alfred m 14 69 112.5 intermacs - uab...2014 2nd quarter implant and event dates: june 23, 2006 to...

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Alfred M 14 69 112.5

INTERMACSInteragency Registry for MechanicallyAssisted Circulatory Support

Quarterly Statistical Report2014 2nd Quarter

Implant and event dates: June 23, 2006 to June 30, 2014

09/22/2014

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]

# HHSN268201100025C

22

INTERMACS Quarterly ReportImplants: June 23, 2006 to June 30, 2014

The Interagency Registry for Mechanically Assisted Circulatory Support is a North Americanregistry established in 2005 for patients who are receiving mechanical circulatory supportdevice therapy to treat advanced heart failure. INTERMACS was established as a joint effortof the National Heart, Lung and Blood Institute (NHLBI), the Centers for Medicare andMedicaid Services (CMS), the Food and Drug Administration (FDA), clinicians, scientists andindustry representatives in conjunction with Dr. James K. Kirklin and the University ofAlabama at Birmingham. This quarterly report includes clinical information from 11796 adultpatients receiving primary prospective implants between June 23, 2006 and June 30, 2014

Table of Contents

Exhibit 1: Hospital Activation and Patient Enrollment

Exhibit 2: Participating Hospital Listing

Exhibit 3: Patient Demographics by Implant Period

Exhibit 4: Implants by Year by Device Strategy

Exhibit 5: Implants per Year by Device Type

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

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

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

Exhibit 9: Patient Status by Device Strategy at Implant

Exhibit 10: Primary Cause of Death

Exhibit 11: Kaplan-Meier Survival for INTERMACS Overall

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

Exhibit 13: Kaplan-Meier Survival for Continuous Flow LVADs* by Implant Era

Exhibit 14: Kaplan-Meier Survival for Continuous Flow LVADs* by Pre-Implant Device Strategy

Exhibit 15: Kaplan-Meier Survival for Continuous Flow LVADs* by Pre-Implant Patient Profile

Exhibit 16: Kaplan-Meier Survival for Continuous Flow LVADs* by Device Type

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

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

Exhibit 19: Competing Outcomes for TAHs

Exhibit 20: Adverse Event Rates for Patients Receiving a Primary Prospective Continuous Flow LVADs*

Exhibit 21: Infection Rates by Location for Continuous Flow LVADs*

Exhibit 22: Follow-up Compliance

* (with or without RVAD implant at time of LVAD operation)

INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 20143

Exhibit 1: Hospital Activation and Patient Enrollment

Between June 23, 2006 and June 30, 2014, 159 hospitals participated in INTERMACS and, ofthese, 144 hospitals actively contributed information on a total of 11796 patients. Cumulativepatient accrual and the number of participating hospitals over this time period are displayedbelow.



As of June 30, 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 HEARTMEDICAL 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

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

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

UNIVERSITY OF WISCONSIN HOSPITAL AND CLINICS MADISON WI

UT SOUTHWESTERN MEDICAL CENTER DALLAS TX

VANDERBILT UNIVERSITY MEDICAL CENTER - VANDERBILT HEART AND VASCULARINSTITUTE

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


Exhibit 3: Patient Demographics by Implant Period

The following tables present demographic characteristics for patients at the time of theirprimary implant (June 23, 2006 to June 30, 2014).

Gender

GENDER

IMPLANT DATE PERIOD

TOTAL< 2010 2010 - 2011 2012 - 2014 (Jan-Jun)

n % n % n % n %

Female 451 20.6 % 763 21.3 % 1271 21.0 % 2485 21.0 %

MISSING 2 0.0 % . . . . 2 0.0 %

Male 1731 79.2 % 2807 78.6 % 4770 78.9 % 9308 78.9 %

Unspecified . . . . 1 0.0 % 1 0.0 %

TOTAL 2184 100.0 % 3570 100.0 % 6042 100.0 % 11796 100.0 %

Race

RACE

IMPLANT DATE PERIOD

TOTAL< 2010 2010 - 2011 2012 - 2014 (Jan-Jun)

n % n % n % n %

African American 486 22.2 % 766 21.4 % 1391 23.0 % 2643 22.4 %

Other, Unknown,Undisclosed 187 8.5 % 290 8.1 % 515 8.5 % 992 8.4 %

White 1511 69.1 % 2514 70.4 % 4136 68.4 % 8161 69.1 %

TOTAL 2184 100.0 % 3570 100.0 % 6042 100.0 % 11796 100.0 %

Age Group

AGE GROUP (yr)

