Quarterly Statistical Report - University Of Alabama At Birmingham

Transcription

#HHSN268200548198C01/04/2008 Page 1 of 26INTERMACSInteragency Registry for MechanicallyAssisted Circulatory SupportQuarterly Statistical ReportImplant dates: March 1, 2006 – November 30, 2007January 4, 2008Prepared by:The Data Collection and Analysis CenterUniversity of Alabama at BirminghamFor questions or comments contact:James K. Kirklin, MD at jkirklin@uab.eduDavid C. Naftel, Ph.D at dnaftel@uab.eduSusan L. Myers at slm@uab.eduMary Lynne Clark at mlclark@uab.eduStephen “Craig” Collum at ccollum@uab.edu1

#HHSN268200548198C01/04/2008 Page 2 of 26Table of Contents:Tables and FiguresProspective and Retrospective patients (n 430)1. Hospital Enrollment Summary Plot32. Site Enrollment Listing43. Demographics74. Month of Implant by device position85. Device strategy at decision of implant96. Patient profile at time of implant107. Patient profile by device strategy at time of implant118. Month of Implant by Retrospective/Prospective129. Quarterly Summaries of Retrospective/Prospective13Prospective patients (n 348)10. Device strategy at time of implant: patient status1411. Primary Cause of Death1512. Kaplan-Meier Survival: Death1713. Kaplan-Meier Survival: Device strategy at implant1814. Kaplan-Meier Survival: Patient profile at implant1915. Kaplan-Meier Survival: Device type2016. Competing Outcomes: Death, transplant & recovery2117. Competing Outcomes: LVADs2218. Competing Outcomes: Bi-VADs2319. Adverse Event Summary: Overall2420. Adverse Event Summary: LVADs2521. Adverse Event Summary: BiVADs262

#HHSN268200548198C01/04/2008 Page 3 of 26Exhibit 1INTERMACS Hospital EnrollmentHospital Enrollment and Patient Summary: Dec 31, 2007Year 19080Year 3Year 4Year 520001800TodayCurrent Activated Hospitals,n 85605016001400120010004080030600Current Hospitals PendingActivation, n 2120400AccruedPatients, n 43010Year 10June 1, 2005Year 2June 1, 2006Year 3June 1, 2007Year 4June 1, 2008# Patients Accrued70# HospitalsYear 2Launch date100200Year 5June 1, 20090June 1, 2010Contract Time LineActivated Centers: These centers have completed and are current in status withthe 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 theircurrent enrollment information including IRB review.Accrued Patients: Total number of implants entered into INTERMACS Registry3

#HHSN268200548198C01/04/2008 Page 4 of 26Exhibit 2Site Enrollment ListingSites Ever Activated in INTERMACS as of December 31, 2007 (n 91)*Center NameCityStateADVOCATE CHRIST MEDICAL CENTEROAK LAWNILALLEGHENY GENERAL HOSPITALPITTSBURGHPAARKANSAS CHILDREN'S HOSPITALLITTLE ROCKARBAPTIST HEALTH MEDICAL CENTERLITTLE ROCKARBAPTIST MEMORIAL HOSPITAL - MEMPHISMEMPHISTNBARNES-JEWISH HOSPITALST. LOUISMOBAYLOR UNIVERSITY MEDICAL CENTERDALLASTXBRIGHAM AND WOMEN'S HOSPITALBOSTONMACALIFORNIA PACIFIC MEDICAL CENTERSAN FRANCISCOCACAROLINAS MEDICAL CENTERCHARLOTTENCCEDARS SINAI MEDICAL CENTERLOS ANGELESCACHILDREN'S HEALTHCARE OF ATLANTAATLANTAGACHILDREN'S HOSPITAL BOSTONBOSTONMACHILDREN'S HOSPITAL OF PITTSBURGHPITTSBURGHPACHILDREN'S MEDICAL CENTERDALLASTXCINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTERCINCINNATIOHCLEVELAND CLINICCLEVELANDOHCOLUMBIA PRESBYTERIAN - CHILDREN'S HOSPITAL OF NEW YORKNEW YORKNYCOLUMBIA UNIVERSITY MEDICAL CENTER-NY PRESBYTERIANNEW YORKNYDUKE UNIVERSITY MEDICAL CENTERDURHAMNCEMORY UNIVERSITY HOSPITALATLANTAGAHAHNEMANN UNIVERSITY HOSPITALPHILADELPHIAPAHENRY FORD HOSPITALDETROITMIHOSPITAL OF THE UNIVERSITY OF PENNSYLVANIAPHILADELPHIAPAINLAND NORTHWEST THORACIC ORGAN TRANSPLANT PROGRAM, SACRED HEART MEDICALSPOKANEWAINOVA FAIRFAX HOSPITALFALLS CHURCHVAINTEGRIS BAPTIST MEDICAL CENTEROKLAHOMA CITYOKJACKSON MEMORIAL HEALTH SYSTEM/UNIVERSITY OF MIAMIMIAMIFLJEWISH HOSPITALLOUISVILLEKYLANKENAU HOSPITALWYNNEWOODPALDS HOSPITALMURRAYUTLOYOLA UNIVERSITY MEDICAL CENTERMAYWOODILLUTHERAN HOSPITAL OF INDIANAFORT WAYNEINMAINE MEDICAL CENTERPORTLANDMEMASSACHUSETTS GENERAL HOSPITALBOSTONMAMAYO CLINIC HOSPITALPHOENIXAZMEDICAL CITY DALLAS HOSPITALDALLASTXMEDICAL UNIVERSITY OF SOUTH CAROLINACHARLESTONSCMETHODIST HOSPITALINDIANPOLISINMETHODIST SPECIALTY AND TRANSPLANT HOSPITALSAN ANTONIOTXMID AMERICA HEART INSTITUTE OF SAINT LUKE'S HOSPITALKANSAS CITYMOMONTEFIORE MEDICAL CENTERBRONXNY4

