Manual of Operations Version 3.0
05/7/2012
MEDAMACS Data Dictionary – Page 1 of 79
2.0Data DictionaryPage
2.1 Screening Log 2
2.2 Demographic Form 4
2.3 Clinical Enrollment Form 6
2.4 Events/Outcomes21
2.5 1 mth/1yr/2yr Follow-up Form23
2.6 6 mth/18 mth Phone Interview Form36
2.7 Rehospitalization Form44
2.8Patient Registry Status Form47
2.9Death form48
2.10Adverse Events
Major Events
Infection49
Neurological Dysfunction50
Bleeding53
2.11Quality of Life58
EuroQoL (EQ-5D/3L)61
Kansas City Cardiomyopathy Questionnaire65
(KCCQ)
VAD Survey75
2.12Seattle Heart Failure
2.1Screening Log
Inclusion: Patient must meet all inclusion criteria:(You must answer all questions)
□ Patient did not sign the informed consent. Select reason(s) why patient was not
consented:
□ Too sick
□ Missed opportunity to consent
□ Patient refused
□ Patient is unable to communicate in English
□ Has the patient had a diagnosis of heart failure or typical symptoms for more than 12 months? Yes/No
□Did the patient have at least 1 hospitalization for heart failure in the previous 12 months? Yes/No
□Does the patient have moderate or severe functional limitation, NYHA Class III or IV symptoms, for at least 45 of the last 60 days. Yes/No
□Has the patient been on oral medical therapy for heart failure for at least 3 months or has documented intolerance? Medications include beta blockers, ACE-inhibitors/ARBs and aldosterone antagonists.
□ Are the results of the patient’s most recent LVEF ≤ 35? Yes/No
□ Is the patient between 18 and 80 years old? Yes/No
□Does the patient have at least oneof the following high risk feature of heart failure? Yes/No
□ An additional unplanned hospitalization for heart failure in the last 12 months, for a total of ≥2 hospitalizations, or
□ Peak oxygen update (VO2) ≤16ml/kg/min for men, or ≤14ml/kg/min for women, or <55% of age- and sex-predicted using the Wasserman equation, or
□ 6 minute walk distance <300 meters without non-cardiac limitation, or
□ Serum BNP >1000 ng/ml
□ Seattle Heart Failure Model Score >1.5(Please calculate the SHF score at: enter the One Year Survival Score
If the patient meets all of the inclusion criteria and none of the exclusion criteria then this patient is enrolled in MEDAMACS and you will be directed to the patient Demographic form.
Exclusion: Any exclusion will disqualify the patient for entry into MEDAMACS:
If patient meets ANY exclusion criteria then check any of the appropriate exclusion reason below (check all that apply):
□Is the patient older than 80 or younger than 18 years old? Yes/No
□Does the patient have intravenous inotropic therapy current or planned? Yes/No
□Does the patient currently have an active listing for heart transplantation? Yes/No
□ Is cardiac surgery anticipated for the patient during this admission? Yes/No
□ Does the patient have a wide QRS (>120msec) and planned biventricular pacemaker (CRT) implant, or biventricular pacemaker (CRT) within the past 90 days? Yes/No
□ Is the patient’s primary functional limitation from a non-cardiac diagnosis? Yes/No
□ Is a non-cardiac diagnosis expected to limit the patient’s 2-year life expectancy? Yes/No
□ Is the patient on chronic hemodialysis or peritoneal dialysis? Yes/No
□ Does the patient have a history of cardiac amyloidosis? Yes/No
□ Does the patient have obvious anatomical or other major contraindication to any cardiac surgery in the future? (e.g. previous pneumonectomy, advanced connective tissue disease) Yes/No
□ Patient is incarcerated (prisoner) Yes/No
2.2Demographics Form
The patient Demographics Form.
Firstname: Enter the patient's first name.
MI (Middle Initial):Enter thepatient's middle initial.
Lastname: Enter thepatient's last name.
SSN: Enter the last 5 digits of the patient's social security if patient has been issued an SSN. If the social security number isnot available, enter 12345.
