r o m e • i ta ly 2 7 a u g - 3 1 a u g 2 0 1 6 n e w s a n d t e c h n o l o g y u p d a t e s f o r c a r d i a c c a r e cardiology 2016 www.healthcare-in-europe.com www.healthcare-in-europe.com research by a team at john hopkins university (jhu) in baltimore, usa highlights the patients who are most likely to face lethal arrhythmias. when patients suffer arrhythmia, cardiologists often respond by fit- ting a small defibrillator implant to sense the onset of arrhythmia and jolt the heart back to a nor- mal rhythm. however, the ques- tion remains over how they decide which patients need the implant and the invasive surgery needed to fit it. aiming to address this, a team from the department of biomedical engineering and institute for computational medicine at jhu has developed a non-invasive 3-d virtu- al heart assessment tool to help doc- tors determine which patients face the highest risk of a life-threatening arrhythmia and would benefit most from a defibrillator implant. early evidence suggests the new digital approach yielded more accu- rate predictions than the current blood pumping measurement used by most physicians. ‘our virtual heart test significant- ly outperformed several existing clinical metrics in predicting future arrhythmic events,’ professor natalia trayanova, the university’s inaugu- ral murray b. sachs professor of biomedical engineering, said. ‘this non-invasive and personalised virtu- al heart-risk assessment could help prevent sudden cardiac deaths and allow patients who are not at risk to avoid unnecessary defibrillator implantations.’ a pioneer in developing personal- ised imaging-based computer mod- els of the heart, she has worked on the project with cardiologist katherine c wu, associate profes- sor in the johns hopkins school of medicine, whose research has focused on mr resonance imaging approaches to improving cardiovas- cular risk prediction. for the study, trayanova’s team formed its predictions by using the distinctive magnetic resonance imaging (mri) records of patients who had survived a heart attack but were left with damaged cardiac tissue that predisposes the heart to deadly arrhythmias. the study involved data from 41 patients who had survived a heart attack and had an ejection fraction – a measure of how much blood is being pumped out of the heart – of less than thirty- five percent. patients in this range are usu- ally recommended implantable defi- brillators, however, with the jhu team concerned about this measur- ing score system, they invented an alternative to these scores by using pre-implant mri scans of the recipi- ents’ hearts to build patient-specific digital replicas of the organs. using computer-modelling tech- niques developed in trayanova’s lab, the geometrical replica of each patient’s heart was brought to life by incorporating representations of the electrical processes in the cardiac cells and the communication among cells. in some cases, the virtual heart developed an arrhythmia, and in others it did not. the new non-invasive way to gauge the risk of sudden cardiac death due to arrhythmia has been named the varp (virtual-heart arrhythmia risk predictor). subsequent tests showed that patients who tested positive for arrhythmia risk by varp were four times more likely to develop arrhythmia than those who tested negative. varp predicted arrhyth- mia occurrence in patients four- to-five times better than the ejec- tion fraction and other, invasive and non-invasive, existing clinical risk predictors. ‘we demonstrated that varp is better than any other arrhythmia prediction method out there,’ trayanova confirmed. ‘by accurately predicting which patients are at risk of sudden cardiac death, the varp approach will provide the doctors with a tool to iden- tify those patients who truly need the costly implantable device, and those for whom the device would not provide any life-saving benefits.’ wu said that the early results indi- cate the more nuanced varp tech- nique could be a useful alternative to the one-size-fits-all ejection frac- tion score. trayanova is hopeful the new risk prediction methodology could also be applied to patients who had prior heart damage, but whose ejection fraction score did not tar- get them for therapy under current clinical recommendations. the next step is to conduct fur- ther tests involving larger groups of heart patients. the virtual-heart arrhythmia risk predictor natalia trayanova phd is the john hopkins university’s inaugural murray b. sachs professor of biomedical engineering in the department of biomedical engineering and institute for computational medicine. she received her doctorate at the bulgarian academy of sciences in sofia (1986) and post-doctoral training in biomedical engineering at duke university. her research focuses on understanding the normal and pathological electrophysiological and electromechanical behaviour of the heart. the virtual heart arrhythmia risk predictor. patient-specific heart models are constructed from clinical imaging data. a virtual-heart model is then used to predict the patient risk of lethal arrhythmias. identifying patients with cardiac injury at risk for lethal arrhythmias using a combination of cardiac imaging and computational simulations. from the patient’s scan (blue), a virtual heart is constructed and the presence of arrhythmia, indicated by the non- uniform electrical activation (red-yellow), is revealed. researchers have developed a personalised 3-d virtual heart that can help predict the risk of sudden cardiac death. mark nicholls reports r o m e • i ta ly 27 a u g - 31 a u g 2016
