Cardiopulmonary Adverse Events Research Articles

Transcutaneous electric nerve stimulation of acupuncture points improves tolerance in adults undergoing diagnostic upper gastrointestinal endoscopy: a single-center, double-blinded, randomized controlled trial.

Oesophagogastroduodenoscopy (OGDS) is the most common diagnostic procedure for upper gastrointestinal diseases. It often causes discomfort and anxiety, which are only mitigated by systemic sedation. However, sedation poses additional risks of adverse cardiopulmonary events, increased medical costs, and prolonged recovery. Transcutaneous electrical nerve stimulation of acupuncture points (Acu-TENS) is a non-invasive and innovative approach that induces analgesic effect during endoscopy. This trial is the first to be reported in English that explores the potential of Acu-TENS to increase patient tolerance during non-sedated elective diagnostic OGDS. A double-blinded randomized controlled trial involving 348 subjects was conducted at a tertiary hospital to evaluate the success rate of OGDS with Acu-TENS. Subjects aged 18-75years scheduled for their first elective diagnostic OGDS were randomized into the intervention (Acu-TENS) and placebo arms. OGDS success was assessed based on subjects' satisfaction ratings on a Likert scale and procedure's technical adequacy. Secondary measures included subjects' willingness to undergo future OGDS under similar conditions, procedure duration, and the endoscopist's perceived ease of the procedure. OGDS success rates were significantly higher with Acu-TENS (77.8%) than with the placebo (68.0%; odds ratio [OR] 1.64, 95% confidence interval [CI] 1.01-2.66, p = 0.043). Subjects who received Acu-TENS expressed higher willingness for future OGDS (78.9%) than those who received the placebo (68.6%; OR 1.71, 95% CI 1.04-2.79, p = 0.031). Procedure duration were significantly shorter in the intervention arm (6.0min) than in the placebo arm (10.0min; p = 0.002). No adverse effects were reported, and endoscopists perceived similar procedure ease in both arms. Acu-TENS improved OGDS success and enhanced patients' experiences during non-sedated OGDS. It demonstrated safety with no side effects and reduced the procedure completion time. It could be used as an adjunct in non-sedated diagnostic OGDS.

Development of a predictive model for hypoxia due to sedatives in gastrointestinal endoscopy: a prospective clinical study in Korea.

Sedation has become a standard practice for patients undergoing gastrointestinal (GI) endoscopy. However, considering the serious cardiopulmonary adverse events associated with sedatives, it is important to identify patients at high risk. Machine learning can generate reasonable prediction for a wide range of medical conditions. This study aimed to evaluate the risk factors associated with sedation during GI endoscopy and develop a predictive model for hypoxia during endoscopy under sedation. This prospective observational study enrolled 446 patients who underwent sedative endoscopy at the Korea University Ansan Hospital. Clinical data were used as predictor variables to construct predictive models using the random forest method that is a machine learning algorithm. Seventy-two of the 446 patients (16.1%) experienced life-threatening hypoxia requiring immediate medical intervention. Patients who developed hypoxia had higher body weight, body mass index (BMI), neck circumference, and Mallampati scores. Propofol alone and higher initial and total dose of propofol were significantly associated with hypoxia during sedative endoscopy. Among these variables, high BMI, neck circumference, and Mallampati score were independent risk factors for hypoxia. The area under the receiver operating characteristic curve for the random forest-based predictive model for hypoxia during sedative endoscopy was 0.82 (95% confidence interval, 0.79-0.86) and displayed a moderate discriminatory power. High BMI, neck circumference, and Mallampati score were independently associated with hypoxia during sedative endoscopy. We constructed a model with acceptable performance for predicting hypoxia during sedative endoscopy.

The efficacy and safety of ciprofol and propofol in patients undergoing colonoscopy: A double-blind, randomized, controlled trial

Study objectivePropofol is a commonly utilized anesthetic for painless colonoscopy, but its usage is occasionally limited due to its potential side effects, including cardiopulmonary suppression and injection pain. To address this limitation, the novel compound ciprofol has been proposed as a possible alternative for propofol. This study sought to determine whether there are any differences in the safety and efficacy of propofol and ciprofol for painless colonoscopy. DesignRandomized clinical trial. SettingSingle-centre, class A tertiary hospital, November 2021 to November 2022. PatientsAdult, American Society of Anesthesiologists Physical Status I to II and body mass index of 18 to 30 kg m−2 patients scheduled to undergo colonoscopy. InterventionsConsecutive patients were randomly allocated in a 1:1 ratio to receive sedation for colonoscopy with ciprofol (group C) or propofol (group P). MeasurementsThe primary outcome was the success rate of colonoscopy. The secondary outcomes were onset time of sedation, operation time, recovery time and discharge time, patients and endoscopists satisfaction, side effects (e.g. injection pain, myoclonus, drowsiness, dizziness, procedure recall, nausea and vomiting) and incidence rate of cardiopulmonary adverse events. Main resultsNo significant difference was found in the success rate of colonoscopy between the two groups (ciprofol 96.3% vs. propofol 97.6%; mean difference − 1.2%, 95% CI: −6.5% to 4.0%, P = 0.650). However, group C showed prolonged sedation (63.4 vs. 54.8 s, P < 0.001) and fully alert times (9 vs 8 min, P = 0.013), as well as reduced incidences of injection pain (0 vs. 40.2%, P < 0.001), respiratory depression (2.4% vs. 13.4%, P = 0.021) and hypotension (65.9% vs. 80.5%, P = 0.034). Patients satisfaction was also higher in Group C (10 vs 9, P < 0.001). ConclusionsCiprofol can be used independently for colonoscopy. When comparing the sedation efficacy of ciprofol and propofol, a 0.4 mg kg−1 dose of ciprofol proved to be equal to a 2.0 mg kg−1 dose of propofol, with fewer side effects and greater patient satisfaction during the procedure.

