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28:13 min
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February 26th, 2013
DOI :
February 26th, 2013
•This video demonstrates a procedure that combines catheter ablation with left atrial appendage occlusion using the watchman left atrial appendage occlusion device for the treatment of atrial fibrillation and prevention of associated strokes. First to perform the catheter ablation. A pulmonary vein ablation catheter or pvac C is inserted through the femoral vein into the heart.
The electrocardiographic information gathered by the Pvac C is used to identify the source of the arrhythmia. Next small ablation lesions are made to electrically isolate potential atrial fibrillation triggers. Once the abnormal signal is terminated, the pvac C is removed and the watchman access sheath and dilator are advanced over the wire into the left atrium.
The guide wire is then removed and the access sheath is carefully advanced into the distal portion of the left atrial appendage over a pigtail catheter. Finally, the Watchman delivery system is inserted, advanced, deployed and released. The device becomes fully endothelial within approximately 45 days following implantation.
Patients with atrial fibrillation have a fivefold increased risk of getting a stroke, and although warfarin or anticoagulation therapy have shown in several studies to significantly reduce the risk of stroke, this therapy also has it drawbacks like is interaction with food and medications, a narrow therapeutical range, and also the risk of bleeding. Of course, also, while warfarin reduces the risk of stroke, it doesn't treat the underlying disease or symptoms of atrial fibrillation like fatigue, dizziness, palpitations, chest pain or dyspnea of the patient. Here we demonstrate a combination of catheter ablation for the relief of symptoms of atrial fibrillation and to treat atrial fibrillation combined with the implantation of a watchman left atrial appendix closure device.
As an alternative for warfarin therapy, visual demonstration of this procedure is critical. Since the early clinical studies like the I have studied, have shown that the majority of complications were operated dependent, and as they have gained experience, there was a significant decrease in complications like in the continuous access protocol. So here we're looking at the steel frame images recorded to measure the length and depth of the left atrial appendage.
And this is really important to decide which device size you're going to use during the procedure. And we need different views of the left atrial append appendix since it can be oval shaped or circular shape and we need different views for that. So first of all, here is the F that most people know is the 90 95 degrees view of the left atrial appendage, which we can see over here.
So here's the left ventricle, the left atrium, and here we can see the left atrial appendage. And we're looking for the circumflex artery, which is over here. And from that line we measure coming across.
So one centimeter from the limbus over here and then we're coming to 1.9 centimeters. And we also need some depth since we need some space to to place the device. Second view we need is the 135, which is not a real regular view of the left atrial appendage.
And also here we can see the left atrial appendage, which is a sort of chicken wing over here and we measure it here 1.6. So this is the smallest part of the left atrial appendage. And if we move on, we go on to 45 degrees.
We can see the aortic valve over here, the right atrium, the tricuspid valve here, the right ventricle here, the left atrium, and again the left atrial appendage over here with the circumflex artery. And again, we measured and we come to two centimeters in this. So then we move on to the last few.
We need, this is zero degrees and again the circumflex artery is over here and we measure, and again, we come to 1.9 centimeters width of the left atrial appendage. We also made some three dimensional images of the the left atrium and we can see here the mitral valve. And looking to the side, we can see here the left atrial appendage.
Here we can see, already see the pigtail catheter in front of the left atrial appendage. Very nice few again of the left atrial appendage. We can see it's it's, it's a little bit oval shape like we measured already in just a few of the mitral valve.
And again, the guide category coming through the intra or septum, which is located over here, passing through the left atrium towards the left atrial bandage. This procedure is performed by a team comprised of an electrophysiologist interventional cardiologist and echocardiographer. This enables the best possible care for atrial fibrillation patients.
The combined catheter ablation and watchman left atrial appendage closure device placement procedure should be performed in an electrophysiology lab with the appropriate diagnostic and imaging equipment for the procedure. The operating room should be prepared for the AF ablation procedure and the patient's sedated using the hospital's general anesthesia protocol. So today we start with a case where we do an ablation for a patient with paroxysmal atrial fibrillation and this patient also a high chest score.
And for that reason, we will end the ablation, end the procedure with a watchman implant. We'll first start to introduce the catheters for that. We will first give some local anesthesia, even though the patient is under general anesthesia, we always give some local anesthesia as well for the follow up after the procedure.
