Radiofrequency versus Cryoballoon Ablation of Atrial Fibrillation: An Evaluation Using ECG, Holter Monitoring, and Implantable Loop Recorders to Monitor Absolute and Clinical Effectiveness

Introduction. While several studies have compared the radiofrequency current (RFC) and cryoablation for the treatment of patients with atrial fibrillation (AF), no study has monitored the long-term outcomes with the usage of implantable loop recorders (ILRs). Methods. We enrolled 89 consecutive patients with nonvalvular paroxysmal AF (N=44 for RFC and N=45 for cryoballoon). The primary efficacy end point was the assessment of effectiveness for each group (RFC versus cryoballoon) when examining freedom from arrhythmia by monitoring with ECG, Holter, and implantable loop recoder (ILR). The primary safety end point compared rates of adverse events between both groups. The secondary efficacy end point examined the duration of the postablation blanking period from ILR retrieved data. Results. The mean age of the study population was 56.6±10.2 years, and the follow-up duration was 12 months. There were no differences in baseline patient characteristics between groups. At 12 months, the absolute effectiveness (measured by ILR) was 65.9% in the RFC group and 51.1% in the cryoballoon group (OR = 1.85; 95% CI: 0.79–4.35; p=0.157), and the clinical effectiveness (measured by ECG and Holter) was 81.8% in the RFC group and 55.6% in the cryoballoon group (OR = 3.6; 95% CI: 1.37–9.46; p=0.008). There was no difference in safety between both groups. Asymptomatic episodes were significantly more present in the RFC group as measured by ILRs (p<0.010). In cryoballoon group, arrhythmia episodes were recorded equally irrespective of the follow-up method (i.e., ECG and Holter versus ILR (p>0.010)). The blanking period does not seem to be as important in cryoballoon as compared to RFC. Conclusion. RFC and cryoballoon ablation had similar absolute effectiveness at 12 months. ECG and Holter were effective when assessing the efficacy of the cryoballoon ablation; however, in the RFC group, ILR was necessary to accurately assess long-term efficacy.

Download Full-text

Abstract 18649: Long-term Outcome and the Mechanisms of Pulmonary Antrum Radial-linear Ablation in Patients With Paroxysmal Atrial Fibrillation

Circulation ◽

10.1161/circ.132.suppl_3.18649 ◽

2015 ◽

Vol 132 (suppl_3) ◽

Author(s):

Xue Zhao ◽

Jianqiang Hu ◽

Yan Huang ◽

Yawei Xu ◽

Yanzhou Zhang ◽

...

Keyword(s):

Atrial Fibrillation ◽

Paroxysmal Atrial Fibrillation ◽

Holter Monitoring ◽

Pericardial Tamponade ◽

Term Outcome ◽

Long Term Outcome ◽

Long Term Follow Up ◽

One Year

Objectives: The aim of this study was to determine the mechanisms and effectiveness of pulmonary antrum radial-linear (PAR) ablation in comparison with pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (AF) after a long-term follow-up. Background: The one-year follow up data suggested that PAR ablation appeared to have a better outcome over the conventional PVI for paroxysmal AF. Methods: The enrollment occurred between March, 2011, and August, 2011, with the last follow-up in May, 2014. A total of 133 patients with documented paroxysmal AF were enrolled from 5 centers and randomized to PAR group or PVI group. Event ECG recorder and Holter monitoring were conductedduring the follow-up for all patients. Results: The average procedure time was 151±23 min in PAR group and 178±43 min in PVI group ( P <0.001). The average fluoroscopy time was 21±7 min in PAR group and 27±11 min in PVI group ( P= 0.002). AF triggering foci were eliminated in 59 patients (89.4%) in PAR group, whereas, only 4 patients (6.0%) in PVI group (P<0.001).At median 36 (37-35) months of follow-up after single ablation procedure, 43 of 66 patients in PAR group (65%) and 28 of 67 patients in PVI group (42%) had no recurrence of AF off antiarrhythmic drug (AAD) (P=0.007); and 47 of 66 patients in PAR group (71%) and 32 of 67 patients in PVI group (48%) had no recurrence of AF with AAD (P=0.006). At the last follow-up, the burden of AF was significantly lower in PAR group than in PVI group (0.9% ± 2.3% vs 4.9% ± 9.9%;90th percentile, 5.5% vs 19.6%; P=0.008). No major adverse event (death, stroke, PV stenosis) was observed in all the patients except one case of pericardial tamponade. Conclusions: PAR ablation is a simple, safe, and effective strategy for the treatment of paroxysmal AF with better long-term outcome than PVI. PAR ablation might exhibit the beneficial effect on AF management through multiple mechanisms. Registration: ChiCTR-TRC-11001191

