Introduction
Atrial fibrillation ablation is a treatment for an irregular and chaotic heartbeat called atrial fibrillation. It uses small burns or freezes to cause some scarring on the inside of the heart to help break up the electrical signals that cause irregular heartbeats. This can help the heart maintain a normal heart rhythm. Atrial fibrillation ablation is most often done using thin, flexible tubes called catheters inserted through the veins or arteries to the heart. Less commonly, ablation is performed during cardiac surgery.
Catheter ablation for atrial fibrillation (AF) has emerged as an important rhythm-control strategy and is by far the most common cardiac ablation procedure performed worldwide. Current guidelines recommend the procedure in symptomatic patients with paroxysmal or persistent AF who are refractory or intolerant to antiarrhythmic drugs. The procedure might also be considered as a first-line approach in selected asymptomatic patients.
Atrial fibrillation (AFib) is a prevalent cardiac arrhythmia characterized by irregular and often rapid heartbeats. It poses significant health risks, including an increased likelihood of stroke, heart failure, and diminished quality of life. Over the years, the treatment landscape for AFib has witnessed a remarkable transformation, primarily driven by advancements in ablation catheter technology. These innovative catheters have revolutionized the field of electrophysiology, offering new hope to millions of individuals worldwide living with AFib.
The benefits are numerous for instance advanced ablation catheters have improved treatment efficacy, reduced procedure times, and enhanced patient safety. Patients can now experience a higher quality of life, with reduced symptoms and minimized risks. Additionally, the integration of telemedicine and remote monitoring ensures that post-procedure care is more accessible and efficient than ever before.
- Data Bridge Market Research analyses that the video telemedicine market will exhibit a CAGR of around 12.20% for the forecast period of 2021-2028. Rising demand for healthcare services owing to the ever-rising geriatric population, increased penetration of smartphones and other smart devices and increased expenditure for the technological advancements in video telemedicine are the major factors attributable to the growth of video telemedicine market.
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However, as with any technological progress, there are challenges to confront. These include the complexity of procedures, the cost of advanced equipment, the need for specialized training, and the ongoing management of complications. The successful navigation of these challenges is essential to ensure that the benefits of ablation catheter technology are maximized, making AFib treatment more effective and accessible for all who require it.Top of Form
The Origin and Backstory
Catheter ablation is a rapidly evolving field and has proven to be a valid solution for many patients suffering from recurrent arrhythmias. It has evolved rapidly over the years and has proven to be first-line therapy for many tachycardia including atrial fibrillation (AFIB) in most of the patients having recurrent symptoms, which limit their productivity and hinder their lifestyle.
The use of catheter ablation was first introduced in the late 1960s, it was designed first for recording, where the surgical treatment of cardiac arrhythmia was the main concept. Dr Scheinman’s work led directly to the development of radiofrequency energy catheters, which use radiofrequency energy to heat the catheter tip and perform much more precise ablation than was possible with DC ablation.
In 1998, Michelle Haissaguerre, a cardiac electrophysiologist in Bordeaux, France first described the use of catheter ablation for patients with atrial fibrillation. He put catheters in patients’ hearts and mapped the origin of the “triggers” that start atrial fibrillation. He found that 95-96% of the time these triggers originate in sleeves of muscle that extend into the pulmonary veins (PV), the veins that drain blood from the lungs back into the left upper chamber of the heart (left atrium). By mapping these triggers during the initiation of AF and ablating them within the pulmonary vein, he was able to render 62% of patients free of AF without the need for antiarrhythmic drugs. This landmark finding has led to the development of catheter ablation as a routine management strategy for AF.
By the 1990's, radiofrequency energy had supplanted direct current. This was mainly due to the high incidence of complications associated with the high-energy discharge such as impaired left ventricular function and cardiac rupture. In addition to this, radiofrequency ablation could be performed on conscious patients, form discrete lesions, and allow termination of lesion formation if complications occur.
Current ablation equipment allows temperature monitoring and temperature control, which is a valuable tool during radiofrequency ablation procedures as it provides important information regarding the adequacy of tissue heating, and minimizes the development of coagulum and lesion size. Newer technical modifications, including a larger distal electrode and saline cooling, have helped to minimize impedance rise and allow the creation of larger and deeper lesions.
