Factors For Major Adverse Events Research Articles

Are there etiology-specific risk factors for adverse outcomes in patients on Impella 5.5 support?

ObjectivesTo identify possible etiology-specific differences in preoperative risk factors for major adverse events during Impella 5.5 support in patients with ischemic (ICM) and nonischemic cardiomyopathy (NICM). MethodsFrom October 2019 to January 2023, 228 Impella 5.5 devices were inserted at our institution. Patients were stratified into ICM (n = 124) and NICM (n = 104) cohorts. The primary outcome was a composite of death/stroke/new-onset dialysis while actively receiving Impella 5.5 support. Random forests identified preoperative factors predictive of the primary outcome separately for each cohort, with ranking by variable importance. ResultsThe primary outcome occurred in 42 (34%) patients with ICM and 35 (34%) patients with NICM. Twenty-one (17%) patients with ICM and 21 (20%) patients with NICM died on Impella 5.5; stroke occurred in 12 (9.7%) patients with ICM and 3 (2.9%) patients with NICM, and new-onset dialysis was initiated in 23 (19%) patients with ICM and 24 (23%) patients with NICM while actively receiving Impella 5.5 support. Risk factors reflecting systemic and myocardial cellular injury, end-organ and cardiopulmonary failure, right ventricular dysfunction, and smaller left ventricular dimensions were most predictive of adverse outcomes in both cohorts. Indications for Impella 5.5 and device strategy (bridge to recovery, advanced therapies, or decision) were not top risk factors in either cohort. ConclusionsRisk factors related to preoperative stability, right ventricular dysfunction, and left ventricular size were more predictive of adverse outcomes while actively receiving Impella 5.5 support than indication or device strategy. These factors could help identify high-risk patients who may benefit from additional tailored management to reduce their risk for these impactful adverse outcomes while on Impella 5.5 support.

Major adverse events in youth-onset type 1 and type 2 diabetes: The SEARCH and TODAY studies

AimsTo determine contemporary incidence rates and risk factors for major adverse events in youth-onset T1D and T2D. MethodsParticipant interviews were conducted once during in-person visits from 2018 to 2019 in SEARCH (T1D: N = 564; T2D: N = 149) and semi-annually from 2014 to 2020 in TODAY (T2D: N = 495). Outcomes were adjudicated using harmonized, predetermined, standardized criteria. ResultsIncidence rates (events per 10,000 person-years) among T1D participants were: 10.9 ophthalmologic; 0 kidney; 11.1 nerve, 3.1 cardiac; 3.1 peripheral vascular; 1.6 cerebrovascular; and 15.6 gastrointestinal events. Among T2D participants, rates were: 40.0 ophthalmologic; 6.2 kidney; 21.2 nerve; 21.2 cardiac; 10.0 peripheral vascular; 5.0 cerebrovascular and 42.8 gastrointestinal events. Despite similar mean diabetes duration, complications were higher in youth with T2D than T1D: 2.5-fold higher for microvascular, 4.0-fold higher for macrovascular, and 2.7-fold higher for gastrointestinal disease. Univariate logistic regression analyses in T1D associated age at diagnosis, female sex, HbA1c and mean arterial pressure (MAP) with microvascular events. In youth-onset T2D, composite microvascular events associated positively with MAP and negatively with BMI, however composite macrovascular events associated solely with MAP. ConclusionsIn youth-onset diabetes, end-organ events were infrequent but did occur before 15 years diabetes duration. Rates were higher and had different risk factors in T2D versus T1D.

Machine learning based major complication prediction for patients undergoing transvenous lead extraction

