Intermacs. Quarterly Statistical Report. Interagency Registry for Mechanically Assisted Circulatory Support

Transcription

1 1 Alfred M Intermacs Interagency Registry for Mechanically Assisted Circulatory Support Quarterly Statistical Report 2016 Q2 Implant and event dates: June 23, 2006 to June 30, /26/2016 Prepared by: The Data and Clinical Coordinating Center University of Alabama at Birmingham For questions or comments contact: James K. Kirklin, MD Ryan S. Cantor, MSPH Susan L. Myers Mary Lynne Clark Craig Collum, MPH Kathryn Hollifield, RN Maceo Cleggett # HHSN C

2 2 Intermacs Quarterly Report Implants: June 23, 2006 to June 30, 2016 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 adult patients receiving primary prospective implants between June 23, 2006 and June 30, 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 Table of Contents 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)

3 3 Exhibit 1: Hospital Activation and Patient Enrollment Between June 23, 2006 and June 30, 2016, 166 hospitals participated in Intermacs and, of these, 161 hospitals actively contributed information on a total of patients. Cumulative patient accrual and the number of participating hospitals over this time period are displayed below.

4 4 Exhibit 2: Participating Hospital Listing As of June 30, 2016 there were 166 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 ST. LUKE'S MEDICAL CENTER HOUSTON TX BAYLOR UNIVERSITY MEDICAL CENTER DALLAS TX 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 HOSPITAL OF WISCONSIN MILWAUKEE WI CHILDREN'S NATIONAL MEDICAL CENTER WASHINGTON DC CHRISTIANA CARE HEALTH SYSTEM NEWARK DE CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER CINCINNATI OH CLEVELAND CLINIC CLEVELAND OH CLEVELAND CLINIC FLORIDA WESTON FL 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 DELRAY MEDICAL CENTER DELRAY FL 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 HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA PHILADELPHIA PA HOUSTON METHODIST HOSPITAL HOUSTON TX INLAND NORTHWEST THORACIC ORGAN TRANSPLANT PROGRAM - SACRED HEART MEDICAL CENTER SPOKANE WA

5 5 Exhibit 2: Participating Hospital Listing HOSPITAL NAME CITY STATE 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 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 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 GENERAL SACRAMENTO CA MERCY HEALTH SPRINGFIELD MO METHODIST HOSPITAL INDIANAPOLIS IN METHODIST SPECIALTY AND TRANSPLANT HOSPITAL SAN ANTONIO TX MID AMERICA HEART INSTITUTE OF SAINT LUKE'S 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 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 PEACEHEALTH / ST. JOSEPH'S 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

6 6 Exhibit 2: Participating Hospital Listing HOSPITAL NAME CITY STATE ROBERT WOOD JOHNSON UNIVERSITY HOSPITAL NEW BRUNSWICK NJ 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 HEALTHCARE SYSTEM HOLLYWOOD FL SPECTRUM HEALTH HOSPITALS GRAND RAPIDS MI ST MARY'S HOSPITAL RICHMOND VA ST. BONIFACE WINNIPEG MB ST. LOUIS CHILDREN'S HOSPITAL ST. LOUIS MO ST. LUKE'S BETHLEHEM PA ST. LUKE'S MEDICAL CENTER MILWAUKEE WI ST. PAUL'S HOSPITAL VANCOUVER BC ST. PETERS HOSPITAL ALBANY NY 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 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 HOSPITAL 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 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

7 7 Exhibit 2: Participating Hospital Listing HOSPITAL NAME CITY STATE 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 PITTSBURGH 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 VASCULAR INSTITUTE NASHVILLE 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 TN

8 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 June 30, 2016). Gender GENDER IMPLANT DATE PERIOD < (Jan-Jun) TOTAL n % n % n % n % Female % % % % Male % % % % Unspecified % % TOTAL % % % % Race RACE IMPLANT DATE PERIOD < (Jan-Jun) TOTAL n % n % n % n % African American % % % % Other, Unknown, Undisclosed % % % % White % % % % TOTAL % % % % Age Group AGE GROUP (yr) IMPLANT DATE PERIOD < (Jan-Jun) TOTAL n % n % n % n % % % % % % % % % % % % % % % % TOTAL % % % %

