THE COST OF MAJOR AMPUTATION - Accredited CME … Yost... · THE COST OF MAJOR AMPUTATION Mary L. Yost, ... ESRD PATIENTS Limb Salvage w ... Arch Phys Med Rehabil 2005; 86: 480-6.

THE COST OF MAJOR AMPUTATION

Mary L. Yost, M.B.A. President

THE SAGE GROUP LLC Research and Consulting

DISCLOSURES

THE SAGE GROUP LLC is a for-profit research and consulting

company specializing in vascular disease in the lower limbs including Peripheral Artery Disease (PAD), Intermittent

Claudication (IC), Critical Limb Ischemia (CLI) Acute Limb Ischemia (ALI) and Diabetic Foot Ulcer (DFU) & Amputation.

CLIENTS

Aastrom Biosciences

Abbott Vascular

ActivBiotics

Advanced Biohealing

AngioScore

ANS (St. Jude Medical)

AtheroMed Inc.

Bain & Company

Bard

Baxter

Bayer (Medrad)

BioMarin Pharmaceutical

Boston Scientific

Boston Scientific India

Chemo France

Cardiovascular Systems, Inc.

CoDa Therapeutics

Cordis (Johnson & Johnson)

Cook Medical

Diffusion Pharmaceuticals LLC

Diomed Inc.

Edwards Lifesciences

Ev3

FoxHollow Technologies

GlaxoSmithKline

Grifols SA

Harvest Technologies

IDev Technologies

Indigo Pharmaceuticals

Infocus Research

Intact Vascular

Jihad Mustapha MD

Joan Piesinger & Associates

Kerberos Proximal Solution

King Pharmaceuticals

Maxis

Medtronic

Merck Serono AG Mexico

Novadaq Technologies

Nuvelo Inc.

OmniSonics Medical

Pathway Medical Technologies

Pluristem Therapeutics

Possis Medical

Rapid Medical

Sanofi-Aventis

Schering-Plough Corp.

Shire Pharmaceuticals

Solvay Pharmaceuticals

Spectranetics Corporation

Stempeutics

Stereotaxis

Straub Medical AG

Terumo

The Medicines Company

ThermoGenesis Corp.

ThromboGenics NV

W. L. Gore

DISCLOSURES

Stock Ownership (January 31, 2015)

Abbott Laboratories, Inc.

AbbVie Inc.

Angiodynamics Inc.

Derma Sciences Inc.

CRITICAL LIMB ISCHEMIA

LIMB SALVAGE CAN:

REDUCE COSTS

FOR THE ECONOMY,

THE HOSPITAL,

& THE PATIENT

CLI PREVALENCE & COST 2015

2-3 Million

400,000-700,000 Treated w/

Revascularization or Amputation-Major & Minor

Cost $40-$66 Billion

Source: Yost. CLI Vol I, Nehler 2014, Baser, HCUP Queries, Barshes 2012, Mahoney 2010, Dillingham 2005 and THE SAGE GROUP estimates.

WHO PAYS THE CLI BILL?

Source: HCUP Query. Outcomes.

CLI “IDEAL” TREATMENT PATHWAY

Source: Allie 2005 and Hallett.

MAJOR AMPUTATION

25%-33% CLI patients undergo primary amputation (PA)

65,000-75,000 major amputations performed annually

Source: Yost. EVT 2014, Henry 2011 and Baser.

CLI PATHWAY TO AMPUTATION

Frequently the first and only therapy for CLI

51%-73% No Angiogram—Despite fact

that angio the odds by 90%

60%-71% No Revascularization

Source: Henry 2011, Allie 2005, Goodney 2012.

AMPUTATION LOTTERY

Probability of major amputation depends on who you are and where you live

Amputation varies by: race, sex, age, socioeconomic status, hospital volume, geographic location

Medicare & Medicaid-More likely than private, Medicaid most likely!

Source: Henry 2011, Baser, Goodney 2012, Jones, Margolis DJ 2011 & Eslami 2007.

MAJOR AMPUTATION ANNUAL ECONOMIC COST*

$11 BILLION

*Total Direct Inpatient and Outpatient Costs in 2014 $ Source: Dillingham 2005, Yost EVT 2014.

COST-EFFECTIVENESS ANALYSIS (CEA)

Model to Assess Value of a Treatment & Allocate Resources

Compares Costs & Outcomes of Therapies

Cost Perspective Macroeconomic, Hospital, Payer, Patient

Source: Barshes 2012, Hlatky and Weintraub.

