Long-term clinical outcomes after single freeze cryoballoon ablation for paroxysmal atrial fibrillation: a 5-year follow-up

Author(s):  
Giacomo Mugnai ◽  
Gaetano Paparella ◽  
Ingrid Overeinder ◽  
Erwin Ströker ◽  
Juan Sieira ◽  
...  
QJM ◽  
2020 ◽  
Vol 113 (Supplement_1) ◽  
Author(s):  
O H M A Riad ◽  
T Wong ◽  
A N Ali ◽  
M T Ibrahim ◽  
M A Abdelhamid ◽  
...  

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.


2017 ◽  
Vol 49 (1) ◽  
pp. 93-100 ◽  
Author(s):  
Ken Takarada ◽  
Ingrid Overeinder ◽  
Carlo de Asmundis ◽  
Erwin Stroker ◽  
Giacomo Mugnai ◽  
...  

Author(s):  
Ermengol Valles ◽  
Jesus Jimenez ◽  
Julio Martí-Almor ◽  
Jorge Toquero ◽  
Jose Ormaetxe ◽  
...  

Introduction: Cryoballoon ablation (CBA) has become a standard treatment for paroxysmal atrial fibrillation (PaAF) but limited data is available for outcomes in patients with persistent atrial fibrillation (PeAF). Methods: We analyzed the first 944 patients included in the Spanish Prospective Multi-center Observation Post-market Registry to compare characteristics and outcomes of patients undergoing CBA for PeAF versus PaAF. Results: A total of 944 patients (57.8±10.4 years; 70.1% male) with AF (27.9% persistent) were prospectively included from 25 centers. PeAF patients were more likely to have structural heart disease (67.7 vs 11.4%; p<0.001) and left atrium dilation (72.6 vs 43.3%; p<0.001). CBA of PeAF was less likely to be performed under general anesthesia (10.7 vs 22.2%; p<0.001), with an arterial line (32.2 vs 44.6%; p<0.001) and assisted transeptal puncture (11.9 vs 17.9%; p=0.025). During an application, PeAF patients had a longer time to -30°C (35.91±14.20 vs 34.93±12.87 sec; p=0.021) and a colder balloon nadir temperature during vein isolation (-35.04±9.58 vs -33.61±10.32ºC; p=0.004), but received fewer bonus freeze applications (30.7 vs 41.1%; p<0.001). There were no differences in acute pulmonary vein isolation and procedure-related complications. Overall, 76.7% of patients were free from AF recurrences at 15-month follow-up (78.9% in PaAF vs. 70.9% in PeAF; p=0.09). Conclusions: Patients with PeAF have a more diseased substrate, and CBA procedures performed in such patients were more simplified, although longer/colder freeze applications were often applied. The acute efficacy/safety profile of CBA was similar between PaAF and PeAF patients, but long-term results were better in PaAF patients.


Author(s):  
Igor Belluschi ◽  
Elisabetta Lapenna ◽  
Davide Carino ◽  
Cinzia Trumello ◽  
Manuela Cireddu ◽  
...  

Abstract OBJECTIVES Previous series showed the outcomes of thoracoscopic ablation of stand-alone symptomatic paroxysmal atrial fibrillation (AF) for up to 7 years of follow-up. The goal of this study was to assess the long-term durability of surgical pulmonary vein isolation (PVI) beyond 7 years. METHODS Fifty consecutive patients {mean age 55 [standard deviation (SD): 11.2] years, previous catheter ablation in 56%, left ventricular ejection fraction 60% (SD: 4.6), left atrium volume 65 ml (SD: 17)} with stand-alone symptomatic paroxysmal AF underwent PVI through bilateral thoracoscopy ablation between 2005 and 2014. The CHA2DS2-VASc score was ≥2 in 12 patients (24%). RESULTS No hospital deaths occurred. At hospital discharge all patients but 1 (2%) were in sinus rhythm (SR). Follow-up was 100% complete [mean 8.4 years (SD: 2.3), max 15]. The 8-year cumulative incidence function of AF recurrence, with death as a competing risk, on or off class I/III antiarrhythmic drugs (AADs)/electrocardioversion/re-transcatheter ablation (TCA) was 20% (SD: 5; 95% confidence interval: 10, 32); and off class I/III AADs/electrocardioversion/re-TCA was 52% (SD: 7; 95% confidence interval: 0.83, 8.02). At 8 years, the predicted prevalence of patients in SR was 87% and 53% were off class I/III AADs/electrocardioversion/re-TCA. The recurrent arrhythmia was AF in all patients except 2, who had atypical atrial flutter (4%). No predictors of AF recurrence were identified. At the last follow-up, 76% of the patients showed European Heart Rhythm Association class I. No strokes or thromboembolic events were documented and 76% of the subjects were off anticoagulation therapy. CONCLUSIONS Despite a considerable AF recurrence rate, our single-centre, long-term outcome of surgical PVI showed encouraging data, with the majority of patients remaining in SR, although many of them were on antiarrhythmic therapy.