d7947_esc-365-european-hospital.indd 1 21/07/2016 09:32 cardiology 6 european hospital vol 25 issue 4/16 within the theme ‘prediction and prevention’, the 2016 british cardio- vascular society annual conference held in manchester this june, fea- tured innovative and interactive presentations, sessions, workshops, panel discussions, debate and a fas- cinating scientific programme. the keynote speech, ‘big data: a big deal for cardiology?’ deliv- ered by professor viktor mayer- schoenberger, professor of internet governance and regulation at oxford university’s internet institute, focused on the role of information in a networked economy. the bcs lecture ‘elucidating the genetic basis of coronary artery disease; implications for prediction, prevention and treatment’ was deliv- ered by professor sir nilesh samani, british heart foundation (bhf) chair of cardiology at leicester university, who was knighted in 2015 for his services to medicine and medical research. professor cliff garratt, chair of the programme committee and bcs vice-president (education & research): ‘over the last few years, professor samani’s group has led large-scale studies that have identi- fied multiple genetic loci that affect risk of coronary artery disease. this presentation will present the cur- rent state of the discovery pro- cess, discuss what we have learned and illustrate the clinical translation potential of the findings.’ prediction and prevention in acute coronary syndromes, the title of the bhf bench-to-bedside session - consisting of presentations (basic, translational or clinical) focused on a particular clinical condition – focused on the work of the bhf centre for cardiovascular science at the university of edinburgh. ‘over the last 30 years, this edinburgh unit has led the way in describing new underlying causes of coronary heart disease, improving the identification of those at great- est risk, and ultimately demonstrat- ing several innovative ways to treat coronary heart disease,’ explained professor garratt. the sir thomas lewis lecture saw professor michael ackerman from the mayo clinic focus on prediction and prevention of sudden cardiac death in the young, while clinical anatomist, author and broadcaster professor alice roberts discussed what embryology of the heart and other organs has taught us about our evolutionary origins. in recent years, the bcs confer- ence has gained recognition for offering ‘something completely dif- ferent’ and, following on from the year’s well-received presentation on music and the cardiovascular system, the focus for the popu- lar tuesday afternoon auditorium session was photography and the heart. the conference also provided coverage of all the new develop- ments in cardiology and cardiovas- cular science in training, a dedi- cated imaging track, arrhythmias with sessions on af ablation and on first–line management of cardiac arrhythmias; intervention with ses- sions on acute coronary syndromes, myocardial infarction and percu- taneous management of structural heart disease; heart failure; and adult congenital heart disease. sessions also included clinical science and translational research, basic science and hot topics, the young investigator’s prize, resus- citation, education for revalidation (e4r) and international sessions in association with the european society of cardiology and the american college of cardiology. an area for interactive education included 100+ hot topic sessions, poster sessions, simulator training, and an imaging village with interac- tive, supervised ct, mri, echo and nuclear imaging work-stations. garratt said the conference, again held with the british heart foundation, has attracted progres- sively increasing numbers of del- egates over recent years. ‘there is little doubt that there’s an increasing - rather than decreasing - need for today’s cardiologists to have a broad understanding of all the major subspecialist areas. the british cardiovascular society annual conference is uniquely positioned to facilitate this in one meeting.’ the 2016 british cardiovascular society conference prediction and prevention big data, the genetic basis of coronary artery disease and sudden car- diac death in the young were among key subjects for british cardiolo- gists at their 2016 annual conference, mark nicholls reports remote monitoring through smaller, more effective, insertable cardiac monitors is playing a significant role in delivering care improvements for heart patients. greater sensitivity and versatility of devices, as well as more patient- friendly implantation options, were issues outlined at the cardiostim 2016 ehra europace world con- gress on cardiac electrophysiology, held in nice, france. the ‘improving patient outcomes in arrhythmia management’ scien- tific session focused on biotronik home monitoring systems, dur- ing which experts from australia, switzerland and the usa discussed the latest research on how remote monitoring systems and insert- able cardiac monitors (icms) can improve patient outcomes. in highlighting the rising impor- tance of using remote monitoring via icms to enable earlier diagnosis and prevention in patients who have arrhythmias (but are not yet indicated for a pacemaker or icd), the senior cardiologists also outlined how home monitoring is reducing mortality, hospitalisation and health- care costs. during the congress, berlin-based cardio and endovascular medical technology specialist biotronik also unveiled findings of the first-in- human trials of its new biomonitor 2 icm device to delegates with experts. covering 30 patients, this pilot study revealed high r-wave amplitudes and a 93.8 percent suc- cess rate for daily home monitoring transmissions from a device that can be inserted in as little as two minutes. ‘for icms to have a significant impact on early arrhythmia diagno- sis, reliable detection including sens- ing, data quality and transmission is critical,’ lead investigator dr sze- yuan ooi, from sydney, explained. ‘this study shows promising results for biomonitor 2 in all of these fields. the high transmission suc- cess rate is key because we need robust, high-integrity data for our patients to derive the maximum benefit.’ biomonitor 2 has an extended sensing vector with the combination of the rigid (55mm long) and flex- ible (33mm) part allowing adjust- ment to the shape of the body. sensitive to changes in heart rhythm with the automated detec- tion of atrial fibrillation, bradycar- dia, sudden rate drop or high ven- tricular rate, this device can make up to six ecg transmissions a day. ooi described the biomonitor 2 as a ‘big step forward’ in terms of technology, design and implantation technique, compared to the first generation biotronik biomonitor device. ‘the pilot study showed that the r-wave amplitude is greater than the original biomonitor device, the implantation pro- cess was easy, straightforward and quick and the other impor- tant finding out of all this was the device sensitivity and versatility increase smaller and more effective insertable cardiac monitors cliff garratt is professor of cardiology at the institute of cardiovascular sciences, professor of cardiology at manchester university and hon. consultant cardiologist at central manchester university foundation trust. a clinical academic with an interest in arrhythmias and clinical cardiac electrophysiology, his research and clinical interests focus on the mechanisms and management of atrial fibrillation and familial sudden cardiac death syndromes. d7947_esc-365-european-hospital.indd 121/07/201609:32
headquarters: schiller ag, altgasse 68, ch-6341 baar phone +41 41 766 42 42, fax +41 41 761 08 80 firstname.lastname@example.org, www.schiller.ch designed for users who value state-of-the-art technology, schiller’s cardiovit ft-1 offers: easy 1-2-3 steps outstanding signal quality for adult and paediatric ecg bidirectional wi-fi communication improved interpretation algorithm with etm sport for athletes maximum performance in a compact electrocardiograph explore the new ecg world: schiller’s cardiovit ft-1 visit us at the esc in rome 27.8.-31.8.2016 e4-0200 eh_2016-08_ft-1_210x297_en.indd 1 11.08.2016 10:41:59 cardiology 9 www.healthcare-in-europe.com from page 6 d versatility increase hospital zurich, who discussed how earlier management of atrial and ventricular arrhythmias is enabled by detection with icms, and dr niraj varma, from the cleveland clinic, who spoke about improving out- come of icd and crt-d patients by continuous remote monitoring. ‘efficient workflow and robust transmissions are critical to leverag- ing the benefits of remote monitor- ing,’ varma said. biotronik home monitoring facilitates this with daily automatic transmissions that pre- serve the highest order of data integrity, and are yet easy to handle. ‘this is a key reason why this system has been associated with improved clinical outcomes in sev- eral trials and why the current remote monitoring guidelines are based largely on home monitoring data,’ varma explained.’ professor josep brugada is medical director of the cardiovascular institute, at hospital clínic, university of barcelona, spain, and a past president of the european heart rhythm society. with his brothers, pedro and ramon, he identified brugada syndrome, a genetic disease characterised by abnormal electrocardiogram (ecg) findings and an increased risk of sudden cardiac death. the group of patients treated with sonr was 75%, compared to 70.4% in the echo group. it also emerged that optimisation with sonr resulted in a significant improvement in clini- cal response for patients with atrial fibrillation and renal dysfunction. professor brugada from the cardiovascular institute, hospital clinic, university of barcelona, said: ‘in order to deliver the very best crt treatment to our heart failure patients, there has been a real need for an optimisation solution that is both automatic and efficient. ‘the results of the respond-crt trial have shown that sonr perfectly meets this need. the high rates of responders together with the ben- eficial improvements in clinical out- comes indicate a significant advance- ment in crt therapy, one that will allow us to better treat a larger num- ber of heart failure patients. ‘automatic optimisation with sonr was as effective as echo-guided opti- misation - 75% v 70.4% – so the primary efficacy end point was met, that a clinical response was in favour of sonr but especially patients with history of af and renal dysfunction, and optimisation, using the sonr contractility sensor, showed signifi- cant reduction of 35% in rates of heart failure hospitalisation during long-term follow up.’ implanted cardiac resynchronisa- tion devices resynchronise the con- tractions of the ventricles of the heart by sending tiny electrical impulses to the heart muscle, helping the heart to pump blood more efficient- ly throughout the body. the sonr sensor uses measurements of car- diac contractility to optimise cardiac resynchronisation therapy. singh, from massachusetts general hospital, boston, explained that although echo-guided optimisation was considered the gold standard in terms of reducing the number of non-responders to crt, it was not widely used because of the com- mitment of time and resources it requires, as well as patients needing to attend the clinic. he added that the sonr can optimise av and vv intervals on a daily basis and on weekly basis for both rest as well as for exercise so patient do not have to come into the clinic or have echo guided optimisation. ‘the device using the sensors can automatically optimise the heart, overcoming the inadequacies of existing optimisation strategies and logistical issues with echo-guided optimisation strategies.’ respond-crt was a prospective, multicentre, randomised, double- blind study designed to evaluate the safety and efficacy of the sonr system. 1,039 patients were enrolled at 125 sites in europe, the usa and australia, who were implanted with a crt-d (cardiac resynchronisation therapy and defibrillation) device, which combines the function of an implantable cardiac defibrillator (icd) with cardiac resynchronisation therapy (crt). patients were randomised 2:1 to receive either av or vv optimisation with sonr or echocardiography, with the study meeting all of its primary safety and efficacy end points. continuous cardiac resynchronisation reduces hospitalisation ng af and renal ion care nce of all imaging modalities – including ate prosthetic heart valves in a new series phone +41417664242, fax +41417610880 eh_2016-08_ft-1_210x297_en.indd 111.08.201610:41:59
cardiology 10 european hospital vol 25 issue 4/16 to sharply focus on the specialised requirements in echocardiography, toshiba engineers built from scratch the aplio i900cv with a total rede- sign of hardware and software. the new aplio i-series is a premi- um addition to the award-winning aplio 500 platform, which today is used in more than 31,000 clini- cal settings worldwide. ‘the system works very fast with a reduced requirement for user interaction, which translates into a significant time saving for the echocardiography lab,’ accord- ing to the head of cardiovascular imaging at the hospital clinico san carlos in madrid, spain, professor leopoldo perez d’isla md. the impressive speed of the new architecture and the resulting time savings, ‘means that we are improving the cost-effectiveness of the echo-lab, avoiding patient discomfort caused by unnecessary waiting times and increasing opportunities for patient examinations’. the aplio i-series jumps ahead to a next generation with an archi- tecture that gives it on-board capa- bilities for ultra-fast processing of advance applications, and with a new range of high frequency and ultra-wideband transducers. to maximise the potential of the new architecture, the aplio i-series matrix transduc- ers utilise a new lens material that effectively introduces a new tech- nology. thinner, lighter and with more flexible cables, a wide range of aplio’s i-series transducers fea- ture the intelligent dynamic micro slicing (idms) capability. new with the aplio i900cv is a 3-d transoesophageal echocardi- ography (tee) transducer that ‘is exactly the tool we need,’ according to professor hans-joachim nesser md. the head of the cardiology, angiology, medical intensive care for the 2nd internal department at the elisabethinen hospital in linz, austria, stated, ‘we have long wanted this, and here it is bringing the possibility to view aortic leaflets, or to measure mitral valve para meters where we can not only see the opening, but can even see the stitches where the valve has been repaired.’ yet, thanks to the new ultra wide- band transducers, a tee exam is not always required. nesser found that, with the wider coverage and what he called extremely good penetra- tion up to 28 centimetres, ‘we can evaluate the aortic valve area with a transthoracic approach. we are able to see distinctly four-chamber views, and have found really fantastic reso- lution in subcostal views.’ continuous wave doppler on the i900cv has a quality not seen before that enables a fast, excellent quality of signal definition that allows an easy diagnosis to determine myocar- dial performance. after working with cardiovascular imaging fusion on the i900cv, nesser concluded, ‘this is the future. in one display using a hybrid format we see calcified segments of coro- nary arteries derived from ct along with a quantification of the stenosis thanks to 3-d strain imaging, and at the same time a superimposi- tion to the myocardium derived by ct. using a very nice tool called activation imaging, we can add measurements to determine torsion, an important parameter for a variety of diseases, or see areas where there is delayed contraction. we can see rest and stress, related to a specific coronary artery as a superimposi- tion on a ct image, enabling us to make a decision as to intervention.’ aplio i-series processors are so fast that the system boots up in 15 seconds. aplio i-series platforms are 30% lighter with a panel streamlined by a reduction of 50% for buttons and controls. the panel arm supports a 23-inch high-definition display and is so flexible it can fold flat for easier, more convenient handling. and the aplio i-series platforms come with an optional second console, a detachable wireless tablet that displays real-time images and can control all operations. the aplio i-series rolls out in three versions where the aplio i700 is designed as a multi-service plat- form across diverse medical special- ties, and the aplio i800 responds to the more exacting requirements of radiology and women’s health departments. yet it is the advanced features and functionalities of the aplio i900cv that are specifically designed to target specialised examinations and interventions in cardiology. at the heart of an enhanced image quality that was described as ‘stun- ning’ by clinicians is the ibeam technology. electrical dynamic focus with individual matrix element con- trol and multiplexing with ultra-fast processing narrows and sharpens the signal for real-time 3-d beam forming. the advanced architecture in the aplio i-series takes pioneering toshiba ultrasound functions to a new level. • advanced superb micro- vascular imaging (smi) combined with the new transducers becomes more brilliant with reduced motion artefacts, for never-seen perfusion examination capabilities across all regions of human anatomy. • quad fusion capability creates impactful viewing for interventional procedures or advanced diagnostics, with a simultaneous combination of ct/mri images with real-time ultra- sound and 3-d ultrasound rendering of a live procedure. • super precise 3-d imaging is boosted by aplio i-series ibeam and thin slice acquisition to render near- photo quality images of anatomical structures. professor adrian lim md, from imperial college london said that, beyond the obvious improvements in ergonomics and speed with the aplio i-series platform, for users of previous models of toshiba ultra- sound systems, ‘there is a very famil- iar workflow such that everything becomes intuitive the moment you step to the console.’ ‘this is the future’. medical scientists endorse a new platform toshiba beams in on cardiology ultrasound next-generation aplio i-series premium platform delivers high- frequency probes, advanced applications and ultra-fast processing at a simple touch of a button, aplio demonstrates the mitral valve as seen by the surgeon to facilitate visual assessment of the leaflets for better surgical planning aplio’s advanced wall motion tracking technology provides immediate visual and quantitative access to global and regional myocardial wall motion dynamics in 2-d and 3-d the automated mva tool provides concise anatomic and functional assessment of the mitral valve. the function’s quad display offers a clear overview of different scan planes live 4-d imaging: the new ultra wideband transducers have a wide coverage and an extremely good penetration up to 28 centimetres. an area of just one square centimetre can be seen and clearly defined
cardiology 11 www.healthcare-in-europe.com editor-in-chief: brenda marsh art director: olaf skrober managing editor: sylvia schulz editorial team: sascha keutel, marcel rasch senior writer: john brosky executive director: daniela zimmermann founded by heinz-jürgen witzke correspondents austria: walter depner, michael kraßnitzer, christian pruszinsky. china: nat whitney france: annick chapoy, jane macdougall.germany: anja behringer, annette bus, bettina döbereiner, matthias simon, axel viola, cornelia wels-maug, holger zorn. great britain: brenda marsh, mark nicholls. malta: moira mizzi. poland: pjotr szoblik. russia: olga ostrovskaya, alla astachova. spain: mélisande rouger, eduardo de la sota. switzerland: dr. andré weissen. usa: cynthia e. keen, i.t. communications, nat whitney. subscriptions janka hoppe, european hospital, theodor-althoff-str. 45, 45133 essen, germany subscription rate 6 issues: 42 euro, single copy: 7 euro. send order and cheque to: european hospital subscription 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equipment 55% of heart recipients now survive for 10 years 3-d transducers prove their mettle in cardiology transplants – a much neglected topic the 3-d tee transducer is fast and offers high volume a small report in the press prompt- ed examination of a much neglected topic. the report read ‘heart centre at university hospital no longer carries out transplants’, and referred to the university hospital frankfurt, one of the 22 heart centres that perform these transplantations. so what happened? only four trans- plants were carried out there between 2010 and 2013, and in 2014 and 2015 only two to three were performed per year. why? the same report also men- tioned that around thirty patients per year wait for donor hearts at this hos- pital. donor hearts continue to be in short supply, and organ donation is the problem. there have bee n no improvements in that situation, not only in frankfurt, or all of germany, but also across europe and globally. the ratio between those who received donor hearts and those waiting for donor hearts is increasingly unfavourable. figures from switzerland show an ‘average’ european example: when 33 people received donor hearts in 2005 not even double that number. i.e. 63, were waiting for donor hearts at the time. ten years later, in 2015, the number of transplants‘only’ increased to 40, whilst the number of patients on the waitlist increased to 134. in germany, says professor f w mohr, president of the german society for thoracic and cardiovascular surgery, more than 1,000 patients are currently one of the first facilities to pur- chase a complete set of the 3-d tee transducer, including the equipment, was the department of cardiology and angiology at university hospital magdeburg, as thomas groscheck, specialist physician for internal medicine at the echocardiography lab explains. since july 2015 he has worked with the new siemens transducer – and is enthusiastic. ‘in our department we treat all types of cardio-vascular disease, from cardiac insufficiency to hyperten- sion, valve repair and aortic valve replacement,’ thomas groscheck explains. ‘we perform all neces- sary studies prior to an intervention and do the follow-up for all car- diac patients, particularly those who underwent valve surgery or received a valve replacement.’ this is where the 3-d tee transducer comes in very handy. ‘what’s so special about this 3-d probe is that it is fast and offers high volume’, the specialist explains. this allows live images with a high frame rate, particularly in 3-d, which is very interesting during valve interventions. ‘i found the hardware and the software in the equipment to be very fast. thus you get high temporal and spatial waiting for donor hearts. however, only 320 hearts were actually transplant- ed. ‘the average patient has very little chance of receiving a donor heart. the organs donated are only allocated to particularly urgent cases,’ mohr explains. at the beginning of the 1990s still more than 420 heart transplants a year were carried out. the allocation of donor hearts in eight european countries (germany, belgium, netherlands, luxembourg, austria, slovenia, hungary and croatia) is coordinated by eurotransplant based in leiden, netherlands. the allocation is based on medical criteria, with no consideration given to national or any other criteria. eurotransplant works with a catchment area of 135 million people across europe. there are simi- lar organisations in scandinavia, cover- ing about 25 million people, or for eastern europe, along with the inter- nationally active society for heart and lung transplantation based in addison (texas, usa). a look at international figures and developments helps to better under- stand the situation. as is known, the first ever heart transplantation was carried out by professor christiaan barnard and a 31-strong team in south africa in 1967. the number of operations increased to 100 transplants (worldwide) in 1980 and to 4003 in 1990, with reported figures of 4203 in 1992, 4364 in 1993, 4429 in 1994 and 4396 in 1995. according resolution with regard to valve visu- alisation in 3-d. this translates into much better quality than our previ- ous transducers delivered.’ length of examination in terms of time spent on exami- nations the new tool also offers benefits. ‘the prep examination for a valve intervention takes ten min- utes on average,’ according to mr groscheck. ‘image acquisition and patient handling pre- and post-exam take about twenty minutes. after to the society for heart and lung transplantation, a total of 80,106 heart transplantations were carried out in 300 officially designated centres between 1967 and 2007. from the mid-1990s the numbers decreased continuously to around 3,000 per year. significantly better and more effective prophylaxis and major advanc- es in treatment, along with the lack of donor organs, are considered the rea- sons for this decline. in january 2016 more than 10,000 patients were waiting for donor hearts across the eight european countries coordinated by eurotransplant. if it had not been for advances in treatment the number of those waiting for donor hearts would be much higher still, say the specialist medical societies. however, documenting advantages and disadvantages with statistics does not do justice to the topic of heart trans- plantations. the history of heart transplants is also one of particular success. as is known, the first person to receive a donor heart, transplanted by prof. christiaan barnard in 1967,‘only’ survived the operation for 18 days. in those days the prospects of a ‘longer’ life after the operation were also generally not particularly rosy. however, over the course of the years and decades not only the surgical pro- cedures and the expertise and routines improved but also the direct care and aftercare for patients. that time all images are available, including the valve models.’ data acquisition is fast and the analysis can be speeded up when all tools for automatic valve assessment are used. the raw data that are gener- ated and which, theoretically, can be read by any machine, are turned into dicom images, which in turn can be viewed with any dicom viewer.’ handling transducer handling has been one of the main problems was, and remains, rejection of the donor organ. not least through the discovery and development of the immune suppres- sor cyclosporine has it been possible to achieve major success in this field. this ring-shaped, small protein which con- sists of 11 amino acids was discovered by the swiss biologist hans peter frey in 1969 and was publicised in the 1970s. it then led to the development of other, very effective drugs. it is assumed that the current, five- year survival rate is around seventy-five percent and the ten-year survival rate is still at around fifty-five percent to conclude, there are three things we can hope for: firstly, that the num- ber of those requiring donor hearts will continue to fall due to improved medical knowledge and prophylaxis, along with healthier lifestyles in large parts of the population. secondly, that the number of organ donors increases rather than decreases, and lastly that the survival rate con- tinues to increase closer towards the 100% mark through more experience, knowledge, routine and capabilities of the surgeons, along with advances in technology and aftercare. improved. with its plastic grip it is lighter than metal models. ‘this makes the transducer easy to handle,’ the physician reports. ‘nevertheless it takes some to get used to the new probe. the head is a bit more angular, not quite as round as we were used to. the loca- tion of the function buttons and the two knobs to control transducer head movement could be improved ergonomically. the control elements are no longer centred, which means the probe has to be held in a certain way in order to use it in an optimum way.’ however, these are the only handling issues thomas groscheck encountered with the new trans- ducers. temperature advantages there is one feature groscheck is particularly enthusiastic about: ‘with this transducer, temperature issues are a thing of the past. finally! although the device does have a cooling mode with reduced trans- mission performance, i have never been compelled to us it. despite the fact that in 3-d mode the trans- ducer heats up to about 40 °c, i always could easily complete longer sequences.’ thus interruptions due to overheating – a common prob- lem in longer examinations with high sound intensity, particularly in 3-d – are no longer required. ‘in 3-d mode, the 3-d tee transducer works for minutes without any tem- perature problems. that makes life much easier for patient and physi- cian alike. obviously, patient safety has been considerably improved with this device,’ groscheck points out. hand in glove the overall interaction of all ele- ments and components of the new transducer convinced the expert. ‘with a bit of training using the transducer is no problem. transducer, software, and process- ing programmes for the valve mod- els – they are all well aligned and integrate easily in any daily work- flows. even though the device with all its functions and settings might seem a bit technologically intimi- dating at first, actually using it is a real pleasure particularly because it works without a hitch and the individual components work hand in glove,’ groscheck sums up. thomas groscheck is an internal medicine specialist in the echo cardiography lab in the cardiology and angiology department, university hospital magdeburg. following his initial training as a nurse he attended medical school at charité – university hospital berlin. he is currently completing his doctorate. walter depner, writer and consultant specialising in the laboratory field phone: +86-0755-81324036 phone: +496735912993, e-mail: firstname.lastname@example.org phone: +33493587743, e-mail: email@example.com phone/fax: +31180620020 & pr co., ltd., phone: +972-3-6955367 phone: +8227301234, e-mail: firstname.lastname@example.org tel: +13018696610, e-mail: email@example.com
cardiology 12 european hospital vol 25 issue 4/16 two new techniques have emerged for cardiovascular diagnostics that are enabling software to help sur- geons and cardiologists measure, and thereby better manage car- diac disease. both rely on powerful computer processing to expose the secrets of the heart. bon-kwon koo md, from the seoul national university hospital in south korea, has successfully shown how building on technique recommended in cardiology guide- lines, called fractional flow reserve (ffr), a retrospective computational analysis of ct exams can pinpoint the plaque rupture that, up to two years later, would cause a confirmed medical emergency for a patient. the creator of the frr tech- nique, nico pijls md, from the catharina hospital in eindhoven, the netherlands, has since devel- oped a technique for the quantita- tive assessment of microcirculatory blood flow and resistance, the vital irrigation of heart muscle. without ffr, a cardiologist has to subjectively interpret fuzzy angio- graphic images to decide if the blockage is so severe it needs a stent the medtronic corevalve evolut r system received its ce mark of approval this august to treat aortic stenosis in patients with an interme- diate risk for undergoing convention- al surgery for a valve replacement. this is a controversial indication for transcatheter aortic valve implanta- tions (tavi) – one that has been eagerly sought by some clinicians but resisted by others. to re-open the vessel. introduced by pijls 20 years ago, ffr is an inva- sive technique in which a catheter is pulled across a suspected coro- nary lesion to objectively measure differences in blood pressure on either side of a blockage and gives the cardiologist evidence to decide whether to place a stent or not. koo builds upon this critical measurement, but uses a non-inva- sive technique. instead of pushing a catheter into the patient, a super- computer analysis of the patient’s ct angiography exam can deter- mine blood pressure measures on either side of suspected lesions. this technique has been validated in studies sponsored by heartflow, based in redwood city, california, and the company now offers this service to cardiologists. going one step further, physi- cians at 11 heart centres in europe and asia initiated a study, led by koo, to test a hypothesis that going backwards, they could look at cta exams and identify not only which patients were at risk for a plaque rupture, but specifically identify the plaque that was going to rupture. director of the structural heart pro- gramme at the university hospital in bonn, germany, stated: ‘the highly- anticipated intermediate risk indica- tion marks an important milestone for the industry as we look to safely expand tavi access to younger and less sick patient populations.’ a medtronic spokesperson told european hospital that ‘a majority of the patients treated with tavi in for the emerald study, spon- sored by heartflow, koo added computational fluids dynamics and fluid-structural interaction simula- tion to the ffr-ct calculations for 226 coronary plaques among the 71 patients enrolled. emerald investigators first identi- fied patient cases where the culprit plaque rupture had been document- ed using angiography, or intravas- cular imaging such as oct or ivus. then the investigators searched the patient file to find a ct exam that had been performed ahead of the medical emergency. the average among enrolled patients was an exam performed one year earlier. these ct images were then run through the emerald algorithms to assess plaque composition, lesion geometry and the haemodynamic forces. results from the retrospec- tive emerald study were presented in may this year in paris, at the interventional cardiology confer- ence, europcr. ‘non-invasive haemodynamic data from ct was a better discrimina- tor of lesions causal of acs than stenosis severity or adverse plaque characteristics,’ koo concluded. moving to a prognostic potential, koo suggested the combination of all plaque characteristics might fur- etration with the indication for a vastly larger population of patients at intermediate risk for savr is not known, though widely expected to be significant. evidence from head-to-head clini- cal trials has indicated that savr and tavi are fairly evenly matched for efficacy, though with dif- ferent complication pro- files. traditional surgery poses a greater risk for ther