A Leader In Advanced Cardiac Treatments

Manatee Memorial performs more TAVR, WATCHMAN, MitraClip procedures than other area hospitals.

Manatee Memorial’s Structural Heart Team: Front row (from left) are Jeffrey Rossi, MD; Alessandro Golino, MD; S. Jay Mathews, MD; Gino Sedillo, MD; and Brian Holyk, DO. Back row (from left) are hospital CFO Joe Hwang; Madison Wanbaugh, RN; cardiovascular invasive specialist Kimberly Chase, RCIS, CVT; Diego Curto, RN, BSN; Amy Kimbell, RN, BSN; Katie Fenton Moore, RN; medical assistant Jan Casavant, CMA; hospital CEO Tom McDougal; Eric Crowell, MSN, APRN; and cardiac sonographers Lavern Dunbar, RCDS; Vivian Chan, RCDS; and Aryssa Tope, RCS.

Cardiologists have a phrase; the doctors and nurses in emergency rooms know it well: Time is muscle. It refers to the fact that the heart loses muscle every passing minute during a heart attack.

This is why the person who goes to the ER complaining of chest pain and shortness of breath gets treated immediately, ahead of someone with a sore throat, strained back or sprained knee.

More importantly, this is why symptoms of a heart attack — when a blockage or malfunction disrupts the normal flow of oxygen-carrying blood to the heart — need to be taken seriously and acted upon immediately.

Unfortunately, not everyone does that. Many pass off mild or moderate symptoms as something unrelated to the heart or ignore them altogether. That’s the “wrong answer,” says Amy Kimball, RN, BSN, divisional director of cardiovascular services at Manatee Memorial Hospital.

“A lot of people don’t want to be a bother to anyone, so if they’re having chest pains, shortness of breath or just feel tired, they’ll ignore those problems or go to bed or lie down or something,” Amy relates.

“But that’s the last thing you want to do because the longer you wait to get treated for a heart attack, the more damage can be done to the heart. That’s why we say, Time is muscle, and why people should seek help immediately for even mild symptoms.”

The tendency of people from all age groups and health levels to ignore symptoms of heart failure is one of the primary reasons heart-related issues account for one in every four deaths, or more than 650,000 in the US each year.

It’s also why Manatee Memorial Hospital continues to devote an array of resources — including time — to provide heart patients with the most technologically advanced treatment options.

Indeed, since it began its work in 2014, the Structural Heart Team at Manatee Memorial has become an industry leader in heart care, performing more advanced treatment procedures than any other hospital in the area and, in some cases, the state.

The V-shaped MitraClip™ tightens leaflets in the mitral valve so blood can resume proper flow.

Those treatments include MitraClip transcatheter mitral valve edge-to-edge repair (TEER), of which the Structural Heart Team has performed more than 550 procedures; the WATCHMAN™ left atrial appendage closure (LAAC) implant (more than 950 procedures); and the transcatheter aortic valve replacement (TAVR) procedure (more than 500).

These leading-edge procedures are less invasive alternatives to traditional open-heart surgery with smaller incisions, less scarring, minimized pain and a decreased risk of bleeding and infection. They also bring shorter hospital stays, faster recovery times and a better quality of life.

“I’m very proud of the programs, the team we’ve assembled and the work we’re doing,” Amy boasts. “In addition to the surgeons and nurses, our Structural Heart Team includes navigators, schedulers, referral coordinators, nurse practitioners; and we all work together with our patients to ensure they are getting the proper treatment.”

MitraClip Procedure

The heart has four valves that keep blood flowing in the right direction, and each has flaps, or leaflets, that open and close once per heartbeat. The mitral valve is between the left atrium and ventricle.

MitraClip is an alternative to open-heart surgery for treating mitral regurgitation, in which improper closure of the mitral valve allows blood to backflow into the heart.

Left untreated, mitral regurgitation can lead to shortness of breath, fatigue, lightheadedness and a rapid or fluttering heartbeat, and while some sufferers do not require treatment, many need medication or surgery to repair the problem.

Traditional surgery for this issue involves opening the chest and temporarily stopping the heart. The MitraClip procedure erases that need by allowing surgeons to access the mitral valve through a catheter fed to the heart through the femoral vein in the groin.

Once the catheter is in place, the surgeon delivers through it the small V-shaped, staple-sized MitraClip. The mitral valve is then accessed through a hole that opens a passageway between the right and left atrium.

