Real-Time Internal Steam Pop Detection during Radiofrequency Ablation with a Radiofrequency Ablation Needle Integrated with a Temperature and Pressure Sensor: Preclinical and Clinical Pilot Tests.

A radiofrequency ablation (RFA) needle integrated with a temperature sensor (T-sensor) and pressure sensor (P-sensor) is designed and utilized for real-time internal steam pop monitoring during RFA. The characteristics of the sensor-integrated RFA needle (sRFA-needle) are investigated quantitatively using a pressure chamber system, and the feasibility and usability of the needle in preclinical and clinical trials is demonstrated. The sharp changes in the temperature and normalized pressure sensor signals induced by the abrupt release of hot and high-pressure steam can be clearly monitored during the steam pop phenomena. The basic mechanism of the preliminary steam pop is hypothesized and verified using in situ ultrasound imaging data and computational analysis data of the RFA procedure. Moreover, the usability of the system in clinical trials is investigated, and the steam pop phenomena during the RFA procedure are detected using T-sensor and P-sensor. The results confirm that the sensor integration on the medical needle can provide critical data for safer and more effective medical practices.

Steerable needles for radio-frequency ablation in cirrhotic livers.

Accurate needle placement in deep-seated liver tumours can be difficult. In this work, we disclose two new manually controlled steerable needles for 17G radio-frequency ablation probe placement. The needles contain stylets with embedded compliant joints for active tip articulations, and concentric tubes for (curved-path) guidance. Needle steering was evaluated sequentially by intended users and in intended-use tissue types. Six interventional radiologists evaluated the needle in repeated ultrasound-guided steering tasks in liver-mimicking phantoms. Targets were located at a 100 mm depth and 20 mm lateral offset from the initial insertion line. The resulting mean absolute tip placement error was 1.0 ± 1.0 mm. Subsequently, steering-induced tissue damage was evaluated in fresh cirrhotic human liver explants. The surface area of puncture holes was estimated in scanned histology slides, using a connected-components analysis. The mean surface area was 0.26 ± 0.16 mm2 after steering with a median radius of curvature of 0.7 × 103 mm, versus 0.35 ± 0.15 mm2 after straight-path insertions with the steerable needle and 0.15 ± 0.09 mm2 after straight-path RFA probe insertions. The steering mechanisms proposed enable clinically relevant path corrections for 17G needles. Radiologists were quickly adept in curved-path RFA probe placement and the evaluation of histological tissue damage demonstrated a potentially safe use during liver interventions.

Prostate Radiofrequency Focal Ablation (ProRAFT) Trial: A Prospective Development Study Evaluating a Bipolar Radiofrequency Device to Treat Prostate Cancer.

PURPOSE: We determined the early efficacy of bipolar radiofrequency ablation with a coil design for focal ablation of clinically significant localized prostate cancer visible at multiparametric magnetic resonance imaging. MATERIALS AND METHODS: A prospective IDEAL phase 2 development study (Focal Prostate Radiofrequency Ablation, NCT02294903) recruited treatment-naïve patients with a single focus of significant localized prostate cancer (Gleason 7 or 4 mm or more of Gleason 6) concordant with a lesion visible on multiparametric magnetic resonance imaging. Intervention was a focal ablation with a bipolar radiofrequency system (Encage™) encompassing the lesion and a predefined margin using nonrigid magnetic resonance imaging-ultrasound fusion. Primary outcome was the proportion of men with absence of significant localized disease on biopsy at 6 months. Trial followup consisted of serum prostate specific antigen, multiparametric magnetic resonance imaging at 1 week, and 6 and 12 months post-ablation. Validated patient reported outcome measures for urinary, erectile and bowel functions, and adverse events monitoring system were used. Analyses were done on a per-protocol basis. RESULTS: Of 21 patients recruited 20 received the intervention. Baseline characteristics were median age 66 years (IQR 63-69) and preoperative median prostate specific antigen 7.9 ng/ml (5.3-9.6). A total of 18 patients (90%) had Gleason 7 disease with median maximum cancer 7 mm (IQR 5-10), for a median of 2.8 cc multiparametric magnetic resonance imaging lesions (IQR 1.4-4.8). Targeted biopsy of the treated area (median number of cores 6, IQR 5-8) showed absence of significant localized prostate cancer in 16/20 men (80%), concordant with multiparametric magnetic resonance imaging. There was a low profile of side effects at patient reported outcome measures analysis and there were no serious adverse events. CONCLUSIONS: Focal therapy of significant localized prostate cancer associated with a magnetic resonance imaging lesion using bipolar radiofrequency showed early efficacy to ablate cancer with low rates of genitourinary and rectal side effects.