Impact of preoperative endoscopic procedures on adverse event rates after surgical resection for main-duct and mixed-type intraductal papillary mucinous neoplasms (IPMNs)

BackgroundMain-duct (MD-) and mixed-type (MT-) IPMNs harbor an increased risk of pancreatic cancer and warrant surgical resection. Preoperative endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) are important in the diagnosis of IPMNs. The aim of this study was to investigate whether endoscopic procedures manipulating the MD impact postoperative adverse events in patients with MD- and MT-IPMNs. MethodsWe performed a retrospective study of 369 patients who underwent resections for MD- or MT-IPMN at two tertiary centers (2000–2019). Multivariable logistic regression analyses were performed for postoperative adverse events to compare the risks between intervention (ERCP, EUS-FNA with branch duct (BD) aspirated, EUS-FNA with MD aspirated from the duct directly or cyst/mass arising from MD) versus no-intervention group. Results33.1 % of patients had a preoperative ERCP and 69.4 % had EUS-FNA. Postoperative adverse events included: 30-day readmission (12.7 %), delayed gastric emptying (13.8 %), pancreatic fistula (10.3 %), abdominal abscess (5.7 %), cardiopulmonary adverse events (11.4 %), and mortality (1.4 %). The model was adjusted for potential confounders. There were no significant differences between the ERCP and no-ERCP groups for specific adverse events. Compared to no-EUS-FNA groups, groups of EUS-FNA with BD aspiration and EUS-FNA with MD aspiration from the main pancreatic duct directly or cyst/mass arising from MD did not show a significant increase in specific adverse events. ConclusionsPostoperative adverse events were not significantly increased among patients who had ERCP or EUS-FNA before surgical resection for MD- or MT-IPMNs. Endoscopic procedures directly sampling the MD can be safely pursued for diagnostic purposes in selected cases.

Comparison of ciprofol–alfentanil and propofol–alfentanil sedation during bidirectional endoscopy: A prospective, double-blind, randomised, controlled trial

BackgroundAlthough propofol is widely used for gastrointestinal endoscopic sedation, cardiopulmonary adverse events remain common. Ciprofol is a new intravenous anaesthetic agent demonstrating respiratory and hemodynamic stability. AimsThis study aimed to clarify the benefits of ciprofol combined with alfentanil in bidirectional endoscopy (esophagogastroduodenoscopy followed by colonoscopy) to reduce adverse events and improve post-endoscopic recovery. MethodsA total of 185 patients scheduled to undergo bidirectional endoscopy were randomly divided into two groups: ciprofol combined with alfentanil or propofol combined with alfentanil. All patients received 7 µg/kg alfentanil intravenously before the study drugs were administered. The propofol group received a bolus of 1.2 mg/kg (0.12 ml/kg) propofol intravenously, whereas the ciprofol group received a bolus of 0.3 mg/kg (0.12 ml/kg) ciprofol intravenously. The primary outcome was the proportion of patients with cardiopulmonary adverse events (i.e., any one of the airway obstruction, apnoea, hypotension, hypertension, bradycardia, tachycardia or arrhythmias). ResultsCompared with propofol, ciprofol reduced cardiopulmonary adverse events by 43.51 % (34.4% vs. 60.9 %, P <0.001), mitigated respiratory adverse events by 54.74 % (17.2% vs. 38.0 %, P = 0.002) overall and by 59.05 % (12.9% vs. 31.5 %, P = 0.002) during the induction period. ConclusionsCiprofol can significantly decrease respiratory depression events and provides a better sedative efficacy than propofol with higher recovery quality and satisfaction.

Etomidate Versus Propofol for Monitored Anesthesia Care During Endoscopic Retrograde Cholangiopancreatography: A Prospective Randomized Controlled Trial.

