Quarterly Statistical Report - The University of Alabama ... · quarterly report – 2014 q1 . 06/23 ... allegheny general hospital pittsburgh pa ... multicare health systems tacoma

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# HHSN268201100025C Quarterly Report – 2014 Q1

06/23/2014 Alfred M 14 69 112.5

Intermacs®

Interagency Registry for Mechanically Assisted Circulatory Support

Quarterly Statistical Report

2014 1st Quarter Implant and event dates: June 23, 2006 to March 31, 2014 06/23/2014 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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06/23/2014 Intermacs® Quarterly Report

Implants: June 23, 2006 to March 31, 2014 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. Intermacs® 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 11162 adult patients receiving primary prospective implants between June 23, 2006 and March 31, 2014.

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: Competing Outcomes for TAHs ................................................................................................................................ 26

Exhibit 20: Adverse Event Rates for Patients Receiving a Primary Prospective Implant - Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) .................................................................................................................................. 27

Exhibit 21: Infection Rates by Location - Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) . 28

Exhibit 20: Follow-up Compliance .............................................................................................................................................. 29

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06/23/2014 Exhibit 1: Hospital Activation and Patient Enrollment

Exhi bit 1: Hospital Acti vati on and Pati ent Enr ollment Between June 23, 2006 and March 31, 2014, 159 hospitals participated in Intermacs® and, of these, 143 hospitals actively contributed information on a total of 11162 patients. Cumulative patient accrual and the number of participating hospitals over this time period are displayed below.

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06/23/2014 Exhibit 2: Participating Hospital Listing

Exhi bit 2: Participati ng Hospital Listi ng As of March 31, 2014 there were 159 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 CJW MEDICAL CENTER RICHMOND VA CLEVELAND CLINIC CLEVELAND OH COLUMBIA PRESBYTERIAN - CHILDREN'S HOSPITAL OF NEW YORK NEW YORK NY COLUMBIA UNIVERSITY MEDICAL CENTER-NY PRESBYTERIAN NEW YORK NY CONE HEALTH SYSTEM GREENSBORO NC 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 HOUSTON METHODIST HOSPITAL HOUSTON TX INLAND NORTHWEST THORACIC ORGAN TRANSPLANT PROGRAM - SACRED HEART MEDICAL CENTER

SPOKANE WA

INOVA FAIRFAX HOSPITAL FALLS CHURCH VA INSTITUT NATIONAL D'EXCELLENCE EN SANTÉ ET EN SERVICES SOCIAUX MONTREAL QC INTEGRIS BAPTIST MEDICAL CENTER OKLAHOMA CITY OK INTERMOUNTAIN HEART INSTITUTE-ARTIFICIAL HEART PROGRAM MURRAY UT

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06/23/2014 HOSPITAL NAME CITY STATE

JACKSON MEMORIAL HEALTH SYSTEM/UNIVERSITY OF MIAMI MIAMI FL JEWISH HOSPITAL LOUISVILLE KY KAISER PERMANENTE SANTA CLARA MEDICAL CENTER SANTA CLARA CA KAISER SUNNYSIDE MEDICAL CENTER CLACKAMAS OR KECK HOSPITAL OF USC LOS ANGELES CA 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 MEDICAL CENTER CHARLESTON SC MEMORIAL HERMANN TEXAS MEDICAL CENTER HOUSTON TX MERCY GENERAL SACRAMENTO CA METHODIST HOSPITAL INDIANAPOLIS 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 NATIONWIDE CHILDREN'S HOSPITAL COLUMBUS OH 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 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

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SOUTH BROWARD HOSPITAL DISTRICT D/B/A MEMORIAL HEALTHCARE SYSTEM HOLLYWOOD FL SPECTRUM HEALTH HOSPITALS GRAND RAPIDS MI ST MARY'S HOSPITAL RICHMOND VA ST PAUL'S HOSPITAL VANCOUVER BC 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 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

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UNIVERSITY OF WISCONSIN HOSPITAL AND CLINICS MADISON WI 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 WILLIS-KNIGHTON HEART AND VASCULAR INSTITUTE SHREVEPORT LA YALE-NEW HAVEN HOSPITAL NEW HAVEN CT YORK HOSPITAL YORK PA

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06/23/2014 Exhibit 3: Patient Demographics by Implant Period

Exhi bit 3: Pati ent D emographics by Implant Period The following tables present demographic characteristics for patients at the time of their primary implant (June 23, 2006 to March 31, 2014).

