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

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

Vascular Study Group of New England

20 Semi-Annual Meeting

May 6, 2013 Tufts Medical Center, Boston, MA

VSGNE 2013

30 Participating Hospitals

15 Community 15 Academic

Fletcher Allen Health Care Cottage Hospital Eastern Maine Medical Center MaineGeneral Medical Center 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 U. Mass. Medical Center Boston Medical Center Tufts Medical Center Baystate Medical Center St. Elizabeth’s Brigham & Women’s Hospital Beth Israel Deaconess Medical Center Hospital St. Francis Hospital Danbury Hospital Center Hartford Hospital Miriam Hospita Rhode Island Hospital l Charlton Memorial Hospital Caritas St. Anne’s Hospital St. Luke’s Hospital Hospital of St. Raphael Yale-New Haven Hospital

>33,000 Procedures Reported

CEA, CAS, oAAA, EVAR, LEB, PVI, TEVAR, Access 35000 30000 25000 20000 15000 10000 5000 0

228 Centers, 45 States + Ontario

as of 5/1/2013

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

Total Procedures Captured (as of May 1st, 2013)

Carotid Endarterectomy Carotid Artery Stent Endovascular AAA Repair Open AAA Repair Peripheral Vascular Intervention Infra-Inguinal Bypass Supra-Inguinal Bypass Thoracic and Complex EVAR Hemodialysis Access

87,226

24,071 3,099 8,986 3,834 25,554 12,691 3,774 1,086 4,003

Collaboration to Add Venous Procedures

American Venous Registry

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 Arterial Research Advisory Committee 2 SVS Representatives 10 Regional Group Representatives Venous Research Advisory Committee 3 AVF + 2 SVS Representatives 10 Regional Group Representatives

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 Arterial Research Advisory Committee Phil Goodney – SVS, Chair Nolan, Schanzer, Shermerhorn - VSGNE Venous Research Advisory Committee To Be Named

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

IVC Filter History Tab

IVC Filter Procedure Tab

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.

VSGNE Center Comparison – 2010 Procedures 9 month or greater follow-up rate

(office visit or phone call, excludes patients who died) Center rate Overall rate = 59% Goal > 80% 100% 90% 80% 70% 60% 50% 40% 30% 20% 24% 28% 30% 30% 39% 49% 53% 63% 67% 69% 72% 72% 73% 76% 77% 10% 0% 0% A 0% B C D E F Procedures: CAS, CEA, EVAR, INFRA, OPEN, PVI, SUPRA G H I

Centers

J K L M N O P Q

VSGNE Center Comparison – 2011 Procedures 9 month or greater follow-up rate

(office visit or phone call, excludes patients who died) Center Goal > 80% Overall rate = 57% 100% 90% 80% 70% 60% 55% 55% 56% 56% 59% 61% 63% 50% 42% 40% 30% 20% 15% 22% 27% 31% 35% 10% 0% 0% 0% 0% 0% 0% 0% 3% A B C D E F G H I J K L M N O P Q R S T 71% 72% 74% 76% 78% 80% 86% 88% U V W X Y Z AA AB

100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 38% 51% CAS (n=178)

VSGNE 9 month or greater follow-up rate for procedures in 2011

(Excluded patients who died 9 months post procedure and technical failure (PVI and CAS) Office or Phone Follow-up VSGNE VQI GOAL 57% 53% 66% 59% 63% 60% 60% 57% 51% 52% 57% 55% 57% 54% CEA (n=1630) EVAR (n=633) INFRA (n=1026) OPEN (n=231) PVI (n=2171) SUPRA (n=386) All procedures (n=6255)

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

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

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

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”

2010-2011 VSGNE Data Audit

Current 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 Exact Matches Corrected in Claims Corrected in VQI Properly excluded from VQI Procedure Added in VQI In VQI, Not in Claims 47% 16% 5% 16% 8% 7%

VSGNE Caregiver Meeting



Kristine Chaisson, RN

Open vs. Endovascular Repair of Popliteal Artery Aneurysm (OVERPAR) Trial An Update

Mohammad H. Eslami, Phil Goodney, and Alik Farber VSGNE Semi-annual Meeting Tufts Medical Center 5/6/2013

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

OVERPAR Trial

• •

Primary hypothesis:

– Major adverse limb event (MALE)-free survival is lower in the EPAR vs OPAR group.

Secondary hypotheses:

– EPAR will be associated with • more secondary interventions • • improved independent living status increased ambulatory status • improved quality of life • decreased LOS

OVERPAR Trial

•

Primary Outcome:

–

MALE-free survival

• adjusted from OPG guidelines to include minor interventions

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)

Patients with

asymptomatic

PAA eligible for repair No No LE CTA of affected limb To plan surgery Yes Informed consent Yes

1:1 randomization

Stent Group

Open Group

4 year study: mean follow-up of 2.5 years

Current VQI Machinery vs. OVERPAR Trial

Current patients at VQI centers Current patients at VQI centers Participating in OVERPAR Patients with PAA at the participating VQI centers Patients with PAA at participating VQI centers and OVER-PAR Trial 1:1 Randomization

PVI Form s

O P A R

E P A R LEB Forms PVI Forms *

O P A R

E P A R LEB Forms* Data is collected at M2S Time: 1month and one year Data is collected at M2S Time*: 1month and annually

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) MALE

1-year Rates

OPAR

20%

EPAR

35%

Hazard Ratio

1.53

Power

80%

• 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

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

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 Survey œ (patients can fill out and send back) ( œ Morgan et al. J Vasc Surg 2001; 33: 679-87)

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

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

Recruiting Strategies

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

Participating Centers

IRB Preparation IRB submission IRB approved ENROLLED

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

Budget

Central Trial Coordinator Statistical Support and randomization scheme Year 1 ($) 2000 1000 Site coordinator support IRB fees Total: Year 2 ($) 4000 1000 Year 3 ($) 4000 1000 5000 ($100/pt enrolled) 2000 10,000 5000 ($100/pt enrolled) n/a 10,000 5000 ($100/pt enrolled) n/a 10,000 Year 4 ($) 0 0 0 n/a 0

A Model for Future Studies using VQI

Compression of OVERPAR budget with an average RO1 award (2007) NIH award budget over years.

Annual amount($) 350 000 300 000 250 000 200 000 150 000 100 000 50 000 0 Average NIH RO1 grants OVERPAR Trial

Thank You

SVS VAM Presentations



Doninique Buck



Randy DeMartino

C RANIAL N ERVE I NJURY C AROTID FOLLOWING E NDARTERECTOMY

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

B ACKGROUND  Impact of cranial nerve injury (CNI)  Relevant safety endpoint  Long-term rates are unknown

A IM OF STUDY  To evaluate transient and persistent CNI  To identify the nerves affected  To identify predictors for CNI

M ETHODS 

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

R ESULTS N = 6878 patients, mean age 69 year (SD ± 9.3), 60.2% men

Preoperative characteristics

Symptomatic Redo-CEA Prior Cervical Radiation Shunt Emergent procedures (<6hr) Urgent procedures (<24hr)

2325 152 88 3237 43 649

33.8% 2.2% 1.3% 47% 0.6% 9.4%

R ESULTS : RATE OF ANY CNI 6% 5% 4% 3% 2% 1% 0%

N = 382 5.6% At discharge N = 47 0.7% At follow-up (persistent)

