Three-Year Outcomes of Bariatric Surgery in Patients With Obesity and Hypertension : A Randomized Clinical Trial.

BACKGROUND: Midterm effects of bariatric surgery on patients with obesity and hypertension remain uncertain. OBJECTIVE: To determine the 3-year effects of Roux-en-Y gastric bypass (RYGB) on blood pressure (BP) compared with medical therapy (MT) alone. DESIGN: Randomized clinical trial. (ClinicalTrials.gov: NCT01784848). SETTING: Investigator-initiated study at Heart Hospital (HCor), São Paulo, Brazil. PARTICIPANTS: Patients with hypertension receiving at least 2 medications at maximum doses or more than 2 medications at moderate doses and with a body mass index (BMI) between 30.0 and 39.9 kg/m2 were randomly assigned (1:1 ratio). INTERVENTION: RYGB plus MT or MT alone. MEASUREMENTS: The primary outcome was at least a 30% reduction in total number of antihypertensive medications while maintaining BP less than 140/90 mm Hg. Key secondary outcomes were number of antihypertensive medications, hypertension remission, and BP control according to current guidelines (<130/80 mm Hg). RESULTS: Among 100 patients (76% female; mean BMI, 36.9 kg/m2 [SD, 2.7]), 88% from the RYGB group and 80% from the MT group completed follow-up. At 3 years, the primary outcome occurred in 73% of patients from the RYGB group compared with 11% of patients from the MT group (relative risk, 6.52 [95% CI, 2.50 to 17.03]; P < 0.001). Of the randomly assigned participants, 35% and 31% from the RYGB group and 2% and 0% from the MT group achieved BP less than 140/90 mm Hg and less than 130/80 mm Hg without medications, respectively. Median (interquartile range) number of medications in the RYGB and MT groups at 3 years was 1 (0 to 2) and 3 (2.8 to 4), respectively (P < 0.001). Total weight loss was 27.8% and -0.1% in the RYGB and MT groups, respectively. In the RYGB group, 13 patients developed hypovitaminosis B12 and 2 patients required reoperation. LIMITATION: Single-center, nonblinded trial. CONCLUSION: RYGB is an effective strategy for midterm BP control and hypertension remission, with fewer medications required in patients with hypertension and obesity. PRIMARY FUNDING SOURCE: Ethicon, represented in Brazil by Johnson & Johnson do Brasil.

Effects of Bariatric Surgery in Obese Patients With Hypertension: The GATEWAY Randomized Trial (Gastric Bypass to Treat Obese Patients With Steady Hypertension).

BACKGROUND: Recent research efforts on bariatric surgery have focused on metabolic and diabetes mellitus resolution. Randomized trials designed to assess the impact of bariatric surgery in patients with obesity and hypertension are needed. METHODS: In this randomized, single-center, nonblinded trial, we included patients with hypertension (using ≥2 medications at maximum doses or >2 at moderate doses) and a body mass index between 30.0 and 39.9 kg/m2. Patients were randomized to Roux-en-Y gastric bypass plus medical therapy or medical therapy alone. The primary end point was reduction of ≥30% of the total number of antihypertensive medications while maintaining systolic and diastolic blood pressure <140 mm Hg and 90 mm Hg, respectively, at 12 months. RESULTS: We included 100 patients (70% female, mean age 43.8±9.2 years, mean body mass index 36.9±2.7 kg/m2), and 96% completed follow-up. Reduction of ≥30% of the total number of antihypertensive medications while maintaining controlled blood pressure occurred in 41 of 49 patients from the gastric bypass group (83.7%) compared with 6 of 47 patients (12.8%) from the control group with a rate ratio of 6.6 (95% confidence interval, 3.1-14.0; P<0.001). Remission of hypertension was present in 25 of 49 (51%) and 22 of 48 (45.8%) patients randomized to gastric bypass, considering office and 24-hour ambulatory blood pressure monitoring, respectively, whereas no patient submitted to medical therapy was free of antihypertensive drugs at 12 months. A post hoc analysis for the primary end point considering the SPRINT (Systolic Blood Pressure Intervention Trial) target reached consistent results, with a rate ratio of 3.8 (95% confidence interval, 1.4-10.6; P=0.005). Eleven patients (22.4%) from the gastric bypass group and none in the control group were able to achieve SPRINT levels without antihypertensives. Waist circumference, body mass index, fasting plasma glucose, glycohemoglobin, low-density lipoprotein cholesterol, triglycerides, high-sensitivity C-reactive protein, and 10-year Framingham risk score were lower in the gastric bypass than in the control group. CONCLUSIONS: Bariatric surgery represents an effective strategy for blood pressure control in a broad population of patients with obesity and hypertension. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov. Unique identifier: NCT01784848.

