intermacs - the university of alabama at …...intermacs quarterly report - 2017 q2 implants: june...

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IntermacsInteragency Registry for MechanicallyAssisted Circulatory Support

Quarterly Statistical Report2017 Q2Implant and event dates: June 23, 2006 to June 30, 2017

09/25/2017

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 20212 adult patientsreceiving primary prospective implants between June 23, 2006 and June 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 Q2 Implants: June 23, 2006 to June 30, 20173

Exhibit 1: Hospital Activation and Patient Enrollment

Between June 23, 2006 and June 30, 2017, 168 hospitals participated in Intermacs and, ofthese, 170 hospitals actively contributed information on a total of 20212 patients. Cumulativepatient accrual and the number of participating hospitals over this time period are displayedbelow.



As of June 30, 2017 there were 168 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

BANNER UNIVERSITY MEDICAL CENTER/UNIVERSITY OF ARIZONA MEDICAL CENTER 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 HOSPITAL OF WISCONSIN MILWAUKEE WI

CHILDREN'S NATIONAL MEDICAL CENTER WASHINGTON DC

CHRISTIANA CARE HEALTH SYSTEM NEWARK DE

CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER CINCINNATI OH

CJW MEDICAL CENTER RICHMOND VA

CLEVELAND CLINIC CLEVELAND OH

CLEVELAND CLINIC FLORIDA WESTON FL

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

DELRAY MEDICAL CENTER DELRAY FL

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

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 & CHILDREN'S 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 GENERAL SACRAMENTO CA

MERCY HEALTH SPRINGFIELD MO

METHODIST HOSPITAL INDIANAPOLIS IN

METHODIST SPECIALTY AND TRANSPLANT HOSPITAL SAN ANTONIO TX

MID AMERICA HEART INSTITUTE OF SAINT LUKE'S 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

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. JOSEPH'S 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 HEALTHCARE SYSTEM HOLLYWOOD FL

SPECTRUM HEALTH HOSPITALS GRAND RAPIDS MI

ST. BONIFACE WINNIPEG MB

ST. LOUIS CHILDREN'S HOSPITAL ST. LOUIS MO

ST. LUKE'S BETHLEHEM PA

ST. LUKE'S EPISCOPAL HOSPITAL / TEXAS HEART INSTITUTE HOUSTON TX

ST. LUKE'S MEDICAL CENTER MILWAUKEE WI

ST. MARY'S HOSPITAL RICHMOND VA

ST. PAUL'S HOSPITAL VANCOUVER BC

ST. PETERS HOSPITAL ALBANY NY

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

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 HOSPITAL 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 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 PITTSBURGH 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

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, 2017).

Gender

GENDER

IMPLANT DATE PERIOD

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

n % n % n % n %

Female 445 20.6 % 1778 20.9 % 2067 21.5 % 4290 21.2 %

Male 1711 79.3 % 6706 79.0 % 7481 78.1 % 15898 78.6 %

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

TOTAL 2156 100.0 % 8485 100.0 % 9571 100.0 % 20212 100.0 %

Race

RACE

IMPLANT DATE PERIOD

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

n % n % n % n %

African American 477 22.1 % 1883 22.1 % 2360 24.6 % 4720 23.3 %

Other, Unknown,Undisclosed 178 8.2 % 712 8.3 % 957 9.9 % 1847 9.1 %

White 1501 69.6 % 5890 69.4 % 6254 65.3 % 13645 67.5 %

TOTAL 2156 100.0 % 8485 100.0 % 9571 100.0 % 20212 100.0 %

Age Group

AGE GROUP (yr)

