Abstract
Background
Transseptal puncture (TSP) is a critical step in Pulsed field ablation (PFA) procedures. Conventional workflows often require initial septal access using a standard transseptal sheath followed by exchange to accommodate large-bore PFA delivery systems. Direct large-bore sheath access may simplify the workflow and reduce procedural resource utilization.
Objectives
To compare procedural efficacy, safety, and cost-effectiveness of a conventional SL0 sheath exchange strategy versus direct Faradrive sheath access for fluoroscopy-guided TSP in PFA-guided pulmonary vein isolation (PVI).
Methods
In this prospective, single-center study, 140 consecutive patients undergoing first-time PFA-guided PVI were included. The first 70 patients underwent TSP using an SL0 sheath followed by sheath exchange to a Faradrive sheath. The subsequent 70 patients underwent direct TSP using Faradrive sheath without exchange. All procedures were performed under fluoroscopic guidance without intracardiac or transesophageal echocardiography. The primary endpoint was total procedural time prespecified as one objective marker of workflow efficiency. Secondary endpoints included fluoroscopy duration, radiation exposure, number of transseptal puncture (TSP) attempts, sheath crossovers, acute procedural success, complication rates, and procedural cost analysis.
Results
Total procedural time was shorter in the direct Faradrive group compared with the SL0 exchange group (35.0 [30.0–40.0] min vs. 40.0 [34.3–50.0] min; p = 0.001). Fluoroscopy time (5.98 [4.57–7.94] min vs. 8.63 [6.04–11.7] min; p < 0.001) and radiation dose (567 [302–730] vs. 715 [434–1002] cGy·cm²; p = 0.001) were also lower with direct access. Time to septal crossing, number of puncture attempts, first-pass success, and acute PVI success were comparable between groups. One air embolism occurred during sheath exchange in the SL0 group without long-term sequelae. No hemolysis, acute kidney injury, stroke, tamponade, or deaths were observed. Estimated per-case cost reduction with direct access was €171.
Conclusion
In a fluoroscopy-guided workflow, direct large-bore Faradrive sheath access for transseptal puncture during PFA-guided pulmonary vein isolation was associated with shorter procedural and fluoroscopy times and lower procedural costs without compromising acute procedural safety or success. These findings support procedural workflow simplification by eliminating sheath exchange in experienced operators.
Supplementary Information
The online version contains supplementary material available at https://doi.org/10.1007/s10840-026-02312-y.
Keywords: Pulmonary vein isolation, Pulsed field ablation, Transseptal puncture, Single-sheath workflow, Cost analysis
Introduction
Pulmonary vein isolation (PVI) remains the cornerstone of catheter-based ablation therapy for atrial fibrillation (AF). Previous studies have demonstrated that catheter ablation not only improves symptoms and quality of life but may also confer prognostic benefits, including reductions in stroke and cardiovascular mortality [1–3].
Pulsed field ablation (PFA), an emerging non-thermal energy source for PVI, has shown promising results regarding both efficacy and safety [4]. Compared to thermal ablation techniques, PFA is associated with a lower incidence of major procedural complications while achieving comparable rates of durable PVI [5].
Transseptal access to the left atrium (LA) is a crucial component of PVI procedures. Several transseptal puncture (TSP) techniques have been described, including single and double transseptal approaches [6]. With the increasing adoption of single-shot devices, there has been a shift towards single transseptal access for PVI in most centers [7]. In standard workflows, a conventional transseptal sheath such as the SL0 is commonly used, which requires sheath exchange to accommodate the larger PFA catheter. Sheath exchanges are associated with an increased risk of air embolism, a recognized cause of periprocedural stroke [8]. Various strategies to mitigate this risk, such as meticulous flushing and aspiration techniques, have been proposed [9].
