Interventional Quarter ISSUE 0 - December 2009 IQ€¦ · ISSUE 0 - December 2009 IR Becomes Ofﬁcial UEMS Division Non-Dedicated Staff: may cause serious side-effects The Early

I S S U E 0 - December 2009

IR Becomes Official UEMS Division

Non-Dedicated Staff: may cause serious side-effects

The Early Days of IR

The Crippling Cost of Diabetes

Type I Diabetes: closer to a cure

IQI n t e r v e n t i o n

Diabetes

I n t e r v e n t i o n a l Q u a r t e r

www.intervention-iq.org

An Interventional Response

Y o u r p o r t a l t o m o d e r n m e d i c i n e

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I Q | I n t e r v e n t i o n a l Q u a r t e r

A Welcome from the Editor

Dear Readers,

First of all, a warm welcome to the launch issue of Inter-ventional Quarter: the independent, non-commercialmagazine taking you on a journey through the world ofminimally invasive therapy under image guidance.

The procedures, the profession, as well as health eco-nomics and politics will all be addressed in an open andunbiased fashion, targeting all levels of healthcare,thereby expanding the current reach of the discipline.

Furthermore, every issue offers an all-encompassing re-port on a specific condition or disease area - in this case,the extensive scope of diabetes - including the benefitsas well as drawbacks of employing specific interventionalradiology methods in the diagnosis, treatment and cureof a condition, with an emphasis on optimal patient serv-ice and care.

Interventional Quarter will be published four times a year;for guaranteed access to some of the latest and most ef-fective treatments in medicine today, make sure your ad-dress is included in our mailing list; please see details onpage 2.

We are especially enthusiastic about the presence of In-terventional Quarter online as it opens the doors to col-laboration with other esteemed publications dealing with minimally invasive image-guided therapy. The product of this friendly teamwork can be witnessed atwww.intervention-iq.org, your “one-stop” daily resourcefor clear, relevant, up-to-date news, reports and high-lights from the realms of the discipline.

We place much importance on freedom of speech andopen discussion; please feel free to contact us [email protected] with your feedback on any of theissues discussed in either the online or printed editionsof Interventional Quarter.

As you may already be aware, interventional radiologyhas undergone rapid development in the last 40 years,evolving into a viable alternative for a number of open-surgery procedures and it is also one of the fastest grow-ing sub-divisions of radiology. Interventional Quarterpresents the discipline with a unique opportunity to di-rectly communicate and interact with its peers tostrengthen the situation of advanced healthcare for all.

We very much hope you enjoy the launch issue of Inter-ventional Quarter.

Professor Jim A. ReekersEditor-in-Chief

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Editorial OfficeGonzagagasse 16/337AT-1010 Vienna, AustriaTel: +43 (0)1 904 2003Fax: +43 (0)1 904 2003 30E-mail: [email protected]

ISSN: 2075-5813

© All rights reserved by Next Publishing Media & Research / 2009The reproduction of whole or parts of articles is prohib-ited without the consent of the Publisher. The Publisherretains the right to republish all contributions and submit-ted materials via the internet and other media.

The Publisher, Editor-in-Chief, Editorial Team and theirrespective employees make every effort to ensure that noinaccurate or misleading data, opinion or statement ap-pears in this publication. Contributed articles do not nec-essarily reflect the views of Interventional Quarter. This isnot a peer-reviewed journal, and professional medical ad-vice should always be sought before following or discon-tinuing any course of treatment. Therefore, the Publisher,Editor-in-Chief, Editorial Team and their respective em-ployees accept no liability for the consequences of anysuch inaccurate or misleading data, opinions or state-ments.

Interventional Quarter is published four times a year. To add an address to the mailing list, please [email protected] or refer to www.intervention-iq.org.

General Information

Editor-in-ChiefProf. Jim A. Reekers

Managing EditorNadja Alomar

Editorial TeamCiara Madden, Tochi Ugbor

Our thanks to the ContributorsProf. José Ignacio Bilbao (Pamplona, Spain)Dr. Christoph A. Binkert (Winterthur, Switzerland)Prof. Elias Brountzos (Athens, Greece)Prof. Alison Halliday (London, United Kingdom)Dr. Tomasz Jargiello (Lublin, Poland)Prof. Michael J. Lee (Dublin, Ireland)Dr. Sumaira Macdonald (Newcastle, United Kingdom)Dr. Marco G. Manzi (Padova, Italy)Dr. Robert A. Morgan (London, United Kingdom)Prof. Jan H. Peregrin (Prague, Czech Republic)Prof. Marc R. Sapoval (Paris, France)Prof. Dierk Vorwerk (Ingolstadt, Germany)

Graphical DesignL O O P. E N T E R P R I S E S media / Austriawww.loop-enterprises.com

IQ is your magazine, and we would welcome your viewsand your news. Readers who wish to comment on any ofthe issues raised (or who would like to raise any of theirown) are most welcome to submit letters to the Editor.Likewise, if you have any promotions, awards, honorarylectures or other tit-bits you’d like to share with the inter-ventional community, please send them to us by post orby email.

We look forward to hearing from you!IQ Editorial Team

Email: [email protected] to: Gonzagagasse 16/337, AT-1010 Vienna, Austria

An invitation to our readers ✱


Diabetes: an Interventional ResponseA look at the causes, complications and control of diabetes - what is diabetes · management · complications · available treatments · why IR is gaining ground · politics

IR gets more involved in Diabetes Management

The Crippling Cost of DiabetesAn economic evaluation of the impact of diabetes, and how best to minimise it

WorldviewDiabetes projects at a glance

Diabetic Feet in the Best HandsWhy the interdisciplinary approach is gaining momentum

Type 1 Diabetes: Closer to a Cure?A look at various efforts to find a cure

Diabetes TrialsA selection of current trials

IR becomes new UEMS DivisionThe hows, whys and implications of this milestone

5 minutes with … Dr. Christoph BinkertWe talk to the Swiss doctor about America, kite-boarding and ideal relationships with clinical colleagues

Non-dedicated Staff: can have serious side effectsA look at the importance of dedicated support staff

Mother Nature Knows BestHow snake poison can help IR

Featured TrialAsymptomatic Carotid Surgery Trial (ACST-2)

Trials and RegistriesA selection of current trials and registries

The Early Days of IRWhere it all began: Charles Dotter and his first patients

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Contents

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4 I Q | I n t e r v e n t i o n a l Q u a r t e r

What is diabetes?

Diabetes is a metabolic disorder affecting the body’s ability to control blood sugar levels.

This is down to either a lack of or insensitivity to a hormone called insulin.

Insulin is produced by the pancreas, and is used to regulate when we store excess glucose (sugar), and when we release stored glucose.

There are several different types of diabetes, the most common being diabetes mellitus Type 1 and Type 2.

Diabetes:an Interventional ResponseIn the Middle Ages, they used to taste urine to test for diabetes; 90 years ago, experiments on dogs paved the way for insulin treatment- how far has medicine come in diabetes treatment, and how much do weactually know about it? Diabetes is predicted to reach pandemic levelswithin 15 years, but what are we doing to prevent its spread? IQ inves-tigates the increasing role interventional radiology is playing to reduceits impact.

www.worlddiabetesday.orgwww.eatlas.idf.orgwww.worlddiabetesfoundation.orgwww.diabetes.orgwww.diabetes.org.ukwww.euphix.orgwww.tcoyd.org


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Type 1 diabetes used to be known varyingly as “child-hood onset” or “insulin-dependant” diabetes, as it mostfrequently occurs in children, and requires life-long man-agement using both insulin injections and strict diet. Itoccurs when the pancreas stops producing enough in-sulin, usually as a result of the body’s immune system at-tacking the Islets of Langerhans, a cluster of cells thathouse the insulin producing cells of the pancreas. With-out sufficient insulin, the blood sugar levels are not regu-lated, and can reach dramatic lows (hypoglycaemia) ordangerous highs (hyperglycaemia), both of which cancause severe damage, immediate and long-term. Onsetis usually sudden and quite dramatic, and symptoms in-clude extreme thirst, frequent urination, insatiablehunger, weight loss and blurry vision. Without insulin,Type 1 diabetes leads to fatal results.

Type 2 diabetes was formerly referred to as “adult-onsetdiabetes”, as it most commonly occurs after the age of 40.However, it is affecting people at an ever younger age,and there are currently a worrying number of reports ofchildren presenting with Type 2 diabetes. Type 2 diabetesis caused by the body becoming resistant to its own in-sulin levels, and having a relative insulin deficiency. It canremain asymptomatic and undetected for years. It is oftenassociated with obesity, poor diet and inactivity - in otherwords, what is known as a “western” lifestyle, and is be-coming ever more prevalent around the globe. Depend-ing on its severity, it can often be managed with strictdiet, improved exercise and weight loss, but some Type 2sufferers can also become insulin dependent. Type 2 ac-counts for 85-95% of diabetes worldwidei.

Diabetes mellitus Type 1

Diabetes mellitus Type 2

Symptoms· Excessive thirst

· Frequent urination

· Constant hunger

· Weight loss

· Blurred vision

· Extreme sudden tiredness

· Irritability

Blood glucoseFor all categories of diabetics, blood glucose monitoringis essential to controlling the disorder. Generally, patientswill feel the effects of very high blood sugar, and get allthe classic symptoms (thirst, fatigue, etc.), but the mosteffective way of monitoring accurately is using a bloodglucose meter (a small computerised machine with asmall screen like a calculator). This meter reads glucosestrips, onto which the patient has put a drop of blood,usually taken from a finger using a special needle calleda lancet. These tests may need to be done after fasting,or before or after meals. An HbA1c test is a profile aver-age built up over several weeks, and gives a more accu-rate, reliable overall indication of your glucose levels.Urine glucose can also be measured using a lower-priced but less accurate test. The disadvantage of thistype of testing is that it only returns a positive result forhigh glucose levels - it does not differentiate betweennormal and low blood sugar.Oral medicationBased on the outcome of these glucose tests, diabeticpatients may need to use the right amount of medicationto balance their blood sugar. For patients with Type 2 dia-betes, this is generally done using oral medication, suchas OHAs, sulphonylureas or biguanides. These medica-tions work by either stimulating the pancreas to producemore insulin or improve the effectiveness of existing in-sulin secretions. These are only effective for patients thatare still producing some amount of insulin independently. InsulinType 1 patients do not produce any of their own insulin,and so it must be delivered into the body artificially.Some Type 2 patients also require it. As insulin is a pro-tein, it cannot be given orally, as stomach acid would dis-solve it. It must be administered through the skin, eitherby injection or insulin pump. An insulin patch has alsobeen devised, but is not ready for commercial sale, dueto ineffectiveness and erratic absorption rates. However,an insulin inhaler is predicted to be ready for the marketwithin a few years. Insulin cannot be substituted by regu-latory tablets, and though it may seem expensive, a dailydose of insulin costs less than 3-4 cups of tea or coffee. Ketone testingThose with diabetes should also check their urine for ke-tones every so often using special testing strips. If pres-ent, they indicate that the body is burning fat for energybecause there is insufficient insulin for glucose usage, orinsufficient sugar in the body. When too many ketonesare present in the body, it can lead to diabetic ketoacido-sis, a life-threatening condition. The risk of developingthis is higher during a period of illness. Lifestyle choicesSupplementary to this, though no less important, are thelifestyle choices that can manage the condition better.Following a diet that carefully regulates intake of sugarsand fats helps the body’s glucose levels to stabilise, andparticularly for Type 2 patients, weight loss could help re-duce the severity of their condition. Alongside dietarymanagement, exercise can help weight loss and generalhealth, as well as aiding stress relief. Stress can changethe body’s hormones, and make it harder for insulin to doits job properly.

