Radiofrequency Needle Research Articles

Discogenic chronic low back pain management: intradiscal radiofrequency biacuplasty versus conservative treatment

BackgroundThis prospective bicentric study aims to evaluate and compare the efficacy of intradiscal radiofrequency biacuplasty (IDB) versus conservative management (CM) in treating chronic discogenic low back pain (CDLBP).MethodsForty-four patients with CDLBP were randomly assigned to either the biacuplasty group or the conservative management group. The biacuplasty group received treatment with two radiofrequency (RF) needles, positioned bilaterally on the annulus fibrosus under fluoroscopic guidance and local anaesthesia, to administer bipolar RF. Patients were monitored for 6 months, with the allowance of pain medication as needed. In the conservative management group, patients who continued to experience low back pain after three months were permitted to switch to the biacuplasty group. The study was conducted over two years, starting on July 1, 2020.ResultsThe studied groups had comparable age and gender distributions, with no significant difference in BMI. The Oswestry Disability Index (ODI) was assessed at baseline, 1 month, 3 months, and 6 months. At baseline, no significant difference was observed between the groups (p = 0.263). However, at the 1-month, 3-month, and 6-month follow-up, the biacuplasty group exhibited significantly lower ODI scores compared to the conservative management group (all p < 0.001), indicating that biacuplasty was more effective in reducing disability caused by chronic low back pain.ConclusionsIntradiscal radiofrequency biacuplasty is a minimally invasive interventional technique that has proven effective for patients with CDLBP who do not respond to conservative management.

Long-term effects of conventional radiofrequency in cases of trigeminal neuralgia

Objective: Trigeminal neuralgia (TN) is defined as severe, episodic pain occurring in one or more branches of the trigeminal nerve. Due to its long-term effect, radiofrequency thermocoagulation (RFT) is used as a first-line treatment. The first choice in the treatment of classical trigeminal neuralgia patients is medical treatment. Additionally, pregabalin and gabapentin are frequently used drugs. Surgical treatment is an option for Trigeminal Neuralgia that cannot be treated with medication, but there is no single method for this. Various surgical methods, such as Trigeminal Radiofrequency (RF) rhizotomy may be effective in treatment. Material and metods: The procedure is performed under operating room conditions and radiological imaging guidance. The patient is placed in the supine position, an IV line is established, and monitoring is initiated. After local field cleaning and sterile draping, optimal imaging is achieved using C-arm fluoroscopy with an ipsilateral 15° oblique and 30° caudal angle. A 22-gauge, 100 mm RF needle with a 5 mm active tip is directed towards the foramen ovale, and the tunnel view is checked. Results: In our study, the minimum age was 41 and the maximum age was 68. Additionally, 9 of the patients were female, and 2 were male. In our series, 9 patients had mandibular nerve involvement, and 2 had maxillary nerve involvement. In our series, 6 patients were using carbamazepine, 4 were using pregabalin, and 1 was using gabapentin. Medication treatment was discontinued in all patients after the procedure. As shown in Table 1, the VAS score decreased to 0 in 6 patients on the 15th day, to 2 in 4 patients, and to 1 in 1 patient. The VAS score exceeded 5 in 1 patient in the 2nd year and in 5 patients in the 4th year, and conventional RFT was repeated for these patients. The VAS score decreased to 0 in 6 patients on the 15th day, to 2 in 4 patients, and to 1 in 1 patient. The VAS score exceeded 5 in 1 patient in the 2nd year and in 5 patients in the 4th year, and conventional RFT was repeated for these patients. Pregabalin 75 mg was started for all patients between the recurrence of pain and the interventional procedure, and it was discontinued once the pain decreased after the procedure. No side effects were observed in the patients. Conclusion: The treatment of trigeminal neuralgia includes medical, surgical, and percutaneous interventional options. Conventional RF thermocoagulation is the first choice among other percutaneous interventional and surgical treatment options in TN treatment due to its selective lesion formation, minimally invasive nature, high success rate, low complication rate, and low cost.

