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Alfred M 14 69 112.5
INTERMACSInteragency Registry for MechanicallyAssisted Circulatory Support
Quarterly Statistical Report2014 2nd Quarter
Implant and event dates: June 23, 2006 to June 30, 2014
09/22/2014
Prepared by:
The Data Collection and Analysis Center University of Alabama at Birmingham
For questions or comments contact:
James K. Kirklin, MD at [email protected] David C. Naftel, Ph.D at [email protected] Susan L. Myers at [email protected] Mary Lynne Clark at [email protected] Stephen Craig Collum at [email protected] Kathryn Hollifield at [email protected] Ryan S. Cantor at [email protected]
# HHSN268201100025C
22
INTERMACS Quarterly ReportImplants: June 23, 2006 to June 30, 2014
The Interagency Registry for Mechanically Assisted Circulatory Support is a North Americanregistry established in 2005 for patients who are receiving mechanical circulatory supportdevice therapy to treat advanced heart failure. INTERMACS was established as a joint effortof the National Heart, Lung and Blood Institute (NHLBI), the Centers for Medicare andMedicaid Services (CMS), the Food and Drug Administration (FDA), clinicians, scientists andindustry representatives in conjunction with Dr. James K. Kirklin and the University ofAlabama at Birmingham. This quarterly report includes clinical information from 11796 adultpatients receiving primary prospective implants between June 23, 2006 and June 30, 2014
Table of Contents
Exhibit 1: Hospital Activation and Patient Enrollment
Exhibit 2: Participating Hospital Listing
Exhibit 3: Patient Demographics by Implant Period
Exhibit 4: Implants by Year by Device Strategy
Exhibit 5: Implants per Year by Device Type
Exhibit 6: Patient Profile at Time of Implant by Implant Period
Exhibit 7: Device Strategy at Time of Implant by Implant Period
Exhibit 8: Patient Profile by Device Strategy at Time of Implant
Exhibit 9: Patient Status by Device Strategy at Implant
Exhibit 10: Primary Cause of Death
Exhibit 11: Kaplan-Meier Survival for INTERMACS Overall
Exhibit 12: Kaplan-Meier Survival by Flow Type and Device
Exhibit 13: Kaplan-Meier Survival for Continuous Flow LVADs* by Implant Era
Exhibit 14: Kaplan-Meier Survival for Continuous Flow LVADs* by Pre-Implant Device Strategy
Exhibit 15: Kaplan-Meier Survival for Continuous Flow LVADs* by Pre-Implant Patient Profile
Exhibit 16: Kaplan-Meier Survival for Continuous Flow LVADs* by Device Type
Exhibit 17: Competing Outcomes for Continuous Flow LVADs (without RVAD implant at time of LVAD operation)
Exhibit 18: Competing Outcomes for Continuous Flow LVADs (with RVAD implant at time of LVAD operation)
Exhibit 19: Competing Outcomes for TAHs
Exhibit 20: Adverse Event Rates for Patients Receiving a Primary Prospective Continuous Flow LVADs*
Exhibit 21: Infection Rates by Location for Continuous Flow LVADs*
Exhibit 22: Follow-up Compliance
* (with or without RVAD implant at time of LVAD operation)
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 20143
Exhibit 1: Hospital Activation and Patient Enrollment
Between June 23, 2006 and June 30, 2014, 159 hospitals participated in INTERMACS and, ofthese, 144 hospitals actively contributed information on a total of 11796 patients. Cumulativepatient accrual and the number of participating hospitals over this time period are displayedbelow.
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 20144
Exhibit 2: Participating Hospital Listing
As of June 30, 2014 there were 159 hospitals participating in INTERMACS.
HOSPITAL NAME CITY STATE
ABBOTT NORTHWESTERN HOSPITAL MINNEAPOLIS MN
ABINGTON MEMORIAL HOSPITAL ABINGTON PA
ADVOCATE CHRIST MEDICAL CENTER OAK LAWN IL
ALBANY MEDICAL CENTER ALBANY NY
ALBERT EINSTEIN MEDICAL CENTER PHILADELPHIA PA
ALLEGHENY GENERAL HOSPITAL PITTSBURGH PA
ANN & ROBERT H. LURIE CHILDREN’S HOSPITAL OF CHICAGO CHICAGO IL
