Primary Use of the TruePath Crossing Device for Infrainguinal Chronic Total Occlusions With Intravascular Ultrasound Evaluation

2018 ◽  
Vol 25 (5) ◽  
pp. 592-598 ◽  
Author(s):  
Yoshimitsu Soga ◽  
Miho Nakamura ◽  
Kaoru Hirose ◽  
Nobuhiro Ito ◽  
Yusuke Tomoi ◽  
...  
Keyword(s):  
Intravascular Ultrasound ◽  
Primary Outcome ◽  
Independent Predictor ◽  
Primary Outcome Measure ◽  
High Rate ◽  
Access Site ◽  
Chronic Total Occlusions ◽  
Ultrasound Evaluation ◽  
The Mean ◽  
Severe Calcification

Purpose: To evaluate the use of the TruePath crossing device as the primary recanalization tool for infrainguinal chronic total occlusions (CTO). Methods: A retrospective analysis was conducted of 50 patients (mean age 75 years; 26 men) with 55 infrainguinal CTOs treated with the TruePath between March 2017 and September 2017 at a single center. The mean occlusion length was 138±55 mm, and femoropopliteal lesions accounted for 65% of the 55 lesions. The primary outcome measure was CTO crossing using the TruePath alone; secondary outcomes were assisted success (>50% lumen gain using the TruePath), device-related complications, and intraluminal crossing evaluated by intravascular ultrasound (IVUS). Results: Complete success was achieved in 33 (60%) of 55 lesions having a mean occlusion length of 145±72 mm. Among these, the true lumen crossing rate was 97% according to IVUS evaluation. Assisted success was achieved in 15 (68%) of the 22 failures. Complete/assisted success, in which the TruePath was thought to have contributed to CTO crossing, was attained in 48 (87%) of the 55 lesions. Three (5.5%) complications were observed: a perforation, an access-site hematoma, and acute occlusion; only the perforation was device related (1.8%). Multivariate analysis showed PACCS grade 4 (odds ratio 4.5, 95% confidence interval 1.33 to 15.5, p=0.02) was an independent predictor of TruePath failure. Conclusion: Primary use of the TruePath crossing device for infrainguinal CTOs demonstrated a satisfactory complete success rate and a high rate of IVUS-documented intraluminal crossing with few device-related complications. Severe calcification is an independent predictor of TruePath failure.

A phase III trial of intramuscular recombinant interferon beta as treatment for exacerbating-remitting multiple sclerosis: design and conduct of study and baseline characteristics of patients

1995 ◽  
Vol 1 (2) ◽  
pp. 118-135 ◽  
Author(s):  
LD Jacobs ◽  
DL Cookfair ◽  
RA Rudick ◽  
RM Herndon ◽  
J R Richert ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Interferon Beta ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Phase Iii ◽  
Secondary Outcome ◽  
Recombinant Interferon ◽  
Study Population ◽  
The Mean ◽  
Baseline Characteristics

The design and conduct of a randomized, double-blinded, placebo-controlled, multicenter, phase III study of recombinant interferon beta-1a (IFN-β-1a) as treatment for exacerbating-remitting MS are described, as are baseline characteristics of the study population. The purpose of the study was to determine if 6.0 × 106 IU (30 μg) of IFN-β-1a, administered by weekly intramuscular (i.m.) injections, was effective in delaying the onset of sustained disability. The primary outcome measure was time to onset of treatment failure, defined as a worsening on the Kurtzke Expanded Disability Status Scale (EDSS) of greater than or equal to 1.0 point compared with baseline, persisting for at least 6 months. An intent-to-treat design was used. The primary outcome measure was analyzed using the Mantel-Cox log-rank statistic and Kaplan-Meier survival curves. Secondary outcomes included quantitative measures of upper and lower extremity function, neuropsychological test performance, functional and quality of life assessments and several measures derived from annual brain MRI studies. Entry criteria included prestudy exacerbation rates of at least 0.67 per year and EDSS scores of 1.0–3.5. A total of 301 MS patients were randomly assigned to receive weekly i.m. injections of IFN-β-1a or placebo. The average age of the study population at entry was 37 years; 92% were Caucasian and 73% were women. The mean prestudy disease duration was 6.5 years, mean prestudy exacerbation rate was 1.2 per year and the mean EDSS score was 2.3. The randomization yielded well-balanced treatment arms. Various aspects of the study are discussed, including: (1) the decision to focus study design on sustained disability; (2) the rationale for the treatment regimen; (3) measures taken to assure the reliability of the primary outcome measure; and (4) a description of the secondary outcome measures.

