INTERMACS Interagency Registry for Mechanically Assisted Circulatory Support

Transcription

1 INTERMACS Interagency Registry for Mechanically Assisted Circulatory Support Quarterly Statistical Report th Quarter Implant and event dates: June 23, 2006 to December 31, 2012 Prepared by: The Data Collection and Analysis Center University of Alabama at Birmingham For questions or comments contact: James K. Kirklin, MD at David C. Naftel, Ph.D at Susan L. Myers at Mary Lynne Clark at Stephen Craig Collum at Kathryn Hollifield at Ryan S. Cantor at Page 1 of 27

2 INTERMACS Quarterly Report Implants: June 23, 2006 to December 31, 2012 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 TM 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 7914 patients receiving primary prospective implants between June 23, 2006 and December 31, Table of Contents Exhibit 1: Hospital Activation and Patient Enrollment... 3 Exhibit 2: Participating Hospital Listing... 4 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 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 (with or without RVAD implant at time of LVAD operation) by Implant Era Exhibit 14: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Pre-Implant Device Strategy Exhibit 15: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Pre-Implant Patient Profile Exhibit 16: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) 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: Adverse Event Rates for Patients Receiving a Primary Prospective Implant - Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) Exhibit 20: Compliance Page 2 of 27

3 Exhibit 1: Hospital Activation and Patient Enrollment Between June 23, 2006 and December 31, 2012, 148 hospitals participated in INTERMACS and, of these, 138 hospitals actively contributed information on a total of 7914 patients. Cumulative patient accrual and the number of participating hospitals over this time period are displayed below. Page 3 of 27

4 Exhibit 2: Participating Hospital Listing As of December 31, 2012 there were 148 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 MEDICAL CENTER DALLAS TX CHRISTIANA CARE HEALTH SYSTEM NEWARK DE CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER CINCINNATI OH CLEVELAND CLINIC CLEVELAND OH COLUMBIA PRESBYTERIAN - CHILDREN'S HOSPITAL OF NEW YORK NEW YORK NY COLUMBIA UNIVERSITY MEDICAL CENTER-NY PRESBYTERIAN NEW YORK NY 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 Page 4 of 27 SPOKANE INOVA FAIRFAX HOSPITAL FALLS CHURCH VA 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 WA

5 Page 5 of 27 Hospital Name CITY STATE KAISER SUNNYSIDE MEDICAL CENTER CLACKAMAS OR 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 CHARLESTON SC MEDICAL UNIVERSITY OF SOUTH CAROLINA MEDICAL CENTER CHARLESTON SC MEMORIAL HERMANN TEXAS MEDICAL CENTER HOUSTON TX METHODIST HOSPITAL INDIANPOLIS 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 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 OSF ST FRANCIS MEDICAL CENTER PEORIA IL 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 ST MARY'S HOSPITAL RICHMOND VA ST PAUL'S HOSPITAL VANCOUVER BC

6 Page 6 of 27 Hospital Name CITY STATE 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 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 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 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 USC UNIVERSITY HOSPITAL LOS ANGELES CA UT SOUTHWESTERN MEDICAL CENTER DALLAS TX VANDERBILT UNIVERSITY MEDICAL CENTER - VANDERBILT HEART AND VASCULAR INSTITUTE NASHVILLE TN VIRGINIA COMMONWEALTH UNIVERSITY HEALTH SYSTEM RICHMOND VA

7 Hospital Name CITY STATE WASHINGTON HOSPITAL CENTER WASHINGTON DC WEILL CORNELL MEDICAL CENTER/NEW YORK PRESBYTERIAN MEDICAL CENTER NEW YORK NY WESTCHESTER MEDICAL CENTER VALHALLA NY YALE-NEW HAVEN HOSPITAL NEW HAVEN CT Page 7 of 27

8 Exhibit 3: Patient Demographics by Implant Period The following tables present demographic characteristics for patients at the time of their primary implant (June 23, 2006 to December 31, 2012). Gender IMPLANT DATE PERIOD GENDER < TOTAL n % n % n % n % Female % % % % Male % % % % Unspecified % % TOTAL % % % % RACE Race IMPLANT DATE PERIOD < TOTAL n % n % n % n % African American % % % % Other, Unknown, Undisclosed % % % % White % % % % TOTAL % % % % Age Category IMPLANT DATE PERIOD AGE GROUP (yr) < TOTAL n % n % n % n % % % % % % % % % % % % % % % % % % % % Unspecified % % TOTAL % % % % Page 8 of 27

9 Exhibit 4: Implants by Year by Device Strategy Page 9 of 27

10 Exhibit 5: Implants per Year by Device Type Number of Implants by Device Type and Implant Date Period IMPLANT DATE PERIOD DEVICE TYPE < TOTAL n % n % n % n % LVAD % % % % BiVAD % % % % TAH % % % % TOTAL % % % % Page 10 of 27