#HHSN268200548198C01/04/2008 Page 5 of 26Center NameCityStateMOUNT SINAI MEDICALNEW YORKNYNEMOURS/A.I. DUPONT HOSPITAL FOR CHILDRENWILMINGTONDENEW YORK UNIVERSITY MEDICAL CENTERNEW YORKNYNEWARK BETH ISRAEL MEDICAL CENTERNEWARKNJNORTHWESTERN MEMORIAL HOSPITALCHICAGOILOCHSNER MEDICAL CENTERNEW ORLEANSLAOREGON HEALTH & SCIENCE UNIVERSITYPORTLANDOROSF ST FRANCIS MEDICAL CENTERPEORIAILPENN STATE MILTON S. HERSHEY MEDICAL CENTERHERSHEYPAPROVIDENCE HEART AND VASCULAR INSTITUTEPORTLANDORRUSH UNIVERSITY MEDICAL CENTERCHICAGOILSAINT MARYS / MAYO CLINICROCHESTERMNSENTARA NORFOLK GENERAL HOSPITALNORFOLKVASETON MEDICAL CENTERAUSTINTXSHANDS AT THE UNIVERSITY OF FLORIDAGAINESVILLEFLSHARP MEMORIAL HOSPITALSAN DIEGOCAST LUKE'S HOSPITAL/ MAYO CLINIC JACKSONVILLEJACKSONVILLEFLST. LOUIS CHILDREN'S HOSPITALST. LOUISMOST. LUKE'S EPISCOPAL HOSPITAL / TEXAS HEART INSTITUTEHOUSTONTXST. LUKE'S MEDICAL CENTERMILWAUKEEWIST. VINCENT HOSPITAL AND HEALTH CARE CENTERINDIANAPOLISINSTANFORD UNIVERSITY MEDICAL CENTERSTANFORDCATAMPA GENERAL HOSPITALTAMPAFLTEMPLE UNIVERSITY HOSPITALPHILADELPHIAPATEXAS CHILDREN'S HOSPITALHOUSTONTXTHE JOHNS HOPKINS HOSPITALBALTIMOREMDTHE METHODIST HOSPITALHOUSTONTXTHE OHIO STATE UNIVERSITY MEDICAL CENTERCOLUMBUSOHTUFTS-NEW ENGLAND MEDICAL CENTERBOSTONMAUCLA MEDICAL CENTERLOS ANGELESCAUNIVERSITY HEALTH CARESALT LAKE CITYUTUNIVERSITY HOSPITALS CASE MEDICAL CENTERCLEVELANDOHUNIVERSITY OF ALABAMA AT BIRMINGHAM HOSPITALBIRMINGHAMALUNIVERSITY OF ARIZONA MEDICAL CENTERTUCSONAZUNIVERSITY OF CHICAGO HOSPITALSCHICAGOILUNIVERSITY OF COLORADO HOSPITALAURORACOUNIVERSITY OF IOWA HOSPITALS AND CLINICSIOWA CITYIAUNIVERSITY OF MARYLAND MEDICAL CENTERBALTIMOREMDUNIVERSITY OF MICHIGAN HEALTH SYSTEMSANN ARBORMIUNIVERSITY OF MINNESOTA MEDICAL CENTER-FAIRVIEWMINNEAPOLISMNUNIVERSITY OF NORTH CAROLINA HOSPITALSCHAPEL HILLNCUNIVERSITY OF PITTSBURGH MEDICAL CENTERPITTSBUGHPAUNIVERSITY OF ROCHESTER MEDICAL CENTER (STRONG MEMORIAL HOSPITAL)ROCHESTERNYUNIVERSITY OF WISCONSIN HOSPITAL AND CLINICSMADISONWIUT SOUTHWESTERN MEDICAL CENTERDALLASTXVIA CHRISTI REGIONAL MEDICAL CENTERWICHITAKSVIRGINIA COMMONWEALTH UNIVERSITY HEALTH SYSTEMRICHMONDVA5

