NCDR CARE Registry Carotid Artery Revascularization and Endarterectomy Registry Carotid Artery Stenting Form v1.09

Transcription

1 NCDR CARE Registry Carotid Artery Revascularization and Endarterectomy Registry Carotid Artery Stenting Fm v1.09 A. PARTICIPANT ADMINISTRATION Participant ID 1000 : Participant Name 1010 : Medicare Provider # 1015 : Participant NPI 1016 : B. DEMOGRAPHICS Last Name 2000 : First Name 2010 : Middle Name 2020 : SSN 2030 : - - No SSN 2031 Unique Pt. ID 2040 : (auto) Other ID 2045 : HIC 2046 : No HIC 2047 Date of Birth 2050 : / / Sex 2060 : Male Female Race 2070 : White Black/African American C. ADMISSION Asian Native Hawaiian/Pacific Islander American Indian/Alaskan Native Other Hispanic Ethnicity 2076 : No Admission Date 3000 : / / Patient Zip Code 3005 : No Zip 3006 Insurance Pays (choose all that apply) 3010 : Medicare Medicaid Commercial Military/VAMC Non-U.S. Insurance Self/None D. HISTORY AND RISK FACTORS GENERAL HISTORY AND RISK FACTORs (PREPROCEDURE) Height 4000 : cm Weight 4005 : kg Preprocedure Creatinine Level (most recent pri to procedure) 4011 : mg/dl Not Assessed 4010 Currently On Dialysis 4015 : No Tobacco Histy 4020 : Current Fmer Never Hypertension 4025 : No Dyslipidemia 4030 : No Peripheral Arterial Disease (PAD) 4035 : No Diabetes Mellitus 4040 : No Chronic Lung Disease 4045 : No If, Home O2 Therapy 4046 : No Maj Surgery Planned w/in Next 8 Wks 4050 : No If, Type of Surgery 4051 : Cardiac Vascular Other Previous Neck Radiation 4055 : No Pri Neck Surgery (other than CEA) 4060 : No Tracheostomy Present 4065 : No Previous Laryngeal Nerve Palsy 4070 : No -Right -Left CARDIAC HISTORY (PREPROCEDURE) Ischemic Heart Disease 4200 : No Histy of Atrial Fibrillation Flutter 4230 : No Two Me Maj Conary Arteries with >= 70% (LAD, LCX, RCA) 4202 : No Left Main Conary Artery >= 50% 4232 : No MI w/in 6 Weeks 4205 : No Moderate to Severe Atic 4235 : No Angina CCS Class III IV w/in 6 Weeks 4210 : No Moderate to Severe Mitral 4240 : No Histy of Heart Failure 4215 : No Mechanical Atic Mitral Valve 4245 : No NYHA Functional Class III IV w/in 6 Weeks 4220 : No Permanent Pacemaker ICD 4250 : No Most Recent LVEF % 4226 : Not Assessed 4225 ASA Grade 4255 : I II III IV V 2008 American College of Cardiology Foundation 7/19/2010 Page 1 of 6