Abstract Funding Acknowledgements Type of funding sources: None. Background Relative benefits of transvenous lead extraction (TLE) should be weighed against the risks on an individual basis. Observational studies have identified disparate risk factors for major adverse events (MAEs), however there are few available tools to aid the clinician risk-stratifying patients. Purpose The purpose of this study was to develop a machine learning (ML)-based risk stratification system to predict risk of MAEs following transvenous lead extraction (TLE). Methods Multiple ML models were derived from a training cohort of 3555 patients undergoing TLE to pre-procedurally identify patients at high and low risk of major adverse events (procedure-related major complication, including procedure-related death). The ML models were then tested on an independent, reference centre cohort of 1171 patients undergoing TLE. Clinical features were selected based on whether they were available in both datasets without large gaps. For model selection we compared the ML algorithms logistic regression, ridge regression, support vector machines (SVM), gradient boosting classifier and random forest. The best performing of these was then compared to a self-normalising network (SNN). Results In total 3122 cases with the required features were included from the training cohort with 53 MAEs (1.7%), and 998 cases in the test cohort with 24 MAEs (2.4%). SVM identified lead dwell time, left ventricular ejection fraction (LVEF), estimated glomerular filtration rate (eGFR), chronic respiratory disease, local infection, heart failure, sepsis and male gender as predictors of MAEs in order of decreasing importance (see figure). For the training data, the SVM provided a more sensitive result compared with SNN (0.83 vs 0.71) at the cost of specificity (0.63 vs 0.79). For the test data, the SVM identified MAEs in 12 out of 123 (9.8%) "high risk" patients, 10 out of 552 (1.8%) "medium risk" patients, and 2 out of 323 (0.006%) "low risk" patients. Conclusion Machine learning provided good discriminative capabilities for identifying patients in a "high risk" and "low risk" category for MAEs. Abstract Figure. 8 most important predictors of MAEs

Thoracic endovascular aortic repair for symptomatic penetrating aortic ulcers and intramural hematomas is associated with poor outcomes

BackgroundThe natural history of penetrating aortic ulcers (PAUs) and intramural hematomas (IMHs) of the aorta has not been well described. Although repair is warranted for rupture, unremitting chest pain, or growth, no threshold has been established for treating those found incidentally. Thoracic endovascular aortic repair (TEVAR) offers an attractive approach for treating these pathologic entities. However, the periprocedural and postoperative outcomes have not been well defined. MethodsPatients aged ≥18 years identified in the Vascular Quality Initiative database who had undergone TEVAR for PAUs and/or IMHs from January 2011 to February 2020 were included. We identified 1042 patients, of whom 809 had follow-up data available. The patient demographics and comorbidities were analyzed to identify the risk factors for major adverse events (MAEs) and postoperative and late mortality. ResultsThe cohort was 54.8% female, and 69.9% were former smokers, with a mean age of 71.1 years. Comorbidities were prevalent, with 57.8% classified as having American Society of Anesthesiologists class 4. Of the 1042 patients, 89.8% had hypertension, 28.3% chronic obstructive pulmonary disease, 17.9% coronary artery disease, and 12.2% congestive heart failure. Patients were predominately symptomatic (74%), and 44.5% had undergone nonelective repair. The MAE incidence was 17%. The independent predictors of MAEs were a history of coronary artery disease, nonwhite race, emergent procedural indication, ruptured presentation, and deployment of two or more endografts. In-hospital mortality was 4.3%. Of the index hospitalization mortalities, 73% were treatment related. For the 809 patients with follow-up (mean, 25.1 ± 19 months), the all-cause mortality was 10.6%. The predictors of late mortality during follow-up included age >70 years, ruptured presentation, and a history of chronic obstructive pulmonary disease and end-stage renal disease. A subset analysis comparing symptomatic (74%) vs asymptomatic (26%) patients demonstrated that the former were frequently women (58.2% vs 45.3%; P < .001), with a greater incidence of MAEs (20.6% vs 6.9%; P < .001), including higher in-hospital reintervention rates (5.9% vs 1.5%; P = .002) and mortality (5.6% vs 0.7%; log-rank P = .015), and a prolonged length of stay (6.9 vs 3.7 days; P < .0001), despite similar procedural risks. During follow-up, late mortality was greater in the symptomatic cohort (12.2% vs 6.5%; log-rank P = .025), with all treatment-related mortalities limited to the symptomatic group. ConclusionsWe found significantly greater morbidity and mortality in symptomatic patients undergoing repair compared with asymptomatic patients, despite similar baseline characteristics. Asymptomatic patients treated with TEVAR had no treatment-related mortality during follow-up, with the overall prognosis largely dependent on preexisting comorbidities. These findings, in conjunction with increasing evidence highlighting the risk of disease progression and attendant morbidity associated with these aortic entities, suggest a need for natural history studies and definitive guidelines on the elective repair of IMHs and PAUs.

Correction: The effect of prior treatment on clinical outcomes in patients with achalasia undergoing peroral endoscopic myotomy.

