INTERMACS Annual Meeting

INTERMACS Annual Meeting
Research Topics in INTERMACS What have we learned? What is next? Panel A: Adverse Events A. Bleeding B. Device Function and Malfunction Neurological Dysfunction Impact of INTERMACS Profiles Right Heart Failure Discussion INTERMACS Annual Meeting March 2012 1

Adverse Events INTERMACS Annual Meeting March 2012

At this point in the meeting are you beginning to feel like this?
INTERMACS Annual Meeting March 2012

Research Topics in INTERMACS INTERMACS Annual Meeting
Adverse Event: Major Bleeding R Kormos INTERMACS Annual Meeting March 2012 4

Coordinator Training Session, March 11, 2012 INTERMACS Annual Meeting
BLEEDING MAJOR BLEEDING AN 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. Note: Mention that the Eligibility Form is removed and incorporated with the Screening Log INTERMACS Annual Meeting March 2012 5

BLEEDING Coordinator Training Session, March 11, 2012 Major Bleeding
“episode” Page 64 An “episode” may span several days. Transfusions for ANEMIA... “It is not the transfusion that determines bleeding, but the recognized bleeding event.”---Dr. Kormos Note: Mention that the Eligibility Form is removed and incorporated with the Screening Log Hemolysis & Hemorrhagic Stroke have their own AE Form INTERMACS Annual Meeting March 2012 6

Jun 2006 – Sept 2010: Risk for Early Bleeding
Adult Primary LVADs, Bi-VADs, TAH: n=3140 LVAD Continuous /Intracorporeal n=2130, events=780 LVAD Pulsatile/Intracorporeal n=521, events=212 % Freedom from Bleeding LVAD Pulsatile/Extracorporeal, n=93, events=45 TAH, n=85, events=38 This actuarial goes out to 48 months. The abstract actually talks about bleeding during the 1st year. Therefore, the next slide is the same as this slide except it stops at 12 months and has a vertical line at 1 month to use as a reference line. All subsequent actuarials stop at 12 months. You will see a collection of slides at the end of this file that go to 48 months but we expect that you will not want to use them. Bi-VAD, n=311, events=184 p < .0001 INTERMACS Annual Meeting March 2012 Event: First Bleeding Episode Months after Implant

Jun 2006 – Sept 2010: Risk for Early Bleeding
Adult Primary LVADs, Bi-VADs, TAH: n=3140 LVAD Continuous /Intracorporeal n=2130, events=780 LVAD Pulsatile/Intracorporeal n=521, events=212 % Freedom from Bleeding LVAD Pulsatile/Extracorporeal, n=93, events=45 TAH, n=85, events=38 Bi-VAD, n=311, events=184 p < .0001 INTERMACS Annual Meeting March 2012 Event: First Bleeding Episode Months after Implant

INTERMACS Patient Profile Levels
Jun 2006 – Sept 2010: Risk for Early Bleeding Adult Primary Pulsatile Intracorporeal LVADs: n=521 INTERMACS Patient Profile Levels 3) Stable but Inotrope Dependent n=54, events=19 4) Levels 4 – 7 n=77, events=25 % Freedom from Bleeding 2) Progressive Decline n=218, events=90 1) Cardiogenic Shock n=172, events=78 p = .06 Event: First Bleeding Episode INTERMACS Annual Meeting March 2012 Months after Implant

Age Jun 2006 – Sept 2010: Risk for Early Bleeding
Adult Primary Continuous Intracorporeal LVADs n=2130 Age Age < 60 years n=1349, events=426 % Freedom from Bleeding Age 60+ years n=781, events=354 p < .0001 Event: First Bleeding Episode INTERMACS Annual Meeting March 2012 Months after Implant

Concommitant Surgery at time of implant
Jun 2006 – Sept 2010: Risk for Early Bleeding Adult Primary Pulsatile Intracorporeal LVADs, n= 521 Concommitant Surgery at time of implant No Concommitant Surgery n=343, events=123 % Freedom from Bleeding Concommitant Surgery n=178, events=89 p = Event: First Bleeding Episode INTERMACS Annual Meeting March 2012 Months after Implant

