Hysteroscopic Lysis of Complex Uterine Adhesions After Interventional Radiology-Guided Access.

OBJECTIVE: To demonstrate a novel surgical technique using hysteroscopic lysis of adhesions after interventional radiology (IR)-guided access in patients with severe intrauterine adhesions and challenging uterine access. DESIGN: This video illustrates the technique of the safe division of intrauterine adhesions after IR-guided access. SETTING: Conventional hysteroscopic adhesiolysis might be inadequate or risky in cases of severely narrowed or obstructed uterine flow tract, possibly resulting in incomplete adhesiolysis, false passages, or uterine perforation. This video presents 2 cases from a tertiary center involving a multidisciplinary team of a reproductive surgeon and an interventional radiologist. The first case involves a 38-year-old with severe Asherman syndrome, who experienced unsuccessful attempt to treat adhesions that was complicated by a false passage. The second case involves a 39-year-old with recurrent severe Asherman syndrome and a history of unsuccessful attempts at hysterosalpingogram and conventional hysteroscopic lysis of adhesions. INTERVENTIONS: In the IR suite, the patient was put in a lithotomy position on the fluoroscopy table. A vaginal speculum was inserted exposing the cervix. The procedure was performed using intravenous sedation and topical anesthetic spray applied to the cervix. Using fluoroscopy, a balloon cannula was inserted through the cervix, followed by contrast injection to assess uterine access. If there is no route, transvaginal ultrasound-guided needle cannulation of the main portion of the uterine cavity would be performed, approximating as closely as possible to the expected route of the cervical canal. A guidewire followed by a locked loop catheter was advanced through adhesions into the uterine cavity. The catheter was left protruding from the cervix to guide the hysteroscope. The patient was then transferred to the operating room for the hysteroscopic procedure. Under the guidance of the intrauterine catheter, the adhesions were carefully lysed using cold scissors. The endometrial cavity and tubal openings were inspected to ensure complete adhesiolysis and exclusion of any other copathologies. CONCLUSION: IR guidance can provide a safe and effective approach to hysteroscopic lysis of adhesions in patients with challenging intrauterine adhesions and difficult uterine access, such as patients with severe Asherman syndrome, intractable cervical stenosis, uterine wall agglutination, previous adhesiolysis failure, marked fixed retroverted retroflexed uteri, and previous false passage or uterine perforation.

Hepatic Hilar Nerve Block for Adjunctive Analgesia during Percutaneous Thermal Ablation of Hepatic Tumors: A Retrospective Analysis.

PURPOSE: To determine whether hepatic hilar nerve block techniques reduce analgesic and sedation requirements during percutaneous image-guided thermal ablation of hepatic tumors. MATERIALS AND METHODS: A single-center retrospective cohort analysis was performed of 177 patients (median age, 67 years; range, 33-86 years) who underwent percutaneous image-guided thermal ablation of liver tumors. All patients were treated utilizing local anesthetic and moderate sedation between November 2018 and November 2021 at a tertiary level hospital, with or without the administration of a hepatic hilar nerve block. Univariable and multivariable linear regression analyses were performed to determine the relationship between the administration of the hilar nerve block and fentanyl and midazolam dosages. RESULTS: A total of 114 (64%) patients received a hilar nerve block in addition to procedural sedation, and 63 (36%) patients received procedural sedation alone. There were no significant differences in the baseline demographic and tumor characteristics between the cohorts. The procedure duration was longer in the hilar block cohort than in the unblocked cohort (median, 95 vs 82 minutes; P = .0012). The technical success rate (98% in both the cohorts, P = .93) and adverse event rate (11% vs 3%, P = .14) were not significantly different between the cohorts. After adjusting for patient and tumor characteristics, ablation modality, and procedure and ablation durations, hilar nerve blocks were associated with lower fentanyl (-18.4%, P = .0045) and midazolam (-22.7%, P = .0007) dosages. CONCLUSIONS: Hepatic hilar nerve blocks significantly decrease the fentanyl and midazolam requirements during thermal ablation of hepatic tumors, without a significant change in the technical success or adverse event rates.

Diagnosis and Management of Pelvic Venous Disorders: AJR Expert Panel Narrative Review.