Date of birth: Enter the patient's date of birth in MMDDYYYY format.
Gender: Click in the appropriate circle to indicate the implant patient's gender. Male, Female, Unknown
Ethnicity: Hispanic or Latino: Select Yes or No
Race: Enter all race choices that apply from the list below:
American Indian or Alaska Native
Asian
African-American or Black
Hawaiian or Other Pacific Islander
White
Unknown/Undisclosed
Other/none of the above
Demographics Form
Marital status: Enter patient’s current marital status from the list below:
Single
Married
Domestic Partners
Divorced/Separated
Widowed
Unknown
Highest education level: Enter patient’s current highest education level from the list below:
None
Grade School (0-8)
High School (9-12)
Attended College/Technical School
Associate/Bachelor Degree
Post-College Graduate Degree
N/A (< 5 yrs old)
Unknown
Working for income: Select Yes if the patient is currently working for income or attending school. If not, select No. If Unknown, select Unknown.
If Yes, select one of the following:
Working Full Time
Working Part Time due to Demands of Treatment
Working Part Time due to Disability
Working Part Time due to Insurance Conflict
Working Part Time due to Inability to Find Full Time Work
Working Part Time due to Patient Choice
Working Part Time Reason Unknown
Working, Part Time vs. Full Time Unknown
If No, select reason patient is not working from one of the following:
Disability
Demands of Treatment
Insurance Conflict
Inabiity to Find Work
Patient Choice - Homemaker
Patient Choice - Student Full Time/Part Time
Patient Choice - Retired
Patient Choice - Other
Not Applicable - Hospitalized
Unknown
2.3Clinical Form-Enrollment
Date of Visit: MM/DD/YYYY
Height: Enter the height of the patient in inches or centimeters. The height must fall between 10 and 80inches or 25 and 203 centimeters. ST(status)=Unknown
Weight: Enter the weight of the patient in the appropriate space, in pounds or kilograms. The weight must fall between 5 and 450 pounds or 2 and 205 kilograms. ST(status)=Unknown
Blood Type: Select the patient's blood type. O, A, B, AB, Unknown,
Current Status Select the patient’s location at time of consent
Inpatient/Outpatient
Length of time followed by Program:
<1 month
1-12 months
1-5 years
>5 years
Referral Source:
Please report the type of health professional who initiated referral to your practice:
Cardiologist
Cardiac surgeon
Internist
Other
Unknown
Prior Heart Transplant Evaluation: Yes/No
If Yes, Evaluation Outcome: accept, reject, defer
Prior DT (Destination Therapy) VAD Evaluation: Yes/No
If Yes, Evaluation Outcome: accept, reject, defer
Please check any condition below that is a co-morbidity and/or concernfor patient treatment or contraindication for transplant.
Checking any of these contraindications/co-morbidities/concerns does not necessarily mean that a condition is a contraindication or concern for the patient. No specific thresholds are provided for these concerns or contraindications. They should represent the results of formal discussion with the medical and surgical transplant teamIf there are no contraindications or concerns specified then select None.
Clinical Form-Enrollment
If so, limitation for
Comorbid ConcernsIs condition present? transplantlisting/VAD?
