Metatarsal Head Resection Versus a Removable Mechanical Device for Offloading of the Neuropathic Diabetic Plantar Forefoot Ulcer

Although surgical offloading seems a more permanent solution for prevention and treatment of neuropathic plantar diabetic forefoot ulcers (DFUs), the evidence for this assumption is weak and needs further studies to be established. The aim of this retrospective study is to compare the healing efficacy, associated morbidity, and recurrence rates of surgical versus removable knee-high offloading for neuropathic plantar (DFUs) healing. From January 2016 to January 2018, 70 neuropathic plantar forefoot DFUs were nonrandomly assigned to either removable knee-high cam-walker (n = 35), or metatarsal head, or accessory bone resection (n = 35). The primary endpoints were the frequency and rate of complete healing, and the rate of ulcer area reduction within 4 months. The secondary endpoints were 4 months morbidity and ulcer recurrence within 12 months. After 4 months, complete healing was significantly inferior with cam-walker compared with surgical offloading; 24 (67.6%) versus 31 patients (88.6%), respectively, P = .015. Ulcer area reduction was 2.4 cm2 (66.7%) versus 2.6 cm2 (83.9%), P = .001, in the mechanical versus the surgical groups, respectively. The mean healing time was 3.6 ± 2.1 versus 2.8 ± 0.6 months in the mechanical versus the surgical groups, respectively, P = .012. Morbidity and recurrence show nonsignificant differences between both groups. Ulcer recurrence was noted in 5/35 (14.3%) versus 2/35 (5.7%), in mechanical versus surgical groups, respectively, P = .23. Therefore, metatarsal head/accessory bone resection offered improved healing efficacy but similar morbidity and recurrence to the removable cam-walker.

Download Full-text

Comparison of combined compression and surgery with high ligation-endovenous laser ablation-foam sclerotherapy with compression alone for active venous leg ulcers

Scientific Reports ◽

10.1038/s41598-019-50617-y ◽

2019 ◽

Vol 9 (1) ◽

Author(s):

Xiaochun Liu ◽

Guofu Zheng ◽

Bo Ye ◽

Weiqing Chen ◽

Hailiang Xie ◽

...

Keyword(s):

Laser Ablation ◽

Ulcer Healing ◽

Healing Time ◽

High Ligation ◽

Ulcer Recurrence ◽

Leg Ulcers ◽

Venous Reflux ◽

Foam Sclerotherapy ◽

Recurrence Rates ◽

Endovenous Laser Ablation

Abstract We aimed to assess the ulcer healing time and recurrence rates after treatment with compression therapy (CT) with or without high ligation-endovenous laser ablation-foam sclerotherapy (HL-EVLA-FS) in people with active venous leg ulcers (VLUs). A retrospective cohort study was conducted with 350 patients with active VLUs treated by compression with or without HL-EVLA-FS in our hospital from 2013 to 2017. The primary outcome was the ulcer healing time; secondary outcomes were the 12-month recurrence rates, the relationship between recurrence and venous reflux, and the complications of the two treatments. In total, 193 patients (200 limbs) underwent compression plus HL-EVLA-FS, and 157 patients (177 limbs) underwent CT alone. The ulcer healing time was shorter in the compression plus HL-EVLA-FS group than in the CT alone group (Hazard Ratio [HR] for ulcer healing, 1.845 [95% CI, 1.474–2.309], P = 0.0001). The 12-month ulcer recurrence rates were significantly reduced in the compression plus HL-EVLA-FS group (HR for ulcer recurrence, 0.418 [95% CI, 0.258–0.677], P = 0.0001). Calf perforator vein reflux (CPVR) and isolated superficial venous reflux (ISVR) were risk factors for ulcer recurrence. The combined operation with CT resulted in faster healing of VLUs, a lower ulcer recurrence rate and lower VCSS values after intervention than CT alone.

Download Full-text

Activity Tracking After Surgery: Does It Correlate With Postoperative Complications?

