CASE PRESENTATIONCASE · PDF fileCASE PRESENTATIONCASE PRESENTATION ... Evaluated the use of Ventricular Assist Devices in patients with endDevices in patients with end--stage heart

CASE PRESENTATIONCASE PRESENTATIONCASE PRESENTATIONCASE PRESENTATIONRavi Dhanisetty, M.D.Ravi Dhanisetty, M.D.

SUNY DownstateSUNY DownstateSUNY DownstateSUNY Downstate23 July 200923 July 2009

www.downstatesurgery.org

CASE PRESENTATIONCASE PRESENTATIONCASE PRESENTATIONCASE PRESENTATION

xxxx yr old female with chest pain foryr old female with chest pain for 33 days.days.xx xx yr old female with chest pain for yr old female with chest pain for 33 days. days.

Initially taken to outside hospitalInitially taken to outside hospitalInitially taken to outside hospital Initially taken to outside hospital 3 days history of chest pain, 3 days history of chest pain, shortness of breath andshortness of breath and orthopneaorthopneashortness of breath and shortness of breath and orthopneaorthopnea..

PMHxPMHx: HTN, DM: HTN, DM

EKG in ER EKG in ER ––DiffuseDiffuse ST elevationsST elevations andand q wavesq waves ininDiffuse Diffuse ST elevationsST elevations and and q wavesq waves in in leads V1 to V5.leads V1 to V5.


CASE PRESENTATIONCASE PRESENTATIONCASE PRESENTATIONCASE PRESENTATIONEmergently taken for cardiac catheterization.Emergently taken for cardiac catheterization.g yg y

Complete occlusion of Left Anterior Descending Complete occlusion of Left Anterior Descending Able to reAble to re--cannulate LAD and long segment cannulate LAD and long segment g gg gstent placed. stent placed. IntraIntra--aortic balloon pump placed.aortic balloon pump placed.

AntiAnti--coagulated and monitored in ICUcoagulated and monitored in ICUO h f 3 dO h f 3 d i di ii di iOver the course of 3 days Over the course of 3 days –– patients condition patients condition did not improve, required pressor support in did not improve, required pressor support in addition to IABPaddition to IABPaddition to IABP. addition to IABP.



Transferred to SUNY DownstateTransferred to SUNY Downstate –– CTCTTransferred to SUNY Downstate Transferred to SUNY Downstate CT CT surgery service.surgery service.Resuscitated on multiple pressors IABPResuscitated on multiple pressors IABPResuscitated, on multiple pressors, IABP, Resuscitated, on multiple pressors, IABP, with blood pressure of 80/40s, CVP of 22, with blood pressure of 80/40s, CVP of 22, Cardiac index of 1 8Cardiac index of 1 8 1 9 and SVR of1 9 and SVR ofCardiac index of 1.8 Cardiac index of 1.8 –– 1.9 and SVR of 1.9 and SVR of >1500.>1500.E h di d t tE h di d t tEchocardiogram: moderate to severe Echocardiogram: moderate to severe MR, minimal LV wall motion, EF 10%.MR, minimal LV wall motion, EF 10%.



HD #2HD #2 –– despite maximal inotropic anddespite maximal inotropic andHD #2 HD #2 despite maximal inotropic and despite maximal inotropic and IABP support, patient continued to be in IABP support, patient continued to be in shock with decreasing cardiac indexshock with decreasing cardiac indexshock with decreasing cardiac indexshock with decreasing cardiac index

P ti t d t t tP ti t d t t tPatient underwent sternotomy Patient underwent sternotomy CABG with RSVG to LADCABG with RSVG to LADLeft ventricular assist device implantation.Left ventricular assist device implantation.

Superior pulmonary vein to aortaSuperior pulmonary vein to aorta


CASE PRESENTATIONCASE PRESENTATIONCASE PRESENTATIONCASE PRESENTATIONPost Operative course: Post Operative course: pp

Maintained on heparin drip with hourly ACT monitoring.Maintained on heparin drip with hourly ACT monitoring.E ti l d d t t i l i t d i fE ti l d d t t i l i t d i fEntirely dependent on ventricular assist device for Entirely dependent on ventricular assist device for cardiac ouput. Remained on multiple pressors and intracardiac ouput. Remained on multiple pressors and intra--aortic balloon pump.aortic balloon pump.Patients condition did not progress to multiPatients condition did not progress to multi--organ failure.organ failure.POD #3 POD #3 –– all intravenous lines and IABP were changedall intravenous lines and IABP were changed

POD #6 POD #6 –– patient transferred to Westchester for patient transferred to Westchester for evaluation for destination therapy.evaluation for destination therapy.


