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Also in this issue

Pulmonary Medicine: Extracorporeal membrane oxygenation

Reducing risks in mechanical ventilation

Optimising shock wave lithotripsy outcomes

Self-treatment for women after pelvic radiotherapy

8

ThE MAgAzinE fOR hEAlThcARE dEciSiOn MAkERS

compact colour ultrasound system

Page 32

intraoperative radiotherapy system

Page 34

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Equipment & solutionsVolume 34 Issue 7

IHE December 2009 / January 2010

Women’s health special

Screening Mammography guidelinesBreast Self Examination – not yet a dinosaur

Celebrating

1975 2010

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A glimpse of the future of cancer medicine

editor’s letter 3

It seems like only yesterday but actu-ally it is now nearly 10 years since the ground-breaking feat of the first sequence of the

human genome was announced, amid hype and (perhaps exagger-ated) optimism. The hope then was that the knowledge of the sequence of the human genome would not only give a deeper understanding of basic biology, but that this could be leveraged into improved under-standing of the many pathologies affecting humans and thus allow a concomitant improvement in their prevention and/or treatment. Although genomics is of course only one aspect of the complex bio-logical systems that make up living organisms, it was felt ten years ago that the central role of genes meant that a knowledge of their sequence (or even existence) would be of huge help in reaching the holy grail of medicine, namely personalised pre-vention or treatment, on the basis of the patient’s genomic character-istics, of the killer diseases such as cancer. Although there have been some successes in the development of anti-cancer drugs based on a deeper understanding of the under-lying biological processes (e.g. ther-apeutic monoclonals for HER2/neu breast cancers and small molecule inhibitors for BCRI/ABL chronic myeloid leukaemia and for EGFR mutations in lung cancer) the out-standing challenges are huge. Cur-rently deaths from cancer are nearly 8 million per year worldwide and, worse, the incidence is increasing dramatically. It is against this som-bre background that the recent news of the first comprehensive analysis of cancer genomes (Pleasance et al, Nature 2009 Dec 16th) is par-ticularly important. Using advanced sequencing techniques teams from the Wellcome Trust Sanger insti-tute have identified all of the muta-tions in two cancers (small cell lung cancer and melanoma). All cancers carry somatic mutations, of which the subset of the so-called driver mutations in cancer genes actu-ally cause the cancer to develop. In

addition to the drivers, there are also “passenger” mutations, which do not actually contribute to the neoplasm but can serve as a molecular record of each cancer’s evolutionary past, reflecting mutagenic exposures and eventual defects of DNA repair. In the melanoma cancer, a total of more than 30000 passenger and driver mutations were found, whereas in lung cancer nearly 23000 mutations

were identified, (corresponding on average to approximately one mutation per 15 cigarettes smoked!). Study of these mutations showed that many occurred long before the tumour actually became apparent and also showed how the cells have attempted (frequently unsuccess-fully) to repair the damage. The hope is that this information will now allow the development of new drugs

targetting the specific mutated genes and which patients would benefit from such treatment. Already the Wellcome team are working to corre-late the genetic changes with response to cancer treatments. The road ahead is still long, but at least it seems to be in the right direction.


– Issue N°7 – Dec. 2009/Jan 2010

ContentsFRONT COVER PRODUCTS[18] self-treatment for

women after pelvic radiotherapy

[32] Compact colour ultrasound system

[34] intraoperative radiotherapy system

FEATURES[6 - 8] Next-generation drug eluting stents

[10 - 15] PUlmONARy mEDICINE

[10 - 12] long-term follow up of Ards patients after extracorporeal membrane oxygenation

[14 - 15] Risk reduction in mechanical ventilation

[16 - 23] WOmEN’S hEAlTh SPECIAl

[16 - 18] Breast cancer screening with breast self-examination: not yet a dinosaur

[19 - 20] Changing the guidelines on mammography screening

[21 - 22] scientific literature review: Women’s health

[23] News in Brief – Women’s health

[24 - 26] UROlOgy optimising outcomes with modern

shockwave lithotripsy

REgUlARS[3] editor’s letter

[27] News in brief

[28 - 32] on show at Arab Health

[33 - 34] Product News

[34] Calendar of upcoming events

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6 CoroNAry Artery diseAse

Next-generation drug eluting stentslate stent thrombosis has emerged as a major concern in the use of drug-eluting stents (des), with studies showing that late des thrombosis delays arterial healing. to meet this challenge, the next generation of des are being developed to increase safety and biocompatibility by optimising the three major components of des, namely the stent platform, the polymer and the drug used.

by dr G. Nakazawa and dr r. Virmani

The Cypher drug-eluting stent (DES) contains polymer-based sirolimus on a stainless steel structure. These three components —the underlying scaffold structure, the polymer coating of the scaffold and the drug itself which is eluted form the polymer — are essential for the overall performance of a DES. Active R&D in all three compo-

nents seems set to result in new stents, with not only higher efficacy but an improved safety profile.

Polymer-based sirolimus and paclitaxel drug eluting stents (DES) have significantly reduced the rates of restenosis compared bare metal stents (BMS) and have quickly become the standard of care for coronary artery disease. However, late stent thrombosis (LST) has emerged as a major safety concern, especially in patients who receive “off-label use” such as bifurcation, long lesions (>30mm), saphenous vein bypass graft, use in the left main coronary artery, chronic total oc-clusion, renal failure and acute myocardial infarc-tion (AMI). Pathology studies of patients dying from late DES thrombosis show delayed arterial healing characterised by persistent fibrin deposi-tion and poor endothelialisation as the primary substrate [1]. Thus there is still lots of room to improve DES technology.

Findings at autopsy – currently used first generation DESIn 2006, we reported that, compared to BMS im-planted for a similar duration, there was delayed arterial healing in DES, as evidenced by the persis-tence of fibrin, incomplete re-endothelialisation, and sparse smooth muscle cell coverage [1]. Later, using the data from a larger number of autopsy cases, we showed that a lack of endothelial strut coverage was the single factor that best correlated with late stent thrombosis [2]. The arterial heal-ing in DES lesions was heterogeneous, especially in thrombosed cases, suggesting that the under-lying lesion morphologies also contribute to the rate of healing. For example, we have observed a significantly higher incidence of late stent throm-bosis in patients treated with DES for AMI com-pared to those treated for stable lesions [3]. In these AMI patients, heterogeneity of healing and delay of healing was observed at culprit sites in contrast to non-culprit sites.

However, it is not only factors concerning the underlying patient and the lesion that affect vas-cular healing — it is also the devices themselves. Hypersensitivity reaction is one of the compli-cations that has been reported following DES implantation [4]. Our observations revealed that this phenomenon is limited to the polymer-based sirolimus “Cypher” stent from Cordis Corp.,

Miami Lakes, FL, USA and does not affect the paclitaxel “Taxus” stent from Boston Scientific, Natick, MA, USA. Most hypersensitivity reactions are observed after one year or more. The problem is thus most probably related to the polymer rather than the drug, as the drug should be completely eluted by this time. The Cypher non-erodable polymer consists of polyethylene-co-vinyl acetate (PEVA) and poly n-butyl methacrylate (PBMA), and both have been associated with hypersen-sitivity reactions in humans and animals when used in non-vascular locations [5,6]. On the other hand, extensive fibrin deposition is observed with the Taxus stent, with or without stent malapposi-tion. It is unclear how the Taxus polymer SIBBS [poly(styrene-b-isobutylene-b-styrene)] con-tributes to these observations, since these reac-tions are drug dose-dependent; this reaction is probably related to the cytotoxicity of paclitaxel.

Components of Drug Eluting StentsDES consists of three major components: 1) the stent platform to scaffold the vessel; 2) the poly-mer to allow controlled release of the drug; and 3) the drug to inhibit neointimal growth.

The stent platformIn the first generation of DES (Taxus and Cypher), 316L stainless steel is used as the platform and the strut thickness ranges from 130 to 140μm. With 316L stainless steel, the radial strength is de-pendent upon the thickness of the stent’s struts. Newer stent designs use cobalt-chromium, which has greater radial strength, radiopacity, and thus allows thinner struts. In fact, the 2nd generation of DES (Endeavor with zotarolimus and Xience V with everolimus-eluting stents) are constructed from cobalt-chromium and have thin stent struts (80-90μm) that result in a decrease in neointimal response and more rapid re-endothelialisation. Preclinical data have demonstrated that stents with thinner struts have greater endothelialisa-tion compared to those with thicker struts [7]. The distance that endothelial cells have to migrate is less in stents with thinner struts than thicker struts, so it is not surprising that stents with thinner struts re-endothelialise faster.

PolymersIn First Generation DES, non-erodable poly-mers were used in both the Cypher and Taxus stents (Cypher: polyethylene-co-vinyl acetate (PEVA) and poly n-butyl methacrylate (PBMA) and Taxus: SIBBS [poly(styrene-b-isobutylene-b-styrene)]). However, as mentioned above, these polymers are likely to provoke an inflammatory reaction [4,8]. This may be the result of poor in-tegrity of the polymer on the underlying metal surface; uneven application, webbing of polymers or surface debris. Once the inflammation process is triggered, the reaction may persist for a long

– Issue N°7 – Dec. 2009/Jan. 2010

7

period because the polymers are non-erodable. For this reason, the use of biodegradable poly-mers for drug delivery is now being investigated. The earliest, and most commonly used, biode-gradable polymers are polyesters which include PLA (poly[lactide]), PGA (poly[glycolide]) and PLGA (poly[glycolic-co-lactic acid]). As de-scribed by Middleton [9] the properties of an ideal biodegradable polymer are: 1) it should not evoke an inflammatory/toxic re-

sponse, 2) it should be metabolised in the body after ful-

filling its purpose, 3) it should be easily processed into the final

product form, 4) it should have acceptable shelf life,5) it should be easily sterilisable. The speed of degradation of the polymer is con-trolled by many factors, such as hydrophilicity of the monomer, pH, number of reactive hydrolytic groups in the backbone, crystallinity, or polymer size [9]. The numbetr of these factors means that the development of biodegradable polymers for use in DES technology remains challenging. If the drug is eluted faster than the rate at which the polymer degrades it is possible that the resulting inflammation will nullify the advantages con-ferred by using biodegradable polymers. An op-timal elution and degradation profile should be aimed for to avoid such mismatches. Our experience shows that it is possible to achieve this balance, and it is thus probable that the ben-efits of biodegradable polymer can be obtained without any significant resultant inflammation. We believe that overall biodegradable polymers are likely to be safer than non-erodable polymers since, as the polymer degrades the inflamma-tion will eventually subside and the bare metal stent-surface will remain.

DrugsThe use of anti-proliferative agents such as si-rolimus and paclitaxel given locally at high con-centration has proved to be very successfully in reducing neointimal formation in animal models [10,11]. Following encouraging results in preclin-ical studies, clinical studies were conducted and it was found that, compared with BMS, there were dramatic reductions in restenosis rates. This has lead to the generalised use of DES in patients with coronary artery disease.

The methods of action of sirolimus and pacli-taxel have been extensively studied. Sirolimus binds to the FK-binding protein 12 (FKBP-12) and subsequently inhibits the mammalian target of rapamycin (mTOR), which prevents the deg-radation of p27kip1, a cyclin-dependent kinase inhibitor that plays an important role in regulat-ing vascular smooth muscle cell migration and proliferation [12]. Paclitaxel is a lipophilic diter-penoid, known to suppress smooth muscle and endothelial cell proliferation and migration by binding to the b-subunit of the tubulin heterodi-

mer, promoting tubulin polymerisation and cell cycle arrest [13]. It is not fully understood how both of the DES devices continue to function long-term after the drug is completely eluted. However, proliferation of smooth muscle cells following stent implanta-tion peaks early (seven days in a porcine coro-nary artery model [14]), so if DES can inhibit smooth muscle cell proliferation during this pe-riod, the DES may remain effective for a long time. However, there is some doubt that DES can be effective permanently, since clinical stud-ies using intravascular ultrasound have shown a slight increase in the target revascularisation rate [15] or neointimal volume over four years [16]. While both drugs reduce neointimal growth by disrupting smooth muscle cell proliferation, re-endothelialisation is also impaired [1]. However, it is not only the extent of endothelialisation that is important but also the structural integrity and anti-thrombotic function in late stent throm-bosis (LST). Recent clinical studies suggest that DES also impairs endothelial responses to ace-tylcholine and exercise-mediated vasodilation in humans [17,18]. Thus, both drugs lead to sup-pressed endothelial function as well as inhibition of endothelial cell proliferation and migration. It is likely that newer analogues of rapamycin, such as zotarolimus and everolimus used in 2nd generation DES (Endeavor and Xience V), have similar biological effects. However, the Xience V stent uses a lower concentration of everolimus than in 1st generation DES, and Endeavor has a higher dose of drug (zotarolimus) than other 1st and 2nd generation DES. It also has the fastest release kinetics among currently available DES, and therefore the concentration in the arterial wall tissue is likely to be less. Recent preclinical studies, which compared the various DES in a rabbit model, show better endothelialisation in 2nd generation DES compared to 1st generation DES [19]. Other drugs being tested in DES in-clude biolimus A9, tacrolimus, and pimecroli-mus. Biolimus A9 is another rapamycin analogue with high lipophilicity, but results in a suppres-sion of smooth muscle cells similar to siroli-mus and its other analogues. The biolimus A9 eluting stent has recently received the CE mark and has shown efficacy in both animals and humans [20-22]. Pimecrolimus and tacrolimus act through the Ca++/ calmodulin-dependent protein phosphatase calcineurin pathway [23]. Inhibition of calcineu-rin results in the suppression of transcription factors, such as the nuclear factor of activated T cells (NFAT). This causes the downregulation of several cytokine genes, including ILs, IFN-g and TNF-a, which leads to suppression of the inflam-matory response, but the ability of these drugs to suppress smooth muscle cell proliferation is questionable. In fact this class of drugs failed to show clinical efficacy, suggesting that calcineurin blockage may not be effective, at least in humans at the concentration used in DES [24,25].