Gender

GENDER IMPLANT DATE PERIOD

TOTAL < 2010 2010 - 2011 2012 - 2014 (Jan-Mar) n % n % n % n %

Female 451 20.6 % 762 21.3 % 1127 20.8 % 2340 20.9 % Male 1731 79.3 % 2810 78.6 % 4280 79.1 % 8821 79.0 % Unspecified . . . . 1 0.0 % 1 0.0 % TOTAL 2182 100.0 % 3572 100.0 % 5408 100.0 % 11162 100.0 %

Race

RACE IMPLANT DATE PERIOD


African American 486 22.2 % 767 21.4 % 1226 22.6 % 2479 22.2 % Other, Unknown, Undisclosed 184 8.4 % 291 8.1 % 469 8.6 % 944 8.4 % White 1512 69.2 % 2514 70.3 % 3713 68.6 % 7739 69.3 % TOTAL 2182 100.0 % 3572 100.0 % 5408 100.0 % 11162 100.0 %

Age Category

AGE GROUP (yr) IMPLANT DATE PERIOD


19-39 355 16.2 % 427 11.9 % 592 10.9 % 1374 12.3 % 40-59 1125 51.5 % 1470 41.1 % 2132 39.4 % 4727 42.3 % 60-79 702 32.1 % 1653 46.2 % 2636 48.7 % 4991 44.7 % 80+ . . 22 0.6 % 48 0.8 % 70 0.6 % TOTAL 2182 100.0 % 3572 100.0 % 5408 100.0 % 11162 100.0 %

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06/23/2014 Exhibit 4: Implants by Year by Device Strategy

Exhi bit 4: Impl ants by Year by Device Str ategy

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06/23/2014 Exhibit 5: Implants per Year by Device Type

Exhi bit 5: Impl ants per Year by Devi ce Type

Number of Implants by Device Type and Implant Date Period

DEVICE TYPE IMPLANT DATE PERIOD


LVAD 1851 84.8 % 3341 93.5 % 5108 94.4 % 10300 92.2 % BiVAD 254 11.6 % 176 4.9 % 179 3.3 % 609 5.4 % TAH 77 3.5 % 55 1.5 % 121 2.2 % 253 2.2 % TOTAL 2182 100.0 % 3572 100.0 % 5408 100.0 % 11162 100.0 %

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06/23/2014 Exhibit 6: Patient Profile at Time of Implant by Implant Period

Exhi bit 6: Pati ent Pr ofile at Ti me of Impl ant 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 - 2014 (Jan-Mar)

n % n % n % n % 1 Critical Cardio Shock 642 29.4 % 531 14.8 % 820 15.1 % 1993 17.8 % 2 Progressive Decline 928 42.5 % 1414 39.5 % 1934 35.7 % 4276 38.3 % 3 Stable but Inotrope dependent 330 15.1 % 953 26.6 % 1622 29.9 % 2905 26.0 % 4 Resting Symptoms 196 8.9 % 477 13.3 % 793 14.6 % 1466 13.1 % 5 Exertion intolerant 42 1.9 % 108 3.0 % 149 2.7 % 299 2.6 % 6 Exertion limited 23 1.0 % 66 1.8 % 50 0.9 % 139 1.2 % 7 Advanced NYHA Class 3 21 0.9 % 23 0.6 % 40 0.7 % 84 0.7 % TOTAL 2182 100.0 % 3572 100.0 % 5408 100.0 % 11162 100.0 %