Plume Effect of Fractional Radiofrequency Verus Laser Resurfacing: Considerations in the COVID-19 Pandemic.

INTRODUCTION: The COVID-19 pandemic requires us all to re-evaluate aesthetic practices to ensure optimal patient safety during elective procedures. Specifically, energy-based devices and lasers require special consideration, as they may emit plume which has been shown to contain tissue debris and aerosolized biological materials. Prior studies have shown transmission of viruses and bacteria via plume (i.e., HIV and papillomavirus). The purpose of this study was to evaluate plume characteristics of the Er:YAG resurfacing laser (Sciton; Palo Alto, CA) and compare it to the Morpheus8 fractional radiofrequency device (InMode; Lake Forest, CA). METHODS: Five patients who underwent aesthetic resurfacing and/or skin tightening of the face and neck were treated with the Er:YAG (Sciton Joule, Palo Alto, CA) and/or fractional radiofrequency (Morpheus8, Lake Forest, CA) between April 1 and May 11, 2020. Data collected included patient demographics, past medical history, treatment parameters, adverse events, particle counter data, as well as high magnification video equiptment. Patients were evaluated during treatment with a calibrated particle meter (PCE; Jupiter, FL). The particle meter was used at a consistent focal distance (6-12 inches) to sample the surrounding environment during treatment at 2.83 L/min to a counting efficiency of 50% at 0.3 µm and 100% at >0.45 µm. Recordings were obtained with and without a smoke evacuator. RESULTS: Of our cohort (n = 5), average age was 58 years old (STD ±7.2). Average Fitzpatrick type was between 2 and 3. Two patients received Er:YAG fractional resurfacing in addition to fractional radiofrequency during the same treatment session. Two patients had fractional radiofrequency only, and one patient had laser treatment with the Er:YAG only. There were no adverse events recorded. The particle counter demonstrated ambient baseline particles/second (pps) at 8 (STD ±6). During fractional radiofrequency treatment at 1-mm depth, the mean recording was 8 pps (STD ±8). At the more superficial depth of 0.5 mm, recordings showed 10 pps (STD ±6). The Er:YAG laser resurfacing laser had mean readings of 44 pps (STD ±11). When the particle sizes were broken down by size, the fractional radiofrequency device had overall smaller particle sizes with a count of 251 for 0.3 µm (STD ±147) compared with Er:YAG laser with a count of 112 for 0.3 µm (STD ±84). The fractional radiofrequency did not appear to emit particles >5 µm throughout the treatment, however, the Er:YAG laser consistently recorded majority of particles in the range of 5-10 µm. The addition of the smoke evacuator demonstrated a 50% reduction in both particles per second recorded as well as all particle sizes. CONCLUSION: Re-evaluation of the plume effect from aesthetic devices has become important during the COVID-19 pandemic. Further studies are required to characterize viability of COVID-19 viability and transmissibility in plume specimens. Based on this pilot study, we recommend that devices that generate little to no plume such as fractional radiofrequency devices be used in Phase I reopening of practice while devices that generate a visible plume such as Er:YAG laser resurfacing devices be avoided and only used with appropriate personal protective equipment in addition to a smoke evacuator in Phase IV reopening.

Efficacy and safety of palliative endobiliary radiofrequency ablation using a novel temperature-controlled catheter for malignant biliary stricture: a single-center prospective randomized phase II TRIAL.

