1.12 Seattle Heart Failure Score MedaMACS Users Guide – Page 1 of 94
Medical Arm of MechanicallyAssisted Circulatory Support
Users Guide(V1.1)
01/15/2014
1.0 Users Guide (V1.1) - Table of Contents
1.0 Users Guide (V1.1) - Table of Contents
1.1 Screening Log
1.2 Demographics Form
1.3 Clinical Enrollment Form
Initial Data
Comorbid Concerns
Physical Exam
General Hemodynamics
Laboratory Values
Exercise Testing
Echocardiography
Right Heart Catheterization Elements
Medications
Quality of Life
1.4 EVENTS/OUTCOMES
1.5 1 Month / 1 Year / 2 Year Follow-up Form
1.6 6 Month / 18 Month Phone Interview Form
1.7 Rehospitalization
1.8 Patient Registry Status Form
1.9 Death Form
1.10 Adverse Events
AE Infection
AE Neurological Dysfunction
AE Major Bleeding
Other Adverse Events
Cardiac Arrhythmias
Myocardial Infarction
Psychiatric Episode
Venous Thromboembolism
Arterial Non-CNS Thromboembolic Event
Other Adverse Event
1.11 Quality of Life
EuroQol (EQ-5D)
Kansas City Cardiomyopathy Questionnaire (KCCQ)
VAD Survey
1.12 Seattle Heart Failure Score
1.1 Screening Log
Informed Consent: Did the patient sign the informed consent?
Yes/No
If No, data entry is concluded and the following message is displayed:
Without informed consent, no patient information can be entered.
IfYes, continue data entry…
Basic Patient Information
Firstname: Enter the patient's first name.
Middle name: Enter the patient's middle name.
Lastname: Enter the patient's last name.
Date of Birth: Enter the patient's date of birth in MM/DD/YYYY format.
Inclusion: Patient must meet all inclusion criteria: You must answer all questions
□ 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.
Yes/No
□ Are the results of the patient’s most recent LVEF less than or equal to 35%?
Yes/No
□ Is the patient between 18 and 80 years old?
Yes/No
□Does the patient have at least one of the following high risk feature failure? Please check all that apply:
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 (If 1 Year Survival is 82% or less (mortality 18% or more), then the patient meets the SHF Criteria for study entry):
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
□Is the patient currently on home IV inotropic therapy?
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
SUBMIT – click the submit button
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.
1.2 Demographics Form
First Name:Automatically populated from screening form.
Middle Name:Automatically populated from screening form.
Last Name:Automatically populated from screening form.
Date of Birth:Automatically populated from screening form.
Social Security Number: Enter the last 5 digits of the patient's social security if patient has been issued an SSN. If the social security number is not available or undisclosed, check not available or undisclosed.
Gender:Select the patient's gender.
MaleFemale
Unknown
Hispanic Ethnicity: Is the patient Hispanic or Latino?
Yes/No
Race:Enter all race choices that apply from the list below:
American Indian or Alaska Native
Asian
African-American or Black
Hawaiian
White
Unknown/Undisclosed
Other/none of the above
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:
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
None
Working for Income:Select ‘Yes’ if the patient is currently working for income or attending school. If not, select ‘No.’ If unknown, select ‘Unknown.’
Yes No
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
Inability to Find Work
Patient Choice - Homemaker
Patient Choice - Student Full Time/Part Time
Patient Choice - Retired
Patient Choice - Other
Not Applicable - Hospitalized
Unknown
1.3 Clinical Enrollment Form
Initial Data
Date of Visit:Enter the date of visit in MM/DD/YYYY format.
Height: Enter the height of the patient in inches or centimeters. The height must fall between 10 and 80 inches or 25 and 203 centimeters. If the height of the patient is unknown check the corresponding box.
Height Units: Select the units in which the height was entered
In
cm
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. If the weight of the patient is unknown check the corresponding box.
Weight Units: Select the units in which the height was entered
Lbs
kg
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 at your institution:Enter the length of time the patient has been followed at your institution.
<3 month
3-12 months
1-2 years
>2 years
Referral Source:Please report the type of health professional who initiated referral to your practice:
Local Internist
Local Cardiologist
Cardiac Surgeon
Self-Referral
Unknown
Other
Prior Heart Transplant Evaluation:
Yes/No
If Yes, Transplant Evaluation Outcome:
Accept
Reject
Defer
Prior DT (Destination Therapy) VAD Evaluation:
Yes/No
If Yes, DT VAD Evaluation Outcome:
Accept
Reject
Defer
Comorbid Concerns
Please select any condition below that is a comorbidity and/or concern for patient treatment or contraindication for transplant.
Checking any of these contraindications/comorbidities/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 team. If there are no contraindications or concerns specified then select No in the 'Is condition present' column.
If so, limitation for
Comorbid Concerns Is Condition Present? Transplantlisting/VAD?
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 psychiatric disorderYes/NoYes/No
Other co-morbidity: (Specify)Yes/NoYes/No If Other co-morbidity:Please specify in text box.
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 failure diagnosis: The length of time that the patient had symptoms or a diagnosis of heart failure. (Month/Year): MM/YYYY
Cardiac diagnosis/primary:Check oneprimary reason for cardiac dysfunction (See drop down list).
