Evolution of Radiofrequency Transseptal Puncture Devices

Abstract

Transseptal puncture (TSP) is an indispensable step for establishing left atrial access and plays a pivotal role in complex left-heart interventions, including catheter ablation for atrial fibrillation, left atrial appendage occlusion, and transcatheter mitral valve therapy. As such, TSP ranks among the core techniques in contemporary cardiovascular interventional cardiology. Since its first description in the 1950s, TSP tools have undergone decades of iterative refinement, evolving from conventional mechanical needles to diverse energy-assisted puncture systems. The performance of a TSP system directly determines procedural success, safety, and patient prognosis. This article systematically reviews the developmental history of TSP devices, with a focused overview of the developmental background, technical evolution, clinical applications, and advantages of radiofrequency-based puncture devices (including radiofrequency guidewires and radiofrequency needles), and briefly outlines future directions for innovation.

Introduction

Transseptal puncture (TSP) is a foundational technique that creates a conduit across the interatrial septum to access the left atrium and left ventricle, enabling a wide spectrum of left-heart interventional procedures. Its safety and precision are tightly linked to the success of subsequent interventions and clinical outcomes.1 Ross et al first reported the TSP technique, and the dedicated transseptal needle developed by Brockenbrough et al established the technical basis for conventional mechanical puncture devices.2–4 With the rapid advancement of cardiovascular interventions, particularly the widespread adoption of complex procedures such as atrial fibrillation (AF) ablation, percutaneous balloon mitral valvuloplasty, and transcatheter aortic valve replacement, conventional mechanical needles face substantial limitations in challenging anatomies, including rigid interatrial septa and distorted cardiac structures, leading to greater technical difficulty, lower success rates, and higher complication risks.5–7 In response, energy-assisted puncture technologies have emerged. Among these, radiofrequency puncture (RFP) devices stand out for their superior controllability and high success rates, and are poised to gradually supplant conventional mechanical devices as the first-line tools for clinical transseptal access.5–8

This review systematically traces the evolution of TSP devices, highlights the emergence, technical iteration, and clinical utility of RFP systems, and provides a forward-looking perspective on future trends to inform clinical practice.

General Evolutions of TSP Devices

Development of TSP devices can be categorized into three distinct eras: the conventional mechanical puncture era, the early energy-assisted puncture era, and the modern RFP era (Table 1). Devices in each era differ markedly in design principles, technical characteristics, and clinical performance, with a consistent trajectory toward enhanced safety, accuracy, and procedural efficiency.

Table 1.

Transseptal Puncture Devices

Product Name	Manufacturer	Technology
Brockenbrough Needle.4	Abbott (US)	Sharp-tipped, manual mechanical force
Safesept™ Guidewire.9	Pressure Products, Inc. (US)	J-shaped, manual mechanical force
NRG™ Transseptal Needle.10	Baylis Medical (Canada)	RF energy
VersaCross™ Transseptal System.11	Baylis Medical (Canada)	RF wire + dedicated generator
AccuSafe™ wire.12	Synaptic Medical (China)	Manual mechanical force
RF‑Cross® Transseptal Needle.13	Huiyang Medical (China)	Mechanical + RF dual‑mode

Abbreviation: RF, radiofrequency.

Conventional Mechanical Puncture Devices (1950s–Early 2000s)

Conventional mechanical puncture systems are centered on metal needles that rely on manual force to traverse the interatrial septum, representing the earliest foundation of TSP. In 1959, Ross et al performed the first TSP using a standard needle for left atrial pressure measurement, marking the primitive prototype of transseptal devices.2,3 In 1962, Brockenbrough et al refined the approach with the dedicated Brockenbrough (BRK) needle, which featured a sharp metallic tip and was used in conjunction with a Mullins sheath. This innovation improved stability and success, opened new avenues for left-heart interventions, and became the dominant platform for decades.4

