Evaluation of Zero-Exchange Transseptal Puncture Devices on Procedural Workflow and Consistency During Left Atrial Appendage Closure

Abstract

Background

Reducing the number of device exchanges during a left atrial appendage (LAA) closure procedure can minimize the risk of injury, air embolism, and thrombus, and optimize procedural workflow. This study compared zero-exchange transseptal puncture (TSP) workflows facilitated by VersaCross Connect (VCC) that integrate directly into WATCHMAN (WM) therapy sheaths (FXD Curve Access [FXD] and TruSteer), with other TSP devices.

Methods

Retrospective chart analysis was performed comparing a radiofrequency needle TSP device, requiring multiple exchanges (NRG, n = 30), requiring at least 1 exchange (VersaCross Large Access, n = 49), to a zero-exchange workflow with VCC paired with WM FXD (VCC-FXD, n = 215), or TruSteer Access (TS) (VCC-TS, n = 78) in terms of time to TSP from procedure start and time to initial WM deployment post-TSP in LAA.

Results

One hundred percent TSP success was achieved in all attempts (n = 372). One reported in-hospital death occurred (1/372, 0.27%, reported as not related to TSP). TSP was similar in all groups. Time to initial WM deployment was significantly improved with zero-exchange devices, as was consistency between cases. Subanalysis of the 2 therapy sheaths integrated to VCC performed similarly in time to TSP time, and to initial WM deployment (VCC-FXD = 8.0 ± 4.0 minutes, VCC-TS = 8.1 ± 4.5; P > .999).

Conclusions

Use of VCC, providing a zero-exchange solution for LAA closure, resulted in an improved workflow and consistency of the first deployment of the WM device in LAA. Integration with FXD or TruSteer sheaths resulted in similar improvements overall.

Introduction

Atrial fibrillation is a major risk factor for cardioembolic stroke.^1,2 In nonvalvular atrial fibrillation, thrombi often originate in the left atrial appendage (LAA).³ Oral anticoagulation with warfarin or direct oral anticoagulants is the first-line therapy for stroke prevention, but many patients cannot tolerate long-term oral anticoagulation due to bleeding. Percutaneous LAA occlusion or left atrial appendage closure (LAAC) has emerged as an important alternative.⁴ By mechanically sealing off the LAA, devices like the WATCHMAN (WM) device (Boston Scientific) reduce stroke risk while allowing cessation of chronic anticoagulation.1, 2, 3, 4

Transseptal puncture (TSP) is a critical step in LAAC procedures, providing access to the left atrium (LA) through the interatrial septum.^5,6 Safe and efficient traversal of the septum is essential for successful device delivery. Traditionally, TSP has been performed with a mechanical needle under fluoroscopic and echocardiographic guidance.^7,8 In recent years, novel radiofrequency (RF) energy-based transseptal systems have been widely adopted for septal crossing^7,9,10 as an alternative to sharp mechanical needles that require force to perforate the septum. The RF transseptal needles, such as the NRG Transseptal Needle (Boston Scientific), apply RF energy at the needle tip to perforate the septum with minimal mechanical force.⁹ By delivering a focused burst of energy, the RF needle can traverse dense septal tissue (“tough septum”) that might resist a mechanical needle.8, 9, 10, 11, 12

In the context of LAAC, precise puncture location (usually inferior-posterior septum) is important to facilitate coaxial alignment of the delivery sheath with the LAA.^11,12 The mechanical needle requires a subsequent exchange over a guide wire to introduce the large delivery sheath into the LA.⁷

The latest advancement in TSP technology is the RF transseptal wire system (eg, Boston Scientific VersaCross),^8,11, 12, 13 which replaces the traditional needle with an RF-tipped guide wire. By combining needle and guide wire functions, it eliminates the need for exchanges, streamlining the procedure. The RF wire significantly reduced transseptal time (median ∼6.9 vs 9.2 minutes; P = .03) and required fewer catheter exchanges, with no difference in success or complication rates.¹⁴ New zero-exchange systems (VersaCross Connect [VCC] with WM FXD Curve Access [FXD] or TruSteer Access [TS], Boston Scientific) further streamline TSP to LAAC delivery.¹² This study aimed to assess the procedural workflow and outcomes from comparing various TSP tools with dedicated RF electrodes in LAAC procedures.

