Abstract and Introduction
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 < 0.001), procedure time (84.5 ± 21–47.4 ± 12 min, P < 0.001), left-atrial dwell time (53.9 ± 18.4–31.9 ± 9.9 min, P < 0.001), and fluoroscopy time (15.8 ± 5.1 vs. 6.2 ± 2.8 min, P < 0.001) decreased. Contrast dye use (116 ± 35 vs. 27 ± 15 mL, P < 0.001) and radiation dose (893 ± 1078 vs. 253 ± 249 cGy cm2, P < 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.
Atrial fibrillation (AF) is the most common cardiac arrhythmia and is associated with increased morbidity and mortality. In the context of an ageing population, there is evidence of a steadily increasing AF prevalence of currently ~5.5% for the overall population (≥55 years) and 17.8% for those aged 85 years and above. Recent analyses suggest that at the index age of 55 years, the lifetime risk for AF development is 37% for individuals of European ancestry. Atrial fibrillation is predicted to affect 15.3 million people in Europe by 2040. In this regard, AF represents a major public health burden with increasing healthcare costs of an estimated €660 million annually to the German and $26 billion to the US-American healthcare system.
Pulmonary vein isolation is an established treatment for symptomatic AF and has demonstrated its superiority over anti-arrhythmic drug therapy in terms of rhythm control. Cryoballoon pulmonary vein isolation (cryoPVI) is equivalent to radiofrequency ablation in terms of safety and efficacy for the treatment of paroxysmal AF, but has significant advantages in terms of laboratory resource utilization due to shorter procedure times and substantial cost savings.
Against the background of rising costs for healthcare systems worldwide, increased demand and limited electrophysiology (EP) lab occupancy time, we sought to prospectively analyse the effect of process optimization (PO) using the 'Lean Six Sigma' method on procedural parameters, safety, and acute procedural efficacy in a large single-centre approach.
Europace. 2022;24(11):1763-1768. © 2022 Oxford University Press
Copyright 2007 European Heart Rhythm Association of the European Society of Cardiology (ESC). Published by Oxford University Press. All rights reserved.