coordinator training session, march 11, 2012 1 robert kormos, md intermacs co-principal...

Coordinator Training Session, March 11, 2012

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Robert Kormos, MDINTERMACS Co-Principal Investigator

GO TO PAGE 58 in the SITE USERS’ GUIDE

INTERMACS Coordinator Training

March 2012


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Device Malfunction

Device malfunction denotes a failure of one or more of the components of the MCSD system which either directly causes or could potentially induce a state of inadequate circulatory support (low cardiac output state) or death . The manufacturer must confirm device failure. A failure that was iatrogenic or recipient-induced will be classified as an Iatrogenic/Recipient-Induced Failure.

Device failure should be classified according to which components fails as follows:

1) Pump failure (blood contacting components of pump and any motor or other pump actuating mechanism that is housed with the blood contacting components). In the special situation of pump thrombosis, thrombus is documented to be present within the device or its conduits that result in or could potentially induce circulatory failure.

2) Non-pump failure (e.g., external pneumatic drive unit, electric power supply unit, batteries, controller, interconnect cable, compliance chamber)

The Adverse Event: Device Malfunction Form is to be collected at time of event. FDA has set forth regulations regarding these events. For the purposes of submitting adverse event device malfunction information to the FDA, you must enter any device malfunction event that occurs within 72 hours of the event.

Service provided by:INTERMACS


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Device Malfunction:

Specific for each device Added: End of pump life

for causative factor

Page 58 & 59


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Lynne Stevenson, MDINTERMACS Co-Principal Investigator



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Major Infection

A clinical infection accompanied by pain, fever, drainage and/or leukocytosis that is treated by anti-microbial agents (non-prophylactic). A positive culture from the infected site or organ should be present unless strong clinical evidence indicates the need for treatment despite negative cultures. The general categories of infection are listed below:

Localized Non-Device InfectionInfection localized to any organ system or region (e.g. mediastinitis) without evidence of systemic involvement (See sepsis definition), ascertained by standard clinical methods and either associated with evidence of bacterial, viral, fungal or protozoal infection, and/or requiring empirical treatment.

Percutaneous Site and/or Pocket InfectionA positive culture from the skin and/or tissue surrounding the drive line or from the tissue surrounding the external housing of a pump implanted within the body, coupled with the need to treat with antimicrobial therapy when there is clinical evidence of infection such as pain, fever, drainage, or leukocytosis.

Internal Pump Component, Inflow or Outflow Tract InfectionInfection of blood-contacting surfaces of the LVAD documented by positive site culture. (There should be a separate data field for paracorporeal pump that describes infection at the percutaneous cannula site, e.g. Thoratec PVAD).

SepsisEvidence of systemic involvement by infection, manifested by positive blood cultures and/or hypotension.


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Major Infection

Page 60

Causative/Contributing Factors:

REMOVED


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Frank Pagani, MDINTERMACS Co-Principal Investigator



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Neurological Dysfunction

Any new, temporary or permanent, focal or global neurological deficit ascertained by a standard neurological examination (administered by a neurologist or other qualified physician and documented with appropriate diagnostic tests and consultation note). The examining physician will distinguish between a transient ischemic attack (TIA), which is fully reversible within 24 hours (and without evidence of infarction), and a stroke, which lasts longer than 24 hours (or less than 24 hours if there is evidence of infarction). The NIH Stroke Scale (for patients > 5 years old) must be re-administered at 30 and 60 days following the event to document the presence and severity of neurological deficits. Each neurological event must be subcategorized as:

1) Transient Ischemic Attack (acute event that resolves completely within 24 hours with no evidence of infarction)

2) Ischemic or Hemorrhagic Cardiovascular Accident/CVA (event that persists beyond 24 hours or less than 24 hours associated with infarction on an imaging study.)


