v9.3 sas system output - uab · between june 23, 2006 and september 30, 2012, 145 hospitals...

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# HHSN268201100025C Quarterly Report – 2012 Q3

12/19/2012

INTERMACS

Interagency Registry for Mechanically Assisted Circulatory Support

Quarterly Statistical Report

2012 3rd Quarter

Implant and event dates: June 23, 2006 to September 30, 2012

12/19/2012 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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12/19/2012

INTERMACS Quarterly Report Implants: June 23, 2006 to September 30, 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 7290 patients receiving primary prospective implants between June 23, 2006 and September 30, 2012.

Table of Contents

Exhibit 1: Hospital Activation and Patient Enrollment .........................................................................................3

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

Exhibit 3: Patient Demographics by Implant Period .............................................................................................8

Exhibit 4: Implants by Year by Device Strategy ....................................................................................................9

Exhibit 5: Implants per Year by Device Type ...................................................................................................... 10

Exhibit 6: Patient Profile at Time of Implant by Implant Period ........................................................................ 11

Exhibit 7: Device Strategy at Time of Implant by Implant Period ..................................................................... 12

Exhibit 8: Patient Profile by Device Strategy at Time of Implant ...................................................................... 13

Exhibit 9: Patient Status by Device Strategy at Implant .................................................................................... 15

Exhibit 10: Primary Cause of Death ..................................................................................................................... 17

Exhibit 11: Kaplan-Meier Survival for INTERMACS Overall .............................................................................. 18

Exhibit 12: Kaplan-Meier Survival for LVADs by Year ....................................................................................... 19

Exhibit 13: Kaplan-Meier Survival by Device Strategy at Implant .................................................................... 20

Exhibit 14: Kaplan-Meier Survival by Device Strategy at Implant for Pulsatile Flow Devices....................... 21

Exhibit 15: Kaplan-Meier Survival by Device Strategy at Implant for Continuous Flow Devices ................. 22

Exhibit 16: Kaplan-Meier Survival by Patient Profile at Implant ....................................................................... 23

Exhibit 17: Kaplan-Meier Survival by Device Type ............................................................................................ 24

Exhibit 18: Competing Outcomes for INTERMACS Overall .............................................................................. 25

Exhibit 19: Competing Outcomes for LVADs ..................................................................................................... 26

Exhibit 20: Competing Outcomes for BiVADs .................................................................................................... 27

Exhibit 21: Adverse Event Rates for Patients Receiving a Primary Prospective Implant .............................. 28

Exhibit 21b: Adverse Event Rates for Patients Receiving a Primary Prospective Continuous-Flow LVAD 29

Exhibit 22: Compliance ......................................................................................................................................... 30

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Exhibit 1: Hospital Activation and Patient Enrollment

Between June 23, 2006 and September 30, 2012, 145 hospitals participated in INTERMACS and, of these, 132 hospitals actively contributed information on a total of 7290 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 September 24, 2012 there were 145 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

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

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

CHILDRENS MEMORIAL HOSPITAL CHICAGO IL

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

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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

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

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

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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 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

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THE OHIO STATE UNIVERSITY MEDICAL CENTER COLUMBUS OH

THE UNIVERSITY OF TOLEDO TOLEDO OH

THOMAS JEFFERSON UNIVERSITY PHILADELPHIA PA

TUFTS MEDICAL CENTER BOSTON MA

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

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

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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 September 30, 2012).

Gender

GENDER

Implant Date Period

TOTAL Pre 2011 2011 2012 (Jan-Sep)

n % n % n % n %

Male 3041 78.2 % 1504 79.2 % 1229 81.4 % 5774 79.2 %

Female 843 21.7 % 394 20.7 % 278 18.4 % 1515 20.7 %

Unknown . . . . 1 0.0 % 1 0.0 %

TOTAL 3884 100.0 % 1898 100.0 % 1508 100.0 % 7290 100.0 %

Race

RACE

Implant Date Period


n % n % n % n %

White 2686 69.1 % 1361 71.7 % 1067 70.7 % 5114 70.1 %

African American 886 22.8 % 379 19.9 % 321 21.2 % 1586 21.7 %

Other, Undisclosed, Unknown 312 8.0 % 158 8.3 % 120 7.9 % 590 8.0 %

TOTAL 3884 100.0 % 1898 100.0 % 1508 100.0 % 7290 100.0 %

Age Category

AGE GROUP (yr)

