Dual-Antiplatelet Therapy for More Than Six Months After Endovascular Revascularization in Patients With Lower-Extremity Artery Disease

Background: The duration of antiplatelet therapy after endovascular revascularization in patients with lower-extremity artery disease (LEAD) has not been well-established. This study aimed to investigate the optimal strategy for antiplatelet therapy after successful endovascular revascularization in patients with LEAD. Methods: From April 2009 to June 2019, 376 patients with LEAD underwent successful endovascular revascularization. After the procedure, the patients received mono-antiplatelet therapy (MAPT) or dual-antiplatelet therapy (DAPT) of various durations and were classified into 2 groups (MAPT or DAPT < 6 months vs. DAPT ≥ 6 months). The primary outcomes were major adverse cardiovascular events (MACE) and major adverse limb events (MALE). The safety outcome was moderate-to-severe bleeding according to the Global Use of Strategies to Open Occluded Arteries (GUSTO) criteria.Results: Over the 40-month follow-up period, MACE occurred less frequently in the DAPT ≥ 6 months group than the MAPT or DAPT < 6 months group (12.4% vs. 23.8%; hazard ratio: 0.62; 95% confidence interval: 0.40 to 0.97; p = 0.038) after inverse probability-weighted adjustment and propensity-score matching. The incidence of MALE showed no significant intergroup difference (17.1% vs. 13.1%; hazard ratio: 0.94; 95% confidence interval: 0.56 to 1.59; p = 0.822). The incidence of moderate-to-severe GUSTO bleeding also showed no significant intergroup difference (3.5% vs. 4.9%; hazard ratio: 0.59; 95% confidence interval: 0.21 to 1.63; p = 0.308). Conclusions: For patients with LEAD, DAPT for ≥6 months after endovascular revascularization was associated with a lower incidence of MACE without increasing the risk of bleeding events.

Determination of Anxiety and Comfort Levels of Patients Who Underwent Fiberoptic Bronchoscopy: A Cross-sectional Study

Objective: The aim of this study was to determine the anxiety and comfort levels of outpatients who underwent fiberoptic bronchoscopy. Method: This cross-sectional study was performed between January-December 2018 in a bronchoscopy unit of a Training and Research Hospital in Ankara. A total of 173 patients who underwent bronchoscopy for the first time were included in the study by purposeful sampling method. The data were obtained by using ”Personal Information Form”, “State Trait Anxiety Inventory (STAI-I)” and Perianesthesia Comfort Scale (PACS)”. The Personal Information Form and the STAI-I were filled out before the bronchoscopy and the PACS after the bronchoscopy procedures by face-to-face interviews. Results: Study population with a mean age of 54.68±16.64 years consisted mostly (72.8%) of male patients. In the present study, mean STAI-I, and PACS scores of the patients were 43.51±5.67, and 5.20±0.43 points, respectively. Mean STAI-I scores of female, and male participants were 41.93±5.73 and 44.06±5.56 points, respectively with a statistically significant intergroup difference (p=0.03). The PACS scores of female, and male participants were 4.99±0.57 and 5.24±0.37 points, respectively with a statistically significant intergroup difference (p=0.001). After the procedure, choking, cough and sore throat were the most common symptoms. Conclusion: It was determined that patients who underwent bronchoscopy had generally experienced anxiety but their comfort was good. Male patients had more anxiety, but female patients had lower levels of comfort. To reduce the level of anxiety due to bronchoscopy; nursing interventions should be planned according to the individual characteristics of the patients.