9 9 Exhibit 4: Implants by Year by Device Strategy Implants by Device Strategy and Implant Date Period IMPLANT YEAR IMPLANT DATE PERIOD < (Jan-Jun) TOTAL n % n % n % n % BTT - Listed % % % % BTT - Likely % % % % BTT - Moderate % % % % BTT - Unlikely % % % % Destination Therapy % % % % Bridge to Recovery % % % % Rescue Therapy % % % % Other % % % TOTAL % % % %

10 10 Exhibit 5: Implants per Year by Device Type Implants by Device Type and Implant Date Period DEVICE TYPE IMPLANT DATE PERIOD < (Jan-Jun) TOTAL n % n % n % n % LVAD % % % % RVAD % % % % BiVAD % % % % TAH % % % % TOTAL % % % %

11 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 < (Jan-Jun) TOTAL n % n % n % n % 1 Critical Cardiogenic Shock % % % % 2 Progressive Decline % % % % 3 Stable but Inotrope Dependent % % % % 4 Resting Symptoms % % % % 5 Exertion Intolerant % % % % 6 Exertion Limited % % % % 7 Advanced NYHA Class % % % % Unspecified % % TOTAL % % % % 1 Critical cardiogenic shock describes a patient who is 'crashing and burning', in which a patient has life-threatening hypotension and rapidily 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 describe 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.

12 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 < (Jan-Jun) TOTAL n % n % n % n % BTT - Listed % % % % BTT - Likely % % % % BTT - Moderate % % % % BTT - Unlikely % % % % Destination Therapy % % % % Bridge to Recovery % % % % Rescue Therapy % % % % 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.

13 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 Pre-Implant Device Strategy BTT - Listed BTT - Likely BTT - Moderate BTT - Unlikely Destination Therapy 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 % % % % % PATIENT PROFILE STATUS OVERALL Pre-Implant Device Strategy Bridge to Recovery Rescue Therapy Other 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 % % % %

14 14 Exhibit 8: Patient Profile by Device Strategy at Time of Implant - by Era IMPLANT DATE PERIOD=< 2010 PATIENT PROFILE STATUS OVERALL Pre-Implant Device Strategy BTT - Listed BTT - Likely BTT - Moderate BTT - Unlikely n % n % n % n % 1 Critical Cardio Shock % % % % 2 Progressive Decline % % % % 3 Stable but Inotrope dependent % % % % 4 Resting Symptoms % % % % 5 Exertion intolerant % % % Exertion limited % % % % 7 Advanced NYHA Class % % % TOTAL % % % % PATIENT PROFILE STATUS OVERALL Destination Therapy Pre-Implant Device Strategy Bridge to Recovery Rescue Therapy 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 % % % %

15 IMPLANT DATE PERIOD= Intermacs Quarterly Report Q2 Implants: June 23, 2006 to June 30, 2016 Exhibit 8: Patient Profile by Device Strategy at Time of Implant - by Era IMPLANT DATE PERIOD= PATIENT PROFILE STATUS OVERALL Pre-Implant Device Strategy BTT - Listed BTT - Likely BTT - Moderate BTT - Unlikely Destination Therapy 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 % % % % % PATIENT PROFILE STATUS OVERALL Pre-Implant Device Strategy Bridge to Recovery Rescue Therapy Other 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 % % % %

16 IMPLANT DATE PERIOD= (Jan-Jun) 16 Intermacs Quarterly Report Q2 Implants: June 23, 2006 to June 30, 2016 Exhibit 8: Patient Profile by Device Strategy at Time of Implant - by Era IMPLANT DATE PERIOD= (Jan-Jun) PATIENT PROFILE STATUS OVERALL Pre-Implant Device Strategy BTT - Listed BTT - Likely BTT - Moderate BTT - Unlikely Destination Therapy 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 % % % % % PATIENT PROFILE STATUS OVERALL Pre-Implant Device Strategy Bridge to Recovery Rescue Therapy Other 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 % % % %

17 17 Exhibit 9: Patient Status by Device Strategy at Implant The following tables present patient status as of June 30, 2016 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 (June 30, 2016) 1. Alive (device in place) 2. Transplant 3. Recovery 4. Dead TOTAL N N N N N BTT - Listed BTT - Likely BTT - Moderate BTT - Unlikely Destination Therapy Bridge to Recovery Rescue Therapy Other TOTAL

