The Future Is Here Today

Wireless pacemaker takes the lead in heart health care.

Memphis, Tennessee native Jim Blackburn spent only two of his 45 years as a sheet metal worker installing ductwork in the Holiday Inn® motels that were popping up all over America back in the 70s. Those two years wound up having a long-lasting impact on him.

Photo by Jordan Pysz.

Jim Blackburn

“That’s when I first got the travel bug,” Jim states. “The contractor I was working for back then knew Kemmons Wilson, the founder of the Holiday Inn chain, and they were so tight that Mr. Wilson wound up giving my boss the contract for the duct work in his hotels. After that, I spent the next two years traveling all over.”

Jim found himself on the road yet again soon after that contract ran out. A Memphis area bricklayers’ strike put a halt to construction in the Mid-South city, forcing Jim to look for work elsewhere. He eventually found it in Kansas City, where he stayed until health matters forced him to retire in 1998.

“I had to have both my knees replaced, and after that, I had to hang up my tools,” Jim explains. “By then, our kids were married and out of the house, so my wife and I decided to sell the house, downsize and start traveling. We bought a motorhome and spent the next several years traveling all over the United States.”

Jim and his wife’s travels took them to all but four states – Alaska, Hawaii, New Hampshire and Vermont – and while they developed a special affinity for Washington and Oregon, the Sunshine State is where they eventually settled. Shortly after making the move, Jim began to feel decidedly unsettled physically.

“It was right about the time we bought our house here in Florida that I started to have trouble with A-Fib,” Jim says, referring to atrial fibrillation, which is a quivering or irregular heartbeat. “I know that with some people, they can live with A-Fib and it doesn’t really bother them. Well, that’s not me. This thing tore me apart.

“Sometimes, my heart would beat really fast and then it would stop and go back to normal, but then it would pick back up again. It was very sporadic, and if I got up off the couch too quickly, I’d get really dizzy and would feel faint. I was always feeling very tired and out of breath. It was like I had no energy.

“It was a real problem, because here we are, my wife and I, and we’re trying to enjoy retirement, but we couldn’t get out and do much. I just didn’t feel up to it. We stopped going out to dinner, except for maybe once a month, and I all but had to give up my favorite hobby, which is fishing. I live on a lake, Lake June, but I had to put my boat in dry dock.”

The symptoms Jim experienced are typical of those suffering from A-Fib, which can also cause fatigue, shortness of breath, lightheadedness and confusion. For many people whose heartbeat fluctuates in and out of normal rhythm, A-Fib can often be controlled through medication. For others, more advanced treatments are required.

One such treatment is electrical cardioversion. Performed while the patient is asleep under anesthesia, this procedure administers an electric current to the patient that resets their heart and normalizes its rhythm. Another procedure often performed to correct A-Fib is called cardiac ablation.

After he was initially diagnosed with A-Fib in 2009, Jim was put on medication. When it was discovered the medication wasn’t correcting the problem, he was given the first of what proved to be six electrical cardioversions, each one losing its impact after a few months. He then underwent a cardiac ablation.

Cardiac ablations are most often performed using a diagnostic catheter that is threaded through a vein or blood vessel in the groin and up into the heart. Once the heart has been reached, the tissue that is found to be disrupting the rhythm of the heartbeat is modified in an effort to re-establish the normal flow of electrical signals to the heart.

The cardiac ablation gave Jim about five years of relief, but he required a second ablation procedure a little more than a year ago. This time, the ablation provided only a few months of relief. That’s when Jim’s cardiologist suggested he get a pacemaker and sent him to Daniel E. Friedman, MD.

Dr. Friedman is a board-certified clinical cardiac electrophysiologist. He works at the Bradenton Cardiology Center and is a member of the Structural Heart Team at Manatee Memorial Hospital, which recently invested in the most advanced pacemaker available – a leadless pacemaker known clinically as the Medtronic Micra Transcatheter Pacing System.

