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With advancements in technology and ablation techniques, catheter ablation for the treatment of atrial fibrillation (AF) has become safer with time. In the past, standard-of-care recommended overnight stay for outpatient procedures. As safety has improved and procedure times have shortened, some centers have allowed for same-day discharge. We report the results of a multi-center, randomized clinical trial investigating the safety of same-day discharge post-cryoballoon ablation.Patients with paroxysmal atrial fibrillation underwent pulmonary vein isolation (PVI) with the Medtronic Arctic Advance cryoballoon at 3 US centers. Six hours after the procedure, patients were randomized to either stay overnight or be discharged same day.A total of 49 patients were enrolled. Two patients were withdrawn prior to randomization. One patient chose to withdraw after randomization. Of the 22 patients randomized to same-day discharge and the 23 patients randomized the overnight stay, no significant adverse outcomes were reported in either group. Occurrence of adverse events did not differ significantly between the two groups. Procedure time and fluoroscopy time did not significantly differ between groups.This is the first randomized trial examining the safety of same-day discharge post-cryoballoon ablation. Based on our results, same-day discharge following cryoballoon ablation for paroxysmal AF is a safe option following uncomplicated ablation for PVI. Operators should use their discretion in selecting patients for same-day discharge.

Pulmonary vein isolation (PVI) is widely used for the ablation of atrial fibrillation, with prior reports suggesting good efficacy. Due to the widespread use of three-dimensional electroanatomic mapping systems and advances in intracardiac echocardiography, fluoroless ablation has been made possible. Fluoroless ablation with a cryoballoon (CB), however, has not been widely performed because of the need to prove occlusion of the vein with contrast dye and fluoroscopy. The objective of this study is to show that CB ablation can be performed safely and effectively without fluoroscopy. A dual-center, case-control study was performed of patients undergoing CB PVI with a fluoroless approach and a control group with traditional fluoroscopic techniques. The absence of color-flow Doppler signals around the periphery of the CB on intracardiac echocardiography and an increase in mean pressure by 5 mmHg, loss of the A-wave, and an increase in the V-wave as measured with continuous-wave pressure monitoring were adopted as indicators of vein occlusion in the absence of fluoroscopy. Temperature at 30 seconds, minimum temperature, time to isolation, procedure length, and complications were evaluated. During the study period of November 15, 2018 to November 15, 2019, a total of 100 patients underwent CB PVI at the participating centers. A total of 50 patients were enrolled in the fluoroless arm [35 men (70%), mean age: 64.9 ± 12 years, mean left atrium size: 44.2 ± 16 mL/m2, left ventricular ejection fraction: 61% ± 5%], while 50 patients were enrolled in the control arm with similar characteristics. Four hundred forty-one 441 PVs were evaluated in the study cohort compared to 339 PVs in the control arm. When comparing fluoroless and traditional techniques, the mean temperature at 30 seconds was -31.7°C ± 6°C versus -32.8°C ± 5°C (p = 0.037), the minimum temperature was -47.4°C ± 6°C versus -47.7°C ± 9°C (p = 0.677), the time to isolation was 56.8 ± 28 seconds versus 74.8 ± 45 seconds (p = 0.212), and the procedure time was 102.2 ± 27.3 seconds versus 104.5 ± 16.9 seconds (p = 0.6436). Ultimately, this proof-of-concept study revealed that fluoroless ablation can be performed with success and efficiency outcomes similar to those of a traditional ablation approach. This suggests that the ablation of atrial fibrillation with CB can be performed safely and effectively without the use of fluoroscopy by experienced operators.

The relation of device related thrombosis (DRT) and major bleeding after left atrial appendage closure (LAAC) to laboratory thrombosis and hemostasis markers has not been studied. We performed a prospective case control study to identify clinical characteristics and laboratory markers in patients who developed DRT and major bleeding following WATCHMAN LAAC. Thromboelastography, platelet aggregation (PA), urinary 11-dehydrothromboxane B2 (UTX), fibrinogen, d-dimer, thrombin time and von Willebrand factor activity were determined at baseline, immediately following, and at 45 and 180 days post-LAAC (n = 32) and outcomes were followed for 1 year. Baseline characteristics and thrombogenic profiles of patients with and without DRT and/or BARC bleeding were compared. Mean age was 76 ± 8 years and CHADS2 VASc score was 4.4 ± 1.4. There were 3 DRTs (2 within 6 months, and 1 at 12 months), 4 Type 3A BARC bleeds, and 2 non-cardiac deaths. Patients with DRT had higher baseline thrombin-induced platelet–fibrin clot strength (68.0 ± 1.8 vs. 62.7 ± 4.7 mm, p = 0.06); FCS (35.6 ± 6.0 vs. 24.4 ± 6.6 mm, p = 0.009); and d-dimer (1712 ± 2330 vs. 283 ± 213 ng/mL, p = 0.001). At baseline, 5 patients had all 3 factors associated with high thrombotic risk and 2 experienced a DRT within 6 months. Patients with Type 3A BARC bleeding had lower baseline collagen-induced and 45-day ADP-induced PA (p

