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www.healthcare-in-europe.com 23CARDIOLOGY Mechanical recanalisation of blocked cerebral arteries for acute severe ischaemic strokes Six international studies endorse thrombectomy A new super-smart medical mobile The interventional procedure of end- ovascular recanalisation, in short thrombectomy, for acute severe ischaemic strokes, is not new. With this procedure, which has been car- ried out worldwide for several years, the occluding blood clot is mechani- cally removed with the help of a so- called stent retriever – a micro-cath- eter developed only quite recently – which is guided to the cerebral artery from the femoral artery. The procedure is carried out in addition to the administration of thrombolytic medication within the first six hours of the start of symp- toms and facilitates recanalisation, which cannot always be achieved with thrombolysis alone (general recanalisation rate in severe strokes around 35%) – particularly for clots >1cm (recanalisation rate for thrombectomy around 80%). Until now no studies could prove the benefit of the endovascular recanalisation for patients with regards to lasting disabilities and mortality compared to the conven- tional procedure of intravenous thrombolysis. However, this has now changed. ‘We now have the certainty, for the first time, that if this procedure is used in a specific and system- atic way, our patients experience fewer lasting disabilities and lower mortality at three months after the procedure,’ said Professor Matthias Endres, Director of the Clinic for Neurology at the Charité University Hospital in Berlin, Germany and Deputy Chairman of the German Stroke Society, during its related press presentation. The first of this round of six stud- ies that recently scientifically con- firmed the benefit of thrombectomy was the Dutch MR CLEAN study pre- sented at the World Stroke Congress in October 2014. This showed that the functional independence rate which scores how patients can inde- HomeMonitoring technology from the firm Biotronik, in itself has advanced the care of patients at home. Now the firm has gained CE approval for its new CardioMessenger Smart, which looks and feels similar to a smartphone. Smart indeed, because this device offers fully-automatic transmission of vital signs, keeps pacemaker and implantable cardi- overter-defibrillator (ICD) wearers connected to their physician from almost anywhere in the world, and also relays technical data about the patient’s device. Dr Volker Leonhardt, Director of Telemedicine at Pacemaker and ICD Centre (HIZ), Berlin, was one of the first physicians to experience working with the product. ‘I can keep track of each patient without subjecting him to needlessly intru- sive in-person follow-ups and react quickly when necessary,’ he said. ‘This has clear clinical advantages for the patient, especially for heart failure patients who, according to the IN-TIME study, benefit from a mortality reduction of more than 50 percent.’ CardioMessenger Smart uses an intrinsic, coded data transmission system to send secure, safe informa- tion from the device to Biotronik’s Home Monitoring Service Centre over the Global System for Mobile Communication (GSM) cellular net- work. ‘Consistent and reliable data transmission occurs both daily and when triggered by an event. A call back message for patients lets phy- sicians get in contact with their patients whenever necessary,’ the firm reports. Wolf Ruhnke, Vice President of Biotronik: ‘Recent years have seen a shift towards early detec- tion and prevention. By helping healthcare providers better man- age their patients, Home Monitoring improves the efficacy and safety of cardiac rhythm therapy.’ Implant patients, he added, can go about their lives ‘with the peace of mind that comes from knowing they are taken care of, anywhere, anytime’. pendently cope with their daily lives 90 days after the procedure (modified Rankin score 0-1) was 13.4 percentage points higher in patients who had received an addi- tional thrombectomy compared to the control group where patients only received thrombolysis (32.6% vs. 19.1%). The following five studies were all terminated early because their preliminary results were, in some cases, significantly higher still than the results of the MR CLEAN study. The continuation of the studies would not have been justifiable for ethical reasons. The first three of these studies – presented at the International Stroke Conference in Nashville, USA in February this year (EXTEND-IA, ESCAPE 2, SWIFT- PRIME) – confirmed that the chanc- es of patients achieving a favour- able treatment outcome through thrombectomy were 20-30% higher overall than those of patients in the control group, Endres said. Patients’ independence was main- tained more frequently, as confirmed