IMPLANT DATE PERIOD

TOTAL< 2010 2010 - 2011 2012 - 2014 (Jan-Jun)

n % n % n % n %

19-39 356 16.3 % 428 11.9 % 659 10.9 % 1443 12.2 %

40-59 1128 51.6 % 1475 41.3 % 2419 40.0 % 5022 42.5 %

60-79 700 32.0 % 1647 46.1 % 2914 48.2 % 5261 44.5 %

80+ . . 20 0.5 % 50 0.8 % 70 0.5 %

TOTAL 2184 100.0 % 3570 100.0 % 6042 100.0 % 11796 100.0 %


Exhibit 4: Implants by Year by Device Strategy


Exhibit 5: Implants per Year by Device Type

Number of Implants by Device Type and Year

Number of Implants by Device Type and Implant Date Period

DEVICE TYPE

IMPLANT DATE PERIOD

TOTAL< 2010 2010 - 2011 2012 - 2014 (Jan-Jun)

n % n % n % n %

LVAD 1850 84.7 % 3339 93.5 % 5703 94.3 % 10892 92.3 %

BiVAD 257 11.7 % 176 4.9 % 199 3.2 % 632 5.3 %

TAH 77 3.5 % 55 1.5 % 140 2.3 % 272 2.3 %

TOTAL 2184 100.0 % 3570 100.0 % 6042 100.0 % 11796 100.0 %


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 ofimplantation.

PATIENT PROFILE AT TIMEOF IMPLANT

IMPLANT DATE PERIOD

TOTAL< 2010 2010 - 2011 2012 - 2014 (Jan-Jun)

n % n % n % n %

1 Critical Cardio Shock 643 29.4 % 532 14.9 % 913 15.1 % 2088 17.7 %

2 Progressive Decline 929 42.5 % 1412 39.5 % 2175 35.9 % 4516 38.2 %

3 Stable but Inotropedependent 330 15.1 % 952 26.6 % 1822 30.1 % 3104 26.3 %

4 Resting Symptoms 196 8.9 % 477 13.3 % 884 14.6 % 1557 13.1 %

5 Exertion intolerant 42 1.9 % 108 3.0 % 156 2.5 % 306 2.5 %

6 Exertion limited 23 1.0 % 66 1.8 % 53 0.8 % 142 1.2 %

7 Advanced NYHA Class 3 21 0.9 % 23 0.6 % 39 0.6 % 83 0.7 %

TOTAL 2184 100.0 % 3570 100.0 % 6042 100.0 % 11796 100.0 %

1 Critical cardiogenic shock describes a patient who is 'crashing and burning', in which apatient has life-threatening hypotension and rapidily escalating inotropic pressor support.

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

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

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

5 Exertion Intolerant describes a patient who is comfortable at rest but unable to engage inany activity, living predominantly within the house or household.

6 Exertion Limited also describes a patient who is comfortable at rest without evidence of fluidoverload, but who is able to do some mild activity.

7 Advanced NYHA Class 3 describes a patient who is clinically stable with a reasonable levelof comfortable activity, despite history of previous decompensation that is not recent.