Implant Date Period


n % n % n % n %

unspecified . . . . 1 0.0 % 1 0.0 %

0-18 53 1.3 % 17 0.8 % 7 0.4 % 77 1.0 %

19-39 546 14.0 % 227 11.9 % 166 11.0 % 939 12.8 %

40-59 1862 47.9 % 715 37.6 % 573 37.9 % 3150 43.2 %

60-79 1417 36.4 % 924 48.6 % 749 49.6 % 3090 42.3 %

80+ 6 0.1 % 15 0.7 % 12 0.7 % 33 0.4 %

TOTAL 3884 100.0 % 1898 100.0 % 1508 100.0 % 7290 100.0 %

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Exhibit 4: Implants by Year by Device Strategy

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Exhibit 5: Implants per Year by Device Type

Number of Implants by Device Type and Implant Date Period

DEVICE TYPE

Implant Date Period


n % n % n % n %

Both (in the same OR visit) 343 8.8 % 90 4.7 % 41 2.7 % 474 6.5 %

LVAD 3441 88.5 % 1785 94.0 % 1446 95.8 % 6672 91.5 %

Total Artificial Heart 100 2.5 % 23 1.2 % 21 1.3 % 144 1.9 %

TOTAL 3884 100.0 % 1898 100.0 % 1508 100.0 % 7290 100.0 %

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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


n % n % n % n %

Unspecified 1 0.0 % . . 13 0.8 % 14 0.1 %

1 Critical Cardiogenic Shock 865 22.2 % 305 16.0 % 236 15.6 % 1406 19.2 %

2 Progressive Decline 1640 42.2 % 727 38.3 % 552 36.6 % 2919 40.0 %

3 Stable but Inotrope dependent 749 19.2 % 525 27.6 % 417 27.6 % 1691 23.1 %

4 Resting Symptoms 439 11.3 % 237 12.4 % 206 13.6 % 882 12.0 %

5 Exertion intolerant 90 2.3 % 65 3.4 % 52 3.4 % 207 2.8 %

6 Exertion limited 58 1.4 % 33 1.7 % 19 1.2 % 110 1.5 %

7 Advanced NYHA Class 3 42 1.0 % 6 0.3 % 13 0.8 % 61 0.8 %

TOTAL 3884 100.0 % 1898 100.0 % 1508 100.0 % 7290 100.0 %

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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


n % n % n % n %

1. BTT Listed 1540 39.6 % 424 22.3 % 303 20.0 % 2267 31.0 %

2. BTT Likely 989 25.4 % 427 22.4 % 321 21.2 % 1737 23.8 %

3. BTT Moderate 391 10.0 % 189 9.9 % 145 9.6 % 725 9.9 %

4. BTT Unlikely 133 3.4 % 79 4.1 % 45 2.9 % 257 3.5 %

5. Destination Therapy 723 18.6 % 742 39.0 % 674 44.6 % 2139 29.3 %

6. BTR 59 1.5 % 17 0.8 % 12 0.7 % 88 1.2 %

7. Rescue Therapy 35 0.9 % 8 0.4 % 7 0.4 % 50 0.6 %

8. Other 14 0.3 % 12 0.6 % 1 0.0 % 27 0.3 %

TOTAL 3884 100.0 % 1898 100.0 % 1508 100.0 % 7290 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

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

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 %

Unspecified 4 0.1 % 6 0.3 % 0 0 1 0.3 % 2 0.0 % 1 1.1 % 0 0 0 0 14 0.1 %

1 Critical Cardiogenic Shock 418 18.4 % 405 23.3 % 184 25.3 % 61 23.7 % 243 11.3 % 45 51.1 % 44 88.0 % 6 22.2 % 1406 19.2 %

2 Progressive Decline 1052 46.4 % 670 38.5 % 292 40.2 % 97 37.7 % 770 35.9 % 20 22.7 % 2 4.0 % 16 59.2 % 2919 40.0 %

3 Stable but Inotrope dependent 457 20.1 % 350 20.1 % 151 20.8 % 54 21.0 % 659 30.8 % 13 14.7 % 3 6.0 % 4 14.8 % 1691 23.1 %