Influence of the radiofrequency applicators arrangement on the sizes of ablative zones inside hepatic tumor

Radiofrequency (RF) ablation is a popular therapeutic technique for heating solid tumors that are medically unsuitable for resection or other treatments. Thermal ablation applicators create high-frequency electromagnetic fields (EMFs) within the tumor site, which causes heating, coagulation, and ultimately death of the cancer cells. The aim of this study is the numerical analysis of the temperature distributions, ablation zones, and specific absorption rates (SAR) during RF ablation in relation to an ellipsoidal shaped tumor placed in the model of liver tissue. The source of heat is a three-element system of RF needle applicators operating at a frequency 100 kHz, with a given electrode potential, inserted into the tumor. In order to obtain an appropriate temperature distribution in the target area, the Laplace equation coupled with the Pennes equation were solved using the finite element method (FEM). The arrangement effect of three needle-type applicators on the resultant thermal profiles and the volumes of ablation zones were analyzed and compared. In addition, the ablation zones for various angles of the RF applicator placed in the center of the tumor were analyzed. The paper shows that in order to control temperature distribution and ablation zones the proposed system of RF applicators and the arrangement of electrodes can be successfully applied in hepatocellular carcinoma treatment.

Effectiveness of combining greater occipital nerve block and pulsed radiofrequency treatment in patients with chronic migraine: a double-blind, randomized controlled trial

BackgroundPulsed radiofrequency (PRF) treatment targeting the greater occipital nerve (GON) has shown efficacy in treating various conditions. This double-blind, randomized controlled study aimed to evaluate the effects of combining PRF therapy with GON block (GONB) therapy in patients with chronic migraine.MethodsThe study consisted of two groups: GONB and GONB + PRF, each comprising 16 patients with chronic migraine. Using 0.5-Hz sensorial stimulation, a 5-cm-long radiofrequency needle was inserted under ultrasound guidance in both groups. Subsequently, all patients received a GONB by administering 2 mL of 0.25% bupivacaine. In the GONB + PRF group, patients underwent 4 min of PRF at 42℃, whereas the GONB group did not receive any PRF treatment. Follow-up examinations were performed at 1, 2, 3 and 6 months after the procedure to evaluate the frequency and severity of migraine attacks, number of headache days, and analgesic consumption.ResultsIn the GONB + PRF group, the visual analog scale (VAS) score, number of migraine attacks, number of headache days, and analgesic consumption were significantly lower compared to the GONB group (P < 0.05). Significant decreases (60%) in mean VAS scores, number of migraine attacks, number of headache days, and consumption of analgesic medications were observed in the GONB + PRF group at the 1-, 2-, 3-, and 6-month follow-ups compared with the pre-treatment period (P < 0.05).ConclusionsThe combination of GONB and PRF presents a promising new treatment option for patients with chronic migraine. This approach has demonstrated efficacy in minimizing analgesic use, decreasing the frequency of migraine attacks, reducing the number of headache days and decreasing the severity of migraine attacks.Trial RegistrationNCT05464212.

First-in-human: Leaflet laceration with balloon mediated annihilation to prevent coronary obstruction with radiofrequency needle (LLAMACORN) for valve-in-valve transcatheter aortic valve replacement.

Coronary obstruction (CO) is a potential pitfall for transcatheter aortic valve replacement (TAVR), especially in valve in valve procedures into degenerated surgical or transcatheter prostheses. Bioprosthetic leaflet modification techniques that incorporate electrosurgery are evolving as the preferred strategy to mitigate the risk of CO in high CO risk settings. The UNICORN method is proposed as a more predictable leaflet modification strategy than the earlier described BASILICA approach, but its proponents have hitherto mandated the use of a balloon-expandable valve (BEV) prosthesis. Many patients have small prostheses and therein face a significant risk of patient prosthesis mismatch with BEV in this setting. This risk may be curtailed if a self-expanding valve (SEV) prosthesis could be used. Herein described is a modified approach to allow for the utilization of SEV systems in this setting.

Clinical outcomes of radiofrequency ablation using a radiofrequency needle device for varicose ulcer: A non-randomized controlled prospective study.

