With adoption of minimally invasive procedures and growing advent of technological advancements pertaining to catheter materials that prevent biofilm formation, catheters market is expected to offer potential opportunities.
Keeping up with the rapid pace of change in today's connected world requires ongoing innovation and improvement. This is especially true in the highly technical world of interventional cardiology, where physicians are increasingly using cutting-edge technologies to perform minimally invasive procedures in the cath lab. With the rise in the number of hospitals and nursing homes in the country, there is a continuous rise in the number of catheterization laboratories. The examination room with diagnostic imaging equipment to visualize the arteries of the heart and the chambers of the heart and treat any stenosis or abnormality found is making way for new state-of-the-art hybrid operating rooms. It gives the patients advanced treatment options and gives surgeons increased flexibility by coupling traditional surgical capabilities with latest imaging modalities. By investing in the newest technology, hospitals set an elite standard of care for health and wellness for the healthcare community. The tremendous advances in transcatheter endovascular procedures currently being applied to the heart and the peripheral vasculature have resulted in a treatment paradigm shift in the care of the cardiovascular patients. To allow these procedures, operating rooms with integrated X-ray imaging capabilities have to be installed. Because of their size and complexity, these integrated endovascular suites, or hybrid operating rooms, require special considerations, planning, and design, as well as new skills to be learned by the team. Guidelines on hybrid ORs are currently missing but are under development by multidisciplinary teams.
In 2015, the Indian cath labs market after stagnant growth in 2014 (over 2013) saw an almost 40 percent growth in 2015 (over 2014), as government tenders which had been pending in 2014, were released in 2015. The increase came primarily from the premium biplane segment. The six new AIIMS hospitals procured premium biplanes; HLL bought about 8 premium biplanes too. Two systems were donated by the Prime Minister's National Relief Fund for flood relief in Jammu and Kashmir and one was bought by Government Medical College and Hospital, Nagpur. The balance major contribution came from the premium monoplane segment.
The value segments remained stagnant, albeit the unit prices dropped by about 10-20 percent since 2014.
New cath labs, new cardiac centers in existing hospitals, and dedicated cardiac centers are emerging in Tier-II and Tier-III cities. The government continues to play a key role both as a buyer and a clinical solution provider in increasing access of cath labs to the patients. State government insurance schemes are making cath lab procedures viable for BPL patients and this will result in expanding the market size.
Over the last decade, advancements in technology have changed imaging and reporting systems. Due to the lower risk of invasive procedures, there are now cardiac cath labs without onsite surgical backup, a trend that highlights the importance of quality assurance and quality improvement initiatives. Meanwhile, the cath labs have become a multipurpose suite for diagnostic and therapeutic procedures for pediatric and adult patients. While hybrid cath labs are not a new phenomenon, more medical centers are looking into creating them as they consider starting trans-catheter aortic valve replacement programs.
Robotics in cath labs. Robotic percutaneous interventional systems represent the future of interventional cardiology. Robotic technology significantly reduces operator exposure to ionizing radiation, and improves ergonomics in the cardiac catheterization laboratory, thereby preventing orthopedic injuries. It may enable more accurate stent implantation and reduce the incidence of contrast-induced nephropathy. Robotics has the potential of converting the current high-risk catheterization laboratory into a safe, physician- and patient-friendly environment. Robotic systems are now used for interventional cardiology and for catheter ablations in the electrophysiology lab, which enables more precise, controlled catheter manipulation than is possible with manual manipulation. However, one of the overarching benefits of these systems is that they remove the operator from the radiation field and allow them to work sitting down behind a console, without the need to wear lead aprons.
Digital angioplasty at its peak. Conventional angiography, or more specifically digital subtraction angiography (DSA), can be used for both diagnostic and interventional angiography. Its high spatial and temporal resolutions have maintained DSA as a very important tool. In conventional angiography; the patient is catheterized, usually via the common femoral artery in the groin. Wires, catheters, clot retrieval devices, stents and aneurysm coils can be passed to the vessel of interest with this access. Iodinated contrast can be injected into a catheter and observed with fluoroscopy, causing the vessel to show up dark relative to the surroundings. DSA is a method of fluoroscopy where an initial mask image is taken prior to administering contrast and saved. After administering contrast, fluoroscopy is continued and the saved pre-contrast mask is subtracted from these newer images obtained after giving contrast.
Hybrid ORs gaining traction. The last few years have seen a paradigm shift in the treatment of cardiovascular-related diseases, from once traditional open-surgical modalities to the entire cardiovascular tree being amenable to percutaneous interventions. The hybrid concept is an attractive strategy in both the setting and the time. The hybrid operation incorporates advanced imaging technology in an operational suite and integrates techniques of interventional cardiology with those of cardiac surgery. This setting allows a combination of the surgical and interventional components in one procedure, and the patient therefore goes under general anesthesia only once. Performing surgery and intervention during the same course allows the patient to avoid multiple episodes of general anesthesia, which is especially helpful for children and high-risk elderly patients. The hybrid concept incorporates benefits from each discipline, offers the best treatment for each lesion, and also minimizes the invasiveness of the surgery to get the best possible outcome for the patient. The hybrid operating room ensures superior patient-safety with high-quality imaging and optimal environment for quick open conversion.