M h i l Ci l tM h i l Ci l tMechanical Circulatory Mechanical Circulatory S t f th H tS t f th H tSupport of the Heart:Support of the Heart:

Ventricular Assist DevicesVentricular Assist DevicesVentricular Assist DevicesVentricular Assist DevicesRavi Dhanisetty, M.D.Ravi Dhanisetty, M.D.

SUNY DownstateSUNY DownstateSUNY DownstateSUNY Downstate23 July 200923 July 2009


OutlineOutlineOutlineOutlineHistoryHistoryyyIndicationsIndicationsPatient selection / risk managementPatient selection / risk managementD i tD i tDevice components:Device components:Device selectionDevice selection

Short termShort termLong termLong term

Surgical techniqueSurgical techniqueComplicationsComplicationsComplicationsComplicationsClinical resultsClinical resultsConclusions.Conclusions.


HistoryHistoryHistoryHistory1953 1953 –– Gibbon Gibbon –– first successful first successful cardiopulmonary bypasscardiopulmonary bypass1963 1963 –– DeBakey DeBakey –– first ventricular assist device first ventricular assist device f dif difor post op cardiac arrestfor post op cardiac arrest1966 1966 –– DeBakey DeBakey –– first successful VAD first successful VAD implanted postimplanted post operativelyoperativelyimplanted postimplanted post--operativelyoperatively1994 1994 –– FDA approval of VAD as bridge to FDA approval of VAD as bridge to transplantationtransplantationt a sp a tat ot a sp a tat o2001 2001 –– FDA approval of VAD for destination FDA approval of VAD for destination therapytherapy

DeBakey 2005DeBakey 2005


Heart FailureHeart FailureHeart FailureHeart Failure

Heart failure accounts for 250,000 deaths / yrHeart failure accounts for 250,000 deaths / yrHeart failure accounts for 250,000 deaths / yrHeart failure accounts for 250,000 deaths / yrAnnual cost of heart failure $60 billionAnnual cost of heart failure $60 billionAbout $23 billion spent on inpatient treatmentAbout $23 billion spent on inpatient treatmentAbout $23 billion spent on inpatient treatmentAbout $23 billion spent on inpatient treatmentLeading cause of hospitalization of patients over Leading cause of hospitalization of patients over 65 years old65 years old65 years old65 years oldDespite optimal medical management Despite optimal medical management ––

50% 5 yr mortality from diagnosis.50% 5 yr mortality from diagnosis.50% 5 yr mortality from diagnosis.50% 5 yr mortality from diagnosis.Demand for cardiac transplantation vs low Demand for cardiac transplantation vs low supply supply –– 2 2 –– 3000 transplants per year.3000 transplants per year.pp ypp y p p yp p y


Indications for VAD PlacementIndications for VAD PlacementIndications for VAD PlacementIndications for VAD Placement

Patient can no longer sustain adequatePatient can no longer sustain adequatePatient can no longer sustain adequate Patient can no longer sustain adequate systemic oxygen delivery to maintain systemic oxygen delivery to maintain normal endnormal end--organ function despite organ function despite g pg pmaximal medical therapy.maximal medical therapy.

“irreversible heart failure.”“irreversible heart failure.”

Can be used for both acute and chronic Can be used for both acute and chronic forms of heart failure.forms of heart failure.

DeBakey 2005DeBakey 2005..


Use of VADUse of VADUse of VAD Use of VAD

Bridge to myocardial recoveryBridge to myocardial recoveryB id t di t l t tiB id t di t l t tiBridge to cardiac transplantationBridge to cardiac transplantationDestination therapyDestination therapy in patients not eligible in patients not eligible for cardiac transplantation for cardiac transplantation


Patient SelectionPatient SelectionPatient SelectionPatient Selection

One of the most critical determinants ofOne of the most critical determinants ofOne of the most critical determinants of One of the most critical determinants of successful outcomes with VAD therapysuccessful outcomes with VAD therapyOperative risk weighted with potentialOperative risk weighted with potentialOperative risk weighted with potential Operative risk weighted with potential benefit from device. benefit from device.