Background Peroral endoscopic myotomy (POEM) is a treatment option for patients with previous surgical or endoscopic treatment. We aimed to evaluate the influence of prior treatment on perioperative and follow-up outcomes in patients undergoing POEM. Methods From August 2010 to December 2014, a total of 1384 patients with achalasia underwent POEM at our center. We retrospectively reviewed 849 patients who completed follow-up. Patients with an Eckardt score ≥ 4 after POEM were considered to have a clinical failure. We compared variables between patients with and without prior treatment. We analyzed risk factors for perioperative major adverse events, and clinical reflux and failure during follow-up. Results 245 patients (28.9 %) had undergone prior treatment, and 34 patients (4.0 %) experienced a major adverse event associated with the POEM procedure. During a median follow-up of 23 months (range 1 – 71), clinical reflux occurred in 203 patients (23.9 %) and clinical failure was recorded for 94 patients (11.1 %). Patients with prior treatment had a longer procedure duration (P = 0.001) and longer hospital stay after POEM (P = 0.001). Prior treatment was not an independent risk factor for major adverse events or clinical reflux (odds ratio [OR] 1.19, P = 0.65; OR 1.26, P = 0.19; logistic regression), but it did increase the rate of clinical failure during follow-up (hazard ratio 1.90, P = 0.002; Cox regression). Conclusions POEM was performed safely with a low rate of major adverse events in patients with achalasia who had undergone prior surgical or endoscopic treatment. However, prior treatment increased the risk of clinical failure after POEM.

Risk Factors for Major Adverse Events after Surgical Closure of Ventricular Septal Defect in Patients Less than 1 Year of Age: A Single-Center Retrospective.

ObjectiveTo reveal the risk factors that can lead to a complicated course and an increased morbidity in patients < 1 year old after surgical ventricular septal defect (VSD) closure.MethodsWe reviewed a consecutive series of patients who were admitted to our institution for surgical VSD closure who were under one year of age, between 2015 and 2018. Mechanical ventilation (MV) time > 24 hours, intensive care unit (ICU) stay longer than three days, and hospital stay longer than seven days were defined as “prolonged”. Unplanned reoperation, complete heart block requiring a permanent pacemaker implantation, sudden circulatory arrest, and death were considered as significant major adverse events (MAE).ResultsVSD closure was performed in 185 patients. The median age was five (1-12) months. There was prolonged MV time in 54 (29.2%) patients. Four patients (2.2%) required permanent pacemaker implantation. Hemodynamically significant residual VSD was observed in six (3.2%) patients. Extracorporeal membrane oxygenation-cardiopulmonary resuscitation was performed in one (0.5%) patient. Small age (< 4 months) (P-value<0.001) and prolonged cardiopulmonary bypass time (P=0.03) were found to delay extubation and to prolong MV time. Low birth weight at the operation was associated with MAE (P=0.03).ConclusionHigher body weight during operation had a reducing effect on the MAE frequency and shortened the MV duration, ICU stay, and hospital stay. As a conclusion, for patients who are scheduled to undergo VSD closure, body weight should be taken into consideration.

The effect of prior treatment on clinical outcomes in patients with achalasia undergoing peroral endoscopic myotomy.

Peroral endoscopic myotomy (POEM) is a treatment option for patients with previous surgical or endoscopic treatment. We aimed to evaluate the influence of prior treatment on perioperative and follow-up outcomes in patients undergoing POEM. From August 2010 to December 2014, a total of 1384 patients with achalasia underwent POEM at our center. We retrospectively reviewed 849 patients who completed follow-up. Patients with an Eckardt score ≥ 4 after POEM were considered to have a clinical failure. We compared variables between patients with and without prior treatment. We analyzed risk factors for perioperative major adverse events, and clinical reflux and failure during follow-up. RESULTS: 245 patients (28.9 %) had undergone prior treatment, and 34 patients (4.0 %) experienced a major adverse event associated with the POEM procedure. During a median follow-up of 23 months (range 1 - 71), clinical reflux occurred in 203 patients (23.9 %) and clinical failure was recorded for 94 patients (11.1 %). Patients with prior treatment had a longer procedure duration (P = 0.001) and longer hospital stay after POEM (P = 0.001). Prior treatment was not an independent risk factor for major adverse events or clinical reflux (odds ratio [OR] 1.19, P = 0.65; OR 1.26, P = 0.19; logistic regression), but it did increase the rate of clinical failure during follow-up (hazard ratio 1.90, P = 0.002; Cox regression). POEM was performed safely with a low rate of major adverse events in patients with achalasia who had undergone prior surgical or endoscopic treatment. However, prior treatment increased the risk of clinical failure after POEM.