Management

Managing diabetes correctly is essential to maintaining good health

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Diabetes


Controlling diabetes is essential to prevent immediate reactions

Controlling diabetes is essential to prevent immediate re-actions such as ketoacidosis and diabetic coma, whichcan be swift and fatal. However, one of the most alarmingand underestimated consequences of diabetes mellitusis the long-term damage that can result. High blood glu-cose levels (hyperglycaemia), which are symptomatic ofdiabetes, are harmful to the body’s nerves and bloodvessels. If left untreated, the damage to these nerves andblood vessels can lead to devastating complications,such as the total loss of sensation in the limbs, impo-tence, blindness, kidney failure, the need for amputationand serious cardiovascular diseases such as heart fail-ure and stroke. Those with diabetes also face increasedrisk of bacterial or fungal skin conditions, oral infections,gastroparesis and depression.

Complications

RetinopathyDamage of the retina (eye)

Symptoms· blurred vision (macular edema -

swelling of retina)· blood leaks forming spots or

clouds in vision· blindness

Femoral ArteryPort of entry for many interventional procedures

Diabetic nephropathyKidney damage due to high blood glucose levels

Symptoms· usually asymptomatic· micro- or macroalbuminuria

(protein leaking into the urine)· build up of toxins in body· higher blood pressure/cholesterol · swelling (edema) in feet and legs

(progressed)Diabetic neuropathyNerve damage as a result of highblood glucose levels. Most commoncomplication and greatest source ofmorbidity and mortality in diabetespatients.

Symptoms· problems urinating, impotence· problems with various bodily organs

(e.g. heart, stomach)· loss of sensation in limbs

(peripheral neuropathy)· dysphagia (swallowing difficulty)· speech or vision impairment

Cardiovascular diseases (CVDs)Diseases of the heart and bloodvessels. Peripheral vascular disease(PVD) is a form of cardiovasculardisease.

Symptoms· Functional PVDs (do not involve

structural malformations of bloodvessels) - examples include: Ray-naud’s disease

· Organic PVDs (blood vessel struc-ture is changed, for example, by ablockage) examples include: coro-nary artery disease, which can re-sult in angina pectoralis. Strokes,heart attacks and peripheral arterialdisease*


7I Q | I n t e r v e n t i o n a l Q u a r t e r

Images supplied courtesy ofCordis Europe, a division of Johnson& Johnson Medical NV

PAD in diabetes is oftenunder-recognised as many patients may not experience symptoms

Increasing degree of atherosclerotic artery damage

*Case Study: Peripheral arterial disease (PAD)Caused by a partial or total blockage of the peripheral ar-teries, it results in a decrease of blood flow in the limbs.In diabetes, this arterial blockage is typically located inthe vessels below the knee. Due to the decreased pe-ripheral blood flow, ulcers may appear, most commonlyon the toes and heels, and may even become infectedand gangrenous. These ulcers are usually painful, exceptin patients with peripheral neuropathy who have lost allsensation in the area. In the severe cases of PAD, the re-striction of blood to the limbs can lead to their amputa-tion.

CausesIn general, atherosclerotic PAD is different from diabeticinduced PAD as this is more often located in the vesselsabove the knee. The most common cause of PAD is ath-erosclerosis - the gradual build up of cholesterol and scartissue in the arteries. This restricts blood flow, limiting thesupply of nutrients and oxygen to the various parts of thebody. The arteries also become rigid and less able to re-spond to changes in blood flow and are thus often re-ferred to as “hardened”. Lifestyle choices such assmoking, poor diet and lack of exercise are also amongthe main causes of atherosclerosis and Type 2 diabetes.

DiagnosisThe Ankle-Brachial Blood Pressure Index (ABPI) is mostcommonly used for PAD screening and diagnosis. Here,the ratio of blood pressure in the lower legs is measuredin relation to the blood pressure in the arms - lower pres-sure in the legs is an indication of atherosclerosis, whichis symptomatic of PAD. Following the ABPI, further testsmay be needed such as an angiograph, CT or MRI,which is a necessity if surgery is to be carried out. Insome cases, the blood supply to the ankle is so weakthat a Doppler probe or a Doppler ultrasonography maybe necessary in order to locate the pulse.

PAD is one of the most common diabetes-induced cardiovascular complications

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Diabetes


Available treatments

Patients with diabetic foot and PAD should beclosely monitored anddaily foot inspections are paramount

For most patients with atherosclerotic PAD, quality of lifecan be improved with specific lifestyle changes, such asgiving up smoking, blood pressure and diabetes control,making dietary changes and increasing their amount ofexercise. In some cases, anti-platelet drugs or simple,common-or-garden aspirin can help those at risk of heartdisease. Patients with diabetic foot and PAD should beclosely monitored and daily foot inspections for injuriesare also paramount to preventing severe infections. Therecommendations of the WHO, International DiabetesFederation and World Bank follow the old adage of pre-vention being better than cure, and often simple, cost-ef-fective treatments yield the greatest results. While lifestyle changes and medication may be effectivein alleviating or preventing symptoms from worsening,some patients may need more advanced medical treat-ment. As diabetic complications are a result of damageto and blockages in the blood vessels, medicine’s bestoption to prevent and reverse this damage is to find waysof increasing blood flow to those areas affected whereverpossible. Luckily, many advances are being made, and anumber of options are available to patients and doctors.

Surgical Procedure What it involves Further considerations

Laser Recanalisation

A balloon-tipped catheter is insertedinto the narrowed artery through asmall nick in the patient’s skin. Theballoon is inflated to expand theblocked artery and then removed. Astent may be inserted to hold the ar-tery open if needed.

Suitable for large and small ar-teries (see illustrations opposite).

Interventional Radiological Procedure What it involves Further considerations

Percutaneous Endarterectomy

Subintimal Angioplasty

Percutaneous Transluminal Angioplasty (PTA)

Cryoplasty

Using the loop-wire technique, a newpassage is created as opposed to re-opening an existing blocked passage.

Uses specially designed catheters tore-open occluded vessels by remov-ing atheroma.

Balloon-tipped catheter filled with liq-uid nitrous oxide dilates and cools oc-clusions. No need for stents.

Laser irradiation of blockage - catheteraccompanied by microlens-tipped opti-cal fibre.

Effective in treating large andsmall blood vessels, longer oc-clusions and calcified blockages.

Can be used in larger vessels,but not in small vessels.

Only suitable for larger periph-eral arteries.

Suitable in peripheral arteries.

Amputation

Bypass Grafting (revascularisation)

Thromboendarterectomy Surgical removal of blockage.

Removal of the affected limb.

Relocates healthy veins to carry bloodsupply past damaged area. Relievesclaudication and helps prevent the needfor amputation.

Effect on quality of life and costof follow-up care.

Patients need to have goodveins available to create the by-pass.

Only suitable for short lesions.



Minimally invasive methods to re-open occluded(blocked) or narrowed arteries include PercutaneousTransluminal Angioplasty (PTA), subintimal angioplasty,percutaneous endarterectomy, cryoplasty and laser re-canalisation. Concerning PTA and subintimal angio-plasty, numerous studies such as the BASIL trialii haveconfirmed their safety and benefits, which include lowerrisk of infection and surgical complications, and shorterhospitalisation and recovery times. This is not just amajor advantage for the patient, but also saves on thecosts of hospitalisation and follow-up costs, which canaccount for a huge portion of the associated costs ofsuch procedures. An Italian studyiii on diabetic patientswith severe PAD concluded that PTA should be regardedas a feasible treatment, especially for patients with se-vere foot ulcers.

Concerning PTA and subintimal angioplasty, numerous studies have confirmed their safety and benefits

Nevertheless, angioplasty is not always the treatment ofchoice for all patients and the importance of carrying outa thorough assessment of the extent of the occlusion be-fore patient referral must be stressed. Surgical optionsshould be reserved for patients for whom the less inva-sive option of PTA is not possible. However, recent ad-vances in below the knee PTA technique with smallerwires and balloons have certainly increased the indica-tions for below the knee PTA. PTA should therefore bethe first choice treatment option. Occasionally PTA maybe unsuccessful and an occlusion may reappear in theblood vessel. In such cases, surgery may be considered.

Angioplasty

1. An artery obstructed byplaque. Poor blood circu-lation accounts for re-lated symptoms.

2. First of all, a guidewire isinserted up to the lesionsite.

3. An angioplasty balloon ispushed over theguidewire.

4. The balloon is inflated soas to widen the arterywalls and compress theplaques (build up of cho-lesterol and fatty depositson the artery walls).

5. In some cases, a stent(small metal mesh tubesupporting the inside ofthe artery) is implanted.This can either be placedon the balloon or is, by na-ture, self-expandable.

6. The stent is positioned atthe level of the lesion, theballoon is deflated and theguidewire removed - onlythe stent remains in place.

7. The artery walls are nowwidened, and blood cir-culation is back to nor-mal.

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Images supplied courtesyof CIRSE

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Diabetes


So far, minimally invasive solutions have been foundfor a number of complications, and have proved tobe highly effective. Of course, improved managementof diabetes is the best solution, and will help reducethe incidence of complications, but even the mostrigid blood sugar regiments can be insufficient tohold back the tide of devastation that this conditioncan wreak.

It is in these cases that interventional radiology can help.In many cases, it provides a better alternative to tradi-tional surgical methods. For patients in a weakened con-dition, open surgery can be physically traumatic anddangerous, and may not be an option. Recovery can takelonger, a negative consequence for both the patient andthe health board’s budget (see page 13). Bypass grafting,while producing similar outcomes, requires that the pa-tient has sufficient healthy veins from which to make agraft vessel - and most often, this is not the case. In par-ticular, for diabetic foot conditions, interventional radiol-ogy can help salvage a limb, which should always be thefirst choice outcome. Indeed, data collected on PADtreatment in New Hampshirev (1996-2006) has shownthat over the course of a decade, interventional proce-dures have increased more than threefold, while simulta-neously, a 42% reduction in amputations occurred - aclear indicator of the growing preference for interven-tional procedures over traditional surgery amongst thosewho are aware of the option.

Given that most diabetic complications stem from thesame cause (high glucose levels damaging blood ves-sels), it is reasonable to assume that in the future, inter-ventional radiology may adapt its current techniques totreat other diabetic complications as well. More than that,interventionists have already pioneered a new treatmentthat could spell the end of artificial insulin dependence -using minimally invasive techniques, doctors have suc-cessfully transplanted donor islets into diabetic patients(see page 20). Interventional radiology has always beena discipline of innovation, and it will be interesting to seewhat else the future holds.

Why IR is gaining ground

Interventional radiology can play an important rolein reversing the effects of diabetic complications

Diabetes is often known as a “silent killer”, as Type 2 canremain undetected for many years, and is often only de-tected when irreparable damage has already occurred,for example to the kidneys or eyes. It is also one of themost underestimated diseases in the world - far frombeing a disease of the rich and elderly, as it is often por-trayed, it is one of the most common non-communicablediseases worldwide, and is on the rise. It is currentlyranked as the fourth or fifth leading cause of death in thedeveloped world, and as most diabetes deaths are offi-cially put down to heart disease, stroke or renal failure(common complications of diabetes), the true toll couldbe even higheriv.

The World Health Organization estimates that diabetescauses as many deaths each year as HIV/AIDS, but it re-ceives far less attention or funding, as it is non-conta-gious. However, international bodies such as the UnitedNations, the WHO and the World Bank are starting towarn of the dangers of ignoring the growing incidence ofdiabetes.

Diabetes causes as many deaths each year as HIV/AIDS

Estimated Worldwide Diabetic Occurance

1985 2007 2025

30 million

246 million

380 million



The incidence of diabetes is set to reach pandemiclevels by 2025 if our current lifestyle and healthcarestructures are left unchecked. In many cases, Type 2diabetes can be prevented, or at least delayed byhealthy lifestyle choices. For those that do developdiabetes, it can be controlled with conscientiousblood glucose management and regular healthchecks. Unfortunately, it seems likely that the direwarnings of the WHO, UN and World Bank will cometo pass unless these recommendations are imple-mented.

