Quarterly Statistical Report

Transcription

1 09/16/2009 Page 1 of 17 INTERMACS Interagency Registry for Mechanically Assisted Circulatory Support Quarterly Statistical Report Implant dates: March 1, 2006 June 30, 2009 September 16, 2009 Prepared by: The Data Collection and Analysis Center University of Alabama at Birmingham For questions or comments contact: James K. Kirklin, MD at jkirklin@uab.edu David C. Naftel, Ph.D at dnaftel@uab.edu Susan L. Myers at slm@uab.edu Mary Lynne Clark at mlclark@uab.edu Stephen Craig Collum at ccollum@uab.edu 1

2 09/16/2009 Page 2 of 17 Table of Contents: Tables and Figures Prospective and Retrospective patients (n=1723) 1. Hospital Enrollment Summary Plot 3 2. Site Enrollment Listing 4 3. Demographics 7 4. Month of Implant by device position 8 5. Device strategy at decision of implant Patient profile at time of implant Patient profile by device strategy at decision of implant Month of Implant by Retrospective/Prospective Quarterly Summary of Retrospective/Prospective 15 Prospective patients (n=1603) 10. Device strategy at decision of implant: patient status 17 2

3 09/16/2009 Page 3 of 17 Exhibit 1 INTERMACS Hospital Enrollment Hospital Enrollment and Patient Summary: July 6, 2009 # Hospitals Year 1 Year 2 Year 3 Year 4 Year 5 Launch date Protocol Amendment 2.2 Protocol Amendment 2.3 Contract Time Line Current Activated Hospitals, n= 98 Accrued Device Implants, n=1783 Year 1 Year 2 Year 3 Year 4 Year 5 June 1, 2005 June 1, 2006 June 1, 2007 June 1, 2008 June 1, 2009 June 1, 2010 Today # Device Implants Accrued Activated Centers: These centers have completed and are current in status with the enrollment process including IRB review and are able to enter patients into the Webbased data entry system. Pending Centers: These centers are in the process of completing or renewing their current enrollment information including IRB review. Accrued Patients: Total number of implants entered into INTERMACS Registry. 3

4 09/16/2009 Page 4 of 17 Exhibit 2 Site Enrollment Listing (as of July 6, 2009) Sites Ever Activated in INTERMACS as of July 6, 2009 (n=106)* Center Name City State ADVOCATE CHRIST MEDICAL CENTER OAK LAWN IL ALLEGHENY GENERAL HOSPITAL PITTSBURGH PA ARKANSAS CHILDREN'S HOSPITAL LITTLE ROCK AR 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 CAROLINAS MEDICAL CENTER CHARLOTTE NC CEDARS SINAI MEDICAL CENTER LOS ANGELES CA CHILDREN'S HEALTHCARE OF ATLANTA ATLANTA GA CHILDREN'S HOSPITAL & REGIONAL MEDICAL CENTER SEATTLE WA CHILDREN'S HOSPITAL BOSTON BOSTON MA CHILDREN'S HOSPITAL OF PITTSBURGH PITTSBURGH PA CHILDREN'S MEDICAL CENTER DALLAS TX 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 EMORY UNIVERSITY HOSPITAL ATLANTA GA 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 SPOKANE WA INOVA FAIRFAX HOSPITAL FALLS CHURCH VA INTEGRIS BAPTIST MEDICAL CENTER OKLAHOMA CITY OK INTERMOUNTAIN MEDICAL CENTER (FORMERLY LDS HOSPITAL) MURRAY UT JACKSON MEMORIAL HEALTH SYSTEM/UNIVERSITY OF MIAMI MIAMI FL JEWISH HOSPITAL LOUISVILLE KY LANCASTER GENERAL HOSPITAL LANCASTER PA LANKENAU HOSPITAL WYNNEWOOD PA LOYOLA UNIVERSITY MEDICAL CENTER MAYWOOD IL LUTHERAN HOSPITAL OF INDIANA FORT WAYNE IN MAINE MEDICAL CENTER PORTLAND ME MASSACHUSETTS GENERAL HOSPITAL BOSTON MA MAYO CLINIC HOSPITAL PHOENIX AZ MAYO CLINIC JACKSONVILLE JACKSONVILLE FL MEDICAL CITY DALLAS HOSPITAL DALLAS TX MEDICAL UNIVERSITY OF SOUTH CAROLINA CHARLESTON SC METHODIST HOSPITAL INDIANPOLIS IN METHODIST SPECIALTY AND TRANSPLANT HOSPITAL SAN ANTONIO TX 4