To evaluate the short-term clinical outcomes of radiofrequency ablation (RFA) using a radiofrequency (RF) needle device for varicose ulcers. From September 2020 to September 2021, a total of 80 patients with varicose ulcers were included in this study. Based on the different surgical methods, the patients were divided into RF group and control groups, with 40 cases in each group. In the RF group, RFA was performed using an RF needle device and foam sclerotherapy was used for superficial veins. The control group was treated with conventional high-ligation stripping. The surgical data, hospitalization data, clinical efficacy, and postoperative complications of two groups were compared. Meanwhile, the correlation between RBC, HB, HCT, and ulcer healing time was analyzed. Compared to the control group, RF group had shorter surgery time, duration in the hospital, and less intraoperative bleeding (p < .05). The VCSS and CIVIQ scores in RF group were significantly higher than that in control group (p < .05). The healing time of ulcers was shorter in the RF group (x2 = 19.766, p = .000). The RF group had fewer postoperative complications. There was a positive correlation between RBC, HB, and HCT, and ulcer healing time (p < .05). The use of the RF needle device for RFA to treat patients with varicose ulcers showed acceptable short-term clinical outcomes with less incidence of trauma, faster recovery, and fewer complications.

Sacroiliac Joint Denervation-A Novel Approach to Target Sacral Lateral Branches: A Practical Approach.

Sacroiliac joint (SIJ) pain is a relatively common cause of low back pain. Percutaneous radiofrequency (RF) techniques for SIJ are limited to ablation of the posterior SIJ innervation. Different techniques have been described for SIJ radiofrequency ablation, including conventional thermal, cooled RF, pulsed RF, bipolar RF, and specialized tip RF needle (i.e., multi-tined); however, additional costs may limit these applications. This new technique for SIJ denervation uses anatomical landmarks and a single RF cannula. Two spinal needles are placed lateral to the posterior S1 and S2 sacral foramina; then, with caudal tilt we get a coaxial view of the sacral bone, we advance an 18-G curved 15-mm active tip RF cannula just lateral to the aligned finder needles. Ablation is performed, and then the RF cannula is retracted 2cm and ablation is repeated for a total of four lesions. The two spinal needles placed lateral to the posterior sacral foramina S1 and S2 guide the final needle in the posterior aspect of the sacrum, lateral to the sacral foramina, where the lateral sacral branches are located. We introduce a cost and time efficient technique to perform radiofrequency ablation of the sacral lateral branches using a single RF needle. This technique utilizes the sacrum's reliable anatomy and angulation and maximizes the surface area of the active tip lesioning. This technique creates a strip lesion lateral to the sacral foramina and reduces time and cost efficacy compared to several of the other techniques and/or commercially available special devices designed for sacroiliac denervation.

Development of an ultrasound-guided radiofrequency ablation technique in the equine cadaveric distal limb: histological findings and potential for treating chronic lameness.

Radiofrequency (RF) relieves chronic pain in humans, but it is unexplored in horses affected by chronic lameness. This study aims to describe the technique and the histological effects of ultrasound (US)-guided radiofrequency ablation (RFA) of palmar digital nerves (PDNs) in horse's fetlock and pastern, ex vivo. After assessing the US anatomy of lateral and medial PDNs in fetlock and pastern in vivo (n = 10 horses; 20 forelimbs), US-guided RFA was performed on these sites in cadaveric forelimbs (n = 10) applying four different settings with increasing invasiveness (n = 40 total treatments): 60°C, 6 min (GROUP LOW); 70°C, 4 min (GROUP MEDIUM); 90°C, 2 min (GROUP HIGH); 80°C, 8 min (GROUP VERY HIGH). Needle-tip-to-nerve proximity was assessed with US and methylene blue, injected through the port of the RF needle. Nerves were collected for microscopical assessment. Transverse palmaro-lateral and palmaro-medial US images of fetlock and pastern detected PDNs consistently, close to the palmar digital artery. With in-plane US technique, RFA was performed at target in 31/40 cases, with significantly higher number of failures in fetlock (p = 0.008). PDNs histology identified thermal injury/coagulation with axonal degeneration and collagen homogenation. Nuclear smearing of arterial leyomyocytes was also observed. Nerve coagulation was significantly associated with treatment (p = 0.03) and needle-tip-to-nerve proximity (US distance: p = 0.009; blue distance: p = 0.04). The PDNs were easily visualized and reached with the RF needle by US in-plane-guided technique. RFA produced axonal thermal damage and intensity-related coagulation effectiveness. To ensure effective nerve coagulation, it is crucial that the needle is accurately positioned in close proximity to the target nerve. Based on the histopathological findings, HIGH and VERY HIGH RFA treatments might be worth of being tested in vivo in clinical studies aimed at treating chronic lameness of the distal forelimb in horses.