Nitroglycerin Is Not Associated with Improved Cerebral Perfusion in Acute Ischemic Stroke

2020 ◽  
pp. 1-9
Author(s):  
Mahesh Kate ◽  
Laura Gioia ◽  
Negar Asdaghi ◽  
Thomas Jeerakathil ◽  
Ashfaq Shuaib ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Cerebral Perfusion ◽  
Primary Outcome ◽  
Infarct Volume ◽  
Univariate Analysis ◽  
Primary Outcome Measure ◽  
Untreated Group ◽  
Stroke Patients ◽  
The Mean

ABSTRACT: Objective: The study was conducted to test the hypothesis that nitroglycerin (NTG) increases cerebral perfusion focally and globally in acute ischemic stroke patients, using serial perfusion-weighted imaging (PWI) magnetic resonance imaging measurements. Patients and methods: Thirty-five patients underwent PWI immediately before and 72 h after administration of a transdermal NTG patch or no treatment. Patients with baseline mean arterial pressure (MAP) > 100 mmHg (NTG group, n = 20) were treated with transdermal NTG (0.2 mg/h) for 72 h, without a nitrate-free interval. Patients with MAP ≤ 100 mmHg (untreated group, n = 15) were not treated. The primary outcome measure was absolute cerebral blood flow (CBF) in the hypoperfused region at 72 h. Results: The mean baseline absolute CBF in the hypoperfused region was similar in the NTG group (33.3 ± 10.2 ml/100 g/min) and untreated (32.7 ± 8.4 ml/100 g/min, p = 0.4) groups. The median (IQR) baseline infarct volume was 10.4 (2.5–49.3) ml in the NTG group and 32.6 (8.6–96.7) ml in the untreated group (p = 0.09). MAP change in the NTG group was 1.2 ± 12.6 and 8 ± 20.7 mmHg at 2 h and 72 h, respectively. Mean absolute CBF in the hypoperfused region at 72 h was similar in the NTG (29.9 ± 12 ml/100 g/min) and untreated groups (24.1 ± 10 ml/100 g/min, p = 0.8). The median infarct volume increased in untreated (11.8 (5.7–44.2) ml) than the NTG group (3.2 (0.5–16.5) ml; p = 0.033) on univariate analysis, however, there was no difference on regression analysis. Conclusion: NTG was not associated with improvement in cerebral perfusion in acute ischemic stroke patients.

scholarly journals A Sternum-Disk Distance Method to Identify the Skin Level for Approaching a Surgical Segment without Fluoroscopy Guidance during Anterior Cervical Discectomy And Fusion

2017 ◽  
Vol 11 (1) ◽  
pp. 50-56
Author(s):  
Gun Woo Lee ◽  
Myun-Whan Ahn ◽  
Ji-Hoon Shin ◽  
Jae Woo Park ◽  
Jae-Hyung Uh ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Kappa Coefficient ◽  
Anterior Cervical Discectomy ◽  
Secondary Outcome ◽  
Distance Method ◽  
Cervical Discectomy ◽  
Observer Reliability ◽  
The Mean

