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I’m now 89 and still have my limbs – Lorraine K. in Grand Forks, ND

Lorraine K. of Grand Forks, ND was diagnosed with severe PAD. For treatment, she at first received a calf-only pneumatic compression device from her hospital. After using this system for a week, she decided that the pressure was too weak and that she was unsatisfied.

Her doctor at the Mayo Clinic in Rochester, MN, then prescribed ArtAssist®…The Arterial Assist Device® for Lorraine in 2002. She was told to use it 4-6 hours a day. Later that year, Lorraine purchased our pump and began to use it in early 2003. She noticed an immediate difference, saying that ACI Medical’s arterial pump “blew [the calf-only system] out of the water.” Since her purchasing of the ArtAssist® device, Lorraine has sent it back to ACI Medical only once for repairs and uses it faithfully for the prescribed amount of time each day.

Lorraine’s only suggestion for the ACI Medical team is to “get the word out” about the therapy that has helped her so much. Sometimes, we receive thank you letters from Lorraine. So, in that spirit, here is a letter she wrote to Don Kjartanson, our Director of Sales & Marketing:

Dear Don,

I wish to thank you for all the good service you have given me, especially for the new blue cuffs, nice to have some color.

The Dr.’s of Rochester, MN have really been surprised to see how well I’ve been doing with my machine. That’s the only thing that keeps me going. I think I’m in the 11th year so am so happy to have found out about this machine. If anyone wants to write to me, I’ll be happy to hear.

Use my remarks as you wish.

And thanks so very much. I could not afford what you’ve given me.

Keep up the good work.

Sincerely,

Lorraine K.

Diana’s note:  I hope you enjoyed reading Lorraine’s sweet note, because patients like her really put the cherry on top of the cake! Even though we already believe in ArtAssist® Arterial Pump Technology as a way to treat PAD, it’s a great feeling to hear from actual patients who need the device. And that, my friends, is what should drive a marketing department!

Update

Since the above entry was based on a telephone conversation and a greeting card, the customer service team at ACI Medical has been reaching out to patients who wish to share their stories. Since Lorraine always has something to add, we invited her to send us all of her thoughts. Among all of our patients, she is certainly one of the most informed about the ArtAssist® device, as she has been using it for almost 12 years! I hope you enjoy her account of how she went from fearing for her limbs to leading a happy, functional life in her own home.

Q:  When it comes to ACI Medical’s customer service, what stands out to you?

To me it’s the very best, very good service. They have always treated me well, they take an interest in you.

Q:  What would you say to a friend, who was looking for a non-surgical solution for PAD, about the ArtAssist® device?

I would say, go for it you have nothing to lose but the pain, it may take a while to get results, so give it time.

Q:  Who prescribed the ArtAssist® device for you?

My son Alvin went to the libraryand got the Reader’s Digest. This is where I found the ArtAssist advertisement, so I contacted the company. They sent me information, and after reading about the ArtAssist machine I went ahead and ordered it. I am so glad we ran across this article. It’s great.

Further thoughts

In March 28, 1996, I had a history of lower peripheral arterial occlusive disease, which had been long standing. I had a left femoral below the knee popliteal bypass graft, which failed in 1999. I had critical lower extremity occlusive disease and was referred for medical treatment. Dr. has been following me since 2000 for this problem. I had severe bilateral peripheral arterial occlusive disease, right 4th toe ulcer to ischemia, in heels then corroded briuts (?) hypertension. I used antifungal cream, I would get pain in calves & feet at a distance of walking across the room, both lower extremities are equally involved. I was using the ArtAssist pump 3 times a day, 90 minutes each hour, it’s remarkable after 11 to 12 years period of no limb loss has ensued. I maintain my activities of daily living and household duties. I have my own house. My son who is disabled lives with me, which is a big help. Dr. says given my age I am doing remarkable with my disease status. I’m now 89, and still have my limbs.

The ArtAssist compression pump is a therapeutic product, a powerful therapy for increasing blood flow with patients effects are for better than any other and without side effects, this has a unique form of pneumatic compression to the patients with diabetic foot ulcers, intermittent claudication, rest pain or non-surgical candidates, have seen positive results with this new technology.

The ArtAssist is very easy to use and very reliable. I look forward to using it, the compression cuffs are durable and designed to last for months of therapy. I am very lucky to have found something that has helped me so much, and I still have my limbs, the medical Dr.’s did all they could and after I got the ArtAssist device, which they didn’t seem to know anything about this machine, but they were happy for me and that I’m doing so well with it. I always use it 3 times a day. It’s the best. You will never find anything better.

Lorraine K.

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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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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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Help for your arteries with the ArtAssist® pneumatic compression pump

When you think of pneumatic compression pumps, what comes to mind? A lot of people would say lymphedema, as they are very common.

However, the ArtAssist® device should not be confused with lymphedema 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. Depending on the nature and severity of your arterial disease, you would be better advised to use the ArtAssist® pump.

Researchers have discovered that, unlike lymphedema pump technology, the ArtAssist® device promoted 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.

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.

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 Lindsay. If you contact me (via WordPress, Twitter, Facebook, email, 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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Diabetic Foot Ulcers: cost realities

Hey, everyone! I recently discovered an excellent site called diabetesfootulcer.com. It is absolutely PACKED with great information about diabetic foot ulcers. If the producer of this website was aiming for a thorough and well-done look at DFU’s, I’d say they achieved it.