Conventional transseptal needles offer key benefits including simplicity, ease of use, and low cost, making them suitable for most routine cases.8 Technical refinements have further improved success rates in selected settings.14,15 Heinroth et al demonstrated that recognition of atrial electrogram morphology and amplitude changes as the needle advances from the muscular septum to the fossa ovalis (muscular septum: sinus rhythm 6.1±2.3 mV, AF 3.5±0.9 mV; fossa ovalis: sinus rhythm 0.5±0.2 mV, AF 0.5±0.1 mV) aids in optimal target identification.15 Rogers et al introduced the FlexPoint steerable mechanical needle with a deflectable tip, allowing in-sheath directional adjustment to enhance positioning accuracy.16 However, critical limitations of conventional TSP have become apparent with BRK needle expanding clinical demands: success is highly operator-dependent; TSP is frequently difficult or unsuccessful in complex scenarios such as rigid septa, atrial septal aneurysm, and prior cardiac surgery;5,6,17,18 mechanical force cannot be precisely titrated, risking septal perforation, cardiac tamponade, and other severe complications with excessive force, while insufficient force prevents successful crossing;1,5 and post-procedural septal laceration may increase the risk of thrombus formation and air embolism.19,20

Adjunctive puncture tools were also developed in this era, including coronary angioplasty guidewires, which assisted in fossa ovalis targeting and puncture but did not resolve the inherent drawbacks of mechanical force.21,22 The novel puncture guidewire is constructed from nitinol with a sharp tip; after septal crossing, the tip assumes a J-shape in the absence of sheath support, preventing deep myocardial penetration and improving safety.9,23,24 The 0.032‑inch × 230‑cm guidewire, used with a dedicated steerable sheath, also enhances ease of use and success.12,25 These guidewires permit direct transseptal crossing without needle–wire exchange, streamlining workflows for AF ablation, yet have not achieved broad clinical adoption.9,12,15,23,25

Early Energy-Assisted Puncture Devices (Early 2000s–Circa 2010)

Over the past two decades, AF catheter ablation has become the primary driver of increased TSP utilization. As complex left-sided structural interventions have proliferated, the limitations of conventional mechanical devices have become increasingly prohibitive, stimulating research into energy-assisted puncture technologies. Devices in this era were predominantly modifications of conventional mechanical needles, representing the initial shift from purely mechanical puncture to energy-mediated crossing, and laying the groundwork for radiofrequency systems.

The working principle of early energy-assisted devices involves delivery of radiofrequency energy from a surgical electrosurgical generator to the tip of a Brockenbrough needle, inducing thermal coagulation and vaporization of adjacent septal tissue to facilitate controlled left atrial access while minimizing mechanical tissue trauma.26,27 In 2001, Justino et al first reported successful radiofrequency-assisted TSP in a patient with congenital heart disease and a thickened interatrial septum.28 Gordon et al applied electrosurgical radiofrequency energy via a transseptal needle to create atrial access in patients with hypoplastic left heart syndrome and intact atrial septum, establishing the feasibility of this strategy.26 In 2012, Maisano et al extended this technique to TSP for MitraClip^® procedures. Under transesophageal echocardiographic guidance, electrosurgical assistance enabled precise puncture with a 100% success rate and no major adverse events.27

Early radiofrequency-assisted devices partially mitigated the shortcomings of conventional mechanical systems and improved safety and success in complex cardiac anatomies.29 Nevertheless, positioning accuracy remained limited and highly operator-dependent; radiofrequency delivery via standard electrosurgical units was poorly controlled, carrying risks of excessive energy delivery, thrombosis, and extensive tissue damage; furthermore, the procedure required coordinated use of conventional needles and electrosurgical generators, resulting in a cumbersome workflow.20

Modern RFP Devices (2010–Present)

Since 2010, progressive refinement of radiofrequency technology and evolving clinical requirements have driven the maturation of modern RFP systems, which now consist of dedicated radiofrequency guidewires and radiofrequency needles integrated with advanced imaging guidance. The defining breakthrough of this era is the development and clinical implementation of radiofrequency guidewires, which have enabled miniaturization, precision, and integration, and markedly improved the safety, accuracy, and efficiency of TSP.8,30

Modern RFP devices have advanced along two primary pathways: (1) iterative enhancement of radiofrequency guidewires from basic designs to steerable, force-sensing dedicated platforms; and (2) full system integration, combining radiofrequency guidewires, sheaths, and dilators into unified kits to streamline workflows and boost procedural efficiency.30–32

In this era, the clinical indications for RFP devices have expanded dramatically. They are routinely employed for transseptal access in AF ablation and left atrial appendage occlusion, and are increasingly used in challenging anatomies including atrial septal aneurysm, prior atrial septal defect closure, and thoracic deformity.8,33 Radiofrequency devices cross the septum using controlled thermal energy that coagulates tissue at the puncture site and reduces bleeding risk. Compared with conventional mechanical puncture, radiofrequency systems achieve higher success rates, shorter puncture times, and significantly lower risks of tissue laceration, cardiac tamponade, and other complications.19,34–36

Emergence and Evolution of RFP Devices

RFP devices represent the dominant evolutionary trajectory of transseptal tools. Developed to overcome the limitations of conventional mechanical systems, they are on track to become the standard of care in clinical practice.

