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

Vascular Study Group of New England

20th Semi-Annual Meeting

May 6, 2013

Tufts Medical Center, Boston, MA

Dartmouth-Hitchcock Medical Center

Fletcher Allen Health Care Eastern Maine Medical Center

Maine Medical Center

Concord Hospital

Lakes Region Hospital

Cottage Hospital

Central Maine Medical Center

Mercy Hospital

U. Mass. Medical Center

Elliot Hospital

Tufts Medical CenterBoston Medical Center

St. Francis Hospital

Massachusetts General Hospital

MaineGeneral Medical Center

Caritas St. Anne’s Hospital

Yale-New Haven Hospital

Baystate Medical Center

VSGNE 201330 Participating Hospitals

Berkshire Medical Center

15 Community - 15 Academic

Hartford HospitalSt. Luke’s Hospital

Charlton Memorial Hospital

Beth Israel Deaconess Medical Center

Hospital of St. Raphael

Cardiothoracic Surgical Associates

Brigham & Women’s Hospital

Danbury Hospital

St. Elizabeth’s Hospital Center

Miriam Hospital

Rhode Island Hospital

>33,000 Procedures ReportedCEA, CAS, oAAA, EVAR, LEB, PVI, TEVAR, Access

Jan-

June

03

Jan-

June

04

Jan-

June

05

Jan-

June

06

Jan-

June

07

Jan-

Jun

08

Jan

- Jun

09

Jan-

Jun

10

Jan-

Jun

11

Jan-

Jun

120

5000

10000

15000

20000

25000

30000

35000

228 Centers, 45 States + Ontarioas 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) 87,226

Carotid Endarterectomy 24,071

Carotid Artery Stent 3,099

Endovascular AAA Repair 8,986

Open AAA Repair 3,834

Peripheral Vascular Intervention 25,554

Infra-Inguinal Bypass 12,691

Supra-Inguinal Bypass 3,774

Thoracic and Complex EVAR 1,086

Hemodialysis Access 4,003

American Venous Registry

Collaboration to Add Venous Procedures

OrganizationGoverning Council

4 SVS Representatives2 AVF Representatives

15 Regional Group Representatives

Arterial Research Advisory Committee

2 SVS Representatives10 Regional Group Representatives

Arterial Quality Committee4 SVS Representatives


Venous Quality Committee3 AVF + 2 SVS Representatives


Venous Research Advisory Committee

3 AVF + 2 SVS Representatives10 Regional Group Representatives

VSGNE RepresentativesGoverning CouncilRichard Cambria – SVS, Chair

Louis Nguyen - SVSJens Jorgensen - VSGNE

Arterial Research Advisory Committee

Phil Goodney – SVS, ChairNolan, Schanzer, Shermerhorn - VSGNE

Arterial Quality CommitteeAndy Schanzer, Marc Schermerhorn - SVS

Phil Goodney - VSGNE

Venous Quality Committee-

Mark Iafrati - 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 ThrombolysisUpper 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.

A B C D E F G H I J K L M N O P Q0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

0% 0%

24%28%

30% 30%

39%

49%53%

63%67%

69%72% 72% 73%

76% 77%

VSGNE Center Comparison – 2010 Procedures9 month or greater follow-up rate

(office visit or phone call, excludes patients who died)

Center rate Overall rate = 59% Goal > 80%

CentersProcedures: CAS, CEA, EVAR, INFRA, OPEN, PVI, SUPRA

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z AA AB0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

0% 0% 0% 0% 0% 0%3%

15%

22%

27%31%

35%

42%

55% 55% 56% 56%59% 61%

63%

71% 72% 74% 76% 78% 80%

86% 88%

VSGNE Center Comparison – 2011 Procedures9 month or greater follow-up rate

(office visit or phone call, excludes patients who died)

Center Goal > 80% Overall rate = 57%

CAS (n=178) CEA (n=1630) EVAR (n=633) INFRA (n=1026) OPEN (n=231) PVI (n=2171) SUPRA (n=386) All procedures (n=6255)

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

38%

57%

66% 63%60%

51%57% 57%

51% 53%59% 60% 57%

52% 55% 54%

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

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


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


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 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

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

VSGNE Caregiver Meeting

Kristine Chaisson, RN

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

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

LE CTA of affected limbTo plan surgery

Informed consent

Yes

No

Exclu

ded No

Yes

Open Group

Stent Group

1:1 randomization

Trial G

rou

p4 year study: mean follow-up of 2.5 years

Patients with PAA at the participating VQI centers

OPAR

EPAR

Data is collected at M2S

PVIForms

LEB Forms

OPAR

EPAR

Data is collected at M2S

PVIForms*

LEB Forms*

Current patients at VQI centers Current patients at VQI centers Participating in OVERPAR

Patients with PAA at participating VQI centers

and OVER-PAR Trial

1:1 Randomization

Current VQI Machinery vs. OVERPAR Trial

Time: 1month and one year

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)

• 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

1-year Rates

OPAR EPAR Hazard Ratio Power

MALE 20% 35% 1.53 80%

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 evaluationArterial Duplex of the graft/stentABI (if possible)QOL Patient Surveyœ (patients can fill out and send back)

