GET READY-WIRELESS COMING SOON

Interesting article in Science Daily that I thought might enjoy:

New small, wireless self-contained pacemaker appears safe and feasible for use in patients, according to a small study in the American Heart Association journal Circulation.

Although traditional pacemakers pose minimal risk, patients are still vulnerable to some short- or long-term complications, said Vivek Y. Reddy, M.D., lead author of the study and director of the Cardiac Arrhythmia Service at Mount Sinai Hospital in New York City.

Those complications can stem from the pulse generator implanted under the skin of the chest, where infections or skin breakdown can occur, and particularly from the leads, or wires, that run from the generator through a vein to the heart. Leads can break, dislodge or contribute to a vein blockage.

However, the new pacemaker has no leads -- its pulse generator lies within the unit in the heart -- and is placed without the need for surgery.

At 6 millimeters in diameter and about 42 millimeters long, the wireless device is smaller than a triple-A battery. It's faster and easier to implant than traditional pacemakers, Reddy said, and it's programmed and monitored similarly.

"While a much larger study is required to prove this, one may expect the leadless pacemaker to be associated with less chance of infection and lead-related problems such as lead fracture," Reddy said. "Overall, the self-contained pacemaker is a paradigm shift in cardiac pacing."

The study, called LEADLESS, was conducted in 33 Caucasian patients, average age 77, two-thirds men, at two hospitals in Prague and one in Amsterdam. The self-contained pacemaker was successfully implanted in 32 patients, or 97 percent. Ninety-four percent were free of complications through the three-month study period, the researchers reported.

The new device is a self-modulating pacer guided into place using a catheter inserted in the femoral vein and is affixed to the heart in the right ventricle, the same place a standard lead would be located. The device is for patients who require single-chamber pacing, or roughly 20 percent to 30 percent of U.S. and European patients who need pacemakers. Patients who need dual-chamber pacing would still require traditional pacemakers, according to Reddy.

Among the study's 33 patients, one suffered complications during the procedure and underwent emergency surgery but later died after suffering a stroke.

After three months, the new pacemakers were functioning well, the researchers found. They are continuing to track the patients and expect to report longer-term outcomes later this year. Meanwhile, a much larger study at multiple U.S. locations that will include longer-term follow-up is under way, Reddy said.

4 Comments

Mt. Sinai Clinical Trial

by Kaitland - 2014-03-26 02:03:58

I was actually considered for the clinical trial on the leadless that they are now performing. The first leadless was inserted in US on March 4th.
Sadly, I didn't qualify, because right now it only works in the lower chamber and my issue stems from upper chamber. Dr. Dukkapati told me they are working toward upper chamber but it is years out and he thinks I need to go ahead with the traditional PM.

Dr. Reddy and Dr. Dukkapti are awesome! I heard back from them quicker than I hear from my local cardiologist.
I am so happy I checked into it because it is my understanding that once you have the PM wires you can never qualify for leadless.

It might not be too late for any of you to get in on the trial that qualify- Dukkapti said afib patients are great candidates. Clinical trial @ Mt. Sinai goes until early 2015. You can get on Mt. Sinai's website and get their contact information . I sent them both emails and called the office number and they got right back to me.

Are you being serious?

by HeartOfBrick - 2014-03-26 08:03:26

Hi ROBO Pop,

I am not quite sure if you’re being serious or sarcastic because you are skeptical about the reality of a leadless pacemaker.I will give you the benefit of the doubt and assume you are being serious first. If you are asking when they will begin clinical trials-the answer is they have already begun. That is stated in the article and validated by the very first post after the article. If you are asking when will a leadless pacemaker be available to the general public, my best educated guess would be by 2017-the latest 2018. I will qualify that statement by saying that the clinical trial results would need to show the same type of results they already have or better. From what I have read, I have no reason to believe they won’t. I agree with “energized” that at some point there will be a procedure to remove existing leads (they already can do this) and implant a leadless pacemaker. The advantage being leadless pacemakers last much longer than pacemakers with leads. That equates to lower health costs.

If you are being sarcastic all I have to say is “play nice.” I very rarely post on this board. Although I read many of the posts, I keep my thoughts and opinions to myself. I read A LOT of medical and technical literature and only post those articles that I believe would be of interest to this specific group. More importantly that the information provides hope to those looking for it.

If you are basing your skepticism on 5 year old data, that may not be a good idea. 5 year old data now is equivalent to reading data 10-20 years old in the early 2000s. That would be analogous to the individual who read about some company called Facebook in 2009 and thought to themselves that idea would never work-bad bet.

Interesting

by energized - 2014-03-26 08:03:50

My cardiologist was telling me about this leadless PM when I went in to discuss getting mine. It's probably still 5-10 years away from being used widely. Who knows in 10 years they may figure out how to remove the leads in order to use this new one in most patients.

Dear Friend w/ a red clay heart:

by donr - 2014-03-27 10:03:17

Every great idea starts out with anecdotal evidence that it is true. They also start out w/ some extremely enthusiastic supporters. They do not necessarily end up as they started.

Having been at the front end of what sounded like a great idea - that eventually failed - I recognize exactly what ROBO is saying. I believe he is serious - w/ a touch of sarcasm added for flavor.

I am NOT scoffing at the proposed concept of a leadless PM, but merely saying that it is still a long way from becoming an everyday device to be used.

Every idea that becomes successful, starts out small. That's where this one is right now. Looking at the small size of the group being used for development testing, I'd say that the device, if it ever becomes successful, is a lot farther out in time than 4 or 5 yrs.

Infection growing on foreign bodies implanted in us is a real problem, & not just for the PM/ICD & their leads. Wholly encapsulated objects like hips, knees & shoulders still involve themselves in serious infections that are difficult to fight - WHOOPS - I forgot to mention artificial heart valves in that category.

I commend the leaders of the project for their enthusiasm & foresight & capability to foresee great things for an idea, but they still have a long way to go.

Just like w/ new drugs - going from a clinical test involving a few thousand individuals to mass use measured in the millions & tens of millions can discover so many unknown bad side effects that it is unbelievable - but real.

These are the reasons that the US FDA is so skittish about approvals for new drugs & devices. To give names to a few failures that passed the approval process: Thalidomide, Yasmine, several diabetes meds, a trans-vaginal mesh.

These men must continue trying - fortune falls to those who take risks.

Don

You know you're wired when...

You can hear your heartbeat in your cell phone.

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I, too, am feeling tons better since my implant.