R ESULTS : RATE PER NERVE 3,0% 2,5% 2,0% 1,5% 1,0% 0,5% 0,0%

2,7% 1,9% 0,7% XII VII X 0,5% IX

R ESULTS

Peri-operative outcome

Re-exploration Return to the OR Reperfusion Any Stroke MI Length of stay, days

217 111 10

3.2

1.6

0.1

64 63 1.5 (0) 0.9

0.9

CNI rate P-value

9.7% 0.01

14.4% 30% <.001

0.02

23.4% <.001

7.9% 2 (1) NS <.001

PREDICTORS AND NON PREDICTORS Urgent* Emergent* Re-exploration Return to the OR *vs elective

45 7 21 16

6.9

16.3

9.7

14.4

1.5

2.6

2.0

2.4

95% CI

1.1 – 2.0

P-value

0.04

1.2 – 5.5

1.3 – 3.0

1.4 – 3.8

0.02

<0.01

Redo-CEA Prior radiation 8 4 5.3

4.5

1 0.9

0.5 – 2.1

0.3 – 2.5

NS NS

N ERVES AT RISK IN SPECIFIC CONDITIONS 14% 12% * 10% 8% 6% 4% 2% 0% * * * * * * * * XII VII X IX Other nerves

C ONCLUSION  Persistent CNI is rare  Most injured nerves: hypoglossal & facial nerve  Predictors for increased risk for CNI   Urgency of procedure Re-exploration during primary procedure  Return to OR

T HANK YOU  Vascular Study Group of New England      Dr. M.L. Schermerhorn Dr. M. Fokkema Prof. F.L. Moll Dr. G.J. de Borst Dr. R.C. Lo     Dr. T. Curran Dr. B.W. Nolan Dr. J. Indes J. Darling

Optimal Medical Management Reduces Mortality Following Vascular Surgery in New England

Randall R. De Martino, J. Eldrup-Jorgensen, B.W. Nolan, D.H. Stone, J. Adams, D.J. Bertges, J.L. Cronenwett, and Philip P. Goodney; For the Vascular Study Group of New England

Introduction

• Although antiplatelet (AP) and statin use is recommended for patients with peripheral vascular disease, many patients remain medically undertreated

Purpose

• To describe the use and impact of optimal medical management on survival following vascular surgical procedures in New England • Optimal medical management was defined as being on AP and statin medications pre-op and at discharge

Infra 21% Supra 5% EVAR 15% oAAA 7% CAS 4%

VSGNE 2005-2012

• First time surgery in the Vascular Study Group of New England • Elective cases only CEA 48% • No missing medication data • 14,489 Patients for analysis • 52% CEA or CAS • 22% AAA • 26% Arterial bypass

Change in Optimal Medical Management Over Time

100% Proportion of Patients on Optimal Medical therapy 75% 50% 51% 57% 61% 66% 65% 64% 66% 63% 25% 0% 2005 2006 2007 2008 2009 2010 2011 2012 P trend <0.01

30 Day Mortality

2,5% 2,0% 1,5% 1,0% 0,5% 0,0% N = P>0.05

1,80% 2,3% Neither 834 Statin 2,422 AP 1,273 Both 9,960

2,5% 2,0% 1,5% 1,0% 0,5% 0,0% N = 1,80% Neither 834

30 Day Mortality

Statin 2,422 P<0.01

1,1% AP 1,273 1,0% Both 9,960

5 Year Survival By Discharge Medication

79% Both 74% Statin 72% AP 55% None SE<0.1 Log rank p<0.01

Survival Benefit by Discharge Medication

Medication Status Adjusted HR

No AP or Statin 1.0 Ref

95% CI

1.0 Ref

Antiplatelet Statin Both 0.72

0.65

0.6-0.9

0.5-0.9

<0.01

0.53

0.4-0.7

Adjusted for patient age, comorbidities, and procedure <0.01

Variation in Optimal Medication use Across Centers

100% AP and Statin at Pre-Op and Discharge 87% 75% 37% 50% 25% 0% Center

Variation in Optimal Medication use Across Procedures

Procedure

Areas For Improvement

• Of all patients in our analysis – 70% of patients overall

were

medications pre-operatively on both • 95% were discharged on both agents • However 5% were taken off one agent – 30% of patients were

not

preoperatively on both agents • 32% of these were discharged on both agents • 68% were not placed on both agent

Conclusions

• Although improving, there is variation and under utilization of optimal medication use in our region • This is associated with higher mortality following vascular surgery

Discussion

• Factors limiting better medication utilization are multifactorial involving patients preference, access to care and systems based factors • Regional quality groups are well suited to close quality gaps in medication use to improve patient outcomes

Smoking Cessation



Nancy A. Rigotti, MD

• Professor of Medicine, Harvard • Director, Tobacco Research and Treatment Center, MGH  Strategies to help a smoker who is struggling to quit. Rigotti NA JAMA. 2012 Oct 17;308:1573-80

VSGNE Smoking Status 2003-2009

7,807 Patients smoking status and 1-year follow-up Past Smokers 50% Current Smokers 33% Never Smokers 17% Continued 55% Quit 45%

Effect of Procedure and Center

Contribution to Variation Smoking Cessation by Procedure Type

20 10 0 60 50 40 30 50 49

oAAA EVAR

LEB

CEA

CAS

HTN Dialysis 1,3% 0,5% COPD 8,9% Age 8,9% Procedure 5,5% Center 75% (Knaus/Wagner chi-pie)

Results: treatment center

80% 70% 60% 50% 40% 30% 20% 10% 0%

Observed and Expected Smoking Cessation Rates by Center

* * * * * 1 2 3 4 5 6 7 VSGNE Center 8 9 10 *P<0.05

O:E Observed Rate Expected Rate

Results: Surgeon Survey

Smoking cessation

60 • Surgeons offering pharmacotherapy or referral to a specialist had higher rates of smoking cessation. (85% response rate) 50 40 30 20 48 33 * P<0.05

10 0 Yes No Pharmacotherapy or referral offered?

2011 VSGNE Smoking Cessation Rate

% of Patients who Quit Smoking at Follow-up (Centers with 10 or more follow-ups) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 18% 21% VSGNE average = 43% (2003-2009 was 45%) 31% 37% 37% 38% 39% 40% 43% 47% 47% 49% 49% 51% 58% 66% 72% 88% 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18

Treating Tobacco Use Best Methods and Recommendations for VSGNE

Nancy Rigotti, MD

Director, MGH Tobacco Research and Treatment Center Professor of Medicine, Harvard Medical School [email protected]

OVERVIEW

   The challenge for treatment 2008 US Public Health Service Clinical Guideline Newer evidence   Better way to use nicotine replacement Safety of varenicline  What can you do?

Rigotti NA. Strategies to help a smoker to who is struggling to quit. JAMA 2012;308:1573

WHY TREATING TOBACCO USE MATTERS



Many people still smoke

(19% of US adults) 

Tobacco is the #1 preventable cause of death

 Tobacco use accounts for 1 in 3 CVD deaths 

Cessation reduces morbidity and mortality

 

Even after CVD - post MI: Quitting → 36% ↓ in mortality 1 Even after age 65 2



Tobacco is the forgotten CVD Risk Factor

1 Critchley et al. JAMA 2003;290:86; 2 Gellert et al. Arch Intern Med 2012; 172:837

QUITTING IN PERSPECTIVE

National Health Interview Survey 2010    69% of current smokers want to quit 52% of smokers try to quit each year Few succeed long-term

(quit for 1 year)

6% succeed without help 25-30% succeed long-term with best treatment Only 32% of those trying to quit seek help

MMWR November 2011;60:1513

THE CHALLENGE FOR TREATMENT

 We have effective treatments, but…  We need better treatments  We need to deliver the treatments we have to more smokers

New paradigm

Treat Tobacco Use Like a Chronic Disease

It needs long-term management and as much of your attention as treating hypertension and lipids

OVERVIEW

   The challenge for treatment 2008 US Public Health Service Clinical Guideline Newer evidence   Better way to use nicotine replacement Safety of varenicline  What can you do?