Predictors of Outcomes After Percutaneous Coronary Intervention in Older Patients Presenting With Non-ST-Elevation Acute Coronary Syndromes: Insights From the VCOR Registry

Background: The benefit of percutaneous coronary intervention (PCI) in elderly patients presenting with non-ST-elevation acute coronary syndromes (NSTEACS) is controversial. Identification of risk factors for major adverse events (MAE) after PCI may help to identify the cohort of older patients most likely to benefit from an invasive management strategy.

Impact of initial aortic diameter and false-lumen area ratio on Type B aortic dissection prognosis.

Medical treatment is the gold standard for uncomplicated acute Type B aortic dissection (ATBAD). Although endovascular treatment could become an alternative therapy, it is unclear which ATBAD patients should undergo endovascular intervention. We aimed to evaluate the outcomes of patients with uncomplicated ATBAD and identify the risk factors for major adverse events. We retrospectively reviewed 134 consecutive patients who underwent initial treatment for uncomplicated ATBAD between 2004 and 2015. Follow-up rate was 98.5%, and the median follow-up period was 47 months. We evaluated the incidence of major adverse events (aortic-related death, aortic surgery and dilated aorta ≥ 55 mm) and identified the predictors of major adverse events using multivariable analysis. In-hospital mortality rate was 0.7% (1/134). During follow-up, 46 patients had major adverse events. The 1-, 3-, and 5-year rates of freedom from major adverse events were 79.8%, 71.4%, and 63.6%, respectively. The independent risk factors for major adverse events were initial aortic diameter ≥40 mm (hazard ratio 3.735, 95% confidence interval 1.888-7.390; P < 0.001) and false-lumen diameter > true-lumen diameter (hazard ratio 3.411, 95% confidence interval 1.491-7.806; P = 0.004). Initial aortic diameter ≥40 mm and false-lumen diameter > true-lumen diameter are predictors of major adverse events after uncomplicated ATBAD. Patients with these risk factors may benefit from early endovascular intervention. UMIN 000025388, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029229.

Morbidity and mortality in children undergoing bronchoscopy for foreign body removal.

Analyze morbidity and mortality among children undergoing bronchoscopy for foreign body removal. Multicenter retrospective review using the American College of Surgeons Pediatric National Surgical Quality Improvement Program from 2014 and 2015. Patients were identified using Current Procedural Terminology code 31635. Demographics, time to surgery, operative times, hospitalization time, and complications were collected. Multivariate logistic regression was used to identify predictive factors for major adverse events. Three hundred thirty-four patients were included (mean age 3.7 years, 59.0% male). Preoperative sepsis syndrome was present in 5.7% of patients and 8.1% had asthma. Of the patients, 5.1% percent of patients had a tracheostomy. Bronchoscopy was performed by an otolaryngologist (65.4%) or a pediatric surgeon (33.1%). Mean operative time was 27.4 minutes, whereas mean total operating room time was 54.6 minutes. Airway foreign bodies were located in 269 patients (80.5%), with 62.5% being located in the mainstem bronchus. Operative time was longer when foreign bodies were in the mainstem bronchus or distal to it. Mean time to surgery from admission was 0 days, and mean duration of hospitalization was 1 day. One patient (0.3%) required reoperation for respiratory reasons, and three (0.9%) required readmission for related reasons. No patients remained hospitalized at 30 days. Two (0.6%) had a postoperative pneumonia, and two (0.6%) required reintubation. One patient death (0.3%) occurred within 2 weeks of bronchoscopy. No significant differences were identified in operative time, time to surgery, or hospitalization time based on age, gender, presence of a tracheostomy, or surgical specialty. Bronchoscopy for identification and removal of airway foreign bodies had minimal morbidity in this group. 2b. Laryngoscope, 128:1226-1229, 2018.

