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IntermacsInteragency Registry for MechanicallyAssisted Circulatory Support

Quarterly Statistical Report2017 Q3Implant and event dates: June 23, 2006 to September 30, 2017

12/18/2017

Prepared by:

The Data and Clinical Coordinating Center University of Alabama at Birmingham

For questions or comments contact:

James K. Kirklin, MD Craig Collum, MPH Nick Timkovich Kathryn Hollifield, RN Maceo Cleggett

#HHSN268201100025C

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Intermacs Quarterly Report

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 effort ofthe National Heart, Lung and Blood Institute (NHLBI), the Centers for Medicare and MedicaidServices (CMS), the Food and Drug Administration (FDA), clinicians, scientists and industryrepresentatives in conjunction with Dr. James K. Kirklin and the University of Alabama atBirmingham. This quarterly report includes clinical information from 20816 adult patientsreceiving primary prospective implants between June 23, 2006 and September 30, 2017.

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 by Era

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 Device Sequence

Exhibit 13: Kaplan-Meier Survival by Flow Type and Device

Exhibit 14: Kaplan-Meier Survival for Continuous Flow LVADs* by Implant Era

Exhibit 15: Kaplan-Meier Survival for Continuous Flow LVADs* by Pre-Implant Device Strategy

Exhibit 16: Kaplan-Meier Survival for Continuous Flow LVADs* by Pre-Implant Patient Profile

Exhibit 17: Kaplan-Meier Survival for Continuous Flow LVADs* by Device Type

Exhibit 18: Competing Outcomes for Continuous Flow LVADs (without RVAD implant at time of LVAD operation)

Exhibit 19: Competing Outcomes for Continuous Flow LVADs (with RVAD implant at time of LVAD operation)

Exhibit 20: Competing Outcomes for TAHs

Exhibit 21: Adverse Event Rates for Patients Receiving a Primary Prospective Continuous Flow LVADs*

Exhibit 22: Infection Rates by Location for Continuous Flow LVADs*

Exhibit 23: Follow-up Compliance

Glossary

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

Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 20173

Exhibit 1: Hospital Activation and Patient Enrollment

Between June 23, 2006 and September 30, 2017, 177 hospitals participated in Intermacsand, of these, 169 hospitals actively contributed information on a total of 20816 patients.Cumulative patient accrual and the number of participating hospitals over this time period aredisplayed below.



As of September 30, 2017 there were 177 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

ARKANSAS CHILDRENS HOSPITAL LITTLE ROCK AR

BANNER GOOD SAMARITAN PHOENIX AZ

BANNER UNIV. MEDICAL CENTER (UNIV. OF ARIZONA) TUCSON 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

BAYSTATE MEDICAL CENTER SPRINGFIELD MA

BETH ISRAEL DEACONESS MEDICAL CENTER BOSTON MA

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 NATIONAL MEDICAL CENTER WASHINGTON DC

