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Cardiogenic Shock and Hemodynamic SupportCardiogenic Shock and Hemodynamic Support

Disclosure Information...Disclosure Information...The following relationships exist related to this presentation:The following relationships exist related to this presentation:

Research Grants:Research Grants: Berlex, Pfizer, Glaxo-Smith Kline, Aventis, Guidant, Eli-Lily, SciMed, J Berlex, Pfizer, Glaxo-Smith Kline, Aventis, Guidant, Eli-Lily, SciMed, J & J, Amersham Health, Otsuka, Esperion Therapeutics, Innercool & J, Amersham Health, Otsuka, Esperion Therapeutics, Innercool Therapies, AstraZenecaTherapies, AstraZeneca

Consultant/ Advisory Consultant/ Advisory Board:Board:

Innercool Therapies, Pfizer, Sanofi-Synthelabo, Inc., Bristol-Meyers Innercool Therapies, Pfizer, Sanofi-Synthelabo, Inc., Bristol-Meyers Squibb/Sanofi, Glaxo-Smith KlineSquibb/Sanofi, Glaxo-Smith Kline

Acknowledgement:Acknowledgement: Contributions from TCDMD (Gregg Stone, Don Baim, Dan Simon, Contributions from TCDMD (Gregg Stone, Don Baim, Dan Simon, Kandzari, Ted Feldman, Robert Sommer)Kandzari, Ted Feldman, Robert Sommer)

Future Directions for Future Directions for Interventional CardiologyInterventional Cardiology

Cindy L. Grines, M.D., F.A.C.C.Cindy L. Grines, M.D., F.A.C.C.Medical Director, Cardiac Catheterization LaboratoriesMedical Director, Cardiac Catheterization Laboratories

William Beaumont HospitalWilliam Beaumont Hospital

Royal Oak, Michigan, U.S.A.Royal Oak, Michigan, U.S.A.

Percutaneous InterventionPercutaneous Intervention2005 – 2025?2005 – 2025?

InterventionalInterventionalCardiologyCardiology

PeripheralPeripheralInterventionIntervention

CoronaryCoronaryInterventionIntervention Primary PCIPrimary PCI

For AMIFor AMI

MyocardialMyocardialPreservationPreservation

CongenitalCongenitalInterventionInterventionStructural andStructural and

ValvularValvular

IntramyocardialIntramyocardialTherapeuticsTherapeutics

InterventionalInterventionalCHFCHF

Neuro-Neuro-InterventionIntervention

InterventionalInterventionalRhythmRhythm

ManagementManagement Detection ofDetection ofVulnerableVulnerable

PlaquePlaque

Acute Myocardial InfarctionAcute Myocardial Infarction

Primary PCI superior to thrombolytic therapyPrimary PCI superior to thrombolytic therapy

Lack of availability of primary PCILack of availability of primary PCI

• Transfer to angioplasty centerTransfer to angioplasty center

• Angioplasty in diagnostic cath lab without surgery on Angioplasty in diagnostic cath lab without surgery on site (no SOS)site (no SOS)

Need to further improve tissue perfusion and Need to further improve tissue perfusion and preserve LV functionpreserve LV function

Percutaneous LV assist devicesPercutaneous LV assist devices

Potential Techniques for Myocardial Potential Techniques for Myocardial Preservation During AMIPreservation During AMI

Improve tissue perfusion (trials negative to date)Improve tissue perfusion (trials negative to date)• Facilitated pretreat with lytic +/- IIb/IIIaFacilitated pretreat with lytic +/- IIb/IIIa• Extract thrombus from lesionExtract thrombus from lesion• Prevent distal embolizationPrevent distal embolization

Prevent injury / alter metabolic state (most trials negative Prevent injury / alter metabolic state (most trials negative or equivocal)or equivocal)• Adenosine (70 µg/kg/min x 3 hrs)Adenosine (70 µg/kg/min x 3 hrs)• Glucose insulin – KGlucose insulin – K++

• Inhibit complementInhibit complement• Myocardiac coolingMyocardiac cooling• Hyperbaric oxygenHyperbaric oxygen

Repair injury (very small or non-randomized/blinded)Repair injury (very small or non-randomized/blinded)• Stem cellsStem cells• MyocytesMyocytes

Characteristics of PlaquesCharacteristics of PlaquesProne to RuptureProne to Rupture

Thin fibrous caps Thin fibrous caps (< 50 µm)(< 50 µm)

Lipid, macrophage-Lipid, macrophage-richrich

Smooth muscle cell Smooth muscle cell poorpoor

Detection of Vulnerable PlaquesDetection of Vulnerable Plaques

Technologies to PredictTechnologies to Predict“Vulnerable” Plaque“Vulnerable” Plaque