Surgical Repair of Ventricular Septal Defect; Contemporary Results and Risk Factors for a Complicated Course

Surgical closure of the ventricular septal defect is the most commonly performed procedure in pediatric cardiac surgery. There are conflicting data on weight at operation as risk factor for a complicated course. We performed a retrospective evaluation of mortality and morbidity in all patients undergoing surgical ventricular septal defect closure at our institution between 2004 and 2012 to identify risk factor for a complicated course. Multivariate logistic regression modeling was performed to identify risk factors for a complicated course. 243 patients who underwent surgical ventricular septal defect closure were included. Median age at operation was 168.0 days (range 17–6898), the median weight 6.0 kg (range 2.1–102.0). No deaths occurred. Two patients (0.8%) required a pacemaker for permanent heart block. Five patients (2.1%) underwent reoperation for a hemodynamically important residual ventricular septal defect. No other major adverse events occurred. No risk factors for major adverse events could be established. Multivariate analysis identified a genetic syndrome, long bypass time and low weight at operation as independent risk factors for a prolonged intensive care stay (>1 day) and prolonged ventilation time (>6 h). Contemporary results of surgical VSD closure are excellent with no mortality and low morbidity in this series. Although it is associated with increased ventilation time and a longer hospital stay, low bodyweight at operation is not associated with an increased risk of complications or major adverse events in our series.

Safety and postoperative adverse events in pediatric airway reconstruction: Analysis of ACS-NSQIP-P 30-day outcomes.

Prior research has shown that airway reconstructive procedures comprise significant composite morbidity compared to the whole of pediatric otolaryngologic cases evaluated in the American College of Surgeon's National Surgery Quality Improvement Program-Pediatric (ACS-NSQIP-P) platform. We describe postoperative sequelae of pediatric airway reconstructive procedures and identify predictive factors for adverse events. Current procedural terminology (CPT) codes were used to identify children undergoing included procedures in the 2012 to 2014 ACS-NSQIP-P public use files (PUF). Targeted variables included patient demographics and 30-day postoperative events (reoperation, readmission, and complications). Event rates were determined and compared within subgroups. Multivariate logistic regression was performed to identify predictive factors for major adverse events. In 3 years of PUF data (183,283 total cases), 198 cases (0.11%) were airway reconstructive procedures. The most common was laryngoplasty (CPT 31580, 31582; n = 111, 56.1%), followed by cervical tracheoplasty (CPT 31750; n = 47, 23.7%), tracheal resection (CPT 31780; n = 24, 12.1%), and cricoid split (CPT 31587, n = 16, 8.1%). There were 131 premature children (66.2%) and 94 children (47.5%) with history of bronchopulmonary dysplasia. Thirty-day postoperative sequelae included readmissions (n = 42, 21.2%), complications (n = 27, 13.6%), and reoperations (n = 14, 7.1%). On univariate analysis, children less than 3 years of age were more likely to undergo an unplanned reoperation. There were no significant predictive factors for readmission or complication. On multivariate analysis, there was a trend toward higher rates of unplanned reoperations in children less than 3 years of age. The 30-day adverse event rate in pediatric airway surgery is high, with no identifiable predictors noted in the analysis of these data. Findings imply that systematic collection of variables and outcomes specific to pediatric airway surgery, in addition to standard NSQIP workflow, will be essential for NSQIP-P to truly effect quality improvement in these high-risk procedures. 4. Laryngoscope, 2016 127:504-508, 2017.

Outcomes of Open Repair of Mycotic Descending Thoracic and Thoracoabdominal Aortic Aneurysms