18 18 PRE-IMPLANT DEVICE STRATEGY IMPLANT DATE PERIOD=< 2010 Patient Status (June 30, 2016) 1. Alive (device in place) 2. Transplant 3. Recovery 4. Dead TOTAL N N N N N BTT - Listed BTT - Likely BTT - Moderate BTT - Unlikely Destination Therapy Bridge to Recovery Rescue Therapy TOTAL IMPLANT DATE PERIOD= PRE-IMPLANT DEVICE STRATEGY Patient Status (June 30, 2016) 1. Alive (device in place) 2. Transplant 3. Recovery 4. Dead TOTAL N N N N N BTT - Listed BTT - Likely BTT - Moderate BTT - Unlikely Destination Therapy Bridge to Recovery Rescue Therapy Other TOTAL IMPLANT DATE PERIOD= (Jan-Jun) PRE-IMPLANT DEVICE STRATEGY Patient Status (June 30, 2016) 1. Alive (device in place) 2. Transplant 3. Recovery 4. Dead TOTAL N N N N N BTT - Listed BTT - Likely BTT - Moderate BTT - Unlikely Destination Therapy Bridge to Recovery Rescue Therapy Other TOTAL

19 19 Exhibit 10: Primary Cause of Death PRIMARY CAUSE OF DEATH IMPLANT DATE PERIOD < (Jan-Jun) 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 % % % % Hematological % % % Major Infection % % % % Multisystem Organ Failure (MSOF) % % % % Nervous System: Neurological Dysfunction % % % % Other, specify % % % % Other: Cancer % % % % Other: Trauma/accident, specify % % % % Psychiatric Episode/Suicide % % % % Respiratory: Pulmonary: Other, specify % % % % Respiratory: Respiratory Failure % % % % Respiratory: Venous Thromboembolism Event % % % % Withdrawal of Support, specify % % % % ~Cardiovascular, Other~ % % % TOTAL % % % % Note: 12 patients have a missing primary cause of death. * Certain pre-relaunch categories are no longer supported as of the v3.0 Launch (May 2012).

20 20 Exhibit 11: Kaplan-Meier Survival for Intermacs Overall Percent Survival [% (70% CI)] Months after Device Implant Intermacs Overall % (93.9%-94.3%) % (89.0%-89.5%) % (84.9%-85.5%) % (78.7%-79.4%) % (67.5%-68.4%) % (57.0%-58.1%) % (47.3%-48.6%)

21 21 Exhibit 12. Kaplan-Meier Survival by Device Sequence The following figure compares survival time on specific devices based on device sequence for all of Intermacs. Each curve represents survival from the time the device was implanted until death. Patients are censored at time of transplant, explant for any reason, or the device was turned off. Percent Survival [% (70% CI)] Months after Device Implant 1st Device 2nd Device 3rd Device % (94.5%-94.9%) 88.0% (87.2%-88.7%) 84.9% (82.6%-86.9%) % (90.0%-90.5%) 81.6% (80.7%-82.5%) 76.2% (73.4%-78.7%) % (86.3%-86.8%) 75.5% (74.5%-76.5%) 66.2% (63.0%-69.2%) % (80.5%-81.2%) 66.5% (65.2%-67.7%) 55.6% (52.0%-59.0%) % (70.1%-71.0%) 54.9% (53.3%-56.4%) 43.3% (39.0%-47.4%)

22 22 Exhibit 13: Kaplan-Meier Survival by Flow Type and Device Percent Survival [% (70% CI)] Months after Device Implant Continuous - LVAD Continuous - BiVAD Pulsatile - LVAD Pulsatile - BiVAD Pulsatile - TAH % (95.1%-95.5%) 78.0% (76.2%-79.7%) 91.7% (90.5%-92.7%) 79.9% (77.6%-81.9%) 86.4% (84.5%-88.1%) % (90.8%-91.2%) 67.6% (65.5%-69.6%) 82.9% (81.3%-84.4%) 69.7% (67.0%-72.2%) 73.0% (70.4%-75.3%) % (87.0%-87.5%) 61.4% (59.2%-63.5%) 75.2% (73.2%-77.0%) 60.0% (56.8%-63.1%) 64.2% (61.1%-67.1%) % (81.0%-81.7%) 54.6% (52.3%-56.8%) 64.4% (62.0%-66.7%) 47.0% (42.7%-51.2%) 55.2% (51.4%-58.8%) % (69.8%-70.7%) 48.7% (46.2%-51.1%) 42.3% (39.3%-45.3%) 31.2% (25.5%-37.1%) 39.7% (32.7%-46.7%) % (58.9%-60.0%) 39.5% (36.6%-42.4%) 37.7% (34.6%-40.7%) 27.3% (21.3%-33.7%) 39.7% (32.7%-46.7%) % (48.7%-50.1%) 36.5% (33.4%-39.6%) 31.9% (28.8%-35.1%) 22.8% (16.5%-29.7%) 19.9% (7.9%-35.7%)