A Randomized, Split-Face, Comparative Study of a Combined Needle Radiofrequency/Intense Pulsed Light Device in Moderate-to-Severe Acne Patients.

Radiofrequency (RF) and intense pulsed light (IPL) have been reported as efficient adjuvant treatment modalities for acne vulgaris. We sought to evaluate the clinical efficacy and safety of a combined needle RF and vacuum IPL device for acne treatment without the use of other conventional topical or oral agents. This randomized, split-faced study was designed to include patients with moderate to severe acne vulgaris. Comedone extraction was performed on both parts of the face prior to laser treatment. One side of the face was treated with RF and IPL in 2-week intervals, while the other side was left untreated as a control. Two independent blinded investigators evaluated the patients for improvement using clinical photographs. We also assessed for possible adverse effects. The study included 44 patients with acne vulgaris (27 men and 17 women). Their ages ranged from 19-39 years (average, 23 years). At the final 12-week follow-up visit, the acne reduction rate was 34.80% (±33.45%; range, 30.92%-19.03%) on the treated side and 13.76% (±37.58%; range, 28.26%-23.27%) in the control group compared to baseline, constituting a significant difference. The difference in reduction rate between the treated and control sides was 21.03% (±25.09%), with the treated side experiencing more significant improvement (p<0.05). In the assessment of adverse events, one patient experienced mild surrounding erythema that spontaneously improved. Combined treatment of needle RF and IPL could improve acne lesions.

Noninvasive treatment of cutaneous neurofibromas (cNFs): Results of a randomized prospective, direct comparison of four methods

BackgroundPeople with Neurofibromatosis Type 1 (NF1) suffer disfigurement and pain when hundreds to thousands of cutaneous neurofibromas (cNFs) appear and grow throughout life. Surgical removal of cNFs under anesthesia is the only standard therapy, leaving surgical scars. ObjectiveEffective, minimally-invasive, safe, rapid, tolerable treatment(s) of small cNFs that may prevent tumor progression. MethodsSafety, tolerability, and efficacy of four different treatments were compared in 309, 2-4mm cNFs across 19 adults with Fitzpatrick skin types (FST) I-IV: radiofrequency (RF) needle coagulation, 755nm alexandrite laser with suction, 980nm diode laser, and intratumoral injection of 10mg/mL deoxycholate. Regional pain, clinical responses, tumor height and volume (by 3D photography) were assessed before, 3 and 6 months post-treatment. Biopsies were obtained electively at 3 months. ResultsThere was no scarring or adverse events >grade 2. Each modality significantly (p<0.05) reduced or cleared cNFs, with large variation between tumors and participants. Alexandrite laser and deoxycholate were fast and least painful; 980nm laser was most painful. Growth of cNFs was not stimulated by treatment(s) based on height and volume values at 3 and 6 months compared to baseline. LimitationsIntervention was a single treatment session; dosimetry has not been optimized. ConclusionsSmall cNFs can be rapidly and safely treated without surgery.

Improved left atrial catheterization efficiency and consistency using a novel steerable transseptal puncture sheath

BackgroundWhile steerable sheaths are widely used to improve catheter stability and contact force during radiofrequency (RF) catheter ablation in patients with atrial fibrillation (AF), steerable sheaths are less commonly used during transseptal puncture. This study evaluated whether left atrial catheterization efficiency can be improved using the VersaCross combined steerable sheath and transseptal system compared to previous standard workflow. MethodsThis study retrospectively analyzed AF ablation performed using the VersaCross Workflow consisting of VersaCross steerable sheath and RF wire for transseptal puncture and catheter ablation (VCW) to the standard workflow using a fixed curve sheath with RF needle followed by exchange for an Agilis steerable sheath for catheter ablation (STW). ResultsThirty patients underwent RF ablation for paroxysmal or persistent AF, 15 using the VCW and 15 using the STW. Transseptal puncture time was 10.8 mins faster with the VCW compared to the standard workflow (20.9 ± 5.9 min vs. 31.7 ± 15.1 min; p = 0.024). Time to left atrial catheterization was 40% faster with the VCW compared to the STW (21.3 ± 5.8 min vs. 35.2 ± 14.4 min; p = 0.003). Overall procedure time was 14.2 min faster in the VCW compared to the STW (86.3 ± 16.1 min vs. 100.5 ± 19.3 min; p = 0.044). ConclusionsUse of the VersaCross steerable system significantly reduced time to transseptal puncture, time to left atrial catheterization, and overall RF ablation time.

