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Why ArtAssist® arterial pump therapy is unique

When you think of therapeutic pneumatic compression pumps, what comes to mind? Many might think of lymphedema or DVT prophylaxes, but it is less widely-known that arterial pump compression therapy, if correctly applied, can actually treat severe PAD.

ArtAssist Arterial Assist Device

ArtAssist®…The Arterial Assist Device®

ArtAssist®…The Arterial Assist Device® (Arterial Pump Technology) should not be confused with lymphedema or DVT prevention treatment because the ArtAssist® device solves an entirely different problem:  facilitating arterial blood flow to the places that need it, especially in the legs and feet (there are also cuffs available for arms, though it is somewhat less common).

So, for example, if you have atherosclerosis (hardening of the arteries) of the lower extremity or a diabetic foot ulcer, your problems would not be solved with a lymphedema pump, even if it has been modified to be more powerful. (Side note:  some arterial pump makers advertise that a more powerful lymphedema or DVT pump will effectively treat arterial disease. We at ACI Medical suggest that you ask for their clinical evidence.)

Depending on the nature and severity of your arterial disease, you may be better advised to use the ArtAssist® device. This device was not based on a lymphedema or DVT pump design – rather, the ArtAssist® device was designed by vascular surgeons with the goal of increasing arterial flow for patients with poor leg circulation.

Researchers have discovered that, unlike lymphedema pump technology, the ArtAssist® device promotes what we call arteriogenesis, or collateralization.  These two synonyms refer to the opening of small collateral arteries that already naturally bypass the obstructed artery. We all have these small collateral arteries, but when the main artery has no blockages, the collateral ones aren’t needed.

angiogram van bemmelen artassist arterial pump technology

Arteriogenesis (or collateralization) explains why patients have long-term results after stopping ArtAssist® device usage

In this case, a person with a blocked artery needs to take action so that blood gets where it needs to be. Sometimes, people make lifestyle changes, such as dieting and exercising. Other times, people take medication to improve blood flow. And in more severe cases, people resort to surgery such as bypass and endovascular procedures (e.g. stenting, angioplasty, etc.).

The problem is that some people exhaust all of those options and vascular surgeons believe they have no other choice but to amputate – but that’s not true! There is actually one last shot at limb salvage for these patients, and that is the ArtAssist® device. In one clinical study, it was shown to have up to a 94% limb salvage rate even after 3.5 years.

Do be advised, though:  no one would ever recommend that you let it get to the point of amputation. As with all diseases, the earlier you solve the problem, the better.

If you or someone you know could use the ArtAssist® device as a non-surgical solution for PAD, please call our toll free number 888-453-4356 and ask to talk to Don or Sylvia. If you contact me (via WordPress, Twitter, Facebook, email, website, etc.), I will refer you to either of the two people I just mentioned as quickly as I can – we know how important limb salvage is.

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Jun 4, 2012 By ArtAssist®...The Arterial Assist Device®

Compressing Ischemic Limbs and Why It’s Beneficial

To download a printable PDF of this article, click here:  Compressing Ischemic Limbs and Why It’s Beneficial

The Misconception

Is it true that arterial occlusive disease is an absolute contraindication for intermittent pneumatic compression (IPC)?

The Answer

Not at all!

Unfortunately, many medical professionals are under the impression that applying even a small external pressure to an ischemic limb with reduced distal arterial pressures may serve to reduce or completely stop the already-compromised blood flow. This article presents strong evidence that, contrary to popular belief, IPC can bring life-changing benefits to those who cannot undergo revascularization.

History

Part of the reason this dogma exists is because, for many who consider it, applying IPC to ischemic limbs seems counterintuitive and likely dangerous. Also contributing to this myth are the literature reviews written by investigators as far back as 1934 who showed a poor understanding of the physiological mechanisms. Though these measured acute effects of compression on increased blood flow in ischemic limbs and relief of symptoms, the assessments made about IPC therapy were muddled due to the use of a great variety of compression schemes and devices. This lack of clarity resulted in literature that only served to feed misgivings about IPC as a treatment modality.