Pelvic venous disorders (PeVD), previously known by various imprecise terms including pelvic congestion syndrome, have historically been underdiagnosed as a cause of chronic pelvic pain (CPP), a significant health problem associated with reduced quality of life. However, progress in the field has helped to provide heightened clarity with respect to definitions relating to PeVD, and evolution in algorithms for PeVD workup and treatment has been accompanied by new insights into the causes of a pelvic venous reservoir and associated symptoms. Ovarian and pelvic vein embolization, as well as endovascular stenting of common iliac vein compression, should be considered as management options for PeVD. Both treatments have been shown to be safe and effective for patients with CPP of venous origin, regardless of age. Current therapeutic protocols for PeVD exhibit significant heterogeneity owing to limited prospective randomized data and evolving understanding of the factors driving successful outcomes; forthcoming clinical trials are anticipated to improve understanding of CPP of venous origin as well as algorithms for PeVD management. This Expert Panel Narrative Review provides a contemporary update relating to PeVD, summarizing the entity's current classification, diagnostic workup, endovascular treatments, management of persistent or recurrent symptoms, and future research directions.

Increased mean R2* in the deep gray matter of multiple sclerosis patients: Have we been measuring atrophy?

BACKGROUND: Magnetic resonance relaxometry studies in multiple sclerosis (MS) have suggested that iron accumulates within deep gray matter (DGM) structures early in the disease course. However, the commonly utilized mean R2* and magnetic susceptibility measures reflect regional iron concentration but not a structure's total iron content. Thus, tissue atrophy could impact mean R2* and magnetic susceptibility estimates. PURPOSE: To demonstrate that both average iron concentration and total iron content need to be reported in order to distinguish between atrophy-related and definite magnetic susceptibility changes. STUDY TYPE: Observational. POPULATION: The study was performed on 30 healthy controls (HCs) and 39 people with definite MS. FIELD STRENGTH/SEQUENCE: 3T Philips Achieva using an 8-channel SENSE head coil. R2* data were acquired using a multiecho gradient echo sequence and diffusion tensor imaging data were acquired using an echo-planar sequence. ASSESSMENT: Total iron content in DGM structures was assessed by calculating the sum of all R2* values within a region (denoted as R2mass* ) and compared to the mean R2* as a measure of iron concentration. STATISTICAL TEST: Significant group differences were investigated in a linear regression model. All DGM structures were assessed individually and the significance threshold was adjusted using the Bonferroni-Holm correction for multiple comparisons. RESULTS: There was an increased mean DGM R2* in MS patients compared to HCs (significant in the pallidus, P = 0.0051). In contrast, R2mass* in patients was found to be lower in the thalamus and the caudate (P = 0.0011) compared to HCs, and similar between the two cohorts in the other DGM regions. DATA CONCLUSION: An increase in mean R2* may not necessarily reflect increased iron accumulation. We propose R2mass* as an additional metric to account for the effects of tissue atrophy when assessing tissue content changes, such as iron deposition or loss. LEVEL OF EVIDENCE: 1 Technical Efficacy: Stage 1 J. Magn. Reson. Imaging 2019;50:201-208.

Research Priorities in Pelvic Venous Disorders in Women: Recommendations from a Multidisciplinary Research Consensus Panel.

Pelvic venous disorders (PeVDs) in women can present with chronic pelvic pain, lower-extremity and vulvar varicosities, lower-extremity swelling and pain, and left-flank pain and hematuria. Multiple evidence gaps exist related to PeVDs with the consequence that nonvascular specialists rarely consider the diagnosis. Recognizing this, the Society of Interventional Radiology Foundation funded a Research Consensus Panel to prioritize a research agenda to address these gaps. This paper presents the proceedings and recommendations from that Panel.

Angiographic and Intracoronary Manifestations of Coronary Fibromuscular Dysplasia.

