Hi, welcome to the ACC Quality Summit for 2022. Hi, I'm Kathleen Maskett, clinical nurse specialist for the Structural Heart Program at El Camino Health in Mountain View, California. My colleagues and I have created a new workflow streamlining the process for the left atrial appendage occlusion. My colleagues include Xuan Chen, who is our data analyst, Natalie Brown, our administrative assistant, and Drs. Dipu Nair and Chad Ramahan. The learning objectives include understanding pre and post-procedure planning, including same-day discharge for left atrial appendage occlusion procedure, recognizing the feasibility, efficiency, and safety of streamlining TEE pre-procedure planning and TEE-guided left atrial appendage occlusion, also identifying strategies that will improve resource utilization, hospital throughput, and cost effectiveness. First, I'd like to start with a little bit of background on atrial fibrillation. And again, the numbers are rather impressive. 2% of the US population have atrial fibrillation and is predicted that by the year 2030 with our aging population, there will be 12.1 million people with atrial fibrillation. AF is associated with about a five times increase in the risk of an ischemic stroke. And AF causes about one in seven strokes in the United States. 90% of the clots actually originate in the left atrial appendage. The Watchman device was approved by the FDA in 2015 for transcatheter closure of the left atrial appendage. The device closes off the left atrial appendage and prevents clots from forming. It's approved for patients who are unable to take oral anticoagulants long-term. These are patients, for instance, who have GI bleeds, frequent GI bleeds, and for patients who have experienced falls with significant bleeding. As you can see, our numbers have been steadily rising. And you can compare both the registry data as well as the data from our own hospital as well. So in 2016, there were roughly 4,800, almost 5,000 devices that were placed for the registry. In 2021, we're talking now up to 48, almost 49,000 devices have been placed. Our own numbers at El Camino Health certainly reflected the same type of increase. And then you can see that significant dip in 2020, which was, of course, COVID-related. This year, we're predicted to go up to almost 70 Watchman devices. My guess is that we'll probably even go higher than that because there has been a significant demand recently. COVID forced us to take a hard look at our process. Patients were afraid to come into the hospital. They were afraid of getting exposed to COVID. So they wanted to limit the number of visits to the hospital. The hospital itself, of course, wanted us to decrease the number of hospital beds that we were occupying. And again, this number in 2020 was, which only fit when you did only 15. That number reflects the fact that all elective procedures were canceled for a significant amount of time during 2020. So again, we needed to take a look to see if we could streamline the process and reduce hospital admissions and tests that needed to be in hospital procedures. Let's take a look at the standard workflow that we certainly have used here at El Camino Health for the left atrial appendage occlusion procedure. We start, of course, with a referral from an outside physician. We meet the patient in the clinic visit. We validate that they meet the indications for the inclusion criteria. And then we meet as a heart team and use a shared decision-making model with the patient to decide whether or not this is actually the right procedure for them. Once that's been decided, the patient would then be scheduled for a transesophageal echo, which is done in the hospital. Patient would come in for that visit. And we use TEEs here to measure the left atrial appendage. We look for the angulation, the length, the number of lobes, the opening size. And basically what we're doing is we're making sure that the patient is a candidate for the device itself. We then send the patient home, bring them back at a later date for the procedure. Again, it's done under a TEE with general anesthesia. Patients spent the night and were discharged the next day. And the post-procedure follow-up was a prior discharge. They had a transthoracic echo done. And then we followed the standard procedures as far as they were discharged with aspirin and a DOAC. At 45 days, they would return to the hospital and have another TEE. Stop the DOACs and started on dual antiplatelet therapy if they met the criteria. And at six months, the patients would come back and they would go and have a transthoracic echo. At that point, again, if there's no leakage, then we would stop the dual antiplatelet therapy and just keep them on aspirin, 81 milligrams. We changed the workflow for the left atrial appendage occlusion procedure because what we did is we eliminated the pre-procedure TEE. Referral was exactly the same. We had the same appointment with the heart team with the shared decision-making process. Eliminated the pre-procedure TEE and then went directly to the in-hospital procedure itself where we did the TEE. Again, checking to see whether or not the anatomy was suitable. We did the TEE. We followed the same protocol for the Watchman. And at that point then, either placed the Watchman or decided that the anatomy was not suitable and so we did not do the procedure. Post-procedure protocols were exactly the same. Prior to discharge, patients were given a transthoracic echo. We followed the very same medication protocols as far as being discharged with aspirin and a DOAC. And the DOACs were stopped, started the dual antiplatelet. And then at six months, we did a transthoracic again, stopped the dual antiplatelet and just left the patient on aspirin afterwards. Again, streamlining it because we eliminated the pre-procedure transesophageal echo. So after we initiated this workflow change, we looked back at our data. Again, the data that we're looking at is from January 2019 to April 2022. And there were a total of 97 patients that we looked at. The workflow pretty much was the same as far as the referral, the heart team, shared decision-making process, coming, having the patient come in and making sure that they met the indications and inclusion criteria. And of those 97 patients that came in for their procedure, we found that only five of them actually were unsuitable for a Watchman procedure. Two of them had a left atrial appendage thrombus and three were found unsuitable due to the size of their appendage. One patient, actually we excluded this patient because the case had to be aborted due to the fact that