Quarterly Statistical Report

Transcription

1 01/04/2008 Page 1 of 26 INTERMACS Interagency Registry for Mechanically Assisted Circulatory Support Quarterly Statistical Report Implant dates: March 1, 2006 November 30, 2007 January 4, 2008 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 01/04/2008 Page 2 of 26 Table of Contents: Tables and Figures Prospective and Retrospective patients (n=430) 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 9 6. Patient profile at time of implant Patient profile by device strategy at time of implant Month of Implant by Retrospective/Prospective Quarterly Summaries of Retrospective/Prospective 13 Prospective patients (n=348) 10. Device strategy at time of implant: patient status Primary Cause of Death Kaplan-Meier Survival: Death Kaplan-Meier Survival: Device strategy at implant Kaplan-Meier Survival: Patient profile at implant Kaplan-Meier Survival: Device type Competing Outcomes: Death, transplant & recovery Competing Outcomes: LVADs Competing Outcomes: Bi-VADs Adverse Event Summary: Overall Adverse Event Summary: LVADs Adverse Event Summary: BiVADs 26 2

3 01/04/2008 Page 3 of 26 Exhibit 1 INTERMACS Hospital Enrollment Hospital Enrollment and Patient Summary: Dec 31, 2007 # Hospitals Year 1 Year 2 Year 3 Year 4 Year 5 Launch date Contract Time Line Current Activated Hospitals, n= 85 Current Hospitals Pending Activation, n= 21 Accrued Patients, n=430 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 # Patients Accrued A ctivated 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 Web- based data entry system. P ending Centers: These centers are in the process of completing or renewing their current enrollment information including IRB review. A ccrued Patients: Total number of implants entered into INTERMACS Registry 3

4 01/04/2008 Page 4 of 26 Exhibit 2 Site Enrollment Listing Sites Ever Activated in INTERMACS as of December 31, 2007 (n=91)* 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 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 HENRY FORD HOSPITAL DETROIT MI HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA PHILADELPHIA PA INLAND NORTHWEST THORACIC ORGAN TRANSPLANT PROGRAM, SACRED HEART MEDICAL SPOKANE WA INOVA FAIRFAX HOSPITAL FALLS CHURCH VA INTEGRIS BAPTIST MEDICAL CENTER OKLAHOMA CITY OK JACKSON MEMORIAL HEALTH SYSTEM/UNIVERSITY OF MIAMI MIAMI FL JEWISH HOSPITAL LOUISVILLE KY LANKENAU HOSPITAL WYNNEWOOD PA LDS HOSPITAL MURRAY UT 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 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 MID AMERICA HEART INSTITUTE OF SAINT LUKE'S HOSPITAL KANSAS CITY MO MONTEFIORE MEDICAL CENTER BRONX NY 4