BANNER GOOD SAMARITAN PHOENIX AZ
BAPTIST HEALTH MEDICAL CENTER LITTLE ROCK AR
BAPTIST MEMORIAL HOSPITAL - MEMPHIS MEMPHIS TN
BARNES-JEWISH HOSPITAL ST. LOUIS MO
BAYLOR UNIVERSITY MEDICAL CENTER DALLAS TX
BRIGHAM AND WOMEN'S HOSPITAL BOSTON MA
BRYANLGH MEDICAL CENTER LINCOLN NE
CALIFORNIA PACIFIC MEDICAL CENTER SAN FRANCISCO CA
CARILION ROANOKE MEMORIAL HOSPITAL ROANOKE VA
CAROLINAS MEDICAL CENTER CHARLOTTE NC
CEDARS SINAI MEDICAL CENTER LOS ANGELES CA
CHILDREN'S HEALTHCARE OF ATLANTA ATLANTA GA
CHILDREN'S HOSPITAL BOSTON BOSTON MA
CHILDREN'S HOSPITAL OF PITTSBURGH PITTSBURGH PA
CHILDREN'S HOSPITAL OF WISCONSIN MILWAUKEE WI
CHILDREN'S MEDICAL CENTER DALLAS TX
CHRISTIANA CARE HEALTH SYSTEM NEWARK DE
CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER CINCINNATI OH
CJW MEDICAL CENTER RICHMOND VA
CLEVELAND CLINIC CLEVELAND OH
COLUMBIA PRESBYTERIAN - CHILDREN'S HOSPITAL OF NEW YORK NEW YORK NY
COLUMBIA UNIVERSITY MEDICAL CENTER-NY PRESBYTERIAN NEW YORK NY
CONE HEALTH SYSTEM GREENSBORO NC
DUKE UNIVERSITY MEDICAL CENTER DURHAM NC
EDWARD HOSPITAL NAPERVILLE IL
EMORY UNIVERSITY HOSPITAL ATLANTA GA
FLORIDA HOSPITAL ORLANDO FL
FROEDTERT & THE MEDICAL COLLEGE OF WISCONSIN MILWAUKEE WI
GEISINGER CLINIC DANVILLE PA
HACKENSACK UNIVERSITY MEDICAL CENTER HACKENSACK NJ
HAHNEMANN UNIVERSITY HOSPITAL PHILADELPHIA PA
HARTFORD HOSPITAL HARTFORD CT
HENRY FORD HOSPITAL DETROIT MI
HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA PHILADELPHIA PA
HOUSTON METHODIST HOSPITAL HOUSTON TX
INLAND NORTHWEST THORACIC ORGAN TRANSPLANT PROGRAM - SACRED HEARTMEDICAL CENTER
SPOKANE WA
INOVA FAIRFAX HOSPITAL FALLS CHURCH VA
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 20145
Exhibit 2: Participating Hospital Listing
HOSPITAL NAME CITY STATE
INSTITUT NATIONAL D'EXCELLENCE EN SANTÉ ET EN SERVICES SOCIAUX MONTREAL QC
INTEGRIS BAPTIST MEDICAL CENTER OKLAHOMA CITY OK
INTERMOUNTAIN HEART INSTITUTE-ARTIFICIAL HEART PROGRAM MURRAY UT
JACKSON MEMORIAL HEALTH SYSTEM/UNIVERSITY OF MIAMI MIAMI FL
JEWISH HOSPITAL LOUISVILLE KY
KAISER PERMANENTE SANTA CLARA MEDICAL CENTER SANTA CLARA CA
KAISER SUNNYSIDE MEDICAL CENTER CLACKAMAS OR
KECK HOSPITAL OF USC LOS ANGELES CA
LANCASTER GENERAL HOSPITAL LANCASTER PA
LANKENAU HOSPITAL WYNNEWOOD PA
LEHIGH VALLEY HEALTH NETWORK ALLENTOWN PA
LOMA LINDA UNIVERSITY MEDICAL CENTER & CHILDREN'S HOSPITAL LOMA LINDA CA
LOYOLA UNIVERSITY MEDICAL CENTER MAYWOOD IL
LUTHERAN HOSPITAL OF INDIANA FORT WAYNE IN
MAIMONIDES MEDICAL CENTER BROOKLYN NY
MASSACHUSETTS GENERAL HOSPITAL BOSTON MA
MAYO CLINIC HOSPITAL PHOENIX AZ
MAYO CLINIC JACKSONVILLE JACKSONVILLE FL
MAYO CLINIC ROCHESTER MN ROCHESTER MN
MEDICAL CITY DALLAS HOSPITAL DALLAS TX
MEDICAL UNIVERSITY OF SOUTH CAROLINA MEDICAL CENTER CHARLESTON SC
MEMORIAL HERMANN TEXAS MEDICAL CENTER HOUSTON TX
MERCY GENERAL SACRAMENTO CA
METHODIST HOSPITAL INDIANAPOLIS IN
METHODIST SPECIALTY AND TRANSPLANT HOSPITAL SAN ANTONIO TX
MID AMERICA HEART INSTITUTE OF SAINT LUKE'S HOSPITAL KANSAS CITY MO
MONTEFIORE MEDICAL CENTER BRONX NY
MORRISTOWN MEMORIAL HOSPITAL - ATLANTIC HEALTH MORRISTOWN NJ
MOUNT SINAI MEDICAL NEW YORK NY
MULTICARE HEALTH SYSTEMS TACOMA WA
NATIONWIDE CHILDREN'S HOSPITAL COLUMBUS OH
NEMOURS/A.I. DUPONT HOSPITAL FOR CHILDREN WILMINGTON DE
NEW YORK UNIVERSITY MEDICAL CENTER NEW YORK NY
NEWARK BETH ISRAEL MEDICAL CENTER NEWARK NJ
NORTH CAROLINA BAPTIST HOSPITAL WINSTON SALEM NC
NORTHWESTERN MEMORIAL HOSPITAL CHICAGO IL
OCHSNER MEDICAL CENTER NEW ORLEANS LA
OREGON HEALTH & SCIENCE UNIVERSITY PORTLAND OR
PALMETTO HEALTH RICHLAND COLUMBIA SC
PENN PRESBYTERIAN MEDICAL CENTER PHILADELPHIA PA
PENN STATE MILTON S. HERSHEY MEDICAL CENTER HERSHEY PA
PIEDMONT HOSPITAL ATLANTA GA
PROVIDENCE ST. VINCENT MEDICAL CENTER PORTLAND OR
ROBERT WOOD JOHNSON UNIVERSITY HOSPITAL NEW BRUNSWICK NJ
RUSH UNIVERSITY MEDICAL CENTER CHICAGO IL
