Impact of Pulsed Field Ablation on Atrial Fibrillation: Insights From Winchester Medical Center-Valley Health
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EP LAB DIGEST. 2025;25(4):24-26.
Emmanuel Ekanem, MD; Todd Teigeler, MD; Daniel Alexander, DO; Timothy O’Neal, BSN, RN; Allison Haggerty, MSN, RN; Taylor Young, RN; Rasheva Sperry, BSN, RN; Bethany Larrimore, BSN, RN; Debra Jenkins, CEPS, RCES; Daniel Reno, RCIS; Jessica Horton, MS; Heather Hostetler, MSN, RN, CRN; Gabrielle Miller, BSN, RN
Winchester Cardiology and Vascular Medicine-Valley Health, Winchester, Virginia
Background
Atrial fibrillation (AF) remains the most common heart rhythm disorder with a global prevalence that continues to increase. The global prevalence was estimated to be 59 million in 2019, of which 8.6 million were in North America, with the latter projected to increase to 15.9 million by 2050.1,2 The systemic effect of AF is well documented, significantly affecting quality of life and contributing to both morbidity and mortality.3,4 Catheter ablation has been shown to be a pivotal tool in the AF management armamentarium and has even been demonstrated as effective first-line therapy.5-8 Historically, catheter ablation has been performed with thermal ablation modalities, with the mainstay being radiofrequency (RF) or cryoablation, and to a lesser extent, laser ablation. However, there remains residual concerns around thermally-mediated complications such as pulmonary vein (PV) stenosis, stroke, phrenic nerve palsy, and atrioesophageal fistula; the latter, though rare, has been associated with a high mortality rate.9,10 Esophageal protection strategies such as the use of esophageal temperature probes and esophageal cooling and deviation have been employed in recent years to reduce the risk of esophageal injury.
In recent years, there have been notable advancements in AF screening, with advancements in digital health, adoption of wearables, and patient awareness, leading to earlier diagnosis and further highlighting the true burden of AF in the population.11 These advancements in diagnostics are at a convergence with the need for technological advancements in catheter ablation to improve safety, efficacy, and efficiency, to try to tackle the growing global burden of AF. As such, the emergence of pulsed field ablation (PFA) has been welcomed with much enthusiasm given the potential to address these factors.
PFA utilizes micro to nanosecond electrical pulses to generate strong electrical fields, causing irreversible nanoscale pore formation as its mechanism of targeted tissue injury. Several pivotal clinical studies have demonstrated its preferential tissue ablation with avoidance of collateral damage to neighboring pericardiac structures, significantly enhancing the safety profile. Several PFA catheters are available, including the multielectrode pentaspline Farawave catheter (Farapulse PFA System, Boston Scientific), PulseSelect PFA System (Medtronic), dual-energy lattice tip ablation system (Sphere-9 mapping and ablation catheter, Medtronic), and Varipulse PFA system (Johnson & Johnson MedTech), each with landmark randomized controlled trials.12-15 The results of these trials have shown noninferiority to thermal ablation platforms, improvement in efficiency with significant reduction in procedure times, and an improved safety profile. Real-world registries, most notably the MANIFEST-17k study, which is the largest post-approval registry of PFA, demonstrated a great safety profile with a major complication rate of 1%.16 Rare complications such as coronary artery spasm and hemolysis were noted. These studies informed the adoption experience in North America as health systems and cardiac electrophysiology (EP) departments started performing PFA for their patients.
Winchester Medical Center-Valley Health was an early adopter of PFA. The Farapulse and PulseSelect are currently utilized in conjunction with contemporary thermal ablation platforms to treat our patients with AF. Here, we provide a brief perspective on our PFA journey and approach based on real-world experience.
Learning Curve and Adoption Experience
Patients. The transition to utilizing PFA at our center has been seamless for all stakeholders involved. This starts in the clinic as patients are educated on the availability of the new technology, which mainly enhances the efficiency and safety of the procedure, particularly when posterior wall isolation is anticipated. However, there is no significant change to the pre- or post-procedural workflow, as most of our patients are discharged the same day. The FlexCath sheath (10 French [F] or 12F inner diameter) and Faradrive sheath (13F inner diameter) are both compatible with the utilization of percutaneous closure devices, which allows for early ambulation or figure-of-8 closure with sutures and manual compression while still facilitating same-day discharge. One notable change is the observed reduction in inflammation-mediated pericarditis symptoms in patients post ablation. When utilizing thermal ablation, our patients are typically and empirically treated with a short course of colchicine depending on the extent of ablation performed as well as a proton pump inhibitor to ameliorate any esophageal irritation.10 However, we have not found this necessary for PFA cases and have not noticed any significant cases of pericarditis post ablation thus far with the benefit of avoiding the gastrointestinal side effects that are sometimes seen with colchicine.