Overall status:
Advanced age Yes/NoYes/No
Frailty Yes/NoYes/No
Musculoskeletal limitationsYes/NoYes/No
Contraindication to immunotherapyYes/NoYes/No
AllosensitizationYes/NoYes/No
Renal dysfunctionYes/NoYes/No
Cardiothoracic issues:
History of symptomatic ventricular tachycardia or
defibrillator shocksYes/NoYes/No
Pulmonary diseaseYes/NoYes/No
Pulmonary hypertensionYes/NoYes/No
Recent pulmonary embolusYes/NoYes/No
History of atrial arrhythmiaYes/NoYes/No
Mediastinal RadiationYes/NoYes/No
More than one prior sternotomy
Thoracic aortic diseaseYes/NoYes/No
Nutritional/GI:
Large BMIYes/NoYes/No
Severe diabetesYes/NoYes/No
Malnutrition/cachexiaYes/NoYes/No
History of GI ulcersYes/NoYes/No
History of hepatitisYes/NoYes/No
Vascular issues:
Heparin-induced thrombocytopeniaYes/NoYes/No
Chronic coagulopathyYes/NoYes/No
Major strokeYes/NoYes/No
Other cerebrovascular diseaseYes/NoYes/No
Peripheral vascular diseaseYes/NoYes/No
Oncology//infectious:
History of solid organ cancerYes/NoYes/No
History of lymphoma, leukemiaYes/NoYes/No
History of HumanImmunodeficiency Virus or AIDS Yes/No Yes/No
Risk of recurrent infectionYes/NoYes/No
Current InfectionYes/NoYes/No
Clinical Form-Enrollment
Psychosocial issues:
Limited cognition/understandingYes/NoYes/No
Limited social supportYes/NoYes/No
Repeated non-complianceYes/NoYes/No
History of illicit drug useYes/NoYes/No
History of alcohol abuseYes/NoYes/No
Narcotic dependenceYes/NoYes/No
History of smokingYes/NoYes/No
Currently smokingYes/NoYes/No
Severe depressionYes/NoYes/No
Other major psychiatricdisorderYes/NoYes/No
Other co-morbidity: (specify)Yes/NoYes/No
Number of cardiac hospitalizations in the last 12 months:
(choose one of the following)
0, 1, 2, 3, 4 or more, unknown
Date of first heart failurediagnosis: The length of time that the patienthad symptoms or a diagnosis of heart failure. (Month/Year). : MM/YYYY
Clinical Form-Enrollment
Cardiac diagnosis/primary: Check oneprimary reason for cardiac dysfunction (See drop down list).
Cancer
Congenital Heart Disease
Coronary Artery Disease
Dilated Myopathy: Adriamycin
Dilated Myopathy: Alcoholic
Dilated Myopathy: Familial
Dilated Myopathy: Idiopathic
Dilated Myopathy: Ischemic
Dilated Myopathy: Myocarditis
Dilated Myopathy: Other Specify
Dilated Myopathy: Post Partum
Dilated Myopathy: Viral
Hypertrophic cardiomyopathy
Sarcoidosis
Other
Congenital Heart Disease
Complete AV Septal Defect VSD/ASD
Congenitally Corrected TranspositionVSD/ASD Other, spec
Ebstein’s AnamolyKawasaki Disease
Hypoplastic Left HeartOther, specify
Left Heart Valvar/Structural HypoplasiaUnknown
Pulmonary Atresia with IVS
Single Ventricle
TF/TOF variant
Transposition of the Great Arteries
Truncus Arteriosus
Clinical Form-Enrollment
Previous cardiac operation: Check all cardiac operations that the patient has hadIf Other, specify is selected, type in the specification in the block provided.
None
CABG
Aneurysmectomy (DOR)
Aortic Valve replacement / repair
Mitral valve replacement / repair
Triscuspid replacement /repair
Congenital cardiac surgery
Other, specify(Include ONLY operations actually performed on heart or great vessels)
Number of Previous Cardiac Operations:_____(Enter total number)
_Clinical Events and Interventionsat Baseline, select all events that apply.
Diabetes
Home oxygen
Previous renal replacement
Any Dialysis
Any Ultrafiltration
Recent Intubation (within 6mths)
Recent intraaortic counterpulsation (within 6 mths)
Physical Exam
INTERMACS®Patient ProfileSelect one. These profiles will provide a general clinical description of the patients Patients who meet MedaMACS entry criteria must fall in INTERMACS Patient Profiles 4-7.
INTERMACS® 4:Resting symptoms describes a patient who is at home on oral therapy but frequently has symptoms of congestion at rest or with ADL. He or she may have orthopnea, shortness of breath during ADLsuch as dressing or bathing, gastrointestinal symptoms (abdominal discomfort, nausea, poor appetite), disabling ascites or severe lower extremity edema. This patient should be carefully considered for more intensive management and surveillance programs, by which some may be recognized to have poor compliance that would compromise outcomes with any therapy. This patient can have modifiers A and/or FF.
