Postoperative Complications In High-risk Patients Research Articles

OCOSO2: study protocol for a single-blinded, multicentre, randomised controlled trial assessing a central venous oxygen saturation-based goal-directed therapy to reduce postoperative complications in high-risk patients after elective major surgery

BackgroundFluid loading-based goal-directed therapy is a cornerstone of anaesthesia management in major surgery. Its widespread application has contributed to a significant improvement in perioperative morbidity and mortality. In theory, only hypovolemic patients should receive fluid therapy. However, to achieve such a diagnosis, a surrogate marker of cardiac output adequacy must be used. Current methods of fluid loading-based goal-directed therapy do not assess cardiac output adequacy. Nowadays, new devices make it possible to continuously monitor central venous oxygen saturation (ScvO2) and therefore, to assess the adequacy of perioperative cardiac output during surgery. In major surgery, ScvO2-based goal-directed therapy can be used to enhance fluid therapy and improve patient outcomes.MethodsWe designed a prospective, randomised, single-blinded, multicentre controlled superiority study with a 1:1 allocation ratio. Patients to be included will be high-risk major surgery patients (> 50 years old, ASA score > 2, major intra-abdominal or intra-thoracic surgery > 90 min). Patients in the control group will undergo standard fluid loading-based goal-directed therapy, as recommended by the guidelines. Patients in the intervention group will have ScvO2-based goal-directed therapy and receive fluid loading only if fluid responsiveness and cardiac output inadequacy are present. The primary outcome will be the Comprehensive Complication Index on day five postoperatively.DiscussionThis study is the first to address the issue of cardiac output adequacy in goal-directed therapy. Our hypothesis is that cardiac output optimisation during major surgery achieved by continuous monitoring of the ScvO2 to guide fluid therapy will result in a reduction of postoperative complications as compared with current goal-directed fluid therapy practices.Trial registrationClinicalTrials.gov. NCT03828565. Registered on February 4, 2019.

Fungating Soft Tissue Sarcoma: A Complex Treatment Dilemma.

Fungating soft tissue sarcoma (STS) occurs in up to 3.7% of STS cases, ulcerate or protrude directly from the skin. Several studies have examined past treatments and outcomes of patients with such tumors and suggest that management can be especially challenging. Considering this, it is plausible that fungating extremity tumors may warrant an individualized treatment approach that differs from standard treatment for non-fungating STS. We sought to examine treatment and outcome trends for fungating extremity STS to guide future treatment considerations. A comprehensive literature review of the PubMed database identified 1515 articles. Inclusion criteria included human subjects, adult population, extremity tumors and fungating tumors. Studies published prior to 1982 were excluded. 10 articles were relevant and met all criteria. Outcomes compare fungating STS with non-fungating STS. Patients with fungating STS are more likely to receive amputations as primary or secondary treatment (23-35 vs. 7.8-12%). Metastatic disease is more common among patients with fungating STS (20-33% vs. 9-15%). Patients with fungating STS have been found to have a higher likelihood of local recurrence (LR) (20.0% vs. 16.5%). 5-year overall survival (OS) is significantly decreased in patients with fungating STS (18.0-26.0% vs. 56.8-71.3%).Patients with fungating STS who receive limb sparing surgery (LSS) are more likely to require plastic surgical intervention (65% vs. 25%). Fungating STS is strongly associated with decreased mean time to death (13.8-16.2 months vs 29.0-30.4 months). Complication rates following surgical treatment of fungating STS are as high at 75% following amputation and 43% following LSS with up to 17% of those requiring reoperation. Infection and flap necrosis are the most common complications described. Though limited, current literature persistently reveals fungation as a poor prognostic factor for patients with soft tissue sarcoma. Expedient primarysurgical treatment may be appropriate given the higher metastatic potential and increased rate of complications associated with fungating STS. Limb salvage surgery is appropriate for primary, non-metastatic surgical treatment, though fungating tumors are treated with primary amputation more often than non-fungating STS, which may reduce postoperative complications in high-risk patients. Fungation is well established as an indication for palliative amputation. Increased rates of primary amputation in fungating STS may correspond to higher rates of metastatic disease at time of initial presentation for fungating STS. Timing of XRT should be carefully considered, as neoadjuvant XRTcoupled with a fungating tumor may result in a higher incidence of pre and postoperative complications and increased need for plastic surgical closure techniques. Adjuvant XRT is appropriate though used less often in patients with fungating STS.

