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HeartmateII Left Ventricular Assist Device

Proven Results for Long Term Support

The HeartMate II™ Left Ventricular Assist Device (LVAD) provides short or long-term circulatory support for intermediate-to-advanced heart failure patients. This small, quiet pump features a simple design — with only one moving part — and can provide blood flow equivalent to that of a healthy heart.
 

Over 27,000 patients implanted with the HeartMate II LVAD
 

Unparalleled real-world experience

The HeartMate II LVAD is indicated for both destination therapy and bridge-to-transplantation in the United States. Additionally, HeartMate II LVAD is backed by more than 10 years of clinical experience.2

To date, more than 27,000 heart failure patients have received the HeartMate II LVAD.1 Many have passed the 5-year milestone on therapy, with some still on therapy after 15-plus years.1 These figures offer more than a decade of living proof that HeartMate II LVAD delivers predictable surgical and clinical performance for improved outcomes.3-8
 

Many patients have lived more than 15 years with HeartMate II LVAD

Proven Long-Term Patient Outcomes

Research has shown the HeartMate II LVAD:

  • Reverses and sustains reduction of heart failure symptoms8

  • Increases patients’ survival rates and quality of life compared with medical management alone

Predictable Performance for Improved Outcomes

Outstanding Two-Year Survival

Significant Improvement in NYHA Class

Significant Increase in 6-Minute Walk Distance

At baseline, patients who were tested completed the 6-minute walk test at an average of 129 meters. At 2 years after HeartMate II LVAD implant, patients completed the test at an average of 361 meters. That's two and a half times as far, for a 150% improvement in distance.

Reduction in Thrombus with Adherence to PREVENT Guidelines

PREVENT Guidelines are a set of clinical and surgical recommendations that are aimed at maximizing flow through the LVAD, reducing risk of cannula malposition, and ensuring that the patients are adequately anti-coagulated while on LVAD support.

Patient-Centric Features

The HeartMate II LVAD is designed for patient comfort and convenience. With its wearable design and several carrying options, the HeartMate II LVAD supports your patients’ lifestyles.

Other features and benefits:

  • Mean blood flow of up to 10 L/min—equal to that of a healthy heart

  • Low-dose anticoagulation regimen

  • Safe for air travel

Safety by Design

The HeartMate II LVAD comes with a lightweight, pocket-sized controller that interfaces with the implanted pump.

Its features are designed for safety:

  • Backup battery provides at least 15 minutes of full power in an emergency situation

  • Prioritized visual alarms provide clear, actionable instructions

  • On-screen instructions eliminate the need for guesswork

  • Driveline diagnostic checks verify that driveline wires are intact and functional

Heart Biopsy (Cardiac Biopsy)

Healthcare providers use heart biopsies (cardiac biopsies) to check for signs of organ rejection after a heart transplant. This test also helps diagnose cardiomyopathies, heart cancer and infections. Also called endomyocardial biopsy, the procedure takes place through cardiac catheterization. Providers remove small pieces of tissue from the heart.

Overview

What is a heart biopsy (cardiac biopsy)?

A heart biopsy is a diagnostic procedure. It involves removing a small amount of tissue from the inner lining of your heart muscle. A specialist in a lab (pathologist) examines the tissue under a microscope. They look for changes in cells that indicate damage or abnormalities.

What are other names for a heart biopsy?

Healthcare providers also use these terms for heart biopsy:

  • Cardiac biopsy.

  • Endomyocardial biopsy.

  • Myocardial biopsy.

Who might need a heart biopsy?

If you've had a heart transplant, you may need multiple biopsies on your heart to check for signs of organ rejection. A heart biopsy often detects organ rejection before symptoms occur. It can also identify the cause.

Immediately after a transplant, you may have this test weekly. Then you may have a heart biopsy every six weeks to three months for at least a year.

Providers may also perform heart biopsies to diagnose:

Who shouldn’t get a heart biopsy?

People with certain health conditions, such as heart valve disease, may have an increased risk of complications following a heart biopsy. Talk to your healthcare provider to see if you’re a good candidate for the procedure.

Test Details

Who performs a heart biopsy?

A cardiologist performs heart biopsies. This medical doctor has advanced training in using catheter-based approaches to diagnose and treat heart problems.

Your doctor will thread a catheter (thin, flexible tube) through blood vessels to perform this procedure. This technique is cardiac catheterization.

How should I prepare for a heart biopsy?

Make sure your healthcare provider has a current list of all medications and supplements you take. You may need to stop taking certain medicines like blood thinners. And you may need to fast (not eat or drink) for a set time before the procedure. Follow your provider’s directions about steps to take before a heart biopsy.

What happens before a heart biopsy?

A heart biopsy procedure is an outpatient procedure that takes about an hour. You’ll receive a sedative to help you relax and an anesthetic to numb the treatment area.

You’ll be awake during the procedure. You may feel some pressure and slight discomfort, but you shouldn’t have any pain. You can go home the same day, although someone should drive you home and stay with you while you recover.

What happens during a heart biopsy?

Your doctor views pictures of your heart and blood vessels to guide the procedure. The imaging may be fluoroscopy X-rays (continuous X-ray images) or a transthoracic echocardiogram (TTE).

During the procedure, your doctor:

  1. Inserts a catheter through a blood vessel until it reaches the heart.

  2. Threads a small, tweezer-like device called a bioptome through the catheter to reach the heart.

  3. Uses the bioptome to snip off and retrieve tiny pieces of tissue from the heart.

  4. Withdraws the bioptome and collects the tissue samples to send to a lab for examination.

  5. Removes the catheter and applies a pressure bandage at the catheter insertion site to stop any bleeding.

What is recovery like after a heart biopsy?

Healthcare providers will monitor your recovery for a few hours and check for signs of problems. During this time, you’ll get chest X-rays to look for signs of potential complications like:

Don’t lift anything heavy or do strenuous activities for 24 hours after the procedure. You should be able to return to work and daily activities the next day.

What are the risks of a heart biopsy?

A heart biopsy is a relatively safe procedure. Minor complications occur in fewer than 6% of procedures. For instance, you may have some bruising and bleeding where your provider inserted the catheter.

Serious complications occur in less than 1% of heart biopsies. These problems may include:

Results and Follow-Up

When will I get the test results?

Results from a heart biopsy may be available as soon as 24 to 48 hours after the procedure. Your healthcare provider will discuss the results with you. Depending on the findings, you may need more tests

.

When should I call my doctor?

You should call your healthcare provider if you experience:

A note from Cleveland Clinic

After a heart transplant, people need regular heart biopsies to look for signs of organ rejection. Healthcare providers also perform heart biopsies to diagnose conditions like cardiomyopathies, heart cancer and infections. The procedure takes place through cardiac catheterization. It involves removing small pieces of tissue from the heart. A specialist examines the tissue under a microscope to look for cell damage or changes. A heart biopsy is an outpatient procedure that has a fast recovery time.

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