The Faradrive sheath is a large-bore sheath (outer diameter 16.8 Fr) that allows direct transseptal access without the need for sheath exchange, potentially streamlining the procedure and reducing complication risk. The feasibility of this zero-exchange approach has been demonstrated in recent studies [10]; however, no direct comparative studies have evaluated its performance against the SL0 sheath in PFA procedures, and data on cost-effectiveness remain scarce.
This study aimed to assess the procedural efficacy and safety of PFA-guided PVI using the Faradrive sheath compared with the SL0 sheath for fluoroscopy-guided transseptal access. By comparing key procedural metrics, complication rates, and cost analyses, we sought to determine whether the Faradrive workflow offers advantages over conventional sheath techniques in clinical practice.
Methods
Study population
This prospective, single-center study included 140 consecutive patients referred for first-time PFA-guided PVI between August 2023 and August 2024. All procedures were performed as part of routine clinical care. Baseline characteristics were extracted from medical records. Eligibility for PFA-guided PVI was based on pulmonary vein (PV) anatomy and left atrial (LA) size as assessed by cardiac magnetic resonance imaging. All patients received adequate oral anticoagulation for at least 4 weeks prior to the procedure or underwent transesophageal echocardiography to exclude LA thrombi when indicated. Patients were treated sequentially according to institutional workflow. The first 70 consecutive patients underwent transseptal puncture (TSP) using a conventional SL0 sheath followed by exchange to a Faradrive sheath. The subsequent 70 consecutive patients underwent direct TSP using the Faradrive sheath without sheath exchange. This was a prospective analysis of consecutively treated patients undergoing standard clinical practice. No intervention beyond routine care was introduced. According to institutional guidelines, separate Ethics Committee approval was not mandated. All patients provided written informed consent for the ablation procedure, and all data were analyzed in anonymized form.
Operator experience
Procedures were performed by two senior electrophysiologists. Both operators had more than 5 years of experience in catheter ablation and transseptal puncture. Prior to study initiation, both had performed more than 300 transseptal punctures and had established experience with pulsed field ablation. During the study period, procedures were distributed between both operators in both workflow phases to minimize operator-specific bias (Operator A: 42 SL0 cases and 40 Faradrive cases; Operator B: 28 SL0 cases and 30 Faradrive cases). However, due to the sequential design, a potential learning curve effect cannot be completely excluded.
Procedural aspects
Oral anticoagulation was held on the morning of the procedure, and patients were fasted for at least six hours. PVI was performed under deep conscious sedation using midazolam, fentanyl, and propofol. Atropine was administered to reduce the risk of vagal responses. Following ultrasound-guided femoral venous access, two venous sheaths (7 Fr and 11 Fr) were inserted for multipolare sinus-coronarias catheter and LA-access. Heparin was administered prior to and following fluoroscopy-guided transseptal puncture (TSP) to maintain an activated clotting time (ACT) > 300 s during ablation.
Imaging and transseptal technique
All transseptal punctures were performed under fluoroscopic guidance alone. Neither intracardiac echocardiography (ICE) nor transesophageal echocardiography (TEE) was routinely used. Septal positioning was guided using standard right anterior oblique (RAO) and left anterior oblique (LAO) fluoroscopic projections. After septal crossing, left atrial access was confirmed by selective contrast injection. Representative fluoroscopic views illustrating the transseptal workflow and a procedural video sequence are provided in Supplementary Figure S1 and Supplementary Video V1.
SL0 workflow
Following standard positioning in the superior vena cava (SVC), the SL0 sheath (Fast-Cath™, 8.5 Fr, Abbott) was advanced to the fossa ovalis using a BRK XS needle (71 cm, Abbott). After successful TSP and LA access, the SL0 sheath was exchanged for the Faradrive sheath (Faradrive™, 16.8 Fr, Boston Scientific) over a guidewire (See Figure 1 for workflow comparison).
Fig. 1.