Location of 1st Bleeding Pulsatile Continuous Episode n % n %
Mar – Sept 2010: Risk for Early Bleeding Location of 1st Bleeding Pulsatile Continuous Episode n % n % Mediastinal % % Chest wall % % Thoracic plural space % % Pump pocket % % Device anastomosis % % Outflow or inflow conduit % % Aortic or venous cann site % % Intra abdominal % % Respiratory % % Urinary tract % % Upper GI % % Lower GI % % Other % % Total % % Note: Recall that INTERMACS did not start recording the location of the bleeding episode until March 5, Also, recall that Heartmate II was approved in April of Therefore, the pulsatile pumps are under-represented in this table. Also, recall that bleeding location is “check all that apply” variable. Therefore, the sum of the locations are greater than the total number of episodes. INTERMACS Annual Meeting March 2012

Pre-Implant Risk Factors for 1st Bleeding Episode
Jun 2006 – Sept 2010: Risk for Early Bleeding Pre-Implant Risk Factors for 1st Bleeding Episode Risk Factor Hazard Ratio P-value Age (older) < .0001 NYHA Class IV Bilirubin (higher) Dialysis Previous CABG INTERMACS Level INTERMACS Level Concommitant Surgery < .0001 (Pulsatile Pump ) Note: We included pulsatile pump in this table so that you can see that it is not a risk factor after adjustment for the significant risk factors. Therefore, you might be willing to conclude that bleeding is more a function of patient characteristics and having an implant rather than a function of the pump flow type. Your original conclusions in the abstract reflect this quite well. INTERMACS Annual Meeting March 2012 1The hazard ratio is calculated for a 10 year increase in age 2The hazard ratio is calculated for a 1 unit increase

Adverse Event: Major Bleeding
Research Topics in INTERMACS Adverse Event: Major Bleeding What are the Next Steps? Device Evaluation and Development Improving Patient Outcomes Is GI bleeding an issue INTERMACS Annual Meeting March 2012 14

Research Topics in INTERMACS INTERMACS Annual Meeting
Adverse Event: Device Function and Malfunction R Kormos INTERMACS Annual Meeting March 2012 15

DEVICE MALFUNCTION 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: ) 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) Note: Mention that the Eligibility Form is removed and incorporated with the Screening Log 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. INTERMACS Annual Meeting March 2012 Service provided by: INTERMACS 16

DEVICE MALFUNCTION Note: Mention that the Eligibility Form is removed and incorporated with the Screening Log INTERMACS Annual Meeting March 2012 17

DEVICE MALFUNCTION Note: Mention that the Eligibility Form is removed and incorporated with the Screening Log INTERMACS Annual Meeting March 2012 18

INTERMACS: June 2006 – March 2010: Device Exchange
Adult Prospective Primary Intracorporeal LVADs, n=1930 LVAD Continuous /Intracorporeal n=1446, events=30 % Freedom from Device Exchange LVAD Pulsatile/Intracorporeal n=469, events=55 p < .0001 Event: First Device Exchange INTERMACS Annual Meeting March 2012 Months after Implant Note: 15 patients have missing intervals

Adverse Event: Device Malfunction
Research Topics in INTERMACS 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 INTERMACS Annual Meeting March 2012 20

Research Topics in INTERMACS Adverse Event: Neurological Dysfunction F Pagani INTERMACS Annual Meeting March 2012 21

Adverse Event: Neurological Dysfunction NEUROLOGICAL DYSFUNCTION
Research Topics in INTERMACS Adverse Event: Neurological Dysfunction 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: Transient Ischemic Attack (acute event that resolves completely within 24 hours with no evidence of infarction) Ischemic or Hemorrhagic Cardiovascular Accident/CVA (event that persists beyond 24 hours or less than 24 hours associated with infarction on an imaging study.) INTERMACS Annual Meeting March 2012 22

Magnitude of the Problem Adverse Event: Neurological Dysfunction
Research Topics in INTERMACS Magnitude of the Problem Adverse 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. INTERMACS Annual Meeting March 2012 23

