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® ® NCDR CARE Registry Carotid Artery Revascularization and Endarterectomy Registry Carotid Artery Stenting Form v1.09 A. PARTICIPANT ADMINISTRATION 1000 Participant ID : ___________________ Medicare Provider # 1015 Participant Name : _________________ 1010 Participant NPI : ____________________________________________________ 1016 : ___________________________ B. DEMOGRAPHICS Last Name 2030 SSN 2046 HIC Race C. 2000 : _______-_______- _________ First Name □ No SSN2031 2070 2047 : ○ White ○ Asian ○ Native Hawaiian/Pacific Islander : ___________________________ 2040 Unique Pt. ID : _________________________ □ No HIC Date of Birth 2020 Middle Name 2045 : ____________ (auto) Other ID 2050 ○ Black/African American ○ American Indian/Alaskan Native ○ Other : _____________________ Sex : ______/______/________ : _____________ 2076 Hispanic Ethnicity 2060 ○ Male ○ Female ○ No ○ Yes : : ADMISSION Admission Date 3000 Patient Zip Code : ________/________/_______________ Insurance Payors (choose all that apply) D. 2010 : ___________________________ 3010 □ Medicare □ Military/VAMC : 3005 : ______________ □ Medicaid □ Non-U.S. Insurance □ No Zip3006 □ Commercial □ Self/None HISTORY AND RISK FACTORS GENERAL HISTORY AND RISK FACTORs (PREPROCEDURE) Height 4000 : __________ cm Weight Preprocedure Creatinine Level (most recent prior to procedure) Currently On Dialysis 4020 Tobacco History Hypertension Dyslipidemia 4025 4030 4015 : : : : Peripheral Arterial Disease (PAD) Diabetes Mellitus 4040 4035 : : Chronic Lung Disease 4045 : Major Surgery Planned w/in Next 8 Wks 4055 Previous Neck Radiation Tracheostomy Present : : Prior Neck Surgery (other than CEA) 4065 4050 4060 : : 4070 Previous Laryngeal Nerve Palsy : 4011 4005 : __________ kg : _______ mg/dL □ Not Assessed4010 ○ No ○ Current ○ No ○ No ○ No ○ No ○ No ○ No ○ No ○ No ○ No ○ No ○ Yes ○ Former ○ Never ○ Yes ○ Yes ○ Yes ○ Yes 4046 ○ Yes ○ Yes If Yes, Home O2 Therapy : ○ No 4051 ○ Yes If Yes, Type of Surgery : ○ Cardiac ○ Vascular ○ Other ○ Yes ○ Yes ○ Yes ○ Yes-Right ○ Yes-Left ○ No ○ Yes History of Atrial Fibrillation or Flutter ○ No ○ No ○ No ○ No ○ No ○ Yes ○ Yes ○ Yes ○ Yes ○ Yes Left Main Coronary Artery Stenosis >= 50% CARDIAC HISTORY (PREPROCEDURE) Ischemic Heart Disease 4200 : Two or More Major Coronary Arteries with 4202 Stenosis >= 70% (LAD, LCX, RCA) : MI w/in 6 Weeks 4205 : Angina CCS Class III or IV w/in 6 Weeks History of Heart Failure 4215 4210 : : NYHA Functional Class III or IV w/in 6 Weeks 4226 Most Recent LVEF % : ______ 4220 : □ Not Assessed4225 © 2008 American College of Cardiology Foundation 4230 ○ No ○ Yes : 4232 ○ Yes 4235 ○ No ○ Yes Moderate to Severe Aortic Stenosis : 4240 ○ No ○ Yes Moderate to Severe Mitral Stenosis : 4245 ○ No ○ Yes Mechanical Aortic or Mitral Valve : 4250 ○ No ○ Yes Permanent Pacemaker or ICD : 4255 ○I ○II ○III ○IV ○V ASA Grade : 7/19/2010 : ○ No Page 1 of 6 Carotid Artery Stenting Form v1.09 NEUROLOGIC HISTORY AND RISK FACTORS (PREPROCEDURE) Dementia or Alzheimer’s Disease 4300 ○ No ○ No ○ No : 4305 History of Seizure or Known Seizure Disorder 4310 Previous Carotid Intervention : : ○ Yes ○ Yes ○ Yes If Yes, select most recent occurrence for each: Carotid Artery Carotid Intervention Right CEA 4311 CAS 4312 