Association between epilepsy and challenging behaviour in adults with intellectual disabilities: systematic review and meta-analysis

Background Previous systematic reviews showed no significant association between epilepsy and challenging behaviours in adults with intellectual disabilities. Aims To identify whether there is an association between epilepsy and challenging behaviour in adults with intellectual disabilities by carrying out a systematic review of published data. PROSPERO registration number: CRD42020178092. Method We searched five databases and hand-searched six journals. Two authors independently screened titles, abstracts and full articles using a standardised eligibility checklist. Several meta-analyses were carried out. Results The narrative analysis of data from 34 included articles (14 168 adults with intellectual disabilities, 4781 of whom also had epilepsy) showed no significant association between epilepsy and challenging behaviour. Meta-analysis was possible on data from 16 controlled studies. This showed no significant intergroup difference but after sensitivity analysis meta-analysis of 10 studies showed a significantly higher rate of overall challenging behaviour in the epilepsy group (effect size: 0.16) compared with the non-epilepsy group. Aggression and self-injurious behaviour both showed a statistically significant higher rate in the epilepsy group, with very small effect sizes (0.16 and 0.28 respectively). No significant intergroup difference was observed in the rate of stereotypy. Conclusions The findings are contradictory and must be interpreted with caution because of the difficulty in pooling data from varied studies, which is likely to introduce confounding. Where significant differences were found, effect sizes are small and may not be clinically significant, and there are major methodological flaws in the included studies, which should be addressed in future large-scale properly controlled studies.

Standard and accelerated corneal cross-linking long-term results: A randomized clinical trial

Purpose: To compare long-term results between accelerated and standard corneal cross-linking protocols in the treatment of progressive keratoconus and compare their effectiveness between central (cone in the central 3 mm) and peripheral (cone beyond 3 mm) cases. Methods: In this randomized clinical trial, we compared 31 eyes treated with accelerated corneal cross-linking (18 mW/cm2, 5 min) and 31 eyes treated with standard corneal cross-linking (3 mW/cm2, 30 min), 16 central and 11 peripheral keratoconus in each group. In this report, 4-year changes in vision, refraction, topography, corneal biomechanics, and corneal cell count were evaluated. Results: Uncorrected distance visual acuity improvement was better with standard corneal cross-linking (0.19 ± 0.30 logMAR) than accelerated corneal cross-linking (0.08 ± 0.35 logMAR), but the intergroup difference was not statistically significant (p = 0.283). Cylinder and spherical equivalent significantly increased similarly in both groups. Among topographic indices, anterior Kmax-3 mm showed more reduction in standard corneal cross-linking than accelerated corneal cross-linking (1.35 ± 1.39 vs 0.36 ± 1.10 D, p = 0.011). Anterior Kmax-8 mm reduced by 1.50 ± 1.82 and 0.37 ± 1.58 D in the standard corneal cross-linking and accelerated corneal cross-linking groups, respectively (p = 0.029). Compared to 18-month results, none of the indices at 4 years showed any significant intergroup difference (all p > 0.05). In cases with peripheral keratoconus, changes in anterior Kmax-3 mm (+0.03 ± 0.66 vs −1.17 ± 1.15 D, p = 0.012) and anterior Kmax-8 mm (+0.43 ± 1.09 vs −1.57 ± 1.40 D, p = 0.003) were greater with standard corneal cross-linking. In central cases, no significant intergroup difference was observed. Conclusion: At 4 years after the procedure, standard corneal cross-linking offered better anterior corneal flattening in the center and periphery. These differences concerned cases of peripheral keratoconus, and the two protocols were similarly effective in central cases. Beyond the 18th month, the two protocols appeared to be similarly effective.

RA03.05: COMPARISON OF OUTCOME OF ESOPHAGECTOMY VERSUS NON-SURGICAL TREATMENT FOR RESECTABLE ESOPHAGEAL CANCER WITH CLINICAL COMPLETE RESPONSE TO NEOADJUVANT THERAPY

