Association between use of enhanced recovery after surgery protocols and postoperative complications after gastric surgery for cancer (POWER 4): a nationwide, prospective multicentre study.

INTRODUCTION: The effectiveness of the Enhanced Recovery After Surgery (ERAS) protocols in gastric cancer surgery remains controversial. METHODS: Multicentre prospective cohort study of adult patients undergoing surgery for gastric cancer. Adherence with 22 individual components of ERAS pathways were assessed in all patients, regardless of whether they were treated in a self-designed ERAS centre. Each centre had a three-month recruitment period between October 2019 and September 2020. The primary outcome was moderate-to-severe postoperative complications within 30 days after surgery. Secondary outcomes were overall postoperative complications, adherence to the ERAS pathway, 30 day-mortality and hospital length of stay (LOS). RESULTS: A total of 743 patients in 72 Spanish hospitals were included, 211 of them (28.4 %) from self-declared ERAS centres. A total of 245 patients (33 %) experienced postoperative complications, graded as moderate-to-severe complications in 172 patients (23.1 %). There were no differences in the incidence of moderate-to-severe complications (22.3% vs. 23.5%; OR, 0.92 (95% CI, 0.59 to 1.41); P = 0.068), or overall postoperative complications between the self-declared ERAS and non-ERAS groups (33.6% vs. 32.7%; OR, 1.05 (95 % CI, 0.70 to 1.56); P = 0.825). The overall rate of adherence to the ERAS pathway was 52% [IQR 45 to 60]. There were no differences in postoperative outcomes between higher (Q1, > 60 %) and lower (Q4, ≤ 45 %) ERAS adherence quartiles. CONCLUSIONS: Neither the partial application of perioperative ERAS measures nor treatment in self-designated ERAS centres improved postoperative outcomes in patients undergoing gastric surgery for cancer. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03865810.

Identification of the haemoglobin level associated with a lower risk of complications after total hip and knee arthroplasty.

BACKGROUND: Preoperative anaemia is associated with poor outcomes in surgical patients, but the preoperative haemoglobin cut-off that determines lower morbidity in total knee arthroplasty (TKA) and total hip arthroplasty (THA) is not well established. METHODS: Planned secondary analysis of data collected during a multicentre cohort study of patients undergoing THA and TKA in 131 Spanish hospitals during a single 2-month recruitment period. Anaemia was defined as haemoglobin <12 g dl-1 for females and < 13 g dl-1 for males. The primary outcome was the number of patients with 30-day in-hospital postoperative complications according to European Perioperative Clinical Outcome definitions and specific surgical TKA and THA complications. Secondary outcomes included the number of patients with 30-day moderate-to-severe complications, red blood cell transfusion, mortality, and length of hospital stay. Binary logistic regression models were constructed to assess association between preoperative Hb concentrations and postoperative complications, and variables significantly associated with the outcome were included in the multivariate model. The study sample was divided into 11 groups based on preoperative Hb values in an effort to identify the threshold at which increased postoperative complications occurred. RESULTS: A total of 6099 patients were included in the analysis (3818 THA and 2281 TKA), of whom 8.8% were anaemic. Patients with preoperative anaemia were more likely to suffer overall complications (111/539, 20.6% vs. 563/5560, 10.1%, p < .001) and moderate-to-severe complications (67/539, 12.4% vs. 284/5560, 5.1%, p < .001). Multivariable analysis showed preoperative haemoglobin ≥14 g dl-1 was associated with fewer postoperative complications. CONCLUSION: Preoperative haemoglobin ≥14 g dl-1 is associated with a lower risk of postoperative complications in patients undergoing primary TKA and THA.

Cost analysis of a patient blood management program for patients undergoing gastric cancer surgery.

Patient Blood Management (PBM) programs have probed to reduce blood transfusions and postoperative complications following gastric cancer resection, but evidence on their economic benefit is scarce. A recent prospective interventional study of our group described a reduction in transfusions, infectious complications and length of stay after implementation of a multicenter PBM program in patients undergoing elective gastric cancer resection with curative intent. The aim of the present study was to analyze the economic impact associated with these clinical benefits. The mean [and 95% CI] of total healthcare cost per patient was lower (-1955 [-3764, -119] €) after the PBM program implementation. The main drivers of this reduction were the hospital stay (-1847 [-3161, -553] €), blood transfusions (-100 [-145, -56] €), and post-operative complications (-162 [-718, 411] €). Total societal cost was reduced by -2243 [-4244, -210] € per patient. These findings highlight the potential economic benefit of PBM strategies.

