Quarterly Statistical Report Centers for Medicare ... · quarterly report – 2013 q1 06/24/2013 ... inova fairfax hospital falls church va integris baptist medical center ... the

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# HHSN268201100025C Quarterly Report – 2013 Q1

06/24/2013

INTERMACS

Interagency Registry for Mechanically Assisted Circulatory Support

Quarterly Statistical Report

Centers for Medicare & Medicaid Services

2013 1st Quarter

Implant and event dates: June 23, 2006 to March 31, 2013

06/24/2013 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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06/24/2013

INTERMACS Quarterly Report Implants: June 23, 2006 to March 31, 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. INTERMACSTM 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 2254 patients 65 years old or older receiving primary prospective implants between June 23, 2006 and March 31, 2013.

Table of Contents

Exhibit 1: Hospital Activation and Patient Enrollment - Patients 65 Years Old and Older ............................................................ 3

Exhibit 2: Participating Hospital Listing ......................................................................................................................................... 4

Exhibit 3: Patient Demographics by Implant Period - Patients 65 Years Old and Older ............................................................... 8

Exhibit 4: Implants by Year by Device Strategy - Patients 65 Years Old and Older ..................................................................... 9

Exhibit 5: Implants per Year by Device Type - Patients 65 Years Old and Older ....................................................................... 10

Exhibit 6: Patient Profile at Time of Implant by Implant Period - Patients 65 Years Old and Older ............................................ 11

Exhibit 7: Device Strategy at Time of Implant by Implant Period - Patients 65 Years Old and Older ......................................... 12

Exhibit 8: Patient Profile by Device Strategy at Time of Implant - Patients 65 Years Old and Older .......................................... 13

Exhibit 9: Patient Status by Device Strategy at Implant - Patients 65 Years Old and Older ....................................................... 15

Exhibit 10: Primary Cause of Death - Patients 65 Years Old and Older ..................................................................................... 17

Exhibit 11: Kaplan-Meier Survival for INTERMACS OVERALL - Patients 65 Years Old and Older ........................................... 18

Exhibit 12: Kaplan-Meier Survival by Flow Type and Device - Patients 65 Years Old and Older ............................................... 19

Exhibit 13: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Implant Era - Patients 65 Years Old and Older .......................................................................................................................... 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 - Patients 65 Years Old and Older ................................................................................................ 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 - Patients 65 Years Old and Older ................................................................................................... 22

Exhibit 16: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Device Type - Patients 65 Years Old and Older ......................................................................................................................... 23

Exhibit 17: Competing Outcomes for Continuous Flow LVADs (without RVAD implant at time of LVAD operation) - Patients 65 Years Old and Older................................................................................................................................................................... 24

Exhibit 18: Competing Outcomes for Continuous Flow LVADs (with RVAD implant at time of LVAD operation) - Patients 65 Years Old and Older ............................................................................................................................................................................. 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) - Patients 65 Years Old and Older ............................................................... 26

Exhibit 20: Compliance ............................................................................................................................................................... 27

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06/24/2013 Exhibit 1: Hospital Activation and Patient Enrollment - Patients 65 Years Old and Older

Between June 23, 2006 and March 31, 2013, 153 hospitals participated in INTERMACS and, of these, 129 hospitals actively contributed information on a total of 2254 patients. Cumulative patient accrual and the number of participating hospitals over this time period are displayed below.

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06/24/2013 Exhibit 2: Participating Hospital Listing

As of March 31, 2013 there were 153 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

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

SPOKANE WA

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

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06/24/2013 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

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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

USC UNIVERSITY HOSPITAL LOS ANGELES CA

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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

YALE-NEW HAVEN HOSPITAL NEW HAVEN CT

YORK HOSPITAL YORK PA

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06/24/2013 Exhibit 3: Patient Demographics by Implant Period - Patients 65 Years Old and Older

The following tables present demographic characteristics for patients at the time of their primary implant (June 23, 2006 to March 31, 2013).

