Comparison of the therapeutic efficacy of magneto-LED therapy and magnetostimulation applied as the adjuvant treatment of venous leg ulcers - preliminary study.

PURPOSE: Venous leg ulcers are chronic wounds that are difficult to cure. The aim of the study was to compare the therapeutic efficacy of two methods of physical medicine - magneto-LED therapy and magnetostimulation, applied as adjuvant treatment in the treatment of venous leg ulcers. METHODS: The study included 81 patients, 37 male (45.6%) and 44 female (54.3%) ones, age range between 45 and 90 years, with venous leg ulcers. The patients were assigned to two study groups: magneto-LED therapy (group 1) or magnetostimulation (group 2). In both groups, a total of 40 daily procedures were performed. Wound healing was evaluated using computerized planimetry and the pain intensity on numeric rating scale. RESULTS: After treatment, the decrease in healing rate in group 1 was statistically significantly higher in comparison to group 2 (p < 0.001), while a statistically significant reduction in the surface area of ulcers was obtained, amounting on the average from 6.34 ± 1.29 cm2 to 2.31 ± 1.25 cm2 in group 1 (p < 0.001), and from 6.52 ± 1.20 cm2 to 4.79 ± 1.17 cm2 in group 2 (p < 0.001). The percentage changes of ulcers area in group 1 (64.21 ± 17.94%) were statistically significantly greater as compared to group 2 (25.87 ± 14.07%) (p < 0.001). After treatment, the decrease in pain relief in group 1 was statistically significantly higher in comparison to group 2 (p = 0.006), while pain intensity after treatment decreased statistically significantly in both compared groups of patients (p < 0.001). CONCLUSIONS: Magneto-LED therapy and magnetostimulation caused significant reduction of surface area of the treated venous leg ulcers and pain intensity, yet magneto-LED therapy was more efficient. Both evaluated methods also significantly reduced pain intensity.

Chronic wounds are wounds, which despite ongoing treatment, do not heal within 6­8 weeks. A wound that occurs as a result of an ongoing disease process is called an ulcer. Leg ulcers are still a significant challenge for modern medicine because they are characterized by complex etiology, chronic pain and require specific diagnostic and therapeutic measures. In many cases, the inability to heal ulcers quickly is associated with social isolation, long-term suffering and deterioration of the quality of life of treated patients. In addition to standard treatment including surgery, pharmacotherapy and compression therapy, new more effective methods of ulcer therapy are still being sought. Nowadays, physical treatment methods are increasingly used as a supporting treatment the healing of chronic wounds. In the study, variable magnetic fields and low-energy light were used in the treatment of 81 patients (including 44 women and 37 men) in aged 45­90 years. All patients had chronic, non-healing of venous leg ulcers accompanied by severe pain. After completion of treatment, both groups of patients experienced a significant reduction of surface area of treated ulcers and a reduction in the intensity of pain ailments. According to our study results, the use of magnetic field and light therapy can be an important supportive treatment option in patients with venous leg ulcers.

Simultaneous Application of High-Intensity Focused Electromagnetic and Synchronized Radiofrequency for Fat Disruption: Histological and Electron Microscopy Porcine Model Study.

BACKGROUND: Radiofrequency (RF) and high-intensity focused electromagnetic (HIFEM) technologies are used for noninvasive body shaping as standalone modalities. OBJECTIVE: To examine the effects of novel synchronized RF and HIFEM on subcutaneous adipose tissue in a porcine animal model. MATERIALS AND METHODS: Seven large white pigs aged 6 months received 3 abdominal treatments of simultaneous application of synchronized RF and HIFEM (30 minutes, once per week). Punch biopsies of treated and control subcutaneous tissue were collected at the baseline, 4 days, 2 weeks, 1 month, and 2 months. Specimens were examined by light and scanning electron microscopy. Adipocyte volume was analyzed. Fat tissue temperature was measured in situ (fiber optic probes) and superficially (thermal imager). RESULTS: Fat layer was heated to temperatures of 42 to 45°C. Signs of fat apoptosis (shape alternations and pyknotic nuclei) appeared at day 4 and peaked between 2 weeks and 1 month. Adipocyte volume decreased significantly (p < .001) by 31.1% at 2 weeks, 1 month (-23.6%), and 2 months (-22.0%). Control samples showed healthy adipocytes. Scanning electron microscopy micrographs corroborated histology findings, showing flattened, volume-depleted and disrupted adipocytes. CONCLUSION: Synchronized RF with HIFEM procedure resulted in a significant and sustained fat reduction with no adverse events.