<sec><title>Study Design</title><p>A retrospective review of prospectively collected data.</p></sec><sec><title>Purpose</title><p>To introduce the sternum-disk distance (SDD) method for approaching the exact surgical level without C-arm guidance during anterior cervical discectomy and fusion (ACDF) surgery and to evaluate its accuracy and reliability.</p></sec><sec><title>Overview of Literature</title><p>Although spine surgeons have tried to optimize methods for identifying the skin level for accessing the operative disk level without C-arm guidance during ACDF, success has rarely been reported.</p></sec><sec><title>Methods</title><p>In total, 103 patients who underwent single-level ACDF surgery with the SDD method were enrolled. The primary outcome measure was the accuracy of the SDD method. The secondary outcome measures were the mean SDD value at each cervical level from the cranial margin of the sternum in the neutral and extension positions of the cervical spine and the inter- and intra-observer reliability of the SDD outcome determined using repeated measurements by three orthopedic spine surgeons.</p></sec><sec><title>Results</title><p>The SDD accuracy (primary outcome measure) was indicated in 99% of the patients (102/103). The mean SDD values in the neutral-position magnetic resonance imaging (MRI) were 108.8 mm at C3–C4, 85.3 mm at C4–C5, 64.4 mm at C5–C6, 44.3 mm at C6–C7, and 24.1 mm at C7–T1; and those in the extension-position MRI were 112.9 mm at C3–C4, 88.7 mm at C4–C5, 67.3 mm at C5–C6, 46.5 mm at C6–C7, and 24.3 mm at C7–T1. The Cohen kappa coefficient value for intra-observer reliability was 0.88 (excellent reliability), and the Fleiss kappa coefficient value for inter-observer reliability as reported by three surgeons was 0.89 (excellent reliability).</p></sec><sec><title>Conclusions</title><p>Based on the results of the present study, we recommend performing ACDF surgery using the SDD method to determine the skin level for approaching the surgical cervical segment without fluoroscopic guidance.</p></sec>

scholarly journals A Cross-Sectional Study on Subjective Fever Assessment in Children by Palpation: Are Fathers as Reliable as Mothers?

2020 ◽  
Vol 2020 ◽  
pp. 1-5
Author(s):  
Ehud Rosenbloom ◽  
Crysta Balis ◽  
Dustin Jacobson ◽  
Melanie Conway ◽  
Ji Cheng ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Pediatric Patients ◽  
Cross Sectional Study ◽  
Primary Outcome Measure ◽  
Sectional Study ◽  
Cross Sectional ◽  
Predictive Values ◽  
Mothers And Fathers ◽  
Significant Difference ◽  
The Mean

Background. Fever is common in pediatric patients. Often, parents rely solely on palpation when assessing their child’s fever. The objective of the current study was to determine the accuracy of parents in detecting their child’s fever by palpation. Methods. A prospective cross-sectional study was conducted at the emergency department (ED) of a tertiary pediatric hospital. Infants and children, 0–4 years of age, presenting to the ED with both parents were included. Parents were separately asked if their child had a fever and, if so, were asked to assess the temperature by palpation. A nurse obtained the rectal temperature. The primary outcome measure was the accuracy of fathers and mothers in detecting fever. Results. A total of 170 children with their parents were enrolled. The mean ages of the children, mothers, and fathers were 18.9 (SD 0.8) months, 31.1 (SD 6.4) years, and 33.7 (SD 6.9) years, respectively. No statistically significant difference was found between mothers and fathers in the ability to assess fever by palpation (OR 0.65, 95% CI 0.39,−1.08). Sensitivities for detecting fever by palpation for mothers and father were 86.4% and 88.2%, respectively (specificity among mothers: 54.2% and specificity among fathers: 43.1%). The overall negative and positive predictive values were 65.9% (95% CI 55%–75.7%) and 75.7% (95% CI 69.9%–80.8%), respectively. Conclusions. Mothers and fathers do not differ in their ability to accurately assess their child’s fever by palpation. The low positive and negative predictive values indicate that if temperature was not measured, physicians cannot rely on parents’ reports.