SMOKING CESSATION METHODS

2008 US Public Health Service Guidelines

 Effective treatments exist 

Counseling



Pharmacotherapy – use

combinations



Combination

is better than either one alone

 More is better but brief intervention works

COUNSELING

    

In person

(Individual or group)

Telephone

   

Proactive

multisession counseling Convenient, private Effective -

OR 1.4 (95% CI 1.3-1.6) – Cochrane review Free Quitline: 1-800-QUIT NOW

Websites 

Becomeanex.com, Quitnet.com

Text Messaging Smart phone app’s

1 st Line -

PHARMACOTHERAPY

2008 US Public Health Service Guidelines

 Nicotine replacement     Skin patch Gum

(OTC) (OTC)

Lozenge

(OTC)

Oral inhaler

(Rx)

 Nasal spray

(Rx)

  Bupropion SR

(Zyban,Wellbutrin SR)

Varenicline

(Chantix)

1.9

1.5

2.0

2.1

2.3

2.0

3.1

OVERVIEW

   The challenge for treatment 2008 US Public Health Service Clinical Guideline Newer evidence   Better way to use nicotine replacement Safety of varenicline  What can you do?

PLASMA NICOTINE LEVELS

Cigarettes vs. Nicotine Replacement Products

18 16 14 12 10 8 6 4 2 0 0 10 20 30 40 50 60 70 80 90 100 110 120 Time post administration (min) Cigarette (1-2 mg) Nasal spray (1 mg) Gum (4 mg) Patch (21 mg)

NICOTINE REPLACEMENT

Long-acting, slow onset

→ skin patch

   Constant nicotine level to avoid withdrawal Simplest to use, best compliance User has no control of dose

Short-acting, faster onset

→ oral

(gum, lozenge, inhaler)

→ nasal

(spray)

   User controls dose Nicotine blood levels fluctuate more Requires more training to use properly

ARE COMBINATIONS BETTER?

2 head-to-head randomized trials

Piper, Arch Gen Psychiat 2009; Smith, Arch Int Med 2010

  

5 drug regimens tested

(vs placebo)

 

Monotherapy

: Patch, lozenge, bupropion

Combos

: Patch + lozenge, bupropion + lozenge

Trials in 2 settings

  Clinical trial Primary care clinics

Results

  Each drug was better than placebo Combinations > monotherapy

BUPROPION SR

(Zyban, Wellbutrin SR)

  Acts via CNS dopaminergic pathways Doubles cessation rate independent of its antidepressant effect  Now a generic drug     Start 1 week before quit day

(150 mg qd→bid)

Treat for 3 months

(up to 6 mo to avoid relapse)

Increases seizure risk

(Risk <0.1%)

Blunts weight gain temporarily

VARENICLINE

N N  Partial agonist at α4β2 nicotinic receptor Receptor subtype that mediates nicotine dependence  Dual mechanism of action  Partial agonist Stimulates receptor to treat craving, withdrawal  Antagonist Prevents nicotine from binding to the receptor

→

Blocks reward, reinforcement of smoking

Varenicline efficacy across studies Continuous Abstinence Rates (Weeks 9 –52)

25 OR: 3.14

(95% CI: 1.93 – 5.11) p < 0.0001

OR 4.04

(95% CI, 2.13, 7.67) p < 0.001

20 19.2

18.6

OR 2.86

(95% CI,1.72, 4.11) p < 0.001

22.4

Varenicline Placebo 15 9.3

10 7.2

5.6

5 0 n = 355 n = 359 Stable CVD 1 n = 248 n = 251 COPD 2 n = 692 n = 684 Healthy smokers 3 1 Rigotti

et al, Circulation

2010; 2 Tashkin D

et al. Chest

2010

3 Gonzales

et al

.; Jorenby

et al

JAMA

2006

FDA Public Health Advisory

July 2009

  “Chantix (varenicline) or Zyban (bupropion) has been associated with reports of changes in behavior such as hostility, agitation, depressed mood, and suicidal thoughts or actions.” “FDA is requiring the manufacturers of both products to add a new

Boxed Warning: People who are taking Chantix or Zyban and experience any serious and unusual changes in mood or behavior or who feel like hurting themselves or someone else should stop taking the medicine and call their healthcare professional right away.

Friends or family members …”

VARENICLINE SAFETY

The dilemma

    Stopping smoking produces nicotine withdrawal symptoms

(depressed mood, anxiety, and irritability)

When these symptoms occur in a smoker who is stopping smoking on varenicline, did the drug or did quitting smoking cause the symptom? Case reports cannot answer this question.

Clinical trials of varenicline could. They detected no excess of depression or suicidal thoughts, but these studies did not include patients with mental illness.

   

VARENICLINE SAFETY

Gunnell et al, BMJ 2009

UK General Practice Research Database

 Population based data: 3.6 million patients in 500 practices  Data from electronic medical records

Patients starting smoking medication

(9/06 – 5/08)    NRT

(n=63,265)

Bupropion Varenicline

(n=6422) (n=10,973)

Outcome

: rates of suicide, suicide attempt, suicidal thoughts, and new antidepressant therapy

Results

: No evidence of increased risk of suicidal outcomes for varenicline vs NRT, bupropion vs NRT

VARENICLINE SAFETY

Bottom Line

  Varenicline may increase risk of psychiatric symptoms in some patients. The potential risk is not yet well defined. Prescribing any drug requires balancing risks and benefits. - Varenicline is one of the most effective drugs available to treat tobacco dependence - Continuing to smoke is clearly hazardous 

FDA Drug Safety Communication

– October 2011

“The Agency continues to believe that the drug’s benefits outweigh the risks.”

VARENICLINE SAFETY - CVD

Two meta-analyses with different conclusions

 Does it ↑risk of serious adverse cardiovascular events?  Singh

et al

CMAJ,

2011  1.06% for varenicline vs. 0.82% for placebo  Peto OR = 1.7, 95% CI (1.1

–2.7)  Risk difference = 0.24%  Prochaska

et al

BMJ

, 2012    0.63% for varenicline vs. 0.47% for placebo MH OR = 1.40, 95% CI (0.82--2.39) Risk difference = 0.27%  Both agree: Absolute risk is very low

OVERVIEW

   The challenge for treatment 2008 US Public Health Service Clinical Guideline Newer evidence   Better way to use nicotine replacement Safety of varenicline  What can you do?