CHILDRENS HOSPITAL OF WISCONSIN MILWAUKEE WI

CHRISTIANA CARE HEALTH SYSTEM NEWARK DE

CINCINNATI CHILDRENS HOSPITAL MEDICAL CENTER CINCINNATI OH

CJW MEDICAL CENTER RICHMOND VA

CLEVELAND CLINIC CLEVELAND OH

CLEVELAND CLINIC FLORIDA WESTON FL

COLUMBIA PRESBYTERIAN - CHILDRENS HOSPITAL OF NEW YORK NEW YORK NY

COLUMBIA UNIVERSITY MEDICAL CENTER-NY PRESBYTERIAN NEW YORK NY

CONE HEALTH SYSTEM GREENSBORO NC

DELRAY MEDICAL CENTER DELRAY FL

DIGNITY HEALTH / MERCY GENERAL SACRAMENTO CA

DUKE UNIVERSITY MEDICAL CENTER DURHAM NC

EDWARD HOSPITAL NAPERVILLE IL

EMORY UNIVERSITY HOSPITAL ATLANTA GA

FLORIDA HOSPITAL ORLANDO FL

FRESNO COMMUNITY MEDICAL FRESNO CA

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

IOWA HEART CENTER DES MOINES IA

JACKSON MEMORIAL HEALTH SYSTEM/UNIVERSITY OF MIAMI MIAMI FL

JEWISH HOSPITAL LOUISVILLE KY

JFK MEDICAL CENTER ATLANTIS FL

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

LEHIGH VALLEY HEALTH NETWORK ALLENTOWN PA

LOMA LINDA UNIVERSITY MEDICAL CENTER & CHILDRENS HOSPITAL LOMA LINDA CA

LOYOLA UNIVERSITY MEDICAL CENTER MAYWOOD IL

LUTHERAN HOSPITAL OF INDIANA FORT WAYNE IN

MAIMONIDES MEDICAL CENTER BROOKLYN NY

MAINE MEDICAL CENTER PORTLAND ME

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 HEALTH SPRINGFIELD MO

METHODIST HOSPITAL INDIANAPOLIS IN

METHODIST SPECIALTY AND TRANSPLANT HOSPITAL SAN ANTONIO TX

MID AMERICA HEART INSTITUTE OF SAINT LUKES HOSPITAL KANSAS CITY MO

MISSION HEALTH SYSTEM ASHEVILLE NC

MONTEFIORE MEDICAL CENTER BRONX NY

MORRISTOWN MEMORIAL HOSPITAL - ATLANTIC HEALTH MORRISTOWN NJ

MOUNT SINAI MEDICAL NEW YORK NY

MULTICARE HEALTH SYSTEMS TACOMA WA

NEBRASKA HEART INSTITUTE LINCOLN NE

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

NORTH SHORE UNIVERSITY HOSPITAL, NORTHWELL HEALTH NEW YORK NY

NORTHSHORE UNIVERSITY HEALTH SYSTEM EVANSTON IL

NORTHWESTERN MEMORIAL HOSPITAL CHICAGO IL

OCHSNER MEDICAL CENTER NEW ORLEANS LA

OHIO HEALTH/RIVERSIDE COLUMBUS OH

OREGON HEALTH & SCIENCE UNIVERSITY PORTLAND OR

PALMETTO HEALTH RICHLAND COLUMBIA SC




PEACEHEALTH / ST. JOSEPHS BELLINGHAM WA

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

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 HEALTHCARESYSTEM) - MEMORIAL REGIONAL HOSPITAL

HOLLYWOOD FL

SPECTRUM HEALTH HOSPITALS GRAND RAPIDS MI

ST FRANCIS HOSPITAL, THE HEART CENTER ROSLYN NY

ST MARYS HOSPITAL RICHMOND VA

ST PAULS HOSPITAL VANCOUVER BC

ST PETERS HOSPITAL ALBANY NY

ST. CLOUD HOSPITAL CENTRACARE HEART AND VASCULAR CENTER ST. CLOUD MN

ST. LOUIS CHILDREN'S HOSPITAL ST. LOUIS MO

ST. LUKES BETHLEHEM PA

ST. LUKES EPISCOPAL HOSPITAL / TEXAS HEART INSTITUTE HOUSTON TX

ST. LUKES MEDICAL CENTER MILWAUKEE WI

ST. VINCENT HOSPITAL AND HEALTH CARE CENTER INDIANAPOLIS IN

ST. VINCENT INFIRMARY HEALTH SYSTEM LITTLE ROCK AR

STANFORD UNIVERSITY MEDICAL CENTER STANFORD CA

STONY BROOK UNIVERSITY MEDICAL CENTER STONY BROOK NY

SUTTER MEMORIAL HOSPITAL SACRAMENTO CA

SWEDISH HEALTH SERVICES / HEART AND VASCULAR INSTITUTE SEATTLE WA

TAMPA GENERAL HOSPITAL TAMPA FL

TEMPLE UNIVERSITY HOSPITAL PHILADELPHIA PA

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 KANSAS MEDICAL CENTER KANSAS CITY KS

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 ALBERTA HOSPITAL EDMONTON AB

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 MISSISSIPPI MEDICAL CENTER JACKSON MS

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

VIDANT MEDICAL CENTER GREENVILLE NC

VIRGINIA COMMONWEALTH UNIVERSITY HEALTH SYSTEM RICHMOND VA

WASHINGTON HOSPITAL CENTER WASHINGTON DC

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

WELLSTAR KENNESTONE REGIONAL MEDICAL CENTER MARIETTA GA

WESTCHESTER MEDICAL CENTER VALHALLA NY

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 September 30, 2017).

Gender

GENDER

IMPLANT DATE PERIOD

TOTAL< 2010 2010 - 20132014 - 2017(Jan-Sep)

n % n % n % n %

Female 445 20.6 % 1778 20.9 % 2193 21.5 % 4416 21.2 %

Male 1711 79.3 % 6707 79.0 % 7958 78.2 % 16376 78.6 %

Unspecified . . 1 0.0 % 23 0.2 % 24 0.1 %

TOTAL 2156 100.0 % 8486 100.0 % 10174 100.0 % 20816 100.0 %

Race

RACE

IMPLANT DATE PERIOD

TOTAL< 2010 2010 - 20132014 - 2017(Jan-Sep)

n % n % n % n %

African American 477 22.1 % 1883 22.1 % 2539 24.9 % 4899 23.5 %

Other, Unknown,Undisclosed 178 8.2 % 712 8.3 % 1025 10.0 % 1915 9.1 %

White 1501 69.6 % 5891 69.4 % 6610 64.9 % 14002 67.2 %

TOTAL 2156 100.0 % 8486 100.0 % 10174 100.0 % 20816 100.0 %

Age Group

AGE GROUP (yr)