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– Issue N°7 – Dec. 2009/Jan 2010

Next generation of DESIn addition to the improvements that have been made in 2nd generation DES, there are currently newer approaches being tested such as biodegrad-able polymers, polymer free drug delivery, the pro-healing approach, and fully biodegradable stents. These approaches are being vigorously pursued and will probably be available in the near future. Importantly, these technologies focus not only on the efficacy, but also on the safety aspects of the de-vice. The FDA guidelines recently stated that “for any given drug devices combination, the potential efficacy observed in animal studies should be bal-anced by any potential safety concerns” [26]. It is likely that the next generation of DES will be safer with better stent design, greater biocompatibility, and appropriate drug dose and release kinetics. References1. Joner M et al. J Am Coll Cardiol 2006;48:193-202.2. Finn AV et al. Circulation 2007;115:2435-41.3. Nakazawa G et al. Circulation 2008;118:1138-45.4. Virmani R et al. Circulation 2004;109:701-5.5. Ahmed DD, Sobczak SC, Yunginger JW. Immunol

Allergy Clin North Am 2003;23:205-19.6. Leggat PA, Kedjarune U. Int Dent J 2003;53:126-31.7. Joner M et al. J Am Coll Cardiol 2008;In press.8. Finn AV et al. Arterioscler Thromb Vasc Biol

2007;27:1500-10.9. Middleton JC, Tipton AJ. Biomaterials 2000;21:

2335-46.10. Gallo R et al. Circulation 1999;99:2164-70.11. Suzuki T et al. Circulation 2001;104:1188-93.12. Sun J et al. Circulation 2001;103:2967-72.13. Abal M, Andreu JM, Barasoain I. Curr Cancer Drug

Targets 2003;3:193-203.14. Carter AJ et al. J Am Coll Cardiol 1994;24:

1398-405.15. Morice MC et al. J Am Coll Cardiol 2007;50:1299-304.16. Aoki J et al. J Am Coll Cardiol 2005;46:1670-6.17. Hofma SH et al. Eur Heart J 2006;27:166-70.18. Togni M et al. J Am Coll Cardiol 2005;46:231-6.19. Joner M et al. J Am Coll Cardiol 2008;52:333-42.20. Ostojic M et al. Eurointervention 2008;3:574-579.21. Grube E, Buellesfeld L. Expert Rev Med Devices

2006;3:731-41.22. Grube E et al. Eurointervention 2005;1:53-57.23. Donners MM et al. Ann Med 2003;35:523-31.24. Onuma Y et al. Eur Heart J 2009;30:1477-85.25. Verheye S et al. JACC Cardiovasc Interv 2009;2:

205-14.26. Administration FaD. Guidance for Industry - Coro-

nary Drug-Eluting Stents, http://www.fda.gov/cdrh/ode/guidance/6255comp.pdf. 2008.

The authorsGaku Nakazawa, MD and Renu Virmani, MDCVPath Institute, Inc., Gaithersburg, Maryland, USACorrespondance:Renu Virmani, MDCVPath Institute, Inc., 19 Firstfield Road, Gaithersburg, MD 20878, USAe-mail: [email protected]

comments on this article?Feel free to post them at

www.ihe-online.com/comment/Des

8 CoroNAry Artery diseAse

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New computer model could lead to safer stents

MIT scientists have developed computer models to predict physiologically realistic drug delivery patterns from stents in branched arterial vessels. They simulated several arterial settings to show that drug distribution in these situations is determined by a complex calculation of the stent’s posi-tion relative to arterial branches and constant blood flow changes caused by the branching.Drug-eluting stents are now widely used all over the world to treat obstructive arterial disease, yet some patients with the stents have suffered life-threatening side effects: an increase risk of blood clotting and heart attacks. Several important questions remain unanswered — in particular, the mechanisms that govern drug delivery to specific lesion sites are poorly defined and pose chal-lenges for stent designers, physicians and regulatory agencies that must evaluate stents’ safety and efficacy.Predicting drug distribution is complicated by the branching of arteries into two or more vessels, which establishes alterations in flow, wall shear stress and geometries. All of those can be modelled and defined mathematically, however, the variations cannot be captured across the full spectrum of perturbations and combinations in animal systems or in the lab, let alone the human. Computa-tional models are therefore required.The computer model was generated by combining principles of digital image processing and para-metric computer-aided geometry design with computational fluid dynamics and mass transport. A video link showing how these geometry models are created can be found on the journal website. The authors believe this modelling technique can be extended to simulate several settings with various stent designs as well as complex arterial geometries with and without disease, altered flow environments and other boundary conditions.

Kolachalama V, Levine E, Edelman E. Luminal flow amplifies stent-based drug deposition in arterial bifurcations. PLoS ONE 2009; Dec. 2 issue.

– Issue N°7 – Dec. 2009/Jan. 2010

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ARDS is a life-threatening complication of vari-ous types of lung injury. It is defined as an acute-in onset condition characterized by arterial hy-poxaemia that is resistant to oxygen therapy alone; diffuse radiological infiltrates are seen in the ab-sence ARDS is the secondary manifestation of a large number of primary processes of pulmonary origin, such as pneumonia, contusion, aspiration, or of extrapulmonary origin such as sepsis [1]. Treatment of ARDS requires aggressive support-ive care that include positive pressure ventilation and increased oxygen concentration, but such treatment risks barotrauma and oxygen toxic-ity, which can further aggravate the lung injury. There are a number of adjuvant treatment strat-egies, such as protective ventilator techniques, ventilation in prone position, permissive hyper-carbia, nitric oxide and use of ECMO that may reduce ventilator-induced lung injury and mor-tality. ECMO involves gas exchange through an extracorporeal oxygenator, and provides

oxygenation and carbon dioxide removal without interfering with the lungs. This enables less aggres-sive ventilation during recovery of the lungs, which may avoid ventilator-associated damage and thus protect the lungs [2].

ECMO: past and presentExtracorporeal circulation procedures were first used in humans in 1953 when an atrial septum defect was successfully repaired on cardiopulmonary bypass; this opened up a new method for open heart surgery. Twenty years later, the first successful use of long term extracorporeal pulmonary support was re-ported, followed by many others, notably from Professor R Bartlett’s group in Ann Arbor, Michigan, USA [3]. Today, ECMO is a well ac-cepted therapy for acute, severe, reversible pulmonary insufficiency in neonates e.g., as a result of meconium aspiration. In paediatric and adult patients the fields of application are

pneumonia, aspiration and near drowning. During recent months a number of patients in Stockholm, Sweden with life-threatening influenza N1H1 pneumonia have also been successfully treated with ECMO.

Although mortality in ARDS is still high, there is an increasing number of patients who have survived the condition. There is therefore a growing need to understand the long-term ef-fects of ARDS and its treatment by ECMO. The ECMO procedure is advanced, invasive and ex-pensive; follow-up studies in patients after se-vere ARDS and ECMO are few in number, and little is known of residual changes and symp-toms that may occur a long time after the ECMO treatment itself [5]].

long-term follow-up of Ards patients after extracorporeal Membrane oxygenation (eCMo) treatment

treatment using extracorporeal membrane oxygenation (eCMo) can result in a high rate of survival in patients with severe acute respiratory distress syndrome (Ards). Both the eCMo technique and its cost are controversial. it is therefore important to evaluate the long-term results of eCMo treatment of severe Ards, particularly in relation to pulmonary morphology, function and Quality of life (Qol). However are only a few such follow-up studies have been published. this article describes the long-term follow-up of Ards patients treated with eCMo in the specialised eCMo unit at Karolinska Hospital, stockholm

by dr V. lindén

10 PUlMoNAry MediCiNe

Figure 1. Chest X-ray of an adult patient with ARDS and ”white lungs” on ECMO. White arrows =

ECMO cannulas in v cava sup- right atrium and arcus aortae.

– Issue N°7 – Dec. 2009/Jan. 2010

A long term study of post-ECMO, post-ARDS patientsDuring a five year period, 37 adults with severe ARDS were treated by ECMO at the ECMO department, Karolinska University Hospital, Stockholm, Sweden [4]. All patients had had good pulmonary function pre-ARDS.

Standard ECMO procedures were carried out in all patients. The ven-tilator settings were reduced within three hours of starting ECMO in order to prevent further ventilator-associated lung injury, and these lower settings were maintained dur-ing lung recovery until the end of ECMO. The patients remained on “gentle” conventional ventilation until they breathed spontaneously.

Twenty-six patients (70%) survived to discharge and, of these, 21 pa-tients agreed to participate in the long-term study. Mean time from discharge to the follow-up study was 26 months. The pulmonary follow-up evaluation consisted of a physical examination, computed tomography (HRCT), extensive pulmonary func-tion tests including scintigraphy and QoL, and assessment of impaired health due to respiratory disease.

Results and discussionFollow-up studies of patients who have been treated for ARDS by con-ventional means have shown that many have residual morphological lung injury such as chronic pulmo-nary fibrosis, reduced pulmonary function and diminished Health Related Quality of Life (HRQoL) after 12 months. Severe disease and prolonged mechanical ventilation are high risk factors for persistent abnormalities. Patients who require ECMO probably have a more se-vere ARDS, which theoretically may result in more serious long-term respiratory sequelae. However, the gentle ventilation strategy that is currently enabled by ECMO may in fact help minimise ventilator-induced lung injury and shorten the recovery phase.

Lung parenchymal abnormalitiesHigh resolution CT (HRCT) showed some degree of reticular pattern and ground-glass opacity, presumed to

represent fibrosis, in a majority of our patients. However, the extent of morphological abnormalities was limited, and the predominance of anterior parenchymal pathology previously described in convention-ally treated ARDS patients was not observed. One reason for this might be that ECMO treatment, with gen-tle ventilation, protects the lungs from ventilator-associated dam-age. The extent of HRCT changes suggestive of fibrosis was corre-lated with the duration of ECMO (p < 0.01).

Lung function testsPulmonary function tests per-formed in patients some time after ARDS point to a variable degree of persistent lung function impair-ment, including obstructive and/or restrictive ventilatory defects, bron-chial hyperreactivity and impaired oxygen transfer. In our patient study group we found that most lung function values had normal-ized, with mean values for all lung spirometry tests in the lower inter-val of normal. The most sensitive test in our study for residual impair-

ment of pulmonary function was radiospirometry. All patients had prolonged wash out durations, which were 50% longer compared with healthy individuals (p<0.05), consistent with subclinical obstruc-tion. Radiospirometry reflects the trapping of air in the peripheral airways, which is thought to be one of the most important reasons for permanent and unspecific pulmonary symptoms after ARDS.

Exercise tests have rarely been used in follow-up studies of ARDS

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11 – Issue N°7 – Dec. 2009/Jan 2010

patients. Our study demonstrated test values in the lower normal interval for two-thirds of the patients. The exercise tests were interrupted due to leg fatigue (75% of patients) and dyspnea. After a long period of time ECMO was signifi-cantly associated with more extensive CT changes, restrictive pulmonary function and impaired lung diffusion (p<0.05). This might be explained by a more severe underlying disease in patients requiring longer periods of ECMO.

Reduced HRQoLSeveral investigations have measured the overall Health-Related QoL (HRQoL) in patients a long time after conventional treatment for ARDS; HRQoL is an im-portant secondary outcome for both physical and mental health. All studies showed that there was some residual im-pairment in QoL due to breathing prob-lems. Pulmonary symptoms as measured by the St George’s Respiratory Questionnaire (SGRQ) are included in only a few follow-up studies. The SGRQ questionnaire measures QoL and impairment of health in airway disease, di-vided into three domains - symptoms, restricted activity and impact on daily life.

Our post-ARDS and post-ECMO patients had mean scores in the SGRQ which were higher than normal values in all domains, indicat-ing subjective respiratory problems with an impact on daily life. The problems were most often described as ‘shortness of breath’ even during light exercise. However, our patients had an overall tendency to score lower than conventionally treated ARDS patients. The older patients had significantly higher SGRQ scores overall (p<0.05), which might reflect the more difficult recovery from severe injuries in elderly patients. None of our patients was in need of extra oxygen, and they all re-turned home after discharge from hospi-tal. The majority (76%) returned to their former occupations after ECMO-treated ARDS. These findings are important from a socioeco-nomic point of view, all the more so since two earlier studies found that the majority of long-time survivors of ARDS and ECMO therapy were in good physical condition and were active both socially and professionally .

Our recommendation is that, in adult sur-vivors of ECMO-treated ARDS, a follow-up programme be carried out 12 months after discharge from hospital. The follow-up should include HRCT of the lungs, exercise tests, diffu-sion capacity tests, radiospirometry and SGRQ. There are only around 30 adult survivors of ARDS and ECMO reported annually to the worldwide Extracorporeal Life support Organi-zation (ELSO); future collaboration between all

ECMO centres in follow-up studies after ARDS is most desirable. In conclusion, lung parenchymal changes on HRCT suggestive of fibrosis and minor pulmo-nary function abnormalities remain common and can be detected more than one year after ECMO-treated severe ARDS. Furthermore, these patients experience a reduction in HRQoL due to the pulmonary sequelae. However such impairments are usually mild and the majority of adult ARDS and ECMO survi-vors are in good physical condition and are active socially and professionally.

References1. Ware L, Matthay M. The acute respiratory distress

syndrome. Review article. N Engl J Med 2000; 342: 1334–49.

2. Lindén V et al. High survival in adult patients with ARDS treated by extracorporeal membrane oxy-genation, minimal sedation and pressure support ventilation. Intensive Care Med 2000; 26: 1630–7.

3. Bartlett R et al. Extracorporeal life support. The University of Michigan experience. J Am Med Assoc 2000; 283: 904–8.

4. Lindén VB et al. Extracorporeal membrane oxy-genation in ARDS: a long-term follow-up study regarding pulmonary function and health-related quality of life. Acta Anaesthesiol Scand 2008; 53: 489–495.

5. Schelling G et al. Pulmonary function and heal-threlated quality of life in a sample of long-term survivors of the acute respiratory distress syndrome. Int Care Med 2000; 26: 1304–11.

The authorViveka Lindén, MD, Assoc ProfessorPediatric Intensive Care UnitAstrid Lindgren Children`s HospitalKarolinska University Hospital,Stockholm, [email protected]


International Fair of Products, Equipment, Services and Technology for Hospitals, Laboratories, Pharmacies, Health Clinics and Medical Offices

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– Issue N°7 – Dec. 2009/Jan. 2010

Figure 2. A patient with ARDS and the ECMO equipment shown with a white/red arrow (oxygenator, pump, heat-

exchanger and tubings), CRRT (continous renal replacement therapy) shown with a white/black arrow and ventilator

(white/green arrow). The patient survived and is included in the ARDS and ECMO follow-up study.

