Interagency Registry for Mechanically Assisted Circulatory Support

INTERMACS Eligibility

Please submit the data below to confirm eligibility for INTERMACS inclusion. Only enter information on consented patients with FDA approved durable (potential for patient discharge) devices. FDA approved temporary devices should be included only if they are implanted simultaneously with a durable device or subsequent to a durable device.

There is one exception to this rule, data entry for patients receiving the Berlin Heart EXCOR device. Authorized Berlin Heart medical centers should proceed to enter EXCOR recipient data in INTERMACS.

Device type:*

Device brand:*
Device brand (RVAD):*
Specify:*
Specify RVAD:*

Implant date:*

mm/dd/yyyy

Reminders:

1. Obtain consent pre-implant. If this is not possible, obtain consent immediately post-implant.

2. Refer to Appendix K of the Protocol for the current list of devices and their FDA approval status.

3. Please remember to complete and submit any device tracking forms that accompany the implanted devices.

Patient Demographics

Pre-Implant

Demographics

Height:*	in cm	ST =
Weight:*	lbs kgs	ST =

Enter List Date:*

mm/dd/yyyy

ST=

Implant decision date:*

mm/dd/yyyy

ST=

Infection type*
Location of infection:*
Other, specify:*

IV inotrope therapy immediately prior to implant:*

YES NO UNK

IV inotrope therapy agents (check all that apply):*

Dobutamine

Dopamine

Milrinone

Levosimendan

Epinephrine

Norepinephrine

Isoproterenol

Other, specify

Unknown

Specify:*

Additional support interventions within 24 hours of implant (check all that apply):*

IABP

Other VAD

Dialysis

Ultrafiltration

Ventilator

Feeding tube

ECMO

None

INTERMACS Patient Profile*

1 "Critical cardiogenic shock" describes a patient who is "crashing and burning", in which a patient has life-threatening hypotension and rapdily escalating inotropic pressor support (see the Site Users' Guide, Section II. 2.4 Pre-Implant Form, INTERMACS Patient Profiles for more details)

2 "Progressive decline" describes a patient who has been demonstrated "dependent" on inotropic support but nonetheless shows signs of continuing deterioration (see the Site Users' Guide, Section II. 2.4 Pre-Implant Form, INTERMACS Patient Profiles for more details)

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 symptoms (see the Site Users' Guide, Section II. 2.4 Pre-Implant Form, INTERMACS Patient Profiles for more details)

4 "Resting symptoms" describes a patient who is at home on oral therapy but frequently has symptoms of congestion at rest or with ADL. (see the Site Users' Guide, Section II. 2.4 Pre-Implant Form, INTERMACS Patient Profiles for more details)

5 "Exertion Intolerant" describes a patient who is comfortable at rest but unable to engage in any activity, living predominantly within the house or household (see the Site Users' Guide, Section II. 2.4 Pre-Implant Form, INTERMACS Patient Profiles for more details)

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 (see the Site Users' Guide, Section II. 2.4 Pre-Implant Form, INTERMACS Patient Profiles for more details)

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 (see the Site Users' Guide, Section II. 2.4 Pre-Implant Form, INTERMACS Patient Profiles for more details)

Co-morbidities

Diabetes:*

YES NO UNK

Insulin-dependent:*

YES

UNK

Cardiac rhythm:*

Other, specify:*

COPD:*

Symptomatic peripheral vascular disease:*

YES

UNK

Connective tissue or inflammatory rheumatologic disease:*

YES

UNK

Hx of Hepatitis A:*

YES

UNK

Hx of Hepatitis B:*

YES

UNK

Hx of Hepatitis C:*

YES

UNK

Carotid artery disease:*

YES

UNK

Definition: Having signs or symptoms of carotid artery disease or >50% narrowing of carotid.