Development of RFP Needles

RFP needles were the first commercially available radiofrequency transseptal devices and remain the technical foundation of RFP. In 2005, Sherman et al described TSP using a radiofrequency needle, which crossed the septum via thermal energy and reduced the risk of myocardial laceration relative to conventional mechanical needles.37 Crystal et al confirmed the safety and efficacy of radiofrequency needles in preclinical studies, demonstrating minimal tissue injury and no severe complications.10 The radiofrequency transseptal needle incorporates small irrigation side holes proximal to the tip; delivery of 5 W for 2–5 seconds achieves septal crossing in 1–4 pulses. It is especially well-suited for rigid, scarred, or calcified septa, enabling atraumatic crossing without excessive force and reducing the risk of posterior left atrial wall perforation.38,39 Guarguagli et al integrated radiofrequency needles with three-dimensional electroanatomic mapping to enable real-time tip visualization, further enhancing puncture precision.40

Multiple clinical investigations have validated the performance of radiofrequency needles. In 2011, Fromentin et al published a prospective comparison showing higher success and lower complication rates with radiofrequency needles relative to conventional mechanical needles.41 Using propensity-score matching, Tokuda et al found that radiofrequency needles were associated with a significantly lower rate of thromboembolism during AF ablation.19 In a randomized controlled trial, Andrade et al demonstrated that radiofrequency needles for TSP during cryoballoon ablation yielded higher success, shorter procedure times, and fewer complications.42 Radiofrequency needles have also been successfully applied for transcatheter atrial septostomy and Fontan fenestration.39

Although radiofrequency needles address many challenges of complex TSP with conventional mechanical devices, their elevated cost has restricted widespread clinical penetration.36,43

Emergence and Evolution of Radiofrequency Guidewires

Radiofrequency guidewires represent a transformative advance in RFP technology. Engineered to address the remaining limitations of radiofrequency needles, they have enabled miniaturization, precision, and full procedural integration. The evolution of radiofrequency guidewires can be divided into three generations: coronary angioplasty guidewires, dedicated radiofrequency guidewires, and steerable radiofrequency guidewires.

Coronary angioplasty guidewires served as the initial prototype for radiofrequency guidewires. The proximal end was connected to a surgical electrosurgical unit, delivering radiofrequency energy to the tip to create a thermal puncture across the septum. As energy-carrying puncture tools, coronary angioplasty guidewires offered advantages of small caliber, maneuverability, and high success in complex anatomies compared with standard needles.11 However, poor compatibility with standard dilators and sheaths resulted in cumbersome workflows, limiting broad clinical implementation.11,22

Driven by evolving clinical needs, dedicated radiofrequency guidewires have been optimized specifically for TSP. They enable an integrated “puncture–dilation–access” workflow without adjunctive tools, greatly simplifying the procedure. Core features include optimized tip design for uniform energy delivery, matched dedicated sheaths and dilators to form closed systems, and enhanced positional accuracy for a wide range of complex clinical scenarios.30,31,44

The novel radiofrequency guidewire is 0.035 inch in diameter and 230 cm in length, with a discrete electrode design that concentrates radiofrequency energy for precise, atraumatic septal crossing. Used with a dedicated dilator and sheath, it allows direct transseptal access without sheath exchange.30,31 Multiple clinical studies have confirmed its safety and efficacy. Relative to conventional mechanical puncture, radiofrequency guidewire-assisted crossing for left atrial appendage occlusion yields higher success and shorter procedure times.45,46 Popat et al reported that zero-sheath-exchange puncture with this radiofrequency guidewire reduced puncture time by 8.23 minutes, total procedure time by 22.6 minutes, and fluoroscopy time by 11.5 minutes compared with conventional methods, substantially improving the efficiency of AF ablation.31 Whitler et al showed that radiofrequency guidewire systems significantly enhance procedural efficiency and reduce fluoroscopy duration during left atrial appendage closure.47 Compared with electrified bare coronary angioplasty guidewires, this radiofrequency guidewire provides superior electrode design and energy delivery, requiring fewer radiofrequency applications, causing less myocardial injury, and achieving higher puncture accuracy.48 In contrast, electrified bare guidewires demand greater energy delivery, risking device damage and myocardial charring, which may increase the likelihood of thrombosis, thermal injury, or scar formation.11

