Safety and efficacy of persistent atrial fibrillation ablation using the second-generation cryoballoon

PubMed ID: 29492703Background: The second-generation cryoballoon (CB) is increasingly used for treatment of persistent atrial fibrillation (AF). Data regarding the clinical outcome and mechanism of arrhythmia recurrence following persistent AF ablation using CB is sparse. In this study, we aimed to assess the efficacy of CB and mechanisms of atrial tachyarrhythmia (ATA) recurrence in patients with persistent AF. Methods and results: A total of 133 patients (66 ± 10 years, 60% male) with symptomatic persistent AF, who were scheduled for PVI using the second-generation CB were enrolled. Follow-up included 24 h Holter recording at 3, 6 and 12 months. Any documented episode of ATA lasting more than 30 s was considered as a recurrent arrhythmic event. All targeted veins were isolated (100%). Phrenic nerve palsy with recovery during follow-up occurred in six patients (4.5%), no patient experienced tamponade or a cerebrovascular event. During 12.6 ± 5.4 months of follow-up, 89/133 (67%) patients were free of ATA recurrences. Multivariable analysis revealed recurrence in the blanking period (HR 11.46, 0.95 CI 3.92–33.49, p < 0.001), presence of cardiomyopathy (HR 2.75, 0.95 CI 1.09–6.96, p = 0.032) and PV abnormality (HR 3.56, 0.95 CI 1.21–10.43, p = 0.021) as predictors for late recurrence. Conclusion: In patients with persistent AF, second-generation cryoballoon use is associated with an excellent safety profile and favorable outcomes. Arrhythmia recurrence during the blanking period, presence of cardiomyopathy and PV abnormality were independent predictors of long-term AF recurrence. © 2018, Springer-Verlag GmbH Germany, part of Springer Nature.Acknowledgements K. Yalin recieved research and educational grant from Turkish Society of Cardiology. E. Lyan received travel grants and Speaker’s Bureau Honoraria from Biosense Webster, Medtronic, Boston Scientific. R. Tilz received travel grants from St. Jude Medical, Topera, Biosense Webster, Daiichi Sankyo, Sentrheart and Speaker’s Bureau Honoraria from Biosense Webster, Biotronik, Pfizer, Topera, Bristol-Myers Squibb; Bayer, Sanofi Aventis

Mechanism, underlying substrate and predictors of atrial tachycardia following atrial fibrillation ablation using the second-generation cryoballoon

PubMed ID: 30878353Background: Data regarding atrial tachycardia (AT) following second-generation cryoballoon ablation (CBA) of atrial fibrillation (AF) are limited. Aim: To describe the incidence, mechanisms, and clinical predictors of ATs following CBA. Methods and results: In this retrospective single-center study 238 patients undergoing CBA for treatment of paroxysmal (91/238; 38.2%) or persistent AF were analyzed. During a mean follow-up of 11.9 ± 5.5 months recurrence of AF occurred in 49/238 patients (20.6%) and AT in 27/238 (11.3%). Twenty-six patients with AT and 14 with AF only underwent a redo ablation. The prevailing mechanism of AT was macroreentry [typical atrial flutter (AFL) (n = 10), left atrial macroreentry (n = 14), focal left-AT (n = 2)]. Non-cavotricuspid-isthmus-dependent macroreentry right-AT was mapped and ablated in 3 patients after initial AFL ablation. In a multivariate regression model, persistent type of AF (HR = 3.3; CI = 1.2–9.4), cardiomyopathy (HR = 3.5; CI = 1.5–8.4), treatment with beta-blockers (HR = 0.3; CI = 0.1–0.6), and pulmonary vein-abnormality (HR = 4.6; CI = 2.1–10.4) were independent predictors of AT. Substrate analysis revealed a significantly higher number of low voltage areas in the left atrium in patients with left-AT in comparison to patients with AF recurrence only (2.0; IQR=2.0?4.0 vs. 0.5; IQR = 0.0–2.25; p = 0.005). Conclusion: In this study, AT after CBA occurred in 11.3% of patients with macroreentry being the prevalent mechanism. All patients with left-AT presented with low voltage areas in the left atrium, suggesting a more progressive underlying fibrotic disease in these patients. © 201

