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# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013INTERMACSInteragency Registry for MechanicallyAssisted Circulatory SupportQuarterly Statistical ReportCenters for Medicare & MedicaidServices2013 1st QuarterImplant and event dates: June 23, 2006 to March 31, 201306/24/2013Prepared 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.eduKathryn Hollifield at kathryn@uab.eduRyan S. Cantor at rcantor@uab.eduPage 1 of 27
# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013INTERMACS Quarterly ReportImplants: June 23, 2006 to March 31, 2013The Interagency Registry for Mechanically Assisted Circulatory Support is a North American registryestablished in 2005 for patients who are receiving mechanical circulatory support device therapy to treatadvanced heart failure. INTERMACSTM was established as a joint effort of the National Heart, Lung andBlood Institute (NHLBI), the Centers for Medicare and Medicaid Services (CMS), the Food and DrugAdministration (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 2254 patients 65 years old or older receivingprimary prospective implants between June 23, 2006 and March 31, 2013.Table of ContentsExhibit 1: Hospital Activation and Patient Enrollment - Patients 65 Years Old and Older . 3Exhibit 2: Participating Hospital Listing. 4Exhibit 3: Patient Demographics by Implant Period - Patients 65 Years Old and Older . 8Exhibit 4: Implants by Year by Device Strategy - Patients 65 Years Old and Older . 9Exhibit 5: Implants per Year by Device Type - Patients 65 Years Old and Older . 10Exhibit 6: Patient Profile at Time of Implant by Implant Period - Patients 65 Years Old and Older . 11Exhibit 7: Device Strategy at Time of Implant by Implant Period - Patients 65 Years Old and Older . 12Exhibit 8: Patient Profile by Device Strategy at Time of Implant - Patients 65 Years Old and Older . 13Exhibit 9: Patient Status by Device Strategy at Implant - Patients 65 Years Old and Older . 15Exhibit 10: Primary Cause of Death - Patients 65 Years Old and Older . 17Exhibit 11: Kaplan-Meier Survival for INTERMACS OVERALL - Patients 65 Years Old and Older . 18Exhibit 12: Kaplan-Meier Survival by Flow Type and Device - Patients 65 Years Old and Older . 19Exhibit 13: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) byImplant Era - Patients 65 Years Old and Older . 20Exhibit 14: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) byPre-Implant Device Strategy - Patients 65 Years Old and Older . 21Exhibit 15: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) byPre-Implant Patient Profile - Patients 65 Years Old and Older . 22Exhibit 16: Kaplan-Meier Survival for Continuous Flow LVADs (with or without RVAD implant at time of LVAD operation) byDevice Type - Patients 65 Years Old and Older . 23Exhibit 17: Competing Outcomes for Continuous Flow LVADs (without RVAD implant at time of LVAD operation) - Patients 65Years Old and Older. 24Exhibit 18: Competing Outcomes for Continuous Flow LVADs (with RVAD implant at time of LVAD operation) - Patients 65 YearsOld and Older . 25Exhibit 19: Adverse Event Rates for Patients Receiving a Primary Prospective Implant - Continuous Flow LVADs (with orwithout RVAD implant at time of LVAD operation) - Patients 65 Years Old and Older . 26Exhibit 20: Compliance. 27Page 2 of 27
# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013Exhibit 1: Hospital Activation and Patient Enrollment - Patients 65 Years Old and OlderBetween June 23, 2006 and March 31, 2013, 153 hospitals participated in INTERMACS and, ofthese, 129 hospitals actively contributed information on a total of 2254 patients. Cumulativepatient accrual and the number of participating hospitals over this time period are displayedbelow.Page 3 of 27
# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013Exhibit 2: Participating Hospital ListingAs of March 31, 2013 there were 153 hospitals participating in INTERMACS.HOSPITAL NAMECITYSTATEABBOTT NORTHWESTERN HOSPITALMINNEAPOLISMNABINGTON MEMORIAL HOSPITALABINGTONPAADVOCATE CHRIST MEDICAL CENTEROAK LAWNILALBANY MEDICAL CENTERALBANYNYALBERT EINSTEIN MEDICAL CENTERPHILADELPHIAPAALLEGHENY GENERAL HOSPITALPITTSBURGHPAANN & ROBERT H. LURIE CHILDREN’S HOSPITAL OF CHICAGOCHICAGOILBANNER GOOD SAMARITANPHOENIXAZBAPTIST HEALTH MEDICAL CENTERLITTLE ROCKARBAPTIST MEMORIAL HOSPITAL - MEMPHISMEMPHISTNBARNES-JEWISH HOSPITALST. LOUISMOBAYLOR UNIVERSITY MEDICAL CENTERDALLASTXBRIGHAM AND WOMEN'S HOSPITALBOSTONMABRYANLGH MEDICAL CENTERLINCOLNNECALIFORNIA PACIFIC MEDICAL CENTERSAN FRANCISCOCACARILION ROANOKE MEMORIAL HOSPITALROANOKEVACAROLINAS MEDICAL CENTERCHARLOTTENCCEDARS SINAI MEDICAL CENTERLOS ANGELESCACHILDREN'S HEALTHCARE OF ATLANTAATLANTAGACHILDREN'S HOSPITAL BOSTONBOSTONMACHILDREN'S HOSPITAL OF PITTSBURGHPITTSBURGHPACHILDREN'S HOSPITAL OF WISCONSINMILWAUKEEWICHILDREN'S MEDICAL CENTERDALLASTXCHRISTIANA CARE HEALTH SYSTEMNEWARKDECINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTERCINCINNATIOHCLEVELAND CLINICCLEVELANDOHCOLUMBIA PRESBYTERIAN - CHILDREN'S HOSPITAL OF NEW YORKNEW YORKNYCOLUMBIA UNIVERSITY MEDICAL CENTER-NY PRESBYTERIANNEW YORKNYDUKE UNIVERSITY MEDICAL CENTERDURHAMNCEDWARD HOSPITALNAPERVILLEILEMORY UNIVERSITY HOSPITALATLANTAGAFLORIDA HOSPITALORLANDOFLFROEDTERT & THE MEDICAL COLLEGE OF WISCONSINMILWAUKEEWIGEISINGER CLINICDANVILLEPAHACKENSACK UNIVERSITY MEDICAL CENTERHACKENSACKNJHAHNEMANN UNIVERSITY HOSPITALPHILADELPHIAPAHARTFORD HOSPITALHARTFORDCTHENRY FORD HOSPITALDETROITMIHOSPITAL OF THE UNIVERSITY OF PENNSYLVANIAPHILADELPHIAPAINLAND NORTHWEST THORACIC ORGAN TRANSPLANT PROGRAM - SACRED HEART MEDICALCENTERSPOKANEWAINOVA FAIRFAX HOSPITALFALLS CHURCHVAINTEGRIS BAPTIST MEDICAL CENTEROKLAHOMA CITYOKINTERMOUNTAIN HEART INSTITUTE-ARTIFICIAL HEART PROGRAMMURRAYUTJACKSON MEMORIAL HEALTH SYSTEM/UNIVERSITY OF MIAMIMIAMIFLJEWISH HOSPITALLOUISVILLEKYPage 4 of 27
# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013HOSPITAL NAMECITYSTATEKAISER SUNNYSIDE MEDICAL CENTERCLACKAMASORLANCASTER GENERAL HOSPITALLANCASTERPALANKENAU HOSPITALWYNNEWOODPALEHIGH VALLEY HEALTH NETWORKALLENTOWNPALOMA LINDA UNIVERSITY MEDICAL CENTER & CHILDREN'S HOSPITALLOMA LINDACALOYOLA UNIVERSITY MEDICAL CENTERMAYWOODILLUTHERAN HOSPITAL OF INDIANAFORT WAYNEINMAIMONIDES MEDICAL CENTERBROOKLYNNYMASSACHUSETTS GENERAL HOSPITALBOSTONMAMAYO CLINIC HOSPITALPHOENIXAZMAYO CLINIC JACKSONVILLEJACKSONVILLEFLMAYO CLINIC ROCHESTER MNROCHESTERMNMEDICAL CITY DALLAS HOSPITALDALLASTXMEDICAL UNIVERSITY OF SOUTH CAROLINACHARLESTONSCMEDICAL UNIVERSITY OF SOUTH CAROLINA MEDICAL CENTERCHARLESTONSCMEMORIAL HERMANN TEXAS MEDICAL CENTERHOUSTONTXMETHODIST HOSPITALINDIANPOLISINMETHODIST SPECIALTY AND TRANSPLANT HOSPITALSAN ANTONIOTXMID AMERICA HEART