Health care utilization in a nurse practitioner-led atrial fibrillation clinic.

BACKGROUND: Atrial fibrillation (AF) is the most common cardiac arrhythmia and is emerging in prevalence with an increasingly aging population. The complex nature of the disease and its association with significant morbidity and mortality has resulted in a call for a new integrative, multidisciplinary approach to AF management. PURPOSE: Determine if the use of a nurse practitioner (NP)-led AF clinic (NPAFC) can improve care for patients. METHODOLOGY: An NPAFC was designed to serve as an independent clinic for standardizing patient care and improving access to care. Baseline patient demographics, care pathway, and interventions were characterized in clinic. Primary outcomes were hospitalizations and emergency department (ER) visits, before and after clinic implementation. RESULTS: Overall, 1,442 patients were enrolled in the AF clinic between January 2016 and June 2018. The mean age at the first AF clinic visit was 68.7 ± 12.6 years, 54% were male, and the mean body mass index was 31 ± 7 kg/m2. Among the patients, 45.2% had paroxysmal AF, 43.6% persistent AF, and 5.5% permanent AF. With an average of 3 ± 3 clinic visits per patient, the number of patients with ≥1 hospitalization decreased by 78% after clinic implementation. Similarly, the number of patients with ≥1 ER visit decreased by 79%, and 22.7% of patients avoided at least one ER visit. CONCLUSIONS: The number of patients with ≥1 hospitalization or ≥1ER visit decreased within two years after the implementation of an NPAFC. IMPLICATIONS: Implementation of an NP-led AF clinic in the United States may reduce hospitalizations and ER visits if implemented in an integrative model.

Evaluation of stroke incidence with duty-cycled multielectrode-phased radiofrequency ablation of persistent atrial fibrillation results of the VICTORY AF Study.

INTRODUCTION: The VICTORY AF Study was designed to evaluate the risk of the procedure and/or device-related strokes in patients with PersAF on warfarin undergoing ablation with a phased radiofrequency (RF) system. METHODS: The VICTORY AF trial was a prospective, multicenter, single-arm, investigational study. PersAF patients on vitamin K antagonism without major structural heart disease or history of stroke/transient ischemic attack undergoing phased RF ablation for atrial fibrillation (AF) were included. The primary outcome was the incidence of the procedure and/or device-related stroke within 30 days of the ablation by a board-certified neurologist's assessment. The secondary outcomes were an acute procedural success, 6 months effectiveness (defined as the reduction in AF/atrial flutter episodes lasting ≥10 minutes by 48-hour Holter 6 months postablation) and the number of patients with pulmonary vein (PV) stenosis. RESULTS: A total of 129 (108 PersAF, 21 long-standing PersAF) patients were treated (mean age: 60.6 ± 7.7; 79.8% male, 54.3% CHA2Ds2-VASc score ≥ 2). Two nondisabling strokes were reported (1.6%); one before discharge and the second diagnosed at the 30-day visit. Due to slow enrollment, the study was terminated before reaching the 95% one-sided upper confidence boundary for stroke incidence. Acute procedural success was 93.8%, and at 6 months, 72.8% of patients demonstrated ≥90% reduction in AF burden, 78.9% were off all antiarrhythmic drugs. There were no patients with PV stenosis of greater than 70%. CONCLUSIONS: VICTORY AF demonstrated a 1.6% incidence of stroke in PersAF undergoing ablation with a phased RF system which did not meet statistical confidence due to poor enrollment. The secondary outcomes suggest comparable efficacy to phased RF in the tailored treatment of permanent AF trial. Rigorous clinical evaluation of the stroke risk of new AF ablation technologies as well as restriction to Vitamin K antagonist anticoagulation appears to be unachievable goals in a clinical multicenter IDE trial of AF ablation in the current era.

Paroxysmal and persistent atrial fibrillation ablation outcomes with the pulmonary vein ablation catheter GOLD duty-cycled phased radiofrequency ablation catheter: quality of life and 12-month efficacy results from the GOLD Atrial Fibrillation Registry.

