federal partners report 2013 - uab

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# HHSN268201100025C Quarterly Report – 2013 Q1

06/24/2013

INTERMACS

Interagency Registry for Mechanically Assisted Circulatory Support

Quarterly Statistical Report

2013 1st Quarter

Implant and event dates: June 23, 2006 to March 31, 2013

06/24/2013 Prepared by: The Data Collection and Analysis Center University of Alabama at Birmingham For questions or comments contact: James K. Kirklin, MD at [email protected] David C. Naftel, Ph.D at [email protected] Susan L. Myers at [email protected] Mary Lynne Clark at [email protected] Stephen Craig Collum at [email protected] Kathryn Hollifield at [email protected] Ryan S. Cantor at [email protected]

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INTERMACS Quarterly Report Implants: June 23, 2006 to March 31, 2013

The Interagency Registry for Mechanically Assisted Circulatory Support is a North American registry established in 2005 for patients who are receiving mechanical circulatory support device therapy to treat advanced heart failure. INTERMACSTM was established as a joint effort of the National Heart, Lung and Blood Institute (NHLBI), the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), clinicians, scientists and industry representatives in conjunction with Dr. James K. Kirklin and the University of Alabama at Birmingham. This quarterly report includes clinical information from 8609 patients receiving primary prospective implants between June 23, 2006 and March 31, 2013.

Table of Contents

Exhibit 1: Hospital Activation and Patient Enrollment ............................................................................................................................... 3

Exhibit 2: Participating Hospital Listing ....................................................................................................................................................... 4

Exhibit 3: Patient Demographics by Implant Period .................................................................................................................................. 8

Exhibit 4: Implants by Year by Device Strategy ......................................................................................................................................... 9

Exhibit 5: Implants per Year by Device Type ........................................................................................................................................... 10

Exhibit 6: Patient Profile at Time of Implant by Implant Period ............................................................................................................. 11

Exhibit 7: Device Strategy at Time of Implant by Implant Period .......................................................................................................... 12

Exhibit 8: Patient Profile by Device Strategy at Time of Implant ........................................................................................................... 13

Exhibit 9: Patient Status by Device Strategy at Implant ......................................................................................................................... 15

Exhibit 10: Primary Cause of Death .......................................................................................................................................................... 17

Exhibit 11: Kaplan-Meier Survival for INTERMACS OVERALL ............................................................................................................ 18

Exhibit 12: Kaplan-Meier Survival by Flow Type and Device ................................................................................................................ 19

Exhibit 13: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Implant Era .................................................................................................................................................................................................... 20

Exhibit 14: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Pre-Implant Device Strategy ...................................................................................................................................................................... 21

Exhibit 15: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Pre-Implant Patient Profile .......................................................................................................................................................................... 22

Exhibit 16: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Device Type .................................................................................................................................................................................................. 23

Exhibit 17: Competing Outcomes for Continuous Flow LVADs (without RVAD implant at time of LVAD operation) .................... 24

Exhibit 18: Competing Outcomes for Continuous Flow LVADs (with RVAD implant at time of LVAD operation) .......................... 25

Exhibit 19: Adverse Event Rates for Patients Receiving a Primary Prospective Implant - Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) .................................................................................................................................. 26

Exhibit 20: Compliance ............................................................................................................................................................................... 27

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Exhibit 1: Hospital Activation and Patient Enrollment

Between June 23, 2006 and March 31, 2013, 153 hospitals participated in INTERMACS and, of these, 141 hospitals actively contributed information on a total of 8609 patients. Cumulative patient accrual and the number of participating hospitals over this time period are displayed below.

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Exhibit 2: Participating Hospital Listing

As of March 31, 2013 there were 153 hospitals participating in INTERMACS.