IMPLANT DATE PERIOD

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

n % n % n % n %

19-39 352 16.3 % 969 11.4 % 1169 12.2 % 2490 12.3 %

40-59 1113 51.6 % 3422 40.3 % 3949 41.2 % 8484 41.9 %

60-79 691 32.0 % 4036 47.5 % 4399 45.9 % 9126 45.1 %

80+ . . 58 0.6 % 54 0.5 % 112 0.5 %

TOTAL 2156 100.0 % 8485 100.0 % 9571 100.0 % 20212 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-Jun)

n % n % n % n %

BTT - Listed 1031 47.8 % 1980 23.3 % 2644 27.6 % 5655 27.9 %

BTT - Likely 580 26.9 % 1873 22.0 % 1342 14.0 % 3795 18.7 %

BTT - Moderate 209 9.6 % 867 10.2 % 760 7.9 % 1836 9.0 %

BTT - Unlikely 87 4.0 % 264 3.1 % 219 2.2 % 570 2.8 %

Destination Therapy 178 8.2 % 3408 40.1 % 4542 47.4 % 8128 40.2 %

Bridge to Recovery 46 2.1 % 52 0.6 % 21 0.2 % 119 0.5 %

Rescue Therapy 25 1.1 % 38 0.4 % 38 0.3 % 101 0.4 %

Other . . 3 0.0 % 5 0.0 % 8 0.0 %

TOTAL 2156 100.0 % 8485 100.0 % 9571 100.0 % 20212 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-Jun)

n % n % n % n %

LVAD 1806 83.7 % 7948 93.6 % 9015 94.1 % 18769 92.8 %

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

BiVAD 268 12.4 % 365 4.3 % 385 4.0 % 1018 5.0 %

TAH 77 3.5 % 164 1.9 % 166 1.7 % 407 2.0 %

TOTAL 2156 100.0 % 8485 100.0 % 9571 100.0 % 20212 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-Jun)

n % n % n % n %

1 Critical Cardiogenic Shock 632 29.3 % 1253 14.7 % 1605 16.7 % 3490 17.2 %

2 Progressive Decline 914 42.3 % 3191 37.6 % 3260 34.0 % 7365 36.4 %

3 Stable but InotropeDependent 330 15.3 % 2415 28.4 % 3417 35.7 % 6162 30.4 %

4 Resting Symptoms 196 9.0 % 1214 14.3 % 1086 11.3 % 2496 12.3 %

5 Exertion Intolerant 42 1.9 % 244 2.8 % 144 1.5 % 430 2.1 %

6 Exertion Limited 23 1.0 % 109 1.2 % 35 0.3 % 167 0.8 %

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

Unspecified . . 4 0.0 % 7 0.0 % 11 0.0 %

TOTAL 2156 100.0 % 8485 100.0 % 9571 100.0 % 20212 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-Jun)

n % n % n % n %

BTT - Listed 1031 47.8 % 1980 23.3 % 2644 27.6 % 5655 27.9 %

BTT - Likely 580 26.9 % 1873 22.0 % 1342 14.0 % 3795 18.7 %

BTT - Moderate 209 9.6 % 867 10.2 % 760 7.9 % 1836 9.0 %

BTT - Unlikely 87 4.0 % 264 3.1 % 219 2.2 % 570 2.8 %

Destination Therapy 178 8.2 % 3408 40.1 % 4542 47.4 % 8128 40.2 %

Bridge to Recovery 46 2.1 % 52 0.6 % 21 0.2 % 119 0.5 %

Rescue Therapy 25 1.1 % 38 0.4 % 38 0.3 % 101 0.4 %

Other . . 3 0.0 % 5 0.0 % 8 0.0 %

TOTAL 2156 100.0 % 8485 100.0 % 9571 100.0 % 20212 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 %

