Document Detail


Impact of operator and site experience on outcomes after angioplasty and stenting in the SAMMPRIS trial.
MedLine Citation:
PMID:  22977278     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND AND PURPOSE: To investigate the relationship between physician and site experience and the risk of 30 day hemorrhagic and ischemic strokes in the stenting arm of the Stenting and Aggressive Medical Management for the Prevention of Recurrent Ischemic Stroke (SAMMPRIS) trial.
METHODS: Study records and an investigator survey were examined for physician and site related factors, including: number of Wingspan and aneurysm stents submitted for credentialing, number of study procedures performed in SAMMPRIS, years in practice after training, primary specialty, and site enrollment. Bivariate and multivariate analyses were performed to determine if these factors were associated with the 30 day rate of cerebrovascular events after angioplasty and stenting.
RESULTS: 213 patients underwent angioplasty alone (n=5) or angioplasty and stenting (n=208) with study devices by 63 interventionists at 48 sites. For credentialing, the median number of Wingspan and similar aneurysm stent cases submitted by study interventionists were 10 and 6, respectively. Interventionists with higher numbers (>10) of Wingspan cases submitted for credentialing tended to have higher rates of 30 day events (19.0% vs 9.9%) than those with <10 cases. High enrolling sites in the trial tended to have lower rates of hemorrhagic stroke (9.8% at sites enrolling <12 patients vs 2.7% at sites enrolling >12 patients).
CONCLUSIONS: Interventionists credentialed with less Wingspan experience were not responsible for the high rate of periprocedural stroke in SAMMPRIS. Hemorrhagic stroke may be related to low enrollment in the trial but not previous Wingspan experience.
Authors:
Colin P Derdeyn; David Fiorella; Michael J Lynn; Stanley L Barnwell; Osama O Zaidat; Philip M Meyers; Y Pierre Gobin; Jacques Dion; Bethany F Lane; Tanya N Turan; L Scott Janis; Marc I Chimowitz;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2012-09-12
Journal Detail:
Title:  Journal of neurointerventional surgery     Volume:  5     ISSN:  1759-8486     ISO Abbreviation:  J Neurointerv Surg     Publication Date:  2013 Nov 
Date Detail:
Created Date:  2013-09-30     Completed Date:  2014-05-07     Revised Date:  2014-11-05    
Medline Journal Info:
Nlm Unique ID:  101517079     Medline TA:  J Neurointerv Surg     Country:  England    
Other Details:
Languages:  eng     Pagination:  528-33     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Angioplasty / adverse effects,  methods*
Brain Ischemia / surgery*,  therapy
Cerebral Hemorrhage / epidemiology,  etiology
Cerebral Infarction / epidemiology,  etiology
Clinical Competence
Credentialing
Follow-Up Studies
Humans
Multivariate Analysis
Neurosurgery
Neurosurgical Procedures / adverse effects,  methods*
Patient Safety
Postoperative Complications / epidemiology
Prospective Studies
Recurrence / prevention & control
Stents*
Stroke / surgery*,  therapy
Treatment Outcome
Grant Support
ID/Acronym/Agency:
1 K23 NS069668-01A1/NS/NINDS NIH HHS; 1 K24 NS050307/NS/NINDS NIH HHS; 1 R01 NS36643/NS/NINDS NIH HHS; EY006360/EY/NEI NIH HHS; EY013287/EY/NEI NIH HHS; K23 NS069668/NS/NINDS NIH HHS; P50 55977//PHS HHS; R01 NS051631/NS/NINDS NIH HHS; TL1 RR029889/RR/NCRR NIH HHS; U01 NS058728/NS/NINDS NIH HHS; U01 NS058728/NS/NINDS NIH HHS; UL1 RR024131/RR/NCRR NIH HHS; UL1 TR000062/TR/NCATS NIH HHS; UL1 TR000077/TR/NCATS NIH HHS; UL1RR024131/RR/NCRR NIH HHS; UL1RR029882/RR/NCRR NIH HHS; UL1RR029889/RR/NCRR NIH HHS; UL1RR029890/RR/NCRR NIH HHS
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