To catch a killer2 May 2018
The rapid growth of minimally invasive surgery has led to new technology aimed at improving patient comfort, speeding up diagnoses and optimising treatment. Colin Castle speaks to Boston Scientific’s Rich Cohen about his company’s recently upgraded SpyGlass DS System, its functionality and how medical imaging technology on specially designed catheters is helping treat some of the most dangerous illnesses on the planet.
When it comes to highly invasive surgery, the smaller the operation, the greater the comfort for the patient.
Additionally, in conditions in which early detection is paramount, the ability to quickly understand a problem – and avoid the complications associated with these kinds of delicate procedures – can make all the difference.
Nowhere are these two principles more important than in medical imaging, where technology is enabling clinicians to use minute microchips on a range of catheters to see into different areas of the body. This gives physicians the ability to diagnose earlier and suggest non-surgical treatments that may keep patients out of hospital, save associated costs and improve outcomes.
By 2014, ‘butterfly’ technology was using ultrasound on chips to create 3D imaging of the inside of the body without making so much as a scratch.
This trend has now reached the treatment of a major killer: cancer of the pancreas. With a five-year survival rate of just 5%, its symptoms are not immediately clear in its early stages, and treatment is complex and, when it does come, is often too little, too late. By the time a diagnosis is made, it may have already spread to other parts of the body.
This particular type of cancer is becoming particularly common in Europe and the US. Alarming statistics from the Pancreatic Cancer Action Network, released in 2012, suggested that lifestyle choices and genetics were among the factors that would make the disease the second most common cause of death by cancer by 2020. It’s also the only variant of the disease in which incidences and deaths are increasing.
Cancer is just one of a number of pancreaticobiliary diseases, which affect everything from the pancreas to the gallbladder and biliary ducts. Because of the complexity of the ways these parts of the body work, X-ray imaging is often not sufficient for a physician to make a definitive diagnosis.
Sometimes it requires direct visualisation, and diagnosis by endoscopic retrograde cholangiopancreatography (ERCP), a procedure around half a million US citizens are reported to undergo every year.
Unsurprisingly, current methods are not always the most effective. About 70% of ERCPs conducted using conventional brush cytology are inconclusive – requiring multiple procedures before a real assessment can be made – and the procedure can actually increase the chances of another nasty illness; in around 5% of cases, it can end up causing pancreatitis, a curable condition that nonetheless often requires hospitalisation and can, in rare circumstances, lead to death.
One solution is cholangioscopy or pancreatoscopy – the inspection of the patient’s bile ducts using an endoscope, allowing direct visualisation of the biliary tree. This procedure, however, is neither cheap nor easy, relying as it does on highly fragile technology and a team of clinicians trained to use the equipment.
“Previously, the biggest challenges with this procedure were that the existing technology was very expensive and required two physicians to use it,” says Rich Cohen, Boston Scientific’s director of marketing for endoscopy, EMEA. “It was also very fragile and therefore infrequently used in clinical practice.”
Hoping to mitigate these shortcomings and improve the treatment, Boston Scientific has developed the SpyGlass DS System, which, the company says, reduces the need for additional testing and repeat procedures, speeds up diagnosis, and improves treatment recommendations.
“Direct visualisation of the bile and pancreatic ducts during ERCP can help obtain biopsy specimens, lead to the diagnosis of abnormalities and guide stone therapy,” the company explains in a press release.
Using high-resolution imaging and therapy, the new system is a continuation of the SpyGlass system. The original model used a fibre optic probe that was independent from the catheter, the real breakthrough, however, was that it enabled a single operator to perform the procedure, reducing the costs associated with the procedure in the past.
“[Boston Scientific’s] research and development team in Marlborough, Massachusetts, US, began thinking about possible ways to incorporate a probe into a catheter system as a way of joining the diagnosis and the treatment together,” Cohen says.
According to Boston Scientific’s press literature, “The first-generation SpyGlass System helped to re-establish cholangioscopy and pancreatoscopy as a valuable diagnostic and therapeutic procedure by enabling a single operator to perform the procedures, as well as guide devices to examine, diagnose and treat conditions such as gallstones and suspected malignancies of the biliary tree and pancreas.”