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. 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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06/23/2014 Exhibit 7: Device Strategy at Time of Implant by Implant Period

Exhi bit 7: Device Str ategy at Ti me 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 - 2014 (Jan-Mar)

n % n % n % n % BTT - Listed 1044 47.8 % 902 25.2 % 1201 22.2 % 3147 28.1 % BTT - Likely 588 26.9 % 811 22.7 % 1127 20.8 % 2526 22.6 % BTT - Moderate 210 9.6 % 362 10.1 % 540 9.9 % 1112 9.9 % BTT - Unlikely 88 4.0 % 125 3.4 % 153 2.8 % 366 3.2 % Destination Therapy 178 8.1 % 1309 36.6 % 2325 42.9 % 3812 34.1 % Bridge to Recovery 44 2.0 % 27 0.7 % 24 0.4 % 95 0.8 % Rescue Therapy 25 1.1 % 15 0.4 % 22 0.4 % 62 0.5 % Other 5 0.2 % 21 0.5 % 16 0.2 % 42 0.3 % TOTAL 2182 100.0 % 3572 100.0 % 5408 100.0 % 11162 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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06/23/2014 Exhibit 8: Patient Profile by Device Strategy at Time of Implant

Exhi bit 8: Pati ent Pr ofile by D evice Strateg y at Ti me of Impl ant 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 527 16.7 % 549 21.7 % 270 24.2 % 86 23.4 % 445 11.6 % 54 56.8 % 54 87.0 % 8 19.0 % 1993 17.8 % 2 Progressive Decline 1429 45.4 % 950 37.6 % 407 36.6 % 136 37.1 % 1307 34.2 % 21 22.1 % 3 4.8 % 23 54.7 % 4276 38.3 % 3 Stable but Inotrope dependent 726 23.0 % 572 22.6 % 275 24.7 % 83 22.6 % 1226 32.1 % 13 13.6 % 4 6.4 % 6 14.2 % 2905 26.0 % 4 Resting Symptoms 335 10.6 % 310 12.2 % 131 11.7 % 46 12.5 % 636 16.6 % 4 4.2 % 0 0 4 9.5 % 1466 13.1 % 5 Exertion intolerant 71 2.2 % 77 3.0 % 19 1.7 % 6 1.6 % 124 3.2 % 0 0 1 1.6 % 1 2.3 % 299 2.6 % 6 Exertion limited 28 0.8 % 51 2.0 % 8 0.7 % 8 2.1 % 43 1.1 % 1 1.0 % 0 0 0 0 139 1.2 % 7 Advanced NYHA Class 3 31 0.9 % 17 0.6 % 2 0.1 % 1 0.2 % 31 0.8 % 2 2.1 % 0 0 0 0 84 0.7 % TOTAL 3147 100.0 % 2526 100.0 % 1112 100.0 % 366 100.0 % 3812 100.0 % 95 100.0 % 62 100.0 % 42 100.0 % 11162 100.0 %

IMPLANT DATE PERIOD=< 2010






n % n % n % n % n % n % n % n % n % 1 Critical Cardio Shock 231 22.1 % 205 34.8 % 78 37.1 % 35 39.7 % 38 21.3 % 30 68.1 % 23 92.0 % 2 40.0 % 642 29.4 % 2 Progressive Decline 500 47.8 % 229 38.9 % 82 39.0 % 38 43.1 % 70 39.3 % 6 13.6 % 1 4.0 % 2 40.0 % 928 42.5 % 3 Stable but Inotrope dependent 177 16.9 % 69 11.7 % 28 13.3 % 8 9.0 % 41 23.0 % 6 13.6 % 0 0 1 20.0 % 330 15.1 % 4 Resting Symptoms 91 8.7 % 59 10.0 % 17 8.0 % 5 5.6 % 22 12.3 % 2 4.5 % 0 0 0 0 196 8.9 % 5 Exertion intolerant 17 1.6 % 18 3.0 % 4 1.9 % 0 0 2 1.1 % 0 0 1 4.0 % 0 0 42 1.9 % 6 Exertion limited 12 1.1 % 6 1.0 % 1 0.4 % 1 1.1 % 3 1.6 % 0 0 0 0 0 0 23 1.0 % 7 Advanced NYHA Class 3 16 1.5 % 2 0.3 % 0 0 1 1.1 % 2 1.1 % 0 0 0 0 0 0 21 0.9 % TOTAL 1044 100.0 % 588 100.0 % 210 100.0 % 88 100.0 % 178 100.0 % 44 100.0 % 25 100.0 % 5 100.0 % 2182 100.0 %