Contraindications: Contraindications: Irreversible endIrreversible end--organ damageorgan damageIrreversible endIrreversible end organ damage organ damage Severe and unrecoverable neurologic injury Severe and unrecoverable neurologic injury Systemic sepsis or bacteremiaSystemic sepsis or bacteremiaSystemic sepsis or bacteremia Systemic sepsis or bacteremia

Aggarwal et al. 2008Aggarwal et al. 2008..


Multivariate analysis of 130 patients undergoing LVADMultivariate analysis of 130 patients undergoing LVADMultivariate analysis of 130 patients undergoing LVADMultivariate analysis of 130 patients undergoing LVADCumulative score ofCumulative score of

> 5 > 5 –– Operative mortality of 46 % Operative mortality of 46 % < 5< 5 –– 12%.12%. 5 5 12%.12%.

Other independent risk factors:Other independent risk factors:Age > 65 multiAge > 65 multi--organ failure right heart failure acute infarctionorgan failure right heart failure acute infarctionAge > 65, multiAge > 65, multi--organ failure, right heart failure, acute infarction.organ failure, right heart failure, acute infarction.

Rao et al. 2003Rao et al. 2003


Device SelectionDevice SelectionDevice SelectionDevice Selection

Anticipated endpoint of treatment (Anticipated endpoint of treatment (destination therapydestination therapyAnticipated endpoint of treatment (Anticipated endpoint of treatment (destination therapy, destination therapy,

bridge to transplantation, or myocardial recoverybridge to transplantation, or myocardial recovery) ) Expected duration of supportExpected duration of supportp ppp ppType of ventricular support (Type of ventricular support (right, left, biventricularright, left, biventricular))Patient factorsPatient factorsPatient factors Patient factors

Body size and habitus, blood type, and preexisting Body size and habitus, blood type, and preexisting contraindications to anticoagulation therapycontraindications to anticoagulation therapy

Surgeon and institution experience with a deviceSurgeon and institution experience with a device


SHORT TERM DEVICESSHORT TERM DEVICESSHORT TERM DEVICESSHORT TERM DEVICES

Ease of implantationEase of implantationEase of implantationEase of implantationShortShort--term term bridgebridge to recovery to recovery B idB id t t t i lt t t i lBridgeBridge to more permanent ventricular to more permanent ventricular assistance. assistance.

Disadvantages Disadvantages –– extracorporeal, require extracorporeal, require gg p , qp , qanticoagulation.anticoagulation.


SHORT TERM DEVICESSHORT TERM DEVICESSHORT TERM DEVICESSHORT TERM DEVICESCOUNTERPULSATIONCOUNTERPULSATION

IntraIntra--Aortic Balloon PumpAortic Balloon Pump

CENTRIFUGAL / AXIAL PUMPCENTRIFUGAL / AXIAL PUMPCENTRIFUGAL / AXIAL PUMPCENTRIFUGAL / AXIAL PUMPBioBio--medicus biopump, Sarns Centrifugal pump, St. Jude medicus biopump, Sarns Centrifugal pump, St. Jude Lifestream centrifugal pumpLifestream centrifugal pump

PercutaneousPercutaneousPercutaneousPercutaneousTandemHeart Percutaneous VAD (LA to fem art)TandemHeart Percutaneous VAD (LA to fem art)Impella Recovery deviceImpella Recovery device

PNEUMATIC PUMPSPNEUMATIC PUMPSAbiomed BVS 5000i: FDA ApprovedAbiomed BVS 5000i: FDA ApprovedAbiomed BVS 5000i: FDA ApprovedAbiomed BVS 5000i: FDA Approved


IntraIntra--Aortic Balloon PumpAortic Balloon PumpIntraIntra Aortic Balloon PumpAortic Balloon Pump1968: first use by Kantrowitz1968: first use by Kantrowitz1968: first use by Kantrowitz 1968: first use by Kantrowitz and colleagues.and colleagues.