The American Surgeon ◽

10.1177/0003134820988818 ◽

2021 ◽

pp. 000313482098881

Author(s):

Yehonatan Nevo ◽

Tali Shaltiel ◽

Naama Constantini ◽

Danny Rosin ◽

Mordechai Gutman ◽

...

Keyword(s):

Postoperative Complications ◽

Enhanced Recovery ◽

Length Of Hospital Stay ◽

Inverse Correlation ◽

Complication Rates ◽

Activity Tracking ◽

Primary Endpoints ◽

Specific Complication ◽

Secondary Endpoints ◽

Enhanced Recovery Programs

Background Postoperative ambulation is an important tenet in enhanced recovery programs. We quantitatively assessed the correlation of decreased postoperative ambulation with postoperative complications and delays in gastrointestinal function. Methods Patients undergoing major abdominal surgery were fitted with digital ankle pedometers yielding continuous measurements of their ambulation. Primary endpoints were the overall and system-specific complication rates, with secondary endpoints being the time to first passage of flatus and stool, the length of hospital stay, and the rate of readmission. Results 100 patients were enrolled. We found a significant, independent inverse correlation between the number of steps on the first and second postoperative days (POD1/2) and the incidence of complications as well as the recovery of GI function and the likelihood of readmission ( P < .05). POD2 step count was an independent risk factor for severe complications ( P = .026). Discussion Digitally quantified ambulation data may be a prognostic biomarker for the likelihood of severe postoperative complications.

Download Full-text

Long-Term Safety and Efficacy of Antiplatelet Therapy in Patients With Cerebral Infarction With Thrombocytopenia

Clinical and Applied Thrombosis/Hemostasis ◽

10.1177/1076029620980067 ◽

2021 ◽

Vol 27 ◽

pp. 107602962098006

Author(s):

Shijie Guo ◽

Yingying Lin ◽

Xiaoye Ma ◽

Yanxin Zhao ◽

Aiping Jin ◽

...

Keyword(s):

Cerebral Infarction ◽

Antiplatelet Therapy ◽

Multivariate Regression Analysis ◽

Acute Cerebral Infarction ◽

Score Change ◽

Recurrence Rates ◽

Primary Endpoints ◽

Hemorrhagic Events

This study aimed to investigate the long-term safety and benefits of antiplatelet therapy in patients with cerebral infarction with thrombocytopenia, as evidence regarding this was limited. This cohort trial assessed patients with acute cerebral infarction with thrombocytopenia treated in the Neurology Department of Shanghai Tenth People’s Hospital from January 2016 to December 2018, and enrolled patients were followed up for 9 months. The patients were divided into non-antiplatelet and antiplatelet groups based on the actual intake of antiplatelet drugs. Primary endpoints included hemorrhagic events, recurrence of cerebral infarction, and activity of daily living (ADL) score changes. To balance baseline clinical data, propensity score matching was applied, and there were finally 65 matched patients, including 30 and 35 in the antiplatelet and non-antiplatelet groups, respectively. There were no differences in hemorrhagic and cerebral infarction recurrence rates between the 2 groups. ADL score change was higher in the antiplatelet group than in the non-antiplatelet group (10 vs 5, p = 0.039). In multivariate regression analysis, antiplatelet therapy significantly predicted a positive change in ADL scores [B = 8.381, 95% confidence interval (0.56-16.19)]. In patients with acute cerebral infarction with thrombocytopenia, antiplatelet therapy could the improve the quality of life in the chronic stage.

Download Full-text

Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study

Cephalalgia ◽

10.1177/0333102421989232 ◽

2021 ◽

Vol 41 (3) ◽

pp. 294-304 ◽

Cited By ~ 2

Author(s):

Messoud Ashina ◽

Uwe Reuter ◽

Timothy Smith ◽

Judith Krikke-Workel ◽

Suzanne R Klise ◽

...