23 23 Exhibit 14: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Implant Era Percent Survival [% (70% CI)] Months after Device Implant < (Jan-Jun) % (93.6%-94.8%) 95.0% (94.6%-95.4%) 94.7% (94.4%-94.9%) % (89.4%-91.0%) 90.3% (89.8%-90.8%) 90.2% (89.9%-90.5%) % (86.2%-88.1%) 85.9% (85.3%-86.5%) 86.5% (86.1%-86.8%) % (80.7%-83.0%) 79.1% (78.4%-79.8%) 80.7% (80.3%-81.1%) % (70.1%-73.3%) 67.4% (66.5%-68.3%) 70.1% (69.5%-70.6%) % (56.3%-60.3%) 56.3% (55.3%-57.3%) 60.1% (59.4%-60.9%) % (42.7%-47.1%) 46.5% (45.4%-47.6%) 51.8% (50.7%-52.9%)

24 24 Exhibit 15: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Pre-Implant Device Strategy Percent Survival [% (70% CI)] Months after Device Implant Bridge to Transplant Bridge to Candidacy Destination Therapy % (95.5%-96.1%) 95.5% (95.2%-95.8%) 93.4% (93.1%-93.7%) % (92.1%-92.9%) 91.3% (90.9%-91.7%) 88.0% (87.6%-88.4%) % (89.4%-90.4%) 87.7% (87.2%-88.2%) 83.3% (82.8%-83.8%) % (84.1%-85.3%) 82.5% (82.0%-83.1%) 76.5% (76.0%-77.1%) % (76.1%-77.9%) 72.0% (71.2%-72.8%) 64.2% (63.5%-64.9%) % (65.3%-67.9%) 61.7% (60.7%-62.7%) 53.2% (52.4%-54.0%) % (52.8%-56.5%) 51.6% (50.3%-52.8%) 44.3% (43.4%-45.3%)

25 25 Exhibit 16: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Pre-Implant Patient Profile Percent Survival [% (70% CI)] Months after Device Implant Level 1 - Critical Cardiogenic Level 2 - Progressive Decline Level 3 - Stable but Inotrope Level 4 - Resting Symptoms Levels 5,6,7 - All Others % (89.6%-90.8%) 94.4% (94.1%-94.7%) 96.4% (96.1%-96.6%) 96.0% (95.6%-96.4%) 96.5% (95.6%-97.1%) % (83.0%-84.5%) 89.5% (89.1%-89.9%) 92.7% (92.3%-93.1%) 92.5% (92.0%-93.1%) 93.3% (92.2%-94.3%) % (79.0%-80.7%) 85.2% (84.8%-85.7%) 89.4% (89.0%-89.9%) 88.6% (87.9%-89.3%) 90.0% (88.7%-91.2%) % (73.2%-75.1%) 79.2% (78.7%-79.8%) 83.4% (82.8%-84.0%) 82.9% (82.1%-83.8%) 84.0% (82.3%-85.5%) % (63.1%-65.5%) 68.2% (67.4%-68.9%) 72.0% (71.2%-72.8%) 71.8% (70.6%-73.0%) 74.7% (72.5%-76.7%) % (54.2%-57.2%) 56.5% (55.5%-57.5%) 60.8% (59.7%-61.8%) 60.9% (59.4%-62.4%) 67.2% (64.6%-69.6%) % (44.2%-47.9%) 46.9% (45.7%-48.0%) 51.3% (50.0%-52.6%) 51.4% (49.6%-53.3%) 53.4% (50.2%-56.4%)

