Abstract
Background
Catheter ablation for atrial fibrillation (AF) typically involves transseptal puncture (TSP) to access the left atrium. Traditional TSP requires sheath upsizing and exchanges, increasing procedural complexity, time, and risks. We evaluated the efficiency and safety of zero-exchange technique using the FlexCath Advance™ sheath combined with the VersaCross™ RF wire compared to the traditional method involving initial puncture with Agilis™ NxT sheath and Baylis RF needle, followed by sheath exchange.
Methods
This retrospective observational study included 109 patients undergoing their first cryoballoon AF ablation between June 2023 to June 2024 at Marshfield Medical Center. Procedural efficiency (time from venous access to TSP, time to first ablation, total procedural time), safety outcomes (pericardial effusion, bleeding, stroke/TIA, phrenic nerve injury, esophageal injury), and fluoroscopy exposure were compared between zero-exchange (n = 50) and traditional (n = 59) groups. Linear regression analyses were adjusted for age, sex, BMI, left ventricular ejection fraction (LVEF), and open-heart surgery history.
Results
The zero-exchange approach significantly improved procedural efficiency, with shorter time from venous access to TSP (20 ± 9 vs. 28 ± 12 min; p < 0.01), time to first ablation (36 ± 9 vs. 48 ± 16 min; p < 0.01), and total procedure duration (107 ± 31 vs. 129 ± 51 min; p < 0.01). Adjusted regression analyses confirmed these reductions (all p < 0.01). Fluoroscopy time was substantially lower with zero-exchange (8.4 ± 4 min vs. 19.9 ± 8.2 min; p < 0.01). No significant complications occurred in either group.
Conclusion
The zero-exchange transseptal puncture technique using FlexCath Advance™ and VersaCross™ RF wire significantly enhances procedural efficiency and reduces radiation exposure without compromising patient safety, supporting its adoption in AF ablation procedures.
1. Introduction
Atrial fibrillation (AF) is the most common cardiac arrhythmia and is associated with significant morbidity, including stroke, heart failure, and reduced quality of life [1]. Pulmonary vein isolation has been recommended by guidelines as a cornerstone in the management of AF.
Transseptal puncture is critical in AF ablation. Traditionally, this is performed using a smaller 8.5F transseptal sheath to cross the interatrial septum, followed by an exchange for a larger-caliber sheath, such as the FlexCath Advance™, to accommodate ablation catheters. This multi-step approach is widely However, sheath exchange may increase procedural risk by introducing air or thrombus to the left atrium. To compare the efficiency and safety of two transseptal puncture techniques in atrial fibrillation ablation: the traditional method using a smaller caliber sheath to go transeptal and exchange to the large caliber FlexCath sheath versus the streamlined, zero-exchange approach using the FlexCath Sheath and VersaCross™ RF Wire (Fig. 1). We hypothesize that the zero-exchange approach will be non-inferior to the traditional method in terms of safety and will demonstrate superior efficiency by reducing the time from venous access to successful TSP.
Fig. 1.
Comparison of traditional and zero-exchange transseptal puncture techniques.
2. Methods
2.1. Study design
This study is a retrospective analysis comparing two transseptal puncture techniques used in cryoballoon atrial fibrillation ablation. Data were collected from the Marshfield Clinic Health System electronic medical records (EMR).
2.2. Patient population
Patients aged 18 to 90 who underwent their first cryoballoon atrial fibrillation ablation between June 2023 and June 2024 at Marshfield Medical Center with complete procedural and three-month follow-up data were included. Exclusions included patients with prior atrial fibrillation ablation or incomplete medical records. Patients were assigned to the traditional or zero-exchange approach based on their operator's standard practice. Both operators performed high volumes of atrial fibrillation ablation procedures annually, and all procedures adhered to standardized institutional protocols.
2.2.1. Procedural steps for zero sheath exchange
The VersaCross™ transseptal system includes an RF wire [Baylis Medical Company Inc, 0.035”, 230 cm], dilator [67 cm large curve D1 dilator], and a dedicated VersaCross™ sheath [63 cm, 55° curve sheath] (Fig. 2, Video 1); however, in this zero-exchange workflow, the FlexCath Advance™ sheath was used in place of the VersaCross™ sheath. After femoral venous access, the VersaCross™ RF wire along with FlexCath Advance™ sheath [Medtronic, 65.6 cm, 10 F inner diameter, 14 F outer diameter] and its dilator [86.5 cm, 0.9 mm inner diameter, 3/3 mm outer diameter] was advanced to the interatrial septum and positioned on the fossa ovalis under standard fluoroscopic and intracardiac echocardiography guidance. The VersaCross™ RF wire was then used to perform transseptal puncture by applying RF energy at the septum, after which the wire was advanced into the left atrium. The dilator was subsequently advanced into the left atrium over the wire, followed by advancement of the FlexCath Advance™ sheath into the left atrium. The dilator and RF wire were then removed, and the cryoballoon catheter was introduced through the FlexCath Advance™ sheath to proceed with pulmonary vein isolation.