HOSPITAL NAME CITY STATE

ABBOTT NORTHWESTERN HOSPITAL MINNEAPOLIS MN

ABINGTON MEMORIAL HOSPITAL ABINGTON PA

ADVOCATE CHRIST MEDICAL CENTER OAK LAWN IL

ALBANY MEDICAL CENTER ALBANY NY

ALBERT EINSTEIN MEDICAL CENTER PHILADELPHIA PA

ALLEGHENY GENERAL HOSPITAL PITTSBURGH PA

ANN & ROBERT H. LURIE CHILDREN’S HOSPITAL OF CHICAGO CHICAGO IL

BANNER GOOD SAMARITAN PHOENIX AZ

BAPTIST HEALTH MEDICAL CENTER LITTLE ROCK AR

BAPTIST MEMORIAL HOSPITAL - MEMPHIS MEMPHIS TN

BARNES-JEWISH HOSPITAL ST. LOUIS MO

BAYLOR UNIVERSITY MEDICAL CENTER DALLAS TX

BRIGHAM AND WOMEN'S HOSPITAL BOSTON MA

BRYANLGH MEDICAL CENTER LINCOLN NE

CALIFORNIA PACIFIC MEDICAL CENTER SAN FRANCISCO CA

CARILION ROANOKE MEMORIAL HOSPITAL ROANOKE VA

CAROLINAS MEDICAL CENTER CHARLOTTE NC

CEDARS SINAI MEDICAL CENTER LOS ANGELES CA

CHILDREN'S HEALTHCARE OF ATLANTA ATLANTA GA

CHILDREN'S HOSPITAL BOSTON BOSTON MA

CHILDREN'S HOSPITAL OF PITTSBURGH PITTSBURGH PA

CHILDREN'S HOSPITAL OF WISCONSIN MILWAUKEE WI

CHILDREN'S MEDICAL CENTER DALLAS TX

CHRISTIANA CARE HEALTH SYSTEM NEWARK DE

CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER CINCINNATI OH

CLEVELAND CLINIC CLEVELAND OH

COLUMBIA PRESBYTERIAN - CHILDREN'S HOSPITAL OF NEW YORK NEW YORK NY

COLUMBIA UNIVERSITY MEDICAL CENTER-NY PRESBYTERIAN NEW YORK NY

DUKE UNIVERSITY MEDICAL CENTER DURHAM NC

EDWARD HOSPITAL NAPERVILLE IL

EMORY UNIVERSITY HOSPITAL ATLANTA GA

FLORIDA HOSPITAL ORLANDO FL

FROEDTERT & THE MEDICAL COLLEGE OF WISCONSIN MILWAUKEE WI

GEISINGER CLINIC DANVILLE PA

HACKENSACK UNIVERSITY MEDICAL CENTER HACKENSACK NJ

HAHNEMANN UNIVERSITY HOSPITAL PHILADELPHIA PA

HARTFORD HOSPITAL HARTFORD CT

HENRY FORD HOSPITAL DETROIT MI

HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA PHILADELPHIA PA

INLAND NORTHWEST THORACIC ORGAN TRANSPLANT PROGRAM - SACRED HEART MEDICAL CENTER

SPOKANE WA

INOVA FAIRFAX HOSPITAL FALLS CHURCH VA

INTEGRIS BAPTIST MEDICAL CENTER OKLAHOMA CITY OK

INTERMOUNTAIN HEART INSTITUTE-ARTIFICIAL HEART PROGRAM MURRAY UT

JACKSON MEMORIAL HEALTH SYSTEM/UNIVERSITY OF MIAMI MIAMI FL

JEWISH HOSPITAL LOUISVILLE KY

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KAISER SUNNYSIDE MEDICAL CENTER CLACKAMAS OR

LANCASTER GENERAL HOSPITAL LANCASTER PA

LANKENAU HOSPITAL WYNNEWOOD PA

LEHIGH VALLEY HEALTH NETWORK ALLENTOWN PA

LOMA LINDA UNIVERSITY MEDICAL CENTER & CHILDREN'S HOSPITAL LOMA LINDA CA

LOYOLA UNIVERSITY MEDICAL CENTER MAYWOOD IL

LUTHERAN HOSPITAL OF INDIANA FORT WAYNE IN

MAIMONIDES MEDICAL CENTER BROOKLYN NY

MASSACHUSETTS GENERAL HOSPITAL BOSTON MA

MAYO CLINIC HOSPITAL PHOENIX AZ

MAYO CLINIC JACKSONVILLE JACKSONVILLE FL

MAYO CLINIC ROCHESTER MN ROCHESTER MN

MEDICAL CITY DALLAS HOSPITAL DALLAS TX

MEDICAL UNIVERSITY OF SOUTH CAROLINA CHARLESTON SC

MEDICAL UNIVERSITY OF SOUTH CAROLINA MEDICAL CENTER CHARLESTON SC

MEMORIAL HERMANN TEXAS MEDICAL CENTER HOUSTON TX

METHODIST HOSPITAL INDIANPOLIS IN

METHODIST SPECIALTY AND TRANSPLANT HOSPITAL SAN ANTONIO TX

MID AMERICA HEART INSTITUTE OF SAINT LUKE'S HOSPITAL KANSAS CITY MO

MONTEFIORE MEDICAL CENTER BRONX NY

MORRISTOWN MEMORIAL HOSPITAL - ATLANTIC HEALTH MORRISTOWN NJ

MOUNT SINAI MEDICAL NEW YORK NY

MULTICARE HEALTH SYSTEMS TACOMA WA

NEMOURS/A.I. DUPONT HOSPITAL FOR CHILDREN WILMINGTON DE

NEW YORK UNIVERSITY MEDICAL CENTER NEW YORK NY

NEWARK BETH ISRAEL MEDICAL CENTER NEWARK NJ

NORTH CAROLINA BAPTIST HOSPITAL WINSTON SALEM NC

NORTHWESTERN MEMORIAL HOSPITAL CHICAGO IL

OCHSNER MEDICAL CENTER NEW ORLEANS LA

