scholarly journals Cryoballoon atrial fibrillation ablation: Single-center safety and efficacy data using a novel cryoballoon technology compared to a historical balloon platform.

2020 ◽  
Author(s):  
Adriano Kochi ◽  
Massimo Moltrasio ◽  
Fabrizio Tundo ◽  
Sfefania Isabella Riva ◽  
Ciro Ascione ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Veins ◽  
Similar Efficacy ◽  
The Novel ◽  
Single Center ◽  
Historical Cohort ◽  
Safety And Efficacy ◽  
Procedural Time ◽  
Front Advance ◽  
First Time

Introduction: Catheter ablation is superior to drugs regarding atrial fibrillation (AF) recurrence, symptoms improvement, and mortality reduction in heart failure. POLARx™ is a novel cryoballoon, with technical improvements seeking to improve outcomes. So far, its clinical evidence is restricted to a case report. Methods: To compare the POLARx™ cryoballoon procedural safety and efficacy to the already established Arctic Front Advance PRO™ (AFAP) in a single-center cohort study, consecutive patients undergoing AF cryoablation with the POLARx™ were enrolled. Data were prospectively gathered. POLARx™ patients were compared to a historical cohort of patients submitted to AF cryoablation with the AFAP. Results: Seventy patients were analyzed, 20 in POLARx™, and 50 in the AFAP group. They all underwent first-time pulmonary vein isolation, 77% were male, 94% had paroxysmal AF, median age was 62.5 years, median CHA2DS2-VASc 1, left-atrium size 34ml/m², and 65% were receiving anticoagulation. The primary end-point, all pulmonary veins isolation, was 100% in both groups. The complication rate was similar (0% POLARx™ vs. 5.7% AFAP, p=0.39). The median total procedural time was longer in the POLARx™ group (90min vs. 60min, p<0.001), but the overall time-to-isolation (TTI) (44.8sec vs. 39sec, p=0.253) and ablation time (15min vs. 13.7min, p=0.122) was similar between POLARx™ and AFAP groups, respectively. Despite equal TTI, the POLARx™ had a lower minimal temperature reached (-57ºC vs -47ºC, p<0.001). Conclusion: The novel POLARx™ cryoballoon had similar efficacy and safety compared to the AFAP. It was also associated with longer procedural times, similar TTI, and lower minimum temperature reached.

scholarly journals Smart Touch Radiofrequency Catheter Ablation versus Cryoballoon Ablation of Pulmonary Veins in Patients with Paroxysmal Atrial Fibrillation

2020 ◽  
Vol 8 (B) ◽  
pp. 563-568
Author(s):  
Walid Shehata Hassan ◽  
Sherief Hamed Zaky ◽  
Khaled Hussein Mohamed ◽  
Moataz Mohammed Ibrahim
Keyword(s):  
Atrial Fibrillation ◽  
Complication Rate ◽  
Paroxysmal Atrial Fibrillation ◽  
Pulmonary Veins ◽  
Cryoballoon Ablation ◽  
Medicine Department ◽  
Free Survival ◽  
Safety And Efficacy ◽  
Significant Difference ◽  
Front Advance

AIM: Evaluation of the safety and efficacy of pulmonary veins isolation in patients with paroxysmal atrial fibrillation (AF) using two new different technologies, cryoballoon (CB) ablation and radiofrequency ablation with contact force (CF)-sensing catheters. METHODS: Prospective single-center evaluation, carried out from January 2016 to June 2018 in Critical Care Medicine Department – Cairo University, comparing CF radiofrequency (Thermocool® SmartTouch, Biosense Webster, Inc.) (CF group) with CB ablation (Arctic Front Advance 28 mm CB, Medtronic, Inc.) (CB group), in regards to procedural safety and efficacy, as well as recurrence at 12 months. Overall, 50 consecutive patients were enrolled (25 in each group). RESULTS: The characteristics of patients of both the groups were similar (46.9 ± 11.2 years, the proportion of women 36%, mean documented AF duration 3 ± 2.3 years, mean CHA2DS2-VASc score 1.4 ± 1.3, and mean HAS-BLED 1.4 ± 0.6). Duration of the procedure was significantly lower in the CB group (171.7 ± 15.24 vs. 199.3 ± 18.94 min, p = 0.002), with a longer duration of fluoroscopy and X-ray exposure in the CB group than the CF group but statistically non-significant difference (58.60 ± 11.57 vs. 48.7 ± 13.86 min and 6273 ± 4934 cGy cm² vs. 6853 ± 5069 cGy cm², p = 0.1 and p = 0.2, respectively). Overall complication rate was similar in both groups: 2 (8%) in each group. At 12 months, AF recurrence occurred in 7 patients (28%) in the CF group and in 9 patients (36%) in the CB group (log rank p = 0.682). CONCLUSION: Pulmonary vein isolation using CF-guided RF and second-generation CB leads to comparable single-procedure arrhythmia-free survival at up to 12 months with similar overall complication rate.

