scholarly journals Safety of cryoballoon ablation for the treatment of atrial fibrillation: First European results from the cryo AF Global Registry

2021 ◽  
Author(s):  
Csaba Földesi ◽  
Silvia Misiková ◽  
Paweł Ptaszyński ◽  
Derick Todd ◽  
Jean‐Manuel Herzet ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Cryoballoon Ablation ◽  
Global Registry

scholarly journals Healthcare utilization after cryoballoon ablation for treatment of atrial fibrillation in patients with heart failure: real-world results from the Cryo AF Global Registry

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
R Rordorf ◽  
F Scazzuso ◽  
KRJ Chun ◽  
S Kaur Khelae ◽  
FJ Kueffer ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Healthcare Utilization ◽  
Real World ◽  
Nyha Class ◽  
Atrial Arrhythmia ◽  
Class I ◽  
Left Ventricular Ejection ◽  
Cryoballoon Ablation ◽  
Global Registry

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Medtronic, Inc. OnBehalf Cryo AF Global Registry Investigators Background Heart failure (HF) concomitant to atrial fibrillation (AF) can exacerbate the risk of hospitalization, morbidity, mortality, and impairment in quality of life posed by each condition alone. While the reciprocal relationship between HF and AF challenges effective treatment for these patients, catheter ablation for treatment of AF is reasonable for select patients with AF and HF according to guidelines. Purpose: Assess real-world usage and healthcare utilization outcomes of cryoablation for patients with AF and HF. Methods: The Cryo AF Global Registry (NCT02752737) is an ongoing, prospective, multicenter registry. Patients with AF were enrolled and treated with cryoballoon ablation (Arctic Front Advance, Medtronic) according to clinical practice at 56 sites in 26 countries world-wide. Subjects with NYHA class I-III at baseline comprised the HF cohort and were compared to patients without HF (No-HF). Freedom from atrial arrhythmia recurrence ≥30 sec, adverse events associated with the AF ablation procedure, repeat ablations, AAD usage, and cardiovascular rehospitalization over a 12-month follow-up were compared between cohorts. Results: A total of 1,303 patients (318 HF, 985 No-HF) were included. The HF cohort included patients with NYHA Class I (56.3%) and II/III (43.7%) with either preserved (81.6%) or mid/reduced (18.4%) left ventricular ejection fraction. HF patients were more often female (45.6% vs 33.6%) with persistent AF (25.8% vs 14.3%), larger left atrial diameter (4.4 ± 0.9 vs 4.0 ± 0.7 cm), and higher rates of hypertension (67.9% vs 49.1%) and prior myocardial infarction (3.8% vs 1.7%; all, P < 0.05). The rate of serious procedure-related complications was 5.3% in HF and 3.0% in No-HF (P = 0.08). Freedom from atrial arrhythmia recurrence at 12-months was not different between HF and No-HF patients with either paroxysmal (84.2% (95% CI:78.6-88.4) vs 86.8% (95% CI: 84.2 – 89.0)) or persistent AF (69.6% (95% CI: 58.1 – 78.5) vs 71.8% (95% CI: 63.2-78.7)), respectively (p = 0.32, HF vs No-HF). AF-related symptoms and antiarrhythmic drug use were significantly reduced after cryoablation in the HF and No-HF cohorts (P < 0.05). Freedom from repeat ablation at 12-months was similar between HF and No-HF patients. Of patients who had a cardiovascular rehospitalization after cryoablation, 78% presented with a supraventricular tachyarrhythmia. Persistent AF and HF at baseline both increased the risk of cardiovascular rehospitalization after cryoballoon ablation (P < 0.05). Conclusion: Cryoablation is used to treat patients with AF and concomitant HF in real-world practice and is similarly safe and effective at 12-months in patients with and without HF.

scholarly journals Cryoballoon Ablation for the Treatment of Atrial Fibrillation in Patients With Concomitant Heart Failure and Either Reduced or Preserved Left Ventricular Ejection Fraction: Results From the Cryo AF Global Registry

2021 ◽  
Author(s):  
Roberto Rordorf ◽  
Fernando Scazzuso ◽  
Kyoung Ryul Julian Chun ◽  
Surinder Kaur Khelae ◽  
Fred J. Kueffer ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Left Ventricular Ejection Fraction ◽  
Ejection Fraction ◽  
Left Ventricular ◽  
Atrial Arrhythmia ◽  
Left Ventricular Ejection ◽  
Cryoballoon Ablation ◽  
Ventricular Ejection Fraction ◽  
Global Registry