they could not cross the septum. It had nothing to do with the size of the left atrial appendage that was deemed suitable, but they couldn't cross the septum. Procedure went exactly the same under transesophageal echo, fluoroscopic guidance. And then again, the post-discharge procedure was exactly the same again. Transthoracic echo, 45 days, six-month follow-up. And we found, again, a feasibility rate of 95%. This is an echo image of one of the patients that was deemed unsuitable due to the LAA size. In this particular case, this patient had a left atrial appendage that was just too small to place the Watchman device. This is another patient that was deemed unsuitable for the left atrial appendage occluder device. The opening was just far too big for the Watchman device itself. And this was a case that was canceled basically because of the size of the left atrial appendage. Here is the third image of a patient that was deemed unsuitable for a Watchman and this was a patient that again was taken in to the cath lab and found to be unsuitable because of the many different lobes within the left atrial appendage itself and that they were unable to occlude. The other change that helped us was the introduction of the Watchman Flex that started in October of 2020. We now use Watchman Flex exclusively for all of the Watchman devices that we put in. And the nice part about it was that it did expand the possibilities as far as the sizing of the ostium. As you can see, the Watchman Flex has an ostium size that goes all the way from 14 to a little over 31, which really has helped us as far as having increased availability of sizes for different anatomies for patients. The two other patients that were deemed ineligible had left atrial appendage thrombus. As you can see here in this echo, both of them had a thrombus in the appendage. You can see the spontaneous echo contrast with a region of thrombus. All of the, both of these patients were on anticoagulant before the procedure and only stopped two days before the actual procedure itself. But in spite of that, they still ended up with thrombus and the case had to be canceled. These images are taken from a patient that the device was deployed successfully. And again, this was done with the TEE and done during the procedure itself. And then the device was deployed. And yet another image that shows that there was no device margin residual leak around the device itself. Again, a successful deployment of the Watchman. So when we looked at all the data, this is what we found. And this again is using no pre-procedure imaging. This is when the TEE is done the day of the procedure as the procedure is taking place. 100%, of course, we met the FDA indication for placing a Watchman. The procedure time was 41 minutes. The successful, procedures were successful 100% of the time. The DMR was less than three millimeters. Procedure room time was 87 minutes. Extubation in the operating room was 100%. Anesthesia time was 117 minutes. Total hospital stay was 27 hours. In-hospital complications were 0%. And these were including any in-hospital bleeding, stroke or mortality. Starting in 2020 quarter two, almost all of our left atrial appendage occlusion patients were discharged on the same day. Again, this is another consequence of COVID. We're trying to free up hospital beds for other patients. And let's look at the numbers. So you can see that we did same day discharges on 14 patients. The procedure time is actually a little bit shorter. It was 39.5. Our procedure room time was 80.2. Again, a little bit shorter. And that may just be because we're getting more familiar with the procedure itself. Anesthesia time was 100 minutes. But the hospital stay, instead of being 27 hours, has now been reduced to 14 hours. So once we decided to create a same day discharge program, we needed to obviously create a protocol. We looked to protocols that were already existing in the cath lab for other cath lab patients. And this was the protocol that we developed. Inclusion criteria. The procedure was initiated only for patients who are undergoing an elective outpatient case completed on a weekday before noon. The interventional structural cardiologist was to determine the patient as meeting favorable criteria and low clinical risk. Exclusion criteria, if the patient met any of the following high risk criteria, that patient would obviously be excluded from the same day discharge procedure. Exclusion criteria included things such as the patient was currently an inpatient. If a patient had any issues as far as social support, no access to emergency care, no telephone, no reliable transportation, or unable to obtain prescription medications as patients were kept. Patients also felt, some of them felt uncomfortable leaving the hospital. So if they felt that they wanted to spend the night and did not agree to the same day discharge, then those patients obviously were kept overnight as well. Other patients that fell into that category were patients who had come from out of town. And we deemed that it was safer for them to stay the night in the hospital rather than being a great distance from our hospital as well. The same day discharge patients generally were discharged around six to seven o'clock in the evening. They had a trans-thoracic echo prior to discharge, which was reviewed for a pericardial effusion. Every one of them had a next day post-discharge phone call from the nurse, as well as information, contact information if the patient were to run into any trouble. Increased patient satisfaction was definitely a byproduct of the same day discharge. Patients were very, very happy to be able to go home the same day as the procedure and not have to spend the night in the hospital. The conclusion we reached was that the transesophageal echo is an appropriate imaging modality for the left atrial appendage occlusion procedure for both the planning and the procedural guidance on the day of the procedure. The streamlined TEE same day protocol for the LAAO can improve throughput and reduce hospital visits as well as length of stay. And same day discharging also increases patient satisfaction. As we continue to evolve in our program, we are now exploring moderate sedation and the use of intercardiac echocardiography to eliminate the need for general anesthesia as well as for patient intubation. Our value proposition is that by combining the imaging with the procedure, you get true same day discharge from planning procedure to discharge.

Kathleen Maskett

clinical nurse specialist

left atrial appendage occlusion procedure

Watchman device

atrial fibrillation