Keyword(s):

Controlled Trial ◽

Study Drug ◽

Statistical Testing ◽

Control Group ◽

Double Blind ◽

Treatment Groups ◽

Primary Endpoints ◽

Registration Number ◽

Secondary Endpoints ◽

Common Teaes

Background We present findings from the multicenter, double-blind Phase 3 study, CENTURION. This study was designed to assess the efficacy of and consistency of response to lasmiditan in the acute treatment of migraine across four attacks. Methods Patients were randomized 1:1:1 to one of three treatment groups – lasmiditan 200 mg; lasmiditan 100 mg; or a control group that received placebo for three attacks and lasmiditan 50 mg for either the third or fourth attack. The primary endpoints were pain freedom at 2 h (first attack) and pain freedom at 2 h in ≥2/3 attacks. Secondary endpoints included pain relief, sustained pain freedom and disability freedom. Statistical testing used a logistic regression model and graphical methodology to control for multiplicity. Results Overall, 1471 patients treated ≥1 migraine attack with the study drug. Both primary endpoints were met for lasmiditan 100 mg and 200 mg ( p < 0.001). All gated secondary endpoints were met. The incidence of treatment-emergent adverse events (TEAEs) was highest during the first attack. The most common TEAEs with lasmiditan were dizziness, paresthesia, fatigue, and nausea; these were generally mild or moderate in severity. Conclusions These results confirm the early and sustained efficacy of lasmiditan 100 mg and 200 mg and demonstrate consistency of response across multiple attacks. Trial Registration Number: NCT03670810

Download Full-text

SARS-COV-2 colonizes coronary thrombus and impairs heart microcirculation bed in asymptomatic SARS-CoV-2 positive subjects with acute myocardial infarction

Critical Care ◽

10.1186/s13054-021-03643-0 ◽

2021 ◽

Vol 25 (1) ◽

Author(s):

Raffaele Marfella ◽

Pasquale Paolisso ◽

Celestino Sardu ◽

Luciana Palomba ◽

Nunzia D’Onofrio ◽

...

Keyword(s):

Myocardial Infarction ◽

Viral Load ◽

Coronary Intervention ◽

Cardiovascular Death ◽

Left Ventricular ◽

Major Adverse Cardiovascular Events ◽

Grade 5 ◽

Primary Endpoints ◽

Load Effects ◽

Secondary Endpoints

Abstract Background The viral load of asymptomatic SAR-COV-2 positive (ASAP) persons has been equal to that of symptomatic patients. On the other hand, there are no reports of ST-elevation myocardial infarction (STEMI) outcomes in ASAP patients. Therefore, we evaluated thrombus burden and thrombus viral load and their impact on microvascular bed perfusion in the infarct area (myocardial blush grade, MBG) in ASAP compared to SARS-COV-2 negative (SANE) STEMI patients. Methods This was an observational study of 46 ASAP, and 130 SANE patients admitted with confirmed STEMI treated with primary percutaneous coronary intervention and thrombus aspiration. The primary endpoints were thrombus dimension + thrombus viral load effects on MBG after PPCI. The secondary endpoints during hospitalization were major adverse cardiovascular events (MACEs). MACEs are defined as a composite of cardiovascular death, nonfatal acute AMI, and heart failure during hospitalization. Results In the study population, ASAP vs. SANE showed a significant greater use of GP IIb/IIIa inhibitors and of heparin (p < 0.05), and a higher thrombus grade 5 and thrombus dimensions (p < 0.05). Interestingly, ASAP vs. SANE patients had lower MBG and left ventricular function (p < 0.001), and 39 (84.9%) of ASAP patients had thrombus specimens positive for SARS-COV-2. After PPCI, a MBG 2–3 was present in only 26.1% of ASAP vs. 97.7% of SANE STEMI patients (p < 0.001). Notably, death and nonfatal AMI were higher in ASAP vs. SANE patients (p < 0.05). Finally, in ASAP STEMI patients the thrombus viral load was a significant determinant of thrombus dimension independently of risk factors (p < 0.005). Thus, multiple logistic regression analyses evidenced that thrombus SARS-CoV-2 infection and dimension were significant predictors of poorer MBG in STEMI patients. Intriguingly, in ASAP patients the female vs. male had higher thrombus viral load (15.53 ± 4.5 vs. 30.25 ± 5.51 CT; p < 0.001), and thrombus dimension (4.62 ± 0.44 vs 4.00 ± 1.28 mm2; p < 0.001). ASAP vs. SANE patients had a significantly lower in-hospital survival for MACE following PPCI (p < 0.001). Conclusions In ASAP patients presenting with STEMI, there is strong evidence towards higher thrombus viral load, dimension, and poorer MBG. These data support the need to reconsider ASAP status as a risk factor that may worsen STEMI outcomes.