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Approximately one fourth to one half of criti-cally ill patients require mechanical ventilation. Although lifesaving, mechanical ventilation can present a variety of significant risks including those related to airway management practices, development of ventilator associated pneumonia and complications from sedation.

Airway management practicesMechanically ventilated patients require fre-quent suctioning to keep the endotracheal tube (ETT) clear, but suctioning can predispose to hypoxaemia. Guidelines for the prevention of hypoxaemia during ETT include hyperoxy-genation using 100% oxygen, either through a manual resuscitation bag (MRB) or the ventila-tor [1]. Hyperinflation to greater than the venti-lated volume has been shown to be detrimental and is recommended only when really needed [2]. In the United States, the majority (60%-80%) of endotracheal tube (ETT) suctioning occurs using closed suctioning systems (i.e. us-ing an in-line suction catheter) [3]; worldwide, open suctioning systems (i.e, using an MRB) to provide hyperoxygenation are still common [4]. However MRB FiO

2 (the proportion of inspired

oxygen in a gas mixture) delivery varies widely (0.24 to 0.97) [5]. MRB oxygen delivery to the patient is directly related to oxygen flow to the MRB, which should always be set at a minimum of 15L/min [6].

Although closed suctioning systems protect healthcare providers from potentially contami-nated secretions and have not been shown to in-crease pulmonary infection rates, their use may result in a buildup of secretions with the ETT in-creasing over time, a narrowing of the tube lumen and increases in the patient’s effort in breathing [7]. In addition, suctioning may cause trauma to the airway, therefore use of the lowest possible continuous pressure is also recommended. ETT suctioning is a necessary intervention for the mechanically ventilated patient and although it presents significant risks, these can be reduced through the use of a proper technique.

Ventilator Associated Pneumonia (VAP)Pneumonia occurs in 25% of ventilated pa-tients, and is responsible for 90% of nosocomial

infections in this patient population, greatly adding to ICU and hospital length of stay and mortality [8].

Backrest elevation of 300 to 450 has been shown to reduce aspiration and ventilator-associated pneumonia (VAP). Aspiration occurs frequently and can even occur around an inflated endotra-cheal tube cuff [9]. ICU mortality rate, pneu-monia rate and aspiration risk are all greater for supine patients than for semirecumbent patients. Supine head positioning during the first 24 hours of mechanical ventilation was one of four VAP risk factors (which also included organ system failure, age greater than 60 years, and prior antibiotic use).

A longitudinal study to describe the relation-ship between backrest elevation and develop-ment of VAP showed that subjects spent the majority of the time at backrest elevations of less than 30º, but that the combination of early, low backrest elevation and greater severity of illness increased the incidence of VAP. Unfor-tunately, use of low backrest positions is com-mon, despite there often being no clear indi-cation for that position [10, 11]. Compliance with backrest elevation for VAP reduction is a national health care focus. Presently the United States National Quality Forum (NQF)recom-mends the use of a “ventilator bundle”, a group of interventions to reduce VAP, which includes backrest elevation of 30 to 450 [12]. Qual-ity improvement projects have illustrated that implementation of higher backrest positions, often in combination with other VAP preven-tion strategies (ventilator bundle), reduce the incidence of VAP.

Colonisation of the oropharynx with potential VAP pathogens is another risk factor for VAP [13]. The majority of organisms that are asso-ciated with VAP have been found to colonise the oral pharynx of the critically ill patient prior to the VAP diagnosis, and they are prob-ably transferred from the oropharynx to the trachea during intubation [14]. After intuba-tion, the endotracheal tube provides a pathway for direct entry of bacteria from the orophar-ynx through the open glottis to the lower respiratory tract.

Oral care practices in the critically ill vary sig-nificantly, and although oral care protocols have been introduced widely in critical care settings, the evidence base for these protocols including care frequency, products and meth-ods of oral care remains limited [15]. Dental plaque increases over time in the critically ill, and appears to be worse at ICU admission in those subsequently infected with respiratory pathogens [16].

Compared to usual care, the use of chlorhexi-dine gluconate (CHX), a broad spectrum anti-bacterial agent, has been shown to reduce respi-ratory tract infection rates including VAP after elective cardiac surgery. Recent meta-analyses of CHX use in critically ill adults have been complicated by the variety of populations stud-ied, the different formulations and dosages of CHX used, and intervening variables. Because CHX is an inexpensive intervention with low potential for adverse effects (other than tem-porary tooth staining with long term use), it has gained wide acceptance despite conflicting evidence of its effectiveness in VAP reduction. Tooth-brushing is also a common oral care intervention, but two recent randomised con-trolled trials found no benefit in VAP reduc-tion from tooth-brushing alone or from the addition of tooth-brushing to CHX use.

Sedation and mechanical ventilation Mechanically ventilated patients require se-dation to help attenuate the anxiety, pain and agitation associated with this interven-tion, and although 85% of intensive care unit (ICU) patients receive sedation, risks associ-ated with sedation in this population are sig-nificant. The overall goals of sedation in the critical care setting are to provide physiologi-cal stability, ventilator synchrony and patient comfort. However, inappropriately high levels of sedation lead to alterations of respiratory drive, inability to maintain and protect the airway, and cardiovascular instability [17] as well as a prolonged duration of mechanical ventilation, and ventilator associated pneu-monia [18]. Conversely, inadequate levels of sedation may result in agitation, placing the intubated patient at risk for self-extubation, haemodynamic instability and physical harm or injury.

To improve patient outcomes, levels of seda-tion and agitation must be measured appro-priately. Although sedation - agitation tools are used to measure the effectiveness of se-dation in ICU patients, many have not been

risk reduction in mechanical ventilationMechanical ventilation, whilst lifesaving, can be a risky procedure. this article discusses how the risks associated with airway management, pneumonia and sedation in mechanically ventilation patients can be reduced.

by dr M. J. Grap and dr C. l. Munro

– Issue N°7 – Dec. 2009/Jan. 2010

15

well tested and do not provide a continuous measure of sedation or agitation. Continuous measures that are readily available, such as blood pressure or heart rate mesurement, may reflect patient status, e.g. higher BP or HR often accompanies increased activity or agitation, although these measures are non-specific.

In addition, continuous use of sedation is often associated with prolonged weaning processes, with 41% of mechanical ventilation time spent wean-ing patients [19]. The use of multidisciplinary weaning protocols has been shown to significantly reduce the duration of mechanical ventilation [20]. The key to successful weaning may be that a protocol is used, rather than specifically how it is constructed or what method of weaning is used [21]. Interestingly, independent clinical judgment or experience about readi-ness to wean is a relatively poor predictor of weaning success. Clinical as-sessments (respiratory pattern, cardiovascular response, comfort/anxiety, oxygenation) are better predictors of success rather than more complex weaning parameters. Daily spontaneous breathing trials (SBT) are supe-rior to gradual ventilator reduction strategies, and these should include an objective measurement of sedation. It is also clear that nurses and re-spiratory therapists can effectively achieve weaning goals based on the use of protocols. Importantly, implementation of weaning protocols requires a consistent team effort that may be difficult to sustain in the complex critical care environment.

Reducing risks of mechanical ventilation is an active area of research. Several modifications of ETT design have been proposed to reduce VAP risk, including tubes which enable continuous aspiration of subglottic secretions (CASS), tubes with silver (antimicrobial) coating, and “mucus shaver” tubes which reduce biofilm accumulation. In addition, continuous instillation of antibiotic into the subglottic space above the ETT cuff is be-ing investigated to reduce VAP. Newer technologies to continuously evalu-ate agitation are based on sensing patient motion using digital video im-age processing, and classify levels of motion that correlate with observed patient agitation [23]. Objective measures of sedation, such as processed electroencephalography signals, also hold promise, but have not achieved widespread implementation.

In summary, reducing the risks associated with airway management, pneumonia and sedation in the mechanically ventilation patients is essential to improve outcomes in the critically ill. However, reducing the risks associated with mechanical ventilation in the critically ill is a vast, complex and interdisciplinary process.

References1. Grap MJ et al. Am J Crit Care 1996;5:192-197.

2. Pedersen CM et al. Intensive Crit Care Nurs 2009;25:21-30.

3. Sole ML Am J Crit Care 2003;12:220-230.

4. Kelleher S, Andrews T. J Clin Nurs 2008;17:360-369.

5. Glass C et al. Heart Lung 1993;22:158-165.

6. Corley M et al. J.Emerg.Nurs 19[1], 45-49. 1993.

7. Glass C, Grap MJ, Sessler CN. American Journal of Critical Care (AM J CRIT

CARE) 1999 Mar ; 8 (2 ): 93 100 (21 ref ). 1999;8:93.

8. Alvarez-lerma F et al. Clinical Intensive Care 1997;8:164-170.

9. Huxley EJ et al. Am J Med 1978;64:564-568.

10. Grap MJ et al. Intensive Crit Care Nurs 2003;19:68-74.

11. Grap MJ et al. Am J Crit Care 1999;8:475-480.

12. Roadmap for safety: National Quality Forum officially releases 30 safe

practices for better healthcare. Qual Lett Healthc Lead 2003;15:12-4, 1.

13. Fourrier F et al. Crit Care Med 1998;26:301-308.

14. Cardenosa Cendrero JA et al. Am J Respir Crit Care Med 1999;116:

462-470.

15. Grap MJ et al. Am J Crit Care 2003;12:113-118.

16. Munro CL et al. Am J Crit Care 2006;15:453-460.

17. Barr J, Donner A. Crit Care Clinics 1995;11:827-847.

18. Rello J et al. Am J Respir Crit Care Med 1999;159:1742-1746.

19. Esteban A et al. Am J Respir Crit Care Med 1994;106:1188-1193.

20. Ely EW et al. N Engl J Med 1996;335:1864-1869.

21. Kollef MH et al. New Horiz 1998;6:52-60.

22. MacIntyre NR et al. Am J Respir Crit Care Med 2001;120:375S-395S.

23. Chase JG et al. Comput Methods Programs Biomed 2004;76:131-141.

The authorsProfessor Mary Jo Grap, RN, PhD, ACNP, FAANandProfessor Cindy L. Munro, RN, PhD, ANP, FAAN

Adult Health and Nursing Systems Department, School of NursingVirginia Commonwealth University, Richmond, VA, USA

Correspondence toMary Jo Grap, School of Nursing,Virginia Commonwealth University , PO Box 9805671100 East Leigh St., Richmond, VA 23219, USATel +1 804-828-0723e-mail: [email protected]


– Issue N°7 – Dec. 2009/Jan 2010

16 WoMeN’s HeAltH

As long ago as 1947 the American Cancer Society (ACS) initiated a public education campaign on “Cancer’s Danger Signals”. One of the seven origi-nal signals of cancer was described as a “lump or thickening in the breast or elsewhere” [1]. Ever since that time just after World War II, when the focus was turning from public safety to public health, there has been an active interest in iden-tifying the most effective means for early identifi-cation of breast cancers. The importance of early identification cannot be understated as breast cancer remains a prevalent disease internationally.

Worldwide, more than 1.3 million women were diagnosed with breast cancer in 2007, with more than 400,000 dying of the disease in that year [2]. In the United States alone, an estimated 192,000 cases of invasive breast cancer per year are diag-nosed with another 62,000 cases of in situ or Stage 0 cancer undergoing treatment. The most notable risk factor for breast cancer remains age. Between the years of 2002 and 2006, women under the age of 24 had the lowest incidence of breast cancer in the United States (1.4 per 100,000), while women aged 75-79 years had the highest incidence of breast cancer (441 per 100,000) [3]. Additional risk factors include early age at menarche, late age at menopause, nulliparity or late age at first birth, and a family history of breast cancer [4]. The majority of women with breast cancer however have minimal risk factors for the disease and therefore national and international efforts to identify the most effec-tive screening tool for breast cancer remain at the forefront of public health efforts.

Screening tools: BSEOne such screening tool that came into promi-nence in the 1970s was Breast Self Examina-tion (BSE). The literature at that time included a study by Foster et al in Vermont, USA, who published an observational trial of 335 patients with breast cancer to assess the relationship between breast self exams and clinical cancer

stage. Unfortunately, a mere 25% of the enrolled patients actually performed BSE on a regular basis. However, those who did perform BSE had an earlier clinical stage as well as a decrease in axillary node metastasis [5]. Another study pub-lished in the New England Journal of Medicine analysed mortality rates when using both breast self exams and clinical exam (CBE) techniques. The analysis suggested that mortality rates would decrease by 18.8% and 24.4% with regular breast self exams and clinical breast exams, respectively [6]. Support for the increased awareness of breast cancers and the potential importance of BSE came from the work of Cady documenting the decrease in size of presenting breast cancers over 60 years in a single Boston hospital. Between 1949 and 1984, the mean tumour diameter of a breast cancer decreased from 3.4 to 2.3, this occurring prior to the mass introduction and availability of screening mammography [7].

Screening tools: mammographyIn both the United States and Western Europe, screening mammography or plain film evaluation of the tissues and structures of the breast became much more prevalent in the 1980s. Since that time multiple randomized clinical trials and observa-tional studies have validated the importance of this screening tool in identifying breast cancer at earlier stages and in reducing the mortality from this disease [8,9]. Variability exists in the cur-rent utilization of screening mammography in the United States but it is estimated that between 40 and 75% of women over age 40 undergo this yearly exam[10].

With these two screening tests, namely BSE and Mammography supported by the American Can-cer Society, multiple nonprofit entities moved for-ward or were established to support the impor-tance of early detection of breast cancer. The Susan G. Komen organization was established in 1982 as a heartfelt promise to a lost loved one

to end the fight against breast cancer. With over 1.5 billion dollars raised, this organization has provided unending support for research to find a cure, educational opportunities to those recently diagnosed as well as a common bond for all breast cancer survivors. The Susan G. Komen and Avon Foundation host an annual walk for survivors and activists to convey their continued support to find a cure. Other programs such as The National Breast Cancer Foundation chose to increase aware-ness by promoting early detection and providing free mammogram screening to underserved com-munities. Since the installation of countless breast cancer foundations, public awareness of the breast and its associated diseases has increased as a result of the vast array of educational materials available on the internet [11-16].