Perioperative nutrition for gastrointestinal surgery: On the cutting edge.

Evidence on perioperative nutrition interventions in gastrointestinal surgery is rapidly evolving. We conducted a narrative review of various aspects of nutrition support, including formula choice and route of administration, as well as duration and timing of nutrition support therapy. Studies have demonstrated that nutrition support is associated with improved clinical outcomes in malnourished patients and those at nutrition risk, emphasizing the importance of nutrition assessment, for which several validated nutrition risk assessment tools exist. The assessment of serum albumin levels has fallen out of favor, as it is an unreliable marker of nutrition status, whereas imaging evidence of sarcopenia has prognostic value and may emerge as a standard component of nutrition assessment. Preoperatively, evidence supports limiting fasting to reduce insulin resistance and improve oral tolerance. Benefits to preoperative carbohydrate loading remain unclear, whereas literature suggests preoperative parenteral nutrition (PN) may reduce postoperative complications in high-risk patients with malnutrition or sarcopenia. Postoperatively, early oral feeding is safe with benefits in time to return of bowel function and reduced hospital stay. There is a signal for potential benefit to early postoperative PN in critically ill patients, though evidence is sparse. There has also been a recent emergence in randomized studies evaluating the use of ω-3 fatty acids, amino acids, and immunonutrition. Meta-analyses have reported favorable outcomes for these supplements, though individual studies are small and with significant methodological limitations and risk of bias, emphasizing the need for high-quality randomized studies to guide clinical practice.

Perioperative Doppler ultrasound assessment of portal vein flow pulsatility in high-risk cardiac surgery patients: a multicentre prospective cohort study

BackgroundPortal vein Doppler ultrasound pulsatility measured by transoesophageal echocardiography is a marker of the haemodynamic impact of venous congestion in cardiac surgery. We investigated whether the presence of abnormal portal vein flow pulsatility is associated with a longer duration of invasive life support and postoperative complications in high-risk patients. MethodsIn this multicentre cohort study, pulsed-wave Doppler ultrasound assessments of portal vein flow were performed during anaesthesia before initiation of cardiopulmonary bypass (before CPB) and after separation of cardiopulmonary bypass (after CPB). Abnormal pulsatility was defined as portal pulsatility fraction (PPF) ≥50% (PPF50). The primary outcome was the cumulative time in perioperative organ dysfunction (TPOD) requiring invasive life support during 28 days. Secondary outcomes included major postoperative complications. Results373 patients, 71 (22.0%) had PPF50 before CPB and 77 (24.9%) after CPB. PPF50 was associated with longer duration of TPOD (median [inter-quartile range]; before CPB: 27 h [11–72] vs 19 h [8.5–42], P=0.02; after CPB: 27 h [11–61] vs 20 h [8–42], P=0.006). After adjusting for confounders, PPF50 before CPB showed significant association with TPOD. PPF50 after CPB was associated with a higher rate of major postoperative complications (36.4% vs 20.3%, P=0.006). ConclusionsAbnormal portal vein flow pulsatility before cardiopulmonary bypass was associated with longer duration of life support therapy after cardiac surgery in high-risk patients. Abnormal portal vein flow pulsatility after cardiopulmonary bypass separation was associated with a higher risk of major postoperative complications although this association was not independent of other factors. Clinical trial registrationNCT03656263.

