quarterly statistical report centers for medicare ...osf st francis medical center peoria il ... st....

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# HHSN268201100025C Quarterly Report – 2012 Q4

03/25/2013

INTERMACS

Interagency Registry for Mechanically Assisted Circulatory Support

Quarterly Statistical Report

Centers for Medicare & Medicaid Services

2012 Q4

Implant and event dates: June 23, 2006 to December 31, 2012

03/25/2013 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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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. 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 2039 patients 65 years old or older receiving primary prospective implants between June 23, 2006 and December 31, 2012.

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

Between June 23, 2006 and December 31, 2012, 148 hospitals participated in INTERMACS and, of these, 119 hospitals actively contributed information on a total of 2039 patients. Cumulative patient accrual and the number of participating hospitals over this time period are displayed below.

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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

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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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 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

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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

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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 December 31, 2012).

Gender

GENDER

IMPLANT DATE PERIOD

TOTAL < 2010 2010-2011 2012

n % n % n % n %

Female 46 14.7 % 152 14.6 % 100 14.5 % 298 14.6 %

Male 266 85.2 % 886 85.3 % 589 85.4 % 1741 85.3 %

TOTAL 312 100.0 % 1038 100.0 % 689 100.0 % 2039 100.0 %

Race

RACE

IMPLANT DATE PERIOD

TOTAL < 2010 2010-2011 2012

n % n % n % n %

African American 35 11.2 % 82 7.8 % 59 8.5 % 176 8.6 %

Other, Unknown, Undisclosed 16 5.1 % 65 6.2 % 49 7.1 % 130 6.3 %

White 261 83.6 % 891 85.8 % 581 84.3 % 1733 84.9 %

TOTAL 312 100.0 % 1038 100.0 % 689 100.0 % 2039 100.0 %

Age Category

AGE GROUP (yr)

IMPLANT DATE PERIOD

TOTAL < 2010 2010-2011 2012

n % n % n % n %

65-69 232 74.3 % 532 51.2 % 353 51.2 % 1117 54.7 %

70-74 65 20.8 % 339 32.6 % 223 32.3 % 627 30.7 %

75-79 15 4.8 % 145 13.9 % 95 13.7 % 255 12.5 %

80+ . . 22 2.1 % 18 2.6 % 40 1.9 %

TOTAL 312 100.0 % 1038 100.0 % 689 100.0 % 2039 100.0 %

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

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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

n % n % n % n %

LVAD 279 89.4 % 1012 97.4 % 671 97.3 % 1962 96.2 %

BiVAD 27 8.6 % 26 2.5 % 15 2.1 % 68 3.3 %

TAH 6 1.9 % . . 3 0.4 % 9 0.4 %

TOTAL 312 100.0 % 1038 100.0 % 689 100.0 % 2039 100.0 %

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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

n % n % n % n %

1 Critical Cardio Shock 75 24.0 % 107 10.3 % 69 10.0 % 251 12.3 %

2 Progressive Decline 143 45.8 % 385 37.0 % 238 34.5 % 766 37.5 %

3 Stable but Inotrope dependent 41 13.1 % 300 28.9 % 213 30.9 % 554 27.1 %

4 Resting Symptoms 37 11.8 % 188 18.1 % 119 17.2 % 344 16.8 %

5 Exertion intolerant 10 3.2 % 36 3.4 % 33 4.7 % 79 3.8 %

6 Exertion limited 3 0.9 % 18 1.7 % 12 1.7 % 33 1.6 %

7 Advanced NYHA Class 3 3 0.9 % 4 0.3 % 5 0.7 % 12 0.5 %

TOTAL 312 100.0 % 1038 100.0 % 689 100.0 % 2039 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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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

n % n % n % n %

1. BTT Listed 116 37.1 % 129 12.4 % 63 9.1 % 308 15.1 %

2. BTT Likely 74 23.7 % 91 8.7 % 55 7.9 % 220 10.7 %

3. BTT Moderate 44 14.1 % 49 4.7 % 47 6.8 % 140 6.8 %

4. BTT Unlikely 20 6.4 % 45 4.3 % 21 3.0 % 86 4.2 %

5. Destination Therapy 53 16.9 % 714 68.7 % 498 72.2 % 1265 62.0 %

6. BTR 3 0.9 % 6 0.5 % 1 0.1 % 10 0.4 %

7. Rescue Therapy 2 0.6 % 2 0.1 % 3 0.4 % 7 0.3 %

8. Other . . 2 0.1 % 1 0.1 % 3 0.1 %

TOTAL 312 100.0 % 1038 100.0 % 689 100.0 % 2039 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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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 1. BTT Listed