SAINT JOSEPH'S HOSPITAL OF ATLANTA, INC. ATLANTA GA
SAINT THOMAS HOSPITAL NASHVILLE TN
SCOTT & WHITE HOSPITAL TEMPLE TX
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 20146
Exhibit 2: Participating Hospital Listing
HOSPITAL NAME CITY STATE
SCRIPPS MEMORIAL HOSPITAL LA JOLLA LA JOLLA CA
SEATTLE CHILDREN'S HOSPITAL SEATTLE WA
SENTARA NORFOLK GENERAL HOSPITAL NORFOLK VA
SETON MEDICAL CENTER - AUSTIN AUSTIN TX
SHANDS AT THE UNIVERSITY OF FLORIDA GAINESVILLE FL
SHARP MEMORIAL HOSPITAL SAN DIEGO CA
SOUTH BROWARD HOSPITAL DISTRICT D/B/A MEMORIAL HEALTHCARE SYSTEM HOLLYWOOD FL
SPECTRUM HEALTH HOSPITALS GRAND RAPIDS MI
ST MARY'S HOSPITAL RICHMOND VA
ST PAUL'S HOSPITAL VANCOUVER BC
ST PETERS HOSPITAL ALBANY NY
ST. LOUIS CHILDREN'S HOSPITAL ST. LOUIS MO
ST. LUKE'S EPISCOPAL HOSPITAL / TEXAS HEART INSTITUTE HOUSTON TX
ST. LUKE'S MEDICAL CENTER MILWAUKEE WI
ST. VINCENT HOSPITAL AND HEALTH CARE CENTER INDIANAPOLIS IN
STANFORD UNIVERSITY MEDICAL CENTER STANFORD CA
STONY BROOK UNIVERSITY MEDICAL CENTER STONY BROOK NY
SUTTER MEMORIAL HOSPITAL SACRAMENTO CA
TAMPA GENERAL HOSPITAL TAMPA FL
TEMPLE UNIVERSITY HOSPITAL PHILADELPHIA PA
TEXAS CHILDREN'S HOSPITAL HOUSTON TX
THE CHILDREN'S HOSPITAL OF PHILADELPHIA PHILADELPHIA PA
THE CHILDRENS HOSPITAL DENVER CO
THE CHRIST HOSPITAL CINCINNATI OH
THE HEART HOSPITAL BAYLOR PLANO PLANO TX
THE INDIANA HEART HOSPITAL INDIANAPOLIS IN
THE JOHNS HOPKINS HOSPITAL BALTIMORE MD
THE MEDICAL CENTER OF CENTRAL GEORGIA MACON GA
THE OHIO STATE UNIVERSITY MEDICAL CENTER COLUMBUS OH
THE UNIVERSITY OF TOLEDO TOLEDO OH
THOMAS JEFFERSON UNIVERSITY PHILADELPHIA PA
TORONTO GENERAL HOSPITAL TORONTO ON
TUFTS MEDICAL CENTER BOSTON MA
TULANE MEDICAL CENTER NEW ORLEANS LA
UC HEALTH UNIVERSITY HOSPITAL CINCINNATI OH
UCLA MEDICAL CENTER LOS ANGELES CA
UNIVERSITY HOSPITALS CASE MEDICAL CENTER CLEVELAND OH
UNIVERSITY OF ALABAMA AT BIRMINGHAM HOSPITAL BIRMINGHAM AL
UNIVERSITY OF ARIZONA MEDICAL CENTER TUCSON AZ
UNIVERSITY OF CALIFORNIA DAVIS MEDICAL CENTER (UCDMC) SACRAMENTO CA
UNIVERSITY OF CALIFORNIA SAN FRANCISCO SAN FRANCISCO CA
UNIVERSITY OF CALIFORNIA, SAN DIEGO MEDICAL CENTER SAN DIEGO CA
UNIVERSITY OF CHICAGO HOSPITALS CHICAGO IL
UNIVERSITY OF COLORADO HOSPITAL AURORA CO
UNIVERSITY OF IOWA HOSPITALS AND CLINICS IOWA CITY IA
UNIVERSITY OF KENTUCKY CHANDLER MEDICAL CENTER LEXINGTON KY
UNIVERSITY OF MARYLAND MEDICAL CENTER BALTIMORE MD
UNIVERSITY OF MICHIGAN HEALTH SYSTEMS ANN ARBOR MI
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 20147
Exhibit 2: Participating Hospital Listing
HOSPITAL NAME CITY STATE
UNIVERSITY OF MINNESOTA MEDICAL CENTER-FAIRVIEW MINNEAPOLIS MN
UNIVERSITY OF NEBRASKA MEDICAL CENTER OMAHA NE
UNIVERSITY OF NORTH CAROLINA HOSPITALS CHAPEL HILL NC
UNIVERSITY OF PITTSBURGH MEDICAL CENTER PITTSBUGH PA
UNIVERSITY OF ROCHESTER MEDICAL CENTER (STRONG MEMORIAL HOSPITAL) ROCHESTER NY
UNIVERSITY OF TEXAS MEDICAL BRANCH GALVESTON TX
UNIVERSITY OF UTAH HOSPITAL SALT LAKE CITY UT
UNIVERSITY OF VIRGINIA HEALTH SYSTEM CHARLOTTESVILLE
VA
UNIVERSITY OF WASHINGTON MEDICAL CENTER SEATTLE WA
UNIVERSITY OF WISCONSIN HOSPITAL AND CLINICS MADISON WI
UT SOUTHWESTERN MEDICAL CENTER DALLAS TX
VANDERBILT UNIVERSITY MEDICAL CENTER - VANDERBILT HEART AND VASCULARINSTITUTE
NASHVILLE TN
VIRGINIA COMMONWEALTH UNIVERSITY HEALTH SYSTEM RICHMOND VA
WASHINGTON HOSPITAL CENTER WASHINGTON DC
WEILL CORNELL MEDICAL CENTER/NEW YORK PRESBYTERIAN MEDICAL CENTER NEW YORK NY
WESTCHESTER MEDICAL CENTER VALHALLA NY
WILLIS-KNIGHTON HEART AND VASCULAR INSTITUTE SHREVEPORT LA
YALE-NEW HAVEN HOSPITAL NEW HAVEN CT
YORK HOSPITAL YORK PA
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 20148
Exhibit 3: Patient Demographics by Implant Period
The following tables present demographic characteristics for patients at the time of theirprimary implant (June 23, 2006 to June 30, 2014).