Procedural workflows for transseptal access in SL0 and Faradrive groups. CS = coronary sinus; FO = fossa ovalis; LA = left atrium; LSPV = left superior pulmonary vein; SVC = superior vena cava; TSP = transseptal puncture; PVI = pulmonary vein isolation
Faradrive workflow
The Faradrive sheath was used for direct TSP without sheath exchange. Following placement in the SVC, a BRK XS needle (98 cm) was advanced through the Faradrive sheath to perform TSP under fluoroscopic guidance. After removal of the needle the Faradrive sheath was advanced into the LA over a guidewire without additional sheath exchange.
PFA-guided PVI
PVI was performed using a standardized institutional protocol, consisting of ≥ 40 PFA applications. A 31-mm Farawave™ PFA catheter (12 Fr, Boston Scientific) was used in all cases. Pericardial effusion was excluded by transthoracic echocardiography post-ablation. Hemostasis was achieved by manual compression and a figure-of-eight suture. Patients remained supine for 6 h and were typically discharged the following day.
TSP facilitation and crossover
If TSP was not successful on the first attempt or was difficult due to anatomical variation, alternative needles, wires, or steerable sheaths (Agilis™, Abbott) were used at the operator’s discretion. Protocol deviations were recorded.
Study endpoints
The primary endpoint was total procedural duration (skin-to-skin time, in minutes) prespecified as one objective marker of workflow efficiency.
Secondary endpoints included:
Procedural efficacy: time to TSP, number of TSP attempts, first-attempt success rate, need for guidewire-facilitated LA access, sheath crossover, and acute procedural success (complete PVI).
Procedural performance: fluoroscopy time (min), radiation dose (dose-area product, cGy·cm²).
Safety: incidence of complications (cardiac tamponade, pericardial effusion, aortic puncture/aortic root contrast opification, stroke/TIA, major bleeding, air embolism, death).
Cost analysis
A cost-consequence analysis compared procedural cost differences between the two workflows. Unit cost estimates were derived from published data and institutional pricing, following a model adapted from van de Kar et al. [11]. Total procedural costs included room time, staff time and sheath costs. Room and staff costs were calculated per minute (€3.4/min for room costs, €1.6/min for physician and 2x€0.6/min for nurses costs), and device costs included sheath pricing (SL0 sheath: approximately €140 based on typical institutional acquisition costs in Germany). Sensitivity analyses were performed using reported ranges for PFA workflows.
Statistical analysis
Continuous variables were summarized as mean ± standard deviation (SD) or median with interquartile range (IQR). Normal distribution was assessed with Shapiro-Wilk tests. Group comparisons were performed using independent t-tests or Mann-Whitney U tests for continuous variables, and chi-square or Fisher’s exact tests for categorical variables. A p-value < 0.05 was considered statistically significant. Analyses were performed using jamovi (Version 2.6).
Results
Study population
A total of 140 consecutive patients underwent PFA-guided pulmonary vein isolation (PVI). Seventy patients were treated using the conventional SL0 sheath exchange workflow and seventy using direct Faradrive sheath access (Fig. 2) between 08/2023 and 2024. All patients underwent first-time ablation procedures. Baseline demographic and clinical characteristics were comparable between the two groups, as detailed in Table 1.
Fig. 2.
Study flow diagram showing screening, workflow, and endpoints. Patients aged 18–85 years undergoing first-time PVI with suitable LA anatomy for PFA (cardiac MRI) were allocated sequentially 1:1 to SL0 or Faradrive sheath (N = 140). All procedures were performed using PFA. The primary endpoint was procedural workflow efficiency assessed by total procedural time. Secondary endpoints included transseptal puncture characteristics, radiation exposure, safety outcomes and workflow resource utilization
Table 1.