Gender

GENDER

IMPLANT DATE PERIOD

TOTAL < 2010 2010 - 2011 2012 - 2013 (Jan-Mar)

n % n % n % n %

Female 46 14.7 % 153 14.6 % 140 15.5 % 339 15.0 %

Male 266 85.2 % 888 85.3 % 761 84.4 % 1915 84.9 %

TOTAL 312 100.0 % 1041 100.0 % 901 100.0 % 2254 100.0 %

Race

RACE

IMPLANT DATE PERIOD

TOTAL < 2010 2010 - 2011 2012 - 2013 (Jan-Mar)

n % n % n % n %

African American 35 11.2 % 83 7.9 % 84 9.3 % 202 8.9 %

Other, Unknown, Undisclosed 16 5.1 % 65 6.2 % 61 6.7 % 142 6.2 %

White 261 83.6 % 893 85.7 % 756 83.9 % 1910 84.7 %

TOTAL 312 100.0 % 1041 100.0 % 901 100.0 % 2254 100.0 %

Age Category

AGE GROUP (yr)

IMPLANT DATE PERIOD

TOTAL < 2010 2010 - 2011 2012 - 2013 (Jan-Mar)

n % n % n % n %

60-79 312 100.0 % 1019 97.8 % 876 97.2 % 2207 97.9 %

80+ . . 22 2.1 % 25 2.7 % 47 2.0 %

TOTAL 312 100.0 % 1041 100.0 % 901 100.0 % 2254 100.0 %

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06/24/2013 Exhibit 4: Implants by Year by Device Strategy - Patients 65 Years Old and Older

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06/24/2013 Exhibit 5: Implants per Year by Device Type - Patients 65 Years Old and Older

Number of Implants by Device Type and Implant Date Period

DEVICE TYPE

IMPLANT DATE PERIOD

TOTAL < 2010 2010 - 2011 2012 - 2013 (Jan-Mar)

n % n % n % n %

LVAD 277 88.7 % 1015 97.5 % 880 97.6 % 2172 96.3 %

BiVAD 29 9.2 % 26 2.4 % 14 1.5 % 69 3.0 %

TAH 6 1.9 % . . 7 0.7 % 13 0.5 %

TOTAL 312 100.0 % 1041 100.0 % 901 100.0 % 2254 100.0 %

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06/24/2013 Exhibit 6: Patient Profile at Time of Implant by Implant Period - Patients 65 Years Old and

Older

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-Mar)

n % n % n % n %

1 Critical Cardio Shock 75 24.0 % 108 10.3 % 82 9.1 % 265 11.7 %

2 Progressive Decline 144 46.1 % 385 36.9 % 320 35.5 % 849 37.6 %

3 Stable but Inotrope dependent 41 13.1 % 301 28.9 % 275 30.5 % 617 27.3 %

4 Resting Symptoms 36 11.5 % 188 18.0 % 158 17.5 % 382 16.9 %

5 Exertion intolerant 10 3.2 % 36 3.4 % 42 4.6 % 88 3.9 %

6 Exertion limited 3 0.9 % 19 1.8 % 14 1.5 % 36 1.5 %

7 Advanced NYHA Class 3 3 0.9 % 4 0.3 % 10 1.1 % 17 0.7 %

TOTAL 312 100.0 % 1041 100.0 % 901 100.0 % 2254 100.0 %

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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06/24/2013 Exhibit 7: Device Strategy at Time of Implant by Implant Period - Patients 65 Years Old

and Older

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-Mar)

n % n % n % n %

BTT - Listed 116 37.1 % 128 12.2 % 85 9.4 % 329 14.5 %

BTT - Likely 74 23.7 % 91 8.7 % 80 8.8 % 245 10.8 %

BTT - Moderate 44 14.1 % 51 4.8 % 58 6.4 % 153 6.7 %

BTT - Unlikely 20 6.4 % 45 4.3 % 28 3.1 % 93 4.1 %

Destination Therapy 53 16.9 % 716 68.7 % 643 71.3 % 1412 62.6 %

Bridge to Recovery 3 0.9 % 6 0.5 % 2 0.2 % 11 0.4 %

Rescue Therapy 2 0.6 % 2 0.1 % 3 0.3 % 7 0.3 %

Other . . 2 0.1 % 2 0.2 % 4 0.1 %

TOTAL 312 100.0 % 1041 100.0 % 901 100.0 % 2254 100.0 %

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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06/24/2013 Exhibit 8: Patient Profile by Device Strategy at Time of Implant - Patients 65 Years Old and Older

The following tables present patient profile status by the device strategy for different time periods.

