Transformation on the cards for cath labs

Cutting-edge technologies will embrace the new and rejuvenated complexion of the cath lab and look forward to the next clinically proven solution.

Hospitals constantly try to predict what the future holds when planning new facilities and equipment purchases that will need to last for the next decade. This is really the greatest period of time in the history of interventional cardiology, the new technologies, and trends of today that are shaping tomorrow. The biggest change will be in the types of procedures performed in the cath lab. New types of more complex procedures and devices, recently introduced or currently in trials, will increase cath lab volumes. These include transcatheter aortic valve replacement (TAVR), renal denervation to treat drug-resistant hypertension, transcatheter structural heart repairs like patent foramen ovale (PFO), and ventricular septal defects (VSDs) and left atrial appendage (LAA) occlusion to eliminate warfarin therapy in atrial fibrillation patients. Some procedures, especially hybrid coronary revascularizations and TAVR, combined with healthcare reforms, also will require new levels of collaboration between various specialists, like surgeons and the interventionalists.

A new year – and decade – offers the opportunity to reflect on the advancements and challenges of years gone by and ponder the question: what is next? For interventional cardiologists, constant innovations in medical technology mean the landscape may not look the same year over year, or certainly from decade to decade.

Global market
The global cardiac catheterization market is likely to ascend at a CAGR of 9.2 percent over the next 7 years, predicts Market Watch. Various factors fueling the market growth for cardiac catheterization include the emergence of numerous technologically advanced devices and rising regulatory approvals from the government. Furthermore, the rising geriatric population, abuse of alcohol, and mounting prevalence of cardiac diseases are also expected to propel the market growth for cardiac catheterization market. Expansive measures taken by many key market players are leading to higher penetration of cardiac catheters by these prime players. This poses as a leading driver for the global cardiac catheter market in coming years. Although the cardiac catheter market is likely to expand at an unparalleled rate, some factors are responsible for curbing the growth during 2020–2027. The elevated cost of surgical procedures and catheters, coupled with side effects associated with catheterization, are estimated to restrain market growth. Simultaneously, the lack of proper healthcare infrastructure and cardiac diseases are also hindering the market growth to a great extent.

North America is set to capture the largest market share for cardiac catheter market during 2020–2027. This market domination can be attributed to the increasing prevalence of cardiovascular diseases amid the geriatric population, and their vulnerability toward hypertension. Additionally, obesity issues leading to heart diseases and disorders are also fueling the market growth for cardiac catheterization. Increasing government initiatives to fund and encourage research, coupled with the rising demand for technologically advanced cardiac catheterization treatments, are showcased to lead the market. Also, developments in advanced medical treatments are likely to propel market growth for cardiac catheters.

Europe is estimated to garner the second-largest market for cardiac catheterization, following North America. Owing to the rising healthcare expenditure and the availability of advanced treatment facilities, along with supportive government initiatives for healthcare, Europe is likely to record a staggering growth rate by the end of 2027.

Asia-Pacific (APAC) is projected to be a promising market for cardiac catheterization during 2020–2027. Rising geriatric population with an alarming rise in the prevalence of cardiac disorders and diabetes is foreseen to drive the market to a great extent in the APAC. A rapid adaptation of the latest healthcare technology, government initiatives supporting the emergence of qualitative healthcare, and favorable insurance are some factors further prompting growth in the cardiac catheterization market.

Some of the renowned global front-runners of the cardiac catheter market include Coloplast, Boston Scientific Corporation, Dispocard GmbH, St. Jude Medical, Becton Dickinson and Company, Abbott, Teleflex Incorporated, Johnson & Johnson Private Limited, Smiths Medical, Medtronic Inc., Edwards Life Sciences Corporation, Rochester Medical Corporation, Terumo Medical Corporation, and Maquet Medical India Private Limited.

Vendor update
In April 2020, Abbott announced that its TriClip Transcatheter Tricuspid Valve Repair (TTVR) System has received European CE mark clearance as a non-surgical treatment for patients with a tricuspid valve regurgitation (TR). It is the second tricuspid valve repair device cleared for use in Europe, following the 2018 approval of the Edwards Lifesciences Cardioband Tricuspid Valve Reconstruction System.

In April 2020, Boston Scientific Corp. recalled its Imager II 5 French angiographic catheters, given the potential for the catheter tip to become detached during a procedure or during procedure preparation. The US Food and Drug Administration (FDA) listed this as a Class-I recall. The FDA said there have been nine reported patient injuries due to the problem with the catheters. The FDA said use of the affected product may lead to additional surgical intervention to remove the catheter tip in the patient’s blood vessel and increased time in the hospital.

In March 2020, Philips started working on a prototype cath lab angiographic imaging system that might be able to replace the current X-ray fluoroscopy imaging systems used for interventional image-guided procedures. The new fiber optic RealShape (FORS) technology creates real-time 3D imaging of anatomy and devices inside the body, using light rather than X-rays. FORS uses light traveling through hair-thin fiber optics inside special FORS-enabled catheter and guidewires. The technology is based on the concept of measuring strain in the optical fibers, using light reflected from density fluctuations in these fibers. The location of the wires is then superimposed on 3D anatomical imaging. The company hopes to break through the current limitations of image guided therapy, so clinicians can reduce their dependency on radiation-emitting fluoroscopy, while being able to see devices and anatomy more clearly inside patients during procedures. The FORS technology enables real-time 3D visualization of devices inside the body without the need for fluoroscopy.