What is certain is that ways of reducing and treating itscomplications will remain an important aspect of diabetescare, as will the ongoing search for a cure. As outlined,interventional radiology is already playing an importantrole in both of these projects, and can be expected tocontinue to do so. While open surgery has saved manylives and limbs, and remains the only option for some pa-tients, the arrival of new interventional radiology tech-niques has given patients and clinicians the option oftreatment that is less invasive, less risky, more economi-cal and can help preserve the integrity of the body.Rather than removing or relocating body parts to overridemalfunctions, interventional radiology aims primarily toheal these malfunctions at the source. As it is minimallyinvasive, patients experience shorter recovery times andfewer negative side-effects, and it is important that thesebenefits are recognised, made available to patients anddeveloped further.

Please refer to www.intervention-iq.org for further reading suggestions.

Conclusion

i www.idf.org/diabetes-prevalenceii Adam D.J., et al, Bypass versus angioplasty in severe ischemia of

the leg (BASIL): multicare, randomised and controlled trial. Lancet

2005; 366:1925-34iii Faglia E., et al, Extensive use of peripheral angioplasty, particularly

infrapopliteal, in the treatment of ischaemic diabetic foot ulcers: clini-

cal results of a multicentric study of 221 consecutive diabetic sub-

jects. Journal of Internal Medicine 2002; 252:225-232iv www.eatlas.idf.orgv Schwarze M.L., et al, Age-related trends in utilization and outcome of

open and endovascular repair for abdominal aortic aneurysm in the

United States 2001-2006. The Journal of Vascular Surgery 29 June

2009; 10.1016/j.jvs.2009.05.010

If interventional radiology holds so many clinical andeconomic benefits, why is it not more commonly per-formed? The main obstacle to access to interven-tional treatment lies in the current medicalstructures.

For myriad reasons, a situation has come about whereinterventional radiologists in Europe have no direct pa-tient contact. This has been a recurrent theme among in-terventional societies, with the presidents of many ofthese societies warning interventionists that without posi-tive action to change this, they will continue to work inobscurity, and will not succeed in establishing them-selves or their techniques. Intervention is a very techni-cally innovative field, but it seems that the medicalsystem has not developed as fast as interventional radiol-ogy. Somewhere along the way, interventionists were leftin the lab to develop the procedures that have beenadapted by other fields with a better aptitude for market-ing. Angioplasty is one example - this image-guided tech-nique is now commonly being performed by vascularsurgeons. The disadvantage of this state of affairs is thattrained radiologists are often better skilled at interpretingmedical images and their skills are to some extent goingto waste. Diagnostic radiology is, of course, invaluable tomodern medicine, but interventional radiology also hasits role to play in patient care.

Without proper clinical facilities, interventionists are los-ing out on many patients - and patients are missing outon many opportunities. Most interventionists in Europehave no admission facilities, no beds, and no patients oftheir own. The current referral structures do little to im-prove access to interventional techniques, as patientsare rarely directly referred to an interventional radiologist.A general practitioner diagnosing obstructive artery dis-ease will most likely refer this patient to a vascular sur-geon - many doctors remain unaware of the availability ofless invasive options. Many patients who do opt for inter-ventional radiology cite the internet as their primarysource of information. This raises serious legal questionsabout informed consent, and this gap in knowledgeneeds to be closed.

Better collaboration between different medical fields isneeded, if patients are to be offered the best possiblecare. The most effective diabetic care clinics are thosethat are multidisciplinary. Diabetologists, podiatrists, inter-ventionists and surgeons all have something to offer apatient, and in working together can better improve theirown outcomes. Many patients treated with surgery wouldhave faster recovery rates if treated with interventionalmethods - similarly, not all patients are suitable candi-dates for such treatments, and should be referred to thesurgery department. What is most important is to makesure that each patient receives the best possible treat-ment available to them.

Politics

The most effective diabeticcare clinics are those thatare multidisciplinary


Universal Symbol of Diabetes

International Diabetes Federation

Leading forces in the area of diabetes awareness andmanagement are the International Diabetes Federa-tion (IDF), the European Association for the Study ofDiabetes (EASD) and the Danish-based World Dia-betes Foundation (WDF).

These groups do much to further awareness and re-search of diabetes and its complications, and throughclose work with other medical societies or industry part-ners, look set to increase the scope of their influence.

One example of interest to readers of IQ is this year’scollaboration between the EASD and CIRSE (Cardiovas-cular and Interventional Radiological Society of Europe).The two groups are working together to promote bothawareness of medical solutions to diabetic complicationsand research into further treatment options. In this frame-work, representatives of EASD have been invited tospeak at the Annual Scientific Congress of CIRSE in adedicated session on the Diabetic Foot.

IR gets more involved in diabetes management

Collaboration between CIRSE and the IDF WorkingGroup on the Diabetic Foot is also underway with thepurpose of revising the existing guidelines for the treat-ment of the condition, as well as launching an educa-tional programme which will deal with such issues ashow to set up a diabetic foot clinic.

The decision to form such a joint venture was taken onthe grounds that vascular disease is the major cause ofdeath in people with diabetes, and is an area in which in-terventional radiology is making incredible progress.

The mutual efforts of the major diabetes associations aimto raise awareness of the benefits of multidisciplinarycare clinics, and encourage individual hospitals, diabetol-ogists and interventional radiologists to establish such in-stitutions.

For more information on the associations, please refer totheir respective websites:

www.cirse.org www.idf.org www.easd.org



The Individual

Diabetes can affect more than a patient’s well-being -it can also take its toll on the patient’s finances, andthose of the relevant healthcare provider. Thesecosts are even higher than might be expected, andwith diabetes set to become pandemic, may place anunbearable strain on economies. The results of manyhealth economic studies indicate that the most af-fordable solution to the overwhelming costs of dia-betic complications is to invest sufficient time,money and attention in basic primary care, and fail-ing that, opt for minimally invasive treatment options.

Lost national income over next 10 years due to premature death** in billions ID

* heart disease and stroke are often diabetes-linked - diabetes not usually given as primary cause of death

** taking disability into account might double or triple estimates

This covers only lost earnings - factoring in socialand medical costs, disability payments and pensionswould drive the cost up further still.

The economic effects of diabetes and its complicationsare manifold. For individuals, diabetes can mean pain,disability or death, as well as horrendous expenses andreduction of quality of life. Diabetic complications canoften cost people their livelihoods, as blindness and dis-ability can make performing certain professional tasksimpossible. It can also cost people their independence,and in many cases, family members are required to be-come temporary or permanent carers. For these familiesand local communities, diabetes can mean poverty andloss of time that would otherwise be used for study, workor leisure. In Latin America, families pay 40-60% of carecosts, while in India, families with a diabetic memberspend on average 25% of their income on private carei.Even in the affluent West, many patients in the US arefinding it hard to afford medical care in the face of theeconomic crisisii (see page 16).

For governments, private insurers and employers dia-betes is no less costly, and these costs are not deter-mined solely by medical bills - individuals also contributeto the economy, and sick leave, disability or prematuredeath can reduce the overall financial health of a country.

The Government, Private Insurerand Employer

Even from a budget perspective, prevention is far better than cure. Early intervention andproper treatment is key, and offers good value for money.

China Russia Tanzania

555

303

2

India

333

Brazil

49

China Russia

250 225

India

210

WHO estimates the following costs per annum basedon mortality from diabetes, heart disease and stroke*in billions ID (International Dollar):

14

Diabetes


Europe in 2003

➡ ➡EstimatedDiabetics

48 million

UlcerIncidence

2%

AssociatedCosts, €

10 billion

A great proportion of costs are attributable to prolongedhospitalisation and amputation. Over 10 million Type 2 di-abetes patients in Europe produce €29 billion of associ-ated costs (of which the highest percentage, 32.7%, isattributed to hospitalisation and only 2.7% to oral anti-di-abetics)v.

Cost Comparisons

The cost of 16 amputations is more than the cost ofmanaging 120 active ulcer cases or 834 preventativecasesiii.

Clearly, even from a budget perspective, prevention is farbetter than cure. Early intervention and proper treatmentis key, and offers good value for money.

The direct costs of 8 below-knee amputations isequal to the combined annual salary of a medicalteam of 3 doctors, 5 nurses, 1 dietician, 1 secretaryand 3 auxiliary staffiv.

Benefits of Proper Care Difficulty of Establishing Data

Numerous health economic studies and computersimulation models have indicated the economic ben-efits of providing proper diabetes care. Often treat-ment can be cost-saving, when therapy stopscomplications developing, thus saving on total carecosts.

· Control of blood pressure, blood sugar and lipids re-duce the need for open-heart surgery, dialysis andother expensive procedures, thereby saving money.Off-patent pills (especially combined polypills) are aninexpensive way of doing this.

· Foot care for those at risk of ulcers.· The IDF estimates that low-dose aspirin treatment for

those with elevated risk of cardiovascular disease re-duces the risk by 25-30%.

The World Bank’s assessment returned the verdict thatalthough certain measures are cost-effective only instronger economies, some were universally beneficial,and recommended glycaemic control in people withHbA1c higher than 9%, blood pressure control in peoplewith pressure higher than 160/95 mmHg, and foot carefor people with a risk of ulcers for all countries.

More detailed health economics studies examine theeconomic outcomes of treating the complications. Itmust be pointed out that this is a difficult task to un-dertake, as different clinics in different regions col-lect different data, and that local variations such asreimbursement schemes and cost-sharing arrange-ments can lead to vastly different evaluations of cost.More specifically, in nearly all countries, reports tendto examine only procedural costs, and can omit tomention the costs of follow-up care or consequencesfor the individual. These costs can be substantial,and should certainly be taken into account when de-vising healthcare budgets.

These costs (indicated below) include far more than thecost of a single procedure, as a patient is far more com-plex than that, in economic as well as personal terms.These costs can amount to a sum that is substantiallymore than the estimates that are currently being madefor medical procedures.

Medical Costs· Homecare nursing· Transportation to and from a clinic· Follow-up procedures· Recurrence of a condition

Non-medical Economic Impact· Loss of earnings due to hospitalisation, recovery or

disability· Disability pensions· Social-service support· Impact on the family (further loss of earnings/study

time)· Potential reduced purchasing power of the individual

or family due to altered economic circumstances

In 2002 alone, the US economy lost $39.8 billion($3,290 per person with diabetes) due to lost workdays, restricted activity days, mortality and perma-nent disability caused by diabetes, according to esti-mates of the American Diabetes Association.

In 2003, there were an estimated 48 million diabetics inEurope, with an ulcer incidence of 2% per year, for whichthe associated costs were as high as €10 billion annu-ally.



Reimbursement also plays a crucial role in reducing am-putations. Currently, cost sharing structures tend not toencourage patients to seek early intervention, as theyusually pay a higher proportion of preventative care thanthey do for curative care, and often patients at risk ofPAD and foot ulcers are not in a position to self-diagnose,meaning that treatment is only sought when conditionsare already advanced, and thus causing pain and greatexpense. In Belgium, for example, curative care is 6times as expensive as preventative care, but proportion-ally, patients pay 10% of curative fees, and 14% of pre-ventativevi. Reimbursement schemes can also functionas financial incentive for clinicians, with some healtheconomists recommending that reimbursement shouldbe adapted to encourage fewer amputations by awardinghigher remuneration for revascularisation, rather than thecurrent “per time investment” structure.