RCT Assessing Efficacy of Perioperative Hydrocortisone and Indomethacin Treatment in Reducing Major Complications after Whipple’s Pancreaticoduodenectomy

Introduction: After Whipple’s Pancreaticoduodenectomy (PD), pancreatic anastomotic leak leading to postoperative pancreatic fistula (POPF), Post pancreatectomy hemorrhage (PPH), delayed gastric emptying (DGE) and Sepsis cause major morbidity. Hydrocortisone and indomethacin have been postulated to reduce post-operative pancreatitis and thus Pancreatic leak. This RCT compares their role in preventing major complications in high-risk patients, Methods: Between January 2018 to April 2019, 146 patients undergoing Whipple’s PD were randomized into 3 arms, intravenous (i.v) hydrocortisone, per rectal (PR) indomethacin, or placebo. Only high-risk patients (n= 105) with >40% of acini (a marker of the soft pancreas) based on the intraoperative frozen section were included. All patients received a total of 8 doses of i.v. treatment (8 hourly) and 6 doses of PR treatment (12 hourly). Primary end-points were major complications (Clavien–Dindo 2-5) Results: As compared to placebo The Hydrocortisone group, had significantly less major complications (14.3% vs 40.0%; P value = 0.003). Clinically significant POPF (8.6% vs 20%) and DGE (14.3% vs 22.9%) were lower. The Indomethacin group did not show decrease in major complications (37.2% vs 40%; p value = 1.00) except for DGE (14.3% vs 22.9%; p value = 0.001). Clinically significant POPF (17.1% vs 20%) and PPH (11.4% vs 14.3%) are not significantly lower in indomethacin group. No 30 day mortality in either group. Conclusion: This RCT shows that Hydrocortisone treatment is significantly better than Indomethacin in reducing the major postoperative complications in high-risk patients after Whipple’s PD.

This Month in Anesthesiology

This Month in Anesthesiology

Efficacy and safety of prophylactic use of ketamine for prevention of postanesthetic shivering: a systematic review and meta analysis

BackgroundPostanesthetic shivering is a common complication of anesthesia, which accounts for much discomfort in postoperative patients and may increase postoperative complications in high-risk patients. Due to the lack of high-quality evidence, it is difficult to draw a conclusion about optimal anti-shivering medication. The main purpose of this meta-analysis was to analyze and evaluate the efficacy and safety of prophylactic use of ketamine for preventing postanesthetic shivering.MethodsWe searched the following databases: Medline, Embase, and the Cochrane Central Register of Controlled Trails for randomized controlled trials. The primary outcome observed was the difference of the incidence rate of postanesthetic shivering between ketamine group and placebo group. The secondary outcomes were the sedation score and incidence of the side effects caused by ketamine and any other drugs utilized in the studies.ResultsIn this meta-analysis, we analyzed a total of 16 trials including 1485 patients. Ketamine reduced the incidence rate of postanesthetic shivering compared to a placebo (odds ratio [OR]: 0.13, 95% confidence interval [CI]: 0.06 to 0.26, P<0.01). Regarding side effects, there was no evident variability of the incidence of nausea and vomiting. Usage of ketamine was associated with a lower rate of hypotension and bradycardia when compared to a placebo. Hallucinations were more frequently observed in patients who received higher doses of ketamine. No significant difference was found in the incidence of postanesthetic shivering with ketamine versus other pharmacological interventions.ConclusionsKetamine can prevent postanesthetic shivering without severe side effects. However, ketamine shows no advantage over other anti-shivering drugs.

The effects of prehabilitation versus usual care to reduce postoperative complications in high-risk patients with colorectal cancer or dysplasia scheduled for elective colorectal resection: study protocol of a randomized controlled trial