INTERMACS: June 2006 – September 2009: Neurological Dysfunction
What have we learned from INTEMACS Importance of device technology PF-Intracorporeal, n=470, neuro events=93 p<.0001 Event: First Neurological Event % Free from Neurological Event 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 INTERMACS Annual Meeting March 2012

What have we learned from INTEMACS Age alone, does not appear to be an independent risk factor for neurological event > 65 yrs, n=141, neuro events=10 Event: First Neurological Event % Free from Neurological Events Months after Device Implant 40 – 65 yrs, n=615, neuro events=52 yrs, n=140, neuro events=16 p = .5 Adult Primary Continuous Intracorporeal LVADs: 896 By Age Groups INTERMACS Annual Meeting March 2012

What have we learned from INTEMACS Severity of illness correlates with risk of neurological event IMACS 3, n=172, neuro events=12 Event: First Neurological Event % Free from Neurological Events Months after Device Implant IMACS 2, n=396, neuro events=28 IMACS 1, n=172, neuro events=23 p = .08 Adult Primary Continuous Intracorporeal LVADs (n=896) By INTERMACS Patient Profile IMACS 4-7, n=156, neuro events=15 INTERMACS Annual Meeting March 2012

Risk Factor Hazard ratio p-value Hazard ratio p-value
INTERMACS: June 2006 – September 2009: Neurological Dysfunction Early Constant Risk Factor Hazard ratio p-value Hazard ratio p-value Female Ascites Cardiogenic Shock Destination Therapy Cholesterol (higher) RA Pressure (higher) Ventilator Concomitant Surgery Pulsatile pump 1 Hazard ratio denotes the increased risk with a 20 year increase in age 2 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 INTERMACS Annual Meeting March 2012

Neurological Dysfunction – Next Steps
Research Topics in INTERMACS 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 INTERMACS Annual Meeting March 2012 28

Neurological Dysfunction – Next Steps
Research Topics in INTERMACS 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 INTERMACS Annual Meeting March 2012 29

Research Topics in INTERMACS Impact of INTERMACS Profiles L Stevenson INTERMACS Annual Meeting March 2012 30

Research Topics in INTERMACS 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. INTERMACS Annual Meeting March 2012 31

Research Topics in INTERMACS 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 INTERMACS Annual Meeting March 2012 32

% of Patients with Pt Profile Level 1 INTERMACS Annual Meeting
INTERMACS: June 2006 – September 2009: Changing Characteristics Adult Primary LVADs and Bi-VADs: n=1646 Patients with Critical Cardiogenic Shock (INTERMACS Patient Profile Level 1) p<0.0001 % of Patients with Pt Profile Level 1 40% 46% 28% 21% INTERMACS Annual Meeting March 2012 Jul 06 – Jun 07 Jul 07 – Mar 08 Apr 08 – Dec 08 Jan 09 – Sep 09 Implant Era

INTERMACS Annual Meeting Months after Device Implant
INTERMACS: June 2006 – September 2009: Pt Profile Study Adult Primary LVADs: BTC, DT and Levels n=718 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 % Survival Level 2 (Progressive Decline), n=304, deaths=79 p (overall) = .01 Event: Death (censored at transplant or explant recovery) INTERMACS Annual Meeting March 2012 Months after Device Implant

% Freedom from Bleeding INTERMACS Annual Meeting
Jun 2006 – Sept 2010: Risk for Early Bleeding Adult Primary Pulsatile Intracorporeal LVADs: n=521 INTERMACS Patient Profile Levels 3) Stable but Inotrope Dependent n=54, events=19 4) Levels 4 – 7 n=77, events=25 % Freedom from Bleeding 1) Cardiogenic Shock n=172, events=78 2) Progressive Decline n=218, events=90 p = .06 Event: First Bleeding Episode INTERMACS Annual Meeting March 2012 Months after Implant

Research Topics in INTERMACS Impact of INTERMACS Profiles What are the Next Steps? Improving Patient Selection and Outcomes Device Evaluation and Development INTERMACS Annual Meeting March 2012 36

