Fully self-contained leadless pacemakers, that are also MRI compatible, will be the future of cardiac pacing enabling patients to avoid lead-related and pocket-related complications such as infection.
Cardiac pacemakers have been around since the 1960s. They have become a cornerstone of treatment for complete heart block and sick sinus syndrome. Patients who used to have recurrent syncope or giddiness could now live normal lives. Indeed, many patients with complete heart block and sick sinus syndrome continue to work and lead very active lives after their pacemaker implantation. The extended use of these high-performance devices has undoubtedly contributed to the improvement of both prognosis and the quality of life of patients with bradyarrhythmias.
Over the years, the size of the pacemaker has shrunk and the electronics within have increased in complexity and function, mirroring the advance in microelectronics. However, the overall form of the pacemaker has not changed significantly – till now. The latest technological achievements in the field of pacing, which are related to battery longevity and miniaturization, device software and programming, lead performance, remote monitoring systems, and implantation techniques, have transformed pacing into an extremely reliable and safe therapy.
There is an increasing need of recognizing the problem of arrhythmia in patients in India. In western countries, for every million people, 600–700 pacemakers are implanted, but in India, for every million people, merely eight to nine pacemakers are implanted. There are many factors that have resulted in lower number of implants per million including low awareness levels, affordability, lack of advanced cardiac centers, indifference to quality of life, and thin cover of insurance system in the country.
India has tremendous potential to have a huge customer base for pacemakers because the country has a large aging population and an increasing prevalence of cardiovascular disease (CVD). In addition to this, detrimental lifestyle is also resulting in increase in the number of people suffering from heart diseases, boosting the demand for cardiac pacemakers. In fact, India is now among top three countries with a high diabetic population and the diabetic population has risen from 11.9 million in 1980 to the current 64.5 million in the country. Diabetes is associated with CVD which can require pacemaker treatment.
The pacemakers market in the country is anticipated to exhibit sturdy growth over the next few years. Several economic government initiatives are anticipated to create a free and open economy. For instance, implementation of Goods and Services Tax (GST) in India to avoid the tax cascading effect is anticipated to improve the ease of doing business in the country.
The Government of India has also launched the National Program for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) for interventions up to the district level under the National Health Mission. The program aims at providing early diagnosis and management of common NCDs (non-communicable diseases) by building capacity at various levels of healthcare facilities for their prevention, diagnosis, and treatment and setting up NCD clinics in district hospitals and community health centers (CHCs). Under the NPCDCS program, so far 103 cardiac care units have been set up across the country.
After curbing of the stent prices in February 2017 by the Union government, patients hope that authorities will turn to cap the overpriced pacemakers. The price cap is just one example of how a life-saving medical device can be made affordable when the government intervenes to regulate prices. In cardiac care, the cost of a conventional pacemaker is in the range of Rs. 40,000–Rs. 2.3 lakh. This cost is almost 40 percent more than its import price and follows a market methodology.
Pacemakers are as life-saving as stents. But the cost is definitely a financial burden on patients. They have to take up loans or pay for the device in EMIs. While the National Pharmaceutical Pricing Authority (NPPA) is already looking at regulating the prices of orthopedic implants and intraocular lenses, the capping of prices of pacemakers will be tough, since there are many local manufacturers for orthopedic implants and lenses who can step in if multinational players withdraw. However, with pacemakers, there are very few Indian manufacturers in the market.
The global pacemaker devices market is expected to exhibit a sturdy 8.1 percent CAGR from 2017 to 2022, rising from USD 5.5 billion in 2017 to USD 8.1 billion in 2022, projects Transparency Market Research.
External and implantable pacemakers are the key product types in the market. Of these, implantable pacemakers accounted for more than 65 percent of the market in 2017 and are likely to remain the dominant segment till 2022. The demand for implantable pacemaker devices has been driven by the steady development of the medical devices sector, which has led to consistent product innovation. Biventricular, single chambered, and dual chambered are the key technology segments of the global market. The dual chambered technology segment dominated the market in terms of volume and revenue and is expected to grow at the fastest growth rate in the coming years.
