#HHSN268201100025C 1 Intermacs Interagency Registry for Mechanically Assisted Circulatory Support Quarterly Statistical Report 2017 Q3 Implant 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
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#HHSN268201100025C
1
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
2
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).
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.
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.
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
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.
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.
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