US COST STUDIES ONLY

Can’t compare costs across countries

Differences in

• Clinical Practice

• Reimbursement Systems

• Prices and Costs

Source: Tenvall.

AMPUTATION NOT COST-EFFECTIVE

Amputation less cost-effective

than either Bypass or Endovascular*

(Barshes)

Amputation less cost-effective

than Bypass

(Brothers)

*Rutherford V-Ulcers

Source: Barshes 2012 & Brothers.

AMPUTATION NOT COST-EFFECTIVE

“MARGINAL” PATIENTS

Conventional Wisdom: Frail, Elderly Pts w Limited Mobility—Primary Amputation “Better”

Limb Salvage w/ Endovascular “Best Option”

PA: Lower Health Benefits & Higher Costs (Need for LT Nursing Home)

Source: Barshes. Ann Vasc Surg 2014.

AMPUTATION

NOT COST-EFFECTIVE ESRD PATIENTS

Limb Salvage w/ Endovascular “Better” in

ESRD Patients w/ Ulcers

Wound Care Only “Better” than Endovascular: Cost $15,403 Less per year of Ambulation

Endo Ambulation 0.22 Years vs Wound Care

Wound Healing to 65%: Endovascular Better

than Wound Care-New Technology?

Source: Barshes. JVS 2014.

Source: Barshes JVS 2014.

ANNUAL COSTS BY TYPE

Source: Dillingham 2005 and Yost Endovascular Today. 2014.

“PATHWAY TO AMPUTATION”

IMPACT ON HOSPITAL

COSTS & OUTCOMES

HOSPITAL CHARGES

Bypass vs Amputation

Study Procedure Charges*

AMP $ Revasc $

Mackey All 26,142 Bypass 27,081 Complicated 40,563 40,769

Gupta BKA 27,225 Bypass 26,194

Raviola BKA 20,400 BP FP 20,300

Complicated BKA 40,600 BP FP 28,700

Source: Mackey 1986, Gupta 1988 and Raviola 1988.

HOSPITAL PROCEDURE COST (Before Complications & Mortality)

$25,000

$21,500

19,000

20,000

21,000

22,000

23,000

24,000

25,000

26,000

Amputation Endovascular

Amputation vs Endovascular

Source: HCUP Query Outcomes.

TOTAL HOSPITAL COSTS

Procedure Cost + Costs of Perioperative:

1. Mortality

2. Morbidity

3. Revision Procedures

Source: Yost Endovascular Today 2014, Perler 1995 and Gupta 1988.

PERIOPERATIVE MORTALITY

AKA & BKA are 2 of the top 5 procedures with the highest perioperative mortality

Source: Hasanadka, Belmont, Aulivola, Alonso, Stone, Vogel 2011, DeRubertis, Sachs, Muradin and Ghaferi.

Amputation Endovascular

AKA 5%-10% 1%-3%

BKA 15%-20%

IN-HOSPITAL DEATH

Average Cost $18,600

(In 2010 $)

Source: Davenport & Yost.

PERIOPERATIVE MORBIDITY INCREASES COSTS

PROCEDURE MORBIDITY

Amputation

20%-37%

General & Vascular Surgery

16%-17%

Endovascular

5%-9%

Source: Alonso, Vogel 2011, DeRubertis, Ghaferi, Dormandy, Boltz and Schneider.

THREE MOST COMMON OPERATIVE MORBIDITIES

Source: Egorova, Nowygrod, Hasanadka, Belmont, Aulivola, Taylor 2008, Toursarkissian, Yeager 1995 & Zickler.

AMPUTATION ENDOVASCULAR

Wound Infection

10%-30%

Bleeding

5%-7%

DVT 13%-26% Infection 1%-4%

Cardiac 9%-10% Cardiac ≈ 1%

IN-HOSPITAL REVISION RATES

AMPUTATION ENDOVASCULAR

Above Knee 12% Endovascular 1%

Below Knee 20% Bypass 4%-9%

Amputation 2%-4%

Source: DeRubertis, Muradin, Faglia 2006, Dillingham 2005, BASIL.

TOTAL HOSPITAL COSTS Including Morbidity, Mortality & Revisions

$35,500

$25,700

0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

Amputation Endovascular

Amputation vs Endovascular

Source: Yost Endovascular Today 2014.

LIMB SALVAGE PROGRAM IMPACT ON HOSPITAL

Substitute Endovascular Procedures for Amputations

Costs

Capture Foregone Revenues from Angiograms (51%-73% PA No Angio)

Revenues-Attract New CLI Patients

Source: Balar, Mustapha, Bell, Sanguily and THE SAGE GROUP.