Atorvastatin for high-risk statin-naïve patients undergoing noncardiac surgery: The Lowering the Risk of Operative Complications Using Atorvastatin Loading Dose (LOAD) randomized trial.

Preliminary evidence suggests that statins may prevent major perioperative vascular complications. METHODS: We randomized 648 statin-naïve patients who were scheduled for noncardiac surgery and were at risk for a major vascular complication. Patients were randomized to a loading dose of atorvastatin or placebo (80 mg anytime within 18hours before surgery), followed by a maintenance dose of 40 mg (or placebo), started at least 12hours after the surgery, and then 40 mg/d (or placebo) for 7days. The primary outcome was a composite of all-cause mortality, nonfatal myocardial injury after noncardiac surgery, and stroke at 30days. RESULTS: The primary outcome was observed in 54 (16.6%) of 326 patients in the atorvastatin group and 59 (18.7%) of 316 patients in the placebo group (hazard ratio [HR] 0.87, 95% CI 0.60-1.26, P=.46). No significant effect was observed on the 30-day secondary outcomes of all-cause mortality (4.3% vs 4.1%, respectively; HR 1.14, 95% CI 0.53-2.47, P=.74), nonfatal myocardial infarction (3.4% vs 4.4%, respectively; HR 0.76, 95% CI 0.35-1.68, P=.50), myocardial injury after noncardiac surgery (13.2% vs 16.5%; HR 0.79, 95% CI 0.53-1.19, P=.26), and stroke (0.9% vs 0%, P=.25). CONCLUSION: In contrast to the prior observational and trial data, the LOAD trial has neutral results and did not demonstrate a reduction in major cardiovascular complications after a short-term perioperative course of statin in statin-naïve patients undergoing noncardiac surgery. We demonstrated, however, that a large multicenter blinded perioperative statin trial for high-risk statin-naïve patients is feasible and should be done to definitely establish the efficacy and safety of statin in this patient population.

The Role of Metabolic Surgery on Blood Pressure Control.

Obesity and hypertension are growing epidemics in the modern world. Lifestyle changes and medical treatment for obesity have disappointing long-term results and albeit drugs for hypertension are usually very effective, the necessity of multiple pills and frequent side effects make the adherence to treatment a huge challenge for healthcare systems. Bariatric/metabolic surgery is a very effective treatment and an exponential number of studies have been showing its positive impact beyond weight loss, mainly on type 2 diabetes. There is also growing evidence suggesting that bariatric/metabolic surgery is associated with reduced incidence of cardiovascular events, but the impact on hypertension and other components of metabolic syndrome usually derive from trials' secondary end points. Taking this limitation in mind, bariatric/metabolic surgery action on blood pressure is reaching a significant proportion of hypertension resolution or improvement. In this review, we discussed the current evidence on the impact of bariatric/metabolic surgery on blood pressure control and pointed out perspectives in this research area.

Prevalence, characteristics, and predictors of early termination of cardiovascular clinical trials due to low recruitment: insights from the ClinicalTrials.gov registry.