2 Carotid Artery Stenting Fm v1.09 NEUROLOGIC HISTORY AND RISK FACTORS (PREPROCEDURE) Dementia Alzheimer s Disease 4300 : No Histy of Seizure Known Seizure Disder 4305 : No Previous Carotid Intervention 4310 : No If, select most recent occurrence f each: Carotid Artery Carotid Intervention No <= 30 days days >= 181 days Right CEA 4311 CAS 4312 Left CEA 4313 CAS 4314 Neurologic Event(s) pri to procedure 4320 : No If, select most recent occurrence f each: Categy Territy No Transient Ischemic Attack (resolved w/in 24 hours) Ischemic Stroke (completed) Intracranial Hemrhage Hemrhagic Stroke <= 30 days days >= 181 days Right Retinal 4321 Left Retinal 4322 Right Hemispheric 4323 Left Hemispheric 4324 Vertebrobasilar 4325 Unknown 4326 Right Retinal 4327 Left Retinal 4328 Right Hemispheric 4329 Left Hemispheric 4330 Vertebrobasilar 4331 Unknown 4332 Intraparenchymal 4333 Subarachnoid 4334 Subdural 4335 Acute Evolving Stroke (ongoing and progressing at the time of the procedure) 4340 : No NEUROLOGIC STATUS (PREPROCEDURE) Preprocedure NIH Stroke Scale Total Sce 4401 : Not Administered 4400 Date Administered 4402 : / / Examiner Name: Last 4405 : First 4406 : Middle 4407 : Certified 4404 : No Preprocedure Modified Rankin Sce 4411 : Not Administered 4410 NON-INVASIVE CAROTID STUDIES (PREPROCEDURE) Carotid Duplex Ultrasound 4500 : MR Angiography (MRA) Perfmed 4600 : CT Angiography (CTA) Perfmed 4700 : No No No If yes, If yes, enter highest values ranges If yes, enter highest values ranges Right Left Peak Systolic Velocity cm/sec 4505 cm/sec 4510 End Diastolic Velocity cm/sec 4515 cm/sec 4520 ICA/CCA Ratio CCA ICA CCA ICA 2008 American College of Cardiology Foundation 7/19/2010 Page 2 of 6 Right Highest % 4605 : Lower % 4610 : Upper % 4615 : Highest % 4635 : Lower % 4640 : Upper % 4645 : Right Highest % 4705 : Lower % 4710 : Upper % 4715 : Highest % 4735 : Lower % 4740 : Upper % 4745 : Left Highest % 4620 : Lower % 4625 : Upper % 4630 : Highest % 4650 : Lower % 4655 : Upper % 4660 : Left Highest % 4720 : Lower % 4725 : Upper % 4730 : Highest % 4750 : Lower % 4755 : Upper % 4760 :

3 Carotid Artery Stenting Fm v1.09 E. PROCEDURE INFORMATION Date of Procedure 5000 : / / Target Carotid Vessel 5005 : Right Left Operat s UPIN 5010 : Operat s NPI 5015 : Operat Name: Last 5020 : First 5021 : Middle 5022 : Current Procedure Part of a Carotid Clinical Trial 5025 : No If, Trial Type5026 : Postmarket Surveillance Premarket Approval IDE Other Anesthesia 5030 : General Local PROCEDURE INDICATIONS AND ANATOMIC VARIABLES Urgent Cardiac Surgery Needed w/in 30 days 5033 : No Contralateral Carotid Artery Occlusion 5050 : No Target Lesion Symptomatic w/in Past 6 Months 5035 : No Fibromuscular Dysplasia of Carotid Artery 5055 : No Restenosis in Target Vessel after pri CAS 5040 : No Spontaneous Carotid Artery Dissection 5060 : No Restenosis in Target Vessel after pri CEA 5045 : No Lesion Difficult to Access Surgically 5500 : No If, Lesion Location 5501 : High Cervical Low Intrathacic Atic Arch Type 5505 : Type I Type II Type III Bovine Arch 5515 : No Contrast Volume 5510 : ml Arterial Access Closure Method(s) 5532,5533 Fluo Time 5520 : minutes Procedural Arterial Access Site 5525 : Femal Brachial/Radial/Axillary Direct Carotid Puncture Carotid Cutdown Other F. LESIONS AND DEVICES (REPEAT SECTION FOR EACH LESION ATTEMPTED) Target Lesion Location 6000 : Isolated CCA Isolated ICA Bifurcation Visible Thrombus Present 6005 : No Ulceration 6010 : No Calcification 6015 : None Mild to Moderate Dense and Concentric Lesion Length 6020 : mm Minimum Luminal Diameter (MLD) 6025 : mm (list methods and/ devices in chronological der below) 2008 American College of Cardiology Foundation 7/19/2010 Page 3 of Diameter of Distal (Non-tapered) ICA f NASCET 6030 : mm Preprocedure % (use NASCET technique unless CCA) 6035 : % Lesion Treatment Incomplete Abted 6040 : No If, Reason 6041 : (Check all that apply below) Failure to gain vascular access Failure to confirm significant stenosis Unable to place guiding catheter/sheath Unable to cross guidewire Unable to cross balloon Unable to deploy EPD Unable to deliver stent Unable to deploy stent Difficult to access due to ttuosity Hypotension Hypertension Arrhythmia Cardiac ischemia Other Embolic Protection Attempted 6100 : No If, Predilation Pri to EPD Deployment 6101 : No If, (list EPD devices in chronological der below) 1 EPD Brand/Model 6114 /Manufacturer 6113 Successfully Deployed 6111 No 2 No Predilation Pri to Attempted Stent Implant (but after Embolic Protection Device) 6201 : No Stent(s) Implanted 6200 : No If, (list stents in chronological der below) Stent Brand/Model 6217 /Manufacturer Diameter6212 Tapered (smallest if tapered) Length 6213 Malposition No mm mm No 2 No mm mm No Postdilation Perfmed 6300 : No If, Nominal Balloon Diameter 6301 : If, Maximum Inflation Pressure 6302 : Final Minimum Luminal Diameter (MLD) 6305 : mm atm mm Final % (use NASCET technique unless CCA) 6310 : %

