: 2014
INTERMACS 4.0 Launches June 2, 2014
David C. Naftel, PhD
1
June 2006 – March 2014
UAB: DCC
UNOS: WBDE
2
: 2006
• What patients are receiving MCSDs?
• Do DT patients ever receive a transplant?
• What are the rates of the major adverse events?
• How do pulsatile and continuous pumps compare?
• Are driveline infections common?
• Characterize changes in in quality of life?
• What are the risk factors for the major outcomes?
• Is “device strategy” a useful construct?
3
April 2014
UAB: DCC
UAB: WBDE
5
: 2014
• Predict time-related outcomes for a patient based on
his/her risk factors
• Compare device types: Axial flow, centrifugal flow,
TAH, Bi-VADs
• MCSD implant, Transplant Medical Therapy: contrast,
compare, optimize timing
• MCSD in pediatric patients
• Is “it” worth it: Quality of Life, functional capacity
• Resource Utilization
6
: 2014
• Predict time-related outcomes for a patient based on
his/her risk factors
Quality Assurance Analyses
• Compare device types: Axial flow, centrifugal flow,
TAH, Bi-VADs
Frontline
ofTransplant
unanticipated
events
• MCSD implant,
Medical Therapy: contrast,
compare, optimize timing
• MCSD in pediatric patients
•
Industry
Collaborations
Is “it” worth it: Quality of Life, functional capacity
• Resource Utilization
7
: 2014
How does all of this happen?
Protocol 4.0
8
: 2014
Key Features of Protocol 4.0:
• Revamped web site
• Waiver of consent
• Added HIV, Modified Rankin Scale
• Adverse event changes: “Zones”
• Dashboard: announcements, etc
9
INTERMACS Website
Protocol 4.0
Waiver of Informed Consent
and Authorization
Justification for Waiver of Informed Consent and
Authorization
•
•
•
•
•
•
•
•
National Quality Improvement System
Rare population (miss approx. 12% of patients)
Minimal risk
Joint Commission requires participation in a
national registry
Procedures are Standard of Care
FDA Reporting
Reimbursement oversight (CMS)
Review of best medical practices by NHLBI
Time Line for Protocol 4.0
March 28, 2014
Distribution of Protocol 4.0
- 64 days for local IRB approval
May 26, 2014
UNOS WBDE – TURNED OFF
June 1, 2014
IRB/EB Acknowledgment
Deadline
June 2, 2014
UAB WBDE – TURNED ON
Additional “Web Ex” training meetings are available
: 2014
• Revamped web site
• Waiver of consent
• Added HIV, Modified Rankin Scale
• Adverse event changes: “Zones”
• Dashboard: announcements, etc
14
Captured Events
“Zones”
1)
Hemolysis Zone
2)
Right Heart Failure Zone
3)
Hypertension **
Right Heart Failure Definition
Definition: Symptoms or findings of persistent right ventricular failure characterized by both of the following:
• Documentation of elevated central venous pressure (CVP) by:
o Direct measurement (e.g., right heart catheterization) with evidence of a central venous pressure (CVP) or
right atrial pressure (RAP) > 16 mmHg.
or
o Findings of significantly dilated inferior vena cava with absence of inspiratory variation by echocardiography,
or
o Clinical findings of elevated jugular venous distension at least half way up the neck in an upright patient.
• Manifestations of elevated central venous pressure characterized by:
o Clinical findings of peripheral edema (>2+ either new or unresolved),
or
o Presence of ascites or palpable hepatomegaly on physical examination (unmistakable abdominal contour) or
by diagnostic imaging,
or
o Laboratory evidence of worsening hepatic (total bilirubin > 2.0) or renal dysfunction (creatinine > 2.0).
IF the patient meets the definition for right heart failure, the severity of the right heart failure will be graded according to
the following scale below.
(NOTE: For right heart failure to meet severe or severe acute severity, direct measurement of central venous pressure
or right atrial pressure must be one of the criteria)
Right Heart Failure Zone
Information that you provide in this section will be used to assess the
existence of right heart failure and its degree.
Clinical Findings
CVP or RAP > 16 mmHg? Yes, No, or Unknown.
Dilated Vena Cava with absence of Inspiratory Variation by Echo? Yes, No,
or
Unknown.
Clinical findings of elevated jugular venous distension at least half way up
the neck in an upright patient? Yes, No, or Unknown.
Peripheral Edema? Yes, No, or Unknown.
Ascites? Yes, No, or Unknown.