Physiological & Optimization Studies | ACI Medicalarteriovenous pressure gradient

To demystify the true value of IPC, our goal was to determine the physiological mechanisms of action, to optimize IPC design for maximal acute effect, and to determine if there is a clinical benefit to patients with lower extremity ischemic disease.

We started with physiological studies1 with compression applied to the dependent limb, which showed these acute mechanisms:

  • Increased arterial-venous pressure gradient
  • Reduced peripheral resistance
  • Abolition of the veno-arteriolar reflex

Further studies2 concerned optimization:

  • Pressure:  at least 120 mmHg
    This high pressure is required to empty the veins in the dependent limb, which temporarily reduces venous pressure to near zero and increases the arterial-to-venous pressure gradient and therefore, flow. Reducing venous pressure also serves to temporarily abolish the veno-arteriolar reflex, which allows for arteriolar dilation.
  • Timing:  3 second pulses followed by 17 seconds of low pressure
    An essential requirement for an arterial pump is the ability to quickly reach inflation and deflation pressures with rise times of 0.25 to 0.30 seconds and fall times under 0.5 seconds.  This rapid squeeze and release creates blood velocities that apply shear stress to the endothelium which releases nitric oxide and further supports the large acute vasodilatory effect in the arterioles.
  • Compressed tissues:  foot, ankle and calf regions
    In order to maximize blood flow through the major arteries and to the toes where ischemic disease often presents, we found that a circumferential foot bladder including the ankle should be compressed first, followed one second later by compression of the calf with a relatively large asymmetrical bladder.

Randomized Controlled Trials | ACI Medical

Intermittent Claudication

Once the arterial IPC device was optimized, three randomized controlled trials3 were performed on patients with intermittent claudication. Not only did these trials yield significantly increased walking distances of two to three times, but also sustained “permanent” improvements begged the question, “What long term mechanisms might be at work?”

Limb Salvage due to Arteriogenesis

Further studies4 showed that arteriogenesis (the opening of collaterals) was responsible for improved ABI’s, PVR’s, toe pressures and popliteal flow. A recently published study from 20105 reported a 94% limb salvage rate at 3.5 years in patients who were unable to undergo revascularization procedures.

Arterial Assist Device, NOT Lymphedema Pump

ArtAssist Arterial Assist Device

ArtAssist®…The Arterial Assist Device®

Today, it is widely-known that IPC devices are designed for prophylaxis against deep vein thrombosis (DVT) and for treatment of lymphedema. However, the understanding behind these devices does not coincide with our exploration of IPC to treat severe forms of arterial disease. Lymphedema and DVT devices do not apply enough pressure to the dependent limb to adequately empty the veins, nor do they apply and release pressure rapidly enough to stimulate release of nitric oxide (NO). While such devices will not significantly improve blood flow in the ischemic limb, it is difficult to say whether they would be harmful without further study.

References in this Publication

  1. Effect of intermittent pneumatic foot compression on popliteal artery haemodynamics. Delis, K.T.; Labropoulos, N.; Nicolaides, A.N.; Glenville, B.; and Stansby, G. Imperial College School of Medicine, Academic Vascular Surgery, St. Mary’s Hospital, London, UK. Eur J Vasc Surg, p. 270-277, vol. 19, no. 3, March 2000.
  2. Optimum intermittent pneumatic compression stimulus for lower-limb venous emptying. Delis, K.T.; Azizi, A.A.; Stevens, R.J.G.; Wolfe, J.H.N. and Nicolaides, A.N. Irvine Lab for Cardiovascular Investigation and Research Academic Vascular Surgery, Imperial College School of Medicine, St. Mary’s Hospital, London, UK. Eur J Vasc Endovasc Surg 19, 261-269 (2000).
  3. Improvement in walking ability, ankle pressure indices and quality of life in vascular claudication using intermittent pneumatic foot and calf compression:  a randomized controlled trial. Delis, K.T.; Nicolaides, A.N.; Cheshire, N.J.W.; Wolfe, J.H.N. St. Mary’s Hospital, London, UK. British Journal of Surgery December 2002; Volume 88, Issue 4:605-606.
  4. Angiographic improvement after rapid intermittent compression treatment (ArtAssist®) for small vessel obstruction. Van Bemmelen, P.; Char, D.; Giron, F.; and Ricotta, J.J. Dept. of Surgery, Div. of Vascular Surgery, State University of New York at Stony Brook, NY. Ann Vasc Surg 2003; 17:224-228.
  5. Sequential compression biomechanical device in patients with critical limb ischemia and nonreconstructable peripheral vascular disease. Sultan, S.; Hamada, N.; Soylu, E.; Fahy, A.; Hynes, N. and Tawfick, W. Department of Vascular and Endovascular Surgery, University College Hospital, Galway, Journal of Vascular Surgery 2011; 54:440-447.
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May 25, 2012 By ArtAssist®...The Arterial Assist Device®, PAD