4 Resting Symptoms 230 10.1 % 202 11.6 % 77 10.6 % 30 11.6 % 337 15.7 % 5 5.6 % 0 0 1 3.7 % 882 12.0 %

5 Exertion intolerant 50 2.2 % 59 3.3 % 14 1.9 % 5 1.9 % 78 3.6 % 0 0 1 2.0 % 0 0 207 2.8 %

6 Exertion limited 25 1.1 % 37 2.1 % 7 0.9 % 8 3.1 % 32 1.4 % 1 1.1 % 0 0 0 0 110 1.5 %

7 Advanced NYHA Class 3 31 1.3 % 8 0.4 % 0 0 1 0.3 % 18 0.8 % 3 3.4 % 0 0 0 0 61 0.8 %

TOTAL 2267 100.0 % 1737 100.0 % 725 100.0 % 257 100.0 % 2139 100.0 % 88 100.0 % 50 100.0 % 27 100.0 % 7290 100.0 %

PATIENT PROFILE STATUS PRE 2011



Moderate 4. BTT



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

Unspecified 1 0.0 % 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0.0 %




4 Resting Symptoms 153 9.9 % 123 12.4 % 37 9.4 % 14 10.5 % 108 14.9 % 3 5.0 % 0 0 1 7.1 % 439 11.3 %

5 Exertion intolerant 29 1.8 % 29 2.9 % 9 2.3 % 1 0.7 % 21 2.9 % 0 0 1 2.8 % 0 0 90 2.3 %

6 Exertion limited 17 1.1 % 20 2.0 % 5 1.2 % 1 0.7 % 15 2.0 % 0 0 0 0 0 0 58 1.4 %

7 Advanced NYHA Class 3 27 1.7 % 4 0.4 % 0 0 1 0.7 % 8 1.1 % 2 3.3 % 0 0 0 0 42 1.0 %

TOTAL 1540 100.0 % 989 100.0 % 391 100.0 % 133 100.0 % 723 100.0 % 59 100.0 % 35 100.0 % 14 100.0 % 3884 100.0 %

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PATIENT PROFILE STATUS 2011



Moderate 4. BTT



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


2 Progressive Decline 192 45.2 % 157 36.7 % 79 41.7 % 31 39.2 % 257 34.6 % 3 17.6 % 0 0 8 66.6 % 727 38.3 %


4 Resting Symptoms 47 11.0 % 38 8.8 % 21 11.1 % 11 13.9 % 118 15.9 % 2 11.7 % 0 0 0 0 237 12.4 %

5 Exertion intolerant 12 2.8 % 24 5.6 % 3 1.5 % 1 1.2 % 25 3.3 % 0 0 0 0 0 0 65 3.4 %

6 Exertion limited 5 1.1 % 12 2.8 % 1 0.5 % 5 6.3 % 10 1.3 % 0 0 0 0 0 0 33 1.7 %

7 Advanced NYHA Class 3 0 0 1 0.2 % 0 0 0 0 4 0.5 % 1 5.8 % 0 0 0 0 6 0.3 %

TOTAL 424 100.0 % 427 100.0 % 189 100.0 % 79 100.0 % 742 100.0 % 17 100.0 % 8 100.0 % 12 100.0 % 1898 100.0 %

PATIENT PROFILE STATUS 2012 (Jan-Sep)



Moderate 4. BTT



% % % % % % % % %

Unspecified 3 0.9 % 6 1.8 % 0 0 1 2.2 % 2 0.2 % 1 8.3 % 0 0 0 0 13 0.8 %

1 Critical Cardiogenic Shock 51 16.8 % 61 19.0 % 33 22.7 % 9 20.0 % 74 10.9 % 2 16.6 % 6 85.7 % 0 0 236 15.6 %


3 Stable but Inotrope dependent 75 24.7 % 76 23.6 % 34 23.4 % 13 28.8 % 215 31.8 % 4 33.3 % 0 0 0 0 417 27.6 %

4 Resting Symptoms 30 9.9 % 41 12.7 % 19 13.1 % 5 11.1 % 111 16.4 % 0 0 0 0 0 0 206 13.6 %

5 Exertion intolerant 9 2.9 % 6 1.8 % 2 1.3 % 3 6.6 % 32 4.7 % 0 0 0 0 0 0 52 3.4 %

6 Exertion limited 3 0.9 % 5 1.5 % 1 0.6 % 2 4.4 % 7 1.0 % 1 8.3 % 0 0 0 0 19 1.2 %

7 Advanced NYHA Class 3 4 1.3 % 3 0.9 % 0 0 0 0 6 0.8 % 0 0 0 0 0 0 13 0.8 %

TOTAL 303 100.0 % 321 100.0 % 145 100.0 % 45 100.0 % 674 100.0 % 12 100.0 % 7 100.0 % 1 100.0 % 1508 100.0 %

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Quarterly Report – 2012 Q3 12/19/2012


12/19/2012

Exhibit 9: Patient Status by Device Strategy at Implant

The following tables present patient status as of September 30, 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.

