What have we learned? What is next? Panel A: Adverse Events A. Bleeding B. Device Function and Malfunction C.Neurological Dysfunction D.Impact of INTERMACS

What have we learned? What is next?

Panel A: Adverse EventsA. BleedingB. Device Function and MalfunctionC.Neurological DysfunctionD.Impact of INTERMACS ProfilesE.Right Heart FailureF.Discussion

Research Topics in INTERMACS

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Adverse EventsAdverse Events

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At this point in the meeting are you beginning to feel like this?

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Adverse Event: Major Bleeding

R Kormos


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Coordinator Training Session, March 11, 2012

5

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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Jun 2006 – Sept 2010: Risk for Early Bleeding

Adult Primary LVADs, Bi-VADs, TAH: n=3140

Months after Implant

% F

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Event: First Bleeding Episode

LVAD Continuous /Intracorporeal n=2130, events=780

LVAD Pulsatile/Intracorporealn=521, events=212

p < .0001

LVAD Pulsatile/Extracorporeal, n=93, events=45TAH, n=85, events=38

Bi-VAD, n=311, events=184

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% F

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LVAD Continuous /Intracorporeal n=2130, events=780 LVAD Pulsatile/Intracorporeal

n=521, events=212

p < .0001

LVAD Pulsatile/Extracorporeal, n=93, events=45TAH, n=85, events=38

Bi-VAD, n=311, events=184

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Adult Primary Pulsatile Intracorporeal LVADs: n=521


% F

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1) Cardiogenic Shockn=172, events=78

2) Progressive Declinen=218, events=90

p = .06

INTERMACS Patient Profile Levels3) Stable but Inotrope Dependent

n=54, events=194) Levels 4 – 7

n=77, events=25

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Adult Primary Continuous Intracorporeal LVADs n=2130


% F

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Age < 60 yearsn=1349, events=426

Age 60+ yearsn=781, events=354

p < .0001

Age

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% F

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Concommitant Surgeryn=178, events=89

No Concommitant Surgeryn=343, events=123

p = .0006

Concommitant Surgery at time of

implant

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Location of 1st Bleeding Pulsatile ContinuousEpisode n % n %

Mediastinal 34 49% 221 39%Chest wall 6 9% 39 7%Thoracic plural space 7 10% 59 10%Pump pocket 0 0% 33 6%Device anastomosis 1 1% 9 2%Outflow or inflow conduit 3 4% 16 3%Aortic or venous cann site 2 3% 4 1%

Intra abdominal 1 1% 4 1%

Respiratory 1 1% 5 1%Urinary tract 0 0% 4 1%

Upper GI 3 4% 54 9%

Lower GI 9 13% 7213%

Other 13 19% 184 32%Total 70 100% 569 100%

Mar 5 2009 – Sept 2010: Risk for Early Bleeding

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Risk Factor Hazard Ratio P-value Age (older)1 1.26 < .0001NYHA Class IV 1.40 .004Bilirubin (higher)2 1.05 .02Dialysis 1.66 .006Previous CABG 1.35 .002INTERMACS Level 1 1.53 .0001INTERMACS Level 2 1.33 .002Concommitant Surgery 1.44 < .0001(Pulsatile Pump 1.15 .14)

Pre-Implant Risk Factors for 1st Bleeding Episode

1The hazard ratio is calculated for a 10 year increase in age2The hazard ratio is calculated for a 1 unit increase


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Adverse Event: Major Bleeding

What are the Next Steps?

• Device Evaluation and Development

• Improving Patient Outcomes

• Is GI bleeding an issue


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Adverse Event: Device Function and Malfunction

R Kormos


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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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INTERMACS: June 2006 – March 2010: Device Exchange

Adult Prospective Primary Intracorporeal LVADs, n=1930


% F

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Ex

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Event: First Device Exchange

LVAD Continuous /Intracorporeal n=1446, events=30

LVAD Pulsatile/Intracorporealn=469, events=55

p < .0001

Note: 15 patients have missing intervals INTERMACS A

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Adverse Event: Device Malfunction

What are the Next Steps?• Improving Data Acquisition

• Analysis based upon patient factors

• Demographics including social issues

• Perceived compliance

• Analysis based upon component


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Adverse Event: Neurological Dysfunction

F Pagani


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Adverse Event: Neurological Dysfunction


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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Magnitude of the ProblemAdverse Event: Neurological Dysfunction


• The most significant complication of MCS therapy impacting survival, functional status, and QOL.– significant impact on caretaker burden and family.

• The most significant concern in the consideration of MCS therapy for treatment of advanced HF in a less ill population of patients.– Improvements in functional status and QOL likely to

outweigh survival benefit– Occurrence of stroke not outweighed by large survival

benefit• Adds significant costs to care.

