v9.3 sas system output - university of alabama at birmingham...2013 2nd quarter implant and event...

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# HHSN268201100025C Quarterly Report – 2013 Q2

09/23/2013

INTERMACS

Interagency Registry for Mechanically Assisted Circulatory Support

Quarterly Statistical Report

2013 2nd Quarter Implant and event dates: June 23, 2006 to June 30, 2013 09/23/2013 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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09/23/2013

INTERMACS Quarterly Report Implants: June 23, 2006 to June 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 9195 adult patients receiving primary prospective implants between June 23, 2006 and June 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: Compliance ...................................................................................................................................................................... 27

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09/23/2013 Exhibit 1: Hospital Activation and Patient Enrollment Between June 23, 2006 and June 30, 2013, 156 hospitals participated in INTERMACS and, of these, 138 hospitals actively contributed information on a total of 9195 patients. Cumulative patient accrual and the number of participating hospitals over this time period are displayed below.

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09/23/2013

Exhibit 2: Participating Hospital Listing As of June 30, 2013 there were 156 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 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

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09/23/2013 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 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 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 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

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09/23/2013 HOSPITAL NAME CITY STATE SHARP MEMORIAL HOSPITAL SAN DIEGO CA 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 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

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09/23/2013 HOSPITAL NAME CITY STATE UNIVERSITY OF VIRGINIA HEALTH SYSTEM CHARLOTTESVILLE VA UNIVERSITY OF WASHINGTON MEDICAL CENTER SEATTLE WA 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 YALE-NEW HAVEN HOSPITAL NEW HAVEN CT YORK HOSPITAL YORK PA

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09/23/2013 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 June 30, 2013).

Gender

GENDER IMPLANT DATE PERIOD

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

Female 454 20.6 % 767 21.3 % 694 20.3 % 1915 20.8 % Male 1746 79.3 % 2820 78.6 % 2713 79.6 % 7279 79.1 % Unspecified . . . . 1 0.0 % 1 0.0 % TOTAL 2200 100.0 % 3587 100.0 % 3408 100.0 % 9195 100.0 %

Race

RACE IMPLANT DATE PERIOD


African American 489 22.2 % 769 21.4 % 736 21.5 % 1994 21.6 % Other, Unknown, Undisclosed 184 8.3 % 290 8.0 % 291 8.5 % 765 8.3 % White 1527 69.4 % 2528 70.4 % 2381 69.8 % 6436 69.9 % TOTAL 2200 100.0 % 3587 100.0 % 3408 100.0 % 9195 100.0 %

Age Category

AGE GROUP (yr) IMPLANT DATE PERIOD


19-39 357 16.2 % 429 11.9 % 368 10.7 % 1154 12.5 % 40-59 1133 51.5 % 1477 41.1 % 1329 38.9 % 3939 42.8 % 60-79 710 32.2 % 1659 46.2 % 1681 49.3 % 4050 44.0 % 80+ . . 22 0.6 % 30 0.8 % 52 0.5 % TOTAL 2200 100.0 % 3587 100.0 % 3408 100.0 % 9195 100.0 %

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09/23/2013 Exhibit 4: Implants by Year by Device Strategy

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09/23/2013 Exhibit 5: Implants per Year by Device Type

Number of Implants by Device Type and Implant Date Period

DEVICE TYPE IMPLANT DATE PERIOD


LVAD 1868 84.9 % 3361 93.6 % 3241 95.0 % 8470 92.1 % BiVAD 255 11.5 % 171 4.7 % 92 2.6 % 518 5.6 % TAH 77 3.5 % 55 1.5 % 75 2.2 % 207 2.2 % TOTAL 2200 100.0 % 3587 100.0 % 3408 100.0 % 9195 100.0 %