IMPLANT DATE PERIOD

TOTAL< 2010 2010 - 20132014 - 2017(Jan-Sep)

n % n % n % n %

19-39 352 16.3 % 969 11.4 % 1232 12.1 % 2553 12.2 %

40-59 1113 51.6 % 3423 40.3 % 4200 41.2 % 8736 41.9 %

60-79 691 32.0 % 4036 47.5 % 4683 46.0 % 9410 45.2 %

80+ . . 58 0.6 % 59 0.5 % 117 0.5 %

TOTAL 2156 100.0 % 8486 100.0 % 10174 100.0 % 20816 100.0 %


Exhibit 4: Implants by Year by Device Strategy

Implants by Device Strategy and Implant Date Period

IMPLANT YEAR

IMPLANT DATE PERIOD

TOTAL< 2010 2010 - 20132014 - 2017(Jan-Sep)

n % n % n % n %

BTT - Listed 1031 47.8 % 1980 23.3 % 2783 27.3 % 5794 27.8 %

BTT - Likely 580 26.9 % 1874 22.0 % 1437 14.1 % 3891 18.6 %

BTT - Moderate 209 9.6 % 867 10.2 % 811 7.9 % 1887 9.0 %

BTT - Unlikely 87 4.0 % 264 3.1 % 229 2.2 % 580 2.7 %

Destination Therapy 178 8.2 % 3409 40.1 % 4846 47.6 % 8433 40.5 %

Bridge to Recovery 46 2.1 % 52 0.6 % 27 0.2 % 125 0.6 %

Rescue Therapy 25 1.1 % 38 0.4 % 37 0.3 % 100 0.4 %

Other . . 2 0.0 % 4 0.0 % 6 0.0 %

TOTAL 2156 100.0 % 8486 100.0 % 10174 100.0 % 20816 100.0 %


Exhibit 5: Implants per Year by Device Type

Implants by Device Type and Implant Date Period

DEVICE TYPE

IMPLANT DATE PERIOD

TOTAL< 2010 2010 - 20132014 - 2017(Jan-Sep)

n % n % n % n %

LVAD 1806 83.7 % 7949 93.6 % 9595 94.3 % 19350 92.9 %

RVAD 5 0.2 % 8 0.0 % 5 0.0 % 18 0.0 %

BiVAD 268 12.4 % 365 4.3 % 405 3.9 % 1038 4.9 %

TAH 77 3.5 % 164 1.9 % 169 1.6 % 410 1.9 %

TOTAL 2156 100.0 % 8486 100.0 % 10174 100.0 % 20816 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 TIME OFIMPLANT

IMPLANT DATE PERIOD

TOTAL< 2010 2010 - 20132014 - 2017(Jan-Sep)

n % n % n % n %

1 Critical Cardiogenic Shock 632 29.3 % 1253 14.7 % 1714 16.8 % 3599 17.2 %

2 Progressive Decline 914 42.3 % 3192 37.6 % 3475 34.1 % 7581 36.4 %

3 Stable but InotropeDependent 330 15.3 % 2415 28.4 % 3641 35.7 % 6386 30.6 %

4 Resting Symptoms 196 9.0 % 1214 14.3 % 1136 11.1 % 2546 12.2 %

5 Exertion Intolerant 42 1.9 % 244 2.8 % 151 1.4 % 437 2.0 %

6 Exertion Limited 23 1.0 % 109 1.2 % 37 0.3 % 169 0.8 %

7 Advanced NYHA Class 3 19 0.8 % 55 0.6 % 17 0.1 % 91 0.4 %

Unspecified . . 4 0.0 % 3 0.0 % 7 0.0 %

TOTAL 2156 100.0 % 8486 100.0 % 10174 100.0 % 20816 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 onmild-moderate doses 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 offluid 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 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 - 20132014 - 2017(Jan-Sep)

n % n % n % n %

BTT - Listed 1031 47.8 % 1980 23.3 % 2783 27.3 % 5794 27.8 %

BTT - Likely 580 26.9 % 1874 22.0 % 1437 14.1 % 3891 18.6 %

BTT - Moderate 209 9.6 % 867 10.2 % 811 7.9 % 1887 9.0 %

BTT - Unlikely 87 4.0 % 264 3.1 % 229 2.2 % 580 2.7 %

Destination Therapy 178 8.2 % 3409 40.1 % 4846 47.6 % 8433 40.5 %

Bridge to Recovery 46 2.1 % 52 0.6 % 27 0.2 % 125 0.6 %

Rescue Therapy 25 1.1 % 38 0.4 % 37 0.3 % 100 0.4 %

Other . . 2 0.0 % 4 0.0 % 6 0.0 %

TOTAL 2156 100.0 % 8486 100.0 % 10174 100.0 % 20816 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.