Optimization of Radiofrequency Needle Placement in Percutaneous Cordotomy Using Electromyography in the Deeply Sedated Patient.

Cordotomy, the selective disconnection of the nociceptive fibers in the spinothalamic tract, is used to provide pain palliation to oncological patients suffering from intractable cancer-related pain. Cordotomies are commonly performed using a cervical (C1-2) percutaneous approach under imaging guidance and require patients' cooperation to functionally localize the spinothalamic tract. This can be challenging in patients suffering from extreme pain. It has recently been demonstrated that intraoperative neurophysiology monitoring by electromyography may aid in safe lesion positioning. The aim of this study was to evaluate the role of compound muscle action potential (CMAP) in deeply sedated patients undergoing percutaneous cervical cordotomy (PCC). A retrospective analysis was conducted of all patients who underwent percutaneous cordotomy while deeply sedated between January 2019 and November 2022 in 2 academic centers. The operative report, neuromonitoring logs, and clinical medical records were evaluated. Eleven patients underwent PCC under deep sedation. In all patients, the final motor assessment prior to ablation was done using the electrophysiological criterion alone. The median threshold for evoking CMAP activity at the lesion site was 0.9 V ranging between 0.5 and 1.5 V (average 1 V ± 0.34 V SD). An immediate, substantial decrease in pain was observed in 9 patients. The median pain scores (Numeric Rating Scale) decreased from 10 preoperatively (range 8-10) to a median 0 (range 0-10) immediately after surgery. None of our patients developed motor deficits. CMAP-guided PCC may be feasible in deeply sedated patients without added risk to postoperative motor function. This technique should be considered in a group of patients who are not able to undergo awake PCC.

Feasibility, efficacy, and safety of intracardiac echocardiography guided transseptal puncture: a single-center retrospective study

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Transseptal puncture (TSP) is routinely performed to gain access into the left atrium for left-sided arrhythmias. Although fluoroscopy is mainly used for visualization of TSP, intracardiac echocardiography has been increasingly used to visualize the TSP. However, the available data to support routine use of ICE for visualization is scarce, particularly for pediatric patients and patients with cardiac implantable electronic devices (CIED). Purpose The purpose of this single-center retrospective study was to evaluate feasibility, efficacy, and safety of ICE guided TSP, also including pediatric patients and patients with CIED. Methods In this retrospective study, we analyzed consecutive patients who underwent ICE guided TSP from July 2014 to December 2021. When TSP was performed in patients with CIED, the device´s parameters were tested before and after the procedure. Adverse events (AE) were classified as those that were directly associated with the TSP and those who might be associated with the TSP. All AE either required an intervention, prolonged hospital stay, or had a negative impact on patient´s health. Results The study included 1360 consecutive patients (44.6% (607/1360) male; mean age 59.1 ± 15.6 years; mean BMI 28.1 ± 5.0 kg/m2), 4.3% (59/1360) of patients were pediatric (the youngest was 4 years old and weighed 17 kg) and 8.9% had a CIED (121/1360 – 56.2% (68/121) single chamber; 33.1% (40/121) dual chamber; 10.7% (13/121) resynchronization device). In majority, atrial fibrillation or atypical atrial flutter were the main indication for TSP (75.4%; 1062/1360), followed by ventricular tachycardia (9.4%; 128/1360), ventricular preexcitation (8.8%; 120/1360), and atrial tachycardia (3.5%; 47/1360). A total of 1839 punctures were performed (64.3% (875/1360) single TSP; 35.7% (485/1360) double TSP). Only in two patients (0.14%; 2/1360) the TSP was initially not possible. In one, it was later performed with radiofrequency needle. In total, there were 0.7% (13/1839) of AE. Two events (0.11%; 2/1839) were directly associated with the TSP. In one patient, a tamponade occurred immediately after a double TSP. In another patient with a dual chamber CIED, the ventricular lead was dislocated during the maneuvering of the TSP assembly. The other 11 events (0.6%; 11/1839 - 2 late tamponades and 9 pericardial effusions) could be associated with the TSP, however, they could also be associated with ablations or maneuvering of the catheters. In patients with CIED, there were 3 AE (2.1%; 3/144) – 1 AE was directly associated with the TSP (ventricular lead dislocation described above) and 2 AE which might be associated with the TSP (1 late tamponade and 1 pericardial effusion). There were no AE (0.0%; 0/60) in pediatric patients. Conclusion ICE guided TSP is an effective and safe method for obtaining left atrial access in adult and pediatric patients. Special care should be given to patients with CIED as lead dislocation is possible.