Download Full-text

Stroke and left atrial thrombi after cryoballoon ablation of atrial fibrillation: incidence and predictors. Results from a long-term follow-up

Journal of Thrombosis and Thrombolysis ◽

10.1007/s11239-020-02148-x ◽

2020 ◽

Author(s):

Francesco Santoro ◽

Natale Daniele Brunetti ◽

Andreas Rillig ◽

Bruno Reissmann ◽

Christine Lemeš ◽

...

Keyword(s):

Atrial Fibrillation ◽

Left Atrial ◽

Cryoballoon Ablation ◽

Long Term Follow Up ◽

Atrial Thrombi

Download Full-text

073_16772-H5 First Long-Term Redo Experiences With Cryo After Cryoballoon Ablation for Atrial Fibrillation: A Two-Year Follow-Up Registry

JACC: Clinical Electrophysiology ◽

10.1016/j.jacep.2017.09.043 ◽

2017 ◽

Vol 3 (10) ◽

pp. S9-S10

Author(s):

S.W. Westra ◽

S.P.G. van Vugt ◽

S. Sezer ◽

R. Evertz ◽

R.J. Beukema ◽

...

Keyword(s):

Atrial Fibrillation ◽

Cryoballoon Ablation

Download Full-text

P2834Diagnostic yield of holter recording after atrial fibrillation ablation - detection of asymptomatic recurrences during a one-year follow-up period

European Heart Journal ◽

10.1093/eurheartj/ehz748.1144 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

S P G Van Vugt ◽

R H J A Volleberg ◽

S W Westra ◽

J Thannhauser ◽

R Evertz ◽

...

Keyword(s):

