heart failure device therapy

Newer advancements in heart failure device therapy

» DR. GOPI KRISHNA

NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY

Introduction• Heart failure prevalence is rising throughout the world.• The reasons for this pandemic include

• the aging populations of both industrialized and developing nations;

• a growing incidence of obesity, diabetes, and hypertension .

• improved survival after myocardial infarction; and success in preventing sudden cardiac death .

• Fortunately, therapies that have emerged during the past few decades can greatly improve outcomes in heart failure patients.

Prevalence rates of heart failure by gender and age in the United States

Data from American Heart Association: Heart Disease and Stroke StatisticsNEWER ADVANCES IN HEART FAILURE

DEVICE THERAPY

Stages of Heart Failure

management

• I.C.D• C.R.T.-P/D.• TEMPERORY SUPPORT DEVICES.• PERMENENT SUPPORT DEVICES.• OTHER SUPPORT DEVICES.

CHF-STAT GESICA SOLVD V-HeFT I MERIT-HF CIBIS-II CARVEDILOL-US

Total Mortality

Sudden Death

Total Mortality ~15-40%; SCD accounts for ~50% of the total deaths.

12 months 16 months41.4 months 27 months 13 months45 months 6 months

I.C.DSCD Rates in CHF Patients with LV Dysfunction

Evolution of ICD Therapy: 1980 to Present

10,000

20,000

30,000

40,000

50,000

60,000

70,000

80,000

90,000

1980 1985 1990 1995 2000 2005

Number of Worldwide ICD Implants Per Year

First Human Implant

FDA Approval of ICDs

•Transvenous Leads•Biphasic Waveform

Smaller Devices

Dual-Chamber ICDsSize ReductionAVIDCASHCIDS

AT Therapies MUSTT

ICDs with Cardiac Resynch

1997/8

Tiered Therapy MADIT

Steroid-eluting Leads Increased Diagnostic and

Memory Capacity

MADIT-II

2004 SCD-HeFT

COMPANION

Cardiac resynchronistion therapy

0 60 120 180 240 300 360

Duration (msec)

90 120

120 170

170 220

• QRS duration is an independent predictor of mortality (>140 ms)

• Other factors are: age, creatinine, EF, and HR

SCD in Heart FailureSCD in Heart Failure

Cardiac resynchronistion therapy

Right AtrialLead

Right VentricularLead

Left VentricularLead

Achieving Cardiac Resynchronization

Goal: Atrial synchronous biventricular pacing

Transvenous approach for left ventricular lead via coronary sinus

Back-up epicardial approach

Right AtrialLead

Right VentricularLead

Left VentricularLead

Cumulative Enrollment in Cardiac Cumulative Enrollment in Cardiac Resynchronization Randomized Resynchronization Randomized

TrialsTrials

1999 2000 2001 2002 2003 2004 2005

Results Presented

PATH CHF

MUSTIC SR

MUSTIC AF

MIRACLE

CONTAK CD

MIRACLE ICD

PATH CHF II

COMPANION

MIRACLE ICD II

CARE HF

NEWER ADVANCES IN HEART NEWER ADVANCES IN HEART FAILURE DEVICE THERAPYFAILURE DEVICE THERAPY

Anatomical Challenges

• Enlarged right atrium• Abnormal CS location• Presence of valves in CS• Altered CS angulation • Acute branch take offs • Tortuous vessel anatomy

CRT Procedure and Device Related Risks relative to CS placement

• CS lead dislogdement 8%• CS dissection or perforation 5%• Failure of lead placement 8%• Phrenic nerve stimulation 2%

– ALL other risks associated with pacer or ICD implantation and anesthesia in these patients.

The 3 levels of asynchrony

1. Intraventricular asynchrony is best treated by placing the LV lead in the best anatomic location-usually the lateral or posterolateral (proven my multiple studies). Get the LV working.

2. Interventricular asynchrony is dealt with by adjusting the V-V interval. Get the RV and the LV to work together.

3. A-V asynchrony is dealt with by adjusting the A-V interval. Get the atria and the ventricles working together.

Extending indications to class II

• REVERSE. • MADIT-CRT.• RAFT

The HF clinical composite response.

Linde C Europace 2009;11:v72-v76

Mean LVESVi, LVEDVi, and LVEF at baseline and 12-month follow-up in the CRT-OFF and CRT-ON groups.

. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY

Time to first HF hospitalization or death in the 18-month follow-up period in the CRT-OFF and CRT-ON groups.

. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY

Other trials

• rethinQ• PROSPECT trial.

Assist devices

• Percutaneous.• Implanted.

I.A.B.P balloon

I.A.B.P

Indications for Intraaortic Balloon Pump Counterpulsation

complications

• vascular compromise• aortic dissection,• aortoiliac laceration, • femoral artery pseudoaneurysm• retroperitoneal hemorrhage, • renal ischemia from malposition, • myocardial ischemia from poor timing of balloon

augmentation,• deep wound infection requiring operative débridement

TANDEM HEART

IMPELLA LP2.5 SYSTEM

Effect of IABP and Impella 2.5 device on important hemodynamic parameters

Contraindications• 1. Mural thrombus in the left ventricle• 2. The presence of a mechanical aortic valve device• 3. Moderate aortic stenosis or moderate to severe aortic

insufficiency • 4. Abnormalities of the aorta that would preclude surgery,

including aneurysms and extreme tortuosity or calcifications.

• 5. Renal failure (creatinine>4 mg/dL)• 6. Liver dysfunction or markedly abnormal coagulation

parameters.• 7. Recent (within 3 months) stroke or transient ischemic attack

THE REITAN CATHETER PUMP

PUMP IMPLANTATION HEMODYNAMIC EFFECTS

Algorithm for device selection.

