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BACKGROUND: Cerebral perfusion may change depending on arterial cannulation site and may affect the incidence of neurologic adverse events in post-cardiotomy extracorporeal life support (ECLS). The current study compares patients' neurologic outcomes with three commonly used arterial cannulation strategies (aortic vs. subclavian/axillary vs. femoral artery) to evaluate if each ECLS configuration is associated with different rates of neurologic complications. METHODS: This retrospective, multicenter (34 centers), observational study included adults requiring post-cardiotomy ECLS between January 2000 and December 2020 present in the Post-Cardiotomy Extracorporeal Life Support (PELS) Study database. Patients with Aortic, Subclavian/Axillary and Femoral cannulation were compared on the incidence of a composite neurological end-point (ischemic stroke, cerebral hemorrhage, brain edema). Secondary outcomes were overall in-hospital mortality, neurologic complications as cause of in-hospital death, and post-operative minor neurologic complications (seizures). Association between cannulation and neurological outcomes were investigated through linear mixed-effects models. RESULTS: This study included 1897 patients comprising 26.5% Aortic (n = 503), 20.9% Subclavian/Axillary (n = 397) and 52.6% Femoral (n = 997) cannulations. The Subclavian/Axillary group featured a more frequent history of hypertension, smoking, diabetes, previous myocardial infarction, dialysis, peripheral artery disease and previous stroke. Neuro-monitoring was used infrequently in all groups. Major neurologic complications were more frequent in Subclavian/Axillary (Aortic: n = 79, 15.8%; Subclavian/Axillary: n = 78, 19.6%; Femoral: n = 118, 11.9%; p < 0.001) also after mixed-effects model adjustment (OR 1.53 [95% CI 1.02-2.31], p = 0.041). Seizures were more common in Subclavian/Axillary (n = 13, 3.4%) than Aortic (n = 9, 1.8%) and Femoral cannulation (n = 12, 1.3%, p = 0.036). In-hospital mortality was higher after Aortic cannulation (Aortic: n = 344, 68.4%, Subclavian/Axillary: n = 223, 56.2%, Femoral: n = 587, 58.9%, p < 0.001), as shown by Kaplan-Meier curves. Anyhow, neurologic cause of death (Aortic: n = 12, 3.9%, Subclavian/Axillary: n = 14, 6.6%, Femoral: n = 28, 5.0%, p = 0.433) was similar. CONCLUSIONS: In this analysis of the PELS Study, Subclavian/Axillary cannulation was associated with higher rates of major neurologic complications and seizures. In-hospital mortality was higher after Aortic cannulation, despite no significant differences in incidence of neurological cause of death in these patients. These results encourage vigilance for neurologic complications and neuromonitoring use in patients on ECLS, especially with Subclavian/Axillary cannulation.

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National trends show rapid increases in the use of mechanical circulatory support devices (MCSD) over the last 20 years. While current literature has not proven a mortality benefit in cardiogenic shock as a complication of acute myocardial infarction (AMI-CS) with percutaneous MCSD, these devices are vital to maximizing cardiopulmonary parameters for definitive therapy. To minimize complications, many different techniques have been described including a novel off-pump direct apical cannulation for venoarterial-extracorporeal membrane oxygenation (VA-ECMO). This technique allows early ambulation and avoids peripheral artery access complications but has only been described in small case series. Our case series represents the largest summary of patients (50) using this technique and contains the only comparison data to date. Fifty-four percentage of our patients were Society for Cardiovascular Angiography and Interventions (SCAI) stage D and 22% were arrested before cannulation. We achieved flows on average >5 L/min and most patients required biventricular drainage (86%) and an oxygenator (92%). Thirty day survival was 56% and most survivors were bridged to heart transplant (30%). Our most common complication was bleeding (16%). This technique showed significant improvement in ejection fraction (EF), cardiac output/index (CO/CI), and pulmonary artery pressures. This case series demonstrates the safety and efficacy of this novel technique for central cannulation in cardiogenic shock at large scale within a single institution.

