Defibrillators: Putting Technology Into Leadership

Defibrillators: Putting Technology Into Leadership

Heart technology has advanced to impressive and astonishing heights, and industry can only expect it to continue to expand.

Sudden cardiac arrest (SCA) has always been one of the leading causes of deaths worldwide. Popularity of automated external defibrillators (AED) has significantly reduced the causalities; however, the penetration of the technology is still insufficient to address the issue globally. Technology and treatment guidelines have been refined over the past few years. Treatment of SCA has changed from stacked shock delivery to a combination of cardiopulmonary resuscitation (CPR) and defibrillation. Modern day defibrillators have evolved to support such a treatment protocol from what used to be a just a shock delivery device. With modern technology and the investment in R&D for defibrillators, it will not be too long before a defibrillator will be something one can carry in a pocket. No doubt they will soon be the size of a mobile device!

Technology will continue to surprise as it pushes the boundaries on what industry thought possible. Thoughtful caregivers and manufacturers will continue to develop, evaluate, and adopt technologies that save and improve lives by preventing and treating heart disease.

Indian market dynamics

The Indian defibrillator market in 2017 was Rs. 133 crore, estimated as 9430 units. Biphasic defibrillators, the highest priced in this segment dominate the market with a 66 percent market share by value and 46 percent market share by volume. Large hospitals have biphasic defibrillators on every floor. The government was not a major buyer in 2017. 2018 looks promising as the government has indicated its plans to procure fully loaded biphasic defibrillators.

The AED defibrillator market grew by 20 percent in 2017 over 2016. With increasing awareness, they are being installed in public places like airports, malls, hotel lobbies, schools, and reception areas of large corporate offices all over the country. However, one of the factors restraining demand is their disposable nature as electrode pads cost Rs. 2000 and have to be changed with every usage.

India is one of the few countries in the world where monophasic defibrillators continue to be popular, albeit only in the rural and semi-urban areas. With stringent budgets, these medical practitioners also do not seem to fully appreciate the benefits of the biphasic defibrillators. The defibrillator is a mere complance formality. BPL is the sole supplier of this product. Biphasic vendors see this as a major replacement market once medical facilities in rural decide to upgrade.

Global market

The global defibrillator market is expected to reach USD 18.8 billion by 2025, according to a recent report by Grand View Research, Inc. Increasing demand due to supportive legislation policies by the government of developed countries is a major driver responsible for the growth of the defibrillator market.

Developed countries such as the United States of America and the United Kingdom are making it mandatory for certain public places which includes sports arenas, schools, government facilities, and institutes to store and maintain AEDs, making them more cardio-friendly. The most common cause of death due to SCA is the unavailability of defibrillators. Such changes in the legislation of a country help cause an upsurge in availability and access, thereby increasing the market size of this industry.

The rising demand for handling cardiovascular conditions is leading to innovation in implantable devices as well as external defibrillators. Innovation with regards to implantable devices includes products, such as subcutaneous and transvenous patches, which aim to increase the comfort level of patients. Swedish Transport Agency is running a program under the test phase, which may deliver AEDs using a drone. This may reduce the delivery time of an AED, increasing chances of survival with faster treatment. Therefore, the defibrillator market is anticipated to grow because of technological advancements and product innovations.

Increasing prevalence of lifestyle diseases, such as cardiac disorders, globally, is causing an increase in noncommunicable diseases (NCD). One of the major segments of NCD is cardiovascular diseases. The prevalence of cardiovascular diseases has increased in individuals below 35 years. Among cardiovascular disorders, SCA is one of the major causes of death in the younger population. Increasing awareness about the disease and rising demand for treatment of SCA is expected to upsurge the demand over the forecast period.

Training programs are being developed and conducted in schools, offices, and other public places to spread awareness about defibrillation. The ongoing training programs may be responsible for substantial increase in the demand for home care, alternate care, and public access defibrillators.