Materials and methods

Study design

A retrospective single center chart review, spanning 5 years (2020-2025) was performed for consecutive LAAC cases using an RF needle (NRG; n = 30; Boston Scientific, 2020-2022), VersaCross Large Access (VLA) TSP system (n = 49; Boston Scientific, 2022-2023), VCC paired with WM FXD (VCC-FXD; n = 215; Boston Scientific, 2023-2024), and VCC paired with WM TruSteer sheath (VCC-TS; n = 78; Boston Scientific, 2024-2025). Figure 1 illustrates the groups based on device pairings. Primary end points evaluated were TSP success and time to TSP, defined as the time from initial femoral access to LA access with needle or RF wire. Secondary end points included the number of TSP devices used, therapy delivery sheath in LA time, initial LAAC device deployment time, overall procedure time, and TSP-related adverse events, defined as pericardial effusions, bleeding or vascular complications, air embolism, aortic puncture, transient ischemic attack—stroke, or device dislodgement (adverse event).

Figure 1.

Study design. Four study groups were reviewed based on the type of transseptal puncture device and left atrial appendage closure (LAAC) implant delivery sheaths. Radiofrequency (RF) needle (NRG; 2020-2022), VersaCross Large Access (VLA) transseptal puncture system (2022-2023), VersaCross Connect (VCC) paired with WATCHMAN FXD Curve Access (FXD) (VCC-FXD; 2023-2024), and VCC paired with WATCHMAN TruSteer Access (TS) (VCC-TS; 2024-2025).

Procedural workflow

All procedures were performed under general anesthesia and guided by fluoroscopy and transesophageal echocardiography. To rule out thrombus, preprocedural transesophageal echocardiography was performed. Vascular access was obtained through the right femoral vein. Patients were anticoagulated with heparin prior to TSP to maintain an activated clotting time ≥300 seconds. The NRG RF needle-based workflow required an introducer guide wire to access and advance the SL1 transseptal sheath and dilator into the superior vena cava (SVC). The guide wire was exchanged for an NRG RF needle to perform TSP. Transseptal location was aimed to ensure coaxial alignment with the LAA ostium, whereby an inferior-posterior position was targeted for most patient anatomies. The RF needle and dilator were then exchanged for a ProTrack pigtail wire (Boston Scientific) to exchange the transseptal sheath for the LAAC therapy delivery sheath (WM FXD or TS, Boston Scientific) into the LA. For wire-based workflows, the 0.035-inch VersaCross RF wire (Boston Scientific) was used to canulate the SVC, tent the septum, perform TSP, and access the LAA. The VersaCross RF wire served as an exchange rail to introduce the WM therapy sheath directly into the LA. Contrast was injected through a pigtail catheter to obtain an LAA angiogram. In all workflows, WM FLX device deployment and release were conducted per standard protocol using the position, anchor, sizing, and seal criteria. After device release, protamine sulfate was administered to neutralize heparin, and venous access was closed with manual compression or a suture-based technique (figure-of-8 or suture-mediated device) to reduce vascular access complications.

Statistical analysis

For descriptive statistics, continuous variables were presented as mean ± SD or median, as appropriate. Categorical variables were presented as percentages. Normal distribution (Shapiro-Wilk test) and variance analysis (F test, calculated to compare variances between groups, assessing whether observed differences in variability [SD] were statistically significant; by evaluating whether the variance in procedure times differed significantly between the groups, the test provides insight into the consistency and operational predictability of each device) were performed and reported for TSP procedural assessment. Categorical significance (ANOVA, Kruskal-Wallis test) was performed as appropriate, using Prism version 10.2.1 (GraphPad Software). A P value of <.05 was considered statistically significant.

Results

Patient baselines

Baseline characteristics for all groups were broadly similar in terms of sex, body mass index, and overall comorbidities, with some exceptions. Coronary artery disease prevalence was lower in the VCC-FXD group (17.2%) compared to all other groups (40.8%-48.1%; P < .001; Table 1). Patients in the NRG group (n = 30) had a statistically significant higher mean CHA₂DS₂-VASc score (5.0 ± 1.3) compared to the VCC-FXD cohort (4.3 ± 1.2; P = .033). No other statistical differences were present between the different groups. Patients were consecutively enrolled for use of each device. There was a single patient death reported in the VCC-FXD group, which was noted to be non–procedure-related.

Table 1.

Patient characteristics.