Systematic review of the introduction and evaluation of magnetic augmentation of the lower oesophageal sphincter for gastro-oesophageal reflux disease.

BACKGROUND: Magnetic sphincter augmentation (MSA) is reported to be an innovative alternative to antireflux surgery for patients with gastro-oesophageal reflux disease. Although used in practice, little is known about how it has been evaluated. This study aimed to systematically summarize and appraise the reporting of MSA and its introduction into clinical practice, in the context of guidelines (such as IDEAL) for evaluating innovative surgical devices. METHODS: Systematic searches were used to identify all published studies reporting MSA insertion. Data collected included patient selection, governance arrangements, surgeon expertise, technique description and outcome reporting. RESULTS: Searches identified 587 abstracts; 39 full-text papers were included (1 RCT 5 cohort, 3 case-control, 25 case series, 5 case reports). Twenty-one followed US Food and Drug Administration eligibility criteria for MSA insertion. Twenty-six documented that ethical approval was obtained. Two reported that participating surgeons received training in MSA; 18 provided information about how MSA insertion was performed, although techniques varied between studies. Follow-up ranged from 4 weeks to 5 years; in 14 studies, it was less than 1 year. CONCLUSION: Most studies on MSA lacked information about patient selection, governance, expertise, techniques and outcomes, or varied between studies. Currently, MSA is being used despite a lack of robust evidence for its effectiveness.

ANTECEDENTES: El aumento de esfínter con un dispositivo magnético (magnetic sphincter augmentation, MSA) se ha descrito como una alternativa innovadora a la cirugía antirreflujo para pacientes con enfermedad por reflujo gastroesofágico. Aunque este procedimiento se utiliza en la práctica, se sabe poco acerca de cómo ha sido evaluado. Este estudio se propuso resumir sistemáticamente y evaluar los trabajos sobre MSA y su introducción en la práctica clínica, en el contexto de las guías (como IDEAL) para la evaluación de dispositivos quirúrgicos innovadores. MÉTODOS: Se identificaron todos los estudios publicados que describían la colocación de MSA efectuando búsquedas sistemáticas. Los datos recogidos incluían la selección de los pacientes, disposiciones de gobernanza, experiencia del cirujano, descripción técnica, y descripción de resultados. RESULTADOS: Las búsquedas identificaron 587 resúmenes, incluyéndose 39 artículos completos (5 estudios de cohortes, 3 estudios de casos y controles, 26 series de casos, 5 casos clínicos). En 21 estudios se siguieron los criterios de elegibilidad de la FDA para la colocación de MSA. En 26 estudios se confirmaba que se había obtenido la aprobación ética. Dos estudios describieron que los cirujanos participantes habían recibido formación en MSA; 18 proporcionaron información sobre cómo se realizó la colocación de MSA, aunque las técnicas variaron entre los estudios. El seguimiento oscilaba entre 4 semanas y 5 años; en 14 estudios fue inferior a un año. CONCLUSIÓN: La mayoría de los estudios sobre MSA fueron casos aislados y series de casos, sin un incremento apreciable en la calidad de la evidencia sobre MSA. La información sobre la selección de los pacientes, gobernanza, experiencia, técnicas, y resultados estaba ausente o variaba entre los estudios, haciendo difíciles las comparaciones. En la actualidad, MSA se utiliza a pesar de la falta de evidencia robusta sobre su efectividad.

Magnetic seizure therapy is efficacious and well tolerated for treatment-resistant bipolar depression: an open-label clinical trial

Background: Treatment-resistant bipolar depression can be treated effectively using electroconvulsive therapy, but its use is limited because of stigma and cognitive adverse effects. Magnetic seizure therapy is a new convulsive therapy with promising early evidence of antidepressant effects and minimal cognitive adverse effects. However, there are no clinical trials of the efficacy and safety of magnetic seizure therapy for treatment-resistant bipolar depression. Methods: Participants with treatment-resistant bipolar depression were treated with magnetic seizure therapy for up to 24 sessions or until remission. Magnetic seizure therapy was applied over the prefrontal cortex at high (100 Hz; n = 8), medium (50 or 60 Hz; n = 9) or low (25 Hz; n = 3) frequency, or over the vertex at high frequency (n = 6). The primary outcome measure was the 24-item Hamilton Rating Scale for Depression. Participants completed a comprehensive battery of neurocognitive tests. Results: Twenty-six participants completed a minimally adequate trial of magnetic seizure therapy (i.e., ≥ 8 sessions), and 20 completed full treatment per protocol. Participants showed a significant reduction in scores on the Hamilton Rating Scale for Depression. Adequate trial completers had a remission rate of 23.1% and a response rate of 38.5%. Per-protocol completers had a remission rate of 30% and a response rate of 50%. Almost all cognitive measures remained stable, except for significantly worsened recall consistency on the autobiographical memory inventory. Limitations: The open-label study design and modest sample size did not allow for comparisons between stimulation parameters. Conclusion: In treatment-resistant bipolar depression, magnetic seizure therapy produced significant improvements in depression symptoms with minimal effects on cognitive performance. These promising results warrant further investigation with larger randomized clinical trials comparing magnetic seizure therapy to electroconvulsive therapy. Clinical trial registration: NCT01596608; clinicaltrials.gov

