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Health Technology Assessment of IPC in Ireland is Challenged by Surgeon

ArtAssist Device collateral artery growth
ArtAssist Arterial Assist Device IPC

ArtAssist®…The Arterial Assist Device®

Intermittent pneumatic compression (referred to as IPC)

As a pioneering technology, ArtAssist®…The Arterial Assist Device® faces resistance in the medical community at large. In this case, Ireland’s Health Information and Quality Authority (HIQA) cites the “lack of high quality, reliable evidence to support the widespread adoption of this technology” in its Health Technology Assessment (HTA).

The ArtAssist® device has been clinically shown to drastically improve circulation in patients with limb-threatening ischemia, a result of advanced peripheral arterial disease (PAD). Many doctors, including Mr. Sultan at the Galway Clinic, prescribe ArtAssist® device therapy to patients who are not candidates for surgical intervention.

Understandably, doctors responsible for the well-being of their patients may be skeptical of new technologies such as IPC to treat PAD. The fact remains, however, that the only “widespread” course of action after failed attempts at revascularization is amputation of the limb. Since PAD often affects the aged population, the aftermath of amputation can be extremely detrimental to a patient’s quality of life in addition to being a financial burden on the state.

Mr. Sultan, in response to the HTA report:

Sherif Sultan

Mr. Sherif Sultan, Galway Consultant Vascular and Endovascular Surgeon

“The question is, is it a safe procedure, does it save limbs, does it decrease pain and does it control ulcers? The answer in all these cases is yes.”

Mr. Sultan continues to say that he has saved over 500 limbs with this IPC technology over the past eight years, which would have otherwise been scheduled for amputation. Furthermore, numerous studies on this device have been published in Vascular and Endovascular Surgery, a peer reviewed medical journal. The cost of renting the machine for three months is comparable to one night in a hospital bed.

To read the article in full, please visit:  http://www.imt.ie/news/latest-news/2013/07/hta-on-ipc-is-challenged-by-surgeon.html?doing_wp_cron

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Jul 15, 2013 By ArtAssist®...The Arterial Assist Device®, PAD

Taiwanese PAD patients have improved quality of life & better walking distances in this new IPC study

Unlike other studies for the ArtAssist® device, these researchers examined the effects of intermittent pneumatic compression (IPC)

ArtAssist Arterial Assist Device IPC therapy

ArtAssist®…The Arterial Assist Device®

therapy on PAD patients suffering from infrapopliteal diffuse or multiple segmental lesions and who were at risk of amputation.

Click here to view the abstract.

 

Patients were separated into study (n=23) and control (n=8) groups and were given the following tests before and after the study period:

  • 6-minute walking test to examine claudication distance.
    Results:      duration and initial and absolute claudication distances significantly increased in study group
  • Transcutaneous oxygen tension (TcPO2).
    Results:  significantly increased in distal end of target limb after IPC therapy
  • Quality of Life (Short-Form 36 questionnaire):
    Results:  significant changes in physical functioning, physical and emotional role functioning, bodily pain, and general and mental health after IPC therapy

The study group received ArtAssist® device therapy for three months, three hours per day. The ArtAssist® device rapidly compresses the foot, ankle, and calf at 120 mmHg approximately every 17 seconds. The rapid inflation and deflation of the cuffs is instrumental to the arteries’ vasodilation.

The significant improvements in walking distance, oxygen levels, and quality of life show both medical and lifestyle benefits for patients who are not candidates for surgical intervention.

To read more about the clinical trials conducted with ArtAssist®…The Arterial Assist Device®, please visit the Clinical Studies Page.

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Jul 11, 2013 By ArtAssist®...The Arterial Assist Device®, PAD

Using a Pneumatic Compression Device for Lower and Upper Extremity Peripheral Arterial Disease | FAIM.org

ArtAssist pneumatic compression device

ArtAssist®…The Arterial Assist Device®

by Steven Kavros, DPM

Intermittent pneumatic compression (IPC) of the lower limb is a well-documented method of arterial leg inflow enhancement in patients with peripheral arterial disease (PAD). The mechanism of action parallels the natural muscular contraction of the leg stimulating blood flow. There are three very short compression cycle per minute inflating a cuff encompassing the legs and or feet simulating the beneficial effects of walking. The rapid rise of the cuff pressure assists with emptying of the venous blood of the extremities and allows oxygenated blood to move down the limb delivering nutrients to deprived tissues. This simple mechanism of action also allows edema or swelling of the extremity to be relieved. By relieving swelling, additional oxygenated blood can be delivered to the ischemic limb. Additionally, there is an increase release of nitric oxide and certain tissue and platelet derived growth factors. The nitric oxide has a positive effect on the internal cells that line the vessel wall, enabling relaxation and improved flow. Other tissue and growth factors lead to the development of new blood vessels and therefore, improve the delivery of additional oxygen and nutrients to the extremity.

Read the rest via Using a Pneumatic Compression Device for Lower and Upper Extremity Peripheral Arterial Disease | Foundation for Alternative and Integrative Medicine.