BACKGROUND: Early termination of clinical trials due to low recruitment represents an understudied challenge for clinical research. We aimed to describe characteristics of cardiovascular trials terminated because of low recruitment and identify the major predictors of such early termination. METHODS: We reviewed all cardiovascular clinical trials (7,042 studies) registered in ClinicalTrials.gov from February 29, 2000, to January 17, 2013, and assessed information about trials that were completed and those that were terminated early. Logistic regression models were developed to identify independent predictors of early termination due to low recruitment. RESULTS: Our search strategy identified 6,279 cardiovascular clinical trials, of which 684 (10.9%) were terminated prematurely. Of these halted trials, the main reason for termination was lower than expected recruitment (278 trials; 53.6%). When comparing trials that terminated early because of low recruitment with those that were completed, we found that studies funded by the National Institutes of Health or other US federal agencies (odds ratio [OR] 0.35, 95% confidence interval [CI] 0.14-0.89), studies of behavior/diet intervention (OR 0.35, 95% CI 0.19-0.65), and single-arm design studies (OR 0.57, 95% CI 0.42-0.78) were associated with a lower risk of early termination. University/hospital-funded (OR 1.52, 95% CI 1.10-2.10) and mixed-source-funded studies (OR 2.14, 95% CI 1.52-3.01) were associated with a higher likelihood of early termination due to lower than expected recruitment rates. CONCLUSIONS: Low recruitment represents the main cause of early termination of cardiovascular clinical trials. Funding source, type of intervention, and study design are factors associated with early termination due to low recruitment and might be good targets for improving enrollment into cardiovascular clinical trials.

Shorter History of Hypertension as a Predictor of Hypertension Remission after 3-years of Bariatric Surgery: Data from the GATEWAY Trial.

BACKGROUND: Previous evidence explored predictors of hypertension (HTN) remission after bariatric but data are limited to observational studies and lack of ambulatory blood pressure monitoring (ABPM). This study was aimed to evaluate the rate of HTN remission after bariatric surgery using ABPM and to define predictors of mid-term HTN remission. METHODS: We included patients enrolled in the surgical arm of the GATEWAY randomized trial. HTN remission was defined as controlled blood pressure (< 130 × 80 mmHg) evaluated by 24-h ABPM while no need of anti-hypertensive medications after 36 months. A multivariable logistic regression model was used to assess the predictors of HTN remission after 36 months. RESULTS: 46 patients submitted Roux-en-Y gastric bypass (RYGB). HTN remission occurred in 39% (n = 14 out of 36 patients with complete data at 36 months). Patients with HTN remission had shorter HTN history than no remission group (5.9 ± 5.5 vs. 12.5 ± 8.1 years; p = 0.01). The baseline insulin levels were lower in patients who presented HTN remission, although not statistically significant (OR: 0.90; CI 95%: 0.80-0.99; p = 0.07). In the multivariate analysis, the HTN history (years) was the only independent predictor of HTN remission (OR: 0.85; 95% CI: 0.70-0.97; p = 0.04). Therefore, for each additional year of HTN history, the chance of HTN remission decreases by approximately 15% after RYGB. CONCLUSION: After 3 years of RYGB, HTN remission defined by ABPM was common and independently associated with a shorter HTN history. These data underscore the need of early effective approach of obesity aiming greater impact in its comorbidities.

Veno-venous extracorporeal membrane oxygenation in patients with SARS-CoV-2 pneumonia in Brazil: a case series.

OBJECTIVE: The world has been suffering from the COVID-19 pandemic. Some COVID-19 patients develop severe viral pneumonia, requiring mechanical ventilation and measures to treat refractory hypoxemia, such as a protective ventilation strategy, prone positioning, and the use of veno-venous extracorporeal membrane oxygenation (VV-ECMO). We describe a case series of 30 COVID-19 patients who needed VV-ECMO at the Hospital Alemão Oswaldo Cruz, located in the city of São Paulo, Brazil. METHODS: We included all patients who required VV-ECMO due to COVID-19 pneumonia between March of 2020 and June of 2021. RESULTS: Prior to VV-ECMO, patients presented with the following median scores: SOFA score, 11; APPS score, 7; Respiratory ECMO Survival Prediction score, 2; and Murray score, 3.3. The 60-day-in-hospital mortality was 33.3% (n = 10). CONCLUSIONS: Although our patients had a highly severe profile, our results were similar to those of other cohort studies in the literature. This demonstrates that VV-ECMO can be a good tool even in a pandemic situation when it is managed in an experienced center.

Interleukin-6 produced in subcutaneous adipose tissue is linked to blood pressure control in septic patients.

