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Injectable Hydrogel Electrodes Open Door To A Novel Painless Treatment Regimen For Arrhythmia

A breakthrough study led by Dr. Mehdi Razavi at The Texas Heart Institute (THI), in collaboration with a biomedical engineering team of The University of Texas at Austin (UT Austin) Cockrell School of Engineering led by Dr. Elizabeth Cosgriff-Hernandez, sets the foundation of a ground-breaking treatment regimen for treating ventricular arrhythmia. Their study published in Nature Communications demonstrates the design and feasibility of a new hydrogel-based pacing modality.

The urgent need for an effective therapeutic regimen for ventricular arrhythmia inspired THI's Electrophysiology Clinical Research & Innovations (EPCRI) team, led by its director, Dr. Razavi, to partner with Dr. Cosgriff-Hernandez and her UT Austin Biomedical Engineering (UT Austin BME) team to co-develop an innovative strategy that addresses the pathophysiology of re-entrant arrhythmia.

Ventricular arrhythmia, which occurs in the lower chambers of the heart or ventricles, is the leading cause of sudden cardiac death in the United States. When heart rhythm abnormality occurs in a self-sustained manner, it is called re-entrant arrhythmia, which is usually fatal.

"Re-entry occurs mainly from delayed conduction in scarred heart tissues, usually after coronary artery occlusion during a heart attack, which can be corrected by enabling pacing in these regions," said Dr. Razavi, a practicing cardiologist and cardiac electrophysiologist. "These hydrogels then can access the scarred tissue, thereby enabling direct pacing of the otherwise inaccessible regions of the heart."

Given hydrogels' biostability, biocompatibility, tunable properties, and the ease of incorporating electrical conductivity, the scientists are exploring them as potential electrodes that can be easily delivered inside coronary veins. A clinical advantage of the unique system is that ischemia can be avoided by delivering the hydrogel using the veins.

The researchers successfully deployed the innovative hydrogel technology through minimally invasive catheter delivery in a pig model.

"The hydrogels have significant conductive properties that enable simultaneous pacing from multiple sites along the length of the hydrogel and create a conduction highway similar to those in Purkinje fibers," according to Dr. Cosgriff-Hernandez.

Today, arrhythmia is treatable with medicines and procedures that control the irregular rhythms. The current anti-arrhythmic drugs on the market are not always effective; although the drugs slow the conduction velocity, they facilitate re-entry arrhythmia. Moreover, these drugs can be toxic and can lead to the destruction of tissues near the diseased regions of the heart. Even with the widely used interventional ablation therapies, arrhythmia recurs in a significant proportion of patients. None of these procedures address the mechanism of re-entry.

Cardiac defibrillators implanted to compensate for the shortfalls in the current therapy options are painful when delivering electric shocks to restore heart rhythm and can severely deteriorate the patient's quality of life. If left untreated, arrhythmia can damage the heart, brain, or other organs, leading to stroke or cardiac arrest, during which the heart suddenly and unexpectedly stops beating.

"When injected into target vessels, the conductive hydrogel conforms to the patient's vessel morphology. Adding a traditional pacemaker to this gel allows for pacing that resembles the native conduction in the heart -- effectively mimicking the native electrical rhythm of the heart -- and extinguishes the cause for arrhythmia, providing painless defibrillation," added Dr. Cosgriff-Hernandez.

The work demonstrates for the first time the ability to confer direct electrical stimulation of the native and scarred mid-myocardium through injectable hydrogel electrodes as a pacing modality.

With minimally invasive catheter delivery and standard pacemaker technologies, this study indicates the feasibility of a novel pacing modality that resembles native conduction, potentially eliminating lethal re-entrant arrhythmia and providing painless defibrillation, which can be successfully adopted in a clinical workflow.

The scientific advance is significant considering pain management is highly relevant to overall wellness for patients with heart, lung, and blood diseases. Such innovation in painless defibrillation and preventing arrhythmia could revolutionize cardiac rhythm management.

Funding was provided by the National Heart, Lung, and Blood Institute of the National Institutes of Health (R01 HL162741); Ford Pre-Doctoral Fellowship, administered by the National Academy of Science, Engineering and Medicine; Ford Dissertation Fellowship, administered by the National Academy of Science, Engineering and Medicine; Office of Vice President for Research, The University of Texas at Austin; The Roderick D. MacDonald Research Fund Award 19RDM004; and The Sultan Qaboos Chair in Cardiology at the St. Luke's Foundation.


