Adopting New Technologies in the EP Lab: Overcoming Challenges and Streamlining Innovation in Clinical Practice
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EP LAB DIGEST. 2025;25(8):11-13.
Guy Rozen, MD, MHA
Director, Tufts Electrophysiology Laboratories; Director, Tufts Atrial Fibrillation Program; Division of Cardiology, Tufts Medical Center; Assistant Professor in Medicine, Tufts Medical School, Boston, Massachusetts
Cardiac electrophysiology (EP) has long been a field defined by innovation and rapid technological evolution. As cardiac arrhythmia management has advanced, from the early days of medical management to simple implantable devices and fluoroscopy-guided ablations with non-irrigated radiofrequency (RF) ablation catheters, today’s electrophysiologists face a landscape brimming with cutting-edge technology. Leadless pacemakers, advanced 3-dimensional (3D) mapping systems and intracardiac echocardiography tools utilizing machine learning for improved imaging, ablation catheters packed with sensors, and new ablation energy modalities are all transforming patient care. However, with progress comes a unique set of challenges. This article explores the key challenges in adopting new technologies in the EP laboratory and offers potential solutions to help clinicians, hospitals, and regulatory bodies navigate these complexities.
The Evolution of EP Technologies
The journey of EP began with modest tools. Over time, as our understanding of cardiac arrhythmias mechanisms improved, so did the tools available for our EP community. The introduction of RF ablation ushered in a new era, with advancements in catheter technology quickly following.1 Initial non-irrigated RF catheters soon gave way to irrigated designs that allowed for better lesion formation and reduced the risk of overheating.2 About one and a half decades ago, the approval of cryoballoon ablation for pulmonary vein isolation (PVI) brought atrial fibrillation (AF) ablation to the masses.3 The introduction of this “one-shot” ablation technology, which offered a dramatically faster PVI procedure that was significantly less operator-dependent in delivering good results, allowed wide adoption of AF ablation across the world, swapping significant proportion of AF ablation procedures, especially in Europe. Further innovation led to the integration of contact force sensing in RF catheters, enabling physicians to measure the pressure exerted by the catheter on the tissue—a critical factor in creating effective and durable RF lesion formation.
Today, the field boasts an array of sophisticated devices. Modern mapping systems now offer real-time, 3D visualization of the heart’s anatomy and intricate electrical network. Advanced ablation systems, including the recently approved pulsed field ablation (PFA) platforms, are emerging as promising alternatives to thermal energy sources, providing tissue-selective ablation while sparing surrounding structures.4-7 These technological leaps have collectively improved both the safety and efficacy of EP procedures.
Key Challenges in the Adoption of New Technologies
Despite the excitement that accompanies these advancements, several challenges must be addressed to ensure that innovations translate into tangible clinical benefits.
1. Rigorous Evaluation of Clinical Data
A central issue in adopting any new technology is the need for robust clinical evidence. The cornerstone of this evidence is data derived from preclinical animal studies, followed by “first-in-man” studies, and eventually, the Investigational Device Exemption trials that deliver the initial data as to the safety and efficacy of these new technologies. We must carefully evaluate trial results, noting key endpoints such as procedural success, long-term outcomes, and complication rates.
For example, while early studies on novel ablation modalities like PFA have shown promising results—such as effective lesion creation and reduced collateral damage—the relatively small cohorts and short follow-up periods in some trials initially left unanswered questions about long-term outcomes. Importantly, the fact that the new PFA technology, “out of the box,” provided similar efficacy in AF ablation as the traditional modalities such as cryo and RF ablation, that we gained a lot of experience with and were perfected for years, was extremely promising. However, these gaps necessitated further research and longer-term, larger, “real-world” studies. Also, we do not have any large head-to-head comparison between the different PFA technologies.
2. Integration with Existing Mapping Systems and Workflow
Today, electrophysiologists rely significantly on sophisticated mapping systems for accurate diagnosis and treatment of cardiac arrhythmias, when in the past, and mainly outside of the United States, many operators do not use electroanatomical mapping systems, including for supraventricular tachycardia ablation, typical flutter, and cryo PVI. Even for some AF ablations utilizing PFA, there is a growing proportion of EP professionals who routinely use these mapping systems. This tendency is also driven in part by the movement toward fluoroless or zero-fluoroscopy EP procedures. Hence, there is a growing notion that any new technology must seamlessly integrate with these systems to allow safe and effective procedures without heavy utilization of fluoroscopy.
