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Vascular Study Group of New England

Vascular Study Group of New England. 20 th Semi-Annual Meeting. May 6, 2013 Tufts Medical Center, Boston, MA. VSGNE 2013 30 Participating Hospitals. 15 Community - 15 Academic. Fletcher Allen Health Care. Eastern Maine Medical Center.

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Vascular Study Group of New England

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  1. Vascular Study Group of New England 20th Semi-Annual Meeting May 6, 2013 Tufts Medical Center, Boston, MA

  2. VSGNE 201330 Participating Hospitals 15 Community - 15 Academic Fletcher Allen Health Care Eastern Maine Medical Center MaineGeneral Medical Center Cottage Hospital Central Maine Medical Center Dartmouth-Hitchcock Medical Center Lakes Region Hospital Maine Medical Center Mercy Hospital Concord Hospital Cardiothoracic Surgical Associates Elliot Hospital Berkshire Medical Center Massachusetts General Hospital Boston Medical Center U. Mass. Medical Center Tufts Medical Center Brigham & Women’s Hospital Baystate Medical Center St. Elizabeth’s Hospital Center Beth Israel Deaconess Medical Center St. Francis Hospital Charlton Memorial Hospital Miriam Hospital Caritas St. Anne’s Hospital Hartford Hospital Rhode Island Hospital St. Luke’s Hospital Danbury Hospital Hospital of St. Raphael Yale-New Haven Hospital

  3. >33,000 Procedures Reported CEA, CAS, oAAA, EVAR, LEB, PVI, TEVAR, Access

  4. 228 Centers, 45 States + Ontario as of 5/1/2013

  5. Organized Regional Groups: • New England • Carolinas • Florida-Georgia • Southern California • South • Virginias • New York City • Rocky Mountains • Illinois • Wisconsin • Mid-Atlantic • Upstate New York • Chesapeake • Indiana • Great Lakes Organizing Regional Groups: • Northern California • Michigan • Missouri • Tennessee/Mississippi • Minnesota 15 Regional Quality Groups

  6. Collaboration to Add Venous Procedures American Venous Registry

  7. Organization Governing Council 4 SVS Representatives 2 AVF Representatives 15 Regional Group Representatives Arterial Quality Committee 4 SVS Representatives 15 Regional Group Representatives Venous Quality Committee 3 AVF + 2 SVS Representatives 15 Regional Group Representatives Venous Research Advisory Committee 3 AVF + 2 SVS Representatives 10 Regional Group Representatives Arterial Research Advisory Committee 2 SVS Representatives 10 Regional Group Representatives

  8. VSGNE Representatives Governing Council Richard Cambria – SVS, Chair Louis Nguyen - SVS Jens Jorgensen - VSGNE Arterial Quality Committee Andy Schanzer, Marc Schermerhorn - SVS Phil Goodney - VSGNE Venous Quality Committee - Mark Iafrati - VSGNE Venous Research Advisory Committee - To Be Named Arterial Research Advisory Committee Phil Goodney – SVS, Chair Nolan, Schanzer, Shermerhorn - VSGNE

  9. SVS PSO IVC Filter Work Group • Reviewed IVC filter module from AVR • Revised, translated into VQI format • Brajesh Lal • Antonios Gasparis • David Gillespie • Mark Meissner • Marc Passman • Joseph Raffetto • Jack Cronenwett Implemented by M2S for current use in VQI Planned: Venous Stenting DVT Thrombolysis Upper Extremity DVT Varicose Veins

  10. IVC Filter History Tab

  11. IVC Filter Procedure Tab

  12. One Year Follow-up • VQI and VSGNE require that a follow-up form be entered for at least 80% of patients at least 9 months after their procedure, based on in person or telephone visit.

  13. One Year Follow-up - Success • Develop a clear plan with key roles • Communicate the plan to all staff • Include in performance evaluation • Physician champion partners with data manager, emphasizes importance • Develop mechanism to identify patients needing follow-up reporting

  14. One Year Follow-up - Success • Paper office records • Print report of patients needing follow-up each month, using web-based system • Be sure each patient has an appointment • Flag chart with colored sticker • Print follow-up form and attach to chart for use during office visit

  15. One Year Follow-up - Success • Electronic office records • Print report of patients needing follow-up each month, using web-based system • Be sure each patient has an appointment • Work with EMR vendor to flag VSGNE Pts • Develop a template to insure that needed data are recorded during office visit • Transfer data to web-based system

  16. One Year Follow-up - Failure • “I didn’t know follow-up was required” • “No one is assigned to do this” • “Our physicians won’t take time in the office to help with this” • “Our physicians don’t think this is important” • “We don’t know which patients need follow-up” • “I am too busy. There is no reward for doing this extra work”

  17. 2010-2011 VSGNE Data AuditCurrent Status Site Participation • 27 sites in VSGNE entered data 2010-2011 • 100% of sites submitted CPT claims data (3 sites incomplete) • 100% of sites have received feedback files • 78% of sites have completed their reconciliation Validation Analysis

  18. VSGNE Caregiver Meeting • Kristine Chaisson, RN

  19. Open vs. Endovascular Repair of Popliteal Artery Aneurysm (OVERPAR) TrialAn Update Mohammad H. Eslami, Phil Goodney, and Alik Farber VSGNE Semi-annual Meeting Tufts Medical Center 5/6/2013