This data is a strong indicator of the advantages of notjust limb-salvage over amputation, but also of the bene-fits of minimally invasive medicine in general - shorterhospital stays, shorter recovery times and less chance ofsustaining disability or deformity. These are very impor-tant considerations, not just for the individual, but also forthe health authority and the state, and minimally invasivetreatment should be given serious consideration for anypatients who are suitable candidates.

i www.idf.org/human-social-and-economicimpact-dia-betes

ii Associated Press, Diabetics skimp on lifesaving carein recession. Diabetes Today, 12.04.2009

iii Assal J.P., 1995 in Van Acker K., The Diabetic Foot.Antwerp 2001, p.93

iv Apelqvist J., et al, The global burden of diabetic footdisease. Lancet 2005; 366:1719-24

v Van Acker K., The Diabetic Foot. Antwerp 2001, p.9-10

vi Van Acker K., The Diabetic Foot. Antwerp 2001, p.66

“Unfortunately, the mostdangerous enemy for thediabetic foot can be thereimbursement system” -Apelqvist

Reimbursement

www.worldbank.orgwww.diabetesvoice.orgwww.pubmed.govwww.diabetes.co.ukwww.intervention-iq.org

The annual salary of:

8 BELOW-KNEE AMPUTATIONS

There is strong evidence that a multidisciplinary approach canreduce amputation rates by a sizable percentage.

3doctors

5nurses

1dietician

1secretary

3auxiliarystaff

16amputations

120 active ulcer cases management or

834 preventative cases

I Q | I n t e r v e n t i o n a l Q u a r t e r16 I Q | I n t e r v e n t i o n a l Q u a r t e r

Diabetic Foot Clinic4.4 million of the world’s 246 million diabetics live inEgypt, ranking it as one of the Top 10 countries for dia-betes incidence. Unfortunately, projections for 2025 esti-mate that this number will rise as high as 7.6 million.Accordingly, the International Diabetes Federation’sBRIDGES programme has given 2 year funding to theFaculty of Medicine in Alexandria, Egypt and the Alexan-dria Western Club of Rotary International to open a dia-betes foot care centre, aiming to provide care andeducation to diabetics in and around Alexandria. The out-come of assessments, routine care, footwear counsellingand workshops to train local healthcare providers will bemeasured by the reduction rate in amputations. The goalis to reduce amputations by at least 25% within 2 years.www.idfbridges.org

RAPIA - Rapid Assessment Protocol for Insulin AccessInsulin is classified by the WHO as an essential drug, yetmany diabetics have limited or no access to it. The Inter-national Insulin Foundation’s RAPIA programme (RapidAssessment Protocol for Insulin Access) was recently im-plemented in Zambia, Mali and Mozambique.The World Bank classifies all three as Highly IndebtedPoor Countries (HIPC), i.e. countries whose income isoutweighed by their debt. The results of the RAPIA revealinteresting findings on healthcare management. Although all countries have similar economic situations,different policies have led to drastically different out-comes. For various reasons, treatment is calculated to be5-10 times better in Zambia than in Mozambique. The lifeexpectancy for a child presenting with diabetes stands at11 years in Zambia, 30 months in Mali, and just 12months in Mozambique. By examining the flaws in thehealth policy, governments can improve their tackling ofthe disease and management of resources. www.access2insulin.org/html/rapia.html

Recession leads to decline in healthcareThe Associated Press has discovered a worrying trend ineconomising in the US - many diabetics are cutting backon or discontinuing medication and doctor visits in an at-tempt to save money. Many Americans who lost their jobsas a result of the recession have also lost their job-linkedhealthcare plans. Many diabetics are thus reducing their medication orswitching to cheaper (often less effective) brands. Sub-sidised clinics are seeing such an increase in demand fortheir services that they, too, are being forced to ration re-sources. Ms. Eileen Collins cut back her medication following herhusband being laid off, and attempted to counter it with astrict diet. Shortly afterwards, she was rushed to hospital,vomiting blood with sky-high blood sugar levels. She, likemany diabetics in a similar situation, simply didn’t realisethe consequences of not managing diabetes carefully.Unmanaged diabetes can lead to costly hospital stays,disability or even death. Many clinics seeing a downturnin patient attendance are asking patients to make their fi-nancial difficulties known to the clinic, rather than notseeking treatment.Used with permission of The Associated Press Copyright© 2009. All rights reserved.

Health Springs EternalIceland has the lowest incidence of diabetes in Europe, amere 2%. Scientists have long wondered why, and havetried everything from genetic surveys to investigating en-vironmental factors. The higher incidence of diabetes inneighbouring Sweden and Finland seems to rule out lati-tude as a factor. They have swabbed cheeks, poured over church records,looked into the shielding properties of omega 3 oil andtested the milk of their cattle, which have been reared inisolation for hundreds of years. A link between largerbirth weight and lower diabetes risk was established, butseems to be a local anomaly. An extensive genetic sur-vey seemed to reveal a mutant gene that is responsiblefor diabetes, but a lot more research is needed beforethis can be established as a primary cause of the disease.

Worldview


Tropical CuresThe University of Ulster and the United Arab EmiratesUniversity are currently jointly researching an interestingphenomenon found in some tropical flora and fauna - theskin of a certain Amazonian frog was found to secrete asubstance that could be used to boost insulin productionin Type 2 diabetics. At the same time, another University of Ulster team is re-searching the bark of a Himalayan plant, chirette. Com-pounds found in this bark contain similar properties tothose of the frog, stimulating production and effectivenessof insulin. Research into both is reported to be at an excit-ing stage, and more potent synthetic versions have the po-tential for development into a treatment for Type 2 diabetes.


Olympian DeterminationSir Steve Redgrave is considered Britain’s greatestOlympian, being one of only four people to have wongold at five consecutive Olympic Games. It’s hard to believe that the fifth was won after he was di-agnosed with insulin-dependent diabetes, but his healthyattitude towards managing this serious condition allowshim to achieve his goals. He retired from rowing in 2000,but remains very active, having completed 3 LondonMarathons, raising a record £1,800,000 for charity in2006 alone - a clear indication that with the right ap-proach, diabetes doesn’t control you: you control it.

The SugarmanSadly, native populations seem to be at higher risk of de-veloping diabetes than their non-indigenous neighbours.South Australia fares no differently, where the diabetesrate among the non-indigenous population stands at 9%- however, in most Aboriginal towns, this figure increasesto over 50%.Registered nurse and diabetes educator, Michael Porter,devised an unconventional but effective workshop to edu-cate communities about diabetes, based on Aboriginalstory-telling tradition, christened “The Sugarman”.The Sugarman is a large canvas outline of a body onwhich participants play games to learn about diabetes. Forexample, participants (representing insulin) try to shootballs (sugar) through a basketball hoop (muscles), actingout metabolism. Michael Porter (diabetes) tries to blockthese balls, much as diabetes prevents sugar getting to themuscles in a real body. Communities have been very posi-tive about the Sugarman helping children understand theirbodies, saying that giving the disease a face and a namehas made it easier to deal with.

TAF and HHF In 1992, Singapore’s government launched the “Trim andFit” programme to combat childhood obesity and its con-sequences, such as Type 2 diabetes. Children over 9deemed overweight by BMI and fitness tests had to takeat least 1.5 hours supplementary exercise. Ration vouchers restricted the holder to a certain maxi-mum of calories in the school canteen. TAF reducedchildhood obesity from 14% in 1992 to 9.8% by 2002, butwas criticised for promoting physical health over psycho-logical health. Some schools even implemented a segre-gation system in canteens, separating overweightchildren from their slimmer peers. Overweight childrenwere stigmatised and eating disorders increased, accord-ing to a 2005 study by the National University of Singa-pore. In 2007, the Holistic Health Framework replacedTAF, aiming to promote physical, mental and social healthin all school children, not just overweight ones.

A Terrible ShameFor many Asian families, the social implications of dia-betes can often be as difficult as the medical implications.Doctors in Hong Kong have reported that many parentssee it as shameful, and many children face bullying orostracisation from their peers. Other families worry that their children will not find mar-riage partners, and sometimes try to hide the diseasefrom the public eye. In one tragic case in Chennai, ayoung bride had kept her condition secret from her fi-ancé, and didn’t take her insulin during her honeymoon.As a result, she slipped into a coma and died. One won-ders if the young widower wouldn’t have been happier tohave a diabetic young bride, rather than a dead one.

➡

18

Diabetes


The Diabetic Foot Clinic

From Roman times to the present day, people havecome from all over the Italian territories to the townof Abano Terme. The hot springs and mud baths ofthe north-western town have long been consideredtherapeutic, but these days, there is something elsewhich attracts those in search of health. We spoke toDr. Marco Manzi, Director of the Interventional Radi-ology Unit of Abano Policlinic’s Foot and Ankle Clinicto find out more …

Multidisciplinary diabetic foot clinics are widely recog-nised to be, both clinically and economically, the most ef-fective way of treating diabetic foot disorders, which of alldiabetic complications are the most costly and have thegreatest toll. Worldwide, 70% of lower limb amputationsare the result of diabetes - 1 every 30 seconds. Despitethis, specialised clinics are not always widely available.

In 2003, the inspired hospital management of AbanoPoliclinic realised that this was precisely what the regionneeded, and provided a modern catheter lab, dedicatedoperating rooms and personnel, heralding the birth of theFoot and Ankle Clinic. In fact, demand is so high that an-other catheter lab is to be opened next December.

The Interventional Radiology Team1 Interventional Radiologist (Dr. M. Manzi)1 Interventional Cardiologist1 Technician5 dedicated Nurses

No. of Patients1,000 treated annually

Foot and Ankle ClinicSpecialists & Staff7 Podologists5 Diabetologists3 Orthopaedics2 Vascular Surgeons1 Interventional Radiology team

Dedicated Beds30

The spice of lifeDr. Manzi explains the advantages of having a mixed bagof medics under one roof - on the one hand, the team issmall enough that communication and discussion of clini-cal problems can be carried out quite easily, and on theother hand, with so many different specialists available, asolution can always be found, whatever the problem. Thisaffords patients at the clinic the best standards of care.

The clinic recognises the value of bringing together bothinterventional radiologists and vascular surgeons - bothspecialists have expertise to offer the patient, and bothplay an important role within the clinic.

“The future will be less and less invasive,and Interventional Radiology must bethere”

Left to right: M. Marangotto (Head of Nursing), J. Alec(Radiographer), G. Erente (Interventional Cardiologist), E. Sultato (Nurse), M. Manzi (Interventional Radiologist),C. Brigato (Nurse)

Diabetic feet in the best hands An exemplary approach to patient care

The Diabetic Foot Clinic


In terms of treatment, the first choice is minimally inva-sive techniques: treating the complication from within theblood vessel, minimising ancillary damage. With new pa-tients, Dr. Manzi and one of the clinic’s diabetologists de-cide the most suitable strategy and the surgicalindications, which he puts at about 10% of presentingcases. The clinic evaluates its clinical and operative suc-cess on the basis of strict follow-up examinations.

Dr. Manzi believes that the natural progression of medi-cine will favour less invasive procedures, and so inter-ventional radiology will take a more prominent role. Assuch, it is important that trained interventionists be avail-able, and he sees the career opportunities for young doc-tors training in this field as favourable: “there will alwaysbe a career opportunity for young IRs, especially in vas-cular, oncological and gynaecological treatments.” Hefirmly believes that IR will develop further techniques fordealing with other diabetic complications, and cites treat-ment of ischemic hand syndrome and management ofaterovenous fistulas in diabetic-dialysed patients as likeli-hoods.

He also believes that the revision of TASC II guidelines(recommendations on best practice treatment of periph-eral artery disease) is long overdue - their recommenda-tion that interventional techniques be used for patientswith TcPO2 of <30mmHg could also be applied to pa-tients with 30-40mmHg, as they are also at risk of ampu-tation, and are thus valid candidates.

