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Experience With the Arstasis-one Access Device
Tell us about this new femoral artery access device from Arstasis. Why were you initially 
interested?
As physicians, we are always looking for a better solution for common clinical issues we face in the cath lab. Though there are some adequate solutions for femoral artery closure today, none are ideal. There are infection and thromboembolic risks associated with the implantation of closure devices, and manual compression is time-consuming for our staff and not at all pleasurable for patients. I found this new, unique approach to be intriguing, and truly revolutionary in its design and concept. The idea of completely reinventing access to improve closure without the need for implanting foreign material into patients was certainly compelling.
How does the device work?
Instead of the typical modified Seldinger approach for femoral arteriotomy, the Arstasisone 
Access Device allows one to create an “Arstaotomy,” which is a longer (5-7mm) and shallower-angle arteriotomy that essentially delivers significant tissue-upon-tissue overlap when the sheath is removed at the end of the case. The intra-arterial pressure is dissipated or reflected over a longer tissue tract that is self sealing, compared to the typical acute angle of entry and short distance found with the classical Seldinger technique. With about 3 minutes of moderate manual compression, clot forms and matures very quickly along this longer channel as the arterial pressure decreases dramatically along the Arstaotomy path, providing for secure arterial closure with nothing left behind.
What is the importance of “nothing left behind”?
Introducing foreign materials in a patient creates its own set of problems, some of which can be very serious, such as infection and critical limb ischemia. Some closure devices can also make it more difficult to re-access the femoral artery. An “access” device (compared to a “closure” device) eliminates these issues.
How has use of the device affected your lab?
We have seen a greater than 95% technical success rate with the product, with a 2-3 minute time to hemostasis and a 1-hour time to ambulation for my diagnostic patients.
The device has an excellent safety profile. Because you are primarily relying on the longer Arstaotomy channel and standard intra-arterial pressure rather than foreign body implants for closure, the risks of thromboembolic complications and infection are less likely.
This device has been very well received by patients, especially repeat patients. Usually only 3 to 5 minutes of moderate pressure versus 10-20 minutes of heavier, occlusive pressure is adequate. Generally, patients are sitting up in 15 minutes and can ambulate in 1 hour. It has really improved our cath lab throughput and patient satisfaction.
What about complications?
No type of access or closure device will be complication free. So far, our experience with the Arstasis device has been positive. The Arstasis device has proven to be a very safe device. In a presentation at TCT 2010, Dr. Thilo Tübler of the Medical Care Center in Hamburg, Germany, presented a 1,191 patient study using the Arstasisone access device in diagnostic (73%) and interventional (27%) patients. Total major and minor device-related complication rates were low (0.34% and 1.68%, respectively). Major device-related complications included pseudoaneurysm requiring intervention (n=3, 0.25%) and surgical repair of severed side branch (n=1, 0.08% — not device-related). Minor device-related complications included groin hematomas larger than 6 cm (n=9, 0.76%), subclinical pseudoaneurysm (n= 4, 0.34%), atriovenous fistula (n=3, 0.25%), recurrent bleeding (n=3, 0.25%) and transient neural pain (n=1, 0.08%). My results at the University of Tennessee are trending at or below these rates. We are tracking all complications with the Arstasis device in a prospective, multi-center U.S. trial, called RECITAL, which is currently enrolling 500 patients.
How does this device compare in cost to manual compression and the average vascular closure device?
The cost of the Arstasis device is comparable to other closure-type devices. When compared to manual compression, the cost of the Arstasis device is offset by decreased compression hold times, decreased length of bed rest, earlier ambulation and earlier patient discharges.
Can you tell us more about standard manual compression versus the compression applied after using the Arstasisone?
Arstasis requires significantly less time to hold and the amount of pressure is less as well. Our staff is very pleased with our adoption of this device. We have seen that one-third of our Arstasis patients had hemostasis in one minute and the majority of patients are closed at 3 minutes.
How long does it take to learn this new procedure?
It only takes a few cases to understand the device; however, it is important to commit the appropriate amount of time to learn how the Arstaotomy procedure works across a myriad of patient subsets. I routinely use fluoroscopy to gauge my puncture site, as advocated by Dr. Zoltan Turi.1
Tell us how you are currently using the device.
I am still gaining experience with the device, but it seems appropriate for all 5 and 6 French diagnostic and interventional procedures.
Dr. Wortham can be contacted at DWortham@utmck.edu
interested?