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09/23/2013 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-Jun)

n % n % n % n % 1 Critical Cardio Shock 646 29.3 % 534 14.8 % 500 14.6 % 1680 18.2 % 2 Progressive Decline 934 42.4 % 1419 39.5 % 1268 37.2 % 3621 39.3 % 3 Stable but Inotrope dependent 335 15.2 % 954 26.5 % 967 28.3 % 2256 24.5 % 4 Resting Symptoms 197 8.9 % 480 13.3 % 500 14.6 % 1177 12.8 % 5 Exertion intolerant 42 1.9 % 109 3.0 % 100 2.9 % 251 2.7 % 6 Exertion limited 25 1.1 % 66 1.8 % 40 1.1 % 131 1.4 % 7 Advanced NYHA Class 3 21 0.9 % 25 0.6 % 33 0.9 % 79 0.8 % TOTAL 2200 100.0 % 3587 100.0 % 3408 100.0 % 9195 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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09/23/2013 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-Jun)

n % n % n % n % BTT - Listed 1051 47.7 % 904 25.2 % 665 19.5 % 2620 28.4 % BTT - Likely 594 27.0 % 818 22.8 % 778 22.8 % 2190 23.8 % BTT - Moderate 214 9.7 % 365 10.1 % 347 10.1 % 926 10.0 % BTT - Unlikely 88 4.0 % 126 3.5 % 108 3.1 % 322 3.5 % Destination Therapy 178 8.0 % 1308 36.4 % 1465 42.9 % 2951 32.0 % Bridge to Recovery 45 2.0 % 30 0.8 % 19 0.5 % 94 1.0 % Rescue Therapy 25 1.1 % 15 0.4 % 18 0.5 % 58 0.6 % Other 5 0.2 % 21 0.5 % 8 0.2 % 34 0.3 % TOTAL 2200 100.0 % 3587 100.0 % 3408 100.0 % 9195 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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09/23/2013 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 465 17.7 % 486 22.1 % 217 23.4 % 75 23.2 % 326 11.0 % 53 56.3 % 51 87.9 % 7 20.5 % 1680 18.2 % 2 Progressive Decline 1224 46.7 % 840 38.3 % 353 38.1 % 123 38.1 % 1038 35.1 % 20 21.2 % 3 5.1 % 20 58.8 % 3621 39.3 % 3 Stable but Inotrope dependent 548 20.9 % 468 21.3 % 224 24.1 % 67 20.8 % 929 31.4 % 12 12.7 % 3 5.1 % 5 14.7 % 2256 24.5 % 4 Resting Symptoms 269 10.2 % 268 12.2 % 108 11.6 % 42 13.0 % 483 16.3 % 5 5.3 % 0 0 2 5.8 % 1177 12.8 % 5 Exertion intolerant 58 2.2 % 65 2.9 % 16 1.7 % 5 1.5 % 106 3.5 % 0 0 1 1.7 % 0 0 251 2.7 % 6 Exertion limited 26 0.9 % 48 2.1 % 8 0.8 % 8 2.4 % 40 1.3 % 1 1.0 % 0 0 0 0 131 1.4 % 7 Advanced NYHA Class 3 30 1.1 % 15 0.6 % 0 0 2 0.6 % 29 0.9 % 3 3.1 % 0 0 0 0 79 0.8 % TOTAL 2620 100.0 % 2190 100.0 % 926 100.0 % 322 100.0 % 2951 100.0 % 94 100.0 % 58 100.0 % 34 100.0 % 9195 100.0 %

IMPLANT DATE PERIOD=< 2010






n % n % n % n % n % n % n % n % n % 1 Critical Cardio Shock 235 22.3 % 205 34.5 % 79 36.9 % 35 39.7 % 37 20.7 % 30 66.6 % 23 92.0 % 2 40.0 % 646 29.3 % 2 Progressive Decline 501 47.6 % 232 39.0 % 83 38.7 % 38 43.1 % 71 39.8 % 6 13.3 % 1 4.0 % 2 40.0 % 934 42.4 % 3 Stable but Inotrope dependent 179 17.0 % 71 11.9 % 29 13.5 % 8 9.0 % 41 23.0 % 6 13.3 % 0 0 1 20.0 % 335 15.2 % 4 Resting Symptoms 91 8.6 % 59 9.9 % 17 7.9 % 5 5.6 % 22 12.3 % 3 6.6 % 0 0 0 0 197 8.9 % 5 Exertion intolerant 17 1.6 % 18 3.0 % 4 1.8 % 0 0 2 1.1 % 0 0 1 4.0 % 0 0 42 1.9 % 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 1.5 % 2 0.3 % 0 0 1 1.1 % 2 1.1 % 0 0 0 0 0 0 21 0.9 % TOTAL 1051 100.0 % 594 100.0 % 214 100.0 % 88 100.0 % 178 100.0 % 45 100.0 % 25 100.0 % 5 100.0 % 2200 100.0 %