The defibrillator market is divided into two segments: implantable convertible defibrillators (ICD) and external defibrillators, based on products. ICDs contributed to more than 50 percent of the overall market in 2017. These devices are used as a continuous monitoring device for arrhythmias as well. The scope of these devices has increased due to the integration of other technologies, such as pacemakers, with defibrillators. As ICDs are used for managing arrhythmias for an extended period, this segment is anticipated to exhibit significant growth.

External defibrillators are expected to grow at a lucrative rate during 2018–2025. The growth can be attributed to supportive legislative policies in developed countries and increasing awareness and training programs pertaining to external defibrillators.

Hospitals held more than 88 percent share of the overall end-use segment. Hospitals are required to be equipped with external as well as implantable defibrillators. Implantable defibrillators are available mostly in hospitals. Thus, hospitals have a substantial contribution to the growth of implantable and external defibrillators. Maximum growth was observed in the public access market in 2017. This growth can be attributed to change in policies by governments of developed countries, making it mandatory for certain arenas and institutions to store and maintain AEDs. In addition, there is an increase in awareness and training programs, driving the growth of this segment.

North America accounted for a significant share of the overall market in 2017. This contribution can be attributed to increasing incidence of cardiovascular diseases, supportive government policies, favorable reimbursement schemes, increasing awareness, and increase in training programs. Asia-Pacific was identified as the fastest growing market for defibrillators. Tremendous growth opportunities are observed in this region due to increasing awareness and accessibility of these devices. In addition, increasing prevalence of cardiovascular diseases in this region also supports growth of this segment.

Technological advances

Defibrillators have now evolved from using transvenous leads to subcutaneous leads, and from transvenous pacemakers to leadless pacemakers. However, the advances eliminated pacing for the subcutaneous ICDs and allowed only single-chamber pacing for leadless pacemakers. The defibrillators have also now moved to single-coil defibrillator leads instead of dual-coil ones.

Newer models have the capability to transmit ECG via wi-fi or cellular connection to the healthcare facility before the patient arrives. Some models have improved CPR coaching and/or real-time feedback. Newer systems indicate when there is an issue with a lead or if it is not capturing pacing data which are often missed in an emergency. Aside from ECG, SPO2 and etCO2 are also added features.

A wearable cardiac defibrillator (WCD) is an external vest-like device that is intended to perform the same functions as an ICD without requiring an invasive procedure. This device is used to monitor and treat abnormal heart rhythms in people at risk. The vest includes an electrode belt that contains the cardiac monitoring electrodes and the therapy electrodes that deliver an electrical shock if a life-threatening ventricular arrhythmia is detected. The WCD is programmable and communicates with the patient through voice and display messages, tones, or alarms and vibration against the skin.

Another major change over time is in the way physicians follow their patients. They can perform remote monitoring of patients to augment in-person checks. Remote monitoring also affords the chance to adjust clinical care after detecting a change in the patient’s clinical condition or device malfunction, which may improve major clinical outcomes such as death and hospitalization. The device telemetry could only travel a few inches, but now it transmits several yards.

Most recently, the devices use bluetooth for telemetry. The ICD uplinks to the bedside monitor, which uses cellular technology to link to central databases and uses the internet to send the information to the physicians. The patient does not have to do anything but sleep. This has revolutionized the way physicians follow the devices and the patients. The patients can travel all over the world and can still be in touch with what is going on with them. The devices themselves now alert both the physician and the patient when there is a problem.

Most of the recent defibrillators can also do automatic internal diagnostics usually once a day to ensure the defibrillator is working properly. They also test the battery and report the status back to a central computer. Some of the modern models also include improved CPR coaching and/or real-time feedback. CPR feedback is a new advancement that most manufacturers are adopting and SpCO (carbon monoxide) measurement for pre-hospital models is also becoming popular.