(œMorgan 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• WE CONTINUE TO RECRUIT

CENTERS:

– CARRIE BOSCELA

– WE TRY TO PRESENT THIS AT ALL

REGIONAL SOCIETY MEETINGS

• CONCEPT PAPER

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

Bosto

n Med

ical C

ente

r

BI-Dea

cone

ss

Darth

mou

th

Maine

Med

ical

UVT

Yale

RI/Bro

wn

LSU

Henry

For

dMGH

St E

lizab

eth'

s Hos

pita

l

Other

cent

ers

IRB PreparationIRB submissionIRB approvedENROLLED

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

Budget

Year 1 ($)

Year 2 ($) Year 3 ($) Year 4 ($)

Central Trial Coordinator

2000 4000 4000 0

Statistical Support and randomization scheme

1000 1000 1000 0

Site coordinator support

5000 ($100/

pt enrolle

d)

5000 ($100/pt enrolled)

5000 ($100/pt enrolled)

0

IRB fees 2000 n/a n/a n/a

Total: 10,000 10,000 10,000 0

A Model for Future Studies using VQI

Compression of OVERPAR budget with an

average RO1 award (2007) NIH award budget over

years.

0

50,000

100,000

150,000

200,000

250,000

300,000

350,000

Annual amount($)

Annual amount($)

Thank You

SVS VAM Presentations

Doninique Buck

Randy DeMartino

CRANIAL NERVE INJURY FOLLOWING

CAROTID ENDARTERECTOMY

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

On behalf of the Vascular Study Group of New

England

http://www.google.com/url?sa=i&rct=j&q=beth+israel+deaconess+medical+center+logo&source=images&cd=&cad=rja&docid=evv4iAoic_b6pM&tbnid=qLjZf8odTxT1zM:&ved=0CAUQjRw&url=http://www.microsoft.com/casestudies/Microsoft-SQL-Server-2012/Beth-Israel-Deaconess-Medical-Center/Hospital-Improves-Availability-and-Speeds-Performance-to-Deliver-High-Quality-Care/5000000011&ei=b2F-Ue-MGKmG0QHgpoDoDg&bvm=bv.45645796,d.dmQ&psig=AFQjCNFDVHw7--FEyZmegaGM1JUXTrl3QA&ust=1367323361187227

BACKGROUND

Impact of cranial nerve injury (CNI)

Relevant safety endpoint

Long-term rates are unknown

AIM OF STUDY

To evaluate transient and persistent CNI

To identify the nerves affected

To identify predictors for CNI

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

RESULTS

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

Preoperative characteristics N %

Symptomatic 2325 33.8%

Redo-CEA 152 2.2%

Prior Cervical Radiation 88 1.3%

Shunt 3237 47%

Emergent procedures (<6hr) 43 0.6%

Urgent procedures (<24hr) 649 9.4%

RESULTS: RATE OF ANY CNI

At discharge At follow-up (persistent)0%

1%

2%

3%

4%

5%

6% N = 3825.6%

N = 470.7%

RESULTS: RATE PER NERVE

XII VII X IX0.0%

0.5%

1.0%

1.5%

2.0%

2.5%

3.0%2.7%

1.9%

0.7%0.5%

RESULTS

Peri-operative outcome N %

Re-exploration 217 3.2

Return to the OR 111 1.6

Reperfusion 10 0.1

Any Stroke 64 0.9

MI 63 0.9

Length of stay, days 1.5 (0)