Download Full-text

Abstract 15116: The Prognostic Value of Left Ventricular Mechanical Dyssynchrony in Patients With Idiopathic Dilated Cardiomyopathy

Circulation ◽

10.1161/circ.142.suppl_3.15116 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Yangjie Li ◽

Yuanwei Xu ◽

Siqi Tang ◽

Xiaoyue Zhou ◽

Yucheng Chen

Keyword(s):

Dilated Cardiomyopathy ◽

Primary Endpoint ◽

Prognostic Value ◽

Mechanical Dyssynchrony ◽

Idiopathic Dilated Cardiomyopathy ◽

Ratio Estimate ◽

Apical Level ◽

Primary Endpoints ◽

Secondary Endpoints ◽

Cmr Imaging

Backgrounds: The mechanical dyssynchrony has been commonly observed in idiopathic dilated cardiomyopathy (DCM) patients, and several cardiac magnetic resonance (CMR) imaging techniques were used to evaluate the mechanical dyssynchrony. Standard deviation of time-to-peak (T2Psd) and uniformity ratio estimate (URE) indices are two widely used parameters to reflect the incoordinate movement of the left ventricle. However, the prognostic value of mechanical dyssynchrony in DCM patients is not clear. Methods and Results: We prospectively enrolled 402 DCM patients undergoing CMR imaging between Jun 2012 to Sep 2018. Mechanical dyssynchrony was measured as T2Psd and URE indices by CMR deformable registration algorithm (DRA) analysis. The primary endpoint was defined as all-cause mortality and heart transplantation, and the secondary endpoint was a combination of primary endpoint, aborted sudden cardiac death, and heart failure readmission. Univariate and multivariate Cox regression analyses were performed to identify the association between variables and outcome. Survival curves were obtained by Kaplan-Meier survival analysis and compared by log-rank test. During a median follow-up of 25.1 months (IQR: 16.2-41.6), there were 57 patients reached primary endpoints, and secondary endpoints occurred in 132 patients. Circumferential uniformity ratio estimate (CURE) at basal, mid and apical level, radial uniformity ratio estimate (RURE)at mid and apical level and longitudinal uniformity ratio estimate (LURE) were significantly worse in patients with primary endpoint compared to patients without primary endpoint. While no significant differences were observed regarding the T2Psd value between patients with and without primary endpoints. In multivariate analysis, CURE at apical level was independently associated with primary endpoints (HR 0.214, P=0.005) and secondary endpoints (HR 0.402, P=0.018). Furthermore, among patients with LVEF <35% or presence of LGE, those with decreased CURE at apical level (<0.917) showed a significantly higher rate of adverse outcome. Conclusion: The CURE at apical level is an independent predictor of adverse cardiac events in DCM patients. Compared with T2Psd, URE index is a better predictor of adverse events.

Download Full-text

Extensive curettage using a high-speed burr versus dehydrated alcohol instillation for the treatment of enchondroma of the hand

Journal of Hand Surgery (European Volume) ◽

10.1177/1753193413517204 ◽

2013 ◽

Vol 40 (4) ◽

pp. 384-391 ◽

Cited By ~ 5

Author(s):

S. M. Cha ◽

H. D. Shin ◽

K. C. Kim ◽

I. Y. Park

Keyword(s):

