Management of Peripheral Vascular Patients at Duke Hospital: An opportunity to SAVE Manesh R. Patel, MD Assistant Professor of Medicine Duke University Medical Center
Disclosures Advisory Board Genzyme Interventional Cardiologist Use of Off-Label Devices for PAD
Outline of Talk Vascular Disease Risk Quality Metrics vs. Performance Measures: what s s the difference? Quality Metric for the vascular center
Question # 1 If you had a family member admitted to Duke Hospital for vascular disease problem (i.e. AAA or post SFA revascularization), how would you measure the quality of the care?
Clinical Cases Case # 1 Case # 2 50 year old female with DM, HTN, and Tob use Sees PCP with calf pain Referred for vascular evaluation 68 year old male with Tobacco Use, HTN and AAA PCP does ultrasound measure AAA 5.6 cm Referred to Duke
Case 1 50 y/o Female DM, HTN, and Tobacco use Calf pain with exertion not clear rest relief No prior CAD history / No back pain Should PAD be suspected / If so why and how should it be evaluated
Current Care of Vascular Patients
Defining a Population At Risk for Lower Extremity PAD Age less than 50 years with diabetes, and one additional risk factor (e.g., smoking, dyslipidemia, hypertension, or hyperhomocysteinemia) Age 50 to 69 years and history of smoking or diabetes Age 70 years and older Leg symptoms with exertion (suggestive of claudication) or ischemic rest pain Abnormal lower extremity pulse examination Known atherosclerotic coronary, carotid, or renal artery disease Slides from ACC/AHA PAD Guideline site www.acc.org
Diagnosis of Peripheral Arterial Disease in High-Risk Patients PARTNERS evaluated 6979 patients in physicians offices Possibility of PAD evaluated in All patients 70 yr; mean (±SD) age: 70 (±10 yr) Patients 50 69 yr with history of diabetes and/or smoking (at least 10 pack/yr) Only 49% of PAD patients physicians knew they had PAD 29% 44% 56% Hirsch AT et al. JAMA. 2001;286:1317 Patients diagnosed with PAD PAD only PAD and cardiovascular disease
Risk Factors for Peripheral Arterial Disease Smoking Diabetes Hypertension Hypercholesterolemia Hyperhomocystinemia Fibrinogen CRP Alcohol Relative Risk Reduced Increased 0.5 1 2 3 4 5 6 Dormandy JA, Rutherford RB, for the TASC Working Group. J Vasc Surg. 2000;31(1 pt 2):S1; Graham IM et al.jama. 1997;277:1775; Hiatt WR et al. Circulation. 1995;91:1472; Newman AB et al. Circulation. 1993;88:837; Ridker PM et al. Circulation. 1998;97:425
Atherothrombotic Diseases in US The Big 3 3 Prevalence (millions) Incidence (millions) Coronary heart disease 13.2 1.2 Cerebrovascular disease 4.8 0.7 Peripheral arterial disease 8.0 12.0 AHA. Heart Disease and Stroke Statistics 2004 Update. Dallas, Tex.; 2003
10-yr Risk* of Atherothrombotic Events in Patients With Vascular Disease Patient population PAD MI Increased risk of MI* 4 (includes only fatal MI and other CHD death) 5 7 (includes death) Increased risk of stroke* 2 3 (includes TIA) 3 4 (includes TIA) Stroke *Compared with general population 2 3 (includes angina and sudden death) 9 greater risk Adult Treatment Panel II. Circulation. 1994;89:1333 Criqui MH et al. N Engl J Med. 1992;326:381 Kannel WB. J Cardiovasc Risk. 1994;1:333 Wilterdink JL, Easton JD. Arch Neurol. 1992;49:857
Hemodynamic Noninvasive Tests Resting Ankle-Brachial Index (ABI) Exercise ABI Segmental pressure examination Pulse volume recordings These traditional tests continue to provide a simple, risk-free, and cost-effective approach to establishing the PAD diagnosis as well as to follow PAD status after procedures.
