alfred m 14 69 112.5 intermacs - uab

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# HHSN268201100025C Quarterly Report – 2013 Q3

01/13/2013 Alfred M 14 69 112.5

INTERMACS

Interagency Registry for Mechanically Assisted Circulatory Support

Quarterly Statistical Report

2013 3rd Quarter Implant and event dates: June 23, 2006 to September 30, 2013 01/13/2013 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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01/13/2013

INTERMACS Quarterly Report Implants: June 23, 2006 to September 30, 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. 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 9791 adult patients receiving primary prospective implants between June 23, 2006 and September 30, 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: Follow-up Compliance ........................................................................................................................................ 27

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01/13/2013 Exhibit 1: Hospital Activation and Patient Enrollment Exhi bit 1: Hospital Acti vati on and Pati ent Enr ollment Between June 23, 2006 and September 30, 2013, 158 hospitals participated in INTERMACS and, of these, 138 hospitals actively contributed information on a total of 9791 patients. Cumulative patient accrual and the number of participating hospitals over this time period are displayed below.

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01/13/2013 Exhibit 2: Participating Hospital Listing Exhi bit 2: Participati ng Hospital Listi ng As of September 30, 2013 there were 158 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 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 JACKSON MEMORIAL HEALTH SYSTEM/UNIVERSITY OF MIAMI MIAMI FL

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01/13/2013 HOSPITAL NAME CITY STATE 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 SPECTRUM HEALTH HOSPITALS GRAND RAPIDS MI

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01/13/2013 HOSPITAL NAME CITY STATE 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 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

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01/13/2013 HOSPITAL NAME CITY STATE 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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01/13/2013 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 September 30, 2013).

Gender

GENDER IMPLANT DATE PERIOD

TOTAL < 2010 2010 - 2011 2012 - 2013 (Jan-Sep) n % n % n % n %

Female 452 20.6 % 762 21.3 % 837 20.7 % 2051 20.9 % Male 1732 79.3 % 2811 78.6 % 3196 79.2 % 7739 79.0 % Unspecified . . . . 1 0.0 % 1 0.0 % TOTAL 2184 100.0 % 3573 100.0 % 4034 100.0 % 9791 100.0 %

Race

RACE IMPLANT DATE PERIOD


African American 487 22.2 % 767 21.4 % 894 22.1 % 2148 21.9 % Other, Unknown, Undisclosed 184 8.4 % 290 8.1 % 346 8.5 % 820 8.3 % White 1513 69.2 % 2516 70.4 % 2794 69.2 % 6823 69.6 % TOTAL 2184 100.0 % 3573 100.0 % 4034 100.0 % 9791 100.0 %

Age Category

AGE GROUP (yr) IMPLANT DATE PERIOD


19-39 355 16.2 % 427 11.9 % 429 10.6 % 1211 12.3 % 40-59 1126 51.5 % 1471 41.1 % 1562 38.7 % 4159 42.4 % 60-79 703 32.1 % 1653 46.2 % 2008 49.7 % 4364 44.5 % 80+ . . 22 0.6 % 35 0.8 % 57 0.5 % TOTAL 2184 100.0 % 3573 100.0 % 4034 100.0 % 9791 100.0 %

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01/13/2013 Exhibit 4: Implants by Year by Device Strategy Exhi bit 4: Impl ants by Year by Device Str ategy

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01/13/2013 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 1854 84.8 % 3347 93.6 % 3834 95.0 % 9035 92.2 % BiVAD 253 11.5 % 171 4.7 % 108 2.6 % 532 5.4 % TAH 77 3.5 % 55 1.5 % 92 2.2 % 224 2.2 % TOTAL 2184 100.0 % 3573 100.0 % 4034 100.0 % 9791 100.0 %

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01/13/2013 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 - 2013 (Jan-Sep)

n % n % n % n % 1 Critical Cardio Shock 642 29.3 % 532 14.8 % 598 14.8 % 1772 18.0 % 2 Progressive Decline 930 42.5 % 1414 39.5 % 1489 36.9 % 3833 39.1 % 3 Stable but Inotrope dependent 330 15.1 % 953 26.6 % 1164 28.8 % 2447 24.9 % 4 Resting Symptoms 196 8.9 % 477 13.3 % 586 14.5 % 1259 12.8 % 5 Exertion intolerant 42 1.9 % 107 2.9 % 117 2.9 % 266 2.7 % 6 Exertion limited 23 1.0 % 66 1.8 % 45 1.1 % 134 1.3 % 7 Advanced NYHA Class 3 21 0.9 % 24 0.6 % 35 0.8 % 80 0.8 % TOTAL 2184 100.0 % 3573 100.0 % 4034 100.0 % 9791 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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01/13/2013 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 - 2013 (Jan-Sep)