- Data Bridge Market Research analyses a growth rate in the global atrial fibrillation market in the forecast period 2022-2029. The expected CAGR of global atrial fibrillation market is tend to be around 12.0% in the mentioned forecast period. The market was valued at USD 2044.95 million in 2021, and it would grow upto USD 5063.22 million by 2029. In addition to the market insights such as market value, growth rate, market segments, geographical coverage, market players, and market scenario, the market report curated by the Data Bridge Market Research team also includes in-depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.
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Advantages of Ablation Catherter in Atrial Fibrillation (AFIB)
The advancements in ablation catheter technology have transformed the treatment landscape for atrial fibrillation. These innovations have not only improved the effectiveness of procedures but also enhanced patient safety, comfort, and overall quality of life. As technology continues to evolve, AFib ablation will likely become even more accessible and successful in the future. Here are some advantages-
Figure 1- Benefits and risk
- Improved Treatment Efficacy
Advanced ablation catheters offer more precise and controlled energy delivery, increasing the success rates of AFib ablation procedures. They enable the creation of more effective lesions that isolate or block abnormal electrical pathways responsible for AFib
Irrigated catheters, force-controlled systems, and single-shot cryoballoon devices allow for quicker and more efficient procedures. This benefits both patients and healthcare providers by reducing the time spent in the operating room
Temperature monitoring, force sensing, and coagulum detection technologies help minimize complications during ablation procedures. These safety features reduce the risk of thermal injury to surrounding tissues and improve patient outcomes
- Patient temperature monitoring market is expected to gain market growth in the forecast period of 2021 to 2028. Data Bridge Market Research analyses the market to grow at a CAGR of 4.85% in the above-mentioned forecast period. Rising prevalence of infectious diseases drives the patient temperature monitoring market.
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Less Pain and Discomfort
Advanced catheters with precise energy delivery techniques often result in less pain and discomfort for patients during and after the procedure. Reduced tissue damage and quicker recovery times contribute to a more comfortable patient experience
Innovations such as force-controlled ablation and improved contact force sensing have led to a decrease in complications like steam pops, char formation, and perforations, making AFib ablation safer
- Minimized Radiation Exposure
Electroanatomic mapping systems and real-time monitoring reduce the reliance on fluoroscopy, thereby decreasing radiation exposure to both patients and healthcare providers
Patient-specific electrophysiological simulations and advanced mapping technologies enable tailored treatment plans based on the individual's heart geometry and electrical activity, optimizing outcomes
Combining catheter ablation with surgical techniques in hybrid procedures allows for a more comprehensive and effective treatment approach, particularly in complex cases
- Reduced AFib Symptoms and Improved Quality of Life:
Successful AFib ablation using advanced catheter technology often leads to a significant reduction in AFib symptoms, such as palpitations, fatigue, and shortness of breath, thereby improving patients' overall quality of life
The improved precision of lesion creation with advanced catheters can result in more durable ablation lines, reducing the likelihood of AFib recurrence and the need for repeat procedures
- Remote Monitoring and Follow-up:
Telemedicine and remote monitoring capabilities allow healthcare providers to closely track patients' progress post-ablation, enabling early detection of recurrence and timely intervention
- Robot-Assisted Precision:
Robot-assisted systems provide a high level of precision and stability during the procedure, minimizing the risk of human error and improving overall outcomes
- The market for robotic assisted endoscopy was estimated to be worth USD 1.84 billion worldwide in 2021 and is projected to grow at a CAGR of 15.05% during the forecast period. The main drivers of the rise include an increasing demand for minimally invasive surgical (MIS) procedures, new product approvals by regulatory agencies including the U.S. Food and Drug Administration (FDA), and the high prevalence of chronic conditions.
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While advanced catheters may have higher upfront costs, the improved efficacy and reduced complication rates can lead to cost savings over the long term by reducing the need for repeat procedures and hospitalizations
Ablation Strategies and Mechanism
Figure 2- Atrial Fibrillation mechanism
The most commonly used procedure for AF ablation is a point-by-point ablation via a single-tip catheter usually combined with a three-dimensional (3D) mapping system, and the most common energy source is radiofrequency (RF). RF-based ablation in conjunction with an electro-anatomical mapping system (EAM) allows a significant reduction of fluoroscopy dosage and provides additional information, such as the LA activation pattern and LA voltage. Beyond that, this technology facilitates an optimized treatment of an additional substrate, non-PV triggers, or atrial tachycardia.