OREGON HEALTH & SCIENCE UNIVERSITY PORTLAND OR

OSF ST FRANCIS MEDICAL CENTER PEORIA IL

PALMETTO HEALTH RICHLAND COLUMBIA SC

PENN PRESBYTERIAN MEDICAL CENTER PHILADELPHIA PA

PENN STATE MILTON S. HERSHEY MEDICAL CENTER HERSHEY PA

PIEDMONT HOSPITAL ATLANTA GA

PROVIDENCE ST. VINCENT MEDICAL CENTER PORTLAND OR

ROBERT WOOD JOHNSON UNIVERSITY HOSPITAL NEW BRUNSWICK NJ

RUSH UNIVERSITY MEDICAL CENTER CHICAGO IL

SAINT JOSEPH'S HOSPITAL OF ATLANTA, INC. ATLANTA GA

SAINT THOMAS HOSPITAL NASHVILLE TN

SCOTT & WHITE HOSPITAL TEMPLE TX

SCRIPPS MEMORIAL HOSPITAL LA JOLLA LA JOLLA CA

SEATTLE CHILDREN'S HOSPITAL SEATTLE WA

SENTARA NORFOLK GENERAL HOSPITAL NORFOLK VA

SETON MEDICAL CENTER - AUSTIN AUSTIN TX

SHANDS AT THE UNIVERSITY OF FLORIDA GAINESVILLE FL

SHARP MEMORIAL HOSPITAL SAN DIEGO CA

SPECTRUM HEALTH HOSPITALS GRAND RAPIDS MI

ST MARY'S HOSPITAL RICHMOND VA

ST PAUL'S HOSPITAL VANCOUVER BC

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ST PETERS HOSPITAL ALBANY NY

ST. LOUIS CHILDREN'S HOSPITAL ST. LOUIS MO

ST. LUKE'S EPISCOPAL HOSPITAL / TEXAS HEART INSTITUTE HOUSTON TX

ST. LUKE'S MEDICAL CENTER MILWAUKEE WI

ST. VINCENT HOSPITAL AND HEALTH CARE CENTER INDIANAPOLIS IN

STANFORD UNIVERSITY MEDICAL CENTER STANFORD CA

STONY BROOK UNIVERSITY MEDICAL CENTER STONY BROOK NY

SUTTER MEMORIAL HOSPITAL SACRAMENTO CA

TAMPA GENERAL HOSPITAL TAMPA FL

TEMPLE UNIVERSITY HOSPITAL PHILADELPHIA PA

TEXAS CHILDREN'S HOSPITAL HOUSTON TX

THE CHILDREN'S HOSPITAL OF PHILADELPHIA PHILADELPHIA PA

THE CHILDRENS HOSPITAL DENVER CO

THE CHRIST HOSPITAL CINCINNATI OH

THE HEART HOSPITAL BAYLOR PLANO PLANO TX

THE INDIANA HEART HOSPITAL INDIANAPOLIS IN

THE JOHNS HOPKINS HOSPITAL BALTIMORE MD

THE MEDICAL CENTER OF CENTRAL GEORGIA MACON GA

THE METHODIST HOSPITAL HOUSTON TX

THE OHIO STATE UNIVERSITY MEDICAL CENTER COLUMBUS OH

THE UNIVERSITY OF TOLEDO TOLEDO OH

THOMAS JEFFERSON UNIVERSITY PHILADELPHIA PA

TORONTO GENERAL HOSPITAL TORONTO ON

TUFTS MEDICAL CENTER BOSTON MA

TULANE MEDICAL CENTER NEW ORLEANS LA

UC HEALTH UNIVERSITY HOSPITAL CINCINNATI OH

UCLA MEDICAL CENTER LOS ANGELES CA

UNIVERSITY HOSPITALS CASE MEDICAL CENTER CLEVELAND OH

UNIVERSITY OF ALABAMA AT BIRMINGHAM HOSPITAL BIRMINGHAM AL

UNIVERSITY OF ARIZONA MEDICAL CENTER TUCSON AZ

UNIVERSITY OF CALIFORNIA DAVIS MEDICAL CENTER (UCDMC) SACRAMENTO CA

UNIVERSITY OF CALIFORNIA SAN FRANCISCO SAN FRANCISCO CA

UNIVERSITY OF CALIFORNIA, SAN DIEGO MEDICAL CENTER SAN DIEGO CA

UNIVERSITY OF CHICAGO HOSPITALS CHICAGO IL

UNIVERSITY OF COLORADO HOSPITAL AURORA CO

UNIVERSITY OF IOWA HOSPITALS AND CLINICS IOWA CITY IA

UNIVERSITY OF KENTUCKY CHANDLER MEDICAL CENTER LEXINGTON KY

UNIVERSITY OF MARYLAND MEDICAL CENTER BALTIMORE MD

UNIVERSITY OF MICHIGAN HEALTH SYSTEMS ANN ARBOR MI

UNIVERSITY OF MINNESOTA MEDICAL CENTER-FAIRVIEW MINNEAPOLIS MN

UNIVERSITY OF NEBRASKA MEDICAL CENTER OMAHA NE

UNIVERSITY OF NORTH CAROLINA HOSPITALS CHAPEL HILL NC

UNIVERSITY OF PITTSBURGH MEDICAL CENTER PITTSBUGH PA

UNIVERSITY OF ROCHESTER MEDICAL CENTER (STRONG MEMORIAL HOSPITAL) ROCHESTER NY

UNIVERSITY OF TEXAS MEDICAL BRANCH GALVESTON TX

UNIVERSITY OF UTAH HOSPITAL SALT LAKE CITY UT

UNIVERSITY OF VIRGINIA HEALTH SYSTEM CHARLOTTESVILLE VA

UNIVERSITY OF WASHINGTON MEDICAL CENTER SEATTLE WA

UNIVERSITY OF WISCONSIN HOSPITAL AND CLINICS MADISON WI

USC UNIVERSITY HOSPITAL LOS ANGELES CA

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UT SOUTHWESTERN MEDICAL CENTER DALLAS TX