Small Arrhythmia Risk Seen When Medical Cannabis Used For Pain

New users of medical marijuana for the treatment of chronic pain appear to have a greater risk of developing arrhythmias, according to a Danish registry study published recently online in the European Heart Journal.

The absolute increase in risk was 0.4% through the first 180 days compared with other patients who had chronic pain, with the difference lessening out to 1 year, researchers led by Anders Holt, MD (Copenhagen University Hospital—Herlev and Gentofte, Denmark), report.

Differences in absolute risk of arrhythmias through 180 days were greatest in the subsets of patients with cancer (1.1%) or cardiometabolic disease (0.8%). Hazards of ACS, stroke, and heart failure, however, did not seem to be influenced by use of medical cannabis.

Taken together, the findings are not a reason to panic, Holt indicated, pointing out that the observational study cannot prove causation. "Medical cannabis might be associated with a risk of arrhythmia, although the risk is very small," he told TCTMD. "More research is certainly needed in this area if we are going to be prescribing medical cannabis for chronic pain, [but] don't refrain from trying medical cannabis if other treatment is inadequate. . . . Just be aware and look out for any new symptoms immediately following this medication."

Agreeing was Robert Page II, PharmD (University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora), who wrote an accompanying editorial.

Although "any arrhythmia is not a good arrhythmia," he told TCTMD, there is not enough here to make a blanket recommendation against trying medical cannabis for chronic pain.

"I think what these data do is allow medical providers and patients to make better informed decisions," Page said. "It just means that when looking at pharmacotherapy options for pain, all of this has to be contextualized so that you are able to find a good pain regimen that works for a patient."

Filling a Knowledge Gap

Recreational pot use has been linked to adverse cardiovascular effects in prior observational studies, the researchers note.

"The active cannabinoid compounds in cannabis, tetrahydrocannabinol (THC) and cannabidiol (CBD), interact with the endocannabinoid system and have been associated with elevated heart rate, hypotension, and increased cardiac oxygen demand—in relation to recreational cannabis use," Holt et al write. "Moreover, recreational cannabis use has been associated with an increased risk of arrhythmia and, to a lesser extent, acute coronary syndrome."

There are, however, limited data on potential side effects with medical cannabis. That's unusual with prescription drugs, which typically are studied extensively in clinical research before being brought to market, Holt underscored.

The investigators aimed to start to fill that gap by examining data from nationwide health registries in Denmark, which started to allow prescriptions of medical cannabis for chronic pain in 2018. Of about 1.88 million patients with chronic pain identified between 2018 and 2021, 5,391 (median age 59 years; 63.2% women) received a first-time prescription for medical cannabis. These patients were matched 1:5 by age, sex, chronic pain diagnosis, and concomitant use of other pain medications with 26,941 controls.

Medical cannabis was dispensed in various forms and could be inhaled or taken as an oromucosal spray, oral solution, tablet, or capsule. The products contained only THC (47%), a mix of THC and CBD (29%), or only CBD (24%).

Be aware and look out for any new symptoms immediately following this medication. Anders Holt

Most of the arrhythmias that developed within 180 days were atrial fibrillation or flutter, both in patients who received medical cannabis (76%) and in those who did not (79%). In the cannabis group, 12% of arrhythmias were paroxysmal tachycardias and 12% were "other." In the control group, 14% of arrhythmias were conduction disorders and 7% were "other."

The greater risk of new-onset arrhythmias within 180 days in the medical cannabis group worked out to a risk ratio (RR) of 2.07 (95% CI 1.34-2.80). This declined to 1.36 (95% CI 1.00-1.73) by 1 year.

At 180 days of follow-up, cannabis users did not have significantly greater risks of acute coronary syndromes (RR 1.20; 95% CI 0.35-2.04), stroke (RR 0.99; 95% CI 0.55-1.43), or heart failure (RR 0.63; 95% CI 0.26-0.99). It could be that medical cannabis truly doesn't influence these outcomes or that follow-up wasn't long enough to detect an effect, Holt speculated, adding that additional studies with larger numbers of cannabis users and longer follow-up will be needed to sort that out.