In general, a low complication rate is reported for RF-based catheter ablation, with the most common complications being pericardial effusion and tamponades and access-site complications, such as groin bleeding or arteriovenous fistula. Although several attempts have been made to optimize navigation properties and to improve tip-to-tissue contact using robotic navigation, manually guided RF ablation is still the most widely used procedure.
Most of the established EAM systems use point-by-point acquisition of electrograms from a roving catheter with or without multi-electrode mapping capability. To date, The Carto system by Biosense Webster and the EnSite NavXsystem by Endocardial Solutions, St. Jude Medical, Inc., have been the most detailed systems based on experience. Recently, a new mapping system Rhythmia by Boston Scientific Corporation that uses a small basket array of 64 electrodes IntellaMap Orion by Boston Scientific Corporation has been introduced with an aim to rapidly obtain an ultra-high-resolution EAM. Some clinical studies have already reported that the Rhythmia system in conjunction with the Orion catheter enables the determination of a successful PVI, may simplify the ablation of complex atrial arrhythmias, and could assist in understanding new targets for AF ablation.
Optimal lesion formation in RF-based ablation depends on a variety of procedural parameters, including power settings, catheter stability, ablation time, size of the catheter tip, temperature and cooling of the catheter tip, and contact force (CF). Ablation using conventional catheters provides only limited information to predict sufficient lesion formation, such as diminution of the local electrogram or impedance drop.
- The catheter stabilization device/catheter securement devices market is expected to witness market growth at a rate of 8.4% in the forecast period of 2021 to 2028 and is expected to reach USD 2.50 billion by 2028. Data Bridge Market Research report on catheter stabilization device/catheter securement devices market provides analysis and insights regarding the various factors expected to be prevalent throughout the forecast period while providing their impacts on the market’s growth. The rise in the prevalence of lifestyle related disorders globally is escalating the growth of catheter stabilization device/catheter securement devices market.
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Challenges
Advancements in ablation catheter technology have undoubtedly brought about many benefits in the treatment of atrial fibrillation (AFib), but they also come with their fair share of challenges and considerations. Here are detailed challenges associated with advanced ablation catheter technology for AFib treatment-
Procedural Complexity
As ablation technology becomes more sophisticated, the procedures themselves can become more complex. This complexity requires electrophysiologists to have advanced training and expertise, which may not be readily available in all healthcare settings.
Cost:
Advanced ablation catheters and equipment tend to be more expensive than their traditional counterparts. This cost can be a barrier to healthcare facilities looking to adopt the latest technology, and it may also impact patients' access to these treatments.
Limited Accessibility
Access to advanced AFib ablation procedures may be limited to specialized centers, making it challenging for patients in remote or underserved areas to receive the treatment.
Operator Learning Curve:
The adoption of new technology often requires electrophysiologists to undergo additional training and gain experience with the equipment. This learning curve can affect the success and safety of the procedures during the early stages of adoption.
Complication Risk:
While advanced technology has reduced the risk of complications, it has not eliminated it. There can still be complications such as bleeding, perforations, or rare events such as atrioesophageal fistula formation, which require careful monitoring and management.
Resource Requirements:
The use of advanced ablation catheters may demand more resources, including longer procedural times, specialized staff, and additional equipment. This can strain healthcare systems and impact scheduling.
Patient Selection
Proper patient selection is crucial for the success of AFib ablation procedures. Not all patients are suitable candidates, and advanced technology may not be appropriate for everyone, depending on their specific medical conditions.
AFib Recurrence
Despite advances in ablation technology, AFib recurrence remains a challenge, especially in cases of more complex or long-standing AFib. Some patients may require multiple procedures or alternative treatment strategies.
Post-Procedure Monitoring
Long-term monitoring and follow-up are essential to detect AFib recurrence or complications. Implementing effective remote monitoring and telemedicine solutions can be a challenge for healthcare providers.
Regulatory and Reimbursement Issues
Regulatory approval and reimbursement policies for new ablation technologies can lag behind innovation, leading to delays in adoption and accessibility for patients.