4313 Left CEA CAS Neurologic Event(s) prior to procedure 4314 4320 ○ No : No Yes <= 30 days Yes 31–180 days Yes >= 181 days ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ No Yes <= 30 days Yes 31–180 days Yes >= 181 days ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ Yes If Yes, select most recent occurrence for each: Category Territory Transient Ischemic Attack (resolved w/in 24 hours) Right Retinal 4321 Left Retinal 4322 4323 Right Hemispheric 4324 Left Hemispheric 4325 Vertebrobasilar Unknown Ischemic Stroke (completed) 4326 4327 Right Retinal Left Retinal 4328 4329 Right Hemispheric 4330 Left Hemispheric 4331 Vertebrobasilar Unknown Intracranial Hemorrhage or Hemorrhagic Stroke 4332 Intraparenchymal Subarachnoid Subdural 4333 4334 4335 Acute Evolving Stroke (ongoing and progressing at the time of the procedure) 4340 ○ No : ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ Yes ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ NEUROLOGIC STATUS (PREPROCEDURE) 4401 Preprocedure NIH Stroke Scale Total Score Examiner Name: Last 4405 :________ : ___________________First Preprocedure Modified Rankin Score 4411 4406 □ Not Administered4400 : ______________Middle : _____________ Date Administered 4402 4407 : _____/_____/_________ : ______________Certified 4404 : ○ No ○ Yes 4410 □ Not Administered NON-INVASIVE CAROTID STUDIES (PREPROCEDURE) Right Carotid Duplex 4500 Ultrasound : ○ No ○ Yes If yes, Left 4505 4510 ________ cm/sec 4515 ________ cm/sec 4525 ____________ Peak Systolic Velocity End Diastolic Velocity ICA/CCA Ratio ________ cm/sec 4520 ________ cm/sec 4530 ____________ Right MR Angiography (MRA) 4600 Performed : ○ No ○ If yes, CCA enter highest Stenosis Yes values or ranges ICA Stenosis Left Highest % Stenosis 4610 Lower % Lower % : ________ or :_____ 4615 Upper % Highest % Stenosis 4640 4605 4635 : ________ or :_____ :_____ 4645 Upper % Highest % Stenosis 4625 Lower % :_____ Lower % Right CT Angiography (CTA) 4700 Performed : ○ No ○ If yes, CCA enter highest Stenosis Yes values or ranges ICA Stenosis © 2008 American College of Cardiology Foundation Highest % Stenosis 4710 Lower % 4740 Lower % 4705 Upper % 4735 or :_____ : ________ 4715 Highest % Stenosis 4630 4650 : ________ or :_____ :_____ 4660 Upper % :_____ Left or :_____ : ________ :_____ Upper % Highest % Stenosis 4655 4620 or Upper % 7/19/2010 4725 :_____ Lower % : ________ 4745 Highest % Stenosis :_____ :_____ Lower % or :_____ : ________ 4730 Upper % Highest % Stenosis 4755 4720 or 4750 :_____ : ________ 4760 Upper % :_____ Page 2 of 6 Carotid Artery Stenting Form v1.09 E. PROCEDURE INFORMATION Date of Procedure 5000 5010 Operator’s UPIN : Target Carotid Vessel _______/________/_____________ : Operator’s NPI ________________________ 5020 5015 : 5005 ○ Right : ○ Left ________________________ 5021 5022 Operator Name: Last : _______________________ First : _______________________ Middle : _______________ Current Procedure Part of 5026 5025 a Carotid Clinical Trial : ○ No ○ Yes If Yes, Trial Type : ○ Postmarket Surveillance ○ Premarket Approval or IDE Anesthesia 5030 ○ General : ○ Other ○ Local PROCEDURE INDICATIONS AND ANATOMIC VARIABLES Urgent Cardiac Surgery Needed w/in 30 days 5033 : ○ No ○ Yes 5035 Target Lesion Symptomatic w/in Past 6 Months : ○ No ○ Yes 