. 3 0.0 % 1 0.0 % 0 0 1 0.1 % 5 0.0 %

1 Critical Cardio Shock 887 15.6 % 804 21.1 % 409 22.2 % 118 20.7 % 1124 13.8 %

2 Progressive Decline 2349 41.5 % 1367 36.0 % 670 36.4 % 208 36.4 % 2729 33.5 %

3 Stable but Inotrope dependent 1620 28.6 % 1005 26.4 % 514 27.9 % 156 27.3 % 2841 34.9 %

4 Resting Symptoms 610 10.7 % 445 11.7 % 203 11.0 % 72 12.6 % 1159 14.2 %

5 Exertion intolerant 114 2.0 % 100 2.6 % 28 1.5 % 7 1.2 % 180 2.2 %

6 Exertion limited 40 0.7 % 55 1.4 % 9 0.4 % 7 1.2 % 55 0.6 %

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

TOTAL 5655 100.0 % 3795 100.0 % 1836 100.0 % 570 100.0 % 8128 100.0 %



TOTALBridge toRecovery Rescue Therapy Other

n % n % n % n %

. 0 0 1 0.9 % 0 0 11 0.0 %

1 Critical Cardio Shock 60 50.4 % 86 85.1 % 2 25.0 % 3490 17.2 %


3 Stable but Inotrope dependent 21 17.6 % 3 2.9 % 2 25.0 % 6162 30.4 %

4 Resting Symptoms 5 4.2 % 2 1.9 % 0 0 2496 12.3 %

5 Exertion intolerant 0 0 1 0.9 % 0 0 430 2.1 %

6 Exertion limited 1 0.8 % 0 0 0 0 167 0.8 %

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

TOTAL 119 100.0 % 101 100.0 % 8 100.0 % 20212 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 % 1873 100.0 % 867 100.0 % 264 100.0 % 3408 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 3191 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 % 3 100.0 % 8485 100.0 %

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



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




Therapy

n % n % n % n % n %

. 2 0.0 % 0 0 0 0 0 0 4 0.0 %






6 Exertion limited 13 0.4 % 6 0.4 % 1 0.1 % 0 0 15 0.3 %

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

TOTAL 2644 100.0 % 1342 100.0 % 760 100.0 % 219 100.0 % 4542 100.0 %




n % n % n % n %

. 0 0 1 2.6 % 0 0 7 0.0 %

1 Critical Cardio Shock 6 28.5 % 30 78.9 % 0 0 1605 16.7 %


3 Stable but Inotrope dependent 8 38.0 % 0 0 1 20.0 % 3417 35.7 %


5 Exertion intolerant 0 0 0 0 0 0 144 1.5 %

6 Exertion limited 0 0 0 0 0 0 35 0.3 %

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

TOTAL 21 100.0 % 38 100.0 % 5 100.0 % 9571 100.0 %


Exhibit 9: Patient Status by Device Strategy at Implant

The following tables present patient status as of June 30, 2017 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 DEVICE STRATEGY

Patient Status (June 30, 2017)

TOTAL

1. Alive(device

inplace) 2. Transplant 3. Recovery 4. Dead

N N N N N

BTT - Listed 1279 3083 78 1215 5655

BTT - Likely 990 1731 107 967 3795

BTT - Moderate 659 493 51 633 1836

BTT - Unlikely 190 93 16 271 570

Destination Therapy 3793 858 175 3302 8128

Bridge to Recovery 30 35 21 33 119

Rescue Therapy 15 25 8 53 101

Other 4 3 0 1 8

TOTAL 6960 6321 456 6475 20212


IMPLANT DATE PERIOD=< 2010



TOTAL

1. Alive(device


N N N N N

BTT - Listed 54 688 17 272 1031

BTT - Likely 32 350 13 185 580

BTT - Moderate 12 77 3 117 209

BTT - Unlikely 7 20 4 56 87




TOTAL 131 1181 66 778 2156

IMPLANT DATE PERIOD=2010 - 2013



TOTAL

1. Alive(device


N N N N N

BTT - Listed 230 1224 34 492 1980

BTT - Likely 303 960 63 547 1873

BTT - Moderate 218 271 29 349 867

BTT - Unlikely 66 52 6 140 264




Other 0 2 0 1 3

TOTAL 1809 2963 223 3490 8485

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



TOTAL

1. Alive(device


N N N N N

BTT - Listed 995 1171 27 451 2644

BTT - Likely 655 421 31 235 1342

BTT - Moderate 429 145 19 167 760

BTT - Unlikely 117 21 6 75 219




Other 4 1 0 0 5

TOTAL 5020 2177 167 2207 9571


Exhibit 10: Primary Cause of Death

PRIMARY CAUSE OF DEATH

IMPLANT DATE PERIOD

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

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 % 117 3.3 % 74 3.3 % 224 3.4 %