CNI rate P-value

9.7% 0.01

14.4% <.001

30% 0.02

23.4% <.001

7.9% NS

2 (1) <.001

PREDICTORS AND NON-PREDICTORS

N % OR 95% CI P-value

Urgent* 45 6.9 1.5 1.1 – 2.0 0.04

Emergent* 7 16.3 2.6 1.2 – 5.5 0.02

Re-exploration 21 9.7 2.0 1.3 – 3.0 <0.01

Return to the OR 16 14.4 2.4 1.4 – 3.8 <0.01

*vs elective

Redo-CEA 8 5.3 1 0.5 – 2.1 NS

Prior radiation 4 4.5 0.9 0.3 – 2.5 NS

NERVES AT RISK IN SPECIFIC CONDITIONS

All

Urgen

t

Emer

gent

Re-ex

plor

atio

n

Retur

n to

the

OR0%

2%

4%

6%

8%

10%

12%

14%

XII VIIXIXOther nerves

*

*

*

*

*

*

*

**

CONCLUSION

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

THANK 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

VSGNE 2005-2012

• First time surgery in the Vascular Study Group of New England

• Elective cases only

• No missing medication data

• 14,489 Patients for analysis

• 52% CEA or CAS• 22% AAA• 26% Arterial bypass

CAS4%

CEA48%

oAAA7%

EVAR15%

Supra5%

Infra21%

Change in Optimal Medical Management Over Time

Proportion of Patients on Optimal Medical therapy

P trend <0.01

2005 2006 2007 2008 2009 2010 2011 20120%

25%

50%

75%

100%

51%57% 61%

66% 65% 64% 66% 63%

30 Day Mortality

N = 834 2,422 1,273 9,960Neither Statin AP Both

0.0%

0.5%

1.0%

1.5%

2.0%

2.5%

1.8%

2.3%P>0.05

30 Day Mortality

N = 834 2,422 1,273 9,960Neither Statin AP Both

0.0%

0.5%

1.0%

1.5%

2.0%

2.5%

1.8%

1.1%1.0%

P<0.01

5 Year Survival By Discharge Medication

SE<0.1 Log rank p<0.01

79% Both74% Statin72% AP

55% None

Survival Benefit by Discharge Medication

Medication Status Adjusted HR 95% CI p

No AP or Statin 1.0 Ref 1.0 Ref

Antiplatelet 0.72 0.6-0.9 <0.01

Statin 0.65 0.5-0.9 <0.01

Both 0.53 0.4-0.7 <0.01

Adjusted for patient age, comorbidities, and procedure

0%

25%

50%

75%

100%

Variation in Optimal Medication use Across Centers

Center

37%

87%AP and Statin at Pre-Op and Discharge

Variation in Optimal Medication use Across Procedures

Procedure

Areas For Improvement

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

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

– 30% of patients were not on both agents preoperatively • 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

Cur-rent

Smokers33%

Never Smokers17%

Past Smokers50%

7,807 Patientssmoking status

and 1-year follow-up

Quit 45%

55%

Continued

Effect of Procedure and Center

oAAA EVAR LEB CEA CAS0

10

20

30

40

50

60

50 4946

43

27

Smoking Cessation by Procedure Type

Pe

rce

nt

(%)

Center75%

Pro-ce-

dure5.5%

Age8.9%

HTN0.5%

Dialysis1.3%

COPD8.9%

Contribution to Variation

(Knaus/Wagner chi-pie)

1 2 3 4 5 6 7 8 9 100%

10%

20%

30%

40%

50%

60%

70%

80%

28

%

29

%

37

%

41

%

47

%

47

%

56

%

57

%

57

% 62%

Observed and Expected Smoking Cessation Rates by Center

Ob-served RateEx-pected Rate

VSGNE Center

Per

cent

Results: treatment center

*P<0.05

* *

* **

O:E

Results: Surgeon Survey

Yes No0

10

20

30

40

50

60

48

33

Smoking ces-sation

Sm

okin

g c

essati

on

(%

)

* P<0.05

Pharmacotherapy or referral offered?

• Surgeons offering pharmacotherapy or referral to a specialist had higher rates of smoking cessation. (85% response rate)

2011 VSGNE Smoking Cessation Rate% of Patients who Quit Smoking at Follow-up

(Centers with 10 or more follow-ups)

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 180%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

18%21%

31%37% 37% 38% 39% 40% 43% 47% 47% 49% 49% 51%

58%66%

72%

88%VSGNE average = 43%(2003-2009 was 45%)

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]

mailto:[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 PERSPECTIVENational Health Interview Survey - 2010

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

69% of current smokers want to quit

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 UseLike a Chronic Disease

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

treating hypertension and lipids

OVERVIEW




What can you do?

SMOKING CESSATION METHODS2008 US Public Health Service Guidelines

Effective treatments exist

More is better but brief intervention works

Counseling

Pharmacotherapy – use combinations

Combination is better than either one alone

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

PHARMACOTHERAPY1st Line - 2008 US Public Health Service Guidelines

Nicotine replacement OR Skin patch (OTC) 1.9

Gum (OTC) 1.5

Lozenge (OTC) 2.0 Oral inhaler (Rx)

2.1

Nasal spray (Rx) 2.3

Bupropion SR (Zyban,Wellbutrin SR) 2.0

Varenicline (Chantix) 3.1

OVERVIEW




What can you do?

0

2

4

6

8

10

12

14

16

18

0 10 20 30 40 50 60 70 80 90 100 110 120

Time post administration (min)

Pla

sma

nico

tine

leve

l (ng

/mL)

Cigarette (1-2 mg)

Nasal spray (1 mg)

Gum (4 mg)

Patch (21 mg)

PLASMA NICOTINE LEVELSCigarettes vs. Nicotine Replacement Products

NICOTINE REPLACEMENT

Long-acting, slow onset → skin patch

Short-acting, faster onset → oral (gum, lozenge, inhaler)

→ nasal (spray)

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

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)

Doubles cessation rate independent of its antidepressant effect

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

Acts via CNS dopaminergic pathways

Now a generic drug

VARENICLINE

Partial agonist at α4β2 nicotinic receptorReceptor subtype that mediates nicotine

dependence

Dual mechanism of action Partial agonist

Stimulates receptor to treat craving, withdrawal

AntagonistPrevents nicotine from binding to the receptor →Blocks reward, reinforcement of smoking

NH

N

N

OR 2.86(95% CI,1.72, 4.11)

p < 0.001

25

20

15

10

0

Con

tinuo

us A

bstin

ence

(%

)

n = 355 n = 359

19.2

7.2

OR: 3.14(95% CI: 1.93 – 5.11)

p < 0.0001

18.6

5.6

OR 4.04(95% CI, 2.13, 7.67)

p < 0.00122.4

9.3

Stable CVD 1

n = 692 n = 684

Healthy smokers 3

n = 248 n = 251

COPD 2

Varenicline

Placebo

5

Varenicline efficacy across studiesContinuous Abstinence Rates (Weeks 9–52)

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 AdvisoryJuly 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 SAFETYThe 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 SAFETYGunnell 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 (n=6422) Varenicline (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 SAFETYBottom 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 - CVDTwo 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




What can you do?