Fig. 2.
VersaCross access system.
Supplementary data related to this article can be found online at https://doi.org/10.1016/j.ipej.2026.01.001
The following are the Supplementary data related to this article:
2.2.2. Procedural steps for traditional sheath exchange
In the traditional approach, femoral venous access was obtained and a guidewire [super stiff guidewire, 0.032”, 180 cm] was advanced into the superior vena cava. An 8.5 F Agilis™ NxT transseptal sheath [St. Jude Medical, 71 cm] with dilator [8.5 F, 94 cm] was then advanced over the wire into the superior vena cava, after which the guidewire was removed. A Baylis™ RF transseptal needle [Baylis Medical Company Inc, NRD transseptal needle, large curve C1, 71 cm, 1.3 mm outer diameter] was introduced through the sheath, and the assembly was brought down to the interatrial septum and positioned on the fossa ovalis under standard fluoroscopic and intracardiac echocardiography guidance per operator preference. Transseptal puncture was performed using the RF needle to gain left atrial access. A guidewire was then advanced into the left atrium to secure access, the Agilis™ sheath was withdrawn while maintaining wire position, and the FlexCath Advance™ sheath was advanced and positioned in the left atrium over the wire. The dilator and wire were removed, and the cryoballoon catheter was subsequently introduced through the FlexCath Advance™ sheath to proceed with pulmonary vein isolation (Video 2, simulation).
Supplementary data related to this article can be found online at https://doi.org/10.1016/j.ipej.2026.01.001
The following are the Supplementary data related to this article:
2.3. Data collection and processing
All relevant data from the EMR was extracted, compiled into a secure Excel database, and anonymized. The dataset included patient demographics, comorbidities, procedures, and outcomes. The cleaned and formatted dataset was then imported into STATA 18 (StataCorp, College Station, Texas) for statistical analysis.
2.4. Statistical analysis
Descriptive statistics were used to summarize baseline characteristics and procedural outcomes. Continuous variables were compared using Student's t-tests, while categorical variables were analyzed using chi-square tests. To assess the impact of the transseptal technique on procedural efficiency, unadjusted and adjusted linear regression models were constructed. Covariates included in the adjusted models were age, sex, body mass index (BMI), left ventricular ejection fraction (LVEF), and history of open-heart surgery. A significance threshold of p < 0.05 was used for all statistical tests.
2.5. Outcome measures
The primary outcomes included procedural efficiency, assessed by the time from venous access to transseptal puncture, and safety outcomes, including the incidence of complications such as pericardial effusion, major bleeding, vascular access complications, stroke or transient ischemic attack (TIA), phrenic nerve injury, and esophageal injury. Secondary outcomes included radiation exposure, measured as fluoroscopy time (minutes), and hospitalization metrics, including the length of hospital stay and the proportion of patients discharged on the same day of the procedure.
2.6. Ethical considerations
This study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and approved by the Marshfield Clinic Research Institute Institutional Review Board (IRB) (Approval Number: IRB-24-1562). Given the retrospective nature of the study, the IRB granted a waiver for individual informed consent.
3. Results
3.1. Patient characteristics
A total of 109 patients were included in the study, with 50 patients undergoing the Zero Exchange approach and 59 patients undergoing the Traditional transseptal puncture technique. The baseline characteristics were well-matched between the two groups (Table 1). The mean age was similar in both groups (67.0 ± 10.9 vs. 67.3 ± 11.5 years, p = 0.89), with a slightly higher proportion of male patients in the Traditional group (52 % vs. 62.7 %, p = 0.26). Other cardiovascular risk factors, including body mass index (BMI), history of heart failure, hypertension, diabetes mellitus, chronic kidney disease (CKD), stroke/transient ischemic attack (TIA), and coronary artery disease, were comparable between groups, except for a higher prevalence of CKD in the Zero Exchange group (14 % vs. 11.9 %, p = 0.01). The use of antiarrhythmic drugs, beta-blockers, calcium channel blockers, and renin-angiotensin-aldosterone system inhibitors was similar across groups. Left ventricular ejection fraction (LVEF) was also comparable (58.5 ± 7.8 % vs. 57.1 ± 7.6 %, p = 0.12).