#HHSN268200548198C01/04/2008 Page 6 of 26Center NameCityStateWASHINGTON HOSPITAL CENTERWASHINGTONDCWESTCHESTER MEDICAL CENTERVALHALLANYSites Pending Initial Activation in INTERMACS as of December 31, 2007 (n 15)Center NameCityStateALL CHILDREN'S HOSPITALST. PETERSBURGFLCHILDREN'S HOSPITAL & REGIONAL MEDICAL CENTERSEATTLEWACHILDREN'S HOSPITAL OF MICHIGANDETROITMICHILDREN'S HOSPITAL OF WISCONSINMILWAUKEEWICHILDRENS HOSPITAL LOS ANGELESLOS ANGELESCALANCASTER GENERAL HOSPITALLANCASTERPAMEMORIAL HOSPITALCHATTANOOGATNMIAMI CHILDREN'S HOSPITALMIAMIFLNORTH CAROLINA BAPTIST HOSPITALWINSTON SALEMNCST. JOSEPH'S HOSPITAL AND MEDICAL CENTERPHOENIXAZSUTTER MEMORIAL HOSPITALSACRAMENTOCATHE CHILDREN'S HOSPITAL OF PHILADELPHIAPHILADELPHIAPATHE CHILDRENS HOSPITALDENVERCOUNIVERSITY OF CALIFORNIA SAN FRANCISCOSAN FRANCISCOCAUNIVERSITY OF VIRGINIA HEALTH SYSTEMCHARLOTTESVILLEVA*Note: As of December 31, 2007 - 6 of the INTERMACS sites have been temporarily deactivated due to administrative and/orregulatory issues. One site has withdrawn.6

#HHSN268200548198C01/04/2008 Page 7 of 267

#HHSN268200548198C01/04/2008 Page 8 of 26Note: Hospitals are allowed 60 days to enter a device implant into INTERMACS.Therefore the data for Oct & Nov will be incomplete.8

#HHSN268200548198C01/04/2008 Page 9 of 269

#HHSN268200548198C01/04/2008 Page 10 of 26Note: Modifier A “Recurrent VT/VF”.10

#HHSN268200548198C01/04/2008 Page 11 of 26Note: Modifier A “Recurrent VT/VF”.11

#HHSN268200548198C01/04/2008 Page 12 of 26DefinitionRetrospective Retrospective patients are those patients who were implanted at a siteprior to that site’s initial activation date.Prospective Prospective patients are those patients who were implanted at a site onor after that site’s initial activation date.After discussions with the individual sites, we learned that the sites were unable to enterany retrospective patients who had died prior to the site’s activation date due to theinability to obtain informed consent. Therefore, these patients are currently excludedfrom all analyses that ‘involve’ time-related major events.12

#HHSN268200548198C01/04/2008 Page 13 of 26Exhibit 9Quarterly Summary of Retrospective/ProspectivePatientsRetrospective and Prospective Patients by 82Qrtr 1Mar 06 - May 07Qrtr 2Mar 06 - Aug 07Qrtr 3Mar 06 - Nov 07Quarter13ProspectiveRetrospective