Gender
GENDER
IMPLANT DATE PERIOD
TOTAL< 2010 2010 - 2011 2012 - 2014 (Jan-Jun)
n % n % n % n %
Female 451 20.6 % 763 21.3 % 1271 21.0 % 2485 21.0 %
MISSING 2 0.0 % . . . . 2 0.0 %
Male 1731 79.2 % 2807 78.6 % 4770 78.9 % 9308 78.9 %
Unspecified . . . . 1 0.0 % 1 0.0 %
TOTAL 2184 100.0 % 3570 100.0 % 6042 100.0 % 11796 100.0 %
Race
RACE
IMPLANT DATE PERIOD
TOTAL< 2010 2010 - 2011 2012 - 2014 (Jan-Jun)
n % n % n % n %
African American 486 22.2 % 766 21.4 % 1391 23.0 % 2643 22.4 %
Other, Unknown,Undisclosed 187 8.5 % 290 8.1 % 515 8.5 % 992 8.4 %
White 1511 69.1 % 2514 70.4 % 4136 68.4 % 8161 69.1 %
TOTAL 2184 100.0 % 3570 100.0 % 6042 100.0 % 11796 100.0 %
Age Group
AGE GROUP (yr)
IMPLANT DATE PERIOD
TOTAL< 2010 2010 - 2011 2012 - 2014 (Jan-Jun)
n % n % n % n %
19-39 356 16.3 % 428 11.9 % 659 10.9 % 1443 12.2 %
40-59 1128 51.6 % 1475 41.3 % 2419 40.0 % 5022 42.5 %
60-79 700 32.0 % 1647 46.1 % 2914 48.2 % 5261 44.5 %
80+ . . 20 0.5 % 50 0.8 % 70 0.5 %
TOTAL 2184 100.0 % 3570 100.0 % 6042 100.0 % 11796 100.0 %
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 20149
Exhibit 4: Implants by Year by Device Strategy
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 201410
Exhibit 5: Implants per Year by Device Type
Number of Implants by Device Type and Year
Number of Implants by Device Type and Implant Date Period
DEVICE TYPE
IMPLANT DATE PERIOD
TOTAL< 2010 2010 - 2011 2012 - 2014 (Jan-Jun)
n % n % n % n %
LVAD 1850 84.7 % 3339 93.5 % 5703 94.3 % 10892 92.3 %
BiVAD 257 11.7 % 176 4.9 % 199 3.2 % 632 5.3 %
TAH 77 3.5 % 55 1.5 % 140 2.3 % 272 2.3 %
TOTAL 2184 100.0 % 3570 100.0 % 6042 100.0 % 11796 100.0 %
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 201411
Exhibit 6: Patient Profile at Time of Implant by Implant Period
Patient profile status provides a general clinical description of the patients at the time ofimplantation.
PATIENT PROFILE AT TIMEOF IMPLANT
IMPLANT DATE PERIOD
TOTAL< 2010 2010 - 2011 2012 - 2014 (Jan-Jun)
n % n % n % n %
1 Critical Cardio Shock 643 29.4 % 532 14.9 % 913 15.1 % 2088 17.7 %
2 Progressive Decline 929 42.5 % 1412 39.5 % 2175 35.9 % 4516 38.2 %
3 Stable but Inotropedependent 330 15.1 % 952 26.6 % 1822 30.1 % 3104 26.3 %
4 Resting Symptoms 196 8.9 % 477 13.3 % 884 14.6 % 1557 13.1 %
5 Exertion intolerant 42 1.9 % 108 3.0 % 156 2.5 % 306 2.5 %
6 Exertion limited 23 1.0 % 66 1.8 % 53 0.8 % 142 1.2 %
7 Advanced NYHA Class 3 21 0.9 % 23 0.6 % 39 0.6 % 83 0.7 %
TOTAL 2184 100.0 % 3570 100.0 % 6042 100.0 % 11796 100.0 %
1 Critical cardiogenic shock describes a patient who is 'crashing and burning', in which apatient has life-threatening hypotension and rapidily escalating inotropic pressor support.
2 Progressive decline describes a patient who has been demonstrated 'dependent' oninotropic support but nonetheless shows signs of continuing deterioration.
3 Stable but inotrope dependent: describes a patient who is clinically stable on mild-moderatedoses of intravenous inotropes.
4 Resting symptoms describe a patient who is at home on oral therapy but frequently hassymptoms of congestion at rest or with ADL.
5 Exertion Intolerant describes a patient who is comfortable at rest but unable to engage inany activity, living predominantly within the house or household.
6 Exertion Limited also describes a patient who is comfortable at rest without evidence of fluidoverload, but who is able to do some mild activity.
7 Advanced NYHA Class 3 describes a patient who is clinically stable with a reasonable levelof comfortable activity, despite history of previous decompensation that is not recent.
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 201412
Exhibit 7: Device Strategy at Time of Implant by Implant Period
Device strategy is determined in conjunction with the heart failure cardiologist and surgeon atthe time of the implant.
