Increasing cath labs are now hybrid in nature, and cater not only to cardiology but are also used for interventional radiology, electrophysiology, vascular interventions, and neurology.
The variety and complexity of percutaneous catheter-based procedures performed in the catheterization laboratory (cath lab) has considerably increased over recent years. In addition to well-established procedures such as transcatheter closure of atrial septal defects (ASDs) and patent foramen ovale (PFO), balloon mitral valvuloplasty (BMV), and transcatheter alcohol septal ablation (TASH) for hypertrophic cardiomyopathy, more complex percutaneous procedures have been developed recently, such as percutaneous left atrial appendage (LAA) closure and percutaneous aortic and mitral valve interventions.
In India, the incidence of coronary artery disease is on the rise and it has been the single biggest factor contributing to increase in interventional cardiac procedures, resulting in more cardiac centers and hence more cath labs.
An increase in the number of coronary angioplasties, which have 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; more individual cath lab centers run by interventional cardiologists as well as new corporate hospitals have led to an increase in market size. The demand has surged as central and state governments have capped reimbursement rates, which has enhanced affordability resulting in an increase in volume.
Apart from the prevalence of coronary artery disease, increasing cases of blockages in blood vessels in non-coronary diseases, particularly among the geriatric population drives demand for cath labs. A growing percentage of people with obesity, resilient R&D, consequent product launches by various leading players, and government subsidies to increase the ubiquity of essential medical equipment are some of the other key factors augmenting demand.
Moving forward, the cath lab market in India is expected to be on an upward surge in the coming years. The cath labs are increasingly hybrid in nature, and cater not only to cardiology but also interventional radiology, electrophysiology, vascular interventions, and neurology.
In 2017, the Indian cath labs market is estimated at Rs. 745 crore, at 414 units, a 12 percent increase in volume terms and a 17 percent in value terms over 2016. The premium biplane segment saw an increase, with 12 units sold at an average unit price of Rs. 6 crore, and 10 units in the Rs. 3.2 crore unit price category. This is a distinct shift from 2016, when the premium segment, here defined as higher than unit price of Rs. 3.2 crore, constituted 6 systems in comparison to 22 systems in 2017. The flat panel digital performance systems, in the unit price range of Rs. 1.5 crore to Rs. 3.2 crore have a combined 56 percent share in volume terms, and 68.5 percent in value terms. The value fixed systems constitute 14.5 percent of the market, and the value mobile 24 percent in quantity terms. In volume terms the corresponding shares are 7.8 percent for value fixed and 9.7 percent for value mobile. The value fixed segment includes 35 units of the refurbished systems.
Philips, GE, and Siemens have a combined 90 percent share in this segment. Toshiba is more successful with the government, whereas Allengers is making inroads with their indigenous machines in Tier-II and Tier-III cities. Ziehm, marketed by Bet Medical; Shimadzu; and Schiller are also aggressive in this segment.
2017 saw more of government buying, while the private sector in the backdrop of price control on stents and challenges in some cases on obtaining funding somewhat held back. The MNC vendors are also being asked to quote prices in Indian rupees. Indigenous systems are being offered by leading brands as Intius from Philips. Metros and Tier-I cities are more or less saturated, and the players are moving into smaller cities and semi urban areas, which are price sensitive. With satellite centers becoming popular, the mobile version is gaining popularity.
The premium systems are focusing on obtaining clearer images and low dose radiation. When it comes to diagnosing disease, image is everything. It is difficult to treat what you can’t see. That’s especially true in the cardiac cath lab where cardiologists performing procedures ranging from simple diagnostic tests to more complex interventional maneuvers rely on imaging technology to guide their course. To ensure patients get the best treatment possible — and to remain competitive — cardiologists more and more are demanding state-of-art equipment in the cath lab.