Table 1.
Baseline demographic and clinical characteristics of patients undergoing cryoballoon atrial fibrillation ablation.
| Variable | Zero Exchange (n = 50) | Traditional (n = 59) | p-value |
|---|---|---|---|
| Age, years | 67.0 ± 10.9 | 67.3 ± 11.5 | 0.89 |
| Male, n (%) | 26 (52.0 %) | 37 (62.7 %) | 0.26 |
| BMI | 33.7 ± 6.6 | 33.8 ± 7.4 | 0.90 |
| White, n (%) | 50 (100 %) | 59 (100 %) | – |
| History of heart failure, n (%) | 12 (24.0 %) | 12 (20.0 %) | 0.65 |
| Hypertension, n (%) | 36 (72.0 %) | 38 (64.4 %) | 0.40 |
| Diabetes mellitus, n (%) | 6 (12.0 %) | 19 (32.2 %) | 0.01 |
| CKD, n (%) | 7 (14.0 %) | 7 (11.9 %) | 0.74 |
| Stroke/TIA, n (%) | 3 (6.0 %) | 3 (5.1 %) | 0.84 |
| Coronary artery disease, n (%) | 13 (26.0 %) | 10 (17.0 %) | 0.25 |
| Use of antiarrhythmic drugs, n (%) | 13 (26.0 %) | 18 (30.5 %) | 0.60 |
| Use of beta-blockers, n (%) | 37 (74.0 %) | 49 (83.0 %) | 0.25 |
| Use of diltiazem, n (%) | 10 (20.0 %) | 11 (18.6 %) | 0.86 |
| Use of ACEI/ARB, n (%) | 18 (36.0 %) | 30 (50.9 %) | 0.12 |
| LVEF (%) | 58.5 ± 7.8 | 57.1 ± 7.6 | 0.88 |
| History of open-heart surgery, n (%) | 3 (6.0 %) | 1 (1.7 %) | 0.23 |
| History of PFO, n (%) | 3 (6.0 %) | 1 (1.7 %) | 0.23 |
| History of ASD repair, n (%) | 1 (2.0 %) | 0 (0.0 %) | 0.28 |
Legend: BMI: Body Mass Index, CKD: Chronic Kidney Disease, TIA: Transient Ischemic Attack, CAD: Coronary Artery Disease, ACEI: Angiotensin-Converting Enzyme Inhibitor, ARB: Angiotensin II Receptor Blocker, LVEF: Left Ventricular Ejection Fraction, PFO: Patent Foramen Ovale, ASD: Atrial Septal Defect. Continuous variables are displayed as mean ± standard deviation, and categorical variables as number (%).
3.2. Procedural outcomes
The procedural outcomes, including procedural time metrics, success rates, anticoagulation use, complications, radiation exposure, and hospitalization details, are summarized in Table 2.
Table 2.
Procedural and clinical outcomes by transseptal access technique.
| Outcome | Zero Exchange (n = 50) | Traditional (n = 59) | p-value |
|---|---|---|---|
| Procedural Time Metrics | |||
| Time from Venous Access to Transseptal (min) | 20 ± 9 | 28 ± 12 | <0.01 |
| Time to First Ablation (min) | 36 ± 9 | 48 ± 16 | <0.01 |
| Total Procedure Time (min) | 107 ± 31 | 129 ± 51 | <0.01 |
| Success Rates | |||
| Successful Transseptal Puncture (%) | 50 (100 %) | 59 (100 %) | – |
| Anticoagulation at Time of Procedure | 0.64 | ||
| Eliquis (%) | 31 (62.0 %) | 38 (64.4 %) | – |
| Xarelto (%) | 10 (20.0 %) | 14 (23.7 %) | – |
| Warfarin (%) | 9 (18.0 %) | 7 (11.8 %) | – |
| Complications | – | ||
| Pericardial Effusion (%) | 0 (0.0 %) | 0 (0.0 %) | – |
| Major Bleeding (%) | 0 (0.0 %) | 0 (0.0 %) | – |
| Vascular Access Complications (%) | 0 (0.0 %) | 0 (0.0 %) | – |
| Stroke/TIA (%) | 0 (0.0 %) | 0 (0.0 %) | – |
| Phrenic Nerve Injury (%) | 0 (0.0 %) | 0 (0.0 %) | – |
| Esophageal Injury (%) | 0 (0.0 %) | 0 (0.0 %) | – |
| Radiation Exposure | |||
| Fluoroscopy Time (min) | 8.4 ± 4.0 | 19.9 ± 8.2 | <0.01 |
| Hospitalization | |||
| Same-Day Discharge (%) | 49 (98.0 %) | 57 (96.6 %) | 0.66 |
Legend: TIA: Transient Ischemic Attack, PFO: Patent Foramen Ovale, ASD: Atrial Septal Defect. Continuous variables are displayed as mean ± standard deviation, and categorical variables as number (%).
