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pdfNCDR® ICD Registry™ V2.1
Data Collection Form – Generator & Leads
A. DEMOGRAPHICS
Last Name2000:
First Name2010:
SSN2030:
□ SSN N/A2031
Birth Date 2050:
Middle Name2020:
Patient ID2040:
Sex2060: O Male
Hispanic or Latino Ethnicity2076:
O Female
□ White2070
□ Black/African American2071
□ American Indian/Alaskan Native2073
Race:
(check all that apply)
Other ID2045:
(auto)
O No
O Yes
□ Asian2072
□ Native Hawaiian/Pacific Islander2074
B. EPISODE OF CARE (ADMISSION)
Arrival Date3000:
□ Zip Code NA3006
Patient Zip Code3005:
Reason for Admission3010: O Admitted for this procedure
O Cardiac Heart Failure
O Cardiac Other
O NonCardiac
□ Private Health Insurance
□ Medicare
□ Medicaid
□ Military Health Care3023
3024
3025
□ StateSpecific Plan (NonMedicaid)
□ Indian Health Service
□ NonUS Insurance3026 □ None3027
3020
Insurance Payor(s):
(check all that apply)
3021
3022
HIC3030:
C. HISTORY AND RISK FACTORS (COMPLETE ONLY ONCE FOR EPISODES OF CARE/ADMISSIONS WITH A GENERATOR IMPLANT OR CHANGE)
Heart Failure4000:
O No
O Yes
If Yes, Duration of Symptoms Since Initial Onset4005:
If Yes, Prior Heart Failure Hospitalization
If Yes, Prior HF Hospital Timeframe
NYHA Functional Classification
4020
:
4010
: O No
:
O No
On Heart Transplant Waiting List
4040
O No
:
4055
:
Atrial Fibrillation/Flutter
:
O Class II
O Yes
O Class III
Ventricular Tachycardia
O No
:
If Yes, Hemodynamic Instablility
O Class IV
4030
If Yes, Timeframe
: O < 3 months
Syncope
O Yes
:
Family History of Sudden Death
O Yes
:
4090
:
4095
:
Syndromes w/Risk of Sudden Death
4100
:
O No
O Yes
:
If Yes, Type
O No
4115
:
O No
O Yes
O Permanent (> 1 year)
O Sustained polymorphic VT
O No
O Yes
O Unknown
O No
O Yes
O Unknown
O No
O Yes
O Unknown
If Yes, Most Recent Arrest Date
O Short QT syndrome
O Catecholaminergic polymorphic VT
Previous ICD
O Yes
O Yes
O Long QT syndrome
If Yes, Syndrome Type4105:
4110
O No
O Unknown
O No
O Yes O Unknown
:
O Nonsustained VT
O Sustained monomorphic VT
4080
If Yes, Bradycardia Arrest
:
O Persistent (> 7 days)
O Sustained monomorphic and polymorphic VT
If Yes, VTach/VFib Arrest
4050
O >9 months
4070
If Yes, VT Type4075:
Cardiac Arrest
O 3 to 9 months
4045
O No
O Yes
O
Paroxysmal
:
O Secondary (reversible cause)
4065
O > 9 months
O Yes
4060
If Yes, AFib/Flutter Classification
O 3 to 9 months
O <= 6 months O > 6 months
O Class I
NonIschemic Dilated Cardiomyopathy
Prior Heart Transplant
O No
4015
4025
4035
:
O < 3 months
4085
mm/dd/yyyy
:
O Brugada syndrome
O Idiopathic/Primary VT/VF
O Other
O Yes
O Single chamber O Dual chamber O CRTD
If Yes, Previous ICD Implant Site4120:
4125
O Pectoral
O Abdominal
mm/dd/yyyy
If Yes, Previous ICD Date
:
If Yes, Previous ICD Reason
4130
:
O Primary prevention
If Primary Prevention, Implant Decision LVEF
4135
O Secondary prevention
: _____________%
□
LVEF Not Available4136
If Secondary Prevention, Reason(s) for Initial Implant: (check all that apply)
□ Cardiac Arrest/ArrhythmiaEtiology Unknown4140 □ Spontaneous Sustained VT4141
□ Syncope with Inducible VT4143
□ Ventricular Fibrillation4144
□ Syncope with High Risk Characteristics4142
□ Not Documented4145
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this
information collection is 09380967. The time required to complete this information collection is estimated to average fifteen (15) minutes per response, including the time to review instructions, search existing
data resources, gather the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please
write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C42605, Baltimore, Maryland 212441850.