INSTITUTE OF SAINT LUKE'S HOSPITALKANSAS CITYMOMONTEFIORE MEDICAL CENTERBRONXNYMORRISTOWN MEMORIAL HOSPITAL - ATLANTIC HEALTHMORRISTOWNNJMOUNT SINAI MEDICALNEW YORKNYMULTICARE HEALTH SYSTEMSTACOMAWANEMOURS/A.I. DUPONT HOSPITAL FOR CHILDRENWILMINGTONDENEW YORK UNIVERSITY MEDICAL CENTERNEW YORKNYNEWARK BETH ISRAEL MEDICAL CENTERNEWARKNJNORTH CAROLINA BAPTIST HOSPITALWINSTON SALEMNCNORTHWESTERN MEMORIAL HOSPITALCHICAGOILOCHSNER MEDICAL CENTERNEW ORLEANSLAOREGON HEALTH & SCIENCE UNIVERSITYPORTLANDOROSF ST FRANCIS MEDICAL CENTERPEORIAILPALMETTO HEALTH RICHLANDCOLUMBIASCPENN PRESBYTERIAN MEDICAL CENTERPHILADELPHIAPAPENN STATE MILTON S. HERSHEY MEDICAL CENTERHERSHEYPAPIEDMONT HOSPITALATLANTAGAPROVIDENCE ST. VINCENT MEDICAL CENTERPORTLANDORROBERT WOOD JOHNSON UNIVERSITY HOSPITALNEW BRUNSWICKNJRUSH UNIVERSITY MEDICAL CENTERCHICAGOILSAINT JOSEPH'S HOSPITAL OF ATLANTA, INC.ATLANTAGASAINT THOMAS HOSPITALNASHVILLETNSCOTT & WHITE HOSPITALTEMPLETXSCRIPPS MEMORIAL HOSPITAL LA JOLLALA JOLLACASEATTLE CHILDREN'S HOSPITALSEATTLEWASENTARA NORFOLK GENERAL HOSPITALNORFOLKVASETON MEDICAL CENTER - AUSTINAUSTINTXSHANDS AT THE UNIVERSITY OF FLORIDAGAINESVILLEFLSHARP MEMORIAL HOSPITALSAN DIEGOCASPECTRUM HEALTH HOSPITALSGRAND RAPIDSMIST MARY'S HOSPITALRICHMONDVAST PAUL'S HOSPITALVANCOUVERBCPage 5 of 27
# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013HOSPITAL NAMECITYSTATEST PETERS HOSPITALALBANYNYST. LOUIS CHILDREN'S HOSPITALST. LOUISMOST. LUKE'S EPISCOPAL HOSPITAL / TEXAS HEART INSTITUTEHOUSTONTXST. LUKE'S MEDICAL CENTERMILWAUKEEWIST. VINCENT HOSPITAL AND HEALTH CARE CENTERINDIANAPOLISINSTANFORD UNIVERSITY MEDICAL CENTERSTANFORDCASTONY BROOK UNIVERSITY MEDICAL CENTERSTONY BROOKNYSUTTER MEMORIAL HOSPITALSACRAMENTOCATAMPA GENERAL HOSPITALTAMPAFLTEMPLE UNIVERSITY HOSPITALPHILADELPHIAPATEXAS CHILDREN'S HOSPITALHOUSTONTXTHE CHILDREN'S HOSPITAL OF PHILADELPHIAPHILADELPHIAPATHE CHILDRENS HOSPITALDENVERCOTHE CHRIST HOSPITALCINCINNATIOHTHE HEART HOSPITAL BAYLOR PLANOPLANOTXTHE INDIANA HEART HOSPITALINDIANAPOLISINTHE JOHNS HOPKINS HOSPITALBALTIMOREMDTHE MEDICAL CENTER OF CENTRAL GEORGIAMACONGATHE METHODIST HOSPITALHOUSTONTXTHE OHIO STATE UNIVERSITY MEDICAL CENTERCOLUMBUSOHTHE UNIVERSITY OF TOLEDOTOLEDOOHTHOMAS JEFFERSON UNIVERSITYPHILADELPHIAPATORONTO GENERAL HOSPITALTORONTOONTUFTS MEDICAL CENTERBOSTONMATULANE MEDICAL CENTERNEW ORLEANSLAUC HEALTH UNIVERSITY HOSPITALCINCINNATIOHUCLA MEDICAL CENTERLOS ANGELESCAUNIVERSITY HOSPITALS CASE MEDICAL CENTERCLEVELANDOHUNIVERSITY OF ALABAMA AT BIRMINGHAM HOSPITALBIRMINGHAMALUNIVERSITY OF ARIZONA MEDICAL CENTERTUCSONAZUNIVERSITY OF CALIFORNIA DAVIS MEDICAL CENTER (UCDMC)SACRAMENTOCAUNIVERSITY OF CALIFORNIA SAN FRANCISCOSAN FRANCISCOCAUNIVERSITY OF CALIFORNIA, SAN DIEGO MEDICAL CENTERSAN DIEGOCAUNIVERSITY OF CHICAGO HOSPITALSCHICAGOILUNIVERSITY OF COLORADO HOSPITALAURORACOUNIVERSITY OF IOWA HOSPITALS AND CLINICSIOWA CITYIAUNIVERSITY OF KENTUCKY CHANDLER MEDICAL CENTERLEXINGTONKYUNIVERSITY OF MARYLAND MEDICAL CENTERBALTIMOREMDUNIVERSITY OF MICHIGAN HEALTH SYSTEMSANN ARBORMIUNIVERSITY OF MINNESOTA MEDICAL CENTER-FAIRVIEWMINNEAPOLISMNUNIVERSITY OF NEBRASKA MEDICAL CENTEROMAHANEUNIVERSITY OF NORTH CAROLINA HOSPITALSCHAPEL HILLNCUNIVERSITY OF PITTSBURGH MEDICAL CENTERPITTSBUGHPAUNIVERSITY OF ROCHESTER MEDICAL CENTER (STRONG MEMORIAL HOSPITAL)ROCHESTERNYUNIVERSITY OF TEXAS MEDICAL BRANCHGALVESTONTXUNIVERSITY OF UTAH HOSPITALSALT LAKE CITYUTUNIVERSITY OF VIRGINIA HEALTH SYSTEMCHARLOTTESVILLE VAUNIVERSITY OF WASHINGTON MEDICAL CENTERSEATTLEWAUNIVERSITY OF WISCONSIN HOSPITAL AND CLINICSMADISONWIUSC UNIVERSITY HOSPITALLOS ANGELESCAPage 6 of 27
# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013HOSPITAL NAMECITYSTATEUT SOUTHWESTERN MEDICAL CENTERDALLASTXVANDERBILT UNIVERSITY MEDICAL CENTER - VANDERBILT HEART AND VASCULAR INSTITUTENASHVILLETNVIRGINIA COMMONWEALTH UNIVERSITY HEALTH SYSTEMRICHMONDVAWASHINGTON HOSPITAL CENTERWASHINGTONDCWEILL CORNELL MEDICAL CENTER/NEW YORK PRESBYTERIAN MEDICAL CENTERNEW YORKNYWESTCHESTER MEDICAL CENTERVALHALLANYYALE-NEW HAVEN HOSPITALNEW HAVENCTYORK HOSPITALYORKPAPage 7 of 27
# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013Exhibit 3: Patient Demographics by Implant Period - Patients 65 Years Old and OlderThe following tables present demographic characteristics for patients at the time of their primaryimplant (June 23, 2006 to March 31, 2013).GenderIMPLANT DATE PERIODGENDER 2010nFemale2010 - 2011%n2012 - 2013 (Jan-Mar)%n%TOTALn%4614.7 %15314.6 %14015.5 %339Male26685.2 %88885.3 %76184.4 %191515.0 %84.9 %TOTAL312100.0 %1041100.0 %901100.0 %2254100.0 %RaceIMPLANT DATE PERIODRACE 2010nAfrican American35Other, Unknown,Undisclosed2010 - 2011%n11.2 %2012 - 2013 (Jan-Mar)%83n7.9 %%84TOTALn9.3 %%2028.9 %165.1 %656.2 %616.7 %1426.2 %White26183.6 %89385.7 %75683.9 %191084.7 %TOTAL312100.0 %1041100.0 %901100.0 %2254100.0 %Age CategoryIMPLANT DATE PERIODAGE GROUP (yr) 2010n60-7980 TOTAL2010 - 2011%n2012 - 2013 (Jan-Mar)%n%TOTALn%312100.0 %101997.8 %87697.2 %2207.222.1 %252.7 %472.0 %312100.0 %1041100.0 %901100.0 %2254100.0 %Page 8 of 2797.9 %
# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013Exhibit 4: Implants by Year by Device Strategy - Patients 65 Years Old and OlderPage 9 of 27
# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013Exhibit 5: Implants per Year by Device Type - Patients 65 Years Old and OlderNumber of Implants by Device Type and Implant Date PeriodIMPLANT DATE PERIODDEVICE TYPE 2010n2010 - 2011%n2012 - 2013 (Jan-Mar)%n%TOTALn%LVAD27788.7 %101597.5 %88097.6 %217296.3 %BiVAD299.2 %262.4 %141.5 %693.0 %61.9 %.70.7 %130.5 %312100.0 %1041100.0 %901100.0 %2254100.0 %TAHTOTALPage 10 of 27
# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013Exhibit 6: Patient Profile at Time of Implant by Implant Period - Patients 65 Years Old andOlderPatient profile status provides a general clinical description of the patients at the time ofimplantation.IMPLANT DATE PERIODPATIENT PROFILE ATTIME OF IMPLANT 2010n2010 - 2011%n2012 - 2013 (Jan-Mar)%n%TOTALn%1 Critical Cardio Shock7524.0 %10810.3 %829.1 %26511.7 %2 Progressive Decline14446.1 %38536.9 %32035.5 %84937.6 %3 Stable but Inotropedependent4113.1 %30128.9 %27530.5 %61727.3 %4 Resting Symptoms3611.5 %18818.0 %15817.5 %38216.9 %5 Exertion intolerant103.2 %363.4 %424.6 %883.9 %6 Exertion limited30.9 %191.8 %141.5 %361.5 %7 Advanced NYHAClass 330.9 %40.3 %101.1 %170.7 %312100.0 %1041100.0 %901100.0 %2254100.0 %TOTAL1 Critical cardiogenic shock describes a patient who is 'crashing and burning', in which a patient has life-threateninghypotension and rapdily escalating inotropic pressor support.2 Progressive decline describes a patient who has been demonstrated 'dependent' on inotropic support butnonetheless