Preventive ventricular tachycardia ablation in patients with ischaemic cardiomyopathy: Meta-analysis of randomised trials

Catheter ablation of ventricular tachycardia (VT) aims to treat the underlying arrhythmia substrate to prevent ICD therapies. The aim of this meta-analysis was to assess the safety and efficacy of VT ablation prior to or at the time of secondary prevention ICD implantation in patients with coronary artery disease, as compared with deferred VT ablation. Based on a systematic literature search, three randomised trials were considered eligible for inclusion in this analysis, and data on the number of patients with appropriate ICD shocks, appropriate ICD therapy, arrhythmic storm, death and major complications were extracted from each study. On pooled analysis, there was a significant reduction of appropriate ICD shocks (OR 2.58; 95% CI [1.54-4.34]; p<0.001) and appropriate ICD therapies (OR 2.04; 95% CI [1.15-3.61]; p=0.015) in patients undergoing VT ablation at the time of ICD implantation without significant differences with respect to complications (OR 1.39; 95% CI [0.43-4.51]; p=0.581). Mortality did not differ between both groups (OR 1.30; 95% CI [0.60-2.45]; p=0.422). Preventive catheter ablation of VT in patients with coronary heart disease at the time of secondary prevention ICD implantation results in a significant reduction of appropriate ICD shocks and any appropriate ICD therapy compared with patients without or with deferred VT ablation. No significant difference with respect to complications or mortality was observed between both treatment strategies. © 2019 RADCLIFFE CARDIOLOGY.Türk Kardiyoloji DerneğiDisclosure: RT received research grants from Hansen, Abbot, Medtronic and Biotronik; travel grants from Biosense Webster, Medtronic, Abbot, Sentrheart and Daiichi Sankyo; speakers’ bureau honoraria/proctor for Biosense Webster, Medtronic, Abbot, Biotronik, Boston Scientific, Pfizer, Bristol-Myers Squibb, Bayer, Sanofi Aventis and AstraZeneca; and worked as a consultant for Biosense Webster and Biotronik. CE received presentation fees from Bayer, Biosense Webster, Impulse Dynamic, St Jude Medical/Abbott, Pfizer, Liva Nova, Zoll, Boston Scientific, Novartis, Daiichi Sankyo and AstraZeneca; and travel grants from St Jude Medical, Biotronik and Medtronic. EL received travel grants from Biosense Webster, Abbott, Medtronic and Boston Scientific; and speakers’ bureau honoraria from Biosense Webster and Abbott. KY received an educational and research grant from the Turkish Society of Cardiology. All other authors have no conflicts of interest to declare. Received: 19 March 2019 Accepted: 17 June 2019 Citation: Arrhythmia & Electrophysiology Review 2019;8(3):173–9. DOI: https://doi.org/10.15420/aer.2019.31.3 Correspondence: Riccardo Proietti, Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Via Giustiniani 2, 35121 Padua, Italy. E: [email protected] Open Access: This work is open access under the CC-BY-NC 4.0 License which allows users to copy, redistribute and make derivative works for non-commercial purposes, provided the original work is cited correctly

Second-generation cryoballoon for pulmonary vein isolation in patients with pulmonary vein abnormality: Safety, efficacy and lessons from re-ablation procedures