© 2010 American College of Cardiology Foundation
2/23/2010
Page 1 of 5
NCDR® ICD Registry™ V2.1
Data Collection Form – Generator & Leads
Permanent Pacemaker 4150:
O No
4155
If Yes, Pacemaker Type
Ischemic Heart Disease
:
O Yes
(Includes previously placed)
O Atrial chamber
4160
:
O No
O Ventricular chamber
Prior MI
:
(Prior to arrival)
Prior PCI4180:
4190
(Prior to arrival)
:
Prior CABG
O Yes
O No
O Yes
If Yes, Most Recent MI Timeframe4175: O <= 40 days O > 40 days
O No
O Yes
If Yes, Most Recent PCI Date4185:
O No
O Yes
4200
:
O No
O Yes
Other Structural Abnormalities4205:
O No
O Yes
Primary Valvular Heart Disease
O CRT
O Yes
If Yes, One Epicardial Artery >=70% Confirmed by Angiography4165: O No
4170
O Dual chamber
If Yes, Most Recent CABG Date
mm/dd/yyyy
4195
mm/dd/yyyy
:
(Moderate to Severe)
If Yes, Structural Abnormality Type(s): (check all that apply)
□ Amyloidosis4210
□ Atrial Septal Defect4211
□ Chagas Disease4212
□ Common Ventricle4213
4214
4215
□ Ebstein’s Anomaly
□ Giant Cell Myocarditis
□ Hypertrophic Cardiomyopathy (HCM)4216
□ Left Ventricular Aneurysm4217
□ LV Noncompaction Syndrome4218 □ Right Ventricular Dysplasia (ARVD)4219 □ Sarcoidosis4220
□ Transposition of Great Vessels4221 □ Tetralogy of Fallot4222
□ Ventricular Septal Defect4223
□ Other4224
OTHER RISK FACTORS
Height4225:
Weight4230:
cm
Cerebrovascular Disease
Diabetes Mellitus
4235
:
O No
4245
:
Currently on Dialysis
:
Patient Life Expectancy of >=1 Year
4270
:
Chronic Lung Disease
O Yes
O No
4255
O Yes
O No
O Yes
:
4250
Sleep Apnea
O Yes
O No
kg
4240
Hypertension
O Not documented
:
4260
:
O No
O Yes
O No
O Yes
O No
O Yes
O Not assessed
(By physician estimate)