So we will start with that Immediately before the procedure begins. Administer local anesthetic in the groin region according to institutional guidelines. To begin the catheter ablation, first locate the femoral vein and then insert a venous introducer to fit a standard transseptal access system.
Then under fluoroscopy, insert a catheter into the coronary sinus as a positional marker to help guide the procedure and introduce a G wire to prepare for transseptal puncture. Flush the transseptal access sheath and prepare the needle. Advance the transseptal sheath over the G wire into the right atrium.
Then exchange the guide wire for the transseptal needle. Now we will pull back the transseptal sheath with the needle to fall against the septum. On the right side, you find the fossa fos Here.
The angle and placement of the quadripolar catheter in syn angiography is used to position the needle for transseptal puncture. Alternatively, the appropriate puncture site can be identified by tenting of the atrial septum. In the bval and short axis.
TEE views This case we were using RF needle to go to the left, Flush the sheath using heparinized saline and deliver a bolus of 10 units of heparin to prevent clotting as a result of the procedure. Introduce 50 milliliters of contrast di by a pigtail catheter positioned in the middle of the left atrium to create a 3D rotational angiogram. Remove the pigtail catheter and flush the transseptal sheath.
Next, prepare the ablation catheter by flushing it and inserting the guide wire. And all these can be used at the same time for ablation and mapping, because it's an over the wire system, the wire is always in the pulmonary vein, which will keep the catheter in the area where we want to do the ablation. It's a steerable catheter that we can manipulate in the left atrium.
To introduce the catheter into the sheath, we first have to capture the spiral at the end and make it straight to fit into the of the sheath. Position the wire in one of the branches of the pulmonary vein, then advance the pvac C into the pulmonary vein antrum. Use fluoroscopic guidance 3D ESI, reconstruction and electrograms to assess the position of the pvac C and adjust it to get the best contact With all of the electrodes on the display, there are two, three dimensional views of the heart.
These can be rotated to view the heart from different angles. To determine the source of the arrhythmia, use the electrodes at the end of the ablation catheter to pace the heart and record its electrical activity. The catheter records the local pulmonary vein endocardial electrograms.
Use these signals to guide the ablation and to confirm isolation. Select the appropriate electrode pairs for delivery of radio frequency energy and adjust the generator power to achieve a target temperature of 60 degrees Celsius for each electrode in the selected pairs. Before each ablation, confirm the position of the pvac C relative to the osteum by biplane, fluoroscopy ablate.
For 60 seconds, check the monitor for conditions during ablation. If the temperature does not rise above 50 degrees Celsius within 15 seconds, discontinue the application, adjust the position of the electrodes and start again Is not optimal. Here in the middle screen you will see the ablation.
We are performing applications at the pulmonary vein antrum with a temperature of 60 degrees. The duration of the application is 60 seconds. So now we see here the screen of the ablation.
We see that all the electrode pairs, which are the electrodes that are on the array, on the spiral that is against the, you see that all these electrodes are all reaching a temperature except electrode one. All the other electrodes are reaching a temperature over 50 degrees, and that is needed to make a lesion inside the heart. In the end, we will destroy the electrical connection between the left atrium and the pulmonary vein.
And you see, if you look at the signal here, this first on the right, we see the signal before the ablation, and on the left we see what is remain, what remains after the application, I see that almost all the local electrical activity is Completely gone. Now apply this procedure to the remaining three pulmonary veins until all pulmonary veins have been electrically isolated. Here we see a clear example.
We see pacing and we see that during pacing there is no capture of the right inferior pulmonary vein. But in the middle of the screen, in between the in between the pacing spikes, we see electrical activity inside that pulmonary vein, which is not conducted to the left Aram anymore. So this is a clear sign that there is isolation of the right inferior pulmonary vein.
Those little spikes that stay within the vein, but they do not connect to the ATE anymore. This is a very nice proof that you really have isolation of the vein. Once all pulmonary veins are isolated, disconnect and remove the pvac C.Inspect the catheter to ensure that there has been no thrombus formation.
The watchman implantation is most easily performed by a two person team. In this video, interventional cardiologist, Dr.Beno Resing, joins the procedure for this step. First, withdraw the Transseptal access sheath, leaving the G wire in place.
Remove the watchman access system and dilator from the packaging under sterile conditions. Carefully inspect it for damage. This is a 14 French sheath with a double curve because we have to go to the anterior side of the left atrium.
