Postoperative Serious Adverse Events Research Articles

A Rapid Increase in Serum Lactate Levels after Cardiovascular Surgery Is Associated with Postoperative Serious Adverse Events: A Single Center Retrospective Study.

Hyperlactatemia is a common predictive factor for poor post-cardiovascular surgery outcomes. However, it is not well understood whether the rapid postoperative lactate level elevation in a short period of time is associated with patient outcomes. Herein, we investigated the relationship between the degree of change in serum lactate levels and postoperative serious adverse events (PSAEs), including mortality, within 24 h of cardiovascular surgery. In this retrospective study, we evaluated the relationship between a rapid serum lactate level increase and PSAEs after open-heart and major vascular surgery. We divided the patients into those with and without PSAEs. Univariate and multivariate analyses were performed to evaluate the association between PSAEs and rapid lactate level increases. We enrolled 445 patients; 16% (n = 71) had PSAEs. The peak lactate levels during the first 24 h of intensive care unit (ICU) stay were higher in patients with PSAEs than in those without. The maximum change in lactate levels between two consecutive lactate measurements during the first 24 h after ICU admission was higher in patients with PSAEs than in those without. A multivariate logistic regression analysis revealed that changes in lactate levels of 2 mmol/L or more between two consecutive lactate measurements were associated with PSAEs. ICU peak lactate levels of 3 mmol/L or more were not associated with PSAEs. Rapid serum lactate level increases of 2 mmol/L or more during the first 24 h of ICU admission post-cardiovascular surgery are associated with PSAEs.

Risk for non-home discharge following surgery for ischemic mitral valve disease

ObjectivesTo determine the frequency and risk factors for non-home discharge (NHD) and its association with clinical outcomes and quality of life (QOL) at 1 year following cardiac surgery in patients with ischemic mitral regurgitation (IMR). MethodsDischarge disposition was evaluated in 552 patients enrolled in trials of severe or moderate IMR. Patient and in-hospital factors associated with NHD were identified using logistic regression. Subsequently, association of NHD with 1-year mortality, serious adverse events (SAEs), and QOL was assessed. ResultsNHD was observed in 30% (154/522) with 25% (n = 71/289) in moderate and 36% (n = 83/233) in patients with severe IMR (unadjusted P = .006), a difference not significant after including age (5-year change: adjusted odds ratio [adjOR], 1.52; 95% confidence interval [CI], 1.35-1.72; P < .001), diabetes (adjOR, 1.94; 95% CI, 1.27-2.94; P = .002), and previous heart failure (adjOR, 1.64; 95% CI, 1.06-2.52; P = .03). Odds of NHD were increased for patients with postoperative SAEs (adjOR, 1.85; 95% CI, 1.19-2.86; P = .01) but not based on type of cardiac surgery. Greater rates of death and SAEs were observed in NHD patients at 1 year: adjusted hazard ratio, 4.29 (95% CI, 2.14-8.59; P < .001) and adjusted rate ratio, 1.45 (95% CI, 1.03-2.02; P = .03), respectively. QOL did not differ significantly between groups. ConclusionsNHD is common following surgery for IMR, influenced by older age, diabetes, previous heart failure, and postoperative SAEs. These patients may be at greater risk of death and subsequent SAEs after discharge. Discussion of NHD with patients may have important implications for decision-making and guiding expectations following cardiac surgery.

Perioperative multidisciplinary implementation enhancing recovery after hip arthroplasty in geriatrics with preoperative chronic hypoxaemia

We investigated risk factors for postoperative serious adverse events (SAEs) in elderly patients with preoperative chronic hypoxaemia undergone total hip arthroplasty (THA) or hemiarthroplasty and performed an implementation to modify and improve clinical outcome. A retrospective medical record review was performed to identify geriatric patients who receiving THA or hemiarthroplasty at a single university teaching hospital, Kunming, Yunnan, China between January 2009 and August 2017. Total of 450 elderly patients were included in the study. Data were collected on baseline characteristics, detailed treatments, and adverse events. Univariate and multivariate logistic regression analysis were used to identify risk factors for SAEs. In multivariate regression analysis, a higher occurrence of general anaesthesia and multiple episodes of hypotension were associated with higher risk of SAEs (general anesthesia: odds ratio [OR] 5.09, 95% confidence interval [CI] 1.96–13.24, P = 0.001; hypotension time: OR 4.29, 95% CI 1.66–11.10, P = 0.003). After the multidisciplinary implementation, the postoperative length of stay was decreased from 15 days to 10 days (P < 0.0001); incidence of SAEs was decreased from 21.1% to 7.0% (P = 0.002), and the all-cause mortality rate within 30 days decreased from 4.6% to 1.0% (P = 0.040). Our observational study demonstrated that an increasing application of general anaesthesia and longer time of hypotension were associated with an increased risk of postoperative SAEs in patients after THA or hemiarthroplasty. Additionally, optimizing stable haemodynamics under higher application of combined-spinal epidural anaesthesia was associated with improved outcome up to 30 days after THA or hemiarthroplasty.