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

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 %

. 2 0.0 % 1 0.0 % 0 0 1 0.1 % 3 0.0 %

1 Critical Cardio Shock 909 15.6 % 828 21.2 % 418 22.1 % 120 20.6 % 1176 13.9 %

2 Progressive Decline 2401 41.4 % 1400 35.9 % 687 36.4 % 214 36.8 % 2834 33.6 %

3 Stable but Inotrope dependent 1669 28.8 % 1038 26.6 % 534 28.2 % 158 27.2 % 2959 35.0 %

4 Resting Symptoms 624 10.7 % 451 11.5 % 208 11.0 % 72 12.4 % 1185 14.0 %

5 Exertion intolerant 116 2.0 % 100 2.5 % 28 1.4 % 7 1.2 % 185 2.1 %

6 Exertion limited 41 0.7 % 55 1.4 % 9 0.4 % 7 1.2 % 56 0.6 %

7 Advanced NYHA Class 3 32 0.5 % 18 0.4 % 3 0.1 % 1 0.1 % 35 0.4 %

TOTAL 5794 100.0 % 3891 100.0 % 1887 100.0 % 580 100.0 % 8433 100.0 %



TOTALBridge toRecovery Rescue Therapy Other

n % n % n % n %

. 0 0 0 0 0 0 7 0.0 %

1 Critical Cardio Shock 60 48.0 % 87 87.0 % 1 16.6 % 3599 17.2 %


3 Stable but Inotrope dependent 23 18.4 % 3 3.0 % 2 33.3 % 6386 30.6 %

4 Resting Symptoms 5 4.0 % 1 1.0 % 0 0 2546 12.2 %

5 Exertion intolerant 0 0 1 1.0 % 0 0 437 2.0 %

6 Exertion limited 1 0.8 % 0 0 0 0 169 0.8 %

7 Advanced NYHA Class 3 2 1.6 % 0 0 0 0 91 0.4 %

TOTAL 125 100.0 % 100 100.0 % 6 100.0 % 20816 100.0 %


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

Time of Implant - by Era

IMPLANT DATE PERIOD=< 2010



BTT - Listed BTT - Likely BTT - Moderate BTT - Unlikely

n % n % n % n %




4 Resting Symptoms 94 9.1 % 56 9.6 % 17 8.1 % 5 5.7 %

5 Exertion intolerant 17 1.6 % 18 3.1 % 4 1.9 % 0 0

6 Exertion limited 12 1.1 % 6 1.0 % 1 0.4 % 1 1.1 %

7 Advanced NYHA Class 3 14 1.3 % 2 0.3 % 0 0 1 1.1 %

TOTAL 1031 100.0 % 580 100.0 % 209 100.0 % 87 100.0 %



TOTALDestination

TherapyBridge toRecovery Rescue Therapy

n % n % n % n %



3 Stable but Inotrope dependent 41 23.0 % 6 13.0 % 0 0 330 15.3 %


5 Exertion intolerant 2 1.1 % 0 0 1 4.0 % 42 1.9 %



TOTAL 178 100.0 % 46 100.0 % 25 100.0 % 2156 100.0 %

IMPLANT DATE PERIOD=2010 - 2013 15



IMPLANT DATE PERIOD=2010 - 2013




Therapy

n % n % n % n % n %

. 1 0.0 % 1 0.0 % 0 0 1 0.3 % 1 0.0 %






6 Exertion limited 15 0.7 % 43 2.2 % 7 0.8 % 6 2.2 % 37 1.0 %

7 Advanced NYHA Class 3 14 0.7 % 12 0.6 % 1 0.1 % 0 0 26 0.7 %

TOTAL 1980 100.0 % 1874 100.0 % 867 100.0 % 264 100.0 % 3409 100.0 %




n % n % n % n %

. 0 0 0 0 0 0 4 0.0 %


2 Progressive Decline 17 32.6 % 2 5.2 % 0 0 3192 37.6 %


4 Resting Symptoms 2 3.8 % 0 0 0 0 1214 14.3 %

5 Exertion intolerant 0 0 0 0 0 0 244 2.8 %



TOTAL 52 100.0 % 38 100.0 % 2 100.0 % 8486 100.0 %

IMPLANT DATE PERIOD=2014 - 2017 (Jan-Sep) 16



IMPLANT DATE PERIOD=2014 - 2017 (Jan-Sep)




Therapy

n % n % n % n % n %

. 1 0.0 % 0 0 0 0 0 0 2 0.0 %






6 Exertion limited 14 0.5 % 6 0.4 % 1 0.1 % 0 0 16 0.3 %

7 Advanced NYHA Class 3 4 0.1 % 4 0.2 % 2 0.2 % 0 0 7 0.1 %

TOTAL 2783 100.0 % 1437 100.0 % 811 100.0 % 229 100.0 % 4846 100.0 %




n % n % n % n %

. 0 0 0 0 0 0 3 0.0 %

1 Critical Cardio Shock 6 22.2 % 31 83.7 % 0 0 1714 16.8 %


3 Stable but Inotrope dependent 10 37.0 % 0 0 1 25.0 % 3641 35.7 %


5 Exertion intolerant 0 0 0 0 0 0 151 1.4 %

6 Exertion limited 0 0 0 0 0 0 37 0.3 %

7 Advanced NYHA Class 3 0 0 0 0 0 0 17 0.1 %

TOTAL 27 100.0 % 37 100.0 % 4 100.0 % 10174 100.0 %


Exhibit 9: Patient Status by Device Strategy at Implant

The following tables present patient status as of September 30, 2017 by the device strategyfor 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-upperiod.Dead: patients who died during this follow-up period.

