FAQs

 

How long does the device last?

The leads (wires) are permanently attached to the heart and then plug into the device. The battery is built into the CCM® device and is designed to last at least 20 years if charged weekly, at which point it might require more frequent charging. However, the system is designed to provide lifelong CCM® therapy for most patients, so the need for repeat procedures to replace the unit and any risks that go with that can be minimized

How long before I feel the benefits of CCM device?

While some of the effects of CCM® happen to the heart immediately, others can take weeks to months to occur. Different hearts respond differently based on a host of factors; not just how severe your heart failure may be.  You may or may not feel some of these effects immediately, but some cases can take 3-6 months or more to show significant improvement in your symptoms. Your cardiologist will make a determination about when to reevaluate your heart function, and it may take several follow-up evaluations to see the full benefit of CCM® therapy over time.

Will I be able to get an MRI if I have the CCM device?

The CCM® device and all FDA-approved leads (wires) used with it have been tested and rated to be safe in an MRI environment.  However, there are specific programming changes that should be performed before and after the MRI, if possible, to keep you on schedule with your CCM® therapy. If these changes cannot be made at the time of your MRI, the device should have programming in place to safely and automatically resume therapy the next day. However, we ask that you please notify your cardiologist or call the Impulse Dynamics patient support line as soon as possible after your study to allow assessment of the device function and be sure CCM® therapy will continue as scheduled.  

What are the potential long term side effects or complications of CCM?

There are no long-term side effects seen with CCM® therapy in clinical studies or real-world usage so far, nor is there expected to be any negative effects from this therapy.  Generally, any complications that could occur over time are the same as those that could potentially occur with any other implanted device, including infection or minimal risk of mechanical damage to the CCM® device or its wires.  Fortunately, a quick system check is performed by your charger prior to each charging session (and in some cases each night, if plugged in nearby) and this can alert you to any issues that could potentially interrupt your CCM® therapy.  Therefore, it is important that you call the Impulse Dynamics patient support line or notify your cardiologist as soon as possible after receiving any alerts on your charging device.

Will I be able to stop some of my medications after receiving the CCM Device?

CCM is intended to work with your medications, not as a substitute for them. As such, you should continue your medications unless your doctor tells you otherwise.

Will I feel the impulses from the device?

Generally not. If you do, the device can usually be reprogrammed to eliminate that sensation.

Will my insurance cover the device?

That is determined on a case-by-case basis.

Why doesn't my doctor know about this?

CCM is relatively new and awareness has been building over the past several years. The pandemic slowed the company’s ability to share information about the device (as access to hospitals and physicians was limited). Hence, many physicians are just now becoming aware of the benefits of CCM therapy.

What is the difference between the smart optimizer and .... pacemaker, icd, crt-d?

The main difference between the Optimizer family of CCM® devices and other implantable cardiac devices (i.e. pacemaker, ICD (defibrillator) or CRT (biventricular pacemaker with or without a defibrillator) is the core function of these devices. Most cardiac devices are designed to correct a problem with the rhythm of the heart. For example, pacemakers (including CRT devices) are used to correct the timing if a heartbeat is too slow or the chambers are out of synch with one another, which can make you feel poorly. Defibrillators (ICDs) are used to shock the heart to stop a life-threatening rhythm that is too fast. CCM® therapy, on the other hand, works differently than these devices. It does not change the rhythm of your heart, but follows that rhythm to provide a painless electrical impulse to boost the squeeze of each beat it sees during specific periods of time throughout the day. 

What exactly qualifies as GDMT? I've been off and on so many different medications.

There are four categories of medications that have shown the ability to improve patients’ survival and to reduce heart failure hospitalizations. You should discuss your medication regimen with your physician.

How long on average does an implant last throughout a lifetime?

The battery is labeled to last for 20 years.

How long will I be out with the anesthesia after the procedure?

Typically you will be under sedation for less than an hour.

What is the rate of success of the implant?

This device can be successfully implanted in almost all cases, unless unusual anatomy is present.

What percentage of patients have to change their implant within a lifetime of the device?

So far, less than 5% of all historical implants have required replacement for battery depletion.

Would my symptoms improve?

In the clinical trials, 80+% of patients have symptomatic improvment.

What is recovery from the implant procedure like?

The procedure is typically an outpatient procedure and, depending on the protocols at your implanting facility, you should be able to go home the next day or may even be able to go home the same day. You will be provided with instructions from the facility when you leave, but generally patients are seen for a wound check visit within 1-2 weeks after discharge and are asked not to lift the arm above your head on the side of the implant (i.e., right chest implant, right arm affected) for 5-6 weeks. In some instances, a sling may be provided to help prevent you from moving the arm excessively.

Can the device be removed if I'm not getting the results I had hoped for? Will it be removed?

This is not a common occurrence. FIrst, even in patients that “don’t respond”, CCM can prevent further deterioration. Second, removing the device comes with risks associated with surgery, so is not often opted for.