D. DIAGNOSTIC STUDIES (COMPLETE ONLY ONCE FOR EPISODES OF CARE/ADMISSIONS WITH A GENERATOR IMPLANT OR CHANGE.)
LVEF Assessed5000:
O No
If Yes, Most Recent LVEF
5005
:
_____________ %
If Yes, Most Recent LVEF Timeframe5010:
Electrophysiology Study
O <1 month
5015
:
O No
If Yes, EP Study Timeframe5020:
5025
If Yes, VT Ablation Performed5030:
(check all that apply)
12 Lead ECG w/Automated Measurements5040:
PR Interval
5055
(Most recent EP Study)
O ≥ 1 to ≤ 3 months
: O No
O Yes
O No
O Yes
O > 3 to ≤ 6 months
O No
O >6 months
O Results Unattainable
□ Nonsustained VT5031 □ Sustained Monomorphic VT5032
□ Ventricular Flutter5034 □ Ventricular Fibrillation5035
If Yes, EP Study Finding(s):
If Yes, ECG Date
O ≥ 1 to ≤ 3 months O > 3 to ≤ 6 months O >6 months
O Yes
O <1 month
If Yes, Ventricular Arrhythmias Induced
5045
O Yes
□ Sustained Polymorphic VT5033
O Yes
mm/dd/yyyy
:
□ PR Interval Not Obtainable5056
: _____________ msec
QRS Duration (NonVentricular Paced Complex)5060: _____________ msec
(Exclude atrial fib , 2nd or 3rd° heart block, vent pacing)
□ Only Ventricular Paced QRS Complexes Present5061
(From surface ECG closest to first generator procedure)
Cardiac Rhythm(s):
(check all that apply)
□ AFib/Flutter
□ Paced5069
5065
□ Atrial Tachycardia
□ Sinus Rhythm5070
□ Idioventricular
□ Junctional5068
□ Second Degree Heart Block5071 □ Third Degree Heart Block5072
5066
5067
If Paced, Underlying Atrial Rhythm5075:
O Sinus rhythm
O Atrial fib/flutter
O Sinus arrest
If Paced, Pacing Type5080:
O Atrial pacing
O Ventricular pacing
O Both
O Unknown
If Ventricular pacing or Both, Ventricular Paced QRS Duration5085: _____________msec
Abnormal Intraventricular Conduction5090:
□ Left Anterior Fascicular Block
□ Delay, Nonspecific5098
5095
© 2010 American College of Cardiology Foundation
O No O Yes
If Yes, Intraventricular Conduction Type(s): (check all that apply)
□ Left Posterior Fascicular Block5096
□ Right Bundle Branch Block (RBBB)5099
2/23/2010
□ Left Bundle Branch Block (LBBB)5097
□ Ventricular Paced Rhythm5100
Page 2 of 5
NCDR® ICD Registry™ V2.1
Data Collection Form – Generator & Leads
Blood Pressure5105/5110:
____________ / ____________ mmHg
BUN5115:
mg/dL
Hemoglobin5120:
g/dL
Sodium5125:
mEq/L
Creatinine5130:
mg/dL
Potassium5135:
mEq/L
BNP5140:
pg/mL (OR)
□ Not Drawn5121
□ Not Drawn5131
NTproBNP5145:
pg/mL □ Not Drawn5146
□
□
□
Not Drawn5116
Not Drawn5126
Not Drawn5136
(Closest to procedure)
E. PROCEDURE INFORMATION (COMPLETE FOR EACH LAB VISIT)
Procedure Date/Time6000/6001:
Procedure Type6005:
O Initial generator implant
O Generator change
O Lead only
6010
Prophylactic Antibiotics w/in 1 Hr of Procedure Start Time
O No – not given, medical reason documented
Routine Warfarin (Coumadin) Therapy
:
O No O Yes
:
6030
If Yes, INR
Premarket Clinical Trial
:
O Yes
: (w/in 1 month) O No O Yes
6025
If Yes, INR Drawn
O No – not given, reason unspecified
6015
6020
If Yes, Held for Procedure
:
O No O Yes
If Yes, INR Drawn Date6035:
____________
6040
: O No
mm/dd/yyyy
If Yes, Clinical Trial Name6045:
O Yes
F. ICD IMPLANT / EXPLANT (COMPLETE FOR EACH LAB VISIT IN WHICH AN INITIAL GENERATOR IMPLANT OR GENERATOR CHANGE WAS PERFORMED)
Operator’s Name6100,6105,6110:
ICD Indication6125:
Planned Device Type
NPI6115:
O Primary prevention
6130
:
Device Implanted6135:
TIN6120:
O Secondary prevention
O Single chamber
O Dual chamber
O CRTD
O No O Yes