Characteristics	NRG (n = 30)	VLA (n = 49)	VCC-FXD (n = 215)	VCC-TS (n = 78)	P value
Female sex	40.0%	46.9%	37.2%	39.7%	.659
Age, y	80.3 ± 6.9	80.0 ± 6.8	79.9 ± 8.1	80.9 ± 6.5	.869
Body mass index, kg/m2	27.5 ± 6.1	28.3 ± 5.3	27.1 ± 4.7	27.2 ± 5.1	.526
Diabetes mellitus	30.0%	20.4%	23.3%	20.5%	.731
CAD	43.3%	40.8%	17.2%a	48.1%	<.05
Atrial fibrillation	100%	100%	100%	100%	1.000
Persistent	20%	25%	14%	14%
Paroxysmal	67%	61%	55%	65%
Permanent	13%	14%	31%	21%
CHA2DS2-VASc score	5.0 ± 1.3b	4.3 ± 1.3	4.3 ± 1.2	4.6 ± 1.4	<.05
HAS-BLED score	3.3 ± 1.1	3.0 ± 1.0	3.0 ± 1.0	2.9 ± 0.9	.363

Values are % or mean ± SD.

CAD, coronary artery disease; FXD, FXD Curve Access; TS, TruSteer Access; VCC, VersaCross Connect; VLA, VersaCross Large Access.

^aP value is significant vs VCC-TS.

^bP value is significant vs VCC-FXD.

Workflow analysis

Transseptal puncture success rate was 100% in all groups with the first device used (Table 2). There was a single case of pericardial effusion recorded in the VCC-FXD group (1/215, resolved during procedure; LAAC was successful). There was no statistical difference in the mean time to TSP between all groups (Table 2). However, variance analysis indicated a statistical significance for the NRG group compared to all other groups (Figure 2), reflecting higher consistency between cases in the VLA and VCC device groups compared to the greater variance within the NRG group (SD: NRG = 14.9 minutes vs VLA = 7.5, VCC = 4.7; F test < 0.001). Zero-exchange workflows result in 0 minutes time to sheath in LA from TSP (VCC-FXD = 0.0 ± 0.03 minutes; VCC-TS = 0.0 ± 0.07 minutes, P < .001 compared to NRG and VLA, Table 2).

Table 2.

Procedural workflow assessment.

Procedural characteristics	NRG (n = 30)	VLA (n = 49)	VCC-FXD (n = 215)	VCC-TS (n = 78)	P value
No. of TSP devices used per case	1.0 ± 0.0	1.0 ± 0.0	1.0 ± 0.0	1.0 ± 0.0	1.000
Time to TSP from start, min	17.2 ± 14.9	13.4 ± 7.5	10.9 ± 4.7	12.0 ± 4.7	.084
Time to sheath in LA from start, min	24.6 ± 15.9	17.8 ± 9.0	10.9 ± 4.7	12.0 ± 4.7	P < .001 (NRG:VCC-FXD, NRG:VCC-TS, VLA:VCC-FXD, VLA:VCC-TS)
Time to sheath in LA from TSP, min	6.1 ± 2.9	4.5 ± 5.7	0.0 ± 0.03	0.0 ± 0.07	P < .001 (NRG:VCC-FXD, NRG:VCC-TS, VLA:VCC-FXD, VLA:VCC-TS)
Time to initial device deployment from TSP, min	38.0 ± 24.1	14.0 ± 10.0	8.0 ± 4.0	8.1 ± 4.5	P < .002 (NRG:VLA, NRG:VCC-FXD, NRG:VCC-TS, VLA:VCC-FXD, VLA:VCC-TS)
Overall procedure time, min	65.8 ± 21.4	41.7 ± 17.0	34.3 ± 12.6	37.7 ± 12.6	P < .001 (NRG:VLA, NRG:VCC-FXD, NRG:VCC-TS) P < .012 (VLA:VCC-FXD)
TSP-related adverse event	0	1a	1a	0

Values are mean ± SD. Reported P values are calculated using categorical significance (ANOVA, Kruskal-Wallis’s test), as appropriate.

FXD, FXD Curve Access; LA, left atrium; TS, TruSteer Access; TSP, transseptal puncture; VCC, VersaCross Connect; VLA, VersaCross Large Access.

^aPericardial effusion was reported as resolved at discharge.

Figure 2.

Transseptal puncture (TSP) timepoint. Needle-based TSP device (NRG) results in higher variability of time to achieve TSP (17.2 ± 14.9 minutes) compared to all other study groups (F test < 0.05). Wire-based TSP improved on the consistency of TSP (VersaCross Large Access [VLA] = 13.4 ± 7.5 minutes, F test < 0.05 compared to NRG). Zero-exchange TSP device VersaCross Connect (VCC) results in similar consistency in achieved TSP time, whether paired with FXD Curve Access (FXD) or TruSteer Access (TS) delivery sheaths (SD = 4.7 minutes, P = .374).

