#HHSN268201100025C
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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.
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 20174
Exhibit 2: Participating Hospital Listing
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
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 20175
Exhibit 2: Participating Hospital Listing
HOSPITAL NAME CITY STATE
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
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 20176
Exhibit 2: Participating Hospital Listing
HOSPITAL NAME CITY STATE
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
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 20177
Exhibit 2: Participating Hospital Listing
HOSPITAL NAME CITY STATE
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
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 20178
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 %
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 20179
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 %
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 201710
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 %
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 201711
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.
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 201712
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.
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 201713
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 %
PATIENT PROFILE STATUSOVERALL
Pre-Implant Device Strategy
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 %
2 Progressive Decline 34 27.2 % 8 8.0 % 3 50.0 % 7581 36.4 %
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 %
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 201714
Exhibit 8: Patient Profile by Device Strategy at Time of Implant - by Era
Time of Implant - by Era
IMPLANT DATE PERIOD=< 2010
PATIENT PROFILE STATUSOVERALL
Pre-Implant Device Strategy
BTT - Listed BTT - Likely BTT - Moderate BTT - Unlikely
n % n % n % n %
1 Critical Cardio Shock 226 21.9 % 202 34.8 % 77 36.8 % 35 40.2 %
2 Progressive Decline 490 47.5 % 227 39.1 % 81 38.7 % 38 43.6 %
3 Stable but Inotrope dependent 178 17.2 % 69 11.8 % 29 13.8 % 7 8.0 %
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 %
PATIENT PROFILE STATUSOVERALL
Pre-Implant Device Strategy
TOTALDestination
TherapyBridge toRecovery Rescue Therapy
n % n % n % n %
1 Critical Cardio Shock 38 21.3 % 31 67.3 % 23 92.0 % 632 29.3 %
2 Progressive Decline 70 39.3 % 7 15.2 % 1 4.0 % 914 42.3 %
3 Stable but Inotrope dependent 41 23.0 % 6 13.0 % 0 0 330 15.3 %
4 Resting Symptoms 22 12.3 % 2 4.3 % 0 0 196 9.0 %
5 Exertion intolerant 2 1.1 % 0 0 1 4.0 % 42 1.9 %
6 Exertion limited 3 1.6 % 0 0 0 0 23 1.0 %
7 Advanced NYHA Class 3 2 1.1 % 0 0 0 0 19 0.8 %
TOTAL 178 100.0 % 46 100.0 % 25 100.0 % 2156 100.0 %
IMPLANT DATE PERIOD=2010 - 2013 15
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 2017
Exhibit 8: Patient Profile by Device Strategy at Time of Implant - by Era
IMPLANT DATE PERIOD=2010 - 2013
PATIENT PROFILE STATUSOVERALL
Pre-Implant Device Strategy
BTT - Listed BTT - Likely BTT - Moderate BTT - UnlikelyDestination
Therapy
n % n % n % n % n %
. 1 0.0 % 1 0.0 % 0 0 1 0.3 % 1 0.0 %
1 Critical Cardio Shock 279 14.0 % 323 17.2 % 177 20.4 % 49 18.5 % 368 10.7 %
2 Progressive Decline 882 44.5 % 707 37.7 % 317 36.5 % 95 35.9 % 1172 34.3 %
3 Stable but Inotrope dependent 496 25.0 % 485 25.8 % 242 27.9 % 69 26.1 % 1112 32.6 %
4 Resting Symptoms 242 12.2 % 244 13.0 % 109 12.5 % 40 15.1 % 577 16.9 %
5 Exertion intolerant 51 2.5 % 59 3.1 % 14 1.6 % 4 1.5 % 116 3.4 %
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 %
PATIENT PROFILE STATUSOVERALL
Pre-Implant Device Strategy
TOTALBridge toRecovery Rescue Therapy Other
n % n % n % n %
. 0 0 0 0 0 0 4 0.0 %
1 Critical Cardio Shock 23 44.2 % 33 86.8 % 1 50.0 % 1253 14.7 %
2 Progressive Decline 17 32.6 % 2 5.2 % 0 0 3192 37.6 %
3 Stable but Inotrope dependent 7 13.4 % 3 7.8 % 1 50.0 % 2415 28.4 %
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 %
6 Exertion limited 1 1.9 % 0 0 0 0 109 1.2 %
7 Advanced NYHA Class 3 2 3.8 % 0 0 0 0 55 0.6 %
TOTAL 52 100.0 % 38 100.0 % 2 100.0 % 8486 100.0 %
IMPLANT DATE PERIOD=2014 - 2017 (Jan-Sep) 16
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 2017
Exhibit 8: Patient Profile by Device Strategy at Time of Implant - by Era
IMPLANT DATE PERIOD=2014 - 2017 (Jan-Sep)
PATIENT PROFILE STATUSOVERALL
Pre-Implant Device Strategy
BTT - Listed BTT - Likely BTT - Moderate BTT - UnlikelyDestination
Therapy
