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Aims: To assess the efficacy of the 2nd generation Cryoballoon for pulmonary vein isolation (PVI) in patients with persistent atrial fibrillation (PersAF), and to compare it to patients with paroxysmal atrial fibrillation (PAF)., Methods: The outcome (arrhythmia recurrence at 12 months) was prospectively assessed in patients with PersAF(n = 77) and compared to that in patients with PAF(n = 62), who underwent PVI within a randomized trial evaluating single versus dual applications with the 2nd generation cryoballoon. Other endpoints included symptoms of AF, quality of life, procedure related characteristics, redo ablation rates and adverse events. Variables predicting recurrences were studied including all patients., Results: Freedom from arrhythmia recurrence was 64.9% after a single ablation and 68.8% after one or more procedures, which was significantly lower compared to PAF patients; 82.2% (p = 0.029) and 83.9% (p = 0.048) respectively, at 12 months. The improvements in EHRA score (-1.3 ± 0.8, p < 0.0001), symptom severity score (SSQ) (-5.0 ± 4.2, p < 0.0001) and EQ5D-5 L global score (+10.4 ± 20.3, p = 0.0002) after ablation was significant compared to baseline. The re-ablation rate was 7/77 (9.1%) which did not differ from that in PAF patients, 9/62 (14.5%), p = 0.42. Procedure duration, 104.8 ± 37.4 versus 113 ± 31.2 min (p = 0.129), application time, 1605 ± 659 versus 1521 ± 557 s (p = 0.103) and total adverse events after 12 months, 8/77 (10.4%) versus 5/62 (8.1%) (p = 0.77) did not differ in PersAF versus PAF patients., Conclusion: Both symptoms and QoL improved significantly in patients with PersAF after ablation. Freedom from AF was clinically significant but lower than in PAF patients. The cryoballoon seems an effective technique also in patients with persistent AF., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Aims: A single cryoballoon (CB) application per vein for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF) could save time and was therefore compared to the standard approach of two consecutive CB applications for acute and long-term efficacy and safety., Methods and Results: Patients with symptomatic AF were randomized to a single CB application per vein guided by an Achieve® catheter (Single cryo-arm) or to two CB applications using a standard guidewire (Routine cryo-arm). The primary endpoint was the rate of acute complete PVI. Secondary endpoints were freedom from AF evaluated by electrocardiogram and 7 days Holter at 6 and 12 months, symptoms by Symptom Severity Questionnaires and EHRA score and quality of life (QoL) by EQ5D-5L at 12 months. Among 140 patients included, PVI was achieved in 271 (100%) veins in the Single cryo-arm and in 269/271 (99.3%) veins in the Routine cryo-arm, P = 0.25. The procedure time was shorter in the Single cryo-arm, mean ± standard deviation 99.4 ± 33.3 min vs. 118.4 ± 34.3 min, P = 0.0015. Freedom from AF after one procedure at 12 months did not differ; 73.9.0% (Single cryo) vs. 71.4% (Routine), P = 0.74. Symptoms and QoL did also not differ between the two groups. There was a lower complication rate in the Single cryo-group, 2.9% vs. 12.9%, P = 0.03., Conclusion: A single CB application shortens the procedure time without affecting acute or long-term efficacy, as compared to the routine two-application strategy, which with the lower complication rates has important implications when defining standards for PVI.

Aims: The urge to facilitate the atrial fibrillation (AF) ablation procedure has led to the development of new ablation catheters specifically designed as 'one-shot tools' for pulmonary vein isolation (PVI). The purpose of this study was to compare the efficacy, safety, and procedure times for two such catheters using different energy sources., Methods and Results: One hundred and ten patients, referred for ablation of paroxysmal or persistent AF, were randomized to treatment with either the cryoballoon or the circular multipolar duty-cycled radiofrequency-based pulmonary vein ablation catheter (PVAC). Complete PVI was achieved in 98 vs. 93% patients in the cryoballoon and PVAC group, respectively, with complication rates of 8 vs. 2% (P = 0.2). Complete freedom from AF, without antiarrhythmic drugs, after one single ablation procedure was seen in 46% in the cryoballoon vs. 34% after 12 months (P = 0.2). Procedure times were comparable, but fluoroscopy time was shorter for the cryoballoon (32 ± 16 min) than for the PVAC procedures (47 ± 17 min) (P < 0.001). A significant improvement of quality of life (QoL) and arrhythmia-related symptoms was seen in both groups after ablation., Conclusion: Both catheters proved comparably effective and safe in achieving acute PVI, apart from the shorter fluoroscopy times achieved with the cryoballoon. At follow-up, there was no statistically significant difference between the groups regarding freedom from AF and clinical success. The QoL increased to the same levels as for the general Swedish population in both groups.

