Big meetings this week: Desert Foot & VEITHsymposium™

Starting tomorrow, two very important meetings will kick off and experts from ACI Medical will be attending both of them.

If you are attending Desert Foot 2012, the 9th Annual High Risk Diabetic Foot Conference, be sure to attend the 20 minute presentations given by Dr. Darwin Eton (University of Chicago) and Dr. Paul van Bemmelen (Temple University). Both will be talking about how pneumatic compression therapy with arterial pump technology can prevent amputations in non-reconstructible limbs. Both have extensive experience using the ArtAssist® device in a clinical setting.

Here is when you can hear them talk:

Paul van Bemmelen, MD
Wednesday, November 14 from 2:10 PM to 2:30 PM “Pneumatic Compression for Non-Reconstructible PAD”

Darwin Eton, MD
Thursday, November 15 from 5:45 PM to 6:05 PM “Combined Cell Therapy and Pneumatic Compression to Treat Limb Ischemia”

VEITHsymposium™ 2012 will be featuring Professor Andrew Nicolaides of the Imperial College of London. He has been invited to discuss non-reconstructible limb salvage using arterial pump technology during a 5 minute talk on Friday, November 16 from 6:46 AM to 6:51 AM (don’t forget to drink your coffee – hearing him talk is always a treat!). Professor Nicolaides has clinical experience with the ArtAssist® device as well.

As pioneers of ArtAssist®…The Arterial Assist Device® technology, we at ACI Medical invite and encourage you to contact us with your questions about anything from the device’s science to ordering one for your patient:
(888) 453-4356 or info@acimedical.com

Nov 13, 2012 By acimedical ArtAssist®...The Arterial Assist Device®, Diabetic Foot, PAD

We like the idea of taking care of feet, and so does LER Online Magazine!

In this month’s issue of Lower Extremity Review, our own ArtAssist® device was featured as one of many products for lower extremity health.

Check it out by going to this link: http://www.lowerextremityreview.com/products/artassist-compression

Sep 26, 2012 By acimedical ArtAssist®...The Arterial Assist Device®

The ArtAssist® device presented by Dr. Sherif Sultan of the Western Vascular Institute

Dr. Sultan is a consultant vascular and endovascular surgeon who has been studying the ArtAssist® device in a clinical setting at his practice in Galway, Ireland.

An excerpt from his presentation at the 2009 Veith Symposium in New York (note that this is before the final results of this ongoing study were released):

Art-Assist SCBD is a valuable tool in the armamentarium for dealing with CLI patients with un-reconstructable PVD. It gives superior limb salvage, ameliorates amputation free survival, enhances ulcer healing rates, reduces length of hospital stay and provides rapid relief of rest pain without any intervention in patients with limited life expectancy.

http://www.veithsymposium.org/pdf/vei/2852.pdf

On a related note, Dr. Sultan’s website features a short video about the ArtAssist® device.

For those in Ireland, the ArtAssist® device is distributed by Deprimo, Ltd. (http://deprimo.ie/)

Aug 16, 2012 By acimedical ArtAssist®...The Arterial Assist Device®, 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

May 25, 2012 By acimedical 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 Medical

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®…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

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.
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).
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.
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.
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.

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

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.

Mar 14, 2012 By acimedical ACI Medical, Health