Tag: pubmed

Clin Cardiol. 2022 Jan 12. doi: 10.1002/clc.23765. Online ahead of print.

ABSTRACT

BACKGROUND: The use of antiarrhythmic drugs (AADs) in patients with chronic kidney disease (CKD) is complex because impaired renal clearance can cause increased drug levels, and risk of intolerance or adverse events. Due to the propensity for CKD to occur alongside atrial fibrillation/atrial flutter (AF/AFL), it is essential that AAD safety and efficacy are assessed for patients with CKD.

HYPOTHESIS: Dronedarone, an approved AAD, may present a suitable therapeutic option for patients with AF/AFL and concomitant CKD.

METHODS: EURIDIS-ADONIS (EURIDIS, NCT00259428; ADONIS, NCT00259376) were identically designed, multicenter, double-blind, parallel-group trials investigating AF/AFL control with dronedarone 400 mg twice daily versus placebo (randomized 2:1). In this post hoc analysis, the primary endpoint was time to first AF/AFL. Patients were stratified according to renal function using the CKD-Epidemiology Collaboration equation and divided into estimated glomerular filtration rate (eGFR) subgroups of 30-44, 45-59, 60-89, and ≥90 ml/min. Time-to-events between treatment groups were compared using log-rank testing and Cox regression.

RESULTS: At baseline, most (86%) patients demonstrated a mild or mild-to-moderate eGFR decrease. Median time to first AF/AFL recurrence was significantly longer with dronedarone versus placebo for all eGFR subgroups except the 30 to 44 ml/min group, where the trend was similar but statistical power may have been limited by the small population. eGFR stratification had no significant effect on serious adverse events, deaths, or treatment discontinuations.

CONCLUSIONS: This analysis suggests that dronedarone could be an effective therapeutic option for AF with an acceptable safety profile in patients with impaired renal function.

PMID:35019175 | DOI:10.1002/clc.23765

Neurourol Urodyn. 2022 Jan 12. doi: 10.1002/nau.24873. Online ahead of print.

ABSTRACT

PURPOSE: The aim of this study was to demonstrate features predictive of treatment response for patient-tailored overactive bladder (OAB) intervention with an implantable tibial neurostimulator using patient and technical prediction factors.

MATERIALS AND METHODS: This study was designed as a follow-up study based on parameter settings and patients’ preferences during the pilot and extended study of the implantable tibial nerve stimulator (RENOVA™ iStim system). For this study, we compared all treatment parameters (stimulation amplitude, frequency, and pulse width) and usage data (duration of treatment) during the different follow-up visits.

RESULTS: We obtained usage data from a total of 32 patients who were implanted with the system between February and September 2015. Age, sex, body mass index (BMI) and previous experience with percutaneous tibial nerve stimulation (PTNS) treatment were considered as possible prediction factors for treatment success. However, only BMI was considered a statistically significant prediction factor (p = 0.042). A statistically significant increase in mean treatment level was seen in the responder group during the 3 month follow-up visit (mean: 6.7 mA, SD 0.416) as compared with the initial system activation visit (mean: 5.8 mA, SD 0.400) (p = 0.049). No other visits demonstrated statistically significant changes in both groups (responders and nonresponders) during the defined timepoints.

CONCLUSION: This data underscores the need to use patient-tailored OAB treatment. BMI was found to be a negative predictive factor for treatment success. However, it was not possible to develop a specific responder model. A model predicting response to treatment could be useful for implementing shared decision making.

PMID:35019163 | DOI:10.1002/nau.24873

Aesthet Surg J. 2021 Nov 20:sjab398. doi: 10.1093/asj/sjab398. Online ahead of print.

ABSTRACT

BACKGROUND: Although there is an abundance of literature on nonablative laser and energy-based therapies for the management of skin conditions, adverse events are inconsistently addressed and range widely across studies. Fitzpatrick skin phototypes (SPTs) IV to VI are believed to be at higher risk.

OBJECTIVES: The aim of this study was to determine the types and rates of adverse events in nonablative laser and energy-based therapies among patients with SPTs IV to VI.

METHODS: Articles addressing nonablative laser and energy-based therapies for skin rejuvenation and acne scarring in patients with SPTs IV to VI that provided data on adverse events were included. The pooled prevalence of each adverse event was calculated. To determine whether age, treatment indication, SPT, and device type influenced incidence, subgroup and meta-regression analyses were performed. Heterogeneity was evaluated with the I2 statistic.