The role of preoperative workup in predicting dysphagia, dilation, or explantation after magnetic sphincter augmentation.

BACKGROUND: Magnetic sphincter augmentation (MSA) is a surgical treatment for gastroesophageal reflux disease using a ring of titanium beads to improve the function of the lower esophageal sphincter. Prior to implantation, a comprehensive preoperative esophageal workup is required to determine patient candidacy in an effort to reduce the dysphagia, dilation, and explantation rate of the device. This study was designed to assess the best predictors for these endpoints. METHODS: A prospectively maintained IRB-approved database was retrospectively reviewed for patients undergoing MSA implantation. Patients were divided into 3 groups, those that needed no intervention, those that needed medical intervention with oral steroids for reported dysphagia, and surgical intervention, which included endoscopic dilation and/or surgical explantation. Primary endpoints included preoperative objective and subjective testing from a comprehensive esophageal workup including intraoperative notation of number of beads on the device. RESULTS: There were 99 patients eligible for the study with a mean age of 52 and mean follow-up of 10.2 months. Mean BMI was 27 and 59% were female. The no-intervention group had 59 patients, medical intervention group had 25 patients, and surgical intervention group had 15 patients. Preoperative esophageal manometry findings, pH testing off medications, endoscopic and radiologic evaluation showed no difference between the 3 groups. No differences were seen in preoperative subjective evaluations based on GERD-HRQL or RSI scores. There was no difference in average number of beads on the device between the 3 groups. CONCLUSION: A comprehensive esophageal workup is important to confirm the presence of gastroesophageal reflux disease and rule out other esophageal pathology. However, this study shows that a preoperative comprehensive esophageal workup does not predict which patients will develop dysphagia or require either medical or surgical interventions following MSA implantation.

A Multicenter, Prospective, Randomized, Placebo-Controlled, Double-Blind Study of a Novel Pain Management Device, AT-02, in Patients with Fibromyalgia.

OBJECTIVES: Existing treatments for fibromyalgia have limited efficacy, and only a minority of individuals clinically respond to any single intervention. This study was a prospective, multicenter, randomized, double-blind, controlled clinical trial to evaluate the feasibility of alternating magnetic field therapy in fibromyalgia patients by comparing the Angel Touch device (AT-02) with a sham control (S-01). METHODS: Two sites enrolled 44 subjects with diagnosed fibromyalgia. After informed consent, subjects taking prohibited concomitant drugs underwent a washout period of two or more weeks. All subjects then began a one-week run-in period. Numerical rating scale (NRS) pain scores were collected without device intervention for one day, followed by S-01 application to four or more painful sites for 10 minutes at each site, twice daily for six days. Subjects were then randomized to AT-02 or S-01, applied to four or more painful sites for 10 minutes at each site, twice daily for eight weeks. NRS scores were obtained twice daily during the entire treatment period. RESULTS: The primary end point (change in NRS ± SD at week 8 vs baseline) was -0.94 ± 1.33 in the AT-02 group and -0.22 ± 1.38 in the S-01 group. A trend toward a between-group difference in eight-week NRS scores favored the AT-02 group (-0.73, 95% confidence interval = -1.56 to 0.11, P = 0.086). An adjusted repeated measure analysis detected a significant difference in NRS scores (P = 0.039). CONCLUSIONS: The reduction in NRS scores for AT-02 relative to sham was comparable to reductions observed in meta-analyses of fibromyalgia drug therapy. The unadjusted results and the persistence of the pain score reductions remain encouraging.

Pulsed Electromagnetic Field Versus Whole Body Vibration on Cartilage and Subchondral Trabecular Bone in Mice With Knee Osteoarthritis.