Indications and hemoglobin thresholds for red blood cell transfusion and iron replacement in adults with gastrointestinal bleeding: An algorithm proposed by gastroenterologists and patient blood management experts.

Gastrointestinal (GI) bleeding is associated with considerable morbidity and mortality. Red blood cell (RBC) transfusion has long been the cornerstone of treatment for anemia due to GI bleeding. However, blood is not devoid of potential adverse effects, and it is also a precious resource, with limited supplies in blood banks. Nowadays, all patients should benefit from a patient blood management (PBM) program that aims to minimize blood loss, optimize hematopoiesis (mainly by using iron replacement therapy), maximize tolerance of anemia, and avoid unnecessary transfusions. Integration of PBM into healthcare management reduces patient mortality and morbidity and supports a restrictive RBC transfusion approach by reducing transfusion rates. The European Commission has outlined strategies to support hospitals with the implementation of PBM, but it is vital that these initiatives are translated into clinical practice. To help optimize management of anemia and iron deficiency in adults with acute or chronic GI bleeding, we developed a protocol under the auspices of the Spanish Association of Gastroenterology, in collaboration with healthcare professionals from 16 hospitals across Spain, including expert advice from different specialties involved in PBM strategies, such as internal medicine physicians, intensive care specialists, and hematologists. Recommendations include how to identify patients who have anemia (or iron deficiency) requiring oral/intravenous iron replacement therapy and/or RBC transfusion (using a restrictive approach to transfusion), and transfusing RBC units 1 unit at a time, with assessment of patients after each given unit (i.e., "don't give two without review"). The advantages and limitations of oral versus intravenous iron and guidance on the safe and effective use of intravenous iron are also described. Implementation of a PBM strategy and clinical decision-making support, including early treatment of anemia with iron supplementation in patients with GI bleeding, may improve patient outcomes and lower hospital costs.

Effect of Perioperative Blood Transfusions and Infectious Complications on Inflammatory Activation and Long-Term Survival Following Gastric Cancer Resection.

Background: The aim of this study was to evaluate the impact of perioperative blood transfusion and infectious complications on postoperative changes of inflammatory markers, as well as on disease-free survival (DFS) in patients undergoing curative gastric cancer resection. Methods: Multicenter cohort study in all patients undergoing gastric cancer resection with curative intent. Patients were classified into four groups based on their perioperative course: one, no blood transfusion and no infectious complication; two, blood transfusion; three, infectious complication; four, both transfusion and infectious complication. Neutrophil-to-lymphocyte ratio (NLR) was determined at diagnosis, immediately before surgery, and 10 days after surgery. A multivariate Cox regression model was used to analyze the relationship of perioperative group and dynamic changes of NLR with disease-free survival. Results: 282 patients were included, 181 in group one, 23 in group two, 55 in group three, and 23 in group four. Postoperative NLR changes showed progressive increase in the four groups. Univariate analysis showed that NLR change > 2.6 had a significant association with DFS (HR 1.55; 95% CI 1.06−2.26; p = 0.025), which was maintained in multivariate analysis (HR 1.67; 95% CI 1.14−2.46; p = 0.009). Perioperative classification was an independent predictor of DFS, with a progressive difference from group one: group two, HR 0.80 (95% CI: 0.40−1.61; p = 0.540); group three, HR 1.42 (95% CI: 0.88−2.30; p = 0.148), group four, HR 2.85 (95% CI: 1.64−4.95; p = 0.046). Conclusions: Combination of perioperative blood transfusion and infectious complications following gastric cancer surgery was related to greater NLR increase and poorer DFS. These findings suggest that perioperative blood transfusion and infectious complications may have a synergic effect creating a pro-inflammatory activation that favors tumor recurrence.

Improved postoperative outcomes and reduced transfusion rates after implementation of a Patient Blood Management program in gastric cancer surgery.