So that's why we have the double curve in the sheath. Flush the 14 French watchman access system and the dilator with heparinized saline. Insert the dilator and advance the excess system over the guide wire that has been placed in the left upper pulmonary vein.
Stop advancing once the access system is in the left atrium while maintaining sheath position, remove the dilator and guide wire. Advance a pigtail catheter through the watchman access sheath. Advancing the watchman access sheath over a pigtail catheter, which is positioned in the distal part of the left atrial appendage, prevents accidental appendage perforation.
Next, connect a syringe with contrast eye to the catheter, inject the contrast eye and obtain angiography. To check the appendage shape, We see that there is a slight shoulder on the upper part, and then there is that deep more anterior lobe of the appendage. So this appendage seems, seems to have one lobe at least on fluoroscopy.
Unscrew the access sheath valve and slowly remove the pigtail catheter from the sheath, allow the sheath to back bleed, then flush the sheath to ensure that it contains no clots. We have already performed the echocardiographic measurements and it seems that the largest diameter is 20 to 21 millimeters at the osteum. So that means that we have to oversize the watchman itself.
So the first size we have is a 21 size, which is too small for this, for this appendage because that if that will not lead to compression and a good fixed position of the device in the osteum. So we need a larger size, but 24 millimeter, which is the next size in line, which will then be compressed to become 21, 22, so that it's really fixed in the opening of the appendage. Under sterile conditions, remove the watchman device from the packaging and inspect it for damage.
So this is the inner sheath which contains the watchman. You see it here. It is now folded into the sheath.
We will first see whether it's connected to a rod, a metal rod, which moves the watchman inside the sheath, and it's really good connected so that once we have it in the left, a will not come loose before we want it to come loose from the sheath. And now we will have to flush the whole system to make sure that there is no air inside the sheath. We first flush the backside.
I put my thumb on the tip and we flush it to the back to make sure that this whole portion on the back is OID of air. And now we start to flush forward and we try to get rid of all the bubbles we need to get rid of all the bubbles that are inside the sheath. So we keep on flushing until we make sure that there are no bubbles inside the system because later on through this side port, we can also introduce contrast injections, and we don't want to push the air through the sheath there Gone, gone calm, no bubbles, no troubles.
Introduce the Watchman device system into the access sheath while maintaining a fluid to fluid connection. The first band marks the distal end of the transseptal sheath, the second band, the length of the 21 millimeter watchman device, the third band, the length of the 27 millimeter device, and the most proximal band. The length of the 33 millimeter device align the appropriate marker band on the delivery catheter.
With the osteum of the appendage, We have to be somewhere between the 21 and the 27 marker band. Since we are using a 24 millimeter device, which I guess should be something like this Under fluoroscopic guidance, slowly advance the delivery catheter until its marker. Band lines up with the most distal marker band on the access sheath.
From this point on, neither access sheath nor device catheter should move forward, retract the access sheath and snap it onto the delivery catheter while fixating the delivery catheter on the patient's leg. The access system and delivery system are now assembled together and will move in unison. Do not advance the excess sheath.
Once the delivery system has been snapped onto it, the delivery system is now positioned for deployment. Next, unscrew the valve on the Watchman delivery catheter. Observe the distal end of the device to ensure that no forward advancement or repositioning relative to the osteum occurs.
To deploy the device, hold the position of the deployment knob fixed and gently retract the assembled watchman system with a slow, stable motion over a period of three to five seconds, leaving the core wire attached. Withdraw the assembly a few centimeters from the device, allowing the device to align with the left atrial appendage. Before releasing the Watchman device, it is essential to confirm the position, anchor size and seal or pass criteria.
First, check the position of the device using both fluoroscopy and echo echocardiography. Confirm that the device's plane of maximum diameter spans the left atrial appendage osteum and is distal to or at the plane of the osteum. Next, perform a tug test by applying gentle traction on the deployment knob.
The device and the left atrial appendage should move in unison. Then confirm that the device is compressed to an appropriate size. Measure the maximum diameter of the metal insert in four different TEE views.
In this case, the device size was at the upper limit of the optimal compression range. The device applies optimal radial force when it is compressed to between 80 and 92%of its original size. Finally, ensure that the device spans the appendage osteum and that all the lobes are sealed using color flow Doppler in four different views.
If all release criteria are met, move the access sheath delivery catheter assembly up to the face of the device and rotate the deployment knob three to five turns counter-clockwise to release after release. Perform angiography with contrast eye to document that the device is still in place. Then using TEE, recheck the size and seal, remove the sheath assembly from the left atrium.