2. BTT Likely

3. BTT Moderate

4. BTT Unlikely

5. Destination Therapy 6. BTR

7. Rescue Therapy 8. Other

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

1 Critical Cardio Shock 53 17.2 % 41 18.6 % 27 19.2 % 16 18.6 % 102 8.0 % 4 40.0 % 7 100.0 % 1 33.3 % 251 12.3 %

2 Progressive Decline 152 49.3 % 81 36.8 % 57 40.7 % 33 38.3 % 438 34.6 % 3 30.0 % 0 0 2 66.6 % 766 37.5 %

3 Stable but Inotrope dependent 61 19.8 % 41 18.6 % 36 25.7 % 21 24.4 % 393 31.0 % 2 20.0 % 0 0 0 0 554 27.1 %

4 Resting Symptoms 30 9.7 % 38 17.2 % 16 11.4 % 12 13.9 % 247 19.5 % 1 10.0 % 0 0 0 0 344 16.8 %

5 Exertion intolerant 7 2.2 % 13 5.9 % 3 2.1 % 2 2.3 % 54 4.2 % 0 0 0 0 0 0 79 3.8 %

6 Exertion limited 4 1.2 % 6 2.7 % 1 0.7 % 2 2.3 % 20 1.5 % 0 0 0 0 0 0 33 1.6 %

7 Advanced NYHA Class 3 1 0.3 % 0 0 0 0 0 0 11 0.8 % 0 0 0 0 0 0 12 0.5 %

TOTAL 308 100.0 % 220 100.0 % 140 100.0 % 86 100.0 % 1265 100.0 % 10 100.0 % 7 100.0 % 3 100.0 % 2039 100.0 %

IMPLANT DATE PERIOD=< 2010



TOTAL 1. BTT Listed

2. BTT Likely

3. BTT Moderate

4. BTT Unlikely


7. 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 % 7 35.0 % 25 47.1 % 0 0 0 0 143 45.8 %

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 % 2 10.0 % 6 11.3 % 0 0 0 0 37 11.8 %

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 %


03/25/2013

IMPLANT DATE PERIOD=2010-2011



TOTAL 1. BTT Listed

2. BTT Likely

3. BTT Moderate

4. BTT Unlikely



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

1 Critical Cardio Shock 18 13.9 % 14 15.3 % 9 18.3 % 5 11.1 % 57 7.9 % 2 33.3 % 2 100.0 % 0 0 107 10.3 %

2 Progressive Decline 65 50.3 % 21 23.0 % 20 40.8 % 19 42.2 % 256 35.8 % 2 33.3 % 0 0 2 100.0 % 385 37.0 %

3 Stable but Inotrope dependent 29 22.4 % 26 28.5 % 14 28.5 % 12 26.6 % 218 30.5 % 1 16.6 % 0 0 0 0 300 28.9 %

4 Resting Symptoms 13 10.0 % 19 20.8 % 6 12.2 % 7 15.5 % 142 19.8 % 1 16.6 % 0 0 0 0 188 18.1 %

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 %

6 Exertion limited 2 1.5 % 2 2.1 % 0 0 1 2.2 % 13 1.8 % 0 0 0 0 0 0 18 1.7 %

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 129 100.0 % 91 100.0 % 49 100.0 % 45 100.0 % 714 100.0 % 6 100.0 % 2 100.0 % 2 100.0 % 1038 100.0 %

IMPLANT DATE PERIOD=2012



TOTAL 1. BTT Listed

2. BTT Likely

3. BTT Moderate

4. BTT Unlikely



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

1 Critical Cardio Shock 11 17.4 % 7 12.7 % 7 14.8 % 3 14.2 % 37 7.4 % 0 0 3 100.0 % 1 100.0 % 69 10.0 %

2 Progressive Decline 29 46.0 % 26 47.2 % 18 38.2 % 7 33.3 % 157 31.5 % 1 100.0 % 0 0 0 0 238 34.5 %

3 Stable but Inotrope dependent 15 23.8 % 11 20.0 % 15 31.9 % 6 28.5 % 166 33.3 % 0 0 0 0 0 0 213 30.9 %

4 Resting Symptoms 6 9.5 % 6 10.9 % 5 10.6 % 3 14.2 % 99 19.8 % 0 0 0 0 0 0 119 17.2 %

5 Exertion intolerant 1 1.5 % 2 3.6 % 1 2.1 % 1 4.7 % 28 5.6 % 0 0 0 0 0 0 33 4.7 %

6 Exertion limited 1 1.5 % 3 5.4 % 1 2.1 % 1 4.7 % 6 1.2 % 0 0 0 0 0 0 12 1.7 %

7 Advanced NYHA Class 3 0 0 0 0 0 0 0 0 5 1.0 % 0 0 0 0 0 0 5 0.7 %

TOTAL 63 100.0 % 55 100.0 % 47 100.0 % 21 100.0 % 498 100.0 % 1 100.0 % 3 100.0 % 1 100.0 % 689 100.0 %

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

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)