4 Carotid Artery Stenting Fm v1.09 G. MEDICATIONS Note: F each med indicate No (not administered), (administered) Contra (Contraindicated Blinded). PREPROCEDURE MEDICATIONS 7000,7001 Categy (Indicate the meds patient received in adequate dose to achieve a therapeutic level at the onset of the procedure.) Preprocedure Categy Preprocedure No Contra No Contra Antiplatelets ASA (Aspirin) Antiplatelets Prasugrel Clopidogrel (Plavix) Ticlopidine (Ticlid) INTRAPROCEDURE AND POSTPROCEDURE MEDICATIONS 7005,7010,7001 (Indicate the meds patient received intra and post procedure.) Categy Anticoagulants Unfractionated Intraprocedure Postprocedure Categy No Contra No Contra IIb/IIIas Intraprocedure Postprocedure No Contra No Contra Heparin LMWH Vasodilats Any Atropine Atropine Vasopresss Any Thrombin Inhibits Any H. POSTPROCEDURE NEUROLOGIC ASSESSMENT (RECOMMENDED TIMEFRAME IS 24 HRS POSTPROCEDURE) Postprocedure NIH Stroke Scale Total Sce 7101 : Not Administered 7100 Date Administered 7102 : / / Examiner Name: Last 7105 : First 7106 : Middle 7107 : Certified 7104 : No Postprocedure Modified Rankin Sce 7111 : Not Administered 7110 I. ADVERSE EVENTS (DURING HOSPITALIZATION FOR CURRENT PROCEDURE) Any New Stroke TIA 7200 : No If, Specify All New Events and Resolution Status below: Territy No New Deficit Developed? - Intra - Post Procedure Procedure - Intra Procedure Deficit Resolved? - W/in 24 hrs of Procedure - Befe Discharge Right Hemispheric Retinal 7205, 7210 If Left Hemispheric Retinal 7215, 7220 If Vertebrobasilar 7225, 7230 If Unknown 7235, 7240 If Other Adverse Events 7300 : No If, Specify All Other Adverse Events 7304,7305 below: Not Resolved Categy Description No Categy Description No Other Neurologic (not TIA/ Stroke) Cardiac and Hemodynamic New Seizure (intra post) Angiographic Unanticipated Carotid Tear Dissection Requiring Treatment Hyperperfusion Syndrome Urgent Surgery Required f Technical Problems with Stent Deployment Persistent Hypotension Requiring Treatment with Parenteral s >24 Hours Post-Procedure Placement Intracranial Hemrhage Intracranial Embolization Bleeding Procedure Related Bleeding Hematoma Requiring Red Blood Cell Transfusion Arrhythmia Requiring Cardioversion, Implantation of a Permanent Pacer ICD Arterial Access Site Pseudoaneurysm Requiring Treatment w/thrombin Injection and/ Compression During Hospitalization Myocardial Infarction Access Site Related Injury requiring open Acute Heart Failure Pulmonary Edema surgical repair Vessel Thrombosis, Peripheral Embolization New Ischemia of Extremity Renal New Requirement f Dialysis Other Unexpected Intubation and/ Resuscitation Infection Contrast Reaction (anaphylactoid type) Infection Related to Procedure, Requiring Antibiotics 2008 American College of Cardiology Foundation 7/19/2010 Page 4 of 6