If Yes, Final Device Type6140:
O Single chamber
6145
If CRTD, CS/LV Lead Successful
O Yes
:
O Dual chamber
O Not implanted
O CRTD
O Previously implanted
6150
If Not Implanted, Reason CS/LV Lead Not Implanted :
O Vascular access
O Coronary sinus access
O CS dissection
O Unacceptable threshold
O Tributary vein access
O Diaphragmatic stimulation
6160
If Yes, ID6155: ________ OR
: _______________________ Model Name6165:
Manufacturer
If Yes, Serial Number
__________________________
Model Number6170: __________________________
6175
: __________________________
If Yes, Lowest Energy Tested (LET) that was Successful6180: ____________ Joules □ LET Not Tested6181
If Yes, Upper Limit of Vulnerability (ULV)6185:
____________ Joules
□ ULV Not Tested6186
If Procedure Type6005 = Generator Change
Reason(s) for ReImplantation: (check all that apply)
□ End of expected battery life6190
□ Replaced at time of lead revision6191
□ Under manufacturer advisory/recalled6194 □ Faulty Connector/Header6195
If Malfunction, Reason for Malfunction6200:
ATP or Shock Therapy Delivered
6205
If Yes, ATP or Shock Therapy Appropriate
If Yes, ATP Therapy Successful
If Yes, Explant Date
:
O Defibrillation
O Premature battery depletion
O No O Yes
(Code ‘Yes’ even if prior to this procedure)
mm/dd/yyyy
If Yes, Device Returned To Manufacturer6235:
O No
6240
If Yes, Battery Voltage
: ________ OR
O Yes
□ Voltage Not Available6241
: ____________
6245
If Yes, ID
6160
Manufacturer
: _______________________ Model Name6165:
6250
If Yes, Serial Number
O RV pacing
O No O Yes
:
6220
O No O Yes
:
O LV pacing
O No O Yes
:
6215
If Yes, Shock Therapy Successful
6230
O Atrial pacing
O No O Yes
:
6210
Device Explanted6225:
□ Upgrade6192
□ Infection6193
□ Device relocation6196 □ Malfunction6197
: __________________________
© 2010 American College of Cardiology Foundation
2/23/2010
__________________________
6170
Model Number
: __________________________
Page 3 of 5
NCDR® ICD Registry™ V2.1
Data Collection Form – Generator & Leads
G. LEAD ASSESSMENT (COMPLETE FOR ALL LEADS, INCLUDING NEW LEADS IMPLANTED, EXISTING LEADS EXTRACTED, ABANDONED, OR REUSED)
Operator’s Name7000,7005,7010:
NPI7015:
Lead Counter7025:
1
7030
TIN7020:
2
3
O New Lead
O Existing Lead
O New Lead
O Existing Lead
O New Lead
O Existing Lead
O RA endocardial
O LV epicardial
O RV endocardial
O SVC/subclavian
O LV via CVS
O Subcutaneous array
O Other
O RA endocardial
O LV epicardial
O RV endocardial
O SVC/subclavian
O LV via CVS
O Subcutaneous array
O Other
O RA endocardial
O LV epicardial
O RV endocardial
O SVC/subclavian
O LV via CVS
O Subcutaneous array
O Other
Existing Lead Function7070:
O Normal
O Abnormal
O Not assessed
O Normal
O Abnormal
O Not assessed
O Normal
O Abnormal
O Not assessed
Manufacturer Advisory/Recall7075:
O No O Yes
O No O Yes
O No O Yes
Existing Lead Status7080:
O Extracted
O Abandoned
O Reused
O Extracted
O Abandoned
O Reused
O Extracted
O Abandoned
O Reused
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
Identification
:
Manufacturer7040:
Model Name7045:
ID7035: OR
Model Number7050:
Serial Number7055:
Lead Location7060:
COMPLETE FOR EXISTING LEADS ONLY
Existing Lead Implant Date7065:
If Extracted, Returned To Manufacturer7085:
7090
Existing Lead Placement Issues
7095
If Yes, Dislodgement
If Yes, Perforation
:
:
7100
:
7105
If Yes, Erosion
:
7110
If Yes, Faulty Connector/Header
:
7115
If Yes, Patient’s Clinical Status