In November 2019, Cook Medical initiated a recall of its CrossCath Support Catheters, which the US FDA identified as a Class-I recall. The FDA said the devices may cause serious injuries or death. Cook identified an error during manufacturing that could cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath support catheters and too tight on certain CXC3.4 CrossCath support catheters. Marker bands that are too loose can dislodge from their original position and marker bands that are too tight can cause buckling.

Technology trends
Advances in cath lab technology are so fast-paced that any new state-of-the-art cath lab starts looking old in less than 5 years. A cath lab now means much more than a fluoroscopy unit. Vascular imaging has become an integral part of any cath lab setup.

Improving soft tissue visualization. Today’s cath lab or hybrid suite faces some challenges that innovators are hard at work to address. The ability to visualize soft tissue, and to appreciate complex three-dimensional structures with a fundamentally two-dimensional X-ray-based imaging modality, still leaves something to be desired. The exposure to ionizing radiation is now known to represent an occupational hazard to interventionalists, carrying radiation-related risks including an elevated cancer rate. And, there yet remain many types of surgical procedures that have no commonly available minimally-invasive counterpart, although conceptually an interventional approach is possible. Nascent solutions have appeared, many reflecting trends in the latest in computational and electromechanical technology. And while these first-movers have made a significant impact, the industry has now advanced to an even more rapid pace of innovation, as access to engineering and design necessities has exploded. Building blocks are increasingly available to those with the concepts, understanding, and ability to execute.

Computational power and high volumes of data storage are widely available in cloud-based form at reasonable monthly rates. Google provides machine learning services online. Three-dimensional hubs allow access to 3D printing for quickly prototyping new inventions. And network infrastructure interconnectedness allows collaboration between innovators around the world.

As a result, the market is at a tipping point after which it will see cath labs and hybrid suites become more and more technologically sophisticated at an increasing rate. The independent components of predictive analytics, interventional robotics, and advanced imaging will converge and provide clinicians with immensely powerful tools.

Robots in the cath lab. Surgical and interventional robotic systems have already made a significant impact. Just as the da Vinci system facilitated minimally invasive therapies, which previously could only be done invasively, the Hansen Magellan and Corindus systems have demonstrated the capability to perform interventional procedures with vastly decreased radiation exposure to the operator. They are joined by startup companies like Restore Surgical who are developing more compact, cost-effective, and workflow-compatible robotic solutions.

The industry is now at the verge of expanding these technologies and truly realizing robot-assisted procedures, in which clinicians are given mechanical and navigational tools that allow certain actions or portions of the procedure to be performed autonomously, with a level of control only possible with robotics.

Integration of augmented reality. A new technology that is already on the horizon to aid procedural navigation in the cath lab is augmented reality (AR). The technology enables operators to see true 3D images of anatomy in a heads-up display while they are looking at the patient or at the main screen in the lab. Manufacturers are showing a conceptual work-in-progress of this technology, and some have already commercialized AR technology to aid in advanced visualization of the patient’s 3D datasets. AR allows physicians to view, measure, and manipulate real-time holographic images of the patient’s heart during procedures, while still being able to clearly see around the room. Using real-time navigation data feeds rather than MRI or CT, the solution provides clinicians with patient-specific anatomy in a holographic display, including catheter movement. The software is aimed at reducing operating time and radiation exposure to clinicians, and potentially improving outcomes for patients.

Predictive analytics. Predictive analytics allow the mining of vast amounts of data to extract information and patterns, which can provide valuable guidance to clinicians. One reason that the highest-volume practitioners are also the highest-performing is that they are able to draw upon the greatest pools of experiential knowledge. Analytics will allow us to spread this wealth. The widespread use of electronic medical records (EMRs) has set the stage for this type of technology, the most significant remaining piece is to encode data regarding anatomy. The development of technologies capable of transforming imaging data into models suitable for computerized analysis will close this gap and allow computational systems to provide valuable clinical decision support.

Reducing use of X-ray image navigation. Advanced forms of imaging with reduced dependence on ionizing radiation are becoming increasingly available. Navigation technologies are allowing improved 3D visualization while also reducing dependence on fluoroscopy. Advanced imaging, combined with robotic control, will provide increasingly precise image guidance, as well as increasingly precise interventional control. Predictive analytics will allow machine learning algorithms to provide optimal robotic navigation, and to augment imaging with the most clinically relevant and useful additional information.

Holographic procedural navigation. In addition to augmented reality, live, 3D, and transesophageal echo (TEE) holographic imaging can be projected in the cath lab now without the need for special glasses or AR visors. Recently, EchoPixel showed how a GE TEE system can project holograms of live views of heart valves or the left atrial appendage (LAA) using a special display screen. A couple of large angiography-system vendors are looking at the system for possible integrations with their own technologies. It may soon be possible to direct LAA occlusions or MitraClip implants using holograms and eliminate the need to have three different 2D echo views, so the operators can reconstruct the 3D image in their brain. The holograms will make visualization much easier and intuitive for device deployments.

Outlook
Looking back to gain perspective on how far industry has come is always a worthwhile effort. Indeed, cutting-edge programs will embrace the new and rejuvenated complexion of the cath lab and look forward to the next clinically proven solution.

Second Opinion