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

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

DEVICE STRATEGY ATTIME OF IMPLANT

IMPLANT DATE PERIOD

TOTAL< 2010 2010 - 2011 2012 - 2014 (Jan-Jun)

n % n % n % n %

BTT - Listed 1045 47.8 % 903 25.2 % 1412 23.3 % 3360 28.4 %

BTT - Likely 589 26.9 % 810 22.6 % 1221 20.2 % 2620 22.2 %

BTT - Moderate 210 9.6 % 362 10.1 % 588 9.7 % 1160 9.8 %

BTT - Unlikely 88 4.0 % 125 3.5 % 165 2.7 % 378 3.2 %

Destination Therapy 178 8.1 % 1307 36.6 % 2590 42.8 % 4075 34.5 %

Bridge to Recovery 44 2.0 % 27 0.7 % 25 0.4 % 96 0.8 %

Rescue Therapy 25 1.1 % 15 0.4 % 25 0.4 % 65 0.5 %

Other 5 0.2 % 21 0.5 % 16 0.2 % 42 0.3 %

TOTAL 2184 100.0 % 3570 100.0 % 6042 100.0 % 11796 100.0 %

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

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

3. Bridge to Transplant (BTT) Moderate - patient in whom the transplant evaluation has notbeen completed, but with some potential concerns that might prevent eligibility.

4. Bridge to Transplant (BTT) Unlikely - patient in whom major concerns that might preventeligibility 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 cardiacfailure (at least 3 months in duration).

7. Rescue Therapy - use of a durable device to support resolution from an acute event withoutmajor previous cardiac dysfunction.