Pulsed electromagnetic field (PEMF) and whole body vibration (WBV) interventions are expected to be important strategies for management of osteoarthritis (OA). The aim of the study was to investigate the comparative effectiveness of PEMF versus WBV on cartilage and subchondral trabecular bone in mice with knee OA (KOA) induced by surgical destabilization of the medial meniscus (DMM). Forty 12-week-old male C57/BL mice were randomly divided into four groups (n = 10): Control, OA, PEMF, and WBV. OA was induced (OA, PEMF, and WBV groups) by surgical DMM of right knee joint. Mice in PEMF group received 1 h/day PEMF exposure with 75 Hz, 1.6 mT for 4 weeks, and the WBV group was exposed to WBV for 20 min/day with 5 Hz, 4 mm, 0.3 g peak acceleration for 4 weeks. Micro-computed tomography (micro-CT), histology, and immunohistochemistry analyses were performed to evaluate the changes in cartilage and microstructure of trabecular bone. The bone volume fraction (BV/TV), trabecular thickness (Tb.Th), and trabecular number (Tb.N) increased, and bone surface/bone volume (BS/BV) decreased by micro-CT analysis in PEMF and WBV groups. The Osteoarthritis Research Society International (OARSI) scores in PEMF and WBV groups were significantly lower than in the OA group. Immunohistochemical results showed that PEMF and WBV promoted expressions of Aggrecan, and inhibited expressions of IL-1ß, ADAMTS4, and MMP13. Superior results are seen in PEMF group compared with WBV group. Both PEMF and WBV were effective, could delay cartilage degeneration and preserve subchondral trabecular bone microarchitecture, and PEMF was found to be superior to WBV. Bioelectromagnetics. 2020;41:298-307 © 2020 Bioelectromagnetics Society.

Polymeric Reactor for the Synthesis of Superparamagnetic-Thermal Treatment of Breast Cancer.

Engineered superparamagnetic iron oxide nanoparticles (SPIONs) have been studied extensively for their localized homogeneous heat generation in breast cancer therapy. However, challenges such as aggregation and inability to produce sub-10 nm SPIONs limit their potential in magnetothermal ablation. We report a facile, efficient, and robust in situ method for the synthesis of SPIONs within a poly(ethylene glycol) (PEG) reactor adsorbed onto reduced graphene oxide nanosheets (rGO) via the microwave hydrothermal route. This promising modality yields crystalline, stable, biocompatible, and superparamagnetic PEGylated SPION-rGO nanocomposites (NCs) with uniform dispersibility. Our findings show that rGO acts as a breeding ground for the spatially distributed nanosites around which the ferrihydrite seeds accumulate to ultimately transform into immobilized SPIONs. PEG, in parallel, acts as a critical confining agent physically trapping the accumulated seeds to prevent their aggregation and create multiple domains on rGO for the synthesis of quantum-sized SPIONs (9 ± 1 nm in diameter). This dual functionality (rGO and PEG) exhibits a pronounced effect on reducing both the aggregation and the sizes of fabricated SPIONs as confirmed by the scanning transmission electron microscopy images, dynamic light scattering analyses, and the specific absorption rates (SARs). Reduced aggregation lowered the toxicity of NCs, where PEGylated SPION-rGO NCs are more biocompatible than PEGylated SPIONs, showing no significant induction of cell apoptosis, mitochondrial membrane injury, or oxidative stress. Significantly less lactate dehydrogenase release and hence less necrosis are observed after 48 h exposure to high doses of PEGylated SPION-rGO NCs compared with PEGylated SPIONs. NCs induce local heat generation with a SAR value of 1760 ± 97 W/g, reaching up to 43 ± 0.3 °C and causing significant MCF-7 breast tumor cell ablation of about 78 ± 10% upon applying an external magnetic field. Collectively, rGO and PEG functionalities have a synergistic effect on improving the synthesis, stability, biocompatibility, and magnetothermal properties of SPIONs.

Safety and Efficacy of a Non-Invasive High-Intensity Focused Electromagnetic Field (HIFEM) Device for Treatment of Urinary Incontinence and Enhancement of Quality of Life.