Higher resolution IVUSHigher resolution IVUS

Optical coherence tomographyOptical coherence tomography

InfraRed SpectroscopyInfraRed Spectroscopy

Thermal imagingThermal imaging

Endovascular MRIEndovascular MRI

Raman spectroscopyRaman spectroscopy

Pulse laser irradiationPulse laser irradiation

Fluorescence-mediated tomography (FMT)Fluorescence-mediated tomography (FMT)

Virtual Histology™ IVUSVirtual Histology™ IVUS

The software then displays the amount and The software then displays the amount and location of the different plaque components as location of the different plaque components as color coded images color coded images • Fibrous TissueFibrous Tissue• Fibro-fattyFibro-fatty• Necrotic CoreNecrotic Core• Dense CalciumDense Calcium

G Vince, A Nair, ATL, Volcano Therapeutics, Cleveland

Chronic Coronary DiseaseChronic Coronary Disease

Distal protection for saphenous vein graft Distal protection for saphenous vein graft interventionsinterventions

Drug eluting stentsDrug eluting stents

New methods of crossing chronic total New methods of crossing chronic total occlusionsocclusions

AngiogenesisAngiogenesis

• Growth factorsGrowth factors

• Gene therapyGene therapy

• Stem cellsStem cells

PercuSurge GuardWire Reduces Distal PercuSurge GuardWire Reduces Distal Embolization and MI in SaphenousEmbolization and MI in Saphenous

Vein Graft InterventionsVein Graft Interventions

Filter Based Distal Protection Allows Filter Based Distal Protection Allows Better VisualizationBetter Visualization

EMBOLI CAPTURE GUIDEWIRE SYSTEM

StentsStents Eliminate Recoil and Eliminate Recoil and RemodelingRemodeling

But neointimal proliferation is increased But neointimal proliferation is increased compared to balloon angioplastycompared to balloon angioplasty

Restenosis 20 – 30%Restenosis 20 – 30%Stent thrombosis 1%Stent thrombosis 1%

Potential Anti-Restenotic CompoundsPotential Anti-Restenotic Compounds

Drug-eluting Stents in 2004Drug-eluting Stents in 2004

Safety and Efficacy ProvenSafety and Efficacy ProvenT

AX

UT

AX

USS

Polyolefin derivative Polyolefin derivative PaclitaxelPaclitaxel ExpressExpress22

DrugDrug PolymerPolymer StentStent

Cyp

he

Cyp

he

rr

PEVA + PBMA blendPEVA + PBMA blendSirolimusSirolimus BX VelocityBX Velocity

DES: A Transforming TechnologyDES: A Transforming Technology

SYNTAX Randomized TrialSYNTAX Randomized Trial

Left main diseaseLeft main disease 3-vessel disease3-vessel disease

De novo disease acceptable for revascularizationDe novo disease acceptable for revascularizationN=3300N=3300

Led by Patrick Serruys Led by Patrick Serruys and Frederick Mohrand Frederick Mohr

andand/or/or

TAXUS PCITAXUS PCI CABGCABG

Randomize 1500

Primary NI endpoint – 1 year MACCEPrimary NI endpoint – 1 year MACCE All cause death, MI, cerebrovascular All cause death, MI, cerebrovascular

events, repeat revascularization events, repeat revascularization

PCIPCIregistryregistryN=50 N=50

CABGCABGregistryregistry N=2750N=2750

123

FREEDOM Trial (NHLBI)FREEDOM Trial (NHLBI)Eligibility: DM patients with MV-CAD eligible for stent or surgeryEligibility: DM patients with MV-CAD eligible for stent or surgery

Exclude:Exclude: Patients with acute STEMI, cardiogenic shock, LMPatients with acute STEMI, cardiogenic shock, LM

MV DES stentingMV DES stenting(Cypher or TAXUS) (Cypher or TAXUS)

and abciximab and abciximab

MV DES stentingMV DES stenting(Cypher or TAXUS) (Cypher or TAXUS)

and abciximab and abciximab

CABG with or withoutCABG with or withoutcardiopulmonary cardiopulmonary

bypassbypass

CABG with or withoutCABG with or withoutcardiopulmonary cardiopulmonary

bypassbypass

PRIMARY Endpoint:PRIMARY Endpoint: 3-year death, MI, stroke 3-year death, MI, strokeSECONDARY Endpoints:SECONDARY Endpoints: 12-month MACCE, 3-year Quality of Life 12-month MACCE, 3-year Quality of Life