DEVICE STRATEGY ATTIME OF IMPLANT
IMPLANT DATE PERIOD
TOTAL< 2010 2010 - 2011 2012 - 2014 (Jan-Jun)
n % n % n % n %
BTT - Listed 1045 47.8 % 903 25.2 % 1412 23.3 % 3360 28.4 %
BTT - Likely 589 26.9 % 810 22.6 % 1221 20.2 % 2620 22.2 %
BTT - Moderate 210 9.6 % 362 10.1 % 588 9.7 % 1160 9.8 %
BTT - Unlikely 88 4.0 % 125 3.5 % 165 2.7 % 378 3.2 %
Destination Therapy 178 8.1 % 1307 36.6 % 2590 42.8 % 4075 34.5 %
Bridge to Recovery 44 2.0 % 27 0.7 % 25 0.4 % 96 0.8 %
Rescue Therapy 25 1.1 % 15 0.4 % 25 0.4 % 65 0.5 %
Other 5 0.2 % 21 0.5 % 16 0.2 % 42 0.3 %
TOTAL 2184 100.0 % 3570 100.0 % 6042 100.0 % 11796 100.0 %
1. Bridge to Transplant (BTT) Listed - patient already listed for transplant or listed within 24hours before device implantation.
2. Bridge to Transplant (BTT) Likely - patient in whom the transplant evaluation has not beencompleted, but no contra-indications are anticipated, or in whom a current contra-indication isanticipated to resolve rapidly.
3. Bridge to Transplant (BTT) Moderate - patient in whom the transplant evaluation has notbeen completed, but with some potential concerns that might prevent eligibility.
4. Bridge to Transplant (BTT) Unlikely - patient in whom major concerns that might preventeligibility have already been identified.
5. Destination Therapy - the patient is definitely not eligible for transplant.
6. Bridge to Recovery (BTR) - use of a durable device to allow recovery from chronic cardiacfailure (at least 3 months in duration).
7. Rescue Therapy - use of a durable device to support resolution from an acute event withoutmajor previous cardiac dysfunction.
8. Other.
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 201413
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 %
1 Critical Cardio Shock 558 16.6 % 566 21.6 % 280 24.1 % 88 23.2 % 478 11.7 %
2 Progressive Decline 1510 44.9 % 988 37.7 % 425 36.6 % 139 36.7 % 1406 34.5 %
3 Stable but Inotrope dependent 797 23.7 % 596 22.7 % 287 24.7 % 87 23.0 % 1313 32.2 %
4 Resting Symptoms 363 10.8 % 323 12.3 % 137 11.8 % 49 12.9 % 677 16.6 %
5 Exertion intolerant 73 2.1 % 79 3.0 % 20 1.7 % 6 1.5 % 126 3.0 %
6 Exertion limited 28 0.8 % 52 1.9 % 9 0.7 % 8 2.1 % 44 1.0 %
7 Advanced NYHA Class 3 31 0.9 % 16 0.6 % 2 0.1 % 1 0.2 % 31 0.7 %
TOTAL 3360 100.0 % 2620 100.0 % 1160 100.0 % 378 100.0 % 4075 100.0 %
PATIENT PROFILE STATUSOVERALL
Pre-Implant Device Strategy
TOTALBridge toRecovery Rescue Therapy Other
n % n % n % n %
1 Critical Cardio Shock 54 56.2 % 56 86.1 % 8 19.0 % 2088 17.7 %
2 Progressive Decline 21 21.8 % 4 6.1 % 23 54.7 % 4516 38.2 %
3 Stable but Inotrope dependent 14 14.5 % 4 6.1 % 6 14.2 % 3104 26.3 %
4 Resting Symptoms 4 4.1 % 0 0 4 9.5 % 1557 13.1 %
5 Exertion intolerant 0 0 1 1.5 % 1 2.3 % 306 2.5 %
6 Exertion limited 1 1.0 % 0 0 0 0 142 1.2 %
7 Advanced NYHA Class 3 2 2.0 % 0 0 0 0 83 0.7 %
TOTAL 96 100.0 % 65 100.0 % 42 100.0 % 11796 100.0 %
IMPLANT DATE PERIOD=< 2010 14
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 2014
Exhibit 8: Patient Profile by Device Strategy at Time of Implant
IMPLANT DATE PERIOD=< 2010
PATIENT PROFILE STATUSOVERALL
Pre-Implant Device Strategy
BTT - Listed BTT - Likely BTT - Moderate BTT - UnlikelyDestination
Therapy
n % n % n % n % n %
1 Critical Cardio Shock 231 22.1 % 206 34.9 % 78 37.1 % 35 39.7 % 38 21.3 %
2 Progressive Decline 501 47.9 % 229 38.8 % 82 39.0 % 38 43.1 % 70 39.3 %
3 Stable but Inotrope dependent 177 16.9 % 69 11.7 % 28 13.3 % 8 9.0 % 41 23.0 %
4 Resting Symptoms 91 8.7 % 59 10.0 % 17 8.0 % 5 5.6 % 22 12.3 %
5 Exertion intolerant 17 1.6 % 18 3.0 % 4 1.9 % 0 0 2 1.1 %
6 Exertion limited 12 1.1 % 6 1.0 % 1 0.4 % 1 1.1 % 3 1.6 %
7 Advanced NYHA Class 3 16 1.5 % 2 0.3 % 0 0 1 1.1 % 2 1.1 %
TOTAL 1045 100.0 % 589 100.0 % 210 100.0 % 88 100.0 % 178 100.0 %
PATIENT PROFILE STATUSOVERALL
Pre-Implant Device Strategy
TOTALBridge toRecovery Rescue Therapy Other
n % n % n % n %
1 Critical Cardio Shock 30 68.1 % 23 92.0 % 2 40.0 % 643 29.4 %
2 Progressive Decline 6 13.6 % 1 4.0 % 2 40.0 % 929 42.5 %
