Page 1 of 27 # HHSN268201100025C Quarterly Report – 2013 Q3 01/13/2013 Alfred M 14 69 112.5 INTERMACS Interagency Registry for Mechanically Assisted Circulatory Support Quarterly Statistical Report 2013 3rd Quarter Implant and event dates: June 23, 2006 to September 30, 2013 01/13/2013 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]
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# HHSN268201100025C Quarterly Report – 2013 Q3
01/13/2013 Alfred M 14 69 112.5
INTERMACS
Interagency Registry for Mechanically Assisted Circulatory Support
Quarterly Statistical Report
2013 3rd Quarter Implant and event dates: June 23, 2006 to September 30, 2013 01/13/2013 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]
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# HHSN268201100025C Quarterly Report – 2013 Q3
01/13/2013
INTERMACS Quarterly Report Implants: June 23, 2006 to September 30, 2013
The Interagency Registry for Mechanically Assisted Circulatory Support is a North American registry established in 2005 for patients who are receiving mechanical circulatory support device therapy to treat advanced heart failure. INTERMACS was established as a joint effort of the National Heart, Lung and Blood Institute (NHLBI), the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), clinicians, scientists and industry representatives in conjunction with Dr. James K. Kirklin and the University of Alabama at Birmingham. This quarterly report includes clinical information from 9791 adult patients receiving primary prospective implants between June 23, 2006 and September 30, 2013.
Table of Contents Exhibit 1: Hospital Activation and Patient Enrollment .......................................................................................................... 3
Exhibit 3: Patient Demographics by Implant Period ............................................................................................................. 8
Exhibit 4: Implants by Year by Device Strategy.................................................................................................................... 9
Exhibit 5: Implants per Year by Device Type ...................................................................................................................... 10
Exhibit 6: Patient Profile at Time of Implant by Implant Period ........................................................................................ 11
Exhibit 7: Device Strategy at Time of Implant by Implant Period ..................................................................................... 12
Exhibit 8: Patient Profile by Device Strategy at Time of Implant ...................................................................................... 13
Exhibit 9: Patient Status by Device Strategy at Implant .................................................................................................... 15
Exhibit 10: Primary Cause of Death ..................................................................................................................................... 17
Exhibit 11: Kaplan-Meier Survival for INTERMACS OVERALL ....................................................................................... 18
Exhibit 12: Kaplan-Meier Survival by Flow Type and Device ........................................................................................... 19
Exhibit 13: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Implant Era....................................................................................................................................................... 20
Exhibit 14: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Pre-Implant Device Strategy ......................................................................................................................... 21
Exhibit 15: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Pre-Implant Patient Profile............................................................................................................................. 22
Exhibit 16: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Device Type ..................................................................................................................................................... 23
Exhibit 17: Competing Outcomes for Continuous Flow LVADs (without RVAD implant at time of LVAD operation) ................................................................................................................................................................................................... 24
Exhibit 18: Competing Outcomes for Continuous Flow LVADs (with RVAD implant at time of LVAD operation) .... 25
Exhibit 19: Adverse Event Rates for Patients Receiving a Primary Prospective Implant - Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation)............................................................................................... 26
01/13/2013 Exhibit 1: Hospital Activation and Patient Enrollment Exhi bit 1: Hospital Acti vati on and Pati ent Enr ollment Between June 23, 2006 and September 30, 2013, 158 hospitals participated in INTERMACS and, of these, 138 hospitals actively contributed information on a total of 9791 patients. Cumulative patient accrual and the number of participating hospitals over this time period are displayed below.