Noninvasive Diagnosis Interpretation of ABI >1.30 Noncompressible 0.91-1.30 Normal 0.41-0.90 Mild/moderate PAD 0.40 Severe PAD/critical limb ischemia
Peripheral Arterial Disease: All-Cause Mortality* Patient Survival (%) 100 75 50 25 0 LV-PAD = large-vessel PAD Criqui MH et al. N Engl J Med.. 1992;326:381 Normal Subjects 0 2 4 6 8 10 12 Time (yr) Asymptomatic LV-PAD Symptomatic LV-PAD Severe Symptomatic LV-PAD ~75% 10-yr mortality ~40% 10-yr mortality *Majority of deaths due to cardiovascular causes
Case 1 50 y/o Female DM, HTN, and Tobacco use Calf pain with exertion not clear rest relief R > L Diminished +1 pulses bilaterally Seen in Vascular Clinic ABI = 0.53 Right and 0.68 on left Vascular Ultrasound performed Likely Right SFA occlusion Cardiovascular risk factor modification and tobacco cessation Treatment options for PAD
Supervised Exercise Rehabilitation I I IIa IIb III IIa IIb III A program of supervised exercise training is recommended as an initial treatment modality for patients with intermittent claudication. Supervised exercise training should be performed for a minimum of 30 to 45 minutes, in sessions performed at least three times per week for a minimum of 12 weeks.
Pharmacotherapy of Claudication I IIa IIb III Cilostazol (100 mg orally two times per day) is indicated as an effective therapy to improve symptoms and increase walking distance in patients with lower extremity PAD and intermittent claudication (in the absence of heart failure).
Endovascular Treatment for Claudication I Endovascular procedures are indicated for individuals with a vocational or lifestyle- limiting disability due to intermittent claudication when clinical features suggest a reasonable likelihood of symptomatic improvement with endovascular intervention and Response to exercise or pharmacologic therapy is inadequate, and/or b.. there is a very favorable risk-benefit ratio (e.g. focal aortoiliac occlusive disease)
Summary of Medical Therapy for PAD RCT no better than placebo
Question # 1 If you had a family member admitted to Duke Hospital for vascular disease problem (i.e. AAA or post SFA revascularization), how would you measure the quality of the care?
What would you put in place if you could to ensure quality care? Bigger Rooms Better Food Better equipment Combined vascular service Are there any interventions that reduce clinical events?
What is the clinical effect of PAD in North Carolina?
Lower Extremity Amputations in North Carolina All Payors, 2006 Data Source: Thompson Reuters Cumberland Cumberland Cumberland Cumberland Cumberland Cumberland Cumberland Cumberland Cumberland Richmond Richmond Richmond Richmond Richmond Richmond Richmond Richmond Richmond Anson Anson Anson Anson Anson Anson Anson Anson Anson Stanly Stanly Stanly Stanly Stanly Stanly Stanly Stanly Stanly Mitchell Mitchell Mitchell Mitchell Mitchell Mitchell Mitchell Mitchell Mitchell Avery Avery Avery Avery Avery Avery Avery Avery Avery Caldwell Caldwell Caldwell Caldwell Caldwell Caldwell Caldwell Caldwell Caldwell Brunswick Brunswick Brunswick Brunswick Brunswick Brunswick Brunswick Brunswick Brunswick New Hanover New Hanover New Hanover New Hanover New Hanover New Hanover New Hanover New Hanover New Hanover Wayne Wayne Wayne Wayne Wayne Wayne Wayne Wayne Wayne Franklin Franklin Franklin Franklin Franklin Franklin Franklin Franklin Franklin Nash Nash Nash Nash Nash Nash Nash Nash Nash Granville Granville Granville Granville Granville Granville Granville Granville Granville Washington Washington Washington Washington Washington Washington Washington Washington Washington Martin Martin Martin Martin Martin Martin Martin Martin Martin Chowan Chowan Chowan Chowan Chowan Chowan Chowan Chowan Chowan Edgecombe Edgecombe Edgecombe Edgecombe Edgecombe Edgecombe Edgecombe Edgecombe Edgecombe Vance Vance Vance Vance Vance Vance Vance Vance Vance Warren Warren Warren Warren Warren Warren Warren Warren Warren Durham Durham Durham Durham Durham Durham Durham Durham Durham Orange Orange Orange Orange Orange Orange Orange Orange Orange Alamance Alamance Alamance