scholarly journals How Close Are We toward an Optimal Balance in Safety and Efficacy in Catheter Ablation of Atrial Fibrillation? Lessons from the CLOSE Protocol

2021 ◽  
Vol 10 (18) ◽  
pp. 4268
Author(s):  
Michelle Lycke ◽  
Louisa O’Neill ◽  
Kris Gillis ◽  
Jean-Yves Wielandts ◽  
Jean-Benoit Le Polain De Waroux ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Prospective Study ◽  
High Power ◽  
Pulmonary Veins ◽  
Anterior Wall ◽  
Cryoballoon Ablation ◽  
Single Center ◽  
Safety And Efficacy ◽  
Rf Applications

Catheter ablation for atrial fibrillation (AF) is a common treatment strategy in patients with drug-resistant, symptomatic AF. In patients with paroxysmal and short-standing persistent AF, pulmonary vein isolation (PVI) is often enough to prevent recurrence of atrial tachyarrhythmia (ATA). Point-by-point encircling of the PVs with radiofrequency (RF) applications, together with cryoballoon ablation, have been the mainstay strategies for the last 10 to 20 years. Each of these strategies, however, suffers from the delicate balance between preventing PV reconnection, on the one hand (toward more energy), and preventing (mainly esophageal) complications (toward less energy), on the other. The CLOSE protocol was developed as an RF ablation strategy that would result in the safe creation of durable isolation leading to improved outcomes. Basically, the aim of the protocol is to enclose the pulmonary veins with stable, contiguous (intertag distance, ITD ≤ 6 mm) and optimized lesions (35 Watts, W, RF applications up to ablation index targets of ≥400 and ≥550 at the posterior and anterior wall). In this review, we describe the background of the CLOSE protocol and the studies from the St Jan Bruges research group on procedural performance, efficacy, and safety of the CLOSE protocol in (a) single-center prospective PILOT study (CLOSE-PILOT), (b) a single-center prospective study with continuous rhythm monitoring (CLOSE to CURE), (c) a database of systematic esophageal endoscopic studies, (d) a multicenter prospective study (VISTAX), and (e) the CLOSE database (comprising > 400 patients). We also discuss the results of the randomized POWER-AF study comparing conventional CLOSE to high power CLOSE (up to 50 W). Finally, we discuss the performance, safety, and efficacy of the CLOSE protocol in light of the emerging changes in the field of catheter ablation being ultra-short high-power ablation and electroporation.

Ablation of atrial fibrillation using the fourth-generation cryoballoon Arctic Front Advance PRO

2021 ◽  
Vol 17 (1) ◽  
pp. 81-87
Author(s):  
Erik Wissner
Keyword(s):  
Atrial Fibrillation ◽  
Second Generation ◽  
Retrospective Studies ◽  
Pulmonary Veins ◽  
Thermodynamic Characteristics ◽  
The Arctic ◽  
Fourth Generation ◽  
Safety And Efficacy ◽  
Front Advance ◽  
Arctic Front

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.

scholarly journals Novel cryoballoon to isolate pulmonary veins in patients with paroxysmal atrial fibrillation: one-year outcomes in a multicenter study

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
A Martin ◽  
T Breskovic ◽  
A Ouss ◽  
L Dekker ◽  
S C Yap ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Paroxysmal Atrial Fibrillation ◽  
De Novo ◽  
Pulmonary Veins ◽  
The Novel ◽  
Private Company ◽  
Index Procedure ◽  
Safety And Efficacy

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

scholarly journals Safety and efficacy of cryoballoon-ablation for atrial fibrillation performed at local hospitals: results of the german register on cryoballoon-ablation in local hospitals (REGIONAL)