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# HHSN268201100025C Quarterly Report – 2013 Q3
01/13/2013 Exhibit 2: Participating Hospital Listing Exhi bit 2: Participati ng Hospital Listi ng As of September 30, 2013 there were 158 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 INLAND NORTHWEST THORACIC ORGAN TRANSPLANT PROGRAM - SACRED HEART MEDICAL 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 JACKSON MEMORIAL HEALTH SYSTEM/UNIVERSITY OF MIAMI MIAMI FL
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# HHSN268201100025C Quarterly Report – 2013 Q3
01/13/2013 HOSPITAL NAME CITY STATE 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 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 SPECTRUM HEALTH HOSPITALS GRAND RAPIDS MI
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# HHSN268201100025C Quarterly Report – 2013 Q3
01/13/2013 HOSPITAL NAME CITY STATE 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 METHODIST HOSPITAL HOUSTON TX 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 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
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# HHSN268201100025C Quarterly Report – 2013 Q3
01/13/2013 HOSPITAL NAME CITY STATE UT SOUTHWESTERN MEDICAL CENTER DALLAS TX VANDERBILT UNIVERSITY MEDICAL CENTER - VANDERBILT HEART AND VASCULAR INSTITUTE 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
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# HHSN268201100025C Quarterly Report – 2013 Q3
01/13/2013 Exhibit 3: Patient Demographics by Implant Period Exhi bit 3: Pati ent D emographics by Implant Period The following tables present demographic characteristics for patients at the time of their primary implant (June 23, 2006 to September 30, 2013).
Gender
GENDER IMPLANT DATE PERIOD
TOTAL < 2010 2010 - 2011 2012 - 2013 (Jan-Sep) n % n % n % n %
01/13/2013 Exhibit 6: Patient Profile at Time of Implant by Implant Period Exhi bit 6: Pati ent Pr ofile at Ti me of Impl ant by Implant Period Patient profile status provides a general clinical description of the patients at the time of implantation.
PATIENT PROFILE AT TIME OF IMPLANT
IMPLANT DATE PERIOD TOTAL < 2010 2010 - 2011 2012 - 2013 (Jan-Sep)
1 Critical cardiogenic shock describes a patient who is 'crashing and burning', in which a patient has life-threatening hypotension and rapdily escalating inotropic pressor support. 2 Progressive decline describes a patient who has been demonstrated 'dependent' on inotropic support but nonetheless shows signs of continuing deterioration. 3 Stable but inotrope dependent: describes a patient who is clinically stable on mild-moderate doses of intravenous inotropes. 4 Resting symptoms describes a patient who is at home on oral therapy but frequently has symptoms of congestion at rest or with ADL. 5 Exertion Intolerant describes a patient who is comfortable at rest but unable to engage in any activity, living predominantly within the house or household. 6 Exertion Limited also describes a patient who is comfortable at rest without evidence of fluid 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 level of comfortable activity, despite history of previous decompensation that is not recent.
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# HHSN268201100025C Quarterly Report – 2013 Q3
01/13/2013 Exhibit 7: Device Strategy at Time of Implant by Implant Period Exhi bit 7: Device Str ategy at Ti me of Implant by Implant Period Device strategy is determined in conjunction with the heart failure cardiologist and surgeon at the time of the implant.
DEVICE STRATEGY AT TIME OF IMPLANT
IMPLANT DATE PERIOD TOTAL < 2010 2010 - 2011 2012 - 2013 (Jan-Sep)
1. Bridge to Transplant (BTT) Listed - patient already listed for transplant or listed within 24 hours before device implantation. 2. Bridge to Transplant (BTT) Likely - patient in whom the transplant evaluation has not been completed, but no contra-indications are anticipated, or in whom a current contra-indication is anticipated to resolve rapidly. 3. Bridge to Transplant (BTT) Moderate - patient in whom the transplant evaluation has not been completed, but with some potential concerns that might prevent eligibility. 4. Bridge to Transplant (BTT) Unlikely - patient in whom major concerns that might prevent eligibility 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 cardiac failure (at least 3 months in duration). 7. Rescue Therapy - use of a durable device to support resolution from an acute event without major previous cardiac dysfunction. 8. Other.
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# HHSN268201100025C Quarterly Report – 2013 Q3
01/13/2013
Exhibit 8: Patient Profile by Device Strategy at Time of Implant Exhi bit 8: Pati ent Pr ofile by D evice Strateg y at Ti me of Impl ant The following tables present patient profile status by the device strategy for different time periods.
