Quantifying the learning curve in the use of a novel vascular closure device: an analysis of the NCDR (National Cardiovascular Data Registry) CathPCI registry

Abstract

Objectives: This study sought to quantify the learning curve for the safety and effectiveness of a newly introduced vascular closure device through evaluation of the NCDR (National Cardiovascular Data Registry) CathPCI clinical outcomes registry.

Background: The impact of learning on the clinical outcomes complicates the assessment of the safety and efficacy during the early experience with newly introduced medical devices.

Methods: We performed a retrospective analysis of the relationship between cumulative institutional experience and clinical device success, defined as device deployment success and freedom from any vascular complications, for the StarClose vascular closure device (Abbott Vascular, Redwood City, California). Generalized estimating equation modeling was used to develop risk-adjusted clinical success predictions that were analyzed to quantify learning curve rates.

Results: A total of 107,710 procedures used at least 1 StarClose deployment, between January 1, 2006, and December 31, 2007, with overall clinical success increasing from 93% to 97% during the study period. The learning curve was triphasic, with an initial rapid learning phase, followed by a period of declining rates of success, followed finally by a recovery to a steady-state rate of improved device success. The rates of learning were influenced positively by diagnostic (vs. percutaneous coronary intervention) procedure use and teaching status and were affected inversely by annual institutional volume.

Conclusions: An institutional-level learning curve for the initial national experience of StarClose was triphasic, likely indicating changes in patient selection and expansion of number of operators during the initial phases of device adoption. The rate of learning was influenced by several institutional factors, including overall procedural volume, utilization for percutaneous coronary intervention procedures, and teaching status.

Figure 1:. Overall learning experience across 107,710 deployments of the StarClose VCD in 468 institutions reporting to NCDR CathPCI.

The graphic displays the estimated clinical success rate, defined as the frequency of successful device deployment without subsequent occurrence of access site complication versus cumulative institutional experience with the StarClose VCD. Dashed lines indicated the 95% confidence interval of the estimated success rate.

Figure 2:. Learning Experience for diagnostic versus coronary interventional procedures.

The graphic displays the clinical success rate, defined as the frequency of successful device deployment without subsequent occurrence of access site complication, stratified by diagnostic only procedures (blue) and coronary interventional procedures (red) versus cumulative institutional experience with the StarClose VCD. Dashed lines indicated the 95% confidence interval of the estimated success rate.

Figure 3:. Learning Experience in use of StarClose VCD stratified by annual Institutional volumes.

The graphic displays the clinical success rate, defined as the frequency of successful device deployment without subsequent occurrence of access site complication, stratified by catheterization laboratory procedural volume versus cumulative average operator experience with the StarClose VCD.

Figure 4:. Tri-phasic Learning Curves illustrated in the largest hospital quartile with annual institutional volume >2,400 VCD implants per year.

The graphic displays the clinical success rate, defined as the frequency of successful device deployment without subsequent occurrence of access site complication, versus cumulative average operator experience with the StarClose VCD. Three phases of the learning curve are noted: Early rapid learning (Phase I), between 0–22 average operator implants, declining clinical success (Phase II), between 23–50 average implants per operator, and steady state learning (Phase III), beyond approximately 50 StarClose VCD implants per operator at the institution.