5 01/04/2008 Page 5 of 26 Center Name City State MOUNT SINAI MEDICAL NEW YORK NY NEMOURS/A.I. DUPONT HOSPITAL FOR CHILDREN WILMINGTON NEW YORK UNIVERSITY MEDICAL CENTER NEW YORK NY NEWARK BETH ISRAEL MEDICAL CENTER NEWARK NJ NORTHWESTERN MEMORIAL HOSPITAL CHICAGO IL OCHSNER MEDICAL CENTER OREGON HEALTH & SCIENCE UNIVERSITY NEW ORLEANS PORTLAND OSF ST FRANCIS MEDICAL CENTER PEORIA IL PENN STATE MILTON S. HERSHEY MEDICAL CENTER HERSHEY PA PROVIDENCE HEART AND VASCULAR INSTITUTE PORTLAND OR RUSH UNIVERSITY MEDICAL CENTER CHICAGO IL SAINT MARYS / MAYO CLINIC ROCHESTER MN SENTARA NORFOLK GENERAL HOSPITAL NORFOLK SETON MEDICAL CENTER AUSTIN TX SHANDS AT THE UNIVERSITY OF FLORIDA GAINESVILLE SHARP MEMORIAL HOSPITAL SAN DIEGO CA ST LUKE'S HOSPITAL/ MAYO CLINIC JACKSONVILLE JACKSONVILLE FL 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 STANFORD UNIVERSITY MEDICAL CENTER INDIANAPOLIS STANFORD TAMPA GENERAL HOSPITAL TAMPA FL TEMPLE UNIVERSITY HOSPITAL PHILADELPHIA PA TEXAS CHILDREN'S HOSPITAL HOUSTON TX THE JOHNS HOPKINS HOSPITAL BALTIMORE MD THE METHODIST HOSPITAL HOUSTON TX THE OHIO STATE UNIVERSITY MEDICAL CENTER TUFTS-NEW ENGLAND MEDICAL CENTER COLUMBUS BOSTON 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 UNIVERSITY OF ARIZONA MEDICAL CENTER TUCSON AZ UNIVERSITY OF CHICAGO HOSPITALS CHICAGO IL UNIVERSITY OF COLORADO HOSPITAL AURORA UNIVERSITY OF IOWA HOSPITALS AND CLINICS IOWA CITY IA 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 UNIVERSITY OF PITTSBURGH MEDICAL CENTER PITTSBUGH PA UNIVERSITY OF ROCHESTER MEDICAL CENTER (STRONG MEMORIAL HOSPITAL) ROCHESTER UNIVERSITY OF WISCONSIN HOSPITAL AND CLINICS MADISON WI UT SOUTHWESTERN MEDICAL CENTER DALLAS TX VIA CHRISTI REGIONAL MEDICAL CENTER WICHITA KS VIRGINIA COMMONWEALTH UNIVERSITY HEALTH SYSTEM RICHMOND VA DE LA OR VA FL IN CA OH MA AL CO NY 5

6 01/04/2008 Page 6 of 26 Center Name City State WASHINGTON HOSPITAL CENTER WASHINGTON DC WESTCHESTER MEDICAL CENTER Sites Pending Initial Activation in INTERMACS as of December 31, 2007 (n=15) VALHALLA Center Name City State ALL CHILDREN'S HOSPITAL ST. PETERSBURG CHILDREN'S HOSPITAL & REGIONAL MEDICAL CENTER SEATTLE WA CHILDREN'S HOSPITAL OF MICHIGAN DETROIT MI CHILDREN'S HOSPITAL OF WISCONSIN MILWAUKEE WI CHILDRENS HOSPITAL LOS ANGELES LOS ANGELES CA LANCASTER GENERAL HOSPITAL MEMORIAL HOSPITAL LANCASTER CHATTANOOGA MIAMI CHILDREN'S HOSPITAL MIAMI FL NORTH CAROLINA BAPTIST HOSPITAL WINSTON SALEM ST. JOSEPH'S HOSPITAL AND MEDICAL CENTER PHOENIX AZ SUTTER MEMORIAL HOSPITAL SACRAMENTO CA THE CHILDREN'S HOSPITAL OF PHILADELPHIA PHILADELPHIA PA THE CHILDRENS HOSPITAL DENVER CO UNIVERSITY OF CALIFORNIA SAN FRANCISCO SAN FRANCISCO CA UNIVERSITY OF VIRGINIA HEALTH SYSTEM CHARLOTTESVILLE VA *Note: As of December 31, of the INTERMACS sites have been temporarily deactivated due to administrative and/or regulatory issues. One site has withdrawn. NY FL PA TN NC 6

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8 01/04/2008 Page 8 of 26 Note: Hospitals are allowed 60 days to enter a device implant into INTERMACS. Therefore the data for Oct & Nov will be incomplete. 8

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10 01/04/2008 Page 10 of 26 Note: Modifier A= Recurrent VT/VF. 10

11 01/04/2008 Page 11 of 26 Note: Modifier A= Recurrent VT/VF. 11

12 01/04/2008 Page 12 of 26 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. 12

13 01/04/2008 Page 13 of 26 Exhibit 9 Quarterly Summary of Retrospective/Prospective Retrospective and Prospective Patients by Quarter Patients Prospective Retrospective Qrtr 1 Mar 06 - May 07 Qrtr 2 Mar 06 - Aug 07 Qrtr 3 Mar 06 - Nov 07 Quarter 13