Overall

PATIENT PROFILE STATUS OVERALL

Pre-Implant Device Strategy

TOTAL BTT - Listed BTT - Likely BTT - Moderate BTT - Unlikely Destination

Therapy Bridge to Recovery

Rescue Therapy Other

n % n % n % n % n % n % n % n % n %

1 Critical Cardio Shock 54 16.4 % 44 17.9 % 28 18.3 % 17 18.2 % 109 7.7 % 5 45.4 % 7 100.0 % 1 25.0 % 265 11.7 %

2 Progressive Decline 166 50.4 % 87 35.5 % 61 39.8 % 37 39.7 % 493 34.9 % 3 27.2 % 0 0 2 50.0 % 849 37.6 %

3 Stable but Inotrope dependent 63 19.1 % 51 20.8 % 41 26.7 % 23 24.7 % 437 30.9 % 2 18.1 % 0 0 0 0 617 27.3 %

4 Resting Symptoms 34 10.3 % 41 16.7 % 17 11.1 % 12 12.9 % 276 19.5 % 1 9.0 % 0 0 1 25.0 % 382 16.9 %

5 Exertion intolerant 7 2.1 % 13 5.3 % 4 2.6 % 2 2.1 % 62 4.3 % 0 0 0 0 0 0 88 3.9 %

6 Exertion limited 4 1.2 % 7 2.8 % 2 1.3 % 2 2.1 % 21 1.4 % 0 0 0 0 0 0 36 1.5 %

7 Advanced NYHA Class 3 1 0.3 % 2 0.8 % 0 0 0 0 14 0.9 % 0 0 0 0 0 0 17 0.7 %

TOTAL 329 100.0 % 245 100.0 % 153 100.0 % 93 100.0 % 1412 100.0 % 11 100.0 % 7 100.0 % 4 100.0 % 2254 100.0 %

IMPLANT DATE PERIOD=< 2010





Rescue Therapy

n % n % n % n % n % n % n % n %

1 Critical Cardio Shock 24 20.6 % 20 27.0 % 11 25.0 % 8 40.0 % 8 15.0 % 2 66.6 % 2 100.0 % 75 24.0 %

2 Progressive Decline 58 50.0 % 34 45.9 % 19 43.1 % 8 40.0 % 25 47.1 % 0 0 0 0 144 46.1 %

3 Stable but Inotrope dependent 17 14.6 % 4 5.4 % 7 15.9 % 3 15.0 % 9 16.9 % 1 33.3 % 0 0 41 13.1 %

4 Resting Symptoms 11 9.4 % 13 17.5 % 5 11.3 % 1 5.0 % 6 11.3 % 0 0 0 0 36 11.5 %

5 Exertion intolerant 4 3.4 % 2 2.7 % 2 4.5 % 0 0 2 3.7 % 0 0 0 0 10 3.2 %

6 Exertion limited 1 0.8 % 1 1.3 % 0 0 0 0 1 1.8 % 0 0 0 0 3 0.9 %

7 Advanced NYHA Class 3 1 0.8 % 0 0 0 0 0 0 2 3.7 % 0 0 0 0 3 0.9 %

TOTAL 116 100.0 % 74 100.0 % 44 100.0 % 20 100.0 % 53 100.0 % 3 100.0 % 2 100.0 % 312 100.0 %


06/24/2013 IMPLANT DATE PERIOD=2010 - 2011






n % n % n % n % n % n % n % n % n %

1 Critical Cardio Shock 17 13.2 % 14 15.3 % 9 17.6 % 5 11.1 % 59 8.2 % 2 33.3 % 2 100.0 % 0 0 108 10.3 %

2 Progressive Decline 65 50.7 % 21 23.0 % 20 39.2 % 19 42.2 % 256 35.7 % 2 33.3 % 0 0 2 100.0 % 385 36.9 %

3 Stable but Inotrope dependent 29 22.6 % 26 28.5 % 15 29.4 % 12 26.6 % 218 30.4 % 1 16.6 % 0 0 0 0 301 28.9 %

4 Resting Symptoms 13 10.1 % 19 20.8 % 6 11.7 % 7 15.5 % 142 19.8 % 1 16.6 % 0 0 0 0 188 18.0 %

5 Exertion intolerant 2 1.5 % 9 9.8 % 0 0 1 2.2 % 24 3.3 % 0 0 0 0 0 0 36 3.4 %


7 Advanced NYHA Class 3 0 0 0 0 0 0 0 0 4 0.5 % 0 0 0 0 0 0 4 0.3 %

TOTAL 128 100.0 % 91 100.0 % 51 100.0 % 45 100.0 % 716 100.0 % 6 100.0 % 2 100.0 % 2 100.0 % 1041 100.0 %

IMPLANT DATE PERIOD=2012 - 2013 (Jan-Mar)