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ABSTRACT: The potential benefits of epidural anesthesia on mortality, atrial fibrillation, and pulmonary complications must be weighed against the risk of epidural hematoma associated with intraoperative heparinization. This study aims to provide an updated assessment of the clinical risks of epidural anesthesia in cardiac surgery, focusing on the occurrence of epidural hematomas and subsequent paralysis. A systematic search of Embase, Medline, Ovid Central, Web of Science, and PubMed was conducted to identify relevant publications between 1966 and 2022. Two independent reviewers assessed the eligibility of the retrieved manuscripts. Studies reporting adult patients undergoing cardiac surgery with epidural catheterization were included. The incidence of hematomas was calculated by dividing the number of hematomas by the total number of patients in the included studies. Risk calculations utilized various denominators based on the rigor of trial designs, and the risks of hematoma and paralysis were compared to other commonly encountered risks. The analysis included a total of 33,089 patients who underwent cardiac surgery with epidural catheterization. No epidural hematomas were reported across all published RCTs, prospective, and retrospective trials. Four case reports associated epidural hematoma with epidural catheterization and perioperative heparinization. The risks of epidural hematoma and subsequent paralysis were estimated at 1:7643 (95% CI 1:3860 to 380,916) and 1:10,190 (95% CI 1:4781 to 0:1), respectively. The risk of hematoma is similar to the non-obstetric population (1:5405; 95% CI 1:4784 to 6134). The risk of hematoma in cardiac surgery patients receiving epidural anesthesia is therefore similar to that observed in some other surgical non-obstetric populations commonly exposed to epidural catheterization.

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OBJECTIVE: Minimally invasive cardiac surgery (MICS) is increasing worldwide. In most cases, the surgical technique includes cannulation of the groin for the establishment of cardiopulmonary bypass, requiring a second surgical incision (SC) for exposure and cannulation of the femoral vessels. With the introduction of arterial closure devices, percutaneous cannulation (PC) of the groin has become a possible alternative. We performed a meta-analysis and systematic review to compare clinical endpoints between the patients who underwent PC and SC for MICS. METHODS: Three databases were assessed. The primary outcome was any access site complication. Secondary outcomes were perioperative mortality, any wound complication, any vascular complication, lymphatic complications, femoral/iliac stenosis, stroke, procedural duration, and hospital length of stay (LOS). A random effects model was performed. RESULTS: A total of 5 studies with 2,038 patients were included. When compared with PC, patients who underwent SC showed a higher incidence of any access site complication (odds ratio [OR] = 3.09, 95% confidence interval [CI]: 1.87 to 5.10, P < 0.01), any wound complication (OR = 10.10, 95% CI: 3.31 to 30.85, P < 0.01), lymphatic complication (OR = 9.37, 95% CI: 2.15 to 40.81, P < 0.01), and longer procedural duration (standardized mean difference = 0.31, 95% CI: 0.12 to 0.51, P < 0.01). There was no significant difference between the 2 groups regarding perioperative mortality, any vascular complication, femoral/iliac stenosis, stroke, or hospital LOS. CONCLUSIONS: The analysis suggests that surgical groin cannulation in MICS is associated with a higher incidence of any access site complication (especially wound complication and lymphatic fistula) and with a longer procedural time compared with PC. There was no difference in perioperative mortality.

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BACKGROUND: When unintentional pancreatic duct access occurs during difficult biliary cannulation, the double guidewire (DGW) or transpancreatic sphincterotomy (TPS) may be utilized. DGW can be easily switched to TPS due to the existing guidewire in the pancreatic duct. However, the efficacy of TPS after DGW, named sequential DGW-TPS technique, versus primary TPS has not been assessed. AIMS: Our aim was to compare the benefits and adverse events of sequential DGW-TPS technique and primary TPS. METHODS: We performed a comparative retrospective cohort study that enrolled a total of 117 patients with native papillae. The patients were divided into one of 2 groups according to the primary bile duct access technique (sequential DGW-TPS or primary TPS), both with pancreatic stenting. RESULTS: Between November 2017 and May 2023, a total of 84 patients were grouped into sequential DGW-TPS and 33 into primary TPS. The overall post-ERCP pancreatitis (PEP) rate was 4.3% in the entire cohort, with no statistical differences were observed between the groups in terms of PEP rates (P = 0.927), PEP severity (P = 1.000), first biliary cannulation success (P = 0.621), overall cannulation success (P = 1.000), hyperamylasemia incidence (P = 0.241), elevated amylase levels (P = 0.881), and postoperative hospital stay (P = 0.185). Furthermore, these results remained consistent in multivariable regression analysis. CONCLUSIONS: The sequential DGW-TPS technique showed a comparable safety and biliary cannulation success rate to primary TPS in difficult biliary cannulation. Given the potential long-term complications associated with TPS, DGW should be first if inadvertent pancreatic access occurs, with TPS serving as second only if DGW fails.