TREATING TOBACCO IN THE OFFICE

2008 U.S. Public Health Service Guidelines – 5A’s



Routine advice to quit is effective



Brief counseling is more effective



ASK



ADVISE



ASSESS



ASSIST



ARRANGE

all patients about smoking all smokers to quit smoker’s readiness to quit smokers to quit follow-up care



ASK



ADVISE



ACT

VERY BRIEF ADVICE

“30 seconds to save a life”

all patients about smoking

Keep asking exsmokers for 3 years

all smokers to quit and offer help

Don’t ask smokers if they want to quit

“

Quitting smoking can be hard but there is good treatment and I can help you. Would you like some help?”

prescribe medication and refer

Fax or email referral directly to state telephone quitline or use community resource Meds: combination NRT or varenicline

TELEPHONE QUITLINE



1-800-QUIT NOW

to access your state quitline  

Proactive

multisession counseling Convenient, private, free  Many states offer free NRT through quitline  How do you connect smoker to quitline?

 Hand out quitline number

(doesn’t work)

 Fax-referral or e-referral from office  Staff helps patient call in office

FAX-REFERRAL SYSTEM You or staff faxes a referral form to the Quitline Quitline calls smoker to offer free counseling and NRT sample

State Quitline Resources for MD Office Source: North American Quitline Consortium (www.naquitline.org) State

CT MA ME NH RI VT

Fax Referral

Y Y Y Y Y Y

Electronic Referral

N Y Y Y Y Y

Free NRT offered

P, G, L P P, G, L P P, G, L

HOSPITALIZATION and SURGERY

“Windows of opportunity” for smoking cessation

 Smoke-free hospitals require temporary tobacco abstinence  Illness motivates smokers to try to quit  Hospitalized smokers are accessible for treatment  Interventions starting pre-op or in the hospital help smokers to stay quit after discharge

PRE-OP SMOKERS

Meta-analysis of Intervention Trials

(Thomsen T, Villebro N, Mollere A. Cochrane Library 2010)

 Starting smoking counseling (single or multi-session) and NRT before elective surgery increases cessation rates by 41% at time of surgery  Multi-session counseling increases long-term cessation  Pre-op intervention may reduce operative complications, especially wound complications

PRE-OP INTERVENTION TRIAL

(Warner DO, et al, Anesthesiology 2011;114:847)

 RCT in pre-op clinic - offered to all smokers  Intervention: Advice + Connect smoker to quitline  Control: Advice + Counseling in office    Result Connected to quitline: 20% vs 0% (p<.001) Quit 30 days post-op: 25% vs 19% (NS)

HOSPITALIZED SMOKERS

Meta-analysis of Intervention Trials

(Rigotti NA, Clair C, Munafo MR, Stead L. Cochrane Library 2012)

 Bedside counseling followed by telephone support for at least one month after discharge increases smoking cessation rates by 40%  It is effective regardless of the reason for admission  It is not effective without continued support after discharge  Starting NRT in hospital increases quit rates by 50% (and relieves nicotine withdrawal symptoms)

2012 Joint Commission Tobacco Quality Measures for Hospitals

 Apply to all hospital patients  Require documentation of smoking status  Require documentation of offer of   Medication and counseling In the hospital and after discharge  Reporting of post-discharge call outcomes  Hospitals are not required to use them

MGH SYSTEM for Inpatients



Step 1: Identify smoking status on admission



Step 2: Brief intervention

(care unit)



Step 3: Extended intervention

(dedicated counselor)



Step 4: Link to post-discharge care

MGH SYSTEM for Inpatients



Step 1: Identify smoking status on admission

Computerized admission order set (MDs, RNs)

⇩ Generates electronic list of smokers sent to the Tobacco Treatment Service

MGH SYSTEM for Inpatients

 

Step 1: Identify smoking status on admission

in an electronic database

Step 2: Brief intervention

(care unit)

MD, RN give advice to quit, order NRT Booklet put on every bed by housekeeping

MGH SYSTEM for Inpatients

  

Step 1: Identify smoking status on admission

in an electronic database

Step 2: Brief intervention

(care unit)

MD, RN give advice to quit, order NRT Booklet put on every bed by housekeeping

Step 3: Extended intervention

(smoking counselor)

Assess nicotine withdrawal relief, desire to quit Encourage and help to make a quit plan

MGH SYSTEM for Inpatients

   

Step 1: Identify smoking status on admission

in an electronic database

Step 2: Brief intervention

(care unit)

MD, RN give advice to quit, order NRT Booklet put on every bed by housekeeping

Step 3: Extended intervention

(smoking counselor)

Assess nicotine withdrawal relief, desire to quit Encourage and help to make a quit plan

Step 4: Link to post-discharge care

Refer to Quitline for counseling Put medication on discharge medication list

Helping HAND Study

Improving tobacco treatment delivery after discharge

( NIH grant: RC1 HL099668)

   Randomized controlled trial at MGH All smokers receive counseling in hospital Standard care vs extended care

Extended Care

5 IVR calls ( 3, 14, 30, 60, 90 days) made to patient Offered call from counselor at each contact 30 days of free medication at discharge, refillable x 2

Standard Care

Medication is recommended Smoker is given telephone number for free quitline

Example of IVR Call Script (Day 14) Would you like a counselor to call you?

Yes

Counselor calls smoker

Institute for Health Policy

- 118 -

60 Tobacco Abstinence after Discharge

Helping HAND 1 Study Self-report

Continuous Abstinence Abstinent for past 7 days 53 50 46 46 42 40 40 37 34 34 29 30 28 24 20 16 10 0 1 mo p<.010

3 mo p<.024

6 mo Intervention p<.007

1 mo Control p<.011

3 mo p<.092

6 mo p<.007

RECOMMENDATIONS TO VSGNE

 Adopt Very Brief Advice model as standard care ASK – ADVISE – ACT  Refer from your office or hospital to the state telephone quitline, using fax- or e-referral system or having office staff make 1 st call  Data: Monitor use of quitline, medications    Partner with state quitline to get data on referrals Chart review to get data on VBA, referrals, medication Collect smoking status, treatment use at f/u

LUNCH BREAK 12-1 PM Data Managers 12-2 PM

Sackler Building, Room 114 East (8 th floor)

Next Meeting: Thursday November 7, 2013 UMASS Medical Center Worcester, MA

Infrainguinal Treatment

  

Bypass vs. Intervention Regional variation Case discussion

• Paul Bloch, Jeff Indes, Matt Menard, Brian Nolan

Infra-inguinal Treatment of Claudication in VSGNE in 2012:

% Bypass

(versus PVI) ( Centers with 10 or more procedures) 100% 90% 80% 70% 60% VSGNE all center average = 27% 70% 50% 40% 30% 20% 10% 10% 11% 11% 15% 19% 29% 29% 30% 31% 33% 33% 35% 38% 39% 40% 41% 0% 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

Infra-inguinal Treatment of CLI in VSGNE in 2012:

% Bypass

(versus PVI) ( Centers with 10 or more procedures) 100% 90% VSGNE all center average = 46% 80% 70% 60% 50% 40% 30% 20% 19% 25% 25% 28% 29% 33% 33% 37% 41% 45% 47% 50% 50% 55% 59% 60% 63% 64% 65% 68% 10% 100% 0% 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21

VSGNE case presentation Spring 2013

Jeffrey E Indes MD, FACS Assistant Professor of Surgery and Radiology Yale University School of Medicine

Nonhealing TMA

• • • • 71 y.o Male Diabetic HTN Prior TMA-Nonhealing wound EC

Tx Options ?

5mm Cutting Balloon

Stop? Or keep going?

Angiosomes of the Foot

Unsuccessful Antegrade Crossing

Questions?