PERMENENT V.A.D.

History of lvad

Mechanical Circulatory Support

Mechanical Circulatory SupportINDICATION NOMENCLATURE DEFINITION

Bridge to transplantation Patient is listed for heart transplantation

Bridge to candidacy

Patient initially deemed ineligible for heart transplantation because of comorbidity (cardiorenal syndrome or pulmonary hypertension), which improves during mechanical support

Bridge to recovery

Patient with a potentially reversible cause of cardiac decompensation (acute myocarditis, postcardiotomy syndrome, peripartum cardiomyopathy)

Bridge to decision Patient in whom the potential for transplantation or recovery is yet unclear

Destination therapy Patient in whom recovery or transplantation is not feasibleNEWER ADVANCES IN HEART FAILURE

DEVICE THERAPY

First generation Second generation

Third generationNEWER ADVANCES IN HEART FAILURE

DEVICE THERAPY

1st generation

2nd generation

3rd generationNEWER ADVANCES IN HEART FAILURE DEVICE THERAPY

FIRST GENERATION DEVICES

FEATURES• is a short-term uni- or

biventricular support system .

• comprised of two 100 mL polyurethane blood sacs.

• the inlet and outlet portions of which are guarded by polyurethane valves

The Abiomed BVS 5000i

Pulsatile Devices

• has a titanium-alloy external housing, with inflow and outflow conduits that use porcine xenograft valves.

• Internal blood-contacting surface is made of textured titanium that results in the development of a pseudo-neointima on which thrombus formation is greatly reduced, thereby decreasing the need for anticoagulation.

Thoratec paracorporeal VAD

• actual pump chamber is outside of the body.

• this device can be used on patients with body sizes too small to house the HeartMate or Novacor devices (i.e., <1.5 m2).

• Pneumatic drivers provide alternating air pressure to fill and empty the blood pump.

• Anticoagulation with warfarin is necessary, as for patients with mechanical valves.

Para carporial

2nd generation

The Jarvik 2000 implanted in the apex of the left ventricle outflow graft anastomosed to the

descending aorta.

• BI VENTRICULAR SUPPORT

• A Jarvik 2000-C removed for transplant after 3 months with no thrombus present on the cone bearings.

• The junction of the microsphere coating with

• the myocardial tissue at the apex is well healed by 2

• months, and free of thrombus.

• A healthy adherent neointema is seen growing into the porous microsphere surface.

Miniature Ventricular Assist Device

CircuLite Synergy Pocket Micropump

• RV dysfunction is an important source of morbidity and mortality after LVAD

insertion.• Recent data demonstrates that early planned

institution of RV support can mitigate the potential adverse consequences of RV dysfunction after LVAD placement.

Parameters identified as risk factors for RVfailure after LVAD placement

INTERMACS: profiles for patient selection

The C-Pulse ( implantable, extra-aortic counterpulsationdevice)

Symphony Counterpulsation Device

TOTAL ARTIFICIAL HEART

Effects of Chronic Hemodynamic Unloading with Ventricular Assist Devices

Structural• Regression of myocyte

hypertrophy.• Reduction in neurohormonal

activation• Normalization in expression of

contractile proteins .• Enhanced electron transport

chain respiratory function• Decreased apoptosis and

cellular stress markers

• Functional • Improvement in left ventricular ejection fraction and

diastolic and systolic dimension• Recovery from spherical to more elliptical left

ventricular shape• Improvement in heart failure–specific indices of quality

of life• Improvement in peak aerobic capacity

complications

• Anticoagulation.• Drive line infections .• Noise.• Durability.• Activation of immune system.

epicardial pads secured and used to tighten the device.

The CorCap device

Percutaneous Leaflet Repair and Annuloplasty for Mitral Regurgitation

90Investigational Device only in the

US; Not available for sale in the US

EVEREST II Randomized Clinical TrialKey Inclusion/Exclusion Criteria

Inclusion– Candidate for MV Surgery– Moderate to severe (3+) or

severe (4+) MR• Symptomatic

– >25% EF & LVESD ≤55mm• Asymptomatic with one or more

of the following– LVEF 25-60%– LVESD ≥40mm– New onset atrial fibrillation– Pulmonary hypertension

Exclusion– AMI within 12 weeks– Need for other cardiac surgery– Renal insufficiency

• Creatinine >2.5mg/dl– Endocarditis– Rheumatic heart disease– MV anatomical exclusions

• Mitral valve area <4.0cm2

• Leaflet flail width (≥15mm) and gap (≥10mm)

• Leaflet tethering/coaptation depth (>11mm) and length (<2mm)

ACC/AHA Guidelines JACC 52:e1-e142, 2008

Figure 6. Core laboratory tracings of the mitral annulus and leaflet line of coaptation from 3D echo data sets recorded at preprocedure baseline and follow-up time points noted from

patients with PTMA implants still observed by x-ray to be in place.

Sack S et al. Circ Cardiovasc Interv 2009;2:277-284

Date of download: 11/6/2012

From: Percutaneous Leaflet Repair and Annuloplasty for Mitral Regurgitation

J Am Coll Cardiol. 2011;57(5):529-537. doi:10.1016/j.jacc.2010.10.012

Direct Annuloplasty

The Guided Delivery Systems Accucinch device is delivered through retrograde catheterization of the left ventricle. (Left) Anchors are placed in the posterior mitral annulus and (right) connected with a “drawstring” to cinch the annular circumference.

Figure Legend:

•Thank you

heart failure device therapy

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