EP lab staff. Education was provided to the lab staff on PFA technology, with in-service sessions to allow for hands-on exposure before cases were performed. Given their exposure to other over-the-wire technologies and associated catheter/sheath preparation techniques, such as for cryoablation and left atrial appendage closure, this transition was also seamless. Considering the larger sheath profile was utilized, a meticulous approach to catheter preparation and catheter exchanges is paramount to reduce the risk of air bubble introduction in the left atrium. Staff members are empowered to vocalize any concerns during the procedure, as we believe this team approach is necessary to ensure the best outcomes. Unique to PFA cases, we ensure that nitroglycerin is available and accessible in the rare case of clinical coronary spasm. The EP lab staff and our anesthesiology colleagues have been educated on the high dose required with intravenous (IV) administration (~2-3 mg) and the need for pre-administration of vasoconstrictors like phenylephrine to mitigate the resultant hypotension. After over 7 months of performing PFA cases post approval, we have not experienced any instances of clinical coronary spasm thus far.
Cardiac electrophysiologists. We currently have 3 cardiac electrophysiologists at our institution. Before the inclusion of PFA, 2 predominantly utilized cryoablation and the other utilized RF ablation for AF ablation cases. The transition from
cryoablation to PFA, both with over-the-wire and single-shot ablation technologies, has been seamless with a minimal learning curve specific to the form factors of the PFA technology utilized. Less preprocedural PV imaging with computed tomography or magnetic resonance imaging to rule out the left common PV is being performed, as we believe we can accommodate the pulmonary anatomy with current PFA platforms. The transition from RF ablation, a point-by-point ablation system, to a single-shot PFA ablation system was also a smooth transition, though perhaps with a little more adjustment required owing to the over-the-wire catheter design, larger sheaths utilized, and more limited catheter manipulation required. The majority of AF ablation cases are now performed with either PFA or RF ablation with a preference for PFA if posterior wall isolation is anticipated.
Procedural Approach
Since the widespread adoption of PFA, there has been growing discussion around the optimal procedural approach with this new technology given its unique factors, which allow for both improved efficiency in the EP lab and enhanced safety. A wide range of considerations and perspectives have been postulated, such as:
• What is the optimal approach for anesthesia (general sedation vs monitored anesthesia care vs conscious sedation)?
• Is PFA compatible with a low or no fluoroscopy workflow, as had been increasing with thermal ablation but is in contrast with the initial PFA experience in Europe, where fluoroscopy was more heavily utilized?
• What is the role for intracardiac echocardiography (ICE) and electroanatomic mapping (EAM) with PFA considering the tissue stunning and resultant loss of electrograms that occurs with initial PFA application?
• How does one interpret acute intraprocedural efficacy? Are new endpoints needed given the stunning effect of PFA and loss of electrograms seen, which is discordant from actual durable PV isolation?
• How to compare empiric- vs substrate-based ablation lesion sets?
• What factors impact long-term efficacy?