Building collateral arteries with ArtAssist® device compression therapy

Arteriogenesis:  the key to success

For patients who are surgical candidates, the solution to their arterial obstruction comes as quickly as a surgeon can work.

English: podiatric surgery

English: podiatric surgery (Photo credit: Wikipedia)

However, this means that non-operable patients and their doctors are left to find alternative solutions to improving lower extremity circulation. Drugs and lifestyle changes may work as long as the regimen is maintained, but these may still present problems according to each patient’s case.

Patients who use the ArtAssist® device every day for at least 90 days have developed permanent collateral arteries as a result of therapy.

This solution may be ideal for doctors with patients who have otherwise run out of options. With proven efficacy and consistently high success rates, those with severe PAD get another chance to rebuild and strengthen the collateral arteries in their lower extremities.

The theory

When developers optimized the ArtAssist® device to maximize blood flow to the lower extremities, they realized that, even after having stopped therapy with the device, patients kept their improved circulation. “Why is this?” they asked.

After some educated guessing, Paul van Bemmelen, MD, PhD of Temple University began looking into the hypothesis more closely. This publication (Fig. 1) is the first to have documented a threatened limb before and after four months of ArtAssist® device therapy.

The Rabbit study

In 2007, Dr. van Bemmelen performed another study, this time with a rabbit model. He and his team were able to confirm that intermittent pneumatic compression on the experimental limbs increased the number of angiographical collateral arteries.

How it works

Arteriogenesis, the growth of collateral arteries, can be achieved with a regimen of intermittent pneumatic compression, as we’ve just seen. But what actually happens inside the vessels?

Rapid compression causes shear stress on the endothelial cells. These cells react by releasing nitric oxide (NO), which acts as a vasodilator, and tissue factor pathway inhibitor (TFPI), which acts as an anticoagulant. These two substances ease the path of nutrient-rich blood through the collateral arteries.

Within a month, patients with peripheral arterial disease (PAD) typically begin to see a dramatic increase in arterial blood flow if they use the ArtAssist® device every day.

After about 90 days, the benefits can be visualized in an arteriogram, as seen above. After this point, a patient may be able to discontinue ArtAssist® device therapy.

Obtaining therapy

Both physicians and patients can contact ACI Medical for information and ordering:  toll free (888) 453-4356 or info@acimedical.com

More detailed information can be found at acimedical.com/artassist/order.

References

Angiographic Improvement After Rapid Intermittent Compression Treatment (ArtAssist®) for Small Vessel Obstruction
van Bemmelen, P.; Char, D.; Giron, F; and Ricotta, J.J. Department of Surgery, Division of Vascular Surgery, State University of New York and Stony Brook, NY, USA. Ann Vasc Surg 2003;17:224-228

Long-term Intermittent Compression Increases Arteriographic Collaterals in a Rabbit Model of Femoral Artery Occlusion 
van Bemmelen, P.S.; Choudry, R.G.; Salvatore, M.D.; Goldenberg, B.I.; and Blebea, J. Departments for Surgery, and Pathology, Temple University, Philadelphia, USA.
Eur J Vasc Endovasc Surg 34, 340-346 (2007) 

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May 25, 2012 By ArtAssist®...The Arterial Assist Device®, PAD

All stents fail. So what happens next?

andrew nicolaidesBackground

If you are familiar with the nature of endovascular procedures, you’ll know that eventually, all stents fail. At this point, many vascular surgeons choose to redo the stent, but what if there was a long-term solution?