n % n % n % n % BTT - Listed 1047 47.9 % 902 25.2 % 816 20.2 % 2765 28.2 % BTT - Likely 587 26.8 % 813 22.7 % 903 22.3 % 2303 23.5 % BTT - Moderate 210 9.6 % 363 10.1 % 417 10.3 % 990 10.1 % BTT - Unlikely 88 4.0 % 125 3.4 % 122 3.0 % 335 3.4 % Destination Therapy 178 8.1 % 1307 36.5 % 1724 42.7 % 3209 32.7 % Bridge to Recovery 44 2.0 % 27 0.7 % 21 0.5 % 92 0.9 % Rescue Therapy 25 1.1 % 15 0.4 % 20 0.4 % 60 0.6 % Other 5 0.2 % 21 0.5 % 11 0.2 % 37 0.3 % TOTAL 2184 100.0 % 3573 100.0 % 4034 100.0 % 9791 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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01/13/2013

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 483 17.4 % 510 22.1 % 231 23.3 % 78 23.2 % 357 11.1 % 53 57.6 % 52 86.6 % 8 21.6 % 1772 18.0 % 2 Progressive Decline 1285 46.4 % 882 38.2 % 374 37.7 % 125 37.3 % 1124 35.0 % 20 21.7 % 3 5.0 % 20 54.0 % 3833 39.1 % 3 Stable but Inotrope dependent 593 21.4 % 497 21.5 % 245 24.7 % 72 21.4 % 1018 31.7 % 12 13.0 % 4 6.6 % 6 16.2 % 2447 24.9 % 4 Resting Symptoms 285 10.3 % 283 12.2 % 115 11.6 % 44 13.1 % 525 16.3 % 4 4.3 % 0 0 3 8.1 % 1259 12.8 % 5 Exertion intolerant 61 2.2 % 68 2.9 % 17 1.7 % 6 1.7 % 113 3.5 % 0 0 1 1.6 % 0 0 266 2.7 % 6 Exertion limited 27 0.9 % 49 2.1 % 7 0.7 % 8 2.3 % 42 1.3 % 1 1.0 % 0 0 0 0 134 1.3 % 7 Advanced NYHA Class 3 31 1.1 % 14 0.6 % 1 0.1 % 2 0.5 % 30 0.9 % 2 2.1 % 0 0 0 0 80 0.8 % TOTAL 2765 100.0 % 2303 100.0 % 990 100.0 % 335 100.0 % 3209 100.0 % 92 100.0 % 60 100.0 % 37 100.0 % 9791 100.0 %

IMPLANT DATE PERIOD=< 2010






n % n % n % n % n % n % n % n % n % 1 Critical Cardio Shock 233 22.2 % 203 34.5 % 78 37.1 % 35 39.7 % 38 21.3 % 30 68.1 % 23 92.0 % 2 40.0 % 642 29.3 % 2 Progressive Decline 501 47.8 % 230 39.1 % 82 39.0 % 38 43.1 % 70 39.3 % 6 13.6 % 1 4.0 % 2 40.0 % 930 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 8.6 % 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 1047 100.0 % 587 100.0 % 210 100.0 % 88 100.0 % 178 100.0 % 44 100.0 % 25 100.0 % 5 100.0 % 2184 100.0 %

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01/13/2013 IMPLANT DATE PERIOD=2010 - 2011






n % n % n % n % n % n % n % n % n % 1 Critical Cardio Shock 133 14.7 % 144 17.7 % 68 18.7 % 20 16.0 % 140 10.7 % 11 40.7 % 12 80.0 % 4 19.0 % 532 14.8 % 2 Progressive Decline 407 45.1 % 308 37.8 % 152 41.8 % 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 % 198 24.3 % 89 24.5 % 31 24.8 % 412 31.5 % 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 22 2.4 % 35 4.3 % 7 1.9 % 2 1.6 % 41 3.1 % 0 0 0 0 0 0 107 2.9 % 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 9 0.9 % 3 0.3 % 0 0 0 0 10 0.7 % 2 7.4 % 0 0 0 0 24 0.6 % TOTAL 902 100.0 % 813 100.0 % 363 100.0 % 125 100.0 % 1307 100.0 % 27 100.0 % 15 100.0 % 21 100.0 % 3573 100.0 %