Background Heart failure (HF) and atrial fibrillation (AF) often coexist; yet, outcomes of ablation in patients with AF and concomitant HF are limited. This analysis assessed outcomes of cryoablation in patients with AF and HF. Methods and Results The Cryo AF Global Registry is a prospective, multicenter registry of patients with AF who were treated with cryoballoon ablation according to routine practice at 56 sites in 26 countries. Patients with baseline New York Heart Association class I to III (HF cohort) were compared with patients without HF. Freedom from atrial arrhythmia recurrence ≥30 seconds, safety, and health care utilization over 12‐month follow‐up were analyzed. A total of 1303 patients (318 HF) were included. Patients with HF commonly had preserved left ventricular ejection fraction (81.6%), were more often women (45.6% versus 33.6%) with persistent AF (25.8% versus 14.3%), and had a larger left atrial diameter (4.4±0.9 versus 4.0±0.7 cm). Serious procedure‐related complications occurred in 4.1% of patients with HF and 2.6% of patients without HF ( P =0.188). Freedom from atrial arrhythmia recurrence was not different between cohorts with either paroxysmal AF (84.2% [95% CI, 78.6–88.4] versus 86.8% [95% CI, 84.2–89.0]) or persistent AF (69.6% [95% CI, 58.1–78.5] versus 71.8% [95% CI, 63.2–78.7]) ( P =0.319). After ablation, a reduction in AF‐related symptoms and antiarrhythmic drug use was observed in both cohorts (HF and no‐HF), and freedom from repeat ablation was not different between cohorts. Persistent AF and HF predicted a post‐ablation cardiovascular rehospitalization ( P =0.032 and P =0.001, respectively). Conclusions Cryoablation to treat patients with AF is similarly effective at 12 months in patients with and without HF. Registration URL: https://www.clinicaltrials.gov ; Unique Identifier: NCT02752737.

scholarly journals Safety of cryoballoon ablation for the treatment of atrial fibrillation: first European results from the Cryo AF Global Registry

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
KRJ Chun ◽  
C Foldesi ◽  
S Misikova ◽  
P Ptaszynski ◽  
D Todd ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Adverse Event ◽  
General Anesthesia ◽  
Real World ◽  
Univariate Analysis ◽  
Cryoballoon Ablation ◽  
Related Complication ◽  
Serious Adverse Events ◽  
Related Adverse Event ◽  
Global Registry

Abstract Funding Acknowledgements Type of funding sources: Other. Main funding source(s): Medtronic, Inc. OnBehalf Cryo AF Global Registry Investigators Background Since introduced in Europe over 15 years ago, cryoballoon ablation for the treatment of patients with atrial fibrillation (AF) has proven to be safe and effective. Purpose Report on patient and procedural characteristics, ablation techniques, and outcomes. Also, determine the independent predictors of a procedural adverse event in real-world usage. Methods Patients with AF were enrolled in the prospective, multicenter Cryo AF Global Registry (NCT02752737) and treated with cryoballoon ablation at 38 European centers according to standard-of-care. The primary efficacy endpoint was freedom from a ≥30 sec episode of AF/atrial flutter (AFL)/atrial tachycardia (AT) at 12-months. The primary safety endpoint was the rate of serious adverse events related to the device and/or procedure. Univariate and multivariable models identified baseline patient and procedural characteristics that predicted a serious procedure-related complication. Results: Of 1,418 subjects who completed an index procedure, the cohort was 62 ± 11 years of age, 37.7% female, and 72.2% paroxysmal AF (PAF). In total, 32.2% of patients were treated with cryoablation as a first-line therapy. Non-general anesthesia was used in 76.0% of procedures. Ablation adjunctive to the cryoballoon pulmonary vein isolation was applied in few cases: 2.0% of patients were treated with a cavotricuspid isthmus (CTI) line with focal radiofrequency ablation and 0.8% of patients received other non-PVI ablation. The mean procedure, left atrial dwell, and fluoroscopy times were 81 ± 34, 54 ± 25, and 14 ± 13 minutes, respectively. Among the 766 patients with 12-month follow-up, freedom from AF/AFL/AT recurrence ≥30 sec was 83.3% (95% CI: 79.8-86.3%) and 71.6% (95% CI: 64.6-77.4%) in patients with PAF and persistent AF, respectively. The serious procedure- and device-related adverse event rates were 4.7% and 2.0%, respectively. Female sex was significantly associated with the occurrence of an adverse event in univariate analysis (P < 0.05), but (after accounting for patient age and NYHA status) no baseline patient characteristic independently predicted a procedure-related adverse event. However, prolonged procedure duration (OR = 1.01 (95% CI: 1.00-1.01)), use of general anesthesia (OR = 1.71 (95% CI: 1.01 – 2.92)), and delivery of a CTI line (OR = 3.04 (95% CI: 1.01-9.20) were each independently associated with the occurrence of a serious procedural safety event (all P < 0.05). Conclusion: Cryoablation treated patients across the AF disease spectrum with one-third of patients treated prior to antiarrhythmic drug usage and another third treated for persistent AF. The results indicate extra diligence is warranted in patients under general anesthesia and for those who receive adjunctive CTI ablation. Cryoballoon ablation is consistently safe for patients independent of baseline patient characteristics and comorbidities in real-world use.