History of neurological event:*

Cancer other than local skin cancer:*

YES NO UNK

Type of cancer:*

Other, specify:*

Any active treatment at time of implant for cancer other than local skin cancer:*

YES

UNK

Smoking history:*

# pack years:*

ST =

General Hemodynamics

Heart rate:*

beats per min

ST=

Systolic BP:*

mm Hg

ST=

Diastolic BP:*

mm Hg

ST=

Volume Status (peripheral edema):*

Ascites:*

YES

UNK

ECG rhythm (cardiac rhythm):*

Specify:*

Echo Hemodynamics

Were Echo Hemodynamics performed at pre-implant interval?*

YES NO UNK

LVSF:*	units	ST=
Mitral regurgitation:*
Tricuspid regurgitation:*
Aortic regurgitation:*
LVEF:*
LVEDD:*	cm	ST=
RVEF:*

Swan Hemodynamics

Is swan in place at pre-implant interval?*

YES NO UNK

Shunt Ratio (QpQs):*	beats per min	ST=
Pulmonary artery systolic pressure:*	mm Hg	ST=
Pulmonary artery diastolic pressure*	mm Hg	ST=
RA Pressure:*	mm Hg	ST=
Pulmonary artery wedge pressure:*	mm Hg	ST=
Cardiac output:*	liters min	ST=

Medications
Angiotensin receptor blocker drug:*
Amiodarone:*
ACE inhibitors:*
Beta-blockers:*
Aldosterone antagonist:*
Loop diuretics:*
Warfarin (coumadin):*

Anteplatelet therapy drug:*

Laboratory
Sodium:*	mmol/L	ST=
Potassium:*	mEq/L	ST=
Blood urea nitrogen:*	mg/dL	ST=
Creatinine:*	mg/dL	ST=
SGPT/ALT:*	u/L	ST=
SGOT/AST:*	u/L	ST=
Total bilirubin:*	mg/dL	ST=
Albumin:*	g/dL	ST=
Pre-albumin:*	mg/dL	ST=
Cholesterol:*	mg/dL	ST=
If value is outside given range please see 'status' drop down field
Brain natriuretic peptide BNP:*	pg/ml	ST=
If value is outside given range please see 'status' drop down field
NT pro brain natriuretic peptide Pro-BNP:*	pg/ml	ST=
White blood cell count:*	K/uL	ST=

Hemoglobin:*	mg/dL	ST=
Platelet:*	K/uL	ST=
INR:*	international units	ST=

CRP (C Reactive Protein):*	mg/L	ST=
Protein C:*	%	ST=
Protein S:*	%	ST=
Anti-phospholipid (IgG):*	gplu/ml	ST=

Medical Condition
NYHA class:*

Exercise Function
6 minute walk:*	feet	ST=
VO2 Max:*	mL/min	ST=
R Value at peak:*	%	ST=

Trailmaking Data
Status:*
Time:*	sec

Implant

Device Information

Additional indication for VAD:*

Failure to wean from CPB Post Cardiac Surgery None

Enter cardiac operation:*

Device type:*

Device brand:*
Device brand (RVAD):*
Specify:*
Specify RVAD:*

Implant date:*

mm/dd/yyyy

LVAD: device tracking number:*		ST=
LVAD: console tracking number:*		ST=
If LVAD is Berlin Heart: What is the Volume of the artificial ventricle?*		ST=
LVAD: cannulae location-inflow:*
Specify:*
LVAD: cannulae location-outflow:*
Specify:*

RVAD: device tracking number:*		ST=
RVAD: console tracking number:*		ST=
If RVAD is Berlin Heart: What is the Volume of the artificial ventricle?:*		ST=
RVAD: cannulae location-inflow:*
Specify:*

TAH: device tracking number:*		ST=
TAH: console tracking number:*		ST=

Device Details

Implant Discharge

Implant discharge date:*	mm/dd/yyyy	ST=
Patient discharged to:*
Acute care (ICU / CCU) duration of post-implant stay*	days	ST=
Intermediate/step-down care - duration of post-implant stay:*	days	ST=
Date of approximate discontinuation of inotropes:*
Intervention since implant:*
Type of surgical procedure:*
Type of non-surgical procedure:*
Other cardiac surgical procedure:*
Other procedure:*
Enter type of procedure:*
Enter procedure:*

