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Purpose: There is still sparse information regarding phrenic nerve palsy (PNP) during the cryoablation of both right-sided pulmonary vein (PV) and its anatomical predictors., Methods: Consecutive patients who had undergone pulmonary vein isolation (PVI) using CB-A and suffered PNP during both right-sided PVs were retrospectively included in our study. Two other groups were then selected among patients who experienced PNP during RIPV application only (group 2) and RSPV application only (group 3)., Results: The incidence of PNI during both right-sided PVs cryoapplications was 2.1%, (32 of 1542 patients). There were no significant clinical differences between the 3 groups. Time from basal temperature to -40 °C significantly differed among the groups for both RIPV (p = 0.0026) and RSPV applications (p = 0.0382). Patients with PNP occurring during RSPV applications had significantly larger RSPV cross-sectional area compared to patients without PNP (p = 0.0116), while in patients with PNP during RIPV application, the angle of RIPV ostium on the transverse plane was significantly smaller compared to patients without PNP (p = 0.0035). The carina width was significantly smaller in patients with PNP occurring during both right-sided PVs cryoapplications compared to patients in which PNP occurred only during one right-sided PV application (p < 0.0001); a cutoff value of 8.5 mm had a sensitivity of 87.3% and a specificity of 75.0%., Conclusion: PNP in both right-sided PVs applications is a complication that occurred in 2.1% of cases during CB-A. Pre-procedural evaluation of right PVs anatomy might be useful in evaluating the risk of PNP.

Objective: To investigate the effect of left atrial appendage (LAA) occlusion device positioning upon periprocedural and long-term outcomes., Background: The Amulet device is designed to cover the ostium of the LAA. Prolapse of the device into the neck of the LAA is not uncommon resulting in incomplete coverage of the ostium. The clinical consequences of this remain uncertain., Methods: Outcomes of 87 patients with successful LAA closure were analyzed according to Amulet disc position: group A (n = 45) had complete LAA ostium coverage; group B (n = 42) had incomplete ostium coverage because of disc prolapse. Periprocedural major adverse events (MAE) (composite of all cause death, tamponade, device/air embolization, cerebrovascular events, myocardial infarction, and major bleeding not related to vascular access complications) and total device-related periprocedural adverse events (defined as MAE and pericardial effusion) were evaluated. All patients were followed up longitudinally with long-term events defined as a composite of: cardiovascular death, cerebrovascular events, systemic embolization, and major bleeding requiring transfusion or intervention., Results: Median follow-up was 234 days (IQR 150-436 days). There was a trend toward more periprocedural MAE in group B (P = 0.07) with deep implantation of the Amulet device associated with significantly more periprocedural adverse events (P = 0.03). There were no differences in reposition attempts (P = 0.9) or long-term events (P = 0.57)., Conclusions: Our data suggest that suboptimal device positioning may be associated with worse periprocedural outcomes but no difference in long-term clinical outcomes. The results of this relatively small cohort does not seem to be affected by repositioning attempts during the index procedure., (© 2018 Wiley Periodicals, Inc.)