Since then, the technology has undergone several updates. “Next came SpyGlass DS – DS stands for digital and simple – and this nextgeneration system uses a digital chip already embedded into the end of the catheter, giving a significant improvement in image quality and ease of use,” Cohen explains.
Through the entire development process, he continues, Boston Scientific sought to improve efficiency and productivity for physicians, as well as making the system simpler to use, while also providing higher image quality – an advance linked to broader trends in the industry.
“This ties in with the trend towards minimally invasive medicine, and together this means that physicians often have the ability to diagnose earlier and consider non-surgical treatments, which may keep patients out of hospital, save associated costs, and improve patient outcomes,” Cohen says.
The company worked with a range of partners in developing the recent upgrade, including tech manufacturers, developers and physicians.
This collaboration with those working on these conditions was part of a broader project by the company that it has deemed the ‘RoadRunner initiative’.
“Through this programme, Boston Scientific facilitates close collaboration between its experienced engineers and leading physicians worldwide to design medical devices that help meet today’s clinical needs and continually improve patient care,” Cohen says.
So, how does it work? Boston Scientific argues the SpyGlass offers four times higher resolution and a 60% wider field of view than conventional ERCP, as well as eliminating the need for probe reprocessing and preventing image degradation over multiple uses.
This is not to say the new technology doesn’t come with risks, with the continuing issues in these kinds of diagnostics leading US FDA to issue a warning in early 2018 on the importance of fighting infection in duodenoscopes – the tubes typically used in ERCP procedures.
“Duodenoscopes are complex instruments that contain many small working parts,” the report warned. “If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient. In rare cases, this can lead to patient-topatient transmission of infection.”
These concerns even led FDA to issue warnings to major manufacturers of the duodenoscopes used in the US for violations of Section 522 of the Federal Food, Drug, and Cosmetic Act and releasing standardised protocols for surveillance sampling and culturing.
Hence the importance of quality control; under the new guidelines, manufacturers must be able to ensure that infections in these kinds of procedures, rare as they usually are, can be kept to a minimum.
“Attention to detail is clearly very important in this field,” says Cohen. “This is part of what led Boston Scientific to develop SpyGlass in the first instance, and what then led it to develop SpyGlass DS, as a continued effort to improve the quality of the system and the procedure for physicians and patients.”
This kind of technology clearly has all sorts of broader uses. Just this month, a new treatment known as geniculate artery embolisation (GAE) saw some of its first clinical trials in the US. Using medical imaging to guide the use of catheters into key arteries to treat knee osteoarthritis – a condition that affects millions across the world – GAE uses pinhole incisions to speed up treatment.
There is also potential for application in treating diseases that hit the heart and blood vessels. Intravascular ultrasound (IVUS), for example, sees clinicians use catheters specifically designed for cardiovascular procedures to visualise the coronary arteries and better treat illness that kill millions every year.
The technology is also being tested in interventional radiology. The Society of Interventional Radiology recently demonstrated the first use of 360° virtual reality (VR) in a transjugular intrahepatic portosystemic shunt procedure, creating a new blood vessel in the liver with the help of 3D imaging.
“Interventional radiology has always been on the forefront of modern medicine and VR360 is the cutting-edge of medical simulation,” said Ziv Haskal, a professor with the department of radiology and medical imaging at the University of Virginia Health System in Charlottesville, in a press release.
“We took one of the hardest procedures we perform and created an all-enveloping, in-the-room VR film allowing an operating physician to return to any complex segment they wish for learning, review and perspective.”
Cohen says Boston Scientific is looking to harness the feedback it’s received from those in the industry work to provide physicians with further options to diagnose and treat patients with gastrointestinal conditions.
When asked whether the SpyGlass DS could be used in other types of treatments, Cohen replies, “Absolutely, though it is dependent on the disease area. But looking at interventional endoscopy, where SpyGlass fits, offering therapeutic imaging that is minimally invasive and more effective, generally means a better experience for the physician and the patient.”