TREATING TOBACCO IN THE OFFICE2008 U.S. Public Health Service Guidelines – 5A’s

Routine advice to quit is effective

Brief counseling is more effective

ASK all patients about smoking

ADVISE all smokers to quit

ASSESS smoker’s readiness to quit

ASSIST smokers to quit

ARRANGE follow-up care

VERY BRIEF ADVICE“30 seconds to save a life”

ASK all patients about smoking Keep asking exsmokers for 3 years

ADVISE 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?”

ACT prescribe medication and referFax 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-REFERRALSYSTEM

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 OfficeSource: North American Quitline Consortium (www.naquitline.org)

State Fax Referral

ElectronicReferral

Free NRT offered

CT Y N P, G, L

MA Y Y P

ME Y Y P, G, L

NH Y Y -

RI Y Y P

VT Y Y 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 SMOKERSMeta-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 SMOKERSMeta-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


Step 1: Identify smoking status on admission

Computerized admission order set (MDs, RNs)

⇩Generates electronic list of smokers

sent to the Tobacco Treatment Service


Step 1: Identify smoking status on admission in an electronic database


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





Step 3: Extended intervention (smoking counselor)

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





Step 3: Extended intervention (smoking counselor)

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

Step 4: Link to post-discharge careRefer to Quitline for counselingPut medication on discharge medication list

Helping HAND StudyImproving 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 Care5 IVR calls ( 3, 14, 30, 60, 90 days) made to

patientOffered call from counselor at each contact30 days of free medication at discharge, refillable

x 2

Standard CareMedication is recommendedSmoker is given telephone number for free

quitline

Institute for Health Policy - 118 -

Example of IVR Call Script (Day 14)

Have you smokeda cigarette in the

last 7 days?

Are you trying to stopsmoking at this time?

NoYes

Great! Howconfident are youthat you would be

able to stay quit forthe next month?

Don’t give up. Quittingisn’t easy, but if you keeptrying and get some help

you can quit smoking.We recommend you talkto a tobacco counselor.

HighLow

Great! Itsounds like

you are doingwell!

It sounds like yourconfidence is a little low.We recommend you talkto our tobacco counselorto help you stay on track.

Would you like a counselor to call you? Counselor calls smokerYes

46

34

28

53

4642

34

24

16

4037

29

0

10

20

30

40

50

60

1 mo 3 mo 6 mo 1 mo 3 mo 6 mo

% A

bs

tin

en

t

Intervention Control

Continuous Abstinence Abstinent for past 7 days

p<.010 p<.024 p<.011 p<.092

Tobacco Abstinence after DischargeHelping HAND 1 Study

Self-report

p<.007 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 1st 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 PMSackler Building, Room 114 East (8th floor)

Next Meeting:

Thursday November 7, 2013UMASS 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)

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 170%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

10% 11% 11%15%

19%

29% 29% 30% 31% 33% 33% 35%38% 39% 40% 41%

70%

VSGNE all center average = 27%

Infra-inguinal Treatment of CLI in VSGNE in 2012:% Bypass (versus PVI)

(Centers with 10 or more procedures)

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 210%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

19%

25% 25%28% 29%

33% 33%37%

41%45% 47%

50% 50%

55%59% 60%

63% 64% 65%68%

100%

VSGNE all center average = 46%

VSGNE case presentationSpring 2013

Jeffrey E Indes MD, FACSAssistant Professor of Surgery and

RadiologyYale 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

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.

ABI Right DP 1.46 BiphasicPT 1.39 BiphasicGreat Toe 0.60 (65) - prior 0.92Left DP 0.97 BiphasicPT 0.87 BiphasicGreat Toe 0.52 (56) - prior 0.77

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 bilatPT: 1/2 right; 0/2 leftDP: 1/2 right; 0/2 left Impression / Plan: Chronic fem-pop PAD w/

claudication. Risk factor management, exercise and Pletal. RTC 2-mo

ABI Right DP 1.07 MonophasicPT 1.79 MonophasicGreat Toe 0.46 (54) - prior 0.60Left DP 0.95 MonophasicPT 0.95 MonophasicGreat Toe 0.37 (44) – prior 0.52

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.