Adverse Event: Right Heart Failure INTERMACS Annual Meeting
Research Topics in INTERMACS Adverse Event: Right Heart Failure F Pagani, R Kormos INTERMACS Annual Meeting March 2012 37

Coordinator Training Session, March 11, 2012 RIGHT HEART FAILURE Right Heart Failure Symptoms 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) Note: Mention that the Eligibility Form is removed and incorporated with the Screening Log INTERMACS Annual Meeting March 2012 38

Significant perioperative adverse event Reduces overall MCS survival
Research Topics in INTERMACS Magnitude of the Problem Adverse 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 INTERMACS Annual Meeting March 2012 39

Pre-Implant Patient Profile LVAD (n=1440) Bi-VAD (n=206)
INTERMACS: June 2006 – September 2009: Bi-VAD Study Adult Primary Implants, n=1706 Pre-Implant Patient Profile LVAD (n=1440) Bi-VAD (n=206) 1 Critical Cardiogenic Shock (26%) (54%) 2 Progressive Decline (43%) (38%) 3 Stable but Inotrope dependent (16%) (4%) 4 Recurrent Advanced HF (10%) (2%) 5 Exertion Intolerant (2%) (1%) 6 Exertion Limited (1%) (1%) 7 Advanced NYHA Class III (2%) (0%) Total (100%) (100%) p < .0001 * Total Artificial Heart devices (TAH) are excluded from this table INTERMACS Annual Meeting March 2012

Bi-VAD Categories INTERMACS: June 2006 – September 2009: Bi-VAD Study
Adult Primary Bi-VAD Implants, n=206 Bi-VAD Categories (LVAD/RVAD) n (%) Durable/Durable (78%) Continuous Flow Device/Durable (2%) Pulsatile Flow Device/Durable 156 (75%) Durable/Temporary (22%) Continuous Flow Device/Temporary (13%) Pulsatile Flow Device/Temporary (10%) Total (100%) INTERMACS Annual Meeting March 2012

What have we learned from INTEMACS Months after Device Implant
Implant Dates: June 2006 – September 2009: Bi-VAD Study What have we learned from INTEMACS Survival significantly worse with the need for BiVAD Event: Death (censored at transplant, recovery) % Survival Months after Device Implant LVAD n=1440, deaths=280 Bi-VAD n=206, deaths=73 p < .0001 INTERMACS Annual Meeting March 2012

What have we learned from INTEMACS Months after Device Implant
Implant Dates: June 23, 2006 – September 30, 2009 What have we learned from INTEMACS Survival favorably influenced by younger age % Survival 30 – 65 yrs n = 160, deaths=63 Months after Device Implant Event: Death (censored at transplant or explant recovery) < 30 yrs n=27 deaths=3 p=.05 > 65 yrs n=19, deaths=7 INTERMACS Annual Meeting March 2012

Implant Dates: June 2006 – September 2009: Bi-VAD Study
Adverse Event Rates within the 1st 12 months post implant Primary LVADS v BiVADs: n=1646 71.6 Episodes per 100 pt months 33.2 14.3 15.5 Bi-VAD 7.9 LVAD 4.9 2.6 2.0 INTERMACS Annual Meeting March 2012

Risk Factor Relative Risk p-value Age (older) 1.56 < 0.0001
Implant Dates: June 2006 – September 2009: Bi-VAD Study All Adult Primary BIVADs: n=206 Risk Factor Relative Risk p-value Age (older) < BSA (higher) Ascites Creatinine (higher) Bilirubin (higher) INR (higher) History of valve surgery < Failure to wean from bypass < INTERMACS Annual Meeting March 2012

Right Heart Failure – Next Steps
Research Topics in INTERMACS 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 INTERMACS Annual Meeting March 2012 46

Research Topics in INTERMACS What have we learned? What is next? Panel A: Adverse Events A. Bleeding B. Device Function and Malfunction Neurological Dysfunction Impact of INTERMACS Profiles Right Heart Failure Panel Discussion Kormos INTERMACS Annual Meeting March 2012 47

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