PAD Characterization Within A Healthcare System" RAPID Face-to-Face Meeting Schuyler Jones, MD September 14, 2016
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1 PAD Characterization Within A Healthcare System" RAPID Face-to-Face Meeting Schuyler, MD September 14, 2016
2 Interventional Cardiology and Cath Labs Disclosures Research Grants: Agency for Healthcare Research and Quality American Heart Association AstraZeneca Bristol Myers Squibb Daiichi Sankyo Doris Duke Charitable Foundation Patient-Centered Outcomes Research Institute Honoraria: American College of Radiology Mondopoint All Rights Reserved, Duke Medicine 2008
3 Interventional Cardiology and Cath Labs Outline Background data and research approach Issues Possible solutions Vascular registries (SVS-VQI, SIR, ACC-PVI) BEST-CLI RAPID How do we design learning healthcare systems that inform general practice (not specific to devices and procedures) in PAD patients? All Rights Reserved, Duke Medicine 2008
4 All Rights Reserved, Duke Medicine 2008 Interventional Cardiology and Cath Labs Lower Extremity Amputations in North Carolina All Payors, 2006 Data Source: Thompson Reuters 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 Population Amputations per 1,000, NC 15 11, , NC 21 19, , NC 24 21, , NC 4 3, , NC 42 53, Top 5 NC Counties with the highest rate of amputations per 1,000 people Note: Amputation defined as procedure codes 84.10, , 84.3
5 Interventional Cardiology and Cath Labs Geographic Variation in LE Amputation WS, Patel MR, et al. J Am Coll Cardiol All Rights Reserved, Duke Medicine 2008
6 Interventional Cardiology and Cath Labs Am Heart J All Rights Reserved, Duke Medicine 2008
7 Retrospective Analysis Baseline ABI Baseline duplex U/S data Follow up patency Follow up ABI & duplex U/S Fluoroscopy time Contrast use Procedure time Supplies used Procedure success Complications Angiographic Data Duke Cardiovascular Databank Hemodynamic & Ultrasound Data Other resources: Cost analysis (DCRI) Follow up symptom status (chart review) Baseline characteristics Occurrence of clinical outcomes: death MI stroke re-hospitalization All Rights Reserved, Duke Medicine 2008
8 Manuscript on SFA Recanalization Rejected at J Am Coll Cardiol CV Interv (5/27/2015) due to priority Rejected at Catheter Cardiovasc Interv (7/21/2015) due to priority No outcomes data Rejected at Clin Cardiol (9/2015) Rejected at Vasc Med (11/2015) Rejected at J Endovasc Therapy (1/2016) Rejected at J Interv Cardiol (3/2016) Submitted to Ann Vasc Surg (6/2016) minor revisions Page 8
9 What s the Problem? Current data sources are inadequate Heterogeneity complicates our understanding of PAD treatment Anatomy and disease severity varies Multiple specialties with different training, experience, bias Multiple devices available for treating similar lesions: Lack of clinical outcomes in electronic health records Many single-center studies, very few large heterogeneous datasets Need data about real-world treatment from multiple sources 9
10 Possible Solutions 3 Major U.S. Societies / Registries Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) American College of Cardiology (ACC) National Cardiovascular Disease Registry (NCDR) Society of Interventional Radiology (SIR) National Interventional Radiology Quality Registry (NIRQR) BEST-CLI RAPID (Registry Assessment of Peripheral Interventional Devices Page 10
11 Figure 1. Diagnostic and Treatment Framework Pre Post Less severe More severe PAD Asymptomatic Atypical Leg Pain Intermittent Claudication Critical Limb Ischemia Ischemic Rest Pain Tissue Ulceration Gangrene Conservative Treatment Risk Factor Modification Medical Therapy & Exercise Training Medical Therapy and/or Wound Care Current gaps in knowledge: Health Literacy Patient Preferences Anatomy/Severity of Disease Physician Preferences Access to Care Disparities in Care * If symptoms persist despite conservative therapy, diagnostic imaging +/- invasive treatment may be indicated Diagnostic Imaging Hemodynamic testing Ultrasound CT angiography MR angiography Invasive angiography ** Not all patients are offered or choose revascularization Aim 1. Assess patient-specific factors associated with clinical care and outcomes 90% stenosis Stent DECISION REGARDING REVASCULARIZATION Endovascular and/or Surgical Revascularization Outcomes Death Myocardial Infarction Lower Extremity Amputation Hospitalization Aim 2. Assess physician- and health system-specific factors associated with clinical care and outcomes Aim 3. Prospectively assess patient-, physician-, and healthcare-specific factors using a uniform case report form
12 Duke University & Duke Lifepoint Health Systems
13 Figure 2
14 Duke University Hospitals Computable Phenotype History of PAD History of Endovascular Revascularization History of Surgical Revascularization ** via clinical information or administrative claims data Data Extraction using Retrieve Form for Data Capture (RFD) Source Document Review and Data Abstraction by Clinical Experts Duke Lifepoint Hospitals REDCAP Database ICD-10 Diagnosis Codes for PAD: I70.2x Atherosclerosis of native arteries I70.3x - I70.7x Atherosclerosis of bypass graft(s) I73.9 PVD, unspecified ICD-9 Diagnosis Codes for PAD: 440.2x 444.8x 440.3x 445.0x 440.9x x ICD-9 Procedure Codes: Angioplasty: , Atherectomy: Stenting: , CPT Codes: Angioplasty: 35450, 35470, 35473, Atherectomy: 35492, 35493, Stenting: Medicare Outcomes Dataset All Patients with ICD-9 and/or ICD-10 codes for PAD in North Carolina Outcomes of interest include: Death, Myocardial Infarction, Stroke, Lower Extremity Amputation *** linkage of REDCAP and Medicare datasets Combined Analytic File
15 Interventional Cardiology and Cath Labs THANKS Questions? 15 All Rights Reserved, Duke Medicine 2008
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Endovascular treatment (EVT) has markedly advanced,
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