C t l ti h i dC t l ti h i dCounterpulsation synchronized Counterpulsation synchronized to either EKG or arterial to either EKG or arterial waveforms waveforms

Reduction in myocardial work Reduction in myocardial work ((afterload reductionafterload reduction))((afterload reductionafterload reduction))Improvement in myocardial Improvement in myocardial oxygen (oxygen (augmentation of diastolic augmentation of diastolic blood pressure and coronary perfusionblood pressure and coronary perfusionblood pressure and coronary perfusion blood pressure and coronary perfusion pressurepressure) )


CENTRIFUGAL PUMPSCENTRIFUGAL PUMPSCENTRIFUGAL PUMPSCENTRIFUGAL PUMPS

Most commonly used wide availabilityMost commonly used wide availabilityMost commonly used, wide availability, Most commonly used, wide availability, ease of use, and relative low cost ease of use, and relative low cost compared to other devicescompared to other devicescompared to other devices.compared to other devices.Need systemic anticoagulation, not Need systemic anticoagulation, not portable and progressive development ofportable and progressive development ofportable, and progressive development of portable, and progressive development of interstitial edema secondary to capillary interstitial edema secondary to capillary leakleakleak.leak.


TandemHeart® PERCUTANEOUS left VADTandemHeart® PERCUTANEOUS left VAD

ExtraExtra--corporeal devicecorporeal devicePercutaneously placed venous catheter (21F)Percutaneously placed venous catheter (21F)Percutaneously placed venous catheter (21F) Percutaneously placed venous catheter (21F) through atrial septum into left atrium under through atrial septum into left atrium under echo guidance.echo guidance.Outflow into femoral arteryOutflow into femoral artery

Can provide flows upto 4 L/min, unloads the Can provide flows upto 4 L/min, unloads the heart, heart,

Ease of placement Ease of placement –– ideal for acutely ideal for acutely decompensated heart failure, post CPRdecompensated heart failure, post CPR

30 day mortality of 44% 30 day mortality of 44% -- postpost--MI cardiogenic MI cardiogenic shockshock

Bruckner BA. Et al. 2008Bruckner BA. Et al. 2008Graphic Graphic –– Cardiac Assist Inc. Cardiac Assist Inc.


Impella PERCUTANEOUS Left VADImpella PERCUTANEOUS Left VADImpella PERCUTANEOUS Left VADImpella PERCUTANEOUS Left VADUse in high risk coronary interventions Use in high risk coronary interventions and for post cardiotomy shockand for post cardiotomy shockp yp y

Smaller, less expensive, easier to place Smaller, less expensive, easier to place (no trans(no trans--septal puncture).septal puncture).

Used in low output cardiac output Used in low output cardiac output syndromesyndrome

Improves survival patients with residual Improves survival patients with residual f f /f f /cardiac function of > 1 L /min. cardiac function of > 1 L /min.

Windecker 2005. Windecker 2005. Siegenthaler et al 2004Siegenthaler et al 2004Siegenthaler et al. 2004.Siegenthaler et al. 2004.


Abiomed BVS 5000iAbiomed BVS 5000iAbiomed BVS 5000i Abiomed BVS 5000i Only FDA approved Only FDA approved device for acutedevice for acutedevice for acute device for acute postcardiotomy failure.postcardiotomy failure.Dual chambered Dual chambered pneumatically drivenpneumatically drivenpneumatically driven pneumatically driven extracorporeal pump.extracorporeal pump.Pulsatile flow up to 6 Pulsatile flow up to 6 L/minL/minEasily implanted, widely Easily implanted, widely available, used in available, used in community practices for community practices for y py pshort term support and short term support and transport.transport.

Aggarwal et al. 2008Aggarwal et al. 2008. .


LONG TERM DEVICESLONG TERM DEVICESLONG TERM DEVICESLONG TERM DEVICES

Bridge to transplantationBridge to transplantationBridge to transplantationBridge to transplantationDestination therapyDestination therapy

Smaller, intracorporeal devices, portable, Smaller, intracorporeal devices, portable, reliable, greater battery life.reliable, greater battery life.