Cytokines are inflammatory mediators of major relevance during sepsis. Recent evidence shows that adipose tissue can produce many distinct cytokines under physiological and pathological conditions, but the role of cytokines produced in adipose tissue was not addressed in sepsis. In the present study the open-flow microperfusion (OFM) technique was used to investigate whether the cytokines produced in subcutaneous adipose tissue (SAT) of patients with severe sepsis correlate with clinical variables. Interstitial fluid effluent samples were collected using an OFM catheter inserted in the abdominal SAT of nine patients with severe sepsis. Blood samples were withdrawn concomitantly and interleukin-1beta (IL-1beta), IL-8, IL-6 and tumor necrosis factor alpha (TNF-alpha) were measured both in SAT effluent and serum samples. Different time profiles were registered for each cytokine. IL-1beta increased in a time-dependent manner, indicating a localized response against the catheter insertion. Interleukin-1beta, 6 and 8 were higher in SAT than in serum suggesting they were locally produced. Diastolic blood pressure (DBP) negatively correlated with IL-1beta, IL-6 and IL-8 in SAT indicating a possible interaction between adipose tissue inflammation and vascular tone regulation. A multiple regression analysis disclosed that mean DBP was significantly related to IL-6 concentrations in SAT (B=-43.9; R-square=0.82; P=0.002).

Adipose tissue, inflammation and cardiovascular disease.

Obesity has become a very frequent condition with important consequences for the health of affected individuals. Current evidence shows that the excess of adipose tissue as observed in obesity is responsible for secreting inflammatory mediators in a deregulated manner, thus inducing a chronic state of systemic low-grade inflammation that underlies the metabolic and cardiovascular outcomes in these populations. This article reviews the state of the art regarding mediators produced in the adipose tissue, their roles in the pathophysiology of obesity-associated insulin resistance and diabetes, and finally, tries to build a bridge between these mechanistically oriented insights and clinical practice.

Effects of Bariatric Surgery Versus Medical Therapy on the 24-Hour Ambulatory Blood Pressure and the Prevalence of Resistant Hypertension.

Bariatric surgery is an effective strategy for blood pressure (BP) reduction, but most of the evidence relies on office BP measurements. In this study, we evaluated the impact of bariatric surgery on 24-hour BP profile, BP variability, and resistant hypertension prevalence. This is a randomized trial including obese patients with grade 1 and 2 using at least 2 antihypertensive drugs at maximal doses or >2 at moderate doses. Patients were allocated to either Roux-en-Y Gastric Bypass (RYGB) combined with medical therapy or medical therapy alone for 12 months. The primary outcome was the 24-hour BP profile and variability (average real variability of daytime and night time BP). We evaluated the nondipping status and prevalence of resistant hypertension as secondary end points. We included 100 patients (76% female, body mass index, 36.9±2.7 kg/m2). The 24-hour BP profile (including nondipping status) was similar after 12 months, but the RYGB group required less antihypertensive classes as compared to the medical therapy alone (0 [0-1] versus 3 [2.5-4] classes; P<0.01). The average real variability of systolic nighttime BP was lower after RYGB as compared to medical therapy (between-group difference, -1.63; 95% CI, -2.91 to -0.36; P=0.01). Prevalence of resistant hypertension was similar at baseline (RYGB, 10% versus MT, 16%; P=0.38), but it was significantly lower in the RYGB at 12 months (0% versus 14.9%; P<0.001). In conclusion, RYGB significantly reduced antihypertensive medications while promoting similar 24-hour BP profile and nondipping status. Interestingly, bariatric surgery improved BP variability and may decrease the burden of resistant hypertension associated with obesity. Clinical Trial Registration- URL: http://www.clinicaltrials.gov . Unique identifier: NCT01784848.