One method of obtaining clearer images of complex vascular and cardiac anatomy is with flat panel digital angiography systems. Angiography systems have been a diagnostic mainstay in cardiac cath labs for over 50 years, playing a pivotal role in the diagnosis and treatment of heart and vascular diseases. The introduction of flat panel detectors (FPD) — replacing image intensifiers — for angiography has broadened digital imaging’s role in the cath lab. Now cardiologists can see, immediately and with greater clarity, the intricacies of the heart, the vascular system and how well they are functioning.
With the image intensifier there are approximately nine steps involved in creating an image, and each step brings with it about 10-15 percent noise. In contrast, flat panel systems can produce an image in two steps, which dramatically reduces the possible number of sources for error and chances for image degradation. Image intensifiers are bulkier and limit the movement of the cameras. Flat panel detector systems give a more discrete image of the anatomy. More acute angles separate out vessels that have a tendency to overlap, opening up the coronary tree for optimal visualization. Better visualization of the vessels is experienced in obese patients with the flat panel systems, and they make it easier and quicker to do peripherals on all patients.
Flat panel systems have done more than produce clearer images. A major advantage of flat panel systems over image intensifiers has been the reduction of X-ray dose to the patient and the people in the room, although this has recently been refuted by a recent ACC abstract where Australian researchers examined radiation exposure pre- and post-FPD technology. Interestingly, according to the study, radiation exposure was actually greater with FPD technology than with conventional image intensifier technology. With flat panel detector technology already a standard of care, multimodality imaging is the next big thing.
A mobile cath lab is gradually becoming a preferred form of cardiac care in tier-II and tier-III cities as it decreases procedural costs, thus increasing feasibility. There has also been a significant growth in the demand for mobile flat-panel cath labs, as they operate on a single phase, thus reducing heavy electricity bills, improving image quality significantly, and lowering dosage.
Some technology trends
Expanding catheter-based interventions for all areas of the body. This will boost interventional radiology and cardiac cath lab volumes and lead to declines in open surgical procedures. As coronary interventions have plateaued, many of the new innovations in the coming years will be for heart failure and structural heart interventions. In the cardiac/vascular lab, new expansion areas will be in peripheral artery disease (PAD), critical limb ischemia (CLI), transcatheter valve repair, and replacement technologies for all four heart valve positions, and interventional heart failure devices.
Closer integration of computed tomography (CT) and echo imaging to provide better pre-procedural planning and peri-procedural guidance.
Analytics software, combined with artificial intelligence, will see rapid uptake to look at big data across healthcare systems. This will enable new ways to manage healthcare, including identification of bottlenecks and inefficiencies within departments or processes. Analysis of big data will also enable population health initiatives to identify high-risk patients for screening programs and proactive outreach for checkup appointments. This can also help assess the readmission or infection risks a specific patient likely poses to help target limited hospital resources. Big data also offers a new way to conduct retrospective clinical studies. This might include analysis of the best protocols for treating patient subgroups that have a specific mix of various diseases. Or, it can highlight long-term outcomes or late complications for patients who are prescribed specific drugs or who received specific implantable devices.
The market will see greater efforts and several new technologies to reduce radiation dose in both CT and cath lab angiography imaging systems. This includes increasing use 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 magnetic resonance imaging (MRI) suites to eliminate radiation entirely for long procedures, such as EP ablations.
There will be greater emphasis on reducing staff radiation dose and related orthopedic problems due to wearing heavy lead aprons all day. This includes adopting new technologies in the lab to better protect staff, including real-time dose monitoring systems, use of new, very light-weight aprons, and possibly robotics to remove the physician from the radiation field.
Transcatheter aortic valve replacement (TAVR) will likely replace the majority of open-heart surgical valve replacements in select patient populations. If clinical trial data continues the very positive trends for TAVR, it will gain more procedural volume than surgical valve replacements. There is a very good possibility that this trend will be duplicated in transcatheter mitral and tricuspid valve repair and replacement technologies in the next few years.
