Louis L. Nguyen, MD, MBA, MPH, FACS

Division of Vascular & Endovascular Surgery

Brigham & Women’s Hospital

Harvard Medical School

22 July 2012

What’s New in Vascular Surgery Quality Improvement

Disclosures

Society for Vascular Surgery liaison to NSQIP Governing Council, SVS Vascular Quality Initiative Member, Partners Healthcare IRB

Discussing off-label use of products No financial conflicts of interest

Outline

Distinguishing QI from research

Notable QI projects in Vascular Surgery Initiating hemodialysis Compliance to IFU in EVAR Surgical training

Does My Project Need IRB Approval?

Human subjects research needs IRB approval Full review Exempt (expedited) status

QI activities do not need IRB review

What is QI and How is It Different from Research?

Office for Human Research Protection A systematic investigation…designed to develop or

contribute to generalizable knowledge

HHS definition of QI An assessment, conducted by a QI organization, of a patient

care problem for the purpose of improving patient care through peer analysis , intervention, resolution, and follow-up

QI Characteristics

Designed to bring immediate improvements in health care delivery

May be only applicable to the local institution Designed to sustain the improvements Protocols may be adaptive over time

QI and Publications

Does intent to publish mean it’s research? No, QI activities can be published if of general interest

QI Oversight

Patients may not be exposed to more than minimal risk Institution assumes responsibility of oversight

When in doubt, ask your IRB

Initiating Hemodialysis

Retrospective review of 1212 pts with 2412 PSC controls

New Patient Intake Process 90-day Patient Education Program 90-day Patient Management Pathway Patient Monitoring and Reports

IMPACT Results

Higher hemoglobin levels (at 90 and 180 days) Higher portion of patients with preferred HD access Lower mortality

Focus patient management benefits patients

Compliance with IFU in EVAR

Adoption of EVAR

0

5000

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15000

20000

25000

30000

35000

40000

45000

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10

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2001 2002 2003 2004 2005 2006 2007

Tot

al A

AA

Rep

airs

Per

cen

t U

tili

zati

on

YearEVAR OPEN Total AAA Repairs

10,228 EVAR patients from 1999-2008 in M2S

Incidence of 41% sac enlargement at 5 years

Incidence increased in later years

Mohammad H. Eslami, Robert J. Goldberg and Louis MessinaAndres Schanzer, Roy K. Greenberg, Nathanael Hevelone, William P. Robinson,

RepairPredictors of Abdominal Aortic Aneurysm Sac Enlargement After Endovascular

2011, 123:2848-2855:Circulation

Compliance with IFU and Sac Enlargement

Surgical Training

14,700 LE bypass in 2005-2009 w/wo trainees

Propensity matched for trainee participation

Level of Trainees and Graft Failure

Summary

Consider assessing the delivery of health care Systematic approach to care Adherence to IFU for devices/medications Surgery education and training

The Vascular Specific modules provide additional relevant variables for analysis

Remember to minimize patient risk

Contact information

Louis L. Nguyen, MD, MBA, MPHVascular & Endovascular Surgery

Brigham & Women’s Hospital75 Francis Street

Boston, MA 02115

(857) 307-1920llnguyen@partners.org