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Background and Objectives: Thoracic epidural catheterization (TEC) can be both uncomfortable and fearful for patients when performed awake with the thought that the procedure may be painful. The aim of this study was to assess the effect of low-dose intravenous ketamine administration on pain and anxiety during the TEC procedure. Materials and Methods: Sixty patients were randomly divided into two groups to receive intravenous (IV) placebo (Group P) and IV low-dose (0.15 mg/kg) ketamine (LDK) (Group K) 3 min before the procedure in a double-blind manner. A visual analog scale (VAS) was used to measure anxiety (VAS-A) and pain (VAS-P) scores. Vital parameters were monitored before premedication (T1), 20 min after premedication (T2), during skin anesthesia (T3), during TEC (T4), and 5 min after TEC (T5). VAS-A values were recorded at T1, T3, T4, and T5 periods, and VAS-P levels were noted at T3, T4, and T5 periods. Results: During TEC (T4), both VAS-P and VAS-A were significantly lower in Group K (p < 0.001). The mean VAS-A value was 10.6 mm lower, and the mean VAS-P value was 9 mm lower in Group K than in Group P at the T4 time point. Additionally, the mean VAS-P value was 7.7 mm lower in Group K compared to Group P at the T3 time point (p < 0.001). Both groups showed a statistically significant difference in VAS-A measurements when compared at their respective time points (p < 0.001). However, only Group P demonstrated a statistically significant difference in VAS-P measurements (p < 0.001). VAS-P values remained stable in Group K. The number of patients who did not recall the procedure was significantly higher in Group K (p < 0.001). Furthermore, the number of patients who would consent to the same procedure in the future was significantly higher in Group K (p = 0.007). Conclusions: A preprocedural LDK (0.15 mg/kg) can effectively prevent anxiety and pain experienced by patients during the TEC procedure. Administration of LDK may provide a more comfortable procedure process without causing ketamine-induced side effects (hemodynamic, respiratory, and psychological).

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Endoscopic Retrograde Cholangiopancreatography (ERCP) is the primary therapeutic procedure for pancreaticobiliary disorders, and studies highlighted the impact of papilla anatomy on its efficacy and safety. Our objective was to quantify the influence of papilla morphology on ERCP outcomes. We systematically searched three medical databases in September 2022, focusing on studies detailing the cannulation process or the rate of adverse events in the context of papilla morphology. The Haraldsson classification served as the primary system for papilla morphology, and a pooled event rate with a 95% confidence interval was calculated as the effect size measure. Out of 17 eligible studies, 14 were included in the quantitative synthesis. In studies using the Haraldsson classification, the rate of difficult cannulation was the lowest in type I papilla (26%), while the highest one was observed in the case of type IV papilla (41%). For post-ERCP pancreatitis, the event rate was the highest in type II papilla (11%) and the lowest in type I and III papilla (6-6%). No significant difference was observed in the cannulation failure and post-ERCP bleeding event rates between the papilla types. In conclusion, certain papilla morphologies are associated with a higher rate of difficult cannulation and post-ERCP pancreatitis.