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

2.0-mm LASER atherectomy

6x200-mmstent

VSGNE Quality Committee

Alik Farber MDVSGNE 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 IDBirth datevisit typeindex admission dateindex discharge dateIndex admiting diagnosisIndex admiting diagnosis present on admission statusIndex Principle diagnosisIndex Principle diagnosis present on admission statusIndex Secondary diagnosis 1Index Secondary diagnosis present on admission status 1Index Secondary diagnosis 2Index Secondary diagnosis present on admission status 2Index Secondary diagnosis 3 Index Secondary diagnosis present on admission status 3Index Secondary diagnosis 4Index Secondary diagnosis present on admission status 4Index Secondary diagnosis 5Index Secondary diagnosis present on admission status 5procedure codeprocedure descriptionprocedure datedays to readmissionreadmission admission dateIndex admiting diagnosisIndex admiting diagnosis present on admission statusIndex Principle diagnosisIndex Principle diagnosis present on admission statusIndex Secondary diagnosis 1Index Secondary diagnosis present on admission status 1Index Secondary diagnosis 2Index Secondary diagnosis present on admission status 2Index Secondary diagnosis 3Index Secondary diagnosis present on admission status 3Index Secondary diagnosis 4Index Secondary diagnosis present on admission status 4Index Secondary diagnosis 5Index Secondary diagnosis present on admission status 5readmission discharge date

Patient ID

Birth date

visit type

index admission date

index discharge 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 present on admission status 1









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











readmission discharge date

• 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

Surgical Site Infection Project

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

** ** **0%

4%

8%

12%

16%

20%

24%

28%

32%

36%

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

4,081 patient procedures, January 2010 December 2012

Observed Expected

Overall rate Wound InfectionVQI = 3.6%AUC = 0.65

VQI Centers

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 ratesDecember – centers were sent an email to share results:

Update on the progress

Jan-11

Feb-11

Mar-11

Apr-11

May-11

Jun-11Jul-1

1

Aug-11

Sep-11

Oct-11

Nov-11

Dec-11

Jan-12

Feb-12

Mar-12

Apr-12

May-12

Jun-12Jul-1

2

Aug-12

Sep-12

Oct-12

Nov-12

Dec-12

Jan-13

Feb-13

Mar-13

Apr-13

May-13

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

61%

81%

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

101 Centers 5,342 proceduresVQI

Jan-11

Feb-11

Mar-11

Apr-11

May-11

Jun-11Jul-1

1

Aug-11

Sep-11

Oct-11

Nov-11

Dec-11

Jan-12

Feb-12

Mar-12

Apr-12

May-12

Jun-12Jul-1

2

Aug-12

Sep-12

Oct-12

Nov-12

Dec-12

Jan-13

Feb-13

Mar-13

Apr-13

May-13

0%

1%

2%

3%

4%

5%

6%

7%

8%

9%

10%

4%

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

101 Centers 5,342 proceduresVQI

Jan-11

Feb-11

Mar-11

Apr-11

May-11

Jun-11Jul-1

1

Aug-11

Sep-11

Oct-11

Nov-11

Dec-11

Jan-12

Feb-12

Mar-12

Apr-12

May-12

Jun-12Jul-1

2

Aug-12

Sep-12

Oct-12

Nov-12

Dec-12

Jan-13

Feb-13

Mar-13

Apr-13

May-13

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

20%

86%


12 Improver Centers with 10 or more procedures in 2011 & 2012914 procedures

VQI

Jan-11

Feb-11

Mar-11

Apr-11

May-11

Jun-11Jul-1

1

Aug-11

Sep-11

Oct-11

Nov-11

Dec-11

Jan-12

Feb-12

Mar-12

Apr-12

May-12

Jun-12Jul-1

2

Aug-12

Sep-12

Oct-12

Nov-12

Dec-12

Jan-13

Feb-13

Mar-13

Apr-13

May-13

0%

1%

2%

3%

4%

5%

6%

7%

8%

9%

10%

6%

2%

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

12 Improver Centers with 10 or more procedures in 2011 & 2012914 procedures

VQI

Jan-11

Feb-11

Mar-11

Apr-11

May-11

Jun-11Jul-1

1

Aug-11

Sep-11

Oct-11

Nov-11

Dec-11

Jan-12

Feb-12

Mar-12

Apr-12

May-12

Jun-12Jul-1

2

Aug-12

Sep-12

Oct-12

Nov-12

Dec-12

Jan-13

Feb-13

Mar-13

Apr-13

May-13

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

55%

67%


20 Centers with 10 or more procedures in 20112,071 procedures

VSGNE

December – centers were sent an email to share results:

2011 Q1 2011 Q2 2011 Q3 2011 Q4 2012 Q1 2012 Q2 2012 Q3 2012 Q4 2013 Q10%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

VSGNE 20 Centers' Chlorhexidine rate over time

Rare (2011 < 10%): 1 center

Selective (10 to 80%): 5 centers

Routine (> 80%): 9 centers

Improver Selective:2 centersImprover Selective to Routine:

2 centers

Improver Rare to Routine:1 center

VSGNE

Jan-11

Feb-11

Mar-11

Apr-11

May-11

Jun-11Jul-1

1

Aug-11

Sep-11

Oct-11

Nov-11

Dec-11

Jan-12

Feb-12

Mar-12

Apr-12

May-12

Jun-12Jul-1

2

Aug-12

Sep-12

Oct-12

Nov-12

Dec-12

Jan-13

Feb-13

Mar-13

Apr-13

May-13

0%

1%

2%

3%

4%

5%

6%

7%

8%

9%

10%

3%

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 20112,071 procedures

rare (n=1)

selective (n=5)

routine (n=9)

rare/low selective to selective (n=2)

rare/selective to routine (n=3)