Background Treatment for patients who have achieved clinical complete response (cCR) after neoadjuvant therapy has not been established, with no consensus regarding the indications for either esophagectomy or non-surgical treatment. Methods Among 1545 patients with esophageal cancer at Toranomon Hospital between January 2006 and August 2017, 39 who achieved cCR after neoadjuvant treatment were divided into two groups according to treatment: esophagectomy group (n = 18) andtreatment group (n = 21) for comparison. Results No significant intergroup difference was observed in baseline characteristics. Pathological complete response was confirmed in 13 (72.2%) of the 18 patients who underwent esophagectomy, while residual tumor was detected at the location of primary tumor in 2 (11.1%) patients and lymph node metastasis was found in 3 (16.7%) patients. Recurrence-free survival (RFS) was significantly longer in the esophagectomy group than in the non-surgical group (P = 0.002). Disease-specific survival (DSS) was significantly longer in the esophagectomy group (P = 0.007). However, no significant intergroup difference was observed in overall survival estimated based on all deaths, including (P = 0.451). Conclusion With improved diagnostic accuracy, non-surgical treatment can be an option for patients estimated as cCR after treatment administered in a neoadjuvant setting. However, surgical resection is considered more appropriate because of residual tumor in some patients with cCR and because of superior DSS and RFS following esophagectomy compared with non-surgical treatment. Future studies must focus on ameliorating late postoperative complications such as respiratory failure and aspiration pneumonia. Disclosure All authors have declared no conflicts of interest.

Cochlear Implant Users with Otosclerosis: Are Hearing and Quality of Life Outcomes Worse than in Cochlear Implant Users without Otosclerosis?

Background: The otosclerotic process may influence the performance of the cochlear implant (CI). Difficulty in inserting the electrode array due to potential ossification of the cochlea, facial nerve stimulation, and instability of the results are potential challenges for the CI team. Objectives: To evaluate hearing results and subjective outcomes of CI users with otosclerosis and to compare them with those of CI users without otosclerosis. Method: Retrospective review of 239 adults with bilateral profound postlingual deafness who underwent unilateral cochlear implantation between 1992 and 2017. Hearing and speech understanding were assessed via pure-tone audiometry and speech perception tests. Subjective outcomes were assessed via the Nijmegen Cochlear Implant Questionnaire (NCIQ), the Glasgow Benefit Inventory (GBI), and the Hearing Implant Sound Quality Index (HISQUI19) at 6 months, 12 months, and at the last follow-up. Results: Subjects were 22 CI users with otosclerosis and 217 without otosclerosis. Both groups had a similar duration of deafness and age at CI implantation. Results did not significantly differ according to group: no significant intergroup difference was found regarding the frequency of complete electrode insertion, facial stimulation, reimplantation, or PTA4 scores at the last follow-up. Regarding speech perception, no significant intergroup difference was found on any test or at any interval. Further, subjective outcomes, as measured by the GBI, NCIQ, and HISQUI19, did not significantly differ between groups. Conclusions: Adults with otosclerosis and profound hearing loss derive significant benefit from CI use. Audiological and self-reported outcomes are not significantly different from that of other CI users with postlingual deafness.

To compare the efficacy of drotaverine hydrochloride with hyoscine butylbroumide for increasing the rate of cervical dilatation

Background: In order to accelerate the labour apart from early amniotomy and early administration of oxytocin, the use of antispasmodic agents like drotaverine and hyoscine butylbromide to hasten the first stage of labor is a common practice. Considering the promising results of hyoscine butylbromide, the present study was planned to to compare the efficacy of drotaverine hydrochloride with hyoscine butylbroumide for increasing the rate of cervical dilatation.Methods: This prospective placebo-controlled crossover study was carried out at Department of Obstetrics and Gynaecology, Era’s Lucknow Medical College, Lucknow. The study was conducted on 60 women in labour who were randomly allocated to group I, group II and group III of 20 patients each. In group I, no intervention was done and comprised the control group. The women in group II were injected intramuscularly one ampoule (20mg) of hyoscine butylbromide. The women in Group III were injected Inj. Drotavrine one ampoule (40mg) intramuscularly at 3 cm dilatation. The data collected was analysed using SPSS Version 15.0. Suitable statistical tests were applied.Results: Majority of subjects were aged between 21-30 years, were multipara and had spontaneous labour. Mean duration of first stage of labour ranged from 3 hoour 34 minutes (drotaverine hydrochloride) to 5 hour 45 minutes (control group) showing a significant intergroup difference. Mean total duration of labour ranged from 4 hr 11 minutes (drotaverine hydrochloride and hyoscine butylbromide groups) to 6 hr 26 minutes (control group) showing a significant intergroup difference (p <0.001). Majority of deliveries were full term normal deliveries.Conclusions: Both drotaverine hydrochloride and hyoscine butylbromide could effectively reduce first stage as well as total duration of labour. Further studies are recommended to establish the comparative efficacy in terms of a side effect profile and relatively efficacy in view of various clinico-demographic variables.