TOTAL

1. Alive (device in

place) 2. Transplant 3. Recovery 4. Dead

N N N N N

1. BTT Listed 90 142 3 73 308

2. BTT Likely 91 75 1 53 220

3. BTT Moderate 61 23 0 56 140

4. BTT Unlikely 53 1 1 31 86

5. Destination Therapy 845 34 1 385 1265

6. BTR 6 0 1 3 10

7. Rescue Therapy 1 2 1 3 7

8. Other 1 0 0 2 3

TOTAL 1148 277 8 606 2039

IMPLANT DATE PERIOD=< 2010



TOTAL

1. Alive (device in


N N N N N

1. BTT Listed 12 66 1 37 116

2. BTT Likely 10 40 0 24 74

3. BTT Moderate 5 10 0 29 44

4. BTT Unlikely 3 0 1 16 20


6. BTR 0 0 1 2 3


TOTAL 48 121 4 139 312

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IMPLANT DATE PERIOD=2010-2011



TOTAL

1. Alive (device in


N N N N N

1. BTT Listed 42 57 2 28 129

2. BTT Likely 35 31 0 25 91

3. BTT Moderate 22 10 0 17 49

4. BTT Unlikely 30 1 0 14 45


6. BTR 5 0 0 1 6


8. Other 0 0 0 2 2

TOTAL 563 124 3 348 1038

IMPLANT DATE PERIOD=2012



TOTAL

1. Alive (device in


N N N N N

1. BTT Listed 36 19 0 8 63

2. BTT Likely 46 4 1 4 55

3. BTT Moderate 34 3 0 10 47

4. BTT Unlikely 20 0 0 1 21


6. BTR 1 0 0 0 1


8. Other 1 0 0 0 1

TOTAL 537 32 1 119 689

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03/25/2013

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

PRIMARY CAUSE OF DEATH

IMPLANT DATE PERIOD

TOTAL < 2010 2010-2011 2012

n % n % n % n %

Circulatory: Arterial Non-CNS Thromboembolism 3 2.1 % 4 1.1 % . . 7 1.1 %

Circulatory: CHF 6 4.2 % 17 4.7 % 4 3.2 % 27 4.3 %

Circulatory: Cardiac Arrhythmia 2 1.4 % 13 3.6 % 2 1.6 % 17 2.7 %

Circulatory: End Stage Cardiomyopathy 1 0.7 % 6 1.6 % 2 1.6 % 9 1.4 %

Circulatory: Heart Disease . . 3 0.8 % 1 0.8 % 4 0.6 %

Circulatory: Hemolysis . . 1 0.2 % 1 0.8 % 2 0.3 %

Circulatory: Ischemic Cardiomyopathy 1 0.7 % 7 1.9 % 1 0.8 % 9 1.4 %

Circulatory: Major Bleeding 10 7.0 % 16 4.4 % 3 2.4 % 29 4.6 %

Circulatory: Myocardial Infarction 1 0.7 % 4 1.1 % 2 1.6 % 7 1.1 %

Circulatory: Other, Specify 6 4.2 % 7 1.9 % 4 3.2 % 17 2.7 %

Circulatory: Pericardial Fluid Collection 1 0.7 % . . . . 1 0.1 %

Circulatory: Right Heart Failure 6 4.2 % 21 5.8 % 5 4.0 % 32 5.1 %

Circulatory: Sudden Unexplained Death 5 3.5 % 16 4.4 % 4 3.2 % 25 4.0 %

Device Malfunction 5 3.5 % 12 3.3 % 1 0.8 % 18 2.8 %

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

Digestive: GI Disorder . . 1 0.2 % 2 1.6 % 3 0.4 %

Digestive: Hepatic Dysfunction 2 1.4 % 6 1.6 % 1 0.8 % 9 1.4 %

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

Digestive: Renal Dysfunction 3 2.1 % 7 1.9 % . . 10 1.6 %

Major Infection 21 14.8 % 42 11.6 % 4 3.2 % 67 10.7 %

Multisystem Organ Failure 9 6.3 % 39 10.8 % 24 19.3 % 72 11.5 %

Nervous System: Neurological Dysfunction 29 20.5 % 47 13.0 % 18 14.5 % 94 15.0 %

Other (Protocol V2.3)* 4 2.8 % 19 5.2 % 7 5.6 % 30 4.8 %

Other: Cancer 1 0.7 % 7 1.9 % 1 0.8 % 9 1.4 %

Other: Trauma/accident, specify . . 2 0.5 % 1 0.8 % 3 0.4 %

Psychiatric Episode/Suicide 1 0.7 % . . 1 0.8 % 2 0.3 %

Respiratory: Pulmonary: Other, specify . . 5 1.3 % 1 0.8 % 6 0.9 %

Respiratory: Respiratory Failure 8 5.6 % 13 3.6 % 13 10.4 % 34 5.4 %

Unknown (Protocol V2.3)* 9 6.3 % 15 4.1 % . . 24 3.8 %

Withdrawal of Support, specify 5 3.5 % 27 7.5 % 21 16.9 % 53 8.4 %

TOTAL 141 100.0 % 359 100.0 % 124 100.0 % 624 100.0 %

Note: 2 patients have a missing primary cause of death. * Certain pre-relaunch categories are no longer supported as of May 2012

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03/25/2013

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 2039 1240 787 513 292 158 52 30 13