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INTERMACS: June 2006 – September 2009: Neurological Dysfunction

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PF-Intracorporeal, n=470, neuro events=93

p<.0001Event: First Neurological Event%

Fre

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Months after Device Implant

CF-Intracorporeal, n=896, neuro events=78

Adult Primary Intracorporeal LVADs: 1366

Hazard ratio (unadjusted) = 3.53, p < .0001

Hazard ratio (adjusted) = 2.11, p =.007

• What have we learned from INTEMACS– Importance of device technology

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> 65 yrs, n=141, neuro events=10

Event: First Neurological Event% F

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40 – 65 yrs, n=615, neuro events=5219 - 40 yrs, n=140,

neuro events=16

p = .5

Adult Primary Continuous Intracorporeal LVADs: 896 By Age Groups


• What have we learned from INTEMACS─ Age alone, does not appear to be an independent risk factor for

neurological event

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IMACS 3, n=172, neuro events=12

Event: First Neurological Event% F

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p = .08

Adult Primary Continuous Intracorporeal LVADs (n=896) By INTERMACS Patient Profile

IMACS 4-7, n=156, neuro events=15

• What have we learned from INTEMACS─ Severity of illness correlates with risk of neurological event

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Early Constant

Risk Factor Hazard ratio p-value Hazard ratio p-valueFemale 2.16 0.002 --- ---Ascites 2.33 0.007 --- ---Cardiogenic Shock 2.45 0.0002 --- --- Destination Therapy 3.05 0.0002 --- ----

Cholesterol (higher) 1.11 0.0003RA Pressure (higher) 1.78 0.0006 --- --- Ventilator 2.20 0.01

Concomitant Surgery 1.88 0.008Pulsatile pump 2.11 0.007

1 Hazard ratio denotes the increased risk with a 20 year increase in age2 Hazard ratio denotes the increased risk with a 1.0 increase in INR

3 Hazard ratio denotes the increased risk of a 10-unit increase in RA pressure


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Neurological Dysfunction – Next Steps


• Patient Selection / Patient Management

– Relationship of stroke risk to occurrence of other AE’s, e.g., infection, hemolysis, pump thrombosis.

• Preliminary data supporting increase risk of stroke in patients with infectious complications

– Timing of the stroke risk in relationship to the infection?

– Specific types of infectious complications that increase stroke risk? e.g., bacteremia vs. device-related vs. non-device-related

– Alteration in management of anticoagulation / antiplatelet therapy

• Preliminary data supporting increase risk of stroke in patients experiencing hemolysis

– What is the natural history of patients experiencing hemolysis?

– Pre-emptive pump replacement vs medical therapy; e.g., lytic therapies

• GI Bleeding

– Frequently withholding or reducing optimal target INR goal

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Neurological Dysfunction – Next Steps


• Patient Selection / Patient Management

– Perioperative risk factors for strokes

• Atrial fibrillation

– Management of the atrial appendage at the time of operation

• Mechanical valve prosthesis in the mitral position

– Replacement with a biological prosthesis at the time of LVAD implant

• Evaluation of New Technology

– Continuous flow pumps with centrifugal design

• Comparison to CF pumps with axial design

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Impact of INTERMACS Profiles

L Stevenson


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INTERMACS® Patient Profile at time of implant: Select one. These profiles will provide a general clinical description of the patients receiving implants. If there is significant clinical change between the initial decision to implant and the initial decision to implant and the actual implant procedure, then the profile closest to the time of implant should be recorded. Patients admitted electively for implant should be described by the profile just prior to admission. INTERMACS® 1: Critical cardiogenic shock describes a patient who is “crashing and burning”,in which a patient has life-threatening hypotension and rapidly escalating inotropic pressor support, with critical organ hypoperfusion often confirmed by worsening acidosis and lactate levels. This patient can have modifier A or TCS (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 have modifiers A or TCS. 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, and if in the hospital with circulatory support can have modifier TCS. 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 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.


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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 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. TCS –Temporary Circulatory Support. This modifier can modify only patients who are confined to the hospital, Patient Profiles 1, 2, and 3 (a patient who is listed as Patient Profile 3 stable on inotropes who has been at home until elective admission for implantable VAD cannot have a TCS modifier.)Support includes IABP, ECMO, TandemHeart, Levitronix, BVS 5000 or AB5000, Impella. 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


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Patients with Critical Cardiogenic Shock(INTERMACS Patient Profile Level 1)

INTERMACS: June 2006 – September 2009: Changing Characteristics

Adult Primary LVADs and Bi-VADs: n=1646

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Era 1 Era 2 Era 3 Era 4

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Jul 06 – Jun 07 Jul 07 – Mar 08 Apr 08 – Dec 08 Jan 09 – Sep 09

p<0.0001

40% 46% 28% 21%

Implant EraIN

TERMACS Annual M

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0 3 6 9 12 15 18 21 24Months after Device Implant