The purpose of this study was to evaluate the short- and intermediate-term outcomes of open repair of mycotic thoracic and thoracoabdominal aneurysms. Contemporary surgical and perioperative techniques were utilized. From November 1997 to May 2014, 14 consecutive patients underwent open repair of descending thoracic (n = 9, 64.3%) and thoracoabdominal (n = 5, 35.7%) mycotic aortic aneurysms. All procedures were performed through the left side of the chest. Infected tissue was completely debrided and excised. Aortic continuity was restored in situ with a Dacron prosthesis (Macquet Corp, Oakland, NJ). Soft tissue coverage of the prosthesis was performed when anatomy and patient condition permitted. Perioperative outcomes, intermediate-term survival, and reinfection rates were examined. All patients presented with either aneurysm-related symptoms or a clinical picture of sepsis. Diagnosis was confirmed utilizing computed tomography imaging. Mean age was 66 ± 13 years, 8 patients (57.1%) were male, and mean aneurysm size was 5.9 ± 1.3 cm. All patients were hypertensive, 3 (21.4%) had prior coronary revascularization, 7 (50%) had chronic pulmonary disease, 5 (35.7%) had diabetes mellitus, and 2 (14.3%) had end-stage renal disease requiring dialysis. Twelve patients (85.7%) had aneurysm-related pain, and 9 (64.3%) of them had contained rupture. Mean time from onset of illness to surgery was 36 days (range, 0 to 153). On preoperative blood cultures, 4 (28.6%) grew Staphylococcus aureus, 4 (28.6%) grew gram negative organisms, 2 (14.3%) grew mycobacterium, and 4 cultures (28.6%) had negative results. Empiric broad-spectrum antibiotics were initiated on all patients and adjusted based on final cultures. A majority of patients underwent repair utilizing a clamp-and-sew technique (n = 10, 71.4%); the remainder (n = 4, 28.6%) required repair under profound hypothermic circulatory arrest. After radical debridement of the infected tissue, grafts were placed in the normal anatomic position; 6 (42.9%) patients had additional soft tissue coverage, 5 (35.7%) utilizing an omental flap and 1 (7.1%), a serratus muscle flap. There was 1 in-hospital death (7.1%) secondary to ischemic bowel. Four patients (28.6%) required tracheostomy, and 1 (7.1%) had recurrent nerve injury. None of the patients incurred spinal cord injury, stroke, or new onset renal failure requiring dialysis. After surgery, all patients were given 6 weeks of intravenous antibiotics. Lifelong suppression therapy was maintained with oral antibiotics. There were no episodes of prosthetic graft infection on follow-up. Univariate analysis revealed that New York Heart Association functional class, diabetes, and preoperative renal dysfunction were preoperative risk factors for major adverse events. Mean follow-up time was 26.5 months (median 8.2; range, 1 to 142). Actuarial 5-year survival was 71%. Open repair of mycotic descending thoracic and thoracoabdominal aortic aneurysms remains the gold standard of therapy. Aggressive intraoperative debridement with in situ prosthetic reconstruction permits a high rate of success in this very high risk cohort of patients. Lifelong antibiotic suppression therapy may prevent late prosthetic graft infection.

Risk factors for major adverse events late after Fontan palliation.

Risk factors for major adverse events late after Fontan palliation are unknown. Prior studies have suggested ventricular function and morphology as important risk factors. The aim of this study is to (1) characterize the late major adverse event profile in adult Fontan patients and (2) identify additional risk factors that may contribute to adverse outcomes. A retrospective review of all adult patients >15 years post-Fontan seen at a tertiary academic center was conducted. Clinical, laboratory, cardiac data, and abdominal imaging were collected via chart review. Major adverse events (death, cardiac transplantation, or listing) were identified, and timing of events was plotted using Kaplan-Meier methods. Univariate and multivariate logistic regression was used to determine independent predictors of late-term events. A total of 123 adult Fontan patients were identified (mean time post-Fontan 22.4 years [±4.4]). Major adverse events occurred in 19/123 patients (15%). In this 15-year survivor cohort, transplant-free survival rates were 94.6%, 82.9%, and 59.8% at 20, 25, and 30 years postoperation, respectively. Modes of death were Fontan failure with preserved function (4), congestive heart failure with decreased function (2), sudden death (2), thromboembolic event (1), post-Fontan conversion (2), and posttransplant (2). No differences in adverse outcomes were found based on morphology of the systemic ventricle, Fontan type, or systolic ventricular function. On the other hand, features of portal hypertension (OR 19.0, CI 4.7-77.3, P < .0001), presence of a pacemaker (OR 13.4, CI 2.6-69.8, P = .002), and systemic oxygen desaturation (OR 0.86, CI 0.75-0.98, P = .02) were risk factors for major adverse events in the multivariate analysis. In adult Fontan patients surviving >15 years post-Fontan, portal hypertension, oxygen desaturation, and need for pacemaker were predictive of adverse events. Traditional measures may not predict late-term outcomes in adult survivors; further study of the liver's role in late outcomes is warranted.

