EH 4_2015

CARDIOLOGY EUROPEAN HOSPITAL  Vol 24 Issue 4/15 20 The Lab2Go project Mechanical thrombectomy performs like a ‘corkscrew’ POC test detects myocardial infarction Stroke is a surgical disease! Biomedical experts at Royal Philips have spent more than 10 years developing a simple test for the emergency department that, in less than 10 minutes, may indicate whether a patient suffering chest pains is having a heart attack. The company’s new Minicare I-20 point-of-care (POC) system is now undergoing field evaluation at six prominent European hospitals as part of Lab2Go, the three-year European Union-funded project. If successful, this handheld, bedside device would open a new pathway for rapid, reliable diagnosis that responds to a long hoped-for, criti- cal need in emergency medicine. Professor Volkher Scharnhorst PhD, from the Catharina Hospital in Eindhoven, the Netherlands, pre- sented the preliminary results of the Lab2Go evaluation to colleagues at EuroMedLab 2015. According to him, Minicare Acute has the poten- tial to support near-patient testing for people suffering acute coronary syndrome when they arrive at the Emergency Department; and there- fore would enable faster diagnosis or treatment. If it sounds simple so far, here comes the fun part − making it work. The widely accepted test for a rule-in/rule-out decision on heart attacks is the Troponin I (cTnI) assay. A physician draws a patient’s blood and the sample is sent to the central lab and after 60 minutes, the answer comes back. While the patient has to wait, often distressed, until the results return and the physician can then determine what treatment to provide. To cut that window for treatment from 60 minutes to 10 minutes, Philips had to overcome a series of technical challenges. First, the sim- ple finger prick to draw a droplet Cardiologists call for the establishment of 24/7 centres for rapid surgical interventions to remove blood clots in the brain, John Brosky reports They did it for heart attacks. Can cardiologists now lead an effort to speed up the emergency medical response for stroke? Over the past five years, the Stent for Life initiative organised by inter- ventional cardiologists has pushed majors medical centres to assure 24/7 coverage and reduce the time to treatment for patients showing up with severe chest pain. Now armed with fresh evidence that a mechanical intervention to pull out blood clots is more effective to halt devastating dam- age to the brain than the slower treatment with drugs to dissolve the clot, the European Association of Percutaneous Cardiovascular Interventions (EAPCI) has formally issued a call to action to mobilise its growing army of interventional cardiologists. ‘We need to build healthcare systems for early intervention in stroke,’ Jean Fajadet MD, the outgo- ing president of EAPCI. Qualified physicians are needed Even a quick glance at the number of interventional neuroradiologists in Europe compared to the number of stroke patients shows there are far too few qualified physicians to offer such a service everywhere, all the time. ‘To offer this intervention rap- idly, the question becomes whether cardiologists can help,’ suggested Kenneth Snyder MD, from the State University of New York in Buffalo, who joined Fajadet at EuroPCR 2015 in calling for next-generation stroke centres. A consensus statement issued this year by the European Stroke Organisation (ESO; Basel, Switzerland) unequivocally recom- mends rapid percutaneous interven- tion within 4.5 hours with a clot retrieval device. ESO developed the statement with the European Society of Minimally Invasive Neurological Therapy (ESMINT; Zurich, Switzerland) and the European Society of Neuroradiology-Diagnostic and Interventional (ESNR; also Zurich). ‘Stroke is a surgical disease,’ Snyder declared. This bold statement challenges the current standard of care and is based on new scientific evidence from four major stroke studies pre- sented this year at the International Stroke Conference in Nashville, USA. Those studies showed that rapid mechanical thrombectomy using a new generation of clot retrieval devices improves patient function after acute ischemic stroke. ‘Five clinical trials have been halt- ed because the new technology is better, because it works,’ said Snyder. The current standard of care for stroke patients is an intravenous (IV) injection of a tissue plasmi- nogen activator (t-PA) meant to dissolve a clot blocking blood circu- lation in the brain. The new proce- dure for mechanical thrombectomy is a surgical intervention, in which a device is used to pull out the blood clot immediately and directly. The procedure is performed without general anaesthesia as the patient is not aware of the catheter snaking through blood vessels to arrive in the brain with a device some call simply a cork-screw. Surgeons have reported that patients in some cases have sat up on the operating table after the clot was removed and began speaking with them. Catheter operators trained through EAPCI have the basic skill set need- ed for the procedure, and with addi- tional training could maintain the 24/7 coverage for this time-critical procedure, according to Fajadet. Membership in EAPCI has grown rapidly since it was founded in 2006. In the first five years 2,700 cardiologists joined to train for angi- oplasty and stenting procedures. That number nearly doubled again so that, in 