Andrew N. Nicolaides, Professor Emeritus of the Imperial College of London is among  a group of researchers who have done the most studies with grafted arteriopaths using ArtAssist®…the Arterial Assist Device®, to improve blood flow to the lower extremities. This group discovered that using the ArtAssist® device on patients who had already undergone a successful endovascular procedure enhanced arterial circulation.

New Hypothesis

After having confirmed this discovery, Professor Nicolaides and his team in London are thinking about the next step:  after the arterial stent inevitably fails, the patient now has an alternative to getting another stent. If a patient uses the ArtAssist® device while his stent is still in place, Professor Nicolaides hypothesizes, by the time the stent fails, his artery will be capable of accommodating the same beneficial amount of blood as before, and he will not need to go in for another procedure.

Interview

Now that you have a bit of a background, I’ll let Professor Nicolaides explain it in his own words.

ArtAssist Arterial Assist Device

UPDATE

July 13, 2012:  A veteran researcher of the ArtAssist® device has recently agreed to test Prof. Nicolaides’ hypothesis. Stay tuned for more information!

References

Effects of Intermittent Pneumatic Compression of the Calf and Thigh on Arterial Calf Inflow: A Study of Normals, Claudicants, and Grafted Arteriopaths
Delis, K.T.; Husmann, J.W.; Cheshire, N.J.; and Nicolaides, A.N. Imperial College School of Medicine, St. Mary’s Hospital, London, UK. 
Surgery, 2000, Vol. 129, No. 2, p. 188-195

Enhancing Foot Skin Blood Flux in Peripheral Vascular Disease Using Intermittent Pneumatic Compression: A Controlled Study on Claudicants and Grafted Arteriopaths. Delis, K.T.; Husmann, M.J.W.; Nicolaides, A.N.; Wolfe. J.H., and Cheshire, N.J., Imperial College School Of Medicine, St. Mary’s Hospital, London, UK. World Journal Surgery, 2002 Jul;26(7):861-6

Haemodynamic Effect of Intermittent Pneumatic Compression of the Leg After Infainguinal Arterial Bypass Grafting 
Delis, K.; Husmann, M.;  Szendro, G.; Peter, N.; Wolfe, J.H.; Mansfield, A.O.  Regional Vascular Center, Surgery and Department of Academic Cardiology, St. Mary’s Hospital, Imperial College School of Medicine, London, UK.
Br J Surg 2004;91:429-34

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May 25, 2012 By ArtAssist®...The Arterial Assist Device®

Arterial Pump Choosing Guide

At ACI Medical, we know that there are more home-use intermittent pneumatic compression devices (in other words, arterialArtAssist device patient pumps) similar to the ArtAssist® device out on the market, but here is the best we can say for them:  they may work, they may not. This is because the ArtAssist® device is the only device of its kind to have been optimized to treat arterial disease through clinical trials at multiple independent centers. In other words, research done on the ArtAssist® device itself supports our claims about its capabilities.

Through numerous clinical trials, ACI Medical’s researchers have determined what the ArtAssist® device system needs to increase blood flow to the lower extremities as much as it does. If you’re thinking about getting an arterial pump to treat PAD (peripheral arterial disease), here’s what you should look for and why:

Cuff Specifications

Bladder Locations

artassist arterial pump cuff

It is important to have air bladders compressing the foot, ankle and calf regions because this promotes more blood flow to the skin.

When you are considering an arterial pump, also take a look at the size of the air bladders. The larger they are, the more tissue they’re

going to reach. The more tissue they reach, the more circulation.