INTERMACS® 5: Exertion Intolerant describes a patient who is comfortable at rest but unable to engage in any activity, living predominantly within the house or housebound. This patient has no congestive symptoms, but may have chronically elevated volume
Clinical Form-Enrollment
status, frequently with renal dysfunction, and may be characterized as exercise intolerant. This patient can have modifiers A and/or FF.
INTERMACS® 6: Exertion Limitedalso describes a patient who is comfortable at rest without evidence of fluid overload, but who is able to do some mild activity. Activities of daily living are comfortable and minor activities outside the home such as visiting friends or going to a restaurant can be performed, but fatigue results within a few minutes or any meaningful physical exertion. This patient has occasional episodes of worsening symptoms and is likely to have had a hospitalization for heart failure within the past year. This patient can have modifiers A and/or FF.
INTERMACS® 7:Advanced NYHA Class 3 describes a patient who is clinically stable with a reasonable level of comfortable activity, despite history of previous decompensation that is not recent. This patient is usually able to walk more than a block. Any decompensation requiring intravenous diuretics or hospitalization within the previous month should make this person a Patient Profile 6 or lower. This patient may have a modifier A only.
MODIFIERS of the INTERMACS® Patient Profiles:
A - Arrhythmia. This modifier can modify any profile. Recurrent ventricular tachyarrhythmias that have recently contributed substantially to the overall clinical course. This includes frequent shocks from ICD or requirement for external defibrillator, usually more than twice weekly.
FF – Frequent Flyer. This modifier is designed for Patient Profiles 4, 5, and 6. This modifier can modify Patient Profile 3 if usually at home (frequent admission would require escalation from
Patient Profile 7 to Patient Profile 6 or worse). Frequent Flyer is designated for a patient requiring frequent emergency visits or hospitalizations for intravenous diuretics, ultrafiltration, or brief inotropic therapy. Frequent would generally be at least two emergency visits/admissions in thepast 3 months or 3 times in the past 6 months. Note: if admissions are triggered by tachyarrhythmias or ICD shocks then the modifier to be applied to would be A, not FF.
NYHA Class: New York Heart Association Class for heart failure:
Class I:No limitation of physical activity; physical activity does not cause fatigue, palpitation or shortness of breath.
Class II:Slight limitation of physical activity; comfortable at rest, butordinaryphysical activity results in fatigue, palpitations or shortness of breath.
Class IIIA:Marked limitation of physical activity; comfortable at rest, butless than ordinary activity causes fatigue, palpitation or shortness of breath.
Class IIIB: Marked limitation of physical activity, with recent resting dyspnea.
Class IV:Unable to carry onminimalphysical activity without discomfort;symptoms may be present at rest.
Unknown
Clinical Form-Enrollment
General Hemodynamics
Heart rate: Beats per minute. ST= Unknown or not done.
Systolic bp: mmHg (millimeters of mercury) should be determined from auscultation or arterial line if necessary. ST= Unknown or not done.
Diastolic bp: mmHg (millimeters of mercury) should be determined from auscultation or arterial line if necessary. ST= Unknown or not done.
Jugular Venous Pressure: CM:_____UNK or Not Done
S3 gallop:Present or Absent? UNK or Not Done
S4 gallop: Present or Absent? UNK or Not Done
Peripheral edema:Choose the most applicable
NONE
1+
2+
>3+
Ascites:Yes, No or Unknown. This is in the clinicians’ best judgment, as it is sometimes difficult to tell whether abdominal protuberance is fluid or adipose tissue.
Hepatomegaly:Present, Absent or Unknown. This is in the clinicians’ best judgement.
ECG Rhythm:(cardiac rhythm):Select one of the following. If Other, specify is selected, type in the specification in the block provided.