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RATIONALE & OBJECTIVE: A history of prior abdominal procedures may influence the likelihood of referral for peritoneal dialysis (PD) catheter insertion. To guide clinical decision making in this population, this study examined the association between prior abdominal procedures and outcomes in patients undergoing PD catheter insertion. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Adults undergoing their first PD catheter insertion between November 1, 2011, and November 1, 2020, at 11 institutions in Canada and the United States participating in the International Society for Peritoneal Dialysis North American Catheter Registry. EXPOSURE: Prior abdominal procedure(s) defined as any procedure that enters the peritoneal cavity. OUTCOMES: The primary outcome was time to the first of (1) abandonment of the PD catheter or (2) interruption/termination of PD. Secondary outcomes were rates of emergency room visits, hospitalizations, and procedures. ANALYTICAL APPROACH: Cumulative incidence curves were used to describe the risk over time, and an adjusted Cox proportional hazards model was used to estimate the association between the exposure and primary outcome. Models for count data were used to estimate the associations between the exposure and secondary outcomes. RESULTS: Of 855 patients who met the inclusion criteria, 31% had a history of a prior abdominal procedure and 20% experienced at least 1 PD catheter-related complication that led to the primary outcome. Prior abdominal procedures were not associated with an increased risk of the primary outcome (adjusted HR, 1.12; 95% CI, 0.68-1.84). Upper-abdominal procedures were associated with a higher adjusted hazard of the primary outcome, but there was no dose-response relationship concerning the number of procedures. There was no association between prior abdominal procedures and other secondary outcomes. LIMITATIONS: Observational study and cohort limited to a sample of patients believed to be potential candidates for PD catheter insertion. CONCLUSION: A history of prior abdominal procedure(s) does not appear to influence catheter outcomes following PD catheter insertion. Such a history should not be a contraindication to PD. PLAIN-LANGUAGE SUMMARY: Peritoneal dialysis (PD) is a life-saving therapy for individuals with kidney failure that can be done at home. PD requires the placement of a tube, or catheter, into the abdomen to allow the exchange of dialysis fluid during treatment. There is concern that individuals who have undergone prior abdominal procedures and are referred for a catheter might have scarring that could affect catheter function. In some institutions, they might not even be offered PD therapy as an option. In this study, we found that a history of prior abdominal procedures did not increase the risk of PD catheter complications and should not dissuade patients from choosing PD or providers from recommending it.

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BACKGROUND AND AIMS: Needle-knife papillotomy (NKP) is widely performed when biliary cannulation is difficult during endoscopic retrograde cholangiopancreatography (ERCP). However, its safety and efficacy in different types of duodenal papilla are not clear. PATIENTS AND METHODS: This retrospective study analyzed 217 patients with difficult biliary cannulation who underwent NKP during ERCP procedures from June 2013 to May 2022 in our institution. Patients were classified according to Haraldsson classification type of duodenal papilla: type 1, regular; type 2, small; type 3, protruding or pendulous; and type 4, creased or ridged. Outcome measures were successful biliary cannulation and incidence of adverse events. RESULTS: Haraldsson classification was type 1 in 115 patients, type 2 in 29, type 3 in 52, and type 4 in 21. Biliary cannulation was successful in 166 patients (76.5%) Success rates according to Haraldsson type were as follows: type 1, 74.8%; type 2, 82.8%; type 3, 80.8%; and type 4, 66.7%. The rates did not significantly differ among the types (p = 0.48). Overall incidence of adverse events was 9.22%. Incidence of adverse events did not significantly differ among the types (p = 0.69). CONCLUSIONS: NKP was useful to achieve successful cannulation in patients with difficult biliary cannulation. The rate of successful cannulation and incidence of adverse events were similar among the different types of duodenal papilla.

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STUDY OBJECTIVE: To assess the duration needed for regaining normal bladder voiding function in patients with postoperative bladder dysfunction requiring intermittent self-catheterization after deep endometriosis surgery and identify risk factors that might affect the recovery process. DESIGN: Retrospective study based on data recorded in a large prospective database. SETTING: Endometriosis referral center. PATIENTS: From September 2018 to June 2022, 1900 patients underwent excision of deep endometriosis in our center; 61 patients were discharged with recommendation for intermittent self-catheterization and were thus included in the study. INTERVENTIONS: Intermittent self-catheterization after endometriosis surgery. MEASUREMENTS AND MAIN RESULTS: A total of 43 patients (70.5%) stopped self-catheterization during the follow-up period. Median follow-up was 25 weeks (range, 7-223 wk). Surgery was performed laparoscopically in 48 patients (78.7%) and robotically in 13 (21.3%); 47 patients (77%) had nodules involving the digestive tract, 11 (18%) had urinary tract involvement, 29 had parametrial nodules (47.5%), and 13 (21.3%) had sacral plexus involvement. The probability of bladder voiding function recovery and arrest of self-catheterization was 24.5%, 54%, 59%, 72%, and 77% at 4, 8, 12, 52, and 78 weeks, respectively. Cox's multivariate model identified preoperative bladder dysfunction as the only statistically significant independent predictor for arrest of self-catheterization (hazard ratio, 0.36; 95% confidence interval, 0.15-0.83). CONCLUSION: Patients requiring intermittent self-catheterization for bladder dysfunction after deep endometriosis excision may spontaneously recover bladder function in 77% of cases. Symptoms suggesting preoperative bladder voiding dysfunction should be reviewed before planning surgery, and patients should be informed of the higher postoperative risk of long-term bladder voiding dysfunction.