Case Presentation
The following is a case that highlights our institution’s procedural approach to PFA. The patient is a 70-year-old man with a history of hypertension, diabetes, and persistent AF/atrial flutter (AFL) (CHA2Ds2-VASc score of 3) who was
diagnosed 1.5 years prior. He was previously cardioverted and maintained on dronedarone with recurrence of symptomatic persistent AF, prompting referral for catheter ablation. He subsequently underwent AF ablation utilizing a pentaspline catheter. Ultrasound guidance was utilized to obtain 3 points of vascular access in the right femoral vein (Figure 1). ICE guidance was utilized for transseptal access and to guide catheter manipulation while ensuring optimal contact with ablation (Figures 2 and 3). Meticulous sheath management was employed, ensuring performance of all sheath exchanges while aspirating to reduce likelihood of air bubble introduction. A baseline electroanatomic voltage map was obtained for a substrate-based approach, which showed a predominantly healthy left atrium despite persistent AF though notably early in its course (Figure 4). There was spontaneous induction of AFL with a cycle length of ~280 ms and response to entrainment and activation mapping most consistent with typical AFL. The decision was made to proceed with PV isolation with confirmation of antral level isolation without significant encroachment on the posterior wall on a post-ablation voltage map (Figure 5). The cavotricuspid isthmus line was outlined on the EAM system with ICE while ensuring the intended ablation path was not in direct proximity to the right coronary artery. Ablation was then performed utilizing the pentaspline catheter in flower configuration after pre-administration of nitroglycerin and phenylephrine with termination of AFL and demonstration of bidirectional block post ablation. Total fluoroscopy time was ~4 minutes, the majority of which was utilized for the typical flutter ablation. The patient tolerated the procedure well and was discharged home 6 hours later. He continues to do well in outpatient follow-up.
Highlighted in this case are key tenets in our procedural approach to PFA. First, similar to other ablation technologies, the majority of complications are usually vascular in origin. These complications are largely mitigated with appropriate ultrasound guidance technique to vascular access, as was demonstrated in the MANIFEST-17k registry.16 The need for meticulous sheath management to reduce air bubble introduction cannot be overstated given the large sheath profiles utilized, to reduce the risk of stroke and coronary air embolism. We maintain that ICE guidance and EAM play a pivotal role in guiding ablation. This is important to ensure adequate contact for optimal energy delivery as there is increasing data highlighting its importance for durability.17
Additionally, the ease of ablation with these large footprint PFA catheters also raises concern of collateral damage to neighboring healthy myocardium such as the posterior wall when perhaps only PVI is the intent. This effect in some instances can be proarrhythmic. The ability provided by these tools comes with significant responsibility to be judicious with ablation lesions which can certainly be better optimized with EAM and ICE guidance. The clinical impact of this will likely be better delineated as we have large-scale, long-term follow-up data. Additionally, ICE and EAM guidance also facilitate a low or no fluoroscopy workflow as there is more data being published on the feasibility of this approach.18 This builds upon the significant trend towards zero-fluoroscopy procedures with thermal ablation platforms, which impact both the patients and EP team.
Challenges and Future Directions
PFA has been transformational to the field of cardiac EP and AF management thus far. It is a welcomed tool for the increasing burden of AF, with its improved efficiency poised to meet this challenge. However, it is also clear that there is more to be learned and optimized going forward.
There has been a significant amount of preclinical randomized controlled trials and real-world registries demonstrating an enhanced safety profile given its preferential tissue ablation characteristics. More continues to be learned about rare complications such as clinical and subclinical coronary artery spasm. Tam et al recently presented data on the presence of predominantly mild coronary artery stenosis at 3-month follow-up optical coherence tomography imaging.19 This is juxtaposed to data recently presented on the absence of long-term clinical sequalae in the largest cohort of coronary spasm cases in real-world clinical practice.20
Hemolysis with rare cases of renal failure have also been previously noted albeit in the context of a very high number of PFA applications.16 As such, a heightened sense of awareness should be maintained, as this was not previously seen with thermal ablation platforms. A dose-dependent effect has since been well demonstrated in vitro.21 However, this has been shown to be mitigated clinically by IV fluid hydration when complex lesion sets requiring a high number of PFA applications are being delivered.22 Patients with co-existent heart failure with a higher prevalence of persistent AF pose a unique conundrum as one must also be judicious with volume administration.
There is also an added overall cost consideration with this new technology, which, in some cases, must be combined with other mapping tools and thermal ablation platforms to perform linear lines. Perhaps of the most interest are considerations around long-term efficacy and ongoing procedural and energy optimization to achieve durable PV isolation. Innovation around real-time lesion assessment might play a role in this going forward as electrogram assessment are of less use in a PFA context. Additionally, the absence of contact force, which represented a significant leap with RF ablation, is yet another avenue for improvement. It will be incumbent on our industry partners with current and incoming participants as well as cardiac electrophysiologists to continue to drive innovation and push for improved outcomes.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Ekanem reports consulting fees from Boston Scientific, J&J MedTech, and Kardium, and speaker honoraria from Boston Scientific and J&J MedTech.
References
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