Successful transseptal puncture was achieved in 100 % of cases in both groups, with no differences in procedural success. There were no major complications reported in either group, including pericardial effusion, major bleeding, vascular access complications, stroke/TIA, phrenic nerve injury, or esophageal injury.
The Zero Exchange technique had 8.23 min less time from venous access to transseptal puncture (p < 0.01), 12.32 min less time to first ablation (p < 0.001), and 22.6 min less total procedure time (p < 0.01) compared to the Traditional technique. After adjusting for age, sex, BMI, ventricular ejection fraction (LVEF), and history of open-heart surgery, the Zero Exchange technique had 8.53 min less time from venous access to transseptal puncture (p < 0.001), 12.61 min less time to first ablation (p < 0.001), and 24.90 min less total procedure time (p = 0.005) compared to the Traditional technique, all of which were statistically significant (Fig. 3).
Fig. 3.
Procedural and Fluoroscopy Times in Atrial Fibrillation Ablation: Zero-Exchange vs. Traditional Transseptal Puncture Techniques.
Fluoroscopy time was significantly reduced in the Zero Exchange group compared to the Traditional approach (8.4 ± 4 min vs. 19.9 ± 8.2 min, p < 0.01). Most patients were discharged on the same day in both groups (98 % vs. 96.6 %, p = 0.66).
4. Discussion
In our study, we demonstrated the feasibility of zero-exchange transseptal access using a large-bore sheath, significantly improving procedural efficiency by reducing the time from venous access to transseptal puncture and balloon delivery. Importantly, this streamlined approach did not increase the risk of complications such as cardiac tamponade, air embolism, TIA, or stroke. To the best of our knowledge, this is one of the first studies comparing the direct use of the FlexCath Advance™ with VersaCross™ RF Wire versus the traditional approach involving the Agilis™ sheath with Baylis RF Needle followed by FlexCath Advance™ exchange. Transseptal puncture has been regarded as a critical step for accessing the left atrium due to its anatomical challenges, including the thin nature of the fossa ovalis, variations in septal anatomy, and the associated risks of complications such as cardiac tamponade, pericardial effusion, and air embolism [2,3]. Increased sheath exchanges during transseptal puncture procedures elevates the risk of air embolism. Kueffer et al. demonstrated that eliminating sheath exchanges by using a direct over-the-needle transseptal access technique can reduce the risk of air embolism, shorten procedure time, and improve safety [4].
Although the Versacross system may incur higher upfront costs compared to traditional tools, the cumulative reduction in procedure duration, fluoroscopy exposure, and manipulation-related risks could offset this through increased case throughput and reduced complication management. A formal cost-effectiveness analysis is warranted in future prospective studies. This reduction benefits both physicians and patients by enhancing safety while maintaining procedural success [5].
Our study supports the adoption of the zero-exchange transseptal technique as a feasible and efficient approach for atrial fibrillation ablation. By eliminating sheath exchanges, this method significantly reduces procedural time, fluoroscopy exposure, and the risk of air embolism, all while maintaining a strong safety profile with no increase in complications.
5. Conclusion
The zero-exchange transseptal technique offers a safe and efficient alternative to traditional multi-sheath methods, significantly reducing procedure times, fluoroscopy exposure, and potential air embolism risk without compromising outcomes.
Data availability statement
The data supporting the findings of this study are available from the corresponding author upon reasonable request and pending Institutional Review Board approval.
Author contributions
Apurva Popat: Study design, data analysis, manuscript writing.
Sweta Yadav: Data acquisition, literature review, critical revisions.
Param Sharma: Supervision, clinical input, manuscript editing.
Weijia Wang: Study oversight, statistical guidance, critical revisions.
All authors have read and approved the final manuscript.
Declaration of competing interest
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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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
The data supporting the findings of this study are available from the corresponding author upon reasonable request and pending Institutional Review Board approval.