Background and objectives Propofol-based sedation is one of the most commonly used methods for endoscopic retrograde cholangiopancreatography (ERCP). The commonest complications during ERCP are in the form of adverse cardiopulmonary events as a result of sedation. Etomidate has a more stable cardiovascular and respiratory profile than propofol and has been used forsedation in simple gastrointestinal endoscopy but has not been studied for procedural sedation in ERCP. The objective of the present study was to compare the safety and feasibility of etomidate and propofol for sedation during ERCP procedures. Methods This single-center, randomized trial included 100 American Society of Anesthesiologists (ASA) physical status class I to II patients who were scheduled for ERCP. All patients received midazolam 0.02 mg/kg, lignocaine (2%) 1 mg/kg, and fentanyl 1 µg/kg intravenously, followed by etomidate or propofol according to the group allocation. The primary outcome was to compare the mean arterial pressure (MAP) at various timepoints between the two groups and secondary outcomes were to compare oxygen saturation, induction and recovery times, and adverse events. Transient hypotension was defined as any decrease in MAPbelow 60 mmHg or 20% below the baseline. Transient hypoxia was defined as desaturation (saturation of peripheral oxygen (SpO2) <92%) lasting for more than 10 seconds requiring airway intervention. Results Fifty patients were enrolled in each group (Group E: etomidate and Group P: propofol). Transient hypotension occurred in eight (16%) patients in Group P, and two (4%) patients in Group E (P= 0.045). Baseline MAP was comparable between the two groups but was significantly lower in Group P at three timepoints during the study. Nine (18 %) patients in Group P had a transient hypoxic episode, compared to none in Group E (p= 0.006). The induction and recovery times were similar in the two groups. Conclusions Etomidate offers better hemodynamic and respiratory stability than propofol and can be recommended for use during ERCP in ASA I/II patients.

Analysis of particle therapy registries based on a unified treatment policy for esophageal cancer.

This study aimed to evaluate the efficacy and safety of particle therapy (proton beam therapy and carbon-ion radiotherapy) for esophageal cancer by analyzing prospective nationwide registry data from particle therapy facilities throughout Japan. Patients diagnosed with esophageal cancer who received particle therapy between May 2016 and June 2018 were recruited from the registries of 12 particle therapy centers in Japan. Eventually, we enrolled 174 patients who met the inclusion criteria. Of the 174 patients, 137 (78.7%) were male, with a median age of 69years (range: 41-88years). Clinical stages included I (n = 55; 31.6%), II (n = 31; 17.8%), III (n = 82; 47.1%), IV (n = 3; 1.7%) and unknown (n = 3; 1.7%) (Union for International Cancer Control, seventh edition), and the median follow-up period was 908days (range: 76-1669days) for all patients. The 3-year overall survival (OS) rate, the 3-year progression-free survival (PFS) rate and the 3-year local control (LC) rates were 60.5, 53.2 and 72.7%, respectively. For each clinical stage, the 3-year OS rates were I, 84.8%; II, 60.3% and III, 42.9%; the 3-year PFS rates were I, 71.9%; II, 58.3% and III, 37.0% and the 3-year LC were I, 78.4%; II, 79.8% and III, 65.2%, respectively. Notably, four patients (2.3%) with ≥Grade 3 cardiopulmonary toxicities were observed (Common Terminology Criteria for Adverse Events, version 5.0). Our study showed that particle therapy for esophageal cancer has lower rates of adverse cardiopulmonary events than X-ray radiotherapy.

Abstract GS4-05: Phase II randomized trial of conventional versus hypofractionated post-mastectomy proton radiotherapy

Abstract Purpose/Objectives: Proton therapy is under investigation in breast cancer as a strategy to reduce heart and lung exposure, which is associated with late cardiopulmonary adverse events and secondary malignancy. To date, studies investigating postmastectomy radiotherapy (PMRT) with protons have used conventional fractionation. We hypothesized that condensing treatment to 15 fractions would be safe based on evidence that breast cancer is more sensitive to higher dose fractions than surrounding normal tissues. Materials/Methods: We conducted a randomized non-inferiority phase II trial comparing conventional and hypofractionated proton PMRT with primary endpoint of 24-month complication rate (defined as grade 3 or higher late adverse events using CTCAE, v 4.0 and/or unplanned surgical intervention in patients undergoing mastectomy with reconstruction). With a 10% non-inferiority margin the study ensured 80% power and had a one sided-type I error rate of 0.05. Cardiotoxicity was assessed with serial transthoracic conventional and 2-dimensional speckle tracking echocardiography (2D-STE). Eligibility included age ≥ 18 years with non-inflammatory breast cancer resected by mastectomy with indications for PMRT. Assignment of treatments was balanced with respect to immediate breast reconstruction (IBR). Conventional fractionation group received 50 Gy in 25 fractions of 2 Gy, and hypofractionation group received 40.05 Gy in 15 fractions of 2.67 Gy (RBE 1.1). Target volume included the chest wall and axillary, supraclavicular, and internal mammary lymph nodes. All patients were treated with multi-field optimized pencil beam scanning (intensity modulated proton therapy). Results: Between 2016 and 2018, 82 patients were enrolled and randomized (41 conventional, 41 hypofractionation). Median patient age was 52 years. 32.9% were staged T3-T4 and 79.3% node positive at diagnosis. 57 of 82 patients (69.5%) elected IBR. The median mean heart dose was 0.49 Gy and the median ipsilateral lung volume receiving 40% of prescription or greater (V40%) was 13.6%. No significant changes on conventional or 2D-STE at end-of-treatment or 3-month follow-up compared to baseline were observed. The rate of ≥ grade 2 acute dermatitis was lower with hypofractionation (44% vs 15%, p = 0.006). Other ≥ grade 2 acute adverse events including esophagitis (0 vs 5%), infection (5% vs 2.4%) and skin hyperpigmentation (7.3% vs 4.8%) were not significantly different between the two arms. With a median follow-up of 38.3 months, the 24-month complication rate was conventional 14.6% vs hypofractionation 17.1% (absolute difference 2.4%, p=0.17, 95% CI [-, 15.7%]). In patients with IBR, 6 of 28 (21.4%) conventional and 7 of 29 (24.1%) hypofractionated patients developed complications (p =0.80). There was no significant difference in 3-year disease-free survival between the conventional (89.4%; 95% CI 80.0 – 99.8%) and hypofractionated (92.4%, 95% CI 84.5 – 100.0%) arms (p = 0.91). One local recurrence occurred in the hypofractionated arm simultaneous with regional and distant relapse. The remaining 6 recurrences were isolated distant events. Conclusions: Proton PMRT provided excellent locoregional control and normal tissue sparing. There were no subclinical echocardiographic changes indicative of radiation-induced cardiac dysfunction. Hypofractionation resulted in comparable disease control, tolerability and reconstruction outcomes as conventional fractionation. Although non-inferiority of hypofractionation could not be established based on the upper bound of the 95% confidence interval for complication rate being greater than 10%, both conventional and hypofractionation may be considered appropriate regimens for ongoing phase 3 randomized trials comparing photon and proton radiotherapy. Citation Format: Robert Mutter, Sharmila Giri, Briant Fruth, Nicholas Remmes, Aman Anand, Kathryn Ruddy, Hector Villarraga, Sebastian Santos Patarroyo, Elizabeth Yan, Kenneth Merrell, Lisa McGee, Tamara Vern-Gross, Bradley Stish, Robert Gao, Judy C. Boughey, Sean Park, Kimberly Corbin, Carlos Vargas. Phase II randomized trial of conventional versus hypofractionated post-mastectomy proton radiotherapy [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr GS4-05.