Since the Internet is all about getting info quickly and moving on, here’s what this medical jargon means in plain English…

Dr. Kavros is talking about a leg pump (what we’ll refer to as an arterial pump) that is proven to improve circulation to the legs and feet when the arteries are blocked. When your arteries are significantly blocked, your muscles start sending pain signals to your brain. This is called PAD –  think of it as a heart attack of the legs.

The way this arterial pump technology works is by simulating walking for your blood-deprived muscles. Instead of making you get up and walk, this therapy happens while you’re sitting in a chair. When you walk, blood in the veins travels up to your heart, gets refreshed and loaded with oxygen/nutrients, and then comes back down to feed the starving muscles. The better circulation you have in your legs, the less they will hurt.

Dr. Kavros says that this compression sequence can also reduce swelling. This pump compresses your leg three times per minute. If you use the pump for three hours a day, imagine how much more blood flow you’re getting!

A fringe benefit to this therapy that was recently discovered is your body’s natural release of nitric oxide. This substance is not to be confused with nitrous oxide, which is what your dentist will give you to make you laugh at his dumb jokes while he’s working on your teeth. When nitric oxide is released by the lining of your arteries, your blood vessels temporarily open up to accept more nutritious blood. Again, this happens three times a minute so that your blood vessels are constantly widened throughout therapy.

This is the compression technology Dr. Kavros is talking about:  The ArtAssist® device. To learn more, click the picture!

Update:  Dr. Paul van Bemmelen has also written an article for faim.org about pneumatic compression device therapy for PAD. Read it here

ArtAssist pneumatic compression device

ArtAssist®…The Arterial Assist Device®

 

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Aug 30, 2012 By ArtAssist®...The Arterial Assist Device®, Diabetic Foot, PAD

Challenge conventions. You may end up saving a limb!

Previously, I posted a whole article about how it’s actually not dangerous to use compression therapy on an ischemic limb. However, that’s not the only misconception that we’ve cleared up at ACI Medical. This article exposes a couple more myths that have been known to float around, and how we’ve found evidence to set the record straight.

Even after some experts dismissed the idea of intermittent pneumatic compression (IPC) as a viable treatment for patients with PAD, the creators and developers of the ArtAssist® device put their theories to the test nonetheless.

Pioneered and developed with vascular surgeons, the ArtAssist® device continues to be the leader in IPC therapy for non-surgical PAD patients with varying levels of severity.

ArtAssist® IPC therapy should not be overlooked or dismissed without having considered the clinical evidence:

in fact, it has both saved limbs and improved patient quality of life.

MYTH: Critically ischemic limbs are maximally vasodilated.

False.

In fact, the ArtAssist® device’s first physiological clinical trial disproves this myth. Even without having been optimized to the extent it is now, the prototype yielded results that suggested transient vasodilation.

Later, in 2005, a study conducted by Professor Labropoulos of SUNY not only confirms the earlier findings, but also suggests that increasing the arteriovenous pressure gradient with foot & calf IPC therapy contributes greatly to significantly increased blood flow in the subjects’ popliteal, gastrocnemial and collateral arteries. Skin blood flow also improved significantly in their findings.

MYTH: The ArtAssist® device is the same as any other arterial pump with similar function.

False.

We encourage you to ask yourself these two important questions when considering other devices which claim to perform as efficaciously as the ArtAssist® device:

1. Is it optimized for arterial disease? And

2. Is there clinical evidence and support for this specific device?

Only the ArtAssist® device satisfies each of these questions with its thorough progression of clinical studies: this device alone has been adjusted and optimized from its initial prototype over the past two decades to effectively treat even the most severe cases of PAD.

  • Physiological
  • Optimization
  • Intermittent Claudication
  • Limb Salvage
  • Critical Limb Ischemia (CLI)
  • Arteriogenesis (Collateralization)

Currently, studies are being conducted to explore the ArtAssist® device’s efficacy for adjunct therapies, such as stem cell treatment and gene expression.

The Bottom Line.

Your patient’s non-reconstructable limb will not wait for hearsay on this form of therapy.

We are here to let you know that therapy with the ArtAssist® device gives patients a dependable option that continues to help non-surgical limbs across the country.

Make the decision that could save your patient from amputation.

References

Augmentation of blood flow in limbs with occlusive arterial disease by intermittent calf compression. Van Bemmelen, P.S.; Mattos, M.A.; Faught, W.E.; Mansour, M.A.; Barkmeier, L.D.; Hodgson, K.J.; Ramsey, D.E.; and Sumner, D.S. Springfield, IL. Journal of Vascular Surgery 1994; 19:1052-8.

Hemodynamic effects of intermittent pneumatic compression in patients with critical limb ischemia. Labropoulos, N.; Leon, L.R.; Bhatti, A.; Melton, S.; Kang, S.S.; Mansour, A.M.; and Borge, M. The Department of Surgery, Loyola University Medical Center, Maywood, IL. Journal of Vascular Surgery, October 2005; Volume 42, Number 4: 710-716

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May 25, 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

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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Nov 11, 2011 By ACI Medical, Health

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