Overall

PRE-IMPLANT DEVICE STRATEGY

Patient Status (September 30, 2017)

TOTAL

1. Alive(device

inplace) 2. Transplant 3. Recovery 4. Dead

N N N N N

BTT - Listed 1249 3207 83 1255 5794

BTT - Likely 1000 1783 113 995 3891

BTT - Moderate 667 515 53 652 1887

BTT - Unlikely 182 100 16 282 580

Destination Therapy 3829 912 190 3502 8433

Bridge to Recovery 36 35 21 33 125

Rescue Therapy 13 28 7 52 100

Other 3 2 0 1 6

TOTAL 6979 6582 483 6772 20816


IMPLANT DATE PERIOD=< 2010



TOTAL

1. Alive(device


N N N N N

BTT - Listed 51 689 17 274 1031

BTT - Likely 31 350 14 185 580

BTT - Moderate 12 77 3 117 209

BTT - Unlikely 6 20 4 57 87




TOTAL 126 1182 67 781 2156

IMPLANT DATE PERIOD=2010 - 2013



TOTAL

1. Alive(device


N N N N N

BTT - Listed 215 1234 34 497 1980

BTT - Likely 286 967 64 557 1874

BTT - Moderate 209 271 30 357 867

BTT - Unlikely 60 53 6 145 264




Other 0 1 0 1 2

TOTAL 1710 2988 227 3561 8486

IMPLANT DATE PERIOD=2014 - 2017 (Jan-Sep)



TOTAL

1. Alive(device


N N N N N

BTT - Listed 983 1284 32 484 2783

BTT - Likely 683 466 35 253 1437

BTT - Moderate 446 167 20 178 811

BTT - Unlikely 116 27 6 80 229




Other 3 1 0 0 4

TOTAL 5143 2412 189 2430 10174


Exhibit 10: Primary Cause of Death

PRIMARY CAUSE OF DEATH

IMPLANT DATE PERIOD

TOTAL< 2010 2010 - 20132014 - 2017(Jan-Sep)

n % n % n % n %

Circulatory: Arterial Non-CNS Thromboembolism 7 0.8 % 25 0.7 % 3 0.1 % 35 0.5 %

Circulatory: CHF 33 4.2 % 122 3.4 % 82 3.3 % 237 3.4 %

Circulatory: Cardiac Arrhythmia 23 2.9 % 100 2.8 % 51 2.0 % 174 2.5 %

Circulatory: End Stage Cardiomyopathy 13 1.6 % 67 1.8 % 46 1.8 % 126 1.8 %

Circulatory: Heart Disease . . 19 0.5 % 6 0.2 % 25 0.3 %

Circulatory: Hemolysis 2 0.2 % 25 0.7 % 15 0.6 % 42 0.6 %

Circulatory: Ischemic Cardiomyopathy 5 0.6 % 37 1.0 % 28 1.1 % 70 1.0 %

Circulatory: Major Bleeding 34 4.3 % 80 2.2 % 62 2.5 % 176 2.5 %

Circulatory: Myocardial Infarction 2 0.2 % 14 0.3 % 8 0.3 % 24 0.3 %

Circulatory: Myocardial Rupture 1 0.1 % . . 1 0.0 % 2 0.0 %

Circulatory: Other, Specify 39 4.9 % 106 2.9 % 90 3.7 % 235 3.4 %

Circulatory: Pericardial Fluid Collection 1 0.1 % 2 0.0 % 3 0.1 % 6 0.0 %

Circulatory: Right Heart Failure 38 4.8 % 145 4.0 % 99 4.0 % 282 4.1 %

Circulatory: Ruptured Aortic Aneurysm 1 0.1 % . . 1 0.0 % 2 0.0 %

Circulatory: Sudden Unexplained Death 31 3.9 % 162 4.5 % 64 2.6 % 257 3.7 %

Device Malfunction 28 3.5 % 150 4.2 % 37 1.5 % 215 3.1 %

Digestive: Fluid/Electrolyte Disorder 4 0.5 % 3 0.0 % . . 7 0.1 %

Digestive: GI Disorder 1 0.1 % 18 0.5 % 13 0.5 % 32 0.4 %

Digestive: Hepatic Dysfunction 13 1.6 % 29 0.8 % 12 0.4 % 54 0.7 %

Digestive: Pancreatitis 1 0.1 % . . 1 0.0 % 2 0.0 %

Digestive: Renal Dysfunction 18 2.3 % 31 0.8 % 13 0.5 % 62 0.9 %

Hematological 4 0.5 % 2 0.0 % 8 0.3 % 14 0.2 %

Major Infection 116 14.8 % 306 8.5 % 157 6.4 % 579 8.5 %

Multisystem Organ Failure (MSOF) 86 11.0 % 504 14.1 % 479 19.7 % 1069 15.7 %

Nervous System: Neurological Dysfunction 164 20.9 % 650 18.2 % 462 19.0 % 1276 18.8 %