INTRODUCTION: Gastric cancer patients are often transfused with red blood cells, with negative impact on postoperative course. This multicenter prospective interventional cohort study aimed to determine whether implementation of a Patient Blood Management (PBM) program, was associated with a decrease in transfusion rate and improvements in clinical outcomes in gastric cancer surgery. METHODS: We compared transfusion practices and clinical outcomes in patients undergoing elective gastric cancer resection before and after implementing a PBM program, including strategies to detect and treat anemia and restrictive transfusion practice (2014-2018). Primary outcome was transfusion rate (TR). Secondary outcomes were complications, reoperations, length of stay, readmissions, 90-day mortality and failure-to-rescue. Differences were adjusted by confounding factors. RESULTS: Some 789 patients were included (496 pre- and 293 post-PBM). TR decreased from 39.1% to 27.0% (adjusted difference -9.1, 95% CI -15.2 to -2.9), being reduction particularly significant in patients with anemia, ASA score 3-4, locally advanced tumors, undergoing open surgery and total gastrectomy. Infectious complications diminished from 25% to 16.4% (-6.1, 95%CI -11.5 to -0.7), reoperations from 8.1% to 6.1% (-2.2, 95%CI -5.1 to +0.6), median length of stay from 11 [IQR 8-18] to 8 [7-12] days (p < 0.001), hospital readmission from 14.1% to 8.9% (-5.4, 95%CI -9.6 to -1.1), mortality from 7.9% to 4.8% (-2.4, 95%CI -4.7 to -0.01), and failure-to rescue from 62.7% to 32.7% (-23.1, 95%CI -37.7 to -8.5). CONCLUSION: Implementation of a PBM program was associated with a reduction in transfusion rate and improvement in postoperative outcomes in gastric cancer patients undergoing curative resection.

Efficacy and safety of high-dose intravenous iron as the first-choice therapy in outpatients with severe iron deficiency anemia.

BACKGROUND: Asymptomatic severe iron deficiency anemia is a common finding in subjects admitted to the outpatient anemia clinic. Although the condition can be easily be reversed with intravenous iron (IVI) therapy and several guidelines have suggested a restrictive threshold for using transfusion in hemodynamically stable patients, transfusion is often the rule in clinical practice. This study describes clinical practice results of IVI therapy without transfusion. STUDY DESIGN AND METHODS: In this multicenter retrospective observational study, data of severely anemic outpatients treated only with high-dose IVI with ferric carboxymaltose were collected. Inclusion criteria were hemoglobin (Hb) level of less than 7.0 g/dL and ferritin level of less than 30 ng/mL or mean corpuscular volume of less than 75 fL. RESULTS: Overall, 303 patients referred to the anemia clinic mainly from primary health care centers (46.2%) or the emergency department (28.7%) met the inclusion criteria. Median (interquartile range [IQR]) age was 47 (37-62) years and 84.5% were female. The median (IQR) Hb concentration at first visit was 6.5 (6.1-6.8) g/dL, 64 patients (21.1%) presented with a Hb level of less than 6.0 g/dL at diagnosis, and 11 of them (3.6%) had extreme anemia (Hb ≤ 5 g/dL). Gynecologic and gastroenteric bleeding were the main cause. After a mean IV administration of 1500 mg of iron, the Hb increased by a median of 5.7 g/dL. Thirteen patients experienced only mild side effects. CONCLUSIONS: In chronic very severe sideropenic anemias, third-generation IVI is effective and safe for quick correction and avoidance of red blood cell transfusion. These results suggest that more specific guidelines for this clinical setting are warranted.

Perioperative anemia: Prevalence, consequences and pathophysiology.

In major elective surgery, patient may be exposed to the effects of pre-operative anemia, blood loss and red cell transfusion, all of which may adversely influence post-operative rates of morbidity, mortality and readmission, and length of hospital stay. Preoperative anemia is prevalent among patients scheduled for major surgery (30-40%), while postoperative anemia is even more frequent (up to 80-90%). However, preoperative anemia is usually regarded as no more than a surrogated marker of patient's physical status, and it is not always adequately addressed before surgery, whereas red blood cell transfusion is the usual default treatment for postoperative anemia. Absolute iron deficiency and iron sequestration are the leading causes of preoperative anemia, whereas surgery-associated blood loss and inflammation may induce and/or maintain postoperative anemia. Hematinic deficiencies without anemia may hamper pre-operative hemoglobin optimization and/or recovery from postoperative anemia. As modifiable risk factors, preoperative anemia and hematinic deficiencies should be detected, classified and treated prior to any major surgery. For elective non-cancer procedures, this may entail to postpone surgery until anemia improvement or resolution.