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09/23/2013 IMPLANT DATE PERIOD=2010 - 2011






n % n % n % n % n % n % n % n % n % 1 Critical Cardio Shock 134 14.8 % 144 17.6 % 68 18.6 % 20 15.8 % 140 10.7 % 12 40.0 % 12 80.0 % 4 19.0 % 534 14.8 % 2 Progressive Decline 410 45.3 % 309 37.7 % 153 41.9 % 48 38.0 % 476 36.3 % 10 33.3 % 0 0 13 61.9 % 1419 39.5 % 3 Stable but Inotrope dependent 213 23.5 % 201 24.5 % 89 24.3 % 31 24.6 % 411 31.4 % 3 10.0 % 3 20.0 % 3 14.2 % 954 26.5 % 4 Resting Symptoms 107 11.8 % 99 12.1 % 43 11.7 % 20 15.8 % 208 15.9 % 2 6.6 % 0 0 1 4.7 % 480 13.3 % 5 Exertion intolerant 22 2.4 % 35 4.2 % 8 2.1 % 2 1.5 % 42 3.2 % 0 0 0 0 0 0 109 3.0 % 6 Exertion limited 9 0.9 % 27 3.3 % 4 1.0 % 5 3.9 % 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 % 3 10.0 % 0 0 0 0 25 0.6 % TOTAL 904 100.0 % 818 100.0 % 365 100.0 % 126 100.0 % 1308 100.0 % 30 100.0 % 15 100.0 % 21 100.0 % 3587 100.0 %

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






n % n % n % n % n % n % n % n % n % 1 Critical Cardio Shock 96 14.4 % 137 17.6 % 70 20.1 % 20 18.5 % 149 10.1 % 11 57.8 % 16 88.8 % 1 12.5 % 500 14.6 % 2 Progressive Decline 313 47.0 % 299 38.4 % 117 33.7 % 37 34.2 % 491 33.5 % 4 21.0 % 2 11.1 % 5 62.5 % 1268 37.2 % 3 Stable but Inotrope dependent 156 23.4 % 196 25.1 % 106 30.5 % 28 25.9 % 477 32.5 % 3 15.7 % 0 0 1 12.5 % 967 28.3 % 4 Resting Symptoms 71 10.6 % 110 14.1 % 48 13.8 % 17 15.7 % 253 17.2 % 0 0 0 0 1 12.5 % 500 14.6 % 5 Exertion intolerant 19 2.8 % 12 1.5 % 4 1.1 % 3 2.7 % 62 4.2 % 0 0 0 0 0 0 100 2.9 % 6 Exertion limited 5 0.7 % 14 1.7 % 2 0.5 % 2 1.8 % 16 1.0 % 1 5.2 % 0 0 0 0 40 1.1 % 7 Advanced NYHA Class 3 5 0.7 % 10 1.2 % 0 0 1 0.9 % 17 1.1 % 0 0 0 0 0 0 33 0.9 % TOTAL 665 100.0 % 778 100.0 % 347 100.0 % 108 100.0 % 1465 100.0 % 19 100.0 % 18 100.0 % 8 100.0 % 3408 100.0 %

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09/23/2013 Exhibit 9: Patient Status by Device Strategy at Implant The following tables present patient status as of June 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 (June 30, 2013)

TOTAL

1. Alive (device in

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

BTT - Listed 735 1365 26 494 2620 BTT - Likely 884 834 24 448 2190 BTT - Moderate 462 189 6 269 926 BTT - Unlikely 161 41 3 117 322 Destination Therapy 1880 151 17 903 2951 Bridge to Recovery 38 22 13 21 94 Rescue Therapy 12 11 4 31 58 Other 15 9 1 9 34 TOTAL 4187 2622 94 2292 9195