65 year old M admitted with MI Dec 2012

•

Pre CABG carotid duplex: PSV R ICA: 429 cm/sec

• • • • •

VRF: HTN, HL, IDDM with neuropathy, non-smoker PMH: Paget’s, pacemaker Meds: Simvastatin 20, Gabapentin, NPH 40 bid, Asa 325 mg 2 small, quiescent ulcerations L great toe. Absent L pedal pulses.

CABG x 4 December 15, 2012

• • • •

One month follow up: worsening ulcerations L great toe (1.5 cm) Planned R CEA deferred. ABI’s 1.2/.65 TBI’s .67/.43

•

Brought for angiography:

65 year old M admitted with L foot CLI

• Options ?

• •

PTA peroneal occlusion: Sprinter 1.5 x 15 mm, 2 x 40 Nanocross PTA AT: Sprinter 1.5 x 15 mm, 2 x 40 mm Nanocross distally; 2.5x 40 mm Coyote proximally

6 weeks later: rapid improvement, then stalled healing

August 2012

History of Present Illness: 55 yo gentleman w/ bilateral calf pain w/ ambulation for ~1-yr. Worse on left than right. He notices it most when walking upstairs or uphill, not much on flat surfaces but says he is not very active. No pain in his foot at night or at rest. No ulcers or open wounds. PMH: IDDM (HgA1C 8.5). Former smoker (quit 20 yr ago). Hyper lipidemia (statin). CAD, h/o angina, cath 2008 3VD, no intervention. No angina in several years (on ASA. prn nitro). ABI toe pressures in 2009 nl

PEx:

Fem 2/2 bilat PT: 1/2 right; 0/2 left DP: 1/2 right; 0/2 left

ABI

Right DP 1.46 Biphasic PT 1.39 Biphasic Great Toe Left 0.60

(65) - prior 0.92

DP 0.97 Biphasic PT 0.87 Biphasic Great Toe 0.52

(56) - prior 0.77

Impression / Plan: Chronic fem-pop PAD w/ claudication. Risk factor management, exercise and Pletal. RTC 2-mo

January 2013

History of Present Illness: Worsening pain in the left calf, now on flat surfaces, at about 20-yards. Still taking Pletal, ASA, statin.

ABI

Right DP 1.07 Monophasic PT 1.79 Monophasic Great Toe Left 0.46

(54) - prior 0.60

DP 0.95 Monophasic PT 0.95 Monophasic Great Toe 0.37

(44) – prior 0.52

Impression / Plan: Clinical deterioration, possible progression of disease but no limb threat. Discussed PVI versus continued conservative approach. Patient decided to undergo arteriography.

18-cm

2.0-mm LASER atherectomy 6x200-mm stent

VSGNE Quality Committee

Alik Farber MD

VSGNE Biannual Meeting Tufts Medical Center, May 6, 2013

Projects

• • • • SSI post LEB QP Discharge on Antiplatelet agent/Statin QP Readmission rate post LEB QP Smoking Cessation QP

SSI post LEB QP

• Change the current definition of wound infection to one used by the CDC and NSQP

• • • • • • • • • • • •

SSI Definition

Superficial Incisional SSI

: infection that occurs within 30 days after operation and infection involves only skin or subQ tissue of the incision + one or more: purulent drainage with or without lab confirmation from the incision Organism isolated from an aseptically obtained culture of fluid or tissue At least one of the following signs or symptoms of infection: pian, localized swelling, redness and incision is deliberately opened by surgeon (unless incision is culture-negative).

Diagnosis of SSI by surgeon or attending physician Note: Stitch abscess, infected burn wound and Deep infections are not reported here

Deep Incisional SSI

: infection that occurs within 30 days after the operation and appears to be related to the operation and infection involved deep soft tissues (fascial/ muscle layers) and has one or more: purulent drainage from the deep incision but not from the organ space A deep incision spontaneously dehisces or is opened by the surgeon when the patient has fever (>38 C) or localized pain unless the site is culture negative.

An abscess or other evidence of infection involving the deep incision is found on direct examination or by radiography Diagnosis of a deep incision SSI is made by the surgeon or attending physician

Wound Disruption

: Total breakdown of the surgical closure compromising the integrity of the procedure – a small separation would not qualify.

SSI post LEB QP

• • • • Include a 30 day follow up and specifically record: presence of SSI, readmission, and ABI Incorporate on the discharge form whether readmission within 30 days is planned (so that we can distinguish between planned and unplanned readmissions) Positive SSI results that are noted before 30 days will be recorded. However, negative SSI results will be recorded only after 30 days.

Data will be based on office visits alone (no phone calls at this time)

SSI post LEB QP

• • • 9 centers agreed to participate in this pilot M2S has almost finished creating dynamic content for participating sites Pilot should start thereafter • Surgical Site Infection Project (Karen Homa)

Discharge on Antiplatelet Agent/Statin QP

• • • Antiplatelet agent and statin use in our patient population is important Variability of antiplatelet agent and statin use (Karen Homa) Utility of this Quality Project

Readmission rate post LEB QP

• • • Readmission rate to the hospital is important Should readmissions be captured within VSGNE Feasibility of such capture

Readmission rate post LEB QP

• • • Committee members made inquiries in their institutions There is interest in this… Logical format was created

Patient ID Birth date visit type index admission date index discharge date Index admiting diagnosis Index Principle diagnosis Index Secondary diagnosis 1 Index Secondary diagnosis 2 Index Secondary diagnosis 3 Index Secondary diagnosis 4 Index Secondary diagnosis 5 procedure code procedure description procedure date days to readmission readmission admission date Index admiting diagnosis Index Principle diagnosis Index Secondary diagnosis 1 Index Secondary diagnosis 2 Birth date visit type index discharge date Index admiting diagnosis Index Principle diagnosis Index Principle diagnosis present on admission status Index Secondary diagnosis present on admission status 1 Index Secondary diagnosis 2 Index Secondary diagnosis 3 Index Secondary diagnosis present on admission status 3 Index Secondary diagnosis present on admission status 4 Index Secondary diagnosis 5 procedure code procedure description procedure date days to readmission readmission admission date Index admiting diagnosis Index admiting diagnosis present on admission status Index Principle diagnosis Index Principle diagnosis present on admission status Index Secondary diagnosis 1 Index Secondary diagnosis 2 Index Secondary diagnosis present on admission status 2 Index Secondary diagnosis present on admission status 3 Index Secondary diagnosis 4 Index Secondary diagnosis 5 Index Secondary diagnosis present on admission status 5 Index Secondary diagnosis 3 Index Secondary diagnosis present on admission status 3 Index Secondary diagnosis 4 Index Secondary diagnosis present on admission status 4 Index Secondary diagnosis 5 Index Secondary diagnosis present on admission status 5 readmission discharge date

Surgical Site Infection Project • • • First national quality improvement initiative VQI workgroup: Adam Beck, Jason Chiriano, Jack Cronenwett, Mark Davies, Alik Farber, Karen Homa, Jeff Kalish, Megan Tracci, Magdiel Trinidad, Mark Wyers Analyzed risk-factors associated with in-hospital SSI after infra-inguinal bypass procedures

SSI outcomes analysis

• • Infra-inguinal – – 7,908 VQI procedures 2003 to June 2012 Univariate Several variables associated with SSI • BMI: OR = 1.35

• Skin prep: OR = 0.62 protective – chlorhexidine or chlorhexidine with alcohol (Chloraprep) versus Iodine • • Tissue loss: OR = 1.38