Perioperative transfusion management in gastric cancer surgery: Analysis of the Spanish subset of the EURECCA oesophago-gastric cancer registry. / Conducta transfusional perioperatoria en la cirugía del cáncer gástrico: análisis del registro del grupo español EURECCA de cáncer esófago-gástrico.

INTRODUCTION: This study evaluated allogenic packed red blood cell (aPRBC) transfusion rates in patients undergoing resection for gastric cancer and the implementation of blood-saving protocols (BSP). METHODS: Retrospective study of all gastric cancer patients operated on with curative intent in Catalonia and Navarra (2011-2013) and included in the Spanish subset of the EURECCA Oesophago-Gastric Cancer Registry. Hospitals with BSP were defined as those with a preoperative haemoglobin (Hb) optimisation circuit associated with restrictive transfusion strategies. Predictors of aPRBC transfusion were identified by multinomial logistic regression analysis. RESULTS: A total of 652 patients were included, 274 (42.0%) of which received aPRBC transfusion. Six of the 19 participating hospitals had BSP and treated 145 (22.2%) patients. Low Hb level at diagnosis (10 vs 12.4g/dL), ASA score III/IV, pT3-4, open surgery, associated visceral resection, and having being operated on in a hospital without BSP were predictors of aPRBC transfusion, while low Hb level, associated visceral resection, and non-BSP hospital remained predictors in the multivariate analysis. In case of comparable risk factors for aPRBC transfusion, there was a higher use of preoperative intravenous iron treatment (26.2% vs 13.2%) and a lower percentage of transfusions (31.7% vs 45%) in hospitals with BSP. CONCLUSIONS: The perioperative transfusion rate in gastric cancer was 42%. Hospitals with BSP showed a significant reduction of blood transfusions but treated only 22% of patients. Main predictors of aPRBC were low Hb level, associated visceral resection, and undergoing surgery at a hospital without BSP.

Preoperative management of colorectal cancer-induced iron deficiency anemia in clinical practice: data from a large observational cohort.

BACKGROUND: Preoperative anemia prevalence among colorectal cancer (CRC) patients is high and may adversely influence postoperative outcome. This study assesses the efficacy of a preoperative anemia managing protocol in CRC. STUDY DESIGN AND METHODS: This was a retrospective analysis of consecutive CRC resections at two Spanish centers (January 2012 to December 2013). Preoperative anemia was defined as a hemoglobin (Hb) level of less than 13 g/dL and treated with intravenous iron (IVI) or standard care (oral iron or no iron). Red blood cell transfusion (RBCT) requirements was the primary outcome variable. Postoperative infection rate and length of hospital stay (LOS) were secondary outcome variables. Patients were managed with a restrictive transfusion trigger (Hb < 8 g/dL). Infection was diagnosed clinically and confirmed by laboratory, microbiologic, and/or radiologic evidence. RESULTS: Overall, 322 of 571 patients (56%) presented with anemia: 232 received IVI and 90 standard care. There were differences in RBCT rate between no anemia and anemia (2% vs. 16%; p < 0.01), but not in postoperative infections (19% vs. 22%; p = NS) or LOS. Compared to those on standard care, anemic patients on IVI presented with lower Hb (10.8 g/dL vs. 12.0 g/dL; p < 0.001) at baseline, but similar Hb on day of surgery and Postoperative Day 30. There were no between-group differences in RBCT rates (16% vs. 17%; p = NS), but infection rates were lower among IVI-treated patients (18% vs. 29%; p < 0.05). No relevant IVI-related side effects were recorded. CONCLUSION: Compared to standard care, IVI was more effective in treating preoperative anemia in CRC patients and appeared to reduce infection rate, although it did not reduce postoperative RBCT.

[Diagnosis and treatment of iron deficiency, with or without anemia, before and after bariatric surgery]. / Diagnóstico y tratamiento del déficit de hierro, con o sin anemia, pre y poscirugía bariátrica.

Bariatric surgery (BS) is an increasingly used therapeutic option for severe obesity which allows patients to achieve sustained weight loss over time and resolution or improvement in most associated pathological conditions. Major mid- and long-term complications of BS include iron deficiency and iron-deficient anemia, which may occur in up to 50% of cases and significantly impair patient quality of life. These changes may be present before surgery. The aim of this review was to prepare schemes for diagnosis and treatment of iron deficiency and iron-deficient anemia before and after bariatric surgery.