5 Carotid Artery Stenting Fm v1.09 J. DISCHARGE Peak Postprocedure Creatinine Level (obtained pri to discharge) 8001 : mg/dl Not Assessed 8000 Discharge Date 8005 : / / Discharge Status 8010 : Alive Deceased If Deceased, Cause of Death 8011 : Neurologic Cardiac Pulmonary Vascular Infection Renal Other If Deceased, Death During Procedure 8012 : No If Alive DISCHARGE MEDICATIONS 8020,7001 (Indicate the meds that were prescribed at discharge.) Categy Anticoagulants Antiplatelets Warfarin Prescribed at Discharge Prescribed at Discharge Categy No Contra No Contra (Coumadin) Statins Any ASA (Aspirin) Other Lipid Lowering Agent (non-statin) Any Clopidogrel (Plavix) Ticlopidine (Ticlid) Prasugrel If Alive Anticipated Follow-up Date 8025 : / / 2008 American College of Cardiology Foundation 11/21/2008 Page 5 of 6

6 NCDR CARE Registry Carotid Artery Revascularization and Endarterectomy Registry Carotid Artery Stenting Follow-Up Fm v1.09 K. FOLLOW-UP (RECOMMENDED TIMEFRAME IS 30 DAYS) PARTICIPANT INFORMATION: Participant ID 1000 : Participant Name 1010 : PATIENT INFORMATION: Last Name 2000 : First Name 2010 : Middle Name 2020 : SSN 2030 : - - No SSN 2031 Date of Birth 2050 : / / Date of Procedure 5000 : / / Target Carotid Vessel 5005 : Right Left Patient Follow-up Perfmed 9000 : No If No, Why Was Follow-up Not Perfmed 9001 : Patient Refused Patient Unavailable Other If, Complete Below: Follow-up Date 9002 : / / Follow-up NIH Stroke Scale Total Sce 9011 : Not Administered 9010 Date Administered 9012 : / / Examiner Name: Last 9015 : First 9016 : Middle 9017 : Certified 9014 : No Follow-up Modified Rankin Sce 9021 : Not Administered 9020 Additional CEA on Target Carotid Vessel 9030 : No Additional CAS on Target Carotid Vessel 9035 : No If the patient has not been discharged at the time of follow-up, do not collect the remaining elements on this fm. Patient Status 9100 : Alive Deceased If Deceased, Date of Death 9101 : / / If Deceased, Cause of Death at Follow-Up 9102 : Neurologic Cardiac Pulmonary Vascular Infection Renal Other If Alive, Complete the Following: Neurologic Deficit(s) Occurred Since Discharge 9110 : No If, Indicate Territies and Timeframes below: Territy No Deficit Occurred Deficit Occurrence and Resolution Timeframe Deficit Occurred, Deficit Occurred, Resolved Duration >24 hours, But w/in 24 hours (i.e. TIA) Completely Resolved Persistent Deficit Occurred Lasting > 24 Hours, Not Completely Resolved Right Retinal 9111 Left Retinal 9112 Right Hemispheric 9113 Left Hemispheric 9114 Vertebrobasilar 9115 Unknown 9116 OTHER EVENTS SINCE DISCHARGE: If Alive Myocardial Infarction Since Discharge 9150 : No If Alive Renal Failure Requiring Dialysis 9165 : No If Alive Most Recent Creatinine Level (obtained since discharge) 9171 : mg/dl If Alive Not Assessed American College of Cardiology Foundation 7/19/2010 Page 6 of 6