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Causative/Contributing Factors: REMOVED

Neurological Dysfunction

Page 61


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Neurological categories expanded….more choices

Location of CNS event expanded….more choices

Description of clinical event….REMOVED

Surgical and Drug Interventions….REMOVED


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Robert Kormos, MDINTERMACS Co-Principal Investigator



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MAJOR BLEEDINGAN EPISODE OF SUSPECTED INTERNAL OR EXTERNAL BLEEDING THAT RESULTS IN ONE OR MORE OF THE FOLLOWING:

1. Death,2. Re-operation,3. Hospitalization,4. Transfusion of red blood cells

If TRANSFUSION IS SELECTED, then apply the following rules:During first 7 days post implant:

Adults (≥ 50 kg): ≥ 4U packed red blood cells (PRBC) within any 24 hour period during first 7 days post implant.

After 7 days post implant Any transfusion of packed red blood cells (PRBC) after 7 days

following implant with the investigator recording the number of units given.

Note: Hemorrhagic stroke is considered a neurological event and not as a separate bleeding event.


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Major Bleeding“episode”

Page 64

An “episode” may span several days.

“It is not the transfusion that determines bleeding, but the recognized bleeding event.”---Dr. Kormos

Transfusions for ANEMIA...

Hemolysis & Hemorrhagic Stroke have their own AE Form


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Major Bleeding

Page 64

Causative/Contributing Factors:

REMOVED


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Lynne Stevenson, MDINTERMACS Co-Principal Investigator

GO TO PAGE 86,85 in the SITE USERS’ GUIDE


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Renal DysfunctionTwo categories of renal dysfunction will be identified: Acute Renal DysfunctionAbnormal kidney function requiring dialysis (including hemofiltration) in patients who did not require this procedure prior to implant, or a rise in serum creatinine of greater than 3 times baseline or greater than 5 mg/dL (in children, creatinine greater than 3 times upper limit of normal for age) sustained for over 48 hours.Chronic Renal DysfunctionAn increase in serum creatinine of 2 mg/dl or greater above baseline, or requirement for hemodialysis sustained for at least 90 days.

Hepatic DysfunctionAn increase in any two of the following hepatic laboratory values (total bilirubin, aspartate aminotransferase/AST and alanine aminotranferease/ALT) to a level greater than three times the upper limit of normal for the hospital, beyond 14 days post-implant (or if hepatic dysfunction is the primary cause of death) .


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Now a Triggered Event

Page 70

This AE will be ‘triggered’ based creatinine > 5 mg/dL.


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Page 69

This AE will be ‘triggered’ based on SGPT/ALT > 190 u/L, Total Bilirubin > 5 mg/dL and SGOT/AST > 123 u/L


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Gail Mertz, RN

INTERMACS Nurse Monitor



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Tier 2 Events:Asked During Each Follow-up & Rehospitalization

Pages 66-68


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Cardiac Arrhythmias

Any documented arrhythmia that results in clinical compromise (e.g., diminished VAD flow, oliguria, pre-syncope or syncope) that requires hospitalization or occurs during a hospital stay. Cardiac arrhythmias are classified as 1 of 2 types:

1) Sustained ventricular arrhythmia requiring defibrillation or cardioversion.2) Sustained supraventricular arrhythmia requiring drug treatment or cardioversion

Pericardial Fluid Collection

Accumulation of fluid or clot in the pericardial space that requires surgical intervention or percutaneous catheter drainage. This event will be subdivided into those with clinical signs of tamponade (e.g. increased central venous pressure and decreased cardiac/VAD output) and those without signs of tamponade.


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Myocardial Infarction

Two categories of myocardial infarction will be identified:

Peri-Operative Myocardial InfarctionThe clinical suspicion of myocardial infarction together with CK-MB or Troponin > 10 times the local hospital upper limits of normal, found within 7 days following VAD implant together with ECG findings consistent with acute myocardial infarction. (This definition uses the higher suggested limit for serum markers due to apical coring at the time of VAD placement, and does not use wall motion changes because the apical sewing ring inherently creates new wall motion abnormalities.)