Objectives: To compare indications and clinical outcomes of two contemporary left atrial appendage (LAA) percutaneous closure systems in a "real-world" population., Background: Percutaneous LAA occlusion is an emerging therapeutic option for stroke prevention in atrial fibrillation. Some questions however remain unanswered, such as the applicability of results of randomized trials to current clinical practice. Moreover, currently available devices have never been directly compared., Methods: We retrospectively analyzed consecutive patients who underwent LAA closure at San Raffaele Hospital, Milan, Italy between 2009 and 2015. Clinical indications and device selection were left to operators' decision; routine clinical and transesophageal echocardiography (TEE) follow-up was performed., Results: One-hundred and sixty-five patients were included in the study, of which 99 were treated with the Amplatzer Cardiac Plug (ACP) and 66 with the Watchman system. During the follow-up period (median 15 months, interquartile range 6-26 months) five patients died. The incidence of ischemic events was low, with one patient suffering a transient ischemic attack and no episodes recorded of definitive strokes. Twenty-six leaks ≥1 mm were detected (23%); leaks were less common with the ACP and with periprocedural three-dimensional TEE evaluation, but were not found to correlate with clinical events. Clinical outcomes were comparable between the two devices., Conclusions: Our data show excellent safety and efficacy of LAA closure, irrespectively of the device utilized, in a population at high ischemic and hemorrhagic risk. The use of ACP and 3D-TEE minimized the incidence of residual leaks; however, the clinical relevance of small peri-device flow warrants further investigation. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Objectives: We compared ablation strategy with antiarrhythmic drug therapy (ADT) in patients with paroxysmal atrial fibrillation (PAF)., Background: Atrial fibrillation (AF) ablation strategy is superior to ADT in patients with an initial history of PAF, but its role in patients with a long history of AF as compared with ADT remains a challenge., Methods: One hundred ninety-eight patients (age, 56 +/- 10 years) with PAF of 6 +/- 5 years' duration (mean AF episodes 3.4/month) who had failed ADT were randomized to AF ablation by circumferential pulmonary vein ablation (CPVA) or to the maximum tolerable doses of another ADT, which included flecainide, sotalol, and amiodarone. Crossover to CPVA was allowed after 3 months of ADT., Results: By Kaplan-Meier analysis, 86% of patients in the CPVA group and 22% of those in the ADT group who did not require a second ADT were free from recurrent atrial tachyarrhythmias (AT) (p < 0.001); a repeat ablation was performed in 9% of patients in the CPVA group for recurrent AF (6%) or atrial tachycardia (3%). At 1 year, 93% and 35% of the CPVA and ADT groups, respectively, were AT-free. Ejection fraction, hypertension, and age independently predicted AF recurrences in the ADT group. Circumferential pulmonary vein ablation was associated with fewer cardiovascular hospitalizations (p < 0.01). One transient ischemic attack and 1 pericardial effusion occurred in the CPVA group; side effects of ADT were observed in 23 patients., Conclusions: Circumferential pulmonary vein ablation is more successful than ADT for prevention of PAF with few complications. Atrial fibrillation ablation warrants consideration in selected patients in whom ADT had already failed and maintenance of sinus rhythm is desired. (A Controlled Randomized Trial of CPVA Versus Antiarrhythmic Drug Therapy in for Paroxysmal AF: APAF/01; http://clinicaltrials.gov/ct/show; NCT00340314).

Introduction: There is limited information describing late changes in the electroanatomic characteristics of the left atrium (LA) associated with recurrence after an anatomical circumferential pulmonary vein ablation (CPVA) for atrial fibrillation (AF)., Methods and Results: Forty-seven patients (57 +/- 8 years) undergoing a repeat ablation after CPVA were included. Using an electroanatomic mapping system, we measured the bipolar voltage by averaging points in the pulmonary vein (PV)-LA junction and four other LA sites. Conduction velocity and AF cycle length (AFCL) were also measured and the results are compared with the first procedure. After an initial decrease observed at the end of the first procedure, voltage and conduction velocity returned to intermediate values in all LA sites, with lower voltage at the LIPV antrum (P = 0.004), and lower conduction velocity across the LIPV and RSPV (P < 0.001). Conduction gaps were more prevalent at the septal aspect of the right PV encircling lines (85%), between the left atrial appendage (LAA) and the LSPV (70%) and lines at the posterior wall (71%). There was a nonsignificant increase in AFCL, with a more widespread distribution of organized electrograms (32.4% vs 46.6%)., Conclusion: Recurrence after CPVA is associated with a reverse process of voltage and conduction velocity increase across ablated areas, especially the PV-LA junction, and is related to the presence of conduction gaps, which are distributed mostly at the septal aspect of the lines encircling the right PVs and at the LAA-LSPV area. Organization of atrial electrograms seen during AF ablation is maintained at a repeat procedure.