BACKGROUND: Endobiliary radiofrequency ablation (EB-RFA) has emerged as a palliative treatment for malignant biliary strictures (MBSs); however, concerns about complications related to thermal injury remain. In this study, we evaluated the efficacy and safety of EB-RFA with a novel catheter for MBS. METHODS: Patients with inoperable cancer causing MBS were randomly assigned to either the radiofrequency ablation (RFA) group or the non-RFA group. The RFA group underwent EB-RFA at the stricture site with a temperature-controlled catheter (ELRA™; STARmed Co., Goyang, Korea) followed by deployment of a self-expanding metal stent (SEMS). For the non-RFA group, only SEMS placement was performed. The duration of stent patency, overall survival (OS), and 30-day complication rate were evaluated. This trial was registered at ClinicalTrials.gov (number NCT02646514). RESULTS: A total of 48 patients were enrolled (24 in each group). During a median follow-up period of 135.0 days (RFA group) and 119.5 days (non-RFA group), the 90-day stent patency rate, median duration of stent patency, and median OS were not different between the groups (58.3% vs. 45.8% [P = 0.386], 132.0 days vs. 116.0 days [P = 0.440], and 244.0 days vs. 180.0 days [P = 0.281], respectively). In the RFA group, procedure-related complications including thermal injury-related complications, such as bile duct perforation or hemobilia, were not reported. The early complication (< 7 days) rates were not different between the groups (4.2% vs. 12.5%, P = 0.609), and there were no late complications (7-30 days) in both groups. CONCLUSION: EB-RFA with a temperature-controlled catheter followed by SEMS placement for patients with inoperable MBS can be safe and feasible with acceptable biliary patency.

Laparoscopic transperitoneal adrenalectomy: a comparative study of different techniques for vessel sealing.

BACKGROUND: Laparoscopic adrenalectomy is the standard surgical approach to adrenal lesions. Adrenal vessel sealing is the critical surgical phase of laparoscopic adrenalectomy. This study aimed at comparing perioperative outcomes of laparoscopic transperitoneal adrenalectomy by means of radiofrequency energy-based device (LARFD) to those performed with traditional clipping device (LACD), while focusing on the different adrenal vessel control techniques. METHODS: Patients who underwent adrenalectomy for adrenal disease between January 1994 and April 2019 at the Surgical Clinic, Polytechnic University of Marche were included in the study. Overall, 414 patients met inclusion criteria for study eligibility: 211 and 203 patients underwent LARFD and LACD, respectively. Multiple models of quantile regression, logistic regression and Poisson finite mixture regression were used to assess the relationship between operative time, conversion to open procedure, length of stay (LoS), surgical procedure and patient characteristics, respectively. RESULTS: LARFD reduced operative time of about 12 min compared to LACD. Additional operative time-related factors were surgery side, surgery approach, conversion to open procedure and trocar number. The probability of conversion to open procedure decreased by about 76% for each added trocar, whereas it increased by about 49% for each added centimeter of adrenal lesion and by about 25% for each added year of surgery. Two patient clusters were identified based on the LoS: long-stay and short-stay. In the long-stay cluster, LoS decreased of about 30% in LARFD group and it was significantly associated with conversion to open procedure and postoperative complications, whereas in short-stay cluster only postoperative complications had a significant effect on LoS. CONCLUSION: Laparoscopic transperitoneal adrenalectomy performed by means of radiofrequency energy-based device for the sealing of adrenal vessels is an effective procedure reducing operative time with potentially improved postoperative outcomes.

Prospective comparative study of different endovenous thermal ablation systems for treatment of great saphenous vein reflux.