14 01/04/2008 Page 14 of 26 This table summarizes status of the patients based on data entered through November 30, 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. Explant 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. 14

15 01/04/2008 Page 15 of 26 15

16 01/04/2008 Page 16 of 26 Note: These primary cause of death tables are based on unadjudicated data. The Adverse Events Committee is currently adjudicating causes of death. Future summaries of causes of death will distinguish between adjudicated and unadjudicated causes of death. 16

17 01/04/2008 Page 17 of 26 Exhibit 12 Kaplan-Meier Survival: Death Implant Dates: June 23, 2006 November 30, 2007 % Survival Months % Survival 1 89% 3 79% 6 74% 9 72% Event: Death n=348, death = Months after Device Implant 17

18 % Survival Exhibit 13 Kaplan-Meier Survival: Device strategy at implant #HHSN C 01/04/2008 Page 18 of 26 Implant Dates: June 23, 2006 November 30, 2007 Device Strategy at Implant BTT = 272, death = 53 Event: Death Dest = 54, death = 12 p= Months after Device Implant 18

19 % Survival Exhibit 14 Kaplan-Meier Survival: Patient profile at implant #HHSN C 01/04/2008 Page 19 of 26 Implant Dates: June 23, 2006 November 30, 2007 Patient Profile at Implant Level 1 (Critical Cardiogenic Level 4 (Recurrent Advanced Shock), n=148, deaths=36 HF), n=29, deaths=3 Level 2 (Progessive Decline), n=128, deaths=26 p (overall) =.25 Event: Death Level 3 (Stable but Inotrope Dependent), n=26, deaths=3 Levels 5,6,7: All Others, n=17, deaths= Months after Device Implant 19

20 % Survival Exhibit 15 Kaplan-Meier Survival: Device type #HHSN C 01/04/2008 Page 20 of 26 Implant Dates: June 23, 2006 November 30, 2007 Device Type TAH n = 18, death=5 LVAD n=258, death=45 Bi-VAD n=67, death=19 20 RVAD n=5, death=3 10 Event: Death p < Months after Device Implant 20

21 Exhibit 16 Competing Outcomes: Death, transplant & recovery #HHSN C 01/04/2008 Page 21 of 26 Implant Dates: June 23, 2006 November 30, 2007 Proportion of Patients Alive (still waiting) 42% 40% Transplant 33% 34% 22% Death (before transplant) 23% 4% Explanted (recovery) 4% Months after Device Implant 21

22 Proportion of Patients Exhibit 17 Competing Outcomes: LVADs #HHSN C 01/04/2008 Page 22 of 26 Implant Dates: June 23, 2006 November 30, 2007 LVAD: n= Alive (still waiting) % Transplant 32% % Death (before transplant) 0.1 3% Explanted (recovery) Months after Device Implant 40% 39% 19% 3% 22

23 Proportion of Patients Exhibit 18 Competing Outcomes: Bi-VADs #HHSN C 01/04/2008 Page 23 of 26 Implant Dates: June 23, 2006 November 30, 2007 Bi-VAD: n= % Transplant Alive (still waiting) 32% % Death (before transplant) 0.1 9% Explanted (recovery) Months after Device Implant 47% 33% 11% 9% 23

24 01/04/2008 Page 24 of 26 Exhibit 19 Adverse Event Summary: Overall INTERMACS: June 23, 2006 November 30, 2007 Total Patients (n=348) Adverse Event Episodes (Pts) 30 days (pt) > 30 days (pt) Device Malfunction 46 (35) 13 (10) 33 (26) Bleeding 292 (131) 205 (113) 87 (41) Cardiac/Vascular Right Heart Failure 22 (22) 18 (18) 4 (4) Myocardial Infarction 1 (1) 1 (1) 0 Cardiac Arrhythmia 105(64) 80 (55) 25 (15) Pericardial Drainage 25 (20) 24 (19) 1 (1) Hypertension 67 (50) 23 (22) 44 (30) Arterial Non-CNS Thromb 6 (6) 2 (2) 4 (4) Venous Thromb Event 19 (15) 16 (14) 3 (3) Hemolysis 12(10) 6 (4) 6 (6) Infection 268 (126) 137 (81) 131(76) Neurological Dysfunction 79 (58) 52 (44) 27(21) Renal Dysfunction 75 (57) 69 (54) 6 (6) Hepatic Dysfunction 40 (32) 24 (21) 16(13) Respiratory Failure 107(77) 97 (70) 10(10) Other Wound Dehiscence 6 (5) 3 (2) 3 (3) Psychiatric Episode 32 (25) 9 (9) 23 (19) Other AEs 160 (95) 60 (43) 100 (62) Total AEs (prospective) 1525(308) Note: This table is based on unadjudicated data. The Adverse Events Committee is currently adjudicating events. Future summaries of adverse events will distinguish between adjudicated and unadjudicated adverse events. 24