AIMS: The GOLD AF Registry has been designed to prospectively assess the population, indications, and outcomes using second-generation phased radiofrequency (RF) ablation (pulmonary vein ablation catheter GOLD) in a global examination of standard-of-care use for the treatment of paroxysmal and persistent atrial fibrillation (AF). METHODS AND RESULTS: GOLD AF (NCT02433613) is a prospective, observational, multi-centre registry designed to characterize efficacy and safety of phased RF ablation in patients with AF. The primary endpoint was freedom from AF recurrence at 12-month follow-up after a 90-day blanking period. Ancillary objectives include safety, procedural efficiency, and quality of life (QoL). The QoL assessment using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and the European Heart Rhythm Association (EHRA) Score of AF-related symptoms was collected at baseline and 12 months. In total, 1054 patients were included in this analysis (age 60.6, 67.6% male, 26.5% PersAF). Kaplan-Meier estimate of freedom from AF recurrence was 77.7% at 12 months. Peri-procedural device or procedure-related complications were observed in 26 (2.5%) patients, with a low stroke rate of 0.3%. One-year post-ablation, the EHRA AF Symptom score decreased in 68% of patients. The AFEQT score improvement was observed in 88.4% and 90.4% of patients who completed the questionnaire in-person or interviewed by phone at 12 month follow-up, respectively. CONCLUSION: Phased RF ablation for the treatment of paroxysmal and persistent AF demonstrated a 77.7% freedom from AF recurrence at 12 months in addition to a significant reduction in arrhythmia symptoms and clinically meaningful improved QoL. Low peri-procedural complication rate of <3% was reported.

The Impact of Cryoballoon Versus Radiofrequency Ablation for Paroxysmal Atrial Fibrillation on Healthcare Utilization and Costs: An Economic Analysis From the FIRE AND ICE Trial.

BACKGROUND: This study sought to assess payer costs following cryoballoon or radiofrequency current (RFC) catheter ablation of paroxysmal atrial fibrillation in the randomized FIRE AND ICE trial. METHODS AND RESULTS: A trial period analysis of healthcare costs evaluated the impact of ablation modality (cryoballoon versus RFC) on differences in resource use and associated payer costs. Analyses were based on repeat interventions, rehospitalizations, and cardioversions during the trial, with unit costs based on 3 national healthcare systems (Germany [€], the United Kingdom [£], and the United States [$]). Total payer costs were calculated by applying standard unit costs to hospital stays, using International Classification of Diseases, 10th Revision diagnoses and procedure codes that were mapped to country-specific diagnosis-related groups. Patients (N=750) randomized 1:1 to cryoballoon (n=374) or RFC (n=376) ablation were followed for a mean of 1.5 years. Resource use was lower in the cryoballoon than the RFC group (205 hospitalizations and/or interventions in 122 patients versus 268 events in 154 patients). The cost differences per patient in mean total payer costs during follow-up were €640, £364, and $925 in favor of cryoballoon ablation (P=0.012, 0.013, and 0.016, respectively). This resulted in trial period total cost savings of €245 000, £140 000, and $355 000. CONCLUSIONS: When compared with RFC ablation, cryoballoon ablation was associated with a reduction in resource use and payer costs. In all 3 national healthcare systems analyzed, this reduction resulted in substantial trial period cost savings, primarily attributable to fewer repeat ablations and a reduction in cardiovascular rehospitalizations with cryoballoon ablation. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Identifier: NCT01490814.

Verification of a novel atrial fibrillation cryoablation dosing algorithm guided by time-to-pulmonary vein isolation: Results from the Cryo-DOSING Study (Cryoballoon-ablation DOSING Based on the Assessment of Time-to-Effect and Pulmonary Vein Isolation Guidance).

BACKGROUND: There are no recommendations on the optimal dosing for cryoablation of atrial fibrillation (Cryo-AF). OBJECTIVE: The purpose of this study was to develop and prospectively test a Cryo-AF dosing protocol guided exclusively by time-to-pulmonary vein (PV) isolation (TT-PVI) in patients undergoing a first-time Cryo-AF. METHODS: In this multicenter study, we examined the acute/long-term safety/efficacy of Cryo-AF using the proposed dosing algorithm (Cryo-AFDosing; n = 355) against a conventional, nonstandardized approach (Cryo-AFConventional; n = 400) in a nonrandomized fashion. RESULTS: Acute PV isolation was achieved in 98.9% of patients in Cryo-AFDosing (TT-PVI = 48 ± 16 seconds) vs 97.2% in Cryo-AFConventional (P = .18). Cryo-AFDosing was associated with shorter (149 ± 34 seconds vs 226 ± 46 seconds; P <.001) and fewer (1.7 ± 0.8 vs 2.9 ± 0.8; P <.001) cryoapplications, reduced overall ablation (16 ± 5 minutes vs 40 ± 14 minutes; P <.001), fluoroscopy time (13 ± 6 minutes vs 29 ± 13 minutes; P <.001), left atrial dwell time (51 ± 14 minutes vs 118 ± 25 minutes; P <.001), and total procedure time (84 ± 23 minutes vs 145 ± 49 minutes; P <.001) but similar nadir balloon temperature (-47°C ± 8°C vs -48°C ± 6°C; P = .41) and total thaw time (43 ± 27 seconds vs 45 ± 19 seconds; P = .09) as compared to Cryo-AFConventional. Adverse events (2.0% vs 2.7%; P = .48), including persistent phrenic nerve palsy (0.6% vs 1.2%; P = .33) and 12-month freedom from all atrial arrhythmias (82.5% vs 78.3%; P = .14), were similar between Cryo-AFDosing and Cryo-AFConventional. However, Cryo-AFDosing was specifically associated with fewer atypical atrial flutters/tachycardias during long-term follow-up (8.5% vs 13.5%; P = .02) as well as fewer late PV reconnections at redo procedures (5.0% vs 18.5%; P <.001). CONCLUSION: A novel Cryo-AF dosing algorithm guided by TT-PVI can help individualize the ablation strategy and yield improved procedural endpoints and efficiency as compared to a conventional, nonstandardized approach.