Baseline characteristics of patients undergoing PFA-guided PVI using SL0 vs. Faradrive workflows
| Characteristic | SL0 group (n = 70) | Faradrive group (n = 70) | p-value |
|---|---|---|---|
| Age, years (median, IQR) | 68.5 (58.3–72.8) | 67.0 (59.0–73.0) | 0.993 |
| Male sex, n (%) | 40 (57.1%) | 47 (67.1%) | 0.223 |
| Body mass index, kg/m² (median, IQR) | 27.2 (24.9–30.7) | 28.0 (24.9–31.0) | 0.370 |
| Type of atrial fibrillation, n (%) | 1.000 | ||
| - Paroxysmal | 38 (54.3%) | 38 (54.3%) | |
| - Persistent | 32 (45.7%) | 32 (45.7%) | |
| Duration since AF diagnosis, months (median, IQR) | 26.5 (9.0-66.8) | 16.0 (4.0–38.0) |
0.086 Welch: 0.524 |
| CHA₂DS₂-VA score (median, IQR) | 2.0 (2.0–3.0) | 2.0 (1.0–3.0) | 0.482 |
| Hypertension, n (%) | 60 (85.7%) | 58 (82.9%) | 0.642 |
| Diabetes mellitus, n (%) | 12 (17.1%) | 12 (17.1%) | 1.000 |
| Coronary artery disease, n (%) | 12 (17.1%) | 12 (17.1%) | 1.000 |
| PCI | 5 (7.1%) | 6 (8.6%) | 1.000 |
| History of stroke or TIA, n (%) | 7 (10.0%) | 13 (18.6%) | 0.147 |
| Left atrial diameter, cm² (median, IQR) | 27.0 (23.0–32.0) | 27.0 (22.0–31.0) | 0.609 |
| Left ventricular ejection fraction, % (median, IQR) | 60.0 (52.0–64.0) | 60.0 (56.0–64.0) | 0.201 |
| Antiarrhythmic drug use, n (%) | 12 (17.1%) | 19 (27.1%) | 0.154 |
| Beta-blocker therapy, n (%) | 57 (81.4%) | 58 (82.9%) | 0.825 |
| Oral anticoagulation at baseline, n (%) | 69 (98.6%) | 70 (100%) | 0.316 |
| Prior history of radiation | 3 (4.3%) | 2 (2.9%) | 1.000 |
| Prior history of cancer | 7 (10%) | 9 (12.9%) | 0.791 |
| CKD | 18 (25.7%) | 17 (24.3%) | 0.845 |
| Heart failure | 15 (21.4%) | 12 (17.1%) | 0.713 |
| Device (Pacemaker) | 2 (3.4%) | 2 (3.4%) | 1.000 |
| Sleepapnoea | 6 (8.6%) | 6 (8.6%) | 1.000 |
Abbreviations: AF = atrial fibrillation; BMI = body mass index; LA = left atrium; LVEF = left ventricular ejection fraction; TIA = transient ischemic attack
Procedural characteristics
Direct Faradrive access was associated with improved procedural efficiency. Total procedural time was shorter in the Faradrive group compared with the SL0 exchange group (35.0 [30.0–40.0] min vs. 40.0 [34.3–50.0] min; p = 0.001, Fig. 3). Fluoroscopy time was significantly reduced with direct access (5.98 [4.57–7.94] min vs. 8.63 [6.04–11.7] min; p < 0.001), as was radiation exposure (567 [302–730] vs. 715 [434–1002] cGy·cm²; p = 0.001). Despite these differences, the time required to achieve first transseptal access was comparable between groups (8.82 [7.54–11.2] min vs. 8.79 [6.98–10.8] min; p = 0.333). Transseptal puncture was successfully completed on the first attempt in 90.0% of Faradrive cases and 87.1% of SL0 cases (p = 0.595). The number of puncture attempts did not differ significantly (1.11 [1.0] vs. 1.23 [1.0]; p = 0.210), nor did the need for guidewire-facilitated access to the left atrium (4.3% vs. 7.1%; p = 0.718). Sheath crossover to a smaller steerable sheath was required in one case per group. Acute procedural success, defined as complete pulmonary vein isolation at the end of the procedure, was achieved in all patients in the Faradrive group and in 98.6% of patients in the SL0 group (p = 0.316) (Table 2).
Fig. 3.