shows signs of continuing deterioration.3 Stable but inotrope dependent: describes a patient who is clinically stable on mild-moderate doses of intravenousinotropes.4 Resting symptoms describes a patient who is at home on oral therapy but frequently has symptoms of congestionat rest or with ADL.5 Exertion Intolerant describes a patient who is comfortable at rest but unable to engage in any activity, livingpredominantly within the house or household.6 Exertion Limited also describes a patient who is comfortable at rest without evidence of fluid overload, but who isable 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.Page 11 of 27
# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013Exhibit 7: Device Strategy at Time of Implant by Implant Period - Patients 65 Years Oldand OlderDevice strategy is determined in conjunction with the heart failure cardiologist and surgeon at thetime of the implant.IMPLANT DATE PERIODDEVICE STRATEGY ATTIME OF IMPLANT 2010n2010 - 2011%n2012 - 2013 (Jan-Mar)%n%TOTALn%BTT - Listed11637.1 %12812.2 %859.4 %32914.5 %BTT - Likely7423.7 %918.7 %808.8 %24510.8 %BTT - Moderate4414.1 %514.8 %586.4 %1536.7 %BTT - Unlikely206.4 %454.3 %283.1 %934.1 %Destination Therapy5316.9 %71668.7 %64371.3 %141262.6 %Bridge to Recovery30.9 %60.5 %20.2 %110.4 %Rescue Therapy20.6 %20.1 %30.3 %70.3 %Other.20.1 %20.2 %40.1 %312100.0 %1041100.0 %901100.0 %2254100.0 %TOTAL1. Bridge to Transplant (BTT) Listed - patient already listed for transplant or listed within 24 hours before deviceimplantation.2. Bridge to Transplant (BTT) Likely - patient in whom the transplant evaluation has not been completed, but nocontra-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 withsome potential concerns that might prevent eligibility.4. Bridge to Transplant (BTT) Unlikely - patient in whom major concerns that might prevent eligibility have alreadybeen 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 3months in duration).7. Rescue Therapy - use of a durable device to support resolution from an acute event without major previouscardiac dysfunction.8. Other.Page 12 of 27
# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013Exhibit 8: Patient Profile by Device Strategy at Time of Implant - Patients 65 Years Old and OlderThe following tables present patient profile status by the device strategy for different time periods.OverallPre-Implant Device StrategyPATIENT PROFILE STATUSOVERALLBTT - Listedn%BTT - LikelynBTT - Moderate%nDestinationTherapyBTT - Unlikely%n%n%Bridge toRecoverynRescueTherapy%nOther%nTOTAL%n%1 Critical Cardio Shock5416.4 %4417.9 %2818.3 %1718.2 %1097.7 %545.4 %7 100.0 %125.0 %26511.7 %2 Progressive Decline16650.4 %8735.5 %6139.8 %3739.7 %49334.9 %327.2 %00250.0 %84937.6 %3 Stable but Inotrope dependent6319.1 %5120.8 %4126.7 %2324.7 %43730.9 %218.1 %000061727.3 %4 Resting Symptoms3410.3 %4116.7 %1711.1 %1212.9 %27619.5 %19.0 %00125.0 %38216.9 %5 Exertion intolerant72.1 %135.3 %42.6 %22.1 %624.3 %000000883.9 %6 Exertion limited41.2 %72.8 %21.3 %22.1 %211.4 %000000361.5 %7 Advanced NYHA Class 310.3 %20.8 %0000140.9 %000000170.7 %TOTAL329 100.0 %245 100.0 %153 100.0 %93 100.0 %1412 100.0 %11 100.0 %7 100.0 %4 100.0 % 2254 100.0 %IMPLANT DATE PERIOD 2010Pre-Implant Device StrategyPATIENT PROFILE STATUSOVERALLBTT - Listedn%BTT - LikelynBTT - Moderate%nDestinationTherapyBTT - Unlikely%n%n%Bridge