General Hemodynamics

Heart rate:*

beats per min

ST=

Systolic BP:*

mm Hg

ST=

Diastolic BP:*

mm Hg

ST=

Volume Status (peripheral edema):*

Ascites:*

YES

UNK

ECG rhythm (cardiac rhythm):*

Specify:*

Height:*

in cm

ST=

Weight:*

lbs kg

ST=

Nitric oxide:*

YES

UNK

Laboratory
Sodium:*	mmol/L	ST=
Potassium:*	mEq/L	ST=
Blood urea nitrogen:*	mg/dL	ST=
Creatinine:*	mg/dL	ST=
SGPT/ALT:*	u/L	ST=
SGOT/AST:*	u/L	ST=
LDH:*	U/L	ST=
Total bilirubin:*	mg/dL	ST=
Bilirubin direct:*	mg/dL	ST=
Bilirubin indirect:*	mg/dL	ST=
Albumin:*	g/dL	ST=
Pre-albumin:*	mg/dL	ST=
Cholesterol:*	mg/dL	ST=
If value is outside given range please see 'status' drop down field
Brain natriuretic peptide BNP:*	pg/ml	ST=
If value is outside given range please see 'status' drop down field
NT pro brain natriuretic peptide Pro-BNP:*	pg/ml	ST=
White blood cell count:*	K/uL	ST=

Reticulocyte count:*

ST=

Hemoglobin:*	mg/dL	ST=
Platelet:*	K/uL	ST=
INR:*	international units	ST=

CRP (C Reactive Protein):*	mg/L	ST=
Protein C:*	%	ST=
Protein S:*	%	ST=
Anti-phospholipid (IgG):*	gplu/ml	ST=

Device Parameters
LVAD device type:*
RVAD device type:*

LVAD Device Parameters (pulsatile)
LVAD flow:*	L/min	ST =
LVAD - pump drive pressure (pneumatic devices only):*	mmHg	ST =
LVAD - Select Control Mode:*
LVAD - Fixed - enter rate:*		ST =

LVAD Device Parameters (rotary)
LVAD flow:*	L/min	ST =
LVAD pump speed:*	rpm	ST =
LVAD power (watts):*	watts	ST =
LVAD current (amps):*	amps	ST =

RVAD Device Parameters (pulsatile)
RVAD flow:*	L/min	ST =
RVAD - pump drive pressure (pneumatic devices only):*	mmHg	ST =
RVAD - Select Control Mode:*
RVAD - Fixed - enter rate:*		ST =

RVAD Device Parameters (rotary)
RVAD flow:*	L/min	ST =
RVAD pump speed:*	rpm	ST =
RVAD power (watts):*	watts	ST =
RVAD current (amps):*	amps	ST =

Adverse Event Reminders

Appendix A: Adverse Event Definitions

Cardiac Arrhythmia

Did a documented arrhythmia result in clinical compromise since last INTERMACS report/last followup?*

YES NO UNK

Event Date:*

mm/dd/yyyy

ST=

Type of cardiac arrhythmia:*

Pericardial Fluid Collection

Did a pericardial effusion that required drainage occur since last INTERMACS report/last followup?:*

YES NO UNK

Event date.:*

mm/dd/yyyy

ST=

Signs of tamponade:*

YES

UNK

Method of drainage:*

Surgical Intervention

Cath

Unknown

Hemolysis

Did clinical signs associated with hemolysis (plasma-free hemoglobin PFHgb > 40 mg/dl) occur after the first 72 hours post-implant and since last INTERMACS report/last followup?:*

YES NO UNK

Plasma-free hemoglobin measurement:*

mg/dL

ST=

Hematocrit measurement:*

ST=

Patient has Hyperbilirubinemia (Total Bilirubin > 2 mg/dl):*

YES

UNK

Cause of Hemolysis:*

Other, specify:*

Hepatic Dysfunction

Did Clinical evidence of liver dysfunction since last INTERMACS report/last followup occur beyond 14 days post implant?:*

