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.

Indian Market

caths-labscaths-labs

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.

caths-labs

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.

Technological Trends

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.

"In the hospitals that are running short of funds or are scared to put a lot of money to buy fixed 100 kW cath labs, Komega Impex plans to include a proposal to install a fixed cath lab for cardiac angiography and angioplasty by investing for the purchase of the machine and its maintenance cost via CMC (comprehensive annual maintenance contract). The machine will be installed on site. All the running charges of the machine such as electricity bill, technician's salary, performing doctor's charges, and the like will be borne by the hospital as the company would be taking only table charges for each case done. The company must get an estimate of the average number of patients the hospital would cater to in a month for the first six months and then for the next six months, and so on, so that it could be figured out if it would be viable for taking forward the project and to decide as to which model of the cath lab would be suitable for installation.

By setting up cath labs, we aim to improve the quality of medical services in India by ensuring that advanced technology is made available to a larger section of the population."

Shreyans Jain
General Manager,
Komega Impex

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.

Shankar Seshadri, Senior Director and Business Head-Image Guided Therapy and Diagnostic X-Ray,Philips Healthcare India
Industry Speak
Innovation and Making Care Affordable to Larger Population Is the Key to Growth

The healthcare industry in India is showing great progress. The number of hospitals and nursing homes in the country is continuously increasing, which results in a growing demand for various kinds of medical equipment and devices.

The incidence of coronary artery disease in India is on the rise and it has been the single biggest factor contributing to increase in interventional cardiac procedures. This means more cardiac centers and hence more cath labs are required to meet this increasing demand.

Indian cath labs market has been growing by more than 10 percent CAGR for the last 4-5 years and has seen more than 20 percent growth in 2015. Growth is driven by both new cardiac centers (primarily in Tier-II and Tier-III cities) and additional cath labs in existing setups in metro and Tier-I cities. Cardiac remains a dominant segment though more growth is witnessed in neuro-vascular segment.

Many systems are sold for mixed use and are equipped with cardiac, vascular, and neuro tools while some dedicated neuro labs have come up in private and government segments. Chest pain clinics have come up in many cities, which help in early detection and timely referral of patients to hospitals equipped with cath labs. The government has to play a major role in increasing access of cath labs to population.

Advanced clinical capabilities. New technologies have primarily focused on making cath labs more accessible and having tools/integrations to support clinical decision in real time.

Tools like real-time 3-D reconstruction and CT-like imaging are essential for vascular and neuro applications. A large number of users are using IVUS and FFR with cath lab systems and prefer to purchase them along with the cath lab. Instantaneous wave-free ratio (IFR) is a new technology that is emerging.

Low radiation dosage. High volume of cases in India makes radiation an even bigger issue for Indian users. As more complex cases are being done on interventional X-ray systems, radiation dose for both patients and staff is a major concern and improvement area for vendors. More and more hospitals are now insisting on buying cath labs with grid switch tubes that help in lowering dose for the patients, technologists, and doctors. Philips has introduced Allura Clarity that reduces patient dose by 83 percent and staff dose up to 70 percent depending on the applications.

Clinically versatile. A number of Tier-II and Tier-III setups are looking for viable and reliable cath lab solution for their low volume setups. In addition, there is an increasing preference for flat-detector labs. Leveraging on its manufacturing plant in Pune, Philips has introduced INTUIS - a new 15" flat-detector cath lab that is clinically versatile.

If we compare the number of cath labs per CHD cases, India stands at one-tenth of developed countries. We need more interventional cardiology and radiology seats and more trained staff to ensure that we catch up with rising disease occurrence and realize our vision of healthcare for all.

Philips is committed to bringing innovative technologies faster to market and increasing access of technology to wider population. The company is organizing CME programs/user meets with the support of interventional cardiac and neuro specialists to create platforms to exchange clinical knowledge across the eco-system. CathUpdate is one such program to enrich skill sets and knowledge of the cath lab technicians on the recent trends on tools, radiation dose and etc. The company will make sure that the full use of its innovation campus in Bangalore and manufacturing facility in Pune would bring products that are designed as per the needs of Indian customers.

Shankar Seshadri
Senior Director and Business Head-Image Guided Therapy and Diagnostic X-Ray,
Philips Healthcare India

Suresh Sharma, CMD,Allengers Group of Companies
Industry Speak
Developing New Platforms

Allengers offers a wide range of fixed and mobile cath labs with image intensifiers and flat-panel detectors (FPDs). Allengers' cath lab has a number of variants, which can suffice the purpose of wide spectrum of cardiology requirements. The total installation base is 200 numbers across the country including mobile and fixed cath labs. As product viability has become the prime concern to all the entrepreneurs, the products get recognized pan India including in Tier-I, Tier-II, and Tier-III cities. In the last fiscal year 2015-16, the company installed 60 cath labs across India, out of which 55 were fixed cath labs with FPDs. It indicates the changing trends from mobile labs to fixed labs with FPDs. Moreover, the company has sold out 70 cath labs directly to interventional cardiologists till date, indicating the confidence, trust, and acceptability of Allengers' products among cardiologists.

{mosimage}The new imaging software named Synergy is designed to give optimum image quality at low radiation dose. Soon the company will be launching ceiling-suspended cath labs, 3-D software, and stent boost. As social media has taken center stage everywhere, the company has initiated a dedicated blog initially for cardiology and neurology named as MEDICASE BOX (www.medicasebox.org) to share operator's insight, clinical studies, challenges, wisdom, and expertise for their critical cases in foster working relationships.