3 Stable but Inotrope dependent 6 13.6 % 0 0 1 20.0 % 330 15.1 %
4 Resting Symptoms 2 4.5 % 0 0 0 0 196 8.9 %
5 Exertion intolerant 0 0 1 4.0 % 0 0 42 1.9 %
6 Exertion limited 0 0 0 0 0 0 23 1.0 %
7 Advanced NYHA Class 3 0 0 0 0 0 0 21 0.9 %
TOTAL 44 100.0 % 25 100.0 % 5 100.0 % 2184 100.0 %
IMPLANT DATE PERIOD=2010 - 2011 15
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 2014
Exhibit 8: Patient Profile by Device Strategy at Time of Implant
IMPLANT DATE PERIOD=2010 - 2011
PATIENT PROFILE STATUSOVERALL
Pre-Implant Device Strategy
BTT - Listed BTT - Likely BTT - Moderate BTT - UnlikelyDestination
Therapy
n % n % n % n % n %
1 Critical Cardio Shock 134 14.8 % 143 17.6 % 68 18.7 % 20 16.0 % 140 10.7 %
2 Progressive Decline 407 45.0 % 307 37.9 % 152 41.9 % 48 38.4 % 476 36.4 %
3 Stable but Inotrope dependent 214 23.6 % 197 24.3 % 88 24.3 % 31 24.8 % 413 31.5 %
4 Resting Symptoms 108 11.9 % 98 12.0 % 43 11.8 % 19 15.2 % 206 15.7 %
5 Exertion intolerant 23 2.5 % 35 4.3 % 7 1.9 % 2 1.6 % 41 3.1 %
6 Exertion limited 9 0.9 % 27 3.3 % 4 1.1 % 5 4.0 % 21 1.6 %
7 Advanced NYHA Class 3 8 0.8 % 3 0.3 % 0 0 0 0 10 0.7 %
TOTAL 903 100.0 % 810 100.0 % 362 100.0 % 125 100.0 % 1307 100.0 %
PATIENT PROFILE STATUSOVERALL
Pre-Implant Device Strategy
TOTALBridge toRecovery Rescue Therapy Other
n % n % n % n %
1 Critical Cardio Shock 11 40.7 % 12 80.0 % 4 19.0 % 532 14.9 %
2 Progressive Decline 9 33.3 % 0 0 13 61.9 % 1412 39.5 %
3 Stable but Inotrope dependent 3 11.1 % 3 20.0 % 3 14.2 % 952 26.6 %
4 Resting Symptoms 2 7.4 % 0 0 1 4.7 % 477 13.3 %
5 Exertion intolerant 0 0 0 0 0 0 108 3.0 %
6 Exertion limited 0 0 0 0 0 0 66 1.8 %
7 Advanced NYHA Class 3 2 7.4 % 0 0 0 0 23 0.6 %
TOTAL 27 100.0 % 15 100.0 % 21 100.0 % 3570 100.0 %
IMPLANT DATE PERIOD=2012 - 2014 (Jan-Jun) 16
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 2014
Exhibit 8: Patient Profile by Device Strategy at Time of Implant
IMPLANT DATE PERIOD=2012 - 2014 (Jan-Jun)
PATIENT PROFILE STATUSOVERALL
Pre-Implant Device Strategy
BTT - Listed BTT - Likely BTT - Moderate BTT - UnlikelyDestination
Therapy
n % n % n % n % n %
1 Critical Cardio Shock 193 13.6 % 217 17.7 % 134 22.7 % 33 20.0 % 300 11.5 %
2 Progressive Decline 602 42.6 % 452 37.0 % 191 32.4 % 53 32.1 % 860 33.2 %
3 Stable but Inotrope dependent 406 28.7 % 330 27.0 % 171 29.0 % 48 29.0 % 859 33.1 %
4 Resting Symptoms 164 11.6 % 166 13.5 % 77 13.0 % 25 15.1 % 449 17.3 %
5 Exertion intolerant 33 2.3 % 26 2.1 % 9 1.5 % 4 2.4 % 83 3.2 %
6 Exertion limited 7 0.4 % 19 1.5 % 4 0.6 % 2 1.2 % 20 0.7 %
7 Advanced NYHA Class 3 7 0.4 % 11 0.9 % 2 0.3 % 0 0 19 0.7 %
TOTAL 1412 100.0 % 1221 100.0 % 588 100.0 % 165 100.0 % 2590 100.0 %
PATIENT PROFILE STATUSOVERALL
Pre-Implant Device Strategy
TOTALBridge toRecovery Rescue Therapy Other
n % n % n % n %
1 Critical Cardio Shock 13 52.0 % 21 84.0 % 2 12.5 % 913 15.1 %
2 Progressive Decline 6 24.0 % 3 12.0 % 8 50.0 % 2175 35.9 %
3 Stable but Inotrope dependent 5 20.0 % 1 4.0 % 2 12.5 % 1822 30.1 %
4 Resting Symptoms 0 0 0 0 3 18.7 % 884 14.6 %
5 Exertion intolerant 0 0 0 0 1 6.2 % 156 2.5 %
6 Exertion limited 1 4.0 % 0 0 0 0 53 0.8 %
7 Advanced NYHA Class 3 0 0 0 0 0 0 39 0.6 %
TOTAL 25 100.0 % 25 100.0 % 16 100.0 % 6042 100.0 %
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 201417
Exhibit 9: Patient Status by Device Strategy at Implant
The following tables present patient status as of June 30, 2014 by the device strategy fordifferent time periods. Patient status is defined as the first of the following events:
Alive (device in place) - patients that were alive on a device at the end of this follow-up period.
Transplant - patients that have received a transplant during this follow-up period.
Recovery: patients that were explanted due to recovery at or before the end of this follow-upperiod.
Dead: patients who died during this follow-up period.
Overall
PRE-IMPLANT DEVICESTRATEGY
Patient Status (June 30, 2014)
TOTAL
1. Alive(device in
place)2.