BACKGROUND: We previously described a strong association between fibromuscular dysplasia (FMD) and spontaneous coronary artery dissection. Angiographic manifestations of coronary FMD aside from dissection were considered rare. However, we observed several coronary FMD angiographic abnormalities with corresponding optical coherence tomography abnormalities. METHODS AND RESULTS: Baseline demographics and imaging of patients with suspected coronary FMD at Vancouver General Hospital were reviewed. Presence of multifocal (string-of-beads) extracoronary FMD was confirmed by 2 specialists. In these patients, coronary angiographic findings (excluding dissected segments) were reviewed and classified by 2 experienced angiographers for irregular stenosis, that is, stenosis with irregular borders in a focal or diffuse pattern with/without systolic accentuation; smooth stenosis, diffuse or focal; segmental dilatation/ectasia; and tortuosity. Optical coherence tomography was performed in a subset of patients. Of 32 patients with extracoronary FMD and suspected coronary involvement, 28 were women (88%), and their mean age was 59.4±9.9 years. Nineteen presented with myocardial infarction (13 caused by spontaneous coronary artery dissection), and 13 had stable symptoms. The observed coronary angiographic abnormalities included tortuosity in all cases (91% were moderate to severe), irregular stenosis in 59%, smooth stenosis in 19%, and segmental dilatation/ectasia in 56%. Fifteen patients had optical coherence tomography of the abnormal segments showing abnormalities, including multiple areas of patchy or diffuse intimal, medial or adventitial abnormalities with thickening/accumulation of varied reflectivities, macrophage infiltration, loss/duplication of elastic membranes, and cavitation. CONCLUSIONS: This is the first case series describing findings suggestive of angiographic and intracoronary manifestations of coronary FMD. Future studies should prospectively review these features in patients with extracoronary FMD.

Durable Clinical Effectiveness With Paclitaxel-Eluting Stents in the Femoropopliteal Artery: 5-Year Results of the Zilver PTX Randomized Trial.

BACKGROUND: This randomized controlled trial evaluated clinical durability of Zilver PTX, a paclitaxel-coated drug-eluting stent (DES), for femoropopliteal artery lesions. Outcomes compare primary DES versus percutaneous transluminal angioplasty (PTA), overall DES (primary and provisional) versus standard care (PTA and provisional Zilver bare metal stent [BMS]), and provisional DES versus provisional BMS. METHODS AND RESULTS: Patients with symptomatic femoropopliteal artery disease were randomly assigned to DES (n=236) or PTA (n=238). Approximately 91% had claudication; 9% had critical limb ischemia. Patients experiencing acute PTA failure underwent secondary randomization to provisional BMS (n=59) or DES (n=61). The 1-year primary end points of event-free survival and patency showed superiority of primary DES in comparison with PTA; these results were sustained through 5 years. Clinical benefit (freedom from persistent or worsening symptoms of ischemia; 79.8% versus 59.3%, P<0.01), patency (66.4% versus 43.4%, P<0.01), and freedom from reintervention (target lesion revascularization, 83.1% versus 67.6%, P<0.01) for the overall DES group were superior to standard care in nonrandomized comparisons. Similarly, clinical benefit (81.8% versus 63.8%, P=0.02), patency (72.4% versus 53.0%, P=0.03), and freedom from target lesion revascularization (84.9% versus 71.6%, P=0.06) with provisional DES were improved over provisional BMS. These results represent >40% relative risk reduction for restenosis and target lesion revascularization through 5 years for the overall DES in comparison with standard care and for provisional DES in comparison with provisional BMS. CONCLUSIONS: The 5-year results from this large study provide long-term information previously unavailable regarding endovascular treatment of femoropopliteal artery disease. The Zilver PTX DES provided sustained safety and clinical durability in comparison with standard endovascular treatments. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00120406.

Transradial Access for Interventional Radiology: Single-Centre Procedural and Clinical Outcome Analysis.

PURPOSE: The study sought to describe a single centre's technical approach to transradial intervention and report on clinical outcomes and safety. METHODS: A total of 749 transradial access (TRA) procedures were performed at a single hospital in 562 patients (174 women and 388 men). Procedures included 445 bland embolizations or chemoembolizations of the liver, 88 uterine artery embolizations, and 148 procedures for Selective Internal Radiation Therapy (Y90), which included mapping and administration. The mean age of the patients was 62 years (range 27-96 years). RESULTS: Four cases (0.5%) required crossover to transfemoral (tortuous anatomy, inability to secure a stable position for embolization, vessel spasm and base catheter not being of a sufficient length). A single asymptomatic, short-segment radial artery occlusion occurred (0.3%), 3 patients (0.4%) developed small hematomas postprocedurally, and 2 patients (0.7%) had transient neurological pain, which was resolved within a week without treatment. It was found that 98% of patients who had a previous femoral access procedure would choose radial access for subsequent procedures. CONCLUSIONS: Transradial access is a safe, effective technique, with a learning curve; however, this procedure has the potential to significantly improve departmental workflow and cost savings for the department and patient experience.