The result of the past 30 years of “breast aware-ness” has led to the question of whether monthly breast self examinations should continue to be a “strong” recommendation from the medical com-munity. The breast is no longer a “hidden organ” and empowered women are now acting as their own advocates by performing breast exams or per-haps becoming more “aware” of breast changes that occur over time. Recently the United States Pre-ventive Services Task force (USPSTF), established in 1984 to prevent premature death in citizens below the age of 65, has issued its current recom-mendations on breast cancer screening [17]. This group has performed an extensive meta-analysis of national and international trials on screening tech-niques. Mammography, despite its false positive rate and increased radiation risk with additional films, remains a key screening methodology for women aged 40 to 69 and continues to show effectiveness in reducing mortality from breast cancer.

Breast Self Examination, however, has been removed from both the ACS and USPSTF

Breast cancer screening with breast self examination: not yet a dinosaurWorldwide, breast cancer is one of the most prevalent cancers and is responsible for nearly half a million deaths per year, although encouragingly the mortality from the disease, in developed countries at least, has gradually been decreasing. this decrease is partly due to improvement in therapy, but screening programs also play a vital role. recent Us recommendations on breast cancer screening have been controversial, particularly with regard to the frequency of mammography and the role of breast self examination (Bse). this article makes a plea for the continua-tion of Bse as the only non-invasive, low cost tool for women, particularly those at high risk of developing the malignancy and as a synergistic adjunct to imaging.

by dr l. G. Wilke and J. Gallagher

– Issue N°7 – Dec. 2009/Jan. 2010

17


www.ihe-online.com/comment/xxxxxxxxx

screening recommendations and is now an optional tool in surveil-lance. The evidence supporting this change comes primarily from three international clinical studies of BSE, as well as a meta-analysis of observational and clinical trials of BSE [18-21]. The largest of the trials was performed with 266,000 women from Shanghai, China; the trial randomized women aged 31-64 to a program of BSE instruction and competency versus a control arm. After 11 years of follow-up the study found no significant difference in the mortality rate of women in the BSE and control groups [18]. One of the primary criticisms of the Shang-hai trial is that BSE was used as the only tool for breast cancer screen-ing; mammography, either screen-ing or diagnostic, was not available to this population of women from China [22]. In the United States the mortality rate from breast cancer has been decreasing 2.3% per year from 1990 to 2001. Though this is in part due to improved, individual-ized therapies and a maximal level of resources, screening programs are also believed to play a role in this mortality reduction [23]. Screen-ing for breast cancer in the United States since the late 1980s has not included BSE in isolation; rather it has been performed in conjunction with imaging modalities and clini-cal breast examination (CBE). The Breast Health Global Initiative 2005 Guidelines report that in a devel-oped society such as the US, popu-lation based mammograms remain the primary screening method [23]. Vetto and Kearney both indicate that increased breast awareness through early support of BSE, however, led to this current societal acceptance of mammography and continues to highlight the co-dependance of the two modalities [22,23]. For exam-ple, in a retrospective cohort study of 27,421 women from the Pacific Northwest, women who reported more frequent BSE and perceived quality of BSE were more likely to have diagnostic mammograms [24]. Recently our Mulitdisciplinary Breast Wellness group at Duke Univeristy published our data on BSE for patients at high risk for the development of breast cancer [25]. In this study of 147 women at high risk for the development of breast cancer based either on prior

history of premalignant breast lesions, family history or genetic mutations, we prospectively tested whether BSE should still be recom-mended for breast cancer surveil-lance in patients undergoing yearly breast MRI and mammography. We found that BSE detected 6 new inva-sive breast cancers and one atypical lesion, representing 46.6% of the abnormalities detected in the 3 year time period. During the same time interval, mammography identified 14% of the malignancies and breast Magnetic Resonance Imaging (MRI)

detected 43% of the new cancers. The 6 breast cancers detected by breast MRI were not detectable by BSE, CBE, or screening mammog-raphy. These findings demonstrated the potential synergy of combined BSE and imaging in screening high-risk women. Notably, a recent study from Harvard, found that 71% of women diagnosed with breast can-cer at age 40 or younger discovered their breast cancers by BSE [26]. Most physicians involved in the routine care of women with breast cancer will report that women do

“find” their cancers in a not insignif-icant number of cases. As we move towards a better understanding of breast cancers and its heterogeneity and the need for individualizing care, BSE remains the only noninvasive, low cost tool for women, especially those at high risk for developing the malignancy to help in the identifica-tion of their cancers. As technology improves, perhaps a more specific and sensitive test will emerge that can replace BSE, CBE and mammog-raphy, but until that time these tools will remain in the armamentarium

Mark the courseSEE US AT ECR 2010 FOR HANDS ON MAMMOGRAPHY EXPERIENCE

Try your hand at reading and manipulating digital mammography cases at our ECR DigitalMammography Self-Assessment Workshops.

The workshops will be facilitated by eminent clinicians Roland Holland, MD, PhD, from the National Expert and Training Centre for Breast Cancer Screening, Radboud UniversityMedical Centre, Nijmegen and Ulrich Bick, MD, Department of Radiology, CCM, Charité-Universitätsmedizin, Berlin.

Participants may register for up to seven one-hour sessions. Each session starts with anintroduction that includes the learning objectives, the method of reading and self-assessment.

Participants will have 45 minutes to read the cases, then assess their own number of falsepositives and false negatives, and discuss the cases with the medical experts. Each modulecontains 30 selected screening mammography cases with a mix of biopsy proven positives and negatives. The modules are independent of each other and do not need to be completed sequentially.

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– Issue N°7 – Dec. 2009/Jan 2010

of physicians and their patients to try and identify breast cancer at its earliest stages.

References1. http://www.cancer.org/docroot/aa/content/aa_1_4_

acs_history.asp2. http://www.cancer.org/downloads/STT/Global_

Facts_and_Figures_2007_rev2.pd3. Horner MJ et al. eds. SEER Cancer Statistics Review,

1975-2006. National Cancer Institute. Bethesda, MD, posted on http://seer.cancer.gov/csr/1975_2006

4. Tchou J and Morrow M. Available Models for Breast Cancer Risk Assessment: How Accurate Are They? JACS 2003; 197: 1029-1035.

5. Foster RS et al. Breast self-examination practices and breast-cancer stages. N Engl J Med, 1978; 299: 265-270.

6. Greenwald P et al. Estimated effect of breast self-examination and routine physician examinations on breast-cancer mortality. N Engl J Med, 1978; 299: 271-273.

7. Cady B, Stone MD, Wayne J. New Therapeutic Possi-bilities for Primary Invasive Breast Cancer. Ann Surg 1993; 218: 338-349

8. Tabar L et al. Mammography service screening and mortality in breast cancer patients: 20-year follow-up before and after introduction of screening. Lancet. Apr 2003; 361:1405-1410

9. Duffy SWet al. The impact of organized mammog-raphy service screening on breast carcinoma mortal-ity in seven Swedish counties. Cancer. Aug 2002; 95: 458-469

10. Behavioral Risk Factor Surveillance System Public Use Data 2006, National Center for Chronic Disease Prevention and Health Promotion, Centers for Dis-ease Control and Prevention, 2007.

11. http://www.bcrfcure.org/12. http://ww5.komen.org/13. http://walk.avonfoundation.org14. http://www.nationalbreastcancer.org/15. http://www.playforpink.org/aboutus.html16. http://www.breastcancerawareness.com/17. Nelson HD et al. Screening for breast cancer: an

update for the U.S. Preventive Services Task Force. Ann Intern Med. 2009;151:727-37

18. Thomas DB et al. Randomized trial of breast self-examination in Shanghai: final results. J Natl Cancer Inst. 2002;94:1445-1457.

19. UK Trial of Early Detection of Breast Cancer Group. 16-year mortality from breast cancer in the UK trial of early detection of breast cancer. Lancet. 1999; 353: 1909-14

20. Semiglazov VF et al. Interim results of a prospec-tive randomized study of self-examination for early detection of breast cancer (Russia/St. Petersburg/WHO). Voprosy-onkologii. 1999; 545: 265-71.

21. Hackshaw AK, Paul EA. Breast Self-examination and death from breast cancer: a meta-analysis. Br J of Cancer. 2003; 88: 1047-53.

22. Kearney AJ, Murray M. Evidence Against Breast Self Examination is not Conclusive: What policymakers and Health Professionals Need to Know. J of Public Health Policy. 2006; 27: 282-94.

23. Vetto JT. Teaching Breast Self-Examination: A Tale of Two Cities. J Cancer Educ 2006; 21: 115-116.

24. Tu S et al. Breast Self-Examination: Self-Reported Frequency, Quality, and Associated Outcomes. J Cancer Educ. 2006; 21: 175-181.

25. Wilke LG et al. Breast self-examination: defining a cohort still in need. Am J Surg 2009; 198: 575-579.

26. Srila Samphao et al. Diagnosis of breast cancer in women age 40 and younger: delays in diagnosis result from underuse of genetic testing and breast imaging. Am J Surg. 2009 Oct;198:538-43.

The authorsLee Gravatt Wilke, MD FACSAssociate Professor of SurgeryDuke University Medical School and Health SystemDurham, NC USA

Jennifer GallagherResearch AssociateDuke University Health SystemDurham, NC, USA


www.ihe-online.com/comment/xxxxxxxxx

18 WoMeN’s HeAltH

FroNt CoVer ProdUCtEffective and gentle self-treatment for women following pelvic radiotherapy

Around 40% of women diagnosed with a gynaecologi-cal malignancy will receive radiation as part of their treat-ment. One effect of this treatment can be altered sexual functioning and partner relations. It is common for

women to experience some adhesions to the treated area after radiotherapy, which can make the vagina narrower, drier and less elastic. Pre-venting the formation of scar tissue within the vagina helps ensure that it remains supple so that coitus and medical vaginal examinations are not painful.Designed in conjunction with the UK National Forum of Gynaecological Oncology Nurses (NFGON), Amielle Care vaginal dilators help women take an active role in their recovery following radiotherapy to the vagina, cervix or pelvis. By using Amielle Care regularly (mini-mum three times weekly), women themselves can gradually help reduce the risk of scarring by keeping the vaginal wall supple, and can be confident about recommencing sexual rela-tions. The device consists of four graduated cones with universal handle and a water-based lubricant, all of which are presented in a dis-creet bag.

Owen MuMfOrd Ltdwoodstock, Oxon, uK www.ihe-online.com & search 45502

– Issue N°7 – Dec. 2009/Jan. 2010

The clinical background Breast cancer is the most frequently diagnosed noncutaneous cancer and the second leading cause of cancer deaths among women. The incidence increases with age and the probability of a woman devel-oping breast cancer is 1 in 69 in her 40s, 1 in 38 in her 50s, and 1 in 27 in her 60s [1]. Data suggest that the incidence of breast cancer in the US and in the developed world has sta-bilised in recent years and mortality has decreased since 1990 thanks to many factors, including screening [2]. In 2005, 68% of women aged 40 to 65 years had screening mammog-raphy within the previous 2 years in the United States. Breast cancer is known to have an asymptomatic phase that can be detected with mammography. Mam-mography screening is sensitive (77% to 95%), specific (94% to 97%),

and acceptable to most women. It is carried out by using either plain film or digital technologies, although the shift to digital is increasing. Con-trast-enhanced magnetic resonance imaging (MRI) has traditionally been used to evaluate women who have already received a diagnosis of breast cancer. Recommendations for its use in screening apply to certain high-risk groups only. If a woman has an abnormal mammographic finding on screening or a concern-ing finding on physical examination, additional imaging and biopsy may be recommended. Such additional imaging may consist of diagnostic mammography or mammography done with additional or special views, targeted breast ultrasonog-raphy, or breast MRI. Additional imaging may help classify the lesion as a benign or suspicious finding to determine the need for

biopsy. Biopsy techniques vary in the level of invasiveness and amount of tissue acquired, which affects yield and patient experience.

The USPSTF The United States Preventive Serv-ices Task Force (USPSTF) is a panel of outside experts that is charged with making evidence-based rec-ommendations to both the public and the health care community regarding the provision of clinical preventive services. The mission of the USPSTF is to produce evidence-based recommendations on the appropriate screening, counselling and provision of preventive medica-tion for asymptomatic patients who are seen in the primary care setting. There are currently 16 members on the USPSTF, with expertise in the fields of primary care, epidemiology,

health policy and public health. The necessary qualifications for serv-ing on the USPSTF are a knowl-edge and experience in the critical evaluation of research published in peer-reviewed literature and in the methods of evidence review. The members should be expert in disease prevention and health pro-motion and have clinical expertise in the primary health care of chil-dren or adults. Crucially, there is no breast cancer screening expert cur-rently serving on the USPSTF. The current USPSTF recommen-dations for mammography screen-ing are shown in Table 1. The new, recently published guidelines [1] are shown in Table 2.

Radiologists respond.A panel of radiologists, expert in mammography got together

Changing the guidelines on mammography screening one of the main talking points at the recent annual meeting of the rsNA held in Chicago at the beginning of december was the recent publication from the U.s. Preventive services task Force (UsPstF) of revised screening mammography guidelines, proposing that mammography screening should be carried out less often and starting at a later age. At one level, this is an affair that seems to affect only the United states since, in europe, the situation regarding recommendations on mammography screening is much more disparate than in America. in europe, different countries have different guidelines, recommendations and re-imbursement policies. However, the fact is that any conclusions drawn about the pros and cons of mammography screening based on the vast Us database have direct relevance to europe. We report here on the background to the controversy and on the reaction of a select rsNA panel of experts in mammography who did not hide their negative response to the proposed new guidelines.

WoMeN’s HeAltH 19

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Table 2. The recently published guidelines for US mammography screening [1].

Breast Cancer Mammography Screening

New USPTF conclusions

• Screening recommended to begin at age 50 for most women.

•Thereafter screening only every two years.

• No screening after age 75

• No benefit shown for clinical breast examination or breast self-examination.

• False positive results and need for additional imaging are common

Table 1. The current guidelines for US mammography screening

Breast Cancer Mammography Screening

Existing US recommendations

• Annual screening recommended to begin at age 40 for most women,

with or without clinical breast examination (CBE).

• Insufficient evidence to decide for or against routine breast self-examination

– Issue N°7 – Dec. 2009/Jan 2010

at the recent RSNA meeting to refute the new guidelines. The panel comprised: • Dr Phil Evans, Director, Center for Breast Care,

University of Texas Southwestern Medical Center and President, Society of Breast Imaging

• Dr Stephen A. Feig, Professor of Radiology, Uni-versity of California Irvine School of Medicine and President-Elect, American Society of Breast Disease

• Dr Daniel B. Kopans, Senior Radiologist, Breast Imaging Division, Massachusetts General Hospital and Professor of Radiology, Harvard Medical School.