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06/23/2014 IMPLANT DATE PERIOD=2010 - 2011






n % n % n % n % n % n % n % n % n % 1 Critical Cardio Shock 133 14.7 % 143 17.6 % 68 18.7 % 20 16.0 % 140 10.6 % 11 40.7 % 12 80.0 % 4 19.0 % 531 14.8 % 2 Progressive Decline 407 45.1 % 308 37.9 % 152 41.9 % 48 38.4 % 477 36.4 % 9 33.3 % 0 0 13 61.9 % 1414 39.5 % 3 Stable but Inotrope dependent 214 23.7 % 197 24.2 % 88 24.3 % 31 24.8 % 414 31.6 % 3 11.1 % 3 20.0 % 3 14.2 % 953 26.6 % 4 Resting Symptoms 108 11.9 % 98 12.0 % 43 11.8 % 19 15.2 % 206 15.7 % 2 7.4 % 0 0 1 4.7 % 477 13.3 % 5 Exertion intolerant 23 2.5 % 35 4.3 % 7 1.9 % 2 1.6 % 41 3.1 % 0 0 0 0 0 0 108 3.0 % 6 Exertion limited 9 0.9 % 27 3.3 % 4 1.1 % 5 4.0 % 21 1.6 % 0 0 0 0 0 0 66 1.8 % 7 Advanced NYHA Class 3 8 0.8 % 3 0.3 % 0 0 0 0 10 0.7 % 2 7.4 % 0 0 0 0 23 0.6 % TOTAL 902 100.0 % 811 100.0 % 362 100.0 % 125 100.0 % 1309 100.0 % 27 100.0 % 15 100.0 % 21 100.0 % 3572 100.0 %

IMPLANT DATE PERIOD=2012 - 2014 (Jan-Mar)






n % n % n % n % n % n % n % n % n % 1 Critical Cardio Shock 163 13.5 % 201 17.8 % 124 22.9 % 31 20.2 % 267 11.4 % 13 54.1 % 19 86.3 % 2 12.5 % 820 15.1 % 2 Progressive Decline 522 43.4 % 413 36.6 % 173 32.0 % 50 32.6 % 760 32.6 % 6 25.0 % 2 9.0 % 8 50.0 % 1934 35.7 % 3 Stable but Inotrope dependent 335 27.8 % 306 27.1 % 159 29.4 % 44 28.7 % 771 33.1 % 4 16.6 % 1 4.5 % 2 12.5 % 1622 29.9 % 4 Resting Symptoms 136 11.3 % 153 13.5 % 71 13.1 % 22 14.3 % 408 17.5 % 0 0 0 0 3 18.7 % 793 14.6 % 5 Exertion intolerant 31 2.5 % 24 2.1 % 8 1.4 % 4 2.6 % 81 3.4 % 0 0 0 0 1 6.2 % 149 2.7 % 6 Exertion limited 7 0.5 % 18 1.5 % 3 0.5 % 2 1.3 % 19 0.8 % 1 4.1 % 0 0 0 0 50 0.9 % 7 Advanced NYHA Class 3 7 0.5 % 12 1.0 % 2 0.3 % 0 0 19 0.8 % 0 0 0 0 0 0 40 0.7 % TOTAL 1201 100.0 % 1127 100.0 % 540 100.0 % 153 100.0 % 2325 100.0 % 24 100.0 % 22 100.0 % 16 100.0 % 5408 100.0 %