Catheter ablation for atrial fibrillation will greatly improve from 60 percent procedural success rates to 80–90 percent in the coming years with the use of more accurate electro-anatomical mapping systems and improved ablation catheter technologies that reduce intra-operator variability. Both of these technologies are also helping reduce the time it takes to map and treat patients, which will allow for greater patient throughput and higher volumes in the EP lab. Improved accuracy and more complete ablations also will reduce the number of repeat procedures.
EP implantable devices will become much smaller and wireless. This will enable catheter-based implant procedures, eliminating the need for surgical pockets and venous leads for pacemakers. These technologies will also reduce the number of leads required for ICDs.
All EP device follow-up and 24-7 monitoring will be conducted via the web through remote monitoring. Artificial intelligence will be used to help track patient data and identify patients who need office follow-up, device reprogramming, and other issues requiring human interventions.
Simple, small wearable patient monitors will largely replace traditional holter monitors. Consumer-grade patient monitors may offer new data to monitor patient health, including watching if a patient’s health is declining or improving based on activity due to lifestyle changes, new drugs, etc. This data will need to be accessible for review and storage in patient electronic medical records. This may be automated as part of the larger trend of the internet of things (IoT), and artificial intelligence will likely play a role in monitoring this data and alerting providers and patients of closely monitored, higher-risk patients.
Greater use of 3-D advanced visualization. This includes fully automated reconstructions to improve efficiency and increase 3-D usage particularly in cardiac imaging. This and other advanced visualization tools and image analysis will be immediately available at all staff workstations, not just dedicated computers. Some of the imaging capability will also be available for patients via their patient portals, and referring physicians via remote image viewing systems integrated with the EMR, PACS, and/or CVIS. Advanced visualization in really complex cases will see a rapid increase in 3-D printed models from medical images. Holographic and true 3-D imaging will also see increasing use in radiology, cardiology, and other specialties to better understand complex anatomy and for procedural planning.
CVIS, PACS, and all other clinical data systems will be upgraded to systems that easily interface into enterprise-wide EMR systems. Some will be based around the hospital system’s EMR as the main digital data access point. Others will be based around a vendor-neutral archive (VNA) that provides enterprise-wide access to the data using content management software to sort the data from all clinical systems and the EMR. Information technology (IT) departments will have a much greater say over what IT reporting systems are purchased and how departments and hospitals are wired, and will be the overall agents to interconnect all departments together into unified, enterprise systems.
With the incidence of heart diseases on the 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.
The number of interventional cardiologists in the country is estimated to be three to five per million population, in contrast to 50–70 per million population in the United States of America. Cath-labs and coronary interventions in India are increasing exponentially, adding substantially to healthcare expenses. The country has more than 1200 cardiac catheterization laboratories in about 1000 cardiac facilities in metropolitan and Tier I and Tier II cities. Keeping the burden of disease in mind, the facilities and infrastructure for invasive treatment modalities in India are inadequate.
Despite these shortcomings, the number of percutaneous coronary interventions (PCI) performed is increasing steadily at an annual growth rate of 6 percent. The total number of PCI procedures carried out in 2016 was 495,000 with an estimated number of 594,000 stents used (1.20 per procedure). With regard to coronary stenting, which had been the bread and butter of the coronary cath lab, it is expected that in future 50 percent of patients will receive a bioresorbable stent as the technology begins to replace permanent metallic stents.
There are a lot of forthcoming revolutions that will change the way physicians utilize their time in the cath lab. 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. Hypertension is epidemic in India and this is a very simple procedure in which benefits can be extended to the patients. Other innovations in the near term are biovascular scaffolds, TAVI, and PMVR.
Rationalizing patient care in the cath lab will be an important area of focus for healthcare systems in order to optimize delivery of care, and succeed both today and moving forward.
Cath Labs – Robotic Procedures to Become Commonplace in Future
Cath lab imaging technology has migrated from the analogue-based image intensifiers (IIs) to fully digital flat-panel technology with 3D reconstruction. The migration of peripheral interventions into the Cath lab has been fueled by cardiologists with an interest in expanding their cardiac catheter skills to other vascular array. In the coming years, we will see an increase in satellite Cath lab clinics installed with mobile Cath lab with an aspiration to penetrate tier II and III cities.
