Download Carotid Artery Stenting Form v1.09

®
®
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