n % n % n % n % n % n % n % n % n %

1 Critical Cardio Shock 13 15.2 % 10 12.5 % 8 13.7 % 4 14.2 % 42 6.5 % 1 50.0 % 3 100.0 % 1 50.0 % 82 9.1 %

2 Progressive Decline 43 50.5 % 32 40.0 % 22 37.9 % 10 35.7 % 212 32.9 % 1 50.0 % 0 0 0 0 320 35.5 %

3 Stable but Inotrope dependent 17 20.0 % 21 26.2 % 19 32.7 % 8 28.5 % 210 32.6 % 0 0 0 0 0 0 275 30.5 %

4 Resting Symptoms 10 11.7 % 9 11.2 % 6 10.3 % 4 14.2 % 128 19.9 % 0 0 0 0 1 50.0 % 158 17.5 %

5 Exertion intolerant 1 1.1 % 2 2.5 % 2 3.4 % 1 3.5 % 36 5.5 % 0 0 0 0 0 0 42 4.6 %


7 Advanced NYHA Class 3 0 0 2 2.5 % 0 0 0 0 8 1.2 % 0 0 0 0 0 0 10 1.1 %

TOTAL 85 100.0 % 80 100.0 % 58 100.0 % 28 100.0 % 643 100.0 % 2 100.0 % 3 100.0 % 2 100.0 % 901 100.0 %

Page 15 of 27


06/24/2013 Exhibit 9: Patient Status by Device Strategy at Implant - Patients 65 Years Old and

Older

The following tables present patient status as of March 31, 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 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 (March 31, 2013)

TOTAL

1. Alive (device in

place) 2. Transplant 3. Recovery 4. Dead

N N N N N

BTT - Listed 90 159 3 77 329

BTT - Likely 105 82 1 57 245

BTT - Moderate 70 25 0 58 153

BTT - Unlikely 55 2 1 35 93

Destination Therapy 928 39 2 443 1412

Bridge to Recovery 6 1 1 3 11

Rescue Therapy 1 2 1 3 7

Other 2 0 0 2 4

TOTAL 1257 310 9 678 2254

IMPLANT DATE PERIOD=< 2010



TOTAL

1. Alive (device in


N N N N N

BTT - Listed 12 66 1 37 116

BTT - Likely 10 40 0 24 74

BTT - Moderate 4 11 0 29 44





TOTAL 45 122 4 141 312

Page 16 of 27


06/24/2013 IMPLANT DATE PERIOD=2010 - 2011



TOTAL

1. Alive (device in


N N N N N

BTT - Listed 34 61 2 31 128

BTT - Likely 33 33 0 25 91

BTT - Moderate 23 11 0 17 51





Other 0 0 0 2 2

TOTAL 528 132 4 377 1041

IMPLANT DATE PERIOD=2012 - 2013 (Jan-Mar)



TOTAL

1. Alive (device in


N N N N N

BTT - Listed 44 32 0 9 85

BTT - Likely 62 9 1 8 80

BTT - Moderate 43 3 0 12 58





Other 2 0 0 0 2

TOTAL 684 56 1 160 901

Page 17 of 27


06/24/2013 Exhibit 10: Primary Cause of Death - Patients 65 Years Old and Older

PRIMARY CAUSE OF DEATH

IMPLANT DATE PERIOD

TOTAL < 2010 2010 - 2011 2012 - 2013 (Jan-Mar)