LONG TERM DEVICESLONG TERM DEVICESLONG TERM DEVICESLONG TERM DEVICES

Pulsatile FlowPulsatile FlowPulsatile FlowPulsatile FlowHeartmate XVE Heartmate XVE Novacor Left Ventricular Assist systemNovacor Left Ventricular Assist systemyy

Newer inflow conduits w/ less thromboembolic eventsNewer inflow conduits w/ less thromboembolic events

Thoratec intracoporeal Ventricular Assist Device.Thoratec intracoporeal Ventricular Assist Device.Axial Flow Pumps (NonAxial Flow Pumps (Non--Pulsatile)Pulsatile)

Micromed Debakey VADMicromed Debakey VADJ ik 2000J ik 2000Jarvik 2000Jarvik 2000Heartmate IIHeartmate II


Heartmate VE LVAD Heartmate VE LVAD -- ComponentsComponents

Pulsatile FlowPulsatile Flow

Rose et al. 2001.Rose et al. 2001.


Heartmate VE LVADHeartmate VE LVADFDA approved as a bridge to transplantation and for FDA approved as a bridge to transplantation and for destination therapydestination therapyUsed in REMATCH trialUsed in REMATCH trialUsed in REMATCH trial.Used in REMATCH trial.Pulsatile flow up to 10 L /min with pump placed in prePulsatile flow up to 10 L /min with pump placed in pre--peritoneal pocket peritoneal pocket Need BSA of > 1.5 m2Need BSA of > 1.5 m2

T t d l th i t l f th tT t d l th i t l f th tTextured polyurethane internal surfaces that Textured polyurethane internal surfaces that encourages a pneudoencourages a pneudo--intima formation intima formation –– so no so no systemic antisystemic anti--coagulation.coagulation.

Extensive experience with over 4000 units implanted Extensive experience with over 4000 units implanted with duration up to 1800 dayswith duration up to 1800 dayswith duration up to 1800 days.with duration up to 1800 days.

Aggarwal et al. 2008Aggarwal et al. 2008


Novacor Left Ventricular Assist SystemNovacor Left Ventricular Assist SystemNovacor Left Ventricular Assist SystemNovacor Left Ventricular Assist SystemFirst successful bridge to First successful bridge to t l t tit l t titransplantation.transplantation.Similar to Heartmate, Similar to Heartmate, except needs except needs

ti l titi l tianticoagulation.anticoagulation.Excellent long term Excellent long term durability with low rates of durability with low rates of device failure ordevice failure ordevice failure or device failure or neurologic dysfunction.neurologic dysfunction.

D i d i INTREPIDD i d i INTREPIDDevice used in INTREPID Device used in INTREPID trial.trial.

A l t l 2008A l t l 2008Aggarwal et al. 2008.Aggarwal et al. 2008.


THORATEC PARACORPOREAL VADTHORATEC PARACORPOREAL VADTHORATEC PARACORPOREAL VADTHORATEC PARACORPOREAL VAD

ParaPara--corporealcorporealParaPara corporeal corporeal placement of pump placement of pump allows use in smaller allows use in smaller patient (as small as patient (as small as 17 kg).17 kg).Used in 2850 patients Used in 2850 patients with >60 % survival to with >60 % survival to transplantationtransplantationtransplantationtransplantation

Kukuy et al 2003Kukuy et al 2003Kukuy et al. 2003.Kukuy et al. 2003.


Axial Flow PumpsAxial Flow PumpsRotating impeller Rotating impeller –– continuous continuous nonnon--pulsatilepulsatile flow.flow.Smaller, use less energy, more durable, easy to Smaller, use less energy, more durable, easy to implant, and used in smaller patientsimplant, and used in smaller patientsDisadv Disadv –– lacks backup mechanisms, hemolysis lacks backup mechanisms, hemolysis secondary to shear forces potential for creatingsecondary to shear forces potential for creatingsecondary to shear forces, potential for creating secondary to shear forces, potential for creating negative intraventricular pressure and device negative intraventricular pressure and device thrombosis, air embolism, or arrhythmias.thrombosis, air embolism, or arrhythmias.Effect of nonEffect of non pulsatile flow on endpulsatile flow on end organ functionorgan functionEffect of nonEffect of non--pulsatile flow on endpulsatile flow on end--organ function organ function is not knownis not known..