  20. OVERPAR Trial A prospective, multicenter randomized trial of open surgical bypass vs. endovascular popliteal artery stent graft repair in asymptomatic patients Trial sponsored by NESVS and orchestrated through VSGNE

  21. OVERPAR Trial • Primary hypothesis: • Major adverse limb event (MALE)-free survival is lower in the EPAR vsOPAR group. • Secondary hypotheses: • EPAR will be associated with • more secondary interventions • improved independent living status • increased ambulatory status • improved quality of life • decreased LOS

  22. OVERPAR Trial • Primary Outcome: • MALE-free survival • adjusted from OPG guidelines to include minor interventions

  23. OVERPAR Trial • Secondary Outcomes • Clinical • Composite MALE - POD ( perioperative death) • Freedom from secondary interventions • Number of interventions • Primary, primary-assisted and secondary patency rates • Procedure duration • 30-day freedom from perioperative MACE • Other perioperative complications • Functional status and quality of life • Resource utilization (LOS)

  24. Patients with asymptomatic PAA eligible for repair LE CTA of affected limb To plan surgery No Excluded Yes No Informed consent 1:1 randomization Yes Stent Group Open Group Trial Group 4 year study: mean follow-up of 2.5 years

  25. Current VQI Machinery vs. OVERPAR Trial Current patients at VQI centers Participating in OVERPAR Current patients at VQI centers Patients with PAA at the participating VQI centers Patients with PAA at participating VQI centers and OVER-PAR Trial 1:1 Randomization O P A R O P A R E P A R E P A R PVI Forms PVI Forms* LEB Forms LEB Forms* Data is collected at M2S Data is collected at M2S Time*: 1month and annually Time: 1month and one year

  26. Sample Size Calculation • MALE survival curves estimated using data from the largest series of OPAR and OPG data describing patients with PAD who underwent bypass • Assumption: patients will be accrued uniformly over three years and then followed for one additional year past accrual period • 50% loss to follow-up within ten years (~7% after first year and 20% after 3 years) • 148(74 in each group) patients to achieve power of .8 for two-sided test with a type I error bound of .05 using a balanced design

  27. Randomization • Participating sites will contact study coordinator at BMC • For each center, electronic folders are created by biostatistician. • Upon receiving the phone call, these electronic folders are accessed and the results (OPAR or EPAR) are relayed to the site study coordinator

  28. Patient Follow-up 0 1 12 24 36 48 Scheduled post-op visits (months) History and physical evaluation Arterial Duplex of the graft/stent ABI (if possible) QOL Patient Surveyœ (patients can fill out and send back) (œMorgan et al. J VascSurg2001; 33: 679-87)

  29. Participating VSGNE Centers: 16 VSGNE centers agreed to participate Connecticut Danbury Medical Center Hartford Hospital YALE Maine Maine Medical Center Massachusetts Bay state Medical Center Boston Medical Center Brigham and Women’s Hospital BI Deaconess Hospital Charlton Memorial Hospital/St. Anne Hospital Massachusetts General Hospital St Elisabeth’s Hospital Tufts Medical Center New Hampshire Cardiothoracic Surgical Associates Dartmouth Medical Center Rhode Island: Rhode Island Brown Hospital Vermont UVT Hospitals

  30. Participating VQI Centers • University of Indiana • University of VA at Charlottesville • Detroit Henry Ford Hospitals • Albany Vascular Group • LSU at Shreveport, LA • Penn State University Hospitals, Hershey, PA

  31. Recruiting Strategies • We continue to recruit centers: • Carrie Boscela • We try to present this at all Regional Society Meetings • Concept paper

  32. What is needed from each Center • Apply to IRB • We have a protocol that can be used to easily complete this task • We can assist with IRB questions • Enroll patients • Follow-up scheme is similar to standard practice • Follow up is slightly longer period • Modified VSGNE forms for PVI and LEB which will be available 5/16/13

  33. Participating Centers

  34. Why Participate and Enroll? • Study answers a relevant question • Will provide level I data • Uses data collection resources already in place for VQI • Case study for running future prospective trials on a modest budget LEVEL I DATA on Budget

  35. Budget

  36. A Model for Future Studies using VQI Compression of OVERPAR budget with an average RO1 award (2007) NIH award budget over years.

  37. Thank You

  38. SVS VAM Presentations • Doninique Buck • Randy DeMartino

  39. Cranial Nerve Injury following Carotid Endarterectomy On behalf of the Vascular Study Group of New England M. Fokkema, G.J. de Borst, B.W. Nolan, J. Indes, R.C. Lo, T. Curran, D.B. Buck, F.L. Moll, M.L. Schermerhorn

  40. Background • Impact of cranial nerve injury (CNI) • Relevant safety endpoint • Long-term rates are unknown

  41. Aim of study • To evaluate transient and persistent CNI • To identify the nerves affected • To identify predictors for CNI

  42. Methods • Patients • VSGNE • patients undergoing CEA • from 2003-2011 • Primary endpoints • CNI at discharge • Persistent CNI at follow-up • Statistics • Bivariate analyses • Multivariable analyses controlling for surgeon and hospital

  43. Results N = 6878 patients, mean age 69 year (SD ± 9.3), 60.2% men

  44. Results: rate of any CNI

  45. Results: rate per nerve

  46. Results

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