Aims: Thrombo-embolic events are one of the most feared complications related to atrial fibrillation (AF) ablation. Since radiofrequency (RF) energy is thought to be associated with a higher risk of thrombus formation than cryoenergy, the purpose of this study was to assess if the degree of activation of coagulation and inflammatory markers differed between ablation procedures performed with a cryoballoon catheter vs. a RF energy-based pulmonary vein ablation catheter (PVAC), respectively., Methods and Results: Thirty patients referred for AF ablation were randomized to pulmonary vein isolation with either the cryoballoon or the PVAC. Biomarkers were studied for endothelial damage (von Willebrand factor antigen), platelet activation (soluble P-selectin), and coagulation activity [prothrombin fragment 1 + 2 (F1 + 2) and D-dimer] at five different time points during the procedure. Troponin I (Trop I) and C-reactive protein were analysed to reflect myocardial destruction and inflammatory activity. Markers of endothelial damage and platelet activation increased after ablation in both the cryo and the RF group. Similarly, the D-dimer levels increased significantly (P = 0.001) in both groups, whereas the F1 + 2 levels increased after the transseptal puncture only (P = 0.001). The overall activation of the coagulation system was, however, comparable between the groups. The cryoballoon was associated with higher Trop I compared with the PVAC (P < 0.001), but the ratios between biomarkers and Trop I were higher with the PVAC than with the cryoballoon., Conclusion: Even though the cryoballoon causes a higher degree of myocardial destruction than the PVAC, markers of coagulation, endothelial damage, and inflammation were comparable between the two techniques.

Purpose: Although radiofrequency (RF) energy is routinely used for tricuspid isthmus (TI) ablation, it is often associated with discomfort. The paucity of studies comparing the feasibility and efficacy of cryo- versus RF energy for TI-ablation urged us to conduct a prospective, randomised trial., Methods: Forty patients with atrial flutter (AFl) were randomised to RF- or cryoenergy for TI-ablation. Perceived pain was scored from 1 to 10 on a Visual Analogue Scale., Results: Significantly lower pain scores were recorded for cryoablation versus RF ablation (0.96 +/- 0.73 versus 4.2 +/- 2.4, p = 0.00004). Cryoablation was associated with significantly longer procedure duration and ablation time (137 +/- 35 versus 111 +/- 29 min, p = 0.016 and 81 +/- 40 versus 48 +/- 30 min, p = 0.007) and lower acute success rate (56% versus 100%, p = 0.001) than RF ablation. The recurrence of AFl was 20% (cryo) versus 15% (RF; p = 0.45) after a mean of 15.1 months follow-up., Conclusion: Cryoablation results in significantly less pain and discomfort compared to RF ablation of AFl, which is offset by the significantly lower acute success rate.

Aims: To assess the acute effects, safety, and clinical outcome of atrial fibrillation (AF) ablation using a cryoballoon catheter., Methods and Results: Forty patients with paroxysmal or persistent AF underwent pulmonary vein (PV) isolation with a cryoballoon catheter (Arctic Front, CryoCath). Electrocardiograms were recorded in case of symptomatic AF recurrences, and a 24 h Holter recording was performed at last follow-up. Complete PV isolation was achieved in 39 (91%) of the 43 procedures (56% with the cryoballoon catheter alone, 44% with an additional conventional ryocatheter). The number of balloon applications per procedure was 9.6 +/- 1.6. The PV isolation rate was significantly higher (83.9%) if total vessel occlusions were obtained than if intermediate (63.6%, P = 0.01) or poor occlusions were achieved (38.1%, P = 0.0002). The mean procedure time was 239 +/- 48 min. At follow-up (mean 8.9 +/- 4.6 months), 52.5% of patients were free from arrhythmia-related symptoms and another 17.5% had reduction of arrhythmia-related symptoms. Two cases each of phrenic nerve paralysis and dysphagia occurred., Conclusions: Cryoballoon PV isolation is a feasible technique with a high acute success rate and comparable clinical outcome to radiofrequency ablation. Although complications were rare, the need for an additional conventional cryocatheter warrants further development of the technique.

Aims: A single cryoballoon (CB) application per vein for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF) could save time and was therefore compared to the standard approach of two consecutive CB applications for acute and long-term efficacy and safety.Methods and results: Patients with symptomatic AF were randomized to a single CB application per vein guided by an Achieve® catheter (Single cryo-arm) or to two CB applications using a standard guidewire (Routine cryo-arm). The primary endpoint was the rate of acute complete PVI. Secondary endpoints were freedom from AF evaluated by electrocardiogram and 7 days Holter at 6 and 12 months, symptoms by Symptom Severity Questionnaires and EHRA score and quality of life (QoL) by EQ5D-5L at 12 months. Among 140 patients included, PVI was achieved in 271 (100%) veins in the Single cryo-arm and in 269/271 (99.3%) veins in the Routine cryo-arm, P = 0.25. The procedure time was shorter in the Single cryo-arm, mean ± standard deviation 99.4 ± 33.3 min vs. 118.4 ± 34.3 min, P = 0.0015. Freedom from AF after one procedure at 12 months did not differ; 73.9.0% (Single cryo) vs. 71.4% (Routine), P = 0.74. Symptoms and QoL did also not differ between the two groups. There was a lower complication rate in the Single cryo-group, 2.9% vs. 12.9%, P = 0.03.Conclusion: A single CB application shortens the procedure time without affecting acute or long-term efficacy, as compared to the routine two-application strategy, which with the lower complication rates has important implications when defining standards for PVI. [ABSTRACT FROM AUTHOR]