BACKGROUND AND OBJECTIVES: Urinary incontinence is a common and distressing condition which interferes with everyday life. Patients frequently experience discomfort related to urine leakage and the subsequent need to use absorbent pads. Since the continence mechanism is primarily maintained by a proper function of pelvic floor muscles (PFM), many treatment methods focused on strengthening of the PFM have been introduced in the past. The aim of this study was to evaluate the safety and efficacy of a high-intensity focused electromagnetic technology (HIFEM) for treatment of urinary incontinence with emphasis on effects on prospective patients' quality of life. STUDY DESIGN/MATERIALS AND METHODS: The study followed an institutional review board approved protocol. A total of 75 women (55.45 ± 12.80 years, 1.85 ± 1.28 deliveries) who showed symptoms of stress, urge, or mixed urinary incontinence were enrolled. They received six HIFEM treatments (2 per week) in duration of 28 minutes. Outcomes were evaluated after the sixth treatment and at the 3-month follow-up. The primary outcome was to assess changes in urinary incontinence by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and changes in the number of absorbent pads used per day. The secondary outcome was subjective evaluation of the therapy and self-reported changes in quality of life. The statistical analysis was conducted by paired T-test and Pearson correlation coefficient ( α = 0.05). RESULTS: After the sixth session, 61 out of 75 patients (81.33%) reported significant reduction of their symptoms. The average improvement of 49.93% in ICIQ-SF score was observed after the sixth treatment, which further increased to 64.42% at the follow-up (both P < 0.001). Individually, the highest level of improvement was reached in patients suffering from mixed urinary incontinence (69.90%). The reduction of absorbent pads averaged 43.80% after the sixth treatment and 53.68% at 3 months (both P < 0.001), while almost 70% of patients (30 out of 43) reported decreased number of used pads. At the follow-up, a highly significant medium correlation (r = 0.53, P < 0.001) was found between the ICIQ-SF score improvement and the reduction in pad usage. A substantial decrease in the frequency of urine leakage triggers was documented. Patients reported no pain, downtime or adverse events, and also reported additional beneficial effects of the therapy such as increased sexual desire and better urination control. CONCLUSIONS: This study demonstrated that HIFEM technology is able to safely and effectively treat a wide range of patients suffering from urinary incontinence. After six treatments, an improvement in ICIQ-SF score and reduction in absorbent pads usage was observed. Based on subjective evaluation, these changes positively influenced quality of life. © 2019 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.

High Intensity Focused Electromagnetic Field (HIFEM) Devices in Dermatology"

Electromagnetic field devices, specifically high intensity focused electro-magnetic field (HIFEM), comprise the latest class of technologies being developed for dermatologic applications. The FDA clearance of these technologies includes such intended uses as "the stimulation of neuromuscular tissue for bulk muscle excitation in the legs or arms" and improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen; strengthening, toning and firming of buttocks, thighs and calves; and improve FFcment of muscle tone and firmness, for strengthening muscles in arms."1,2

Simultaneous Changes in Abdominal Adipose and Muscle Tissues Following Treatments by High-Intensity Focused Electromagnetic (HIFEM) Technology-Based Device: Computed Tomography Evaluation

Objective: This study investigates the effects of high-intensity focused electromagnetic technology for induction of changes in abdominal muscles and abdominal subcutaneous fat. Methods: 22 male and female subjects (aged 34 to 64, mean BMI, 23.5kg/m2) underwent 8 treatments of the abdomen (2 per week) with a high-intensity focused electromagnetic field device. Subjects were scanned by computed tomography (CT) at baseline and 1 month after the eighth treatment. Sub-umbilical and epi-umbilical slices were used to measure the thickness of subcutaneous fat and abdominal muscles and the abdominal separation. In addition, standardized photographs, weight, and circumference measurements were collected. Results: While comparing baseline to follow-up measurements, CT data showed on average 17.5% (-3.1±1.9mm) reduction in subcutaneous fat and simultaneous 14.8% (+1.5±0.8mm) thickening of the rectus abdominis muscle. Subjects lost on average 3.9±3.1cm in the waist circumference. Most of the waist reduction effect was achieved after the fourth treatment. The width of abdominal separation decreased by 9.5% (-2.0±1.7mm). All results were highly significant (P<0.01) while weight change was insignificant (P<0.05). Digital photographs showed aesthetic improvement in most subjects. The treatments were painless and without adverse events. Conclusion: Results suggest that the investigated device is effective for abdominal body sculpting. This technology produced rectus muscle hypertrophy and a reduction in subcutaneous abdominal fat. Data suggests 4 treatments as the ideal protocol delivering 86% of the observed improvement. J Drugs Dermatol. 2019;18(11):1098-1102.

Miniaturized Electromagnetic Device Abutment Improves Stability of the Dental Implants.