To ascertain the types of childhood glaucoma managed at major international centers, current clinical practice, and intraocular pressure (IOP) control and visual acuity (VA) outcomes.Prospective, multicenter, consecutive case series.All children with newly diagnosed glaucoma in at least 1 eye who fulfilled the Childhood Glaucoma Research Network (CGRN) definition of childhood glaucoma were recruited over a 1-year period with the aim of 18 months follow up.Demographic, clinical, management data (including complications), and outcomes (IOP and VA) were entered in a secure online database. All cases included in the outcome analysis had a minimum of 6 months follow-up.The management of childhood glaucoma, IOP control, and VA outcomes.A total of 441 children (691 eyes) with newly diagnosed glaucoma were enrolled from 17 international centers. Approximately 60% of patients came from 2 centers in India; however, 47.5% of Indian patients had no or less than 6 months of follow-up outcome data from diagnosis. Primary congenital glaucoma (PCG) was the most common diagnosis (45.4%, n = 314 eyes). There was a statistically significant association between diagnosis and ethnicity/race (P0.001), with PCG more frequent in nonwhite patients, glaucoma associated with acquired conditions more frequent in South Asian patients, and glaucoma after cataract surgery more frequent in white patients. The initial surgical procedure of choice for eyes with PCG significantly differed by country. Angle surgery alone was first line in centers in the United States, United Kingdom, Germany, Saudi Arabia, Singapore, and Israel (Group 1), whereas combined trabeculotomy-trabeculectomy was the first-line procedure for PCG in centers in India and Ghana (Group 2). There was no significant difference in IOP control nor VA between the 2 groups.The most common diagnoses in this international study of children with newly diagnosed glaucoma in order of frequency were PCG, glaucoma after congenital idiopathic cataract surgery, and glaucoma associated with trauma. Indian children had a disproportionately high loss to follow-up rate. Despite international differences in the surgical approach to PCG, there was no statistically significant difference in IOP or VA outcomes. We hope the results of this study will inform key areas of future international, collaborative clinical research in childhood glaucoma.

Introduction: With advancements in technology and techniques, catheter ablation for the treatment of atrial fibrillation (AF) has become safer with time. Historically, standard-of-care recommended overnight stay after procedure. With improved safety and shorter procedure times, some centers have allowed for same-day discharge (SDD). We report the results of a multi-center, randomized clinical trial investigating the safety of SDD after cryoballoon (CB) ablation of paroxysmal AF. Methods: Patients underwent pulmonary vein isolation (PVI) with the Medtronic Arctic Advance TM cryoballoon at 3 experienced U.S. centers. Six hours after procedure, patients were randomized to either stay overnight or be discharged same-day after meeting study inclusion criteria. Results: A total of 51 patients were enrolled. Two were determined to be screen-fails following ablation of extra-pulmonary foci. Final analysis encompassed the 46 patients who completed randomization and follow-up, with 23 randomized to each group. No significant adverse outcomes were reported in either group, defined as major cardiovascular or cerebrovascular events. Occurrence of any adverse events, including arrhythmia recurrence, vascular complication, ventricular arrhythmia, syncope, pacemaker implant, pulmonary vein stenosis, and persistent phrenic nerve palsy, did not differ significantly between the two groups (p=1.0). Four patients had symptomatic and/or documented recurrence of atrial arrhythmia, three of which were in the same-day discharge group. Two patients developed cough post-operatively, one from each group. One patient from the next-day discharge cohort was diagnosed with pneumonia >2 weeks post-procedure. No patients from either group required emergency room visits due to delayed procedural-related complications. Conclusions: This is the first randomized trial to our knowledge examining the safety of SDD post CB ablation. Based on our results, SDD following CB ablation is a safe option following uncomplicated ablation for PVI. Operators should use their discretion in selecting patients for SDD.