The principal point that the panel made was that the new guidelines were not based on scientific evidence. Most importantly, according to many experts, the guidelines would actually cause unnecessary deaths. In fact the panel presented screening mammography as being one of the great women’s health success stories of the last couple of decades. The reduction in mortality from breast cancer in women who were screened annually is actually between 40 and 50% so that today the average patient with invasive cancer is 39% less likely to die from her disease than in the

early 1980s. Perhaps reflecting this, the number of women aged 40 and older who actually fol-lowed the old recommendation on mammogra-phy screening has risen from 29% in 1987 to 70% in 2003. Several randomised trials, including European studies [3,4] were presented as proof of the benefits of initiating screening in women between the age of 40 and 50 [Table 3]. Turning to the points raised by the USPSTF regarding the potential radiation risk caused by mammography screening, the panel of mam-mography experts quoted recent studies by the US National Council on Radiation Protec-tion and Measurements which showed that at

current mammography radiation doses, even a 1% reduction in mortality confers more benefit than the risk of the screening procedure itself [5]. Since the actual mortality reduction is of the order of 40 % the benefits far outweigh the theoretical radiation risk. As for the psycho-logical stress caused to the patient as a result of the level of false positives which required a recall for further investigation or in extreme cases, even a biopsy, the panel admitted that screening mammography was not perfect but pointed out that the real stress occurred with women who had not had screening and who unfortunately realised that they had potentially lethal breast cancer.

References 1. Nelson, HD et al Screening for breast cancer: an

update for the US preventive task force. Ann Intern Med. 2009 ;Nov 17;151(10):727-37, W237-42.

2. Edwards BK et al Annual report to the nation on the status of cancer, featuring population-based trends in cancer treatment. J Natl Cancer Inst. 2005; 97:1407.

3. Bjurstam N et al. The Gothenburg breast screen-ing trial: first results on mortality, incidence, and mode of detection for women ages 39-49 years at randomization. Cancer 1997 Dec 1;80(11):2091-9.

4. Andersson, I & Janzon L. Reduced breast cancer mor-tality in women under age 50: updated results from the Malmö Mammographic Screening Program. J Natl Cancer Inst Monogr 1997;(22):63-7.

5. National Council on Radiation Protection and Measurements “A guide to mammography and other breast imaging procedures” NRCP report no 149, 2004


www.ihe-online.com/comment/mammo

20 WoMeN’s HeAltH

Breast PET scanner

The MAMMI Breast PET system is a scan-ner dedicated to the early detection of breast cancer and treatment follow up. Thanks to its spatial resolution and image contrast, the system makes it possible to visualise breast cancer tumours at early stages. In addition the progress of chemotherapy or radiotherapy treatments can be followed. The MAMMI system does not require any breast compression as with X-ray examina-tion. Indeed, the acquisition is carried out in the prone position and the 3D images are accurately quantified and with charac-teristic PET effects corrected. The hanging breast device makes the examination com-fortable for the patient. The ring detector allocates 12 modules each using a single continuous crystals and a position sensitive photomultiplier. Acquisition times are about 5 minutes per frame.

OncOvisiOn GeM iMaGinGvalencia, spain www.ihe-online.com & search 45507

“... screening mammography is one of the great women’s health success stories of the last couple

of decades ...”

Prof. D.B. Kopans, Harvard Medical School

Table 3. Many randomised controlled trials from Europe, including the so-called Gothenburg [3] and Malmo [4] were cited as proof of the advantages in reducing breast cancer mortality by screening in

women under 50 years of age.

Statistically signifcant mortality reduction from single randomised controlled trials of mammography screeing of women age 40 - 49 at entry Trial Mortality reduction Gothenburg 45% Malmo 36%

– Issue N°7 – Dec. 2009/Jan. 2010

Estrogen therapy and cognition: a review of the cholinergic hypothesis. by GB GibbsEndocr. Review Dec 2009

The pros and cons of estrogen therapy for use in postmeno-pausal women continue to be a major topic of debate in wom-en’s health. Much of this debate focuses on the potential benefits vs. the harm of estrogen therapy on the brain and the risks of cognitive impairment associated with aging and Alzheimer’s dis-ease. Many animal and human studies suggest that estrogens can have significant beneficial effects on brain aging and cognition and reduce the risk of Alzheimer’s-related dementia; however, others disagree. Important discoveries have been made, and hypotheses have emerged that may explain some of the inconsistencies. This review focuses on the cholinergic hypothesis, specifically on evi-dence that beneficial effects of estrogens on brain aging and cog-nition are related to interactions with cholinergic projections ema-nating from the basal forebrain. Evidence suggests that many of the effects of estrogens on neu-ronal plasticity and function and cognitive performance are related to or rely upon interactions with

these cholinergic projections; however, studies also suggest that the effectiveness of estrogen ther-apy decreases with age and time after loss of ovarian function. The author proposes a model in which deficits in basal forebrain cholin-ergic function contribute to age-related changes in the response to estrogen therapy. Based on this model, it is proposed that cholinergic-enhancing drugs, used in combination with an appropriate estrogen-containing drug regimen, may be a viable therapeutic strategy for use in older postmenopausal women with early evidence of mild cognitive decline.

Women bound to be active: one year follow-up to an innovative pilot intervention to increase physical activity and self-worth in women.by JL Hubert, et al.Women’s Health 2009; 49(6): 522.

The purpose of the study reported in this paper was to assess the effec-tiveness of a lifestyle intervention (a women’s book club;

Women Bound to be Active) in promoting long-term physical activity. Thirty-five women (26-70 years; mean age 50.6 years) completed the 8-month inter-vention and participated in the one-year follow-up. At follow-up,

physical activity returned to base-line levels; however, self-worth and body mass index significantly improved. Women were more knowledgeable about physical activity at follow-up; however, they failed to maintain physical activity after the intervention. To enhance long-term physical activ-ity adherence, continued research and intervention modifications are needed.

The “Acupuncture on Hot Flashes Among Menopausal Women” study: observational follow-up results at 6 and 12 months.by EK Boroud et al.Menopause Dec 2009 The previously published “Acu-puncture on Hot Flashes Among Menopausal Women” study compared the effectiveness of

A selection of peer-reviewed literature on women’s healththe number of peer-reviewed papers covering the vast field of women’s health is huge, to such an extent that it is frequently difficult for healthcare professionals to keep up with the literature. As a special service to our readers, iHe presents a few key literature abstracts from the clinical and scientific literature chosen by our editorial board as being particularly worthy of attention.

WoMeN’s HeAltH 21


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– Issue N°7 – Dec. 2009/Jan 2010

individualized acupuncture treatment plus self-care versus self-care alone on hot flashes and health-related quality of life in postmenopausal women. This paper reports on the observa-tional follow-up results at 6 and 12 months. The study was a prag-matic, multicenter randomized controlled trial with two paral-lel arms. The 267 participants were postmenopausal women

experiencing, on average, 12.6 hot flashes per 24 h. The acupuncture group received 10 individualized acupuncture treatments during 12 weeks and advice on self-care, whereas the control group received only advice on self-care. Hot flash frequency and inten-sity (0-10 scale) and hours of sleep per night were registered in a diary. Health-related qual-ity of life was assessed by the Women’s Health Questionnaire. From baseline to 6 months, the mean reduction in hot flash fre-quency per 24 hours was 5.3 in the acupuncture group and 5.0 in the control group, a nonsig-nificant difference of 0.3. At 12 months, the mean reduction in hot flash frequency was 6.0 in the

acupuncture group and 5.8 in the control group, a nonsignificant difference of 0.2. Differences in quality-of-life scores were not statistically significant at 6 and 12 months. The statistically sig-nificant differences between the study groups found at 12 weeks were no longer present at 6 and 12 months. The study showed that acupuncture can contrib-ute to a more rapid reduction in vasomotor symptoms and increase in health-related qual-ity of life in postmenopausal women but probably has no long-term effects.

Is green tea drinking associated with a later onset of breast cancer?Q Dai et al.; Ann Epidemiol 2010 Jan; 20(1): 74 -81Studies have found that tea polyphenols inhibit aromatase. Because of the substantial differ-ence in levels of estrogens between premenopausal and postmeno-pausal women, the relationship between tea consumption and breast cancer risk may depend on menopausal status. The authors examined this hypothesis in the Shanghai Women’s Health Study, a population-based cohort study of

74,942 Chinese women. A time-dependent interaction between green tea consumption and age of breast cancer onset was found (p for interaction, 0.03). In com-parison with non-tea drinkers, women who started tea-drinking at 25 years of age or younger had a hazard ratio (HR) of 0.69 to develop premenopausal breast cancer. On the other hand, com-pared with non-tea drinkers, women who started tea drink-ing at 25 years of age or younger had an increased risk of post-menopausal breast cancer with an HR of 1.61. Additional analy-ses suggest regularly drinking green tea may delay the onset of breast cancer but that further studies are needed to confirm the findings.

22 WoMeN’s HeAltH

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Carestream Health Offers Free Hands On Mammography Experience at ECR 2010

During the upcoming European Congress of Radiology (ECR 2010) to be held in Vienna, Austria on March 4 - 8, Carestream Health will be running a series of free Digital Mammography Self-Assessment Workshops to help healthcare professionals acquaint and train themselves in digital mammog-raphy reading.The workshops will be facilitated by the eminent clinicians Roland Holland MD, PhD from the National Expert and Training Centre for Breast Cancer Screening, Radboud University Medical Centre, Nijmegen, The Netherlands and Ulrich Bick, MD, Department of Radiology, CCM, Charité- Universitätsmedizin, Berlin, Germany.Participants may register for up to seven one-hour sessions. Each ses-sion starts with an introduction that includes the learning objectives, the method of reading and self-assessment. Participants will have 45 minutes to read the cases, then assess their own number of false positives and false negatives, and discuss the cases with the medical experts. Each module contains 30 selected screening mammography cases with a mix of biopsy proven positives and negatives. The modules are independent of each other and do not need to be completed sequentially.

Participation is limited and early registration is advised. Visit www.carestreamhealth.com for details of how to register on-line.

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– Issue N°7 – Dec. 2009/Jan. 2010

Protein from pregnancy hormone may prevent breast cancerResearchers have found that hormones produced during pregnancy induce a protein that directly inhib-its the growth of breast cancer. This protein, alpha-fetoprotein (AFP), may serve as a viable, well-tol-erated agent for the treat-ment and prevention of breast cancer, according to

findings published in Cancer Prevention Research, a journal of the American Association for Cancer Research.Recent studies have shown that hormones released during pregnancy, such as oestrogen, progesterone and human chorionic gonadotropin, reduce a women’s risk for breast cancer. AFP is a protein normally produced by the liver and yolk sac of the foetus. A study lead by Dr Herbert Jacobson, who is a basic breast cancer researcher at Albany Medical College, USA sought to determine whether administering pregnancy hormones to carcinogen-exposed rats led them to produce AFP, which in turn produces the protective effect of pregnancy in the absence of pregnancy. Results from this study showed that treatment with oes-trogen plus progesterone, oestrogen alone or human chorionic gonadotropin reduced the incidence of mammary cancers in rats. Furthermore, the research-ers noted that each of these treatments elevated the serum level of AFP and that AFP directly inhibited the growth of breast cancer cells growing in culture, suggesting that these hormones of pregnancy are preventing breast cancer through their induction of AFP.http://cancerpreventionresearch.aacrjournals.org/rss/

Study shows antibiotic unsuccessful in preventing preterm labour

The antibiotic azithromy-cin is effective in treat-ing infections such as syphilis, Chlamydia and Ureaplasma urealyticum, which are thought to play a significant role in causing preterm labour. Recent studies have also shown that the drug is effective in reducing the

risk of miscarriage following amniocentesis. The drug is currently used to treat infection in patients all over the world, but has not been previously tested on pregnant women at high risk of preterm labour. Researchers at Liverpool Uni-versity, UK investigated how effective the antibiotic could be in women in South-ern Malawi, where one in five babies are born prematurely. Women living in this region are also at high risk of sexually transmitted infections and other diseases, which may have a significant impact on labour and the long-term development of a foetus. In a study of 2,000 pregnant women, half were treated with the oral antibiotic and half were treated with placebo drugs. It was found that the antibiotic made no significant difference to the outcome of the pregnancies between the two groups of women. The drug was effective in treating infection, but a high number of women still went on to experience preterm labour. The findings suggest that infection may not be the primary cause of preterm birth and other treatments should be investigated. A high number of women with infection still went on to experience preterm labour. The study suggests that it is important to investigate other factors, apart from infection to determine the cause of preterm labour. www.liv.ac.uk/better-births

Dynamic MRI identifies pelvic organ prolapseIn women with lower urinary tract symptoms, dynamic MRI allows clinicians to diagnose pelvic organ prolapse — a condition that often goes

undiagnosed on static MRI and at physical examination. Pelvic organ prolapse is relatively common and occurs when the pelvic floor muscles become weak or damaged and can no longer support the pelvic organs. If left untreated, living with prolapse can be a challenge, both physically and emotionally, as the symptoms can disrupt day-to-day life. Dynamic MRI is carried out while the patient performs a straining maneuver, such as bearing down. A study performed at NYU Langone Medical Center in New York, USA included 84 women with lower urinary tract symptoms who underwent dynamic and static MRI scans for a suspected urethra abnormality. Ten of the 84 patients were found to have an abnormality of the urethra. However 33 patients were diagnosed with pelvic organ prolapse, of whom 29 were diagnosed exclusively on dynamic imaging.http://www.arrs.org/

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– Issue N°7 – Dec. 2009/Jan 2010

24 UroloGy

Basics of shockwave lithotripsyShockwave lithotripters serve to fragment renal and ureteral stones sufficiently such that the patient will pass the fragments spontaneously, without the need for more invasive therapy, ren-dering them stone and symptom-free. Shock-waves are generated by electrohydraulic, electro-magnetic or piezo-electric systems, depending on the design of the lithotripter and are propa-gated through the patient where they are focused on the stone. The stones are targeted by means of fluoroscopy or ultrasonic imaging.