OBJECTIVE: The aim of our study was to compare three different endovenous thermal ablation (EVTA) modalities in the treatment of great saphenous vein (GSV) incompetence. METHODS: We performed a single-center, prospective, comparative cohort study that included consecutive patients undergoing EVTA of the GSV. Patients were treated with either segmental radiofrequency ablation (sRFA) or endovenous laser ablation (EVLA) with a 1470-nm dual radial fiber or with a 1470-nm jacket-tip fiber. The clinical classification CEAP (clinical, etiologic, anatomic, pathophysiologic), 10-cm visual analog scale scores for pain, Venous Clinical Severity Scores (VCSSs), and chronic venous insufficiency quality-of-life questionnaire (CIVIQ-20) scores were recorded. The primary outcome was clinical success, which was defined as the absence of reflux or recanalization of the GSV and procedure-related complications, assessed at 7 and 30 days and 1 year postoperatively. The secondary outcomes were the assessment of postoperative pain using the VAS and improvement in the VCSSs and CIVIQ-20 scores. RESULTS: A total of 153 patients (160 limbs) had undergone sRFA (sRFA group; n = 53 limbs), 1470-nm radial fiber EVLA (EVLA-R group; n = 55 limbs), or 1470-nm jacket-tip fiber EVLA (EVLA-J group; n = 52 limbs). The patient demographics, CEAP clinical class, and intraoperative details were comparable among the three groups. The GSV occlusion rate at 1 year was 93% in the sRFA group, 93% in the EVLA-R group, and 95% in the EVLA-J group. No major complications were observed postoperatively. Endothermal heat-induced thrombosis was observed in 2 (4.4%), 1 (2.2%), and 2 (4.4%) patients in the sRFA, EVLA-R, and EVLA-J groups, respectively (P > .5). The VCSS showed greater improvement in the EVLA-R group at 1 week compared with that in the sRFA (P = .05) and EVLA-J (P = .002) groups. Changes in the CIVIQ-20 score were in favor of the EVLA-R group at 7 days (-14.3 ± 10.3 vs -7.9 ± 5.9; adjusted difference, 6.06; 95% confidence interval [CI], 1.57-10.55; P = .01) and 30 days (-12 ± 8 vs -11.2 ± 7; adjusted difference, 5.5; 95% CI, 1.21-9.81; P = .02) postoperatively compared with the sRFA group and at 7 days compared with the EVLA-J group (-14.3 ± 10.3 vs -9.6 ± 7.9; adjusted difference, -4.4; 95% CI, -9.06 to 0.22; P = .05). Analyzing the different components of the CIVIQ-20, pain, and physical scores showed a greater reduction in the EVLA-R group in the early postoperative period compared with that in the sRFA and EVLA-J groups. CONCLUSIONS: All three EVTA modalities showed equal effectiveness and safety for the treatment of GSV reflux. EVLA with the 1470-nm radial fiber showed better outcomes in terms of early postoperative VCSSs and pain and physical CIVIQ scores. The clinical and quality of life benefits were similar for all modalities at 1 year postoperatively.

Oclusión de la vena safena con cianocrilato, una alternativa para el tratamiento de insuficiencia venosa crónica. Experiencia inicial en el Instituto Guatemalteco de Seguridad Social ­ IGSS / Occlusion of the saphenous vein with cyanoacrylate, an alternative for the treatment of chronic venous insufficiency. Initial experience at the Guatemalan Social Security Institute - IGSS

Las técnicas de termo ablación han revolucionado el tratamiento de la insuficiencia venosa crónica, siendo actualmente el estándar de tratamiento. Con el avance tecnológico han surgido nuevas técnicas quirúrgicas, no térmicas, no tumescentes; como el uso de cianocrilato para la oclusión venosa, el cual ha demostrado ser seguro y eficaz en el tratamiento, y tener menos complicaciones posoperatorias. Objetivo: Describir la experiencia en nuestro hospital con el uso de cianocrilato para la oclusión de vena safena mayor para el tratamiento de insuficiencia venosa crónica. Describir la eficacia a corto y mediano plazo del cierre, las complicaciones y la mejoría de la sintomatología utilizando el cuestionario CIVIQ-20 y EVA. Material y métodos: Estudio retrospectivo observacional. Entre enero y diciembre de 2019 que incluye a pacientes con insuficiencia de unión safeno femoral, sintomáticos. Con diagnóstico mediante clasificación CEAP y ultrasonido Doppler. Seguimiento clínico y ecográfico valorando oclusión de los segmentos tratados y presencia de venas varicosas a los 3 y 6 meses. Se trataron 5 pacientes con oclusión venosa con cianocrilato (100% mujeres). Valoramos la calidad de vida mediante cuestionario CIVIQ-20 y EVA (Escala Analógica Visual) previo y un mes después del procedimiento. También se describe la tasa de éxito y complicaciones inmediatas y tardías. Resultados: La totalidad de los procedimientos se realizaron con anestesia local, siendo bien tolerados. Con un éxito inmediato del 100 % sin necesidad de conversión. Solo se presentó como complicación urticaria en un paciente en el trayecto de la vena tratada con cianocrilato, la cual se trató con esteroides y resolvió. El CIVIQ-20 mostró mejoría global pasando de 35 a 29 puntos en promedio; siendo el parámetro de actividad física el que mostró una mejoría mayor. EVA demostró que la pesadez (principal síntoma) se redujo un 67%. Durante el seguimiento, ningún caso presento repermeabilización o recanalizaciones segmentarias. Conclusiones: El tratamiento endovenoso de la insuficiencia venosa crónica con las nuevas técnicas no térmicas, no tumescentes es seguro y efectivo. A corto-mediano plazo ofrecen resultados similares a las técnicas termoablativas obviando el inconveniente de la tumescencia y el uso de medias compresivas en el posoperatorio, evitando lesiones térmicas y observándose mejoría en la sintomatología. (AU)