Investigation of the dose-dependent neuroprotective effects of agmatine in experimental spinal cord injury: a prospective randomized and placebo–control trial

Object No definitive treatment for spinal cord injuries (SCIs) exists, and more research is required. The use of agmatine [4-(aminobutyl)-guanidine-NH2-CH2-CH2-CH2-CH2-NH-C(-NH2)(=NH)], a guanidinium compound formed by decarboxylation of l-arginine by arginine decarboxylase, is a neurotransmitter–neuromodulator with both N-methyl-d-aspartate receptor (NMDAR)–antagonizing and nitric oxide synthase (NOS)–inhibiting activities. The purpose of this study was to demonstrate the dose-dependent activity of agmatine, an inducible NOS (iNOS) inhibitor and selective NMDAR antagonist, on biochemical and functional recovery in an experimental rat SCI model. Methods This study involved 40 Wistar albino male rats. The rats were subjected to sleep–awake cycles for 7 days before surgery. In each group, general anesthesia was induced by a 60-mg/kg ketamine injection. For the surgical SCI model, a Yas¸argil aneurysm clip was placed in the spinal cord. The study was conducted in the following four main groups: Group I (control group) laminectomy only; Group II, trauma-only group and SCI; Group III, laminectomy, SCI and agmatine 50 mg/kg for 10 days; and Group IV, laminectomy, SCI, and agmatine 100 mg/kg for 10 days. On Day 1, no statistical difference was observed in any group (p < 0.005, analysis of variance [ANOVA] and the Fisher protected least significant difference [PLSD]). On Day 2, no statistical difference was noted among Groups II, III, and IV (p = 0.27, p = 0.42, and p = 0.76, respectively; ANOVA and Fisher PLSD). Beginning on Day 3, recovery in Groups III and IV differed significantly from that in Group II (p < 0.005, ANOVA and Fisher PLSD), and a statistically significant difference between Groups III and IV was observed, which also was present on Days 5, 7, and 10 (p = 0.003, p = 0.0024, and p = 0.0036, respectively; ANOVA and Fisher PLSD). Several observations were noteworthy: motor function scores were reduced significantly in the spinal cord–injured rats compared with the controls (p < 0.005); on Day 1, the agreement of motor function scores in rats in each SCI group indicated that the traumatic event had been replicated equally across all groups (p = 0.59, p = 0.59, and p = 0.28); a statistically significant difference in motor function scores developed on Day 3 between the rats subjected to trauma alone (Group II) and those treated with agmatine (Groups III and IV) (p < 0.005); and no statistically significant intergroup difference in motor function existed at any postinjury interval between the 50- and 100-mg/kg/day agmatine–treated rats (p > 0.005). Conclusions Agmatine administration following SCI was shown to reduce NO levels significantly. No statistically significant intergroup difference in the reduction of NO levels was found between rats treated with 50- and 100-mg/kg/day doses of agmatine. Administration of a 100-mg/kg/day dose of agmatine reduced the NO levels to those measured in controls. The authors conclude that with additional studies into the role of agmatine, this drug may be helpful in the treatment of patients with SCIs.