Of all older patients that opt for elective colorectal surgery, approximately one-third has one or more postoperative complications, particularly those patients with a low cardiorespiratory fitness (ventilatory anaerobic threshold (VAT) < 11 mL/kg/min). A physical exercise training program prior to surgery (prehabilitation) can improve their cardiorespiratory fitness. It remains to be seen whether prehabilitation also reduces postoperative complications, as most of the studies so far were rather underpowered, heterogeneous, and biased toward selection of patients with a lower risk of postoperative complications. The primary objective of this study is to evaluate the effects of a three-week prehabilitation program on 30-day postoperative complications in patients with a VAT < 11 mL/kg/min planned for elective colorectal resection for colorectal cancer or dysplasia. In this multicenter prospective randomized controlled trial, patients ≥ 60 years with colorectal cancer or dysplasia grade I, II, or III, planned for elective colorectal resection in two hospitals in the Netherlands, will be recruited. Eligible patients must have a score ≤ 7 metabolic equivalents on the veterans-specific activity questionnaire, and should be able to perform a cardiopulmonary exercise test. A total of 86 patients will be randomized (block-stratified randomization) to prehabilitation (intervention group) or usual care (control group). For final inclusion, VAT should be < 11 mL/kg/min. Three times a week for 3 weeks, a 60-min supervised prehabilitation session will be completed in community physical therapy practices by the 43 patients in the prehabilitation group, consisting of moderate-to-high intensity interval training to improve cardiorespiratory fitness, and resistance training to improve peripheral muscle strength. Additionally, patients perform home exercises twice a week on a moderate intensity level. The 43 patients in the usual care group will receive usual care. Optimizing preoperative physical fitness may decrease the postoperative complication rate, may lead to fewer reoperations, less intense clinical care, a shorter length of stay, a more effective surgical planning (process-optimization), fewer readmissions, less intense rehabilitation, shorter rehabilitation period, earlier resumption of work, enhance patient perceived health-related quality of life, and promote performance in daily life. Cost-effectiveness should therefore be expected and evaluated. Medical Ethics Committee Twente, Enschede, the Netherlands (NL45001.044.13, September 3, 2013); Netherlands Trial Register (NTR; NTR4032 , June 14, 2013).

Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial.

The aim of this study was to assess the impact of personalized prehabilitation on postoperative complications in high-risk patients undergoing elective major abdominal surgery. Prehabilitation, including endurance exercise training and promotion of physical activity, in patients undergoing major abdominal surgery has been postulated as an effective preventive intervention to reduce postoperative complications. However, the existing studies provide controversial results and show a clear bias toward low-risk patients. This was a randomized blinded controlled trial. Eligible candidates accepting to participate were blindly randomized (1:1 ratio) to control (standard care) or intervention (standard care + prehabilitation) groups. Inclusion criteria were: i) age >70 years; and/or, ii) American Society of Anesthesiologists score III/IV. Prehabilitation covered 3 actions: i) motivational interview; ii) high-intensity endurance training; and promotion of physical activity. The main study outcome was the proportion of patients suffering postoperative complications. Secondary outcomes included the endurance time (ET) during cycle-ergometer exercise. We randomized 71 patients to the control arm and 73 to intervention. After excluding 19 patients because of changes in the surgical plan, 63 controls and 62 intervention patients were included in the intention-to-treat analysis. The intervention group enhanced aerobic capacity [ΔET 135 (218) %; P < 0.001), reduced the number of patients with postoperative complications by 51% (relative risk 0.5; 95% confidence interval, 0.3-0.8; P = 0.001) and the rate of complications [1.4 (1.6) and 0.5 (1.0) (P = 0.001)] as compared with controls. Prehabilitation enhanced postoperative clinical outcomes in high-risk candidates for elective major abdominal surgery, which can be explained by the increased aerobic capacity.

Preoperative high-intensity training in frail old patients undergoing pulmonary resection for NSCLC.

Thoracic surgery remains the better therapeutic option for non-small cell lung cancer patients that are diagnosed in early stage disease. Preoperative lung function assessment includes respiratory function tests (RFT) and cardio-pulmonary exercise testing (CPET). Vo2 peak, FEV1 and DLCO as well as recognition of performance status, presence of co-morbidities, frailty indexes, and age predict the potential impact of surgical resection on patient health status and survival risk. In this study we have retrospectively assessed the benefit of a high-intensity preoperative pulmonary rehabilitation program (PRP) in 14 patients with underlying lung function impairment prior to surgery. Amongst these, three patients candidate to surgical resection exhibited severe functional impairment associated with high score of frailty according CHS and SOF index, resulting in a substantial mortality risk.Our observations indicate that PRP appear to reduce the mortality and morbidity risk in frail patients with concurrent lung function impairment undergoing thoracic surgery. PRP produced improvement of VO2 peak degree and pulmonary function resulting in reduced postoperative complications in high-risk patients from our cases. Our results indicate that a preoperative training program may improve postoperative clinical outcomes in fraillung cancer patients with impaired lung function prior to surgical resection.