Right Heart Failure Zone
Information that you provide in this section will be used to assess the existence
of right heart failure and its degree
Has the patient been on Inotropes since the last Follow-up or
rehospitalization?
Yes, No, or Unknown.
If yes, select all that apply:
Dopamine
Dobutamine
Milrinone
Isoproterenol
Epinephrine
Norepinephrine
Levosimendan
Unknown
Nesiritide? Yes, No, or Unknown.
Has the patient had a RVAD implant since the last Follow-up or
rehospitalization?
Yes, No, or Unknown.
“DashBoard”
Download,
print or
copy your
own patient
listings or
datasets
“DashBoard”
Announcements
• Global
• Site specific
“DashBoard”
Pending Forms
• Download
• Print
• Copy
• Sort
Protocol 3.0 Web Based Data Entry
22
Protocol 4.0 Web Based Data Entry
23
INTERMACS® Protocol and
Data Entry Evolution
Protocol 1.0
June 23, 2006
Data
Mapping
Protocol 2.0
March 9, 2007
Data
Mapping
Protocol 2.3
March 5, 2009
Data
Mapping
Protocol 3.0
May 12, 2012
Data
Mapping
Protocol 4.0
June 2, 2014
Mapped/”Cleaned” Data
• New cause of death drop-down list:
Mapping of “OTHER” Cause of Death
into specified categories
• Removal of duplicate bleeding and
infection adverse events (same date
and location)
• Removal of ‘ongoing’ infection
adverse events
• Avoid complex mapping (but no data
is lost)
25
Duo 2 Factor Login
THE END
Hemolysis Definition
Minor Hemolysis: A plasma-free hemoglobin value
greater than 20 mg/dl or a serum lactate dehydrogenase
(LDH) level greater than two and one-half time (2.5x)
the upper limits of the normal range at the implanting
center occurring after the first 72 hours post-implant in
the absence of clinical symptoms or findings of
hemolysis or abnormal pump function.
Hemolysis Definition
Major Hemolysis: A plasma-free hemoglobin value greater than 20
mg/dl or a serum lactate dehydrogenase (LDH) level greater than two and
one-half times (2.5x) the upper limits of the normal range at the implanting
center occurring after the first 72 hours post-implant and associated with
clinical symptoms or findings of hemolysis or abnormal pump function.
Major Hemolysis requires the presence of one or more of the following
conditions:
• Hemoglobinuria (“tea-colored urine”)
• Anemia (decrease in hematocrit or hemoglobin level that is out of
proportion to levels explainable by chronic illness or usual post-VAD
state)
• Hyperbilirubinemia (total bilirubin above 2 mg%, with predominately
indirect component)
• Pump malfunction and/or abnormal pump parameters
Hemolysis Zone
Information that you provide in this section will be used to assess the
existence of hemolysis and its degree
Please enter the peak Plasma-free hemoglobin (PFhg) since the last follow-up
visit:
_______ mg/dL. ST= Unknown or Not Done.
What is your hospital’s upper limit of the normal range of PFhg:
_______mg/dl. ST= Unknown or Not Done.
Please enter the peak serum lactate dehydrogenase (LDH) since the last followup visit:
_______ U/L. ST= Unknown or Not Done.
What is your hospital’s upper limit of the normal range of LDH:
________ U/L. ST= Unknown or Not Done.
Hemolysis Zone
Information that you provide in this section will be used to assess the existence of
hemolysis and its degree
Enter the Maximum and Minimum HCT or HGB since the last Follow-up visit:
Max. HCT: _________ ST = Unknown or Not Done.
Max. HGB: _________ ST = Unknown or Not Done.
Min. HCT: _________ ST = Unknown or Not Done.
Min. HGB: _________ ST = Unknown or Not Done.
Highest Total Bilirubin since the last Follow-up period: _______ mg/dl.
ST= Unknown or Not Done.
Has the following been present at any time since the last Follow-up period?
Physical Findings: Select all that apply:
Hemoglobinuria (Tea-Colored Urine)? Yes, No, or Unknown.
Pump malfunction and/or abnormal pump parameters? Yes, No, or
Unknown.
(If yes, please fill out the Device Malfunction Adverse Event Form)
Hypertension Definition
New onset blood pressure elevation greater than or
equal to 140 mm Hg systolic or 90 mm Hg diastolic
(pulsatile pump) or 110 mm Hg mean pressure (rotary
pump).
PediMACS: Hypertension is defined as systolic, diastolic, or mean
blood pressure greater than the 95th percentile for age which requires
the addition of a new IV or oral therapy for management. The event
shall be considered resolved upon the discontinuation of the treatment.