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06/23/2014 Exhibit 9: Patient Status by Device Strategy at Implant

Exhi bit 9: Pati ent Status by D evice Strateg y at Impl ant The following tables present patient status as of March 31, 2014 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 on a device 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, 2014)

TOTAL

1. Alive (device in

place) 2. Transplant 3. Recovery 4. Dead N N N N N

BTT - Listed 933 1588 30 596 3147 BTT - Likely 900 1030 37 559 2526 BTT - Moderate 515 243 14 340 1112 BTT - Unlikely 173 54 3 136 366 Destination Therapy 2295 247 28 1242 3812 Bridge to Recovery 36 26 12 21 95 Rescue Therapy 11 14 4 33 62 Other 16 11 1 14 42 TOTAL 4879 3213 129 2941 11162

IMPLANT DATE PERIOD=< 2010



TOTAL

1. Alive (device in



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06/23/2014

IMPLANT DATE PERIOD=2010 - 2011



TOTAL

1. Alive (device in



IMPLANT DATE PERIOD=2012 - 2014 (Jan-Mar)



TOTAL

1. Alive (device in



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06/23/2014 Exhibit 10: Primary Cause of Death

Exhi bit 10: Primar y C ause of D eath

PRIMARY CAUSE OF DEATH IMPLANT DATE PERIOD


Cardiovascular, Other . . 1 0.0 % 4 0.3 % 5 0.1 % Circulatory: Arterial Non-CNS Thromboembolism 8 1.0 % 18 1.5 % 6 0.5 % 32 1.0 % Circulatory: CHF 28 3.8 % 39 3.2 % 30 2.9 % 97 3.3 % Circulatory: Cardiac Arrhythmia 23 3.1 % 40 3.3 % 22 2.1 % 85 2.9 % Circulatory: End Stage Cardiomyopathy 11 1.5 % 18 1.5 % 16 1.5 % 45 1.5 % Circulatory: Heart Disease 1 0.1 % 8 0.6 % 5 0.4 % 14 0.4 % Circulatory: Hemolysis 1 0.1 % 5 0.4 % 5 0.4 % 11 0.3 % Circulatory: Ischemic Cardiomyopathy 4 0.5 % 9 0.7 % 13 1.2 % 26 0.8 % Circulatory: Major Bleeding 36 4.9 % 36 3.0 % 26 2.5 % 98 3.3 % Circulatory: Myocardial Infarction 3 0.4 % 7 0.5 % 7 0.6 % 17 0.5 % Circulatory: Myocardial Rupture 1 0.1 % . . . . 1 0.0 % Circulatory: Other, Specify 41 5.6 % 38 3.1 % 38 3.7 % 117 3.9 % Circulatory: Pericardial Fluid Collection 1 0.1 % 1 0.0 % 1 0.0 % 3 0.1 % Circulatory: Right Heart Failure 35 4.8 % 67 5.5 % 35 3.4 % 137 4.6 % Circulatory: Ruptured Aortic Aneurysm 1 0.1 % . . . . 1 0.0 % Circulatory: Sudden Unexplained Death 27 3.7 % 65 5.4 % 33 3.2 % 125 4.2 % Device Malfunction 20 2.7 % 51 4.2 % 34 3.3 % 105 3.5 % Digestive: Fluid/Electrolyte Disorder 5 0.6 % 3 0.2 % . . 8 0.2 % Digestive: GI Disorder . . 5 0.4 % 10 0.9 % 15 0.5 % Digestive: Hepatic Dysfunction 12 1.6 % 17 1.4 % 5 0.4 % 34 1.1 % Digestive: Pancreatitis 1 0.1 % . . . . 1 0.0 % Digestive: Renal Dysfunction 20 2.7 % 20 1.6 % 2 0.1 % 42 1.4 % Hemotalogical 2 0.2 % . . 1 0.0 % 3 0.1 % Major Infection 106 14.5 % 128 10.6 % 52 5.1 % 286 9.7 % Multisystem Organ Failure (MSOF) 72 9.8 % 141 11.7 % 216 21.5 % 429 14.6 % Nervous System: Neurological Dysfunction 147 20.1 % 222 18.5 % 179 17.8 % 548 18.7 % Other, specify 14 1.9 % 25 2.0 % 27 2.6 % 66 2.2 % Other: Cancer 6 0.8 % 26 2.1 % 8 0.7 % 40 1.3 % Other: Trauma/accident, specify 6 0.8 % 10 0.8 % 7 0.6 % 23 0.7 % Psychiatric Episode/Suicide 5 0.6 % 2 0.1 % 4 0.3 % 11 0.3 % Respiratory: Pulmonary: Other, specify 3 0.4 % 15 1.2 % 13 1.2 % 31 1.0 % Respiratory: Respiratory Failure 36 4.9 % 60 5.0 % 53 5.2 % 149 5.0 % Respiratory: Venous Thromboembolism Event 1 0.1 % 3 0.2 % 1 0.0 % 5 0.1 % Withdrawal of Support, specify 37 5.0 % 90 7.5 % 149 14.8 % 276 9.4 % ~Unknown~ 14 1.9 % 27 2.2 % . . 41 1.4 % TOTAL 728 100.0 % 1197 100.0 % 1002 100.0 % 2927 100.0 %