Boxplots of total procedure time, fluoroscopy time, and radiation dose for SL0 and Faradrive workflows. Median (IQR) values were: Procedure time: SL0 40 min (34.3–50) vs. Faradrive 35 min (30–40), p = 0.001. Fluoroscopy time: SL0 8.63 min (6.04–11.7) vs. Faradrive 5.98 min (4.57–7.94), p < 0.001. Radiation dose: SL0 715 cGy·cm² (434–1002) vs. Faradrive 567 cGy·cm² (302–730), p = 0.001. Boxes indicate interquartile range (IQR), horizontal lines the median, and whiskers the minimum and maximum values
Table 2.
Procedural outcomes, safety events, and acute success rates in SL0 vs. Faradrive workflows for PFA-guided PVI
| Parameter | SL0 group (n = 70) | Faradrive group (n = 70) | p-value |
|---|---|---|---|
| Total procedure time, min (median, IQR) | 40.0 (34.3–50.0) | 35.0 (30.0–40.0) | 0.001 |
| Fluoroscopy time, min (median, IQR) | 8.63 (6.04–11.7) | 5.98 (4.57–7.94) | <0.001 |
| Radiation dose, cGy·cm² (median, IQR) | 715 (434–1002) | 567 (302–730) | 0.001 |
| Time to transseptal access, min (median, IQR) | 8.79 (6.98–10.8) | 8.82 (7.54–11.2) | 0.333 |
| Number of puncture attempts (median, IQR) | 1.23 (1.0) | 1.11 (1.0) | 0.210 |
| Successful first puncture attempt, n (%) | 61 (87.1%) | 63 (90.0%) | 0.595 |
| Direct LA access via needle only, n (%) | 65 (92.8%) | 66 (94.3%) | 0.730 |
| LA access facilitated by guidewire, n (%) | 5 (7.1%) | 3 (4.3%) | 0.718 |
| Complications, n (%) | 3 (4.3%) | 1 (1.4%) | 0.620 |
| - Aortic root contrast opification | 1 (1.4%) | 1 (1.4%) | 1.000 |
| - Air embolism | 1 (1.4%) | 0 | |
| Pericardial effusion | 0 | 0 | 1.000 |
| Need for sheath crossover, n (%) | 1 (1.4%) | 1 (1.4%) | 1.000 |
| Acute procedural success, n (%) | 69 (98.6%) | 70 (100%) | 0.316 |
Abbreviations: PVI = pulmonary vein isolation; TSP = transseptal puncture; LA = left atrium; ACT = activated clotting time; cGy·cm² = centigray square centimeters
Safety outcomes
Overall complication rates were low and not statistically different between groups (1.4% in the Faradrive group vs. 4.3% in the SL0 group; p = 0.620). In the SL0 group, one case demonstrated transient contrast opacification of the aortic root during septal positioning without hemodynamic compromise or need for intervention. One case of air embolism occurred during sheath exchange in the SL0 workflow after successful transseptal puncture and placement of a guidewire in the left superior pulmonary vein. Immediately after withdrawal of the SL0 sheath from the left atrium, the patient developed transient hemodynamic instability accompanied by ST-segment elevations on electrocardiographic monitoring. The procedure was immediately interrupted and supportive management was initiated, including high-flow oxygen, intravenous fluids, vasopressor support with Akrinor, and temporary atrial overdrive pacing. Emergent coronary angiography was performed and demonstrated normal coronary arteries without evidence of obstruction. The procedure was subsequently aborted. The patient remained under continuous monitoring for two additional days and was discharged without neurological deficits or other clinical sequelae. No long-term complications related to this event were observed during follow-up. In the Faradrive group, one case of transient contrast visualization of the aortic root was observed without clinical consequence. No cases of pericardial effusion, cardiac tamponade, stroke, transient ischemic attack, or death occurred in either group. No clinically relevant hemolysis, acute kidney injury, or significant post-procedural deterioration in renal function was observed during hospitalization in either cohort (Table 2).