Patient Expectations
Patients may have high expectations regarding the effectiveness of advanced ablation techniques. Managing these expectations and providing realistic outcomes can be challenging, especially in cases of complex or persistent AFib.
Data Security and Privacy
The integration of advanced technology and remote monitoring systems raises concerns about data security and patient privacy, requiring robust safeguards to protect sensitive medical information.
Technological Evolution:
The rapid pace of technological advancement means that healthcare providers must stay up-to-date with the latest innovations. This can pose a challenge in terms of continuous training and equipment upgrades.
While advanced ablation catheter technology has brought significant improvements to the treatment of atrial fibrillation, it also presents challenges related to complexity, cost, accessibility, and ongoing patient care. Addressing these challenges requires a multi-faceted approach involving healthcare providers, regulatory bodies, and technology developers to ensure that the benefits of advanced AFib ablation technology are maximized while mitigating potential drawbacks.
Recent Innovative Approaches and Advancements in Ablation Catheter Technology
- There has been various research conducted by various organizations and research firms to enhance the result of ablation procedures in cardiac patients. An innovative ablation strategy has recently been proposed by Narayan et al. who hypothesized that ablation of AF drivers (so-called rotors or focal impulses) might result in improved and longer arrhythmia-free survival in patients with highly symptomatic PAF or persistent AF than would ablation of pulmonary and non-pulmonary vein triggers.
- To test this hypothesis, the authors conducted the CONFIRM trial (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation), which enrolled 92 patients with highly symptomatic PAF or persistent AF in a two-arm 1:2 design with ablation of AF sources (Focal Impulse and Rotor Modulation [FIRM]-guided) followed by conventional ablation, mainly PVI (n = 36), or conventional ablation alone (n = 71; FIRM-blinded). Analysis of the data revealed that FIRM ablation at patient-specific sources could acutely terminate or slow the AF cycle length and improve clinical outcomes [61]. While the initial results and long-term data of the CONFIRM trial were promising, subsequent studies have shown inconsistent results.
- Despite high operator-dependent variability, the fact that active and passive sources cannot be discriminated by this technology might play an additional role regarding the efficacy of AF driver elimination during FIRM-guided ablation
- Electrographic flow (EGF) mapping has recently been introduced as a novel technology for the identification and characterization of AF sources in humans. Bellmann et al. demonstrated that EGF is the first method to have the potential to identify active AF sources during AF ablation and to be able to discriminate these from passive rotational phenomena, thereby possibly allowing for improved guidance of the AF ablation procedure
New Product Development in the Field of Ablation Catheter for Atrial Fibrillation
Catheter ablation for atrial fibrillation (AF) has emerged as an important rhythm-control strategy and is by far the most common cardiac ablation procedure performed worldwide. Current guidelines recommend the procedure in symptomatic patients with paroxysmal or persistent AF who are refractory or intolerant to antiarrhythmic drugs.
The various limitations of catheter ablation using RF and other techniques have led to further interest in the development of novel catheter designs and alternative energy sources for PVI. These include balloon-based ablation systems, such as the cryoballoon (CB) by Medtronic, Inc., the laserballoon Heartlight™ by CardioFocus, the RF Hot Balloon by Hayama Arrhythmia Institute, and the “Globe” multi-electrode contact mapping and ablation system by Kardium Inc.,
Numerous exciting new technologies are in various stages of development for instance-
- According to the article by the American College of Cardiology Foundation on Mar 06, 2023 - A new ablation technology known as pulsed-field ablation was successful at eliminating episodes of abnormal heart rhythms for 12 months in up to two-thirds of patients
- Abbott received the CE Mark of the TactiFlex Ablation Catheter, Sensor Enabled (SE), the world’s first ablation catheter designed with a unique flexible tip and contact force sensing, proven to reduce procedure times3 and patients’ exposure to radiation compared to standard power ablation4. When integrated with Abbott’s EnSite X EP System, which allows physicians to accurately identify areas in the heart that require an ablation treatment, the TactiFlex catheter can deliver high-power while more easily adapting to the heart tissue compared to conventional catheters5
- In June 2020, Boston Scientific announced the U.S. launch of the DIRECTSENSETechnology, a tool for monitoring the effect of radiofrequency (RF) energy delivery during cardiac ablation procedures. Available on the RHYTHMIA HDx Mapping System, the DIRECTSENSE Technology, which received U.S. Food and Drug Administration approval in April, is the only tool to monitor changes in local impedance – electrical resistance – around the tip of the INTELLANAV MiFi Open-Irrigated (OI) ablation catheter, offering physicians an additional measurement of therapy effect during an ablation
- In September 2022, Biosense Webster, Inc., part of Johnson & Johnson MedTech, announced the release of the OCTARAY Mapping Catheter with TRUEref Technology powered by the CARTO 3 Version 7 System. This OCTARAYMapping Catheter with TRUEref Technology provides physicians with the precise information needed for catheter ablation procedures that treat cardiac arrhythmias
Future Perspective of Ablation Catheter for Atrial Fibrillation
Novel technologies aim to improve the safety profile and clinical outcomes of AF ablation, reduce procedure time and fluoroscopy dosages, shorten the learning curve of the operators, and possibly also help to improve our still limited understanding of the underlying mechanism of AF, especially of persistent and long-standing persistent AF.