5040 Restenosis in Target Vessel after prior CAS : ○ No ○ Yes 5045 Restenosis in Target Vessel after prior CEA : ○ No ○ Yes 5500 Lesion Difficult to Access Surgically : ○ No ○ Yes 5505 Aortic Arch Type : ○ Type I ○ Type II ○ Type III 5050 Contralateral Carotid Artery Occlusion 5055 Fibromuscular Dysplasia of Carotid Artery Spontaneous Carotid Artery Dissection If Yes, Lesion Location Bovine Arch 5515 5501 : 5060 : : ○ No ○ Yes ○ No ○ Yes ○ No ○ Yes ○ High Cervical ○ Low Intrathoracic ○ No ○ Yes : 5510 Contrast Volume : ______________ ml 5520 Fluoro Time : ______________ minutes 5525 Procedural Arterial Access Site : ○ Femoral ○ Brachial/Radial/Axillary ○ Direct Carotid Puncture ○ Other : 5532,5533 Arterial Access Closure Method(s) (list methods and/or devices in chronological order below) 1 2 ○ Carotid Cutdown 3 F. LESIONS AND DEVICES (REPEAT SECTION FOR EACH LESION ATTEMPTED) Target Lesion Location 6000 Visible Thrombus Present Ulceration 6010 Calcification Lesion 6020 Length : ○ Isolated CCA ○ Isolated ICA ○ No ○ Yes ○ No ○ Yes ○ None ○ Mild to Moderate : 6005 : : 6015 : Minimum Luminal Diameter ______mm 6025 (MLD) : Lesion Treatment Incomplete or Aborted _______mm 6040 : ○ No ○ Yes ○ Bifurcation ○ Dense and Concentric Diameter of Distal Preprocedure % Stenosis (Non-tapered) ICA (use NASCET technique _______mm 6030 6035 unless CCA) : for NASCET : If Yes, Reason 6041 ______% : (Check all that apply below) □ Failure to gain vascular access □ Unable to cross guidewire □ Unable to deploy stent □ Arrhythmia □ Failure to confirm significant stenosis □ Unable to place guiding catheter/sheath □ Unable to cross balloon □ Unable to deploy EPD □ Unable to deliver stent □ Difficult to access due to tortuosity □ Hypotension □ Hypertension □ Cardiac ischemia □ Other 6100 ○ No ○ Yes Embolic Protection Attempted : 6101 ○ No ○ Yes If Yes, Predilation Prior to EPD Deployment : If Yes, (list EPD devices in chronological order below) EPD Brand/Model 6114 6113 /Manufacturer Successfully Deployed 1 6111 ○ No ○ Yes ○ No ○ Yes 2 Predilation Prior to Attempted Stent Implant (but after Embolic Protection Device) Stent(s) Implanted 6200 : ○ No Stent Brand/Model If Yes, (list stents in chronological order below) 6212 6216 6211 Diameter /Manufacturer Tapered (smallest if tapered) 2 : ○ No ○ Yes ○ Yes ○ No ○ Yes ○ No ○ Yes 6300 : 6217 1 Postdilation Performed 6201 Length 6213 _________mm _________mm _________mm _________mm 6214 Malposition ○ No ○ Yes ○ No ○ Yes ○ No ○ Yes 6301 If Yes, Nominal Balloon Diameter : 6302 If Yes, Maximum Inflation Pressure : Final Minimum Luminal Diameter (MLD) 6305 : Final % Stenosis (use NASCET technique unless CCA) © 2008 American College of Cardiology Foundation ________ mm ________ atm ________ mm 6310 : ________ % 7/19/2010 Page 3 of 6 Carotid Artery Stenting Form v1.09 G. MEDICATIONS Note: For each med indicate No (not administered), Yes (administered) or Contra (Contraindicated or Blinded). PREPROCEDURE MEDICATIONS 7000,7001 Category Medication Antiplatelets ASA (Aspirin) (Indicate the meds patient received in adequate dose to achieve a therapeutic level at the onset of the procedure.) No ○ ○ ○ Clopidogrel (Plavix) Ticlopidine (Ticlid) INTRAPROCEDURE AND POSTPROCEDURE MEDICATIONS Medication Anticoagulants Unfractionated Heparin LMWH