VANDERBILT UNIVERSITY MEDICAL CENTER - VANDERBILT HEART AND VASCULAR INSTITUTE NASHVILLE TN

VIRGINIA COMMONWEALTH UNIVERSITY HEALTH SYSTEM RICHMOND VA

WASHINGTON HOSPITAL CENTER WASHINGTON DC

WEILL CORNELL MEDICAL CENTER/NEW YORK PRESBYTERIAN MEDICAL CENTER NEW YORK NY

WESTCHESTER MEDICAL CENTER VALHALLA NY

YALE-NEW HAVEN HOSPITAL NEW HAVEN CT

YORK HOSPITAL YORK PA

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Exhibit 3: Patient Demographics by Implant Period

The following tables present demographic characteristics for patients at the time of their primary implant (June 23, 2006 to March 31, 2013).

Gender

GENDER

IMPLANT DATE PERIOD

TOTAL < 2010 2010 - 2011 2012 - 2013 (Jan-Mar)

n % n % n % n %

Female 472 21.0 % 778 21.5 % 555 20.1 % 1805 20.9 %

Male 1767 78.9 % 2837 78.4 % 2199 79.8 % 6803 79.0 %

Unspecified . . . . 1 0.0 % 1 0.0 %

TOTAL 2239 100.0 % 3615 100.0 % 2755 100.0 % 8609 100.0 %

Race

RACE

IMPLANT DATE PERIOD

TOTAL < 2010 2010 - 2011 2012 - 2013 (Jan-Mar)

n % n % n % n %

African American 499 22.2 % 779 21.5 % 600 21.7 % 1878 21.8 %

Other, Unknown, Undisclosed 193 8.6 % 292 8.0 % 230 8.3 % 715 8.3 %

White 1547 69.0 % 2544 70.3 % 1925 69.8 % 6016 69.8 %

TOTAL 2239 100.0 % 3615 100.0 % 2755 100.0 % 8609 100.0 %

Age Category

AGE GROUP (yr)

IMPLANT DATE PERIOD

TOTAL < 2010 2010 - 2011 2012 - 2013 (Jan-Mar)

n % n % n % n %

0-18 39 1.7 % 31 0.8 % 8 0.2 % 78 0.9 %

19-39 357 15.9 % 428 11.8 % 287 10.4 % 1072 12.4 %

40-59 1133 50.6 % 1477 40.8 % 1076 39.0 % 3686 42.8 %

60-79 710 31.7 % 1657 45.8 % 1359 49.3 % 3726 43.2 %

80+ . . 22 0.6 % 25 0.9 % 47 0.5 %

TOTAL 2239 100.0 % 3615 100.0 % 2755 100.0 % 8609 100.0 %

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Exhibit 4: Implants by Year by Device Strategy

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Exhibit 5: Implants per Year by Device Type

Number of Implants by Device Type and Implant Date Period

DEVICE TYPE

IMPLANT DATE PERIOD

TOTAL < 2010 2010 - 2011 2012 - 2013 (Jan-Mar)

n % n % n % n %

LVAD 1895 84.6 % 3384 93.6 % 2621 95.1 % 7900 91.7 %

BiVAD 266 11.8 % 175 4.8 % 76 2.7 % 517 6.0 %

TAH 78 3.4 % 56 1.5 % 58 2.1 % 192 2.2 %

TOTAL 2239 100.0 % 3615 100.0 % 2755 100.0 % 8609 100.0 %

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Exhibit 6: Patient Profile at Time of Implant by Implant Period

Patient profile status provides a general clinical description of the patients at the time of implantation.

PATIENT PROFILE AT TIME OF IMPLANT

IMPLANT DATE PERIOD

TOTAL < 2010 2010 - 2011 2012 - 2013 (Jan-Mar)

n % n % n % n %

1 Critical Cardio Shock 661 29.5 % 543 15.0 % 401 14.5 % 1605 18.6 %

2 Progressive Decline 953 42.5 % 1433 39.6 % 1056 38.3 % 3442 39.9 %

3 Stable but Inotrope dependent 337 15.0 % 956 26.4 % 772 28.0 % 2065 23.9 %

4 Resting Symptoms 200 8.9 % 481 13.3 % 391 14.1 % 1072 12.4 %

5 Exertion intolerant 42 1.8 % 110 3.0 % 77 2.7 % 229 2.6 %

6 Exertion limited 25 1.1 % 67 1.8 % 30 1.0 % 122 1.4 %

7 Advanced NYHA Class 3 21 0.9 % 25 0.6 % 28 1.0 % 74 0.8 %

TOTAL 2239 100.0 % 3615 100.0 % 2755 100.0 % 8609 100.0 %

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.

2 Progressive decline describes a patient who has been demonstrated 'dependent' on inotropic support but nonetheless shows signs of continuing deterioration.