Prognostic effect of limited surgery to avoid severe postoperative complications in high-risk patients with gastric cancer

Prognostic effect of limited surgery to avoid severe postoperative complications in high-risk patients with gastric cancer

Low-dose dobutamine after surgery in high-risk patients: effects on postoperative complications

Dobutamine may have a role in increasing splanchnic perfusion, thereby protecting this area from further injury. We aimed to investigate the effects of low-dose dobutamine (5 μg/kg/min) on tissue perfusion and postoperative complications in high-risk patients.

Invited commentary

Background. The aim of this study was to compare hospital, early, and late clinical outcomes for patients undergoing one-stage, coronary and abdominal aortic surgical intervention with and without cardiopulmonary bypass. Methods. From March 1990 to September 1999, 42 consecutive patients underwent combined operations at a single institution. Cardiopulmonary bypass and cardioplegic arrest were used during coronary revascularization in the first 20 patients (on-pump group), and the next 22 patients received the one-stage operations on the beating heart (off-pump group). Results. Baseline characteristics were similar between groups. Three cardiac-related hospital deaths occurred in the on-pump group and one such death in the off-pump group (p = 0.25). Cardiac-related events, pulmonary complications, inotropic support, blood loss and transfusion requirements, intensive care unit stay, and hospital stay were significantly reduced in the off-pump group (all, p < 0.05). The actuarial survival rates in the on-pump and off-pump groups were 80% and 95%, respectively, at 1 year (p = 0.13) and 75% and 89%, respectively, at 3 years (p = 0.22). Freedom from cardiac-related events at 1-year follow-up was 91% in the off-pump group and 65% in the on-pump group (p < 0.05). No difference in cardiac-related events between groups was observed at 3 years. Conclusions. Off-pump coronary surgical procedures decrease postoperative complications in high-risk patients undergoing simultaneous coronary and abdominal aortic operations compared with the conventional one-stage procedure. The early benefits achieved with off-pump surgical intervention are not at the expense of the long-term clinical outcome.

One-stage coronary and abdominal aortic operation with or without cardiopulmonary bypass: early and midterm follow-up

Background. The aim of this study was to compare hospital, early, and late clinical outcomes for patients undergoing one-stage, coronary and abdominal aortic surgical intervention with and without cardiopulmonary bypass. Methods. From March 1990 to September 1999, 42 consecutive patients underwent combined operations at a single institution. Cardiopulmonary bypass and cardioplegic arrest were used during coronary revascularization in the first 20 patients (on-pump group), and the next 22 patients received the one-stage operations on the beating heart (off-pump group). Results. Baseline characteristics were similar between groups. Three cardiac-related hospital deaths occurred in the on-pump group and one such death in the off-pump group ( p = 0.25). Cardiac-related events, pulmonary complications, inotropic support, blood loss and transfusion requirements, intensive care unit stay, and hospital stay were significantly reduced in the off-pump group (all, p < 0.05). The actuarial survival rates in the on-pump and off-pump groups were 80% and 95%, respectively, at 1 year ( p = 0.13) and 75% and 89%, respectively, at 3 years ( p = 0.22). Freedom from cardiac-related events at 1-year follow-up was 91% in the off-pump group and 65% in the on-pump group ( p < 0.05). No difference in cardiac-related events between groups was observed at 3 years. Conclusions. Off-pump coronary surgical procedures decrease postoperative complications in high-risk patients undergoing simultaneous coronary and abdominal aortic operations compared with the conventional one-stage procedure. The early benefits achieved with off-pump surgical intervention are not at the expense of the long-term clinical outcome.