% S

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p (overall) = .01

Level 2 (Progressive Decline), n=304, deaths=79

Level 3 (Stable but Inotrope Dependent), n=110, deaths=18

Level 4 (Resting symptoms), n=83, deaths=16

Level 1 (Critical Cardiogenic Shock), n=221, deaths=62

Event: Death (censored at transplant or explant recovery)

INTERMACS: June 2006 – September 2009: Pt Profile Study

Adult Primary LVADs: BTC, DT and Levels 1-4 - n=718

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1) Cardiogenic Shockn=172, events=78

2) Progressive Declinen=218, events=90

p = .06

INTERMACS Patient Profile Levels3) Stable but Inotrope Dependentn=54, events=19

4) Levels 4 – 7 n=77, events=25

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Impact of INTERMACS Profiles

What are the Next Steps?

• Improving Patient Selection and Outcomes

• Device Evaluation and Development


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Adverse Event: Right Heart Failure

F Pagani, R Kormos


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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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Magnitude of the ProblemAdverse Event: Right Heart Failure

• Significant perioperative adverse event• Reduces overall MCS survival

– Survival to transplant adversely influenced• Increases cost, length of stay and hospital resource

utilization

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Pre-Implant Patient Profile LVAD (n=1440) Bi-VAD (n=206)

1 Critical Cardiogenic Shock 380 (26%) 112 (54%) 2 Progressive Decline 612 (43%) 78 (38%)

3 Stable but Inotrope dependent 226 (16%) 9 (4%)

4 Recurrent Advanced HF 150 (10%) 4 (2%)

5 Exertion Intolerant 27 (2%) 1 (1%)

6 Exertion Limited 22 (1%) 2 (1%)

7 Advanced NYHA Class III 23 (2%) 0 (0%)

Total 1440 (100%) 216 (100%)

p < .0001

* Total Artificial Heart devices (TAH) are excluded from this table

Adult Primary Implants, n=1706

INTERMACS: June 2006 – September 2009: Bi-VAD Study

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Bi-VAD Categories (LVAD/RVAD) n (%)

Durable/Durable 160 (78%)

Continuous Flow Device/Durable 4 (2%)

Pulsatile Flow Device/Durable 156 (75%)

Durable/Temporary 46 (22%)

Continuous Flow Device/Temporary 26 (13%)

Pulsatile Flow Device/Temporary 20 (10%)

Total 206 (100%)

Adult Primary Bi-VAD Implants, n=206

INTERMACS: June 2006 – September 2009: Bi-VAD Study

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Implant Dates: June 2006 – September 2009: Bi-VAD Study

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% S

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Bi-VAD n=206, deaths=73

p < .0001

• What have we learned from INTEMACS─ Survival significantly worse with the need for BiVAD

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30 – 65 yrs n = 160, deaths=63


Event: Death (censored at transplant or explant recovery)

< 30 yrs n=27deaths=3

p=.05

> 65 yrs n=19, deaths=7

Implant Dates: June 23, 2006 – September 30, 2009

• What have we learned from INTEMACS─ Survival favorably influenced by younger age

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Infection Bleeding Neurological DeviceMalfunction

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2.6 2.0

Bi-

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LV

AD

Adverse Event Rates within the 1st 12 months post implantPrimary LVADS v BiVADs: n=1646


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Risk Factor Relative Risk p-value

Age (older) 1.56 < 0.0001

BSA (higher) 4.85 0.0008

Ascites 2.28 0.004

Creatinine (higher) 1.05 0.0001

Bilirubin (higher) 2.64 0.001

INR (higher) 1.51 0.004

History of valve surgery 6.01 < 0.0001

Failure to wean from bypass 7.52 < 0.0001


All Adult Primary BIVADs: n=206

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Right Heart Failure – Next Steps


• Patient Management

– Need to identify improved methodology for assessment of the RV

– Need to define perioperative risk factors for RV Failure

• Severe

• Moderate

• Mild

– Need to accurately define / identify reversible and irreversible forms of right heart failure

• Identify patients with the ability to recover

– Impact on patient management: Durable vs. Temporary forms of RV support

– Perioperative factors identifying likelihood of RV recovery

• “Failure to thrive” syndromes and its relationship to right heart failure

• Evaluation of New Technology

– Smaller CF devices provide the option of long-term BiVAD support

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What have we learned? What is next?

Panel A: Adverse EventsA. BleedingB. Device Function and MalfunctionC.Neurological DysfunctionD.Impact of INTERMACS ProfilesE.Right Heart FailureF.Panel Discussion Kormos


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Documents

What have we learned? What is next? Panel A: Adverse Events A. Bleeding B. Device Function and Malfunction C.Neurological Dysfunction D.Impact of INTERMACS