n % n % n % n %

Circulatory: Arterial Non-CNS Thromboembolism 3 2.1 % 4 1.0 % 1 0.5 % 8 1.1 %

Circulatory: CHF 6 4.2 % 17 4.3 % 4 2.3 % 27 3.8 %

Circulatory: Cardiac Arrhythmia 2 1.4 % 14 3.5 % 2 1.1 % 18 2.5 %

Circulatory: End Stage Cardiomyopathy 1 0.7 % 7 1.7 % 3 1.7 % 11 1.5 %

Circulatory: Heart Disease . . 3 0.7 % 2 1.1 % 5 0.7 %

Circulatory: Hemolysis . . 2 0.5 % 1 0.5 % 3 0.4 %

Circulatory: Ischemic Cardiomyopathy 1 0.7 % 7 1.7 % 2 1.1 % 10 1.4 %

Circulatory: Major Bleeding 10 7.0 % 17 4.3 % 7 4.0 % 34 4.8 %

Circulatory: Myocardial Infarction 1 0.7 % 4 1.0 % 2 1.1 % 7 0.9 %

Circulatory: Other, Specify 6 4.2 % 7 1.7 % 4 2.3 % 17 2.4 %

Circulatory: Pericardial Fluid Collection 1 0.7 % . . 1 0.5 % 2 0.2 %

Circulatory: Right Heart Failure 6 4.2 % 21 5.3 % 6 3.5 % 33 4.7 %

Circulatory: Sudden Unexplained Death 5 3.5 % 18 4.6 % 4 2.3 % 27 3.8 %

Device Malfunction 5 3.5 % 14 3.5 % 5 2.9 % 24 3.4 %

Digestive: Fluid/Electrolyte Disorder 1 0.7 % 2 0.5 % . . 3 0.4 %

Digestive: GI Disorder . . 1 0.2 % 3 1.7 % 4 0.5 %

Digestive: Hepatic Dysfunction 2 1.4 % 6 1.5 % 1 0.5 % 9 1.2 %

Digestive: Pancreatitis 1 0.7 % . . . . 1 0.1 %

Digestive: Renal Dysfunction 3 2.1 % 8 2.0 % . . 11 1.5 %

Major Infection 21 14.8 % 43 11.0 % 8 4.6 % 72 10.2 %

Multisystem Organ Failure 10 7.0 % 43 11.0 % 36 21.0 % 89 12.6 %

Nervous System: Neurological Dysfunction 29 20.5 % 49 12.5 % 24 14.0 % 102 14.5 %

Other 4 2.8 % 26 6.6 % 11 6.4 % 41 5.8 %

Other: Cancer 1 0.7 % 8 2.0 % 2 1.1 % 11 1.5 %

Other: Trauma/accident, specify . . 2 0.5 % 1 0.5 % 3 0.4 %

Psychiatric Episode/Suicide 1 0.7 % . . 2 1.1 % 3 0.4 %

Respiratory: Pulmonary: Other, specify . . 5 1.2 % 1 0.5 % 6 0.8 %

Respiratory: Respiratory Failure 8 5.6 % 16 4.1 % 16 9.3 % 40 5.7 %

Unknown v2.3 8 5.6 % 15 3.8 % . . 23 3.2 %

Withdrawal of Support, specify 5 3.5 % 30 7.7 % 22 12.8 % 57 8.1 %

TOTAL 141 100.0 % 389 100.0 % 171 100.0 % 701 100.0 %

Note: 3 patients have a missing primary cause of death. * Certain pre-relaunch categories are no longer supported as of the v3.0 Launch (May 2012).

Page 18 of 27


06/24/2013 Exhibit 11: Kaplan-Meier Survival for INTERMACS OVERALL - Patients 65 Years

Old and Older

Number of Patients at Risk

Month

0 6 12 18 24 30 36 42 48

INTERMACS Overall 2254 1395 890 591 363 204 88 32 16

Page 19 of 27


06/24/2013 Exhibit 12: Kaplan-Meier Survival by Flow Type and Device - Patients 65 Years Old

and Older


Flow Type and Device

Month

0 6 12 18 24 30 36 42 48

Continuous - LVAD 2083 1342 859 572 348 190 77 25 10

Continuous - BiVAD 45 17 13 9 7 7 5 2 2

Pulsatile - LVAD 89 35 21 11 9 8 8 7 6

Pulsatile - BiVAD 24 2 2 2 2 2 1 1 1

Pulsatile - TAH 13 3 1 1 1 1 1 1 1

Page 20 of 27


06/24/2013 Exhibit 13: Kaplan-Meier Survival for Continuous Flow LVADs (with or without

RVAD implant at time of LVAD operation) by Implant Era - Patients 65 Years Old and Older


Implant Era Month

0 6 12 18 24 30 36 42 48

< 2010 205 132 97 77 68 57 43 26 11

2010-2011 1032 794 669 504 287 140 39 1 1

2012-2013 (Jan-Mar) 891 433 106 1 1 1 1 1 1

Page 21 of 27



RVAD implant at time of LVAD operation) by Pre-Implant Device Strategy - Patients 65 Years Old and Older

Bridge to Transplant (BTT) includes: BTT-listed, BTT-likely, BTT-moderately likely, and BTT-unlikely.