N=2400 at 100 centers from N=2400 at 100 centers from NA, SA, EU, Rand. 1:1NA, SA, EU, Rand. 1:1

PI:PI: Valentin Fuster Valentin Fuster

FFUTURE UTURE REREVASCULARIZATION VASCULARIZATION EEVALUATIONVALUATIONIN PATIENTS WITH IN PATIENTS WITH DDIABETES MELLITUS:IABETES MELLITUS:

OOPTIMAL MANAGEMENT OF PTIMAL MANAGEMENT OF MMULTIVESSEL DISEASEULTIVESSEL DISEASE

Mortality (%)

TrialSuccess

(n)Failure

(n)Duration of

Follow-up (y) Success FailureP

Value

British Columbia Cardiac Registries1 1118 340 1

Suero et al. 20012 1491 514 10

Total Occlusion Angioplasty Study—Societá Italiana di Cardiologia Invasiva (TOAST-GISE)3

286 83 6

Chronic Total Coronary Occlusion - Should They Be Opened? Support for The Late Open

Artery Hypothesis

10.0

26.5

1.1 3.6

35.0

19.0 <.001

.001

.13

1. Ramanathan K et al. Circulation. 2001;104:II-415. 2. Suero JA et al. J Am Coll Cardiol. 2001;38:409-414. 3. Olivari Z, et al. J Am Coll Cardiol. 2003;41:1672-1678.

CTO RevascularizationEvolving Technology and Strategy

Guidewire Tapered tip: CROSS IT®, Conquest, Miracle Steerable guidewire Optical coherence reflectometry

Ablative Excimer laserUltrasound Radiofrequency ablation

Mechanical Blunt microdissection FibrinolysisDemineralization, collagenase

Re-Entry Percutaneous bypass

Post-Crossing

Drug-eluting stentsDistal protection

Chronic Total OcclusionsNew Solutions To Old Problems

Safe-Cross® System

No Artery Wall Detected Artery Wall Detected No Artery Wall Detected

Source: IntraLuminal Therapeutics, Inc., Carlsbad, California.

Chronic Total OcclusionsNew Solutions To Old Problems

Frontrunner® X39 Catheter

Source: LuMend, Inc., Redwood City, California.

CTO RevascularizationAlternative Technologies

Reprinted with permission from Strauss BH et al. Circulation. 2003;108:1259-1262.

Placebo at 24 Hours

450 µg Collagenase at 24 Hours

Collagenase Plaque Digestion

Structural Heart DiseaseStructural Heart Disease

Left atrial appendage closure – reduce risk of LA Left atrial appendage closure – reduce risk of LA thrombus and stroke in atrial fibrillation patientsthrombus and stroke in atrial fibrillation patients

CongenitalCongenital• PFOPFO• ASDASD

ValvularValvular• Balloon valvuloplastyBalloon valvuloplasty• Percutaneous AVR for aortic stenosisPercutaneous AVR for aortic stenosis• Percutaneous mitral ring for mitral regurgitationPercutaneous mitral ring for mitral regurgitation

When to Intervene:When to Intervene:Transcatheter Closure of Atrial Septal DefectTranscatheter Closure of Atrial Septal Defect

Indications:Indications:• Clinical symptomsClinical symptoms• Dilated RV in absence of symptomsDilated RV in absence of symptoms• Need for transvenous pacemaker, scuba diver, Need for transvenous pacemaker, scuba diver,

altitude workaltitude work

ContraindicationsContraindications• Pulmonary hypertension with cyanosis at restPulmonary hypertension with cyanosis at rest• Sinus venous or primum-type ASDSinus venous or primum-type ASD• PregnancyPregnancy

When To Intervene: PFOWhen To Intervene: PFO

Indicated: Patients with multiple neuro events Indicated: Patients with multiple neuro events despite medical therapydespite medical therapy

Controversial: After first neurologic event Controversial: After first neurologic event (multi-center trials in progress)(multi-center trials in progress)

Systemic embolizationSystemic embolization

Not yet approved: Migraine patients (national Not yet approved: Migraine patients (national studies later this year)studies later this year)

Not indicated: Incidental finding on TEENot indicated: Incidental finding on TEE

Atrial Septal Defect ClosureAtrial Septal Defect ClosureResultsResults

Nearly 40,000 implants worldwide since 1993Nearly 40,000 implants worldwide since 1993

Closure rate nearly 100% when device implantedClosure rate nearly 100% when device implanted

With learning curve, device implanted in > 95%With learning curve, device implanted in > 95%