Graft recipient (distal: below knee): OR = 1.3

• Transfusion > 3 units: OR = 2.7

Multivariate logistic regression model

• • • • • Ankle-Branchial Index <0.35 on procedure side was associated with higher odds of SSI (OR 1.5) Chlorhexidine or chlorhexidine with alcohol was associated with lower odds of SSI (thus protective; OR 0.5) Transfusion > 3 units was associated with higher odds of SSI (OR 3.3) Surgery time longer than 220 minutes was associated with higher odds of SSI – 221 to 290 minutes OR 2.1

– > 290 minutes OR 2.9

Area under ROC curve = 0.71

Wound Infection Rate after Infra-Inguinal Bypass Procedure Observed and Expected by Centers

4,081 patient procedures, January 2010 December 2012 Observed Expected 36% 32% 28% 24% 20% 16% 12% 8% 4% 0%

VQI Centers Overall rate Wound Infection

VQI = 3.6% AUC = 0.65

adjusted for: skin preperation, ankle/brachial systolic pressure index, transfusion, length of procedure

********** **

Significantly higher than expected

: * p<0.05

**p<0.01

October meeting given your rates December – centers were sent an email to share results:

Update on the progress

VQI 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0%

P Chart: Percent of Patients with Infra-Inguinal Bypass procedure that received Chlorhexidine skin prep per month

101 Centers 5,342 procedures 61% 81%

10% VQI 3% 2% 1% 0% 6% 5% 4% 9% 8% 7%

P Chart: Patients with Infra-Inguinal Bypass procedure Percent surgical site infection per month

101 Centers 5,342 procedures 3,5%

VQI 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0%

P Chart: Percent of Patients with Infra-Inguinal Bypass procedure that received Chlorhexidine skin prep per month

12 Improver Centers with 10 or more procedures in 2011 & 2012 914 procedures 20% 86%

VQI 10% 9% 8% 7% 6% 5% 4% 3% 2% 1% 0%

P Chart: Patients with Infra-Inguinal Bypass procedure Percent surgical site infection per month

12 Improver Centers with 10 or more procedures in 2011 & 2012 914 procedures 6% 2%

VSGNE

P Chart: Percent of Patients with Infra-Inguinal Bypass procedure that received Chlorhexidine skin prep per month

20 Centers with 10 or more procedures in 2011 2,071 procedures 100% 50% 40% 30% 20% 90% 80% 70% 60% 55% 67% 10% 0%

100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0%

VSGNE 20 Centers' Chlorhexidine rate over time

Routine (> 80%): 9 centers Improver Selective to Routine: 2 centers Improver Rare to Routine: 1 center 2011 Q1 2011 Q2 2011 Q3 2011 Q4 2012 Q1 Improver Selective: 2 centers Selective (10 to 80%): 5 centers 2012 Q2 Rare (2011 < 10%): 1 center 2012 Q3 2012 Q4 2013 Q1

9% 8% 3% 2% 1% 0% 7% 6% 5% 4% 10% VSGNE

P Chart: Percent of Patients with Infra-Inguinal Bypass procedure that Percent surgical site infection per month

20 Centers with 10 or more procedures in 2011 2,071 procedures 3%

VSGNE: Surgical Site Infection by Year and Chlorhexidine category

0,0% 2,0% 4,0% 6,0% 8,0% 10,0% 12,0% 14,0% rare (n=1) 10,7% 11,8% selective (n=5) 1,6% 2,9% routine (n=9) 1,7% 3,9% 2011 2012 rare/low selective to selective (n=2) rare/selective to routine (n=3) 1,0% 6,0% 5,8% 5,3% p = 0.058

Need 258 patients in each group only have 133 and 105

14,0% 12,0% 10,0% 13%; 11,8% 0%; 10,7%

rare

8,0% 6,0% 4,0% 2,0% 0,0% 0%

selective improver

11%; 6,0% 54%; 5,8% 37%; 5,3% 23%; 2,9% 95%; 3,9%

routine

23%; 1,6%

selective

99%; 1,7% 94%; 1,0%

improver

50% 100%

Chlorhexidine Rate

150% 2011 2012

VQI 5,0% 4,5% 4,0% 3,5% 3,0% 2,5% 2,0% 1,5% 1,0% 0,5% 0,0% 4,1%

VQI Infra-Inguinal Bypass Procedures Surgical Site Infection rate by year and Chlorhexidine usage rate category

4,4% 3,2% 1,4% Improver 12 centers p = 0.009

Chlorhexidine 2011: 26% 2012: 77% 2,8% Routine 25 centers p = 0.045

Chlorhexidine 2011: 93% 2012: 93% 1,2% Rare/Selective 4 centers p = 0.052

Chlorhexidine 2011: 19% 2012: 22% 2011 2012

In your center’s packet – your center report

Discharge medicine

100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% VSGNE Center Variation Percent Patients discharged on Antiplatelet and Statin 2012 & 2013 Centers with 10 or more procedures

VSGNE = 79%

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28

35% 30% 25% 20% 15% VSGNE Center Variation Percent Patients discharged on Antiplatelet only 2012 & 2013 Centers with 10 or more procedures

VSGNE = 14%

10% 5% 0% 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28

VSGNE Center Variation Percent Patients discharged on Statin Only 2012 & 2013 Centers with 10 or more procedures 10% 9% 8% 7% 6% 5% 4% 3% 2% 1% 0%

VSGNE = 4%

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28

In your center’s packet – your center report

AAA Repair Costs



Length of stay variation



EVAR and open cost analysis

• Andy Stanley MD 

EVAR care path cost reductions

• David Stone MD

% Patients with Length of Stay > 2 Days after Non-Ruptured EVAR Observed and Expected by VSGNE Centers

80% 70% 60% 50% 40% 30% 20% 10% 0% Centers with 13 or more procedures 2,750 patient procedures, 2003 to June 2012 (Excludes in-hospital deaths) observed *A **B **C **D E **F **G **H I expected J K

Centers

L M N O P **R S

Overall rate LOS > 2 day

VSGNE = 28% VQI = 35% AUC = 0.70

adjusted for: age, gender, race, congestive heart failure, COPD, creatinine, stress test, living nursing home, max AAA diameter >6.5 cm, hypogastric intentionally covered, concomitant procedure

T **U **V

Significantly lower or

higher than expected: * p<0.05

**p<0.01

Cost and Resource Utilization in treating AAA patients (FAHC)

Stanley 5/6/13

Global Health Economics Unit Center for Clinical and Translational Science

GLOBAL HEALTH ECONOMICS UNIT



Marion Couch, MD, PhD, MBA, Interim Chair, Department of Surgery



Richard Galbraith, MD, PhD, Director, Center for Clinical and Translational Science

 Christopher Jones, D.Phil, Director  Richie Spitsberg, MSc, Information Technology Assistant/Programmer  Robert Everett, Jr., PhD, Visiting Professor of Health Economics  Mujde Erten, Assistant Professor, Health Economics  Ellen Dimick, Coordinator  Caroline Rudisill, PhD, MSc, Affiliated  Jeffrey Petrozzino, MD, PhD, Consultant

Why Cost/Why VSGNE

• Current decision making in treating AAA involves – Anatomy of Disease – Patient co-morbidities – Surgeon preference/experience/expertise – Adding Cost will allow us to assess resource utilization.

Linking Cost of Therapy to VSGNE

• • VSGNE is a tool that was devised to help assess risk-based quality and to improve quality. Created by clinicians Excellent clinical tool to help us assess resource utilization.