Remain Vigilant

The study provides a unique perspective on the cardiovascular safety of pot when compared with prior research, which primarily has focused on recreational use of smoked marijuana containing lower concentrations of THC and CBD than what are found in some newer preparations, including edibles, Page said. Previous analyses also have involved mostly chronic cannabis users, which contrasts with the population of new users studied here.

However, there are some limitations, he said. He pointed, for instance, to the lack of information on cigarette smoking, which muddies interpretation of the CV risks of cannabis.

I don't like to wave my hands in the air and say the sky is falling, but actually the general public should realize that this is a signal and it's not a good signal. Robert Page II

Nonetheless, these data are important, showing that even in a relatively low-risk population with few cardiovascular comorbidities, medical cannabis may increase the risk of arrhythmias, Page said. "I treat it like a psychotropic medication, to be honest with you, because it carries the same types of side effects," he added. "I don't like to wave my hands in the air and say the sky is falling, but actually the general public should realize that this is a signal and it's not a good signal."

Many prescription medications have cardiovascular side effects, so what this means is that patients and physicians should be aware of the potential risk when deciding on a treatment for chronic pain and remain vigilant for any signs of arrhythmias if medical cannabis is started, Page said, underscoring that patients need to be honest with their doctors about what they're taking should problems arise.

The potential risk of new-onset arrhythmia needs to be put into context, Holt said. The absolute risk difference observed equates to a number needed to harm of more than 200, and whether that's acceptable depends on what it's being compared to, he said, noting that other medications used to treat chronic pain—opioids, for instance—come with cardiovascular side effects of their own.

Still, Holt said, "I think it's important to keep in mind that there might be this increased risk of arrhythmias."


Arrhythmia Monitoring Devices Market Size Worth USD 15.33 Billion In 2032Emergen Research

Emergen Research

Increasing use of tele cardiology, increasing portability and usability of cardiac arrhythmia monitoring devices, and innovative cardiac monitoring device development are major factors driving Arrhythmia Monitoring Devices market revenue growth

Vancouver, Jan. 15, 2024 (GLOBE NEWSWIRE) -- The global arrhythmia monitoring devices market size was USD 7.43 billion in 2022 and is expected to register a rapid revenue CAGR of 7.7% during the forecast period. Increasing use of tele cardiology, increasing portability and usability of cardiac arrhythmia monitoring devices, and innovative cardiac monitoring device development are major factors driving market revenue growth.

Heart arrhythmias can now be managed with various specialized medicines. These include implantable cardiac defibrillators, synthetic pacemakers, antiarrhythmic medications, and the ablation of damaged or defective heart tissue. However, it is crucial that the right diagnosis be made in a timely manner to enable a doctor to select the best course of care for a patient. Electrocardiogram (ECG) data from cardiac monitors can be used by the doctor to either confirm or rule out the existence of an arrhythmia.

The provision of patient care in homecare settings, clinics, outpatient centers, and outdoor care models has undergone revolutionary changes due to real-time heart disease monitoring. Physicians are now able to make more accurate treatment decisions due to the combination of diagnostic equipment and real-time patient monitoring platforms. The overall effectiveness of treatment has increased as a result, and patient morbidity brought on by delayed diagnosis has decreased.

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Field of cardiac monitoring has evolved with the rise of telemedicine and widespread use of smartphone technology. Furthermore, key players in the market introducing more sophisticated and networked cardiac arrhythmia monitoring equipment is also expected to drive market revenue growth during the forecast period. Limited adoption of telemetry technology is a key factor, which could restrain market revenue growth. Automatic event-activated recorders are exempt from these restrictions because these can capture both symptomatic and asymptomatic arrhythmias.

Story continues

Depending on the setting, device might not record during specific symptomatic events or might trigger prematurely (false event). The device would trigger and record because of preprogrammed rhythm specifications. Insufficient memory on the device may also cause a bogus event to overwrite a genuine event that was previously recorded. One limitation of post-symptom looping devices is that the recorder may not be activated post-event since the arrhythmia may have terminated before it did.

Segment Insights

Type Insights:

On the basis of type, the global arrhythmia monitoring devices market is segmented into Electrocardiogram Monitors (ECG), Insertable Cardiac Monitors (ICM), holter monitoring devices, event recorders, smart wearable monitor, Mobile Cardiac Telemetry (MCT) devices, portable heart monitors, heartbeat measuring instruments, and others. The holter monitoring devices segment accounted for largest revenue share in the global arrhythmia monitoring devices market in 2022 due to rising use of holter monitoring devices for a prolonged amount of time to diagnose random symptoms in patients.