YES NO UNK

Total bilirubin measurement:*

mg/dL

ST=

SGOT/AST measurement:*

u/L

ST=

SGPT/ALT measurement:*

u/L

ST=

Hypertension

Did onset bp >= 140mm Hg systolic or 90mm Hg diastolic (Pediatric patient: > 95th percentile, see definition) occur since last INTERMACS report/last followup?:*

YES NO UNK

Systolic bp:*

mm Hg

ST=

Diastolic bp:*

mm Hg

ST=

Myocardial Infarction

Did a myocardial infarction occur since last INTERMACS report/last followup/admission?:*

YES NO UNK

Date of event:*

mm/dd/yyyy

ST=

Psychiatric Episode

Did a disturbance in thinking, emotion or behavior that required intervention occur in patient since last INTERMACS report/last followup?:*

YES

UNK

Renal Dysfunction

Did renal dysfunction (by definition) occur since last INTERMACS report/last followup?:*

YES NO UNK

Event date.:*

mm/dd/yyyy

ST=

Dialysis duration:*

weeks

ST=

Peak creatinine measurement:*

mg/dL

ST=

Respiratory Failure

Did an impairment of respiratory function requiring intubation or mechanical ventilation occur since last INTERMACS report/last followup?:*

YES NO UNK

Date of event:*

mm/dd/yyyy

ST=

Intubation duration:*

days

ST=

Was a trachoetomy performed?:*

YES

UNK

Right Heart Failure

Did symptoms or signs of right heart failure occur requiring RVAD implantation or inotropic therapy at least 14 days post implant and since last update?:*

YES NO UNK

Event date.:*

mm/dd/yyyy

ST=

Check all signs/symptoms that apply:*

CVP > 18 mmHg

CI < 2.0 L/min/M2

Ascites

Peripheral Edema

Arterial Non-CNS Thromboembolism

Did an acute perfusion deficit in any non-cerebrovascular organ system occur since last INTERMACS report/last followup?*

YES NO UNK

Date:*

mm/dd/yyyy

ST=

Location:*

Other acute perfusion deficit:*

Confirmation source:*

Anticoagulant therapy at time of event - check all that apply - :*

Specify:*

Wound Dehiscence

Did a disruption of the apposed surfaces of surgical incision require surgical repair since last INTERMACS report/last followup?*

YES NO UNK

Date:*

mm/dd/yyyy

ST=

Other

Did an Other Major Serious Adverse Event occur since last INTERMACS report/last followup?:*

YES NO UNK

Other Major Serious Adverse Event since last INTERMACS report/last followup:

Adverse Events

Was there a major infection?*

YES NO UNK

Was there a neurological dysfunction?*

YES NO UNK

Was there a device malfunction?*

YES NO UNK

Was there a Major Bleeding Event?:*

YES NO UNK

Death

Is the patient deceased?*

YES NO

Death date:*

mm/dd/yyyy

ST=

Was device functioning normally?:*

YES NO UNK

Was there an operation associated with device malfunction?:*

INTERMACS® Screening Log

INTERMACS Eligibility

Reminders:

Patient Demographics

Pre-Implant

Demographics

Medical Support Status

Co-morbidities

General Hemodynamics

Echo Hemodynamics

Swan Hemodynamics

Medications

Laboratory

Medical Condition

Exercise Function

Quality of Life

Trailmaking Data

Implant

Device Information

Device Details

Implant Discharge

General Hemodynamics

Medications

Laboratory

Device Parameters

LVAD Device Parameters (pulsatile)

LVAD Device Parameters (rotary)

RVAD Device Parameters (pulsatile)

RVAD Device Parameters (rotary)

Adverse Event Reminders

Appendix A: Adverse Event Definitions

Cardiac Arrhythmia

Pericardial Fluid Collection

Hemolysis

Hepatic Dysfunction

Hypertension

Myocardial Infarction

Psychiatric Episode

Renal Dysfunction

Respiratory Failure

Right Heart Failure

Arterial Non-CNS Thromboembolism

Venous Thromboembolism Event

Wound Dehiscence

Other

Adverse Events

Death