scholarly journals A Randomized Controlled Trial of Four Precolonoscopy Bowel Cleansing Regimens

2011 ◽  
Vol 25 (12) ◽  
pp. 657-662 ◽  
Author(s):  
Dina Kao ◽  
Eoin Lalor ◽  
Gurpal Sandha ◽  
Richard N Fedorak ◽  
Bloeme van der Knoop ◽  
...  
Keyword(s):  
Bowel Preparation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Short Interval ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Bowel Cleansing ◽  
The Mean ◽  
Clinically Significant ◽  
The Ideal

BACKGROUND: The ideal bowel cleansing regimen for colonoscopy has yet to be determined.OBJECTIVE: To compare the cleansing efficacy, and patient tolerability and safety of four bowel preparation regimens.METHODS: A total of 834 patients undergoing outpatient colonoscopy were randomly assigned to one of four regimens: 4 L polyethylene glycol (PEG); 2 L PEG + 20 mg bisacodyl; 90 mL of sodium phosphate (NaP); or two sachets of a commercially available bowel cleansing solution (PSMC) + 300 mL of magnesium citrate (M). The primary outcome measure was cleansing efficacy, which was scored by blinded endoscopists using the Ottawa Bowel Preparation Scale. Secondary outcome measures were bowel preparation quality according to time of colonoscopy, and patient tolerability and safety.RESULTS: The mean total cleansing score was significantly worse in the NaP group compared with the other three groups (P<0.0001). The mean cleansing scores were worse in patients who underwent morning versus afternoon colonoscopy, a finding that was consistent in all four groups. PSMC + M was the best tolerated regimen. No clinically significant mean changes in creatinine or electrolyte levels were identified, although a significantly higher proportion of patients in the NaP group developed hypokelemia (P<0.0001).CONCLUSIONS: 2 L PEG + 20 mg bisacodyl, or PSMC + M was as efficacious as 4 L PEG and superior to NaP for bowel cleansing. A short interval between the completion of bowel preparation and the start of colonoscopy (ie, ‘runway time’), irrespective of bowel preparation regimen, appeared to be a more important predictor of bowel cleanliness than the cathartic agents used.

The rate of successful four-corner arthrodesis with a locking, dorsal circular polyether-ether-ketone (PEEK-Optima) plate

2013 ◽  
Vol 38 (7) ◽  
pp. 767-773 ◽  
Author(s):  
P. C. Rhee ◽  
A. Y. Shin
Keyword(s):  
Circular Plate ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Accurate Assessment ◽  
Polyether Ether Ketone ◽  
The Mean ◽  
Ether Ketone ◽  
Mean Time

The purpose of this study is to evaluate the rate of union after four-corner arthrodesis with a locking, dorsal circular plate comprised of polyether-ether-ketone. A retrospective review was conducted of all patients who underwent four-corner arthrodesis with a locking, dorsal circular plate at our institution from January 2005 to May 2009. The primary outcome measure was radiographic and clinical union. During the study period, 26 consecutive wrists underwent four-corner arthrodesis with a locking, dorsal circular plate. Twenty-three wrists were included. The mean clinical follow-up was 16 months (range 3–37). Union was achieved in 22 of 23 wrists at a mean time of 3 months (range 1–12). There was one partial union that underwent successful revision arthrodesis. In summary, four-corner fusion with a polyether-ether-ketone locking, dorsal circular plate results in high union rates. The use of a radiolucent plate allows for more accurate assessment of union with the biomechanical advantages of a fixed angle construct.