Suresh Sharma
CMD,
Allengers Group of Companies

Dr Vineet Hingankar, Chairman,Ozone Multispecialty Hospital & Critical Care Centre, Akola
Second Opinion
Mobile Labs to Drive Growth

The market is growing with the proliferation of cath labs and physicians using interventional cardiology products. New drug-eluting stent designs are expected to assist physicians in treating vulnerable plaque, thus accelerating market acceptance of the products. Advancements in medical technology accompanied by improved patient outcomes have led to an increase in the number of catheter-based therapies performed by clinicians, a trend that is expected to continue with the discovery of novel techniques and superior medical technology. However, the potential patient population for coronary stenting has historically been under-penetrated due to the high cost of the devices. Despite the rising incidences of coronary artery disease in the country and lowering prices of the interventional devices, many patients choose to forego a coronary intervention due to lack of insurance coverage and their inability to privately finance these procedures.

With coming of newer devices/technology, the market for cath lab is set for a giant leap. Quality of images used in cath labs has improved. Another lift is the use of intravascular ultrasound and optical tomography. There has been huge development in electrophysiology, pacemakers, and defibrillators as well. From single-panel to digital flat-panel labs, catheterization laboratory (cath lab) has come a long way in serving Indian healthcare better. Mobile cath labs can be a key growth element as they can easily be wheeled into the sterile environment of the operation theater that enables the cardiologist to carry out procedures peacefully. Mobile cath avoids the inconvenience of patients travelling to big cities to avail the facilities.

The next generation of advances will improve operator performance, enable more complex procedures, change the reimbursement system, improve patient and operator safety, and expand the use of minimally invasive cardiovascular procedures into new areas that were previously only the domain of surgeons.

Dr Vineet Hingankar
Chairman,
Ozone Multispecialty Hospital & Critical Care Centre, Akola

Dr Nagamalesh UM, Senior Consultant Cardiologist, MS Ramaiah Narayana Heart Center, Bangalore
Second Opinion
Expanding Horizons through Technology

The market has grown remarkably, supported by a rise in coronary angioplasties which has resulted from surge in cardiovascular diseases, augmented healthcare spending as well as an increase in the number of interventional cardiologists and cath labs in government and private hospitals, including individual cath lab centers run by interventional cardiologists as well as new corporate hospitals. The demand has surged as central and state governments have capped reimbursement rates, which has enhanced affordability resulting in an increase in volume.

With declining coronary procedure volumes and many new interventional technologies, 50 percent of the financial return from cardiac cath labs will come from non-coronary procedures by 2020. These will include trans-catheter valve repairs or replacements (TAVR) and left-atrial appendage (LAA) occlude placements to eliminate the need for warfarin in atrial fibrillation (AF) patients.

Most modern angiography systems offer rotational 3-D angiography, which uses a quick spin around the patient to create a CT-like 3-D image of the anatomy. Some systems allow these or CT, or MRI 3-D images to be fused with the live 2-D fluoroscopic images. This fusion technology is used with TAVR planning. The next step in advanced visualization will be the use of free-floating, 3-D holographic images in the cath lab. It allows physicians to interact with the 3-D datasets, rotating them and even being able to slice through the image on any plane to see cross sections. In robotic cath lab, the operator uses joystick controls to navigate vessels on a screen in front of them while seated in a lead-lined cockpit. There are also new radiation-protection systems available to help block radiation from scattering and the zero-gravity ceiling gantry-mounted lead suit system that takes the weight of lead aprons off the physicians.

Advances will improve operator performance, enable more complex procedures, improve patient and operator safety, and expand the use of minimally invasive cardiovascular procedures into new areas that were previously only the domain of surgeons.

Dr Nagamalesh UM
Senior Consultant Cardiologist,
MS Ramaiah Narayana Heart Center, Bangalore

Dr Sanjeev Aggarwal, Director and HOD-Centre for Cardiac Sciences, Saroj Super Speciality Hospital, Delhi
Second Opinion
Technology Advancements Propelling the Market

Advanced cath labs are used to perform variety of procedures like complex varieties of therapeutic interventional procedures, including complex coronary angioplasty even triple vessel, valvuloplasty of mitral valve, dual-chamber pacemaker/bi-ventricular pacing, ICD implantation, and others.

{mosimage}In the past five years, cath labs market has developed with the growth rate of more than 10 percent per annum. Advancement in technology and constant increase in demand from hospitals, nursing homes, and other medical centers has resulted in steady growth of Indian cath lab market. The rising incidences of cardiac diseases in the country and the increasing need for various therapeutic and diagnostic procedures conducted in cath labs, growing medical tourism, and increasing healthcare spending are the major growth factors for the market. Due to increasing healthcare centers, the market has huge potential for growth, thereby bringing immense benefit to market players.

Several technological trends are visible in the market. With the rapid advancement and development of newer technologies, the market will get a further boost. Both domestic and foreign companies operate in the market and high competitive rivalry exists between them. The expansion of hospitals in Tier-II and Tier-III cities will help the Indian companies as these centers generally have a budget constraint and would prefer to buy the products of domestic manufacturers who generally sell their products at a lower price than those of foreign manufacturers.

Dr Sanjeev Aggarwal
Director and HOD-Centre for Cardiac Sciences,
Saroj Super Speciality Hospital, Delhi


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