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The volume of atrial fibrillation (AF) catheter ablation procedures has increased to address the growing patient population with AF; however, the impact of cryoballoon ablation on electrophysiology (EP) lab throughput is under-studied when treating patients with persistent AF (PsAF).To assess EP lab utilization associated with cryoballoon ablation for the treatment of patients with PsAF and to evaluate mechanisms that optimize hospital resources.Procedural data derived from the STOP Persistent AF trial were input into a discrete event simulation to assess EP lab utilization during AF ablation procedures. Patient and physician delays and lab occupancy times were modeled in a nominal and efficient EP lab setting over 1000 days. Accounting for variation in procedural times, we evaluated the number of days in which preplanned pulmonary vein isolation (PVI) cases resulted in overtime or excess time for non-ablation EP cases within a given lab day. A sensitivity analysis determined the parameters that most strongly influenced EP lab throughput.Lab occupancy times for the Nominal Use (NU) case included 165 procedures, and the High-Efficiency Use (HEU) case was derived from 69 procedures conducted at sites with faster procedure times than average. The HEU case had shorter lab occupancy times than the NU case (158 ± 32 minutes vs 188 ± 51 minutes, respectively). In the NU case, a total of 2000 procedures were conducted, with 28 lab days (2.8%) extending into overtime and 900 lab days (90%) exhibiting excess time for a non-ablation EP case. In the HEU case, a total of 3000 procedures were conducted, with 87 lab days (8.7%) extending into overtime and 635 lab days (63.5%) exhibiting excess time for a non-ablation EP case. The model was most sensitive to lab occupancy duration and the time of day that overtime started.Cryoballoon ablation for the treatment of patients with PsAF confers EP lab efficiencies that can support 3 PVI cases in a lab day.

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.

The VALUE PVI study demonstrated that atrial fibrillation (AF) ablation procedures and electrophysiology laboratory (EP lab) occupancy times were reduced for the cryoballoon compared with focal radiofrequency (RF) ablation. However, the economic impact associated with the cryoballoon procedure for hospitals has not been determined.Assess the economic value associated with shorter AF ablation procedure times based on VALUE PVI data.A model was formulated from data from the VALUE PVI study. This model used a discrete event simulation to translate procedural efficiencies into metrics utilized by hospital administrators. A 1000-day period was simulated to determine the accrued impact of procedure time on an institution's EP lab when considering staff and hospital resources. The simulation demonstrated that procedures performed with the cryoballoon catheter resulted in several efficiencies, including: (1) a reduction of 36.2% in days with overtime (422 days RF vs 60 days cryoballoon); (2) 92.7% less cumulative overtime hours (370 hours RF vs 27 hours cryoballoon); and (3) an increase of 46.7% in days with time for an additional EP lab usage (186 days RF vs 653 days cryoballoon). Importantly, the added EP lab utilization could not support the time required for an additional AF ablation procedure.The discrete event simulation of the VALUE PVI data demonstrates the potential positive economic value of AF ablation procedures using the cryoballoon. These benefits include more days where overtime is avoided, fewer cumulative overtime hours, and more days with time left for additional usage of EP lab resources.

Background: Sustained atrial fibrillation (AF) is a common risk factor for stroke. While intermittent AF also appears to pose a substantial stroke risk, the quantitative relationship between the percentage of time spent in AF and stroke risk is poorly specified and “intermittent” AF is not the same as paroxysmal AF. Improved assessment of the impact of AF burden on stroke risk will allow more targeted and safer use of antithrombotic therapy. Methods and Results: The primary objective of this study is to determine if AT/AF (all device detected atrial tachyarrhythmias, including atrial flutter, atrial fibrillation, and atrial tachycardia) burden over a 30 day period is an independent predictor of the occurrence of ischemic stroke, transient ischemic attack (TIA) and/or systemic embolism in subjects not receiving anticoagulation therapy. TRENDS is a prospective, post-market, non-randomized, multicenter study designed to enroll 3100 subjects who have an independent Class I/II indication for cardiac rhythm device implantation and who have demographic features suggestive of an increased risk for thromboembolic complications related to AT/AF. All implanted devices will have the ability to collect long-term AT/AF burden trending data and will be equivalently programmed to ensure consistent data collection. All subjects will be followed with device interrogations every 3 months and clinic visits every 6 months for 1 year. Subjects with a documented history of AT/AF prior to enrollment and those who develop AT/AF during the 12-month follow-up will be followed until the last subject enrolled in the study has completed their 24-month follow-up. Conclusions: The results of the TRENDS study should help clarify the implications of data retrieved from an implantable device with regard to the risk for thromboembolic complications from atrial arrhythmias, even in the absence of symptoms.