IMPLANT DATE PERIOD=< 2010



TOTAL

1. Alive (device in



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09/23/2013 IMPLANT DATE PERIOD=2010 - 2011



TOTAL

1. Alive (device in



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



TOTAL

1. Alive (device in



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09/23/2013 Exhibit 10: Primary Cause of Death

PRIMARY CAUSE OF DEATH IMPLANT DATE PERIOD


Circulatory: Arterial Non-CNS Thromboembolism 7 0.9 % 16 1.5 % 2 0.3 % 25 1.0 % Circulatory: CHF 25 3.5 % 35 3.3 % 15 2.8 % 75 3.2 % Circulatory: Cardiac Arrhythmia 20 2.8 % 35 3.3 % 12 2.2 % 67 2.9 % Circulatory: End Stage Cardiomyopathy 11 1.5 % 14 1.3 % 9 1.7 % 34 1.4 % Circulatory: Heart Disease . . 6 0.5 % 5 0.9 % 11 0.4 % Circulatory: Hemolysis 1 0.1 % 5 0.4 % 3 0.5 % 9 0.3 % Circulatory: Ischemic Cardiomyopathy 4 0.5 % 9 0.8 % 10 1.9 % 23 1.0 % Circulatory: Major Bleeding 35 4.9 % 36 3.4 % 15 2.8 % 86 3.7 % Circulatory: Myocardial Infarction 3 0.4 % 7 0.6 % 6 1.1 % 16 0.6 % Circulatory: Myocardial Rupture 1 0.1 % . . . . 1 0.0 % Circulatory: Other, Specify 40 5.6 % 37 3.5 % 20 3.8 % 97 4.2 % Circulatory: Pericardial Fluid Collection 1 0.1 % 1 0.0 % 1 0.1 % 3 0.1 % Circulatory: Right Heart Failure 36 5.0 % 61 5.7 % 18 3.4 % 115 5.0 % Circulatory: Ruptured Aortic Aneurysm 1 0.1 % . . . . 1 0.0 % Circulatory: Sudden Unexplained Death 25 3.5 % 52 4.9 % 16 3.0 % 93 4.0 % Device Malfunction 20 2.8 % 41 3.8 % 12 2.2 % 73 3.1 % Digestive: Fluid/Electrolyte Disorder 4 0.5 % 3 0.2 % . . 7 0.3 % Digestive: GI Disorder . . 4 0.3 % 5 0.9 % 9 0.3 % Digestive: Hepatic Dysfunction 14 1.9 % 17 1.6 % 3 0.5 % 34 1.4 % Digestive: Pancreatitis 1 0.1 % . . . . 1 0.0 % Digestive: Renal Dysfunction 21 2.9 % 17 1.6 % 1 0.1 % 39 1.7 % Major Infection 102 14.4 % 109 10.3 % 27 5.1 % 238 10.4 % Multisystem Organ Failure (MSOF) 67 9.4 % 113 10.6 % 101 19.3 % 281 12.2 % Nervous System: Neurological Dysfunction 132 18.6 % 187 17.6 % 84 16.0 % 403 17.6 % Other 27 3.8 % 61 5.7 % 48 9.1 % 136 5.9 % Other: Cancer 6 0.8 % 20 1.8 % 4 0.7 % 30 1.3 % Other: Trauma/accident, specify 6 0.8 % 6 0.5 % 2 0.3 % 14 0.6 % Psychiatric Episode/Suicide 4 0.5 % . . 2 0.3 % 6 0.2 % Respiratory: Pulmonary: Other, specify 3 0.4 % 12 1.1 % 4 0.7 % 19 0.8 % Respiratory: Respiratory Failure 40 5.6 % 51 4.8 % 30 5.7 % 121 5.2 % Respiratory: Venous Thromboembolism Event 1 0.1 % 3 0.2 % 1 0.1 % 5 0.2 % Unknown v2.3 17 2.4 % 30 2.8 % . . 47 2.0 % Withdrawal of Support, specify 33 4.6 % 69 6.5 % 67 12.8 % 169 7.3 % TOTAL 708 100.0 % 1057 100.0 % 523 100.0 % 2288 100.0 %