3 Stable but inotrope dependent: describes a patient who is clinically stable on mild-moderate doses of intravenous inotropes.

4 Resting symptoms describes a patient who is at home on oral therapy but frequently has symptoms of congestion at rest or with ADL.

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.

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.

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.

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Exhibit 7: Device Strategy at Time of Implant by Implant Period

Device strategy is determined in conjunction with the heart failure cardiologist and surgeon at the time of the implant.

DEVICE STRATEGY AT TIME OF IMPLANT

IMPLANT DATE PERIOD

TOTAL < 2010 2010 - 2011 2012 - 2013 (Jan-Mar)

n % n % n % n %

BTT - Listed 1072 47.8 % 922 25.5 % 533 19.3 % 2527 29.3 %

BTT - Likely 604 26.9 % 824 22.7 % 645 23.4 % 2073 24.0 %

BTT - Moderate 217 9.6 % 370 10.2 % 271 9.8 % 858 9.9 %

BTT - Unlikely 89 3.9 % 126 3.4 % 83 3.0 % 298 3.4 %

Destination Therapy 179 7.9 % 1307 36.1 % 1184 42.9 % 2670 31.0 %

Bridge to Recovery 46 2.0 % 30 0.8 % 16 0.5 % 92 1.0 %

Rescue Therapy 27 1.2 % 15 0.4 % 16 0.5 % 58 0.6 %

Other 5 0.2 % 21 0.5 % 7 0.2 % 33 0.3 %

TOTAL 2239 100.0 % 3615 100.0 % 2755 100.0 % 8609 100.0 %

1. Bridge to Transplant (BTT) Listed - patient already listed for transplant or listed within 24 hours before device implantation.

2. Bridge to Transplant (BTT) Likely - patient in whom the transplant evaluation has not been completed, but no contra-indications are anticipated, or in whom a current contra-indication is anticipated to resolve rapidly.

3. Bridge to Transplant (BTT) Moderate - patient in whom the transplant evaluation has not been completed, but with some potential concerns that might prevent eligibility.

4. Bridge to Transplant (BTT) Unlikely - patient in whom major concerns that might prevent eligibility have already been identified.

5. Destination Therapy - the patient is definitely not eligible for transplant.

6. Bridge to Recovery (BTR) - use of a durable device to allow recovery from chronic cardiac failure (at least 3 months in duration).

7. Rescue Therapy - use of a durable device to support resolution from an acute event without major previous cardiac dysfunction.

8. Other.

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Exhibit 8: Patient Profile by Device Strategy at Time of Implant

The following tables present patient profile status by the device strategy for different time periods.

Overall

PATIENT PROFILE STATUS OVERALL

Pre-Implant Device Strategy

TOTAL BTT - Listed BTT - Likely BTT - Moderate BTT - Unlikely Destination

Therapy Bridge to Recovery

Rescue Therapy Other

n % n % n % n % n % n % n % n % n %

1 Critical Cardio Shock 458 18.1 % 470 22.6 % 201 23.4 % 71 23.8 % 297 11.1 % 50 54.3 % 51 87.9 % 7 21.2 % 1605 18.6 %

2 Progressive Decline 1187 46.9 % 803 38.7 % 343 39.9 % 117 39.2 % 950 35.5 % 20 21.7 % 3 5.1 % 19 57.5 % 3442 39.9 %

3 Stable but Inotrope dependent 517 20.4 % 432 20.8 % 195 22.7 % 59 19.7 % 841 31.4 % 13 14.1 % 3 5.1 % 5 15.1 % 2065 23.9 %

4 Resting Symptoms 257 10.1 % 246 11.8 % 95 11.0 % 37 12.4 % 430 16.1 % 5 5.4 % 0 0 2 6.0 % 1072 12.4 %

5 Exertion intolerant 53 2.0 % 63 3.0 % 16 1.8 % 4 1.3 % 92 3.4 % 0 0 1 1.7 % 0 0 229 2.6 %

6 Exertion limited 26 1.0 % 44 2.1 % 8 0.9 % 8 2.6 % 35 1.3 % 1 1.0 % 0 0 0 0 122 1.4 %

7 Advanced NYHA Class 3 29 1.1 % 15 0.7 % 0 0 2 0.6 % 25 0.9 % 3 3.2 % 0 0 0 0 74 0.8 %

TOTAL 2527 100.0 % 2073 100.0 % 858 100.0 % 298 100.0 % 2670 100.0 % 92 100.0 % 58 100.0 % 33 100.0 % 8609 100.0 %

IMPLANT DATE PERIOD=< 2010






n % n % n % n % n % n % n % n % n %



3 Stable but Inotrope dependent 179 16.6 % 72 11.9 % 29 13.3 % 9 10.1 % 41 22.9 % 6 13.0 % 0 0 1 20.0 % 337 15.0 %

4 Resting Symptoms 92 8.5 % 61 10.0 % 17 7.8 % 5 5.6 % 22 12.2 % 3 6.5 % 0 0 0 0 200 8.9 %

5 Exertion intolerant 17 1.5 % 18 2.9 % 4 1.8 % 0 0 2 1.1 % 0 0 1 3.7 % 0 0 42 1.8 %

6 Exertion limited 12 1.1 % 7 1.1 % 2 0.9 % 1 1.1 % 3 1.6 % 0 0 0 0 0 0 25 1.1 %

7 Advanced NYHA Class 3 16 1.4 % 2 0.3 % 0 0 1 1.1 % 2 1.1 % 0 0 0 0 0 0 21 0.9 %

TOTAL 1072 100.0 % 604 100.0 % 217 100.0 % 89 100.0 % 179 100.0 % 46 100.0 % 27 100.0 % 5 100.0 % 2239 100.0 %

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IMPLANT DATE PERIOD=2010 - 2011