Sinus
Atrial fibrillation
Atrial flutter
Paced (choose one)
Atrial pacing
Ventricular pacing
Atrial and ventricular pacing
Not done
Other, specify
Unknown
Clinical Form-Enrollment
QRS duration (Please enter in milliseconds):______
ECHOCARDIOOGRAPHY
(Within 30 days of baseline visit)
Date:MM/DD/YYYY
Left Ventricular (LV) Ejection fraction: Enter %_____
ST=Not Recorded or Not Documented
LVEDD:Left ventricular end-diastolic dimension in centimeters. ____cm
ST=Not Recorded or Not Documented
Mitral regurgitation:Mitral regurgitation should be recorded on a qualitative scale (if ‘trivial’ then assign as mild). Moderate-severe would be recorded as “severe”.
0 (none)
1 (mild)
2 (moderate)
3 (severe)
Not Recorded or Not Documented
Tricuspid regurgitation:Tricuspid regurgitation should be recorded on a qualitative scale (if ‘trivial’ then assign as mild). Moderate-severe would be recorded as “severe”.
0 (none)
1 (mild)
2 (moderate)
3 (severe)
Not Recorded or Not Documented
Aorticinsufficiency:Aortic regurgitation should be recorded on a qualitative scale (if ‘trivial’ then assign as mild). Moderate-severe would be recorded as “severe”.
0 (none)
1 (mild)
2 (moderate)
3(severe)
Not Recorded or Not Documented
Aortic Stenosis: Aortic regurgitation should be recorded on a qualitative scale (if ‘trivial’ then assign as mild). Moderate-severe would be recorded as “severe”.
0 (none)
Clinical Form-Enrollment
1 (mild)
2 (moderate)
3 (severe)
Not Recorded or Not Documented
Inferior Vena Cava Dilated: Yes/No
Inferior Vena Cava Respiration Variation:
Yes
Blunted
None
Right ventricular (RV) Indices:
RV Function: Is generally NOT measured in numbers, as it is difficult to quantify. It may be described as “right ventricular function” or “right ventricular contractility”. “Mild impairment, mildly reduced, or mild decrease” would all be characterized as “mild”. Again, mild-moderate would be recorded as moderate, and moderate-severe would be recorded as “severe”.
Qualitative RV Function:Choose One
Normal
Mild
Moderate
Severe
ST=Not Recorded or Not Documented
Qualitative RV Size: Is generally NOT measured in numbers, as it is difficult to quantify. It may be described as “right ventricular function” or “right ventricular contractility”. “Mild impairment, mildly reduced, or mild decrease” would all be characterized as “mild”. Again, mild-moderate would be recorded as moderate, and moderate-severe would be recorded as “severe”.
Qualitative RV Size:
Normal
Mild
Moderate
Severe
ST=Not Recorded or Not Documented
Maximum mid RV dimension in centimeters. ____cm
ST=Not Recorded or Not Documented
Tricuspid annular plane excursion in millimeters.____mm
ST=Not Recorded or Not Documented
Tricuspid regurgitant velocity in millimeters per second.____mmper sec
ST=Not Recorded or Not Documented
Clinical Form-Enrollment
RIGHT HEART CATHETERIZATION ELEMENTS
(Must be within 6 months of baseline visit)
Date:MM/DD/YYYY
Therapies at RHC:
No IV:
IV:
IABP:
None:
Unknown:
Systolic Blood Pressure: Systolic bp: mmHg (millimeters of mercury) should be determined from auscultation or arterial line if necessary. ST= Unknown or not done.
Diastolic bp: mmHg (millimeters of mercury) should be determined from auscultation or arterial line if necessary. ST= Unknown or not done.
Heart Rate: Enter beats per minute. ST=Unknown and Not Done
Pulmonary artery systolic pressure:This may be abbreviated PAS or pulmonary pressures. mmHg (millimeters of mercury).
ST= Unknown and Not Done.
Pulmonary artery diastolic pressure:This may be abbreviated PAD or pulmonary pressures. mmHg (millimeters of mercury).
ST= Unknown and Not Done.