However, many innovative devices come with proprietary software that may not be immediately compatible with widely used platforms. Incompatibility can disrupt clinical workflow, increase procedural times, and require additional training for staff. Smooth integration is critical, not only for operational efficiency, but also to ensure that data collected during procedures are accurate and comprehensive. When new technology disrupts an established workflow, the potential for errors increases, which can negatively impact patient outcomes.
3. Quality and Consistency of Clinical Support
Introducing new technology into the clinical environment is not just about acquiring the hardware or software; it also involves forging a long-term partnership with the manufacturer and their clinical support team. High-quality clinical support—including comprehensive training, troubleshooting, and regular updates—is crucial for the successful implementation of any new tool.
EP procedures are complex and nuanced, meaning that even slight differences in device performance or user interface can lead to significant variations in patient outcomes. Without consistent and reliable clinical support, EP clinicians may struggle to maximize the technology’s potential, leading to suboptimal results and frustration among the clinical team.
4. Economic Considerations and Reimbursement Issues
Financial constraints represent a substantial hurdle in adopting new technologies. The initial capital expenditure on advanced generators, consoles, and ancillary equipment can be significant. Additionally, the recurring costs associated with disposable items—such as novel ablation catheters, cables, and other single-use components—can further strain hospital budgets.
These high costs are compounded by often outdated reimbursement models. While new technologies may lead to improved outcomes and shorter recovery times, the reimbursement rates set by health care payers may not fully reflect these long-term benefits. This misalignment between cost and reimbursement can deter institutions from investing in technologies that ultimately offer better safety profiles and efficacy.
5. Navigating Regulatory and Safety Considerations
New devices must pass stringent regulatory standards before they can be used in routine clinical practice. Regulatory bodies are tasked with ensuring that innovations do not compromise patient safety, a challenge that is particularly acute in a field as dynamic as EP. The rapid pace of innovation often means that regulators are playing catchup, reviewing applications and post-market data to confirm that new devices meet established safety benchmarks. This can be even more challenging in the current political environment with significant cuts in the United States’ Food and Drug Administration personnel and budgets that can slow down the process of approval of much needed technologies.
Furthermore, as devices become increasingly complex, the need for ongoing post-market surveillance grows. This continuous oversight is essential to identify potential safety issues that may not have been evident during initial trials. Balancing the promise of new technology with the imperative of patient safety can be a significant challenge.
6. Training and Adaptation in Clinical Practice
Introducing new technologies sometimes necessitates a paradigm shift in clinical practice. Even the most advanced device is only as effective as the operator using it. As such, comprehensive training programs are essential to ensure that clinicians can quickly adapt to and master new tools. However, the learning curve can be steep, particularly for technologies that represent a departure from established techniques.
The need for ongoing education and certification places additional demands on already busy electrophysiologists. Without sufficient training resources and institutional support, even promising new technologies may fail to achieve their full potential, limiting their impact on patient care.
Potential Solutions to Overcome Adoption Challenges
Addressing these challenges requires a multifaceted approach involving clinicians, health care institutions, manufacturers, and regulatory bodies. Below are several strategies that can facilitate the smoother adoption of new EP technologies.
To build confidence in new technologies, it is essential to invest in long-term, multicenter clinical trials that provide robust data on safety and efficacy. These studies should not only evaluate immediate procedural outcomes but also track long-term clinical outcomes, including hard endpoints. By establishing a solid evidence base, clinicians can make informed decisions and overcome skepticism regarding newer devices.
Manufacturers must prioritize the development of technologies that are fully integrated with advanced electroanatomical mapping systems and clinical workflows. This may involve designing devices with open architecture or providing middleware solutions that enable disparate systems to communicate effectively. Pilot programs and trial periods can offer valuable insights into how well new devices integrate with current systems, allowing for adjustments before full-scale adoption.
A strong relationship between health care providers and device manufacturers is crucial. Hospitals and EP labs should negotiate comprehensive service agreements that include ongoing training, technical support, and regular updates. Establishing long-term professional relationships with clinical support teams that closely get to know each provider’s workflow and preferences can help bridge the gap between the vendor/technology and end users, ensuring that any issues are addressed promptly and efficiently.
Economic challenges can be mitigated by conducting detailed cost-benefit analyses that factor in both short-term expenditures and long-term savings. Institutions should assess not only the purchase price of new equipment but also the per-case costs of disposables and the potential for improved patient outcomes. Most importantly, as procedures become shorter, the improved efficiency in the lab and the potential an additional case per lab can allow adoption of slightly more expensive technologies while maintaining financial balance, driven by increased volume of procedures. In parallel, advocacy for revised reimbursement models that recognize the value of advanced technologies is essential. Health care systems and professional societies should work together to educate payers about the long-term benefits of investing in state-of-the-art EP tools and demand adjustment in reimbursement that reflects the increased costs of these procedures.