n % n % n % n % n % n % n % n % n %


2 Progressive Decline 420 45.5 % 314 38.1 % 153 41.3 % 48 38.0 % 475 36.3 % 10 33.3 % 0 0 13 61.9 % 1433 39.6 %

3 Stable but Inotrope dependent 214 23.2 % 202 24.5 % 91 24.5 % 31 24.6 % 409 31.2 % 3 10.0 % 3 20.0 % 3 14.2 % 956 26.4 %

4 Resting Symptoms 108 11.7 % 99 12.0 % 43 11.6 % 20 15.8 % 208 15.9 % 2 6.6 % 0 0 1 4.7 % 481 13.3 %

5 Exertion intolerant 23 2.4 % 35 4.2 % 8 2.1 % 2 1.5 % 42 3.2 % 0 0 0 0 0 0 110 3.0 %

6 Exertion limited 9 0.9 % 26 3.1 % 5 1.3 % 5 3.9 % 22 1.6 % 0 0 0 0 0 0 67 1.8 %

7 Advanced NYHA Class 3 9 0.9 % 3 0.3 % 0 0 0 0 10 0.7 % 3 10.0 % 0 0 0 0 25 0.6 %

TOTAL 922 100.0 % 824 100.0 % 370 100.0 % 126 100.0 % 1307 100.0 % 30 100.0 % 15 100.0 % 21 100.0 % 3615 100.0 %

IMPLANT DATE PERIOD=2012 - 2013 (Jan-Mar)






n % n % n % n % n % n % n % n % n %



3 Stable but Inotrope dependent 124 23.2 % 158 24.4 % 75 27.6 % 19 22.8 % 391 33.0 % 4 25.0 % 0 0 1 14.2 % 772 28.0 %

4 Resting Symptoms 57 10.6 % 86 13.3 % 35 12.9 % 12 14.4 % 200 16.8 % 0 0 0 0 1 14.2 % 391 14.1 %

5 Exertion intolerant 13 2.4 % 10 1.5 % 4 1.4 % 2 2.4 % 48 4.0 % 0 0 0 0 0 0 77 2.7 %

6 Exertion limited 5 0.9 % 11 1.7 % 1 0.3 % 2 2.4 % 10 0.8 % 1 6.2 % 0 0 0 0 30 1.0 %

7 Advanced NYHA Class 3 4 0.7 % 10 1.5 % 0 0 1 1.2 % 13 1.0 % 0 0 0 0 0 0 28 1.0 %

TOTAL 533 100.0 % 645 100.0 % 271 100.0 % 83 100.0 % 1184 100.0 % 16 100.0 % 16 100.0 % 7 100.0 % 2755 100.0 %

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Exhibit 9: Patient Status by Device Strategy at Implant

The following tables present patient status as of March 31, 2013 by the device strategy for different time periods. Patient status is defined as the first of the following events:

• Alive (device in place) - patients that were alive at the end of this follow-up period

• Transplant - patients that have received a transplant during this follow-up period

• Recovery: patients that were explanted due to recovery at or before the end of this follow-up period

• Dead: patients who died during this follow-up period.

Overall

PRE-IMPLANT DEVICE STRATEGY

Patient Status (March 31, 2013)

TOTAL

1. Alive (device in

place) 2. Transplant 3. Recovery 4. Dead

N N N N N

BTT - Listed 710 1322 26 469 2527

BTT - Likely 861 787 18 407 2073

BTT - Moderate 428 182 7 241 858

BTT - Unlikely 153 38 3 104 298

Destination Therapy 1734 136 15 785 2670

Bridge to Recovery 36 21 13 22 92

Rescue Therapy 14 11 4 29 58

Other 15 8 1 9 33

TOTAL 3951 2505 87 2066 8609

IMPLANT DATE PERIOD=< 2010



TOTAL

1. Alive (device in


N N N N N

BTT - Listed 109 701 12 250 1072

BTT - Likely 71 356 8 169 604

BTT - Moderate 34 75 2 106 217

BTT - Unlikely 13 21 1 54 89




Other 1 1 1 2 5

TOTAL 297 1199 40 703 2239

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IMPLANT DATE PERIOD=2010 - 2011



TOTAL

1. Alive (device in


N N N N N

BTT - Listed 256 484 12 170 922

BTT - Likely 287 352 6 179 824

BTT - Moderate 171 91 5 103 370

BTT - Unlikely 74 13 1 38 126




Other 7 7 0 7 21

TOTAL 1539 1046 37 993 3615

IMPLANT DATE PERIOD=2012 - 2013 (Jan-Mar)