Alamance Alamance Alamance Alamance Alamance Alamance Alleghany Alleghany Alleghany Alleghany Alleghany Alleghany Alleghany Alleghany Alleghany McDowell McDowell McDowell McDowell McDowell McDowell McDowell McDowell McDowell Rutherford Rutherford Rutherford Rutherford Rutherford Rutherford Rutherford Rutherford Rutherford Cherokee 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Wilkes Wilkes Wilkes Wilkes Wilkes Wilson Wilson Wilson Wilson Wilson Wilson Wilson Wilson Wilson Yadkin Yadkin Yadkin Yadkin Yadkin Yadkin Yadkin Yadkin Yadkin Yancey Yancey Yancey Yancey Yancey Yancey Yancey Yancey Yancey NC Counties: Amputations per 1,000 people 1.04 to 1.3 (3) 0.78 to 1.04 (3) 0.52 to 0.78 (20) 0.26 to 0.52 (47) 0 to 0.26 (27) County # Amputations FFY 2006 2007 Population Amputations per 1,000 Gates, NC 15 11,569 1.30 Warren, NC 21 19,018 1.10 Northampton, NC 24 21,767 1.10 Tyrrell, NC 4 3,922 1.02 Franklin, NC 42 53,303 0.79 Top 5 NC Counties with the highest rate of amputations per 1,000 people Note: Amputation defined as procedure codes 84.10, 84.12 84.18, 84.3
Lower Extremity Amputations MEDPAR, 2006 Washington Montana North Dakota Minnesota Oregon Idaho Nevada Utah California Arizona Wyoming Colorado New Mexico South Dakota Nebraska Kansas Oklahoma Maine Wisconsin Vermont Michigan New Hampshire New York Iowa Massachusetts Indiana Connecticut Rhode Island Pennsylvania Illinois Ohio New Jersey Maryland Delaware West Virginia Missouri Washington DC Kentucky Virginia Tennessee North Carolina Arkansas South Carolina Alabama Mississippi Georgia Texas Louisiana Amputation rates per 1,000 people age 65+ Nearly 70% of lower extremity amputations (excluding toes) in North Carolina were for patients with Medicare. Florida 3 to 3.75 (1) 2.25 to 3 (1) 1.5 to 2.25 (10) 0.75 to 1.5 (32) 0 to 0.75 (7) Puerto Ric Note: Amputation defined as procedure codes 84.10, 84.12 84.18, 84.3
SAVE Stop Amputations and Vascular Events
A proposal Quality Cycle Structure Process Outcomes Duke CPOE Structure Standardized Order sets Measure pre and post use Outcomes
Quality Metric vs. Performance Measure Quality Metric Measureable entity that is believed to represent some part of quality of care (process or outcome) generally not publically reported Performance Measure A measure that is so grounded in evidence that failure to adhere results in poor patient outcomes (reduced CMR pay for performance Daily Weights with CHF vs. ASA administration
Measure # 1 Anti-platelet therapy for vascular disease ACC/AHA Class I Level of Evidence A ASA or Clopidogrel as secondary prevention for patients with CHD - Dose OASIS 7 25,000 patients randomized 2 x 2 factorial design in press NEJM ASA 81 mg vs. 325 similar efficacy with mild increase in bleeding with 325 mg Admission order set for all vascular patients includes ASA 81 mg as a default Recommendation Post-Endovascular Therapy order set for all patients includes ASA 81 mg and Plavix 75 mg
Proposal Measure # 2 Statin Therapy Fluvastatin and Perioperative Events in Patients Undergoing Vascular Surgery Olaf Schouten, Eric Boersma, Sanne E Hoeks, Robbert Benner, et al. The New England Journal of Medicine. Boston: Sep 3, 2009. Vol. 361, Iss.. 10; pg. 980 Background Adverse cardiac events are common after vascular surgery. We hypothesized that perioperative statin therapy would improve postoperative outcomes. Methods In this double-blind, blind, placebo-controlled controlled trial, we randomly assigned patients who had not previously been treated with a statin to receive, in addition to a beta-blocker, blocker, either 80 mg of extended-release fluvastatin or placebo once daily before undergoing vascular surgery. Lipid, interleukin-6, and C-reactive C protein levels were measured at the time of randomization and before surgery. The primary end point was the occurrence of myocardial ischemia, defined as transient electrocardiographic abnormalities, release of troponin T, or both, within 30 days after surgery. The secondary end point was the composite of death h from cardiovascular causes and myocardial infarction.
