Strokes claim the lives of 6.2 million people globally every year.1 Every two seconds, someone in the world has a stroke. Every 10 seconds, someone dies from a stroke.1 What’s more, strokes are affecting more young people than ever before, with 25% occurring in patients younger than 60 — and new studies indicate that this group is increasingly at risk.2
One of the most significant risk factors for stroke is atrial fibrillation (AF), which affects about 33.5 million people worldwide.3 According to the American Stroke Association, an estimated 15 percent of strokes are a result of untreated AF.4 Additionally, 91% of strokes in people with AF are caused by blood clots that form in the left atrial appendage.
Blood thinners are often prescribed for AF patients, but not all patients can be successfully treated with them, either because they can’t tolerate the medications or the continuous monitoring and testing they require. In some situations, it’s too high risk to have patients on long-term anticoagulation. Many patients bleed with it, or have lifestyle reasons that make it difficult to be on blood thinners long term.
That’s why at Saint Thomas Midtown Hospital, we’re using left atrial appendage closure (LAAC), a minimally invasive procedure which seals off the small sac in the heart where blood clots can form and be pumped out to the brain to possibly cause a stroke.
LAAC is an ideal option for younger patient populations, with permanent and positive outcomes that are sparking interest in patients and doctors looking for innovative treatments for life-threatening conditions. As a researcher in the PROTECT-AF and PREVAIL trials, I’ve been performing them since 2005. I see growth in its utilization, and anticipate seeing even more growth in the future.
Step 1: The Assessment
First, we make sure that the patient with AF meets the approved criteria as released by the Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA). We assess the patient using the CHA2DS2-VASc score for stroke risk stratification in patients with AF. If the patient has a score of 3 or higher, or a score of 2 or higher on the CHADS2 score, they are an excellent candidate for LAAC.
Second, we confirm that patients have a condition that makes it difficult to be on blood thinners long term. This includes if they are at risk for falls, in a high-risk profession, or they have another medical condition that raises the risk of bleeding.
Step 2: The Right Technology
Traditional fluoroscopic images or echo images are 2D, but the presence of 3D imaging allows anatomic variations in patient anatomy to be more readily visualized. The presence of a heavy trabeculation within the walls of the appendage or sharp turns in the presence of a “chicken-wing” variant appendage can more readily be appreciated and planned for with the CT reconstruction.
Saint Thomas Midtown Hospital was one of the first sites in the world to use fusion technology from GE Healthcare, which overlays pre-op 3D CT rendering on top of live fluoroscopic images.
To perform the procedure, we first conduct a CT angiogram (CTA) of the heart and make a 3D model of the left atrium so we can clearly visualize the shape and size of the left atrial appendage, which is a real advantage in performing the LAAC procedure.
This 3D recreation of the sac complements the data we get from the ultrasound to help us plan our approach for the transseptal puncture and device delivery. We have found it particularly easy to import from tableside the pre-op 3D CT images and overlay with live fluoroscopic image, thanks to the smooth integration of the AW Workstation (GE Healthcare). As a result, we’re able to use it in our daily clinical practice. The solution helps us fine-tune how we navigate towards the appendage and deliver the device.
During the procedure, Dr. Phil Wines, our echocardiographer, uses ultrasound to give us real-time measurements and images of the left atrial appendage. We use that information to complement the CT scan images and confirm the correct placement after the device is deployed.
When LAAC is done in medical centers with the right equipment, the complication rates are exceptionally low and the number of devices required for successful deployment are also very low.
Step 3: The LAAC Procedure
Once a patient is identified as being a good candidate, they come to the hospital for the procedure. They receive general anesthesia, and Dr. Wines conducts a transesophageal echo to make sure there are no clots. Then we place a small catheter in the femoral artery so the anesthesia team can monitor blood pressure, and we place a larger catheter in the femoral artery to begin placing the LAAC device (WATCHMAN device, Boston Scientific).
We perform a transseptal puncture and position the catheter in the left atrial appendage. Using IV contrast to take pictures of the appendage, we take measurements with ultrasound to ensure we’re in the right location.
Next, we load the LAAC implant in the catheter already in the appendage, pull the sheath back, and it self-expands into the opening of the left atrial appendage.