improve the pre- diction of plaque-related clinical events to optimise treatment strategies for high- risk patients. emerald is an exploratory study, said heartflow ceo john stevens, ‘and it shows we are very good at i d e n t i f y i n g the plaque at high risk for rupture eight times in 10, which is not just good but extraordinary. for the moment we still have several hundred more patients cases for validation’. dr pijls also presented his novel approach for measuring microcir- culatory in myocardial irrigation at europcr 2016, and when he had finished the panellists applauded in admiration and one of the audi- ence step forward to say: ‘it blows my mind.’ the calculations for this novel car- diac quantification are so complex it took the software engineering of st. jude medical to capture them. the procedure, which required a con- trolled injection of saline solution yet little is known about the dura- bility of tavi valves that were first introduced in 2002 and did not reach a significant patient population until 2007. unlike surgical valves, the delicate valve leaflets for tavi devices are squeezed, or crimped, to fit into the cath- eter that snakes through the femoral artery. once in place, the valve stent holding the leaflets is expanded. placing a prosthesis that is expected to last eight years in an 80-year old patient at high risk for surgery has been seen as a benefit for extending the patient’s life from an expected one year out to eight years, which is widely accepted as being the expected limit of tavi valve durability. the question of placing the shorter-term tavi device in a 70-year-old patient who could undergo surgery and receive a time-tested savr valve is at the heart of the current controversy. the extension of tavi to lower risk patients was the focus for the great debate in may 2016 at europcr, which pitted three leading clinicians on either side of the question. into coronary arter- ies, is so complex that paris-based hexacath stepped in to invent a new catheter so that pijls could realise his experiments. pijls then streamlined the proce- dure to conform to a standard cath lab workflow and removed depend- ence on operator interpretation. as a result, using the hexacath rayflow monorail infusion catheter combined with one of st. jude’s pressure wires for ffr, and then standing back to watch the results on the st. jude monitor, an inter- ventional cardiologist can measure volumetric blood flow directly in selective coronary arteries during cardiac catheterisation and simulta- neously, with the same guide wire, calculate the absolute myocardial blood flow, collateral flow, and myo- cardial resistance. ‘we don’t know yet what it all means, but at least we have a method to measure it,’ nico pijls concluded. the debate at europcr quickly centred on valve durability because earlier the same day, at the same congress, results from the first effort to study valves beyond the three- to five-year follow-up in manufacturers’ studies was released. danny dvir md from st. paul’s hospital in vancouver, canada, effectively punctured the balloon of tavi enthusiasm with a report titled ‘a first look at long- term durability of transcatheter heart valves: assessment of function up to 10 years after implantation’. among the 378 patients enrolled, dvir reported that the median time to degeneration of the implanted valve was five years, and at eight years, some form of valve degenera- tion affected half of all patients with early tavi devices. ‘everyone should know there is the phenomenon of valve degenera- tion, so that when we target younger patients, the lower risk patients who may survive longer, their valve may fail,’ he advised. break-through techniques tap software to reveal disease causes despite unknown valve leaflet durability… exposing the secrets of the heart tavi is approved for lower risk patients coronary interventions often rely more on art than science as the decision to treat a patient tends to be based on what clinicians can see, a subjective interpretation of cardiac imaging. younger patients will receive artificial valves shown to degenerate at five years for half of all patients, john brosky reports medtronic announced its next- generation evolut valve was granted regulatory clearance in europe for cases where a decision to go ahead with the procedure is made by an interdisciplinary heart team. meanwhile edwards lifesciences, the dominant provider of tavi devic- es in europe, reported to investors that it filed for a ce mark to expand into this same indication with its sapien 3 tavi valve in the second quarter of 2016, and that it expects approval in late 2016 or early 2017. in the medtronic announcement professor eberhard grube md, europe will continue to be of the extreme and high-risk patient popu- lations, but expanding the indication for the corevalve evolut r system will help heart teams provide excel- lent clinical outcomes for broader indicated patient populations.’ tavi procedures currently hold a 37% share of the market in europe, against traditional surgical aortic valve repair (savr) according to esti- mates from wells fargo securities. medtronic devices are used in 31% of those procedures against a 52% share for edwards lifesciences. the opportunity to expand tavi pen- bleeding, kidney dam- age and the onset of atrial fibrillation requiring a pacemaker implantation. tavi has strug- gled against persistent paravalvu- lar aortic regurgitation and a high pacemaker implantation rate. yet, for patients at lower risk for traditional surgery, who tend to be younger, the key concern among cli- nicians is the durability of the valve leaflets on tavi devices. savr valves have a long history regarding dura- bility that stretches to 25 or 30 years.