This article was originally published in EP Lab Digest. The author, Tara Mudd, is the better half of Yes Louisville founder and editor Jason Mudd. This device and the accompanying procedure is so revolutionary and Tara is so cool that we wanted to share this here. Everyone knows someone who takes some sort of blood thinner on a regular basis. This device and procedure eliminate the need for blood thinning medication.
In February 2016, Norton Hospital became the first facility in Louisville, Kentucky to begin implanting the WATCHMAN Left Atrial Appendage Closure device (Boston Scientific). Since that time, we have gone on to implant a total of 24 devices in patients who have previously been unsuitable for long-term anticoagulation. Each patient has had his or her own unique complication with anticoagulation, but one patient in particular was faced with the extraordinary choice of preserving her vision or preventing a stroke.
A 68-year-old female with a history of paroxysmal atrial fibrillation suffered vitreous hemorrhage in her right eye in 2014 while anticoagulated for her arrhythmia. This occurred just five months after suffering a similar hemorrhage in her left eye, which was corrected with surgery and her vision was restored. After the hemorrhage occurred in her right eye, she again had corrective surgery with full restoration of her vision. In the post-operative period, she developed endophthalmitis and lost all vision in her right eye. She underwent removal of her right eye and was fitted with a prosthetic.
In April 2016, she underwent successful implantation of the WATCHMAN device. She was placed on warfarin and low-dose aspirin until her six-week post-operative transesophageal echocardiogram (TEE), which showed the device remained in good position with no residual leak. At that point, her warfarin was discontinued. Her aspirin dose was increased to 325 mg and clopidogrel 75 mg daily was added for another four and a half months. At six months post implant, the clopidogrel was discontinued, and she currently remains on only a daily 325 mg aspirin.
When we were presented with the opportunity to begin implanting this device, this patient was one of the first individuals that came to mind when selecting the initial patients to screen for the procedure. She was well known to our practice, as we had been managing her atrial fibrillation for many years. Though her ocular bleeding presented potentially the most life-altering complication, she also had other significant bleeds, including recurrent epistaxis as well as gastrointestinal bleeding, the latter of which resulted in nearly six weeks of being in and out of the hospital as well as a subsequent stay in a rehabilitation facility.
When we received approval to begin implanting, we brought her into the office to have a discussion about the procedure, and she expressed immediate interest. However, she did have a few concerns, particularly since it was a new procedure and we were a new implanting center. She was encouraged by the initial data showing 95 percent implant success in the hands of both new and experienced operators.1 This has since been confirmed in a recent real-world post-market analysis demonstrating a 95.6 percent implant success rate despite a large fraction of previously inexperienced operators.2
As the coordinator for the program, I fielded the majority of her questions and concerns, as well as walked her through the screening and implant procedures so that she would know what to expect each step of the way. Once her screening was completed and we set her procedure date, she was cautiously optimistic that she may finally be able to discontinue the use of a pill that she dreaded taking each and every day.
Since having the implant and ultimately being able to come off of anticoagulation, she feels a tremendous sense of freedom and peace of mind that she never experienced while being on anticoagulation. She very much enjoys traveling, but avoided it for many years due to fear of having a bleed far away from home. Now that she is no longer on anticoagulation, she has begun traveling again and is making a list of all of the places she’d like to go. It also has made a significant financial impact, as she was spending over $100/month on her anticoagulant.
Role of the Coordinator
Oftentimes, in the launch of a new program at a facility, we become bogged down in the proverbial t’s that must be crossed and the i’s that must be dotted. Coordinating many working parts to come together with forward momentum is no small task. Stories such as this one help us as clinicians remember the impact of what we do and inspire the why.
There are many centers across the United States with successful WATCHMAN programs. Each center has its own unique challenges, and it is the job of the coordinator to recognize those challenges and collaborate with the team to develop processes that ensure growth of your program. In my experience as coordinator, having a level of trust between administration and the clinical team is the cornerstone to building a successful program. We are fortunate to have a good working relationship with our administration and communicate routinely on where we are with the program and what we can do to continue to grow.
I have learned a few things along the way that I often share with coordinators of programs in their developmental phase. Of paramount importance is staying organized, in whatever method works best for you. You will be the person everyone goes to when there is a question about anything related to the program. Being able to quickly access the information will save you time to focus on other things.
As noted above, trust between administration and the clinical team is critical to launching a new program. In addition to that, trust within the clinical team itself will help things run much more smoothly. Our team has two interventional cardiologists and one EP physician as well as myself, an EP nurse practitioner, as the coordinator. We discuss difficult cases as a team and ensure there is consensus on whether or not the patient is a suitable candidate to proceed with the implant.
We perform all of our cases in the EP lab. Maintaining good communication with the EP lab manager also helps keep things running smoothly, particularly on implant days. Though I am based solely in the outpatient setting, I am present in the hospital for each of our implant days. This helps me assess the temperature of how things are going from a procedural and post-operative standpoint. For example, due to previous high staff turnover in our recovery units, we decided to re-educate the nursing staff approximately six months into our program. This has helped expedite the patient discharge process and improve patient satisfaction.
I believe the introduction of the WATCHMAN device to structural heart programs across the country will continue over the next several years, and this will likely include other devices aimed at the occlusion of the left atrial appendage. Our overall experience with the WATCHMAN device in the first year of our program has been extraordinarily positive. Our success rates have been comparable to the national average, and we continue to feel confident in offering this as a treatment for patients who have been intolerant of long-term anticoagulation but remain at increased risk of stroke from atrial fibrillation. The role of the coordinator will continue to be vital in launching and maintaining a successful program, not only to facilitate things from an administrative and clinical perspective, but in being an advocate for patients like the one discussed here, who is now able to make her long-awaited trip to the Grand Canyon and see it for herself.
Disclosure: The author has no conflicts of interest to report regarding the content herein.
- Holmes D, Kar S, Price M, et al. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014;64(1):1-12.
- Reddy V, Gibson D, Kar S, et al. Post-FDA approval, initial US clinical experience with Watchman left atrial appendage closure for stroke prevention in atrial fibrillation. J Am Coll Cardiol. 2016 Nov 2.