Analogue Scale ◽

High Speed ◽

Proximal Phalanx ◽

Healing Time ◽

Complete Healing ◽

Pathological Fractures ◽

Active Motion ◽

The Mean ◽

High Speed Burr

The purpose of this retrospective study was to compare the clinical and radiological outcomes of patients treated with different adjuvant methods after curettage for enchondromas of the hand. Sixty-two patients with enchondroma were treated with high-speed burring (29 patients) or alcohol instillation (33 patients) after curettage. The mean follow-up was 40.8 months. No significant differences in the visual analogue scale, Disabilities of the Arm, Shoulder, and Hand scores, total range of active motion, grip strength, and complete healing time were observed between the groups. The distribution of the results of the formula by Wilhelm and Feldmeier were not significantly different between the groups. No surgery-related complications, postoperative pathological fractures, or recurrence was found in either group. For the treatment of enchondroma in the metacarpal and proximal phalanx, alcohol instillation immediately after curettage was as effective as extensive curettage using a high-speed burr.

Download Full-text

Procalcitonin and Interleukin-6 Levels: Are They Useful Biomarkers in Cardiac Surgery Patients?

Blood Purification ◽

10.1159/000454672 ◽

2017 ◽

Vol 43 (4) ◽

pp. 290-297 ◽

Cited By ~ 4

Author(s):

Anna Clementi ◽

Alessandra Brocca ◽

Grazia Maria Virzì ◽

Massimo de Cal ◽

Davide Giavarina ◽

...

Keyword(s):

Intensive Care Unit ◽

Cardiac Surgery ◽

Interleukin 6 ◽

Independent Predictor ◽

Chronic Renal Disease ◽

Kidney Injury ◽

Renal Outcome ◽

Primary Endpoints ◽

Secondary Endpoints ◽

Overall Mortality

Background/Aim: Cardiac surgery-associated acute kidney injury is an independent predictor of chronic renal disease and mortality. The scope of this study was to determine the utility of procalcitonin (PCT) and plasma interleukin-6 (IL-6) levels in predicting renal outcome and mortality in these patients. Methods: PCT and plasma IL-6 levels of 122 cardiac surgery patients were measured at 48 h after the surgical procedure. Primary endpoints were adverse renal outcome and mortality. Secondary endpoints were length of stay, bleeding, and number of transfusions. Results: PCT was found to be a better predictor of adverse renal outcome than IL-6. IL-6 seemed to be a better predictor of both 30-day and overall mortality than PCT. Neither PCT nor IL-6 levels were found to be good predictors of intensive care unit stay and bleeding. Conclusion: PCT may be considered a good predictor of adverse renal outcome in cardiac surgery patients, whereas IL-6 seems to possess a good predictive value for mortality in this population of patients.

Download Full-text

Biotic Supplements for Renal Patients: A Systematic Review and Meta-Analysis

Nutrients ◽

10.3390/nu10091224 ◽

2018 ◽

Vol 10 (9) ◽

pp. 1224 ◽

Cited By ~ 10

Author(s):

Anna Pisano ◽

Graziella D’Arrigo ◽

Giuseppe Coppolino ◽

Davide Bolignano

Keyword(s):

Systematic Review ◽

Large Scale ◽

Meta Analysis ◽

Outcome Data ◽

Reactive Protein ◽

Surrogate Outcomes ◽

Ovid Medline ◽

Primary Endpoints ◽

Intestinal Dysbiosis ◽

Secondary Endpoints

Intestinal dysbiosis is highly pervasive among chronic kidney disease (CKD) patients and may play a key role in disease progression and complications. We performed a systematic review and meta-analysis to evaluate effects of biotic supplements on a large series of outcomes in renal patients. Ovid-MEDLINE, PubMed and CENTRAL databases were searched for randomized controlled trials (RCTs) comparing any biotic (pre-, pro- or synbiotics) to standard therapy or placebo. Primary endpoints were change in renal function and cardiovascular events; secondary endpoints were change in proteinuria/albuminuria, inflammation, uremic toxins, quality of life and nutritional status. Seventeen eligible studies (701 participants) were reviewed. Biotics treatment did not modify estimated glomerular filtration rate (eGFR) (mean difference (MD) 0.34 mL/min/1.73 m2; 95% CI −0.19, 0.86), serum creatinine (MD −0.13 mg/dL; 95% confidence interval (CI) −0.32, 0.07), C-reactive protein (MD 0.75 mg/dL; 95% CI −1.54, 3.03) and urea (standardized MD (SMD) −0.02; 95% CI −0.25, 0.20) as compared to control. Outcome data on the other endpoints of interest were lacking, sparse or in an unsuitable format to be analyzed collectively. According to the currently available evidence, there is no conclusive rationale for recommending biotic supplements for improving outcomes in renal patients. Large-scale, well-designed and adequately powered studies focusing on hard rather than surrogate outcomes are still awaited.