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






n % n % n % n % n % n % n % n % n % 1 Critical Cardio Shock 117 14.3 % 163 18.0 % 85 20.3 % 23 18.8 % 179 10.3 % 12 57.1 % 17 85.0 % 2 18.1 % 598 14.8 % 2 Progressive Decline 377 46.2 % 344 38.0 % 140 33.5 % 39 31.9 % 577 33.4 % 5 23.8 % 2 10.0 % 5 45.4 % 1489 36.9 % 3 Stable but Inotrope dependent 202 24.7 % 230 25.4 % 128 30.6 % 33 27.0 % 565 32.7 % 3 14.2 % 1 5.0 % 2 18.1 % 1164 28.8 % 4 Resting Symptoms 86 10.5 % 126 13.9 % 55 13.1 % 20 16.3 % 297 17.2 % 0 0 0 0 2 18.1 % 586 14.5 % 5 Exertion intolerant 22 2.6 % 15 1.6 % 6 1.4 % 4 3.2 % 70 4.0 % 0 0 0 0 0 0 117 2.9 % 6 Exertion limited 6 0.7 % 16 1.7 % 2 0.4 % 2 1.6 % 18 1.0 % 1 4.7 % 0 0 0 0 45 1.1 % 7 Advanced NYHA Class 3 6 0.7 % 9 0.9 % 1 0.2 % 1 0.8 % 18 1.0 % 0 0 0 0 0 0 35 0.8 % TOTAL 816 100.0 % 903 100.0 % 417 100.0 % 122 100.0 % 1724 100.0 % 21 100.0 % 20 100.0 % 11 100.0 % 4034 100.0 %

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01/13/2013 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 September 30, 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 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 (September 30, 2013)

TOTAL

1. Alive (device in

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

BTT - Listed 776 1435 26 528 2765 BTT - Likely 870 912 30 491 2303 BTT - Moderate 476 213 10 291 990 BTT - Unlikely 159 46 3 127 335 Destination Therapy 1989 192 20 1008 3209 Bridge to Recovery 37 23 13 19 92 Rescue Therapy 10 13 4 33 60 Other 16 9 1 11 37 TOTAL 4333 2843 107 2508 9791