Veno-venous extracorporeal membrane oxygenation in patients with SARS-CoV-2 pneumonia in Brazil: a case series / Oxigenação por membrana extracorpórea venovenosa em pacientes com pneumonia por SARS-CoV-2 no Brasil: série de casos

ABSTRACT Objective: The world has been suffering from the COVID-19 pandemic. Some COVID-19 patients develop severe viral pneumonia, requiring mechanical ventilation and measures to treat refractory hypoxemia, such as a protective ventilation strategy, prone positioning, and the use of veno-venous extracorporeal membrane oxygenation (VV-ECMO). We describe a case series of 30 COVID-19 patients who needed VV-ECMO at the Hospital Alemão Oswaldo Cruz, located in the city of São Paulo, Brazil. Methods: We included all patients who required VV-ECMO due to COVID-19 pneumonia between March of 2020 and June of 2021. Results: Prior to VV-ECMO, patients presented with the following median scores: SOFA score, 11; APPS score, 7; Respiratory ECMO Survival Prediction score, 2; and Murray score, 3.3. The 60-day-in-hospital mortality was 33.3% (n = 10). Conclusions: Although our patients had a highly severe profile, our results were similar to those of other cohort studies in the literature. This demonstrates that VV-ECMO can be a good tool even in a pandemic situation when it is managed in an experienced center.

RESUMO Objetivo: O mundo vem sofrendo com a pandemia de COVID-19. Alguns pacientes com COVID-19 desenvolvem pneumonia viral grave, necessitando ventilação mecânica e medidas para tratar a hipoxemia refratária, como estratégias de ventilação protetora, posição prona e uso de oxigenação por membrana extracorpórea venovenosa (ECMO-VV). Descrevemos uma série de casos de 30 pacientes com COVID-19 que necessitaram de ECMO-VV no Hospital Alemão Oswaldo Cruz, localizado na cidade de São Paulo, Brasil. Métodos: Foram incluídos todos os pacientes que necessitaram de ECMO-VV devido à pneumonia por COVID-19 entre março de 2020 e junho de 2021. Resultados: Antes da ECMO-VV, os pacientes apresentavam as seguintes medianas: escore SOFA de 11; escore APPS de 7; escore Respiratory ECMO Survival Prediction de 2; e escore de Murray de 3,3. A mortalidade hospitalar em 60 dias foi de 33,3% (n = 10). Conclusões: Apesar de nossos pacientes apresentarem um perfil de alta gravidade, nossos resultados foram semelhantes aos de outros estudos de coorte na literatura. Isso demonstra que a ECMO-VV pode ser uma boa ferramenta mesmo em uma situação de pandemia quando administrada em um centro experiente.

Evaluation of the Society of Thoracic Surgeons score system for isolated coronary bypass graft surgery in a Brazilian population.

OBJECTIVE: Report the experience with the Society of Thoracic Surgeons scoring system in a Brazilian population submitted to isolated coronary artery bypass graft surgery. METHODS: Data were collected from January-2010 to December-2011, and analyzed to determine the performance of the Society of Thoracic Surgeons scoring system on the determination of postoperative mortality and morbidity, using the method of the receiver operating characteristic curve as well as the Hosmer-Lemeshow and the Chi-square goodness of fit tests. From the 1083 cardiac surgeries performed during the study period 659 represented coronary artery bypass graft procedures which are included in the present analysis. Mean age was 61.4 years and 77% were men. RESULTS: Goodness of fit tests have shown good calibration indexes both for mortality (X2=6.78, P=0.56) and general morbidity (X2=6.69, P=0.57). Analysis of area under the ROC-curve (AUC) demonstrated a good performance to detect the risk of death (AUC 0.76; P<0.001), renal failure (AUC 0.79; P<0.001), prolonged ventilation (AUC 0.80; P<0.001), reoperation (AUC 0.76; P<0.001) and major morbidity (AUC 0.75; P<0.001) which represents the combination of the assessed postoperative complications. STS scoring system did not present comparable results for short term hospital stay, prolonged length of hospital stay and could not be properly tested for stroke and wound infection. CONCLUSION: Society of Thoracic Surgeons scoring system presented a good calibration and discrimination in our population to predict postoperative mortality and the majority of the harmful events following coronary artery bypass graft surgery. Analysis of larger samples might be needed to further validate the use of the score system in Brazilian populations.

Effects of gastric bypass surgery in patients with hypertension: rationale and design for a randomised controlled trial (GATEWAY study).