TOTAL

1. Alive (device in


N N N N N

BTT - Listed 345 137 2 49 533

BTT - Likely 503 79 4 59 645

BTT - Moderate 223 16 0 32 271

BTT - Unlikely 66 4 1 12 83




Other 7 0 0 0 7

TOTAL 2115 260 10 370 2755

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Exhibit 10: Primary Cause of Death

PRIMARY CAUSE OF DEATH

IMPLANT DATE PERIOD

TOTAL < 2010 2010 - 2011 2012 - 2013 (Jan-Mar)

n % n % n % n %

Circulatory: Arterial Non-CNS Thromboembolism 7 0.9 % 16 1.5 % 2 0.4 % 25 1.1 %

Circulatory: CHF 25 3.4 % 35 3.4 % 9 2.2 % 69 3.2 %

Circulatory: Cardiac Arrhythmia 20 2.7 % 33 3.2 % 7 1.7 % 60 2.8 %

Circulatory: End Stage Cardiomyopathy 13 1.8 % 13 1.2 % 8 1.9 % 34 1.5 %

Circulatory: Heart Disease . . 6 0.5 % 3 0.7 % 9 0.4 %

Circulatory: Hemolysis 1 0.1 % 5 0.4 % 3 0.7 % 9 0.4 %

Circulatory: Ischemic Cardiomyopathy 4 0.5 % 10 0.9 % 7 1.7 % 21 0.9 %

Circulatory: Major Bleeding 38 5.2 % 35 3.4 % 14 3.4 % 87 4.0 %

Circulatory: Myocardial Infarction 3 0.4 % 7 0.6 % 6 1.4 % 16 0.7 %

Circulatory: Myocardial Rupture 1 0.1 % . . . . 1 0.0 %

Circulatory: Other, Specify 40 5.5 % 40 3.9 % 17 4.2 % 97 4.5 %

Circulatory: Pericardial Fluid Collection 1 0.1 % 1 0.0 % 1 0.2 % 3 0.1 %

Circulatory: Right Heart Failure 35 4.8 % 57 5.6 % 15 3.7 % 107 5.0 %

Circulatory: Ruptured Aortic Aneurysm 1 0.1 % . . . . 1 0.0 %

Circulatory: Sudden Unexplained Death 24 3.3 % 50 4.9 % 10 2.4 % 84 3.9 %

Device Malfunction 20 2.7 % 39 3.8 % 9 2.2 % 68 3.1 %

Digestive: Fluid/Electrolyte Disorder 4 0.5 % 3 0.2 % . . 7 0.3 %

Digestive: GI Disorder . . 4 0.3 % 4 0.9 % 8 0.3 %

Digestive: Hepatic Dysfunction 14 1.9 % 19 1.8 % 3 0.7 % 36 1.6 %

Digestive: Pancreatitis 1 0.1 % . . . . 1 0.0 %

Digestive: Renal Dysfunction 20 2.7 % 17 1.6 % 1 0.2 % 38 1.7 %

Major Infection 104 14.4 % 108 10.6 % 24 5.9 % 236 11.0 %

Multisystem Organ Failure 69 9.5 % 107 10.5 % 83 20.6 % 259 12.1 %

Nervous System: Neurological Dysfunction 135 18.7 % 179 17.6 % 63 15.7 % 377 17.6 %

Other 29 4.0 % 47 4.6 % 25 6.2 % 101 4.7 %

Other: Cancer 6 0.8 % 18 1.7 % 2 0.4 % 26 1.2 %

Other: Trauma/accident, specify 6 0.8 % 6 0.5 % 2 0.4 % 14 0.6 %

Psychiatric Episode/Suicide 4 0.5 % . . 2 0.4 % 6 0.2 %

Respiratory: Pulmonary: Other, specify 3 0.4 % 11 1.0 % 3 0.7 % 17 0.7 %

Respiratory: Respiratory Failure 39 5.4 % 47 4.6 % 26 6.4 % 112 5.2 %

Respiratory: Venous Thromboembolism Event 2 0.2 % 3 0.2 % 1 0.2 % 6 0.2 %

Unknown v2.3 17 2.3 % 31 3.0 % . . 48 2.2 %

Withdrawal of Support, specify 33 4.5 % 65 6.4 % 51 12.7 % 149 6.9 %

TOTAL 719 100.0 % 1012 100.0 % 401 100.0 % 2132 100.0 %

Note: 6 patients have a missing primary cause of death. * Certain pre-relaunch categories are no longer supported as of the v3.0 Launch (May 2012).

