The purpose of this study was to compare the efficiency between 2 thermal blanket models: the upper blanket and the underbody blanket in patient heating and hypothermia prevention during endovascular ...surgery.
Fifty patients, American Society of Anesthesiologists physical status 2-4, receiving endovascular surgery repair of infrarenal abdominal aortic aneurysm or lower limb angioplasty by endovascular technique were studied. Primary outcome was to determine which forced-air blanket is more warming effective during the surgeries. Age, type of surgery, gender, body mass index, surgery duration, and initial patient temperature were analyzed to determine possible hypothermia association as secondary outcomes. Patients were randomized and split into 2 groups based on blanket model. All patients received general anesthesia, and temperature was obtained by an esophageal thermometer inserted after tracheal intubation and registered at intervals of 15 min until extubation.
Groups significantly differed in body temperature (P = 0.006) and hypothermia occurrence (P = 0.020). The underbody blanket group hada higher ratio of hypothermic patients and a lower average temperature at the end of surgery. The average temperature after 60 min in the underbody blanket group was lower than the upper blanket group,although this difference was only significant after 150 min (P = 0.020).
We conclude that upper thermal blanket is more effective thanunderbody thermal blanket in patient warming and hypothermia prevention during endovascular abdominal aortic aneurysm repair and lower limb angioplasty after 150 min of anesthetic-surgical time duration.
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/m. 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:URLhttps://clinicaltrials.gov. Unique identifierNCT01784848.
Midterm effects of bariatric surgery on patients with obesity and hypertension remain uncertain.
To determine the 3-year effects of Roux-en-Y gastric bypass (RYGB) on blood pressure (BP) compared ...with medical therapy (MT) alone.
Randomized clinical trial. (ClinicalTrials.gov: NCT01784848).
Investigator-initiated study at Heart Hospital (HCor), São Paulo, Brazil.
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/m
were randomly assigned (1:1 ratio).
RYGB plus MT or MT alone.
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).
Among 100 patients (76% female; mean BMI, 36.9 kg/m
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;
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 (
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 B
and 2 patients required reoperation.
Single-center, nonblinded trial.
RYGB is an effective strategy for midterm BP control and hypertension remission, with fewer medications required in patients with hypertension and obesity.
Ethicon, represented in Brazil by Johnson & Johnson do Brasil.
Obesity represents a major obstacle for controlling hypertension, the leading risk factor for cardiovascular mortality.
The purpose of this study was to determine the long-term effects of bariatric ...surgery on hypertension control and remission.
We conducted a randomized clinical trial with subjects with obesity grade 1 or 2 plus hypertension using at least 2 medications. We excluded subjects with previous cardiovascular events and poorly controlled type 2 diabetes. Subjects were assigned to Roux-en-Y gastric bypass (RYGB) combined with medical therapy (MT) or MT alone. We reassessed the original primary outcome (reduction of at least 30% of the total antihypertensive medications while maintaining blood pressure levels <140/90 mm Hg) at 5 years. The main analysis followed the intention-to-treat principle.
A total of 100 subjects were included (76% women, age 43.8 ± 9.2 years, body mass index: 36.9 ± 2.7 kg/m
). At 5 years, body mass index was 36.40 kg/m
(95% CI: 35.28-37.52 kg/m
) for MT and 28.01 kg/m
(95% CI: 26.95-29.08 kg/m
) for RYGB (P < 0.001). Compared with MT, RYGB promoted a significantly higher rate of number of medications reduction (80.7% vs 13.7%; relative risk: 5.91; 95% CI: 2.58-13.52; P < 0.001) and the mean number of antihypertensive medications was 2.97 (95% CI: 2.33-3.60) for MT and 0.80 (95% CI: 0.51-1.09) for RYGB (P < 0.001). The rates of hypertension remission were 2.4% vs 46.9% (relative risk: 19.66; 95% CI: 2.74-141.09; P < 0.001). Sensitivity analysis considering only completed cases revealed consistent results. Interestingly, the rate of apparent resistant hypertension was lower after RYGB (0% vs 15.2%).
Bariatric surgery represents an effective and durable strategy to control hypertension and related polypharmacy in subjects with obesity. (GAstric bypass to Treat obEse Patients With steAdy hYpertension GATEWAY; NCT01784848).
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/m). 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—URLhttp://www.clinicaltrials.gov. Unique identifierNCT01784848.
We compared the albuminuria-lowering effects of Roux-en-Y gastric bypass (RYGB) to best medical treatment in patients with diabetic kidney disease and obesity to determine which treatment is better.
...A 5 year, open-label, single-centre, randomised trial studied patients with diabetic kidney disease and class I obesity after 1:1 randomization to best medical treatment (n = 49) or RYGB (n = 51). The primary outcome was the proportion of patients achieving remission of microalbuminuria after 5 years. Secondary outcomes included improvements in diabetic kidney disease, glycemic control, quality of life, and safety. For efficacy outcomes, we performed an intention-to-treat (ITT) analysis. This study was registered with ClinicalTrials.gov, NCT01821508.