Cost analysis
The Faradrive workflow resulted in reduced total procedural costs. A detailed cost breakdown is provided in Table 3. Based on an economic model incorporating room and staff time as well as additonal device costs, the mean cost per case was estimated at €217.00 for the Faradrive workflow and €388.00 for the SL0 workflow. This corresponds to a mean cost savings of €171 per procedure. Across 70 consecutive Faradrive cases, the total estimated cost savings amounted to €11,170.
Table 3.
Detailed procedural cost breakdown
| Cost component | SL0 workflow (40 min) | Faradrive workflow (35 min) |
|---|---|---|
| Room cost (€3.4/min) | €136.00 | €119.00 |
| Physician cost (€1.6/min) | €64.00 | €56.00 |
| Nursing cost (2 × €0.6/min) | €48.00 | €42.00 |
| Subtotal time-dependent cost | €248.00 | €217.00 |
| Additional SL0 sheath cost | €140.00 | — |
| Total procedural cost | €388.00 | €217.00 |
| Per-case cost difference | €171.00 |
Procedural data summary
Figure 4 summarizes detailed procedural outcomes.
Fig. 4.
Central illustration: comparison of transseptal workflow strategies and key outcomes between SL0 sheath exchange and direct Faradrive access in PFA-guided pulmonary vein isolation, summarizing workflow differences, fluoroscopy exposure, procedural metrics, and cost implications
Discussion
Transseptal access remains a critical and potentially vulnerable step in left atrial ablation procedures. In contemporary PFA workflows, large-bore sheaths are required for device delivery. Conventional approaches typically involve initial septal access with a standard transseptal sheath followed by exchange, introducing additional manipulation within the venous system and left atrium. In this prospective single-center study, we compared two transseptal workflows for fluoroscopy-guided pulsed field ablation: a conventional SL0 sheath followed by exchange to a large-bore delivery sheath, and a direct large-bore Faradrive sheath access without exchange. The principal findings are that elimination of sheath exchange was associated with shorter overall procedural duration, reduced fluoroscopy time, lower radiation exposure, and lower procedural costs, without compromising acute procedural success or in-hospital safety. Although total procedural time was the prespecified primary endpoint, the clinical relevance of the present findings lies less in acceleration itself than in procedural simplification in PFA-guided PVI.
Overall procedure times (< 60 min in both groups) were consistent with reported efficiencies of PFA-guided PVI [12, 13]. The additional time savings with the Faradrive workflow likely reflect the avoidance of additional sheath preparation, flushing, and exchange steps required in the SL0 workflow. Similar procedural benefits have been reported with other zero-exchange approaches in PFA and cryoballoon ablation [10, 13].
Direct transseptal access with the large-bore Faradrive sheath was feasible and safe, with a high first-attempt success rate and no increase in complications. Although the Faradrive sheath has a larger diameter and increased stiffness compared with the SL0, transseptal access was straightforward when performed under fluoroscopic guidance. The enhanced steerability of the Faradrive sheath facilitated precise positioning at the fossa ovalis.
Safety considerations
Transseptal-related complications were infrequent in both cohorts. Rates of first-attempt TSP success and need for guidewire assistance were similar between workflows. Guidewire use can facilitate TSP in anatomically challenging cases; however, multiple sheath exchanges may increase the risk of air embolism. One case of air embolism occurred during sheath exchange in the SL0 group. Although the patient recovered without long-term sequelae, this event highlights that exchange maneuvers represent a moment of potential vulnerability [8]. In contrast, no embolic events were observed in the direct-access cohort. Other PFA-related studies have shown that minimizing sheath exchanges through zero-exchange workflows can enhance the safety and efficiency of PFA-guided PVI [14, 15]. Transient contrast opacification of the aortic root was observed in a small number of cases in both workflows, without clinical consequence. No pericardial effusion, stroke, tamponade, or death occurred. Furthermore, no clinically significant hemolysis or deterioration in renal function was observed during hospitalization. The study was not powered to detect differences in rare complications. Given the low incidence of transseptal-related adverse events, substantially larger multicenter studies would be required to definitively assess safety superiority. Overall, the findings suggest that direct large-bore access can be performed safely in experienced hands within a fluoroscopy-guided practice.