Circulatory: Cardiac Arrhythmia 23 2.9 % 98 2.8 % 48 2.1 % 169 2.6 %

Circulatory: End Stage Cardiomyopathy 13 1.6 % 65 1.8 % 43 1.9 % 121 1.8 %

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

Circulatory: Hemolysis 2 0.2 % 25 0.7 % 13 0.5 % 40 0.6 %

Circulatory: Ischemic Cardiomyopathy 5 0.6 % 36 1.0 % 27 1.2 % 68 1.0 %

Circulatory: Major Bleeding 34 4.3 % 80 2.2 % 61 2.7 % 175 2.7 %

Circulatory: Myocardial Infarction 2 0.2 % 13 0.3 % 8 0.3 % 23 0.3 %

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

Circulatory: Other, Specify 39 5.0 % 105 3.0 % 75 3.3 % 219 3.3 %

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

Circulatory: Right Heart Failure 38 4.8 % 142 4.0 % 88 3.9 % 268 4.1 %

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

Circulatory: Sudden Unexplained Death 31 3.9 % 160 4.5 % 59 2.6 % 250 3.8 %

Device Malfunction 28 3.5 % 146 4.1 % 35 1.5 % 209 3.2 %

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 0.5 % 54 0.8 %

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

Digestive: Renal Dysfunction 18 2.3 % 31 0.8 % 12 0.5 % 61 0.9 %

Hematological 4 0.5 % 1 0.0 % 7 0.3 % 12 0.1 %

Major Infection 116 14.9 % 305 8.7 % 140 6.3 % 561 8.6 %

Multisystem Organ Failure (MSOF) 86 11.0 % 493 14.1 % 443 20.0 % 1022 15.7 %

Nervous System: Neurological Dysfunction 164 21.0 % 643 18.4 % 415 18.8 % 1222 18.8 %

Other, specify 27 3.4 % 244 6.9 % 185 8.3 % 456 7.0 %

Other: Cancer 8 1.0 % 73 2.0 % 17 0.7 % 98 1.5 %

Other: Trauma/accident, specify 5 0.6 % 40 1.1 % 17 0.7 % 62 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 1.1 % 18 0.8 % 61 0.9 %

Respiratory: Respiratory Failure 28 3.5 % 197 5.6 % 88 3.9 % 313 4.8 %

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

Withdrawal of Support, specify 34 4.3 % 320 9.1 % 290 13.1 % 644 9.9 %

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

TOTAL 778 100.0 % 3490 100.0 % 2207 100.0 % 6475 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 79.3% (79.0%-79.7%)

24 68.2% (67.8%-68.6%)

36 57.6% (57.1%-58.1%)

48 48.0% (47.4%-48.6%)


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%) 88.4% (87.7%-89.0%) 86.6% (84.6%-88.3%)

3 90.4% (90.2%-90.6%) 81.8% (80.9%-82.6%) 78.6% (76.3%-80.8%)

6 86.8% (86.5%-87.0%) 75.9% (75.0%-76.8%) 69.5% (66.8%-72.1%)

12 81.2% (80.9%-81.5%) 66.6% (65.5%-67.7%) 60.7% (57.6%-63.6%)

24 71.0% (70.6%-71.4%) 54.3% (52.9%-55.6%) 43.2% (39.6%-46.9%)


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%) 77.5% (75.8%-79.1%) 91.7% (90.5%-92.8%) 79.5% (77.2%-81.6%) 86.4% (84.6%-88.1%)