Thermo ablation techniques have revolutionized the treatment of chronic venous insufficiency, being currently the standard of treatment. With technological advancement, new non-thermal, non-tumescent surgical techniques have emerged; such as the use of cyanoacrylate for venous occlusion, which has been shown to be safe and effective in treatment, and have fewer postoperative complications. Objective: To describe the experience in our hospital with the use of cyanoacrylate for occlusion of the greater saphenous vein for the treatment of chronic venous insufficiency. Describe the shortand medium-term efficacy of closure, complications, and symptom improvement using the CIVIQ-20 questionnaire and VAS. Material and methods: Retrospective observational study. Between January and December 2019 that includes patients with symptomatic saphenous femoral junction insufficiency. With diagnosis by CEAP classification and Doppler ultrasound. Clinical and ultrasound follow-up evaluating occlusion of the treated segments and the presence of varicose veins at 3 and 6 months. 5 patients with venous occlusion were treated with cyanoacrylate (100% women). We assessed the quality of life using the CIVIQ-20 questionnaire and VAS (Visual Analogue Scale) before and one month after the procedure. The immediate and late success rate and complications are also described. Results: All the procedures were performed under local anesthesia, being well tolerated. With immediate 100% success without the need for conversion. Urticaria only presented as a complication in a patient in the path of the vein treated with cyanoacrylate, which was treated with steroids and resolved. The CIVIQ-20 showed global improvement, going from 35 to 29 points on average; being the physical activity parameter the one that showed the greatest improvement. VAS showed that heaviness (main symptom) was reduced by 67%. During follow-up, no case presented segmental recanalization or recanalization. Conclusions: Endovenous treatment of chronic venous insufficiency with new non-thermal, non-tumescent techniques is safe and effective. In the short-medium term, they offer results similar to thermoablative techniques, avoiding the inconvenience of tumescence and the use of compression stockings in the postoperative period, avoiding thermal injuries and observing improvement in symptoms. (AU)

A Systematic Review of Nonsurgical Vulvovaginal Restoration Devices: An Evidence-Based Examination of Safety and Efficacy.

BACKGROUND: The efficacy and safety of vulvovaginal restoration devices were called into question in a U.S. Food and Drug Administration statement on July 30, 2018, claiming that women are being harmed by laser and other energy-based devices. The goal of this systematic literature review was to assess existing data, determine gaps in evidence, and propose opportunities for continued investigation pertaining to laser and energy-based vaginal restoration techniques. METHODS: A review of literature using PubMed, Cochrane Library databases, Embase, MEDLINE, and the Cumulative Index to Nursing and Allied Health Literature was conducted on January 9, 2019, and articles up to this point were considered. For inclusion, studies had to be available or translated in English and relate to clinical medicine, direct patient care, and nonsurgical energy-based vulvovaginal procedures. RESULTS: The authors found five level I studies, 19 level II studies, four level III studies, and 46 level IV studies that used 15 different devices. Various degrees of improvement of symptoms were reported in all studies. Adverse events/side effects were noted in two of the 13 radiofrequency device studies, 15 of the 23 erbium:yttrium-aluminum-garnet device studies, and 17 of the 37 carbon dioxide device studies. The majority of adverse events were considered mild. CONCLUSIONS: The majority of studies resulted in mild to no adverse side effects. However, there is a large gap in level I evidence. As a result, the authors emphasize the necessity of supplemental data surrounding this subject and suggest that additional randomized sham-controlled studies be conducted to further investigate vulvovaginal restoration devices in an effort to address women's health issues.