“Once we’ve reached the mitral valve, we maneuver the clip down and grasp the leaflet of the valve where it’s leaking with the clip, which has these little grippers on it,” explains Gino J. Sedillo, MD, FACC, a member of the Structural Heart Team.

“The clip is about a centimeter long, and it’s open to about 180 degrees at that point. Once we grasp the leaflets with it, we close the clip down to about 30 degrees. That holds the leaflets tight and allows blood to flow normally from the heart.”

The MitraClip procedure is designed for patients who are deemed too high risk for standard open-heart procedures and is typically performed in 90 minutes or less under general anesthesia. After a night’s rest, patients usually leave the hospital the next day.

“We sometimes complete the procedure in as little as 45 minutes,” Dr. Sedillo notes. “When it lasts longer, it’s usually because we find that the leaflets of the mitral valve are thick and calcified, which makes them a little harder to grasp.”

Manatee Memorial ranks first in the state and fourth in the country in the number of successful implantations of the MitraClip, which has aided more than 150,000 patients experiencing mitral valve regurgitation.

“Our team was one of the first in the area to adopt the MitraClip program, and when you think about it, it’s amazing that this hospital in little old Bradenton, Florida, is up there with all the big-name hospitals in the country in terms of successful procedures,” Dr. Sedillo adds.

“That’s a big deal, and I think it’s because of the support we get from Manatee Memorial Hospital, and the fact that one of our surgeons (Alessandro Golino, MD) is known for his exceptional work in mitral valve surgery.

“We get a lot of referrals through Dr. Golino because doctors from around the state send him patients for mitral valve surgery. And now that the word is out that we have such a successful program, we’re getting even more referrals, which is great.”

WATCHMAN Implant

The WATCHMAN is for patients with atrial fibrillation (AFib), which causes an irregular or rapid heartbeat that can lead to blood clots that make patients five times more likely to suffer a stroke or heart failure.

AFib is considered the most common form of irregular or rapid heart rate, and while some who have it may show no symptoms, others experience dizziness, shortness of breath, lightheadedness or chest pains.

Traditional treatment options for AFib include blood thinning medications as well as ablation procedures in which blocks of scar tissue are created within the heart to alter cardiac electrical signals and regulate the heartbeat.

In recent years, the WATCHMAN has emerged as an advanced treatment alternative and Manatee Memorial as a national leader in successful implants and outcomes.

“The WATCHMAN is a device that gets placed into the heart, where it mechanically blocks the blood clots that form in response to atrial fibrillation,” educates Daniel E. Friedman, MD, FACC, FHRS, medical director of the hospital’s WATCHMAN program.

“Those blood clots can travel through the heart, up to the brain and cause a stroke,” Dr. Friedman adds. “The WATCHMAN prevents strokes by preventing blood clots from ever forming in the appendage.

“Candidates for this procedure are patients who have atrial fibrillation, whether it be intermittent or all the time, and have risk factors for stroke with their atrial fibrillation such as diabetes, high blood pressure or previous stroke. The best candidates are patients who cannot take blood thinners safely long term or someone who has major bleeding problems with blood thinners.”

The WATCHMAN is larger than a nickel but smaller than a quarter, with a fabric top. It’s inserted into a small pouch in the heart called the left atrial appendage through a catheter during a procedure typically completed in about an hour.

Like blood thinners, the WATCHMAN doesn’t correct the electrical malfunction that hinders the heart’s ability to pump blood.

The WATCHMAN’s purpose is to take away the increased risk for stroke that the clots create. As a result, patients still need to take medication to control irregular heart rhythm. Patients may also be advised to take a daily aspirin, depending on age and risk factors.

The WATCHMAN received FDA approval in 2015. Manatee Memorial began its WATCHMAN program soon after and is now on the second generation of the device, which is called the WATCHMAN FLX. It is safer and accommodates both larger and smaller appendages than the original WATCHMAN device.

“We wanted to be the first to do this procedure because we had so many patients who could not take blood thinners long term and were at great risk for a stroke,” says Dr. Friedman, who has implanted more than 500 WATCHMAN/WATCHMAN FLX devices.

“Another reason is because it represents a paradigm shift in the treatment for AFib. The WATCHMAN not only prevents a stroke, but it also prevents bleeding, in essence because recipients no longer need to take blood thinners.