Time to initial deployment of the LAAC device was improved in each group from the needle-based TSP (NRG = 38.0 ± 24.1 minutes, P < .002) to wire-based TSP device (VLA = 14.0 ± 10.0 minutes, P < .001) to the integrated systems (VCC-FXD = 8.0 ± 4.0 minutes, P < .001; and VCC-TS = 8.1 ± 4.5 minutes, P < .001, compared to NRG and VLA). Variance analysis showed increased consistency from NRG to VLA to VCC (and no difference between VCC-FXD and VCC-TS, F test, Figure 2). Overall procedure time was significantly improved from needle-based to wire-based TSP devices (NRG = 65.8 ± 21.4 minutes, P < .001 to VLA and VCC), and further improved from nonintegrated system (VLA = 41.7 ± 17.0 minutes, P < .012 to VCC) compared to the fully integrated VCC systems (VCC-FXD = 34.3 ± 12.6 minutes; VCC-TS = 37.7 ± 12.6 minutes, P < .012).

There was no statistical difference in time or variance between the VCC systems, whether integrated into the FXD or TruSteer therapy delivery sheaths (VCC-FXD vs VCC-TS P > .999, F test NS, Figure 3).

Figure 3.

Deployment post-TSP time. Needle-based transseptal puncture (TSP) device (NRG) resulted in significantly longer time in the left atrium post-TSP to achieve initial deployment of the WATCHMAN device in the left atrial appendage (LAA) (38.0 ± 24.1 minutes) compared to VersaCross Large Access (VLA) (14.0 ± 10.0; P < .002) and compared to VCC-FXD (8.0 ± 4.0; P < .001) and VCC-TS (8.1 ± 4.5; P < .001). RF wire-based TSP were more consistent (F test < 0.05) than NRG. Zero-exchange solution VersaCross Connect (VCC), paired with FXD Curve Access (FXD) or TruSteer Access (TS), was more consistent than VLA (F test < 0.05). No statistical differences were observed in terms of the time to initial device deployment or variance between cases performed using VCC-FXD or VCC-TS integrated systems (P > .999, F test NS).

Discussion

This single center retrospective study investigated the differences between TSP workflows performed using RF needle-based and RF wire-based TSP devices, including zero-exchange systems integrating VCC with WM FXD or TruSteer access sheaths. The NRG cohort in the study represented cases performed using an RF needle. Needle-based workflows require a starter guide wire for sheath and dilator placement into the SVC, followed by a guide wire exchange post-TSP. In contrast, the VLA system uses an RF wire that functions as both the puncture tool and guide wire, enabling advancement from femoral access to the LA with fewer exchanges. The VLA also features a larger bore transseptal sheath (outer diameter [OD] = 12.5F vs 8.5F for NRG), which acts as a tapered dilator, facilitating de novo dilation for less force requirement for delivery of large bore catheters post-TSP. Recent research has been published comparing 8.5F and 12.5F TSP device dilators,¹⁵ where it was demonstrated, using bench models, that the 12.5F dilator required less crossing force (N), and less work (mJ), compared to the 8.5F dilator TSP device.

The zero-exchange cohorts of the study utilize the same TSP system, namely the VCC TSP system. This evolution of the TSP workflow allows for the unique ability for the TSP device (RF wire and dilator) to preintegrate into the WM device delivery sheaths (FXD, single or double curve; and TS). The VCC-FXD and VCC-TS cohorts enabled comparison between the older FXD and the newer TS, designed for improved maneuverability and broader anatomical compatibility during LAAC. Approved by the FDA in 2024, TruSteer is compatible with WM FLX and FLX Pro devices. The VCC system integrates seamlessly with both FXD and TS sheaths (inner diameter = 12F), forming zero-exchange systems with OD of 15F (VCC-FXD) and 17F (VCC-TS). This integration enhances workflow efficiency and minimizes risks of injury or air embolism during exchanges. Of note, there was no reported increase in bleeding or vascular complications detected related to the increase in OD at the groin site from 8.5F NRG to 15/17F VCC, and there was no requirement for an additional TSP for any of the cases presented for the duration of the study.