Since I’m always looking for cost references, I was so excited by the information I found here. For example, did you know that the annual cost of healing just ONE ulcer with conventional care is $56,516? CRAZY.

Also, I learned that 2/3 or diabetes-related amputations are actually paid for by Medicare. And the cost of a major amputation? $45,000 according to the research on this website.

ACI Medical rents the ArtAssist® device at $1200/3 months to Veteran’s Administrations around the country, at no cost to our veterans. The alternative is 37.5 times more expensive. Our government has enough money troubles, wouldn’t you say?

via Diabetic Foot Ulcers: cost realities.

How was this possible? Learn more by clicking the healed foot:

                                    diabetic foot ulcer     diabetic foot ulcer healed

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Paul van Bemmelen, MD, PhD: Arterial Pumps for Limb Salvage and Wound Healing

paul van bemmelen md phdLast October, Dr. Paul van Bemmelen gave a presentation at the podiatry conference Superbones West about using arterial pump technology to treat peripheral arterial disease of the lower extremities.

Click on the link below to view the presentation – it lets you skip to the parts you want to see!

Arterial pumps for limb-salvage and wound-healing

Dr. van Bemmelen’s personal blog:  PaulvanBemmelenMD.wordpress.com

 

 

ArtAssist Arterial Assist Device

ArtAssist®…The Arterial Assist Device®

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President Barack Obama Recognizes April 2012 as Limb Loss Awareness Month

On Monday, April 2, The White House released a letter from President Barack Obama recognizing April 2012 as Limb Loss Awareness Month.

“As a nation, we must remain committed to ensuring that those living with limb loss have the support they need to reach their greatest potential,” wrote President Obama. “We must also provide those at risk with information that can help prevent this condition. Greater public knowledge of the causes and warning signs is essential to decreasing the rates of preventable limb loss,” the letter continued, “and by working with the limb loss community, we can help reduce new cases.”

via Amputee Coalition – President Barack Obama Recognizes April 2012 as Limb Loss Awareness Month.

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More research into the cost of lower-limb amputation

Recently, while summarizing key studies for a history and literature review that I’m working on, I was reminded that this particular study (the abstract is below) also included comparative costs.

In this case, you will see that although SCBD (in other words, ArtAssist®) therapy doesn’t exactly come cheap, it’s still less than half the average cost of a primary amputation.

Want to hear even better news? This study yielded an 88% limb salvage rate, even after 18 months. Fancy that.

Edit:  A 3-month rental of the ArtAssist® device in the United States is more than 36 times less expensive than the cost of primary amputation per patient, according to the following study. And even if you take the SCBD patient cost (below), it still sounds like a better deal to me.

Nonoperative Active Management of Critical Limb Ischemia: Initial Experience Using a Sequential Compression Biomechanical Device for Limb Salvage

Sherif Sultan; Olubunmi Esan; Anne Fahy

Department of Vascular and Endovascular Surgery, Western Vascular Institute, University College Hospital Galway, Galway, Ireland

Vascular 2008;163:130-139

Critical limb ischemia CLI patients are at high risk of primary amputation. Using a sequential compression biomechanical device SCBD represents a nonoperative option in threatened limbs. We aimed to determine the outcome of using SCBD in amputation-bound nonreconstructable CLI patients regarding limb salvage and 90-day mortality.

Thirty-five patients with 39 critically ischemic limbs rest pain = 12, tissue loss = 27 presented over 24 months. Thirty patients had nonreconstructable arterial outflow vessels, and five were inoperable owing to severe comorbidity scores. All were Rutherford classification 4 or 5 with multilevel disease. All underwent a 12-week treatment protocol and received the best medical treatment.

The mean follow-up was 10 months SD ± 6 months. There were four amputations, with an 18-month cumulative limb salvage rate of 88% standard error [SE] ± 7.62%. Ninety-day mortality was zero. Mean toe pressures increased from 38.2 to 67 mmHg SD ± 33.7, 95% confidence interval [CI] 55 – 79. Popliteal artery flow velocity increased from 45 to 47.9 cm/s 95% CI 35.9 – 59.7. Cumulative survival at 12 months was 81.2% SE ± 11.1 for SCBD, compared with 69.2% in the control group SE ± 12.8% p = .4, hazards ratio = 0.58, 95% CI 0.15 – 2.32. The mean total cost of primary amputation per patient is €29,815 ($44,000) in comparison with €13,9000 ($20,515) for SCBD patients.

SCBD enhances limb salvage and reduces length of hospital stay, nonoperatively, in patients with nonreconstructable vessels.

via ACI Medical – ArtAssist® Device.

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Patients should be proactive and aware about their PAD

Today, a man came in to our office to talk to us about renting an ArtAssist® device. He has had peripheral arterial disease for years and previously rented our device a few years back.

He came in because, as he said, wound care in other places wasn’t very well agreed upon, and he saw hair regrowth on his feet when he rented and used our device a few years back. His other options were too costly for him, including hyperbaric oxygen therapy (I found a link – click here – to get a ballpark idea of how much each HBO session is).

Today, we wish that more patients were like him because he has lately noticed hair loss on his feet again and is taking steps to prevent his PAD from advancing.

Visit the ArtAssist® device website to see if you or someone you know can benefit from therapy. You can also poke around on the clinical studies page to read what researchers have to say about the device (in a nutshell, it’s efficacious and cost-effective, but don’t feel like you have to take my word for it).

Also, check out all the posts I have on amputation – it would take quite a while to post them all here, but I do have a lot of articles on cost comparison and quality of life.

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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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