Operator experience and sequential design
Procedures were performed by two experienced operators with established expertise in transseptal puncture and pulsed field ablation. However, due to the sequential study design, a learning curve effect cannot be entirely excluded. Although both operators participated throughout the study period, improvements in overall laboratory efficiency over time may have contributed to observed differences. Future randomized or crossover designs would be valuable to further isolate workflow-related effects from temporal learning influences.
Alternative transseptal strategies
The present study focused on conventional needle-based septal access. Alternative techniques, including radiofrequency (RF) guidewire-assisted transseptal crossing in combination with large-bore sheaths, may further optimize zero-exchange workflows [16, 17]. Such strategies may reduce mechanical septal force and facilitate first-pass success, particularly in challenging anatomy. While not evaluated here, future comparative studies incorporating RF-assisted techniques may help define the optimal large-bore access strategy.
Cost implications
Data on the cost-effectiveness of optimized PFA workflows remain limited. The cost reduction observed in this study was driven by two factors: reduced procedural room time and elimination of the additional sheath required for exchange. The absolute per-case savings were modest but may become meaningful in high-volume centers. It should be noted that the present analysis reflects institutional cost structures and does not incorporate broader health economic modeling. Given the rising global demand for AF ablation [15], the findings suggest that workflow simplification may provide incremental economic benefits independent of energy source selection.
Limitations
This study has several limitations. First, it was a prospective, single-center analysis without randomization, introducing potential selection bias and confounding. Second, while the sample size was adequate for procedural comparisons, long-term follow-up data were not available. Third, TSP was performed under fluoroscopic guidance alone; results may differ with additional imaging modalities such as transesophageal echocardiography but would come with higher costs. Fourth, operator experience and the sequential design introduces the possibility of temporal learning effects. This may also have influenced outcomes, and results may not be generalizable to other PFA systems. Fifth, the sample size was insufficient to detect statistically significant differences in rare complications. Finally, the cost analysis was based on a simplified model using published data from European high-volume centers. Although key procedural and staffing costs were included, indirect costs and long-term economic outcomes were not analyzed. Cost structures vary across institutions and healthcare systems, limiting generalizability.
Conclusion
In conclusion, the Faradrive sheath workflow offers practical advantages for improving procedural efficiency in PFA-guided AF ablation compared with the conventional SL0 workflow. These findings support consideration of a streamlined, single-sheath approach in clinical practice, with potential benefits for procedural standardization, patient safety, and healthcare resource utilization.
Supplementary information
Below is the link to the electronic supplementary material.
Acknowledgements
AI-based language assistance (ChatGPT, OpenAI) was used to optimize language style and consistency. The authors retain full responsibility for the content of this work.
Author contributions
Marcel Feher: conception and design of the study, data collection, statistical analysis, drafting.Timm Seewöster: data collection, critical revision of the manuscript.Kerstin Bode: interpretation of data, supervision, critical revision of the manuscript.All authors have read and approved the final version of the manuscript.
Funding
Boston Scientific supported this study through a publication grant. This funding has been instrumental in enabling the completion and publishing of this project.
Data availability
No datasets were generated or analysed during the current study.
Declarations
Competing interests
The authors declare no competing interests.
Footnotes
What’s New?
• Direct transseptal access using the Faradrive sheath reduces procedural duration and fluoroscopy time in PFA-guided PVI.
• Eliminating sheath exchange reduces procedural costs by an estimated €171 per patient.
• The Faradrive-only workflow improves procedural efficiency with a comparable safety profile.
Publisher’s note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Marcel Feher and Timm Seewöster contributed equally to this work.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
No datasets were generated or analysed during the current study.