Application Insights

On the basis of application, the global arrhythmia monitoring devices market is segmented into atrial fibrillation, bradycardia, conduction disorders, premature contraction, tachycardia, ventricular fibrillation, and others. The atrial fibrillation segment is expected to account for significantly large revenue share in the global arrhythmia monitoring devices market during the forecast period due to increasing introduction of pipeline products.

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Regional Insights:

North America market accounted for largest revenue share in the global arrhythmia monitoring devices market in 2022 due to increasing approvals for arrhythmic monitoring devices by the U.S. FDA. In addition, region's strong healthcare infrastructure and rising use of cutting-edge cardiovascular solutions are also expected to drive market revenue growth of this region during the forecast period. According to the Centers for Disease Control and Prevention (CDC), by 2030, 12.1 million Americans will suffer from atrial fibrillation.

Europe market accounted for second-largest revenue share in the global arrhythmia monitoring devices market in 2022 due to increasing number of procedures performed. There were 29,444 isolated coronary artery bypass grafting procedures, 35,469 isolated heart valve procedures, and 843 assist device implantations including left, right, and biventricular assist devices as well as total artificial devices registered in Germany.

Scope of Research

Report Details

Outcome

Market Size in 2022

USD 7.43 Billion

CAGR (2023–2032)

7.7%

Revenue Forecast To 2032

USD 15.33 Billion

Base Year For Estimation

2022

Historical Data

2019–2021

Forecast Period

2023–2032

Quantitative Units

Revenue in USD Million and CAGR in % from 2023 to 2032

Report Coverage

Revenue forecast, company ranking, competitive landscape, growth factors, and trends

Segments Covered

Type, application, end-use, and region

Regional Scope

North America, Europe, Asia Pacific, Latin America, and Middle East & Africa

Country Scope

U.S., Canada, Mexico, Germany, France, UK, Italy, Spain, Benelux, Rest of Europe, China, India, Japan, South Korea, Rest of APAC, Brazil, Rest of LATAM, Saudi Arabia, UAE, South Africa, Turkey, and Rest of Middle East & Africa

Key Companies Profiled

Abbott, Medtronic Plc, Biotronik, AliveCor, Inc., General Electric, ACS Diagnostics, Koninklijke Philips N.V., Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Boston Scientific Corporation, BioTelemetry, BPL Medical Technologies, RhythMedix, MicroPort Scientific Corp, Lepu Medical Technology, and Shree Pacetronix

Customization Scope

10 hours of free customization and expert consultation

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Major Companies and Competitive Landscape

The global arrhythmia monitoring devices market is fragmented, with large and medium-sized players accounting for most of the market revenue. Major players are deploying various strategies, entering mergers & acquisitions, strategic agreements & contracts, developing, testing, and introducing more effective arrhythmia monitoring devices products.Some of the major companies included in the global arrhythmia monitoring devices market report are:

  • Abbott

  • Medtronic Plc

  • Biotronik

  • AliveCor, Inc.

  • General Electric

  • ACS Diagnostics

  • Koninklijke Philips N.V.

  • Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

  • Boston Scientific Corporation

  • BioTelemetry

  • BPL Medical Technologies

  • RhythMedix

  • MicroPort Scientific Corp

  • Lepu Medical Technology

  • Shree Pacetronix

  • Strategic Development

  • In September 2022, Medtronic, the multinational healthcare technology company launched LINQ II Insertable Cardiac Monitor (ICM) system. This is the first and only ICM to be approved by the U.S. FDA for use in pediatric patients older than 2 who have irregular heart rhythms and need continuous, long-term monitoring.

  • In November 2021, Cardiologs, a French medical technology startup specializing in heart diagnostics with Artificial Intelligence (AI) and cloud computing, acquired by Philips. With cutting-edge software, electrocardiogram analysis, and reporting services, the acquisition will enhance Philips' cardiac monitoring and diagnostics offering.

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    For the purpose of this report, Emergen Research has segmented the global arrhythmia monitoring devices market on the basis of type, application, end-use, and region:

  • Atrial Fibrillation

  • Bradycardia

  • Conduction Disorders

  • Premature Contraction

  • Tachycardia

  • Ventricular Fibrillation

  • Others

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