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03/25/2013

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 1872 1188 757 495 277 144 44 23 8

Continuous - BiVAD 44 17 11 8 7 7 3 2 2

Pulsatile - LVAD 90 35 21 11 9 8 7 7 5

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

Pulsatile - TAH 9 2 1 1 1 1 1 1 1

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03/25/2013

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 205 133 98 79 70 59 46 24 9

2010-2011 1029 792 669 424 214 92 1 1 1

2012 682 280 1 1 1 1 1 1 1

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03/25/2013

Exhibit 14: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Pre-Implant Device Strategy - 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 676 409 250 162 100 72 32 18 7

Destination Therapy 1228 788 514 340 183 77 15 7 3

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03/25/2013

Exhibit 15: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) by Pre-Implant Patient Profile - 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 203 115 72 46 31 21 12 7 3

Level 2 - Progressive Decline 715 450 283 191 113 62 20 12 4

Level 3 - Stable but Inotrope Dependent 541 347 226 145 74 39 9 6 4

Level 4 - Resting Symptoms 338 216 146 94 52 20 5 2 1

Levels 5,6,7 - All Others 119 78 44 30 17 11 5 1 1

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03/25/2013

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


Implant Year

Month

0 6 12 18 24 30 36 42 48

LVAD 1872 1188 757 495 277 144 44 23 8

BiVAD 44 17 11 8 7 7 3 2 2

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03/25/2013

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

1872 1188 757 495 279 144 46

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03/25/2013

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

44 17 11 9 7 7 5

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03/25/2013

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 December 31, 2012. 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 5080.48 patient months and the total follow-up time for the late period was 17893.03 patient months. All rates are reported in episodes per 100 patient months.

Adverse Event Type

Event Count

(n=10903)

Patient Count

(n=1916)

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

31 27 1.4 % 25 0.49 6 0.03

Bleeding 1987 856 44.6 % 1302 25.63 685 3.83

Cardiac Arrythmia 722 482 25.1 % 559 11.00 163 0.91

Device Malfunction 246 197 10.2 % 72 1.42 174 0.97

Hemolysis 108 90 4.6 % 52 1.02 56 0.31

Hepatic Dysfunction 107 98 5.1 % 74 1.46 33 0.18

Hypertension 138 97 5.0 % 74 1.46 64 0.36

Infection 1560 776 40.5 % 874 17.20 686 3.83

Myocardial Infarction 14 12 0.6 % 9 0.18 5 0.03

Neurological Dysfunction 426 342 17.8 % 208 4.09 218 1.22

Other Serious Adverse Event 988 578 30.1 % 623 12.26 365 2.04

Pericardial Drainage 105 94 4.9 % 100 1.97 5 0.03

Psychiatric Episode 163 142 7.4 % 112 2.20 51 0.29

Rehospitalization 3079 1130 58.9 % 860 16.93 2219 12.40

Renal Dysfunction 271 233 12.1 % 201 3.96 70 0.39

Respiratory Failure 480 378 19.7 % 409 8.05 71 0.40

Right Heart Failure 326 280 14.6 % 253 4.98 73 0.41

Venous Thromboembolism 120 112 5.8 % 110 2.17 10 0.06

Wound Dehiscence 32 29 1.5 % 23 0.45 9 0.05

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03/25/2013

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 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%.

quarterly statistical report centers for medicare ...osf st francis medical center peoria il ... st....

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