| Quantifying the Learning Curve in the Use of a Novel Vascular Closure Device An Analysis of the NCDR (National Cardiovascular Data Registry) CathPCI Registry. | |
| | |
MedLine Citation:
|
PMID: 22230153 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
|
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. |
| | |
Authors:
|
Frederic S Resnic; Tracy Y Wang; Nipun Arora; Venkatesan Vidi; David Dai; Fang-Shu Ou; Michael E Matheny |
Related Documents
:
|
22141203 - The organization of an educational program for specialists in clinical chemistry by the... 21572063 - Effective radiography clinical instructor characteristics. 9285983 - Use of the brief psychiatric rating scale to measure success in a psychosocial day prog... |
Publication Detail:
|
Type: Journal Article |
Journal Detail:
|
Title: JACC. Cardiovascular interventions Volume: 5 ISSN: 1876-7605 ISO Abbreviation: JACC Cardiovasc Interv Publication Date: 2012 Jan |
Date Detail:
|
Created Date: 2012-01-10 Completed Date: - Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 101467004 Medline TA: JACC Cardiovasc Interv Country: United States |
Other Details:
|
Languages: eng Pagination: 82-9 Citation Subset: IM |
Copyright Information:
|
Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. |
Affiliation:
|
Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
|
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: The Sirolimus-Eluting Cypher Select Coronary Stent for the Treatment of Bare-Metal and Drug-Eluting ...
Next Document: Prevention of contrast nephropathy by furosemide with matched hydration: the MYTHOS (Induced Diuresi...