Successful ablation of atrial fibrillation in a patient with a highly calcified septum after an atrial septal defect operation.

Successful ablation of atrial fibrillation in a patient with a highly calcified septum after an atrial septal defect operation.

Improved left atrial appendage closure procedural efficiency using radiofrequency transseptal wire system.

The radiofrequency(RF) needle has been shown to improve transseptal puncture efficiency and safety compared to mechanical needles. This study aimed to investigate the use of VersaCross RF transseptal wire system (Baylis Medical) to improve procedural efficiency of left atrial appendage closure (LAAC) compared to the standard RF needle-based workflow. Eighty-one LAAC procedures using WATCHMAN FLX were retrospectively analyzed comparing the standard RF needle-based workflow to a RF wire-based workflow. Study primary endpoint was time to WATCHMAN device release, and secondary endpoints were transseptal puncture time, LAAC success, fluoroscopy use, and procedural complications. Twenty-five cases using standard RF needle-based workflow were compared to 56 cases using the RF wire-based workflow. Baseline patient characteristics were similar between both groups. LAAC was successful in all patients with no differences in intraprocedural complication rates (p = 0.40). Transseptal puncture time was 1.3 min faster using the RF wire-based workflow compared to the standard RF needle-based workflow (6.5 ± 2.3 vs. 7.8 ± 2.3 min, p = 0.02). Overall, time to final WATCHMAN device release was 4.5 min faster with the RF wire-based workflow compared to the RF needle-based workflow (24.6 ± 5.6vs. 29.1 ± 9.6 min, p = 0.01). Fluoroscopy time was 21% lower using the RF wire-based workflow (7.6 ± 2.8vs. 9.6 ± 4.4 min; p = 0.05) and fluoroscopy dose was 67% lower (47.1 ± 35.3vs. 144.9 ± 156.9 mGy, p = 0.04) and more consistent (F-test, p ˂ 0.0001). The RF wire-based workflow streamlines LAAC procedures, improving LAAC efficiency and safety by reducing fluoroscopy, device exchanges, and delivery sheath manipulation.

Randomized Comparison of a Radiofrequency Wire Versus a Radiofrequency Needle System for Transseptal Puncture

BackgroundTransseptal puncture is a necessary component of many electrophysiology and structural heart procedures. Improving this technique has broad ramifications for the overall efficiency and safety of these interventions. A new technology uses a specialized introducer wire to cross the septum with radiofrequency (RF) energy, eliminating the need for a transseptal needle and wire/needle exchanges. ObjectivesThis study sought to compare the efficacy and safety of an RF needle versus RF wire approach for transseptal puncture. MethodsIndividuals ≥18 years of age undergoing double transseptal puncture for atrial fibrillation or left atrial flutter ablation were randomized to a transseptal approach with either an RF needle or RF wire. The primary outcome was time to achieve first transseptal puncture. Secondary outcomes included second and combined transseptal puncture time, fluoroscopy time, number of equipment exchanges, and complications. ResultsA total of 75 participants were enrolled (36 RF needle, 39 RF wire). No crossovers occurred. Randomization to the RF wire resulted in a significant reduction in first transseptal time compared with the RF needle (median 9.2 [IQR: 5.7-11.2] minutes vs 6.9 [IQR: 5.2-8.4] minutes, P = 0.03). Second and combined transseptal times, and number of equipment exchanges, were also reduced with the RF wire. One participant in the RF needle group experienced transient atrioventricular block due to mechanical trauma from the sheath/dilator assembly. There were no complications in the RF wire group. ConclusionsThe RF wire technique resulted in faster time to transseptal puncture and fewer equipment exchanges compared with an RF needle with no difference in complications.