The study assessed the efficacy and time required to achieve various LAAC procedural workflow steps (Table 2). Further analysis included the time to achieve TSP from procedural start at the femoral vein access site to transseptal crossing (Figure 2), and time to achieve initial deployment of the LAAC device post-TSP, including time to navigate toward the LAA, perform imaging assessment, and deliver the WM device into the LAA, prior to disengaging the anchoring wire (Figure 3). TSP times from femoral access to septal crossing were similar across groups (Figure 2), reflecting the efficiency of RF-based puncture devices over mechanical needles.^7,8 However, RF wire technology showed significantly greater consistency in achieving TSP compared to RF needle devices (Figure 2, F test < 0.05). Reduced variability in TSP times with VLA and VCC devices vs NRG (Figure 4) highlights the benefit of eliminating the starter wire and needle exchanges.

Figure 4.

Study summary. (A) Steps to transseptal puncture (TSP). Radiofrequency (RF) needle (NRG) requires 6 steps to achieve TSP, whereas RF wire-based devices (VersaCross Large Access [VLA], VersaCross Connect [VCC] paired with FXD Curve Access [FXD] or TruSteer Access [TS] sheath) require 4 steps, eliminating an exchange and the need for a guide wire acting as a starter wire to rail in the device from the femoral vein access site into the right atrium. (B) After the TSP, NRG requires an additional 6 steps to achieve the first deployment of the WATCHMAN device, whereas VLA requires 4 steps, eliminating an exchange for a guide wire to use in the left atrium. VCC paired with either FXD or TS sheaths requires only 2 steps post-TSP to achieve deployment of the WATCHMAN device in the left atrial appendage, providing a true zero-exchange workflow from femoral access to left atrial appendage closure (LAAC).

In LAAC procedures, precise TSP location is critical for optimal sheath alignment with the LAA. The VC RF wire enhances control by allowing easy repositioning—such as pulling back into the SVC to optimize septal drop-down—while also serving as an exchange wire. Its 24 mm atraumatic pigtail tip enables safe navigation and anchoring in the LAA. In the VCC workflow, the therapy sheath doubles as the transseptal sheath, enabling a true zero-exchange setup when preassembled with the RF wire. This integration improves efficiency, with significantly faster device deployment times compared to RF needle and earlier RF wire systems (NRG = 38 ± 24 minutes; VLA = 14 ± 10 minutes; VCC-FXD = 8 ± 4 minutes; VCC-TS = 8.1 ± 4.5 minutes; P < .001 vs NRG/VLA). VCC devices performed equivalently with FXD and TruSteer sheaths (Figure 3, P > .999).

The use of zero-exchange access systems, such as the VCC, may offer meaningful procedural advantages in the LAAC procedures, particularly as clinical practice continues to evolve toward streamlined, minimally invasive workflows. The 2025 SCAI/HRS guidelines¹⁶ emphasize the growing procedural volume of LAAC and the importance of reducing complexity and resource demands, especially as same-day discharge becomes more common. By consolidating transseptal access and guide wire exchange into a single platform, zero-exchange systems reduce procedural time and may lower the risk of complications associated with multiple device manipulations, and ease the operational burden on clinical teams. These efficiencies may be especially relevant in high-throughput or resource-limited environments, where optimizing workflow and minimizing reliance on ancillary equipment and personnel are critical to maintaining quality and scalability. Although further data are needed to quantify these benefits, the integration of such technologies aligns with the broader goals of enhancing safety, consistency, and accessibility in LAAC procedures.

Limitations

This study is a retrospective analysis from a single center with high LAAC volume and 6 experienced operators. Three implanters were electrophysiologists, and 3 were interventional cardiologists. It is not known whether the results of this study would translate to less experienced operators or centers. Additional studies are required to confirm results. The number of cases included in this study is not powered for safety. Fluoroscopy measurements were not assessed in this study due to data availability. Observations from this study may not be generalizable to all patients determined eligible for LAAC. Confounding factors include accumulated operator experience, and other nonmeasurable factors may have contributed to observed improvements in procedural steps and time.

Conclusion

The use of optimized RF transseptal tools has been shown to enable effective and predictable left atrial access to simplify LAAC procedures. Predictability is especially important in the absence of preprocedural imaging and with the increasing number of patients with scarred septa from previous LA catheterization. This study demonstrated that a zero-exchange approach using the VCC system resulted in a more improved workflow and consistency of the first deployment of the WM device in LAA (Central Illustration). Integration of VCC with the WM FXD or with TruSteer sheaths resulted in similar improvements overall.

Central Illustration.

Transseptal device workflow differences between radiofrequency needle, wire with large bore dilator, fixed curve integrated transseptal device, and left atrial appendage closure (LAAC) device delivery sheath, and transseptal device integrated into steerable LAAC device delivery sheath. FXD, FXD Curve Access; TS, TruSteer Access; VCC, VersaCross Connect; VLA, VersaCross Large Access.