electrogram voltage using multielectrode fast automated mapping (ME-FAM) and first pass isolation with radiofrequency ablation.MethodsWe included consecutive patients (pts) undergoing first time ablation for paroxysmal AF (pAF), and compared the voltage characteristics between patients with and without first pass isolation. Left atrium (LA) adjacent to PVs was divided into 6 regions, and mean voltages obtained with ME-FAM (Pentaray, Biosense Webster) in each region and compared. LA electrograms with marked low voltage (<0.5 mV) were identified and the voltage characteristics at the site of difficult isolation was compared to the voltage in adjacent region.ResultsTwenty consecutive patients (10 with first pass and 10 without) with a mean age of 63.3 ± 6.2 years, 65% males, were studied. Difficult isolation occurred on the right PVs in eight pts and left PVs in three pts. The mean voltage in pts without first pass isolation was lower in all 6 regions; posterior wall (1.93 ± 1.46 versus 2.99 ± 2.19; p < 0.001), roof (1.83 ± 2.29 versus 2.47 ± 1.99; p < 0.001), LA-LPV posterior (1.85 ± 3.09 versus 2.99 ± 2.19, p < 0.001), LA-LPV ridge (1.42 ± 1.04 versus 1.91 ± 1.61; p < 0.001), LA-RPV posterior (1.51 ± 1.11 versus 2.30 ± 1.77, p < 0.001) and LA-RPV septum (1.55 ± 1.23 versus 2.31 ± 1.40, p < 0.001). Patients without first pass isolation also had a larger percentage of signal with an amplitude of <0.5 mV for each of the six regions (12.8% versus 7.5%). In addition, the mean voltage at the site of difficult isolation was lower at 8 out of 11 sites compared to mean voltage for remaining electrograms in that region.ConclusionIn patients undergoing PVI for paroxysmal AF, failure in first pass isolation was associated with lower global LA voltage, more marked low amplitude signal (<0.5 mV) and lower local signal voltage at the site with difficult isolation. The results suggest that a greater degree of global and segmental fibrosis may play a role in ease of PV isolation with radiofrequency energy.


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.


PLoS ONE ◽  
2021 ◽  
Vol 16 (9) ◽  
pp. e0257050
Author(s):  
Nándor Szegedi ◽  
Zoltán Salló ◽  
Péter Perge ◽  
Katalin Piros ◽  
Vivien Klaudia Nagy ◽  
...  

Introduction Our pilot study aimed to evaluate the role of local impedance drop in lesion formation during pulmonary vein isolation with a novel contact force sensing ablation catheter that records local impedance as well and to find a local impedance cut-off value that predicts successful lesion formation. Materials and methods After completing point-by-point radiofrequency pulmonary vein isolation, the success of the applications was evaluated by pacing along the ablation line at 10 mA, 2 ms pulse width. Lesions were considered successful if loss of local capture was achieved. Results Out of 645 applications, 561 were successful and 84 were unsuccessful. Compared to the unsuccessful ablation points, the successful applications were shorter (p = 0.0429) and had a larger local impedance drop (p<0.0001). There was no difference between successful and unsuccessful applications in terms of mean contact force (p = 0.8571), force-time integral (p = 0.0699) and contact force range (p = 0.0519). The optimal cut-point for the local impedance drop indicating successful lesion formation was 21.80 Ohms on the anterior wall [AUC = 0.80 (0.75–0.86), p<0.0001], and 18.30 Ohms on the posterior wall [AUC = 0.77 (0.72–0.83), p<0.0001]. A local impedance drop larger than 21.80 Ohms on the anterior wall and 18.30 Ohms on the posterior wall was associated with an increased probability of effective lesion creation [OR = 11.21, 95%CI 4.22–29.81, p<0.0001; and OR = 7.91, 95%CI 3.77–16.57, p<0.0001, respectively]. Conclusion The measurement of the local impedance may predict optimal lesion formation. A local impedance drop > 21.80 Ohms on the anterior wall and > 18.30 Ohms on the posterior wall significantly increases the probability of creating a successful lesion.


EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
A P Martin ◽  
M Fowler ◽  
N Lever

Abstract Background Pulmonary vein isolation using cryotherapy is an established treatment for the management of patients with paroxysmal atrial fibrillation. Ablation using the commercially available balloon cryocatheter has been shown to create wide antral pulmonary vein isolation. A novel balloon cryocatheter (BCC) has been designed to maintain uniform pressure and size during ablation, potentially improving contact with the antral anatomy. The extent of ablation created using the novel BCC has not previously been established. Purpose To determine the anatomical extent of pulmonary vein isolation using electroanatomical mapping when performing catheter ablation for paroxysmal atrial fibrillation using the novel BCC. Methods Nine consecutive patients underwent pre-procedure computed tomography angiography of the left atrium to quantify the chamber dimensions. An electroanatomical map was created using the cryoablation system mapping catheter and a high definition mapping system. A bipolar voltage map was obtained following ablation to determine the extent of pulmonary vein isolation ablation. A volumetric technique was used to quantify the extent of vein and posterior wall electrical isolation in addition to traditional techniques for proving entrance and exit block. Results All patients had paroxysmal atrial fibrillation, mean age 56 years, 7 (78%) male. Electrical isolation was achieved for 100% of the pulmonary veins; mean total procedure time was 109 min (+/- 26 SD), and fluoroscopy time 14.9 min (+/- 2.4 SD). The median treatment applications per vein was one (range one - four), and median treatment duration 180 sec (range 180 -240). Left atrial volume 32 mL/m2 (+/- 7 SD), and mean left atrial posterior wall area 22 cm2 (+/- 4 SD). Data was available for quantitative assessment of the extent of ablation for eight patients. No lesions (0 of 32) were ostial in nature. The antral surface area of ablation was not statistically different between the left and right sided pulmonary veins (p 0.63), which were 5.9 (1.6 SD) and 5.4 (2.1 SD) cm2 respectively. In total 50% of the posterior left atrial wall was ablated.  Conclusion Pulmonary vein isolation using a novel BCC provides a wide and antral lesion set. There is significant debulking of the posterior wall of the left atrium. Abstract Figure.


2014 ◽  
Vol 25 (2) ◽  
pp. 121-122
Author(s):  
Karin Nentwich ◽  
Mattias Duytschaever ◽  
Thomas Deneke

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