Month

0 6 12 18 24 30 36 42 48

Bridge to Transplant 738 447 271 179 118 73 40 19 9

Destination Therapy 1376 904 594 401 236 123 42 8 3

Page 22 of 27



RVAD implant at time of LVAD operation) by Pre-Implant Patient Profile - Patients 65 Years Old and Older


Pre-Implant Patient Profile Month

0 6 12 18 24 30 36 42 48

Level 1 - Critical Cardiogenic Shock 217 122 83 47 35 22 14 8 5

Level 2 - Progressive Decline 797 503 323 213 142 81 32 12 4

Level 3 - Stable but Inotrope Dependent 605 403 257 176 96 52 20 7 4

Level 4 - Resting Symptoms 374 241 157 112 66 30 11 2 1

Levels 5,6,7 - All Others 135 93 53 37 19 15 8 1 1

Page 23 of 27



RVAD implant at time of LVAD operation) by Device Type - Patients 65 Years Old and Older


Device Type

Month

0 6 12 18 24 30 36 42 48

LVAD 2083 1342 859 572 348 190 77 25 10

BiVAD 45 17 13 9 7 7 5 2 2

Page 24 of 27


06/24/2013 Exhibit 17: Competing Outcomes for Continuous Flow LVADs (without RVAD

implant at time of LVAD operation) - Patients 65 Years Old and Older


Month

0 6 12 18 24 30 36

2083 1342 859 572 349 192 77

Page 25 of 27


06/24/2013 Exhibit 18: Competing Outcomes for Continuous Flow LVADs (with RVAD implant

at time of LVAD operation) - Patients 65 Years Old and Older


Month

0 6 12 18 24 30 36

45 17 13 9 7 7 6

Page 26 of 27


06/24/2013 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) - Patients 65 Years Old and Older

The following table summarizes adverse events in patients receiving primary prospective implants between June 23, 2006 and March 31, 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 5603.575 patient months and the total follow-up time for the late period was 20858.87 patient months. All rates are reported in episodes per 100 patient months.

Adverse Event Type

Event Count

(n=12499)

Patient Count

(n=2128)

Patient Percentage

(%)

Early Event Count

(n)

Early Event Rate

(per 100 pt mo)

Late Event Count

(n)

Late Event Rate

(per 100 pt mo)

Arterial Non-CNS Thromboembolism

33 29 1.3 % 27 0.48 6 0.03

Bleeding 2212 964 45.3 % 1384 24.70 828 3.97

Cardiac Arrythmia 790 527 24.7 % 601 10.73 189 0.91

Device Malfunction 302 245 11.5 % 83 1.48 219 1.05

Hemolysis 124 103 4.8 % 58 1.04 66 0.32

Hepatic Dysfunction 112 103 4.8 % 76 1.36 36 0.17

Hypertension 156 110 5.1 % 78 1.39 78 0.37

Infection 1771 870 40.8 % 953 17.01 818 3.92

Myocardial Infarction 16 13 0.6 % 11 0.20 5 0.02

Neurological Dysfunction 490 394 18.5 % 233 4.16 257 1.23

Other Serious Adverse Event 1169 663 31.1 % 741 13.22 428 2.05

Pericardial Drainage 111 100 4.6 % 106 1.89 5 0.02

Psychiatric Episode 182 160 7.5 % 127 2.27 55 0.26

Rehospitalization 3651 1284 60.3 % 978 17.45 2673 12.81

Renal Dysfunction 313 271 12.7 % 226 4.03 87 0.42

Respiratory Failure 530 417 19.5 % 450 8.03 80 0.38

Right Heart Failure 370 320 15.0 % 287 5.12 83 0.40

Venous Thromboembolism 133 124 5.8 % 119 2.12 14 0.07

Wound Dehiscence 34 31 1.4 % 25 0.45 9 0.04

Page 27 of 27


06/24/2013 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 primary devices are included. Only sites that have at least 10 follow-up forms expected are included. INTERMACS has defined required compliance as 90%.

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