Statins with vascular surgery Results A total of 250 patients were assigned to fluvastatin, and 247 to placebo, a median of 37 days before vascular surgery. Levels of total cholesterol, low- density lipoprotein cholesterol, interleukin-6, and C-C reactive protein were significantly decreased in the fluvastatin group but were unchanged in the placebo group. Postoperative myocardial ischemia occurred in 27 patients (10.8%) in the fluvastatin group and in 47 (19.0%) in the placebo group (hazard ratio, 0.55; 95% confidence interval [CI], 0.34 to 0.88; P=0.01). Death from cardiovascular causes or myocardial infarction occurred in 12 patients (4.8%) in the fluvastatin group and 25 patients (10.1%) in the placebo group (hazard ratio, 0.47; 95% CI, 0.24 to 0.94; P=0.03). Fluvastatin therapy was not associated with a significant increase in the rate of adverse events.
Statin Therapy in Vascular Surgery Conclusions In patients undergoing vascular surgery, perioperative fluvastatin therapy was associated with an improvement in postoperative cardiac outcome.
Recommendations Beta-blocker therapy around the time of surgery reduce events and AF
Recommendations Beta-Blocker Blocker and Statin Bisoprolol 2.5 5 mg fixed dose (low) Duke version Toprol XL 50-100 mg Fluvastatin XR 80 mg Duke Favored Simvastatin 20 mg
Post procedure Groin Care? Arteriotomy Closure Device AHA Scientific Statement (in press) Arteriotomy closure devices should not routinely be utilized to reduce vascular complications in patients undergoing invasive cardiovascular procedures via the femoral artery approach (Class III Level of Evidence B). Post closure or pull need standard evaluation and nursing checks
Proposal Pre Endovascular Procedure Order Set ASA 81 mg Plavix 75 mg Simvastatin 20 mg ½ NS with Sodium Bicarbonate Admission Vascular Service Orders ASA 81 mg Bisoprolol 2.5 mg (or home B-blocker) B Simvastatin 20 mg (or home statin) Smoking Cessation Counseling Nurses to provide
Clinical Cases Case # 1 Case # 2 50 year old female with DM, HTN, and Tob use Sees PCP with calf pain Referred for vascular evaluation 68 year old male with Tobacco Use, HTN and AAA PCP does ultrasound measure AAA 5.6 cm Referred to Duke
Lower Extremity Amputations in North Carolina Lower Extremity Amputations in North Carolina All All Payors Payors, 2006, 2006 Data Source: Thompson Reuters Cumberland Cumberland Cumberland Cumberland Cumberland Cumberland Cumberland Cumberland Cumberland Richmond Richmond Richmond Richmond Richmond Richmond Richmond Richmond Richmond Anson Anson Anson Anson Anson Anson Anson Anson Anson Stanly Stanly Stanly Stanly Stanly Stanly Stanly Stanly Stanly Mitchell Mitchell Mitchell Mitchell Mitchell Mitchell Mitchell Mitchell Mitchell Avery Avery Avery Avery Avery Avery Avery Avery Avery Caldwell Caldwell Caldwell Caldwell Caldwell Caldwell Caldwell Caldwell Caldwell Brunswick Brunswick Brunswick Brunswick Brunswick Brunswick Brunswick Brunswick Brunswick New Hanover New Hanover New Hanover New Hanover New Hanover New Hanover New Hanover New Hanover New Hanover Wayne Wayne Wayne Wayne Wayne Wayne Wayne Wayne Wayne