Cognitive Complexity of the Medical Record Is a Risk Factor for Major Adverse Events

Patients in tertiary care hospitals are more complex than in the past, but the implications of this are poorly understood as "patient complexity" has been difficult to quantify. We developed a tool, the Complexity Ruler, to quantify the amount of data (as bits) in the patient’s medical record. We designated the amount of data in the medical record as the cognitive complexity of the medical record (CCMR). We hypothesized that CCMR is a useful surrogate for true patient complexity and that higher CCMR correlates with risk of major adverse events. The Complexity Ruler was validated by comparing the measured CCMR with physician rankings of patient complexity on specific inpatient services. It was tested in a case-control model of all patients with major adverse events at a tertiary care pediatric hospital from 2005 to 2006. The main outcome measure was an externally reported major adverse event. We measured CCMR for 24 hours before the event, and we estimated lifetime CCMR. Above empirically derived cutoffs, 24-hour and lifetime CCMR were risk factors for major adverse events (odds ratios, 5.3 and 6.5, respectively). In a multivariate analysis, CCMR alone was essentially as predictive of risk as a model that started with 30-plus clinical factors. CCMR correlates with physician assessment of complexity and risk of adverse events. We hypothesize that increased CCMR increases the risk of physician cognitive overload. An automated version of the Complexity Ruler could allow identification of at-risk patients in real time.

Risk factors for major adverse events of video-assisted thoracic surgery lobectomy for lung cancer.

Aims: The purpose of this study was to identify the risk factors for major adverse events of VATS (Video-Assisted Thoracic Surgery) lobectomy for primary lung cancer.Methods: 1806 Patients (1032 males, 57.1%) planned to undergo VATS lobectomy for stage IA-IIIA lung cancer from July 2007 to June 2012. The Thoracic Morbidity and Mortality Classification TM&M system was used to evaluate the presence and severity of complications. Postoperative complications were observed during a 30-day follow up. Univariate and multivariate analysis were used to analyze the independent risk factors for major adverse events.Results: Successful rate of VATS lobectomy was 97.6% (1763/1806). Major complications occurred in 129 patients (7.3%), with a mortality of 0.3% (5/1763). Pulmonary complications contribute up to 90.7% of the major complications and 80% of mortality. Logistic regression indicated that comorbidities, elder age ≥70y, operative time ≥240min and hybrid VATS were predictors for major adverse events (P<0.05). Hybrid and converted VATS lobectomy result in higher major adverse events compared with complete VATS, 15.1%, 20.9% and 7.4% respectively (P=0.013).Conclusions: The overall complication rate and mortality of VATS lobectomy are low, while major complications sometimes occur. Pulmonary complications are the most common major complications and cause of mortality. Age ≥70y, comorbidities, operative time ≥240min and Hybrid VATS are predictors of major adverse events.

Risk factors to predict the incidence of surgical adverse events following open or laparoscopic surgery for apparent early stage endometrial cancer: Results from a randomised controlled trial

AimsTo identify risk factors for major adverse events (AEs) and to develop a nomogram to predict the probability of such AEs in patients who have surgery for apparent early stage endometrial cancer. MethodsWe used data from 753 patients who were randomised to either total laparoscopic hysterectomy or total abdominal hysterectomy in the LACE trial. Serious adverse events that prolonged hospital stay or postoperative adverse events (using common terminology criteria 3+, CTCAE V3) were considered major AEs. We analysed pre-surgical characteristics that were associated with the risk of developing major AEs by multivariate logistic regression. We identified a parsimonious model by backward stepwise logistic regression. The six most significant or clinically important variables were included in the nomogram to predict the risk of major AEs within 6weeks of surgery and the nomogram was internally validated. ResultsOverall, 132 (17.5%) patients had at least one major AE. An open surgical approach (laparotomy), higher Charlson’s medical co-morbidities score, moderately differentiated tumours on curettings, higher baseline Eastern Cooperative Oncology Group (ECOG) score, higher body mass index and low haemoglobin levels were associated with AE and were used in the nomogram. The bootstrap corrected concordance index of the nomogram was 0.63 and it showed good calibration. ConclusionsSix pre-surgical factors independently predicted the risk of major AEs. This research might form the basis to develop risk reduction strategies to minimise the risk of AEs among patients undergoing surgery for apparent early stage endometrial cancer.