“It offers AFib patients the best of both worlds. There’s also a cost-effectiveness aspect to it because research shows that within a few years patients break even in terms of the cost of getting the WATCHMAN versus taking blood thinners. That’s why this is something that’s going to be done more and more. At Manatee Memorial Hospital, we have a great team involved in the implantation of the WATCHMAN device.

“Not only do we have the nurses and the nurse practitioners we need to perform this procedure, but we also have at least two cardiologists who perform this procedure on a routine basis. Manatee Memorial Hospital is perfectly outfitted with everything we need.

“In fact, I would say that if someone is going to have this procedure done, Manatee Memorial Hospital is the place to go. It’s an effective procedure, and the hospital’s complication rate is less than the national average, which is less than half of 1 percent.”

TAVR Procedure

As with the MitraClip and WATCHMAN, the transcatheter aortic valve replacement was developed as an alternative to open-heart surgery — in this case, for aortic stenosis.

“When someone has aortic stenosis, the blood flow to the rest of the body, including the brain and the other vital organs, is restricted,” says S. Jay Mathews, MD, MS, FACC, FSCAI. “The most common symptoms are a lack of energy, fatigue and shortness of breath.

“With some patients with severe cases of aortic stenosis, the symptoms are so severe that they get tired or run out of breath just walking across a small room. I’ve had patients who struggle just to walk from one end of my office to the other.”

For years, the most common approach to repairing a damaged aortic valve was open-heart surgery, but for patients who have a long history of progressive heart failure, Dr. Mathews often recommends the TAVR procedure.

Approved by the FDA in 2011, the TAVR procedure is designed to repair an old or damaged aortic valve. It is typically achieved by first running a catheter through a small puncture near the groin to the heart.

The replacement valve is run through the catheter to the damaged area in the existing valve. Similar to a stent, the replacement valve is wedged into place to create a valve-within-a-valve structure.

Though the procedure has been performed for years, it is still considered to be on the leading edge of medical technology. So, too, are the replacement valves used in the procedure. Unlike manufactured mechanical valves used during open-heart surgery, the valves used in the TAVR procedure are derived from animal donors.

“There are two varieties – bovine, which is from a cow, and porcine, which come from a pig,” Dr. Mathews explains. “It’s actual tissue, and because it’s mounted on a stent cage, we literally inflate this balloon that allows us to replace the valve completely.

“One of the advantages of this type of valve is that it conforms well to the original valve. As a result, there are very little gradients, which is the pressure drop-off across the valve. It’s about as close as you can come to replacing the kind of valve you were actually born with, which is critical.

“Sometimes, with manufactured valves, there can be a mismatch between the size that’s put in and the one you were born with. We don’t get that mismatch with this type of procedure or this type of valve. That’s one of the technological advances in this field.”

Another advantage is that by employing the catheter, which can also be inserted into the arm or chest, the need to reach the damaged valve by surgically separating the chest is eliminated. As a result, most patients are ready to leave the hospital within two days.

In 2019, the FDA expanded TAVR indications to include low-risk patients. The approval allows access for all patients with aortic stenosis to have greater treatment options with a lower risk of major complications. The FDA requires patients to have at least a 4 percent risk of mortality to be a candidate for the TAVR procedure.

Similar to a stent, the TAVR replacement valve
is wedged into place to create a valve-within-a-valve structure.

Dr. Mathews says that optimal treatment is determined through consultation with other cardiologists and surgeons as well as the use of an algorithm the team has developed.

In 2021, Manatee Memorial Hospital became the first and only hospital in Manatee County to receive Transcatheter Valve Certification™ from the American College of Cardiology. Dr. Mathews adds that patients with a lower risk of complications may soon become candidates and notes that the highly skilled team of cardiologists and surgeons at Manatee Memorial has achieved an excellent success rate with the procedure.

According to the Transcatheter Valve Therapy Registry™, a partnership of the American College of Cardiology and the Society of Thoracic Surgeons, Manatee Memorial’s success rate is above the national average in terms of outcomes, Dr. Mathews says.

“We’ve been doing some really challenging cases,” Dr. Mathews asserts. “Some of them are patients who, in the past, have been turned down for operative replacement. We are now performing this procedure on patients like that every day.”

© FHCN article by Roy Cummings. Photo courtesy of Manatee Memorial Hospital. mkb
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