The mobile Cath lab segment has seen some major technological advancements right from X-ray tubes, dual cooling techniques to low-dose, low-scatter, and high-resolution image quality. These labs are now built at par with the fix Cath lab. Basic cardiac systems are now used for complete array of vascular studies along with orthopedic – spinal, cranial, and general surgery. Currently, however, we are seeing a shift toward hybrid procedures, mixing components of both surgical and interventional therapies, giving rise to the hybrid operating room (OR) or hybrid Cath lab.
Some of the key growth drivers include continued rising incidence of cardiac diseases, economic growth leading to higher disposable incomes, increase public spending in healthcare from 1 percent of GDP to 3 percent to radically alter the provision of healthcare services, and increased penetration of health insurance. The hybrid operating room is an emerging model that combines surgery and intra operative imaging system. This is increasingly replacing conventional open surgery approaches with minimally invasive surgery (MIS).
On Buyer’s Perspective
Today’s buyer demands cost-effective solutions, justifying viability, and workload of his clinic. They want to invest in a technology which does not get obsolete after a decade.
On Challenges and Opportunities
Challenges in the market include minimizing installation and maintenance costs, growing adoption of the refurbished Cath lab market in developing nations, uncertainty of consumable market in the Cath lab industry, shortage of well-trained and skilled healthcare professionals. While the market also presents several opportunities for growth such as emerging markets on hybrid Cath lab, satellite Cath lab centers, adoption and benefits of MIS, ongoing market shift toward image-guided medical interventions, and government encouragement to local manufacturing of sophisticated medical equipment.
On Future Outlook
Cath labs have definitely come a long way. Perhaps robot-assisted procedures in the Cath lab will become commonplace in the near future. The healthcare aids of the future will require a willingness to think creatively and investigate out-of-the-box solutions.
Product Head, Radiology,
Change is the Only Constant
A totally equipped cath lab is an unmet dream of any interventional cardiologist. 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. Majority of cath labs in India are however working only on a flat panel X-ray fluoroscope with a few basic software like QCA and IC stent. In these centers, additional devices like IVUS, OCT, FFR, rotational atherectomy are often hired on a case-to-case basis. Availability of software with CT imaging has now enabled 3D reconstruction of angiographic data in the cath lab itself. This can provide information like coronary stent apposition to the vessel wall or facilitate therapeutic decision making during trans-aortic valve replacement with derivation of values like aortic sinus diameter, coronary ostial heights, etc. Any cath lab should have all of these devices integrated into its system and used regularly to qualify as a state-of-the-art facility. A ceiling-mounted cath lab allows more freedom of movement, especially for surgical procedures to be done on the same table.
Hybrid cath labs designed for doing a surgical procedure alongside cardiac interventions have now come up in a few high-volume centers. In the near future, cath lab usage will see a dynamic shift with proportion of cases performed by a coronary interventional cardiologist reducing. On the other hand, procedures done by peripheral interventionist, interventional neurologists, structural heart specialists, electrophysiologists, pediatric cardiologists, interventional gastroenterologists, and interventional nephrologists will see a rise. The cath lab of the newer generation may thus become a multipurpose unit, which will be cost-effective for the hospital and allow better space and time utilization. Radiation safety is now being taken more seriously than ever before. The radiation safety kit of an interventionist now includes radiation absorbent goggles and caps and radiation pads and shields. The heavier lead aprons and neck collars are now replaced with lighter material containing barium. X-ray generators are now designed to reduce emissions, working at lower frame rates. Biplane and rotational C-arms allow more images to be taken with lesser radiation; however, very few centers in India can boast of having these. The latest innovation is use of robotics, wherein the operator sits out of the cath lab and controls the procedure through joysticks.
Dr Harshal Lahoti
Consultant Interventional Cardiologist,
MGM New Bombay Hospital