INTRODUCTION: Obesity and overweight are becoming progressively more prevalent worldwide and are independently associated with a significant increase in the risk of cardiovascular diseases. Systemic arterial hypertension is frequently found in association with obesity and contributes significantly to increased cardiovascular risk. We hypothesise that Roux-en-Y gastric bypass (RYGB) surgery, a procedure that effectively reduces body weight, can also positively impact blood pressure control in obese and hypertensive individuals. METHODS AND ANALYSIS: A unicentric, randomised, controlled, unblinded clinical trial. Sixty obese (body mass index between 30 and 39.9) and moderately well controlled hypertensive patients, in use of at least two antihypertensive medications at maximum doses or more than two in moderate doses, will be randomly allocated, using an online, electronic and concealed method, to receive either RYGB plus optimised clinical treatment (OCT) or OCT alone. The primary end point is the reduction of antihypertensive medication at 1 and 2 years of follow-up. Data analysis will primarily be conducted on an intention-to-treat basis. ETHICS AND DISSEMINATION: The study was approved by the local institutional review board that works in total compliance with the latest version of the Helsinki Declaration, the Good Clinical Practices (GCP), the 'America's Document' and the national regulatory laws. Before the beginning of any study-related activities, each study participant is asked to provide a signed informed consent. TRIAL REGISTRATION NUMBER: NCT01784848.

Effects of bariatric surgery versus medical therapy on the 24-hour ambulatory blood pressure and the prevalence of resistant hypertension

Bariatric surgery is an effective strategy for blood pressure (BP) reduction, but most of the evidence relies on office BP measurements. In this study, we evaluated the impact of bariatric surgery on 24-hour BP profile, BP variability, and resistant hypertension prevalence. This is a randomized trial including obese patients with grade 1 and 2 using at least 2 antihypertensive drugs at maximal doses or >2 at moderate doses. Patients were allocated to either Roux-en-Y Gastric Bypass (RYGB) combined with medical therapy or medical therapy alone for 12 months. The primary outcome was the 24-hour BP profile and variability (average real variability of daytime and night time BP). We evaluated the nondipping status and prevalence of resistant hypertension as secondary end points. We included 100 patients (76% female, body mass index, 36.9±2.7 kg/m2). The 24-hour BP profile (including nondipping status) was similar after 12 months, but the RYGB group required less antihypertensive classes as compared to the medical therapy alone (0 [0­1] versus 3 [2.5­4] classes; P<0.01). The average real variability of systolic nighttime BP was lower after RYGB as compared to medical therapy (between-group difference, −1.63; 95% CI, −2.91 to −0.36; P=0.01). Prevalence of resistant hypertension was similar at baseline (RYGB, 10% versus MT, 16%; P=0.38), but it was significantly lower in the RYGB at 12 months (0% versus 14.9%; P<0.001). In conclusion, RYGB significantly reduced antihypertensive medications while promoting similar 24-hour BP profile and nondipping status. Interestingly, bariatric surgery improved BP variability and may decrease the burden of resistant hypertension associated with obesity. (AU)

Effects of intermittent fasting on metabolism in men.

This review analyzes the available literature on the impact of intermittent fasting (IF), a nutritional intervention, on different aspects of metabolism. The epidemic of metabolic disturbances, such as obesity, metabolic syndrome (MS), and diabetes mellitus type 2 has led to an increase in the prevalence of cardiovascular diseases, and affected patients might significantly benefit from modifications in nutritional habits. Recent experimental studies have elucidated some of the metabolic mechanisms involved with IF. Animal models have shown positive changes in glucose (lower plasma glucose and insulin levels) and in lipid metabolism (reduced visceral fat tissue and increased plasma adiponectin level), and an increased resistance to stress. Despite the limited number of samples studied, positive results have been reported on the impact of IF for human health. IF is reported to improve the lipid profile; to decrease inflammatory responses, reflected by changes in serum adipokine levels; and to change the expression of genes related to inflammatory response and other factors. Studies on obese individuals have shown that patient compliance was greater for IF than other traditional nutritional approaches (calorie restriction), and IF was found to be associated with low oxidative stress. Recent reports suggest that IF exerts a positive impact on the metabolic derangements commonly associated with cardiovascular diseases, and that it may be a viable and accessible intervention for most individuals. Therefore, further clinical studies are essential to test the effectiveness of IF in preventing and controlling metabolic and cardiovascular diseases.