Inflation and Deflation Rates

Research shows that quick inflation and deflation rates of the air bladders (less than half a second) put what’s called shear stress on your blood cells. Shear stress is good, because when your endothelial cells experience it, they release a muscle relaxant (or a vasodilator called nitric oxide) that helps open the small collateral arteries that are capable of naturally bypassing the blocked artery. It takes around 3 months, and the improvements are long-term. We call this process arteriogenesis or collateralization. 

Now, this process I described does take a lot longer (typically between 3-6 months) than an open bypass operation, but for people who aren’t good candidates for surgery, it may be worth it to look into arterial pump treatment.

Cuff Pressure

ArtAssist compression sequence 120mmhg

Rapid sequential compression

Now you know that cuffs should have large bladders at the foot, ankle and calf and that they should inflate and deflate quickly. But what kind of pressure should the air bladders reach?

The answer that researchers found was 120 millimeters of Mercury (mmHg), which is about the pressure of a very firm handshake. Below this pressure, blood flow was not as high. Above 120 mmHg was unnecessary and, furthermore, uncomfortable for patients.

Clinical Research

You know I’ve been hinting at it, and I can’t stress it enough:  make sure the device you invest in has clinical research supporting its claims. Research done at respected institutions is usually a very good sign for an arterial pump you’re considering. Also, if you can find a study that’s been done on patients with your diagnosis, even better!

UPDATE:

Being optimized to treat arterial disease is of the utmost importance. Research at the Mayo Clinic suggested that if a pump is NOT optimized for arterial disease, using it could actually DECREASE blood flow – a waste of your precious time and money! For example, some arterial pumps on the market have been modified from DVT prophylaxes and do not have much published clinical support.

So, like any decision you make concerning your health, I encourage you to do a bit of research and ask yourself:  did the makers of this arterial pump design it specifically to treat arterial disease? Straight answers are the best.

Customer Service

Patient Compliance

Basically, make sure you can commit to using your arterial pump for however often your physician has prescribed it. As an example, we’ve seen the ArtAssist® device do amazing things for people – and it’s because they got into the habit of using it every day.

Patient Accommodation

Are you dealing with a special condition? Have you already had a below-knee amputation or are you unable to tolerate foot compression? Is your situation unique? It’s helpful to know that your arterial pump provider is knowledgeable enough to listen to what you’re going through and find a solution so you can get the therapy you need.

Obtaining Your Therapy

Just consider:  how many numbers do you have to call to get an arterial pump? Do you have to go to a clinic every day or can you conveniently keep it at home? Find an arterial pump provider that makes it as easy as possible.

The Arterial Pump That Comes Out On Top

artassist device arterial pump technologyThere’s only one number to call if you want to order, prescribe, or just get more information about the ArtAssist® device:  (888) 4 LEG FLO (888-453-4356). Alternatively, you can email info@acimedical.com any time of the day.

For our references, see our Clinical Studies page.

To read documented success stories of ArtAssist® device patients, take a look through the Case Reports page.

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May 25, 2012 By ArtAssist®...The Arterial Assist Device®

Also at Desert Foot 2011: Ideal Adjunct Therapy Solutions

In addition to our theme of laser Doppler demonstrations with the ArtAssist® device, we will also be giving out information about how ArtAssist® therapy can be used in conjunction with other treatments.

Take, for example, a case report from Dr. Darwin Eton and Dr. Hong Yu (both from the University of Chicago). They combined intermittent pneumatic compression (IPC) therapy (with the ArtAssist® device) with specific doses of a growth factor called granulocyte-colony stimulation factor (G-CSF…and what a mouthful!).

Though the two patients were of different genders and ages and had different conditions, the combination of IPC and G-CSF worked to heal both of their limbs within a year.

Patient 1’s lower extremity necrosis was healed after 5 months of adjunct therapy and Patient 2’s dorsal ankle ulcer and exposed Achilles’ tendon was healed after one year.

You can read the abstract at this link (CLICK HERE).

And again, if you’re going to Desert Foot next week, we hope to see you there!

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