Note: 14 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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06/23/2014 Exhibit 11: Kaplan-Meier Survival for INTERMACS OVERALL

Exhi bit 11: Kapl an-M eier Sur vi val for IN TERM ACS OVER ALL

Percent Survival

Months after

Device Implant

Intermacs Overall

1 94% 3 89% 6 85% 12 78% 24 67% 36 57% 48 46% 60 41%

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06/23/2014 Exhibit 12: Kaplan-Meier Survival by Flow Type and Device

Exhi bit 12: Kapl an-M eier Sur vi val by Fl ow Type and D evice

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06/23/2014 Exhibit 13: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time

of LVAD operation) by Implant Era Exhi bit 13: Kapl an-M eier Sur vi val for C ontinuous Flow LVADs ( with or wi thout R VAD implant at ti me of LVAD oper ati on) by Impl ant Era

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of LVAD operation) by Pre-Implant Device Strategy Exhi bit 14: Kapl an-M eier Sur vi val for C ontinuous Flow LVADs ( with or wi thout R VAD implant at ti me of LVAD oper ati on) by Pre-Impl ant Devi ce Str ateg y Bridge to Transplant (BTT) includes: BTT-listed, BTT-likely, BTT-moderately likely, and BTT-unlikely.

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of LVAD operation) by Pre-Implant Patient Profile Exhi bit 15: Kapl an-M eier Sur vi val for C ontinuous Flow LVADs ( with or wi thout R VAD implant at ti me of LVAD oper ati on) by Pre-Impl ant Pati ent Profil e

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of LVAD operation) by Device Type Exhi bit 16: Kapl an-M eier Sur vi val for C ontinuous Flow LVADs ( with or wi thout R VAD implant at ti me of LVAD oper ati on) by D evice Type

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06/23/2014 Exhibit 17: Competing Outcomes for Continuous Flow LVADs (without RVAD implant at time of LVAD

operation) Exhi bit 17: C ompeti ng Outcomes for C ontinuous Flow LVAD s ( without R VAD i mpl ant at time of LVAD operati on)

Number of Patients at Risk

Month 0 1 3 6 9 12 24 36 48

9690 9075 8031 6590 5379 4366 2012 825 266

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06/23/2014 Exhibit 18: Competing Outcomes for Continuous Flow LVADs (with RVAD implant at time of LVAD

operation) Exhi bit 18: C ompeti ng Outcomes for C ontinuous Flow LVAD s ( with RVAD i mplant at ti me of LVAD operation)