Monopolar Radiofrequency Energy Delivered by a Conductive Endovascular Basket or Guidewire Leads to Thermal Occlusion in a Swine Model.

PURPOSE: To assess the feasibility of inducing vascular occlusion by application of radiofrequency (RF) energy via conductive endovascular wires or baskets. MATERIALS AND METHODS: A retrievable nitinol basket and stainless steel guidewire with a platinum tip were evaluated as conductors for endovascular application of RF energy. Tissue-mimicking thermochromic gel phantoms that change color with heating were cast with 2-, 5-, and 7-mm-diameter lumens and filled with 37 oC saline. After ablation, the phantoms were sectioned, and the thermal footprints were evaluated. Six castrated male domestic swine underwent endovascular ablation using the basket in iliac arteries and guidewires in renal arteries. Post-procedural angiography was performed, and postmortem arterial segments were resected for histopathologic analysis. RESULTS: In the phantom, the depth of thermal change in the 5- and 7-mm lumens averaged 6.3 and 6.0 mm along the basket, respectively, and in the 2- and 5-mm lumens, the depth of thermal change averaged 1.9 and 0.5 mm along the wire, respectively. In the swine, RF energy delivery led to angiographic occlusion at 12 of 13 sites. Thermal injury and occlusion were similar at the proximal, middle, and distal basket treatment zone, whereas injury and occlusion decreased from the proximal to the distal end of the 5-cm wire treatment zone. CONCLUSIONS: Endovascular delivery of RF energy via a conductive basket in medium-sized arteries or a guidewire in small arteries led to acute angiographic and histologic occlusion. The potential to induce stasis might be useful in settings where rapid occlusion is desirable.

Endoscopic Ultrasound-Guided Antegrade Radiofrequency Ablation and Metal Stenting With Hepaticoenterostomy for Malignant Biliary Obstruction: A Prospective Preliminary Study.

OBJECTIVES: Endobiliary radiofrequency ablation (RFA) for malignant biliary obstruction is a promising option for improving biliary stent patency, but its efficacy and safety with endoscopic ultrasound (EUS)-guided biliary drainage are uncertain. We examined the feasibility of EUS-guided hepaticoenterostomy with antegrade stenting (EUS-HEAS) and RFA in patients with unresectable malignant biliary obstruction. METHODS: This was a prospective, single-center, single-arm, preliminary study. Twenty patients who met the eligibility criteria for inclusion between August 2018 and January 2020 were enrolled. We evaluated the technical success, functional success, recurrent biliary obstruction (RBO), and adverse events other than RBO associated with EUS-HEAS with RFA. RESULTS: The technical and functional success rates were both 80% (16/20). The procedure was unsuccessful in a total of 4 patients due to failure to insert the RFA catheter through the fistula (2 patients) or failure to pass the RFA catheter through the stricture (2 patients). Early and late adverse events other than RBO occurred in 10% (2/20) and 13% (2/16) of subjects, respectively. The RBO rate was 25% (4/16), and the median time to RBO was 276 days. The success rate of endoscopic reintervention using hepaticoenterostomy was 100% (4/4). DISCUSSION: This preliminary study showed that EUS-HEAS with RFA achieves good results but RFA catheter insertion can be difficult. Further evaluation and device improvements are warranted.