WEO Newsletter.

WEO Newsletter.

The need to monitor emerging issues in etomidate usage: the misuse or abuse potential.

Since 2011, the misuse or abuse of etomidate has gradually increased when propofol was designated a controlled drug under the Narcotics Control Act in Korea. Accordingly, the Ministry of Food and Drug Safety announced that etomidate would be under the 'Regulation on the designation of drugs that may cause concerns of misuse or abuse' rule in June 2020, which is less stringent than the Narcotics Control Act. Therefore, this review investigates potential misuse or abuse cases of etomidate to consider strengthening its management. A literature search was conducted to compare etomidate with other sedatives in their efficacy and side effects, as well as identify the adverse health outcomes, abuse cases, and analytical methods of etomidate. Etomidate has an equal or higher sedative efficacy and lower risk of adverse cardiopulmonary events than propofol. However, major adverse effects of etomidate include adrenocortical suppression and unproven associated deaths, as well as myoclonus requiring pre-treatment. Although the issue of abuse and misuse of etomidate is emerging in recent years, there are few academic reports on these issues and analytical methods in the forensic field. In order to effectively manage the misuse or abuse of etomidate, it is necessary to continuously monitor related cases with great interest and to be more intensively studied on its abuse potential.

Plasma VWF: Ag levels predict long-term clinical outcomes in patients with acute myocardial infarction.

A vital role in coronary artery disease is played by Von Willebrand factor (VWF), which serves as a bridge between platelets and the subendothelial matrix after vessel damage. The purpose of the study was to assess the validity of plasma VWF antigen (VWF: Ag) levels as a predictor of clinical outcomes after acute myocardial infarction (AMI). Three hundred and seventy-four patients were studied following coronary angiography, including 209 patients suffering from acute myocardial infarction and 165 healthy participants. Coronary angiography was followed by measurement of plasma VWF: Ag levels. Over a 2-year follow-up period, major adverse cardiopulmonary and cerebrovascular events (MACEs) were the primary endpoint. All-cause mortality was investigated as a secondary endpoint. When compared to controls, patients with AMI had mean plasma VWF: Ag levels that were ~1.63 times higher (0.860 ± 0.309 vs. 0.529 ± 0.258 IU/ml; P < 0.001). The plasma VWF: Ag levels were substantially higher in patients who experienced MACEs after myocardial infarction vs. those without MACEs (1.088 ± 0.253 vs. 0.731 ± 0.252 IU/ml; P < 0.001). For predicting long-term MACEs using the optimal cut-off value (0.7884 IU/ml) of VWF: Ag, ROC curve area for VWF: Ag was 0.847, with a sensitivity of 87.2% and a specificity of 66.3% (95%CI: 0.792-0.902; P = 0.001). Two-year follow-up revealed a strong link between higher plasma VWF: Ag levels and long-term MACEs. At the 2-year follow-up, multivariate regression analysis revealed an independent relationship between plasma VWF: Ag levels and MACEs (HR = 6.004, 95%CI: 2.987-12.070). We found evidence that plasma VWF: Ag levels were independent risk factors for AMI. Meanwhile, higher plasma VWF: Ag levels are associated with long-term MACEs in people with AMI.