:
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
If Yes, Failure to Capture with
Acceptable Safety Margin7150:
O No O Yes
O No O Yes
O No O Yes
If Yes, Extracardiac Stimulation7155:
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
O No O Yes
If Yes, Infection
7120
:
If Yes, Documented Infection7125:
COMPLETE IF “EXISTING LEAD FUNCTION7070” IS “ABNORMAL”
Pacing Issues7130:
If Yes, Oversensing
7135
:
7140
If Yes, Undersensing
If Yes, Failure to Pace
:
7145
:
Defibrillation Issues7160:
7165
If Yes, Oversensing w/Shock or ATP
:
7170
If Yes, Oversensing w/o Shock or ATP
If Yes, Failure to Shock with Inadequate
DFT Safety Margin7175:
Lead Integrity Issues7180:
If Yes, Insulation Failure
7185
If Yes, Conductor Failure
:
7190
:
© 2010 American College of Cardiology Foundation
:
2/23/2010
Page 4 of 5
NCDR® ICD Registry™ V2.1
Data Collection Form – Generator & Leads
H. INTRA OR POST PROCEDURE EVENTS (COMPLETE FOR EACH LAB VISIT)
Intra or Post Procedure Events Occurred8000:
O No
O Yes
If Yes, specify the Event(s):
Cardiac Arrest 8005:
Drug Reaction
O No
8010
:
O No
Cardiac Perforation
8015
Cardiac Valve Injury
Conduction Block
:
O No
8020
:
O No
8025
:
O No
Coronary Venous Dissection
8030
:
O No
Hematoma (Req reop, evacuation or transfusion)
Hemothorax
: O No
:
8050
Lead Dislodgement
O Yes
O Yes
Pericardial Tamponade
8060
O No
O Yes
O Yes
8065
:
O Yes
O No
O Yes
:
O No
O Yes
O No
O Yes
: O No
O Yes
O Yes
: O No
O Yes
O No
O Yes
:
O No
8075
Set Screw Problem
:
8070
Peripheral Nerve Injury
O Yes
8045
Peripheral Embolus
O Yes
O Yes
O No
Infection Requiring Antibiotics
Myocardial Infarction8055:
O No
O Yes
8035
8040
O Yes
:
8080
Pneumothorax
:
TIA or Stroke (CVA)
8085
Urgent Cardiac Surgery
Venous Obstruction
8090
:
8095
:
O No
O Yes
O No
O Yes
I. DISCHARGE (COMPLETE FOR EACH EPISODE OF CARE/ADMISSION)
CABG9000: (During this admission)
O No
O Yes
If Yes, CABG Date9005:
PCI9010: (During this admission)
O No
O Yes
If Yes, PCI Date9015:
Discharge Date9020: mm/dd/yyyy
Discharge Status9025:
O Alive
If Deceased, Cause of Death
9030
:
If Deceased, Death During the Procedure
O Deceased
O Cardiac O NonCardiac
9035
:
If Alive, Discharged Against Medical Advice
9040
:
O No
O Yes
O No
O Yes
If No, specify the Discharge Medication(s) Prescribed:
Medication
No
Amiodarone9050
Dofetilide9060
Flecainide
9070
O
O
O
O
O
9130
Digoxin (Any)
O
O
O
O
O
O
O
O
O
O
Statin9145
O
O
O
O
NonStatin9150
O
O
O
O
Long Acting Nitroglycerin9155
O
O
O
O
Clopidogrel9160
O
O
O
O
Prasugrel9165
O
O
O
O
Ticlopidine9170
O
O
O
O
O
O
O
O
Diuretic (Any)
O
O
O
O
Hydralazine (Any)
O
O
O
O
O
O
O
O
9140
O
O
O
O
O
O
O
Propafenone9080
O
O
O
O
Mexiletine9085
O
O
O
O
Quinidine9090
O
O
O
O
Sotalol9095
O
O
O
O
Warfarin (Coumadin)9175
O
O
O
O
O
O
O
O
O
O
O
O
O
O
O
O
O
O
O
O
O
O
O
O
ASA (Any)
9100
9105
Beta Blocker (Any)
Diltiazem
Other
9110
9115
9120
Verapamil
9125
© 2010 American College of Cardiology Foundation
Blinded
O
O
Procainmide
Prescribed
Yes
Con
O
9135
9075
Other
ARB (Any)
Calcium
Channel
Blockers
9065
O
O
No
Platelet
Aggregation
Inhibitors
Antiarrhythmic Agents
Disopyramide
9055
O
Medication
Blinded
Lipid
Lowering
Agents
ACE Inhibitor (Any)
9045
Prescribed
Yes
Con
2/23/2010
Page 5 of 5
| File Type | application/pdf |
| File Title | Visio-ICD_v2_DataCollectionForm_GenLeads_2.1_022310.vsd |
| Author | akhalid |
| File Modified | 2012-11-27 |
| File Created | 2010-02-23 |