I had heard about the device approval by the FDA in the spring of 2010 and met with the company during the summer to learn more about the device. What intrigued me was that the Arstasis device really does offer a very unique approach to arterial access, one that is a significant improvement over what we have been doing with the Seldinger approach for the last 60 years. I like to use new technology if it shows extreme promise. The device really is very revolutionary compared to the last two decades, where we focused solely on closure after arterial access, and that is what intrigued me the most.
How does the device work?
The Arstaotomy procedure creates a surgically precise, ultra-low angle arteriotomy through the arterial wall and into the artery. For their most recent generation Axera access device, the procedure begins with a thin-wall needle to puncture into the lumen of the femoral artery. Then a J-tipped, 0.032” latchwire is passed through the needle and into the true lumen. The needle is removed, and the Axera device is attached to the latchwire and advanced into the artery. Once in the artery, we deploy a small heel on the device and pull tension on it to prepare the artery for the low-angle arteriotomy. A secondary needle is then plunged into the arterial wall, creating an ultra-low angle (5-10 degrees) access point through the muscular wall of the artery, what the company calls the Arstaotomy. This shallow angle arteriotomy tract is utilized to place the procedural sheath, through which you perform your angiograms and interventions. It turns out that this surgically engineered entrance through the arterial wall is what provides hemostasis, because when the case is concluded and you pull out the sheath and the hardware, just by means of the way that this access was created through the arterial wall, it seals up and thromboses closed without any bleeding problems. Our time to hemostasis (TTH) is somewhere less than 3 minutes.
After the sheath is pulled, manual compression is used?
Yes. The sheath is pulled at the end of the case and we immediately assess for any bleed back, and then normally just hold light to intermediate pressure for anywhere from 1-3 minutes.
That is done on the table?
Usually. If we don’t have an immediate case to go onto the table, our technologists find it convenient to hold pressure right in the lab, because the time to hemostasis is so quick. If we have done an intervention on a patient and given them bivalirudin or eptifibatide, we will allow about an hour for those drugs to metabolize off, then pull the sheath in the cath lab recovery area. Time to hemostasis is the same, however, and these are very brisk hemostatic times.
You are absolutely correct. The original Seldinger technique of accessing an artery has been around a long time, and with all the closure devices, you are left at the end trying to plug the hole in the dike, like the little Dutch boy putting his finger in the hole. The idea of the Arstaotomy technique is that it is a surgically precise access point into the artery. Whether you are using a plug, a surgical clip or some other form of closure, it’s after the fact. A hole has been created, and now you are trying to plug it and dealing with the obvious hemostatic factors of pressure trying to push the plug out. “Holistic” might be the appropriate term here; the other thing we like to say is “nothing left behind,” because the great majority of patients, at least in our practice, are elderly and have multi-vessel coronary disease, and often other vascular disease. These patients will have multiple trips to the cath lab over their lifetime. The beauty of this device is that nothing is left behind at your access site. It is then easy to re-access the patient anywhere from within a couple of hours to a couple of weeks or months, and not have to deal with the scarring and the foreign material left behind. That is what I like about it.
The company is currently involved in a study called RECITAL, which is a post-approval study. It was started in November 2010 and will continue up through about 500 patients. RECITAL will look at specific issues like time to hemostasis, time to elevation of head of the bed, time to ambulation, and time to hospital discharge.
We are a fairly high-volume lab and at present, are using the device in almost every case, unless we exclude the patient up front. Our average time to hemostasis is about 3 minutes; the average person is sitting upright in bed after about 15 minutes, and then we will try to ambulate the patient at the end of an hour. Our average time to hospital discharge has been shortened to between 2-3 hours.
Any issues with vessel health limiting access?
The first-generation Arstasisone device is out in the field; there was a product launch on that mid-last year. The new, second-generation Axera access device was recently approved by the FDA and the company just lanched it just a few weeks ago. The improvements from the more robust Axera device aids in access for those patient groups that are a little more difficult, well known in the vascular realm. The first group includes those with previous femoral artery surgery, previous lymph node dissections in the area, radiation, patients with prostate cancer, really, anything where there is a lot of fibrotic scarring. That has sometimes been an impediment to smoothly advancing the needle or the guidewire for the catheter. The second group includes extremely obese people, particularly obese females (300-350 lbs), who are a unique challenge. These are two patient groups are red flags for any operator. The Axera device is a substantial leap forward in helping these patients. Our own patient population is skewed in that direction where I practice, and the device has proven very effective; substantially better than anything we have right now.