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
J Michaelsen ◽  
U Parade ◽  
H Bauerle ◽  
K-D Winter ◽  
U Rauschenbach ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Phrenic Nerve ◽  
Nerve Palsy ◽  
Pulmonary Veins ◽  
Hospital Death ◽  
Cryoballoon Ablation ◽  
Complication Rates ◽  
Community Hospitals ◽  
Phrenic Nerve Palsy ◽  
Safety And Efficacy

Abstract Funding Acknowledgements Type of funding sources: None. OnBehalf REGIONAL Background Pulmonary vein isolation (PVI) using cryoballoon ablation (CBA) has become an established procedure for the treatment of symptomatic paroxysmal and persistent atrial fibrillation (AF). The safety and efficacy of PVI at community hospitals with low to moderate case numbers is unknown. Aim To determine safety and efficacy of PVI using CBA performed at community hospitals with limited annual case numbers. Methods 1004 PVI performed consecutively between 01/2019 and 09/2020 at 20 community hospitals (each &lt;100 PVI using CBA/year) for symptomatic paroxysmal AF (n = 563) or persistentAF (n= 441) were included in this registry. CBA was performed considering local standards. Procedural data, efficacy and complications were determined. Results Mean number of PVI using CBA/year was 59 ± 26. Mean procedure time was 90.1 ± 31.6 min and mean fluoroscopy time was 19.2 ± 11.4 min. Isolation of all pulmonary veins could be achieved in 97.9% of patients, early termination of CBA due to phrenic nerve palsy was the most frequent reason for incomplete isolation. There was no in-hospital death. 2 patients (0.2%) suffered a clinical stroke. Pericardial effusion occurred in 6 patients (0.6%), 2 of them (0.2%) required pericardial drainage. Vascular complications occurred in 24 patients (2.4%), in 2 of these patients (0.2%) vascular surgery was required. In 48 patients (4.8 %) phrenic nerve palsy was noticed which persisted up to hospital discharge in 6 patients (0.6%). Conclusions PVI for paroxysmal or persistent AF using CBA can be performed at community hospitals with high efficacy and low complication rates despite low to moderate annual procedure numbers.

Experience in cryobaloon atrial fibrillation ablation – Polish operators perspective

2019 ◽  
Vol 2 (51) ◽  
pp. 4-7
Author(s):  
Agnieszka Wojdyła-Hordyńska ◽  
Jakub Baran ◽  
Paweł Derejko
Keyword(s):  
Atrial Fibrillation ◽  
Second Generation ◽  
Pulmonary Veins ◽  
Atrial Fibrillation Ablation ◽  
Cryoballoon Ablation ◽  
Years Of Experience ◽  
Technology Changes ◽  
Front Advance ◽  
Arctic Front ◽  
Over 40 Years

The first use of cryoablation in the treatment of arrhythmia has already been described over 40 years ago [1]. Since the introduction of cryoballoon in pulmonary veins isolation in atrial fibrillation treatment, the method has started to attract a lot of interest. Over 350,000 procedures around the word were carried out only by 2018 [2]. Recently, there have been several new publications on the results of second-generation cryoballoon ablation [2, 3, 4]. In view of technology changes, and to summarize years of experience in the treatment of atrial fibrillation, the first Cryousers conference was organized, and held in 2018 in Poland. During this meeting a survey was conducted, obtaining data on the practice of atrial fibrillation treatment in 38 Polish electrophysiological centers performing cryoablation of atrial fibrillation using both balloons, Arctic Front Advance, Medtronic Inc., Minneapolis MN, and radiofrequency point by point ablation. Around 3,745 cryoballoon procedures were performed in the surveyed centers during the year preceding the survey. The survey concerned practical issues related to the qualification and preparation of patients for the procedure, its course, and the results of pulmonary veins isolation in Poland.