C rrentl ndergoing clinical trialsC rrentl ndergoing clinical trialsCurrently undergoing clinical trials.Currently undergoing clinical trials.

Micromed Debakey VADMicromed Debakey VADJarvik 2000Jarvik 2000Jarvik 2000Jarvik 2000Heartmate IIHeartmate II

Aggarwal et al. 2008.Aggarwal et al. 2008.


MICROMEDMICROMED--DEBAKEY VADDEBAKEY VADMICROMEDMICROMED DEBAKEY VADDEBAKEY VAD(1980s) developed w/ (1980s) developed w/ collaboration with NASAcollaboration with NASAcollaboration with NASAcollaboration with NASA3 x 1.2 in, 95 gms.3 x 1.2 in, 95 gms.Need anticoagulationNeed anticoagulationNeed anticoagulationNeed anticoagulationFlow of 5 L/minFlow of 5 L/minPortability allows forPortability allows forPortability allows for Portability allows for greater patient greater patient rehabilitation.rehabilitation.

Kukuy et al. 2003Kukuy et al. 2003DeBakey 2005..DeBakey 2005..


Jarvik 2000Jarvik 2000Jarvik 2000Jarvik 2000Implanted via Left Implanted via Left thoracotomythoracotomyyyActual pumping chamber Actual pumping chamber is implanted within the left is implanted within the left ventricle ventricle

Newer version with Newer version with transcutaneous energy transcutaneous energy t ft ftransfer.transfer.

Aggarwal et al. 2008Aggarwal et al. 2008..


NewerNewer--generations and future generations and future d id idevicesdevices

Newer devices: Newer devices: Magnetic levitation technology Magnetic levitation technology Advanced energy systemsAdvanced energy systemsSmaller control consolesSmaller control consolesSmaller control consoles.Smaller control consoles.

Incor Left VAD: magneticallyIncor Left VAD: magnetically--actuated axial flow actuated axial flow g yg ypumppump

Heartmate III: magnetically suspendedHeartmate III: magnetically suspendedHeartmate III: magnetically suspended Heartmate III: magnetically suspended centrifugal pumpcentrifugal pump

Aggarwal et al. 2008Aggarwal et al. 2008


POSTPOST--OPERATIVE CAREOPERATIVE CAREPOSTPOST OPERATIVE CAREOPERATIVE CARE

Ensure proper/optimal device functionEnsure proper/optimal device functionEnsure proper/optimal device functionEnsure proper/optimal device functionAggressively treat right heart failure. Aggressively treat right heart failure. Decrease excessive afterloadDecrease excessive afterloadDecrease excessive afterloadDecrease excessive afterloadAntibiotic prophylaxis for 48 to 72 hoursAntibiotic prophylaxis for 48 to 72 hoursO ti i fl id b l / iO ti i fl id b l / iOptimize fluid balance w/ aggressive Optimize fluid balance w/ aggressive diuresisdiuresisE l ti l ti di ti lE l ti l ti di ti lEarly anticoagulation once mediastinal Early anticoagulation once mediastinal bleeding has subsided.bleeding has subsided.

Aggarwal et al 2008Aggarwal et al 2008Aggarwal et al. 2008.Aggarwal et al. 2008.


ComplicationsComplicationsBleeding Bleeding –– early and late early and late InfectionInfection

Most common cause of mortalityMost common cause of mortalityUp to 50% of patientsUp to 50% of patientsStaphylococcusStaphylococcus, , PseudomonasPseudomonas, , EnterococcusEnterococcus, and , and CandidaCandidayy

ThromboThrombo--embolic eventsembolic eventsRight Heart FailureRight Heart FailureRight Heart FailureRight Heart FailureDevice FailureDevice FailureImmunologic Effects and AllosensitizationImmunologic Effects and AllosensitizationImmunologic Effects and AllosensitizationImmunologic Effects and Allosensitization

Progressive defects in cellular immunity Progressive defects in cellular immunity –– increased risk of infectionincreased risk of infectionBB--cell activation cell activation –– sensitization to HLA antigens sensitization to HLA antigens

(66% t 6% i t t l t)(66% t 6% i t t l t)(66% to 6% prior to transplant)(66% to 6% prior to transplant)John et al. 2003.John et al. 2003.