S1163 Endoscopic Full Thickness Resection of Gastrointestinal Neoplasia – Single Center Experience

Introduction: Endoscopic full-thickness resection (EFTR) is emerging therapeutic option for en-bloc treatment of subepithelial tumors and epithelial neoplasia with significant fibrosis. Study aim was to evaluate results at advanced endoscopy center. Methods: This was retrospective analysis of 18 EFTR cases from 01/2020 till 11/2021, that were performed in advanced endoscopy center with a dedicated full thickness resection device (FTRD®, Ovesco, Germany). We recorded the demographic, procedural and technical characteristics. Lesion pathology (surface size, type, location), timing of procedure, technical success (defined as reaching the lesion, deploying the clip, and performing an en bloc and macroscopically complete resection), clinical success (defined as R0 resection and histopathology evaluation compatible with adequate endoscopic treatment) and rate of procedure-related complications (bleeding, perforation, need for emergency surgery, infectious complications and cardio-pulmonary adverse events associated with sedation) were also recorded (Table). Results: Majority of lesions had previous failed attempts at removal (n=10, 55.5%). Other lesions (n=8, 44.4%) included appendiceal orifice (n=6, 33.3%) or neuroendocrine neoplasia (n=2, 11.1%). Mean age of patients was 67.4 years +/- (SD) 10.9 years. 8/18 (44.4%) patients were female. Procedures were performed with conscious sedation (midazolam) and analgesia (piritramide), with pulse oximetry monitoring. There were no cardiopulmonary adverse events. (Figure) One procedure was aborted due to postsurgical anatomy; the endoscope with the FTRD device could not be passed through. One patient developed post procedural appendicitis and a surgical appendectomy was performed, although the EFTR was technically successful. No other complications were recorded. Mean procedure time was 42.1 +/- (SD) 14.3 minutes. Technical success of the procedure was 94.4% (n=17/18), clinical success was achieved in 88.2% (n=15/17). One patient was referred to surgery due to insufficient safety margins of removed specimen and one patient due to presence of invasive adenocarcinoma (pT2). All but one (post-procedural appendicitis) patients were discharged after one day of observation. Conclusion: Our results confirm that EFTR is effective endoscopic technique. It is exceptionally useful in fibrotic lesions and neuroendocrine neoplasia. Technically less challenging than endoscopic submucosal dissection it can still pose technical difficulties especially in cases with postsurgical anatomy.Figure 1.: A) Pre-EFTR marks of a 20 mm sessile serrated lesion of the appendiceal orifice. B) Deployment of the EFTR device. C) Resection defect after EFTR. D) Mucosal side of the resected specimen. The pathology showed sessile serrated lesion. Table 1. - Demographics and Procedure Characteristics. SD - standard deviation. Timing of procedure (time of endoscopy and deployment of the device). Technical success (defined as reaching the lesion, deploying the clip, and performing an en bloc and macroscopically complete resection). Clinical success (defined as R0 resection and histopathology evaluation compatible with adequate endoscopic treatment). Other – hyperplastic polyps, fibrotic tissue and lipoma Sex (n=18) (n, %) Male 10 (55.6) Female 8 (44.4) Mean age +/- SD (years) 67.4 +/- 10.9 ASA classification, (n, %) II 12 (66.7) III 6 (33.3) Mean dose of midazolam +/- SD, mg 0.7 +/- 0.83 Mean dose of piritramide +/- SD, mg 4.5 +/- 5.1 Location of the lesion, n=18 (n, %) Rectum 8 (44.4) Transverse Colon 2 (11.1) Ascending Colon 1 (5.6) Appendiceal Orifice 6 (33.3) Body of Stomach 1 (5.6) Mean Procedure Time +/- SD, min 42.1 +/- 14.3 Technical success, n=18 (n, %) Yes 17 (94.4) No 1 (0.06) Clinical success, n=17 (n, %) Yes 15 (88.2) No 2 (12.8) Pathohistology of the Retrieved Specimen, n=17 (n, %) Adenoma with Low Grade Dysplasia 5 (29.4) Sessile Serrated Lesion 3 (17.6) Adenocarcinoma 3 (17.6) Neuroendocrine Neoplasia 2 (11.8) Other 4 (23.5)

Intraoperative changes and prognostic implications of pulmonary hypertension in patients with hypertrophic obstructive cardiomyopathy undergoing surgical septal myectomy

ObjectivesPatients with hypertrophic cardiomyopathy often have concomitant pulmonary hypertension, which has a negative prognostic effect in patients undergoing myectomy. Our objective was to investigate the effect of myectomy on pulmonary artery pressure obtained via Swan-Ganz catheter and characterize how changes in pulmonary artery systolic pressure may indicate outcomes in these patients. MethodsWe performed a single-center retrospective analysis of 271 patients with recordings of intraoperative pulmonary artery pressures during surgical myectomy. We analyzed primary composite outcomes as 30-day or in-hospital major cardiopulmonary adverse events. ResultsThere was a 5.17% adverse event rate. Patients with adverse events were older, were more likely to be female, had chronic obstructive pulmonary disease, and had longer cardiopulmonary bypass times. Some 35.7% of those with adverse events had moderate to severe pulmonary hypertension (pulmonary artery systolic pressure ≥50 mm Hg) on postbypass stress test, compared with 4.3% of those without adverse events (P < .001). Further, 21.4% of patients with adverse events had pulmonary artery systolic pressure 50 mm Hg or greater at the end of surgery, compared with 1.9% of patients without adverse events (P < .001). The pulmonary artery systolic pressure decrease after surgery in those without adverse events was on average 5 mm Hg more than in those with adverse events. ConclusionsPostoperative pulmonary hypertension was associated with a higher rate of adverse cardiopulmonary events. This may influence the decision to use Swan-Ganz catheters in patients undergoing septal myectomy in monitoring pulmonary artery pressures to better risk stratify and manage these patients postoperatively.