#HHSN268200548198C01/04/2008 Page 14 of 26This table summarizes status of the patients based on dataentered through November 30, 2007. The three statusvariables are mutually exclusive:Patient Status Dead: This column summarizes all deathsafter implant and prior to transplant or explant for recovery.Transplant Status Yes: This column summarizes alltransplants.Explant Status Yes: This column summarizes all explantsfor recovery. Patients who died post-“recovery” or weretransplanted post-“recovery” are not included in the death ortransplant columns.14

#HHSN268200548198C01/04/2008 Page 15 of 2615

#HHSN268200548198C01/04/2008 Page 16 of 26Note: These ‘primary cause of death’ tables are based on unadjudicated data.The Adverse Events Committee is currently adjudicating causes of death. Futuresummaries of causes of death will distinguish between adjudicated andunadjudicated causes of death.16

#HHSN268200548198C01/04/2008 Page 17 of 26Exhibit 12Kaplan-Meier Survival: DeathImplant Dates: June 23, 2006 – November 30, 20071009080n 348, death 72% Survival70605020Months136910Event: Death40300012% Survival89%79%74%72%3456789Months after Device Implant1710 11 12

#HHSN268200548198C01/04/2008 Page 18 of 26Exhibit 13Kaplan-Meier Survival: Device strategy at implantImplant Dates: June 23, 2006 – November 30, 2007Device Strategy at Implant10090Dest 54, death 1280% Survival70BTT 272, death 5360504030201000p .81Event: Death123456789Months after Device Implant1810 11 12

#HHSN268200548198C01/04/2008 Page 19 of 26Exhibit 14Kaplan-Meier Survival: Patient profile at implantImplant Dates: June 23, 2006 – November 30, 2007Patient Profile at Implant100Level 3 (Stable but InotropeDependent), n 26, deaths 39080% Survival706050Level 1 (Critical CardiogenicLevel 4 (Recurrent AdvancedShock), n 148, deaths 36HF), n 29, deaths 3 Level 2 (Progessive Decline),n 128, deaths 2640Levels 5,6,7: All Others, n 17,deaths 330p (overall) .25201000Event: Death123456789Months after Device Implant1910 11 12

#HHSN268200548198C01/04/2008 Page 20 of 26Exhibit 15Kaplan-Meier Survival: Device typeImplant Dates: June 23, 2006 – November 30, 2007Device Type10090LVAD n 258, death 4580% Survival7060Bi-VAD n 67, death 195040TAH n 18, death 53020RVAD n 5, death 3p .00011000Event: Death123456789Months after Device Implant2010 11 12

#HHSN268200548198C01/04/2008 Page 21 of 26Exhibit 16Competing Outcomes: Death, transplant & recoveryImplant Dates: June 23, 2006 – November 30, 20071.0Proportion of Patients0.90.80.7Alive (still waiting)0.60.542%0.440%34%Transplant 33%0.322% Death (before transplant)0.20.10.004%1234523%Explanted (recovery)6789Months after Device Implant2110 11 124%

#HHSN268200548198C01/04/2008 Page 22 of 26Exhibit 17Competing Outcomes: LVADsImplant Dates: June 23, 2006 – November 30, 2007LVAD: n 2581.0Proportion of Patients0.90.80.7Alive (still waiting)0.646%0.50.40.3Death (before transplant)19%0.219%0.10.0040%39%Transplant 32%3%12345Explanted (recovery)6789Months after Device Implant2210 11 123%

#HHSN268200548198C01/04/2008 Page 23 of 26Exhibit 18Competing Outcomes: Bi-VADsImplant Dates: June 23, 2006 – November 30, 2007Bi-VAD: n 671.0Proportion of Patients0.90.80.70.60.526% Transplant47%0.40.3Alive (still waiting)0.226%Death (before transplant)0.10.0033%32%Explanted (recovery)9%123456789Months after Device Implant2311%9%10 11 12