88% of patients (44 per arm) completed 5-year follow-up. Remission of albuminuria occurred in 59.6% (95% CI = 45.5–73.8) after best medical treatment and 69.7% (95% CI = 59.6–79.8) after RYGB (risk difference: 10%, 95% CI, −7 to 27, P = 0.25). Patients after RYGB were twice as likely to achieve an HbA1c ≤ 6.5% (60.2% versus 25.4%, risk difference, 34.9%; 95% CI = 15.8–53.9, P < 0.001). Quality of life after five years measured by the 36-Item Short Form Survey questionnaire (standardized to a 0-to-100 scale) was higher in the RYGB group than in the best medical treatment group for several domains. The mean differences were 13.5 (95% CI, 5.5–21.6, P = 0.001) for general health, 19.7 (95% CI, 9.1–30.3, P < 0.001) for pain, 6.1 (95% CI, −4.8 to 17.0, P = 0.27) for social functioning, 8.3 (95% CI, 0.23 to 16.3, P = 0.04) for emotional well-being, 12.2 (95% CI, 3.9–20.4, P = 0.004) for vitality, 16.8 (95% CI, −0.75 to 34.4, P = 0.06) for mental health, 21.8 (95% CI, 4.8–38.7, P = 0.01) for physical health and 11.1 (95% CI, 2.24–19.9, P = 0.01) for physical functioning. Serious adverse events were experienced in 7/46 (15.2%) after best medical treatment and 11/46 patients (24%) after RYGB (P = 0.80).
Albuminuria remission was not statistically different between best medical treatment and RYGB after 5 years in participants with diabetic kidney disease and class 1 obesity, with 6–7 in ten patients achieving remission of microalbuminuria (uACR <30 mg/g) in both groups. RYGB was superior in improving glycemia, diastolic blood pressure, lipids, body weight, and quality of life.
The study was supported by research grants from Johnson & Johnson Brasil, Oswaldo Cruz German Hospital, and by grant 12/YI/B2480 from Science Foundation Ireland (Dr le Roux) and grant 2015-02733 from the Swedish Medical Research Council (Dr le Roux). Dr Pereira was funded by the Chevening Scholarship Programme (Foreign and Commonwealth Office, UK).
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Iodine contrast medium (ICM) is considered gold standard in endovascular revascularization procedures. However, nephrotoxicity and hypersensitivity to ICM are causes that limit its indiscriminate ...use. Carbon dioxide (CO2) contrast angiography has been used as an alternative in patients with formal contraindication to ICM. However, no studies to the present date have compared in a randomized and prospective way, outcomes of revascularization procedures performed with either ICM or CO2 in patients eligible for use of both contrasts.
Between April 2012 and April 2013, 35 patients with peripheral arterial disease with arterial lesions classified as Trans-Atlantic Inter-Society Consensus A or B (identified on preoperative angio computed tomography scan) and adequate runoff underwent femoropopliteal revascularization by endovascular technique in a prospective, randomized, and controlled study. Patients were randomized into 2 groups: CO2 group and ICM group, according to the contrast media selected of the procedure. We evaluated the following outcomes in both groups: feasibility of the procedures, complications, surgical outcomes (ankle-brachial index ABI), glomerular filtration rate using the Cockcroft-Gault formula, relationship between the volume of injected iodine and postoperative creatinine clearance, quality of the angiographic images obtained with CO2, costs of the endovascular materials, and finally, cost of contrast agents.
We were able to perform the proposed procedures in all patients treated in this series (ICM group and CO2). There were no CO2-related complications. No procedures required conversion to open surgery. Clinical results were satisfactory, with regression of ischemia and increased levels of ABI in both groups. Variations in creatinine clearance levels showed a numerical increase in the CO2 group and a decrease in ICM group, however, with no statistically significant difference between the delta clearance in each group. All CO2 arteriograms of the supragenicular arteries were graded as good or fair by both observers with high interobserver image quality concordance. There was no statistical difference between endovascular material costs between the groups, but the contrast cost was significantly lower in CO2 group (P < 0.001).
The use of CO2 in patients with no restriction for ICM is an alternative that does not limit the feasibility of the procedures. Similar outcomes were observed with CO2 when compared with the gold standard contrast (ICM) regarding quality of images produced, with no associated changes in creatinine clearance or hypersensitivity reactions and also allows a reduction in contrast-related costs in angioplasty procedures.
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/m
). 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.
Abstract only
Background:
Bariatric surgery represents an effective strategy for office blood pressure (BP) reduction in obese hypertensive patients. However, no previous study evaluated the impact ...of bariatric surgery on 24-h BP profile, non-dipping status and incidence of resistant hypertension (RH).
Methods:
This is a sub-analysis of a randomized clinical trial including hypertensive patients with grade 1 and 2 obesity, aged 18 to 65 years, using at least 2 drugs at optimal doses or >2 at moderate doses. Patients were randomly allocated to either Roux-en-Y Gastric Bypass (RYGB) with medical therapy (MT) or MT alone for 12 months. We analyzed the 24-h BP profile, non-dipping status (defined by <10% of systolic BP reduction during sleep as compared to the daytime period) and RH incidence.
Results:
A total of 100 patients were included (76% female, age 43.8±9.2 years, BMI 36.9±2.7 Kg/m
2
). The 24-h BP profile was similar at 12 months in both groups, but the RYGB group required less anti-hypertensive classes compared to the MT alone (Figure). The rate of non-dipping BP did not change significantly during the follow-up (RYGB: from 18/48 (37.5%) to 22/48 (45.8%); p=0.30; MT: from 16/33 (48.5%) to 15/33 (45.5%); p=0.80). In an exploratory analysis, the incidence of RH was similar at the baseline (RYGB 10% (5/50) and MT 16% (8/50); p=0.38). After 12 months, it changed significantly in the RYGB group: 0% (0/49) while remained stable in the MT group: 14.9% (7/47) (p<0.001).
Conclusions:
RYGB significantly reduced anti-hypertensive medications while promoting similar 24-h BP profile and non-dipping BP status compared to the MT alone. RYGB may be an attractive strategy to reduce RH incidence in obese patients.
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