Symptomatic Rathke cleft cysts: extent of resection and surgical complications

2011 ◽  
Vol 31 (1) ◽  
pp. E2 ◽  
Author(s):  
Dominique M. Higgins ◽  
Jamie J. Van Gompel ◽  
Todd B. Nippoldt ◽  
Fredric B. Meyer
Keyword(s):  
Surgical Complications ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Extent Of Resection ◽  
Primary Outcome Measure ◽  
Gross Total Resection ◽  
Total Resection ◽  
Repeat Surgery ◽  
The Mean ◽  
Operative Notes

Object Rathke cleft cysts (RCCs) are benign masses arising from the embryological Rathke pouch, and are commonly treated by transsphenoidal surgery. The authors retrospectively compared RCC extent of resection—either gross-total resection (GTR) or decompression—to the primary outcome measure, which was recurrences resulting in repeat surgery, and the secondary outcome measure, which was complications. Methods Seventy-four patients presenting to the neurosurgical department with RCC were analyzed retrospectively. Sixty-eight patients had a total of 78 surgical procedures, with the diagnosis of RCC confirmed by histological investigation; of these, 61 patients had adequate operative notes for the authors to evaluate extent of resection. Groups were separated into GTR (32 patients) or decompression (subtotal resection or fenestration into the sphenoid sinus; 29 patients) based on operative notes and postoperative imaging. The mean follow-up duration was 60.5 ± 72.1 months (the mean is expressed ± SD throughout). Results The average age at the time of the initial surgery was 42.8 ± 17.4 years, and 70% of patients were female. The mean cyst diameter preoperatively was 16.9 ± 17.8 mm. Eight patients had repeat surgery, our primary outcome measure; 3 repeat operations occurred in the GTR group, and 5 in the decompression group. There was no significant difference in recurrence when comparing groups (GTR 9%, decompression 17%; p = 0.36). There were no major complications; however, analysis of postoperative minor complications revealed that 11 (34%) GTRs resulted in surgical complications, whereas the decompression cohort accounted for only 3 complications (10%) (p = 0.03), with diabetes insipidus (6) and CSF leaks (5) being the most common. Gross-total resection also resulted in an increase in postoperative hyperprolactinemia compared with decompression (p = 0.03). Conclusions It appears that RCCs require repeat surgery in 13% of cases, and attempted GTR does not appear to reduce the overall rate of recurrence. However, more aggressive resections are associated with more complications in this series.

scholarly journals Psoas muscle area index as a predictor of major adverse cardiovascular and limb events in patients with infrarenal aortic occlusions

2021 ◽  
Vol 30 (2) ◽  
pp. 133-140
Author(s):  
Ender Özgün Çakmak ◽  
Emrah Erdoğan ◽  
Cengiz Köksal ◽  
Mesut Şişmanoğlu ◽  
Uğur Fındıkçıoğlu
Keyword(s):  
Primary Outcome ◽  
Psoas Muscle ◽  
Primary Outcome Measure ◽  
Muscle Area ◽  
Area Index ◽  
Hazard Ratios ◽  
Study Results ◽  
Computed Tomography Scans ◽  
The Mean

Objectives: In this study, we aimed to investigate whether the total psoas muscle area index (TPAI) was a predictive factor of major adverse cardiovascular and limb events (MACLEs) in patients with infrarenal aortic occlusion (IAO). Patients and methods: Between January 2011 and December 2019, a total of 72 patients with IAO (56 males, 16 females; mean age: 58.8±7.0 years; range, 46 to 75 years) were retrospectively reviewed. The TPAI was measured by dividing total psoas muscle area to squared patient height. The primary outcome measure was MACLEs. To estimate the effect of TPAI and clinical factors on prognosis, hazard ratios (HRs) with 95% confidence intervals (CIs) were used. Results: The median follow-up was 32 months (interquartile range 15.9-44). The patients were divided into two groups as MACLE-positive (n=30, 41.6%) and MACLE-negative (n=42, 58.4%). The mean TPAI for MACLE-negative and MACLE-positive patients was 615±171 mm2/m2 and 521±129 mm2/m2, respectively (p=0.036). The presence of increased TPAI values was associated with the decreased MACLE rate (HR: 0.19; 95% CI: 0.09-0.42; p=0.008). Conclusion: Our study results indicate that the TPAI measured by computed tomography scans is an independent prognostic factor for MACLEs in patients with chronic IAO.

