One year follow-up after cryoballoon isolation of the pulmonary veins in patients with paroxysmal atrial fibrillation (original) (raw)
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Europace, 2011
We examined the efficacy and safety of pulmonary vein (PV) isolation, using a cryoballoon catheter. Methods and results We studied 117 consecutive patients presenting with paroxysmal (n ¼ 92) or persistent (n ¼ 25) atrial fibrillation (AF), who underwent attempts at isolation of 442 PV with a cryoballoon catheter. They were followed in our ambulatory department for every 3 months, or earlier if they reported symptoms. A 48 h ambulatory electrocardiogram was recorded at the 3-month visit. We analysed the immediate and long-term procedural and clinical outcomes. We isolated 385 of 442 PV (87%) with a single cryoballoon application. In 19 patients (16%), an irrigated-tip radiofrequency (RF) catheter was used to create a supplemental focal lesion. A median of nine applications per procedure (range 6-12) was delivered. The mean, overall procedural duration was 155 + 43 min (range 75-275), and mean duration of fluoroscopic exposure was 35 + 15 min (range 12-73). At the end of the procedure, 103 patients (88%) were in sinus rhythm. Over a median period of 9.6 months (range 3-12), 11 patients were lost to followup. At 3, 6, 9, and 12 months of follow-up, respectively, 79, 79, 79, and 69% of patients presenting with paroxysmal AF had remained recurrence free, vs. 83, 73, 59, and 45% of patients, respectively, with persistent AF. Phrenic nerve palsy was the most frequent, although reversible complication. Conclusions Pulmonary vein isolation, using a cryoballoon catheter, was completed with a high rate of procedural and long-term success and low rate of minor complications. Supplemented, when needed, by focal RF, cryoballoon ablation was a safe and an effective alternative to a circumferential RF procedure.
Heart Rhythm, 2013
BACKGROUND Phrenic nerve palsy (PNP) is the most frequently observed complication during cryoballoon ablation (CB; Arctic Front, Medtronic, MN) occurring in roughly 7%-9% of the cases. The new second-generation cryoballoon ablation Arctic Front Advance (CB-A) (Arctic Front) has recently been launched in the market. OBJECTIVE To evaluate the incidence of right PNP with the new CB-A in comparison with the first-generation balloon in a series of consecutive patients that underwent pulmonary vein isolation with this modality. METHODS The study was designed as an observational study with a prospective follow-up. In total, 121 consecutive patients were included: 80 patients with the CB (group 1) and 41 with the CB-A (group 2). RESULTS Mean procedural times, fluoroscopic times, and time to pulmonary vein isolation documented by real-time recordings were significantly lower in group 2 (P ≤ .05). The occurrence of PNP was significantly higher in group 2 (6.25% [5 of 80] in group 1 vs 19.5% [8 of 41] in group 2; P ¼ .033). At 7 months, PNP persisted in 1 (2.5%) patient in the CB-A group. CONCLUSIONS Right PNP seems to occur in a significantly larger number of patients with the second-generation CB-A. However, this complication is reversible in nearly all cases on short-term followup. More refined phrenic nerve monitoring during right-sided pulmonary vein ablation and less vigorous wedging maneuvers in the pulmonary vein ostia might significantly reduce the occurrence of this complication.
Heart, 2010
Background To prevent atrial fibrillation (AF) recurrence after catheter ablation, pulmonary venous isolation (PVI) at an antral level is more effective than segmental ostial ablation. Cryoablation around the pulmonary venous (PV) ostia for AF therapy is potentially safer compared to radiofrequency ablation (RFA). The aim of this study was to investigate the efficacy of a strategy using a large cryoablation balloon to perform antral cryoablation with 'touch-up' ostial cryoablation for PVI in patients with paroxysmal and persistent AF. Methods Paroxysmal and persistent AF patients undergoing their first left atrial ablation were recruited. After cryoballoon therapy, each PV was assessed for isolation and if necessary, treated with focal ostial cryoablation until PVI was achieved. Follow-up with Holter monitoring was performed. Clinical outcomes of the cryoablation protocol were compared, with consecutive patients undergoing PVI by RFA. Results 124 consecutive patients underwent cryoablation. 77% of paroxysmal and 48% of persistent AF subjects were free from AF at 12 months after a single procedure. Over the same time period, 53 consecutive paroxysmal AF subjects underwent PVI with RFA and at 12 months, 72% were free from AF at 12 months (p¼NS). There were too few persistent AF subjects (n¼8) undergoing solely PVI by RFA as a comparison group. Procedural and fluoroscopic times during cryoablation were significantly shorter than RFA. Conclusions PV isolation can be achieved in less than 2 h by a simple cryoablation protocol with excellent results after a single intervention, particularly for paroxysmal AF.
Revista Española de Cardiología (English Edition), 2009
Electrical isolation of the pulmonary veins and disconnection of the left atrial musculature from their arrhythmogenic effects is the cornerstone of definitive and curative treatment in patients with symptomatic recurrent paroxysmal atrial fibrillation that is refractory to antiarrhythmic therapy. The type of lesion produced by balloon cryoablation is such that the tissue architecture is preserved and thrombus formation and the risk of pulmonary vein stenosis are reduced. We report on immediate outcomes in the first 5 patients who underwent treatment. These cases represent initial experience with the technique in Spain. A total of 20 pulmonary veins were treated and complete acute electrical isolation was achieved in all cases (100%). Patients were discharged from hospital within 72 hours of the procedure, and there were no complications. In conclusion, balloon cryoablation of the pulmonary veins is a practical, safe, and effective technique for achieving the electrophysiologic goal of acute pulmonary vein isolation in patients with paroxysmal atrial fibrillation.