Transplant 3. Recovery 4. Dead
N N N N N
BTT - Listed 1036 1660 33 631 3360
BTT - Likely 905 1093 42 580 2620
BTT - Moderate 530 262 16 352 1160
BTT - Unlikely 169 57 3 149 378
Destination Therapy 2440 267 32 1336 4075
Bridge to Recovery 35 26 14 21 96
Rescue Therapy 13 14 4 34 65
Other 16 11 2 13 42
TOTAL 5144 3390 146 3116 11796
IMPLANT DATE PERIOD=< 2010
PRE-IMPLANT DEVICESTRATEGY
Patient Status (June 30, 2014)
TOTAL
1. Alive(device in
place)2.
Transplant 3. Recovery 4. Dead
N N N N N
BTT - Listed 85 689 13 258 1045
BTT - Likely 50 352 9 178 589
BTT - Moderate 22 75 1 112 210
BTT - Unlikely 11 20 1 56 88
Destination Therapy 51 29 4 94 178
Bridge to Recovery 11 10 9 14 44
Rescue Therapy 0 5 3 17 25
Other 1 1 1 2 5
TOTAL 231 1181 41 731 2184
1818
IMPLANT DATE PERIOD=2010 - 2011
PRE-IMPLANT DEVICESTRATEGY
Patient Status (June 30, 2014)
TOTAL
1. Alive(device in
place)2.
Transplant 3. Recovery 4. Dead
N N N N N
BTT - Listed 161 527 13 202 903
BTT - Likely 187 389 15 219 810
BTT - Moderate 118 105 9 130 362
BTT - Unlikely 55 16 1 53 125
Destination Therapy 549 123 16 619 1307
Bridge to Recovery 11 8 2 6 27
Rescue Therapy 4 5 1 5 15
Other 4 9 0 8 21
TOTAL 1089 1182 57 1242 3570
IMPLANT DATE PERIOD=2012 - 2014 (Jan-Jun)
PRE-IMPLANT DEVICESTRATEGY
Patient Status (June 30, 2014)
TOTAL
1. Alive(device in
place)2.
Transplant 3. Recovery 4. Dead
N N N N N
BTT - Listed 790 444 7 171 1412
BTT - Likely 668 352 18 183 1221
BTT - Moderate 390 82 6 110 588
BTT - Unlikely 103 21 1 40 165
Destination Therapy 1840 115 12 623 2590
Bridge to Recovery 13 8 3 1 25
Rescue Therapy 9 4 0 12 25
Other 11 1 1 3 16
TOTAL 3824 1027 48 1143 6042
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 201419
Exhibit 10: Primary Cause of Death
PRIMARY CAUSE OF DEATH
IMPLANT DATE PERIOD
TOTAL< 2010 2010 - 20112012 - 2014(Jan-Jun)
n % n % n % n %
Cardiovascular, Other . . 2 0.1 % 4 0.3 % 6 0.1 %
Circulatory: Arterial Non-CNS Thromboembolism 8 1.0 % 18 1.4 % 6 0.5 % 32 1.0 %
Circulatory: CHF 28 3.8 % 41 3.3 % 35 3.1 % 104 3.3 %
Circulatory: Cardiac Arrhythmia 23 3.1 % 41 3.3 % 23 2.0 % 87 2.8 %
Circulatory: End Stage Cardiomyopathy 11 1.5 % 20 1.6 % 18 1.6 % 49 1.5 %
Circulatory: Heart Disease 1 0.1 % 8 0.6 % 6 0.5 % 15 0.4 %
Circulatory: Hemolysis 1 0.1 % 5 0.4 % 8 0.7 % 14 0.4 %
Circulatory: Ischemic Cardiomyopathy 4 0.5 % 9 0.7 % 13 1.1 % 26 0.8 %
Circulatory: Major Bleeding 36 4.9 % 36 2.9 % 28 2.5 % 100 3.2 %
Circulatory: Myocardial Infarction 3 0.4 % 7 0.5 % 9 0.8 % 19 0.6 %
Circulatory: Myocardial Rupture 1 0.1 % . . . . 1 0.0 %
Circulatory: Other, Specify 41 5.6 % 39 3.1 % 44 3.9 % 124 4.0 %
Circulatory: Pericardial Fluid Collection 1 0.1 % 1 0.0 % 1 0.0 % 3 0.0 %
Circulatory: Right Heart Failure 35 4.8 % 69 5.6 % 40 3.5 % 144 4.6 %
Circulatory: Ruptured Aortic Aneurysm 1 0.1 % . . . . 1 0.0 %
Circulatory: Sudden Unexplained Death 27 3.7 % 67 5.4 % 35 3.1 % 129 4.2 %
Device Malfunction 21 2.8 % 53 4.3 % 37 3.3 % 111 3.6 %
Digestive: Fluid/Electrolyte Disorder 5 0.6 % 3 0.2 % . . 8 0.2 %
Digestive: GI Disorder . . 5 0.4 % 10 0.8 % 15 0.4 %
Digestive: Hepatic Dysfunction 12 1.6 % 17 1.3 % 6 0.5 % 35 1.1 %
Digestive: Pancreatitis 1 0.1 % . . . . 1 0.0 %
Digestive: Renal Dysfunction 20 2.7 % 21 1.7 % 2 0.1 % 43 1.4 %
Hemotalogical 2 0.2 % . . 1 0.0 % 3 0.0 %
Major Infection 106 14.5 % 131 10.6 % 58 5.2 % 295 9.6 %
Multisystem Organ Failure (MSOF) 72 9.8 % 145 11.7 % 240 21.5 % 457 14.8 %
Nervous System: Neurological Dysfunction 147 20.1 % 226 18.3 % 194 17.4 % 567 18.4 %
Other, specify 28 3.8 % 50 4.0 % 37 3.3 % 115 3.7 %
Other: Cancer 6 0.8 % 27 2.1 % 9 0.8 % 42 1.3 %
Other: Trauma/accident, specify 6 0.8 % 10 0.8 % 8 0.7 % 24 0.7 %
Psychiatric Episode/Suicide 5 0.6 % 2 0.1 % 4 0.3 % 11 0.3 %
Respiratory: Pulmonary: Other, specify 3 0.4 % 15 1.2 % 13 1.1 % 31 1.0 %
Respiratory: Respiratory Failure 35 4.8 % 65 5.2 % 59 5.2 % 159 5.1 %
Respiratory: Venous Thromboembolism Event 1 0.1 % 3 0.2 % 1 0.0 % 5 0.1 %
Withdrawal of Support, specify 37 5.0 % 93 7.5 % 165 14.8 % 295 9.6 %
TOTAL 728 100.0 % 1229 100.0 % 1114 100.0 % 3071 100.0 %
Note: 45 patients have a missing primary cause of death.