Other, specify 28 3.5 % 259 7.2 % 202 8.3 % 489 7.2 %

Other: Cancer 8 1.0 % 76 2.1 % 19 0.7 % 103 1.5 %

Other: Trauma/accident, specify 5 0.6 % 41 1.1 % 17 0.6 % 63 0.9 %

Other: Wound Dehiscence . . . . 1 0.0 % 1 0.0 %

Psychiatric Episode/Suicide 5 0.6 % 10 0.2 % 2 0.0 % 17 0.2 %

Respiratory: Pulmonary: Other, specify 4 0.5 % 39 1.0 % 21 0.8 % 64 0.9 %

Respiratory: Respiratory Failure 28 3.5 % 198 5.5 % 92 3.7 % 318 4.6 %

Respiratory: Venous Thromboembolism Event 2 0.2 % 7 0.1 % 1 0.0 % 10 0.1 %

Withdrawal of Support, specify 36 4.6 % 330 9.2 % 334 13.7 % 700 10.3 %

~Cardiovascular, Other~ . . 4 0.1 % . . 4 0.0 %

TOTAL 781 100.0 % 3561 100.0 % 2430 100.0 % 6772 100.0 %

Note: 0 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 [% (70% CI)]

Monthsafter

DeviceImplant Intermacs Overall

1 94.2% (94.0%-94.3%)

3 89.4% (89.1%-89.6%)

6 85.4% (85.1%-85.7%)

12 79.4% (79.1%-79.7%)

24 68.2% (67.9%-68.6%)

36 57.7% (57.2%-58.2%)

48 48.2% (47.7%-48.8%)


Exhibit 12. Kaplan-Meier Survival by Device Sequence

The following figure compares survival time on specific devices based on device sequence forall of Intermacs. Each curve represents survival from the time the device was implanted untildeath. Patients are censored at time of transplant, explant for any reason, or the device wasturned off.


Monthsafter

DeviceImplant 1st Device 2nd Device 3rd Device

1 94.8% (94.6%-94.9%) 88.5% (87.8%-89.1%) 86.7% (84.9%-88.4%)

3 90.4% (90.2%-90.6%) 82.0% (81.2%-82.8%) 78.9% (76.7%-80.9%)

6 86.8% (86.6%-87.0%) 76.3% (75.4%-77.2%) 69.9% (67.4%-72.4%)

12 81.2% (80.9%-81.5%) 67.0% (65.9%-68.1%) 61.1% (58.2%-63.9%)

24 71.1% (70.7%-71.5%) 54.1% (52.8%-55.4%) 42.8% (39.3%-46.3%)


Exhibit 13: Kaplan-Meier Survival by Flow Type and Device


Monthsafter

DeviceImplant Continuous - LVAD Continuous - BiVAD Pulsatile - LVAD Pulsatile - BiVAD Pulsatile - TAH

1 95.3% (95.2%-95.5%) 77.2% (75.5%-78.7%) 91.6% (90.4%-92.6%) 79.5% (77.2%-81.6%) 86.3% (84.5%-87.9%)

3 91.1% (90.9%-91.3%) 66.3% (64.5%-68.1%) 82.3% (80.6%-83.9%) 69.3% (66.6%-71.8%) 73.3% (71.0%-75.5%)

6 87.4% (87.2%-87.7%) 59.6% (57.6%-61.5%) 74.7% (72.6%-76.6%) 59.4% (56.1%-62.5%) 64.7% (61.8%-67.4%)

12 81.5% (81.2%-81.8%) 53.8% (51.8%-55.8%) 63.5% (61.0%-65.9%) 45.9% (41.5%-50.2%) 56.3% (52.8%-59.7%)

24 70.4% (70.0%-70.8%) 47.5% (45.3%-49.7%) 39.8% (36.7%-43.0%) 28.7% (22.8%-34.8%) 40.8% (34.7%-46.7%)

36 59.5% (59.0%-60.0%) 39.2% (36.7%-41.8%) 34.3% (31.1%-37.6%) 24.6% (18.4%-31.2%) 27.2% (16.2%-39.3%)

48 49.7% (49.1%-50.3%) 35.4% (32.7%-38.2%) 27.6% (24.4%-31.0%) 20.5% (14.4%-27.3%) 13.6% (4.9%-26.8%)


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


Monthsafter

DeviceImplant < 2010 2010-2013 2014-2017 (Jan-Sep)

1 94.2% (93.5%-94.8%) 95.2% (95.0%-95.5%) 94.3% (94.0%-94.5%)

3 90.1% (89.2%-90.9%) 90.4% (90.1%-90.7%) 90.1% (89.8%-90.4%)

6 87.2% (86.2%-88.1%) 86.2% (85.8%-86.6%) 86.6% (86.3%-87.0%)