Objectives: We assessed feasibility of magnetic catheter guidance in patients with atrial fibrillation (AF) undergoing circumferential pulmonary vein ablation (CPVA)., Background: No data are available on feasibility of remote navigation for AF ablation., Methods: Forty patients underwent CPVA for symptomatic AF using the NIOBE II remote magnetic system (Stereotaxis Inc., St. Louis, Missouri). Ablation was performed with a 4-mm tip, magnetic catheter (65 degrees C, maximum 50 W, 15 s). The catheter tip was guided by a uniform magnetic field (0.08-T), and a motor drive (Cardiodrive unit, Stereotaxis Inc.). Left atrium maps were created using an integrated CARTO RMT system (Stereotaxis Inc.). End point of ablation was voltage abatement >90% of bipolar electrogram amplitude., Results: Remote ablation was successful in 38 of 40 patients without complications. The median mapping and ablation time was 152.5 min (range, 90 to 380 min) but was much longer in the first 12 patients (192.5 min vs. 148 min; p = 0.012). Median ablation time was 49.5 min (range, 17 to 154 min), but it was much shorter in the last 28 patients than in the first 12 patients (49 min vs. 70 min; p = 0.021). Patients receiving remote ablation had longer procedure times than control patients (p < 0.001) with similar mapping time but shorter ablation time on right-sided pulmonary veins. Many more mapping points regardless of their location were collected remotely (p < 0.001)., Conclusions: Remote magnetic navigation for AF ablation is safe and feasible with a short learning curve. Although all procedures were performed by a highly experienced operator, remote AF ablation can be performed even by less experienced operators.

Objectives: Few data have been published on transcatheter ablation of atrial fibrillation (AF) in patients with mitral valve prostheses. Thus, we sought to report our experience., Background: Ablation is an effective treatment for AF. Patients with prosthetic mitral valves represent a special group because of an increased risk from the ablation procedure due to the possibility of damage to the prosthetic valve., Methods: Between July 2001 and July 2003, 26 patients with mitral valve prostheses (MVP) underwent circumferential pulmonary vein ablation for AF. A matched group of 52 ablated patients without MVP acted as control subjects. After a blanking period of three months, a follow-up of 12 months was considered for MVP patients and controls. Holter recordings were performed in all subjects at 3, 6, and 12 months., Results: Radiation exposure was higher in the MVP group, with fluoroscopy times of 35.3 +/- 21 min versus 20.9 +/- 15 min in controls. At the end of follow-up, 73% of MVP patients were in sinus rhythm, compared with 75% of controls. Atrial tachycardia occurred in six (23%) MVP patients, requiring repeat ablation in three, and one (2%) control subject, which settled without treatment. One transient ischemic attack and one femoral pseudoaneurysm occurred in the MVP group. No complications occurred in the control group., Conclusions: Ablation of AF in patients with MVP is feasible, with outcomes similar to those of standard patients. Complications were higher among MVP patients with a greater radiation exposure and a higher incidence of post-ablation atrial tachycardia.

Background: Circumferential pulmonary vein ablation (CPVA) is effective in curing atrial fibrillation (AF), but new-onset left atrial tachycardia (AT) is a potential complication. We evaluated whether a modified CPVA approach including additional ablation lines on posterior wall and the mitral isthmus would reduce the incidence of AT after PV ablation., Methods and Results: A total of 560 patients (291 men, 52%; age, 56.5+/-7.3 years) entered the study; 280 were randomized to CPVA alone (group 1) and 280 to modified CPVA (group 2). The primary end point was freedom from AT after the procedure. In group 1, 28 patients (10%) experienced new-onset AT, and 41 (14.3%) experienced recurrent AF. In group 2, 11 patients (3.9%) experienced AT, and 36 (12.9%) had recurrent AF. Group 1 was more likely to experience AT than group 2 (P=0.005). Freedom from AF after ablation was similar in both groups (P=0.57). Among those in group 1, gap-related macroreentrant AT was documented in 23 of the 28 patients (82%), and focal AT was found in 5 (18%). In group 2, gap-related macroreentrant AT was found in 8 of the 11 patients (73%), and focal AT was seen in 3 (27%). Two patients in group 1 and 1 patient in group 2 had both AT and AF. The strongest predictor of AT was the presence of gaps (P<0.001)., Conclusions: Modified CPVA is as effective as CPVA in preventing AF but is associated with a lower risk of developing incessant AT.