Optical coherence tomography, a next-generation coronary imaging platform, assists in stent selection using near-infrared light to create images that provide more details than angiograms alone.
The diversity of procedures performed in the cardiac catheterization laboratory (cath labs) has evolved significantly since the original design primarily aimed at coronary revascularization. The clinical landscape has shifted from the provision of coronary angiography and percutaneous coronary intervention to the inclusion of electrophysiology (EP) procedures, cardiac device implantation, noncoronary interventions, and transcatheter heart valve implantation. There is no consensus on adopting a label that reflects this expanded scope of care when describing this specialized area.
High-end cath labs are indeed costly and are the main constraints for developing countries like India. In addition to financial constraints, major concerns have been raised over exposure to ionizing radiation. With a multifold increase in interventional cardiology procedures that rely on fluoroscopy, there is an exponential rise in the incidences of damages due to chronic exposure to ionizing radiation. As more complex cases are being done, radiation dose for both patients and staff is a major concern and improvement area for vendors.
All major vendors have introduced new systems and technologies in the past few years to reduce dose and enhance visualization in the cath lab. The vendors have tailored their systems into various models for specific specialties and at various price points depending on the degree of functionality. This includes real-time dose monitoring systems; lightweight, ultra-thin, disposable radiation protection aprons; and also robotics to remove the physician from the radiation field.
In 2016, the Indian cath labs market is estimated at Rs. 632 crore, with the imported segment at Rs. 295.75 crore and the indigenous and unorganized segment constituting Rs. 70 crore. The contribution of this segment is for the performance and value systems, which are more popular in Tier-II and now in Tier-III cities. The government continues to account for the top-of-the line models. The mobile systems are finding preference over the fixed ones in the value segment.
The differentiating factors between various brands are diminishing, with most systems on similar price points offering similar capabilities and features. Gradually, brand loyalty and other factors such as prompt servicing, attitude of sales and marketing team, proximity with customers, etc., will be the determining factors for gaining market share. Undoubtedly, digital detector size, the smaller ones optimal for cardiac procedures and the larger ones used to perform run-offs, ablation techniques, or tumor/vein embolization are major causes of price variation. On a similar note, swing labs, digital cath lab equipment that is suitable for both cardiac work and a variety of vascular and neurological applications, are gaining popularity.
Philips continues to lead the segment, with GE and Siemens offering stiff competition. Toshiba is more successful with the government, whereas Allengers is dominating the indigenous segment at Tier-II (and now Tier-III) cities. Shimadzu and Schiller are also aggressive in this segment.
The industry is witnessing a shift in technologies from well-established procedures such as transcatheter closure of atrial septal defects (ASDs) and patent foramen ovale, balloon mitral valvuloplasty (BMV), and transcatheter alcohol septal ablation (TASH) for hypertrophic cardiomyopathy to next-generation coronary imaging technology and robotic-assisted percutaneous coronary intervention. With the advancements in the use of intracardiac echocardiography (ICE), 3-D echocardiography (3-DE), and multidetector computed tomography (MDCT), with fluoroscopic overlay to produce 3-D images of intracardiac structures, operators can better visualize cardiac anatomy and provide real-time information to support a faster, more precise surgical workflow, optimize patient outcomes, and minimize risk.
Advancements in angiography systems. Angiographic imaging system vendors have developed several new technologies to address emerging cath lab trends, including the need to reduce radiation dose, improve image quality, and enable advanced procedural image guidance. All three of these have become increasingly important as more complex procedures are attempted in interventional cardiology cath labs and hybrid ORs. These procedures include transcatheter aortic valve replacement (TAVR), MitraClip repairs, left atrial appendage (LAA) occlusions, atrial and ventricular septal defect closures, and new interventions for both EP and heart failure.
Newer imaging systems enable advanced 3-D imaging with rotational angiography, which uses a quick spin around the patient to create a computed tomography (CT)-like, 3-D image of the anatomy. This can all be done tableside in the cath lab. Some systems allow these images, or CT, or magnetic resonance imaging (MRI) 3-D images, to be overlaid or fused with the live 2-D fluoroscopic images. This fusion technology is used with TAVR planning and navigation software to better guide precise device placement. Software also allows 3-D images to be integrated with EP electromapping systems to guide catheter ablation procedures without the need for live fluoroscopy, helping to reduce dose.
Next-generation coronary imaging technology. Optical coherence tomography is a next-generation coronary imaging platform that helps the physicians to analyze vessel characteristics. This information assists in stent selection using near-infrared light to create images that provide more details than angiograms alone, creating an even more effective cath lab.
Robotic-assisted percutaneous coronary intervention. The cath lab industry has been on a revolutionary edge right from the introduction of robotics in cath labs to successful implementation of robotic-assisted percutaneous coronary intervention procedures in hospitals. Recent reports have claimed the safety and feasibility of these robotic systems in the treatment of complex intervention, augmenting the ability to deliver treatment with robotic precision and significant reduction in radiation exposure.
Monitoring dose in real time. The concern for modern research resides in real-time X-ray radiation dose monitoring for cath lab staff, where the detector badges relay live dose data to a display monitor in the cath lab. It has visual display, showing colored indications (red, yellow, green) to give each individual user insight about the current dose exposure. The accumulated dose per individual user also is captured and displayed on the touch screen display. The data is stored and can be viewed in a dose dashboard in the system's dose manager software, which includes total dose history and easily generates reports for staff use and archives.
One of the major imaging advancements that will have an impact on the cath lab in the near future is computed tomographic fractional flow reserve (CT-FFR). This will allow noninvasive FFR readings for the entire coronary tree with one CT scan. Not only will cardiologists immediately be able to identify culprit lesions with quantifiable, significant flow restriction, but it allows implantation of a virtual stent(s) to see how it impacts flow. This will also greatly speed procedure times, since diagnosis and planning will have occurred ahead of the procedure. Greater efforts and several new technologies to reduce radiation dose in cath lab will be seen at increasing rate in the near future. This includes increasing adoption of ultrasound and transesophageal echo (TEE) during procedures to cut or eliminate use of angiographic X-ray. There also will be increased use of 3-D navigation aids using 3-D echo, pre-procedural CT, or rotational angiography imaging to reduce procedure times. A handful of centers also will build out interventional MRI suites to eliminate radiation entirely for long procedures, such as EP ablations. With the pace at which technologies are evolving, the next decade promises an even brighter scope for the industry to reach new heights.