In 2025, Zeidan et al introduced the SeptalPro force-sensing robotic puncture system. By integrating real-time remote control and force-sensing technology, it continuously monitors peak force during TSP, significantly reducing tissue trauma and improving precision and consistency, particularly for less-experienced operators.49 Laser systems—especially femtosecond lasers—have demonstrated favorable precision and thermal control under defined parameters for TSP, although further investigation is required to characterize underlying mechanisms.50

Furthermore, TSP devices have been integrated with three-dimensional mapping, intracardiac echocardiography, and 3D-printing technologies for precision guidance. Chen et al used unipolar electrogram-based tip localization under three-dimensional mapping guidance to improve puncture accuracy.51 In a propensity-score matched study, Chokesuwattanaskul et al found that ICE-guided puncture shortened procedure duration and lowered complication rates compared with conventional methods.52 Accurate, time-efficient TSP has also been achieved using 3D printing, multiplanar CT reconstruction, and real-time MRI guidance.53,54 Robotic catheter remote control systems have been applied for TSP and endocardial catheter navigation and mapping.55 Transseptal devices are increasingly fused with imaging modalities to enable real-time tip visualization and reduce radiation exposure. They are evolving toward fully integrated platforms that combine radiofrequency needles (guidewires), sheaths, dilators, and radiofrequency generators into unified systems, providing a one-stop “puncture–dilation–access” workflow that markedly streamlines procedures and boosts efficiency.31,49,52,56

Limitations of RFP Devices

Despite their compelling clinical advantages—most notably radiofrequency guidewires—RFP devices have important limitations that warrant further optimization to meet evolving clinical demands. The manufacturing cost of radiofrequency systems is considerably higher than that of conventional mechanical needles, increasing patient financial burden and procedural costs, and limiting adoption in community and primary-care hospitals.30,43 Operation of radiofrequency devices requires specialized training in energy titration and guidewire manipulation, creating a dependency on operator experience and proficiency.1,49 Steerable/force-sensing radiofrequency guidewires and robot-assisted systems, in particular, demand structured training for safe and effective use, restricting broad dissemination.49 Although safety profiles are generally favorable, radiofrequency devices carry residual risks including tissue charring, thrombosis, and air embolism related to energy delivery.20,57 In addition, radiofrequency energy may injure adjacent structures such as the esophagus and coronary arteries, necessitating strict adherence to energy parameters and puncture site selection.20,58

Future Development

Future innovation in radiofrequency TSP devices will center on precision, intelligence, cost-effectiveness, and ultra-miniaturization to further refine device design and workflows and elevate clinical performance. First, intelligent integration: incorporation of artificial intelligence and robotic technologies will enable automated positioning and puncture of radiofrequency guidewires, minimizing human error and reducing operator dependence.31,59 Second, cost reduction: technological advances and scaled manufacturing will lower production costs and facilitate adoption in resource-limited settings.30,43 Third, multi-modal integration: deeper fusion with advanced imaging and three-dimensional mapping systems will enable real-time visualization and closed-loop control, further enhancing safety and accuracy.52,60,61 In addition, large-scale, long-term follow-up studies are needed to establish the long-term safety and effectiveness of radiofrequency devices and generate high-level evidence to support routine clinical adoption.30,31

Conclusion

TSP devices have evolved over several decades from conventional mechanical devices to modern radiofrequency-based systems. Owing to their superior safety, precision, efficiency, and broad adaptability, RFP devices have been increasingly adopted in diverse cardiovascular interventions, including AF ablation, left atrial appendage occlusion, and transcatheter mitral valve interventions. They offer an irreplaceable advantage especially for TSP in patients with complex atrial anatomy.

Although current RFP devices still carry limitations such as relatively high cost and demanding technical requirements, ongoing technological innovation will drive further refinement and optimization, delivering safer, more precise, and more efficient transseptal access solutions for cardiovascular interventional therapy. Moving forward, large-scale clinical investigations and continuous technological innovation are warranted to accelerate the widespread clinical application of RFP devices.

Disclosure

All authors have declared that they have no interests with industry relevant to the contents of this paper to disclose.