* Certain pre-relaunch categories are no longer supported as of the v3.0 Launch (May 2012).
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 201420
Exhibit 11: Kaplan-Meier Survival for INTERMACS Overall
Percent Survival
Monthsafter
DeviceImplant
INTERMACSOverall
1 94%
3 89%
6 85%
12 79%
24 68%
36 57%
48 47%
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 201421
Exhibit 12: Kaplan-Meier Survival by Flow Type and Device
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 201422
Exhibit 13: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVADimplant at time of LVAD operation) by Implant Era
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 201423
Exhibit 14: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVADimplant at time of LVAD operation) by Pre-Implant Device Strategy
Bridge to Transplant (BTT) includes patients listed for transplant at time of implant.Bridge to Candidacy (BTC) include patients who are not yet listed for transplant at the time ofimplant.
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 201424
Exhibit 15: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVADimplant at time of LVAD operation) by Pre-Implant Patient Profile
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 201425
Exhibit 16: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVADimplant at time of LVAD operation) by Device Type
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 201426
Exhibit 17: Competing Outcomes for Continuous Flow LVADs (without RVAD implant attime of LVAD operation)
Number of Patients at Risk
Month
0 12 24 36 48 60
10280 4783 2257 986 331 88
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 201427
Exhibit 18: Competing Outcomes for Continuous Flow LVADs (with RVAD implant at timeof LVAD operation)
Number of Patients at Risk
Month
0 12 24 36 48 60
302 101 54 38 28 9
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 201428
Exhibit 19: Competing Outcomes for TAHs
Number of Patients at Risk
Month
0 12 24
272 23 6
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 201429
Exhibit 20: Adverse Event Rates for Patients Receiving a Primary ProspectiveImplant - Continuous Flow LVADs (with or without RVAD implant at time of LVAD
operation)
The following table summarizes adverse events in patients receiving primary prospectiveimplants between June 23, 2006 and June 30, 2014. Event count is the number of episodesobserved for each event type allowing multiple episodes per patient. Patient count is thenumber of patients experiencing at least one episode of a particular event type. Patientpercentage is the percent of patients experiencing a specific event type. Early and late eventcounts are the number of episodes observed either within three months post-implant or afterthree months post-implant, respectively. Event rates are calculated by dividing the number ofepisodes observed for each event type during a period by the total amount of follow-up timethe patients were observed during the period. The total follow-up time for the early period was28805.34 patient months and the total follow-up time for the late period was 129920.6 patientmonths. All rates are reported in episodes per 100 patient months.
Adverse Event TypeEarly EventCount (n)
Early Event Rate(per 100 pt m)
Late EventCount (n)
Late Event Rate(per 100 pt m)
Arterial Non-CNS Thromboembolism 123 0.43 53 0.04
Bleeding 5425 18.83 4324 3.33
Cardiac Arrhythmia 3271 11.36 1384 1.07
Device Malfunction 801 2.78 2054 1.58
Hepatic Dysfunction 417 1.45 302 0.23
Infection 4332 15.04 5054 3.89
Myocardial Infarction 40 0.14 39 0.03
Neurological Dysfunction 1162 4.03 1591 1.22
Other Serious Adverse Event 3769 13.08 2476 1.91
Pericardial Drainage 518 1.80 23 0.02
Psychiatric Episode 719 2.50 431 0.33
Rehospitalization 5991 20.80 20856 16.05
Renal Dysfunction 1114 3.87 637 0.49
Respiratory Failure 2151 7.47 650 0.50
Venous Thromboembolism 510 1.77 96 0.07
Wound Dehiscence 147 0.51 35 0.03
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 201430
Exhibit 21: Infection Rates by Location - Continuous Flow LVADs (with or without RVADimplant at time of LVAD operation)
Adverse Event TypeEarly EventCount (n)
Early Event Rate(per 100 pt m)
Late EventCount (n)
Late Event Rate(per 100 pt m)
GI 387 1.34 273 0.21
Line Sepsis 170 0.59 128 0.10
Mediastinum 184 0.64 75 0.06
Other Specify 645 2.24 709 0.55
Peripheral Wound 123 0.43 124 0.10
Positive Blood Cultures 863 3.00 1379 1.06
Pulmonary 1375 4.77 616 0.47
Pump/Related - Drive Line 412 1.43 2085 1.60
Pump/Related - Exit Cannula 10 0.03 34 0.03
Pump/Related - Pump Interior 13 0.05 30 0.02
Pump/Related - Pump Pocket 116 0.40 264 0.20
Unknown 148 0.51 99 0.08
Urinary Tract 1033 3.59 809 0.62
INTERMACS Quarterly Report - 2014 Q2 Implants: June 23, 2006 to June 30, 201431
Exhibit 22: Follow-up Compliance
Site compliance is determined by the percentage of all follow-up forms that are due duringthis reporting period that have been completed. This calculation has been updated to includeALL follow-up forms expected for ALL patients and ALL devices. Only sites that have at least10 follow-up forms expected are included in this figure. INTERMACS has defined requiredcompliance as 90%.