Prevalence of Extracranial Venous Narrowing on Magnetic Resonance Venography Is Similar in People With Multiple Sclerosis, Their Siblings, and Unrelated Healthy Controls: A Blinded, Case-Control Study.

PURPOSE: The study sought to assess and compare the prevalence of narrowing of the major extracranial veins in subjects with multiple sclerosis and controls, and to assess the sensitivity and specificity of magnetic resonance venography (MRV) for describing extracranial venous narrowing as it applies to the chronic cerebrospinal venous insufficiency theory, using catheter venography (CV) as the gold standard. METHODS: The jugular and azygos veins were assessed with time-of-flight MRV in this assessor-blinded, case-control study of subjects with multiple sclerosis, their unaffected siblings, and unrelated controls. The veins were evaluated by diameter and area, and compared with CV. Collateral vessels were also analyzed for maximal diameter, as a potential indicator of compensatory flow. RESULTS: A high prevalence of extracranial venous narrowing was demonstrated in all study groups, collectively up to 84% by diameter criteria and 90% by area, with no significant difference between the groups when assessed independently (P = .34 and .63, respectively). There was high interobserver variability in the reporting of vessel narrowing (kappa = 0.32), and poor vessel per vessel correlation between narrowing on MRV and CV (kappa = 0.064). Collateral neck veins demonstrated no convincing difference in maximum size or correlation with jugular narrowing. CONCLUSION: There is a high prevalence of narrowing of the major extracranial veins on MRV in all 3 study groups, with no significant difference between them. These findings do not support the chronic cerebrospinal venous insufficiency theory. Although MRV has shown a high sensitivity for identifying venous narrowing, time-of-flight imaging demonstrates poor interobserver agreement and poor specificity when compared with the gold standard CV.

Prevalence of extracranial venous narrowing on catheter venography in people with multiple sclerosis, their siblings, and unrelated healthy controls: a blinded, case-control study.

BACKGROUND: Chronic cerebrospinal venous insufficiency has been proposed as a unique combination of extracranial venous blockages and haemodynamic flow abnormalities that occurs only in patients with multiple sclerosis and not in healthy people. Initial reports indicated that all patients with multiple sclerosis had chronic cerebrospinal venous insufficiency. We aimed to establish the prevalence of venous narrowing in people with multiple sclerosis, unaffected full siblings, and unrelated healthy volunteers. METHODS: We did an assessor-blinded, case-control, multicentre study of people with multiple sclerosis, unaffected siblings, and unrelated healthy volunteers. We enrolled the study participants between January, 2011 and March, 2012, and they comprised 177 adults: 79 with multiple sclerosis, 55 siblings, and 43 unrelated controls, from three centres in Canada. We assessed narrowing of the internal jugular and azygous veins with catheter venography and ultrasound criteria for chronic cerebrospinal venous insufficiency proposed by Zamboni and colleagues. Catheter venography data were available for 149 participants and ultrasound data for 171 participants. FINDINGS: Catheter venography criteria for chronic cerebrospinal venous insufficiency were positive for one of 65 (2%) people with multiple sclerosis, one of 46 (2%) siblings, and one of 32 (3%) unrelated controls (p=1·0 for all comparisons). Greater than 50% narrowing of any major vein was present in 48 of 65 (74%) people with multiple sclerosis, 31 of 47 (66%) siblings (p=0·41 for comparison with patients with multiple sclerosis), and 26 of 37 (70%) unrelated controls (p=0·82). The ultrasound criteria for chronic cerebrospinal venous insufficiency were fulfilled in 35 of 79 (44%) participants with multiple sclerosis, 17 of 54 (31%) siblings (p=0·15 for comparison with patients with multiple sclerosis) and 17 of 38 (45%) unrelated controls (p=0·98). The sensitivity of the ultrasound criteria for detection of greater than 50% narrowing on catheter venography was 0·406 (95% CI 0·311-0·508), and specificity was 0·643 (0·480-0·780). INTERPRETATION: This study shows that chronic cerebrospinal venous insufficiency occurs rarely in both patients with multiple sclerosis and in healthy people. Extracranial venous narrowing of greater than 50% is a frequent finding in patients with multiple sclerosis, unaffected siblings, and unrelated controls. The ultrasound criteria are neither sensitive nor specific for narrowing on catheter venography. The significance of venous narrowing to multiple sclerosis symptomatology remains unknown. FUNDING: MS Society of Canada, Saskatoon City Hospital Foundation, Lotte and John Hecht Memorial Foundation, Vancouver Coastal Health Foundation, and the Wolridge Foundation.