術後SAEs対策のための病棟別RRSシミュレーション訓練のすすめ

当院ではKinan Simulation Studio（KiSS）を立ち上げ，RRS訓練を開始した．1年目は，呼吸評価，気道確保訓練を行い，2年目は，チーム医療のためのnon-technical skillのトレーニングを行った．一般的な症例をもとに訓練をしたため，重要性は理解できるが個々人の実際の問題として捉えにくい傾向にあった．3年目は，SAEsを教材にしたグループトレーニングを行った．SAEsは，手術を起点とした重症化であり，その発生パターンに時系列の特徴がある．また，悪化所見に疾患特異的な特徴がある．これらを意識すれば，一般的な病態の悪化より，増悪に気づきやすい．主に取り扱う疾患が病棟ごとに違うので，SAEsをもとにしたシナリオトレーニングは，RRSを身近に感じてもらえる良い教材である．

579P - Final Results of a Randomized Phase Ii Study with Neo-Adjuvant Triplet or Doublet Therapy, Radiation and Total Mesorectal Excision for Locally Advanced Rectal Cancer: Axe Beam

ABSTRACT Aim: To assess the activity and safety of bevacizumab (A) with capecitabine (X) and radiotherapy (RT) with or without oxaliplatin (E) in the preoperative treatment (thx) of locally advanced rectal cancer (LARC). To identify biomarkers for early response prediction. Methods: Patients (pts) with LARC were randomized to RT (1.8Gy/day) with the triplet A (5mg/kg), X (1650mg/m2/day) and E (50mg/m2) in Arm A or the doublet A + X without E in Arm B. Chemoradiotherapy (CRT) started at 2 weeks after 1st infusion of A and continued for 5 weeks. Total mesorectal excision (TME) was planned at 6-8 weeks post CRT. Pathological complete response (pCR) rate in Arm A was the primary endpoint. Safety profile and identification of biomarkers for early response prediction were secondary endpoints. Immunohistochemical staining for the functionality of blood vessels, proliferation and hypoxia as well as Luminex analyses to assess changes in circulating VEGF ligands are performed on tissues and blood samples from consenting pts. Results: Eighty-four pts with median age 61 completed thx, 81 including surgery, with a relative dose intensity of 98% for A and X and 93% for E. During CRT, serious adverse events (SAEs) were more frequent in Arm A vs Arm B: fever (4 vs 0), diarrhea (3 vs 0), infection (4 vs 1). Postoperative SAEs (wound infections, leaks) occurred in 17 pts, 10 in Arm A and 7 in Arm B. Five pts deceased post-study, 3 due to distant disease progression, 2 to postoperative complications. Post-surgery data are available for 81 pts. pCR was seen in 18 pts, 33% (14/43) in Arm A and 10% (4/41) in Arm B in an intent-to-treat analysis (ITT). The rate of good responders (Dworak TRG 3, 4) was higher in Arm A 29/43 vs Arm B 16/41 in ITT. Changes of the pericyte coverage of the blood vessels were observed. The decrease of plasma concentration of PDGF-AA and PDGF-BB correlated with pCR (p = 0.04 and 0.03 respectively). Conclusions: Both triplet and doublet combination showed acceptable safety profiles. The addition of E to X and A with RT seemed beneficial in terms of pCR rates in this patient population, with a slight increase of toxicity. The main endpoint has been reached with 14/43 pCRs in Arm A. PDGF may be a predictor of response in this setting. Final data after a blind central review of the main endpoint and translational research data will be available at the conference. Support from Roche and Sanofi Aventis. Disclosure: K. Haustermans: The author declares an educational grant from Roche for this study. No further conflict of interest; E. Van Cutsem: The author received research funding from Roche and Sanofi, paid to the university. All other authors have declared no conflicts of interest.

Adding Preoperative Radiotherapy Plus Cetuximab to Perioperative Chemotherapy for Resectable Esophageal Adenocarcinoma: A Single-Center Prospective Phase II Trial

Local and systemic recurrence are important sources of treatment failure following surgical resection of esophageal adenocarcinoma. We hypothesized that adding preoperative cetuximab and radiotherapy (cetux-RT) to perioperative chemotherapy would increase treatment efficacy with acceptable toxicity. In this prospective phase II trial, patients were treated with three cycles of epirubicin, cisplatin, and capecitabine (ECX), followed by cetux-RT. After surgery with curative intent, patients received three more cycles of ECX. Primary endpoints were efficacy, determined by histopathological complete response (pCR) rate, and safety, which was assessed with resectability rate. Of the 12 patients enrolled in this trial, six received at least one dose of cetux-RT. In five patients, cetux-RT was not started because of adverse events (AEs) related to preoperative chemotherapy; one patient had progressive disease. Addition of cetux-RT was well tolerated and did not interfere with the resectability rate (100%). However, the pCR rate was 0, and 50% of patients experienced serious adverse events (SAEs) postoperatively. With 12 patients enrolled, the lack of initial signs of efficacy and a high incidence of postoperative SAEs prompted us to end this study prematurely. Perioperative ECX was associated with considerable toxicity, and further treatment intensification is problematic.