Interventional Procedures

Roadmap

• Valve Diseases• PCI & CABG• Cardiac Devices• Cardiac Resynchronization Therapy• Artificial Heart

VALVE DISEASES

Introduction

• Heart valve disease refers to several conditions that prevent one or more of the valves in the heart from opening and closing properly.

• Heart valve disease can cause either a leaky valve (regurgitation) or a valve that does not open wide enough (stenosis).

• Untreated heart valve disease can cause symptoms and reduce a person's quality of life and overall survival.

• When the heart’s valves become severely damaged, heart surgery is used to repair or replace the valve.

• Most patients are able to undergo surgery without difficulty. 

• However, for people whose heart function is too severely compromised to withstand surgery, several approaches to treat heart valve disease without surgery have been developed.

• These approaches can be divided into three categories:o Clinical Practice – used in every day clinical practiceo Investigational – current clinical studies are underwayo Early Development –early stages of investigation

Percutaneous Aortic Valve Replacement –

An Investigational Approach• Percutaneous aortic valve replacement (AVR) is a new treatment

being investigated for select patients with severe symptomatic aortic stenosis (narrowing of the aortic valve opening).

• A stenotic valve prevents the flow of blood antegrade from the left ventricle to the aorta, during systole.

• There is an increased rate of sudden death of patients with aortic stenosis.

• Dyspnea (labored breathing), fatigue, and palpitations are late symptoms of aortic insufficiency.

• Angina pectoris is associated with the latest stages of aortic insufficiency.

Percutaneous Aortic Valve Replacement –

Initial Diagnosis

• By auscultation (listening) with a stethoscope.

• Additional procedures associated with diagnosis to judge severity of the lesion include - – chest x ray, – Echocardiography– angiography with cardiac catheterization. – In the absence of angiography, magnetic resonance

imaging (MRI) or computed tomographic (CT) imaging may be used.

• The procedure is performed in the catheterization lab.• During the procedure a catheter is placed through the femoral

artery (in the groin) and guided into the chambers of the heart.  • A compressed tissue heart valve is placed on the balloon-mounted

catheter and is positioned directly over the diseased aortic valve.  • Once in position, the balloon is inflated to secure the valve in place.• For patients with severe peripheral vascular disease, surgeons  and

cardiologists are testing an alternative approach through the left ventricular apex of the heart.

Percutaneous Aortic Valve Replacement –

Procedure

Balloon catheter with valve is inserted in the diseased valve

Balloon is inflated to secure the valve

Valve is secured in placeReplaced Aortic Valve

Percutaneous Mitral Valve Repair An Investigational Approach

• Clinical trial is currently being performed to determine the effectiveness of a percutaneous approach for treating mitral valve regurgitation.

• The procedure is performed in the cardiac catheterization laboratory with the aid of echocardiography.

Percutaneous Mitral Valve Repair Procedure

• A very small, specially made metal clip device is delivered through a catheter inserted into the femoral vein (in the groin) and advanced to the heart.

• Guided by echocardiography, the cardiologist attaches the clip to the flaps of the mitral valve.

• Placement of the clip is adjusted until optimal improvement in blood flow and pressures through the valve are observed.

• Then, the clip is released, and the catheter is withdrawn. The clip holds the valve flaps in position, which limits the leakage.

Mitral Valve Clip Percutaneous Valve Repair System

*Evalve, Inc.

• In some patients, mitral regurgitation could be treated percutaneously by placement of a device in the coronary sinus via a catheter.  

• Placement of the prosthetic device pushes the support structures of the mitral valve and its leaflets back into more normal alignment, mimicking a surgical annuloplasty.

• The prosthesis is a metal bar, about 7 cm in usable length and 1.5 mm in diameter, flexible at both ends and stiff in the middle.

• Guided by fluoroscopy and transesophageal echocardiography, the bar is positioned within the coronary sinus, near the posterior valve annulus.

• By exerting pressure on the dilated annulus and pushing it and its attached leaflet closer toward the other leaflet, the device helps restore more normal valve alignment and hemodynamics. 

The catheter resides within the coronary sinus

The prosthesis (shown within catheter) straightens the natural curvature of the vein and exerts pressure on the dilated annulus, pushing it and its attached leaflet forward to help restore more normal valve leaflet alignment. 

*Evalve, Inc.

PCI & CABG

Percutaneous Coronary Intervention

Introduction• Percutaneous coronary intervention (PCI), commonly known as

coronary angioplasty or simply angioplasty, is a therapeutic procedure to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease.

• These stenotic segments are due to the build up of cholesterol-laden plaques that form due to atherosclerosis.

• Percutaneous coronary intervention can be performed to reduce or eliminate the symptoms of coronary artery disease, including angina (chest pain), dyspnea (shortness of breath) on exertion, and congestive heart failure.

• PCI is also used to abort an acute myocardial infarction, and in some specific cases it may reduce mortality.

Coronary Artery Bypass GraftIntroduction

• Coronary artery bypass surgery, also coronary artery bypass graft surgery, and colloquially heart bypass or bypass surgery is a surgical procedure performed to relieve angina and reduce the risk of death from coronary artery disease.

• Arteries or veins from elsewhere in the patient's body are grafted to the coronary arteries to bypass atherosclerotic narrowings and improve the blood supply to the coronary circulation supplying the myocardium (heart muscle).

• This surgery is usually performed with the heart stopped, necessitating the usage of cardiopulmonary bypass; techniques are available to perform CABG on a beating heart, so-called "off-pump" surgery.