in the EXTEND-IA study: 90 days after the stroke occurrence almost twice as many patients could lead their lives without any functional impairments (71 vs. 40% ) compared to the control group. Mortality was also considerably reduced from 19% to 10.4% in one study (ESCAPE). These results were also confirmed by the results achieved with the REVASCAT and THERAPY studies so far, which were presented at the European Stroke Organisation Conference in Glasgow in April this year, with some minor devia- tions attributed to the design of the studies. Professor Bernd Eckert, Head of the Department for Neuroradiology The rate of complications for a thrombectomy compared to the rate of complications for alternative pro- cedures is relatively small and in view of its large benefits negligible, Endres and Eckert said. One pos- sible complication is that a blood clot floats upwards. New proce- dures that produce a vacuum in the carotid artery when the catheter is removed could lower the risk to below 5% of cases, Eckert said. A further risk lies in the fact that blood vessels may be dam- aged or burst while the catheter is being guided, resulting in bleed- ing. However, said the neurologist, ‘studies show that this risk, at 3%, is comparatively low in experienced hands.’ Thrombectomy as acute thera- py is suitable for only 5-10% of all patients who have suffered an ischaemic stroke, said Endres. In Germany this corresponds to at least 11,000 patients a year. Ischaemic stroke caused by a blood clot must be confirmed in the proximal cere- bral arteries and the patient must be treated no later than six hours after symptoms first appear. The extent of irreversible damage suffered must be low and there must be saveable ischaemic tissue for thrombectomy to be effective. Germany is not alone in prepa- rations to continue to offer high quality thrombectomy to all patients who would benefit from it is, based on the scientific evidence of the effectiveness of the procedure. The European Stroke Organisation, European Society of Minimally Invasive Neurological Therapy and European Society of Neuroradiology are already working on respective updates of their guidelines. Up till then, the Consensus statement on mechanical thrombectomy in acute ischaemic stroke, jointly published in February this year, will continue to be the binding recommendation for the use of this procedure. Results from six international randomised controlled studies conclusively and uniformly confirm, for the very first time, the effectiveness of thrombectomy in patients with acute, severe ischaemic strokes caused by a blood clot in one of the proximal cerebral arteries. The endovascular procedure is an add- on to conventional thrombolysis. Bettina Döbereiner reports from a German Stroke Society (DSG) press presentation held this May in Berlin. A new portable mobile-style device, supports even earlier therapy adjustments in cardiac patients with pacemakers, implantable cardioverter defibrillators (ICDs), cardiac resynchronisation therapy device (CRT) and biomonitors. A thrombectomy shown in a biplane, flat panel angiography carried out at the Department for Neuroradiology, Asklepius Klinikum, Altona, Germany; while the neuroradiologist and head of the department, Prof. Bernd Eckert, and an assistant carried out this procedure the patient (not visible) lay under the table under general anaesthetic. The procedure can also be carried out under local anaesthetic. The insertion of the micro-catheter from the femoral into the cerebral artery is controlled via the monitors shown on the right side of the image. A thrombectomy usually takes between 20 and 60 minutes. Photo:©Prof.BerndEckert Photo:©Prof.BerndEckert Source: Neuroradiologie Asklepios Hamburg Altona The microcatheter (blue) is guided into the blood clot in the cerebral artery. The stent retriever (dimension 0.4mm – max 4mm) is then pushed into the micro- catheter via the sleeve, expands in the blood clot in the cerebral artery and is then removed together with the blood clot, so that blood flow in the brain can be restored. Angiography before and after thrombectomy at the Asklepios Clinic in Altona, essentially attributes the positive results of the new studies to the uti- lisation of modern, cranial imaging procedures as the basis for precise patient selection, and, in particular, to CT angiography (vs. unenhanced CT as in the 2013 studies), and overall also to considerably short- er processes and the predominant use of modern stent retrievers (see image 2). CardioMessenger Smart provides fully automatic transmission of vital information from a patient’s cardiac implant to their physician via Biotronik Home Monitoring Dr Volker Leonhardt is Director of Telemedicine at the Pacemaker and ICD Centre (HIZ) in Berlin

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