11 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 of implantation. PATIENT PROFILE AT TIME OF IMPLANT IMPLANT DATE PERIOD < TOTAL n % n % n % n % 1 Critical Cardio Shock % % % % 2 Progressive Decline % % % % 3 Stable but Inotrope dependent % % % % 4 Resting Symptoms % % % % 5 Exertion intolerant % % % % 6 Exertion limited % % % % 7 Advanced NYHA Class % % % % TOTAL % % % % 1 Critical cardiogenic shock describes a patient who is 'crashing and burning', in which a patient has life-threatening hypotension and rapidly 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. Page 11 of 27

12 Exhibit 7: Device Strategy at Time 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 n % n % n % n % 1. BTT Listed % % % % 2. BTT Likely % % % % 3. BTT Moderate % % % % 4. BTT Unlikely % % % % 5. Destination Therapy % % % % 6. BTR % % % % 7. Rescue Therapy % % % % 8. Other % % % % TOTAL % % % % 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. Page 12 of 27

13 Exhibit 8: Patient Profile by Device Strategy at Time of Implant The following tables present patient profile status by the device strategy for different time periods. PATIENT PROFILE STATUS OVERALL 1. BTT Listed 2. BTT Likely 3. BTT Moderate Overall Pre-Implant Device Strategy 4. BTT Unlikely 5. Destination Therapy 6. BTR 7. Rescue Therapy 8. Other TOTAL n % n % n % n % n % n % n % n % n % 1 Critical Cardio Shock % % % % % % % % % 2 Progressive Decline % % % % % % % % % 3 Stable but Inotrope dependent % % % % % % % % % 4 Resting Symptoms % % % % % % % % 5 Exertion intolerant % % % % % % % 6 Exertion limited % % % % % % % 7 Advanced NYHA Class % % % % % % TOTAL % % % % % % % % % IMPLANT DATE PERIOD=< 2010 Pre-Implant Device Strategy PATIENT PROFILE STATUS OVERALL 1. BTT Listed 2. BTT Likely 3. BTT Moderate 4. BTT Unlikely 5. Destination Therapy 6. BTR 7. Rescue Therapy 8. Other TOTAL n % n % n % n % n % n % n % n % n % 1 Critical Cardio Shock % % % % % % % % % 2 Progressive Decline % % % % % % % % % 3 Stable but Inotrope dependent % % % % % % % % 4 Resting Symptoms % % % % % % % 5 Exertion intolerant % % % % % % 6 Exertion limited % % % % % % 7 Advanced NYHA Class % % % % % TOTAL % % % % % % % % % Page 13 of 27

14 IMPLANT DATE PERIOD= Pre-Implant Device Strategy PATIENT PROFILE STATUS OVERALL 1. BTT Listed 2. BTT Likely 3. BTT Moderate 4. BTT Unlikely 5. Destination Therapy 6. BTR 7. Rescue Therapy 8. Other TOTAL n % n % n % n % n % n % n % n % n % 1 Critical Cardio Shock % % % % % % % % % 2 Progressive Decline % % % % % % % % 3 Stable but Inotrope dependent % % % % % % % % % 4 Resting Symptoms % % % % % % % % 5 Exertion intolerant % % % % % % 6 Exertion limited % % % % % % 7 Advanced NYHA Class % % % % % TOTAL % % % % % % % % % IMPLANT DATE PERIOD=2012 Pre-Implant Device Strategy PATIENT PROFILE STATUS OVERALL 1. BTT Listed 2. BTT Likely 3. BTT Moderate 4. BTT Unlikely 5. Destination Therapy 6. BTR 7. Rescue Therapy 8. Other TOTAL n % n % n % n % n % n % n % n % n % 1 Critical Cardio Shock % % % % % % % % % 2 Progressive Decline % % % % % % % % % 3 Stable but Inotrope dependent % % % % % % % % 4 Resting Symptoms % % % % % % 5 Exertion intolerant % % % % % % 6 Exertion limited % % % % % % % 7 Advanced NYHA Class % % % % TOTAL % % % % % % % % % Page 14 of 27

15 Exhibit 9: Patient Status by Device Strategy at Implant The following tables present patient status as of December 31, 2012 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 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 (December 31, 2012) 1. Alive (device in place) 2. Transplant 3. Recovery 4. Dead TOTAL N N N N N 1. BTT Listed BTT Likely BTT Moderate BTT Unlikely Destination Therapy BTR Rescue Therapy Other TOTAL IMPLANT DATE PERIOD=< 2010 Patient Status (December 31, 2012) 1. Alive PRE-IMPLANT DEVICE (device in STRATEGY place) 2. Transplant 3. Recovery 4. Dead TOTAL N N N N N 1. BTT Listed BTT Likely BTT Moderate BTT Unlikely Destination Therapy BTR Rescue Therapy Other TOTAL Page 15 of 27

16 IMPLANT DATE PERIOD= Patient Status (December 31, 2012) 1. Alive PRE-IMPLANT DEVICE (device in STRATEGY place) 2. Transplant 3. Recovery 4. Dead TOTAL N N N N N 1. BTT Listed BTT Likely BTT Moderate BTT Unlikely Destination Therapy BTR Rescue Therapy Other TOTAL IMPLANT DATE PERIOD=2012 Patient Status (December 31, 2012) 1. Alive PRE-IMPLANT DEVICE (device in STRATEGY place) 2. Transplant 3. Recovery 4. Dead TOTAL N N N N N 1. BTT Listed BTT Likely BTT Moderate BTT Unlikely Destination Therapy BTR Rescue Therapy Other TOTAL Page 16 of 27