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INTRODUCTION: Endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic sphincterotomy (EST) are essential skills for performing endoscopic cholangiopancreatic procedures. However, these procedures have a high incidence of adverse events, and current training predominantly relies on patient-based approaches. Herein, we aimed to develop an ERCP/EST simulator model to address the need for safer training alternatives, especially for learners with limited ERCP experience. METHODS: The model was designed to facilitate the use of actual endoscopic devices, supporting learning objectives that align with the components of the validated Bethesda ERCP Skill Assessment Tool (BESAT). BESAT focuses on skills, such as papillary alignment, maintenance of duodenoscope position, gentle and efficient cannulation, controlled sphincterotomy in the correct trajectory, and guidewire manipulation. Thirty gastroenterology trainees used the simulator between May 2022 and March 2023, and their satisfaction was assessed using a visual analog scale (VAS) and pre- and post-training questionnaires. RESULTS: The novel simulator model comprised a disposable duodenal papillary section, suitable for incision with an electrosurgical knife, alongside washable upper gastrointestinal tract and bile duct sections for repeated use. The duodenal papillary section enabled reproduction of a realistic endoscope position and the adverse bleeding events due to improper incisions. The bile duct section allowed for the reproduction of fluoroscopic-like images, enabling learners to practice guidewire guidance and insertion of other devices. Following training, the median VAS score reflecting the expectation for model learning significantly increased from 69.5 (interquartile range [IQR]: 55.5-76.5) to 85.5 (IQR: 78.0-92.0) (p < 0.01). All participants expressed a desire for repeated simulator training sessions. CONCLUSIONS: This innovative simulator could serve as a practical educational tool, particularly beneficial for novices in ERCP. It could facilitate hands-on practice with actual devices, enhancing procedural fluency and understanding of precise incisions to minimize the risk of bleeding complications during EST.

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INTRODUCTION: PD catheter tip migration is a common complication and a significant cause of catheter malfunction. In this perspective, we present our experience with a new catheter and a new technique that involves the use of a new triple cuff PD catheter and a low entry site in an attempt to prevent PD catheter migration. METHODS: A total of 503 incident PD patients have been studied in more than one PD center over a period of 5 years. RESULTS: During the 5-year follow up we recorded zero percent catheter migration. Other technical complications were poor drainage in 3.4%, omental wrap in 2.8%, early leakage in 3.4%, and catheter replacement in 2.4%. By the end of the study, the one-year PD catheter survival was 97.6%. CONCLUSION: Our new triple cuff PD catheter and our low-entry approach seem to be effective in preventing PD catheter migration and minimizing other mechanical complications.

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INTRODUCTION: Umbilical vein catheterization (UVC) can cause portal venous thrombosis, leading to the development of extrahepatic portal venous obstruction (EHPVO) and portal hypertension (PHT). The feasibility of the Meso-Rex bypass (MRB) for the treatment of EHPVO in patients with a history of UVC has been questioned. We compared the feasibility of performing an MRB in patients with or without a history of previous UVC. METHODS: A retrospective review of patients with EHPVO and known UVC status explored for a possible MRB at our institution was performed (1997-2022). Patients were categorized in two groups: with (UVC(+)) or without (UVC(-)) a history of UVC for comparison. A p-value less than 0.05 was considered significant. RESULTS: One hundred and eighty-seven patients were included (n = 57 in UVC(+); n = 130 in UVC(-)). Patients in the UVC group were significantly younger at surgery and the incidence of prematurity was higher. Other risk factors for the development of EHPVO were similar between the groups, but only history of UVC could predict the ability to receive MRB (odds ratio [OR]: 7.4 [3.5-15.4]; p < 0.001). The success rate of MRB was significantly higher in patients with no history of UVC (28/57 [49.1%] in UVC(+) vs. 114/130 [87.7%] in UVC(-); p < 0.001). However, MRB patency at discharge (25/28 [89.3%] in UVC(+) vs. 106/114 [94.7%] in UVC(-); p = 0.3) was equally high in both groups. CONCLUSION: Our results indicate that a history of UVC is not a contraindication to MRB. Half of the patients were able to successfully receive an MRB. Patients with symptomatic PHT from EHPVO should not be excluded from consideration for MRB based on UVC history.

