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(1) Background: Cryoballoon pulmonary vein isolation (cryoPVI) is established for symptomatic paroxysmal atrial fibrillation (AF) treatment, but its value in persistent AF is less clear. In particular, limited data are available on its efficacy in elderly patients (≥75 years) with persistent AF. Age is an important modifier of AF progression and represents a risk-factor for AF recurrence. (2) Methods: Prospective, single-center observational study to evaluate the impact of age on efficacy and safety of cryoPVI in elderly patients. Primary efficacy endpoint was symptomatic AF recurrence after 90-day blanking period. Primary safety endpoints were death from any cause, procedure-associated complications or stroke/transient ischemic attack. Median follow-up was 17 months (range 3–24). (3) Results: We included 268 patients with persistent AF (94 ≥ 75 years of age). Multivariate Cox regression analysis identified age as the only independent factor influencing AF recurrence in the overall cohort (p = 0.006). To minimize confounding bias in efficacy and safety analysis of cryoPVI, we matched younger and elderly patients with respect to baseline characteristics. At 24 months, primary efficacy endpoint occurred in 13/69 patients <75 years and 31/69 patients ≥75 years of age (24 months Kaplan–Meier event-rate estimates, HR 0.34; 95% CI, 0.19 to 0.62; log-rank p = 0.0004). No differences were observed in the occurrence of safety end points. (4) Conclusions: Elderly (≥75 years) patients with persistent AF undergoing cryoPVI had an approximately threefold higher risk of symptomatic AF recurrence than matched younger patients. Accordingly, other treatment modalities may be evaluated in this population.

Background Atrial fibrillation (AF) and heart failure (HF) are of growing prevalence and increasing mortality. Radiofrequency ablation is safe and effective for patients with AF and HF. Prognosis might be improved in patients treated. However, there is no prospective trial investigating efficacy and safety of cryoballon ablation in patients with AF and HF. Objective To prospectively compare cryoballoon ablation in patients with and without HF (defined as LVEF ≤40%) in terms of safety and efficacy. Methods Ongoing POLAR-HF trial is a prospective, investigator-initiated, single-center, non-inferiority, open-label study. We analyzed 244 consecutive patients who underwent cryoballoon ablation. Of these 217 had normal LVEF (age 68.1±9.6 years, CHA2DS2-VASc Score 2.5±1.3, 55.3% male) while 27 patients (11%) suffered from HF (age 70.4±8.6 years, CHA2DS2-VASc Score 3±1.2, 70.4% male). Follow-up was performed at 3, 6 and 12 months after ablation. Kaplan-Meier method was used to calculate 12-month event-rate estimates. Log-Rank Test to estimate hazard ratios in the primary analysis. Endpoints were: symptomatic AF relapse for efficacy and bleeding, stroke or death for safety. Results Analysis showed no difference in AF-free survival rate between patients with and without HF (81% vs. 76.3%, Log-Rank-Test P=0.81, Figure). Primary safety end point occurred in 5 patients with normal LVEF (2.3%) and none in the HF-group. No deaths were observed. Conclusion Results of POLAR-HF indicate that cryoballoon ablation is an effective ablation method for patients suffering from AF and HF. Event-Free Survival (Efficacy Endpoint) Funding Acknowledgement Type of funding source: None

Aims In the light of an increasing prevalence of atrial fibrillation (AF) and growing evidence for the superiority of early invasive rhythm control, the demand for ablation therapy is rising. Accordingly, ablation centres will have to maximize their capacity by either adding electrophysiology laboratory resources or optimizing process management. In order to optimize process management, we applied “Lean Six Sigma” method to a single ablation center. We compared procedural parameters, acute efficacy and safety of cryoballoon pulmonary vein isolation (cryoPVI) before and after modifications. Methods and results Patients (n = 713) undergoing cryoPVI (108 before and 605 after process optimization) were analysed. Within 3 years of process optimization, electrophysiology laboratory occupancy time (150.7 ± 44.4 vs. 94 ± 22.1 min, P &lt; 0.001), procedure time (84.5 ± 21–47.4 ± 12 min, P &lt; 0.001), left-atrial dwell time (53.9 ± 18.4–31.9 ± 9.9 min, P &lt; 0.001), and fluoroscopy time (15.8 ± 5.1 vs. 6.2 ± 2.8 min, P &lt; 0.001) decreased. Contrast dye use (116 ± 35 vs. 27 ± 15 mL, P &lt; 0.001) and radiation dose (893 ± 1078 vs. 253 ± 249 cGy cm2, P &lt; 0.001) were reduced by ∼77 and ∼72%, respectively. There was no difference in safety endpoint occurrence (3.7 vs. 1.5%, P = 0.11). Conclusion The process optimization of cryoPVI for AF therapy using the ‘Lean Six Sigma’ method significantly increases efficiency without compromising patient safety.

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