Download Full-text

Nivolumab (NIVO) plus ipilimumab (IPI) or NIVO plus chemotherapy (chemo) versus chemo as first-line (1L) treatment for advanced esophageal squamous cell carcinoma (ESCC): First results of the CheckMate 648 study.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.lba4001 ◽

2021 ◽

Vol 39 (18_suppl) ◽

pp. LBA4001-LBA4001

Author(s):

Ian Chau ◽

Yuichiro Doki ◽

Jaffer A. Ajani ◽

Jianming Xu ◽

Lucjan Wyrwicz ◽

...

Keyword(s):

Tumor Cell ◽

Objective Response ◽

Progression Free Survival ◽

Phase Iii ◽

Primary Endpoints ◽

First Results ◽

Duration Of Response ◽

Secondary Endpoints ◽

Phase Iii Study ◽

Previously Treated Patients

LBA4001 Background: NIVO demonstrated superior overall survival (OS) vs chemo in previously treated patients (pts) with ESCC (ATTRACTION-3). We report OS and progression-free survival (PFS) from CheckMate 648, the first global phase III study to evaluate both an immuno-oncology (I-O)/chemo combination and an I-O/I-O combination in advanced ESCC. Methods: Adults with previously untreated, unresectable advanced, recurrent or metastatic ESCC were enrolled regardless of tumor cell PD-L1 expression. Pts were randomized to NIVO (240 mg Q2W) + chemo (fluorouracil + cisplatin Q4W), NIVO (3 mg/kg Q2W) + IPI (1 mg/kg Q6W), or chemo alone. Primary endpoints for both comparisons were OS and PFS per blinded independent central review (BICR) in pts with tumor cell PD-L1 ≥ 1%. Hierarchically tested secondary endpoints included OS and PFS in all randomized pts. Results: 970 pts were randomized to NIVO + chemo, NIVO + IPI, and chemo arms (49% with tumor cell PD-L1 ≥ 1%). With 13 months (mo) minimum follow-up, NIVO + chemo and NIVO + IPI led to statistically significant improvement in OS vs chemo in pts with tumor cell PD-L1 ≥ 1% and all randomized pts (Table). Statistically significant PFS benefit was also observed for NIVO + chemo vs chemo (HR 0.65 [98.5% CI 0.46–0.92]; P = 0.0023) in pts with tumor cell PD-L1 ≥ 1%. PFS in NIVO + IPI vs chemo in pts with tumor cell PD-L1 ≥ 1% did not meet the prespecified boundary for significance. The objective response rate (per BICR) was 53% (NIVO + chemo), 35% (NIVO + IPI), and 20% (chemo) in pts with tumor cell PD-L1 ≥ 1% and in all randomized pts was 47%, 28%, and 27%, respectively; longer median (95% CI) duration of response was observed vs chemo for pts with tumor cell PD-L1 ≥ 1%: 8.4 (6.9–12.4), 11.8 (7.1–27.4), and 5.7 (4.4–8.7) mo and for all randomized pts: 8.2 (6.9–9.7), 11.1 (8.3–14.0), and 7.1 (5.7–8.2) mo, respectively. No new safety signals were identified (Table). Conclusions: NIVO plus chemo and NIVO plus IPI both demonstrated superior OS vs chemo, along with durable objective responses and acceptable safety, in pts with advanced ESCC, and each represents a potential new 1L treatment option. Clinical trial information: NCT03143153. [Table: see text]

Download Full-text