XXIX Congreso Latinoamericano de cirugia vascular y angiologia

Santa Cruz de la Sierra, Bolivia

Dr. Jhon Jairo Berrio is  the Chief of Vascular Surgery at the Clinica San Francisco, Tulua, Colombia, which is a small community outside of Cali.  He attended medical school in Colombia, completing his general surgery residency at Hospital clinics for Carlos.  He completed additional training at New York University and he completed his vascular surgery residency in Bogota at the Hospital de Kennedy  and trained under the instruction of Dr. Albert Munoz, the current president of the Association of Latin American Vascular Surgery and Angiography (ALCVA) .  He does a range of vascular procedures such as aortic aneurysm repair, fistula creation as well as endovascular surgery but his favorite procedures are limb salvage procedures such as aorto-femoral bypass, femoral-popliteal bypass and other treatments designed to prevent amputation.

He is here in Bolivia giving a presentation on the use of Prostaglandin E1 for critical ischemia / and last chance limb salvage.

Today we are talking to Dr. Berrio about the use of prostaglandin E1 (Iloprost/ iprostadil) for peripheral vascular disease (PAD).  In the past, we have used a myriad of treatments including statins, pentoxifylline, clopidogrel and even quinine for the prevention and relief of claudication symptoms.  However, all of these previous agents are designed for early PAD and are only minimally effective at treating later stages of disease.  Treatment of severe disease (rest pain or ulceration/ ischemia wounds) has been limited to stenting (angioplasty) and surgical revascularization – but this strategy often fails for patients with microvascular disease (or disease that affects vessels that can not be operated on.)

Last effort at Limb Salvage in critical ischemia

No – Prostaglandin E is not some magic ‘panacea’ for peripheral vascular disease.  There is no such thing – but it is a medication in the treatment arsenal for vascular surgeons – and it has shown some promising results particularly in treating limb-threatening ischemia.  In fact, the data goes back over 20 years – even though most people in the United States have never heard of it.  That’s because prostaglandin E1 is more commonly used for other reasons in the USA.  It is a potent vasodilator, and in the US, this medication is often used in a different (aerosolized form) for primary pulmonary hypertension.  It is also used for erectile dysfunction.  Despite a wealth of literature supporting its use for critical ischemia it is not currently marketed for such use in the United States – and thus – must be individually compounded in a hospital pharmacy for IV use.  Supplies of this medication in this form are often limited and costly.

Intravenous Prostaglandin E1

This medication offers a desparately needed strategy for patients with critical ischemia who (for multiple reasons) may not be surgical candidates for revascularization and is a last-ditch attempt to treat ‘dry’ gangrene and prevent amputation and limb loss.  Since more than 25% of all diabetes will undergo amputation due to this condition – this is a critical development that potentially affects millions of people.  (Amputations also lead to high mortality for a variety of reasons not discussed here.)

What is Prostaglandin E1?

As mentioned above, prostaglandin E1 is a potent vasodilator – meaning it opens up blood vessels by forced the vessels to dilate.  This brings much-needed blood to ischemia tissue (areas of tissue dying due to lack of blood.)

Treatment details:

A full course of treatment is 28 days.  Patients receive 60 micrograms per day by IV.

Patients must be admitted to the hospital for observation for the first intravenous administration of prostaglandin E1.  While side effects such as allergic reactions, rash or tachycardia are rare – since this medication is given as an IV infusion, doctors will want to observe you for the first few treatments. The most common side effect is IV irritation.  If this occurs the doctors will stop the infusion and dilute it further to prevent discomfort.  Once your treatment has been established, doctors may arrange for you to have either out-patient therapy at an infusion center, or home health – where a nurse comes to your house to give you the medication.

The surgeons will evaluate your legs before, during and after treatment.  If the ischemia or rest pain are not improving, or worsen during treatment – doctors may discontinue therapy.

Prostaglandin E1 therapy is compatible with other medications for PAD such as clopidogrel, aspirin, pentoxifylline and statins, so you can continue your other medications for PAD while receiving this treatment.  However, if you are taking nitrates such as nitroglycerin, (Nitro-dur, Nitropaste) or medications for pulmonary hypertension or erectile dysfunction – please tell your surgeon.

In Colombia, the average cost of the entire course of treatment (4 weeks of daily therapy) is 12 million Colombian pesos.  At today’s exchange rate – that is  a little under $ 7000.00  (seven thousand dollars, USD).

While this is a hefty price tag – it beats amputation.  In some cases, arrangements can be made with insurance companies to cover some of the costs.  (Insurance companies know that amputation-related costs are higher over the long run, since amputation often leads to a lot of other problems due to decreased mobility).

Additional Information about Dr. Berrio:

Dr. Jhon Jairo Berrio, MD

Vascular surgeon

Calle 414 – 30

Buga, Colombia

Tele: 236 9449

Email: vascular@colombia.com

Speaks fluent English, Espanol.

References/ Additional information about peripheral arterial disease (PAD) and prostaglandin e1

Pharmacotherapy for critical limb ischemia  Journal of Vascular Surgery, Volume 31, Issue 1, Supplement 1, January 2000, Pages S197-S203

de Donato G, Gussoni G, de Donato G, Andreozzi GM, Bonizzoni E, Mazzone A, Odero A, Paroni G, Setacci C, Settembrini P, Veglia F, Martini R, Setacci F, Palombo D. (2006).  The ILAILL study: iloprost as adjuvant to surgery for acute ischemia of lower limbs: a randomized, placebo-controlled, double-blind study by the italian society for vascular and endovascular surgery.  Ann Surg. 2006 Aug;244(2):185-93.  An excellent read – even for novices.

S Duthois, N Cailleux, B Benosman, H Lévesque (2003).   Tolerance of Iloprost and results of treatment of chronic severe lower limb ischaemia in diabetic patients. A retrospective study of 64 consecutive cases .  Diabetes & Metabolism, Volume 29, Issue 1, February 2003, Pages 36-43

Katziioannou A, Dalakidis A, Katsenis K, Koutoulidis V, Mourikis D. (2012).  Intra-arterial prostaglandin e(1) infusion in patients with rest pain: short-term results.  Scientific World Journal. 2012;2012:803678. Epub 2012 Mar 12.e Note extremely small study size (ten patients).

Strecker EP, Ostheim-Dzerowycz W, Boos IB. (1998).  Intraarterial infusion therapy via a subcutaneous port for limb-threatening ischemia: a pilot study.  Cardiovasc Intervent Radiol. 1998 Mar-Apr;21(2):109-15.

Ruffolo AJ, Romano M, Ciapponi A. (2010).  Prostanoids for critical limb ischaemia.  Cochrane Database Syst Rev. 2010 Jan 20;(1):CD006544.