Clinical TrialsClinical TrialsClinical TrialsClinical Trials

REMATCH (2001)REMATCH (2001)REMATCH (2001)REMATCH (2001)INTrEPID (2007)INTrEPID (2007)

Evaluated the use of Ventricular Assist Evaluated the use of Ventricular Assist Devices in patients with endDevices in patients with end--stage heart stage heart failure who are ineligible for failure who are ineligible for transplantation.transplantation.


REMATCH TrialREMATCH TrialREMATCH TrialREMATCH Trial129 patients with end129 patients with end--stage heart failure who stage heart failure who pp ggwere not eligible for transplantation.were not eligible for transplantation.Randomized to either LVAD or optimal medical Randomized to either LVAD or optimal medical hhtherapy.therapy.

Primary end point Primary end point –– mortalitymortality

LVAD Group:LVAD Group:48% reduction in mortality from any cause48% reduction in mortality from any cause48% reduction in mortality from any cause 48% reduction in mortality from any cause Higher qualityHigher quality--ofof--life and functional status life and functional status





INTrEPID TrialINTrEPID TrialINTrEPID TrialINTrEPID Trial

55 inotrope dependent patients with end55 inotrope dependent patients with end--stagestage55 inotrope dependent patients with end55 inotrope dependent patients with end stage stage heart failure who were ineligible for heart failure who were ineligible for transplantation randomized to LVAD or medical transplantation randomized to LVAD or medical therapytherapy

Primary endPrimary end--point point –– 6 month mortality6 month mortality

Conclusion LVAD provided survival advantageConclusion LVAD provided survival advantageRogers et al. 2007.Rogers et al. 2007.


INTrEPID TrialINTrEPID TrialINTrEPID TrialINTrEPID Trial

Rogers et al. 2007.Rogers et al. 2007.


INTrEPID Trial INTrEPID Trial –– Adverse OutcomesAdverse Outcomes

Rogers et al. 2007.Rogers et al. 2007.


ConclusionsConclusionsConclusionsConclusions

Mechanical circulatory support is an importantMechanical circulatory support is an importantMechanical circulatory support is an important Mechanical circulatory support is an important therapeutic option in treatment of both acute and therapeutic option in treatment of both acute and chronic heart failure.chronic heart failure.Currently, indications are limited for use as a Currently, indications are limited for use as a bridge to recovery and transplantation.bridge to recovery and transplantation.In certain situations (endIn certain situations (end--stage heart failure) can stage heart failure) can be a useful alternative to medical treatment.be a useful alternative to medical treatment.Devices still have many limitations due to Devices still have many limitations due to excessive frequency of adverse events, which excessive frequency of adverse events, which

d ith t h ld ith t h lmay decrease with newer technology.may decrease with newer technology.


QuestionsQuestionsQuestionsQuestions1.1. Most common complication of LVAD insertionMost common complication of LVAD insertionpp

a.a. BleedingBleedingb.b. InfectionInfectioncc ThromboThrombo--embolic eventsembolic eventsc.c. ThromboThrombo--embolic eventsembolic eventsd.d. Device failureDevice failure

2.2. Mechanical circulatory support can be used for Mechanical circulatory support can be used for ll f th f ll i tll f th f ll i tall of the following except.all of the following except.

a.a. As a bridge to recoveryAs a bridge to recoveryb.b. Bridge to transplantationBridge to transplantationg pg pc.c. Destination therapyDestination therapyd.d. Enhance normal cardiac function Enhance normal cardiac function


QuestionsQuestionsQuestionsQuestions3. Which of the following is an indication for mechanical 3. Which of the following is an indication for mechanical gg

circulatory support.circulatory support.a.a. Heart failure requiring diuretic therapyHeart failure requiring diuretic therapyb.b. Cardiogenic shock in a comatosed patientCardiogenic shock in a comatosed patientg pg pc.c. Heart failure with persistent dyspnea on excertionHeart failure with persistent dyspnea on excertiond.d. Cardiogenic shock that is refractory to inotropes and IABPCardiogenic shock that is refractory to inotropes and IABP