3 91.1% (90.9%-91.3%) 66.5% (64.6%-68.4%) 82.5% (80.8%-84.0%) 69.3% (66.6%-71.8%) 73.3% (70.9%-75.6%)

6 87.4% (87.2%-87.7%) 60.3% (58.3%-62.2%) 74.6% (72.6%-76.5%) 59.4% (56.1%-62.5%) 64.5% (61.7%-67.2%)

12 81.5% (81.2%-81.8%) 54.3% (52.2%-56.4%) 63.4% (61.0%-65.8%) 45.9% (41.5%-50.2%) 55.9% (52.3%-59.3%)

24 70.4% (70.0%-70.8%) 47.7% (45.4%-49.9%) 39.8% (36.6%-42.9%) 28.7% (22.8%-34.8%) 40.2% (34.2%-46.2%)

36 59.5% (59.0%-60.0%) 39.5% (36.9%-42.1%) 34.3% (31.1%-37.6%) 24.6% (18.4%-31.2%) 26.8% (16.0%-38.8%)

48 49.5% (48.9%-50.1%) 36.4% (33.6%-39.1%) 27.6% (24.3%-30.9%) 20.5% (14.4%-27.3%) 13.4% (4.8%-26.5%)


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-Jun)

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%) 90.2% (89.8%-90.5%)

6 87.2% (86.2%-88.1%) 86.2% (85.8%-86.6%) 86.7% (86.3%-87.1%)

12 81.9% (80.7%-83.0%) 79.6% (79.2%-80.1%) 81.4% (81.0%-81.9%)

24 71.5% (69.9%-73.1%) 68.4% (67.8%-69.0%) 70.8% (70.1%-71.4%)

36 58.0% (55.9%-60.0%) 57.8% (57.1%-58.4%) 61.0% (60.0%-61.9%)

48 44.8% (42.5%-47.1%) 48.5% (47.8%-49.2%)


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%-96.1%) 95.5% (95.2%-95.7%) 93.5% (93.2%-93.8%)

3 92.7% (92.3%-93.0%) 91.4% (91.0%-91.7%) 88.1% (87.7%-88.4%)

6 90.0% (89.5%-90.4%) 87.9% (87.5%-88.4%) 83.5% (83.1%-83.9%)

12 84.8% (84.3%-85.4%) 82.6% (82.0%-83.1%) 76.9% (76.4%-77.4%)

24 76.4% (75.6%-77.2%) 72.3% (71.5%-73.0%) 64.7% (64.1%-65.3%)

36 66.4% (65.2%-67.5%) 61.7% (60.7%-62.6%) 53.7% (53.0%-54.4%)

48 54.8% (53.2%-56.3%) 52.2% (51.1%-53.3%) 44.4% (43.5%-45.2%)


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 90.1% (89.6%-90.7%) 94.5% (94.2%-94.7%) 96.4% (96.2%-96.7%) 95.9% (95.4%-96.3%) 96.6% (95.9%-97.3%)

3 83.8% (83.1%-84.5%) 89.6% (89.3%-90.0%) 92.8% (92.5%-93.2%) 92.4% (91.9%-92.9%) 93.2% (92.2%-94.1%)

6 80.0% (79.2%-80.8%) 85.5% (85.1%-86.0%) 89.6% (89.2%-90.0%) 88.4% (87.7%-89.0%) 89.7% (88.5%-90.9%)

12 74.1% (73.2%-75.0%) 79.6% (79.0%-80.1%) 83.6% (83.1%-84.1%) 82.8% (82.0%-83.6%) 84.0% (82.4%-85.5%)

24 64.6% (63.5%-65.7%) 68.4% (67.7%-69.0%) 72.1% (71.4%-72.8%) 71.6% (70.5%-72.6%) 74.3% (72.2%-76.3%)