toRecoverynRescueTherapy%n1 Critical Cardio Shock2420.6 %2027.0 %1125.0 %840.0 %815.0 %22 Progressive Decline5850.0 %3445.9 %1943.1 %840.0 %2547.1 %003 Stable but Inotrope dependent1714.6 %45.4 %715.9 %315.0 %916.9 %133.3 %4 Resting Symptoms119.4 %1317.5 %511.3 %15.0 %611.3 %05 Exertion intolerant43.4 %22.7 %24.5 %0023.7 %6 Exertion limited10.8 %11.3 %000017 Advanced NYHA Class 310.8 %0000002TOTAL116 100.0 %74 100.0 %44 100.0 %Page 13 of 2720 100.0 %n24.0 %00 14446.1 %004113.1 %0003611.5 %0000103.2 %1.8 %000030.9 %3.7 %000030.9 %3 100.0 %2 100.0 %%7553 100.0 %66.6 %TOTAL%2 100.0 % 312 100.0 %
# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013IMPLANT DATE PERIOD 2010 - 2011Pre-Implant Device StrategyPATIENT PROFILE STATUSOVERALLBTT - ListednBTT - Likely%nBTT - Moderate%nDestinationTherapyBTT - Unlikely%n%n%Bridge toRecoverynRescueTherapy%nOther%nTOTAL%n%1 Critical Cardio Shock1713.2 %1415.3 %917.6 %511.1 %598.2 %233.3 %2 100.0 %0010810.3 %2 Progressive Decline6550.7 %2123.0 %2039.2 %1942.2 %25635.7 %233.3 %002 100.0 %38536.9 %3 Stable but Inotrope dependent2922.6 %2628.5 %1529.4 %1226.6 %21830.4 %116.6 %000030128.9 %4 Resting Symptoms1310.1 %1920.8 %611.7 %715.5 %14219.8 %116.6 %000018818.0 %5 Exertion intolerant21.5 %99.8 %0012.2 %243.3 %000000363.4 %6 Exertion limited21.5 %22.1 %11.9 %12.2 %131.8 %000000191.8 %7 Advanced NYHA Class 30000000040.5 %00000040.3 %TOTAL128 100.0 %91 100.0 %51 100.0 %45 100.0 %716 100.0 %6 100.0 %2 100.0 %2 100.0 % 1041 100.0 %IMPLANT DATE PERIOD 2012 - 2013 (Jan-Mar)Pre-Implant Device StrategyPATIENT PROFILE STATUSOVERALLBTT - ListednBTT - Likely%n%BTT - Moderaten%DestinationTherapyBTT - Unlikelyn%n%Bridge toRecoverynRescueTherapy%nOther%nTOTAL%n%829.1 %1 Critical Cardio Shock1315.2 %1012.5 %813.7 %414.2 %426.5 %150.0 %3 100.0 %12 Progressive Decline4350.5 %3240.0 %2237.9 %1035.7 %21232.9 %150.0 %0000 32035.5 %3 Stable but Inotrope dependent1720.0 %2126.2 %1932.7 %828.5 %21032.6 %000000 27530.5 %4 Resting Symptoms1011.7 %911.2 %610.3 %414.2 %12819.9 %0000150.0 % 15817.5 %5 Exertion intolerant11.1 %22.5 %23.4 %13.5 %365.5 %000000424.6 %6 Exertion limited11.1 %45.0 %11.7 %13.5 %71.0 %000000141.5 %7 Advanced NYHA Class 30022.5 %000081.2 %000000101.1 %TOTAL85 100.0 %80 100.0 %58 100.0 %28 100.0 %643 100.0 %2 100.0 %3 100.0 %50.0 %2 100.0 % 901 100.0 %
# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013Exhibit 9: Patient Status by Device Strategy at Implant - Patients 65 Years Old andOlderThe following tables present patient status as of March 31, 2013 by the device strategy fordifferent 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.OverallPatient Status (March 31, 2013)PRE-IMPLANT DEVICESTRATEGY1. Alive(device inplace)2. Transplant3. Recovery4. DeadNNNNTOTALNBTT - Listed90159377329BTT - Likely10582157245BTT - Moderate7025058153BTT - Unlikely552135939283924431412Bridge to Recovery611311Rescue Therapy12137Other20024125731096782254Destination TherapyTOTALIMPLANT DATE PERIOD 2010Patient Status (March 31, 2013)PRE-IMPLANT DEVICESTRATEGY1. Alive(device inplace)2. Transplant3. Recovery4. DeadNNNNTOTALNBTT - Listed1266137116BTT - Likely104002474BTT - Moderate41102944BTT - Unlikely3011620Destination Therapy16503253Bridge to Recovery00123Rescue Therapy00112451224141312TOTALPage 15 of 27
# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013IMPLANT DATE PERIOD 2010 - 2011Patient Status (March 31, 2013)PRE-IMPLANT DEVICESTRATEGY1. Alive(device inplace)2. Transplant3. Recovery4. DeadNNNNTOTALNBTT - Listed3461231128BTT - Likely333302591BTT - Moderate231101751BTT - Unlikely29101545403252286716Bridge to Recovery50016Rescue Therapy11002Other0002252813243771041Destination TherapyTOTALIMPLANT DATE PERIOD 2012 - 2013 (Jan-Mar)Patient Status (March 31, 2013)PRE-IMPLANT DEVICESTRATEGY1. Alive(device inplace)2. Transplant3. Recovery4. DeadNNNNTOTALNBTT - Listed44320985BTT - Likely6291880BTT - Moderate43301258BTT - Unlikely231042850990125643Bridge to Recovery11002Rescue Therapy01023Other20002684561160901Destination TherapyTOTALPage 16 of 27
# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013Exhibit 10: Primary Cause of Death - Patients 65 Years Old and OlderIMPLANT DATE PERIODPRIMARY CAUSE OF DEATH 2010n2010 - 2011%n2012 - 2013 (Jan-Mar)%n%TOTALn%Circulatory: Arterial Non-CNS Thromboembolism32.1 %41.0 %10.5 %81.1 %Circulatory: CHF64.2 %174.3 %42.3 %273.8 %Circulatory: Cardiac Arrhythmia21.4 %143.5 %21.1 %182.5 %Circulatory: End Stage Cardiomyopathy10.7 %71.7 %31.7 %111.5 %Circulatory: Heart Disease.30.7 %21.1 %50.7 %Circulatory: Hemolysis.20.5 %10.5 %30.4 %Circulatory: Ischemic Cardiomyopathy10.7 %71.7 %21.1 %101.4 %107.0 %174.3 %74.0 %344.8 %Circulatory: Myocardial Infarction10.7 %41.0 %21.1 %70.9 %Circulatory: Other, Specify64.2 %71.7 %42.3 %172.4 %Circulatory: Pericardial Fluid Collection10.7 %.10.5 %20.2 %Circulatory: Right Heart Failure64.2 %215.3 %63.5 %334.7 %Circulatory: Sudden Unexplained Death53.5 %184.6 %42.3 %273.8 %Device Malfunction53.5 %143.5 %52.9 %243.4 %Digestive: Fluid/Electrolyte Disorder10.7 %20.5 %.30.4 %Digestive: GI Disorder.10.2 %31.7 %40.5 %Digestive: Hepatic Dysfunction21.4 %61.5 %10.5 %91.2 %Digestive: Pancreatitis10.7 %.10.1 %Digestive: Renal Dysfunction32.1 %82.0 %.111.5 %Major Infection2114.8 %4311.0 %84.6 %7210.2 %Multisystem Organ Failure107.0 %4311.0 %3621.0 %8912.6 %Nervous System: Neurological Dysfunction2920.5 %4912.5 %2414.0 %10214.5 %Other42.8 %266.6 %116.4 %415.8 %Other: Cancer10.7 %82.0 %21.1 %111.5 %Other: Trauma/accident, specify.20.5 %10.5 %30.4 %Psychiatric Episode/Suicide10.7 %.21.1 %30.4 %Respiratory: Pulmonary: Other, specify.51.2 %10.5 %60.8 %Respiratory: Respiratory Failure85.6 %164.1 %169.3 %405.7 %Unknown v2.385.6 %153.8 %.233.2 %Withdrawal of Support, specify53.5 %307.7 %2212.8 %578.1 %141100.0 %389100.0 %171100.0 %701100.0 %Circulatory: Major BleedingTOTALNote: 3 patients have a missing primary cause of death.* Certain pre-relaunch categories are no longer supported as of the v3.0 Launch (May 2012).Page 17 of 27
# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013Exhibit 11: Kaplan-Meier Survival for INTERMACS OVERALL - Patients 65 YearsOld and OlderNumber of Patients at RiskMonth0INTERMACS Overall62254 139512182430890591363204Page 18 of 27368842324816
# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013Exhibit 12: Kaplan-Meier Survival by Flow Type and Device - Patients 65 Years Oldand OlderNumber of Patients at RiskFlow Type andDeviceContinuous - LVADMonth062083 134212182430859572348190367742254810Continuous - BiVAD451713977522Pulsatile - LVAD8935211198876Pulsatile - BiVAD2422222111Pulsatile - TAH1331111111Page 19 of 27
# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013Exhibit 13: Kaplan-Meier Survival for Continuous Flow LVADs (with or withoutRVAD implant at time of LVAD operation) by Implant Era - Patients 65 Years Oldand OlderNumber of Patients at RiskImplant Era 20102010-20112012-2013 695042871403911891433106111111Page 20 of 2730364248
# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013Exhibit 14: Kaplan-Meier Survival for Continuous Flow LVADs (with or withoutRVAD implant at time of LVAD operation) by Pre-Implant Device Strategy - Patients65 Years Old and OlderBridge to Transplant (BTT) includes: BTT-listed, BTT-likely, BTT-moderately likely, andBTT-unlikely.Number of Patients at RiskPre-Implant DeviceStrategyMonth06121824Bridge to Transplant7384472711791187340199Destination Therapy13769045944012361234283Page 21 of 2730364248
# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013Exhibit 15: Kaplan-Meier Survival for Continuous Flow LVADs (with or withoutRVAD implant at time of LVAD operation) by Pre-Implant Patient Profile - Patients65 Years Old and OlderNumber of Patients at RiskPre-Implant Patient ProfileMonth06Level 1 - Critical Cardiogenic Shock21712212834735221485Level 2 - Progressive Decline7975033232131428132124Level 3 - Stable but Inotrope Dependent60540325717696522074Level 4 - Resting Symptoms37424115711266301121Levels 5,6,7 - All Others1359353371915811Page 22 of 27182430364248
# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013Exhibit 16: Kaplan-Meier Survival for Continuous Flow LVADs (with or withoutRVAD implant at time of LVAD operation) by Device Type - Patients 65 Years Oldand OlderNumber of Patients at RiskDeviceTypeLVADBiVADMonth062083 134245171218243085957234819077251013977522Page 23 of 27364248
# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013Exhibit 17: Competing Outcomes for Continuous Flow LVADs (without RVADimplant at time of LVAD operation) - Patients 65 Years Old and OlderNumber of Patients at RiskMonth0620831213421885924572Page 24 of 27303493619277
# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013Exhibit 18: Competing Outcomes for Continuous Flow LVADs (with RVAD implantat time of LVAD operation) - Patients 65 Years Old and OlderNumber of Patients at RiskMonth064512171813249Page 25 of 273073676
# HHSN268201100025CQuarterly Report – 2013 Q106/24/2013Exhibit 19: Adverse Event Rates for Patients Receiving a Primary ProspectiveImplant - Continuous Flow LVADs (with or without RVAD implant at time of LVADoperation) - Patients 65 Years Old and OlderThe following table summarizes adverse events in patients receiving primary prospectiveimplants between June 23, 2006 and March 31, 2013. Event count is the number ofepisodes observed for each event type allowing multiple episodes per patient. Patientcount is the number of patients experiencing at least one episode of a particular eventtype. 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 threemonths post-implant or after three months post-implant, respectively. Event rates arecalculated by dividing the number of episodes observed for each event type during aperiod 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 5603.575 patient months and
06/24/2013 Page 2 of 27 # HHSN268201100025C Quarterly Report - 2013 Q1 INTERMACS Quarterly Report Implants: June 23, 2006 to March 31, 2013 The Interagency Registry for Mechanically Assisted Circulatory Support is a North American registry