8. Other.



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

Overall

PATIENT PROFILE STATUSOVERALL

Pre-Implant Device Strategy

BTT - Listed BTT - Likely BTT - Moderate BTT - UnlikelyDestination

Therapy

n % n % n % n % n %

1 Critical Cardio Shock 558 16.6 % 566 21.6 % 280 24.1 % 88 23.2 % 478 11.7 %

2 Progressive Decline 1510 44.9 % 988 37.7 % 425 36.6 % 139 36.7 % 1406 34.5 %

3 Stable but Inotrope dependent 797 23.7 % 596 22.7 % 287 24.7 % 87 23.0 % 1313 32.2 %

4 Resting Symptoms 363 10.8 % 323 12.3 % 137 11.8 % 49 12.9 % 677 16.6 %

5 Exertion intolerant 73 2.1 % 79 3.0 % 20 1.7 % 6 1.5 % 126 3.0 %

6 Exertion limited 28 0.8 % 52 1.9 % 9 0.7 % 8 2.1 % 44 1.0 %

7 Advanced NYHA Class 3 31 0.9 % 16 0.6 % 2 0.1 % 1 0.2 % 31 0.7 %

TOTAL 3360 100.0 % 2620 100.0 % 1160 100.0 % 378 100.0 % 4075 100.0 %



TOTALBridge toRecovery Rescue Therapy Other

n % n % n % n %



3 Stable but Inotrope dependent 14 14.5 % 4 6.1 % 6 14.2 % 3104 26.3 %

4 Resting Symptoms 4 4.1 % 0 0 4 9.5 % 1557 13.1 %

5 Exertion intolerant 0 0 1 1.5 % 1 2.3 % 306 2.5 %

6 Exertion limited 1 1.0 % 0 0 0 0 142 1.2 %

7 Advanced NYHA Class 3 2 2.0 % 0 0 0 0 83 0.7 %

TOTAL 96 100.0 % 65 100.0 % 42 100.0 % 11796 100.0 %

IMPLANT DATE PERIOD=< 2010 14



IMPLANT DATE PERIOD=< 2010




Therapy

n % n % n % n % n %





5 Exertion intolerant 17 1.6 % 18 3.0 % 4 1.9 % 0 0 2 1.1 %


7 Advanced NYHA Class 3 16 1.5 % 2 0.3 % 0 0 1 1.1 % 2 1.1 %

TOTAL 1045 100.0 % 589 100.0 % 210 100.0 % 88 100.0 % 178 100.0 %




n % n % n % n %



3 Stable but Inotrope dependent 6 13.6 % 0 0 1 20.0 % 330 15.1 %

4 Resting Symptoms 2 4.5 % 0 0 0 0 196 8.9 %

5 Exertion intolerant 0 0 1 4.0 % 0 0 42 1.9 %

6 Exertion limited 0 0 0 0 0 0 23 1.0 %

7 Advanced NYHA Class 3 0 0 0 0 0 0 21 0.9 %

TOTAL 44 100.0 % 25 100.0 % 5 100.0 % 2184 100.0 %

IMPLANT DATE PERIOD=2010 - 2011 15



IMPLANT DATE PERIOD=2010 - 2011




Therapy

n % n % n % n % n %







7 Advanced NYHA Class 3 8 0.8 % 3 0.3 % 0 0 0 0 10 0.7 %

TOTAL 903 100.0 % 810 100.0 % 362 100.0 % 125 100.0 % 1307 100.0 %




n % n % n % n %


2 Progressive Decline 9 33.3 % 0 0 13 61.9 % 1412 39.5 %


4 Resting Symptoms 2 7.4 % 0 0 1 4.7 % 477 13.3 %

5 Exertion intolerant 0 0 0 0 0 0 108 3.0 %

6 Exertion limited 0 0 0 0 0 0 66 1.8 %

7 Advanced NYHA Class 3 2 7.4 % 0 0 0 0 23 0.6 %

TOTAL 27 100.0 % 15 100.0 % 21 100.0 % 3570 100.0 %

IMPLANT DATE PERIOD=2012 - 2014 (Jan-Jun) 16



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




Therapy

n % n % n % n % n %







7 Advanced NYHA Class 3 7 0.4 % 11 0.9 % 2 0.3 % 0 0 19 0.7 %

TOTAL 1412 100.0 % 1221 100.0 % 588 100.0 % 165 100.0 % 2590 100.0 %




n % n % n % n %




4 Resting Symptoms 0 0 0 0 3 18.7 % 884 14.6 %

5 Exertion intolerant 0 0 0 0 1 6.2 % 156 2.5 %

6 Exertion limited 1 4.0 % 0 0 0 0 53 0.8 %

7 Advanced NYHA Class 3 0 0 0 0 0 0 39 0.6 %

TOTAL 25 100.0 % 25 100.0 % 16 100.0 % 6042 100.0 %


Exhibit 9: Patient Status by Device Strategy at Implant

The following tables present patient status as of June 30, 2014 by the device strategy fordifferent 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-upperiod.

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

Overall

PRE-IMPLANT DEVICESTRATEGY

Patient Status (June 30, 2014)

TOTAL

1. Alive(device in

place)2.

Transplant 3. Recovery 4. Dead

N N N N N

BTT - Listed 1036 1660 33 631 3360

BTT - Likely 905 1093 42 580 2620

BTT - Moderate 530 262 16 352 1160

BTT - Unlikely 169 57 3 149 378

Destination Therapy 2440 267 32 1336 4075

Bridge to Recovery 35 26 14 21 96

Rescue Therapy 13 14 4 34 65

Other 16 11 2 13 42

TOTAL 5144 3390 146 3116 11796

IMPLANT DATE PERIOD=< 2010



TOTAL

1. Alive(device in

place)2.


N N N N N

BTT - Listed 85 689 13 258 1045

BTT - Likely 50 352 9 178 589

BTT - Moderate 22 75 1 112 210

BTT - Unlikely 11 20 1 56 88




Other 1 1 1 2 5

TOTAL 231 1181 41 731 2184

1818

IMPLANT DATE PERIOD=2010 - 2011



TOTAL

1. Alive(device in

place)2.


N N N N N

BTT - Listed 161 527 13 202 903

BTT - Likely 187 389 15 219 810

BTT - Moderate 118 105 9 130 362

BTT - Unlikely 55 16 1 53 125




Other 4 9 0 8 21

TOTAL 1089 1182 57 1242 3570

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



TOTAL

1. Alive(device in

place)2.