0.0% 2.0% 4.0% 6.0% 8.0% 10.0% 12.0% 14.0%

10.7%

2.9%

1.7%

6.0%

5.3%

11.8%

1.6%

3.9%

5.8%

1.0%

VSGNE: Surgical Site Infection by Year and Chlorhexidine category

20122011

Need 258 patients in each group only have 133 and 105

p = 0.058

0% 20% 40% 60% 80% 100% 120%0.0%

2.0%

4.0%

6.0%

8.0%

10.0%

12.0%

14.0%

Series1; 11.8%

1.6%

3.9%

5.8%

1.0%

Series1; 10.7%

2.9%1.7%

6.0%5.3%

20112012

Chlorhexidine Rate

Surg

ical

Site

Infe

ction rare

selective

routine

selective improver

improver

0.0%1.0%2.0%3.0%4.0%5.0% 4.1%

2.8% 3.2%

1.4%

4.4%

1.2%

VQI Infra-Inguinal Bypass ProceduresSurgical Site Infection rate by year and Chlorhex-

idine usage rate category

20112012

VQI

In your center’s packet – your center report

Discharge medicine

VSGNE Center VariationPercent Patients discharged on Antiplatelet and Statin

2012 & 2013Centers with 10 or more procedures

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 27 280%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

VSGNE = 79%

VSGNE Center VariationPercent Patients discharged on Antiplatelet only


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 27 280%

5%

10%

15%

20%

25%

30%

35%

VSGNE = 14%

VSGNE Center VariationPercent Patients discharged on Statin Only


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 27 280%

1%

2%

3%

4%

5%

6%

7%

8%

9%

10%

VSGNE = 4%

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

*A **B **C **D E **F **G **H I J K L M N O P **R S T **U **V0%

10%

20%

30%

40%

50%

60%

70%

80%

Centers with 13 or more procedures2,750 patient procedures, 2003 to June 2012 (Excludes in-hospital deaths)

observed expected

Centers

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

Significantly lower or higher than expected:

* p<0.05**p<0.01

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

Global Health Economics UnitCenter for Clinical and Translational Science

Cost and Resource Utilization in treating AAA patients

(FAHC)

Stanley5/6/13

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

StayTotal

Charges Direct Cost Indirect Cost Total Cost

1.19 $43,557.72 $17,832.34 $6,747.81 $24,580.15

1.66 $50,484.57 $20,190.13 $8,121.17 $28,311.30

1.66 $54,060.67 $22,068.22 $8,811.27 $30,879.49

2.48 $60,519.05 $24,737.76 $10,118.31 $34,856.07

4.13 $77,079.20 $31,570.78 $13,153.19 $44,723.97

Length of Stay

Total Charges Direct Cost Indirect Cost Total Cost

5.32 $27,369.59 $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

EVAR

OPEN

Specific Cost Breakdown for Open Patients

63%11%

26%

Breakdown of Total Costs in a Lower Quartile Open Patient

OR CostsM-SICUHostpital Costs

OR Costs $11,214.24

M-SICU $1,993.53Hospital Costs $4,602.56Total Cost $17,810.33

49%

11%

40%

Breakdown of Total Costs in a Upper Quartile Open Patient

OR CostM-SICUHospital Cost

OR Cost $20,693.50

M-SICU $4,860.68Hospital Cost $17,078.74Total Cost $42,632.92

Shep 3 Ct - Pv $3,335.77Lab-Blood-Bank $2,085.05M-Baird-6 $3,534.48

Other high cost items

Specific Cost Breakdown for EVAR Patient

30%

25%

28%

17%

Breakdown of Total Costs in an Upper Quartile Patient

Device CostsOther OR CostsHospital CostsM-SICU

Device Costs $15,033.56Other OR Costs $12,788.79Total OR Costs $27,822.35

M-SICU $8,588.89Hospital Costs $13,906.30Total Cost $50317.54

50%

39%

12%

Breakdown of Total Costs in a Lower Quartile Patient

Device Costs

Other OR Costs

Hospital Cost

Device Costs $14,613.25Other OR Costs $11,382.21Total OR Costs $25,995.46

Hospital Cost $3,430.18Total Cost $29,425.64


Predictive Modeling

Estimate model using OPEN dataset Estimate model using EVAR dataset

Total sample = 230 cases Total sample = 158 cases

Statistically significant predictorsOf Total Cost:

Age (p=.00)Transfer (p =.00)COPD (p=.00)

Statistically significant predictorsOf Total Cost:

Betablockers (p=.00)Creatinine > 1.45 mg/dl (p =.03)Iliac (p=.00)Ejection fraction < 30% (p=.10)


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


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

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, MDSection 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

Define Measure Analyze Improve Control

Define

Measure

Analyze

Improve

Control

Pre-Clinic Clinic Visit Pre-Admission Testing

Same Day Surgery

Admission

Surgery Recovery Room (PACU)