IMPLANT DATE PERIOD=< 2010



TOTAL

1. Alive (device in



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01/13/2013

IMPLANT DATE PERIOD=2010 - 2011



TOTAL

1. Alive (device in



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



TOTAL

1. Alive (device in



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01/13/2013

Exhibit 10: Primary Cause of Death Exhi bit 10: Primar y C ause of D eath

PRIMARY CAUSE OF DEATH

IMPLANT DATE PERIOD

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

n % n % n % n % Circulatory: Arterial Non-CNS Thromboembolism 7 0.9 % 15 1.3 % 3 0.4 % 25 0.9 % Circulatory: CHF 26 3.6 % 38 3.4 % 20 2.9 % 84 3.3 % Circulatory: Cardiac Arrhythmia 22 3.0 % 38 3.4 % 13 1.9 % 73 2.9 % Circulatory: End Stage Cardiomyopathy 11 1.5 % 16 1.4 % 9 1.3 % 36 1.4 % Circulatory: Heart Disease . . 8 0.7 % 5 0.7 % 13 0.5 % Circulatory: Hemolysis 1 0.1 % 5 0.4 % 3 0.4 % 9 0.3 % Circulatory: Ischemic Cardiomyopathy 4 0.5 % 9 0.8 % 12 1.7 % 25 0.9 % Circulatory: Major Bleeding 35 4.8 % 33 2.9 % 18 2.6 % 86 3.4 % Circulatory: Myocardial Infarction 3 0.4 % 7 0.6 % 6 0.8 % 16 0.6 % Circulatory: Myocardial Rupture 1 0.1 % . . . . 1 0.0 % Circulatory: Other, Specify 40 5.5 % 36 3.2 % 24 3.5 % 100 3.9 % Circulatory: Pericardial Fluid Collection 1 0.1 % 1 0.0 % 1 0.1 % 3 0.1 % Circulatory: Right Heart Failure 36 5.0 % 66 5.9 % 22 3.2 % 124 4.9 % Circulatory: Ruptured Aortic Aneurysm 1 0.1 % . . . . 1 0.0 % Circulatory: Sudden Unexplained Death 26 3.6 % 54 4.8 % 22 3.2 % 102 4.0 % Device Malfunction 20 2.7 % 44 3.9 % 18 2.6 % 82 3.2 % Digestive: Fluid/Electrolyte Disorder 4 0.5 % 3 0.2 % . . 7 0.2 % Digestive: GI Disorder . . 4 0.3 % 6 0.8 % 10 0.3 % Digestive: Hepatic Dysfunction 12 1.6 % 17 1.5 % 4 0.5 % 33 1.3 % Digestive: Pancreatitis 1 0.1 % . . . . 1 0.0 % Digestive: Renal Dysfunction 20 2.7 % 18 1.6 % 1 0.1 % 39 1.5 % Major Infection 102 14.2 % 119 10.6 % 35 5.2 % 256 10.2 % Multisystem Organ Failure (MSOF) 67 9.3 % 126 11.3 % 135 20.0 % 328 13.1 % Nervous System: Neurological Dysfunction 137 19.1 % 198 17.7 % 113 16.8 % 448 17.9 % Other 29 4.0 % 65 5.8 % 58 8.6 % 152 6.0 % Other: Cancer 6 0.8 % 20 1.7 % 5 0.7 % 31 1.2 % Other: Trauma/accident, specify 6 0.8 % 7 0.6 % 3 0.4 % 16 0.6 % Psychiatric Episode/Suicide 4 0.5 % 1 0.0 % 3 0.4 % 8 0.3 % Respiratory: Pulmonary: Other, specify 3 0.4 % 13 1.1 % 5 0.7 % 21 0.8 % Respiratory: Respiratory Failure 39 5.4 % 50 4.4 % 35 5.2 % 124 4.9 % Respiratory: Venous Thromboembolism Event 1 0.1 % 3 0.2 % 1 0.1 % 5 0.1 % Withdrawal of Support, specify 35 4.8 % 73 6.5 % 92 13.6 % 200 7.9 % ~Unknown~ 15 2.0 % 27 2.4 % . . 42 1.6 % TOTAL 715 100.0 % 1114 100.0 % 672 100.0 % 2501 100.0 %

Note: 7 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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01/13/2013 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 66% 36 56% 48 45% 60 40%

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01/13/2013 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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01/13/2013

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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01/13/2013

Exhibit 14: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Pre-Implant Device Strategy 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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01/13/2013 Exhibit 15: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Pre-Implant Patient Profile 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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01/13/2013

Exhibit 16: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time 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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01/13/2013 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

8423 7875 6897 5544 4441 3613 1561 582 134

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01/13/2013

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)

Number of Patients at Risk

Month 0 1 3 6 9 12 24 36 48

221 168 132 106 92 79 46 30 15

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01/13/2013

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) Exhi bit 19: 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 September 30, 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 23253.17 patient months and the total follow-up time for the late period was 91736.73 patient months. All rates are reported in episodes per 100 patient months.

Adverse Event Type

Event Count

(n=54533)

Patient Count

(n=8644)

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 131 115 1.3 % 96 0.41 35 0.04 Bleeding 7362 3366 38.9 % 4355 18.73 3007 3.28 Cardiac Arrythmia 3483 2264 26.1 % 2530 10.88 953 1.04 Device Malfunction 1917 1486 17.1 % 539 2.32 1378 1.50 Hemolysis 790 628 7.2 % 319 1.37 471 0.51 Hepatic Dysfunction 514 473 5.4 % 308 1.32 206 0.22 Hypertension 629 486 5.6 % 317 1.36 312 0.34 Infection 8121 3799 43.9 % 3562 15.32 4559 4.97 Myocardial Infarction 64 58 0.6 % 33 0.14 31 0.03 Neurological Dysfunction 1874 1502 17.3 % 790 3.40 1084 1.18 Other Serious Adverse Event 4327 2370 27.4 % 2649 11.39 1678 1.83 Pericardial Drainage 424 385 4.4 % 406 1.75 18 0.02 Psychiatric Episode 841 714 8.2 % 544 2.34 297 0.32 Rehospitalization 18472 5809 67.2 % 4253 18.29 14219 15.50 Renal Dysfunction 1225 1059 12.2 % 786 3.38 439 0.48 Respiratory Failure 2022 1589 18.3 % 1591 6.84 431 0.47 Right Heart Failure 1708 1432 16.5 % 1264 5.44 444 0.48 Venous Thromboembolism 496 468 5.4 % 419 1.80 77 0.08 Wound Dehiscence 133 117 1.3 % 108 0.46 25 0.03

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01/13/2013

Exhibit 20: Follow-up Compliance Exhi bit 20: F ollow- 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%.

alfred m 14 69 112.5 intermacs - uab

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