The implantation procedure described here was first performed in a canine model to examine the process of healing following implantation. This image is an on fast view of the left atrial appendage. 30 days after implantation, the watchman device is still visible but is already endothelial After 45 days, complete endothelialization of the watchman device is observed and the left atrial appendage is fully closed.
This image shows an anatomical specimen from a patient who died of a cause unrelated to the watchman implantation. Here again, complete endothelialization is seen nine months after implantation. A preliminary study was conducted in which 10 patients for whom oral anticoagulation therapy is relatively contraindicated, underwent catheter ablation followed by placement of the watchman device and follow-up clinic visits.
These patients had symptomatic drug refractory AF without contraindication for ablation, and had CHADS two scores of two or greater and or a relative contraindication for oral anticoagulation. Following the procedure, patients stayed on OAC until TEE was performed at 45 days when left atrial appendage occlusion was successful, OAC was discontinued and patients started aspirin at 81 milligrams per day. Patients visited an outpatient clinic for follow-up at three, six and 12 months.
The table shown here outlines procedural characteristics based on patient anatomy determined during preliminary TEE three different device sizes were used in this group of patients, the total procedure time, including catheter ablation and left atrial appendage occlusion range from 38 to 137 minutes with an average time of 56 minutes. There were minimal complications and the implantation of the device was successful In all 10 patients, one patient had residual flow. On average, patients were hospitalized for two days.
This table summarizes patient's status at 45 days after the procedure, 10 of the patients were followed at 45 days and TEE was performed at this point. Minimal residual flow was seen in three of the patients in one patient. The device embolized thrombus was not seen on the device.
In any cases, six patients continued warfarin, the rest switched to aspirin. Complications following the procedure were limited to bleeding in one patient. The bleeding was not procedural or device related.
The patient developed hematuria requiring bladder flushing. The bleeding occurred within the 45 to 60 days after ablation when all patients were still on vitamin K antagonist. Since discontinuation was not allowed before, the echocardiographic criteria for complete sealing were met on the control TEE.
After watching this video, you should have a good understanding how to perform an ablation in combination with a watchman left atrial appendage closure. When implanting the device, it's important that the whole process is monitored by TE and fluoroscopy. It's also important to properly flush the catheters to make sure you don't have air inside.
We started using left atrial appendage closure devices in our center because of the problems associated with atrial fibrillation. And the biggest problem is stroke. So in patients that have a higher risk of stroke and that need oral anticoagulation, sometimes patients need this at young age already and they need to use this for a longer period of time.
And one of the problems you that is associated with using these drugs is bleeding. So on the one hand, we have a high stroke risk, and on the other hand, we have the risk of bleeding when you use these drugs. And so we think that in patients that that have this combination, that this is a good indication to, to close the left atrial appendage instead of using drugs to tackle this problem.
The watchman device is device that has been studied in a large randomized clinical trial where the watchman was compared to oral anticoagulation and that trial showed that the watchman was non-inferior to oral anticoagulation. So that's why we, on the basis of that evidence, we felt that in patients that with the combination of high stroke rate, but also complications with bleeding, that this would be an ideal way to, to close the left atrial appendage with the only device that is currently, that has currently been investigated, which is the watchman. We were already involved in an early stage with left atrial appendage closure with the plateau device, which then did not reach the, the commercial market.
So one of our interventional cardiologists, Dr.Sing, was involved already several years with that. And now finally, when the watchman became available, we decided that the combination of an interventional cardiologist who is used to working in the heart and an electrophysiologist who's used to working in the left atrium and who performs ablation in the left atrium, that that would be a very nice combination to join our forces and to, to have patients that either need an ablation or patients that also need a device to combine our forces and, and, and use the best of both worlds to, to perform safe and good implants of the of the Watchman device.
La ablación con catéter se combina con la colocación del dispositivo auricular izquierdo WATCHMAN Cierre Appendage para prevenir el accidente cerebrovascular isquémico en un paciente con no-valvular fibrilación auricular.
0:05
Title
2:45
Pre-procedure Imaging of Left Atrial Appendage Shape
5:11
Pre-procedure Preparation
6:28
Catheter Ablation
13:29
Implantation of the WATCHMAN Device
21:57
Results from Preliminary Studies
25:34
Conclusion
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