As physicians, we are always looking for a better solution for common clinical issues we face in the cath lab. Though there are some adequate solutions for femoral artery closure today, none are ideal. There are infection and thromboembolic risks associated with the implantation of closure devices, and manual compression is time-consuming for our staff and not at all pleasurable for patients. I found this new, unique approach to be intriguing, and truly revolutionary in its design and concept. The idea of completely reinventing access to improve closure without the need for implanting foreign material into patients was certainly compelling.
How does the device work?
Instead of the typical modified Seldinger approach for femoral arteriotomy, the Arstasisone 
Access Device allows one to create an “Arstaotomy,” which is a longer (5-7mm) and shallower-angle arteriotomy that essentially delivers significant tissue-upon-tissue overlap when the sheath is removed at the end of the case. The intra-arterial pressure is dissipated or reflected over a longer tissue tract that is self sealing, compared to the typical acute angle of entry and short distance found with the classical Seldinger technique. With about 3 minutes of moderate manual compression, clot forms and matures very quickly along this longer channel as the arterial pressure decreases dramatically along the Arstaotomy path, providing for secure arterial closure with nothing left behind.
What is the importance of “nothing left behind”?
Introducing foreign materials in a patient creates its own set of problems, some of which can be very serious, such as infection and critical limb ischemia. Some closure devices can also make it more difficult to re-access the femoral artery. An “access” device (compared to a “closure” device) eliminates these issues.
How has use of the device affected your lab?
We have seen a greater than 95% technical success rate with the product, with a 2-3 minute time to hemostasis and a 1-hour time to ambulation for my diagnostic patients.
The device has an excellent safety profile. Because you are primarily relying on the longer Arstaotomy channel and standard intra-arterial pressure rather than foreign body implants for closure, the risks of thromboembolic complications and infection are less likely.
This device has been very well received by patients, especially repeat patients. Usually only 3 to 5 minutes of moderate pressure versus 10-20 minutes of heavier, occlusive pressure is adequate. Generally, patients are sitting up in 15 minutes and can ambulate in 1 hour. It has really improved our cath lab throughput and patient satisfaction.
What about complications?
No type of access or closure device will be complication free. So far, our experience with the Arstasis device has been positive. The Arstasis device has proven to be a very safe device. In a presentation at TCT 2010, Dr. Thilo Tübler of the Medical Care Center in Hamburg, Germany, presented a 1,191 patient study using the Arstasisone access device in diagnostic (73%) and interventional (27%) patients. Total major and minor device-related complication rates were low (0.34% and 1.68%, respectively). Major device-related complications included pseudoaneurysm requiring intervention (n=3, 0.25%) and surgical repair of severed side branch (n=1, 0.08% — not device-related). Minor device-related complications included groin hematomas larger than 6 cm (n=9, 0.76%), subclinical pseudoaneurysm (n= 4, 0.34%), atriovenous fistula (n=3, 0.25%), recurrent bleeding (n=3, 0.25%) and transient neural pain (n=1, 0.08%). My results at the University of Tennessee are trending at or below these rates. We are tracking all complications with the Arstasis device in a prospective, multi-center U.S. trial, called RECITAL, which is currently enrolling 500 patients.
How does this device compare in cost to manual compression and the average vascular closure device?
The cost of the Arstasis device is comparable to other closure-type devices. When compared to manual compression, the cost of the Arstasis device is offset by decreased compression hold times, decreased length of bed rest, earlier ambulation and earlier patient discharges.
Can you tell us more about standard manual compression versus the compression applied after using the Arstasisone?
Arstasis requires significantly less time to hold and the amount of pressure is less as well. Our staff is very pleased with our adoption of this device. We have seen that one-third of our Arstasis patients had hemostasis in one minute and the majority of patients are closed at 3 minutes.
How long does it take to learn this new procedure?
It only takes a few cases to understand the device; however, it is important to commit the appropriate amount of time to learn how the Arstaotomy procedure works across a myriad of patient subsets. I routinely use fluoroscopy to gauge my puncture site, as advocated by Dr. Zoltan Turi.1
Tell us how you are currently using the device.
I am still gaining experience with the device, but it seems appropriate for all 5 and 6 French diagnostic and interventional procedures.
Dr. Wortham can be contacted at DWortham@utmck.edu
References
- Overview of Vascular Closure. May 2010. Endovascular Today 2010 May;9(5): 65–74. Online at https://www.bmctoday.net/ evtoday/2010/05/article.asp?f=overview-of-vascular-closure. Accessed February 14, 2011.
- Vascular Access Device Achieves Low Complication Rates. October 4, 2010. TCTMD.com. Available online at https:// www.arstasis.com/company/news/tctmd10042010.php. Accessed February 3, 2011.