Geographically, North America is the dominant contributor to the global market. The North American market was valued at USD 1921.6 million in 2017 and is expected to rise to USD 2917.9 million by 2022, reflecting a CAGR of 8.7 percent. The robust healthcare research scenario in North America is conducive for strong growth of the pacemaker devices market in the region, in addition to the proliferation of numerous medical institutions and global leaders in the field of cardiac medical device innovation. Europe is also a key contributor to the global pacemaker devices market and is likely to account for around 25 percent of the market in the coming years. Asia-Pacific, except Japan, is also expected to become a leading regional market for pacemaker devices over the years due to the rising prevalence of cardiac conditions in the region. The APEJ market for pacemaker devices is expected to rise to a valuation of USD 1692.2 million by 2022, exhibiting a strong 8.3 percent CAGR from 2017 to 2022.
Medtronic, St. Jude Medical, Boston Scientific, and Biotronik together constitute around 80–85 percent of the overall market share. The competition is high between these top players in the market. The shares accounted by regional players in the global market are small. The companies are investing in marketing their products in developing nations where the medical needs are unmet and are benefitting from this strategy. For instance, in July 2016, St. Jude Medical received the US FDA approval for SyncAV, a CRT software compatible with the company’s MultiPoint pacing technology. The software was approved earlier in the European market in June 2016.
Other key companies in the market include Abbott Laboratories, Lepu Medical Technology, Osypka Medical, Zoll Medical Corporation, LivaNova Plc, Vitatron, and Pacetronix Limited.
Therapeutic cardiac stimulation by permanent pacemakers has revolutionized the field of cardiology. Since the implantation of the first internal pacemaker, pacing technology has evolved a lot, including reduction in size of pulse generator, increase in longevity, and complexity of devices. Recently, leadless pacing systems have emerged as a therapeutic alternative to conventional pacing systems, while eliminating potential transvenous lead- and pacemaker pocket-related complications. It is highly probable that further developments in leadless technology will lead to even smaller devices in the future and that abandoning depleted devices will become more widely accepted.
Leadless pacemakers. Leadless pacemakers will most likely be the future of cardiac pacing. Leadless pacing employs a single-chamber system to pace only the right ventricle and is fully self-contained, which eliminates the need for transvenous leads. These devices enable patients to avoid lead-related complications, from lead fracture to extraction challenges, as well as pocket-related complications such as infection and disfigurement. Leadless pacemakers are also compatible with MRI and do not require surgical placement, so patients avoid postoperative mobility restrictions. In early 2016, the US FDA approved the Medtronic Micra device, one of the first headless, catheter-implanted pacemaker.
MRI compatibility. The concern for people with ICDs has been that the magnetic force generated by the MRI device might cause their pacemakers or defibrillators to malfunction, leading to an arrhythmia or shock, or that the wires contained in the ICDs could overheat, causing injury to the patient. Advances in technology are now producing a new generation of pacemakers that are MRI compatible. These pacemakers are safer than ever before. They have no ferromagnetic elements, abolishing the risk of interaction of pacemakers with MRI. Now, MRI compatible pacemakers are also available in few of the leading hospitals in the country including Max Hospital, Apollo Hospitals, B M Birla, and SGPGI.
Improved size and battery life. Pacemakers have improved a lot since the early days, most visibly in size, and also in battery life and functionality. Due to development of integrated circuits and miniaturization of components, modern pacemakers are getting progressively smaller despite more complex operations. Similarly, battery technology has kept pace, resulting in safer and longer lasting devices. Initially, pacemakers paced the heart at a fixed rate irrespective of the patient’s demand and intrinsic rhythm. The current generation of pacemakers tries to encourage the intrinsic activity and pace only when it is absolutely necessary. When pacemakers act on stand-by, encouraging the internal rhythm, the quality of life for the patients is better and the longevity of the pacemaker increases.