The origin of clinical SWL was with the Dornier HM3 lithotripter. Although very powerful, this instrument was cumbersome in that patients were required to be submerged in a water bath in order to couple the shockwaves to the soft tis-sue of the patient and, although resulting in an excellent clinical outcome, its sheer power neces-sitated anaesthesia. More modern lithotripters have been simplified by advances in the coupling mechanisms that have alleviated the need for water submersion. In addition, they have been in essence “de-tuned” in order to improve patient tolerance and eliminate the need for anaesthe-sia. Typically patients can be treated with intra-venous sedation. This has led to a reduction in the success rates of modern SWL series, but has increased patient acceptance and satisfaction so that SWL remains as a reasonable non-invasive treatment option.

Methods of increasing successful outcomes with SWLThe success SWL can be optimised by careful patient selection, consideration of stone charac-teristics, alteration of treatment parameters and augmenting fragment passage. A discussion regarding patient selection should

begin with a review of absolute contraindica-tions to SWL, which include pregnancy, the presence of distal urinary tract obstruction and patients who are anticoagulated or having bleed-ing diatheses. Relative contraindications include proximity of the stone to be treated to abdomi-nal or renal aneurysms, morbid obesity, uncon-trolled hypertension and patients whose body habitus precludes adequate positioning to target the stone.

Patient factorsPatient factors which may contribute to poor outcomes with SWL include obesity and the distance of the skin to the stone. Obesity has been reported as an independent predictor of SWL failure on multivariate analysis of series. More recently, several authors have reported skin to stone distance (SSD), measured by pre-treatment non-contrast computed tomography, as being predictive of SWL failure. Published data have reported a decrease in success rates when SSD was greater than 10cm and 9cm respectively.These data may not apply to all lithotriptors however, given the differences in focal zones between machines. Patients with congenital renal anomalies such as a horse-shoe kidney may also have problems passing fragments created by SWL.

Stone factorsIt is well known that SWL success correlates with stone burden. Patients with multiple stones should expect to undergo more than one treat-ment to be rendered stone-free, and therefore may be considered for more invasive procedures such as ureteroscopy or percutaneous nephro-lithotripsy should they desire to be stone free with a single treatment. Stone size correlates with success rates with 79.9%, 64.1%, and 53.7%

of patients with renal stones respectively less than 10mm, 11-20mm and greater than 20mm being rendered stone free. It is generally thought that for stones less than 20mm in diameter, SWL is the first line treatment option, whilst recog-nising that more than one SWL session may be required, and that it may take several weeks to pass the fragments created. Stones that are known to be of hard composition such as cys-tine, brushite and calcium oxalate monohydrate may be best treated by another modality. It may be difficult to know, however, what type of stone the patient has unless a history of cystine stones, or known hard compositions from previous stone events, can be elucidated.

Stone location deserves special mention, par-ticularly stones within the lower pole of the kidney. The lower pole study group compared SWL and percutaneous stone removal for lower pole stones and found stone free rates of 37% and 95% respectively for stones measuring 11-20mm in diameter. In a follow-up study, the group found no difference between SWL and ureteroscopy with respect to stone-free rates for lower pole stones of less than 10mm. SWL was however favoured from the point of view of patient acceptance and convalescence compared to the more invasive ureteroscopic approach. Methods to improve fragment clearance from the lower pole will be discussed in further detail later. With respect to ureteral stones, recent jointly developed guidelines of the EUA and

optimising outcomes in the modern era of shockwave lithotripsyshockwave lithotripsy (sWl) remains the least invasive treatment modality for renal and ureteral stones. other management options for renal stones include observation (with intervention if symptoms develop), ureteroscopic stone extraction and percutaneous stone extraction. Management alternatives for ureteral stones include medical expulsive therapy, ureteroscopy and, rarely, percutaneous extraction. in brief, sWl involves the production in a generator of shockwaves which are focused on a stone within the kidney or ureter. Numerous adaptations to the equipment itself, the methods of patient selection, treatment and follow-up have been developed since the introduction of sWl into clinical practice in the early 1980s. this article reviews the current status of sWl therapy.

by dr t. schuler

– Issue N°7 – Dec. 2009/Jan. 2010

25

AUA recommend SWL as being superior to ureteroscopy for stones less than 10mm in size within the upper ureter, with ureteroscopy being superior for both stones in the distal ureter and stones greater than 10mm in size in the upper ureter.

More recently, several authors have reported on the predictive value of Hounsfield Unit (HU) attenuation of the stone on computed tomog-raphy in predicting the outcome of SWL therapy. A 100% clearance of stones less than 500 HU was noted compared with 55% for stones >1000 HU. Further to this, several authors have reported a signifi-cant reduction in successful treat-ments when stone attenuation was >900 HU.

Treatment parametersOnce the urologist and patient have elected to proceed with SWL as a stone management modality, it is important to optimise the treat-ment itself in order to achieve the best possible outcome. As decribed earlier, the initial method of cou-pling the shockwaves to the patient was with emersion in a water bath. This has largely been abandoned by the development of dry treat-ment heads, which have enclosed water cushions that are positioned against the patient’s skin. The patient must however be coupled to the water filled cushion. Numer-ous coupling agents have been described, with the end goal being elimination of air bubbles within the coupling medium. It has been suggested that optimal results are achieved by applying 250cc of gel directly to the treatment head and subsequently using the inflation of the water cushion to collapse any air pockets. This minimises han-dling of the coupling medium and the potential for introduction of air, which scatters the shockwaves. In order to overcome difficul-ties with coupling, some modern lithotripters utilise a shallow water bath. Once coupling is established, it is important to try to mini-mise patient movement, which may introduce air and reduce the efficiency of coupling.

Little clinical data exist on the ideal way in which to increase the

shockwave energy during treat-ment. A small clinical study showed that step-wise escalation of shock-wave energy resulted in a significant improvement in overall success rate eight weeks post treatment. Addi-tionally, the benefit of priming the kidney with low energy shockwaves may reduce renal injury induced by shockwaves.

The rate at which the shockwaves are delivered during treatment has also been demonstrated to impact on success rates. A recent

meta-analysis revealed a 10.2% weighted risk difference in suc-cess rates in favour of patients treated at slower rates. Tradition-ally, patients have been treated with 120 shocks per minute, with recent data suggesting the addi-tional benefits of treatment rates of 60-90 shocks per minute. This does however increase the time required for treatment, and in areas with long waiting lists for SWL it may negatively impact the access to care. Notably, the increase in success rate for stones treated at

slower rates was most significant for stones >100mm2 in a recent study in which larger renal stones treated at 60 shocks per minute were successfully treated in 75.7% of cases compared with 40% treated at 120 shocks per minute. The same group from the Uni-versity of Toronto have recently published their data demonstrat-ing an improvement in outcomes in a series of exclusively ureteral stones randomised to treatment at 60 versus 120 shocks per minute. Again the slow treatment group

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– Issue N°7 – Dec. 2009/Jan 2010

achieved a significantly higher success rate of 64.9% compared with 48.8%. More stud-ies are required to determine if the effect of slowing shockwave delivery rates will be effective on all types of lithotripters and to identify stone and patient characteristics that would most benefit from reduction in treatment rate.

Augmentation of fragment passageFragment passage may be augmented by physi-cal treatment to aid in stone passage (mechani-cal percussion, inversion and diuresis [MPID]) as well as treatments with medical agents to expel the fragments (medical expulsive therapy [MET]) or medications such as postassium citrate to dissolve fragments.

The first study to report on MPID was a cross-over randomisation of 69 patients who had fragments in the lower pole of the kidney post-SWL. Patients were inverted on a treatment table, treated with an intravenous diuretic and had their backs percussed with a physiotherapy mechanical chest percussor. This resulted in 40% of the treatment arm become stone free as compared to 3% in the observation arm.

The use of medical expulsive therapy to aid in the passage of fragments was recently sum-marised in a meta-analysis. This identified four studies in which MET was used to aid in

fragment passage after SWL. It included tri-als with both renal and ureteral stones and a variety of medical expulsive agents includ-ing alpha blockers, calcium channel blockers and an herbal agent Phyllanthus niruri alone or in combination with an oral corticosteroid. The analysis revealed a weighted risk differ-ence of 17% in favour of MET in addition to SWL with respect to treatment success com-pared to SWL. MET was well tolerated and was most beneficial for stones greater than 10mm. Subsequent this study, further trials have sug-gested the benefit of tamsulosin, an alpha adrenergic blocker, with repect to aiding in fragment passage.

The utility of potassium citrate (60mEq/day in divided doses) to aid in reduction of stone burden, post SWL has been demonstrated. In patients treated with potassium citrate, 44% were stone free while 56% of patients had a stable residual stone burden as opposed to the control group, of whom only 12.5% became stone free, 25% had a stone burden that was unchanged and 62.5% had an increase in their stone burden during follow-up.

ConclusionShockwave lithotripsy represents the least invasive and most tolerable option for most urinary calculi. The decision to undergo SWL versus other stone treatment modalities must

be discussed with the patient and should be based on stone factors, patient factors and the patient’s expectation of treatment outcome. Once the decision to use SWL has been made, consideration should be given to methods which optimise fragmentation of stones and their subsequent passage in order to prevent the need for additional SWL or more invasive therapies.

Further readingSchuler TD, Shahani R, Honey RJ, Pace KT. Medical expulsive therapy as an adjunct to improve shock-wave lithotripsy outcomes: a systematic review and meta-analysis. J Endourol 2009; 23: 387-393.

A complete bibiography is available from the author

The authorDr Trevor Schuler, Assistant Professor , SurgeryUniversity of AlbertaOff CampusEdmonton, AB,Canada. e-mail: [email protected]

26 UroloGy – Issue N°7 – Dec. 2009/Jan. 2010


www.ihe-online.com/comment/sWl

Physiologic factors linked to image quality in MDCT

A large multicentre international trial has found that the image quality of multi-detector computed tomography (MDCT) scans, used for the nonin-vasive detection of coronary artery disease, can be significantly affected by patient characteristics such as ethnicity, body mass index (BMI), and heart rate, according to a study to be published in the January issue of the American Journal of Roentgenology. The study included 291 patients with coronary artery calcification and found that, compared with exami-nations of white patients, studies of black patients had significantly poorer image quality. Physiologic factors such as high heart rate, arrhythmia, obesity, and high coronary calcium burden with motion continue to limit the diagnostic accuracy of MDCT as compared with conventional invasive coronary angiography. The study is significant because a rel-evant effect of BMI, heart rate, ethnicity, and breath-ing artifact on the degradation of image quality was found, according to the lead author of the study, Dr Melvin E. Clouse. “The diagnostic ability of any imaging method is directly dependent on image quality,” said Clouse. “With this new knowledge combined with new and advanced CT scanners, we have the potential to improve image quality of coronary CT angiogra-phy, further making the test even more accurate and independent of patient characteristics,” he said. www.ajronline.org/

Self-monitoring of blood glucose using test strips is inefficient use of health-care resources

Routine self-monitoring of blood glucose levels by people with type 2 diabetes who are not taking insulin is an ineffective use of health resources as the modest benefits are outweighed by the signifi-cant cost of test strips, suggest two recently pub-lished studies from Canada. In Ontario, blood glucose test strips were the third largest cost for the Ontario Public Drug Programs in 2007/08, accounting for $100 million or 3.3% of all drug expenditures. Usage of test strips increased by almost 250% from 76,320 people in 1997 to 263,513

people in 2008. Almost 53% of people aged 65 and over with diabetes received diabetes test strips by 2008. Sixty-three per cent of patients not receiving insulin used blood glucose test strips in 2008. In light of the overall costs and questionable benefits of blood glucose self-monitoring in many patients, more focused policy decisions regarding test strips have been proposed in several jurisdictions accord-ing to Muhammad Mamdani and coauthors of St. Michael’s Hospital in Toronto in a study on options to reduce test strip usage. They project that expen-ditures associated with blood glucose self-moni-toring will exceed $1 billion in Canada and suggest policy changes could lead to cost reductions.www.cmaj.ca

Poverty greater health burden than smoking or obesity

The average low-income person loses 8.2 years of perfect health, smokers 6.6 years and the obese lose 4.2 years, accord-ing to researchers at Columbia Universi-ty’s Mailman School of Public Health.

But poverty rates are typically not seen as health problems. A new study published in the Decem-ber 2009 issue of the American Journal of Public Health, shows that poverty and school dropout rates are at least as important a health problem as smoking. On average, poverty showed the greatest impact on health. Smoking was second, followed by being a high school dropout, non-Hispanic Black, obese, a binge drinker, and unin-sured. Healthy life lost combines both health and life expectancy into a single number, sometimes known as quality-adjusted life years. To analyse the medical and non-medical policies that might affect population health, the researchers exam-ined such policy goals as smoking prevention, increased access to medical care, poverty reduc-tion, and early childhood education to provide policymakers with a sense of how different policy priorities might influence population health. www.mailman.hs.columbia.edu

Should patients be obliged to take part in research?A leading UK heart stem cell scientist, Professor Anthony Mathur argues that if people want treat-ment for a heart problem, they should be obliged to take part in the research. His experience at Barts Hospital, London, UK is based on the conduct of stem cell trials designed for patients brought in as emergencies suffering a heart attack. The possibil-ity of using a patient’s own stem cells to repair the damage caused by their heart attack could benefit the thousands of people suffering with this condi-tion each year. However stringent laws and regula-tions are in place to ensure that trials of such new therapies are carefully conducted and the patient’s

health protected. When patients are admitted for treatment for a heart attack and after being given as much information as reasonable to make an informed decision to consent to a trial of stem cells they almost always accept. However, several hours later, following successful treatment of the heart attack when the patient is approached for consent in full for the main part of the study, they often decline. Prof Mathur suggests that a new con-tract may be needed between medicine and soci-ety that assumes a default position that says that everyone attending hospital should be involved in medical research, unless they specifically opt out of the process at the time of consent.www.bartsandthelondon.nhs.uk

Study shows reduction in ventilator-associated pneumonia (VAP)

Ventilator-associated pneumonia (VAP) is one of the top three infection concerns of clinicians today; it may account for up to 60 percent of all deaths from health-care-associated infections (HAIs). Approxi-mately 8 to 28 percent of critical care patients develop VAP, which has a mortality rate of 20 to 33 per-cent. A leading cause of VAP is micro-aspiration of potentially infectious secretions through gaps in the endotracheal tube cuff. The cuff seal is the final barrier that protects the lungs from aspiration of potentially infectious oropharyngeal secretions. A new study pre-sented at the recent American Society of Critical Care Anesthesiologists (ASCCA) meeting in New Orleans showed that a significant reduction could be achieved in the incidence of ventilator-associated pneumonia The study, supported by an educational grant from Kimberly-Clark, was conducted at the Tampa General Hospital in Tampa, Florida and showed that the use of the Kimberly-Clark MicroCuff ET Tube, a micro-thin cuff designed to reduce micro-aspiration, could reduce VAP by 61 percent per patient ventilator day. There was also a decrease in the number of ICU days. No significant differences were observed in median length of hospital stay, median length of mechanical ventilation or mortality between baseline data and data collected after use of the new cuff. www.kchelathcare.com/microcuff.