5 09/16/2009 Page 5 of 17 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 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 PENN STATE MILTON S. HERSHEY MEDICAL CENTER HERSHEY PA PROVIDENCE HEART AND VASCULAR INSTITUTE PORTLAND OR ROBERT WOOD JOHNSON UNIVERSITY HOSPITAL NEW BRUNSWICK NJ RUSH UNIVERSITY MEDICAL CENTER CHICAGO IL SAINT MARYS / MAYO CLINIC ROCHESTER MN SENTARA NORFOLK GENERAL HOSPITAL NORFOLK VA SETON MEDICAL CENTER AUSTIN TX SHANDS AT THE UNIVERSITY OF FLORIDA GAINESVILLE FL SHARP MEMORIAL HOSPITAL SAN DIEGO CA 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 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 JOHNS HOPKINS HOSPITAL BALTIMORE MD THE METHODIST HOSPITAL HOUSTON TX THE OHIO STATE UNIVERSITY MEDICAL CENTER COLUMBUS OH THOMAS JEFFERSON UNIVERSITY PHILADELPHIA PA TUFTS MEDICAL CENTER BOSTON MA UCLA MEDICAL CENTER LOS ANGELES CA UNIVERSITY HEALTH CARE SALT LAKE CITY UT UNIVERSITY HOSPITALS CASE MEDICAL CENTER CLEVELAND OH UNIVERSITY OF ALABAMA AT BIRMINGHAM HOSPITAL BIRMINGHAM AL UNIVERSITY OF ARIZONA MEDICAL CENTER TUCSON AZ 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 NORTH CAROLINA HOSPITALS CHAPEL HILL NC 5

6 09/16/2009 Page 6 of 17 UNIVERSITY OF PITTSBURGH MEDICAL CENTER PITTSBUGH PA UNIVERSITY OF ROCHESTER MEDICAL CENTER (STRONG MEMORIAL HO ROCHESTER NY 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 VIA CHRISTI REGIONAL MEDICAL CENTER WICHITA KS VIRGINIA COMMONWEALTH UNIVERSITY HEALTH SYSTEM RICHMOND VA WASHINGTON HOSPITAL CENTER WASHINGTON DC WEILL CORNELL MEDICAL CENTER/NEW YORK PRESBYTERIAN MEDICAL NEW YORK NY WESTCHESTER MEDICAL CENTER VALHALLA NY Note: As of July 6, of the INTERMACS sites have been temporarily deactivated due to administrative and/or regulatory issues. One site has withdrawn. 6

7 7 #HHSN C 09/16/2009 Page 7 of 17

8 8 #HHSN C 09/16/2009 Page 8 of 17

9 09/16/2009 Page 9 of 17 Note: Hospitals are allowed 30 days to enter a device implant into INTERMACS. Therefore the data for June will be incomplete. 9

10 10 #HHSN C 09/16/2009 Page 10 of 17

11 11 #HHSN C 09/16/2009 Page 11 of 17

12 12 #HHSN C 09/16/2009 Page 12 of 17

13 13 #HHSN C 09/16/2009 Page 13 of 17

14 09/16/2009 Page 14 of 17 Definition Retrospective = Retrospective patients are those patients who were implanted at a site prior to that site s initial activation date. Prospective = Prospective patients are those patients who were implanted at a site on or after that site s initial activation date. After discussions with the individual sites, we learned that the sites were unable to enter any retrospective patients who had died prior to the site s activation date due to the inability to obtain informed consent. Therefore, these patients are currently excluded from all analyses that involve time-related major events. 14

15 09/16/2009 Page 15 of 17 Exhibit 9 Quarterly Summary of Retrospective/Prospective Patients Q2: 2006 Q3: 2006 Q4: 2006 Q1: 2007 Q2: 2007 Q3: 2007 Q4: 2007 Q1: 2008 Q2: 2008 Q3: 2008 Q4: 2008 Q1: 2009 Q2: 2009 Quarter Retrospective Prospective Note: to see prospective and retrospective numbers by quarter, see Exhibit 8 on the previous page. 15

16 09/16/2009 Page 16 of 17 All subsequent tables and figures include only Prospective patients (n=1603) 16

17 09/16/2009 Page 17 of 17 The three status variables are mutually exclusive: Patient Status = Dead: This column summarizes all deaths after implant and prior to transplant or explant for recovery. Transplant Status = Yes: This column summarizes all transplants. Recovery Status = Yes: This column summarizes all explants for recovery. Patients who died post- recovery or were transplanted post- recovery are not included in the death or transplant columns. 17