Atrial Fibrillation ◽

Catheter Ablation ◽

Diagnostic Yield ◽

Holter Monitoring ◽

Implantable Devices ◽

Cryoballoon Ablation ◽

Procedural Success ◽

One Year ◽

The One

Abstract Background Strategies to detect recurrences after atrial fibrillation (AF) catheter ablation vary widely. Whereas a symptom-based approach may overestimate procedural success due to asymptomatic recurrences, continuous invasive monitoring with implantable devices may be refused by patients and is not routinely recommended. In trial settings, Holter monitoring is recommended at one year after ablation, though more frequent and intensive follow-up is encouraged for more accurate detection of arrhythmia recurrences. Purpose To study the diagnostic yield of Holter monitoring in the detection of asymptomatic recurrent arrhythmias after cryoballoon catheter ablation for AF. Methods Prospective registry on AF patients who underwent cryoballoon ablation with subsequent follow-up in our centre. Follow-up comprised routine (i.e. at 3, 6, and 12 months) and symptom-driven electrocardiographic (ECG) registrations after a three-month blanking period. In addition, patients were scheduled for six-day Holter monitoring shortly after the blanking period, at six months and at the end of the one-year follow-up period. For the current analysis, we studied the Holter recordings of the patients without previously detected arrhythmia recurrence and determined the proportion of asymptomatic recurrences at each respective monitoring period. Results We studied 364 patients with a median age of 60 years (IQR 54–66) and a median CHA2DS2-VASc score of 1 (IQR 1–2). One-year recurrences were documented in 119 (32.7%) patients, of which 90 were initially detected on Holter recording and 39 on ECG registrations (Table). A total of 34 patients did not report symptoms during the documentation of recurrent arrhythmia and comprised 28.6% (34/119) of all recurrences and 37.8% (34/90) of the Holter-detected recurrences. At the three-month Holter registration, 33.3% of the patients with recurrences did not report symptoms, which was 29.4% and 62.5% at the six- and twelve-month registrations, respectively (Figure). Timing and detection of recurrences Time after ablation 3 months 3–6 months 6 months 6–12 months 12 months Patients with Holter-detected recurrences 57/119 (47.9%) 17/119 (14.3%) 16/119 (13.4%) Patients with ECG-documented recurrences 18/119 (15.1%) 11/119 (9.2%) Proportions of asymptomatic recurrences Conclusions In this cohort of AF patients with serial six-day Holter monitoring after cryoballoon ablation, up to one-third of the patients had asymptomatic recurrences. Whereas Holter monitoring shortly after the blanking period detected nearly half of all one-year recurrences, the proportion of asymptomatic detected recurrences was higher in recordings at one year and seems therefore important in the detection of asymptomatic recurrences after catheter ablation.

Download Full-text

GW25-e1142 Long-term follow-up outcome of cryoballoon ablation for atrial fibrillation from single center

Journal of the American College of Cardiology ◽

10.1016/j.jacc.2014.06.760 ◽

2014 ◽

Vol 64 (16) ◽

pp. C165

Author(s):

Liu Jun ◽

Ming Tang ◽

Yan Kaufmann ◽

Charalampos Kriatselis ◽

Eckart Fleck ◽

...

Keyword(s):

Atrial Fibrillation ◽

Cryoballoon Ablation ◽

Single Center ◽

Long Term Follow Up

Download Full-text

Safety and outcome of cryoballoon ablation versus radiofrequency catheter ablation of the pulmonary veins in patients with paroxysmal atrial fibrillation

QJM ◽

10.1093/qjmed/hcaa041.027 ◽

2020 ◽

Vol 113 (Supplement_1) ◽

Author(s):

O H M A Riad ◽

T Wong ◽

A N Ali ◽

M T Ibrahim ◽

M A Abdelhamid ◽

...

Keyword(s):

Atrial Fibrillation ◽

Radiofrequency Ablation ◽

Catheter Ablation ◽

Pulmonary Vein ◽

Paroxysmal Atrial Fibrillation ◽

Pulmonary Veins ◽

Cryoballoon Ablation ◽

The Mean

Abstract Background Pulmonary vein isolation (PVI) has become the mainstay of catheter ablation of atrial fibrillation (AF). There are two commonly used methods to isolate the pulmonary veins, either point-by-point delivery of circumferential lesion sets around ipsilateral pulmonary veins using radiofrequency energy, or the application of the cryoballoon to the pulmonary vein antrum with occlusion of the vein ostium. The cryoballoon has proven to be a reliable alternative to radiofrequency ablation in acute and long-term freedom from AF. We describe our results using both modalities. Aim and Objectives to compare the safety and efficacy of cryoballoon (CB) ablation and radiofrequency (RF) ablation in treatment of paroxysmal atrial fibrillation. Patients and Methods Forty-four consecutive patients having paroxysmal AF underwent PVI using the second generation cryoballoon were compared to a retrospective cohort of 69 patients who had radiofrequency induced PVI, either by conventional RF catheter (n = 32), or a contact-force sensing-catheter (n = 37). The study took place at Ain Shams university hospitals and Royal Brompton & Harefield NHS trust. Patient data, procedural data and follow up data- at 3, 6 and 12 months- were collected and analysed. Recurrence was defined as documented AF or atrial arrhythmias with duration exceeding 30 seconds, either by 12 lead ECG or an ambulatory monitoring device. Results A total of 113 patients were studied. The mean age was 53.84 ± 15.01 for the CB group and 55.78 ± 14.84 for the RF group and females representing 40.9% vs 34.8% respectively. The mean procedural times in minutes were significantly less in the CB group (94.37 ± 39.32 vs 184.57 ± 88.19, p < 0.0001), while the median fluoroscopy times were similar [30 (11.04 - 40) vs 37.25 (14.2 - 70), p = 0.172]. Procedural complications were comparable between the two groups (p = 0.06) with 1 patient (2.3%) having long term phrenic nerve paresis. At 1 year follow up, after an initial 90-day blanking period, recurrence rate of CB was similar to RF (27.3% vs 30.4% respectively, p = 0.719), the Kaplan Meier estimates of AF- free survival for a period of 1 year were comparable between both groups (log rank test, p = 0.606). Conclusion Cryoballoon is a feasible method for pulmonary vein isolation with similar success rates to radiofrequency ablation. Cryoballoon ablation is safe with shorter duration of the procedure.