No Atropine Any ○ ○ ○ 7005,7010,7001 Intraprocedure Category Atropine Thrombin Inhibitors Preprocedure Category Yes Contra ○ ○ ○ ○ ○ ○ ○ ○ Prasugrel ○ ○ ○ Category Medication IIb/IIIas Any Vasodilators Any Vasopressors Any Intraprocedure Yes Contra ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ (Indicate the meds patient received intra and post procedure.) Postprocedure Yes Contra No ○ ○ ○ ○ Antiplatelets ○ ○ ○ Preprocedure No Yes Contra Medication ○ ○ ○ ○ ○ ○ ○ ○ Postprocedure No Yes Contra No Yes Contra ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ H. POSTPROCEDURE NEUROLOGIC ASSESSMENT (RECOMMENDED TIMEFRAME IS 24 HRS POSTPROCEDURE) Postprocedure NIH Stroke Scale Total Score Examiner Name: Last 7105 :________ : ___________________First 7111 Postprocedure Modified Rankin Score I. 7101 7106 □ Not Administered7100 : ______________Middle : _____________ □ Not Administered Date Administered 7102 : _____/_____/_________ 7107 : _____________Certified 7104 : ○ No ○ Yes 7110 ADVERSE EVENTS (DURING HOSPITALIZATION FOR CURRENT PROCEDURE) 7200 New Stroke or TIA ○ No : If Yes, Specify All New Events and Resolution Status below: New Deficit Developed? Yes - Intra Yes - Post No Procedure Procedure Territory 7205, 7210 Right Hemispheric or Retinal 7215, 7220 Left Hemispheric or Retinal 7225, 7230 Vertebrobasilar Unknown ○ Yes 7235, 7240 Other Adverse Events Category 7300 : ○ ○ ○ ○ ○ ○ ○ ○ ○ No Description If Yes ○ ○ ○ ○ ○ Yes If Yes If Yes If Yes No Yes ○ ○ Hyperperfusion Syndrome ○ ○ Intracranial Hemorrhage ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ Renal Infection Persistent Hypotension Requiring Treatment with Parenteral Medications >24 Hours Post-Procedure Arrhythmia Requiring Cardioversion, or Implantation of a Permanent Pacer or ICD Myocardial Infarction Acute Heart Failure or Pulmonary Edema New Requirement for Dialysis Infection Related to Procedure, Requiring Antibiotics © 2008 American College of Cardiology Foundation ○ ○ ○ ○ Deficit Resolved? Yes - W/in 24 hrs Yes - Before of Procedure Discharge ○ ○ ○ ○ If Yes, Specify All Other Adverse Events Other Neurologic New Seizure (intra or post) (not TIA/ Stroke) Cardiac and Hemodynamic Yes - Intra Procedure Category 7304,7305 ○ ○ ○ ○ Description Urgent Surgery Required for Technical Problems with Stent Deployment or Placement Intracranial Embolization Bleeding Procedure Related Bleeding or Hematoma Requiring Red Blood Cell Transfusion Arterial Access Site Pseudoaneurysm Requiring Treatment w/Thrombin Injection and/or Compression During Hospitalization Access Site Related Injury requiring open surgical repair Vessel Thrombosis, Peripheral Embolization or New Ischemia of Extremity Unexpected Intubation and/or Resuscitation Contrast Reaction (anaphylactoid type) 7/19/2010 ○ ○ ○ ○ below: Angiographic Unanticipated Carotid Tear or Dissection Requiring Treatment Other Not Resolved No Yes ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ Page 4 of 6 Carotid Artery Stenting Form v1.09 J. DISCHARGE Peak Postprocedure Creatinine Level (obtained prior to discharge) Discharge Date 8005 Discharge Status : _______ mg/dL □ Not Assessed8000 : ______/________/_____________ 8010 : ○ Alive ○ Deceased 8011 ○ Neurologic ○ Cardiac 8012 If Deceased, Death During Procedure : ○ No ○ Yes If