N N N N N

BTT - Listed 790 444 7 171 1412

BTT - Likely 668 352 18 183 1221

BTT - Moderate 390 82 6 110 588

BTT - Unlikely 103 21 1 40 165




Other 11 1 1 3 16

TOTAL 3824 1027 48 1143 6042


Exhibit 10: Primary Cause of Death

PRIMARY CAUSE OF DEATH

IMPLANT DATE PERIOD

TOTAL< 2010 2010 - 20112012 - 2014(Jan-Jun)

n % n % n % n %

Cardiovascular, Other . . 2 0.1 % 4 0.3 % 6 0.1 %

Circulatory: Arterial Non-CNS Thromboembolism 8 1.0 % 18 1.4 % 6 0.5 % 32 1.0 %

Circulatory: CHF 28 3.8 % 41 3.3 % 35 3.1 % 104 3.3 %

Circulatory: Cardiac Arrhythmia 23 3.1 % 41 3.3 % 23 2.0 % 87 2.8 %

Circulatory: End Stage Cardiomyopathy 11 1.5 % 20 1.6 % 18 1.6 % 49 1.5 %

Circulatory: Heart Disease 1 0.1 % 8 0.6 % 6 0.5 % 15 0.4 %

Circulatory: Hemolysis 1 0.1 % 5 0.4 % 8 0.7 % 14 0.4 %

Circulatory: Ischemic Cardiomyopathy 4 0.5 % 9 0.7 % 13 1.1 % 26 0.8 %

Circulatory: Major Bleeding 36 4.9 % 36 2.9 % 28 2.5 % 100 3.2 %

Circulatory: Myocardial Infarction 3 0.4 % 7 0.5 % 9 0.8 % 19 0.6 %

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

Circulatory: Other, Specify 41 5.6 % 39 3.1 % 44 3.9 % 124 4.0 %

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

Circulatory: Right Heart Failure 35 4.8 % 69 5.6 % 40 3.5 % 144 4.6 %

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

Circulatory: Sudden Unexplained Death 27 3.7 % 67 5.4 % 35 3.1 % 129 4.2 %

Device Malfunction 21 2.8 % 53 4.3 % 37 3.3 % 111 3.6 %

Digestive: Fluid/Electrolyte Disorder 5 0.6 % 3 0.2 % . . 8 0.2 %

Digestive: GI Disorder . . 5 0.4 % 10 0.8 % 15 0.4 %

Digestive: Hepatic Dysfunction 12 1.6 % 17 1.3 % 6 0.5 % 35 1.1 %

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

Digestive: Renal Dysfunction 20 2.7 % 21 1.7 % 2 0.1 % 43 1.4 %

Hemotalogical 2 0.2 % . . 1 0.0 % 3 0.0 %

Major Infection 106 14.5 % 131 10.6 % 58 5.2 % 295 9.6 %

Multisystem Organ Failure (MSOF) 72 9.8 % 145 11.7 % 240 21.5 % 457 14.8 %

Nervous System: Neurological Dysfunction 147 20.1 % 226 18.3 % 194 17.4 % 567 18.4 %

Other, specify 28 3.8 % 50 4.0 % 37 3.3 % 115 3.7 %

Other: Cancer 6 0.8 % 27 2.1 % 9 0.8 % 42 1.3 %

Other: Trauma/accident, specify 6 0.8 % 10 0.8 % 8 0.7 % 24 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 1.1 % 31 1.0 %

Respiratory: Respiratory Failure 35 4.8 % 65 5.2 % 59 5.2 % 159 5.1 %

Respiratory: Venous Thromboembolism Event 1 0.1 % 3 0.2 % 1 0.0 % 5 0.1 %

Withdrawal of Support, specify 37 5.0 % 93 7.5 % 165 14.8 % 295 9.6 %

TOTAL 728 100.0 % 1229 100.0 % 1114 100.0 % 3071 100.0 %

Note: 45 patients have a missing primary cause of death.

* Certain pre-relaunch categories are no longer supported as of the v3.0 Launch (May 2012).