Catheter ablation using the third-generation cryoballoon provides an enhanced ability to assess time to pulmonary vein isolation facilitating the ablation strategy: Short- and long-term results of a multicenter study.

BACKGROUND: Limited data exist on cryoablation of atrial fibrillation (Cryo-AF) using the newly available third-generation (Arctic Front Advance-Short Tip [AFA-ST]) cryoballoon. OBJECTIVE: In this multicenter study, we evaluated the safety and efficacy of Cryo-AF using the AFA-ST vs the second-generation (Arctic Front Advance [AFA]) cryoballoon. METHODS: We examined the procedural safety and efficacy and the short- and long-term clinical outcomes associated with a first-time Cryo-AF performed in 355 consecutive patients (254/355 [72%] with paroxysmal AF), using either the AFA-ST (n = 102) or the AFA (n = 253) cryoballoon catheters. RESULTS: Acute isolation was achieved in 99.6% of all pulmonary veins (PVs) (AFA-ST: 100% vs AFA: 99.4%; P = .920). Time to pulmonary vein isolation was recorded in 89.2% of PVs using AFA-ST vs 60.2% using AFA (P < .001). PVs targeted using AFA-ST required fewer applications (1.6 ± 0.8 vs 1.7 ± 0.8; P = .023), whereas there were no differences in the balloon nadir temperature (AFA-ST: -47.0°C ± 7.3°C vs AFA: -47.5°C ± 7.8°C; P = .120) or thaw time (AFA-ST: 41 ± 24 seconds vs AFA: 44 ± 28 seconds; P = .056). However, AFA-ST was associated with shorter left atrial dwell time (43 ± 5 minutes vs 53 ± 16 minutes; P < .001) and procedure time (71 ± 11 minutes vs 89 ± 25 minutes; P < .001). Furthermore, Cryo-AF using AFA-ST was completed more frequently by "single-shot" PV ablation (27.4% vs 20.2%; P = .031). Persistent phrenic nerve palsy (AFA-ST: 0% vs AFA: 0.8%; P = .507) and procedure-related adverse events (AFA-ST: 1.0% vs AFA: 1.6%; P = .554) were similar, as was the freedom from recurrent atrial arrhythmias at 10 months of follow-up (AFA-ST: 81.8% vs AFA: 79.9%; P = .658). CONCLUSION: Cryo-AF using the AFA-ST cryoballoon offers an enhanced ability to assess time to pulmonary vein isolation, allowing for fewer cryoapplications and shorter left atrial dwell time and procedure time. Consequently, this allowed for procedural completion more frequently using a "single-shot" PV ablation with equivalent safety and efficacy.

Safety and Efficacy of Cryoballoon Ablation for Paroxysmal Atrial Fibrillation in Japan　- Results From the Japanese Prospective Post-Market Surveillance Study.

BACKGROUND: Outcomes of cryoballoon ablation for paroxysmal atrial fibrillation (PAF) have been reported in the Western countries but not in Japan. The CRYO-Japan PMS study was a single-arm, observational, multicenter, prospective study of the 2nd-generation cryoballoon Arctic Front Advance(TM). We evaluated device- and procedure-related complications and clinical outcomes at 6 months. METHODS AND RESULTS: The 616 patients (male, 72%; mean age, 63±11 years) were enrolled from 33 Japanese hospitals. Of all patients, 610 had PAF, and procedural data were analyzed in 607. A subset of 328 patients was followed for 6 months for the primary efficacy analysis. AF recurrence outside the 3-month blanking period or repeat ablation was considered treatment failure. Pulmonary vein isolation was achieved in 606/607 patients (99.8%); 1 patient (0.3%) had a repeat ablation during the blanking period. Freedom from AF at 6 months was 88.4% (95% CI: 84.1-91.6%). Device- and/or procedure-related adverse events included phrenic nerve injury unresolved at hospital discharge in 9/616 patients (1.5%), which resolved within 6 months in 7, pericardial effusion in 5/616 (0.8%), and tamponade in 4/616 (0.6%). One non-device-related death from pneumonia was reported 6 days post-procedure. CONCLUSIONS: Cryoballoon ablation is safe and effective for Japanese PAF patients, with 88.4% AF freedom at 6 months post-ablation. (Circ J 2016; 80: 1744-1749).