P1415Wide antral circumferential pulmonary vein isolation ablation using a novel balloon cryoablation catheter

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
A P Martin ◽  
M Fowler ◽  
N Lever
Keyword(s):  
Atrial Fibrillation ◽  
Left Atrium ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Paroxysmal Atrial Fibrillation ◽  
Left Atrial ◽  
Pulmonary Veins ◽  
Posterior Wall ◽  
The Novel ◽  
Median Treatment

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.

scholarly journals Normal distal pulmonary vein anatomy

PeerJ ◽  
2016 ◽  
Vol 4 ◽  
pp. e1579 ◽  
Author(s):  
Wiesława Klimek-Piotrowska ◽  
Mateusz K. Hołda ◽  
Katarzyna Piątek ◽  
Mateusz Koziej ◽  
Jakub Hołda
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Vein ◽  
Interventional Procedures ◽  
Critical Role ◽  
Pulmonary Veins ◽  
Safety And Efficacy ◽  
Classical Pattern ◽  
The Common ◽  
The Mean ◽  
Pulmonary Vein Anatomy

Background.It is well known that the pulmonary veins (PVs), especially their myocardial sleeves play a critical role in the initiation and maintenance of atrial fibrillation. Understanding the PV anatomy is crucial for the safety and efficacy of all procedures performed on PVs. The aim of this study was to present normal distal PV anatomy and to create a juxtaposition of all PV ostium variants.Methods.A total of 130 randomly selected autopsied adult human hearts (Caucasian) were examined. The number of PVs ostia was evaluated and their diameter was measured. The ostium-to-last-tributary distance and macroscopic presence of myocardial sleeves were also evaluated.Results.Five hundred forty-one PV ostia were identified. Four classical PV ostia patterns (two left and two right PVs) were observed in 70.8% of all cases. The most common variant was the classical pattern with additional middle right PV (19.2%), followed by the common ostium for the left superior and the inferior PVs (4.44%). Mean diameters of PV ostia (for the classical pattern) were: left superior = 13.8 ± 2.9 mm; left inferior = 13.3 ± 3.4 mm; right superior = 14.3 ± 2.9 mm; right inferior = 13.7 ± 3.3 mm. When present, the additional middle right PV ostium had the smallest PV ostium diameter in the heart (8.2 ± 4.1 mm). The mean ostium-to-last-tributary (closest to the atrium) distances were: left superior = 15.1 ± 4.6 mm; left inferior = 13.5 ± 4.0 mm; right superior = 11.8 ± 4.0 mm; right inferior = 11.0 ± 3.7 mm. There were no statistically significant differences between sexes in ostia diameters and ostium-to-last-tributary distances.Conclusion.Only 71% of the cases have four standard pulmonary veins. The middle right pulmonary vein is present in almost 20% of patients. Presented data can provide useful information for the clinicians during interventional procedures or radiologic examinations of PVs.

scholarly journals Near zero fluoroscopy in cryoballoon catheter ablation in patients with atrial fibrillation using the new KODEX-EPD imaging system

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
V Schillaci ◽  
G Stabile ◽  
A Arestia ◽  
G Shopova ◽  
F Solimene
Keyword(s):  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Imaging System ◽  
The Arctic ◽  
Fluoroscopy Time ◽  
Cryoballoon Ablation ◽  
The Novel ◽  
Funding Sources ◽  
Front Advance ◽  
Mapping Catheter

Abstract Funding Acknowledgements Type of funding sources: None. Background. Fluoroscopy is commonly used in cryoballoon catheter ablation for pulmonary vein (PV) isolation procedures in patients with atrial fibrillation (AF). Objective The purpose of this study was to verify the feasibility of a new dielectric imaging system in reducing the radiation exposure during cryoballoon ablation in patients with AF. Methods We enrolled 26 consecutive patients with paroxysmal AF: 13 patients underwent the procedure under fluoroscopy guidance before the new system introduction, while 13 patient underwent the procedure under fluoroscopy and KODEX-EPD system guidance with its occlusion tool software. After transseptal access a detailed image reconstruction of left atrium and PVs was achieved with the Achieve octapolar circular mapping catheter and the cryoablation was performed with the Arctic Front Advance cryoballoon. Results Total time of the procedure was comparable between the two groups (90.15 ± 28.67 vs 80.77 ± 17.17 using KODEX-EPD, p = 0.34), while fluoroscopy time was significantly lower in the group using KODEX-EPD (16.92 ± 8.96 vs 5.54 ± 2.06, p &lt; 0.01). Acute isolation was achieved in all PVs. No 30 days complication was observed. Conclusion This is the first study that demonstrates the feasibility of a reduce fluoroscopy workflow using the novel KODEX-EPD system in a cryoballoon procedure. Abstract Figure. Fluoroscopy time

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