A prospective randomized trial of povidone-iodine prophylactic cleansing of the rectum before transrectal ultrasound guided prostate biopsy.

PURPOSE: Transrectal ultrasound guided prostate biopsy can lead to urinary tract infections in 3% to 11% and sepsis in 0.1% to 5% of patients. We investigated the efficacy of rectal cleansing with povidone-iodine before transrectal ultrasound guided prostate biopsy to reduce infectious complications. MATERIALS AND METHODS: Between 2009 and 2011, 865 men were prospectively randomized to rectal cleansing (421) or no cleansing (444) before transrectal ultrasound guided prostate biopsy. Patients received ciprofloxacin prophylaxis and rectal swab cultures were obtained before transrectal ultrasound guided prostate biopsy. Patients completed a telephone interview 7 days after undergoing the biopsy. The primary end point was the rate of infectious complications, a composite end point of 1 or more of 1) fever greater than 38.0C, 2) urinary tract infection or 3) sepsis (standardized definition). Chi-square significance testing was performed for differences between groups and a multivariate analysis was performed to assess risk factors for infectious complications. RESULTS: Infectious complications were observed in 31 (3.5%) patients, including 11 (2.6%) treated and 20 (4.5%) control patients (p = 0.15). Sepsis was observed in 4 (1.0%) treated and 7 (1.6%) control patients (p = 0.55). On multivariate analysis resistance to ciprofloxacin in the rectal swab culture (p = 0.002) and a history of taking ciprofloxacin in the 3 months preceding transrectal ultrasound guided prostate biopsy (p = 0.009) predicted infectious complications. CONCLUSIONS: Rectal cleansing with povidone-iodine before transrectal ultrasound guided prostate biopsy was safe, but the 42% relative risk reduction of infectious complications was not statistically significant. Patients who have received ciprofloxacin within 3 months of transrectal ultrasound guided prostate biopsy should be considered for alternate prophylaxis or possibly a delay of biopsy beyond 3 months.

Ciprofloxacin resistance in the faecal carriage of patients undergoing transrectal ultrasound guided prostate biopsy.

UNLABELLED: WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Transrectal ultrasound guided prostate biopsies (TRUSBx) are associated with a spectrum of complications, including most significantly infection, which affects up to 5% of patients. In the most severe cases, infection leads to sepsis, a life-threatening complication. Escherichia coli is the primary responsible pathogen. Although antibiotic prophylaxis with fluoroquinolones is routinely used, there is evidence that the infection rate after TRUSBx is increasing, and this appears to be due to an increasing prevalence of ciprofloxacin-resistant rectal flora. This is the largest prospective clinical trial to date analysing the rectal flora of men undergoing prostate biopsies. We determined the microbial and antibiotic sensitivity profiles from 849 patients. Ciprofloxacin-resistant Gram-negative organisms were identified in the rectal flora of 19.0% of men. Furthermore, fluoroquinolone use within 6 months preceding a TRUSBx and the presence of a prosthetic heart valve were significant predictors of ciprofloxacin resistance on rectal swab. Determining the prevalence of rectal fluoroquinolone resistance has important implications in evaluation of the suitability of prophylactic regimens. Antimicrobial profiles derived from rectal swabs pre-biopsy may prove useful in guiding targeted antibiotic prophylaxis. OBJECTIVES: To establish the prevalence of ciprofloxacin-resistant bacteria in patients undergoing transrectal ultrasound guided prostate biopsies (TRUSBx) and to determine whether this predicts subsequent infectious complications. To identify risk factors for harbouring ciprofloxacin-resistant flora. PATIENTS AND METHODS: Any patient undergoing a TRUSBx from 2009 to 2011 was eligible for enrolment in this prospective study. Pre-biopsy rectal and urine cultures and post-biopsy urine cultures were obtained and antimicrobial susceptibility was determined. Univariate and multivariate analyses were performed to identify independent patient risk factors associated with ciprofloxacin-resistant rectal flora. RESULTS: A total of 865 patients underwent TRUSBx, of whom 19.0% were found to have ciprofloxacin-resistant Gram-negative coliforms. Escherichia coli was the most prevalent Gram-negative rectal isolate (80.9%) and accounted for 90.6% of ciprofloxacin resistance. Patient characteristics that conferred an increased risk of harbouring ciprofloxacin-resistant organisms included a history of a heart valve replacement (P < 0.05) and ciprofloxacin use in the past 3 months (P < 0.05). Infectious complications were observed in 3.6% (n = 31) of the patient population and 48% of these patients grew ciprofloxacin-resistant organisms on the pre-biopsy rectal swab (P < 0.001). CONCLUSIONS: Antimicrobial resistance to ciprofloxacin in the rectal flora was common, particularly in patients with recent ciprofloxacin use and a heart valve replacement. Despite a significant correlation between those patients who developed infections and the detection of ciprofloxacin-resistant organisms, only 9.0% (n = 15) of the total group with ciprofloxacin resistance developed an infectious complication. Future studies will need to evaluate the cost effectiveness and clinical utility of a pre-biopsy rectal culture in targeting antibiotic prophylaxis.