36 54.6% (53.2%-55.9%) 57.3% (56.4%-58.2%) 60.8% (59.9%-61.7%) 60.5% (59.1%-61.8%) 67.3% (65.0%-69.6%)

48 45.7% (44.0%-47.3%) 47.5% (46.4%-48.5%) 51.1% (50.0%-52.2%) 50.4% (48.8%-52.0%) 55.2% (52.3%-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%) 77.5% (75.8%-79.1%)

3 91.1% (90.9%-91.3%) 66.5% (64.6%-68.4%)

6 87.4% (87.2%-87.7%) 60.3% (58.3%-62.2%)

12 81.5% (81.2%-81.8%) 54.3% (52.2%-56.4%)

24 70.4% (70.0%-70.8%) 47.7% (45.4%-49.9%)

36 59.5% (59.0%-60.0%) 39.5% (36.9%-42.1%)

48 49.5% (48.9%-50.1%) 36.4% (33.6%-39.1%)


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

18158 9855 5587 3122 1747 894


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


Month

0 12 24 36 48 60

670 231 119 72 48 31


Exhibit 20: Competing Outcomes for TAHs


Month

0 12 24 36

407 51 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 June 30, 2017. 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 was51538.77 patient months and the total follow-up time for the late period was 315630.2 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 181 165 0.9% 0.35 100 91 0.5% 0.03

Bleeding 9026 5545 29.5% 17.51 10637 4707 25.0% 3.37

Cardiac Arrhythmia 5665 4111 21.8% 10.99 3540 2286 12.1% 1.12

Device Malfunction and/or Pump Thrombosis 1856 1550 8.2% 3.60 5972 3823 20.3% 1.89

Hepatic Dysfunction 692 650 3.5% 1.34 535 476 2.5% 0.17

Infection 7713 5285 28.1% 14.97 12729 6221 33.0% 4.03

Myocardial Infarction 66 63 0.3% 0.13 89 83 0.4% 0.03

Neurological Dysfunction 2194 1930 10.3% 4.26 3871 2878 15.3% 1.23

Other Serious Adverse Event 6245 3892 20.7% 12.12 5620 3095 16.4% 1.78

Pericardial Drainage 932 831 4.4% 1.81 29 29 0.2% 0.01

Psychiatric Episode 1140 1047 5.6% 2.21 844 676 3.6% 0.27

Rehospitalization 11333 7285 38.7% 21.99 50860 12699 67.4% 16.11

Renal Dysfunction 2007 1839 9.8% 3.89 1359 1116 5.9% 0.43

Respiratory Failure 3817 3049 16.2% 7.41 1511 1248 6.6% 0.48

Venous Thromboembolism 715 671 3.6% 1.39 166 159 0.8% 0.05

Wound Dehiscence 249 229 1.2% 0.48 105 94 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 658 607 3.2% 1.28 681 584 3.1% 0.22

Line Sepsis 234 228 1.2% 0.45 305 275 1.5% 0.10

Mediastinum 309 292 1.6% 0.60 190 155 0.8% 0.06

Other Specify 1048 958 5.1% 2.03 1688 1366 7.3% 0.53

Peripheral Wound 196 184 1.0% 0.38 321 281 1.5% 0.10

Positive Blood Cultures 1395 1239 6.6% 2.71 3346 2326 12.4% 1.06

Pulmonary 2334 1985 10.5% 4.53 1594 1272 6.8% 0.51

Pump/Related - Drive Line 655 617 3.3% 1.27 4497 2837 15.1% 1.42

Pump/Related - Exit Cannula 20 19 0.1% 0.04 79 73 0.4% 0.03

Pump/Related - Pump Interior 20 20 0.1% 0.04 82 78 0.4% 0.03

Pump/Related - Pump Pocket 204 194 1.0% 0.40 513 417 2.2% 0.16

Unknown 265 249 1.3% 0.51 250 237 1.3% 0.08

Urinary Tract 1631 1431 7.6% 3.16 1830 1297 6.9% 0.58


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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