Surgical Post-Op Floor

Post-Op Day 1 Discharge

Clinic Visit 1- Month

Clinic Visit every

12- Months for 5 years

Surgical Candidate

Patient Decision Surgery

EVAR

Standard EVAR Case Planning

(Device Selection/Clinical Trial)

y

y

y

Purchasing

SurveillanceOpen Repair

Medical ManagementBranched EVAR

Further Work-up

n

n

Current State

Phone Call from Referring Provider

Phone call from the Connection Line

Electronic Referral

Aneurysm >= 5 cm CT Available

Vascular Ultrasound

Current Labs

y

n

Obtain CT from outside

diagnostics center

Review lab values to

determine additional

testing

Obtain necessary labs

y

n

n

y

Schedule CT(questionnaire

& measure time)

Schedule Clinic Visit(Sched Secretary)

Schedule Vascular Lab

(Sched Secretary)

Lab Tech reviews patient data and

consults with MD (if no clear protocol)

Order Vascular Lab study

y

n

Collect Patient Information

(Sched Secretary

Pre-Clinic

FaxeD-H or CIS reviewMailElectronic transfer

Image required (not written report)Portable Media (CD)PACs to PACs transfer

Patient DemographicsOffice NotesImagingRecent Labs

Standardize process for

obtaining CT prior to clinic

visit

1

CT AvailablePatient has or is

planning to obtain CD

Patient instructed to bring CD to

appointment

Call PCP or outside diagnostics center to

obtain CTPACs Transfer

Request CD to be mailed to Vascular

Surgery

MD receives patient CT on CD

DHMC Film Library notified by secretary

y

n

y

y

n

n

CT Imagine available for MD review through eD-H

Patient Clinic Appointment

Outside CT

Patient asked where they would like to have labs drawn

DHMC

Fax requisition to Lab

Fax requisition to outside lab

Patient has labs drawn

Results sent to ordering provider

via eD-H

Patient has labs drawn

Results faxed to Vascular Surgery

Creat > 1.3Results scanned into

eD-H

Provider Reviews y

n

y

Action RequiredBi-Carb

Protocol

Patient has CT scan with contrast

Patient has CT scan without contrast

Patient Clinic Appointment

y

y

n

Appointment Cancelled

y

n

Labs

Scheduling secretary monitors & tracks to assure labs are current prior to CT

Clinic Visit

Rece

ption

Clin

ic N

ursi

ngPr

ovid

erCl

inic

Sec

reta

ryO

R/IR

Sch

ed

Secr

etar

y

Phase

Patient Arrives at Reception

Receptionist provides current

med list from eD-H for patient to review

Patient roomed(Vitals recorded

Medications reviewed)

Review CT and other paperwork relevant

to referral

Provider completes standard office visit and conducts H&P

Provider and Patient discuss options SurgeryFurther Work-up

Needed

Schedule additional tests ordered (M2S,

other) and return clinic visit

y

n

n

Provider communicates with clinic secretary to

schedule EVAR

y

Patient scheduled for PAT & Surgery

Patient Exits Clinic

Case Planning

Prepare referring provider notes, labs,

imaging

Review clinic preparation

regarding central versus

de-central scannin

CT and 3D imaging at office visit

Use eD-H functions in clinic visit documentation (Problem Lists, History, etc..) to reduce re-work

Standard patient

teaching and risk/benefit discussion

Scheduling Surgery & PAT

Clin

ic S

ecre

tary

OR

Sche

d Se

cret

ary

Clin

ic N

ursin

gPr

ovid

er

Phase

Provider communicates with clinic secretary to

schedule EVAR

Surgery Order PAT OrdersPend Orders to Provider

Provider signs orders

n

Provides surgery Date

Update Outlook Calendar

Update weekly schedule for conference

Check Insurance

y

Provider signs orders

Pend Orders to Provider

n

Schedule PAT Appointment DHMC

PAT DHMC

yExternal PAT

Process

y

n

Financial Clearance y

n

Same Day Surgery

Admission

Patient Completes

Testing

Update Problem Lists, History &

Medications

Standardize communication to prevent re-

work

Standardize communication to prevent re-

work

Patient complete PAT questionnaire

before reporting to

PAT

Review changes in PAT hours to get more patients

to use DHMC

eD-H orderset for EVAR – Start with

Carotid

eD-H orderset for EVAR – Start with

Carotid

Review codes for case and

impact on OR case times

Use eD-H functionality to reduce re-

work

External PAT

Clin

ic S

ecr

eta

ryO

R S

che

d S

ecr

eta

ryP

CP

Offi

ceM

ed

ical

Re

cord

s

Phase

PAT DHMC

Send letter to PCP communicating

surgery scheduled and PAT order

instruction

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

Scan results into eD-H

Send results to Medical Records

Email Provider results received &

available for review

Review PAT Results

n

Receive Results ynCall PCP

PAT Results Review

OR

Sch

ed

S

ecr

eta

ryP

rov

ide

rA

ne

sth

esi

aS

D N

urs

e

Phase

Email Provider results received &

available for review

eD-H Results Review results from Patient testing Cancel

Review results from Patient testing

Review results from Patient testing

Same Day Surgery

Admission

Provider and Patient discuss optionsy

n

Call Patient with instructions for

Surgery

Measure cancellations

by type to provide

feedback to process

Case Planning

Prov

ider

Fello

wO

R N

ursi

ngPu

rcha

sing

&

Rece

ivin

gVe

ndor

Phase

Order M2S 3D ReconstructionM2S

Reconcile plan for patient (grafts

pieces, size, approach, etc.)