Does the Arstasis device limit sheath size?
Not really. The Axera device is available in a 5F or 6F set. I am typically using 5F for all of my diagnostic cases and 6F for my cath-possibles. We have upsized as far as an 8 Fr, and on one occasion, a 9 Fr sheath, with a time to hemostasis of about 8 minutes on the 9 Fr sheath.
What about time to access?
Probably the device adds no more than 15 to 30 seconds of additional time. What I recommend, which is similar to any other approach, is to identify landmarks with respect to the femoral head and iliac crest, and then once the artery is punctured and the latchwire is passed, take a quick fluoro to ensure a straight path into the iliac and distal aorta, which most people do anyway. I would not recommend the blind approach without confirming under fluoroscopy where the latchwire is going. Once it is confirmed with a brief fluoro, then make a skin nick, bring the Axera device down and place it into the artery. Deploy the device, bring your sheath over the wire, and you are good to go. In the hands of most skilled interventionalists or anyone who has worked in the cath lab for a long time, I do not think there is any real additional increase in procedural time. As the physician and staff gain confidence in using the device, the actual procedural time, as well as the care time, decreases.
How was your learning curve with the device?
To get familiar with the device and feel really comfortable using it, I think 25 cases is a minimum. As far as troubleshooting and seeing some of the unique things within certain patient populations, 50 cases will probably bring you to an expert level. There is definitely a learning curve; it is not a device where within 2-3 cases people can immediately start to use the device. The company may suggest a commitment of at least 50 cases. They want people to be comfortable and for everybody to have success with the device. If you did 2-3 cases, and the first 2-3 cases didn’t go as planned, you might get discouraged. But like any other technology in interventional cardiology, there is a learning curve.
Right now we have almost 400 cases, and our failure to access the artery is approximately 0.6%. Out of that group, we had a total of 8 unsuccessful cases, of which 6 were based on patient anatomical issues. The remaining two patients turned out to have aortoiliac occlusive disease, so although we would have access to the artery, because of the presence of disease, we couldn’t advance the device adequately.
How did you end up getting access on these patients?
In 2 of the cases, we converted from one side to the other and gained access that way, and then in the remaining cases, switched up to the arm.
Do you see any kind of benefit to this type of access for transradial use?
It’s probably not necessary. Arstasis has looked at possible use of the device in the brachial artery, but the artery size is not large enough to accommodate the device, and currently the approved use is for femoral access only.
Do you use the device in acute myocardial infarction patients?
In acute ST-elevation myocardial infarction (STEMI), we have done 9 acute STEMIs since November 2010, and our average door-to-balloon (D2B) time is about 30-32 minutes. The device has not impacted our D2B times. I am in a small community hospital, so we have kind of a truncated process where if the patient goes in the ER with a STEMI, it’s a very rapid process to call the cath lab and bring the patient right over. The fascinating thing is that these patients are almost being treated as outpatients. In the midst of an acute MI, the patient comes over, has an intervention, and the D2B time is 30-32 minutes. We then shut off the bivalirudin. Our actual procedure is elevation of the head of the bed after 15 minutes, and out of bed and ambulatory in 1 hour. The patient ambulates to use the restroom at 2 hours. The patient can then be discharged to home at 2-3 hours if they have done these things successfully and are stable. That is how efficient we have become, and I expect it will continue. As most people realize, the major complications with any kind of vascular access and the major complications for acute STEMI treatment all stem from bleeding complications. Greater than 95% of all mortality and morbidity in STEMI patients is associated with bleeding complications, not the original myocardial infarction. If we can eliminate vascular bleeding complications, it will improve outcomes for our patients.
Does the time savings with this device decrease costs for your lab?
The Seldinger approach has been around for a long time, and the original thought process was very basic, as far as thinking, gee, rather than doing a surgical cut-down, wouldn’t it be nice to puncture the artery and utilize an over-the-wire technique? That was revolutionary at the time, and the Arstasis device revolutionizes access yet again. Here we are 60 years later, and we have had an incredible breakthrough. I put the Arstaotomy up there with previous great breakthroughs in cardiology like balloon angioplasty, the use of stents, thrombolytic therapy and our understanding of acute myocardial infarction. This new method of arterial access is going to rate as one of the great breakthroughs in interventional cardiology for the 21st century.
Dr. Kresock can be contacted at TheCVCenter@yahoo.com.
Disclosure: Dr. Kresock reports no business disclosure or affiliation with industry.