2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Karapet Davtyan ◽  
Victoria Shatakhtsyan ◽  
Hermine Poghosyan ◽  
Alexandr Deev ◽  
Alexey Tarasov ◽  
...  

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.


Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Xue Zhao ◽  
Jianqiang Hu ◽  
Yan Huang ◽  
Yawei Xu ◽  
Yanzhou Zhang ◽  
...  

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


Author(s):  
Masaharu Masuda ◽  
Mitsutoshi Asai ◽  
Osamu Iida ◽  
Shin Okamoto ◽  
Takayuki Ishihara ◽  
...  

Introduction: The randomized controlled VOLCANO trial demonstrated comparable 1-year rhythm outcomes between patients with and without ablation targeting low-voltage areas (LVAs) in addition to pulmonary vein isolation among paroxysmal atrial fibrillation (AF) patients with LVAs. To compare long-term AF/atrial tachycardia (AT) recurrence rates and types of recurrent-atrial-tachyarrhythmia between treatment cohorts during a > 2-year follow-up period. Methods: An extended-follow-up study of 402 patients enrolled in the VOLCANO trial with paroxysmal AF, divided into 4 groups based on the results of voltage mapping: Group A, no LVA (n=336); group B, LVA ablation (n=30); group C, LVA presence without ablation (n=32); and group D, incomplete voltage map (n=4). Results: At 25 (23, 31) months after the initial ablation, AF/AT recurrence rates were 19% in group A, 57% in group B, 59% in group C, and 100% in group D. Recurrence rates were higher in patients with LVAs than those without (group A vs. B+C, p<0.0001), and were comparable between those with and without LVA ablation (group B vs. C, p=0.83). Among patients who underwent repeat ablation, ATs were more frequently observed in patients with LVAs (Group B+C, 50% vs. A, 14%, p<0.0001). In addition, LVA ablation increased the incidence of AT development (group B, 71% vs. C, 32%, p<0.0001), especially biatrial tachycardia (20% vs. 0%, p=0.01). Conclusion: Patients with LVAs demonstrated poor long-term rhythm outcomes irrespective of LVA ablation. ATs were frequently observed in patients with LVAs, and LVA ablation might exacerbate iatrogenic ATs.


Author(s):  
Hisashi Ogawa ◽  
Yoshimori An ◽  
Kenjiro Ishigami ◽  
Syuhei Ikeda ◽  
Kosuke Doi ◽  
...  

Abstract Aims Oral anticoagulants reduce the risk of ischaemic stroke but may increase the risk of major bleeding in atrial fibrillation (AF) patients. Little is known about the clinical outcomes of patients after a major bleeding event. This study assessed the outcomes of AF patients after major bleeding. Methods and results The Fushimi AF Registry is a community-based prospective survey of the AF patients in Fushimi-ku, Kyoto, Japan. Analyses were performed on 4304 AF patients registered by 81 institutions participating in the Fushimi AF Registry. We investigated the demographics and outcomes of AF patients who experienced major bleeding during follow-up period. During the median follow-up of 1307 days, major bleeding occurred in 297 patients (6.9%). Patients with major bleeding were older than those without (75.6 vs. 73.4 years; P &lt; 0.01). They were more likely to have pre-existing heart failure (33.7% vs. 26.7%; P &lt; 0.01), history of major bleeding (7.7% vs. 4.0%; P &lt; 0.01), and higher mean HAS-BLED score (2.05 vs.1.73; P &lt; 0.01). On landmark analysis, ischaemic stroke or systemic embolism occurred in 17 patients (3.6/100 person-years) after major bleeding and 227 patients (1.7/100 person-years) without major bleeding, with an adjusted hazard ratio (HR) of 1.93 [95% confidence interval (CI), 1.06–3.23; P = 0.03]. All-cause mortality occurred in 97 patients with major bleeding (20.0/100 person-years) and 709 (5.1/100 person-years) patients without major bleeding [HR 2.73 (95% CI, 2.16–3.41; P &lt; 0.01)]. Conclusion In this community-based cohort, major bleeding is associated with increased risk of subsequent all-cause mortality and thromboembolism in the long-term amongst AF patients. Trial registration https://www.umin.ac.jp/ctr/index.htm. Unique identifier: UMIN000005834. (last accessed 22 October 2020)


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