01/13/2013 Exhibit 9: Patient Status by Device Strategy at Implant Exhi bit 9: Pati ent Status by D evice Strateg y at Impl ant The following tables present patient status as of September 30, 2013 by the device strategy for 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-up period • Dead: patients who died during this follow-up period
Overall
PRE-IMPLANT DEVICE STRATEGY
Patient Status (September 30, 2013)
TOTAL
1. Alive (device in
place) 2. Transplant 3. Recovery 4. Dead N N N N N
01/13/2013 Exhibit 12: Kaplan-Meier Survival by Flow Type and Device Exhi bit 12: Kapl an-M eier Sur vi val by Fl ow Type and D evice
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# HHSN268201100025C Quarterly Report – 2013 Q3
01/13/2013
Exhibit 13: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Implant Era Exhi bit 13: Kapl an-M eier Sur vi val for C ontinuous Flow LVADs ( with or wi thout R VAD implant at ti me of LVAD oper ati on) by Impl ant Era
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# HHSN268201100025C Quarterly Report – 2013 Q3
01/13/2013
Exhibit 14: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Pre-Implant Device Strategy Exhi bit 14: Kapl an-M eier Sur vi val for C ontinuous Flow LVADs ( with or wi thout R VAD implant at ti me of LVAD oper ati on) by Pre-Impl ant Devi ce Str ateg y Bridge to Transplant (BTT) includes: BTT-listed, BTT-likely, BTT-moderately likely, and BTT-unlikely.
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# HHSN268201100025C Quarterly Report – 2013 Q3
01/13/2013 Exhibit 15: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Pre-Implant Patient Profile Exhi bit 15: Kapl an-M eier Sur vi val for C ontinuous Flow LVADs ( with or wi thout R VAD implant at ti me of LVAD oper ati on) by Pre-Impl ant Pati ent Profil e
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# HHSN268201100025C Quarterly Report – 2013 Q3
01/13/2013
Exhibit 16: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Device Type Exhi bit 16: Kapl an-M eier Sur vi val for C ontinuous Flow LVADs ( with or wi thout R VAD implant at ti me of LVAD oper ati on) by D evice Type
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# HHSN268201100025C Quarterly Report – 2013 Q3
01/13/2013 Exhibit 17: Competing Outcomes for Continuous Flow LVADs (without RVAD implant at time of LVAD operation) Exhi bit 17: C ompeti ng Outcomes for C ontinuous Flow LVAD s ( without R VAD i mpl ant at time of LVAD operati on)
Number of Patients at Risk
Month 0 1 3 6 9 12 24 36 48
8423 7875 6897 5544 4441 3613 1561 582 134
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# HHSN268201100025C Quarterly Report – 2013 Q3
01/13/2013
Exhibit 18: Competing Outcomes for Continuous Flow LVADs (with RVAD implant at time of LVAD operation) Exhi bit 18: C ompeti ng Outcomes for C ontinuous Flow LVAD s ( with RVAD i mplant at ti me of LVAD operation)
Number of Patients at Risk
Month 0 1 3 6 9 12 24 36 48
221 168 132 106 92 79 46 30 15
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# HHSN268201100025C Quarterly Report – 2013 Q3
01/13/2013
Exhibit 19: Adverse Event Rates for Patients Receiving a Primary Prospective Implant - Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) Exhi bit 19: Adverse Event Rates for Pati ents R ecei ving a Primar y Prospecti ve Implant - Conti nuous Fl ow LVADs ( with or without RVAD i mplant at ti me of LVAD operation) The following table summarizes adverse events in patients receiving primary prospective implants between June 23, 2006 and September 30, 2013. Event count is the number of episodes observed for each event type allowing multiple episodes per patient. Patient count is the number of patients experiencing at least one episode of a particular event type. Patient percentage is the percent of patients experiencing a specific event type. Early and late event counts are the number of episodes observed either within three months post-implant or after three months post-implant, respectively. Event rates are calculated by dividing the number of episodes observed for each event type during a period by the total amount of follow-up time the patients were observed during the period. The total follow-up time for the early period was 23253.17 patient months and the total follow-up time for the late period was 91736.73 patient months. All rates are reported in episodes per 100 patient months.
Exhibit 20: Follow-up Compliance Exhi bit 20: F ollow- up Compliance Site compliance is determined by the percentage of all follow-up forms that are due during this reporting period that have been completed. This calculation has been updated to include ALL follow-up forms expected for ALL patients and ALL devices. Only sites that have at least 10 follow-up forms expected are included in this figure. INTERMACS has defined required compliance as 90%.