ARTERIAL THROMBOSIS IN PATIENTS WITH TYPE 2 DIABETES AND COVID-19

The aim of the study: to assess the importance of the inflammatory status of the body in patients with diabetic 2 type and severe COVID-19 as an unfavorable factor for the occurrence of arterial thrombosis of the lower extremities, the course of acute ischemia and the prognosis for ischemic limb. Materials and Methods. The study included 35 patients with type 2 diabetes mellitus and acute arterial thrombosis of the lower extremities without a history of intermittent claudication with an ischemia of 6-12 h, who underwent urgent surgical successful thrombectomy. All studied patients were tested for the SARS-CoV-2 virus, 18 had a negative result (control group), the diagnosis of COVID-19 in 17 patients of the main group was confirmed by a transcriptional polymerase chain reaction. The average age of patients in the control group was 72.3 yrs, the main group — 69.8 yrs. Results. During examination, distal forms of arterial thrombosis were registered in 70.6 % of patients in the main group and 72.2 % in the controls. The concentration of myoglobin in the serum at 6 h after the surgery was the highest, reaching the highest values in patients of the main group. There was a significantly lower concentration of myoglobin in the control group during the first days after the restoration of blood flow. ICAM-1 levels were significantly higher in the COVID-19 group than in the control group during the first day after blood flow recovery. The association between endothelial dysfunction and subsequent thrombotic events is already well known in cardiovascular disease and diabetes. Six of our cases had comorbidities such as arterial hypertension, dyslipidemia, diabetes mellitus, and signs of chronic arterial disease. Thus, previous endothelial activation status caused by these comorbidities exacerbated endothelial dysfunction caused by SARS-CoV-2 infection and its inflammatory response, and may have been the cause of the most common fatalities described in these patients. Recurrences of thrombosis in the early postoperative period occurred in 5 (29.4 %) patients of the main group, which led to amputation. In the control group, recurrent thrombosis led to amputation in 2 (11.1 %) cases. In 7 patients of the main group (41.2 %) and 2 patients of the control group (11.1 %) in the early postoperative period developed adverse cardiopulmonary events, which in 4 patients of the main group (23.5 %) caused death. Conclusions. Оur results suggest the involvement of endothelial dysfunction and thrombosis in COVID-19. Consistent with this hypothesis, patients with type 2 diabetes mellitus and severe COVID-19 have been noted to have significant increase in serum level of inflammatory markers (TNF-α, IL-1β, IL-6, IL-8, IL-10). One of the significant factors of endothelial dysfunction as a result of our study was ICAM-1 thereby indicating the occurrence of macrophage activation syndrome. These thrombotic events can be fatal in patients with type 2 diabetes, and early diagnosis can help health professionals adjust the anticoagulation regimen and affect endothelial stabilization in high-risk patients, alleviate thrombogenic events, systemic inflammatory response syndrome, and multiorgan failure. K ey wor d s : type 2 diabetes mellitus, COVID-19, arterial thrombosis.

Patient characteristics and procedural outcomes of moderate sedation for endoscopic procedures in patients with obesity: A retrospective, propensity score-matched study.

Background Endoscopic procedures are performed commonly with moderate sedation. Obesity can pose a challenge in its safe administration. This study was aimed at assessing outcomes of endoscopy procedures performed with moderate sedation in obese patients. Patients and methods This was a retrospective study of patients undergoing esophagogastroduodenoscopy (EGD) and/or colonoscopy with moderate sedation from July 17, 2017 to December 31, 2019. Demographics, comorbidities, outpatient medications and procedure-related outcomes (procedure time, recovery time, cardiopulmonary adverse events, 7-day post-procedure hospitalization, cecal intubation time, withdrawal time, tolerance of moderate sedation and sedation medications administered) were compared for patient with and without obesity after propensity score matching. Standard statistical methods were used for analysis. Results A total of 7601 procedures were performed with moderate sedation for 5746 patients. Propensity score matching identified 1360 and 1740 pairs of EGDs and colonoscopies with moderate sedation for patients with and without obesity. Recovery time was found to be shorter for obese patients undergoing EGD (OR: 0.989, 95 % CI: 0.981–.998; P = 0.01). Obese patients did not differ from non-obese patients in any other procedure-related outcomes for EGDs or colonoscopies. Conclusions Outcomes for endoscopy procedures performed with moderate sedation were noted to be similar between obese and non-obese patients. These findings suggest that moderate sedation can be used safely for endoscopic procedures in patients with obesity.