Effect of aprotinin on endothelial cell activation

Background: Cardiopulmonary bypass surgery is often accompanied by a systemic inflammatory response, which can lead to postoperative complications in high-risk patients. This is mediated in part through a systemic rise in inflammatory cytokine levels and the sequestration of leukocytes within organs. Aprotinin has previously been shown to exert an anti-inflammatory effect by preventing the capacity of leukocytes to transmigrate through vascular endothelium. Here we have focused on whether aprotinin has an effect on endothelial cell activation and adhesion molecule expression in response to tumor necrosis factor–α, particularly with reference to whether aprotinin inhibits tumor necrosis factor–stimulated neutrophil transendothelial migration. Methods and Results: Intercellular adhesion molecule–1, vascular cell adhesion molecule–1, and E-selectin expression was studied in tumor necrosis factor–α–activated human umbilical vein endothelial cells in the presence of aprotinin at 200, 800, and 1600 kIU/mL. Aprotinin inhibited tumor necrosis factor–α–stimulated expression of intercellular adhesion molecule–1 (P =.019 at 1600 kIU/mL) and vascular cell adhesion molecule–1 (P =.003 at 1600 kIU/mL) but not E-selectin. Similar results were obtained in the dermal microvascular endothelial cell line, HMEC-1, which exhibited diminished intercellular adhesion molecule–1 expression in the presence of aprotinin (P =.040 at 800 kIU/mL and P <.001 at 1600 kIU/mL). Aprotinin also significantly inhibited neutrophil transmigration across tumor necrosis factor–α–activated human umbilical vein endothelial cells (P =.046 at 1600 kIU/mL). Conclusions: We have demonstrated that aprotinin inhibits intercellular adhesion molecule–1 and vascular cell adhesion molecule–1, but not E-selectin, expression on tumor necrosis factor–α–activated endothelial cells and that transendothelial migration by neutrophils is also specifically suppressed under these conditions. Our results indicate that endothelial cells can be specifically targeted by aprotinin, therefore adding to our understanding of the anti-inflammatory mechanism of action of aprotinin during cardiopulmonary bypass.J Thorac Cardiovasc Surg 2001;122:123-8

4.8 Flat reduction of postoperative complications in high-risk patients who underwent CABG without cardiopulmonary bypass (CPB)

CO2 and holmium:yttrium aluminum garnet (YAG) transmyocardial laser revascularization (TMLR) are used to treat patients with refractory angina. A randomized trial to investigate the efficacy and safety of XeCl excimer TMLR was performed.Thirty patients with refractory angina were randomized in pairs to excimer TMLR or maximal medication. We assessed angina, quality of life (QOL), exercise time, myocardial perfusion, and ventricular wall motion at base line and at 3, 6, and 12 months after TMLR.TMLR patients manifested a significantly better outcome with respect to angina class and quality of life. One TMLR patient died perioperatively versus none in the control group. After TMLR angina decreased from class 3.8 ± 0.4 at base line to 1.9 ± 0.9 at 12 months versus 3.9 ± 0.3 to 3.7 ± 0.6 in the control group, respectively (p = 0.000001). At 12 months a decrease of greater than or equal to two angina classes was indicated in 11 out of 14 TMLR patients versus none in the control group (p = 0.00001). Improved myocardial perfusion or exercise time was not indicated despite a small decrease in reversible wall motion abnormality score.Excimer TMLR significantly relieves angina and improves QOL without evidence of improved cardiac perfusion or function.

A cost-utility analysis of preoperative total parenteral nutrition.

It has been suggested that preoperative total parenteral nutrition may be used to reduce the risk of nutrition-associated postoperative complications in high-risk patients. These patients can be identified based on their nutritional status. The efficiency of this intervention is assessed using the technique of cost-utility analysis. Data from multiple sources is integrated to perform the economic assessment. The cost-utility ratios for treating several malnourished patients with localized upper gastrointestinal cancer are below $40,000. These cost-utility ratios compare favorably with published results of other programs. The ratios increase considerably if patients who are better nourished (at lower risk of postoperative complication) receive the intervention. The analysis is very sensitive to the efficacy of the intervention.