Looking Ahead: Embracing the Technological Revolution
The challenges in adopting new technologies in EP are not merely obstacles, they are indicators of a field in dynamic evolution. Each challenge represents an opportunity to refine our practices, improve patient outcomes, and drive the field forward. By embracing a collaborative approach that includes clinicians, manufacturers, regulatory bodies, and payers, the community can ensure that innovation is not only achieved but also effectively integrated into everyday practice.
The rapid pace of technological advancements in EP is transforming patient care. Innovations that once seemed futuristic are now becoming standard practice, from high-resolution mapping systems to energy modalities that prioritize tissue selectivity and safety. As the field continues to evolve, it is incumbent upon all stakeholders to remain agile, continually reassessing both the benefits and the limitations of new technologies.
While the financial and operational challenges may seem daunting, they are balanced by the potential to significantly improve procedural outcomes and enhance patient quality of life. The current landscape is a testament to the incredible progress made over the past few decades and a harbinger of the innovations yet to come. In this era of rapid change, the ability to critically assess new technologies, integrate them effectively, and support their adoption through robust clinical data and vendor partnerships will define the future of EP.
Conclusion
The adoption of new technologies in EP is a complex, multi-dimensional process. As we stand on the brink of a new technological revolution in EP, it is essential to recognize that these challenges are not roadblocks, but rather, stepping stones toward a future where patient care is more precise, less invasive, and more effective than ever before. By collaborating across disciplines and continuously innovating, the EP community can harness the full potential of advanced technologies to transform the way arrhythmias are diagnosed and treated.
The path forward demands vigilance, adaptability, and a commitment to ongoing education and partnership. With a strategic approach to evaluating new devices, integrating them into our clinical workflows, and addressing financial and regulatory barriers, the future of EP is indeed promising. In embracing the challenges of today, we are laying the groundwork for the breakthroughs of tomorrow—ensuring that the promise of innovation translates into real-world benefits for patients worldwide.
As we continue to adapt to these advancements, the field of EP stands as a testament to human ingenuity and resilience. The ongoing evolution of technology offers not only new tools, but also new opportunities for improving lives. By embracing the challenges and working together across disciplines, we can transform these obstacles into catalysts for progress, ushering in a new era of excellence in cardiac care.
Disclosure: Dr Rozen has completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest, and has no conflicts of interest to report regarding the content herein.
References
1. Joseph JP, Rajappan K. Radiofrequency ablation of cardiac arrhythmias: past, present and future. QJM. 2012;105(4):303-314. doi:10.1093/qjmed/hcr189
2. Nakagawa H, Yamanashi WS, Pitha JV, et al. Comparison of in vivo tissue temperature profile and lesion geometry for radiofrequency ablation with a saline-irrigated electrode versus temperature control in a canine thigh muscle preparation. Circulation. 1995;91(8):2264-2273. doi:10.1161/01.cir.91.8.2264
3. Packer DL, Kowal RC, Wheelan KR, et al. Cryoballoon ablation of pulmonary veins for paroxysmal atrial fibrillation: first results of the North American Arctic Front (STOP AF) pivotal trial. J Am Coll Cardiol. 2013;61(16):1713-1723. doi:10.1016/j.jacc.2012.11.064
4. Anter E, Mansour M, Nair DG, et al. Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial. Nat Med. 2024;30(8):2303-2310. doi:10.1038/s41591-024-03022-6
5. Reddy VY, Calkins H, Mansour M, et al. Pulsed field ablation to treat paroxysmal atrial fibrillation: safety and effectiveness in the AdmIRE pivotal trial. Circulation. 2024;150(15):1174-1186. doi:10.1161/CIRCULATIONAHA.124.070333
6. Reddy VY, Gerstenfeld EP, Natale A, et al. Pulsed field or conventional thermal ablation for paroxysmal atrial fibrillation. N Engl J Med. 2023;389(18):1660-1671. doi:10.1056/NEJMoa2307291
7. Verma A, Haines DE, Boersma LV, et al. Pulsed field ablation for the treatment of atrial fibrillation: PULSED AF pivotal trial. Circulation. 2023;147(19):1422-1432. doi:10.1161/CIRCULATIONAHA.123.063988