Hypertension in HIV-infected patients: prevalence and related factors.

BACKGROUND: Little is known about hypertension in the HIV-infected population. This study aimed to assess the prevalence of hypertension and related factors in HIV-infected patients. METHODS: In this prospective cross-sectional study, 710 HIV-infected patients (626 on combination antiretroviral therapy and 84 naive) managed at the outpatient clinic of a tertiary hospital during 2003 and 802 controls completed the study protocol consisting of medical examination and a 6-month follow-up period including three control visits. RESULTS: Hypertension prevalence was 13.1% in HIV-infected patients and 13.5% in the control group. Age (per 10-year increment) (odds ratio [OR]: 1.92; 95% confidence interval [CI]: 1.48-2.48), body mass index (OR: 1.18; 95% CI: 1.10-1.27), and lipoaccumulation pattern of fat redistribution (OR: 2.26; 95% CI: 1.20-4.24) were independently and significantly associated with the presence of hypertension in HIV-infected patients at logistic regression analysis. CONCLUSIONS: The present results suggest no meaningful difference in prevalence of hypertension between subjects with and without HIV infection. Thus, the influence of combination antiretroviral therapy appears to have little impact on the prevalence of hypertension.

Metabolic syndrome among HIV-infected patients: prevalence, characteristics, and related factors.

OBJECTIVE: To assess the prevalence in HIV-infected patients of the metabolic syndrome as defined by the National Cholesterol Education Program, i.e., three or more of the following components: abdominal obesity, hypertriglyceridemia, low HDL cholesterol, high blood pressure, and high fasting glucose. RESEARCH DESIGN AND METHODS: In this cross-sectional study, 710 HIV-infected patients managed at the outpatient clinic of a tertiary hospital during 2003 completed the study protocol consisting of a medical examination and laboratory analysis after a 12-h overnight fast. RESULTS: Metabolic syndrome prevalence was 17% and increased from 5.1% among HIV-infected patients under age 30 years to 27.0% for those aged 50-59 years. Age (per 10-year increment) (odds ratio [OR] 1.41 [95% CI 1.12-1.77]), BMI (1.27 [1.19-1.36]), past and present protease inhibitor exposure (2.96 [1.03-3.55] and 4.18 [1.4-12.5], respectively) were independently associated with the metabolic syndrome on logistic regression analysis. Furthermore, only stavudine (d4T) (1.74 [1.01-2.98]) and lopinavir/ritonavir (2.46 [1.28-4.71]) were associated with the metabolic syndrome after adjustment for age and BMI. CONCLUSIONS: The prevalence of metabolic syndrome among these HIV-infected patients is similar to that previously reported in uninfected individuals. Of specific concern is the association of protease inhibitor exposure with the metabolic syndrome and, more specifically, with exposure to stavudine and lopinavir/ritonavir when individual antiretroviral drugs were analyzed.

[Cardiovascular disease in HIV-infected patients on highly active antiretroviral therapy]. / Enfermedad cardiovascular sintomática en pacientes infectados por el virus de la inmunodeficiencia humana que reciben tratamiento antirretroviral de gran actividad.

BACKGROUND AND OBJECTIVE: Our goal was to assess the main characteristics of cardiovascular disease in HIV-infected patients on highly active antiretroviral therapy (HAART). PATIENTS AND METHOD: Retrospective analysis of the clinico-epidemiological characteristics of 16 HIV-infected patients treated with HAART who had suffered a cardiovascular event from a 1,459 patients' cohort. RESULTS: Clinical presentation of cardiovascular disease was an acute coronary syndrome in 12 cases, ischemic stroke in 2 and peripheral vascular disease in 2. Patients included in the study had a mean of 3.2 cardiovascular risk factors, smoking and low HDL levels being the more prevalent risk factors. Eight (50%, 95% CI, 25-75%) patients fulfilled the criteria of metabolic syndrome. The mean CD4 count was 548 x 10(6)/l. CONCLUSIONS: HIV-infected patients on HAART ha-ve a high cardiovascular risk. A strict management of modifiable risk factors must be warranted in these patients.