4 Which of the following factors affect device selection:4 Which of the following factors affect device selection:4. Which of the following factors affect device selection:4. Which of the following factors affect device selection:a.a. Goal and duration of therapyGoal and duration of therapyb.b. Surgeon and institution experienceSurgeon and institution experience

Patient factorsPatient factors including body habitus and sizeincluding body habitus and sizec.c. Patient factors Patient factors –– including body habitus and sizeincluding body habitus and sized.d. All of the aboveAll of the above


ReferencesReferencesReferencesReferencesAggarwal S et al. LongAggarwal S et al. Long--Term Mechanical Circulatory support. Cardiac Surgery in the Adult. 3Term Mechanical Circulatory support. Cardiac Surgery in the Adult. 3rdrd

Ed. New York: McGrawEd. New York: McGraw--Hill, 2008:1609Hill, 2008:1609--1628. 1628. ,,Bruckner, BA. Et al. Clinical experience with TandemHeart Percutaneous VAD as a bridge to Bruckner, BA. Et al. Clinical experience with TandemHeart Percutaneous VAD as a bridge to cardiac transplantation. Tex Heart Inst J. 2008; 35(4):447cardiac transplantation. Tex Heart Inst J. 2008; 35(4):447--450.450.DeBakey, ME. Development of Mechanical Heart Devices. Ann Thorac Surg 2005; 79.DeBakey, ME. Development of Mechanical Heart Devices. Ann Thorac Surg 2005; 79.John R, Lietz K, Schuster M, et al: Immunologic sensitization in recipients of left ventricular assist John R, Lietz K, Schuster M, et al: Immunologic sensitization in recipients of left ventricular assist devices. devices. J Thorac Cardiovasc SurgJ Thorac Cardiovasc Surg 2003; 125:578. 2003; 125:578. gg ;;Kukuy EL. Et al. LongKukuy EL. Et al. Long--Term Mechanical Circulatory support. Cardiac Surgery in the Adult. 3Term Mechanical Circulatory support. Cardiac Surgery in the Adult. 3rdrd Ed. Ed. 2003.2003.Rao V, Oz MC, Flannery MA, et al: Revised screening scale to predict survival after insertion of a Rao V, Oz MC, Flannery MA, et al: Revised screening scale to predict survival after insertion of a left ventricular assist device. left ventricular assist device. J Thorac Cardiovasc SurgJ Thorac Cardiovasc Surg 2003; 125:8552003; 125:855Rogers JG, Butler J, Lansman SL, et al. Chronic mechanical circulatory support for inotropeRogers JG, Butler J, Lansman SL, et al. Chronic mechanical circulatory support for inotrope--g , , , y pp pg , , , y pp pdependent heart failure patients who are not transplant candidates. Results of the INTrEPID trial. dependent heart failure patients who are not transplant candidates. Results of the INTrEPID trial. J Am Coll CardiolJ Am Coll Cardiol 2007; 50:7412007; 50:741--747. 747. Rose EA, Gelijns AC, Moskowitz AJ, et al: LongRose EA, Gelijns AC, Moskowitz AJ, et al: Long--term use of left ventricular assist device for endterm use of left ventricular assist device for end--stage heart failure. stage heart failure. N Engl J MedN Engl J Med 2001; 345:1435. 2001; 345:1435. Siegenthaler et al. Impella Recover microaxial left VAD reduces mortality for postcardiotomy Siegenthaler et al. Impella Recover microaxial left VAD reduces mortality for postcardiotomy f il thf il th t it i J Th C di SJ Th C di S 2004 127 8122004 127 812 822822failure: a threefailure: a three--center experience. center experience. J Thorac Cardiovasc SurgJ Thorac Cardiovasc Surg 2004; 127: 8122004; 127: 812--822.822.Windecker, S. Impella Assisted High risk percutaneous coronary intervention. Kar Med. 2005; Windecker, S. Impella Assisted High risk percutaneous coronary intervention. Kar Med. 2005; 8:1878:187--189.189.Zevitz, ME. Heart Failure. eMedicine, 2006.Zevitz, ME. Heart Failure. eMedicine, 2006.


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CASE PRESENTATIONCASE · PDF fileCASE PRESENTATIONCASE PRESENTATION ... Evaluated the use of Ventricular Assist Devices in patients with endDevices in patients with end--stage heart