Ablación por radiofrecuencia del lecho quirúrgico tras tumorectomía en cirugía conservadora del cáncer de mama / Radiofrequency Ablation of the Surgical Bed After Lumpectomy in Breast-conserving Surgery

INTRODUCCIÓN: Obtener márgenes libres en cirugía conservadora del cáncer de mama (CCCM) es esencial para evitar la recurrencia local, precisando para ello la reintervención en múltiples ocasiones. La ablación por radiofrecuencia (ARF) de los márgenes tras tumorectomía parece ser una herramienta útil para evitar las reintervenciones, aunque con insuficiente evidencia. En este estudio se analiza la eficacia y seguridad de la ARF tras la CCCM para obtener márgenes libres. MÉTODOS: Estudio experimental, no aleatorizado, realizado en un grupo intervención de 40 pacientes al que se aplicó ARF tras tumorectomía y exéresis posterior de los márgenes, y otro grupo control histórico de 40 pacientes al que se realizó CCCM. En el grupo intervención, se analizó el efecto de la ARF sobre la viabilidad de las células tumorales en los márgenes extirpados. Se realizó además un análisis comparativo sobre el porcentaje de reintervenciones, las complicaciones y el resultado estético en ambos grupos. RESULTADOS: Se estudiaron 240 márgenes extirpados tras ARF, evidenciando un elevado número de márgenes libres. Comparado con el grupo control, disminuyó significativamente el número de reintervenciones (0% vs. 12%; p = 0,02), sin hallar diferencias respecto a las complicaciones (5% vs. 10%; p = 0,67) ni al resultado estético (excelente o bueno 92,5% vs. 95%; p = 0,3). CONCLUSIONES: La ARF tras tumorectomía es una técnica sencilla, segura y eficaz para la obtención de márgenes libres, y permite reducir las reintervenciones sin afectar a las complicaciones ni al resultado estético

INTRODUCTION: Obtaining tumor-free margins during breast conservative surgery (BCS) is essential to avoid local recurrence and frequently requires reoperation. Radiofrequency ablation (RFA) of surgical margins after lumpectomy seems to be a helpful tool to avoid reoperations, but evidence is insufficient. This study analyzes the efficacy and safety of RFA after BCS to obtain free surgical margins. METHODS: Non-randomized experimental study performed in an intervention group of 40 patients assigned to receive RFA after lumpectomy and successive resection of surgical margins, and a historical control group of 40 patients treated with BCS alone. In the intervention group, the RFA effect on tumor cell viability in the surgical margins was analyzed. Also, reoperation rate, complications and cosmetic results were compared in both groups. RESULTS: A total of 240 excised margins were analyzed after RFA, obtaining a high number of tumor-free margins. Compared to the control group, the reoperation rate decreased significantly (0% vs 12%; P = .02), without differences in terms of postoperative complications (10% vs 5%; P = .67) or cosmetic results (excellent or good 92.5% vs 95%; P = .3). CONCLUSIONS: RFA after lumpectomy is a reliable, safe and successful procedure to obtain tumor-free surgical margins and to decrease the reoperation rate without affecting complications or compromising cosmetic results

Radiofrequency ablation for DYT-28 dystonia: short term follow-up of three adult cases.

Mutations in the lysine methyltransferase 2B (KMT2B) gene have recently been reported to be associated with childhood-onset generalized dystonia. There have been no studies investigating ablative treatments for the management of this disorder. Three patients underwent either a staged unilateral pallidotomy and contralateral pallidothalamic tractotomy (19-year-old man, 2-year follow-up), a unilateral pallidothalamic tractotomy (34-year-old man, 6-month follow-up) or a simultaneous unilateral pallidothalamic tractotomy and ventro-oral thalamotomy (29-year-old man, 6-month follow-up). The average total patient score on the Burke-Fahn-Marsden Dystonia Rating Scale-Movement Scale improved from 39.5 to 13.2 (66.6%) after the procedures. No significant complications were identified. Ablative treatments appear to be a promising alternative surgical option for generalized dystonia with KMT2B mutation.

A Saline/Bipolar Radiofrequency Energy Device As an Adjunct for Hemostasis in Solid Organ Injury/Trauma.