S1038 Sedation – Only Gastric Endoscopic Submucosal Dissection – A Single Center Experience

Introduction: Data regarding the efficacy and safety of sedation-only endoscopic submucosal dissection (ESD) in the upper gastrointestinal (GI) tract is scarce. We aimed to study the efficacy and safety of sedation-only ESD in the upper GI tract. Methods: This was a retrospective analysis of 26 consecutive ESD cases from 4/2019 till 05/2021, that were performed in our advanced endoscopy center. Data was gathered from our electronic medical records. During ESD a sedation (midazolam) and/or analgesia (dipyridamole) was used. We evaluated the incidence of procedure-related complications, including bleeding, perforation, need for emergency surgery and cardio-pulmonary adverse events associated with sedation. Data regarding lesion pathology (surface size, type, location), ESD procedure (duration, lifting solution) were also recorded. In all procedures an Olympus DualKnife J was used. Results: Mean age of patients was 75.8 years +/- 8.8 years. 14/26 patients were female. Based on American Society of Anaesthesiologists’ (ASA) classification of Physical Health, 2 patients were ASA 1, 20 patients ASA 2 and 4 patients ASA 3. During the procedure a low dose of midazolam median 2.0 mg, IQR [0.5 – 4.0 mg]) was used with the addition of analgesia (dipyridamole) median 7.5 mg [IQR 3.8 – 10.3 mg]. During the procedure, patients were monitored with pulse oximetry. There were no cardiopulmonary adverse events in our group. 2 perforations and 1 delayed bleeding were treated endoscopically with the use of endoscopically placed clips. EleviewTM (Aries Pharmaceuticals, Inc.) or OriseTM (Boston Scientific) were used as lifting agents. Bleeding during procedures was managed with hemostatic forceps. Median procedure time was 136 minutes [IQR: 101 – 193 minutes]. ESD was performed in 21 cases (80.8%), and hybrid technique with snare was used in 5 cases (19.2%). R0 resection was achieved in 22 cases (84.6%). Median surface size of the lesions was 9.0 cm2 [IQR: 8.3 – 18.3 cm2]. R0 resection was achieved in 22 (84.6%) cases. Median length of hospital stay was 2 days.Table 1.: Demographics and procedure characteristics. IQR interquartile range, ESD endoscopic submucosal dissection, R0 resection. Conclusion: The results of our cohort study show that sedation-only gastric ESD is safe and efficacious.

389 Atropine Pretreatment and Adverse Events in Emergency Pediatric Intubation

Atropine may blunt the vagal response to laryngoscopy and endotracheal intubation in children, though its role in emergency pediatric intubation remains unclear. Pediatric Advanced Life Support (PALS) guidelines recommend against the routine use of prophylactic atropine when intubating critically-ill children and infants, but state it “may be reasonable” in specific situations with high risk of bradycardia (eg, when using succinylcholine for paralysis). Our goal was to describe the use of atropine for pediatric intubation in the emergency department (ED) and estimate its association with peri-intubation adverse events (AE). We performed a secondary analysis of prospectively-collected data from the National Emergency Airway Registry (NEAR), a multicenter registry of academic and community EDs in the United States requiring reporting of ≥90% of intubations for participation. Patients ≤15 years of age were included from 2016 through 2018. We report proportions with associated 95% CIs and multivariable logistic regression estimating the association between atropine pretreatment and AEs including bradycardia, hypotension, cardiac arrest, and hypoxia while adjusting for age, pre-intubation blood pressure and oxygen saturation, sedative and paralytic choice, type of laryngoscopy, intubator level of training, number of attempts and clustering within hospitals. 25 EDs provided data for 612 pediatric intubations: 139 <1 year of age; 129 ages 1 year to <3 years; 144 ages 3 years to <8 years; and 200 ages 8 years to ≤15 years. While all intubations were ultimately successful, first pass success rate was 78%. Atropine pretreatment was given in 7% of intubations, of which, 51% were <1 year and 23% received succinylcholine. AEs occurred in 16% of intubation attempts with hypoxia being the most common AE; cardiopulmonary AEs occurred in 4%; bradycardia in 2%. Of the 9 patients who did not receive atropine pretreatment and experienced bradycardia, 6 received rocuronium for paralysis and 3 received succinylcholine. After adjusting for confounding, atropine pretreatment was associated with an increased occurrence of cardiopulmonary AEs (OR 2.60, 95% CI 1.02-6.61). In this multicenter prospective cohort of pediatric intubations, atropine pretreatment was uncommon and associated with increased adverse cardiopulmonary events. This finding challenges the use of atropine to prevent bradycardia in emergency pediatric intubation and further research is required to explore the unexpected association with cardiopulmonary adverse events.

Abstract P452: Stem Cells Defect And Alarmins S100A8/A9 Overexpression Associate With Early-stage Frailty And Poor Cardiovascular Health In Older Adults

Importance: Frailty affects the physical, cognitive, and social domains exposing older adults to an increased risk of cardiovascular diseases and death. The mechanisms linking frailty and cardiovascular outcomes are mostly unknown. Objective: Here, we studied the association of hematopoietic stem/progenitor cells (HSPCs) and molecular markers of inflammaging with the cardiopulmonary phenotype and prospective adverse events of individuals classified according to levels of frailty. Methods: We conducted one observational study on two patients’ cohorts of older adults characterized for their frailty status examining the abundance (flow cytometry) and gene expression profile (RNAseq) of HSPCs, and the levels of cardiac dysfunction-associated alarmins S100A8/A9 and inflammatory cytokines (ELISA). Results: In a cohort of pre-frail 35 individuals (average age: 75 years), a physical frailty score above the median identified subjects with initial alterations in cardiorespiratory function and increased alarmins S100A8/A9 and inflammatory cytokines in peripheral blood. RNA sequencing revealed S100A8/A9 upregulation in HSPCs from the bone marrow (&gt;10-fold) and peripheral blood (&gt;200-fold) of individuals with greater physical frailty. We then interrogated the biomarkers in a cohort of 104 frail individuals (average age: 81 years) with multi-domain health deficits. Reduced levels of circulating HSPCs and increased S100A8/A9 concentrations were independently associated with the frailty index. Remarkably, low HSPCs and high S100A8/A9 simultaneously predicted major adverse cardiovascular events at 1-year follow-up after adjustment for age and frailty index. Conclusions and Relevance: Inflammaging resulting from alarmin and pro-inflammatory cytokines in pre-frail individuals is followed by pauperization of HSPCs in frail older people with comorbidities. S100A8/A9 upregulation is activated within HSPCs, identifying a phenotype that drives poor cardiovascular outcomes.

Implementation of the Feed and Swaddle Technique as a Non-Pharmacological Strategy to Conduct Brain Magnetic Resonance Imaging in Very Low Birth Weight Infants

Purpose: Magnetic resonance imaging (MRI) is a useful tool for evaluating brain injury and maturation in preterm infants and often requires sedation to acquire images of sufficient quality. Infant sedation is often associated with adverse events, despite extreme precautions. In this study, the swaddling technique was investigated as an alternative non-pharmacological strategy to obtain brain MRIs of sufficient quality.Methods: We applied the feed and swaddle technique during routine brain MRI as a quality improvement project and compared its morbidity with that of sedation in a historic age-matched group. Seventy-nine very low birth weight infants in the neonatal intensive care unit of Ajou University Hospital (Suwon, Korea) were enrolled. Thirty-two (40.5%) infants were in the feed and swaddling group, and 47 (59.5%) were in the sedation group.Results: The morbidity associated with the cardiopulmonary system (swaddling group vs. sedation group: 53.13% [n=17] vs. 63.83% [n=30], P=0.723) and central nervous system (40.63% [n=13] vs. 29.79% [n=14], P=0.217) were not significantly different between groups. The MRI failure rate was not significantly different (swaddling group vs. sedation group: 12.5% [n=4] vs. 4.3% [n=2], P=0.174). The MRI scanning time was longer in the swaddling group than in the sedation group (76.5±20.3 minutes vs. 61.5±13.6 minutes, P=0.001). Cardiopulmonary adverse events were significantly less common in the swaddling group than in the sedation group (3.13% [n=1] vs. 34.04% [n=16], P=0.002).Conclusion: The success rate of MRI was comparable between the swaddling technique and sedation. Furthermore, despite the drawback of prolonged scan time, cardiopulmonary adverse events are fewer with swaddling than with sedative agents. Therefore, swaddling can be an alternative to sedation or anesthesia when performing neonatal MRI scans.

Implementation of Evidence-Based Presurgical Testing Guidelines in Patients Undergoing Ambulatory Surgery for Endometrial Cancer.

The aim of this quality improvement intervention was to evaluate the safety and cost savings of presurgical testing (PST) guidelines for patients undergoing hysterectomy for endometrial pathology in the ambulatory setting. Evidence-based presurgical testing (PST) guidelines were developed by a multidisciplinary team. These guidelines were implemented on the gynecologic surgery service of a comprehensive cancer center in January 2016. All patients with a diagnosis of endometrial pathology who underwent ambulatory surgery during the specified time periods were included in this analysis. A pre-post analysis was performed (preperiod, July 2014-December 2015; postperiod, July 2016-December 2017). Rates of completed presurgical tests and perioperative adverse events were compared between time periods. Cost savings related to the reduction in PST were calculated using the direct cost of testing and reported in percentage cost reduction. A total of 749 hysterectomies were completed in the preperiod and 775 in the postperiod. After implementation of PST guidelines, complete blood counts, coagulation testing, comprehensive metabolic panels, chest x-rays, and electrocardiograms were reduced by 13.4%, 78.1%, 36.8%, 39.0%, and 15.5%, respectively (all P < .001). Rates of perioperative cardiopulmonary adverse events (0% v 0%) and hematologic adverse events (3.3% v 2.0%; P = .10) were stable between time periods. There were no deaths within 90 days of surgery. There was a 41.4% reduction in direct costs related to PST in the postperiod. The use of evidence-based PST guidelines for patients with endometrial pathology undergoing hysterectomy in the ambulatory setting is safe and cost-effective. A multidisciplinary approach is essential for successful development and implementation.