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Airway balloons are widely used by otolaryngologists to treat laryngotracheal stenosis. We review an adverse event and interventions that may prevent similar occurrences. There are no other reports of similar incidents in the Food and Drug Administration Manufacturer and User Facility Device Experience. We implore Acclarent to redesign their airway balloon device to prevent accidental airway irrigation.

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Venovenous extracorporeal membrane oxygenation (VV-ECMO) is a life-saving therapy for critically ill patients, but it carries an increased risk of thrombosis due to blood interacting with non-physiological surfaces. While the relationship between clinical variables and thrombosis remains unclear, our study aimed to identify which factors are most predictive of thrombosis. The Extracorporeal Life Support Organization Registry was queried to obtain a cohort of VV-ECMO patients aged 18 years and older from 2015 to 2019. Patients who were over 80-years-old, at the extremes of weight, who received less than 24 h of ECMO, multiple rounds of ECMO, or had missing data were excluded. Multivariate logistic regression modeling was used to assess predictors of thrombosis and mortality. A total of 9809 patients were included in the analysis, with a mean age of 47.1 ± 15.1 years and an average ECMO run time of 305 ± 353 h. Thrombosis occurred in 19.9% of the cohort, with circuit thrombosis (8.6%) and membrane lung failure (6.1%) being the most common. Multivariate analysis showed that ECMO runs over 14 days (OR: 2.62, P < 0.001) and pregnancy-related complications (OR: 1.79, P = 0.004) were associated with an increased risk of thrombosis. Risk factors for circuit thrombosis included incremental unit increases in the pump flow rate at 24 h (OR: 1.07 [1.00-1.14], P = 0.044) and specific cannulation sites. Increased body weight (OR: 1.02 [1.00-1.04], P = 0.026) and increased duration on ECMO (OR: 3.82 [3.12-4.71], P < 0.001) were predictive of membrane lung failure. Additionally, patients with thrombosis were at increased likelihood of in-hospital mortality (OR: 1.52, P < 0.001). This study identified multiple thrombotic risk factors in VV-ECMO, suggesting that future studies investigating the impact of pregnancy associated complications and ECMO flow rate on hemostasis would be illuminating.

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AIMS: Current guidelines recommend an early (<24 h) invasive coronary angiography (ICA) strategy in non-ST-segment elevation acute coronary syndrome (NSTE-ACS) patients with Global Registry of Acute Coronary Events (GRACE) score over 140. Evidence for this recommendation is based on older trials. METHODS AND RESULTS: Between 1 February 2016 and 31 July 2021, 1767 patients with a primary diagnosis of NSTE-ACS without indication for urgent ICA underwent ICA during index hospitalization. Six hundred and fifty-five patients underwent early invasive ICA (within 24 h) and 1112 underwent late ICA (between 24 h and 1 week). One hundred and seven patients had a GRACE risk score of 140 or above and 1660 had a GRACE risk score under 140. The primary composite outcome was all-cause mortality, stroke, and recurrent myocardial infarction (MI). Median time from admission to ICA was 13.3 h (IQR 6.0-20.6) for the early group and 59.9 h for the late group (IQR 23.5-96.3). There was no difference between the early and late ICA groups in the primary composite outcome [late catheterization >24 h hazard ratio 1.196, 95% confidence interval (CI) 0.969-1.475, P -value 0.096]. A multivariable Cox regression model for the composite outcome revealed no difference between the early and late ICA groups (late catheterization >24 h hazard ratio 1.0735, 95% CI 0.862-1.327, P -value 0.512) with no effect for performing early ICA in patients with GRACE score over 140 (hazard ratio 1.291, 95% CI 0.910-1.831, P -value 0.151). CONCLUSION: An early ICA strategy in patients with NSTE-ACS patients and GRACE risk score over 140, compared with late ICA, was not associated with improved composite outcome of death, myocardial infarction, and stroke at 1 year.

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