Development of a unilateral porcine emphysema model induced by porcine pancreatic elastase.

Emphysema is one of the pathological hallmarks of chronic obstructive pulmonary disease. We have recently reported that radiofrequency therapy improves lung function in rodent models of emphysema. However, preclinical data using large animals is necessary for clinical translation. Here, we describe the work performed to establish a unilateral porcine emphysema model. Different doses of porcine pancreatic elastase (PPE) were instilled into the left lung of 10 Yucatan pigs. Three additional pigs were used as controls. Six weeks after instillation, lungs were harvested. Lung compliance was measured by a water displacement method and plethysmography. Systematic uniform random sampling of the left and right lungs was performed independently to measure alveolar surface area using micro-computed tomography (micro-CT) and histology. In pigs instilled with 725-750 U/kg of PPE (PPE group, n = 6), the compliance of the left lung was significantly higher by 37.6% than that of the right lung (P = 0.03) using the water displacement method. With plethysmography, the volume of the left lung was significantly larger than that of the right lung at 3, 5, and 10 cmH2O. Measurements from either micro-CT or histology images showed a significant decrease in alveolar surface area by 14.2% or 14.5% (P = 0.031) in the left lung compared with the right lung of the PPE group. A unilateral model for mild emphysema in Yucatan pigs has been established, which can now be used for evaluating novel therapeutics and interventional strategies.NEW & NOTEWORTHY For clinical translation, preclinical data using large animal models is necessary. However, papers describing an emphysema model in pigs, which are anatomically and physiologically similar to humans, are lacking. Here, we report success in creating a unilateral mild-emphysema model in pigs with only one single dose of porcine pancreatic elastase. This model will be useful in bringing novel technologies and therapies from small animals to humans with emphysema.

Cortical morphology predicts placebo response in multiple sclerosis.

Despite significant insights into the neural mechanisms of acute placebo responses, less is known about longer-term placebo responses, such as those seen in clinical trials, or their interactions with brain disease. We examined brain correlates of placebo responses in a randomized trial of a then controversial and now disproved endovascular treatment for multiple sclerosis. Patients received either balloon or sham extracranial venoplasty and were followed for 48 weeks. Venoplasty had no therapeutic effect, but a subset of both venoplasty- and sham-treated patients reported a transient improvement in health-related quality of life, suggesting a placebo response. Placebo responders did not differ from non-responders in total MRI T2 lesion load, count or location, nor were there differences in normalized brain volume, regional grey or white matter volume or cortical thickness (CT). However, responders had higher lesion activity. Graph theoretical analysis of CT covariance showed that non-responders had a more small-world-like CT architecture. In non-responders, lesion load was inversely associated with CT in somatosensory, motor and association areas, precuneus, and insula, primarily in the right hemisphere. In responders, lesion load was unrelated to CT. The neuropathological process in MS may produce in some a cortical configuration less capable of generating sustained placebo responses.

Safety and feasibility report on nonimplantable endovenous valve formation for the treatment of deep vein reflux.