One of the latest technology advancements is the use of drones to carry an AED to an emergency location. The AED drone was created by the Swedish Transportation Agency, and now more nations are beginning to install this AED assistance technology as well. The AED drone arrives at emergency situations 16 minutes before first responders. This means that the survival rate of an individual with cardiac arrest will drastically increase. It is said that each minute without the assistance of an AED will decrease the survival rate by 10 percent. Having an AED already installed in a location nearby can assist with this, but in the case where an AED is unavailable, the public is able to use an AED brought by a drone.

Can a cardiac device be hacked?

Medical devices, including cardiovascular implantable electronic devices, could be at risk for hacking. In a paper published online in the Journal of the American College of Cardiology, the American College of Cardiology’s Electrophysiology Council examines the potential risk to patients and outlines how to improve cybersecurity in these devices.

Cybersecurity in the medical field refers to the integration of medical devices, computer networks, and software. While there have been no actual clinical reports of malicious or inadvertent hacking or malware attacks affecting cardiac devices, recent reports have discovered this possibility. Reasons for hacking include political, financial, social, and personal motives. Devices can be hacked locally or remotely. The US Food and Drug Administration (FDA) has issued both pre-market and post-market guidance for the security of medical devices, and legislative proposals related to medical device security have been advanced in the US Congress.

“True cybersecurity begins at the point of designing protected software from the outset, and requires the integration of multiple stakeholders, including software experts, security experts, and medical advisors,” maintains Dhanunjaya R Lakkireddy, M.D., professor of medicine at the University of Kansas Hospital, a member of the Electrophysiology Council and the corresponding author of the paper.

Medical devices have been targets of hacking for over a decade. The increasing number of medical devices using software has created the need to protect devices from intentional harmful interference on their normal functioning. Advanced wireless communications between healthcare providers and patients’ devices have created the theoretical possibility for the deactivation of features, the alteration of programming, and the delaying, interfering, or interrupting of communications.

There are a number of possible clinical consequences that may result from the hacking of a cardiac device. In patients with pacemakers, concerns mostly consist of oversensing or battery depletion. For patients with ICDs, it is possible for hackers to interrupt wireless communications, inhibiting the value of telemonitoring and allowing any clinically relevant events to go undetected by the system. Oversensing may inhibit pacing or result in inappropriate or life-threatening shocks. Battery depletion can lead to a device being unable to deliver therapies during life-threatening arrhythmias.

At this time, there is no evidence that one can reprogram a cardiovascular implantable electronic device or change device settings in any form. The likelihood of an individual hacker successfully affecting a cardiovascular implantable electronic device or being able to target a specific patient is very low. A more likely scenario is that of a malware or ransomware attack affecting a hospital network and inhibiting communication.

Cybersecurity needs should also be addressed during product testing both in the pre- and post-market stages. Because cyber vulnerabilities can emerge quickly, strong post-market processes must be in place to monitor the environment for new vulnerabilities and to respond in a timely manner. The council suggests that firmware may be useful in devices with possible vulnerabilities. Physicians who manage cardiac devices should be aware of both documented and possible cybersecurity risks. Systems should be established to communicate updates in these areas quickly and in an understandable way to the rest of the clinical team that manages patients with devices.

The council members said they do not feel that enhanced monitoring or elective device replacement is necessary at this time.

Given the lack of evidence that hacking of cardiac devices is a relevant clinical problem, coupled with evidence of the benefits of remote monitoring, one should exercise caution in depriving a patient of the clear benefit of remote monitoring.

Way ahead

With the never-ending advancements in technology, there is no doubt that we will find better ways to stay safe and remain healthy. Science is an evolving practice that changes as technology improves. This is especially beneficial in the health and safety fields, where heart technology is concerned. The AED for example, once did not exist. It was not until technology improved, and researchers realized that electrical shocks could be administered to the heart to save a life, that these lifesaving machines came into being! Heart technology has advanced to impressive and astonishing heights, and industry can only expect it to continue to expand.

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