Percutaneous mechanical circulatory support (MCS) revamping cardiac care. MCS has seen rapid evolution, given the increased complexity of patients treated for acute myocardial infarction, chronic systolic dysfunction, decompensated heart failure, acute cardiogenic shock, as well as high-risk (HR) percutaneous coronary interventions (PCIs), and a strong belief that hemodynamic support can substantially improve outcomes in each of these settings. The potential benefits of MCS in a state of profound hemodynamic compromise, such as cardiogenic shock, include the ability to maintain vital organ perfusion; reduce intracardiac filling pressures; reduce LV volumes, wall stress, and myocardial oxygen consumption; improve coronary perfusion; support the circulation during complex procedures; and limit infarct size. Accordingly, such devices may provide both short- and long-term benefits in both extricating the patient out of the acute decompensated setting but also preserving myocardial function and end-organ function such that long-term survival is improved.
Cardiovascular information systems scaling new heights. Cardiovascular information systems (CVIS) have undergone a transformation to meet demands for better interoperability and the changing healthcare IT landscape and infrastructure. In the current market, most of the CVIS vendors are driving their solutions to yield a single point of access with an integrated or single platform comprised of multiple software modules; majority of vendors are working to consolidate their cath lab reporting, electrocardiogram (ECG) management, hemodynamics, echo PACS (picture archiving and communication systems), nuclear medicine, advanced visualization imaging, and other specialty modalities into a single CVIS. It has come a long way but there are vendors that still continue to advance their solutions by consolidating their individual cardiology components into an integrated or single platform.
CVIS vendors have completely redesigned new software platforms based on the newest technology trends to move beyond the limitations of their previous systems. Most of the new CVIS platforms are web-based so they are zero-footprint in regard to needing a hard drive to house the software, as with traditional workstations. These platforms also eliminate the need to network all the workstations in a department together, since they can transfer data across the web. This has also eliminated the need for tethered workstations, so now staff can work on any web-based computer or mobile device, regardless of their location.
Challenges and Opportunities
Translesional stenosis physiology determines the ischemic potential of a given coronary stenosis. While FFR-guided compared to angiographic-guided stenting is now strongly associated with superior outcomes, FFR is still infrequently used in most labs. One of the postulated reasons for such low utilization is the need for IV adenosine and it is perceived as uncertain hyperemic response. The notion that a hyperemia-free index can accurately determine the ischemic potential of the stenosis is conceptually appealing, but fundamentally challenging.
Patients with severely depressed left ventricular (LV) function who undergo percutaneous coronary intervention (PCI) for a stenotic left main coronary artery lesion, last patent conduit, or three-vessel disease have a markedly increased risk of mortality in comparison with the general nonemergent PCI population. During PCI, contrast dye injections, balloon inflations, atherectomy passes, and stent manipulations temporarily interrupt blood flow in the target coronary artery, which can reduce the force of the heart's contractions. This is generally well tolerated. However, there are circumstances where temporary interruption of coronary blood flow can cause hemodynamic compromise or collapse that may affect the way the PCI procedure is conducted and the completeness of revascularization. For many complex PCI cases, hemodynamic support is necessary to protect the patient during a high-risk procedure.
Medical therapies, including vasopressors and inotropes/vasodilators, remain the first-line treatment for shock despite a dearth of randomized trial data showing mortality benefit and, on the contrary, association with potentially negative physiologic effects, including tachycardia, arrhythmogenicity, and an increase in left ventricular (LV) afterload. These pharmacologic therapies increase myocardial oxygen demand in the most precarious of clinical settings, resulting in both acute and long-term declines of cardiac function. Although patients have traditionally been able to get out of the immediately critical setting, with the use of such agents, long-term survival appears negatively affected due to these effects.
A chronic total occlusion (CTO) is one of the highest complexity lesion subsets witnessed in the cath lab. Barriers to starting a CTO program include appreciating the clinical benefits, costs, time, and the acquisition of the needed special skill-set. It is known that high costs are associated with CTO PCI procedures. An average CTO case requires 5-10 guide wires, adjunctive imaging, multiple stents, specialized catheters, and additional vascular access sites. The lab and operators must devote several hours to these procedures until the team's skill-sets have developed to the level of the experts performing multiple CTOs in less than an hour. The acquisition of special techniques includes increased expertise in wiring collaterals, retrograde wire tracking, and the use of microcatheters with special sub-intimal luminal re-entry systems. Contrast load and radiation exposure will need to be monitored more closely.
Computed tomography FFR (CT-FFR) is one of the major imaging advancements impacting the cath lab. Not only cardiologists can identify culprit lesions immediately with quantifiable, significant flow restriction, but it also allows implantation of a virtual stent or stents to see how it impacts flow. This tool will enable cardiologists to plan the access route and take extremely accurate measurements so that a personalized procedural kit for each patient can be assembled for required guide catheters, wires, balloons, and stents. While the technology has shown considerable promise, it is by no means the perfect diagnostic test. Under the current model of CT-FFR analysis, where data has to be sent for FFR calculation and sent back to the hospital, turnaround times are a concern, particularly for emergency department cases. The other limitation of the technology is that the FFR calculations can only be as precise as the CT images allow, and it is also noted that false-positives are still a risk, but a conclusive result is retrieved in more than 95 percent of cases.
The Road Ahead
Much new advancement in technology have taken place, the technologies which are going to be very useful for the cardiologists will be stent boost and hybrid cath labs, in the near future. With incidence of heart diseases on rise, interventional cardiologists increasing in number, and primary angioplasty becoming standard of care for acute heart patients, the demand for cath labs is going to increase and facilities will enter into small towns. The day is not far when cath labs will be available like X-ray machines even in the smallest town of the country.