Background

• • • Many ways to look at medical finance – Cost (Direct/Indirect/Total) – – Charges Average costs Accounting practices/assigning costs are different at each center (DHMC/FAHC/MM). Charges are more indiscriminately assigned based on profitability/contracting.

Costs are arguably a better measure of “resource utilization”. – Total Cost was our measurement.

Process

• • • Simple link of Indirect/Direct/Total cost to VSGNE work (FAHC methodology for cost definitions) Simple plotting of cost data/univariate/multivariate analysis followed by linear regression to develop a model for cost based on FAHC data.

Goal was to identify patient characteristics that lead to “High Cost Quartile” in both EVAR and Open AAA.

Total Cost vs. LOS

Quintile Cost (Low to High)

Length of Stay Total Charges Direct Cost Indirect Cost Total Cost 1.19

1.66

$43,557.72

$50,484.57

$17,832.34

$20,190.13

$6,747.81

$8,121.17

$24,580.15

$28,311.30

1.66

$54,060.67

$22,068.22

2.48

$60,519.05

$24,737.76

$8,811.27

$30,879.49

$10,118.31

$34,856.07

4.13

$77,079.20

$31,570.78

EVAR $13,153.19

$44,723.97

Length of Stay 5.32

Total Charges $27,369.59

OPEN Direct Cost Indirect Cost Total Cost $8,189.10

$7,681.38

$15,870.48

6.15

$31,646.41

$9,484.97

$9,191.07

$18,676.04

6.74

$36,960.48

$10,962.37

$10,434.47

$21,396.84

8.28

$46,576.39

$14,281.51

$12,926.60

$27,208.11

16.51

$97,805.59

$34,318.93

$24,377.72

$58,696.65

Specific Cost Breakdown for Open Patients

Breakdown of Total Costs in a Lower Quartile Open Patient

26% 11% 63% OR Costs M-SICU Hostpital Costs OR Costs M-SICU Hospital Costs Total Cost $11,214.24

$1,993.53

$4,602.56

$17,810.33

Breakdown of Total Costs in a Upper Quartile Open Patient

40% 49% OR Cost M-SICU Hospital Cost Total Cost 11% $20,693.50

$4,860.68

$17,078.74

$42,632.92

Other high cost items Shep 3 Ct - Pv Lab-Blood-Bank M-Baird-6 $3,335.77

$2,085.05

$3,534.48

OR Cost M-SICU Hospital Cost

Specific Cost Breakdown for EVAR Patient

11%

Breakdown of Total Costs in a Lower Quartile Patient

89% Device Costs Other OR Costs Total OR Costs Hospital Cost Total Cost 50% 39% $14,613.25

$11,382.21

$25,995.46

$3,430.18

$29,425.64

Breakdown of Total Costs in an Upper Quartile Patient

Device Costs Other OR Costs Hospital Cost 17% 28% 55% Device Costs Other OR Costs Total OR Costs M-SICU Hospital Costs Total Cost 30% 25% Device Costs Other OR Costs Hospital Costs M-SICU $15,033.56

$12,788.79

$27,822.35

$8,588.89

$13,906.30

$50317.54

Predictive Modeling Estimate model using OPEN dataset Total sample = 230 cases Statistically significant predictors Of Total Cost: Age (p=.00) Transfer (p =.00) COPD (p=.00) Estimate model using EVAR dataset Total sample = 158 cases Statistically significant predictors Of Total Cost: Betablockers (p=.00) Creatinine > 1.45 mg/dl (p =.03) Iliac (p=.00) Ejection fraction < 30% (p=.10)

Global Health Economics Unit Center for Clinical and Translational Science

Predictive Modeling – OPEN

OPEN predictive model:

Total cost = -$21,715 + $653 Age + $26,075 Transfer + $10,798 COPD ( + $7,949 Bypass) “Stress Test” model – Actual cost vs. predicted on OPEN dataset - good overall predictive ability, more so on higher costs - over-estimate predicted cost on lower cost deciles

Global Health Economics Unit Center for Clinical and Translational Science

Predictive Modeling – EVAR

EVAR predictive model:

Total cost = $35,152 - $4,672 Beta + $3,427 Creatin + $3,550 Iliac + $4,860 EF “Stress Test” model – Actual cost vs. predicted on EVAR dataset - predictive ability acceptable, all risk factor dichotomous, finite predicted values - less overall variation relative to OPEN

Global Health Economics Unit Center for Clinical and Translational Science

Thoughts

• All centers (FAHC/DHMC/MM) calculate cost differently. – Combining cost data into one set might not be as beneficial is developing model for each center to evaluate cost independently – Prove this we’d like to trial our FAHC model on other centers and establish its predictive value.

– Analysis/Data like this will help docs oversee cost/resource use and treatment strategies LOCALLY based on home grown resource/financial constraints.

• Goal might be to accept higher cost during times of bed need/availability • Goal might be to negotiate better contracts for stent grafts

Endovascular Aneurysm Repair (EVAR) Care Path David H. Stone, MD Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center

EVAR

•Decreased morbidity and mortality •Prevalent high value procedure •Remains associated with significant procedure associated costs.

US Healthcare Expenditures

•Projected to reach over 20% of US GDP by 2020 •Given prevalence of EVAR in contemporary practice, this trend in healthcare delivery may be unsustainable!

-US Census Bureau, 2009

Purpose:

•Comprehensive analysis of how we deliver EVAR at DHMC.

•Focus on processes of care, quality, and cost •Identify multiple targets for quality improvement and cost reduction

Control

D

efine

M

easure

A

nalyze

I

mprove

C

ontrol Define Measure Improve Analyze

Pre-Clinic

Clinic Visit Pre-Admission Testing Surgical Candidate

Surveillance Open Repair Medical Management Branched EVAR Further Work-up n y

Patient Decision Surgery

n y

EVAR

Standard EVAR Case Planning (Device Selection/ Clinical Trial)

Same Day Surgery Admission Surgery Recovery Room (PACU)

Surgical Post Op Floor Purchasing Post-Op Day 1 Discharge

Current State

Clinic Visit 1- Month Clinic Visit every 12- Months for 5 years

Pre-Clinic Phone Call from Referring Provider Phone call from the Connection Line Electronic Referral Standardize process for obtaining CT prior to clinic visit Patient Demographics Office Notes Imaging Recent Labs Collect Patient Information (Sched Secretary Fax eD-H or CIS review Mail Electronic transfer Aneurysm >= 5 cm n y CT Available n Current Labs y y Review lab values to determine additional testing Vascular Ultrasound n Obtain necessary labs Pre-Clinic Obtain CT from outside diagnostics center Schedule CT (questionnaire & measure time) n y Lab Tech reviews patient data and consults with MD (if no clear protocol) Order Vascular Lab study Outside CT Image required (not written report) Portable Media (CD) PACs to PACs transfer Schedule Clinic Visit (Sched Secretary) Schedule Vascular Lab (Sched Secretary) CT Available y Patient has or is planning to obtain CD n Call PCP or outside diagnostics center to obtain CT y n Patient instructed to bring CD to appointment PACs Transfer y DHMC Film Library notified by secretary n Request CD to be mailed to Vascular Surgery CT Imagine available for MD review through eD-H MD receives patient CT on CD Patient Clinic Appointment Patient asked where they would like to have labs drawn Fax requisition to Lab y DHMC n Fax requisition to outside lab Patient has labs drawn Patient has labs drawn Labs Results sent to ordering provider via eD-H Results scanned into eD-H Provider Reviews y Creat > 1.3

y Action Required y Appointment Cancelled n 1 y Patient has CT scan without contrast Patient Clinic Appointment Results faxed to Vascular Surgery n Scheduling secretary monitors & tracks to assure labs are current prior to CT