Franklin Franklin Franklin Franklin Franklin Franklin Franklin Franklin Franklin Nash Nash Nash Nash Nash Nash Nash Nash Nash Granville Granville Granville Granville Granville Granville Granville Granville Granville Washington Washington Washington Washington Washington Washington Washington Washington Washington Martin Martin Martin Martin Martin Martin Martin Martin Martin Chowan Chowan Chowan Chowan Chowan Chowan Chowan Chowan Chowan Edgecombe Edgecombe Edgecombe Edgecombe Edgecombe Edgecombe Edgecombe Edgecombe Edgecombe Vance Vance Vance Vance Vance Vance Vance Vance Vance Warren Warren Warren Warren Warren Warren Warren Warren Warren Durham Durham Durham Durham Durham Durham Durham Durham Durham Orange Orange Orange Orange Orange Orange Orange Orange Orange Alamance Alamance Alamance Alamance Alamance Alamance Alamance Alamance Alamance Alleghany Alleghany Alleghany Alleghany Alleghany Alleghany Alleghany Alleghany Alleghany McDowell McDowell McDowell McDowell McDowell McDowell McDowell McDowell McDowell Rutherford Rutherford Rutherford Rutherford 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Caswell Caswell Catawba Catawba Catawba Catawba Catawba Catawba Catawba Catawba Catawba Chatham Chatham Chatham Chatham Chatham Chatham Chatham Chatham Chatham Cleveland Cleveland Cleveland Cleveland Cleveland Cleveland Cleveland Cleveland Cleveland Columbus Columbus Columbus Columbus Columbus Columbus Columbus Columbus Columbus Currituck Currituck Currituck Currituck Currituck Currituck Currituck Currituck Currituck Dare Dare Dare Dare Dare Dare Dare Dare Dare Davidson Davidson Davidson Davidson Davidson Davidson Davidson Davidson Davidson Davie Davie Davie Davie Davie Davie Davie Davie Davie Duplin Duplin Duplin Duplin Duplin Duplin Duplin Duplin Duplin Forsyth Forsyth Forsyth Forsyth Forsyth Forsyth Forsyth Forsyth Forsyth Gates Gates Gates Gates Gates Gates Gates Gates Gates Graham Graham Graham Graham Graham Graham Graham Graham Graham Greene Greene Greene Greene Greene Greene Greene Greene Greene Guilford Guilford Guilford Guilford Guilford Guilford Guilford Guilford Guilford Halifax Halifax Halifax Halifax Halifax Halifax Halifax Halifax Halifax Harnett Harnett Harnett Harnett Harnett Harnett Harnett Harnett Harnett Haywood Haywood Haywood Haywood Haywood Haywood Haywood Haywood Haywood Hoke Hoke Hoke Hoke Hoke Hoke Hoke Hoke Hoke Hyde Hyde Hyde Hyde Hyde Hyde Hyde Hyde Hyde Iredell Iredell Iredell Iredell Iredell Iredell Iredell Iredell Iredell Jackson Jackson Jackson Jackson Jackson Jackson Jackson Jackson Jackson Johnston Johnston Johnston Johnston Johnston Johnston Johnston Johnston Johnston Jones Jones Jones Jones Jones Jones Jones Jones Jones Lee Lee Lee Lee Lee Lee Lee Lee Lee Lenoir Lenoir Lenoir Lenoir Lenoir Lenoir Lenoir Lenoir Lenoir Lincoln Lincoln Lincoln Lincoln Lincoln Lincoln Lincoln Lincoln Lincoln Macon Macon Macon Macon Macon Macon Macon Macon Macon Madison Madison Madison Madison Madison Madison Madison Madison Madison Moore Moore Moore Moore Moore Moore Moore Moore Moore Pamlico Pamlico Pamlico Pamlico Pamlico Pamlico Pamlico Pamlico Pamlico Pender