Exhibit 9a: Patient Status by Device Strategy at Time of Implant - Overall

PRE-IMPLANT DEVICE STRATEGY

Patient Status (September 30, 2012)

TOTAL

1. Alive (device

in place) 2. Transplant 3. Recovery 4. Dead

1. BTT Listed 667 1168 23 409 2267

2. BTT Likely 685 691 17 344 1737

3. BTT Moderate 356 154 5 210 725

4. BTT Unlikely 133 32 2 90 257

5. Destination Therapy 1449 103 7 580 2139

6. BTR 37 18 12 21 88

7. Rescue Therapy 8 12 4 26 50

8. Other 9 8 1 9 27

TOTAL 3344 2186 71 1689 7290

Exhibit 9b: Patient Status by Device Strategy at Time of Implant - Pre 2011



TOTAL

1. Alive (device


1. BTT Listed 254 949 16 321 1540

2. BTT Likely 201 524 14 250 989

3. BTT Moderate 122 115 3 151 391

4. BTT Unlikely 40 23 2 68 133


6. BTR 18 14 10 17 59


8. Other 4 4 1 5 14

TOTAL 988 1703 54 1139 3884

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12/19/2012

Exhibit 9c: Patient Status by Device Strategy at Time of Implant - 2011



TOTAL

1. Alive (device


1. BTT Listed 177 174 5 68 424

2. BTT Likely 209 145 2 71 427

3. BTT Moderate 112 33 2 42 189

4. BTT Unlikely 54 8 0 17 79


6. BTR 11 2 2 2 17


8. Other 4 4 0 4 12

TOTAL 1092 400 14 392 1898

Exhibit 9d: Patient Status by Device Strategy at Time of Implant - 2012 (Jan-Sep)