RF energy and cryoenergy are to date the two most widely used energy modalities for the treatment of cardiac arrhythmias. Thermal ablation, however, may lead to severe complications, such as PV stenosis and esophageal ulceration, despite several improvements to these technologies and applied safety algorithms. A novel technology, irreversible electroporation (IRE), may overcome these limitations. With IRE, a direct current is applied and the generated high electrical field produces pores in the phospholipid membranes of the cells, which leads to an irreversible breakdown of membrane structure and function and ultimately cell death. The first animal studies confirmed a significant effect of IRE on cardiac cells and therefore lesion formation as well as the safety of the system on surrounding intra- and extracardiac structures.
A “High Power, Short Duration” strategy (HPSD) has recently been propagated as a further step toward the improvement of lesion quality during RF ablation in patients with symptomatic AF. Although this strategy is not new, it has been shown that HPSD ablation creates wider but more shallow lesions ex vivo as well as in vivo, which could avoid damage to adjacent structures, such as the esophagus or the phrenic nerve, during ablation procedures. The feasibility and safety of HPSD strategy during AF ablation have already been confirmed in a clinical setting. Additional advantages of this procedure are the possible decreases in procedure and fluoroscopy times, particularly when novel catheter technologies, such as the QDOT-FAST catheter, are used.
The HELIOSTAR RF Balloon Ablation Catheter by Biosense Webster, Inc. has recently been introduced. It conforms to any pulmonary vein anatomy and has ten irrigated electrodes, which allows the operator to deliver different levels of energy during ablation. The device is compatible with the Biosense Webster CARTO 3 Mapping System by Biosense Webster, Inc. and can therefore reduce radiation exposure during an ablation procedure. Its feasibility and safety profile as well as the clinical impact for the treatment of AF are still under evaluation. The STELLAR study (Safety and Effectiveness of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic paroxysmal Atrial Fibrillation) is a pivotal, prospective, multicenter, single-arm clinical evaluation of the multi-electrode RF-balloon.
Conclusion
Catheter ablation is a well-established treatment option for patients with symptomatic AF and is more effective at maintaining SR than antiarrhythmic drugs. Currently, the most effective technique for AF ablation is circumferential isolation of the PVs, irrespective of AF type. RF-based and CB ablation are equally effective in patients with PAF. Patients with persistent or long-standing persistent AF and with recurrence after an index ablation procedure might benefit from additional and more extensive ablation strategies.
The advancements in ablation catheter technology for the treatment of atrial fibrillation (AFib) have ushered in a new era of improved outcomes, safety, and patient experience. These technologies have significantly enhanced the field of electrophysiology and have become essential tools for managing AFib.
Despite the challenges, the evolution of ablation catheter technology continues to improve the outlook for patients with AFib. Collaboration among healthcare providers, regulatory bodies, and technology developers is crucial to address these challenges and ensure that the benefits of advanced AFib ablation technology are accessible to a broader population, ultimately improving the quality of care for individuals with AFib. The field of AFib treatment remains dynamic, and ongoing research and development are expected to bring further innovations in the future.