Note: 4 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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09/23/2013 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 9195 5608 3596 2326 1526 949 583 278 169

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09/23/2013 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 7841 5102 3295 2129 1380 827 480 201 105 Continuous - BiVAD 207 101 76 59 45 38 24 10 6 Pulsatile - LVAD 627 297 189 117 89 75 72 61 53 Pulsatile - BiVAD 311 62 26 15 11 10 9 8 7 Pulsatile - TAH 207 47 16 9 5 3 2 2 2

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09/23/2013 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 1326 900 638 485 381 310 254 210 110 2010-2011 3430 2571 2035 1703 1044 554 250 1 1 2012-2013 (Jan-Jun) 3292 1731 696 1 1 1 1 1 1

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09/23/2013 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.


Pre-Implant Device Strategy Month

0 6 12 18 24 30 36 42 48 Bridge to Transplant: Listed 2137 1300 798 540 375 251 174 96 49 Bridge to Candidacy 2998 1963 1249 791 518 322 194 85 47 Destination Therapy 2809 1872 1278 828 515 280 127 27 12

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09/23/2013 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 1198 727 471 306 200 123 86 51 29 Level 2 - Progressive Decline 3161 1994 1307 831 556 347 199 78 40 Level 3 - Stable but Inotrope Dependent 2150 1445 917 595 387 212 114 43 25 Level 4 - Resting Symptoms 1102 722 467 317 205 126 68 25 12 Levels 5,6,7 - All Others 437 315 210 142 81 58 40 17 9

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09/23/2013 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 7841 5102 3295 2129 1380 827 480 201 105 BiVAD 207 101 76 59 45 38 24 10 6

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09/23/2013 Exhibit 17: Competing Outcomes for Continuous Flow LVADs (without RVAD implant at time of LVAD operation)


Month 0 6 12 18 24 30 36

7841 5102 3295 2129 1384 827 482

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09/23/2013 Exhibit 18: Competing Outcomes for Continuous Flow LVADs (with RVAD implant at time of LVAD operation)


Month 0 6 12 18 24 30 36

207 101 76 61 45 40 24

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09/23/2013 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 June 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 21595.93 patient months and the total follow-up time for the late period was 82175.23 patient months. All rates are reported in episodes per 100 patient months.

Adverse Event Type

Event Count

(n=50297)

Patient Count

(n=8048)

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

118 102 1.2 % 89 0.41 29 0.04

Bleeding 7247 3113 38.6 % 4420 20.47 2827 3.44 Cardiac Arrythmia 3186 2066 25.6 % 2351 10.89 835 1.02 Device Malfunction 1721 1331 16.5 % 498 2.31 1223 1.49 Hemolysis 705 571 7.0 % 288 1.33 417 0.51 Hepatic Dysfunction 467 426 5.2 % 285 1.32 182 0.22 Hypertension 576 443 5.5 % 296 1.37 280 0.34 Infection 7877 3489 43.3 % 3423 15.85 4454 5.42 Myocardial Infarction 58 53 0.6 % 32 0.15 26 0.03 Neurological Dysfunction 1698 1364 16.9 % 726 3.36 972 1.18 Other Serious Adverse Event 4035 2217 27.5 % 2470 11.44 1565 1.90 Pericardial Drainage 392 356 4.4 % 375 1.74 17 0.02 Psychiatric Episode 764 650 8.0 % 496 2.30 268 0.33 Rehospitalization 16383 5245 65.1 % 3833 17.75 12550 15.27 Renal Dysfunction 1135 974 12.1 % 734 3.40 401 0.49 Respiratory Failure 1850 1457 18.1 % 1469 6.80 381 0.46 Right Heart Failure 1500 1261 15.6 % 1118 5.18 382 0.46 Venous Thromboembolism 465 438 5.4 % 396 1.83 69 0.08 Wound Dehiscence 120 106 1.3 % 97 0.45 23 0.03

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09/23/2013 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%.

v9.3 sas system output - university of alabama at birmingham...2013 2nd quarter implant and event...

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