Conventional CABG

• Most common arteries bypassed:

– Right coronary artery– Left anterior descending

coronary artery– Circumflex coronary artery

Adapted from BJ Harlan, et al; Manual of Cardiac Surgery

CARDIAC DEVICES

Implantable Cardioverter Defibrillator (ICD)

What is it?

• An implantable Cardioverter Defibrillator (ICD) is a device that monitors heart rhythms, and delivers shocks if dangerous rhythms are detected.

• Many ICDs record the heart’s electrical patterns whenever an abnormal heart beat occurs.

• ICDs are used to treat patients:– Whose lower heart chambers (ventricles) beat too

quickly (tachycardia) or quiver ineffectively (fibrillation).

– Also used in patients who are at risk of these conditions due to previous cardiac arrest, heart failure, or ineffective drug therapy for abnormal heart rhythms.

Implantable Cardioverter Defibrillator (ICD)

When is it used?

• Like a pacemaker, an ICD consists of a battery and electrical circuitry (pulse generator) connected to one or more insulated wires.

• The pulse generator and batteries are sealed together and implanted under the skin, usually near the shoulder.

• The wires are threaded through blood vessels from the ICD to the heart muscle.

• The ICD continuously checks the heart rate. When it detects a too-rapid or irregular heartbeat, it delivers a shock that resets the heart to a more normal rate and electrical pattern (cardioversion).

• Stopping the potentially fatal fibrillation is called defibrillation.

Implantable Cardioverter Defibrillator (ICD)

How does it work?

•An ICD detects a rapid heartbeat coming from the bottom of the heart

•ICDs protect against sudden cardiac death from ventricular tachycardia and ventricular fibrillation

Implantable Cardioverter Defibrillator (ICD)Types

Single chamber ICD

•Lead is attached in the right ventricle. •If needed, energy is delivered to the ventricle to help it contract normally.

Dual chamber ICD

•Leads are attached in the right atrium & the right ventricle. •Energy is delivered first to the right atrium and then to the right ventricle, helping your heart to beat in a normal sequence

Implantable Cardioverter Defibrillator (ICD)Types

Biventricular ICD

•Leads are attached in the right atrium, the right ventricle and the left ventricle. •This technique helps the heart beat in a more balanced way and is specifically used for patients with heart failure.

CARDIAC RESYNCHRONIZATION THERAPY

Cardiac Resynchronization TherapyIntroduction

• Cardiac resynchronization therapy (CRT) is used to treat the delay in heart ventricle contractions that occur in some people with advanced heart failure.

• Heart failure means the heart’s pumping power is weaker than normal.

• A delay between the contraction of the right and left ventricles often occurs with heart failure, so the walls of the left ventricle are unable to contract at the same time.

Cardiac Resynchronization Therapy

Device• The CRT pacing device (also called a biventricular pacemaker) is an

electronic, battery-powered device that is surgically implanted under the skin.

• The device has 2 or 3 leads (wires) that are positioned in the heart to help the heart beat in a more balanced way.

• The leads are implanted through a vein in the right atrium and right ventricle and into the coronary sinus vein to pace the left ventricle.

• The CRT device (biventricular pacemaker) has 2 or 3 leads that are positioned in the: – Right atrium – Right ventricle – Left ventricle (via the coronary sinus vein)

Cardiac Resynchronization TherapyHow Does It Works?

• When your heart rate drops below the set, the device generates (fires) small electrical impulses that pass through the leads to the heart muscle.

• These impulses make the lower chambers (ventricles) of the heart muscle contract, causing the right and left ventricles to pump together.

• The end result is improved cardiac function.

Cardiac Resynchronization TherapyBenefits

• CRT improves symptoms of heart failure in about 50% of patients who have been treated maximally with medications but still have severe or moderately severe heart failure symptoms.

• CRT improves survival, quality of life, heart function, the ability to exercise, and helps decrease hospitalizations in select patients with severe or moderately severe heart failure.

CRT and ICD therapy

• Some patients with heart failure may benefit from a combination of CRT and an implantable cardiac defibrillator (ICD).

• These devices combine biventricular pacing with anti-tachycardia pacing and internal defibrillators to deliver treatment as needed.

• The CRT/ICD combination devices: – Resynchronize the heartbeat – Slow down an abnormal fast heart rhythm – Prevent abnormally slow heart rhythms – Record a history of the patient’s heart rate and rhythm

ARTIFICIAL HEART

Artificial Heart Introduction

• An artificial heart is a mechanical device that is implanted into the body to replace the biological heart.

• The term “artificial heart” has often inaccurately been used to describe ventricular assist devices (VADs), which are pumps that assist the heart but don’t replace it.

• An artificial heart is also distinct from a cardiopulmonary bypass machine (CPB), which is an external device used to provide the functions of both the heart and lungs.

• CPBs are only used for a few hours at a time, most commonly during heart surgery.

FDA-Approved Artificial Hearts

• CardioWest™ temporary Total Artificial Heart– It is the world’s first and only

FDA-approved Total Artificial Heart.

– Originally designed as a permanent replacement heart, it is currently approved as a bridge to human heart transplant for patients dying because both sides of their hearts are failing (irreversible end stage biventricular failure).

• AbioCor® Replacement Heart

– The AbioCor is approved for use in severe biventricular end stage heart disease patients who are not eligible for heart transplant and have no other viable treatment options.

FDA-Approved Artificial Hearts

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