Non-Perioperative Myocardial InfarctionThe presence at > 7 days post-implant of two of the following three criteria: a) chest pain which is characteristic of myocardial ischemia,

b) ECG with a pattern or changes consistent with a myocardial infarction, and c) Troponin or CK (measured by standard clinical pathology/laboratory medicine methods) greater than the normal range for the local hospital with positive MB fraction (≥ 3% total CK). This should be accompanied by a new regional LV or RV wall motion abnormality on a myocardial imaging study.


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Psychiatric Episode

Disturbance in thinking, emotion or behavior that causes substantial impairment in functioning or marked subjective distress requiring intervention. Intervention is the addition of new psychiatric medication, hospitalization, or referral to a mental health professional for treatment. Suicide is included in this definition.

Respiratory Failure

Impairment of respiratory function requiring reintubation, tracheostomy or (for patients older than age 5 years) the inability to discontinue ventilatory support within six days (144 hours) post-VAD implant. This excludes intubation for re-operation or temporary intubation for diagnostic or therapeutic procedures.


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Venous Thromboembolism

Evidence of venous thromboembolic event (e.g. deep vein thrombosis, pulmonary embolism) by standard clinical and laboratory testing.

Wound Dehiscence

Disruption of the apposed surfaces of a surgical incision, excluding infectious etiology, and requiring surgical repair.


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Arterial Non-CNS Thromboembolic Event

An acute systemic arterial perfusion deficit in any non-cerebrovascular organ system due to thromboembolism confirmed by one or more of the following:

1) standard clinical and laboratory testing2) operative findings3) autopsy findings

This definition excludes neurological events.

Other SAE An event that causes clinically relevant changes in the patient’s health (e.g. cancer).


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Hypertension

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). Pediatric patients: for patients under 18 years of age weighing < 50 kg, hypertension is defined as systolic, diastolic, or mean blood pressure greater than the 95 th percentile for age which requires the addition of iv or oral therapy for management.

Triggered Event

Page 69


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Robert Kormos, MD Frank Pagani, MD

INTERMACS Co-Principal Investigators



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Right Heart FailureSymptoms and signs of persistent right ventricular dysfunction [central venous pressure (CVP) > 18 mmHg with a cardiac index <2.3 L/min/m2 in the absence of elevated left atrial/pulmonary capillary wedge pressure (greater than 18 mmhg), tamponade, ventricular arrhythmias or pneumothorax] requiring RVAD implantation; or requiring inhaled nitric oxide or inotropic therapy for a duration of more than 1 week at any time after LVAD implantation.” LEVEL OF RIGHT HEART FAILURE

Severe RHF: RVAD

Moderate RHF: Inotrope or intravenous or inhaled pulmonary vasodilator (e.g. prostaglandin E or inhaled nitric oxide)

Mild RHF: Meets 2 of the 4 clinical criteria listed below CVP > 18 mmHg or mean RA pressure > 18 mmHg CI < 2.3 L/min/MW2 (by Swan) Ascites or evidence of moderate to worse peripheral edema Evidence of elevated CVP by echo (dilated VC, IVS with collapse), physical exam (signs of increased jugular venous pressure)


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Page 71


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After the follow up form is submitted, this screen will appear for triggered events.

New Version


March 2012

Kathy Grady, PhD, APNChair of Quality of Life Committee

Darlene Schmuhl, RNCleveland Clinic




March 2012

MobilityI have no problems in walking about I have some problems in walking about I am confined to bed Self-CareI have no problems with self-care I have some problems washing or dressing myself I am unable to wash or dress myself Usual Activities (e.g. work, study, housework, family orleisure activities)I have no problems with performing my usual activities I have some problems with performing my usual activities I am unable to perform my usual activities Pain/DiscomfortI have no pain or discomfort I have moderate pain or discomfort I have extreme pain or discomfort Anxiety/DepressionI am not anxious or depressed I am moderately anxious or depressed I am extremely anxious or depressed

EQ-5D-3LHealth QuestionnaireEnglish version for the US

Patient Instruments: EQ-5D-3LPatient Instruments: EQ-5D-3L

EuroQol Group, 1990INTERMACS Coordinator T

raining

March 2012

Additional Patient QuestionsAdditional Patient Questions(page 4, attached to the EQ-5D-3L)(page 4, attached to the EQ-5D-3L)

2 Versions: (sample questions)

PRE IMPLANT FORM Please answer questions #1-8 below, so as to provide with us with some additional information.