#HHSN268200548198C01/04/2008 Page 24 of 26Exhibit 19Adverse Event Summary: OverallINTERMACS: June 23, 2006 – November 30, 2007Total Patients (n 348)Adverse EventEpisodes (Pts)Device MalfunctionBleedingCardiac/VascularRight Heart FailureMyocardial InfarctionCardiac ArrhythmiaPericardial DrainageHypertensionArterial Non-CNS ThrombVenous Thromb EventHemolysisInfectionNeurological DysfunctionRenal DysfunctionHepatic DysfunctionRespiratory FailureOtherWound DehiscencePsychiatric EpisodeOther AEsTotal AEs (prospective) 30 days (pt) 30 days (pt)46 (35)292 (131)13 (10)205 (113)33 (26)87 (41)22 (22)1 (1)105(64)25 (20)67 (50)6 (6)19 (15)12(10)268 (126)79 (58)75 (57)40 (32)107(77)18 (18)1 (1)80 (55)24 (19)23 (22)2 (2)16 (14)6 (4)137 (81)52 (44)69 (54)24 (21)97 (70)4 (4)025 (15)1 (1)44 (30)4 (4)3 (3)6 (6)131(76)27(21)6 (6)16(13)10(10)6 (5)32 (25)160 (95)1525(308)3 (2)9 (9)60 (43)3 (3)23 (19)100 (62)Note: This table is based on unadjudicated data. TheAdverse Events Committee is currently adjudicating events.Future summaries of adverse events will distinguish betweenadjudicated and unadjudicated adverse events.24

#HHSN268200548198C01/04/2008 Page 25 of 26Exhibit 20Adverse Event Summary: LVADINTERMACS: June 23, 2006 – November 30, 2007LVADs - Total Patients (n 258)Adverse EventEpisodes (Pts)Device MalfunctionBleedingCardiac/VascularRight Heart FailureMyocardial InfarctionCardiac ArrhythmiaPericardial DrainageHypertensionArterial Non-CNS ThrombVenous Thromb EventHemolysisInfectionNeurological DysfunctionRenal DysfunctionHepatic DysfunctionRespiratory FailureOtherWound DehiscencePsychiatric EpisodeOther AEsTotal AEs (prospective) 30 days (pt) 30 days (pt)33 (23)167 (81)8 (5)105 (67)25 (19)62 (28)19 (19)1 (1)89 (54)14 (12)54 (37)2 (2)17 (13)4 (4)205 (91)51 (39)44 (34)16 (13)70 (49)15 (15)1 (1)66 (45)23 (11)15 (14)1 (1)14 (12)1 (1)105 (56)36 (30)38 (31)7 (7)62 (44)4 (4)023 (14)1 (1)39 (25)1 (1)3 (2)3 (3)100 (56)15 (15)6 (6)9 (7)8 (8)3 (2)7 (7)25 (20)3 (3)21 (17)75 (46)6 (5)28 (21)100 (62)1071 (223)Note: This table is based on unadjudicated data. TheAdverse Events Committee is currently adjudicating events.Future summaries of adverse events will distinguish betweenadjudicated and unadjudicated adverse events.25

#HHSN268200548198C01/04/2008 Page 26 of 26Exhibit 21Adverse Event Summary: BiVADINTERMACS: June 23, 2006 – November 30, 2007BiVADs - Total Patients (n 67)Adverse EventEpisodes (Pts)Device MalfunctionBleedingCardiac/VascularRight Heart FailureMyocardial InfarctionCardiac ArrhythmiaPericardial DrainageHypertensionArterial Non-CNS ThrombVenous Thromb EventHemolysisInfectionNeurological DysfunctionRenal DysfunctionHepatic DysfunctionRespiratory FailureOtherWound DehiscencePsychiatric EpisodeOther AEsTotal AEs (prospective) 30 days (pt) 30 days (pt)12 (11)96 (38)5 (5)74 (35)7 (6)22 (10)3 (3)016 (10)6 (5)7 (7)4 (4)2 (2)6 (4)46 (25)23 (16)19 (15)20 (15)30 (22)3 (3)014 (10)6 (5)4 (4)1 (1)2 (2)4 (2)22 (18)12 (11)19 (15)14 (11)29 (21)002 (1)03 (3)3 (3)02 (2)24 (14)11 (5)06 (5)1 (1)02 (2)43 (23)353 (64)0023 (16)02 (2)20 (13)Note: This table is based on unadjudicated data. TheAdverse Events Committee is currently adjudicating events.Future summaries of adverse events will distinguish betweenadjudicated and unadjudicated adverse events.26

13. Kaplan-Meier Survival: Device strategy at implant 18 . 14. Kaplan-Meier Survival: Patient profile at implant 19 . TER TUCSON AZ : UNIVERSITY OF CHICAGO HOSPITALS . CHICAGO : IL . UNIVERSITY OF COLORADO HOSP: ITAL AURO. RA CO: . PHOENIX . AZ . SUTTER MEMORIAL HOSPITA: L SACRAME. NTO CA THE CHILDREN'S HOSPITAL OF PHILADELPHIA PHIL: