Reducing complication rates and hospital readmissions while revising the enhanced recovery after bariatric surgery (ERABS) protocol.

BACKGROUND: To optimize the postoperative phase following bariatric surgery, the enhanced recovery after bariatric surgery pathway (ERABS) has been developed. The aim of ERABS is to create a care path that is as safe, efficient and patient-friendly as possible. Continuous evaluation and optimization of ERABS are important to ensure a safe treatment path and may result in better outcomes. The objective of this study was to compare the clinical outcomes of patients undergoing bariatric surgery over 2014-2017, during which the ERABS protocol was continuously evaluated and optimized. METHODS: This is a retrospective cohort study. Data were collected from patients undergoing a primary Roux-en-Y gastric bypass or sleeve gastrectomy between January 2014 and December 2017. Outcomes were early complications, unplanned hospital revisits, readmissions, duration of surgery and length of hospital stay. RESULTS: 2889 patients underwent a primary bariatric procedure in a single center. There was a significant decrease in minor complications over the years from 7.0 to 1.9% (p < 0.001). Hospital revisit rates decreased after 2015 (p < 0.001). Readmission rates decreased over time (p < 0.001). The mean duration of surgery decreased from 52 (in 2014) to 41 (in 2017) minutes (p < 0.001). Median length of hospital stay decreased from 1.8 to 1.5 days in 2015 (p = 0.002) and remained stable since. CONCLUSION: An improvement of the ERABS protocol was associated with a decrease in minor complication rates, number of unplanned hospital revisits and readmission rates after primary bariatric procedures.

Low-pressure pneumoperitoneum with deep neuromuscular blockade in metabolic surgery to reduce postoperative pain: a randomized pilot trial.

BACKGROUND: For metabolic laparoscopic surgery, higher pressures up to 20 mmHg are often used to create a surgical field of sufficient quality. This randomized pilot study aimed to determine the feasibility, safety and tolerability of low intraabdominal pressure (IAP) and deep neuromuscular blockade (NMB) to reduce postoperative pain. METHODS: In a teaching hospital in the Netherlands, 62 patients eligible for a laparoscopic Roux-en-Y gastric bypass (LRYGB) were randomized into one of four groups in a 2 × 2 factorial design: deep/moderate NMB and standard (20 mmHg)/low IAP (12 mmHg). Patient and surgical team were blinded. Primary outcome measure was the surgical field quality, scored on the Leiden-Surgical Rating Scale (L-SRS). Secondary outcome measures were (serious) adverse events, duration of surgery and postoperative pain. RESULTS: 62 patients were included. L-SRS was good or perfect in all patients that were operated under standard IAP with deep or moderate NMB. In 40% of patients with low IAP and deep NMB, an increase in IAP was needed to improve surgical overview. In patients with low IAP and moderate NMB, IAP was increased to improve surgical overview in 40%, and in 75% of these cases a deep NMB was requested to further improve the surgical overview. Median duration of surgery was 38 min (IQR34-40 min) in the group with standard IAP and moderate NMB and 52 min (IQR46-55 min) in the group with low IAP and deep NMB. CONCLUSIONS: The combination of moderate NMB and low IAP can create insufficient surgical overview. Larger trials are needed to corroborate the findings of this study. TRIAL REGISTRATION: Dutch Trial Register: Trial NL7050, registered 28 May 2018. https://www.trialregister.nl/trial/7050 .

The effect of sex and menopause on carotid intima-media thickness and pulse wave velocity in morbid obesity.

BACKGROUND: Women are relatively protected from cardiovascular disease compared with men. Since morbid obesity is an independent risk factor for cardiovascular disease, the current study investigated whether the association between sex and cardiovascular risk factors and outcomes can be demonstrated in subjects suffering from morbid obesity. MATERIALS AND METHODS: Two hundred subjects enrolled in a study on cardiovascular risk factors in morbid obesity underwent extensive laboratory screening, carotid intima-media thickness (cIMT) and pulse wave velocity (PWV) measurements. Gender differences were analysed using univariate and multivariable linear regression models. In addition, the effect of menopause on cIMT and PWV was analysed. Results of these models were reported as B coefficients with 95% confidence intervals. RESULTS: The group consisted of 52 men and 148 women, with a mean age of 41 (±11.8) years and a mean body mass index (BMI) of 42.7 (±5.2) kg/m2 . Both, cIMT and PWV were significantly higher in men than in women, although the difference in cIMT disappeared after adjustment for covariables such as waist circumference, age, high-density lipoprotein cholesterol and mean arterial pressure. PWV was associated with sex after adjustments for covariables in morbidly obese patients. Postmenopausal women had significantly increased cIMT and PWV when compared with premenopausal women. CONCLUSION: Sex differences in PWV persist in subjects suffering from morbid obesity. However, no difference was found in cIMT between morbidly obese men and women after adjustment for classic cardiovascular risk factors. Premenopausal morbidly obese women are protected for cardiovascular disease when compared with postmenopausal morbidly obese women.

Long-term effect of sleeve gastrectomy vs Roux-en-Y gastric bypass in people living with severe obesity: a phase III multicentre randomised controlled trial (SleeveBypass).

Background: Sleeve gastrectomy is the most performed metabolic surgical procedure worldwide. However, conflicting results offer no clear evidence about its long-term clinical comparability to Roux-en-Y gastric bypass. This study aims to determine their equivalent long-term weight loss effects. Methods: This randomised open-label controlled trial was conducted from 2012 until 2017 in two Dutch bariatric hospitals with a 5-year follow-up (last follow-up July 29th, 2022). Out of 4045 patients, 628 were eligible for metabolic surgery and were randomly assigned to sleeve gastrectomy or Roux-en-Y gastric bypass (intention-to-treat). The primary endpoint was weight loss, expressed by percentage excess body mass index (BMI) loss. The predefined clinically relevant equivalence margin was -13% to 13%. Secondary endpoints included percentage total kilograms weight loss, obesity-related comorbidities, quality of life, morbidity, and mortality. This trial is registered with Dutch Trial Register NTR4741: https://onderzoekmetmensen.nl/nl/trial/25900. Findings: 628 patients were randomised between sleeve gastrectomy (n = 312) and Roux-en-Y gastric bypass (n = 316) (mean age 43 [standard deviation (SD), 11] years; mean BMI 43.5 [SD, 4.7]; 81.8% women). Excess BMI loss at 5 years was 58.8% [95% CI, 55%-63%] after sleeve gastrectomy and 67.1% [95% CI, 63%-71%] after Roux-en-Y gastric bypass (difference 8.3% [95% CI, -12.5% to -4.0%]). This was within the predefined margin (P < 0.001). Total weight loss at 5 years was 22.5% [95% CI, 20.7%-24.3%] after sleeve gastrectomy and 26.0% [95% CI, 24.3%-27.8%] after Roux-en-Y gastric bypass (difference 3.5% [95% CI, -5.2% to -1.7%]). In both groups, obesity-related comorbidities significantly improved after 5 years. Dyslipidaemia improved more frequently after Roux-en-Y gastric bypass (83%, 54/65) compared to sleeve gastrectomy (62%, 44/71) (P = 0.006). De novo gastro-oesophageal reflux disease occurred more frequently after sleeve gastrectomy (16%, 46/288) vs Roux-en-Y gastric bypass (4%, 10/280) (P < 0.001). Minor complications were more frequent after Roux-en-Y gastric bypass (5%, 15/316) compared to sleeve gastrectomy (2%, 5/312). No statistically significant differences in major complications and health-related quality of life were encountered. Interpretation: In people living with obesity grades 2 and 3, sleeve gastrectomy and Roux-en-Y gastric bypass had clinically comparable excess BMI loss according to the predefined definition for equivalence. However, Roux-en-Y gastric bypass showed significantly higher total weight loss and significant advantages in secondary outcomes, including dyslipidaemia and GERD, yet at a higher rate of minor complications. Major complications, other comorbidities, and overall HRQoL did not significantly differ between the groups. Funding: Not applicable.

Peroperative administration of tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce haemorrhage in patients with morbid obesity: protocol for randomised controlled trial (PATRY trial).

INTRODUCTION: By implementation of Enhanced Recovery After Bariatric Surgery protocols and day-care surgery, early discharge poses a challenge if excessive bleeding occurs after bariatric surgery. Tranexamic acid (TXA) has demonstrated efficacy in other surgical fields and in bariatric pilot studies. This trial aims to assess the efficacy of peroperative administration of TXA in reducing haemorrhage in patients undergoing gastric bypass surgery. METHOD AND ANALYSIS: This is a multicentre, phase III, double-blind randomised controlled trial in six high-volume bariatric centres in the Netherlands. A total of 1524 eligible patients, aged 18 years or older, undergoing primary gastric bypass surgery (either Roux-en-Y gastric bypass or one-anastomosis gastric bypass) will be randomised between TXA and placebo (1:1, variable block, stratified for centre, day-care/overnight stay and type of surgery) after obtaining informed consent (2.5% less haemorrhage, power 80%, 2-sided-α 0.05 and 10% dropout). Exclusion criteria are pregnancy, amedical history of acute bleeding (without cause), venous thrombotic events (VTEs), epilepsy, anticoagulant use and iatrogenic bleeding during surgery (aside from staple line). The primary outcome is postoperative haemorrhage requiring intervention within 30 days postoperatively. Secondary outcome measures are staple line reinforcement, blood loss, duration of surgery, postoperative haemoglobin, vital parameters, minor and major complications, side effects of TXA (nausea, hypotension and VTE), length of hospital stay and directly made costs. ETHICS AND DISSEMINATION: Written informed consent will be obtained from all participants. The protocol has been approved by the Medical Research Ethics Committees United, Nieuwegein, on 7 February 2023 (registration number: R22.102). Results will be disseminated through peer-reviewed publications and conferences. TRIAL REGISTRATION NUMBER: NCT05464394.

Fluvastatin and perioperative events in patients undergoing vascular surgery.

BACKGROUND: Adverse cardiac events are common after vascular surgery. We hypothesized that perioperative statin therapy would improve postoperative outcomes. METHODS: In this double-blind, placebo-controlled trial, we randomly assigned patients who had not previously been treated with a statin to receive, in addition to a beta-blocker, either 80 mg of extended-release fluvastatin or placebo once daily before undergoing vascular surgery. Lipid, interleukin-6, and C-reactive protein levels were measured at the time of randomization and before surgery. The primary end point was the occurrence of myocardial ischemia, defined as transient electrocardiographic abnormalities, release of troponin T, or both, within 30 days after surgery. The secondary end point was the composite of death from cardiovascular causes and myocardial infarction. RESULTS: A total of 250 patients were assigned to fluvastatin, and 247 to placebo, a median of 37 days before vascular surgery. Levels of total cholesterol, low-density lipoprotein cholesterol, interleukin-6, and C-reactive protein were significantly decreased in the fluvastatin group but were unchanged in the placebo group. Postoperative myocardial ischemia occurred in 27 patients (10.8%) in the fluvastatin group and in 47 (19.0%) in the placebo group (hazard ratio, 0.55; 95% confidence interval [CI], 0.34 to 0.88; P=0.01). Death from cardiovascular causes or myocardial infarction occurred in 12 patients (4.8%) in the fluvastatin group and 25 patients (10.1%) in the placebo group (hazard ratio, 0.47; 95% CI, 0.24 to 0.94; P=0.03). Fluvastatin therapy was not associated with a significant increase in the rate of adverse events. CONCLUSIONS: In patients undergoing vascular surgery, perioperative fluvastatin therapy was associated with an improvement in postoperative cardiac outcome. (Current Controlled Trials number, ISRCTN83738615.)

Nissen-Sleeve procedure versus laparoscopic Roux-en-Y gastric bypass in patients with morbid obesity and gastro-oesophageal reflux disease: protocol for a non-inferiority randomised trial (GINSBY).

INTRODUCTION: Laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) are the most frequently performed procedures in bariatric surgery. In patients with morbid obesity and gastro-oesophageal reflux disease (GORD), LRYGB is the most accepted procedure. For patients with a contraindication for LRYGB or a strong preference for LSG, the Nissen-Sleeve procedure may be a viable new option. The aim of this study is to compare effectiveness of Nissen-Sleeve with LRYGB. METHOD AND ANALYSIS: This is a single-centre, phase III, parallel-group randomised controlled trial in a high-volume bariatric centre in the Netherlands. A total of 88 patients with morbid obesity and GORD will be randomised to evaluate non-inferiority of Nissen-Sleeve versus LRYGB (non-inferiority margin 15%, power 80%, one-sided α 0.025, 9% drop out). Patients with morbid obesity aged 18 years and older with GORD according to the Montreal definition will be included after obtaining informed consent. Exclusion criteria are achalasia, neoplastic abnormalities diagnosed during endoscopy, super obesity (body mass index ≥50 kg/m2), Crohn's disease and medical history of major abdominal surgery. After randomisation, all patients will undergo an upper gastrointestinal endoscopy. Patients in the Nissen-Sleeve arm will undergo a timed barium oesophagram to exclude oesophageal motility disorders. Patients will complete six questionnaires at baseline and every year until 5 years of follow-up. At day 1 postoperative, patients in the Nissen-Sleeve arm will undergo a swallow X-ray to confirm passage. At 1 year, all patients will undergo another endoscopy. The primary outcome is GORD status. Absence of GORD is defined as <8 points on the GORD questionnaire. Secondary outcome measures are long-term GORD improvement; failure rate of procedure; health-related quality of live; weight loss; proton pump inhibitor use; postoperative complications <30 days and >30 days; length of hospital stay; duration of primary surgery; effect on comorbidities; presence and grade of oesophagitis (grade A-D) and/or presence of Barrett's oesophagus and cost-effectiveness. ETHICS AND DISSEMINATION: The protocol was approved by the Medical Research Ethics Committees United (MEC-U), Nieuwegein, on 15 September 2021. Written informed consent will be obtained for all participants in the study. The study results will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NL9789; The Netherlands Trial Registry.

Midterm Results from the Dutch Common Channel Trial (DUCATI): Superior Weight Loss Results of the Long Roux Limb Gastric Bypass in Comparison to the Standard Bypass at 3-Year Follow-Up.

In the multi-center Dutch Common Channel Trial (DUCATI), a very long Roux limb Roux-en-Y gastric bypass (VLRL-RYGB: BP-limb 60 cm, Roux limb variable, and common channel 100 cm) was compared to a standard Roux-en-Y gastric bypass (S-LRYGB: BP-limb 60 cm, Roux limb 150 cm, and common channel variable) in the treatment of morbidly obese patients. As all trial patients are beyond 3-year follow-up a midterm analysis was performed to investigate the effect of the VLRL-RYGB. METHODS: A total of 444 patients were randomized (1:1) to receive either a VLRL-RYGB or a S-LRYGB. Follow-up results for weight loss, effect on obesity-related comorbid conditions, complications, reoperation, and malnutrition are investigated. RESULTS: At 3-year follow-up a significant difference in %TWL (34.0% vs. 31.4%, p = 0.017) and %EWL (84.7% vs. 76.6%, p = 0.043) was observed in favor of VLRL-LRYGB group. Overall complication rate 3-years after surgery was 15.8% in the VLRL-LRYGB group vs. 9% in the S-LRYGB group (p = 0.031). Eight (3.6%) patients in the VLRL-LRYGB group versus 2 (0.9%) in the S-LRYGB group (p = 0.055) required revisional surgery for malabsorption. In the VLRL-LRYGB group 71.9% of patients had resolution of T2DM versus 48.9% in the S-LRYGB group (p = 0.044). CONCLUSION: At midterm FU a considerable, significantly increased effect on weight loss of the VLRL-LRYGB was observed compared to the S-LRYGB, with a higher risk of overall complications, but no significant nutritional side effects. These results might impact the current view on the value of the Roux limb in the discussion on optimum limb lengths in Roux-en-Y gastric bypass surgery.

Effects of Morbid Obesity and Metabolic Syndrome on the Composition of Circulating Immune Subsets.

Morbid obesity is characterized by chronic, low-grade inflammation, which is associated with 'inflamm-aging'. The presence of metabolic syndrome (MetS) might accelerate this phenomenon of metaflammation. In this study, we assessed the effects of morbid obesity and MetS on the composition of a broad spectrum of immune cells present within the circulation. A total of 117 morbidly obese patients (MOP) without MetS (MetS-), 127 MOP with MetS (MetS+) and 55 lean controls (LC) were included in this study. Absolute numbers of T cell, B cell, NK cell and monocyte subsets were assessed within peripheral blood using flow cytometry. Both absolute cell numbers and proportion of cells were evaluated correcting for covariates age, body mass index and cytomegalovirus serostatus. Although the absolute number of circulating CD4+ T cells was increased in the MetS+ group, the CD4+ T cell composition was not influenced by MetS. The CD8+ T cell and B cell compartment contained more differentiated cells in the MOP, but was not affected by MetS. Even though the absolute numbers of NK cells and monocytes were increased in the MOP as compared to LC, there was no difference in proportions of NK and monocyte subsets between the three study groups. In conclusion, although absolute numbers of CD4+ and CD8+ T cells, B cells, NK cells and monocytes are increased in MOP, obesity-induced effects of the composition of the immune system are confined to a more differentiated phenotype of CD8+ T cells and B cells. These results were not affected by MetS.

Correction to: One anastomosis gastric bypass vs. Roux-en-Y gastric bypass, remedy for insufficient weight loss and weight regain after failed restrictive bariatric surgery.

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Trial protocol: preoperative administration of tranexamic acid in sleeve gastrectomy (PATAS) to reduce haemorrhage rates. A randomised controlled trial.

INTRODUCTION: Fast-track protocols often include short-term thromboprophylaxis and short length of hospital stay. These treatment strategies may negatively affect the occurrence and diagnosis of postoperative haemorrhage. Over the years, the rates of venous thromboembolic events (VTEs) have decreased, while there seems to be an increase in the occurrence of postoperative haemorrhage. Tranexamic acid (TXA) can potentially lower the incidence of postoperative haemorrhage. This trial aims to investigate whether preoperative administration of TXA reduces the preoperative and postoperative haemorrhage rates in laparoscopic sleeve gastrectomy (LSG). METHODS AND ANALYSIS: This is a single centre double-blind randomised placebo-controlled trial. Patients undergoing an LSG are included after obtaining informed consent. Patients are randomised between two groups: (1) administration of placebo infusion and (2) administration of 1500 mg TXA. In both groups, the infusions will be administered during the induction phase of the procedure. Primary outcome measures are preoperative use of haemostatic clips, postoperative haemoglobin decrease and postoperative haemorrhage. Secondary outcome measure is the rates of VTE. ETHICS AND DISSEMINATION: The protocol version 3 was approved by the medical ethical committee Medical Research Ethics Committees United (MEC-U), Nieuwegein, on 29 July 2019. The trial results will be submitted for publication in a peer-reviewed journal and at conference presentations. TRIAL REGISTRATION NUMBER: The Netherlands Trial Registry (NL8029); Pre-results.

One anastomosis gastric bypass vs. Roux-en-Y gastric bypass, remedy for insufficient weight loss and weight regain after failed restrictive bariatric surgery.

BACKGROUND: Failure occurs in up to 60% of the patients that were treated with primary restrictive bariatric operations such as Laparoscopic Adjustable Gastric Banding (LAGB), or restrictive/metabolic operations like Laparoscopic Sleeve Gastrectomy (LSG). Insufficient weight loss and weight regain are the most commonly reported reasons of failure. The aim of this retrospective multicenter study was to compare One Anastomosis Gastric Bypass (OAGB) to Roux-en-Y Gastric Bypass (RYGB) as a revisional procedure in terms of weight loss, procedure time, complication rate and morbidity. METHODS: 491 patients operated on between 2012 and 2017 for failed restrictive surgery were included in this study (OAGB (n=185) or RYGB (n=306)). Failure was defined as total weight loss (TWL) less than 25%, excess weight loss (EWL) less than 50% and/or a remaining body mass index (BMI) larger than 40 kg/m2 at two years of follow up. Primary outcome measures were %TWL and % excess BMI loss (EBMIL) at 12, 24 and 36 months of follow-up. Secondary outcomes were procedure time, reduction of comorbidity, early and late complication rate, and mortality. RESULTS: %TWL was significantly larger in the OAGB group at 12 months (mean 24.1±9.8 vs. 21.9±9.7, p = 0.023) and 24 months (mean 23.9±11.7 vs. 20.5±11.2, p = 0.023) of follow-up. %EBMIL was significantly larger in the OAGB group at 12 months (mean 69.0±44.6 vs. 60.0±30.1, p = 0.014) and 24 months (mean 68.6±51.6 vs. 56.4±35.4, p = 0.025) of follow-up. Intra-abdominal complications (leakage, bleeding, intra-abdominal abscess and perforation) occurred less frequently after revisional OAGB (1.1% vs. 4.9%, p = 0.025). Surgical intervention for biliary reflux (5.4% vs. 0.3%, p < 0.001) was more prevalent in the OAGB group. Surgical intervention for internal herniation (0.0% vs. 4.9%, p = 0.002) was more prevalent in the RYGB group. CONCLUSIONS: This study suggests that OAGB is superior to RYGB as a remedy for insufficient weight loss and weight regain after failed restrictive surgery with more weight loss and a lower early complication rate. To substantiate these findings, further research from prospective randomized controlled trials is needed.

Does the Length of the Common Channel as Part of the Total Alimentary Tract Matter? One Year Results from the Multicenter Dutch Common Channel Trial (DUCATI) Comparing Standard Versus Distal Roux-en-Y Gastric Bypass with Similar Biliopancreatic Bowel Limb Lengths.

PURPOSE: Although the laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is the gold-standard bariatric procedure, it remains uncertain what the optimal bowel limb lengths are to accomplish maximal weight loss while minimizing nutritional deficiencies and related gastro-intestinal complaints. The aim of this randomized controlled multicenter trial is to investigate the effect of significant lengthening of the length of the Roux limb (RL) at the cost of the length of the common channel (CC) while keeping the biliopancreatic limb (BPL) lengths the same on both study arms. METHODS: Four hundred forty-four patients were randomized to receive either a Very Long Roux Limb LRYGB (VLRL-LRYGB) (variable RL length, BPL 60 cm, and CC 100 cm) or a Standard LRYGB (S-LRYGB) (RL 150 cm, BPL 60 cm, and a variable CC length). Results at 1-year follow-up for weight loss, effect on obesity-related comorbid conditions, complications, re-operation rate, malnutrition rate, and re-admission rate were investigated. RESULTS: Weight loss at 1-year showed no significant differences for %EWL (84.3% versus 85.3%, p = 0.72) and %TWL (34.2% versus 33.6%, p = 0.359) comparing VLRL-LRYGB versus S-LRYGB. Malabsorption requiring surgical bowel length adjustment was observed in 1.4% in VLRL-LRYGB group versus 0.9% in S-LRYGB group (p = 0.316). CONCLUSION: Significant lengthening of the RL at the cost of the common channel seems to have no effect on the weight loss at 1-year follow-up, which supports the theory that absorption of nutrients also occurs in the RL. Nevertheless, long-term results of the VLRL-LRYGB have to be awaited to draw final conclusions as part of the discussion towards optimal limb length in LRYGB surgery.

Bisoprolol and fluvastatin for the reduction of perioperative cardiac mortality and myocardial infarction in intermediate-risk patients undergoing noncardiovascular surgery: a randomized controlled trial (DECREASE-IV).

OBJECTIVE: This study evaluated the effectiveness and safety of beta-blockers and statins for the prevention of perioperative cardiovascular events in intermediate-risk patients undergoing noncardiovascular surgery. SUMMARY BACKGROUND DATA: Beta-blockers and statins reduce perioperative cardiac events in high-risk patients undergoing vascular surgery by restoring the myocardial oxygen supply/demand balance and/or stabilizing coronary plaques. However, their effects in intermediate-risk patients remained ill-defined. METHODS: In this randomized open-label 2 x 2 factorial design trial 1066 intermediate cardiac risk patients were assigned to bisoprolol, fluvastatin, combination treatment, or control therapy before surgery (median: 34 days). Intermediate risk was defined by an estimated risk of perioperative cardiac death and myocardial infarction (MI) of 1% to 6%, using clinical data and type of surgery. Starting dose of bisoprolol was 2.5 mg daily, titrated to a perioperative heart rate of 50 to 70 beats per minute. Fluvastatin was prescribed in a fixed dose of 80 mg. The primary end point was the composite of 30-day cardiac death and MI. This study is registered in the ISRCTN registry and has the ID number ISRCTN47637497. RESULTS: Patients randomized to bisoprolol (N = 533) had a lower incidence of perioperative cardiac death and nonfatal MI than those randomized to bisoprolol-control (2.1% vs. 6.0% events; hazard ratios: 0.34; 95% confidence intervals: 0.17-0.67; P = 0.002). Patients randomized to fluvastatin experienced a lower incidence of the end point than those randomized to fluvastatin-control therapy (3.2% vs. 4.9% events; hazard ratios: 0.65; 95% confidence intervals: 0.35-1.10), but statistical significance was not reached (P = 0.17). CONCLUSION: Bisoprolol was associated with a significant reduction of 30-day cardiac death and nonfatal MI, while fluvastatin showed a trend for improved outcome.

Preoperative oral glucose tolerance testing in vascular surgery patients: long-term cardiovascular outcome.

BACKGROUND: Diabetes mellitus (DM) is an important risk factor in vascular surgery patients, influencing late outcome. Screening for diabetes is recommended by fasting glucose measurement. Oral glucose tolerance testing (OGTT) could enhance the detection of patients with impaired glucose tolerance (IGT) and DM. AIM: To assess the additional value of OGTT on top of fasting glucose levels in vascular surgery patients to predict long-term cardiovascular outcome. METHODS: A total of 404 patients without signs or histories of IGT (plasma glucose 7.8-11.1 mmol/L) or DM (glucose >/=11.1 mmol/L) were prospectively included and subjected to OGTT. Cardiac risk factors were noted. Primary outcome was the occurrence of late cardiovascular events (composite of cardiovascular death, angina pectoris, myocardial infarction, percutaneous coronary intervention/coronary artery bypass grafting, or cerebral vascular accident/transient ischemic attack), and secondary outcome included all-cause and cardiovascular mortality rates, in survivors of vascular surgery. Median follow-up was 3.0 (interquartile range 2.4-3.8) years. RESULTS: Impaired glucose tolerance (n = 104) and DM (n = 43) were detected by fasting glucose levels in 26 (25%) and 12 (28%) patients, and by OGTT in 78 (75%) and 31 (72%) patients, respectively. During follow-up, 131 patients experienced a cardiovascular event. With multivariable analysis, patients with IGT showed a significant increased risk for cardiovascular events (hazard ratio 2.77, 95% CI 1.83-4.20) and mortality (hazard ratio 2.06, 95% CI 1.03-4.12). Patients with DM showed a nonsignificant increased risk for cardiovascular events. CONCLUSION: Vascular surgery patients with IGT or DM detected by preoperative OGTT have an increased risk of developing cardiovascular events and mortality during long-term follow-up. It is recommended that nondiabetic vascular surgery patients should be tested for glucose regulation disorders before surgery.

The interrelationship between preoperative anemia and N-terminal pro-B-type natriuretic peptide: the effect on predicting postoperative cardiac outcome in vascular surgery patients.

INTRODUCTION: N-terminal pro-B-type natriuretic peptide (NT-proBNP) predicts adverse cardiac outcome in patients undergoing vascular surgery. However, several conditions might influence this prognostic value, including anemia. In this study, we evaluated whether anemia confounds the prognostic value of NT-proBNP for predicting cardiac events in patients undergoing vascular surgery. METHODS: A detailed cardiac history, resting echocardiography, and hemoglobin and NT-proBNP levels were obtained in 666 patients before vascular surgery. Anemia was defined as serum hemoglobin <13 g/dL for men and <12 g/dL for women. Troponin T measurements and 12-lead electrocardiograms were performed on postoperative days 1, 3, 7, and 30 and whenever clinically indicated. The primary end point of the study was the composite of 30-day postoperative cardiovascular death, nonfatal myocardial infarction, and troponin T release. Receiver operating characteristic curve analysis was used to assess the optimal cutoff value of NT-proBNP for the prediction of the composite end point. Multivariable regression analysis was used to assess the additional value of NT-proBNP for the prediction of postoperative cardiac events in nonanemic and anemic patients. RESULTS: Anemia was present in 206 patients (31%) before surgery. Hemoglobin level was inversely related with the NT-proBNP levels (beta coefficient = -2.242; P = 0.025). The optimal predictive cutoff value of NT-proBNP for predicting the composite cardiovascular outcome was 350 pg/mL. After adjustment for clinical cardiac risk factors, both anemia (odds ratio [OR] 1.53; 95% confidence interval [CI]: 1.07-2.99) and increased levels of NT-proBNP (OR 4.09; 95% CI: 2.19-7.64) remained independent predictors for postoperative cardiac events. However, increased levels of NT-proBNP were not predictive for the risk of adverse cardiac events in the subgroup of anemic patients (OR 2.16; 95% CI: 0.90-5.21). CONCLUSIONS: Both anemia and NT-proBNP are independently associated with an increased risk for postoperative cardiac events in patients undergoing vascular surgery. NT-proBNP has less predictive value in anemic patients.

Structural and functional vascular improvement 1 year after bariatric surgery: a prospective cohort study.

BACKGROUND: Obesity is a major risk factor for cardiovascular disease. Data on structural and functional arterial changes after bariatric surgery are scarce. OBJECTIVES: The aim of this study was to determine the effects of bariatric surgery on the carotid intima media thickness (cIMT) and pulse wave velocity (PWV). SETTING: General hospital. METHODS: We collected data prospectively in 200 patients scheduled for bariatric surgery between 2015-2017. Based on an increase or decrease of 1 standard deviation of the mean difference in cIMT and PWV 1 year postoperatively, patients were divided into progressors, regressors', and unchanged. We analyzed data on medical history, baseline body mass index, surgery type, and difference in body mass index after 1 year. RESULTS: Data on cIMT were available for 134 patients. Thirty-four patients (25.4%) had a cIMT regression with a mean decrease of .1 mm (-.24 to -.06), 10 patients (7.5%) were progressors with a mean increase of .1 mm (.07-.30), and 90 patients (67.2%) remained unchanged. Progressors more often had type 2 diabetes (P = .035) and hypertension (P = .020). Data on PWV were available for 120 patients, of whom 91 (75.8%) were regressors, 26 (21.6%) remained unchanged, and 3 (2.5%) were progressors. Predictors of PWV changes were total plasma cholesterol and hypertension at baseline. CONCLUSIONS: A significant improvement of the vascular quality already after 1 year of follow-up was established in 25%-76% of all patients after bariatric surgery and the vast majority showed stabilization.

Influence of renal function on the usefulness of N-terminal pro-B-type natriuretic peptide as a prognostic cardiac risk marker in patients undergoing noncardiac vascular surgery.