Cost-effective medicineThe Foot and Ankle Clinic offers more than just clinicalbenefits: it has impressive economic ones as well. Dr.Manzi calculates that the average cost per patient of ma-terials used in revascularisation (limb salvage) is €1,170,whereas in the US, an elective amputation alone costs$6,000 (around €4,300), and one following a by-pass fail-ure will cost $28,000 (around €20,000), without takinginto account any health or socioeconomic costs.

CommunicationWith most interventional units, one of the major stum-bling blocks is the lack of direct referrals. The Foot andAnkle Clinic has a solution for this too: they have estab-lished both a website (www.policlinicoabano.it) and goodGP relations. Meetings are organised with small groupsof GPs to involve them in prevention and early detectionof clinic signs. They are also kept up-to-date with inter-ventional and diagnostic procedures for diabetic foot andCLI. Using this “grass-roots” network, the clinic managesto promote both interventional radiology and better dia-betic foot care in the wider community.

Dr. Manzi qualified as a radiologist in 1990, but devel-oped an interest in interventional procedures, and inves-tigated Ultrasound-guided PEIT (Percutaneous EthanolInjection Therapy) of thyroid and liver tumours. For him,the main advantage of the interventional approach wasthe therapeutic role, which is not part of diagnostic radi-ology. This convinced him to specialise as an interven-tionist, and he pursued his chosen field at variouscentres in Italy and France. In 1996, he became respon-sible for the IR unit of the Radiology Department of Vi-cenza Regional Hospital, where he devoted himself toestablishing an effective IR Unit and instilling a passionfor IR in young radiologists. As far as current treatmentsare concerned, Dr. Manzi has published papers on thePedal-Plantar Loop technique, a new approach to re-canalise below-the-knee occlusions that do not respondto commonly-practiced revascularisation techniques.One such study published in the June 2009 issue of theJournal of Cardiovascular Surgery demonstrates the ef-fectiveness of this technique - of the 1,331 CLI patients,135 were treated with the pedal-plantar foot loop andacute success was achieved in 115 (85%), demonstrat-ing the safety and effectiveness of this new technique.

Results published with kind permission of the Journal of Cardiovascular Surgery and Minerva Medica.

“For us, ambulationfunction salvage is most important”

The Vitals

❜

Using such approaches, Dr. Manzi’s colleagues seek togive each patient the best possible outcome. Unlike gen-eral medical literature, which defines limb salvage astime free of amputation, the Foot and Ankle Clinic sees itas salvaging or restoring ambulation in a patient - it is nottheir aim to simply spare the limb, but also to return it tofull health and function. Interventional radiology has avery important role to play in this, providing as it does aminimally invasive option of re-opening the blocked ves-sels that cause so many diabetic foot problems.

www.policlinicoabano.it

20

Diabetes


Pancreatic Islet Transplantations

How is this interventional procedure carried out?Step 1Pancreatic islets are extracted from the pancreas of a re-cently deceased donor and isolated using specialisedenzymes. They are fragile and must be transplantedsoon after their removal.Step 2The patient receives a local anaesthetic and a sedativeand the whole procedure is carried out through a tinynick in the skin. An interventional radiologist uses x-raysand ultrasound to guide a catheter through the patient’supper abdomen into the portal vein of the liver. Step 3The islets are then infused into the patient’s liver wherethey soon secrete insulin. The patient may need to un-dergo more than one transplant in order to achieve fullinsulin independence.

Edmonton Protocol

Working to find a solution to the problem of immunosup-pressive drugs, researchers of the University of Edmon-ton prescribed a novel combination ofimmunosuppressant drugs to patients following suc-cessful pancreatic islet transplantations. Their findingswere dubbed the Edmonton Protocol and showed howpatients could attain a state of insulin independencewhen sufficient numbers of pancreatic islets were trans-planted and how the side effects of immunosuppressivedrugs could be reduced. The success of the Edmontonprotocol has provided researchers with new hope for im-proving the pancreatic islet transplantation process.

In 1972, Dr. Paul E. Lacy embarked on a well-plannedexperiment that would help bring the ideas of manyscientists before him to fruition. He successfully trans-planted pancreatic islets into a laboratory rat with Type1 diabetes, curing it. These pancreatic islets, or isletsof Langerhans, contain the body’s insulin producingbeta cells. Type 1 diabetes results from an autoim-mune reaction in which the pancreatic islets are de-stroyed. Further experiments followed and in 1989,Lacey and his team successfully carried out the firstpancreatic islet transplantation on a human being.

Type1 Diabetes: Closer to a Cure?

Finding a cure for Type 1 diabetes has long eludedscientists as its cause still remains unclear. However,modern medical advances are enabling the develop-ment of several curative procedures all of which holdthe promise of a cure. Such a cure would not onlyfree diabetics from their dependence on insulin butalso decrease their risk of serious diabetes-relatedcomplications. The two main curative procedurescurrently being used are pancreatic islet transplanta-tions and pancreas transplantations.

What are the advantages?· Patients become free from the need for daily insulin

injections, and potentially dangerous hypoglycaemicepisodes are prevented.

· By helping to control blood sugar, the transplantedislets also aid in reducing the risk of diabetes-relatedcomplications.

· The minimally invasive technique shortens the patient’srecovery time in comparison to those who undergo sur-gical transplants and operations costs are less.

What are the disadvantages?· There is a shortage of islets with which to carry out

the transplantation as they make up only 2% of pan-creatic tissue. Patients normally need islets from morethan 1 pancreas to achieve insulin independence.

· As with all transplantations, there is a risk of organ re-jection. Rejection occurs when the body’s immunesystem recognises a newly transplanted organ as “for-eign”, and in turn attempts to destroy it. This autoim-mune reaction was what triggered the destruction ofthe patient’s own pancreatic islets to begin with.

· Expensive immunosuppressive drugs are prescribedto prevent rejection and must be taken for life or aslong as the islets function. The long term effects ofsuch drugs are unclear but they can cause seriousside effects such as decreased kidney function and in-creased susceptibility to viral and bacterial infections.However, research carried out in the University of Ed-monton showed that the adverse effects of immuno-suppressive drugs can be lessened.

Type 1 Diabetes: Closer to a Cure?


What are the advantages?· Usually, the newly transplanted pancreas starts func-

tioning immediately as do the new kidneys. Occasion-ally, this can take up to a few weeks to start.

· By helping to control blood sugar, the transplantedpancreas also aids in reducing the risk of diabetes-re-lated complications.

· Successful pancreas transplants free the patient fromthe need for daily insulin injections.

What are the disadvantages?· Shortage of donors.· Risk of organ rejection means strong immunosuppres-

sant drugs must be prescribed. · Complications associated with open surgery such as

excessive bleeding and infection can occur, unlike withthe minimally invasive procedure of pancreatic islettransplantation.

· General anaesthesia can be dangerous for certain pa-tients, increasing the chances of heart attack andbreathing problems during the operation.

· Some patients risk thrombosis and pancreatitis, an in-flammation of the pancreas as a result of pancreastransplantations.

Pancreas TransplantationIn pancreas transplantations, the whole organ istransplanted, not just the insulin producing pancre-atic islets. Following the first successful combinedpancreas and kidney transplant by Dr. Richard Lille-hei in 1966, the patient remained independent frominsulin for a few months until her body rejected thenew organ. Dr. Lillehei carried out further transplan-tations and in 1968, he lead a team which carried outthe first pancreas-only transplant. There are 3 typesof pancreas transplants; simultaneous pancreas-kid-ney transplantation (SPK), pancreas after kidneytransplantations (PAK) and pancreas-only transplan-tations. Pancreas-only transplantations are only car-ried out on patients who have numerous lifethreatening hypoglycaemic episodes.

How is this surgical procedure carried out?Step 1A pancreas is extracted from a recently deceased donor.In rare cases, a part of the pancreas of a living donorcan be used.Step 2The donor pancreas is grafted to the small intestine andto blood vessels in the lower abdomen of the patient.The patient’s own pancreas is not removed so that it cancontinue its function in aiding digestion. Depending onthe type of operation, the kidney may also be trans-planted.

ConclusionThe discovery of insulin and the insulin producingbeta cells of the pancreatic islets has proved to bean essential step in the search for a cure. As re-search into possible cures is being carried out in var-ious fields of medicine, doctors could be on thebrink of finding a definitive cure. The minimally inva-sive treatment of pancreatic islet transplantations of-fers patients an effective alternative to open surgerywith the added benefits of being less painful andmore cost-effective. With advances such as the Ed-monton Protocol being made into decreasing the riskof immunosuppressant drugs, pancreatic islet trans-plantations could well be a key future diabetic cure.

Treatment What is it?

Nano-medical techniques

Stem cell-basedtreatment

Stem cells, differentiated into insulin pro-ducing beta cells are administered to thepatient via intravenous injection.Stem cells can be extracted in variousways including from 5-day-old human em-bryos, or from the patient’s own bone mar-row.Risks unclear due to lack of research.

A new medical specialty based on engi-neering and production on the scale of ananometre (a billionth of a metre and 20times wider than the diameter of a hydro-gen atom). One procedure involves trans-planting beta cells contained in siliconboxes with holes large enough for insulinand glucose to pass through but too smallfor the body’s immune system moleculesto enter and attack the beta cells.Risks unclear due to lack of research.

Other Treatments on the Horizon

http://diabetes.niddk.nih.govwww.intervention-iq.org


Diabetes

Diabetes TrialsTrial: a study carried out with the purpose of testinga new medical treatment on a defined group of peo-ple. The results are compared with a group that aretreated using another method and/or a control group.

Coronary CT Angiography in Asymptomatic Diabetes Mellitus

Contact personProf. David A. Halon, Lady Davis Carmel Medical Center, IsraelDate openedAugust, 2007Status of trialRecruiting finished, data to followSourcewww.clinicaltrials.gov

DescriptionIn this study readily available patient medical data relat-ing to diabetes and its complications/risk factors will becollected and patients will be referred for exercise, stresstesting and eye examinations. The coronary CT an-giogram will be examined for early signs of coronary ar-tery disease and the outcomes will be examined after 2years or later using computerised databases.

Islet Transplantation for Type 1 Diabetes Mellitus

Contact personDeborah L. Dicke-HenslinMayo Clinic Rochester, Minnesota, USDate openedJuly, 2006Status of trialRecruitingSourcewww.clinicaltrials.gov

DescriptionThis study evaluates the safety and efficiency of islettransplantation in five patients with Type 1 diabetes, sat-isfying extensive inclusion and exclusion criteria underIND, approved recently by the FDA.

Percutaneous Transluminal Balloon Angioplasty(PTA) and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia (PADI)

Contact personDr. Hans Van OverhagenNetherlands Society for Interventional Radiology, NetherlandsDate openedAugust, 2007 Status of trialRecruitingSourcewww.clinicaltrials.gov

DescriptionThis study aims to investigate the performance of pacli-taxel-coated balloon expandable stainless steel coronarystent for the treatment of infrapopliteal stenoses and oc-clusions in patients with critical limb ischemia comparedto percutaneous transluminal balloon angioplasty (PTA).

Solitary Islet Transplantation for Type 1 Diabetes Mellitus Using Steroid Sparing Immunosuppression

Contact personDr. David M. HarlanNational Institute of Diabetes and Digestive & KidneyDiseases, USDate openedNovember, 2000Status of trialRecruiting finished, data to followSourcewww.clinicaltrials.gov

DescriptionThis study will test whether a new islet transplant proce-dure using the findings of the Edmonton Protocol can en-able patients with Type 1 diabetes mellitus to stop insulintherapy. Radiation and lower-dose chemotherapy will notbe used.

Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY)

Contact personKathryn HirstGeorge Washington University Biostatistics Center, USDate openedMay, 2004Status of trialRecruiting finished, data to followSourcewww.todaystudy.org

DescriptionThe TODAY trial aims to compare the efficacy of met-formin alone, metformin plus rosiglitazone, and met-formin plus on the length of time to treatment failurebased on glycaemic control.

Please note that this does not constitute an exhaustiveoverview of Diabetes trials. If you are aware of a Dia-betes trial or registry, which may be of interest to ourreaders, please feel free to contact us at [email protected].

IQ takes no responsibility for the content of the individualtrials; please refer to their Source for further information.

✱

www.clinicaltrials.govwww.who.int/trialsearch/default.aspxhttp://clinicaltrials.mayo.edu

Polit ics


Interventional Radiology becomes Official UEMS Division

Established in 1958, the UEMS represents medical as-sociations of the European Union and other associ-ated countries on a non-profit basis. It is credited withthe creation of the influential European AccreditationCouncil of Continuing Medical Education (EACCME).

The current president is Dr. Zlatko Fras.

UEMS main objectives:· Studying and promoting various medical

specialities· Harmonising medical specialist training in the

European Union· Assuring a high level of professional autonomy

for medical specialists· Preserving the right of all European citizens to

quality medical care

THE EUROPEAN UNION OF MEDICAL SPECIALISTS(UEMS)

At the Czech Radiological Congress in 1962, an as-tounded group of physicians listened attentively asCharles Dotter described how angiography could beused for treatment and not merely for diagnosis. Hispivotal speech sparked the bright beginning of inter-ventional radiology’s journey. A few decades later,this journey continues and has seen numerous mile-stones, which have helped IR develop into the multi-faceted and valuable discipline it is today.Another milestone came on 25th April 2009 as mem-bers of the European Union of Medical Specialists(UEMS) voted to establish a division for IR under theauspices of their Radiology Section. The new divi-sion will be instrumental in complementing ongoingefforts to establish and promote IR in Europe, whileat the same time opening up new avenues for IR’sfurther development. How did the division come to be?

Efforts made in advance of the meeting in April were keyto the establishment of the division as delegates wereclearly informed on IR and the significance of having anInterventional Radiology Division in the UEMS. The co-operation between CIRSE President Jim A. Reekers, Eu-ropean Society of Radiology (ESR) President ChristianHerold and UEMS Radiology Section Chairman PeterPattynama was central to the success of the effortsmade.

What does the new division mean for IR?

More acknowledgement of the benefits of IR procedures IR offers patients an invaluable alternative to open sur-gery. The new division will reinforce actions being takento raise awareness of the benefits of IR to patients andother specialists as well as to referring physicians andhospital management.

Increased involvement in health politicsIR’s international backing by the UEMS will helpstrengthen its position in negotiations with national healthpoliticians particularly in the areas of greater media cov-erage, improved patient access to IR treatment andmeeting public health objectives.

The promotion of IR researchCutting edge technology is central to IR‘s minimally inva-sive procedures, and official recognition from the UEMSwill reinforce the vital research behind it. This will in turnlead to safer more effective treatments and improvedquality of life for patients.

Synchronisation of European IR training and certificationThe compilation of existing IR training curricula into asingle European training curriculum and the establish-ment of a European IR Skill Certificate would be an im-portant step towards synchronising IR training and toproviding IRs with recognised Europe-wide certificationof their IR training and skill.

Common guidelines for IR clinical practice in EuropeEfficient clinical practice has become crucial for IR andthe relationship between physicians and patients helpsforge a bond of trust. This bond is not only important forsuccessful post-procedural care but also for giving physi-cians a greater understanding of the patient’s needs, en-abling them to tailor treatment accordingly. A set ofcommon guidelines can improve and unify clinical prac-tice across Europe.

Greater reach for IR training institutions Institutions for IR training, like the European School of In-terventional Radiology (ESIR), have come a long wayover the past years, constantly updating the training theyprovide to adhere to the latest training standards. IRtraining institutions strive to expand training to countriesin which IR has yet to be established and recognition bythe UEMS will reinforce their efforts.

Greater interdisciplinary cooperationInterdisciplinary cooperation is fundamental to offeringpatients high quality medical care. Having an Interven-tional Radiology Division in the UEMS will encouragesuch cooperation between IR and the other specialtiesrepresented.

www.uems.netwww.uemsradiology.euwww.cirse.org

24

Interview


5 minutes with …Dr. Christoph Binkert

Many European doctors choose to gain professionalexperience in America. Why did you decide to gothere?“Well even now, there is no structured IR training pro-gramme in Europe, so the 2-year fellowship offered at theDotter Institute was very attractive for me. Hospitals in theUS have more consistent case loads, which is an advan-tage for trainees. There were also the personal reasons -I, like many others, wanted to spend some time abroad,and the US is a very interesting place to do that, as wellas being justifiable career wise.”

What opportunities did it provide? What impact did ithave on your career? “Often in Europe IR training is autodidactic, but in the USit’s very methodical. Also, any time spent in a different en-vironment can be eye-opening, and shows you a differentapproach to both work and life. Overall, I would recom-mend going away to any young doctor, because whenyou come back you appreciate more what your countryhas to offer, and you’re more open-minded to manythings, in personal life but also in the hospital. You cansee that things are done differently and I think, beside theexcellent education I got in the US and my experiencesin the medical field, this was the most valuable thing thatI learned.”

It’s been two years since you returned to Switzerland.What have the main challenges been coming back toEurope? What ideas did you bring home with you?“I was actually surprised when I returned how easy it wasto adapt, and how little had changed in the 7 years I wasgone. The biggest change I had to get used to was mynew professional position, but returning to my homecountry wasn’t the shock one might expect.”

What was the situation in Winterthur when you cameback?“In general, many things were similar to the situation inthe US. Diagnostic radiology was structured the sameway, but the interventional radiology situation was a bitdifferent, as IR isn’t so well established in Europe yet.The Kantonsspital Winterthur was quite advanced in thisfield by European standards. My predecessor, also an in-terventionist, had already done a lot of work, which gaveme a good starting position.”

Promoting IR is a main consideration for interven-tional radiologists, especially in the areas of patientinformation and patient referral. How is this dealtwith in Winterthur? How does it compare with yourexperiences in the US?“The hospital itself doesn’t have any specific patient infor-mation programmes promoting IR, but our managementis very open-minded, and was very supportive of the vari-ous changes I tried to make, for example, the collabora-tion between interventional radiology, vascular surgeryand angiology or the start of a vertebroplasty pro-gramme. Surprisingly, it was quite easy, as I have veryforward-thinking clinical colleagues, but essentially, I hadto take the initiative to implement them myself.”

What, in your opinion, constitutes an ideal relation-ship between an IR and a vascular surgeon and howwould one be established?“I think personality is important - it’s not something thatcan be enforced by outside regulation, you’ve got to ne-gotiate the best working set-up yourself. I was lucky be-cause I work with a very open-minded vascular surgeonwho was really interested in a good collaboration. Asteam members, both sides have to play fair - this appliesto the interventional radiologists just as much as to thevascular surgeons. For me, the main issue is that youdiscuss things on an equal footing, you can both makesuggestions, you can approach your patients the wayyou want to, and the surgeon can do it his way. I thinkyou have to deserve this position by being clinically ac-tive, by actually seeing patients and emergency cases,making judgements yourself and also doing follow-upson these patients. I think it was my clinical involvementwhich allowed me to achieve a good working relation-ship.”

What is it that IRs need to do?“Again, I have to say I was already in a very good startingposition in terms of the existing structures and my open-minded colleagues here at Winterthur. But if that hadn’tbeen the case, I definitely would have tried to do more onmy own. Interventionists cannot use the excuse, “I’m notlucky, it’s just not working for me.” I think most interven-tionists want to have it easy; they would rather not be

We speak to Dr. Christoph Binkertabout America, Switzerland andthe importance of good workingrelations.

An Ideal Relationship … with your vascular surgeon

”I think it was my clinical involvement which allowedme to achieve a good working relationship”

www.ksw.ch

5 minutes with…


Christoph A. Binkert, MD, MBA Director of the Institute of Radiology, and Chairman

of Diagnostic and Interventional Radiology, Winterthur Kantonspital, Switzerland

clinically-involved and simply have the vascular surgeonprepare the patient for the procedure, where they canthen step in to do a procedure and then send the patientright back to the surgeon. This is a model that doesn’t re-ally work well and I can understand that surgeons don’treally like that.But if you as an interventionist take care of your patientsfrom work-up and consent, informing the patient to talk-ing to the family, you usually earn respect. I think theother important thing you have to make sure is that youhave visibility, for example that you’re on the letterheadso people understand that you’re part of this team.”

So do surgeons prefer IRs to take responsibility?“I think at the beginning they may not. When I first tookthe initiative to see patients and get my own referrals,they were a little bit anxious about what was happening.Once the Head of Vascular Surgery understood that Iplay fair and inform him about the cases and keep him inthe loop, he realised that it’s a great arrangement, that Ibring additional patients into the vascular institute andthe vascular system and everyone benefits. That was cru-cial to establishing a good working relationship. In gen-eral, I don’t think it’s a question of whether they like it ornot, I think it’s absolutely mandatory that interventionistssee their patients - that’s the only way for the future.”

Do you have any words of wisdom for your youngercolleagues?“Teamwork and the interdisciplinary approach are crucial- not just when working with vascular surgeons, but gen-erally. That’s what I’d recommend to everybody.

Interventional radiologists should have enough self-confi-dence to see their own patients, make their own plans,ensure that they are allowed to do their jobs properly andare seen as clinical colleagues. This is something Ilearned from the States. The lack of referrals hit themhard over there and as a result, they quickly adapted newstrategies. I think in Europe this would be a great time todo this, because we still are involved in PVD work, but Idon’t think we can keep that going if we’re not adapting a

more clinical work style. This is a message I’d really liketo give to my younger colleagues, because I think it iskey.”

We know that you have an MBA in hospital manage-ment from the American Intercontinental University.How important are management skills for interven-tional radiologists?“In advancing my career, I knew the next step would in-volve more administrative duties. I think in standard med-ical education, we learn a lot about medicine, but not somuch about how to lead and structure a department, andfor me it was helpful to learn how to do that and to under-stand a little bit more about how things are done, whatcosts are involved, how a hospital is structured, how todecide when expensive equipment is justified, how youcan set up a contract. For me, this information was morevaluable from the point of view of head of a department,than as an interventionist. Nevertheless, I think it’s impor-tant for interventionists to be aware of the costs, so weknow when we are expensive, and when we are less ex-pensive compared with other specialties.”

Moving to different environments must have influ-enced your leisure time. What does Dr. Binkert dowhen he is not in office?“I’m an outdoor person, and I have 3 boys, and it wasgreat for them in the States: the sports activities andother things available to them in their spare time wereunbelievably good, so that is something we miss a littlebit back in Switzerland. I am an enthusiastic skier, andam naturally doing more of it being back in Switzerland.What I brought home with me was a new sport: kite-surf-ing. I started kiting on the Pacific Coast when the kidswere little, but only with a training kite. Although I’m stillnot very good at this point, practice makes perfect. Thereare opportunities to do it in Switzerland too, but themountains with very cold lakes aren’t ideal, especially forsomeone like me who’s still most of the time in and notout of the water.”

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"It's absolutely mandatorythat interventionists seetheir patients - that's theonly way for the future"

“Teamwork and the interdisciplinary approachare crucial - not just whenworking with vascular surgeons, but generally"

26

Daily Practice


A huge number of clichés exist about the value of aharmonious and well-structured team: “a chain isonly as strong as its weakest link,”“the strength ofthe team is each individual member - the strength ofeach member is the team,” and so on. While suchclichés are… well, clichéd, their existence nonethe-less reveals a basic truth - that in all walks of life,more can be achieved by a specialised group than byan individual.