Wireless Technology

A pacemaker is a small device that delivers subtle electrical impulses that keep the heart beating in proper rhythm. Standard pacemakers consist of a pulse generator and a series of wires, or leads, that deliver the impulses to the specific chamber or chambers of the heart where they are placed.

A leadless pacemaker is smaller (about the size of a AAA battery) than a standard pacemaker. It is a completely self-contained pacing device that includes a battery that lasts about 12 years, and in place of wires, it has at one end a small electrode that literally touches the heart to stimulate the heartbeat.

Designed in the 1970s, the leadless pacemaker was first approved for use by the US Food and Drug Administration in 2016. Since then, its popularity has grown exponentially among physicians, many of whom believe it will soon become the standard for patients requiring pacemakers. Its many advantages over the current standard are the reason.

Among those advantages is the simplicity of the implantation procedure. The implantation of the leadless pacemaker is not as invasive as the procedure for the traditional pacemaker, where the surgeon must implant the pacing device in the chest, then run the wires through the veins to the chambers of the heart.

That surgery usually leaves about a two-inch scar as well as a visible pocket in the skin where the device is placed. It’s a procedure that is also prone to infection, notes Dr. Friedman, who says one to two percent of all patients receiving traditional pacemakers wind up with infections.

The leadless pacemaker carries with it a much lesser risk of infection. In fact, according to Dr. Friedman, there are currently no known reports of infection associated with the leadless pacemaker, which is delivered directly to the right ventricle of the heart through a catheter that is threaded through a vein that runs from the groin to the heart.

“Because it’s a catheter-delivered device, there’s no cutting involved in the implant procedure for the leadless pacemaker,” Dr. Friedman informs. “Once the device is delivered, the catheter is removed, and you’re done. Overall, the implant procedure for the leadless pacemaker is much easier and much quicker than it is for the traditional pacemaker.”

“Manatee Memorial Hospital often allows physicians to use new technologies to benefit their patients, and there is definitely a need for these leadless pacemakers. They are, without question, the future . . .” – Dr. Friedman

Another advantage of the leadless pacemaker is that the time needed to recover from the implant procedure is much less than it is with a traditional pacemaker. Patients receiving a leadless pacemaker can typically return home within 24 hours of its implantation and are usually allowed to resume normal activities immediately thereafter.

That’s not the case with patients receiving traditional pacemakers. The far more invasive surgical procedure associated with traditional pacemakers typically requires a hospital stay of a few days and a three- to four-week period in which the patient is limited in terms of activities. It can also leave an emotional scar that the leadless pacemaker does not.

“We have found that patient acceptance of the leadless pacemaker is much higher because patients don’t feel like they have a device because they can’t see it or feel it under their skin,” Dr. Friedman confirms. “It’s not visible to anybody, so it’s seamless in that regard, and that’s a big advantage, too.”

Immediate Impact

When he first met with Dr. Friedman, Jim was given the choice of receiving either a traditional pacemaker or a leadless model. After hearing of all the advantages associated with the leadless pacemaker, he chose the latter. He knew he made the right choice within minutes of waking up from the implantation procedure.

“As soon as the anesthetic wore off and I was awake again, I knew I was better,” Jim enthuses. “I noticed immediately that I was breathing easier and that I could take deep breaths again. I could tell right away that my heartbeat was in rhythm, because I wasn’t feeling dizzy or lightheaded or faint in any way. I felt great.”

Jim felt even greater a couple days later when, for the first time in months, he went fishing again. That’s something he would not have been able to do for another few weeks had he opted for the traditional pacemaker. The leadless pacemaker allows people to live life normally again immediately after implantation, and Jim is definitely doing that.

Since receiving his pacemaker, he has taken his boat out of dry dock and is out on the water almost daily. He’s also venturing out for dinner more often. His quality of life has improved so much, in fact, that Jim says he wishes he had received a pacemaker years ago instead of going through the electrical cardioversions and cardiac ablations.

