Abstract 344: Interoperator Variability and Physician Learning with Medical Devices: Experience with Three New Vascular Closure Devices

Background: Clinical outcomes following medical device deployment depend on device design, patient traits, and operator experience. We use data from the Massachusetts PCI registry to compare freedom from vascular complications as a function of physician experience for three new vascular closure devices (VCDs): AngioSeal VIP , Mynx, and StarClose. Methods: Patients were included if they received a VCD between January 5, 2006 and June 27, 2009, received only one method of hemostasis after PCI, did not receive intra-aortic balloon pump, and had only one PCI during admission. The primary outcome was a composite of successful VCD deployment and absence of vascular complications before discharge. Physician experience with specific VCDs was calculated using all PCI meeting inclusion criteria. A generalized linear mixed effects model controlling for 12 patient characteristics and 6 procedure medications was used to determine the role of operator experience on outcomes. Early experience was defined as the first 20 deployments. The effect of experience was defined as the odds ratio of successful vs. unsuccessful deployment for each additional deployment for a device. Interoperator variability was defined as the odds ratio for successful deployment for an operator one standard deviation above average vs. an operator one standard deviation below average. Results: Patient, physician, and hospital characteristics are described in detail in Table 1. Interoperator variability was greater for StarClose (OR 9.4) and Mynx (4.22) than for AngioSeal VIP (1.00). There was a positive but not statistically significant association between experience and outcome for StarClose (OR 1.21, 95% CI: 0.98-1.49) and AngioSeal VIP (1.02, 0.85-1.23), and a statistically significant negative association for Mynx (0.66, 0.45-0.97). Conclusion: Interoperator variability was significant for devices with a new design (Mynx and StarClose) and not observed for a device based on an existing design (AngioSeal VIP). Physician experience has differing effects on vascular complications following VCD deployment. This likely reflects both design features and changes in patient selection between early and late deployments of the devices, including unobserved patient characteristics that may explain worsening outcomes with experience for Mynx. ![Graphic][1] [1]: /embed/inline-graphic-1.gif