26 26 Exhibit 17: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Device Type Percent Survival [% (70% CI)] Months after Device Implant LVAD BiVAD % (95.1%-95.5%) 78.0% (76.2%-79.7%) % (90.8%-91.2%) 67.6% (65.5%-69.6%) % (87.0%-87.5%) 61.4% (59.2%-63.5%) % (81.0%-81.7%) 54.6% (52.3%-56.8%) % (69.8%-70.7%) 48.7% (46.2%-51.1%) % (58.9%-60.0%) 39.5% (36.6%-42.4%) % (48.7%-50.1%) 36.5% (33.4%-39.6%)

27 27 Exhibit 18: Competing Outcomes for Continuous Flow LVADs (without RVAD implant at time of LVAD operation) Number of Patients at Risk Month

28 28 Exhibit 19: Competing Outcomes for Continuous Flow LVADs (with RVAD implant at time of LVAD operation) Number of Patients at Risk Month

29 29 Exhibit 20: Competing Outcomes for TAHs Number of Patients at Risk Month

30 30 Exhibit 21: 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 June 30, 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. Adverse Event Type Early Event Count (n) Early Patient Count (n) Early Patient Percent (%) Early Event Rate (per 100 pt m) Late Event Count (n) Late Patient Count (n) Early Patient Percent (%) Late Event Rate (per 100 pt m) Arterial Non-CNS Thromboembolism % % 0.03 Bleeding % % 3.31 Cardiac Arrhythmia % % 1.11 Device Malfunction % % 1.43 Hepatic Dysfunction % % 0.18 Infection % % 4.03 Myocardial Infarction % % 0.03 Neurological Dysfunction % % 1.21 Other Serious Adverse Event % % 1.85 Pericardial Drainage % % 0.01 Psychiatric Episode % % 0.28 Rehospitalization % % Renal Dysfunction % % 0.44 Respiratory Failure % % 0.48 Venous Thromboembolism % % 0.06 Wound Dehiscence % % 0.03

31 31 Exhibit 22: Infection Rates by Location - Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) Adverse Event Type Early Event Count (n) Early Patient Count (n) Early Patient Percent (%) Early Event Rate (per 100 pt m) Late Event Count (n) Late Patient Count (n) Early Patient Percent (%) Late Event Rate (per 100 pt m) GI % % 0.21 Line Sepsis % % 0.10 Mediastinum % % 0.06 Other Specify % % 0.53 Peripheral Wound % % 0.10 Positive Blood Cultures % % 1.06 Pulmonary % % 0.50 Pump/Related - Drive Line % % 1.43 Pump/Related - Exit Cannula % % 0.03 Pump/Related - Pump Interior % % 0.03 Pump/Related - Pump Pocket % % 0.16 Unknown % % 0.08 Urinary Tract % % 0.57

32 32 Exhibit 23: Follow-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%.

33 33 Glossary BiVAD: BiVentricular Assist Device BMI: Body Mass Index BP: Blood Pressure BSA: Body Surface Area BTC: Bridge to Candidacy BTT: Bridge to Transplant BUN: Blood Urea Nitrogen CMS: Centers for Medicare and Medicaid COPD: Chronic Obstructive Pulmonary Disease CNS: Central Nervous System CRP: C - Reactive Protein CVA: Cerebrovascular Accident DCC: Data Coordinating Center DT: Destination Therapy ECMO: Extracorporeal-membrane Oxygenation EQ-5D: Euro Quality of Life FDA: Federal Drug Administration HF: Heart Failure IABP: Intra-Aortic Balloon Pump IgG: Immunoglobulin G INR: International Normalized Ratio Intermacs: Interagency Registry for Mechanically Assisted Circulatory Support LVAD: Left Ventricular Assist Device LVEF: Left Ventricular Ejection Fraction LVEDD: Left Ventricular End Diastolic Dysfunction LVSF: Left Ventricular Shortening Fraction MCSD: Mechanically Circulatory Support Device NHLBI: National Heart Lung and Blood Institute NIH: National Institute of Health NT pro brain natriuretic peptide: N-Terminal pro brain Natriuretic peptide NYHA: New York Heart Association OR: Operating Room Regurg: Regurgitation RVAD: Right Ventricular Assist Device RVEF: Right Ventricular Ejection Fraction SAE: Serious Adverse Event SGOT-AST: Serum Glutamic Oxaloacetic Transaminase SGPT-ALT: Serum Glutamic Pyruvic Transaminase TAH: Total Artificial Heart TIA: Transient Ischemic Attack VAD: Ventricular Assist Device VAS: Visual Analog Scale