Exhibit 11: Kaplan-Meier Survival for INTERMACS Overall

Percent Survival

Monthsafter

DeviceImplant

INTERMACSOverall

1 94%

3 89%

6 85%

12 79%

24 68%

36 57%

48 47%


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


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


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

Bridge to Transplant (BTT) includes patients listed for transplant at time of implant.Bridge to Candidacy (BTC) include patients who are not yet listed for transplant at the time ofimplant.


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


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


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

Number of Patients at Risk

Month

0 12 24 36 48 60

10280 4783 2257 986 331 88


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


Month

0 12 24 36 48 60

302 101 54 38 28 9


Exhibit 19: Competing Outcomes for TAHs


Month

0 12 24

272 23 6


Exhibit 20: Adverse Event Rates for Patients Receiving a Primary ProspectiveImplant - Continuous Flow LVADs (with or without RVAD implant at time of LVAD

operation)

The following table summarizes adverse events in patients receiving primary prospectiveimplants between June 23, 2006 and June 30, 2014. Event count is the number of episodesobserved for each event type allowing multiple episodes per patient. Patient count is thenumber of patients experiencing at least one episode of a particular event type. Patientpercentage is the percent of patients experiencing a specific event type. Early and late eventcounts are the number of episodes observed either within three months post-implant or afterthree months post-implant, respectively. Event rates are calculated by dividing the number ofepisodes observed for each event type during a period by the total amount of follow-up timethe patients were observed during the period. The total follow-up time for the early period was28805.34 patient months and the total follow-up time for the late period was 129920.6 patientmonths. All rates are reported in episodes per 100 patient months.

Adverse Event TypeEarly EventCount (n)

Early Event Rate(per 100 pt m)

Late EventCount (n)

Late Event Rate(per 100 pt m)

Arterial Non-CNS Thromboembolism 123 0.43 53 0.04

Bleeding 5425 18.83 4324 3.33

Cardiac Arrhythmia 3271 11.36 1384 1.07

Device Malfunction 801 2.78 2054 1.58

Hepatic Dysfunction 417 1.45 302 0.23

Infection 4332 15.04 5054 3.89

Myocardial Infarction 40 0.14 39 0.03

Neurological Dysfunction 1162 4.03 1591 1.22

Other Serious Adverse Event 3769 13.08 2476 1.91

Pericardial Drainage 518 1.80 23 0.02

Psychiatric Episode 719 2.50 431 0.33

Rehospitalization 5991 20.80 20856 16.05

Renal Dysfunction 1114 3.87 637 0.49

Respiratory Failure 2151 7.47 650 0.50

Venous Thromboembolism 510 1.77 96 0.07

Wound Dehiscence 147 0.51 35 0.03


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

Adverse Event TypeEarly EventCount (n)

Early Event Rate(per 100 pt m)

Late EventCount (n)

Late Event Rate(per 100 pt m)

GI 387 1.34 273 0.21

Line Sepsis 170 0.59 128 0.10

Mediastinum 184 0.64 75 0.06

Other Specify 645 2.24 709 0.55

Peripheral Wound 123 0.43 124 0.10

Positive Blood Cultures 863 3.00 1379 1.06

Pulmonary 1375 4.77 616 0.47

Pump/Related - Drive Line 412 1.43 2085 1.60

Pump/Related - Exit Cannula 10 0.03 34 0.03

Pump/Related - Pump Interior 13 0.05 30 0.02

Pump/Related - Pump Pocket 116 0.40 264 0.20

Unknown 148 0.51 99 0.08

Urinary Tract 1033 3.59 809 0.62


Exhibit 22: Follow-up Compliance

Site compliance is determined by the percentage of all follow-up forms that are due duringthis reporting period that have been completed. This calculation has been updated to includeALL follow-up forms expected for ALL patients and ALL devices. Only sites that have at least10 follow-up forms expected are included in this figure. INTERMACS has defined requiredcompliance as 90%.

alfred m 14 69 112.5 intermacs - uab...2014 2nd quarter implant and event dates: june 23, 2006 to...

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