scholarly journals Procedural Safety and Efficacy for Pulmonary Vein Isolation with the Novel Polarx™ Cryoablation System: A Propensity Score Matched Comparison with the Arctic Front™ Cryoballoon in the Setting of Paroxysmal Atrial Fibrillation

2020 ◽  
Vol 14 (1) ◽  
Author(s):  
Dhanunjaya Lakkireddy
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.


Heart Rhythm ◽  
2011 ◽  
Vol 8 (7) ◽  
pp. 988-993 ◽  
Author(s):  
Andreas Metzner ◽  
Boris Schmidt ◽  
Alexander Fuernkranz ◽  
Erik Wissner ◽  
Roland R. Tilz ◽  
...  

2021 ◽  
Vol 17 (1) ◽  
pp. 81-87
Author(s):  
Erik Wissner

The cryoballoon (CB) is a popular ablation technology used for pulmonary vein isolation. The fourth-generation CB, Arctic Front Advance PRO features a 40% shorter distal tip but retains the internal design from its second-generation predecessor. The Arctic Front Advance PRO and the second-generation CB demonstrated similar thermodynamic characteristics in a computational model. Several observational and retrospective studies established the acute safety and efficacy of the Arctic Front Advance PRO. Real-time electrical isolation was observed in 75–85% of pulmonary veins targeted with the Arctic Front Advance PRO resulting in shorter fluoroscopy and procedure times.


Author(s):  
Antonio Bisignani ◽  
Luigi Pannone ◽  
Vincenzo Miraglia ◽  
Juan Sieira ◽  
Saverio Iacopino ◽  
...  

Introduction: Left atrial posterior wall isolation (LAPWI) is often performed in addition to pulmonary vein isolation (PVI) to improve outcome in patients with persistent atrial fibrillation (AF). In this setting, LAPWI + PVI using cryoballoon ablation had comparable results with radiofrequency ablation (RFA). The aim of the study is to evaluate the feasibility and safety of a new cryoballoon ablation system in PVI + LAPWI isolation, comparing it with the historical platform. Methods: The study was a prospective, non-randomized, single center study. Forty consecutive patients, undergoing PVI + LAPWI with the novel POLARx™, were compared to 40 consecutive patients who underwent the same procedure with the established Arctic Front Advance PRO™. Results: Acute isolation was achieved in all PVs in both groups and LAPWI was achieved in 38 patients (95%) in the POLARx group and in 36 patients (90%) in Arctic Front group. Procedural outcomes were similar between the two groups, except for lower temperatures during cryoapplications in the POLARx group, for both PVI and LAPWI. The complication rate was low and similar between groups. Conclusion: LAPWI+PVI with the novel POLARx™ Cryoballoon is feasible and safe; the results are comparable with the Arctic Front Advance PRO™ system.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
A Martin ◽  
T Breskovic ◽  
A Ouss ◽  
L Dekker ◽  
S C Yap ◽  
...  

Abstract Background Recently, a novel cryoballoon (CB; POLARx) has been developed with increased steerability which maintains size and pressure throughout the ablation. Initial clinical data has demonstrated acute procedural safety and efficacy in de novo pulmonary vein isolation (PVI) procedures in patients with paroxysmal atrial fibrillation (AF). However, there are limited studies demonstrating the long-term efficacy of the CB. Purpose To evaluate the long-term safety and efficacy of the novel CB in treating paroxysmal AF. Methods This was a non-randomized, prospective, multi-center study. Fifty-eight consecutive patients with paroxysmal AF were enrolled at 4 centers for de novo PVI procedures. Cryoablation was delivered for 180s if time to isolation was ≤60s. Otherwise a 240s cryoablation was performed. PVI was confirmed with entrance and exit block testing. Patients were followed for 1 year with 24-hour Holter monitoring at 3, 6, and 12 months. After a 3-month blanking period, recurrence was defined as having any documented, symptomatic episode(s) of AF or atrial tachycardia. Results Acute isolation with the CB was achieved in 230 of 231 pulmonary veins (99.6%) with 5.2±1.5 cryoapplications per patient (1.3±0.6 cryoapplications per vein). There were 4 patients (6.9%) with phrenic nerve injury (3 resolved during the index procedure; 1 resolved at 6 months follow-up). One serious adverse device event was reported: femoral arterial embolism event occurring 2 weeks post index procedure (1.7%). Of the 56 patients that had complete 12-month follow-up, 43 (76.8%) were free from recurrent atrial arrhythmias. Conclusion Initial multicenter clinical experience with the novel CB has demonstrated long-term safety and efficacy of PVI in patients with paroxysmal AF. Further studies are underway to confirm these findings. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Boston Scientific


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