The clinical application of atrial tachyarrhythmia (AT) episode data stored by implantable devices is presently limited by the high proportion of inappropriate detection. We quantified the percentage of inappropriate AT detection in two implantable devices with AT diagnostics and therapies via meta-analysis of stored AT episodes from a number of clinical trials. The AT500 and GEM III AT, contain dual chamber logic to discriminate AT from ventricular tachycardia and far-field R wave (FFRW) oversensing using dual chamber bipolar electrograms. A subset of data from four clinical trials of 1,142 patients was considered. Manual analysis was performed on 21,553 stored episodes with atrial EGM and marker channel from 409 patients with stored episodes and the market-released device detection configuration. The percentage of episodes with inappropriate detection and termination was evaluated and compared between septal and nonseptal lead locations. The percentage of inappropriately detected episodes receiving ATP therapy was also determined. The percentage of episodes appropriately detected and the percentage of net episode duration (i.e., burden) recorded by the device were also determined from a separate analysis of 24-hour Holter recordings from a subset of 40 patients from one trial. Adjusted estimates of the percentage of appropriate [corrected] detection were 95.3% (93.5-96.7; 95% CI) for AT500 and 95.7% (84.3-98.9) for GEM III AT. Inappropriate detection was primarily due to FFRW oversensing or brief runs of premature atrial contractions (PACs). The device detected 100% of the sustained atrial arrhythmia episodes and 95.3% (range 76.1-99.9) of the net AT duration observed on the Holter recordings. AT detection was not influenced by atrial lead location. Appropriate detection of normal sinus rhythm at episode termination was 83.7% (80.7-86.3) for AT500 and 92.1% (84.5-96.2) for GEM III AT. Accurate detection and discrimination of FFRWs validates the reliability of AT diagnostic data and decreases the risk of inappropriate device therapy.

Introduction: The combined role of atrial septal lead location and atrial pacing algorithms in the prevention of atrial tachyarrhythmias (AT/AF), including both atrial fibrillation and flutter, is unknown. We tested the hypothesis that atrial prevention pacing algorithms could decrease AT/AF frequency in patients with atrial septal leads, bradycardia, and paroxysmal AT/AF. Methods and Results: A total of 298 patients (age 70 ± 10 years; 61% male) from 35 centers were implanted with a DDDRP pacing system including three AT/AF prevention pacing algorithms. Lead site was randomized at implant to right atrial septal or nonseptal. Patients were randomized 1 month postimplant to AT/AF prevention ON or OFF for 3 months and then crossed over for 3 months. Patients logged symptomatic AT/AF episodes via a manual activator. Prevention efficacy was evaluated based on intention-to-treat in 277 patients (138 septal) with complete follow-up. No changes in device-recorded AT/AF frequency or burden were observed with algorithms OFF versus ON or between patients randomized to septal versus nonseptal lead location. Analysis of other secondary outcomes revealed that AT/AF prevention pacing resulted in decreased atrial premature contractions in both the septal (1.9 [0.2–8.7] vs 3.3 [0.3–10.6]× 103/day; P < 0.01) and nonseptal groups (0.9 [0.2–3.3] vs 1.3 [0.3–5.5]× 103/day; P < 0.001). Patients with septal leads had fewer symptomatic AT/AF episodes ON versus OFF (1.4 ± 3.0 vs 2.5 ± 5.2/month, P = 0.01). Conclusion: The combination of three atrial prevention pacing algorithms did not decrease device classified atrial tachyarrhythmia frequency or burden during a 3-month cross-over period in bradycardic patients and septal or nonseptal atrial pacing leads. Prevention pacing was associated with decreased frequency of premature atrial contractions and with decreased symptomatic atrial tachyarrhythmia frequency in patients with atrial septal leads. (J Cardiovasc Electrophysiol, Vol. 14, pp. 1189-1195, November 2003)