This is not only true for football teams, Formula 1 teamsand factory workers; it is also true for medical depart-ments. It seems not only an obvious, but also an obso-lete statement, as most medical departments alreadyconsist of a well-regimented team of doctors, nurses,technicians, secretarial staff, and any other personnelthey need for their purposes. It seems laughable that ahighly-trained surgeon should have to bother with order-ing medical supplies, or that a technician would have nobackground experience of the specialist department hefinds himself working in. Yet, for interventional radiologydepartments, this is very often the case.

The recent recognition by the UEMS of interventional ra-diology as an official division within radiology was a hugecoup for interventionists everywhere, but it is only the tipof the iceberg. Up till now, it was very often seen as asort of sideline to diagnostic radiology - something akinto Dads having a passion for tinkering around in the shedat the end of the garden after their real working day wasover. However, this attitude is not at all justified, as inter-ventional radiology has proven its mettle time and againover the last 4 decades. Indeed, many of their proce-dures are being adapted and used by other specialists.

A quick look through history shows us that the deriding ofnew ideas is more often than not a last-ditch attempt tocounter a perceived threat - usually only seen as suchbecause of a lack of understanding. But as it turns out,

the world is not flat, women are capable of voting, and in-terventional radiology procedures have been proven tobe safe and effective. Being such a multidisciplinarybranch, treating as it does cardiovascular and vertebralcomplaints, oncology, gynaecology and the rest, it isoften perceived as being competition by many other hos-pital departments. For the patient, interventional radiol-ogy can be a lifeline; for the non-interventional specialist,it can seem like an intruder.

As such, interventional radiology tends to find itself with-out allies within the hospital system. Whether due to alack of knowledge of its potential or a fear that it couldundermine the existing status quo, there is a tendency totreat it like a bothersome younger sibling: someone to beshunted elsewhere, mocked and ignored. Usually there isno independent interventional radiology department inthe hospital. If they are lucky, they are hosted by the Ra-diology Department, some of which are supportive of in-terventional radiology, and some of which are fullycommitted to diagnostic radiology, having a limited viewof the needs of an interventionist. One thing that is cer-tain is that there are no existing legal guidelines as towhat constitutes an interventional radiology department,and thus, no framework for resource allocation.

One of the most important resources of any medical de-partment is its staff. For optimal care to be provided,each member of the team must be able to perform theirduties correctly and efficiently. However, in a large num-ber of hospitals, interventional radiologists do not havededicated staff, and share nurses and radiographers withother departments. The problem with this is that with con-stantly rotating staff, there is nobody available to ensurethat medical supplies are maintained and correctly storedand kept track of. Another problem is that nurses and ra-diographers who are required to assist with a wide vari-ety of procedures have less opportunity to familiarisethemselves with their roles within these procedures, or tobuild up a working rapport with the performing clinician.

While no legislation exists about allocating dedicatedstaff to interventional radiology departments, a number ofinterventionists have nonetheless reported that their hos-pital managers are very supportive of their work, and thatthey have the resources they need to perform their jobsoptimally. These doctors can testify to the advantages ofhaving dedicated staff - Professor Jan Peregrin of theCzech Republic stated that he “cannot imagine working

Non-Dedicated Staff:may cause serious side effects*

"Cannot imagine working in an IR suite without dedicated staff"

Non-dedicated staff: can cause serious side-effects


in an IR suite without dedicated staff.” Professor DierkVorwerk describes his designated technician as “an ab-solute must to prevent friction and frustration.” St.George’s Vascular Institute in the UK also allocates ade-quate staff to its interventional radiology department: in-terventionist Dr. Robert Morgan said, “I cannot see howany IR department can work unless there are constantpersonnel who have the task of ordering catheters, bal-loons, etc. and monitoring the stock to make sure that itdoes not run out.”

Other doctors are not so fortunate. Professor José Igna-cio Bilbao, while more than content with his own staffingarrangements, tells us that “in Spain, we do not have anindependent section of IR, apart from the radiology de-partment in even the largest hospitals. A nurse can be inCT one week, then in MR, and later in IR.” ProfessorMarc Sapoval tells of a similar situation in France: “…thesituation is very different from one place to another anddedicated personnel are not always available. This is amajor reason for failure, complications, redoing and post-poning the intervention.” Professor Elias Brountzos ofGreece, while blessed with dedicated nurses, tells us “wedon’t have dedicated technicians, and I believe this is aproblem in difficult and complicated cases.”

There is debate as to whether legislation is the answer tothis problem. Dr. Tomasz Jargiello says that in Poland,despite there being no specific regulations on the sub-ject, every department has staff members responsible forsupplies. In his opinion, legislation is not needed, as it isan issue for local hospital administration. Indeed, it doesjust seem common sense that all departments should be

given the resources they need, but unfortunately, not allhospital directors think the same way. As Professor Bil-bao puts it, “our work is fully dependent on the sensibilityof our chiefs and directors.”

Professor Michael J. Lee of Beaumont Hospital, Dublinhas another suggestion for circumnavigating the lack oflegislation, and points out that these issues could bedeemed to fall under the category of risk management.Indeed, the issue at hand is one of basic patient safety.Having irregular staff and fluctuations in availability ofmedical supplies is not simply inconvenient for the inter-ventionist (although, understandably, it is); it also in-creases the risk of mistakes being made. Lack ofequipment can mean certain conditions cannot betreated, and staff unfamiliar with the equipment increasesthe likelihood of errors. And errors in a medical settingcan have more serious consequences than mere incon-venience.

As such, many interventionists feel that legislation isneeded to make sure that these errors are avoided. It isthe general opinion of interventional experts in Europethat having an international charter on interventional radi-ology would be beneficial, and some are already takingsteps towards drawing one up. Should such a documentbe published, it seems certain that allocation of re-sources and staff will be a priority issue. Department di-rectors and hospital managers need to be aware of thesupport needed by interventionists if they are to ensurestate-of-the-art care for the patient, particularly the sup-port provided by skilled and dedicated staff. A chain, afterall, is only as strong as its weakest link.

"Dedicated personnel are not always available ...a major reason for failure, complications, redoing and postponing the intervention"

* please note, the hard work carried out by supporting staff is not brought into question, rather the difficult working situation they and their colleagues are faced with.

The issue at hand is one of basic patient safety

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28

New Horizons


Mother Nature Knows BestThe natural world often has ingenious solutions tosolve the most complicated of problems, and scien-tists can harness this for our use.

The snake has always been an object of fear formankind, and rightly so: prey has very little defenceagainst the venom or constrictions of a hungry snake. Itsvenom is either haemotoxic (attacking circulatory andmuscle tissue, causing scarring, gangrene and loss ofmotor skills), neurotoxic (attacking the central nervoussystem and resulting in heart failure or breathing difficul-ties), or a combination of the two.

This use of chemicals to manipulate biological responsesis central to medicine, and scientists have already foundways to isolate and use the venom elements that can, forexample, prevent blood clotting or destroy blood vessels(feeding tumours). When these elements are isolated asa treatment, they can have better results than completelysynthetic compounds, as natural toxins have evolved totarget very specific cell types, which avoids many of theside effects caused by their synthetic counterparts (suchas chemotherapy drugs).

So far, the venom compounds have been used for re-search into treatment for cancer, Alzheimer's and Parkin-son's diseases, blood clots in strokes and thinning theblood. For interventional radiology, the work into drugs toregulate cardiovascular disorders is of particular signifi-cance. Anti-platelet and anti-coagulant drugs (to thin theblood and prevent clots) can help patients who are at riskof restenosis following angioplasty. The most commonlyprescribed are aspirin and warfarin.

A study on Exanta, an anti-coagulant drug derived fromcobra venom, has been presented as a more effective al-ternative to warfarin. Warfarin is hard to monitor, as it actsdifferently in different patients, and can be influenced byminor dietary changes. Patients taking this substancemust have their blood checked every month to ensurethat their blood is not becoming too thin, which cancause internal bleeding or haemorrhage following an ac-cident. Exanta, on the other hand, seems to be more sta-ble and, after the initial routine blood tests, patientswould be spared the need for frequent check-ups. Thedrug has been submitted to the FDA for approval.

The potential of using natural venoms to reduce the riskof restenosis further is very exciting, and may make an-gioplasty an even more effective technique that is suit-able for a wider range of patients. Whether thesevenom-based drugs could be used as post-operativecontrol tablets or even incorporated into drug-elutingstents remains to be seen, but initial results are certainlyvery encouraging, and are a step on the ladder to win-ning the game.

Snake venom compoundshave been used for researchinto treatment for cancer,Alzheimer's and Parkin-son's diseases, blood clots in strokes and thinning the blood

http://news.nationalgeographic.comwww.annieappleseedproject.org

Featured Trial


The five year results from the first ACST trial (comparingimmediate CEA with deferred endarterectomy in patientson best medical therapy) were published in the Lancet in2004. In asymptomatic patients ≤75 years of age with a≥70% stenosis (many of whom were on aspirin, antihy-pertensive, and, in recent years, statin therapy), immedi-ate endarterectomy halved the net 5-year stroke risk fromabout 12% to about 6% (including the 3% perioperativehazard). Half of this 5-year benefit involved disabling orfatal strokes.

Since publication of these data, the (traditionally conser-vative) Northern European countries have increased theirrates of carotid intervention in younger asymptomatic pa-tients. Audit of UK carotid interventions shows an in-crease in CEA for asymptomatic patients (8% in 2002,16% 2006-8 and around 20-25% currently).

ACST-2 (Asymptomatic Carotid Surgery Trial)

ACST-2, a large simple international randomised con-trolled trial, is comparing carotid stenting (CAS) andcarotid endarterectomy (CEA) in patients having in-tervention for asymptomatic carotid stenosis. Inde-pendently funded (£1.8m, UK NIHR & BUPAFoundation), the recruitment target is 5,000 patients.

Stroke is associated with a very impaired quality oflife and high mortality. Patients consider majorstroke a worse fate than many cancers. On a scale of0 (death) to 1 (perfect health), major stroke scores aquality of life weighting of around 0.36 (0.2-0.7) com-pared to 0.6-0.7 for many cancers. We plan to evalu-ate the effect of CAS and CEA on patients’ quality oflife. This will involve procedural and stroke relatedhealthcare costs and EuroQol-based quality of lifeassessments in a subset of patients.

The influence of ACST on the medical community

Current status of ACST-2Randomisation in ACST-2 began in 2008. The randomi-sation process is simple (a 2-minute phone call to thecentre [open 24/7]), with one post-procedure clinical fol-low-up. The trial design ensures that collaborator work isminimised. Patients from centres in nine countries havealready been entered and there is worldwide interest;over 180 interventionist from 96 centres have submittedtrack record forms and have joined or are doing so. Carotid interventionists regardless of specialty, workingwith stroke physicians/neurologists are invited to partici-pate in ACST-2.

Please see overleaf for a selectionof other relevant trials and registries…

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Report kindly submitted by Prof. Alison Halliday and Dr. Sumaira Macdonald.

Professor Alison Halliday MS FRCSConsultant Vascular SurgeonSt George’s University of London, UKPrinciple Investigator, ACST

Dr. Sumaira Macdonald MBChB (Comm.), FRCP, FRCR, PhDConsultant Vascular Radiologist & Honorary ClinicalSenior LecturerFreeman Hospital, Newcastle, UKSteering & Technical Management Committees ACST-2

www.asct.org.uk


ICSS (International Carotid Stenting Study)

Contact personProf. Martin M. Brown, UCL Institute of Neurology, UKDate opened2005Status of trialRecruiting finished, data to followSourcewww.cavatas.com

DescriptionA follow-on study to the Carotid and Vertebral ArteryTransluminal Angioplasty Study (CAVATAS), ICSS is aninternational, multicentre, randomised, controlled, open,prospective clinical trial evaluating primary stenting ofcarotid artery stenosis in patients with symptomatic dis-ease in comparison to endarterectomy.