Communicate graft pieces and size using

email form

Develop EVAR plan and select graft pieces and sizes

Review Case at Monday Conference the week of planned

surgery

n

y

Pieces in Inventory Pull pieces for CaseCreate manual req

for purchasing

Rush Order Call in rush order to vendor

Confirm PO with Nurse Manager

Pick, Pack & Ship Overnight

Receive packages & sort for expedited Transport to OR

n

y

Pick, Pack & Ship Standard

y

Pre-Op H&P

Review cases needing inventory in advance of current week to reduce rush orders & Improve inventory management

Explore standardization of graft vendors to reduce cost and variation

Use functions in eD-H, such as prob list, history, medications to reduce re-work. Develop standard template for quality

& data collection

Compare cost of different options

for procedure including clinical

trial arrangements

Post-Op

Prov

ider

Fello

wRe

side

ntPA

CU4

Wes

t

Phase

Out of Room Brief Op Note (Within 30 minutes)

Fellow gives hand-off to PACU Nurses/

Intern

Post-Op orders

Patient stays in PACU for 4 hours CBC OK

Patient assessed

n

Patient moved to Floor (4W)

y

Post-Op check PM Rounds

PM Rounds

Communication and education hand-off

standard between fellow and intern Order set development

targeted at timely discharge, i.e. foley removed before am

rounds

Post-Op Day 1

Prov

ider

Fello

wN

urse

Clin

icia

nRe

siden

tO

R Sc

hed

Secr

etar

y

Phase

AM Rounds

AM Rounds

Discharge Ready Dischargey

Discharge Planning with Intern

n

Continued Hospital Stay

Schedule CT and 30 day follow-up in

clinic

Develop discharge template and standard patient

education

Tighten up planning and coordination with research clinical trials

Post Discharge

Nu

rse

Cli

nic

ian

Pro

vid

er

Cli

nic

al

Se

cre

tary

Ra

dio

log

y

Phase

VSG Data Collection

Discharge Patient ???s

Nurse Clinician takes calls, provides

education, coordinates needed

care

Patient has CT scan

Patient has clinic visit with provider

M2S 3D reconstruction

Provider reviews for graft position/status

and endoleakProblem

Clinic Secretary plans follow-up for 1-year with CT and

M2S

y

Provider and patient discuss options

y

n

n

Clinical Trial Protocol

Log Calls and categorize as feedback to process

Detailed Process Map

Pre-Clinic

ClinicCase Planning

Post-Op

Follow-up

Define Measure Analyze Improve Control

Define

Measure

Analyze

Clinic

Visits

Instrument Usage

Extra Instruments

per case

Implant Cost

Cost per Case

Clinic

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

0%

10%

20%

30%

40%

50%

60%

Patients with CorrectImaging

Patients requiring follow-up imaging

New Patients with Greater than 5cm AAA

0%

20%

40%

60%

80%

100%

Patients with CorrectImaging

Patients RequiringFollow-up Imaging

New Patients with Greater than 5cm AAA

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

Process Improvement

SuccessInstrument Use Reduction

EVAR Margin

$(15,000)

$(10,000)

$(5,000)

$-

$5,000

$10,000

$15,000

$20,000

$25,000

$30,000

$35,000

$40,000

TechincalRevenue

Technical Cost Technical Margin ProfessionalRevenue

Professional Cost ProfessionalMargin

Total Margin

EVAR Net Financial Margin

Grafts & Implants - 52%

Other Technical Costs- 48%- Supplies- Technical Overhead- Statistically Allocated- Technical Direct

$27,657

$32,877

-$5,220

$2,481

$7,746

-$5,265

-$10,485

DRG 238 - 2012 Mean Total Cost by AMC

Source: UHC 2012

0

10,000

20,000

30,000

40,000

50,000

60,000

DHMC

UHC 2012

Combo7%

Manufacturer A12%

Manufacturer B9%

Manufacturer C18%

Manufacturer D54%

Market Share

$20,894

$20,833

$16,636

$15,182

$18,607

Summary

Appointments

Instruments

Grafts

50 saved per year

$50,000 saved per year

$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

• 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

$12,413$17,030$18,020 $13,816 $22,083

54%

18%

12%9% 7%

30%

10%

33%

23%

4%0%

10%

20%

30%

40%

50%

60%

Manufacturer D Manufacturer C Manufacturer A Manufacturer B Combo

Mar

ket

Sh

are

Market Share

New Market Share

5% to 20%

17% to 20%20% & Cap

3% to 6%

3% to 20%

Next Meeting

Date: Thursday, November 7, 2013

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

Caregivers meeting: 8-10 am

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

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