European Heart Journal, 2007
Aims To assess safety, feasibility and short term outcome of pulmonary vein (PV) isolation in paroxysmal atrial fibrillation (AF) with a cryoballoon. Methods We consecutively treated 57 patients with a double lumen 23 or 28 mm cryoballoon. The acute results, complications and follow-up over the first three months were analysed, using a comprehensive and intensive follow-up period. Results During 57 procedures, 185 of 220 targeted PV's were successfully isolated using the cryoballoon (84%) (balloon group, 33 patients). In 33 veins (15%) an additional segmental isolation (hybrid group, 24 patients) was necessary with a standard cryocatheter to achieve isolation. The average procedure times were respectively 211 + 108 and 261 + 83 minutes (NS), the average fluoroscopy times 52 + 36 and 66 + 33 minutes (NS). The number of balloon applications did not differ between both groups: respectively a median 9 (4-18) and 10 (5-17) (NS). We observed four phrenic nerve paralysis after ablation of the right superior PV: two resolved immediately after cessation of the cryoenergy, one recovered after 3 months, one persisted up to 6 months. A daily transtelephonic rhythm recording showed a significant drop in mean AF burden from 24% to 10%, 8% and 5% during the three consecutive months of follow-up (p , 0.01 versus baseline). No differences were observed between the treatment groups. 34 patients (60%) were completely free from AF after a single procedure. Conclusions Balloon cryoablation of the pulmonary veins with additional segmental isolation if necessary, is a good approach for patients presenting with paroxysmal AF, showing a significant reduction in AF burden after a single procedure. The major complication seems to be phrenic nerve paralysis after ablation of the right superior PV, but this is potentially reversible over several months.
European Heart Journal
The second-generation cryoballoon (CB2) with increased surface cooling has recently become available. The aim was to investigate the incidence and characteristics of phrenic nerve palsy (PNP) during pulmonary vein isolation (PVI) using the CB2 as compared with the first-generation balloon (CB1). A total of 360 consecutive patients with atrial fibrillation underwent PVI with the CB1 (106 patients) or the CB2 (254 patients). Right PN function was monitored by continuous stimulation and palpation during septal PV ablation. Persistent PNP (present at discharge) occurred in 2.8 and 1.9% (P = 0.63) of patients, transient PNP (full recovery before discharge) in 5.9 and 3.8% (P = 0.41) of patients in the CB2 and CB1 group, respectively. Phrenic nerve palsy during ablation at the right inferior PV was observed in 0% (CB1) and 4.3% (CB2, P = 0.03) of patients. Using the CB2, a trend of reduced incidence of persistent PNP over quartiles of consecutive patients was observed [4.8% (Q1) vs. 0% (Q...
International Journal of Cardiology, 2018
Background: Real-time visualization of the electrical activity of the pulmonary veins (PV) is not always possible in the setting of atrial fibrillation (AF) cryoballoon ablation. We investigated the relation between the effective documentation of time to PV isolation and the clinical outcome in a cohort of patients with paroxysmal AF who underwent cryoballoon ablation. Methods: One thousand forty two consecutive patients were enrolled. An inner lumen mapping catheter was typically used to visualize real-time electrical activity inside the PVs. Results: Time to PV isolation was documented in all targeted PVs in 391 patients (Group 1), in 651 patients it was not possible to record PV potentials and assess time to PV isolation in at least one PV (Group 2). In Group 1 a longer procedure duration and ablation time were observed, while a longer fluoroscopy time was observed in Group 2. After a mean follow-up of 14 ± 11 months, 209/1042 (20%) patients had an atrial arrhythmia recurrence (20.2% in Group 1, 19.9% in Group 2, p = 0.25). Complications occurred in 54/1042 (5.2%) patients without any difference among the two study groups. Conclusion: In our retrospective analysis, in about two thirds of patients undergoing cryoballoon ablation it was not possible to acutely assess time to PV isolation in all PVs. However, one-year freedom from clinically symptomatic atrial tachyarrhythmia was similar to that of patients in which time to PV isolation was documented in all targeted veins. Clinical Trial Registration: clinicaltrials.gov (NCT01007474).
Journal of Interventional Cardiac Electrophysiology
Background Paroxysmal atrial fibrillation (PAF) can be triggered by non-pulmonary vein foci, like the superior vena cava (SVC). The latter is correlated with improved result in terms of freedom from atrial tachycardias (ATs), when electrical isolation of this vessel utilizing radiofrequency energy (RF) is achieved. Objectives Evaluate the clinical impact, in patients with PAF, of the SVC isolation (SVCi) in addition to ordinary pulmonary vein isolation (PVI) by means of the second-generation cryoballoon (CB) Methods A total of 100 consecutive patients that underwent CB ablation for PAF were retrospectively selected. Fifty consecutive patients received PVI followed by SVCi by CB application, and the following 50 consecutive patients received standard PVI. All patients were followed 12 months. Results The mean time to SVCi was 36.7 ± 29.0 s and temperature at SVC isolation was − 35 (− 18 to − 40) °C. Real-time recording (RTR) during SVCi was observed in 42 (84.0%) patients. At the end...