NeWs iN BrieF 27 – Issue N°7 – Dec. 2009/Jan 2010

Increase in productivity in MRIToday’s healthcare environment is increas-ingly faced with fewer staff, and less time. With its advanced RF solution, Siemens has been able to focus on the productivity across the entire MRI work-flow, and as a result developed the Day

optimizing throughput (Dot) engine. Dot multiplies the power of Siemens’ Tim technology, resulting in greater image consistency, improved diagnostic confidence, greater ease of use, and increased productivity. The new gen-eration of Siemens’ Tim (Total imaging matrix) technology and the Dot (Day optimizing throughput) engine are incorporated in the new MAGNE-TOM Skyra 3T scanner. The combination of Tim and Dot delivers patient-centred care and significantly improves productivity across the entire MRI workflow. Additional innovations include the Tim Dockable Table for easy patient preparation outside the scanner room, and an all new coil architec-ture incorporating DirectConnect coil design, providing cableless coils for fast and easy set up and higher Signal-to-Noise Ratio (SNR). Consistent, robust images can be achieved by automating exams, as well as personal-izing each exam for virtually every patient to better help staff to provide superb, more effective patient care. Dot proposes optimized exam strategies, requiring only confirmation prior to scanning. Dot adapts to each patient’s breath-hold capacity and then links to the best scanning protocol to match. Personalized, high-quality exams can be easily reproduced, even when con-ditions change. Now, every patient gets the same consistent exam every time. Dot can also be customized easily to reflect the standards of care of each individual institution. The 70 cm Open-bore design of the MAGNETOM Skyra can accommodate a large variety of patient sizes, shapes and condi-tions. The super-short magnets allow many studies to be completed with the patient’s head outside the bore while still supporting a full 50 cm FoV (45 cm in z-direction).

sieMens HeaLtHcareMunich, GermanyArab Health Stand 3B30 www.ihe-online.com & search 45504

Blood pressure monitors with touch screenTwo new blood pressure moni-tors have been introduced by the Germany-based health equip-ment specialist Beurer who has succeeded in combining two of its core competencies into one unique innovation. A leading producer of blood pressure monitors, Beurer brings design to a new level with two eye-catching medical devices, the BM58 and the BC58. Their striking design highlights the

main features while offering a high level of convenience and ease of use. By employing touchscreen technology, the designers were able to avoid using buttons in favour of a large display with easily readable numbers and symbols. Thanks to a WHO indicator and an integrated arrhythmia identification, the upper arm or wrist blood pressure monitors provide reliable and accurate blood pressure readouts. Both models are oper-ated via a generously sized touchscreen, whose touch-sensitive surface responds accurately and provides intuitive control of every feature. To

avoid undesired activation, both devices include a power switch at the side. A mini-USB port allows users to transfer their data (up to 2x60 readings) to a computer using supplied software.

Beurer GMBHulm, GermanyArab Health Stand ZY10 www.ihe-online.com & search 45503

LED-based surgical lightsThe Dräger Polaris line of medical illumination systems represents a union of innovation and proven technology to give a a source of light that is brilliant, cool, efficient and economical. High-power LEDs last up to 25 times longer than con-ventional halogen or gas discharge lamps while consuming just a frac-tion of the energy. This translates to significant savings for both the hospital and the environment. The

LEDs used in the system will provide approximately 30,000 hours of quality illumination. There are several models in the range. The Polaris 700 features 54 precision reflectors, each holding two LEDs, to give a total of 108 LEDs. These are bundled together in 6 separate arrays that move in unison when the central handle is rotated. This reflector array design provides adequate shadow control and depth illumination. The Polaris 500 is a good choice to expand the perform-ance of the surgical light system. Featuring a total of 60 LEDs the light head provides additional illumination capacity. The Polaris 500 can be used as single minor surgical light as well as in several combinations. The colour temperature of both lights is 4,600 K neutral white, giving the surgeon a realistic, detailed and undisturbed view of the operating field. The light beam projected by the LEDs is inherently cool; the thermal energy produced is dissipated by the integrated thermal management system.

draeGerLübeck, GermanyArab Health Stand 3B10 www.ihe-online.com & search 45505

ECG with highly visible LCDThe new CardiMax FX-8222 from Fukuda Denshi comes with a large LCD, which displays a clear ECG wave-form. The operation of the unit is carried out through the user-friendly function keys or via the touch panel. It is possible to save the data in an SD card or in a USB memory. Alternatively, the system can be connected to

a DMS (Data Management System) via either a wired or wireless network. The system is equipped with a large 6.4 inch Color TFT (640 x 480 dots) display. The recording uses 145 mm paper.

fuKuda densHitokyo, JapanArab Health Stand 6D10 www.ihe-online.com & search 45506

oN sHoW At ArAB HeAltH28 – Issue N°7 – Dec. 2009/Jan. 2010

Advanced imaging for radiology and cardiologyWith the introduction of the Synapse 3D sys-tem, Fujifilm is entering the advanced visualiza-tion field and, by build-ing on the company’s core strength in image processing, is now offer-ing its own advanced imaging capabilities for both general radio-graphic and cardiovas-cular applications. The

company has also made other significant enhancements to its Synapse PACS including the introduction of Synapse communications and new features to further aid the interpretation of breast imaging studies. The 3D product offers more than a dozen clinical applications delivering both radiology- and cardiovascular-specific applications such as 2D, 3D, 4D, virtual ultrasound, liver analysis, lung analysis, coronary CT/MR analysis and cardiac fusion. Developed in conjunction with radiologists, cardiologists and surgeons who performed joint research with engineers, Synapse 3D is integrated into Fuji-film’s Synapse PACS application – eliminating the need for a 3rd party soft-ware. The application is enterprise capable, and is available at any workstation where Synapse PACS is available. Powered by server-based rendering tech-nology, Synapse 3D enables the radiologist or the technologist to perform the renderings. Synapse has undergone significant refinements to support not only the image and information managements needs of radiology and cardiology departments, as well as other critical care departments including oncology, pathology and ophthalmology. The ability to provide both stor-age and distribution of images throughout the enterprise in both DICOM and web formats is critical to the integrated healthcare network. Additional features including smart forwarding and smart pre-fetching functionally have been added to allow images to flow seamless from and to Synapse PACS from third-party systems.

fuJifiLM MedicaL sYsteMsstamford, ct, usaArab Health stand 2F10 www.ihe-online.com & search 45497

4D Ultrasound The release of the CTS-8800 from SIUI looks set to promote the popularisation of 4D ultrasound imag-ing. Through the match of 4D ultrasound and B&W imaging, users of the new system can obtain 4D ultrasound imaging function at the price of a B&W

ultrasound, instead of paying for an expensive high-end colour Doppler. In contrast to the complicated operation of traditional 4D ultrasound imaging, the CTS-8800 is simple and easy to use, so that in just a few simple steps high quality 4D ultrasound images can be easily obtained.

siui shantou, Guangdong, chinaArab Health stand SAJ39 www.ihe-online.com & search 45496

oN sHoW At ArAB HeAltH 29

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– Issue N°7 – Dec. 2009/Jan 2010

Portable ultrasound systemDesigned using the latest tech-nology suitable for use in the medical envi-ronment and equipped with a large range of wide-band probes (convex, micro-convex, e n d o - c a v i t y

and linear), the exaGo ultrasound system offers exceptional image quality and is suitable for all applications. Thanks to the wide-band probes, the new instrument provides the benefits of variable frequency technology in optimising the details of the tissues observed during examination. Com-pact and powerful, the new system is easily porta-ble yet, when docked on its trolley, converts into a traditional US scanner.

ecMangoulême franceArab Health.Stand Z511 www.ihe-online.com & search 45498

Advanced mammography system with 3MP monitorThe recently introduced Senographe Essen-tial e mammography system with its 3 Mega-pixel (MP) monitor is the latest member of the Senographe Essential family of products in GE Healthcare’s mammography portfolio.The new system provides all the benefits of the Senog-raphe Essential platform for either the doctor’s office, screening clinic, mobile unit or hospital and in every case always uses just the technol-ogy that is needed to meet specific requirements. For example, the new system is equipped with the technology needed to conduct a screening

exam, but allows the addition of interventional capabilities to further extend its clinical value. The Senographe Essential e has the largest active field of view available, enabling fast and efficient imaging of nearly any sized woman. The ergo-nomic design allows fast and comfortable posi-tioning to promote patient comfort and clinical efficiency. As a digital system, the Senographe provides outstanding image quality with dose efficiency, minimizing re-takes to help promote patient safety and provide a smooth workflow. Bringing higher resolution at the time of acqui-sition has been a key need for screening and diagnostic breast imaging centres. Many tech-nologists currently use 1 MP monitors when acquiring mammography images to confirm positioning and check the images for quality standards before they are sent to the radiologist. The radiologist may need additional views after the patient has been released based on the first

set of images. The patient must return for the additional images. Now, centres have the option to choose a higher resolution monitor in the exam room, enabling technologists and radiolo-gists to have a clearer vision of the breast image at the point of acquisition. The non-diagnostic 3 MP monitor helps to refine and define the breast tissue and can eliminate retakes. During inter-ventional procedures, the 3 MP monitor can also help radiologists better visualize faint micro-calcifications during the procedure, promoting better outcomes.

Ge HeaLtHcarechalfont st Giles, uK.Arab Health Stand 4D30 www.ihe-online.com & search 45501

Image-guided surgical tableThe SurgiGraphic 6000 table from Steris offers a new level of operating room performance and control—and brings radiology-quality imaging into the operating room. All aspects of the new table have been designed to meet the demands of the operating room environment—whether for minimally-invasive vascular, orthopaedic, or other procedures. The table delivers the patient positioning and mobility required for most minimally invasive procedures requiring fluor-oscopy; lateral and longitudinal float, Trende-lenburg and reverse Trendelenburg, lateral tilt,

height adjustment and the most useful combi-nations of these movements. The table can be instantly returned to its starting position, be levelled or be moved to four easily programmed memory positions. The patient anatomy can be positioned relative to the C-arm with new precision and speed. Using the innovative and intuitive Palm Control system, the surgeon can single-handedly control every table movement; a lock-out function is included to prevent acci-dental table movement. Because there are no motorized controls in the float feature of the Palm Control, it is like the table top is gliding on a pristine sheet of ice.

steris saran cedex, franceArab Health Stand 4D50 www.ihe-online.com & search 45500

Abdominal fat analyser High levels of visceral fat and trunk fat have been scientifically proven to be linked to heart disease, metabolic syndrome and type 2 diabe-tes. Until now abdominal fat has been difficult and expensive to measure, especially in larger research studies or in routine clinical practice. Now, the AB 140MA system from Tanita enables abdominal fat to be measured simply and easily. The system uses a specially designed electrode belt placed on the bare mid-riff of the subject. By means of dual frequency BIA technology, a measurement is taken in 30 seconds and gives directly both trunk and visceral fat percentages.

tanita eurOpeHoofddorp, The netherlandsArab Health 5C50 www.ihe-online.com & search 45499

oN sHoW At ArAB HeAltH30


– Issue N°7 – Dec. 2009/Jan. 2010

Test tools for QA of diagnostic X-ray imaging systems

The TNT 12000 X-Ray Test Tools package from Fluke Biomedical is an expanded X-ray test tool platform that includes the new DoseMate dosim-eter and has integrated mA/mAs measurement capability. The new range is the most up-to-date and most comprehensive family of instruments available for assuring the quality and safety of diagnostic X-ray imaging systems. With its choice of all-in-one exposure solid-state detector, dosimeter, ion chambers, optional mA/mAs invasive shunt or non-invasive clamp device, and the option of handheld display or laptop interfaces (both completely wireless), the range of tools provide state-of-the-art solutions for all X-ray test protocols.

fLuKe BiOMedicaL everett,wa, usaArab Health Stand 1H19 www.ihe-online.com & search 45485

Syringe pump with large memory capacitySuitable for standard and intensive care use as well as in anaesthesia, the new A606 S syringe pump from CODAN ARGUS has a 32-bit controller enabling fast communi-

cation with other devices, such as a PDMS. It is equipped with a battery capa-ble of nine hours autonomy and a fast recharging time of only six hours. The large LCD screen shows clearly all relevant infusion parameters at a glance. Since the recording of all user pump manipulations is important, especially for traceability in case of an incident, the new syringe pump has been designed to have a large memory capacity which can store up to 1000 events in its log, so that pump usage that might have been carried out even weeks or months previously can be examined. The use of the ARGUSmedb medication library minimises the chances of dosing errors, through the establishment of both soft and hard limits, which can be set individually for each medication.

cOdan arGusBaar, switzerlandArab Health Stand 7D10 www.ihe-online.com & search 45487

Multi-modality LCD displayThe Modalixx LCD display provides versatil-ity to meet the specific demands of any medi-cal institution, and is the only multi-modality solution on the market that autosyncs to any legacy colour or grayscale analogue modal-ity including Cath Lab, MRI, CT, RF rooms, C-Arm, Endoscopy/ Surgical, Portable X-Ray,

and Nuclear Medicine applications. The display is compatible with a range of low line to high line video signals and can upgrade to 2 mega pixel resolution.

aMprOnixirvine, ca, usaArab Health 1H01 www.ihe-online.com & search 45492

Automatically adaptive surgical lightThe new TruLight 5520 OR light eases the surgeon’s workload by automati-cally adapting illumination as situations change during surgery. It provides the perfect lighting for each phase of a sur-gical procedure. All the surgeon has to do is set the ideal lighting intensity at the beginning of the operation. Even if the light is moved during the operation, the light maintains the illumination pre-set by the surgeon. The “Adaptive Light

Control plus” system thus ensures the best possible lighting conditions during the entire operation without the surgeon or the assistant having to readjust the light settings.