BACKGROUND: The overall success and predictability of dental implant treatment hinge on the primary stability, direct bone-to implant contact formation, and quantity and/or quality of residual bone. Pulsed electromagnetic field has been reported to increase bone regeneration in various clinical situations. Therefore, it was hypothesized that devices which could locally generate a Pulsed electromagnetic field would stimulate bone healing and increase bone density surrounding implants. OBJECTIVE: To retrospectively assess the effects of the miniaturized electromagnetic device (MED) on the implants stability for the first time in human subjects, in a prospective case controlled series. METHODS: Twelve consecutive patients (28 implants) were included in the study.Twelve MED healing caps and 16 regular control healing caps were inserted. Resonance frequency analysis (RFA) was performed at implant placement and abutment connection and an implant stability quotient value was given for each implant. RESULTS: Twenty-eight dental implants were included in the current study. Maxillary implants stability was significantly higher with MED healing cups compared with controls at 15 days postimplantation (66.2 vs 62.1, P = .0008). Resonance frequency analysis test performed at 30 days postimplantation demonstrated significantly increased stability in MED as compared with the control 73.5 ±â€Š3.2 vs 66.7 ±â€Š4.8 in mandibular implants and 74 ±â€Š1.7 vs 65 ±â€Š2.3 in maxillary implants. At the 50 days postimplantation, RFA tests revealed markedly higher stability of the maxillary implants with MED active healing caps compared with nonactive 75.4 ±â€Š5.1 vs 68.5 ±â€Š8.5, respectively. CONCLUSIONS: We conclude that MED-abutment implants demonstrated a superior stability during the early phase of healing as compared with standard implants.

Hyoid Bone Movement at Rest by Peripheral Magnetic Stimulation of Suprahyoid Muscles in Normal Individuals.

OBJECTIVES: Neuromuscular electrical stimulation has been widely used in patients with dysphagia. However, obtaining sufficient hyoid bone movement through surface electrodes seems difficult. The aim of this study was to evaluate hyoid bone movement at rest through peripheral magnetic stimulation of the suprahyoid muscles in normal individuals. METHODS: Healthy adult men were recruited. A specially designed coil was connected to the peripheral magnetic stimulator. The coil was placed on the submental area of the subjects. Magnetic stimulation was performed at 30 Hz for 2 sec. The intensity level selected induces hyoid bone movement without causing intolerable pain to the subjects. The hyoid bone at rest between on- and off-magnetic stimulations of the suprahyoid muscles were identified using fluoroscopy at 30 frames/sec in lateral projection. Pain during peripheral magnetic stimulation was evaluated using the numerical rating scale (NRS). RESULTS: Eleven subjects aged 32 ± 9 years participated in this study. Magnetic stimulation resulted in 10.9 ± 2.8 mm forward displacement and 8.3 ± 4.1 mm (mean ± SD) upward displacement of the hyoid bone. The median NRS score during magnetic stimulation was 1. CONCLUSIONS: Peripheral magnetic stimulation is noninvasive and easy to perform. It does not require skin preparation, facilitates sufficient hyoid bone movement, and causes minimum level of pain.

New device for nonvolitional evaluation of quadriceps force in ventilated patients.

INTRODUCTION: In mechanically ventilated patients, nonvolitional assessment of quadriceps weakness using femoral-nerve stimulation (twitch force) while the leg rests on a right-angle trapezoid or dangles from the bed edge is impractical. Accordingly, we developed a knee-support apparatus for use in ventilated patients. METHODS: Ninety subjects (12 ventilated patients, 28 ambulatory patients, and 50 healthy subjects) were enrolled. Twitches with leg-dangling, trapezoid, and knee-support setups were compared. RESULTS: Knee-support twitches were similar to trapezoid twitches but smaller than leg-dangling twitches (P < 0.0001). Inter- and intraoperator agreement was high for knee-support twitches at 1 week and 1 month. In ventilated patients, knee-support twitches were smaller than in healthy subjects and ambulatory patients (P < 0.004). DISCUSSION: The new knee-support apparatus allows accurate recording of quadriceps twitches. The ease of use in ventilated patients and excellent inter- and intraoperator agreement suggest that this technique is suitable for cross-sectional and longitudinal studies in critically ill patients. Muscle Nerve 57: 784-791, 2018.

Hiatal hernia recurrence following magnetic sphincter augmentation and posterior cruroplasty: intermediate-term outcomes.