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06/24/2013

Exhibit 11: Kaplan-Meier Survival for INTERMACS OVERALL

Number of Patients at Risk

Month

0 6 12 18 24 30 36 42 48

INTERMACS Overall 8609 5172 3256 2099 1331 829 470 239 143

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06/24/2013

Exhibit 12: Kaplan-Meier Survival by Flow Type and Device


Flow Type and Device

Month

0 6 12 18 24 30 36 42 48

Continuous - LVAD 7254 4677 2953 1902 1182 712 369 163 80

Continuous - BiVAD 197 94 74 54 44 31 21 9 6

Pulsatile - LVAD 644 301 193 120 92 77 72 60 51

Pulsatile - BiVAD 320 60 27 16 12 11 10 9 8

Pulsatile - TAH 192 43 16 10 5 2 2 2 2

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06/24/2013

Exhibit 13: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Implant Era


Implant Era Month

0 6 12 18 24 30 36 42 48

< 2010 1342 909 644 492 388 317 262 171 85

2010-2011 3450 2584 2047 1464 838 425 128 1 1

2012-2013 (Jan-Mar) 2659 1277 334 1 1 1 1 1 1

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06/24/2013

Exhibit 14: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Pre-Implant Device Strategy

Bridge to Transplant (BTT) includes: BTT-listed, BTT-likely, BTT-moderately likely, and BTT-unlikely.



Month

0 6 12 18 24 30 36 42 48

Bridge to Transplant 4824 3037 1897 1224 807 515 306 149 75

Destination Therapy 2527 1670 1084 703 404 217 78 20 8

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06/24/2013

Exhibit 15: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Pre-Implant Patient Profile


Pre-Implant Patient Profile Month

0 6 12 18 24 30 36 42 48

Level 1 - Critical Cardiogenic Shock 1116 672 425 266 176 107 73 38 26

Level 2 - Progressive Decline 2976 1835 1180 757 493 303 158 65 32

Level 3 - Stable but Inotrope Dependent 1961 1304 814 530 312 181 81 38 18

Level 4 - Resting Symptoms 997 660 418 283 178 104 49 22 8

Levels 5,6,7 - All Others 401 300 190 124 71 50 33 13 5

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06/24/2013

Exhibit 16: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Device Type


Device Type

Month

0 6 12 18 24 30 36 42 48

LVAD 7254 4677 2953 1902 1182 712 369 163 80

BiVAD 197 94 74 54 44 31 21 9 6

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06/24/2013

Exhibit 17: Competing Outcomes for Continuous Flow LVADs (without RVAD implant at time of LVAD operation)


Month

0 6 12 18 24 30 36

7254 4677 2953 1902 1185 712 371

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06/24/2013

Exhibit 18: Competing Outcomes for Continuous Flow LVADs (with RVAD implant at time of LVAD operation)


Month

0 6 12 18 24 30 36

197 94 74 57 44 37 22

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06/24/2013

Exhibit 19: Adverse Event Rates for Patients Receiving a Primary Prospective Implant - Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation)

The following table summarizes adverse events in patients receiving primary prospective implants between June 23, 2006 and March 31, 2013. Event count is the number of episodes observed for each event type allowing multiple episodes per patient. Patient count is the number of patients experiencing at least one episode of a particular event type. Patient percentage is the percent of patients experiencing a specific event type. Early and late event counts are the number of episodes observed either within three months post-implant or after three months post-implant, respectively. Event rates are calculated by dividing the number of episodes observed for each event type during a period by the total amount of follow-up time the patients were observed during the period. The total follow-up time for the early period was 19891.26 patient months and the total follow-up time for the late period was 73254.83 patient months. All rates are reported in episodes per 100 patient months.

Adverse Event Type

Event Count

(n=44327)

Patient Count

(n=7451)

Patient Percentage

(%)

Early Event Count

(n)

Early Event Rate

(per 100 pt mo)

Late Event Count

(n)

Late Event Rate

(per 100 pt mo)

Arterial Non-CNS Thromboembolism

107 92 1.2 % 81 0.41 26 0.04

Bleeding 6400 2850 38.2 % 4056 20.39 2344 3.20

Cardiac Arrythmia 2946 1912 25.6 % 2176 10.94 770 1.05

Device Malfunction 1503 1152 15.4 % 446 2.24 1057 1.44

Hemolysis 619 505 6.7 % 259 1.30 360 0.49

Hepatic Dysfunction 430 390 5.2 % 266 1.34 164 0.22

Hypertension 537 411 5.5 % 283 1.42 254 0.35

Infection 6433 3083 41.3 % 3063 15.40 3370 4.60

Myocardial Infarction 53 48 0.6 % 29 0.15 24 0.03

Neurological Dysfunction 1489 1205 16.1 % 653 3.28 836 1.14

Other Serious Adverse Event 3821 2070 27.7 % 2345 11.79 1476 2.01

Pericardial Drainage 371 336 4.5 % 357 1.79 14 0.02

Psychiatric Episode 694 588 7.8 % 448 2.25 246 0.34

Rehospitalization 14324 4669 62.6 % 3446 17.32 10878 14.85

Renal Dysfunction 1044 892 11.9 % 677 3.40 367 0.50

Respiratory Failure 1681 1332 17.8 % 1354 6.81 327 0.45

Right Heart Failure 1324 1113 14.9 % 991 4.98 333 0.45

Venous Thromboembolism 438 413 5.5 % 372 1.87 66 0.09

Wound Dehiscence 113 99 1.3 % 90 0.45 23 0.03

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06/24/2013

Exhibit 20: Compliance

Site compliance is determined by the percentage of all follow-up forms that are due during this reporting period that have been completed. Follow-up forms for primary devices are included. Only sites that have at least 10 follow-up forms expected are included. INTERMACS has defined required compliance as 90%.

federal partners report 2013 - uab

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