Improvement of Negative Symptoms in Schizophrenia: A Doubleblind Clinical Trial by Escitalopram in Male Patients

2020 ◽  
Vol 9 (3) ◽  
pp. 211-217
Author(s):  
Saeed S. Shafti
Keyword(s):  
Negative Symptoms ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Psychiatric Rehabilitation ◽  
Depression Scale ◽  
Primary Outcome Measure ◽  
Neuronal Uptake ◽  
Hamilton Depression Scale ◽  
Male Patients ◽  
The Mean

Background: The negative symptoms of schizophrenia remain a major clinical trouble against psychiatric rehabilitation and available therapeutic treatments. Objective: Escitalopram is known as the most selective SSRI with minimal effects on norepinephrine and dopamine neuronal uptake. The aim of the present study is to assess the effect of escitalopram on negative symptoms of schizophrenia. Methods: This study was an eight-week, randomized, placebo-controlled trial of escitalopram set against placebo, as an add-on medication, in the treatment of 50 patients with a diagnosis of schizophrenia. While the Scale for Assessment of Negative Symptoms was used as the primary outcome measure, the Scale for Assessment of Positive Symptoms, the Simpson-Angus Scale and the Hamilton Depression Scale, as well, were used as a secondary measure for evaluation of positive, extrapyramidal and depressive symptoms, respectively. Results: The primary outcome of the present assessment was a significant reduction in the mean total score of the Scale for Assessment of Negative Symptoms (SANS) in the target group, compared to placebo, at the end of eight weeks. In this regard, most of the subscales of SANS, as well, demonstrated significant improvements by escitalopram. Conclusion: According to the findings, escitalopram can be helpful, as add-on medication, in amelioration of negative symptoms of schizophrenia.

scholarly journals Screening for Frailty in Older Emergency Patients and Association with Outcome

Geriatrics ◽  
2020 ◽  
Vol 5 (1) ◽  
pp. 20 ◽  
Author(s):  
Siobhan Lewis ◽  
Louis Evans ◽  
Timothy Rainer ◽  
Jonathan Hewitt
Keyword(s):  
Older Patients ◽  
Primary Outcome ◽  
Independent Predictor ◽  
Care Home ◽  
Adverse Outcomes ◽  
Urgent Care ◽  
High Incidence ◽  
Screening Questions ◽  
The Mean ◽  
Secondary Outcomes

Older people have a high incidence of adverse outcomes after urgent care presentation. Identifying high-risk older patients early is key to targeting interventions at those patients most likely to benefit. This study used the Frailsafe three-point screening questions amongst older Emergency Department (ED) attendees. Consecutive unplanned ED attendances in patients aged ≥75 were assessed for Frailsafe status. The primary outcome was mortality at 180 days. A Frailsafe screen was completed in 356 patients, of whom 194/356 (54.5%) were Frailsafe positive. The mean age was 85.8 for Frailsafe screen positive and 82.2 for Frailsafe screen negative patients (p < 0.001). A positive Frailsafe screen was a predictor of death within 180 days of presentation to the ED and remained so after adjustment (AOR = 3.23, 95% CI 1.45–7.19, p = 0.004). A positive Frailsafe screen was an independent predictor of a new care home admission at 180 days (AOR = 8.95, 95% CI 2.01–39.83, p = 0.004). A positive Frailsafe screen was also predictive of a number of secondary outcomes, such as length of stay of >28 days (AOR 3.42, 95% CI 1.41–8.31, p = 0.007) and re-attendance within 30 days of discharge after admission (OR = 2.73, 95% CI 1.27–5.88, p = 0.01). Frailsafe screen results independently predict a range of outcomes amongst older ED attendees.

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