The LAAC device looks like a jellyfish, with a round base covered by fabric, followed by a series of small feet. Along the feet and body lie a series of little barbs that allow the device to compress into the tissue of the left atrial appendage and make the device stable. Once the device is in, the body forms a scar over it that acts like a stopper: nothing going in and nothing coming out. Once that happens (about 45 days after the device is put in), it is a permanent solution to reducing — if not completely eliminating — stroke risk due to AF.
The procedure is relatively fast; we can implant a device in 20 minutes, but we’ve done one as quickly as 13 minutes.
Step 4: Recovery
Recovery involves an overnight stay in the hospital for observation. Most patients are released the next day with instructions to avoid bending, squatting and heavy lifting for about a week to let the groin heal. They go home on a blood thinner, and at the 45-day mark, they come back as an outpatient for another transesophageal echo. If everything is healed, we discontinue the blood thinner and prescribe a course of aspirin and clopidogrel for six months. Most people are back to normal activity within a week after the procedure.
Three Patients Whose Lives Were Changed by LAAC
LAAC has been FDA approved for roughly three years, but I’ve been conducting these procedures for more than a decade in participation with the research trials. It is important to note that many of my patients aren’t the frail, elderly people you’d expect to receive this kind of treatment, but are much younger and more active than traditional AF patients.
Case 1: How One Pilot’s Stroke Risk Nearly Ended His Career
An airline pilot in his early 60s had grown accustomed to taking blood thinners to treat his AF. But due to FAA regulations, he wasn’t able to renew his flight license until he stopped taking blood thinners once and for all. However, if he stopped taking the medication, he would be at major risk of having a stroke.
The procedure was a complete success. We put the LAAC in and got him off the blood thinners. He got his FAA license back and now he’s flying again.
Case 2: Taking the Pain Out of Arthritis
A 65-year-old male, who enjoyed an active life working and traveling, developed severe arthritis in most of his joints, including his hands, shoulders, hips, and feet. This limited his mobility and caused a lot of neuropathic pain that made him miserable.
He couldn’t be treated with any arthritis therapies because he was on blood thinners for AF. Many of the anti-inflammatories and pain medicines put him at risk of bleeding while being on the blood thinners for his AF — a risk that was considered to be high enough that his physicians did not feel like they could successfully treat his arthritis.
We implanted the LAAC device, and 45 days later, he came off his blood thinners. Now he can take the arthritis treatment his physician prescribed for him, his pain is under control, and his quality of life is considerably better.
Case 3: A Taste of Freedom
A 64-year-old chef in Nashville owns several local restaurants and continues to work in the kitchen. His physician had reasonable concerns about him being on long-term blood thinners while working in professional kitchens, including risk of bleeding and contamination issues.
After we implemented the LAAC device, he stopped using blood thinners and now he has peace of mind that allows him to continue to successfully do his job.
LAAC: Low Risk, High Rewards
LAA closure not only impacts a patient’s stroke risk, it improves their quality of life. They’re no longer on blood thinners or worried about the risk of injury, and they’re not dealing with the regular blood tests and medical issues associated with blood thinners. We believe our patients who have gone through LAAC are universally pleased that they decided to undergo the procedure.
As imaging technology continues to evolve, as the data keeps getting better, and as the patients learn more about it, we think LAAC will be more frequently utilized and that more doctors will offer this procedure. In addition, we believe it’s going to lead to other technology that will help assess stroke risk with a fresh perspective, and work to decrease stroke rates in the U.S.
Disclosures: Dr. Pickett has no conflicts of interest to report regarding the content herein; outside the submitted work, he reports research with Boston Scientific, Medtronic, and Abbott.
- Facts and Figures. World Stroke Campaign. Available online at http://www.worldstrokecampaign.org/learn/facts-and-figures.html. Accessed September 19, 2017.
- Smajlović D. Strokes in young adults: epidemiology and prevention. Vasc Health Risk Manag. 2015;11:157-164.
- World Health Organization Study: Atrial Fibrillation is a Growing Global Health Concern. Cedars-Sinai. Published December 17, 2013. Available online at https://www.cedars-sinai.edu/About-Us/News/News-Releases-2013/World-Health-Organization-Study-Atrial-Fibrillation-is-a-Growing-Global-Health-Concern.aspx. Accessed September 19, 2017.
- When the Beat is Off – Atrial Fibrillation. American Heart Association/American Stroke Association. Published December 6, 2016. Available online at http://bit.ly/2ybxcdx. Accessed September 19, 2017.