PubMed ID: 30170919Second generation cryoballoon (CB) has been shown to be effective for treatment of paroxysmal and persistent atrial fibrillation (AF). However, the fixed size of the non-compliant balloon may limit its use in patients with pulmonary vein (PV) abnormalities. In this study we investigated the acute success, procedural complications and long term outcome of CB based PV isolation (PVI) in patients with PV abnormality. A total of 238 patients [64.8 ± 11.1 years; 91 paroxysmal (38.2%), 147 persistent AF (61.8%)] underwent PVI using the second generation CB without preprocedural imaging. In 43/238 (18.1%) patients PV abnormality (left common PV in 26, right middle PV in 20) was observed. All targeted veins including abnormal PVs were isolated (100%). Transient phrenic nerve palsy (PNP) occurred in one (2.3%) patient in the PV anomalous group and 6 (3.0%) in the control group (p = NS). There was no other adverse event including PV stenosis, atrio-esophageal fistula or cerebrovascular events related to the procedure. During mean follow-up of 11.8 ± 5.4 month a total of 59 patients (24.7%) had atrial tachyarrhythmia (ATA) recurrence [27 (11.3%) had AT recurrence]. In the PV anomalous group, 20/43 (46.5%) patients had ATA recurrence compared to 39/195 (20%) in the control group (p < 0.001). AT recurrence was observed in 27 (11.3) patients [11 (25.5%) in the PV anomalous group and 16 (8.2%) in controls respectively, p = 0.003]. In patients with PV abnormality CB-based AF ablation results in a similar acute PVI rate but a higher ATA recurrence rate during follow up as compared to patients without PV abnormality. © 2018 Elsevier B.V.Türk Kardiyoloji Derneği, TKDK. Yalin received research and educational grant from Turkish Society of Cardiology . E. Lyan received travel grants and Speaker's Bureau Honoraria from Biosense Webster, Medtronic, Boston Scientific. R. Tilz received travel grants from St. Jude Medical, Topera, Biosense Webster, Daiichi Sankyo, Sentrheart and Speaker's Bureau Honoraria from Biosense Webster, Biotronik, P zer, Topera, Bristol-Myers Squibb; Bayer, Sano Aventis

Safety and efficacy of cryoballoon ablation for the treatment of atrial fibrillation in elderly patients

PubMed ID: 30187178Background: Catheter ablation (CA) is an established therapy for treatment of atrial fibrillation (AF). However, data about AF ablation using the cryoballoon (CB) in the elderly population are sparse. The aim of this single center retrospective study is to evaluate the safety and efficacy of CB ablation in patients ? 75 years compared to patients < 75 years. Methods and results: Fifty-five consecutive patients aged ? 75 years (elderly group) were compared with 183 patients aged < 75 years (control group). All patients underwent pulmonary vein isolation (PVI) using the second-generation CB. The mean age in the elderly group was 78 ± 2.8 years and 60.8 ± 9.5 in the control group (p < 0.001). During 11.8 ± 5.4 months of follow-up, single procedure success rate for the elderly and the control group was 72.8 and 76%, respectively (p = 0.37). During redo ablation (n = 40), low-voltage areas in the LA were more frequently observed in elderly patients compared to the control group [1.0 (IQR 0–2.0) segments vs 2.0 (IQR 2.0–3.0) segments, respectively, p = 0.03]. The most common complication was transient phrenic nerve palsy, which only occurred in patients < 75 years (0 vs 7, p = 0.33). No severe complication such as procedure-related deaths, atrio-esophageal fistula, or cerebrovascular embolic events occurred. Conclusions: Our data strengthen the value of CB ablation for the treatment of AF as an effective and safe procedure in elderly patients, with similar success and complication rates when compared with a younger population. © 2018, Springer-Verlag GmbH Germany, part of Springer Nature.Conflict of interest K. Yalin received research and educational grant from Turkish Society of Cardiology. E. Lyan received travel grants and Speaker’s Bureau Honoraria from BiosenseWebster, Medtronic, Boston Scientific. R. Tilz received travel grants from St. Jude Medical, Topera, BiosenseWebster, Daiichi Sankyo, Sentrheart and Speaker’s Bureau Honoraria from BiosenseWebster, Biotronik, Pfizer, Topera, Bristol-Myers Squibb; Bayer, Sanofi Aventis. Christian Heeger received travel grants and research grants by Medtronic, Claret Medical and SentreHeart. All other authors have no disclosures