25 01/04/2008 Page 25 of 26 Exhibit 20 Adverse Event Summary: LVAD INTERMACS: June 23, 2006 November 30, 2007 LVADs - Total Patients (n=258) Adverse Event Episodes (Pts) 30 days (pt) > 30 days (pt) Device Malfunction 33 (23) 8 (5) 25 (19) Bleeding 167 (81) 105 (67) 62 (28) Cardiac/Vascular Right Heart Failure 19 (19) 15 (15) 4 (4) Myocardial Infarction 1 (1) 1 (1) 0 Cardiac Arrhythmia 89 (54) 66 (45) 23 (14) Pericardial Drainage 14 (12) 23 (11) 1 (1) Hypertension 54 (37) 15 (14) 39 (25) Arterial Non-CNS Thromb 2 (2) 1 (1) 1 (1) Venous Thromb Event 17 (13) 14 (12) 3 (2) Hemolysis 4 (4) 1 (1) 3 (3) Infection 205 (91) 105 (56) 100 (56) Neurological Dysfunction 51 (39) 36 (30) 15 (15) Renal Dysfunction 44 (34) 38 (31) 6 (6) Hepatic Dysfunction 16 (13) 7 (7) 9 (7) Respiratory Failure 70 (49) 62 (44) 8 (8) Other Wound Dehiscence 6 (5) 3 (2) 3 (3) Psychiatric Episode 28 (21) 7 (7) 21 (17) Other AEs 100 (62) 25 (20) 75 (46) Total AEs (prospective) 1071 (223) Note: This table is based on unadjudicated data. The Adverse Events Committee is currently adjudicating events. Future summaries of adverse events will distinguish between adjudicated and unadjudicated adverse events. 25

26 01/04/2008 Page 26 of 26 Exhibit 21 Adverse Event Summary: BiVAD INTERMACS: June 23, 2006 November 30, 2007 BiVADs - Total Patients (n=67) Adverse Event Episodes (Pts) 30 days (pt) > 30 days (pt) Device Malfunction 12 (11) 5 (5) 7 (6) Bleeding 96 (38) 74 (35) 22 (10) Cardiac/Vascular Right Heart Failure 3 (3) 3 (3) 0 Myocardial Infarction Cardiac Arrhythmia 16 (10) 14 (10) 2 (1) Pericardial Drainage 6 (5) 6 (5) 0 Hypertension 7 (7) 4 (4) 3 (3) Arterial Non-CNS Thromb 4 (4) 1 (1) 3 (3) Venous Thromb Event 2 (2) 2 (2) 0 Hemolysis 6 (4) 4 (2) 2 (2) Infection 46 (25) 22 (18) 24 (14) Neurological Dysfunction 23 (16) 12 (11) 11 (5) Renal Dysfunction 19 (15) 19 (15) 0 Hepatic Dysfunction 20 (15) 14 (11) 6 (5) Respiratory Failure 30 (22) 29 (21) 1 (1) Other Wound Dehiscence Psychiatric Episode 2 (2) 0 2 (2) Other AEs 43 (23) 23 (16) 20 (13) Total AEs (prospective) 353 (64) Note: This table is based on unadjudicated data. The Adverse Events Committee is currently adjudicating events. Future summaries of adverse events will distinguish between adjudicated and unadjudicated adverse events. 26