2014, there were 5,500 members. There are almost 13,000 interventional cardiologists attend- ing EuroPCR events in 2015. New devices that are generat- ing the excitement surrounding this procedure include the Solitaire revascularisation device from Covidien and the Trevo from Stryker Neurovascular. of blood for the POC test means drawing capillary blood, which is different from venous blood used in today’s lab tests. Would the results be comparable? Second, to reduce work for emer- gency departments, the Philips POC test needs to be user friendly and reliable by relying on microfluidics and chemistry that require no addi- tional steps for staff. Third, all the complexity of a laboratory instrument needs to be reduced to a hand-held device that anyone can operate without special training. To solve the miniaturisation challenge, Philips brings together an unexpected combination of nano- technology with a compact disc player. It turns out that the optics used for reading music and film, an early Philips invention, work with a precision and reliability that can be applied to chemical testing. By mixing magnetically charged nano- particles in the blood sample, the optics can detect and quantify the prevalence of a given biomarker – in this case, the cTnI protein indicating acute coronary syndrome. At Philips, the potential was dis- covered long ago. The work to create a handheld diagnostic reader instrument began in earnest in 2009 by looking at ways to enhance the sensitivity of the detection and reduce the sample concentration required. According to Michel Simons, Marketing Director of Philips Handheld Diagnostics in Eindhoven, ‘no one else can deliver these high quality results from a finger-prick sample in less than 10 minutes.’ Looking beyond this first cardiac test, he sees a wider range of poten- tial applications in the emergency department for the Minicare system. ‘We will be able to measure all the different proteins in less than 10 minutes. We can do multiplexing on our device to test different param- eters so that, with one drop of blood on the same cartridge with a nano- dispensing technology, we will be able to conduct up to 20 different tests at the same time.’ Jos Rijntjes, who leads Commercial Operations for Philips Handheld Diagnostics said that ‘with the suc- cessful implementation of this first assay for chest pain, we can go on to apply the same technology and methodologies to additional assays. In one square millimetre we might, for example, be able to load tests for high fever, trauma, brain injury, or mental disorders – offer- ing a series of assays to help emer- gency physicians understand which patient needs immediate attention and treatment when rapid results are critical.’ The second challenge for ease- of-use for the device is at the heart of the current test in the Lab2Go project. In addition to clinical results, the aim of the project is to gather evaluations of real-world use and identify where the workflow or usability can be improved. Rijntjes explains that the Minicare I-20 car- tridges use dry chemistry without the liquid reagents found in central laboratories. ‘The only fluid in the disposable cartridge comes from the tiny droplet of the patient’s blood,’ he said. ‘There is no need to add agents, no need to wash, to dilute − no need for the staff to do anything but put the patient’s finger on the cartridge and then insert it in the Minicare Acute reader.’ Returning to the first challenge, after all the engineering and tech- nological marvels, the entire success for this break-through approach comes down to that finger prick and the micro droplet of blood from the patient. As one physician said, if there is not a strong correlation between results from a capillary blood sample and the traditional troponin results using venous blood, ‘out go the finger-pricks and the utter simplicity.’ Scharnhorst is cautiously optimis- tic, reporting what he called a cor- relation that is ‘very comparable and offers the potential to interchange- ably use both capillary and venous samples.’ The full results of the evaluation from hospitals in Austria, France, Germany, Netherlands and the United Kingdom are not expected until 2016. Meanwhile, Philips faces one more critical challenge, clinical tri- als that will put the Minicare Acute troponin assay up against laboratory results in a head-to-head compari- son. Simons explained: ‘We plan to start in Europe, but aim to have parallel trials running in the US as soon as possible. Discussions are currently underway with the FDA (Food & Drug Administration) to determine what our clinical trial needs to look like. Several sites in the U.S. have already expressed interest in joining the trial.’ Philips Minicare delivers rule-in/rule-out readings for heart attacks in 10 minutes. It takes a lot of hard work to make things easy, John Brosky reports. Michel Simons, Marketing Director of Philips Handheld Diagnostics, in Eindhoven Jos Rijntjes, Head of Commercial Operations for Philips Handheld Diagnostics in Eindhoven Philips’ Minicare I-20 POC system is designed to help physicians, nurses and paramedics identify patients at high risk for acute cardiac events– right at the bedside or in pre-hospital settings. Solitaire is a mechanical thrombectomy device used to retrieve a clot in patients experiencing acute ischemic stroke Source:Covidien

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