Download Full-text

Acute and Long-term Outcomes of Cryoballoon Ablation in Patients with Atrial Fibrillation. Primary Results of the Spanish Cryoballoon Ablation Registry (RECABA)

10.21203/rs.3.rs-440392/v1 ◽

2021 ◽

Author(s):

Ángel Ferrero Loma-Osorio ◽

Rocío Cózar ◽

Arcadio García-Alberola ◽

Ermengol Valles ◽

Alberto Barrera ◽

...

Keyword(s):

Atrial Fibrillation ◽

Real World ◽

Standard Of Care ◽

Patient Characteristics ◽

Early Recurrence ◽

Cryoballoon Ablation ◽

Procedural Time ◽

Secondary Endpoints ◽

Procedural Strategy

Abstract Background Cryoablation is safe and effective for the treatment of atrial fibrillation (AF) in controlled clinical trials, but contemporary real-world usage and outcomes are limited. Objectives The Report of the Spanish Cryoballoon Ablation Registry (RECABA) was designed to evaluate acute and 12-month outcomes of cryoballoon ablation for the treatment of AF in Spain. Methods Patients from 27 Spanish centers were prospectively enrolled. Patients were treated with cryoballoon ablation and managed according to standard of care protocols at each center. Theprimary endpoint was ≥ 30 sec freedom from AF at 12-mo after a 3-mo blanking period. Secondary endpoints included a description of patient characteristics, cryoablation procedural strategy and safety, and predictors of efficacy. Results In total, 1742 patients (71.4% PAF, 68.8% male, mean age 58.02 ± 10.40 years, 76.1% overweight or obese, CHA2DS2-VASc index 1.40 ± 1.28) were enrolled. Patients received 7.2 ± 2.67 cryoapplications. PV potentials could be detected in 61% of the PVs during ablation, with a mean time to block of 52.9 ± 37.02 seconds. Acute PVI was observed in 97% of PVs with 75.8% isolated with the first cryoapplication. Mean procedural time was 113 ± 41 minutes. Acute complications occurred in 4.4% of the cases21. With follow-up in 1628 patients, AF-free survival was 78.5% (PAF: 80.6% vs PersAF 73.3%; p < 0.001). Left atrium enlargement, female sex, non-PAF, and early recurrence were independent predictors of AF recurrence (p < 0.05). Conclusions RECABA provides detailed insight into current dosing practices and demonstrates cryoablation is safe and effective in real-world use.

Download Full-text

Primary results of the Spanish Cryoballoon Ablation Registry: acute and long-term outcomes of the RECABA study

Scientific Reports ◽

10.1038/s41598-021-96655-3 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Ángel Ferrero-De-Loma-Osorio ◽

Rocío Cózar ◽

Arcadio García-Alberola ◽

Ermengol Valles ◽

Alberto Barrera ◽

...