Implementation of an institutional protocol for rational use of blood products and its impact on postoperative of coronary artery bypass graft surgery.

OBJECTIVE: Cardiac surgeries are sometimes followed by significant blood loss, and blood transfusions may be necessary. However, indiscriminant use of blood components can result in detrimental effects for the patient. We evaluated the short-term effects of implementation of a protocol for the rational use of blood products in the perioperative period of cardiac surgery. METHODS: Between April and June 2011, an institutional protocol was implemented in a private hospital specializing in cardiology to encourage rational use of blood products, with the consent and collaboration of seven cardiac surgery teams. We collected clinical and demographic data on the patients. The use of blood products and clinical outcomes were analyzed during hospital stay before and after protocol implementation. The protocol consisted of an institutional campaign with an educational intervention to surgical and anesthesiology teams; the goal was to tailor blood transfusion practice according to clinical goals (anemia with hemodynamic changes and significant ventricular dysfunction) and to make routine the prescription of ε-aminocaproic acid intraoperatively, which is recommended by international guidelines based on scientific evidence. RESULTS: After three months of protocol implementation, the use of ε-aminocaproic acid increased from 31% to 100%. A total of 67% of surgeries before protocol implementation required any blood transfusion, compared with 40% that required any blood transfusion after protocol implementation in subsequent months of the same year (p<0.001). There was no significant difference in clinical outcomes assessed before and after implementation of the protocol. CONCLUSION: The rational use of blood products associated with infusion of ε-aminocaproic acid has the potential to reduce the number of blood transfusions in perioperative of cardiac surgeries, but it can affect the risk of complications.

Effects of bariatric surgery in obese patients with hypertension: the GATEWAY randomized trial (Gastric Bypass to Treat Obese Patients With Steady Hypertension)

BACKGROUND: Recent research efforts on bariatric surgery have focusedon metabolic and diabetes mellitus resolution. Randomized trials designedto assess the impact of bariatric surgery in patients with obesity andhypertension are needed.METHODS: In this randomized, single-center, nonblinded trial, we includedpatients with hypertension (using ≥2 medications at maximum doses or >2 atmoderate doses) and a body mass index between 30.0 and 39.9 kg/m2. Patientswere randomized to Roux-en-Y gastric bypass plus medical therapy or medicaltherapy alone. The primary end point was reduction of ≥30% of the totalnumber of antihypertensive medications while maintaining systolic and diastolicblood pressure <140 mmHg and 90 mmHg, respectively, at 12 months. RESULTS: We included 100 patients (70% female, mean age 43.8±9.2 years,mean body mass index 36.9±2.7 kg/m2), and 96% completed follow-up.Reduction of ≥30% of the total number of antihypertensive medicationswhile maintaining controlled blood pressure occurred in 41 of 49 patientsfrom the gastric bypass group (83.7%) compared with 6 of 47 patients(12.8%) from the control group with a rate ratio of 6.6 (95% confidenceinterval, 3.1–14.0; P<0.001). Remission of hypertension was present in 25of 49 (51%) and 22 of 48 (45.8%) patients randomized to gastric bypass,considering office and 24-hour ambulatory blood pressure monitoring...

The Role of Metabolic Surgery on Blood Pressure Control

Obesity and hypertension are growing epidemics inthe modern world. Lifestyle changes and medical treatmentfor obesity have disappointing long-term results and albeitdrugs for hypertension are usually very effective, the necessityof multiple pills and frequent side effects make the adherenceto treatment a huge challenge for health care systems. Bariatric/metabolic surgery is a very effective treatment andan exponential number of studies have been showing its positiveimpact beyond weight loss, mainly on type 2 diabetes. There is also growing evidence suggesting that bariatric/metabolic surgery is associated with reduced incidence of cardiovascular events, but the impact on hypertension and other components of metabolic syndrome usually derive from trials’secondary end points. Taking this limitation in mind, bariatric/metabolic surgery action on blood pressure is reaching a significant proportion of hypertension resolution or improvement. In this review, we discussed the current evidence onthe impact of bariatric/metabolic surgery on blood pressurecontrol and pointed out perspectives in this research area...