Cancer
Congenital Heart Disease
IfCongenital Heart Disease, Please choose all that apply:
Complete AV Septal Defect
Congenitally Corrected Transposition
Ebstein’s Anomaly
Hypoplastic Left Heart
Left Heart Valvar/Structural Hypoplasia
Pulmonary Atresia with IVS
Single Ventricle
TF/TOF Variant
Transposition of the Great Arteries
Truncus Arteriosus
VSD/ASD
VSD/ASD Other, specify
IfOther co-morbidity: Please specify in text box.
Kawasaki Disease
Unknown
Other, specify
IfOther Specify:Please specify in text box.
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
If Other Specify:Please specify in text box.
Dilated Myopathy: Post Partum
Dilated Myopathy: Viral
Hypertrophic cardiomyopathy
Sarcoidosis
Other, specify
If Other Specify:Please specify in text box.
Previous cardiac operation:
Check all cardiac operations that the patient hashad:
None
CABG
Aneurysmectomy (DOR)
Aortic Valve replacement / repair
Mitral valve replacement / repair
Triscuspid replacement /repair
Congenital cardiac surgery
Other, specify
IfOther, Specify: Please specify in text box.
(Include only operations actually performed on heart or great vessels)
Number of previous cardiac operations:
Enter total number previous cardiac operations.
Clinical Events and Interventions at Baseline: Select all events that apply.
None
Diabetes
Home oxygen
Recent intubation (within 6 months)
Recent intraaorticcounterpulsation (within 6 months)
Previous renal replacement
Any Dialysis
Any Ultrafiltration
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 1:Critical cardiogenic shockdescribes a patient who
is “crashing and burning”,in which a patient has life-threatening
hypotension and rapidly escalating inotropic pressor support, with critical
organhypoperfusion often confirmed by worsening acidosis and lactate
levels. This patient can have ModifierA (see ‘Modifiers’ below).
INTERMACS 2:Progressive decline describes a patient who has been
demonstrated “dependent” on inotropic support but nonetheless shows
signs of continuing deterioration in nutrition, renal function, fluid retention,
or other major status indicator. Patient profile 2 can also describe a
patient with refractory volume overload, perhaps with evidence of impaired
perfusion, in whom inotropic infusions cannot be maintained due to
tachyarrhythmias, clinical ischemia, or other intolerance. This patient can
haveModifier A.
INTERMACS 3:Stable but inotrope dependent describes a patient who
is clinically stable on mild-moderate doses of intravenous inotropes (or
has a temporary circulatory support device) after repeated documentation
of failure to wean without symptomatic hypotension, worsening symptoms,
or progressive organ dysfunction (usually renal). It is critical to monitor
nutrition, renal function, fluid balance, and overall status carefully in order
to distinguish between a patient who is truly stable at Patient Profile 3
and a patient who has unappreciated decline rendering them Patient
Profile 2. This patient may be either at home or in the hospital. Patient
Profile 3 can have Modifier A, If patient is at home most of the time on
outpatient inotropic infusion, this patient can have a Modifier FF if he or
she frequently returns to the hospital.
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 ADL
such 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
status, frequently with renal dysfunction, and may be characterized
as exercise intolerant. This patient can have Modifiers A and/or FF.
INTERMACS 6: Exertion Limited also 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
haveModifiers 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 the past 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, but
ordinaryphysical activity results in fatigue, palpitations or shortness
of breath.
Class III:Marked limitation of physical activity; comfortable at rest,
butless than ordinary activity causes fatigue, palpitation or shortness
of breath.
Class IV:Unable to carry onminimalphysical activity without
discomfortsymptoms may be present at rest.
Unknown
General Hemodynamics
Heart rate:Enter ____bpm (beats per minute). If Unknown or Not Done, please check corresponding box.
Systolic bp:Enter ____mmHg (millimeters of mercury) should be determined from auscultation or arterial line if necessary. If Unknown or Not Done, please check corresponding box.
Diastolic bp: Enter ____mmHg (millimeters of mercury) should be determined from auscultation or arterial line if necessary. If Unknown or Not Done, please check corresponding box.
Jugular Venous Pressure: CM:_____ If Unknown or Not Done, please check corresponding box.
S3 gallop:
Present
Absent
Unknown
Not Done
S4 gallop:
Present
Absent
Unknown
Not Done
Peripheral edema: Choose the most applicable.
None
1+
2+
>3+
Ascites:This is in the clinicians’ best judgment, as it is sometimes difficult to tell whether abdominal protuberance is fluid or adipose tissue.
Yes
No
Unknown
Hepatomegaly:This is in the clinicians’ best judgment.
Present
Absent
Unknown
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)
If Paced: Choose one
Atrial pacing
Ventricular pacing
Atrial and ventricular pacing
Not done
Unknown
Other, specify
If Other, specify:Please specify in text box.
QRS duration:Please enter in milliseconds (ms). If Unknown or Not Done, please check corresponding box.
Laboratory Values
Blood laboratories should be within 30 days of enrollment. Please record data closest to enrollment.
For all labs, if Unknown or Not Done, please check corresponding box.
Chemistry:
Sodium
Potassium
Blood urea nitrogen
Creatinine
SGPT/ALT (alanine aminotransferase/ALT)
SGOT/AST (aspartate aminotransferase/AST)
Total Bilirubin
Direct Bilirubin
Institutions generally perform only one of the two following assays.The other one should be indicated as “Not Done.”
B-type natriuretic peptide (BNP)
If > 7500 pg/mL,please check corresponding box.
NT- pro BNP
Metabolism:
Albumin
Pre-Albumin
TotalCholesterol
If < 50 mg/dl,please check corresponding box.