Deceased, Cause of Death If Alive DISCHARGE MEDICATIONS Category Medication Anticoagulants Warfarin (Coumadin) Antiplatelets 8001 : 8020,7001 ○ Vascular ○ Infection ○ Renal ○ Other (Indicate the meds that were prescribed at discharge.) Prescribed at Discharge ASA (Aspirin) Clopidogrel (Plavix) Ticlopidine (Ticlid) Prasugrel If Alive Anticipated Follow-up Date ○ Pulmonary 8025 No Yes Contra ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ Category Medication Statins Other Lipid Lowering Agent (non-statin) Prescribed at Discharge No Yes Contra Any ○ ○ ○ Any ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ : _______/_______/___________ © 2008 American College of Cardiology Foundation 11/21/2008 Page 5 of 6 ® ® NCDR CARE Registry Carotid Artery Revascularization and Endarterectomy Registry Carotid Artery Stenting Follow-Up Form v1.09 K. FOLLOW-UP (RECOMMENDED TIMEFRAME IS 30 DAYS) PARTICIPANT INFORMATION: 1000 Participant ID : ___________________ Participant Name 1010 : ____________________________________________________ PATIENT INFORMATION: Last Name 2030 SSN 2000 2010 : __________________________ : ______-_____- ________ Date of Procedure 5000 First Name 2031 □ No SSN Date of Birth 2050 9000 : ○ No If No, Why Was Follow-up Not Performed 9001 ○ Patient Refused : Middle Name : _____________ : _____/_____/_____________ :_____/_____/___________ Target Carotid Vessel Patient Follow-up Performed 2020 : ________________________ 5005 ○ Right : ○ Left ○ Yes ○ Patient Unavailable ○ Other If Yes, Complete Below: Follow-up Date 9002 : _____/_____/___________ Follow-up NIH Stroke Scale Total Score Examiner Name: Last 9015 9011 : ___________________ First Follow-up Modified Rankin Score 9021 □ Not Administered9010 :________ 9016 : _____________ Additional CEA on Target Carotid Vessel 9030 : Additional CAS on Target Carotid Vessel 9035 : ○ No ○ No Date Administered 9017 : ______________ Middle 9012 : _____/_____/___________ : ______________ Certified 9014 : ○ No ○ Yes □ Not Administered9020 ○ Yes ○ Yes If the patient has not been discharged at the time of follow-up, do not collect the remaining elements on this form. Patient Status 9100 ○ Alive : If Deceased, Date of Death 9101 ○ Deceased : _______/_______/___________ 9102 If Deceased, Cause of Death at Follow-Up ○ Neurologic ○ Cardiac ○ Pulmonary ○ Vascular ○ Infection ○ Renal ○ Other : If Alive, Complete the Following: Neurologic Deficit(s) Occurred Since Discharge 9110 : ○ No ○ Yes If Yes, Indicate Territories and Timeframes below: Territory No Deficit Occurred Right Retinal Left Retinal 9111 9112 Right Hemispheric Left Hemispheric 9113 9114 9115 Vertebrobasilar Unknown Deficit Occurrence and Resolution Timeframe Deficit Occurred, Deficit Occurred, Resolved Duration >24 hours, But w/in 24 hours (i.e. TIA) Completely Resolved 9116 ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ Persistent Deficit Occurred Lasting > 24 Hours, Not Completely Resolved ○ ○ ○ ○ ○ ○ OTHER EVENTS SINCE DISCHARGE: If Alive Myocardial Infarction Since Discharge If Alive Renal Failure Requiring Dialysis 9165 : 9150 : ○ No ○ No If Alive Most Recent Creatinine Level (obtained since discharge) © 2008 American College of Cardiology Foundation 9171 ○ Yes ○ Yes : _______ mg/dL 7/19/2010 If Alive □ Not Assessed9170 Page 6 of 6