RESULTS: Forty-three studies were included in the meta-analysis. The sample size was 1654, and the median age of subjects was 39.4 years. The most common adverse events were postinflammatory hyperpigmentation (PIH) (rate, 8.1%) and prolonged erythema (rate, 0.6%). The rate of PIH was significantly higher for diode and erbium-doped lasers compared with intense pulsed light and radiofrequency. PIH correlated positively with SPT, laser density, and total energy delivered.

CONCLUSIONS: Although the overall rate of adverse events in nonablative laser and energy-based therapies for SPTs IV to VI is low, the incidence of PIH is not insignificant. Certain lasers, such as diode, Q-switched Nd:YAG, and erbium-doped lasers, tend to have higher rates of PIH, whereas intense pulsed light and radiofrequency have minimal risk. Higher SPTs and higher energy deliverance correlate positively with the incidence of PIH.

PMID:35019139 | DOI:10.1093/asj/sjab398

Clin Cardiol. 2022 Jan 12. doi: 10.1002/clc.23773. Online ahead of print.

ABSTRACT

BACKGROUND: Despite low-density lipoprotein cholesterol-lowering therapies and other standard-of-care therapy, there remains a substantial residual atherosclerotic risk among patients with an acute coronary syndrome (ACS). This study aims to estimate the risk of early and late recurrent major adverse cardiovascular events (MACE) and address its implications on trial design.

METHODS: A literature search was performed to collect phase III interventional trials on high-risk ACS patients. Pooled event rates at 90 and 360 days were estimated by fitting random-effects models using the DerSimonian-Laird method. Under the assumption of a total sample size of 10,000 and 1:1 allocation at a one-sided alpha of 0.025 using the log-rank test, the relationship between power and relative risk reduction (RRR) or absolute risk reduction (ARR) was explored for early versus late MACE endpoint.

RESULTS: Seven trials representing 82,727 recent ACS patients were analyzed. The pooled rates of recurrent MACE were 4.1% and 8.3% at 90 and 360 days. Approximately 49% of events occurred within the first 90 days. Based on the estimated risks at 90 and 360 days, to attain 90% statistical power, a lower magnitude of RRR is required for late MACE than early MACE (22% vs. 30%), whereas a lower magnitude of ARR is required for early MACE than late MACE (1.2% vs. 1.8%).

CONCLUSION: The initial 90-day window after ACS represents a vulnerable period for recurrent events. From a trial design perspective, determining a clinically important benefit by RRR versus ARR may influence the decision between early and late MACE as the study endpoint.

PMID:35019162 | DOI:10.1002/clc.23773

Arq Bras Cir Dig. 2022 Jan 5;34(3):e1622. doi: 10.1590/0102-672020210002e1622. eCollection 2022.

ABSTRACT

BACKGROUND: The incidence of abdominal hernia in cirrhotic patients is as higher as 20%; in cases of major ascites the incidence may increase up to 40%. One of the main and most serious complications in cirrhotic postoperative period (PO) is acute kidney injury (AKI).

AIM: To analyze the renal function of cirrhotic patients undergoing to hernia surgery and evaluate the factors related to AKI.

METHODS: Follow-up of 174 cirrhotic patients who underwent hernia surgery. Laboratory tests including the renal function were collected in the PO.AKI was defined based on the consensus of the ascite´s club. They were divided into two groups: with (AKI PO) and without AKI .

RESULTS: All 174 patients were enrolled and AKI occurred in 58 (34.9%). In the AKI PO group, 74.1% had emergency surgery, whereas in the group without AKI PO it was only 34.6%.In the group with AKI PO, 90.4% presented complications, whereas in the group without AKI PO they occurred only in 29.9%. Variables age, baseline MELD, baseline creatinine, creatinine in immediate postoperative (POI), AKI and the presence of ascites were statistically significant for survival.

CONCLUSIONS: There is association between AKI PO and emergency surgery and, also, between AKI PO and complications after surgery. The factors related to higher occurrence were initial MELD, basal Cr, Cr POI. The patients with postoperative AKI had a higher rate of complications and higher mortality.

PMID:35019134 | DOI:10.1590/0102-672020210002e1622

Arq Bras Cir Dig. 2022 Jan 5;34(3):e1617. doi: 10.1590/0102-672020210002e1617. eCollection 2022.

ABSTRACT

BACKGROUND: Due to the longer life expectancy and consequently an increase in the elderly population, a higher incidence of gastric cancer is expected in this population in the coming decades.