BACKGROUND: We have previously reported short-term outcomes after hiatal hernia repair (HHR) at the time of magnetic sphincter augmentation (MSA) for gastroesophageal reflux disease (GERD). Here we report intermediate-term outcomes and hernia recurrence rate after concomitant MSA and HHR. METHODS: This is a retrospective cohort study of patients who underwent repair of a hiatal hernia 3 cm or larger at the time of MSA implantation between May 2009 and December 2015. The primary endpoint was hiatal hernia recurrence identified by routine postoperative videoesophagography or endoscopy. Recurrence was defined by a 2 cm or greater upward displacement of the stomach through the diaphragmatic esophageal hiatus. Secondary endpoints included cessation of proton-pump inhibitor (PPI), persistent dysphagia requiring intervention, and GERD health-related quality-of-life (HRQL) scores 1 year from surgery. RESULTS: During the study period, 47 of 53 (89%) patients underwent concomitant MSA with HHR and complied with surveillance. Hiatal hernias ranged from 3 to 7 cm (mean 4 ± 1). Mean clinical follow-up time was 19 months (range 1-39). GERD-HRQL score decreased from 20.3 to 3.1 (p < .001), 89% of patients remained off PPIs, and 97% of patients reported improvement or resolution of symptoms. Two recurrent hiatal hernias were identified on surveillance imaging for a recurrence rate of 4.3% at a mean 18 (± 10) months after initial operation. Persistent dysphagia occurred in 13% (6/47) over the first year, which resolved after a single balloon dilation in 67% (4/6). Two patients elected for device removal due to dilation-refractory dysphagia and persistent reflux symptoms. CONCLUSION: Concomitant magnetic sphincter augmentation and hiatal hernia repair in patients with gastroesophageal reflux disease and a moderate-sized hiatal hernia demonstrates durable subjective reflux control and an acceptable hiatal hernia recurrence rate at 1- to 2-year follow-up.

Moderate intensity low frequency rotating magnetic field inhibits breast cancer growth in mice.

Moderate intensity low frequency rotating magnetic field (LF-RMF) has been shown to inhibit melanoma, liver and lung cancer growth in mice. However, its effects on other types of cancers have not been investigated in vivo. Here, we show that 0-0.15T moderate intensity 4.2 Hz LF-RMF can inhibit tumor growth in mice bearing MDA-MB231 and MCF7 human breast cancer cells by over 30%. In contrast, the human gastrointestinal stromal tumor GIST-T1 growth was not inhibited by LF-RMF. In all RMF treatments, there were no apparent adverse effects on mice organs, body weight or water/food consumptions. However, the alanine aminotransferase (ALT) level was decreased in LF-RMF-treated mice bearing MCF7 and GIST-T1 cells, which indicated alleviated liver damage. Therefore, our study shows that moderate intensity LF-RMF might be a safe physical method that has clinical potentials to be used to inhibit breast cancer growth in the future.

Manometric Changes to the Lower Esophageal Sphincter After Magnetic Sphincter Augmentation in Patients With Chronic Gastroesophageal Reflux Disease.

OBJECTIVE: To evaluate the manometric changes, function, and impact of magnetic sphincter augmentation (MSA) on the lower esophageal sphincter (LES). BACKGROUND: Implantation of a MSA around the gastroesophageal junction has been shown to be a safe and effective therapy for gastroesophageal reflux disease, but its effect on the LES has not been elucidated. METHODS: Retrospective case control study (n = 121) evaluating manometric changes after MSA. Inclusion criteria consisted of a confirmed diagnosis of gastroesophageal reflux disease by an abnormal esophageal pH study (body mass index <35 kg/m, hiatal hernia <3 cm, and absence of endoscopic Barrett disease). Manometric changes, pH testing, and proton pump inhibitor use were assessed preoperatively and 6 and 12 months after MSA. RESULTS: MSA was associated with an overall increase in the median LES resting pressure (18 pre-MSA vs 23 mm Hg post-MSA; P = 0.0003), residual pressure (4 vs 9 mm Hg; P < 0.0001), and distal esophageal contraction amplitude (80 vs 90 mm Hg; P = 0.02). The percent peristalsis remained unaltered (94% vs 87%; P = 0.71).Overall, patients with a manometrically defective LES were restored 67% of the time to a normal sphincter with MSA. Those with a structurally defective or severely defective LES improved to a normal LES in 77% and 56% of patients, respectively. Only 18% of patients with a normal preoperative manometric LES deteriorated to a lower category. CONCLUSION: MSA results in significant manometric improvement of the LES without apparent deleterious effects on the esophageal body. A manometrically defective LES can be restored to normal sphincter, whereas a normal LES remains stable.

Use of supercharged cover screw as static magnetic field generator for bone healing, 2nd part: in vivo enhancement of bone regeneration in rabbits.