Keyword(s):

Real World ◽

Standard Of Care ◽

Patient Characteristics ◽

Early Recurrence ◽

Cryoballoon Ablation ◽

Procedural Time ◽

Secondary Endpoints ◽

Procedural Strategy

AbstractCryoablation is safe and effective for the treatment of atrial fibrillation (AF) in controlled clinical trials, but contemporary real-world usage and outcomes are limited. The Report of the Spanish Cryoballoon Ablation Registry (RECABA) was designed to evaluate acute and 12-month outcomes of cryoballoon ablation for the treatment of AF in Spain. Patients from 27 Spanish centers were prospectively enrolled. Patients were treated with cryoballoon ablation and managed according to standard of care protocols at each center. The primary endpoint was ≥ 30 s freedom from AF at 12-month after a 3-month blanking period. Secondary endpoints included a description of patient characteristics, cryoablation procedural strategy and safety, and predictors of efficacy. In total, 1742 patients (71.4% PAF, 68.8% male, mean age 58.02 ± 10.40 years, 76.1% overweight or obese, CHA2DS2-VASc index 1.40 ± 1.28) were enrolled. Patients received 7.2 ± 2.67 cryo-applications. PV potentials could be detected in 61% of the PVs during ablation, with a mean time to block of 52.9 ± 37.02 s. Acute PVI was observed in 97% of PVs with 75.8% isolated with the first cryo-application. Mean procedural time was 113 ± 41 min. Acute complications occurred in 4.4% of the cases. With follow-up in 1628 patients, AF-free survival was 78.5% (PAF: 80.6% vs PersAF 73.3%; p < 0.001). Left atrium enlargement, female sex, non-PAF, and early recurrence were independent predictors of AF recurrence (p < 0.05). RECABA provides detailed insight into current dosing practices and demonstrates cryoablation is safe and effective in real-world use.ClinicalTrials.gov number: NCT02785991.

Download Full-text

Predictive role of early recurrence of atrial fibrillation after cryoballoon ablation

EP Europace ◽

10.1093/europace/euaa239 ◽

2020 ◽

Vol 22 (12) ◽

pp. 1798-1804 ◽

Cited By ~ 1

Author(s):

Giuseppe Stabile ◽

Saverio Iacopino ◽

Roberto Verlato ◽

Giuseppe Arena ◽

Paolo Pieragnoli ◽

...

Keyword(s):

Atrial Fibrillation ◽

Strong Predictor ◽

Early Recurrence ◽

Cryoballoon Ablation ◽

Term Outcome ◽

Long Term Outcome ◽

Group B ◽

Af Recurrence

Abstract Aims The aims of this study were to determine the rate and the predictors of early recurrences of atrial fibrillation (ERAF) after cryoballoon (CB) ablation and to evaluate whether ERAF correlate with the long-term outcome. Methods and results Three thousand, six hundred, and eighty-one consecutive patients (59.9 ± 10.5 years, female 26.5%, and 74.3% paroxysmal AF) were included in the analysis. Atrial fibrillation recurrence, lasting at least 30 s, was collected during and after the 3-month blanking period. Three-hundred and sixteen patients (8.6%) (Group A) had ERAF during the blanking period, and 3365 patients (Group B) had no ERAF. Persistent AF and number of tested anti-arrhythmic drugs ≥2 resulted as significant predictors of ERAF. After a mean follow-up of 16.8 ± 16.4 months, 923/3681 (25%) patients had at least one AF recurrence. The observed freedom from AF recurrence, at 24-month follow-up from procedure, was 25.7% and 64.8% in Groups A and B, respectively (P < 0.001). ERAF, persistent AF, and number of tested anti-arrhythmic drugs ≥2 resulted as significant predictors of AF. In a propensity score matching, the logistic model showed that ERAF 1 month after ablation are the best predictor of long-term AF recurrence (P = 0.042). Conclusion In patients undergoing CB ablation for AF, ERAF are rare and are a strong predictor of AF recurrence in the follow-up, above all when occur >30 days after the ablation.

Download Full-text