AIM: To compare the results of laparoscopic GC surgical treatment between individuals aged<65 years (group I) and ≥ 65 years (group II), according to clinical, surgical, and histopathological characteristics.

METHODS: A observational retrospective study was performed by analyzing medical charts of patients with gastric cancer undergoing total or subtotal laparoscopic gastrectomy for curative purposes by a single oncologic surgery team.

RESULTS: Thirty-six patients were included in each group. Regarding the ASA classification, 31% of the patients in group I was ASA 1, compared to 3.1% in group II. The mean number of concomitant medications in group II was statistically superior to group I (5±4.21 x 1.42±3.08, p<0.001). Subtotal gastrectomy was the most performed procedure in both groups (69.4% and 63.9% in groups I and II, respectively) due to the high prevalence of distal tumors in both groups, 54.4% group I and 52.9% group II. According to Lauren’s classification, group I presented a predominance of diffuse tumors (50%) and group II the intestinal type (61.8%). There was no difference between the two groups regarding the number of resected lymph nodes and lymph node metastases and the days of hospitalization and mortality.

CONCLUSION: Laparoscopic gastrectomy showed to be a safe procedure, without a statistical difference in morbidity, mortality, and hospitalization time between both groups.

PMID:35019129 | DOI:10.1590/0102-672020210002e1617

Arq Bras Cir Dig. 2022 Jan 5;34(3):e1621. doi: 10.1590/0102-672020210002e1621. eCollection 2022.

ABSTRACT

BACKGROUND: Multimodal therapy with neoadjuvant chemoradiotherapy, followed by esophagectomy has offered better survival results, compared to isolated esophagectomy, in advanced esophageal cancer. In addition, patients who have a complete pathological response to neoadjuvant treatment presented greater overall survival and longer disease-free survival compared to those with incomplete response.

AIM: To compare the results of overall survival and disease-free survival among patients with complete and incomplete response, submitted to neoadjuvant chemoradiotherapy, with two therapeutic regimens, followed by transhiatal esophagectomy.

METHODS: Retrospective study, approved by the Research Ethics Committee, analyzing the medical records of 56 patients with squamous cell carcinoma of the esophagus, divided into two groups, submitted to radiotherapy (5040 cGY) and chemotherapy (5-Fluorouracil + Cisplatin versus Paclitaxel + Carboplatin) neoadjuvants and subsequently to surgical treatment, in the period from 2005 to 2012, patients.

RESULTS: The groups did not differ significantly in terms of gender, race, age, postoperative complications, disease-free survival and overall survival. The 5-year survival rate of patients with incomplete and complete response was 18.92% and 42.10%, respectively (p> 0.05). However, patients who received Paclitaxel + Carboplatin, had better complete pathological responses to neoadjuvant, compared to 5-Fluorouracil + Cisplatin (47.37% versus 21.62% – p = 0.0473, p <0.05).

CONCLUSIONS: There was no statistical difference in overall survival and disease-free survival for patients who had a complete pathological response to neoadjuvant. Patients submitted to the therapeutic regimen with Paclitaxel and Carboplastin, showed a significant difference with better complete pathological response and disease progression. New parameters are indicated to clarify the real value in survival, from the complete pathological response to neoadjuvant, in esophageal cancer.

PMID:35019133 | DOI:10.1590/0102-672020210002e1621

Arq Bras Cir Dig. 2022 Jan 5;34(3):e1615. doi: 10.1590/0102-672020210002e1615. eCollection 2022.

ABSTRACT

BACKGROUND: Obesity and bariatric surgery may be related with mental and oral disorders.

AIM: To evaluate the impact of bariatric surgery on anxiety, initial dental caries lesion and gingival bleeding in obese patients.

METHODS: Eighty-nine patients were divided in two groups: Control Group (CG) – obese patients and Experimental Group (EG) – patients submitted to bariatric surgery. EG was analyzed before and 12 months after bariatric surgery; for the CG, was respected an interval of 12 months between the evaluations. International Caries Detection and Assessment System, Gingival Bleeding Index and Trace-State Anxiety Inventory were used. Medical profile, anthropometrics data, sociodemographic and behavioral variables were considered.

RESULTS: There were no statistically significant differences between groups in evaluation times regarding to initial dental caries lesion and anxiety. However, the number of teeth with initial dental caries lesion (p=0.0033) and gingival bleeding (p<0.0001) increased significantly after bariatric surgery in EG.