12 81.9% (80.7%-83.0%) 79.6% (79.2%-80.1%) 81.3% (80.9%-81.8%)

24 71.5% (69.9%-73.1%) 68.4% (67.8%-69.0%) 70.7% (70.1%-71.3%)

36 57.9% (55.8%-59.9%) 57.7% (57.1%-58.4%) 60.8% (59.9%-61.6%)

48 44.6% (42.3%-46.9%) 48.4% (47.7%-49.1%)


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


Monthsafter

DeviceImplant Bridge to Transplant Bridge to Candidacy Destination Therapy

1 95.8% (95.5%-96.0%) 95.5% (95.2%-95.7%) 93.5% (93.2%-93.8%)

3 92.6% (92.2%-93.0%) 91.4% (91.0%-91.7%) 88.1% (87.7%-88.4%)

6 89.9% (89.4%-90.3%) 88.0% (87.5%-88.4%) 83.5% (83.1%-83.9%)

12 84.8% (84.2%-85.4%) 82.7% (82.1%-83.2%) 76.9% (76.4%-77.4%)

24 76.3% (75.4%-77.1%) 72.5% (71.8%-73.2%) 64.7% (64.1%-65.3%)

36 66.6% (65.5%-67.7%) 62.2% (61.3%-63.1%) 53.5% (52.8%-54.2%)

48 55.6% (54.1%-57.1%) 52.8% (51.7%-53.9%) 44.3% (43.5%-45.0%)


Exhibit 16: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVADimplant at time of LVAD operation) by Pre-Implant Patient Profile


Monthsafter

DeviceImplant

Level 1 - CriticalCardiogenic

Level 2 - ProgressiveDecline

Level 3 - Stable butInotrope

Level 4 - RestingSymptoms

Levels 5,6,7 - AllOthers

1 90.0% (89.4%-90.5%) 94.5% (94.2%-94.8%) 96.5% (96.3%-96.7%) 95.8% (95.4%-96.2%) 96.5% (95.8%-97.2%)

3 83.6% (82.9%-84.3%) 89.7% (89.3%-90.1%) 92.9% (92.5%-93.2%) 92.3% (91.8%-92.9%) 93.2% (92.1%-94.1%)

6 79.8% (79.1%-80.6%) 85.6% (85.1%-86.0%) 89.6% (89.2%-90.0%) 88.4% (87.7%-89.0%) 89.8% (88.5%-90.9%)

12 73.9% (73.1%-74.8%) 79.7% (79.2%-80.2%) 83.6% (83.1%-84.1%) 82.7% (81.9%-83.5%) 83.8% (82.2%-85.2%)

24 64.7% (63.6%-65.7%) 68.3% (67.7%-69.0%) 72.3% (71.6%-73.0%) 71.4% (70.3%-72.5%) 74.0% (71.9%-75.9%)

36 54.4% (53.1%-55.7%) 57.3% (56.5%-58.2%) 61.0% (60.1%-61.9%) 60.5% (59.1%-61.7%) 66.9% (64.6%-69.2%)

48 45.9% (44.4%-47.5%) 47.7% (46.8%-48.7%) 51.4% (50.4%-52.5%) 50.2% (48.6%-51.7%) 55.2% (52.4%-57.9%)


Exhibit 17: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVADimplant at time of LVAD operation) by Device Type


Monthsafter

DeviceImplant LVAD BiVAD

1 95.3% (95.2%-95.5%) 77.2% (75.5%-78.7%)

3 91.1% (90.9%-91.3%) 66.3% (64.5%-68.1%)

6 87.4% (87.2%-87.7%) 59.6% (57.6%-61.5%)

12 81.5% (81.2%-81.8%) 53.8% (51.8%-55.8%)

24 70.4% (70.0%-70.8%) 47.5% (45.3%-49.7%)

36 59.5% (59.0%-60.0%) 39.2% (36.7%-41.8%)

48 49.7% (49.1%-50.3%) 35.4% (32.7%-38.2%)


Exhibit 18: 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

18746 10297 5887 3330 1894 988


Exhibit 19: Competing Outcomes for Continuous Flow LVADs (with RVAD implant attime of LVAD operation)


Month

0 12 24 36 48 60

690 232 126 74 47 33


Exhibit 20: Competing Outcomes for TAHs


Month

0 12 24 36

410 55 12 3


Exhibit 21: 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 September 30, 2017. Event count is the number ofepisodes observed for each event type allowing multiple episodes per patient. Patient countis the number 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 was53316.98 patient months and the total follow-up time for the late period was 333407.6 patientmonths. All rates are reported in episodes per 100 patient months.