TOTAL

1. Alive (device


1. BTT Listed 236 45 2 20 303

2. BTT Likely 275 22 1 23 321

3. BTT Moderate 122 6 0 17 145

4. BTT Unlikely 39 1 0 5 45


6. BTR 8 2 0 2 12


8. Other 1 0 0 0 1

TOTAL 1264 83 3 158 1508

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12/19/2012

Exhibit 10: Primary Cause of Death

PRIMARY CAUSE OF DEATH

Implant Date Period


n % n % n % n %

Circulatory: Arterial Non-CNS Thromboembolism 20 1.7 % 6 1.5 % . . 26 1.4 %

Circulatory: CHF 39 3.3 % 12 3.0 % 6 3.4 % 57 3.2 %

Circulatory: Cardiac Arrhythmia 41 3.5 % 12 3.0 % 4 2.2 % 57 3.2 %

Circulatory: End Stage Cardiomyopathy 18 1.5 % 1 0.2 % 4 2.2 % 23 1.3 %

Circulatory: Heart Disease 2 0.1 % 4 1.0 % 1 0.5 % 7 0.4 %

Circulatory: Hemolysis 2 0.1 % 4 1.0 % 2 1.1 % 8 0.4 %

Circulatory: Ischemic Cardiomyopathy 7 0.6 % 3 0.7 % 2 1.1 % 12 0.6 %

Circulatory: Major Bleeding 61 5.2 % 11 2.7 % 8 4.5 % 80 4.6 %

Circulatory: Myocardial Infarction 6 0.5 % 4 1.0 % 4 2.2 % 14 0.8 %

Circulatory: Myocardial Rupture 1 0.0 % . . . . 1 0.0 %

Circulatory: Other, Specify 57 4.8 % 21 5.2 % 9 5.1 % 87 5.0 %

Circulatory: Pericardial Fluid Collection 2 0.1 % . . . . 2 0.1 %

Circulatory: Right Heart Failure 67 5.7 % 22 5.5 % 4 2.2 % 93 5.3 %

Circulatory: Ruptured Aortic Aneurysm 1 0.0 % . . . . 1 0.0 %

Circulatory: Sudden Unexplained Death 48 4.1 % 17 4.2 % 8 4.5 % 73 4.2 %

Device Malfunction 42 3.6 % 12 3.0 % . . 54 3.1 %

Digestive: Fluid/Electrolyte Disorder 6 0.5 % 1 0.2 % . . 7 0.4 %

Digestive: GI Disorder 1 0.0 % 2 0.5 % 1 0.5 % 4 0.2 %

Digestive: Hepatic Dysfunction 22 1.8 % 10 2.5 % 3 1.7 % 35 2.0 %

Digestive: Pancreatitis 1 0.0 % . . . . 1 0.0 %

Digestive: Renal Dysfunction 30 2.5 % 6 1.5 % 1 0.5 % 37 2.1 %

Major Infection 154 13.2 % 42 10.5 % 9 5.1 % 205 11.7 %

Multisystem Organ Failure 101 8.6 % 47 11.8 % 36 20.6 % 184 10.5 %

Nervous System: Neurological Dysfunction 216 18.5 % 74 18.5 % 30 17.2 % 320 18.4 %

Other (Protocol V2.3)* 35 3.0 % 13 3.2 % 6 3.4 % 54 3.1 %

Other: Cancer 13 1.1 % 3 0.7 % 1 0.5 % 17 0.9 %

Other: Trauma/accident, specify 9 0.7 % 2 0.5 % . . 11 0.6 %

Psychiatric Episode/Suicide 4 0.3 % . . 1 0.5 % 5 0.2 %

Respiratory: Pulmonary: Other, specify 7 0.6 % 6 1.5 % 3 1.7 % 16 0.9 %

Respiratory: Respiratory Failure 63 5.4 % 19 4.7 % 12 6.8 % 94 5.4 %

Respiratory: Venous Thromboembolism Event 4 0.3 % 1 0.2 % 1 0.5 % 6 0.3 %

Unknown (Protocol V2.3)* 37 3.1 % 16 4.0 % . . 53 3.0 %

Withdrawal of Support, specify 49 4.2 % 27 6.7 % 18 10.3 % 94 5.4 %

TOTAL 1166 100.0 % 398 100.0 % 174 100.0 % 1738 100.0 %

Note: 4 patients have a missing primary cause of death. * Certain pre-relaunch categories are no longer supported as of May 2012

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12/19/2012

Exhibit 11: Kaplan-Meier Survival for INTERMACS Overall

Number of Patients at Risk by Months after Implant

0

months 12

months 24

months 36

months 48

months

7290 2623 1005 289 101

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12/19/2012

Exhibit 12: Kaplan-Meier Survival for LVADs by Year


Implant Era 0

months 12

months 24

months 36

months 48

months

2006 (Jun-Dec) 78 27 19 14 13

2007 257 73 33 26 19

2008 651 278 152 101 61

2009 903 434 263 128 1

2010 1552 899 494 1 1

2011 1785 817 3 3 3

2012 (Jan-Sep) 1446 2 2 2 2

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12/19/2012

Exhibit 13: Kaplan-Meier Survival by Device Strategy at Implant


Device Strategy 0

months 12

months 24

months 36

months 48

months

Bridge to Transplant 4986 1705 705 222 68

Destination Therapy 2139 869 282 57 30

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12/19/2012

Exhibit 14: Kaplan-Meier Survival by Device Strategy at Implant for Pulsatile Flow Devices


Device Strategy 0

months 12

months 24

months 36

months 48

months



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12/19/2012

Exhibit 15: Kaplan-Meier Survival by Device Strategy at Implant for Continuous Flow Devices


Device Strategy 0

months 12

months 24

months 36

months 48

months



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12/19/2012

Exhibit 16: Kaplan-Meier Survival by Patient Profile at Implant


Patient Profile 0

months 12

months 24

months 36

months 48

months

Level 1 - Critical Cardiogenic Shock 1406 390 160 68 33

Level 2 - Progressive Decline 2919 1037 419 111 34

Level 3 - Stable but Inotrope Dependent 1691 679 234 62 25

Level 4 - Resting Symptoms 882 362 134 32 7

Levels 5,6,7 - All Others 378 159 64 19 5

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12/19/2012

Exhibit 17: Kaplan-Meier Survival by Device Type


Device

Type 0

months 12

months 24

months 36

months 48

months

LVADs 6672 2524 957 266 91

Bi-VADs 474 87 44 21 10

TAHs 144 13 6 4 2

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12/19/2012

Exhibit 18: Competing Outcomes for INTERMACS Overall

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12/19/2012

Exhibit 19: Competing Outcomes for LVADs

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12/19/2012

Exhibit 20: Competing Outcomes for BiVADs

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12/19/2012

Exhibit 21: Adverse Event Rates for Patients Receiving a Primary Prospective Implant

The following table summarizes adverse events in patients receiving primary prospective implants between June 23, 2006 and September 30, 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 18948 patient months and the total follow-up time for the late period was 61135.74 patient months. All rates are reported in episodes per 100 patient months.