Detailed Process Map

Clinic Clinic Visit Phase Patient Arrives at Reception Receptionist provides current med list from eD-H for patient to review Patient roomed (Vitals recorded Medications reviewed) Use eD-H functions in clinic visit documentation (Problem Lists, History, etc..) to reduce re-work Review CT and other paperwork relevant to referral Provider completes standard office visit and conducts H&P Provider and Patient discuss options Prepare referring provider notes, labs, imaging Further Work-up Needed CT and 3D imaging at office visit Standard patient teaching and risk/benefit discussion y Schedule additional tests ordered (M2S, other) and return clinic visit n Review clinic preparation regarding central versus de-central scannin Scheduling Surgery & PAT Surgery Order n Standardize communication to prevent re work Pend Orders to Provider PAT Orders n Surgery n y Provider communicates with clinic secretary to schedule EVAR Patient scheduled for PAT & Surgery Case Planning Patient Exits Clinic Standardize communication to prevent re work Pend Orders to Provider y PAT DHMC Phase Patient complete PAT questionnaire before reporting to PAT y n Schedule PAT Appointment DHMC External PAT Process Patient Completes Testing y Provides surgery Date Update Outlook Calendar Update weekly schedule for conference n Check Insurance Review changes in PAT hours to get more patients to use DHMC Financial Clearance y Same Day Surgery Admission eD-H orderset for EVAR – Start with Carotid Update Problem Lists, History & Medications Use eD-H functionality to reduce re work Provider communicates with clinic secretary to schedule EVAR Provider signs orders Review codes for case and impact on OR case times Provider signs orders eD-H orderset for EVAR – Start with Carotid External PAT Phase PAT DHMC n Send letter to PCP communicating surgery scheduled and PAT order instruction Call PCP n Receive Results y Send results to Medical Records Email Provider results received & available for review Review PAT Results Scan results into eD-H Orders testing required prior to surgery at local hospital Communicates with patient and provides instruction on testing needed Patient completes testing Results received and faxed to OR Sched Secretary PAT Results Review Case Planning Email Provider results received & available for review Cancel Measure cancellations by type to provide feedback to process y Provider and Patient discuss options eD-H Results Review results from Patient testing Phase Review results from Patient testing n Review results from Patient testing Call Patient with instructions for Surgery Same Day Surgery Admission Case Planning M2S n Order M2S 3D Reconstruction Compare cost of different options for procedure including clinical trial arrangements Reconcile plan for patient (grafts pieces, size, approach, etc.) Review Case at Monday Conference the week of planned surgery y Explore standardization of graft vendors to reduce cost and variation Develop EVAR plan and select graft pieces and sizes Pre-Op H&P Use functions in eD-H, such as prob list, history, medications to reduce re-work. Develop standard template for quality & data collection Create manual req for purchasing n Communicate graft pieces and size using email form Review cases needing inventory in advance of current week to reduce rush orders & Improve inventory management Pieces in Inventory y Phase Pull pieces for Case Rush Order y Call in rush order to vendor Confirm PO with Nurse Manager Receive packages & sort for expedited Transport to OR Pick, Pack & Ship Overnight Pick, Pack & Ship Standard Post-Op Post-Op Out of Room Brief Op Note (Within 30 minutes) Patient assessed Post-Op orders n Fellow gives hand off to PACU Nurses/ Intern Patient stays in PACU for 4 hours Communication and education hand-off standard between fellow and intern CBC OK y Patient moved to Floor (4W) PM Rounds Post-Op check Order set development targeted at timely discharge, i.e. foley removed before am rounds PM Rounds Post-Op Day 1 AM Rounds Discharge Ready n Continued Hospital Stay y Discharge AM Rounds Develop discharge template and standard patient education Discharge Planning with Intern Tighten up planning and coordination with research clinical trials Schedule CT and 30 day follow-up in clinic Phase Phase Follow-up Post Discharge Discharge Patient ???s

y Nurse Clinician takes calls, provides education, coordinates needed care Log Calls and categorize as feedback to process n Patient has CT scan Patient has clinic visit with provider M2S 3D reconstruction VSG Data Collection Problem y Provider reviews for graft position/status and endoleak Provider and patient discuss options n Clinic Secretary plans follow-up for 1-year with CT and M2S Clinical Trial Protocol Phase

Clinic Visits

D

efine

M

easure

A

nalyze

I

mprove

C

ontrol Define Measure Analyze Instrument Usage Extra Instruments per case Implant Cost Cost per Case

60% 50% 40% 30% 20% 10% 0%

New Patients with Greater than 5cm AAA

Clinic

100%

New Patients with Greater than 5cm AAA

80% 60% 40% 20% Patients with Correct Imaging Patients requiring follow up imaging

Process Improvement

0% Patients with Correct Imaging Patients Requiring Follow-up Imaging

45% (1.6 appointments per patient) of referred AAA patients needed follow-up imaging before surgical decision could be discussed.

6% (1.1 appointments per patient) of referred AAA patients needed follow-up imaging before surgical decision could be discussed.

Success

Instrument Use Reduction

$40,000 $35,000 $30,000 $25,000 $20,000 $15,000 $10,000 $5,000 $ $(5,000) $(10,000) $(15,000)

$27,657 $32,877 EVAR Net Financial Margin

EVAR Margin

Grafts & Implants - 52% Other Technical Costs- 48% - Supplies - Technical Overhead - Statistically Allocated - Technical Direct $2,481 -$5,220 $7,746 -$5,265 Techincal Revenue Technical Cost Technical Margin Professional Revenue Professional Cost Professional Margin -$10,485 Total Margin

DRG 238 - 2012 Mean Total Cost by AMC 60,000 50,000 40,000 30,000 20,000 10,000 0 DHMC UHC 2012 Source: UHC 2012

$18,607 Manufacturer D 54% Market Share $20,894 Combo 7% Manufacturer A 12% $15,182 Manufacturer B 9% $16,636 Manufacturer C 18% $20,833

Summary

Appointments 50 saved per year Instruments $50,000 saved per year Grafts $200,000 per year Additional annual savings on grafts are anticipated for other procedures.

Conclusions

• Timely project to foster Surgeon/Industry partnerships • Multidisciplinary Team is Essential for Success • Support from Hospital Administration and Purchasing

Response To RFP

60%

3% to 6%

50%

Market Share New Market Share

40%

5% to 20%

30%

54% 20% & Cap 17% to 20%

20%

33% 30% 23%

10%

18% 10% 12% 9%

0% Manufacturer D

$18,020

Manufacturer C

$17,030

Manufacturer A

$12,413

Manufacturer B

$13,816 3% to 20% 7% 4%

Combo

$22,083

• • • •

44% of Endo AAA Cases can use any manufacturer option Market share shifts from Manufacturer D to A & B All Manufacturers are a combination of price plus incentive Savings approximately $325,000 Case Planning: $181,000

+

Improved Pricing: $144,000

Next Meeting



Date: Thursday, November 7, 2013

 

Location: UMASS Medical Center Time: 10 am – 4 pm