CORAL Study Cardiovascular Outcomes in RenalAtherosclerotic Lesions

Contact personDr. Lance D. DworkinDate opened2005Status of trialRecruiting finished, data to followSourcewww.coralclinicaltrial.org

DescriptionThe purpose of the CORAL study is to determine thebest treatment for patients who have high blood pressureand blockage of the renal artery that supplies blood tothe kidney. As a patient in the study there are 2 coursesof treatment. One group will receive blood pressure med-ication only. The second group will receive blood pres-sure medication plus a surgically placed stent, which isused to open the blockage.

CREST (Carotid Revascularization Endarterectomy vs. Stenting Trial)

Contact personDr. Thomas G. Brott, Mayo Clinic and University of Medi-cine and Dentistry, New Jersey, USDate openedFebruary, 2000Status of trialRecruiting finished, data to followSourcewww.umdnj.edu/crestweb

DescriptionThe purpose of this trial is to compare stent-assisted carotidangioplasty (CAS) with carotid endarterectomy (CEA) forthe treatment of carotid artery stenosis to prevent recurrentstrokes in those patients who have had a TIA (transient is-chemic attack) or a mild stroke within the past 6 months(symptomatic) and in those patients who have not had anysymptoms within the past 6 months (asymptomatic).

ASTRAL (Angioplasty and STent for Renal Artery Lesions)

Contact personDr. Jan HardingDate openedApril, 2007Status of trialRecruiting finished, data to followSourcewww.astral.bham.ac.uk

DescriptionASTRAL is designed to address the issue of whetherrenal arterial revascularisation with balloon angioplastyand/or endovascular stenting can safely prevent progres-sive renal failure amongst a wide range of patients withARVD.

Trans-Catheter Arterial Embolization and Surgery inPatients with Peptic Ulcer Bleeding Uncontrolled byEndoscopic Therapy (TAE)

Contact personDr. James Y.W. Law, Kim W.L. Au, Hong Kong UniversityDate openedOctober, 2008Status of trialRecruitingSourcewww.clinicaltrials.gov

DescriptionThe aim of the study is to examine the hypothesis thattrans-catheter arterial embolisation (TAE) is safer thanand probably as effective as surgery in the control ofbleeding from ulcers after failed endoscopic therapy.

Trials and RegistriesTrial: a study carried out with the purpose of testinga new medical treatment on a defined group of peo-ple. The results are compared with a group that aretreated using another method and/or a control group.

Registry: a (retrospective) collection of data about acertain treatment/illness. Using the compiled data,conclusions can be drawn about effectiveness of aparticular treatment method.

Angioplasty

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www.clinicaltrials.govwww.who.int/trialsearch/default.aspxhttp://clinicaltrials.mayo.edu

Trials & Registries


Angio-Seal Vascular Closure Device Registry

Contact personProf. Jim A. Reekers, CIRSEDate openedJanuary, 2009Status of registryRecruiting finished, data to followSourcewww.e-dendrite.com/databases.php

DescriptionClosure devices have enabled the benefits of earlysheath removal and mobilisation resulting in early patientdischarge. In some cases, a reduction in complications atthe access site has also been reported. However, there isstill limited data regarding the use of closure devices afternon-coronary procedures. This registry has been initiatedas a new research initiative to determine the experienceof the device in interventional radiology patients. The reg-istry has been designed to collect data from up to 100sites by members of CIRSE and intends to recruit 1,000patients. The data collected will include deployment suc-cess, time to haemostasis, time to mobilisation and timeto discharge. A record of all in-hospital access site com-plications will also be made. Also, patients returning withlate closure device problems can be included in this reg-istry.

A Safety and Efficacy Study for Treatment of Painful Ver-tebral Compression Fractures Caused by Osteoporosis

Contact personDr. Maarten Persenaire, Chief Medical Officer, Orthovita, USDate openedFebruary, 2006Status of trialRecruiting finished, data to followSourcewww.clinicaltrials.gov

DescriptionTo describe the methods for the clinical evaluation of Cor-toss for vertebroplasty in patients with painful osteoporoticcompression fractures.

Restoration of Disc Height Reduces Chronic LowBack Pain

Contact personDr. Joseph V. Pergolizzi Jr., NEMA Research, Inc., USDate openedJanuary, 2009Status of trialCompletedSourcewww.clinicaltrials.gov

DescriptionThe investigators hypothesised that a 6-week treatment ofnon-invasive spinal decompression reduces discogeniclow back pain (LBP), increases lumbar disk height, andthat an increase in lumbar disc height is associated withdecreased LBP.

Pain Quantification and Pain Management in Interven-tional Radiology

Contact personDr. Ravi Murthy, Associate Professor, U.T.M.D. AndersonCancer Center, USDate openedJuly, 2007Status of trialRecruiting finished, data to followSourcewww.clinicaltrials.gov

DescriptionThis trial aims to measure and record patients' pain levelsbefore, during, and after standard procedures performedin IR. Different procedures will also be compared in termsof respective pain levels and patient satisfaction (as deter-mined by questionnaire).

EmbolisationPilot Study of MRI-Guided High Intensity Focused Ul-trasound Ablation of Uterine Fibroids

Contact personSarah BaxterDate openedFebruary, 2009Status of trialRecruitingSourcewww.clinicaltrials.gov

DescriptionTo study the use of magnetic resonance imaging (MRI) inenhancing the safety of the FDA approved technique totreat fibroids called High Intensity Focused Ultrasound(HIFU). In this pilot study, women with symptomatic fibroidswill undergo MRI guided HIFU and then have a hysterec-tomy. This will allow us to confirm studies done in animalswhich show that it is possible to destroy specific tissue with-out harming normal tissue surrounding the targeted area.

For more trials and registries, please visit www.intervention-iq.org. Please note that this does notconstitute an exhaustive overview of trials and registries.If you are aware of a trial or registry which may be of in-terest to our readers, please feel free to contact us [email protected].

IQ takes no responsibility for the content of the individualtrials and registries; please refer to their Source for fur-ther information.

Vertebroplasty/Back/PainManagement


It’s amazing where accidents can lead. While manyadvances are the work of knowledge, inspiration andhard graft, countless others are just happy coinci-dences. Examples include such revolutionary inno-vations as penicillin, the microwave, Viagra, and themighty, monumentally important potato chip.

Another such happy accident was the original inspirationbehind interventional radiology. In November 1963, Dr.Charles Dotter was performing an everyday abdominalaortogram in a patient with renal artery stenosis. Whilepassing a percutaneously introduced catheter retro-gradely through the occlusion, he accidentally re-canalised an occluded right iliac artery. This led him torealise that, similar to plumbers using augers and drainrods to unblock pipes, catheters could be used to removeor dislodge blockages in the blood vessels. These theo-ries were reported at the Czechoslovak RadiologicalCongress in June that year.

However, this was still all very theoretical - surgery wasan effective discipline, and what did radiologists knowabout fixing patients? Finding someone to try this out onwas going to prove difficult.

As luck would once again have it, the Oregon Health Sci-ences University soon admitted just such a candidate.82-year-old Laura Shaw presented with a painful left foot,which was found to be due to a non-healing ulcer andgangrenous toes. All doctors she had consulted recom-mended that the foot be amputated, but the strong-willedlady refused. Her surgeon, Dr. William Krippaehne, had agood working relationship with Dotter, and figured if shewas refusing surgery, Dotter might as well have a look ather. The reason for the injury was established to be anideal lesion on which to perform this new therapy, andshe agreed to try it. Within minutes of the procedure, herfoot was warm, blood flowed easily, her pain disappearedwithin a week, and the ulcer soon healed. She died 3years later of an unrelated heart complaint, with both feetstill intact.

The Early Days of IR

Surprisingly (given the positive outcome), many sur-geons were not best pleased. Perhaps they genuinely feltthat such experimental therapy was irresponsible andagainst the best interests of the patients, or perhaps theyfelt their specialty to be threatened - we can’t be sure. Butthe relationship between the early interventionists andtheir surgical colleagues was certainly strained.

One surgeon, when sending a patient to have a left su-perficial femoral artery imaged, even wrote “visualize, butdo not try to fix!!!” on the case notes. Dotter did what wasasked, but with one slight difference: the diagnostic an-giogram revealed that there were not one, but two occlu-sions in the leg - the deep femoral artery also showedsigns of stenosis.

So Dotter fixed the one not mentioned in the case notes.He later took great delight in highlighting the fact thatwhile the open superior femoral arterioplasty (surgical)procedure failed, his dilated stenosis remained open for 5years.

Despite his interventional procedure having, in this caseand in many others, a better outcome than surgically-treated occlusion, many still felt disinclined to considerthese procedures as a valid treatment. Some even at-tempted to have his medical licence revoked. In trying toget the results of his work published, he met with diffi-culty - the surgical journals were not interested in thisnew quackery, and the radiology journals (diagnostic asthey were) did not understand his papers. In the end, thefirst clinical results of angioplasty were published in, of allplaces, a gynaecology magazine. Funny how things go.

· Youngest person ever to chair a radi-ology department in a major Ameri-can medical school (Department ofDiagnostic Radiology at OregonHealth Sciences University) - 1952-1985

· Goal: use of catheters for diagnosisand treatment in an attempt to re-place the scalpel

· Gold medals from the American Col-lege of Radiology, the RadiologicalSociety of North America, theChicago Medical Society and theChicago Radiological Society

· In 1978, nominated for Nobel Prize inMedicine

· Interventional Institute opened in hishonour at Oregon Health & ScienceUniversity in 1990

Charles Dotter 1920 - 1985“the Father of Interventional Radiology”

“Do not fix” case notes, from 1964Images reproduced by kind permission of the Dotter Inter-ventional Institute, Oregon Health and Science University

www.sirweb.orgwww.cirse.orgwww.pubmedcentral.nih.gov

IQWhat's in store

Interventional oncology is working alongside themore traditional treatment fields of medical on-cology, surgical oncology and radiation oncologyto treat this highly-prevalent disease.Interventional breakthroughs have been made inmany types of cancer, with the most commonlytreated being lung, liver and prostate cancer.Interventional oncology techniques can be usedto target the tumour directly, to relieve pain or todiagnose cancer without the need for more inva-sive surgical biopsy. Interventional oncology hasbecome well established in the following areas:

- Chemoembolisation- Tumour ablation- Relief of obstructions- Tumour biopsy

Taking a closer look at the increasing role interventional oncology is playing in the fightagainst cancer

Also featured:

- MRI Developments: implications for IR

- E-learning CME: the next step for Europe

- Clinical Practice: a new direction for IRs

- Recruiting IRs: how much is known about the profession?

If you are interested in contributing to IQ, please contact [email protected]

Coming up in Issue 1, March 2010

... Quarterly Focus

O c t o b e r 2 0 0 9

I S S U E 1 - March 2010

IQI n t e r v e n t i o nI n t e r v e n t i o n a l Q u a r t e r


Y o u r p o r t a l t o m o d e r n m e d i c i n e

E-learning CME:

the next step for Europe

MRI Developments:

implications for IR

Clinical Practice:

a new direction for IRs

Recruiting IRs:

how much is known

about IR?

The Oncology Team

Too Soon to

Talk of a Cure?

Interventional

Oncology

Interventional Oncology

Documents

Interventional Quarter ISSUE 0 - December 2009 IQ€¦ · ISSUE 0 - December 2009 IR Becomes Ofﬁcial UEMS Division Non-Dedicated Staff: may cause serious side-effects The Early