Adverse Event Type

Event Count

(n=42441)

Patient Count

(n=7290)

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

122 105 1.4 % 93 0.49 29 0.05

Bleeding 6856 2854 39.1 % 4813 25.40 2043 3.34

Cardiac Arrythmia 2830 1831 25.1 % 2184 11.53 646 1.06

Device Malfunction 1452 1110 15.2 % 439 2.32 1013 1.66

Hemolysis 563 431 5.9 % 246 1.30 317 0.52

Hepatic Dysfunction 492 428 5.8 % 332 1.75 160 0.26

Hypertension 666 503 6.8 % 384 2.03 282 0.46

Infection 6553 3021 41.4 % 3435 18.13 3118 5.10

Myocardial Infarction 45 43 0.5 % 28 0.15 17 0.03

Neurological Dysfunction 1488 1191 16.3 % 734 3.87 754 1.23

Other Serious Adverse Event

3631 1987 27.2 % 2305 12.16 1326 2.17

Pericardial Drainage 453 402 5.5 % 440 2.32 13 0.02

Psychiatric Episode 714 590 8.0 % 460 2.43 254 0.42

Rehospitalization 11981 4076 55.9 % 2981 15.73 9000 14.72

Renal Dysfunction 1102 925 12.6 % 792 4.18 310 0.51

Respiratory Failure 1793 1410 19.3 % 1488 7.85 305 0.50

Right Heart Failure 1121 954 13.0 % 866 4.57 255 0.42

Venous Thromboembolism 462 428 5.8 % 396 2.09 66 0.11

Wound Dehiscence 117 101 1.3 % 93 0.49 24 0.04

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12/19/2012

Exhibit 21b: Adverse Event Rates for Patients Receiving a Primary Prospective Continuous-Flow LVAD

The following table summarizes adverse events in patients receiving primary prospective implants between June 23, 2006 and September 30, 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 16153.62 patient months and the total follow-up time for the late period was 54718.05 patient months. All rates are reported in episodes per 100 patient months.

Adverse Event Type

Event Count

(n=33348)

Patient Count

(n=6033)

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

90 76 1.2 % 67 0.41 23 0.04

Bleeding 4916 2231 36.9 % 3227 19.98 1689 3.09

Cardiac Arrythmia 2368 1538 25.4 % 1783 11.04 585 1.07

Device Malfunction 1112 842 13.9 % 340 2.10 772 1.41

Hemolysis 448 363 6.0 % 188 1.16 260 0.48

Hepatic Dysfunction 333 298 4.9 % 206 1.28 127 0.23

Hypertension 459 357 5.9 % 251 1.55 208 0.38

Infection 4818 2375 39.3 % 2359 14.60 2459 4.49

Myocardial Infarction 43 41 0.6 % 26 0.16 17 0.03

Neurological Dysfunction 1142 928 15.3 % 510 3.16 632 1.16

Other Serious Adverse Event

2709 1570 26.0 % 1660 10.28 1049 1.92

Pericardial Drainage 288 261 4.3 % 276 1.71 12 0.02

Psychiatric Episode 556 474 7.8 % 357 2.21 199 0.36

Rehospitalization 10616 3578 59.3 % 2694 16.68 7922 14.48

Renal Dysfunction 785 663 10.9 % 526 3.26 259 0.47

Respiratory Failure 1272 1015 16.8 % 1043 6.46 229 0.42

Right Heart Failure 960 808 13.3 % 725 4.49 235 0.43

Venous Thromboembolism 343 322 5.3 % 294 1.82 49 0.09

Wound Dehiscence 90 79 1.3 % 69 0.43 21 0.04

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12/19/2012

Exhibit 22: 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 due are included in this figure (n = 112 sites). INTERMACS has defined required compliance as 90%.

v9.3 sas system output - uab · between june 23, 2006 and september 30, 2012, 145 hospitals...

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