Abstract 9803: Randomized Comparison of a Radiofrequency Wire versus a Radiofrequency Needle System for Transseptal Puncture

Introduction: Transseptal puncture is a necessary component of many electrophysiology and structural heart procedures. A new technology utilizes a specialized introducer wire to cross the septum with radiofrequency (RF) energy, eliminating the need for a transseptal needle and wire/needle exchanges. The RF wire technique, however, has not been evaluated in a randomized trial. Methods: The Wire Instrumentation with Radiofrequency Energy to Impact Transseptal puncture (WIRE IT, NCT04645342) study was an investigator-initiated and designed trial that enrolled individuals ≥18 years of age undergoing double transseptal puncture for atrial fibrillation or left atrial flutter ablation. Participants were randomized to a transseptal approach with either a RF needle (NRG Transseptal Needle, Baylis Medical) or RF wire (Versacross RF Wire, Baylis Medical). The primary outcome was time to achieve first transseptal puncture. Timing was started at insertion of the guidewire into the short femoral vein sheath and was stopped once the transseptal sheath was positioned in the left atrium and the dilator and guidewire were removed. Secondary outcomes included second and combined transseptal puncture time, fluoroscopy time, number of equipment exchanges, and complications. Results: A total of 75 participants were enrolled between November 30, 2020 and February 2, 2022 (36 RF needle, 39 RF wire). No crossovers occurred. Randomization to the RF wire resulted in a statistically significant reduction in first transseptal time compared to the RF needle (Figure). Second and combined transseptal times and number of equipment exchanges were also reduced with the RF wire. One participant in the RF needle group experienced transient AV block due to mechanical trauma. There were no complications in the RF wire group. Conclusions: The RF wire technique resulted in faster time to transseptal puncture and fewer equipment exchanges compared to an RF needle with no difference in complications.

First-in-Human Undermining Iatrogenic Coronary Obstruction With Radiofrequency Needle (UNICORN) Procedure During Valve-in-Valve Transcatheter Aortic Valve Replacement.

First-in-Human Undermining Iatrogenic Coronary Obstruction With Radiofrequency Needle (UNICORN) Procedure During Valve-in-Valve Transcatheter Aortic Valve Replacement.

A point source model to represent heat distribution without calculating the Joule heat during radiofrequency ablation

Numerous liver cancer oncologists suggest bridging therapies to limit cancer growth until donors are available. Interventional radiology including radiofrequency ablation (RFA) is one such bridging therapy. This locoregional therapy aims to produce an optimal amount of heat to kill cancer cells, where the heat is produced by a radiofrequency (RF) needle. Less experienced Interventional Radiologists (IRs) require a software-assisted smart solution to predict the optimal heat distribution as both overkilling and untreated cancer cells are problematic treatments. Therefore, two of the big three partial differential equations, 1) heat equation (Pennes, Journal of Applied Physiology, 1948, 1, 93–122) to predict the heat distribution and 2) Laplace equation (Prakash, Open Biomed. Eng. J., 2010, 4, 27–38) for electric potential along with different cell death models (O’Neill et al., Ann. Biomed. Eng., 2011, 39, 570–579) are widely used in the last three decades. However, solving two differential equations and a cell death model is computationally expensive when the number of finite compact coverings of a liver topological structure increases in millions. Since the heat source from the Joule losses Qr = σ|∇V|2 is obtained from Laplace equation σΔV = 0, it is called the Joule heat model. The traditional Joule heat model can be replaced by a point source model to obtain the heat source term. The idea behind this model is to solve σΔV = δ0 where δ0 is a Dirac-delta function. Therefore, using the fundamental solution of the Laplace equation (Evans, Partial Differential Equations, 2010) we represent the solution of the Joule heat model using an alternative model called the point source model which is given by the Gaussian distribution.Qrx=∑xi∈Ω1K∑icie−|x−xi|22σ2where K and ci are obtained by using needle parameters. This model is employed in one of our software solutions called RFA Guardian (Voglreiter et al., Sci. Rep., 2018, 8, 787) which predicted the treatment outcome very well for more than 100 patients.

Successful Fenestration of an Extracardiac Conduit in a Fontan Patient With the Baylis NRG RF Transeptal Needle and Creation of Fontan Fenestration with a 20-mm 535 Formula Stent

Successful Fenestration of an Extracardiac Conduit in a Fontan Patient With the Baylis NRG RF Transeptal Needle and Creation of Fontan Fenestration with a 20-mm 535 Formula Stent