Pender Pender Pender Pender Pender Pender Pender Pender Perquimans Perquimans Perquimans Perquimans Perquimans Perquimans Perquimans Perquimans Perquimans Pitt Pitt Pitt Pitt Pitt Pitt Pitt Pitt Pitt Polk Polk Polk Polk Polk Polk Polk Polk Polk Randolph Randolph Randolph Randolph Randolph Randolph Randolph Randolph Randolph Robeson Robeson Robeson Robeson Robeson Robeson Robeson Robeson Robeson Rowan Rowan Rowan Rowan Rowan Rowan Rowan Rowan Rowan Sampson Sampson Sampson Sampson Sampson Sampson Sampson Sampson Sampson Scotland Scotland Scotland Scotland Scotland Scotland Scotland Scotland Scotland Stokes Stokes Stokes Stokes Stokes Stokes Stokes Stokes Stokes Surry Surry Surry Surry Surry Surry Surry Surry Surry Swain Swain Swain Swain Swain Swain Swain Swain Swain Tyrrell Tyrrell Tyrrell Tyrrell Tyrrell Tyrrell Tyrrell Tyrrell Tyrrell Union Union Union Union Union Union Union Union Union Wake Wake Wake Wake Wake Wake Wake Wake Wake Watauga Watauga Watauga Watauga Watauga Watauga Watauga Watauga Watauga Wilkes Wilkes Wilkes Wilkes Wilkes Wilkes Wilkes Wilkes Wilkes Wilson Wilson Wilson Wilson Wilson Wilson Wilson Wilson Wilson Yadkin Yadkin Yadkin Yadkin Yadkin Yadkin Yadkin Yadkin Yadkin Yancey Yancey Yancey Yancey Yancey Yancey Yancey Yancey Yancey NC Counties: Amputations per 1,000 people 1.04 to 1.3 (3) 0.78 to 1.04 (3) 0.52 to 0.78 (20) 0.26 to 0.52 (47) 0 to 0.26 (27) County # Amputations FFY 2006 2007 Population Amputations per 1,000 Gates, NC 15 11,569 1.30 Warren, NC 21 19,018 1.10 Northampton, NC 24 21,767 1.10 Tyrrell, NC 4 3,922 1.02 Franklin, NC 42 53,303 0.79 Top 5 NC Counties with the highest rate of amputations per 1,000 people Note: Amputation defined as procedure codes 84.10, 84.12 84.18, 84.3
Case 1 50 y/o Female DM, HTN, and Tobacco use Case 1 Angiogram
Case 1 50 y/o Female DM, HTN, and Tobacco use Innovation Lower Extremity PAD Approach - Endo vs. Surgical Device PTA Cryotherapy Stent Biliary Stents Fracture Risk DES-Lower Ext. Atherectomy Directional / Orbital Laser
Invasive Angio Room Immediate Multi-angle view
90-CLI - Angiogram
Clinical Significance of PAD 10 million in US, 5-15% 5 >50 years No gender bias 50% symptomatic; 2.5 million undiagnosed Disease severity directly related to CV event rate Critical limb ischemia 25% annual mortality Same CV death risk as those with established CAD, regardless of symptom status Shared cardiac risk factor profile implies similar treatment strategies
Collaborative Research Amputation Rates North Carolina / USA PAD database all patients with PAD in cath lab Location Angiographic Stenosis Radiation Exposure during cases PAD Gene Clinical Outcomes
Thank You
Popular Mechanics,, 1954
ADA Consensus Statement: PAD in People With Diabetes Due to the high estimated prevalence of PAD in patients with diabetes A screening ABI should be performed in patients >50 yr who have diabetes If normal, test should be repeated every 5 yr Screening ABI should be considered in diabetic patients <50 yr who have other atherothrombotic risk factors Smoking Hypertension Hyperlipidemia Duration of diabetes >10 yr ADA. Diabetes Care. 2003;26:3333