N-terminal pro-B-type natriuretic peptide (NT-pro-BNP) is related to stress-induced myocardial ischemia and/or volume overload, both common in patients with renal dysfunction. This might compromise the prognostic usefulness of NT-pro-BNP in patients with renal impairment before vascular surgery. We assessed the prognostic value of NT-pro-BNP in the entire strata of renal function. In 356 patients (median age 69 years, 77% men), cardiac history, glomerular filtration rate (GFR, ml/min/1.73 m(2)), and NT-pro-BNP level (pg/ml) were assessed preoperatively. Troponin T and electrocardiography were assessed postoperatively on days 1, 3, 7, and 30. The end point was the composite of cardiovascular death, Q-wave myocardial infarction, and troponin T release. Multivariate analysis was used to evaluate the interaction between GFR, NT-pro-BNP and their association with postoperative outcome. Median GFR was 78 ml/min/1.73 m(2) and the median concentration of NT-pro-BNP was 197 pg/ml. The end point was reached in 64 patients (18%); cardiac death occurred in 7 (2.0%), Q-wave myocardial infarction in 34 (9.6%), and non-Q-wave myocardial infarction in 23 (6.5%). After adjustment for confounders, NT-pro-BNP levels and GFR remained significantly associated with the end point (p = 0.005). The prognostic value of NT-pro-BNP was most pronounced in patients with GFR > or =90 (odds ratio [OR] 1.18, 95% confidence interval [CI] 0.80 to 1.76) compared with patients with GFR 60 to 89 (OR 1.04, 95% CI 1.002 to 1.07), and with GFR 30 to 59 (OR 1.12, 95% CI 1.03 to 1.21). In patients with GFR <30 ml/min/1.73 m(2), NT-pro-BNP levels have no prognostic value (OR 1.00, 95% CI 0.99 to 1.01). In conclusion, the discriminative value of NT-pro-BNP is most pronounced in patients with GFR > or =90 ml/min/1.73 m(2) and has no prognostic value in patients with GFR <30 ml/min/1.73 m(2).

Anemia as an independent predictor of perioperative and long-term cardiovascular outcome in patients scheduled for elective vascular surgery.

Anemia is common in patients scheduled for vascular surgery and is a risk factor for adverse cardiac outcome. However, it is unclear whether this is an independent risk factor or an expression of underlying co-morbidities. In total, 1,211 patients (77% men, 68 +/- 11 years of age) were enrolled. Anemia was defined as serum hemoglobin levels <13 g/dl for men and <12 g/dl for women and was divided into tertiles to compare mild (men 12.2 to 13.0, women 11.2 to 12.0), moderate (men 11.0 to 12.1, women 10.2 to 11.1), and severe (men 7.2 to 11.0, women 7.5 to 10.1) anemia with nonanemia. Outcome measurements were 30-day and 5-year major adverse cardiac events (MACEs; cardiac death or myocardial infarction). All risk factors were noted. Multivariable logistic and Cox regression analyses were used, adjusting for all cardiac risk factors, including heart failure and renal disease. Data are presented as hazard ratios with 95% confidence intervals. In total, 74 patients (6%) had 30-day MACEs and 199 (17%) had 5-year MACEs. Anemia was present in 399 patients (33%), 133 of whom had mild anemia, 133 had moderate anemia, and 133 had severe anemia. Presence of anemia was associated with renal dysfunction, diabetes, and heart failure. After adjustment for all clinical risk factors, 30-day hazard ratios for a MACE per anemia group were 1.8 for mild (0.8 to 4.1), 2.3 for moderate (1.1 to 5.4), and 4.7 for severe (2.6 to 10.9) anemia, and 5-year hazard ratios for MACE per anemia group were 2.4 for mild (1.5 to 4.2), 3.6 for moderate (2.4 to 5.6), and 6.1 for severe (4.1 to 9.1) anemia. In conclusion, the presence and severity of preoperative anemia in vascular patients are significant predictors of 30-day and 5-year cardiac events, regardless of underlying heart failure or renal disease.

Usefulness of preoperative oral glucose tolerance testing for perioperative risk stratification in patients scheduled for elective vascular surgery.

Patients scheduled for major vascular surgery are screened for cardiac risk factors using standardized risk indexes, including diabetes mellitus (DM). Screening in patients without a history of DM includes fasting glucose measurement. However, an oral glucose tolerance test (OGTT) could significantly improve the detection of DM and impaired glucose tolerance (IGT) and the prediction of perioperative cardiac events. In a prospective study, 404 consecutive patients without signs or histories of IGT or DM were included and subjected to OGTT. The primary study end point was the composite of perioperative myocardial ischemia, assessed by 72-hour Holter monitoring using ST-segment analysis and troponin release. The primary end point was noted in 21% of the patients. IGT was diagnosed in 104 patients (25.7%), and new-onset DM was detected in 43 patients (10.6%). The OGTT detected 75% of the patients with IGT and 72% of the patients with DM. Preoperative glucose levels significantly predicted the risk for perioperative cardiac ischemia; odds ratios for DM and IGT were, respectively, 3.2 (95% confidence interval 1.3 to 8.1) and 1.4 (95% confidence interval 0.7 to 3.0). In conclusion, the prevalence of undiagnosed IGT and DM is high in vascular patients and is associated with perioperative myocardial ischemia. Therefore, an OGTT should be considered for all patients who undergo elective vascular surgery.