CONCLUSION: These results reinforce the need for multi-professional team follow-up, including dental care, for both obese and bariatric patients.

PMID:35019127 | DOI:10.1590/0102-672020210002e1615

Arq Bras Cir Dig. 2022 Jan 5;34(3):e1606. doi: 10.1590/0102-672020210003e1606. eCollection 2022.

ABSTRACT

RATIONAL: The metabolic response to surgical trauma is enhanced by prolonged preoperative fasting, contributing to increased insulin resistance. This manifestation is more intense on the 1st and 2nd postoperative days and is directly proportional to the size of the operation.

AIM: To compare whether preoperative fasting abbreviation and early postoperative refeeding associated with intraoperative and postoperative fluid restriction interfere in the evolution of patients undergoing gastrojejunal bypass.

METHODS: Eighty patients indicated for Roux-en-Y gastrojejunal bypass were selected. They were randomly divided into two groups: Ringer Lactate (RL) group, who underwent a 6 hours solids fasting, with the administration of 50 g of maltodextrin in 100 ml of mineral water 2 hours before the beginning of anesthesia; and Physiologic Solution (PS) group, who underwent a 12 hours solids and liquids fasting. Anesthesia was standardized for both groups. During the surgical procedure, 1500 ml of ringer lactate solution was administered in the RL and 2500 ml of physiological solution (0.9% sodium chloride) in the PS. In both groups, the occurrence of bronchoaspiration was analyzed during intubation, and the residual gastric volume was measured after opening the abdominal cavity. In the postoperative period in Group RL, patients started a liquid diet 24 hours after the end of the operative procedure; whilst for PS group, fasting was maintained for the first 24 hours, it was prescripted 2000 ml of physiological solution and a restricted liquid diet after 36 hours. Each patient underwent CPK, insulin, sodium, potassium, urea, creatinine, PaCO2, pH and bicarbonate dosage in the immediate postoperative period, and 48 hours later, the exams were repeated.

RESULTS: There were no episodes of bronchoaspiration and gastrojejunal fistulas in either group. In the analysis of the residual gastric volume of the PS and RL groups, the mean volumes were respectively 16.5 and 8.8, which shows statistical significance between the groups. In laboratory tests, there was no difference between groups in sodium; PS group showed a higher level of serum potassium (p=0.029); whilst RL group showed a higher urea and creatinine values; CPK values were even for both; PS group demonstrated a higher insulin level; pH was higher in PS group; sodium bicarbonate showed a significant difference at all times; PaCO2 values in RL group was higher than in PS. In the analysis of the incidence of nausea and flatus, no statistical significance was observed between the groups.

CONCLUSIONS: The abbreviation of preoperative fasting and early postoperative refeeding of Roux-en-Y gastrojejunal bypass with the application of ERAS or ACERTO Project accelerated the patient’s recovery, reducing residual gastric volume and insulin level, and do not predispose to complications.

PMID:35019120 | DOI:10.1590/0102-672020210003e1606

Arq Bras Cir Dig. 2022 Jan 5;34(3):e1591. doi: 10.1590/0102-672020210003e1591. eCollection 2022.

ABSTRACT

BACKGROUND: Abdominal obesity or android obesity, that is, the increase in adipose tissue in the abdominal region, is considered a risk factor for several morbidities. Different ways of quantifying it have been proposed, one method is the measurement of the abdominal fat area by computed tomography.

AIM: To establish correspondence between the groups defined by degree of obesity in relation to the total, subcutaneous and visceral fat area.

METHODS: Cross-sectional observational study carried out through the analysis of tomographic examinations. Horos v3.3.5 medical image visualization software was used, with abdominal tomography in a single cut including the L4 vertebral body and the umbilical scar, to obtain the areas of total, visceral and subcutaneous fat.

RESULTS: Of the 40 patients, 10 had grade II obesity, 23 grade III and 7 superobese. The amount of total fat showed an increase in relation to the degree of obesity. Visceral fat did not show significant differences between the degrees of obesity, but the data showed a lower average in the group of obesity grade II. The area of subcutaneous fat, as well as total fat, showed an increase in its measurements, according to the progression of the patients’ BMI, but there was no statistical significance in this difference between the groups of grade II and super-obese individuals.

CONCLUSION: The area of total and subcutaneous fat showed an increase in its measurements according to the progression of the BMI groups, which did not happen with visceral fat.

PMID:35019117 | DOI:10.1590/0102-672020210003e1591