Programmability. The function of programmability of pacemakers has also changed over time. Initially, pacemakers were not programmable at all. The functioning parameters were pre-set by the manufacturer. Now the programmable pacemakers are developed which can be programmed from outside the body using telemetry.
The development of the implantable cardiac pacemaker nearly 60 years ago represented a paradigm shift in the control of potentially lethal heart rhythms and has revolutionized the lives of those at risk of sudden death from bradycardia. Although current generation devices are limited to single-chamber pacing, future generation devices are expected to progress to multichamber multicomponent pacing systems, and eventually to battery-less and wireless devices. Several researches are being undertaken worldwide to improve cardiac function in patients and increase longevity.
Biological pacemaker. Although electronic pacemakers are the current treatment for symptomatic atrioventricular block or sinoatrial node dysfunction, however their maintenance, inability to react to hormone signals, battery life, and the risk of complications and infections have motivated research on biological alternatives. Considering all drawbacks of an artificial pacemaker, Canadian research teams at the McEwen Centre for Regenerative Medicine in Toronto have developed the first functional pacemaker cells using human pluripotent stem cells. These cells can regulate heart beats with electrical impulses.
Flexible and organic batteries. Researchers from Queen’s University Belfast in Northern Ireland have designed a flexible and organic supercapacitor that can replace rigid batteries in pacemakers and other medical implants, making them more comfortable for patients. The flexible device is made up of nonflammable electrolytes and organic composites, which are safe to the human body. It can also be easily decomposed without incurring the major costs associated with recycling or disposing off metal-based batteries. The device could be manufactured using readily available natural feedstock, rather than sophisticated and expensive metals or semiconductors.
Wireless and battery-less pacemaker. Researchers at Rice University in the United States have developed a new wireless, battery-less pacemaker that can be implanted directly into a patient’s heart, an advance that could lead to triple crown of treatment for irregular heartbeat. The pacemaker harvests energy wirelessly from radio frequency radiation transmitted by an external battery pack. This greatly simplifies battery-replacement surgery and could reduce complications associated with conventional pacemakers. The chip at the systems heart is less than 4 mm wide and incorporates the receiving antenna, a current rectifier, a power management unit, and a pacing activation signal. An earlier wire-free pacemaker won the US FDA approval in April 2016; the Rice team’s pacemaker combines the battery accessibility of the traditional device with the wireless feature of the 2016 version.
The Road Ahead
The introduction of leadless cardiac devices in clinical practice, undoubtedly, represents the dawn of a new era in pacing. However, further technological advances are necessary to ameliorate the performance of these systems. Since the leadless pacemaker is only approved for use in the right ventricle, they can currently only be used in patients who need single-chamber ventricular pacemakers. This comprises about 10–20 percent of patients who need pacemakers. As the technology advances, the next generation of leadless pacemakers could service multiple chambers and be able to work with defibrillators.
India is a price sensitive market. Most patients are not covered by any medical insurance, which means pacemaker implantation is a mostly out-of-pocket expense. In that case, a device with superior technological advantages faces a challenge in gaining popularity and thus capturing market share. On the other hand the recent reimbursement plans by the Indian government – including revision of the reimbursement ceilings for medical devices (Medical Devices Rule 2017) – would help reduce out-of-pocket expenses. Of course, other manufacturers will also get into the foray offering their own leadless device, driving down prices. All this will support the adoption of leadless pacemakers in India.
Wireless pacemakers are expected to hit the Indian market in a big way. In future, pacemakers are expected to have longer battery life or there will be battery-free pacemakers powered by one’s own heart. As of now, the first step is to generate enough awareness about this technological marvel, so that many precious lives can be saved. This is a first-generation device in what promises to be an ongoing technology development leading to improved options for the majority of patients who require cardiac pacing.