7. How confident are you that you can do the tasks and activities needed to manage your heart failure so as to reduce how much having heart failure affects your everyday life? 1 2 3 4 5 6 7 8 9 10 Not at all confident Totally confident 8. How satisfied are you with the outcome of your therapy for heart failure during the past 3 months?

1 2 3 4 5 6 7 8 9 10 Not satisfied Very satisfied

POST IMPLANT FORM Please answer questions #1-9 below, so as to provide with us with some additional information.

7. How confident are you that you can do the tasks and activities needed to manage your ventricular assist device so as to reduce how much having a ventricular assist device affects your everyday life?

1 2 3 4 5 6 7 8 9 10 Not at all confident Totally confident 8. How satisfied are you with the outcome of your ventricular assist device surgery, during the past 3 months?

1 2 3 4 5 6 7 8 9 10 Not satisfied Very satisfied

9. If you had to do it all over again, would you decide to have a ventricular assist device know what you know now? 1 2 3 4 5

definitely no probably no not sure probably yes definitely yesINTERMACS Coordinator T

raining

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Kansas City Cardiomyopathy QuestionnaireKansas City Cardiomyopathy Questionnaire• 23 items (measures health status in heart failure patients)

• Dimensions and 2 summary scores- symptoms (frequency & severity) - self-efficacy- physical limitations - quality of life- social limitations

Clinical summary: Physical limitations and symptoms Overall summary: Clinical summary + social limitations and

QOL

• Response Format- Likert scale (5-7 point range)

• Scoring- range = 0-100; higher score = fewer symptoms, better function, better QOL

• Psychometrics- reliable and valid in HF patients KCCQ, Spertus J, et al. 2000 KCCQ, Spertus J, et al. 2000


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Schedule for Data CollectionSchedule for Data Collection

• Administer the pre implant QOL forms as soon as possible after consent is obtained.• If consent is obtained after MCS implant, administer the first post-implant forms at the next time period due (e.g., 3 months)


March 2012

ProceduresProcedures• Administer the QOL forms to adult patients (> 19 years).

• Patients are to complete forms via self-report and independently- If unable, the questionnaires may be read to patients by the

coordinator or family members (no coaching)- Indicate if forms were self-administered or completed verbally on the forms

• Research coordinators will review all questionnaires for data errors (e.g., missing or unclear data) with patients at the time of forms completion.

- Corrections must be made with patients at that time.

• Regarding non-completion of questionnaires If patients do not complete questionnaires, research coordinators will enter the reason why.

• Missing QOL Data Form Sample reasons:_____ Too sick_____ No time / too busy_____ Coordinator too busy or forgot


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What is the best way to deal with missing data?What is the best way to deal with missing data?


March 2012

Avoiding Missing dataAvoiding Missing dataStatistical issues regarding missing data

Fewer observations → loss of power

Nonrandom missing data → bias

Primary prevention• Although there are analytic strategies for dealing with missing data, their use is much less satisfactory than initial prevention.

• Some missing data, such as that due to death, is not preventable.

• Note: a common reason for questionnaire non-completion is staff perception that the patient is too ill to complete questionnaires. To minimize bias by selecting out these patients, all patients (within reason) should be asked to complete questionnaires.

• Thus, missing data should be minimized for INTERMACS.

• Tips to encourage questionnaire completion:• Educate patients about the importance of completing QOL questionnaires.

• E.g., “We want to know more about the quality of life of patients as they participate in this registry and the only way to know is to ask you. It takes about ___ minutes to complete the questionnaires.”