Acute procedural efficacy and safety of a novel cryoballoon for the treatment of paroxysmal atrial fibrillation: Results from the POLAR ICE study

Introduction: Pulmonary vein isolation (PVI) is well established as a primary treatment for atrial fibrillation (AF). The POLAR ICE study was designed to collect prospective real world data on the safety and effectiveness of the POLARxTM cryoballoon for PVI to treat paroxysmal AF. Methods: POLAR ICE, a prospective, non-randomized, multicenter (international) registry (NCT04250714), enrolled 399 patients across 19 European centers. Procedural characteristics, such as time to isolation, cryoablations per pulmonary vein (PV), balloon nadir temperature, and occlusion grade were recorded. PVI was confirmed with entrance block testing. Results: Data on 372 de novo PVI procedures (n = 2190 ablations) were collected. Complete PVI was achieved in 96.8% of PVs. Procedure and fluoroscopy times were 68.2 ± 24.6 and 15.6 ± 9.6 min, respectively. Left atrial dwell time was 46.6 ± 18.3 min. Grade 3 or 4 occlusion was achieved in 98.2% of PVs reported and 71.2% of PVs isolation required only a single cryoablation. Of 2190 cryoapplications, 83% had a duration of at least 120 s; nadir temperature of these ablations averaged −56.3 ± 6.5°C. There were 6 phrenic nerve palsy events, 2 of which resolved within 3 months of the procedure. Conclusion: This real-world usage data on a novel cryoballoon suggests this device is effective, safe, and relatively fast in centers with cryoballoon experience. These data are comparable to prior POLARx reports and in keeping with reported data on other cryoballoons. Future studies should examine the long-term outcomes and the relationship between biophysical parameters and outcomes for this novel cryoballoon

Outcomes of cryoballoon or radiofrequency ablation in symptomatic paroxysmal or persistent atrial fibrillation

Aims: To evaluate the effectiveness and safety of cryoballoon ablation (CBA) compared with radiofrequency ablation (RFA) for symptomatic paroxysmal or drug-refractory persistent atrial fibrillation (AF). Methods and results: Prospective cluster cohort study in experienced CBA and RFA centres. Primary endpoint was 'atrial arrhythmia recurrence', secondary endpoints were as follows: procedural results, safety, and clinical course. A total of 4189 patients were included: CBA 2329 (55.6%) and RFA 1860 (44.4%). Cryoballoon ablation population was younger, with fewer comorbidities. Procedure time was longer in the RFA group (P = 0.01). Radiation exposure was 2487 (CBA) and 1792 cGycm2 (RFA) (P < 0.001). Follow-up duration was 441 (CBA) and 511 days (RFA) (P < 0.0001). Primary endpoint occurred in 30.7% (CBA) and 39.4% patients (RFA) [adjusted hazard ratio (adjHR) 0.85, 95% confidence interval (CI) 0.70-1.04; P = 0.12). In paroxysmal AF, CBA resulted in a lower risk of recurrence (adjHR 0.80, 95% CI 0.64-0.99; P = 0.047). In persistent AF, the primary outcome was not different between groups. Major adverse cardiovascular and cerebrovascular event rates were 1.0% (CBA) and 2.8% (RFA) (adjHR 0.53, 95% CI 0.26-1.10; P = 0.088). Re-ablations (adjHR 0.46, 95% CI 0.34-0.61; P < 0.0001) and adverse events during follow-up (adjHR 0.64, 95% CI 0.48-0.88; P = 0.005) were less common after CBA. Higher rehospitalization rates with RFA were caused by re-ablations. Conclusions: The primary endpoint did not differ between CBA and RFA. Cryoballoon ablation was completed rapidly; the radiation exposure was greater. Rehospitalization due to re-ablations and adverse events during follow-up were observed significantly less frequently after CBA than after RFA. Subgroup analysis suggested a lower risk of recurrence after CBA in paroxysmal AF. Trial Registration: ClinicalTrials.gov (NCT01360008), https://clinicaltrials.gov/ct2/show/NCT01360008