n % n % n % n % n %
. 1 0.0 % 0 0 0 0 0 0 2 0.0 %
1 Critical Cardio Shock 404 14.5 % 303 21.0 % 164 20.2 % 36 15.7 % 770 15.8 %
2 Progressive Decline 1029 36.9 % 466 32.4 % 289 35.6 % 81 35.3 % 1592 32.8 %
3 Stable but Inotrope dependent 995 35.7 % 484 33.6 % 263 32.4 % 82 35.8 % 1806 37.2 %
4 Resting Symptoms 288 10.3 % 151 10.5 % 82 10.1 % 27 11.7 % 586 12.0 %
5 Exertion intolerant 48 1.7 % 23 1.6 % 10 1.2 % 3 1.3 % 67 1.3 %
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 %
PATIENT PROFILE STATUSOVERALL
Pre-Implant Device Strategy
TOTALBridge toRecovery Rescue Therapy Other
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 %
2 Progressive Decline 10 37.0 % 5 13.5 % 3 75.0 % 3475 34.1 %
3 Stable but Inotrope dependent 10 37.0 % 0 0 1 25.0 % 3641 35.7 %
4 Resting Symptoms 1 3.7 % 1 2.7 % 0 0 1136 11.1 %
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 %
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 201717
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
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 201718
IMPLANT DATE PERIOD=< 2010
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 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
Destination Therapy 19 31 15 113 178
Bridge to Recovery 7 10 11 18 46
Rescue Therapy 0 5 3 17 25
TOTAL 126 1182 67 781 2156
IMPLANT DATE PERIOD=2010 - 2013
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 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
Destination Therapy 924 429 85 1971 3409
Bridge to Recovery 14 18 7 13 52
Rescue Therapy 2 15 1 20 38
Other 0 1 0 1 2
TOTAL 1710 2988 227 3561 8486
IMPLANT DATE PERIOD=2014 - 2017 (Jan-Sep)
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 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
Destination Therapy 2886 452 90 1418 4846
Bridge to Recovery 15 7 3 2 27
Rescue Therapy 11 8 3 15 37
Other 3 1 0 0 4
TOTAL 5143 2412 189 2430 10174
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 201719
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).
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 201720
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%)
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 201721
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.
Percent Survival [% (70% CI)]
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%)
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 201722
Exhibit 13: Kaplan-Meier Survival by Flow Type and Device
Percent Survival [% (70% CI)]
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%)
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 201723
Exhibit 14: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVADimplant at time of LVAD operation) by Implant Era
Percent Survival [% (70% CI)]
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%)
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 201724
Exhibit 15: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVADimplant at time of LVAD operation) by Pre-Implant Device Strategy
Percent Survival [% (70% CI)]
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%)
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 201725
Exhibit 16: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVADimplant at time of LVAD operation) by Pre-Implant Patient Profile
Percent Survival [% (70% CI)]
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%)
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 201726
Exhibit 17: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVADimplant at time of LVAD operation) by Device Type
Percent Survival [% (70% CI)]
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%)
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 201727
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
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 201728
Exhibit 19: Competing Outcomes for Continuous Flow LVADs (with RVAD implant attime of LVAD operation)
Number of Patients at Risk
Month
0 12 24 36 48 60
690 232 126 74 47 33
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 201729
Exhibit 20: Competing Outcomes for TAHs
Number of Patients at Risk
Month
0 12 24 36
410 55 12 3
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 201730
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
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 201731
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
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 201732
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%.
Intermacs Quarterly Report - 2017 Q3 Implants: June 23, 2006 to September 30, 201733
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