OBJECTIVE: Definitive treatment techniques for symptomatic deep venous reflux have been relegated to complex and invasive open surgery which is rarely performed today. The BlueLeaf System provides an endovenous method for the formation of deep venous valves without an implant, avoiding the complications associated with permanent foreign materials. The system has the adaptability to form valves within the femoral and popliteal veins at multiple levels in a single procedure. The aim was to determine the midterm safety and efficacy of this novel device in an early feasibility study. METHODS: Feasibility of endovenous deep venous valve formation was assessed in patients with chronic venous insufficiency (Clinical, Etiologic, Anatomic, Pathophysiologic [CEAP] 4-6). Follow-up was completed through 1 year, assessing vein patency and reflux time (RT) with duplex ultrasound examination. Venous clinical improvement was evaluated using the revised Venous Clinical Severity Scale. RESULTS: Of the 14 patients, 13 (93%) had successful formation of at least one monocuspid valve, with a mean number of 1.4 valves (range, 0-3 valves) per patient. There were no device-related serious adverse events during the index procedure. There were no deep venous thromboses reported at any time point, including 10 patients through the 1-year follow-up. In patients with at least one valve formed, site reported duplex ultrasound examination measured the average RT in the popliteal vein below valve formations, was 3.0 ± 1.0 seconds at baseline, 3.9 ± 3.1 seconds at 30 days, and 3.6 ± 2.1 seconds at 360 days. The revised Venous Clinical Severity Scale improved in all 13 successfully treated patients, decreasing from 15.0 ± 6.0 at baseline to 11.6 ± 5.5 at 30 days, 10.7 ± 5.3 at 210 days, and 9.4 ± 5.0 at 360 days (P = .0002; baseline to 360 days). Among the five patients with an ulcer who reached the 360-day follow-up visit, all (100%) healed at least one ulcer. Two patients (40%) healed all ulcers and three patients (60%) had a decrease in ulcers number but remained at C6 at 360 days. The five patients with a total of nine active ulcers at baseline had four active ulcers at 360 days. CONCLUSIONS: The BlueLeaf System holds promise as a minimally invasive means to safely form fully autogenous deep venous valves. Reconstructed deep veins remained patent, without deep venous thrombosis and symptomatic improvement was consistently observed; however, a decrease in the RT was not. Incremental device design improvements have been undertaken to improve valve function. The results of these iterations await further clinical evaluation.

Radiofrequency therapy improves exercise capacity of mice with emphysema.

Emphysema is a common phenotype of chronic obstructive pulmonary disease (COPD). Although resection of emphysematous tissue can improve lung mechanics, it is invasive and fraught with adverse effects. Meanwhile, radiofrequency (RF) treatment is an extracorporeal method that leads to tissue destruction and remodeling, resulting in "volume reduction" and overall improvement in lung compliance of emphysematous lungs. Whether these changes lead to improved exercise tolerance is unknown. Here, we investigated the effectiveness of RF treatment to improve the exercise capacity of mice with emphysema. Fifty-two mice (7 weeks of age) were used in this experiment. A bilateral emphysema model was created by intratracheally instilling porcine pancreatic elastase (PPE) (1.5U/100 g body weight). RF treatment (0.5 W/ g body weight) was administered extracorporeally 14 days later and mice were sacrificed after another 21 days. The exercise capacity of mice was measured using a treadmill. Treadmill runs were performed just before PPE instillation (baseline), before RF treatment and before sacrifice. Following sacrifice, lung compliance and mean linear intercept (Lm) were measured and fibrosis was assessed using a modified Ashcroft score. There were 3 experimental groups: controls (instilled with saline, n = 12), emphysema (instilled with porcine pancreatic elastase, PPE, n = 11) and emphysema + treatment (instilled with PPE and given RF, n = 9). At endpoint, the maximum velocity of the emphysema + treatment group was significantly higher than that of the emphysema group, indicating improved exercise tolerance (86.29% of baseline vs 61.69% of baseline, p = 0.01). Histological analysis revealed a significant reduction in emphysema as denoted by Lm between the two groups (median 29.60 µm vs 35.68 µm, p = 0.03). The emphysema + treatment group also demonstrated a higher prevalence of lung fibrosis (≧Grade 3) compared with the emphysema group (11.7% vs 5.4%, p < 0.01). No severe adverse events from RF were observed. RF treatment improved the exercise capacity of mice with emphysema. These data highlight the therapeutic potential of RF treatment in improving the functional status of patients with COPD.