“I’m doing all the things I want to do now, and never experienced any pain as a result of having this procedure,” Jim shares. “I had a little bit of soreness down around my groin area from where they ran the catheter, but that went away after a couple of weeks. Since then, I’ve just felt better and better.”

Taking the Lead

Better is exactly how Becky Grohoske, 74, feels these days. Like Jim, she too was recently fit with a leadless pacemaker, the implantation of which was part of a 14-year-long health struggle that began with the onset of Parkinson’s disease and included a battle with breast cancer.

Becky Grohoske

“I learned I had breast cancer about two years after I learned I had Parkinson’s disease,” Becky relates. “Then, about four years ago, I was diagnosed with A-Fib. It was discovered during a check-up, and at the time, they decided to give me a loop monitor to keep track of my heartbeat.”

A loop monitor is a recording device about the size of a computer thumb drive. It is typically implanted under the skin of the chest, where it can continuously record the electric signals of the heart for up to three years. That information is then downloaded into a computer by a doctor to determine whether the heart is beating in proper rhythm.

The monitor Becky was fitted with showed that she was suffering from a very rapid heartbeat. To correct that problem, she was put on medication. At times, however, the medication caused Becky’s heart to beat so slowly that she would nearly faint. It was then that she was told she needed to get a pacemaker.
“I knew I needed to do something because I was always feeling like I was going to pass out,” Becky says. “One day, I went to the grocery store, and no sooner did I get inside the door when everything went white. I had to put my hand out over a chair to keep from falling. It was just a horrible feeling.”

Her fear of passing out forced Becky to cut back on a number of normal, daily activities, including driving. For a while, she was virtually homebound, in part because her cardiologist had recently retired, and she was in the process of having her care transferred to another doctor. That doctor
was Dr. Friedman.

Just as he did with Jim, Dr. Friedman gave Becky the option of receiving a traditional pacemaker or the new leadless model. Becky was a little hesitant at first to commit to the new pacemaker, but she eventually accepted the offer and received the new device earlier this year. She hasn’t had any heart issues since.

“To begin with, the surgery – if you can even call it that – went great,” Becky enthuses. “It’s so easy. They don’t have to cut you open or anything. And they put this tiny, little thing in your heart that you don’t even know is there, but I know it’s working because I don’t have any feelings like I’m going to pass out anymore. I feel great.”

Becky continues to take medication for a rapid heartbeat and high blood pressure, but the pacemaker is allowing her to tolerate the medication by eliminating the pauses that were causing her to feel faint. She says she’s thankful for Dr. Friedman’s advice and expertise in suggesting and implanting the leadless pacemaker.

“I really like Dr. Friedman,” she says. “He’s very quiet, methodical and meticulous, and I really trust him. I was a little nervous about getting this new kind of pacemaker, but he told me it was going to be the best thing for me, and he was right. It’s working great.”

Willing and Able

Dr. Friedman says he can only take part of the credit for how much better Becky and Jim are feeling. He says the bulk of the credit has to go to Manatee Memorial Hospital for its decision to support the implantation of the leadless pacemaker and for having the foresight to invest in that and other new technologies. “They’re very accommodating,”

Dr. Friedman says of the hospital. “When there’s new technology like this, a lot of times the knee-jerk reaction to it from a hospital is that it’s way too expensive to invest in, because the hospital is worried about the return on their investment. That’s not how it is at Manatee Memorial Hospital.

“Manatee Memorial Hospital has always been on the leading edge of new technologies. They often allow physicians to use new technologies to benefit their patients, and there is definitely a need for these leadless pacemakers. They are, without question, the future of pacemakers.”

It’s not just the doctors who are accommodated at Manatee Memorial Hospital. Patients are treated with special care as well. “And Dr. Friedman is an excellent doctor. Instead of speaking in a bunch of medical terms that you can’t understand, he speaks English. And he’s so well informed on all the new technologies and trends. He told me all about this new pacemaker and told me it was a perfect fit for me, and he was absolutely right. I recommend them both.”

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