17 Exhibit 10: Primary Cause of Death PRIMARY CAUSE OF DEATH IMPLANT DATE PERIOD < TOTAL n % n % n % n % Circulatory: Arterial Non-CNS Thromboembolism % % % Circulatory: CHF % % % % Circulatory: Cardiac Arrhythmia % % % % Circulatory: End Stage Cardiomyopathy % % % % Circulatory: Heart Disease % % % Circulatory: Hemolysis % % % % Circulatory: Ischemic Cardiomyopathy % % % % Circulatory: Major Bleeding % % % % Circulatory: Myocardial Infarction % % % % Circulatory: Myocardial Rupture % % Circulatory: Other, Specify % % % % Circulatory: Pericardial Fluid Collection % % % Circulatory: Right Heart Failure % % % % Circulatory: Ruptured Aortic Aneurysm % % Circulatory: Sudden Unexplained Death % % % % Device Malfunction % % % % Digestive: Fluid/Electrolyte Disorder % % % Digestive: GI Disorder % % % Digestive: Hepatic Dysfunction % % % % Digestive: Pancreatitis % % Digestive: Renal Dysfunction % % % % Major Infection % % % % Multisystem Organ Failure % % % % Nervous System: Neurological Dysfunction % % % % Other (Protocol V2.3)* % % % % Other: Cancer % % % % Other: Trauma/accident, specify % % % % Psychiatric Episode/Suicide % % % Respiratory: Pulmonary: Other, specify % % % % Respiratory: Respiratory Failure % % % % Respiratory: Venous Thromboembolism Event % % % % Unknown (Protocol V2.3)* % % % Withdrawal of Support, specify % % % % TOTAL % % % % Note: 2 patients have a missing primary cause of death. * Certain pre-relaunch categories are no longer supported as of May 2012 Page 17 of 27

18 Exhibit 11: Kaplan-Meier Survival for INTERMACS OVERALL Number of Patients at Risk Month INTERMACS Overall Page 18 of 27

19 Exhibit 12: Kaplan-Meier Survival by Flow Type and Device Number of Patients at Risk Flow Type and Device Month Continuous - LVAD Continuous - BiVAD Pulsatile - LVAD Pulsatile - BiVAD Pulsatile - TAH Page 19 of 27

20 Exhibit 13: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Implant Era Number of Patients at Risk Implant Era Month < Page 20 of 27

21 Exhibit 14: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Pre-Implant Device Strategy Bridge to Transplant (BTT) includes: BTT-listed, BTT-likely, BTT-moderately likely, and BTT-unlikely. Number of Patients at Risk Pre-Implant Device Strategy Month Bridge to Transplant Destination Therapy Page 21 of 27

22 Exhibit 15: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Pre-Implant Patient Profile Number of Patients at Risk Pre-Implant Patient Profile Month Level 1 - Critical Cardiogenic Shock Level 2 - Progressive Decline Level 3 - Stable but Inotrope Dependent Level 4 - Resting Symptoms Levels 5,6,7 - All Others Page 22 of 27

23 Exhibit 16: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Device Type Number of Patients at Risk Implant Month Year LVAD BiVAD Page 23 of 27

24 Exhibit 17: Competing Outcomes for Continuous Flow LVADs (without RVAD implant at time of LVAD operation) Number of Patients at Risk Month Page 24 of 27

25 Exhibit 18: Competing Outcomes for Continuous Flow LVADs (with RVAD implant at time of LVAD operation) Number of Patients at Risk Month Page 25 of 27

26 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) The following table summarizes adverse events in patients receiving primary prospective implants between June 23, 2006 and December 31, 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 patient months and the total follow-up time for the late period was patient months. All rates are reported in episodes per 100 patient months. Event Patient Patient Early Event Early Event Late Event Late Event Count Count Percentage Count Rate Count Rate Adverse Event Type (n=39200) (n=6796) (%) (n) (per 100 pt mo) (n) (per 100 pt mo) Arterial Non-CNS % Thromboembolism Bleeding % Cardiac Arrythmia % Device Malfunction % Hemolysis % Hepatic Dysfunction % Hypertension % Infection % Myocardial Infarction % Neurological Dysfunction % Other Serious Adverse Event % Pericardial Drainage % Psychiatric Episode % Rehospitalization % Renal Dysfunction % Respiratory Failure % Right Heart Failure % Venous Thromboembolism % Wound Dehiscence % Page 26 of 27

27 Exhibit 20: Compliance Site compliance is determined by the percentage of all follow-up forms that are due during this reporting period that have been completed. Follow-up forms for both primary and subsequent devices are included. Only sites that have at least 10 follow-up forms expected are included. INTERMACS has defined required compliance as 90%. Page 27 of 27