Secondary preventionINTERMACS Coordinator T

raining

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0.0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

0 3 6 9 12 15 18 21 24

Months Post Implant

Pro

po

rtio

n o

f P

atie

nts

Pre-implant

83%

69%

50%

8%9%

0%

19%

11%

1%

34%

15%1%

41

Primary Continuous Flow LVADs: June 2006 – March 2010 (n=1559)

Alive (device in place)

Txpl

Dead

Recovery


March 2012

Status of Patients at 1 year post implant by patient profile levels, n=1559

Patient Profile Levels (Pre-Implant) 1 2 3 4 5-7 Total

EQ-5D status at 1 year n= 262 n=695 n=330 n=175 n=97 n=1559 1 Year Form not addressed* 157 377 169 86 45 834

Patient not seen in clinic No 4 20 12 9 5 50 1 yr Follow-up ‘Due’ 11 9 12 3 3 38 Patient Seen in clinic 90 289 137 77 44 637Did Pt complete EQ-5D?

Yes 46 169 91 51 29 386Unknown 3 12 2 0 3 20 No 41 108 45 26 12 232

Reasons EQ-5D incomplete Too Sick 3 4 6 3 1 17

Pt unavailable 0 3 0 3 1 7Did not contact 7 29 12 5 1 54Unknown 12 35 10 7 4 68Reason missing 9 7 4 3 1 24Other 10 30 12 5 4 61

* Patient died, transplanted, recovery, device exchange or transferred before 1 year42

Primary Continuous Flow LVADs: June 2006 – March 2010 (n=1559)


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Pages 72-74 All Adult patients should complete the QOL

instruments. New Addition: KCCQ KCCQ: Kansas City Cardiomyopathy

Questionnaire Collected: pre-implant, 3 months, 6 months &

q6 months thereafter


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Page 74

Please Read Administrative Reason Additions


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Jo Ann Lindenfield, MD



March 2012

Why do a 15 foot walkfor gait speed

• It provides additional data to the V02 exercise test and the 6 minute walk

• It can often be done when V02 and 6 minute walk are not feasible

• It is highly predictive ( at least in those over 60 years) of mortality, duration of hospitalization, discharge to a SNF or NH, long term disability in community elderly and those undergoing cardiac surgery


March 2012

Gait Speed adds Predictive Ability to the STS Risk Score

Afilalo J et al. JACC 2010; 56: 1668-76INTERMACS Coordinator T

raining

March 2012

How to perform the 15 foot walk

• A well lit unobstructed area used for the 6 minute walk

• You will time the first 15 feet of the 6 minute walk and the total 6 minutes

• You will need two stopwatches or a double stopwatch

• Mark end of 15 feet from “0” line

• Take the time to go from 0-15 feet and time for total 6 minute walk


March 2012

How to perform the 15 foot walk• Subjects in comfortable walking clothing

• May use cane or walker

• If require IV pole will need another person

• Walk at a comfortable pace—do not slow down at the marker but continue for total of 6 minutes

• Patient’s foot is on the “0” marker

• Start on the word go

• Stop the stopwatch with first footfall after the 15 foot line

• Record time in tenths of seconds, i.e. 6.3 secINTERMACS Coordinator Training

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Kathy Grady, PhD, APN

GO TO PAGE in the SITE USERS’ GUIDE


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Neurocognitive function is to be measured by the Trail-Making Part B test.

Patients age 19 years and older, at the time of implant will be asked to complete this test

Administered at pre-implant,post implant (3 months, 6 months and q 6 months therafter)

After the subject completes Part B, take the test sheet and record the time in seconds.

If the patient completes the test, but the test is considered invalid, select “completed but invalid (score not entered).”

Do not allow the patient to retake the test.


March 2012

coordinator training session, march 11, 2012 1 robert kormos, md intermacs co-principal...

Documents

coordinator training

device failure

device malfunction event

nonpump failure

device malfunction form

circulatory failure

clinical evidence of

end of pump life