Adverse Event Type

EarlyEventCount

(n)

EarlyPatientCount

(n)

EarlyPatient

Percent(%)

Early EventRate

(per 100 pt m)

LateEventCount

(n)

LatePatientCount

(n)

LatePatient

Percent(%)

Late EventRate

(per 100 pt m)

Arterial Non-CNS Thromboembolism 183 167 0.9% 0.34 106 97 0.5% 0.03

Bleeding 9336 5746 29.6% 17.51 11229 4949 25.5% 3.37

Cardiac Arrhythmia 5842 4248 21.9% 10.96 3699 2369 12.2% 1.11

Device Malfunction and/or Pump Thrombosis 1923 1607 8.3% 3.61 6321 4005 20.6% 1.90

Hepatic Dysfunction 707 665 3.4% 1.33 558 496 2.6% 0.17

Infection 7999 5497 28.3% 15.00 13363 6511 33.5% 4.01

Myocardial Infarction 68 65 0.3% 0.13 90 84 0.4% 0.03

Neurological Dysfunction 2279 2007 10.3% 4.27 4084 3030 15.6% 1.22

Other Serious Adverse Event 6465 4007 20.6% 12.13 5850 3223 16.6% 1.75

Pericardial Drainage 961 854 4.4% 1.80 30 30 0.2% 0.01

Psychiatric Episode 1163 1066 5.5% 2.18 867 691 3.6% 0.26

Rehospitalization 11832 7586 39.0% 22.19 53952 13263 68.2% 16.18

Renal Dysfunction 2072 1905 9.8% 3.89 1414 1165 6.0% 0.42

Respiratory Failure 3917 3133 16.1% 7.35 1579 1304 6.7% 0.47

Venous Thromboembolism 728 684 3.5% 1.37 172 165 0.8% 0.05

Wound Dehiscence 256 236 1.2% 0.48 111 98 0.5% 0.03


Exhibit 22: Infection Rates by Location - Continuous Flow LVADs (with or without RVADimplant at time of LVAD operation)

Adverse Event Type

EarlyEventCount

(n)

EarlyPatientCount

(n)

EarlyPatient

Percent(%)

Early EventRate

(per 100 pt m)

LateEventCount

(n)

LatePatientCount

(n)

LatePatient

Percent(%)

Late EventRate

(per 100 pt m)

GI 675 624 3.2% 1.27 721 618 3.2% 0.22

Line Sepsis 237 231 1.2% 0.44 317 287 1.5% 0.10

Mediastinum 320 302 1.6% 0.60 204 167 0.9% 0.06

Other Specify 1096 1003 5.2% 2.06 1777 1431 7.4% 0.53

Peripheral Wound 209 197 1.0% 0.39 340 298 1.5% 0.10

Positive Blood Cultures 1468 1310 6.7% 2.75 3512 2449 12.6% 1.05

Pulmonary 2404 2050 10.5% 4.51 1661 1325 6.8% 0.50

Pump/Related - Drive Line 688 648 3.3% 1.29 4730 2984 15.4% 1.42

Pump/Related - Exit Cannula 20 19 0.1% 0.04 83 76 0.4% 0.02

Pump/Related - Pump Interior 20 20 0.1% 0.04 86 81 0.4% 0.03

Pump/Related - Pump Pocket 219 207 1.1% 0.41 535 433 2.2% 0.16

Unknown 284 266 1.4% 0.53 259 246 1.3% 0.08

Urinary Tract 1671 1466 7.5% 3.13 1907 1346 6.9% 0.57


Exhibit 23: 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%.


Glossary

BiVAD: BiVentricular Assist DeviceBMI: Body Mass IndexBP: Blood PressureBSA: Body Surface AreaBTC: Bridge to CandidacyBTT: Bridge to TransplantBUN: Blood Urea NitrogenCMS: Centers for Medicare and MedicaidCOPD: Chronic Obstructive Pulmonary DiseaseCNS: Central Nervous SystemCRP: C - Reactive ProteinCVA: Cerebrovascular AccidentDCC: Data Coordinating CenterDT: Destination TherapyECMO: Extracorporeal-membrane OxygenationEQ-5D: Euro Quality of LifeFDA: Federal Drug AdministrationHF: Heart FailureIABP: Intra-Aortic Balloon PumpIgG: Immunoglobulin GINR: International Normalized RatioIntermacs: Interagency Registry for Mechanically Assisted Circulatory SupportLVAD: Left Ventricular Assist DeviceLVEF: Left Ventricular Ejection FractionLVEDD: Left Ventricular End Diastolic DysfunctionLVSF: Left Ventricular Shortening FractionMCSD: Mechanically Circulatory Support DeviceNHLBI: National Heart Lung and Blood InstituteNIH: National Institute of HealthNT pro brain natriuretic peptide: N-Terminal pro brain Natriuretic peptideNYHA: New York Heart AssociationOR: Operating RoomRegurg: RegurgitationRVAD: Right Ventricular Assist DeviceRVEF: Right Ventricular Ejection FractionSAE: Serious Adverse EventSGOT-AST: Serum Glutamic Oxaloacetic TransaminaseSGPT-ALT: Serum Glutamic Pyruvic TransaminaseTAH: Total Artificial HeartTIA: Transient Ischemic AttackVAD: Ventricular Assist DeviceVAS: Visual Analog Scale

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