truMpf MedicaL sYsteMsditzingen, GermanyArab Health Stand 3A1 www.ihe-online.com & search 45475

Portable nasal wash system Designed for upper airways and nasopharynx washing using an aero-sol with constant composition and properties, the Rhino Clear Mobile system has been designed to be prac-tical and easy to use. Being much less cumbersome than other systems it is easily portable and is suitable for use not only with saline solutions but also with all medications commonly used in aerosol therapy. The device is man-

ufactured from biocompatible and non-allergenic material and, in compli-ance with EU regulations, does not contain any phthalates. Individual nasal adaptors are available for personal use and exist in three formats: for up to 3 years of age; up to 10 years and over 10 years of age.

fLaeM nuOvaMartino della Battaglia, italy Arab Health Stand ZZB50 www.ihe-online.com & search 45488

oN sHoW At ArAB HeAltH 31

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– Issue N°7 – Dec. 2009/Jan 2010

Range of LED surgical lamps Now available on international markets, the Green Series of Medical Exam Lights from Welch Allyn feature energy-efficient light-emitting diodes (LEDs) as opposed to halogen lamps and so do not require bulb replacement. Producing white, bright light with a colour temperature of 5,500ºK, the lights provide a superior light that offers industry-leading lumen performance and 50,000 hours of life. The touchless auto on/off and intensity control features reduce the risk of infections due to cross-contamination. There are several models

in the new range: GS Exam Light IV is designed for the OB/GYN office, whereas the GS 300 General Exam Light combines intense light output and cool operation in a compact design for in-office procedures. The GS 600 Minor Procedure Light features three LEDs and a wider head designed for minor surgical procedures and exams and finally the GS 900 Procedure Light has six LEDs, for nearly every application in any environment.

weLcH aLLYnskaneateles falls, nY, usa,Arab Health Stand 6A50 www.ihe-online.com & search

Enhancing breast imaging with elastographyElastography is a non-invasive medical imaging technique that can detect tumours based on their stiffness (elasticity) com-pared to normal tissue. The most common type of elastography uses ultra-sonic imaging to compare the shapes of the tissue under examination before and after it is compressed

slightly. Cancerous tumors tend to be many times stiffer than normal tissue, which “gives” under compression. Many tumours, including breast tumours, show up better in an elastogram than in conventional ultrasonic images. The latest version of the iU22 ultrasound system from Philips features advanced breast imaging capabilities, including elastography, which in addition to fea-tures such as volume imaging, tissue aberration correction and smart exam, makes the iU22 well-suited for breast imaging., Elastography on the iU22 system with L12-5 transducer and Advanced Breast Tissue Specific Imaging (TSI) preset enables clinicians to differentiate the relative stiffness of tissue through sonographic examination.

pHiLipseindhoven, The netherlandsArab Health Stand 3E30 www.ihe-online.com & search

Whole body exercising by vibration systemUnique because of its use of sonic wave tech-nology, a whole body vibration device has been introduced to the market. The TurboSonic system is a highly efficient and stable training system which provides exercise effects for all body parts. Using vibrations of approximately 50 Hz, it is claimed that the system stimulates muscles, bones, nerves and the heart as well as the hormone system. It is also claimed that the user’s strength, flexibility, energy, endurance, balance and coordination is improved. Pain, stress, and fatigue are reduced. The system is suitable for people of all ages in the areas of sports, wellness and fitness, as it keeps the muscles and bones in general good shape.

scHwa.MedicOehrighausen, GermanyArab Health Stand ZD11 www.ihe-online.com & search

oN sHoW At ArAB HeAltH32


FroNt CoVer ProdUCtMulti-performance in all Ultrasound applications

The ProSound Alpha 6 from Aloka belongs to the next generation of com-pact colour ultrasound systems. The new system is multi-purpose fully upgrada-ble and provides unprecedented per-formance in all ultrasound applications. Incorporating the benefits of the high end ProSound Alpha series and building

on the ProSound technology strengths, the Alpha 6 addresses all diagnostic applications in one system, a marked difference to other ultrasound systems. The system supports a full range of application-specific probes and software, designed to target all specialist diagnostic areas in general imaging, cardio-vascular, obstetrics & gynaecology and internal medicine. The ProSound Alpha 6 high power processor allows a number of different imaging modes previously seen only in high end systems, without compromise on image quality and colour Doppler sensitivity. The compact, ergonomic design of the ProSound Alpha 6 features a large, programmable touch screen panel for quick access to frequently used controls. A height adjustable operation panel and swivel LCD monitor provides ease of use to the examiner.

aLOKa eurOpe,Zug, switzerlandArab Health Stand 2F20 www.ihe-online.com & search

– Issue N°7 – Dec. 2009/Jan. 2010

Portable warmer for infusion fluidsThe treatment of patients suffering from hypothermia remains a real challenge for emergency health serv-ices, particularly in countries that have severe winters. This has led to several innovations being introduced so that IV fluids may be warmed in the field. These range from simply leaving the IV fluids on the dashboard of the attending vehicle with the heating set to high, to car battery-powered heaters and small insulating blankets for the IV bag and tubing. In a more rigorous approach, the FlexWarmer device from Elltech uses a reusable chemical heating pack and a heat-transfer case which warms a loop of the IV tubing as the fluid flows to the patient. The system is extremely simple to operate — all that is needed is to place the heat pack

in its case and the IV tubing in the warming channel, and then to activate the pack. The device is available in two formats, for 4 and 5mm channel standard tube sets respectively.

eLLtecnagoya, Japan www.ihe-online.com & search 45484

Exercise stress test system Comprising the cycloergometer CRG 200 exercise bicycle and the CardioTEST software, the com-plete CardioTEST Alfa System is a professional tool specifically designed for the measurement of both exercise and resting ECGs. Controlled by a PC running the CardioTEST software via an RS-232 interface, the exercise bicycle incorporates the most modern technology and ena-

bles load adjustment within the range of 25 – 400 W. Since the load level is controlled by microprocessor, it does not depend on speed, which can be adjusted according to the patient’s individual needs. The cycloergometer is equipped with ECG mode recording 12 standard leads. The design of the bicycle not only ensures comfort and safety but also facilitates easy operation and cleaning.

aspeL Zabierzów, poland www.ihe-online.com & search 45486

Managing H1N1 influenza within ICUs A booklet containing best practice guidance and bringing together a summary of the latest advice and protocols for Intensive Care Units (ICUs) preparing for the H1N1 influ-enza virus is available from Kim-berly-Clark Health Care via a simple download from the company’s special web site (www.haiwatch.com). The booklet extracts relevant information for ICUs from documents published by a wide range of organisations and

professional bodies including the World Health Organisation (WHO), the national UK and Portuguese governments, clinical societies in Germany

and Ireland as well as other information from Canada.The guidance out-lines the need for ICUs to focus upon strict infection control practices and planning for sufficient supplies of key drugs, equipment and staff and for health care workers, patients and visitors to follow the appropriate infec-tion control precautions to minimise the possibility of health-care associ-ated transmission. Focusing on the control of the spread of respiratory droplets as the proven route of human-to-human transmission, the guid-ance also outlines general personal protective equipment measures in a check-list format. Concentrating specifically on mechanical ventilation, the document draws from key national guidelines which state that closed suctioning should be employed and that ventilation circuits should not be broken unless absolutely necessary. KiMBerLY-cLarK HeaLtH careZaventem, Belgium www.ihe-online.com & search 45491

Brushes for cleaning surgical instrumentsThe quality and integ-rity of surgical instru-ments have an impor-tant impact on the quality of surgical care — instruments will last much longer if they are cleaned with an appropriate solution immediately after sur-

gery and if they are regularly sharpened, lubricated and sterilised. The new range of “Cleanables” brushes from Sharn has been designed for the effi-cient cleaning of all medical instruments. Brushes are available with single or double ended bristles of 5mm, 8mm or 10mm bristle diameter. All the brushes are 63 cm in length and feature anti-microbial nylon bristles with a large bristle area that provides up to 50% more brushing power. The shal-low cannula cleaning brushes illustrated are 13 cm long and are available with 5mm, 7mm and 10mm bristle diameter. Also new is a box lock brush featuring a comfortable flat white handle. It is 18 cm long with a brushing surface of 3 cm by 7 cm. sHarn anestHesia, inctampa, fL, usa www.ihe-online.com & search 45490

ProdUCt NeWs 33


– Issue N°7 – Dec. 2009/Jan 2010

Endotracheal tube introducerCombining the benefits of an introducer and stylet in one device, the new purple - coloured malleable endotracheal tube introducer features an internal wire that allows the “bougie” to be pre-bent for optimum use. There are graduation marks every 5 cm which enables the depth of placement to be controlled. The new introducers can be used with ET tubes, rigid bron-choscopes, laryngeal mask airways and double lumen

endobronchial tubes. The adult version has a diameter of 15 french and the paediatric version is 10 french in diameter; both are 70 cm in length and have a safety stopper. Designed for single patient use, the devices are latex-free and sterile packed.

sHarn anestHesia inctampa, fL, usa www.ihe-online.com & search 45474

Notebook-based ultrasound systemThe ClarUs u l t r a s o u n d system has been devel-oped as a com-pact and light-weight colour system for applications in obstetrics

and gynaecology, general and musculoskeletal imag-ing, vascular access and other fields. The system is flexible and easy to use, thus making it an excellent choice for any practice wanting a high quality colour Doppler imaging system. Supporting a wide range of linear, convex and microconvex transducers, the unit provides a platform that is versatile and offers great expansion potential as needs grow. Providing uncom-promising quality of images along with precision measurement, storage, recall and convenient commu-nication capability, the system incorporates variable frequency and focusing, an extended cine memory and the ability to output data in a variety of formats.

teLeMed uLtrasOund MedicaL sYsteMsvilnius, Lithuania www.ihe-online.com & search 45489

ProdUCt NeWs34

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www.cardiostim.fr

pubcom136x86_v2.indd 1 6/10/09 14:53:43

CAleNdAr oF eVeNtsFebruary 25-28, 2010Early Disease Detection and Pre-vention (EDDP) conference 2010Munich, GermanyTel. +41 22 5330 948Fax +41 22 5802 953e-mail: [email protected]/eddp2010/

February 26-28, 2010 2010 First International Meeting on Cardiac Problems in Pregnancy (CPP)Valencia, SpainTel. +41 22 5330948 e-mail: [email protected] www.CPP2010.com

march 4-8, 2010ECR 2010Vienna, AustriaTel. +43 1 533 40 64 - 0Fax +43 1 533 40 64 - 448e-mail: [email protected] http://myESR.org

march 9-12, 201030th international Symposium on Intensive Care and Emergency Medicine (ISICEM)Brussels, BelgiumTel. +32 2 555 3631 Fax +32 2 555 4555 e-mail: [email protected]

march 15-18, 2010World of Health IT Conference & ExhibitionBarcelona, SpainTel. +32 2 793 76 37Fax +32 2 793 76 31e-mail: [email protected] www.worldofhealthit.org

march 18-21, 2010KIMES 2010Seoul, KoreaTel. +82 (2) 551 0102Fax +82 (2) 551 0103e-mail: [email protected]

April 14-16, 2010Med-e-Tel 2010Luxembourg, LuxembourgTel. +32 2 269 84 56Fax +32 2 269 79 53e-mail: [email protected]

April 18-21, 201063rd CMEF Spring 2010Shenzhen, ChinaTel. +86 10 6202 8899 ext 3825Fax +86 20 6235 9314e-mail: [email protected]://en.cmef.com.cn

may 11-13, 2010Medical Fair Australia 2010Sydney, AustraliaTel. +1 312 781 5180Fax +1 312 781 5188e-mail: [email protected]/shows/medfair-australia.html

may 19-20, 2010World Health Care Congress - Europe 2010Brussels, BelgiumTel. +1 800 767 9499Fax +1 781 939 2692e-mail: [email protected] www.worldcongress.com/europe

may 25-28, 2010Hospitalar 2010São Paulo, Brazilwww.hospitalar.com/ingles/

June 1-3, 2010Hospital Build Middle East Exhibition and Congress 2010Dubai, United Arab EmiratesTel. +971 4 3365161 Fax +971 4 3364021e-mail: [email protected]

June 10-13, 201015th Congress of the European Hematology AssociationBarcelona, SpainTel. +31 70 3455563Fax +31 70 3923663e-mail: [email protected]

June 12-15, 2010Euroanaesthesia 2010Helsinki, FinlandTel. +32-2-743 3290Fax +32-2-743 3298e-mail: [email protected] www.euroanaesthesia.com

June 16-19, 2010World Congress of Cardiology Scientific Sessions 2010Featuring the 3rd International Conference on Women, Heart Disease and StrokeBeijing, Chinae-mail: [email protected]

June 16-19, 2010CARDIOSTIM 201017th World Congress in Cardiac Electrophysiology & Cardiac TechniquesNice , Francewww.cardiostim.fr?xtor=ADI-5

August 28 – September 1, 2010ESC Congress 2010Stockholm, SwedenTel. +33 492 947 600Fax +33 492 947 601www.escardio.org/congresses/esc-2010

September 15-17, 2010Medical Fair Asia 2010Suntec SingaporeTel: + 65 6332 9620Fax: +65 6332 9655 / 6337 4633e-mail: [email protected]

October 9-13, 2010ESICM 2010Barcelona, SpainTel. +32 2 559 03 55Fax +32 2 527 00 62e-mail: [email protected]

dates and descriptions of future events have been obtained from usually reliable official

industrial sources. iHe cannot be held respon-sible for errors, changes or cancellations.

For more events see www.ihe-online.com/events/

FroNt CoVer ProdUCtIntraoperative radiotherapy system

Developed after a careful analy-sis of the limita-tions of current intraoperative radiotherapy procedures that are carried out during surgery, the LIAC sys-tem from the

Italian company Sordina uses an electron beam to treat neoplastic tissue that is exposed during surgery. Thanks to the ability to rapidly position the system and the intensity of its radiation, the LIAC is suitable for all intraoperative therapies and does not result in any lengthening of the duration of even short surgical interventions. The innovative characteristics of the LIAC, such as its small size, safety features and variable power set-tings of the electron beam mean that it is possible for the system to be used in any operating room without the need for any structural alterations.

sOrdinasaonara, italy www.ihe-online.com & search 45476

– Issue N°7 – Dec. 2009/Jan. 2010

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