Month 0 1 3 6 9 12 24 36 48

285 220 171 132 111 97 52 33 19

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06/23/2014 Exhibit 19: Competing Outcomes for TAHs

Exhi bit 19: C ompeti ng Outcomes for TAHs


Month 0 1 3 6 9 12 24

253 204 128 59 34 21 6

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06/23/2014 Exhibit 20: Adverse Event Rates for Patients Receiving a Primary Prospective Implant - Continuous

Flow LVADs (with or without RVAD implant at time of LVAD operation) Exhi bit 20: Adverse Event Rates for Pati ents R ecei ving a Primar y Prospecti ve Implant - Conti nuous Fl ow LVADs ( with or without RVAD i mplant at ti me of LVAD operation) The following table summarizes adverse events in patients receiving primary prospective implants between June 23, 2006 and March 31, 2014. 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 27032.1 patient months and the total follow-up time for the late period was 117447.1 patient months. All rates are reported in episodes per 100 patient months.

Adverse Event Type Early Event Count (n)

Early Event Rate (per 100 pt m)

Late Event Count (n)

Late Event Rate (per 100 pt m)

Arterial Non-CNS Thromboembolism 118 0.44 51 0.04 Bleeding 5273 19.51 3971 3.38 Cardiac Arrhythmia 3094 11.45 1249 1.06 Device Malfunction 747 2.76 1870 1.59 Hemolysis 578 2.14 812 0.69 Hepatic Dysfunction 395 1.46 271 0.23 Hypertension 390 1.44 377 0.32 Infection 4464 16.51 5917 5.04 Myocardial Infarction 36 0.13 37 0.03 Neurological Dysfunction 1087 4.02 1454 1.24 Other Serious Adverse Event 3535 13.08 2271 1.93 Pericardial Drainage 496 1.83 21 0.02 Psychiatric Episode 689 2.55 395 0.34 Rehospitalization 5584 20.66 18987 16.17 Renal Dysfunction 1047 3.87 577 0.49 Respiratory Failure 2034 7.52 587 0.50 Right Heart Failure 1718 6.36 608 0.52 Venous Thromboembolism 495 1.83 90 0.08 Wound Dehiscence 138 0.51 31 0.03

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06/23/2014 Exhibit 21: Infection Rates by Location - Continuous Flow LVADs (with or without RVAD implant at

time of LVAD operation) Exhi bit 21: Infec tion R ates by Location - C ontinuous Flow LVADs ( with or wi thout R VAD impl ant at ti me of LVAD oper ati on)

Adverse Event Type Early Event Count (n)

Early Event Rate (per 100 pt m)

Late Event Count (n)

Late Event Rate (per 100 pt m)

GI 396 1.46 273 0.23 Line Sepsis 164 0.61 154 0.13 Mediastinum 185 0.68 98 0.08 Other Specify 661 2.45 757 0.64 Peripheral Wound 123 0.46 125 0.11 Positive Blood Cultures 867 3.21 1614 1.37 Pulmonary 1367 5.06 608 0.52 Pump/Related - Drive Line 431 1.59 2898 2.47 Pump/Related - Exit Cannula 8 0.03 37 0.03 Pump/Related - Pump Interior 14 0.05 57 0.05 Pump/Related - Pump Pocket 126 0.47 358 0.30 Unknown 145 0.54 100 0.09 Urinary Tract 1029 3.81 796 0.68

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06/23/2014 Exhibit 20: Follow-up Compliance

Exhi bit 20: Follow- up Compliance Site compliance is determined by the percentage of all follow-up forms that are due during this reporting period that have been completed. This calculation has been updated to include ALL follow-up forms expected for ALL patients and ALL devices. Only sites that have at least 10 follow-up forms expected are included in this figure. Intermacs® has defined required compliance as 90%.

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