Author + information
- Received July 7, 2011
- Revision received August 16, 2011
- Accepted September 3, 2011
- Published online January 1, 2012.
- Frederic S. Resnic, MD, MSc⁎,⁎ (, )
- Tracy Y. Wang, MD, MHS, MSc†,
- Nipun Arora, MD⁎,
- Venkatesan Vidi, MD⁎,
- David Dai, PhD†,
- Fang-Shu Ou, MS† and
- Michael E. Matheny, MD, MPH, MSc‡
- ↵⁎Reprint requests and correspondence:
Dr. Frederic S. Resnic, Cardiovascular Division, Brigham and Women's Hospital, 75 Francis Street, Boston, Massachusetts 02115
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.
This study was funded, in part, by grants from National Library of Medicine (NIH R01-LM008142), the American College of Cardiology Foundation's National Cardiovascular Data Registry (NCDR), as well as by the Veteran's Administration Health Services Research and Development Service (CDP 09-387).
The views expressed in this manuscript represent those of the author(s), and do not necessarily represent the official views of the NCDR or its associated professional societies identified at https://www.ncdr.com/webncdr/DefaultCathPCI.aspx. CathPCI Registry is an initiative of the American College of Cardiology Foundation and The Society for Cardiovascular Angiography and Interventions. Dr. Resnic is a consultant for St. Jude Medical and Medtronic Corporation. Dr. Wang received research grants from Bristol-Myers Squibb/Sanofi Partnership, Merck (previously Schering-Plough), The Medicines Company, Eli Lilly/Daiichi Sankyo Partnership, Canyon Pharmaceuticals, Heartscape, AstraZeneca, and Medco. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 7, 2011.
- Revision received August 16, 2011.
- Accepted September 3, 2011.
- American College of Cardiology Foundation