Rare complications: Arrhythmia, thrombosis, Rare complications: Arrhythmia, thrombosis, erosionerosion

Amplatzer FDA approval 9/2001Amplatzer FDA approval 9/2001

Balloon Valvotomy In Mitral StenosisBalloon Valvotomy In Mitral Stenosis

LocationLocation ClassClass

Class II-IV, MVA < 1.5 cm, favorable morphology, Class II-IV, MVA < 1.5 cm, favorable morphology, no LA clot and no moderate-to-severe MRno LA clot and no moderate-to-severe MR II

Asymptomatic, MVA < 1.5, PASP > 50 mm at rest Asymptomatic, MVA < 1.5, PASP > 50 mm at rest or 60 mm with exerciseor 60 mm with exercise IIaIIa

Class III-IV, MVA < 1.5 cm, calcified valve, high Class III-IV, MVA < 1.5 cm, calcified valve, high risk for MVRrisk for MVR IIaIIa

Asymptomatic, MVA < 1.5 cm, new atrial fib.Asymptomatic, MVA < 1.5 cm, new atrial fib. IIbIIb

Class III-IV, MVA < 1.5 cm, calcified valve, low Class III-IV, MVA < 1.5 cm, calcified valve, low surgical risksurgical risk IIbIIb

Mild MSMild MS IIIIII

ACC/AHA Task Force.ACC/AHA Task Force. JACC 1998;32:1486JACC 1998;32:1486

Double Balloon TechniqueDouble Balloon Technique

Balloon Valvuloplasty in The Young Balloon Valvuloplasty in The Young (≤ 21 yrs)(≤ 21 yrs) With Congenital With Congenital Aortic Stenosis & Normal C.O.Aortic Stenosis & Normal C.O.

IndicationIndication ClassClass

Angina, syncope, DOE with peak gradient > 50 Angina, syncope, DOE with peak gradient > 50 mmHgmmHg II

Cath peak gradient > 60 mmHgCath peak gradient > 60 mmHg II

New onset ECG changes at rest or with exercise New onset ECG changes at rest or with exercise with gradient > 50 mmwith gradient > 50 mm II

Gradient > 50 mm, patient desires competitive Gradient > 50 mm, patient desires competitive sports or pregnancysports or pregnancy IIaIIa

Cath gradient < 50 mm, no symptoms or ECG Cath gradient < 50 mm, no symptoms or ECG changeschanges IIIIII

ACC/AHA Task Force.ACC/AHA Task Force. JACC 1998;32:1486JACC 1998;32:1486

Major Points: ValvuloplastyMajor Points: Valvuloplasty

Percutaneous mitral commissurotomy is the therapy of Percutaneous mitral commissurotomy is the therapy of choice for most patients with predominant mitral choice for most patients with predominant mitral stenosis.stenosis.

• Randomized comparisons with surgery show no advantages to Randomized comparisons with surgery show no advantages to surgical commissurotomysurgical commissurotomy

Congenital AS in patients <21 years old should be Congenital AS in patients <21 years old should be treated with balloon valvuloplasty (Class I)treated with balloon valvuloplasty (Class I)

There are no Class I indications for aortic valvuloplasty There are no Class I indications for aortic valvuloplasty in adult patientsin adult patients

• Bridge to surgery in hemodynamically unstable high-risk Bridge to surgery in hemodynamically unstable high-risk patients for AVR (IIa)patients for AVR (IIa)

• Palliation in patients with serious comorbid conditions (IIb)Palliation in patients with serious comorbid conditions (IIb)

• Prior to urgent non-cardiac surgery (IIb)Prior to urgent non-cardiac surgery (IIb)

AntegradeAntegrade

TransseptalTransseptal

ApproachApproach

Future Directions of Interventional Future Directions of Interventional CardiologyCardiology

Improve survival with AMIImprove survival with AMI• Increase access to proceduresIncrease access to procedures • Myocardial preservation, improve tissue perfusionMyocardial preservation, improve tissue perfusion

• Detection and treatment of vulnerable plaquesDetection and treatment of vulnerable plaques

Increase number of patients eligible for percutaneous Increase number of patients eligible for percutaneous coronary interventions - left main, 3-vessel, CTOcoronary interventions - left main, 3-vessel, CTO

Improve safety of PCI and longevity of saphenous vein Improve safety of PCI and longevity of saphenous vein graftgraft

Reduce need for open-heart proceduresReduce need for open-heart procedures• Percutaneous treatment of structural heart diseasePercutaneous treatment of structural heart disease

Gene and stem cell therapiesGene and stem cell therapies• Angiogenesis and myogenesisAngiogenesis and myogenesis