Solid organ (liver, spleen, and kidney) hemorrhage is often life-threatening and can be difficult to stop in critically ill patients. Traditional techniques for arresting this ongoing bleeding include coagulation by high voltage electrocautery, topical hemostatic application, and the delivery of ignited argon gas. The goal of this study/video was to demonstrate the efficacy of a new energy device for arresting persistent solid organ hemorrhage.A novel instrument utilizing bipolar radiofrequency (RF) energy which acts to ignite/boil dripping saline from a simple handpiece is employed to arrest ongoing bleeding from solid organ injuries in a porcine model. This instrument is extrapolated from experience within elective hepatic resections. An escalating series of injuries to solid organs within a porcine model will be created. This will be followed by arresting hemorrhage with this novel energy device in sequence. A standard suction device will also be employed. This simple saline/RF energy instrument has the potential to arrest ongoing solid organ surface/capsular bleeding, as well as moderate hemorrhage associated with deep lacerations.

Transjugular Intrahepatic Portosystemic Shunt Creation Using a Radiofrequency Wire: Prospective Clinical Safety and Feasibility Trial in Cirrhosis.

PURPOSE: To assess the safety and feasibility of using a radiofrequency (RF) wire for portosystemic shunt creation. MATERIALS AND METHODS: Ten patients undergoing elective creation of a transjugular intrahepatic portosystemic shunt (TIPS) or a direct intrahepatic portosystemic shunt (DIPS) were prospectively enrolled. Primary outcomes were the safety and feasibility of RF wire used for the creation of TIPS and DIPS. Median age was 66.5 ± 6.1 years. Causes of liver disease included alcohol (n = 5), nonalcoholic steatohepatitis (n = 2), hepatitis C virus (n = 1), primary biliary cirrhosis (n = 1), autoimmune hepatitis (n = 1). The median score for model for end-stage liver disease was 11 ± 4.3. The Rosch-Uchida TIPS set was used with intravascular ultrasonography guidance in all cases. A 0.035-inch RF wire was used in lieu of the trocar needle through the 5-F TIPS set catheter to create a track between the hepatic vein and the portal vein. All shunts were created using stent grafts. RESULTS: Technical success rate was 100%. In 7 of 10 patients, portal vein access was achieved with a single pass. A DIPS was created in 2 patients based on anatomic favorability. Median fluoroscopy time was 13.3 ± 3.8 min, and median total procedure time was 102 ± 19 min. The wire passed through parenchyma without subjective deflection. There was 1 case of extracapsular puncture with no clinical consequence. The RF wire was too stiff to curve into the main portal vein, requiring wire exchange in all but 1 case. Mean portosystemic gradient decreased from 13.9 ± 3.3 to 5.9 ± 2.1 mm Hg. No immediate complications were encountered. Shunt patency was 100% at 30 days. CONCLUSIONS: Creation of TIPS and DIPS using an RF wire was safe and feasible, enabling creation of an intrahepatic track without subjective deflection in cirrhotic patients.

One-Stage Versus Sequential Hybrid Radiofrequency Ablation: An In Vitro Evaluation.

OBJECTIVE: To compare lesion size and depth between a 1-step, a sequential, and a delayed radio-frequency ablation in a hybrid setup. METHODS: Left atrium tissues obtained from fresh porcine hearts were mounted into the ABLABOX simulator. Based on the time differences between the index epicardial (epi) and consequent endocardial (endo) ablation, 3 study groups were compared: a 1-stage (SEQ- 0) group (0-minute delay), an SEQ 1 group (60-minute delay), and an SEQ 2 group (240-minute delay). During the experiment, a constant epicardial (300 gr) and endocardial (30 gr) force were applied. Per group, 20 samples were studied, and the resulting lesion size and depth were quantified with morphometric evaluation. RESULTS: Overall, no transmural lesion was obtained. Lesions in SEQ 0 had better maximum and minimum diameters (P < 0.001), a larger total area (P < 0.001), and volume (P < 0.001) than SEQ 1 and SEQ 2. There was no statistical difference in morphometric parameters (all, P > 0.05) between the delayed procedures (SEQ 1 and SEQ 2). CONCLUSIONS: In our in vitro model, different time sequences of combined epi-endo ablation did not result in transmural lesions. However, simultaneous epi-endo ablation produced broader and deeper lesions. Our findings need to be confirmed by further research.