scholarly journals Clinical Applications of Laser Technology: Laser Balloon Ablation in the Management of Atrial Fibrillation

Micromachines ◽  
2021 ◽  
Vol 12 (2) ◽  
pp. 188
Author(s):  
Jamario R. Skeete ◽  
Jeanne M. Du-Fay-de-Lavallaz ◽  
David Kenigsberg ◽  
Carlos Macias ◽  
Jeffrey R. Winterfield ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Laser Energy ◽  
Clinical Applications ◽  
Ablation Techniques ◽  
Cryoballoon Ablation ◽  
Laser Technology ◽  
Balloon Ablation ◽  
Established Role ◽  
Laser Balloon Ablation ◽  
Laser Balloon

Catheter-based ablation techniques have a well-established role in atrial fibrillation (AF) management. The prevalence and impact of AF is increasing globally, thus mandating an emphasis on improving ablation techniques through innovation. One key area of ongoing evolution in this field is the use of laser energy to perform pulmonary vein isolation during AF catheter ablation. While laser use is not as widespread as other ablation techniques, such as radiofrequency ablation and cryoballoon ablation, advancements in product design and procedural protocols have demonstrated laser balloon ablation to be equally safe and effective compared to these other modalities. Additionally, strategies to improve procedural efficiency and decrease radiation exposure through low fluoroscopy protocols make this technology an increasingly promising and exciting option.

scholarly journals Technical and procedural comparison of two different cryoballoon ablation systems in patients with atrial fibrillation

2021 ◽  
Author(s):  
Sven Knecht ◽  
Christian Sticherling ◽  
Laurent Roten ◽  
Patrick Badertscher ◽  
Laurève Chollet ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Left Atrial Volume ◽  
Median Number ◽  
Volume Index ◽  
Group Differences ◽  
Cryoballoon Ablation ◽  
Left Atrial Volume Index ◽  
Ice Cap ◽  
Total Procedure Time ◽  
Catheter Design

Abstract Purpose The aim was to report procedural and technical differences of a novel cryoballoon (NCB) ablation catheter for pulmonary vein isolation (PVI) compared to the standard cryoballoon (SCB) catheter. Methods Consecutive patients with atrial fibrillation (AF) undergoing PVI using the NCB and the SCB were included. Procedural parameters, technical differences, acute efficacy, and safety are reported. Results Eighty patients (age 66 ± 10 years, ejection fraction 57 ± 10%, left atrial volume index 40 ± 6 ml/m2) were studied. With the NCB, 156 of 158 PVs (99%) were isolated compared to isolation of 159 of 159 PVs (100%) with the SCB. The median number of freezes in the NCB and the SCB group was 6 (IQR 5–8) and 5 (IQR 4–7), respectively (p = 0.051), with 73% and 71% of the PVs isolated with a single freeze, respectively. Nadir temperature and temperature at isolation were − 59 ± 6 °C and − 45 ± 17 °C in the NCB group and − 46 ± 7 °C and − 32 ± 23 °C in the SCB group, respectively (both p < 0.001) with no difference in time to isolation (TTI). Procedural differences were observed for the total procedure time (84 ± 29 min in the NCB group and 65 ± 17 min in the SCB group, p = 0.003). There was a peri-procedural stroke in one patient in the NCB group. Differences in catheter design were observed that may account for the differences in temperature recordings and ice cap formation. Conclusions Acute efficacy and TTI were similar with the NCB compared to the SCB. Measured temperatures were lower with the NCB, most likely due to differences in catheter design.

Fluoroscopy and contrast media use in cryoballoon ablation of atrial fibrillation using a novel imaging system

2021 ◽  
Author(s):  
Vincenzo Schillaci ◽  
Giuseppe Stabile ◽  
Alberto Arestia ◽  
Gergana Shopova ◽  
Alessia Agresta ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Contrast Media ◽  
Imaging System ◽  
Media Use ◽  
Cryoballoon Ablation

scholarly journals THE ROLE OF SMOKING ON CRYOBALLOON ABLATION OUTCOMES FOR PAROXYSMAL ATRIAL FIBRILLATION

2021 ◽  
Vol 77 (18) ◽  
pp. 324
Author(s):  
Abhishek Bose ◽  
Parag Anilkumar Chevli ◽  
Zeba Hashmath ◽  
Ajay K. Mishra ◽  
Gregory Berberian ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Paroxysmal Atrial Fibrillation ◽  
Cryoballoon Ablation
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