In 1979, Pulsed electromagnetic fields (PEMFs) were approved by the Food and Drug Administration as an effective method in the treatment of non-unions. As well as PEMFs, also static magnetic fields (SMFs) have been widely investigated in orthopaedic studies. Even if the exact mechanism of action is not well understood, a large number of studies showed specific effects both at cellular and tissue levels. As bone fracture healing and osseointegration share the same biological events, the application of magnetic field stimulation in order to facilitate the osseointegration process has been suggested. In this study we investigated BIC and newly formed bone volume around dental implants inserted in the tibia of New Zealand rabbits after SMF stimulation, generated by a small-customized cover-screw-shaped neodymium-iron-bore magnet placed in the inner cavity of dental implants. As a result, we found that the SMF field generated around dental implants enhanced bone healing in the animal model. Our findings represent, to our knowledge, the first ready clinical technique for dental implants showing the ability of SMF to promote the osteogenesis process in vivo.

Efficacy of magnetic sphincter augmentation in patients with large hiatal hernias.

BACKGROUND: Magnetic sphincter augmentation (MSA) has demonstrated long-term safety and efficacy in the treatment of patients with gastroesophageal reflux (GERD), but its efficacy in patients with large hiatal hernias has yet to be proven. The aim of our study was to assess outcomes of MSA in patients with hiatal hernias ≥3 cm. METHODS: We retrospectively reviewed all patients who underwent MSA at our institutions over a 6-year period. Information obtained consisted of patient demographics, symptoms of GERD, preoperative GERD Health-Related Quality-of-Life (HRQL) scores, perioperative details, and implantation of the MSA device. Primary endpoints included postoperative GERD-HRQL scores, proton-pump inhibitor (PPI) use, symptom change, and procedure-related complications. A large hiatal hernia was defined as a hernia measuring ≥3 cm by intraoperative measurement. RESULTS: A total of 192 patients were reviewed. Median follow-up was 20 months (3-75 months). Mean GERD-HRQL scores in the overall population before and after MSA were 18.9 and 5.0, respectively (p < 0.001). In the majority of patients symptoms improved or resolved (N = 177, p < 0.001). Fifty-two patients (27.0 %) had a hiatal hernia ≥3 cm (range 3-7 cm). Their mean GERD-HRQL score decreased from 20.5 to 3.6 (p < 0.001) following MSA. When compared to patients with smaller hernias, patients with large hiatal hernias had decreased postoperative PPI requirement (9.6 vs. 26.6 %, p = 0.011) and lower mean postoperative GERD-HRQL scores (3.6 vs. 5.6, p = 0.027). The percent of patients requiring postoperative intervention for dysphagia was similar (13.5 vs. 17.9 %, p = 0.522), as was the incidence of symptom resolution or improvement (98.1 vs. 91.3 %, p = 0.118). CONCLUSION: MSA in patients with large hiatal hernias demonstrates decreased postoperative PPI requirement and mean GERD-HRQL scores compared to patients with smaller hernias. The incidence of symptom resolution or improvement and the percentage of patients requiring intervention for dysphagia are similar. Short-term outcomes of MSA are encouraging in patients with gastroesophageal reflux disease and large hiatal hernias.

The Fenix System for Fecal Incontinence: An Overview and Surgical Demonstration.

STUDY OBJECTIVE: This video shows a new technique for the surgical management of fecal incontinence using the Fenix Continence Restoration System (TORAX Medical Inc, Shoreview, MN) in 2 patients. DESIGN: A step-by-step explanation of the video using videos and pictures (educational video) for surgeons (Canadian Task Force classification III). SETTING: The use of the Fenix System received United States Food and Drug Administration approval under a humanitarian device exemption and can be used with institutional review board approval in patients who have failed previous medical and surgical management of fecal incontinence. The device is a small, flexible band of interlinked titanium, magnetic beads on a titanium string that is placed using a perineal approach around the anal canal. Increased intra-abdominal pressure opens the beads to allow for the passage of stool. INTERVENTIONS: Placement of the device was performed in 2 patients. Case 1 is a 63-year-old woman with a long-standing history of fecal incontinence who failed sphincteroplasty, sacral neuromodulation, and an artificial sphincter cuff and pump. Case 2 is a 60-year-old woman with a long-standing history of fecal incontinence secondary to radiation therapy for rectal cancer who failed physical therapy and sacral neuromodulation. CONCLUSION: Both Fenix Continence Restoration Systems were placed successfully. Long-term postoperative effectiveness is currently being evaluated.