LIMB SALVAGE PROGRAM IMPACT ON HOSPITAL

Procedure Mix-100 Pts. Before Limb Salvage Program: 40% PA, 60% ET

After: 10% PA, 90% ET

Per Pt. Costs Reduced by $3,000 or $300,000 Total Assumes PA Total Costs $35,500 & ET $25,700

Capture Foregone Revenues from Angiograms—$11,600 per Pt. Assume 50% PA No Angio & Avg. Inpatient Angio DRG $5,800 X 2

50 New CLI Patients— Revenues by $1.3 Mil Avg. Inpatient Angio DRG $5,800 X 2 + Avg. Inpt. ET DRG $14,240

Source: Yost. THE SAGE GROUP estimates.

CLI—WHY IS EARLY DIAGNOSIS &

TREATENT IMPORTANT?

Costs ↑ w/ Disease Severity— IC Lowest, Amp Highest Hospital Costs: 62%-87% of PAD Costs Hospitalizations ↑ w/ Disease Severity (IC 25% Amp 36%)

70% Have Polyvascular Disease—50% PAD + CAD CVD Costs Add Significantly—43% of Total Costs

CVD Events ↑ w/ Disease Severity—AS 21% Amp 34%

Source: Yost PAD real cost 2011, Mahoney 2008, Mahoney 2010, Margolis 2005 and Gupta 1988.

PAD A RISK FACTOR EQUIVALENT TO CAD

RISK FACTOR MODIFICATION THERAPY UNDERUTILIZED

Antihypertensive No Rx 12%-50%

Antiplatelet No Rx 33%-70%

Antilipid No Rx 44%-60%

CLI Cost Morbidity & Mortality

Source: Margolis J, Hirsch 2001, Conte 2005 and Armstrong 2014.

ENDOVASCULAR PATIENT

OUTCOMES

•Discharge Status

– 62% go home routinely 18% (NH, Rehab) 17% Home HC

•Ambulation-2 Year

– 81% walking

– 88% living independently

•Revascularization (18 mos.)

– 30%-40%

•Mortality-2 Year

– 16%-24%

Source: Allie 2005, Sachs, HCUP Query DRG 252-254, Taylor 2006, Bradbury, Vogel 2008, Conrad, Aiello, Abularrage.

AMPUTATION

PATIENT OUTCOMES

•Discharge Status

– 18%-24% go home routinely majority (70%) go to another institution (NH, Rehab etc.)

•Ambulation

– 60%-80% can’t walk

•Depression 35%

•Mortality-2 Year

– 30%-50% (frequently MI)

•Contralateral Amputation – 36%-50%

•Patient $ Costs – Lost wages, copayments & deductibles, modifications for disabled living,

nursing home & home care. Source: Allie 2005, Belmont, Dillingham 2005, HCUP Query DRG 239-241, Dillingham 2011, Dormandy, Yeager 2005, Jackson, Jencks, Norgren, Gardner & Subramaniam.

AMPUTATION MORE PATIENT OUTCOMES

•Lengthy Healing Process

– At 100 days 45% BKA & 24% AKA not healed

•Quality of Life Reduced

– Severe physical impairment in ambulation, body care, movement and mobility

•Chronic Pain 95%

– Phantom Limb Pain 79%-80%

– Residual Limb Pain 68%-74%

– Back Pain 52%-62%

•Skin Problems in Stump 15%-41%

– Results in reduced prosthetic use and reduced walking time Source: Nehler 2003, Peters 2001, Ephraim, Ehde, Meulenbelt, Dudek & Bui.

CONCLUSIONS

CLI: ACTUAL TREATMENT SIGNIFICANTLY DIFFERENT FROM IDEAL— COSTS

AMPUTATION IS LESS COST-EFFECTIVE THAN LIMB SALVAGE—EVEN IN MARGINAL & ESRD PTS

AMPUTATION COSTS THE HOSPITAL MORE THAN LIMB SALVAGE

CLI EARLY DIAGNOSIS & TREATMENT: COULD REDUCE COSTS, MORBIDITY & MORTALITY

AMPUTATION: HIGH PATIENT COSTS—NOT JUST $$$$ BUT POOR QUALITY OF LIFE, PAIN, INABILITY TO AMBULATE

MORE RESEARCH: COSTS/ECONOMICS & OC

THANK YOU—THE STAFF

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