Prospective validation of a risk score to predict pacemaker implantation after transcatheter aortic valve replacement.

INTRODUCTION: The need for pacemaker is a common complication after transcatheter aortic valve replacement (TAVR). We previously described the Emory Risk Score (ERS) to predict the need for new pacemaker implant (PPM) after TAVR. Metrics included in the score are a history of syncope, pre-existing RBBB, QRS duration ≥140 ms, and prosthesis oversizing ≥16%. To prospectively validate the previously described risk score. METHODS: We prospectively evaluated all patients without pre-existing pacemakers, ICD, or pre-existing indications for pacing undergoing TAVR with the Edwards SAPIEN 3 prosthesis at our institution from March 2019 to December 2020 (n = 661). Patients were scored prospectively; however, results were blinded from clinical decision-making. The primary endpoint was PPM at 30 days after TAVR. Performance of the ERS was evaluated using logistic regression, a calibration curve to prior performance, and receiver operating characteristic (ROC) analysis. RESULTS: A total of 48 patients (7.3%) had PPM after TAVR. A higher ERS predicted an increased likelihood of PPM (OR 2.61, 95% CI: 2.05-3.25 per point, p < 0.001). There was good correlation between observed and expected values on the calibration curve (slope = 1.04, calibration at large = 0.001). The area under the ROC curve was 0.81 (95% CI [0.74-0.88], p < 0.001). CONCLUSIONS: The ERS prospectively predicted the need for PPM in a serial, real-world cohort of patients undergoing TAVR with a balloon-expandable prosthesis, confirming findings previously described in retrospective cohorts. Notably, the prospective performance of the score was comparable with that of the initial cohorts. The risk score could serve as a framework for preprocedural risk stratification for PPM after TAVR.

EAES rapid guideline: updated systematic review, network meta-analysis, CINeMA and GRADE assessment, and evidence-informed European recommendations on the management of common bile duct stones.

BACKGROUND: Choledocholithiasis presents in a considerable proportion of patients with gallbladder disease. There are several management options, including preoperative or intraoperative endoscopic cholangiopancreatography (ERCP), and laparoscopic common bile duct exploration (LCBDE). OBJECTIVE: To develop evidence-informed, interdisciplinary, European recommendations on the management of common bile duct stones in the context of intact gallbladder with a clinical decision to intervene to both the gallbladder and the common bile duct stones. METHODS: We updated a systematic review and network meta-analysis of LCBDE, preoperative, intraoperative, and postoperative ERCP. We formed evidence summaries using the GRADE and the CINeMA methodology, and a panel of general surgeons, gastroenterologists, and a patient representative contributed to the development of a GRADE evidence-to-decision framework to select among multiple interventions. RESULTS: The panel reached unanimous consensus on the first Delphi round. We suggest LCBDE over preoperative, intraoperative, or postoperative ERCP, when surgical experience and expertise are available; intraoperative ERCP over LCBDE, preoperative or postoperative ERCP, when this is logistically feasible in a given healthcare setting; and preoperative ERCP over LCBDE or postoperative ERCP, when intraoperative ERCP is not feasible and there is insufficient experience or expertise with LCBDE (weak recommendation). The evidence summaries and decision aids are available on the platform MAGICapp ( https://app.magicapp.org/#/guideline/nJ5zyL ). CONCLUSION: We developed a rapid guideline on the management of common bile duct stones in line with latest methodological standards. It can be used by healthcare professionals and other stakeholders to inform clinical and policy decisions. GUIDELINE REGISTRATION NUMBER: IPGRP-2022CN170.

Outcomes of Micra leadless pacemaker implantation with uninterrupted anticoagulation.

BACKGROUND: Implantation of the MICRA Leadless pacemaker requires the use of a 27 French introducer, blunt delivery system and device fixation to the myocardium via nitinol tines. While prior studies have proven its safety, it is unclear whether performing this procedure with uninterrupted anticoagulation exposes patients to increased risks. We sought to investigate the feasibility and safety of continuing therapeutic anticoagulation during the periprocedural period. METHODS: We evaluated all patients undergoing MICRA placement at our institution between April 2014 and August 2018 with complete follow-up data (n = 170). Patients were stratified into two groups: those on active anticoagulation (OAC, n = 26), defined as having an International normalized ratio >2.0 or having continued a direct oral anticoagulant, and those not anticoagulated (Off-OAC, n = 144). We evaluated for a composite outcome of all major complications, including access site complications and pericardial effusion. RESULTS: OAC and Off-OAC groups had similar mean age (74 ± 13 vs 75 ± 13 years; P = .914). The OAC group had a nonsignificantly lower prevalence of end-stage renal disease (8% vs 17%; P = .375) and aspirin use (27% vs 47%; P = .131). Those in the OAC group were more likely to be on warfarin than those in the Off-OAC group (81% vs 30%; P < .001). The rate of the composite endpoint was similar between the OAC and Off-OAC groups (3.8 % vs 1.4%, respectively; P = .761). Length of stay was similar between groups (1.3 ± 2.6 vs 2.3 ± 3.4 days; P = 0.108). CONCLUSION: Continuation of therapeutic anticoagulation during MICRA implantation appears to be feasible, safe and associated with shorter hospitalization among appropriately selected individuals.

Predictors of appendiceal perforation in an equal access system.

BACKGROUND: Discrepancies in socioeconomic factors have been associated with higher rates of perforated appendicitis. As an equal-access health care system theoretically removes these barriers, we aimed to determine if remaining differences in demographics, education, and pay result in disparate outcomes in the rate of perforated appendicitis. MATERIALS AND METHODS: All patients undergoing appendectomy for acute appendicitis (November 2004-October 2009) at a tertiary care equal access institution were categorized by demographics and perioperative data. Rank of the sponsor was used as a surrogate for economic status. A multivariate logistic regression model was performed to determine patient and clinical characteristics associated with perforated appendicitis. RESULTS: A total of 680 patients (mean age 30±16 y; 37% female) were included. The majority were Caucasian (56.4% [n=384]; African Americans 5.6% [n=38]; Asians 1.9% [n=13]; and other 48.9% [n=245]) and enlisted (87.2%). Overall, 6.4% presented with perforation, with rates of 6.6%, 5.8%, and 6.7% (P=0.96) for officers, enlisted soldiers, and contractors, respectively. There was no difference in perforation when stratified by junior or senior status for either officers or enlisted (9.3% junior versus 4.40% senior officers, P=0.273; 6.60% junior versus 5.50% senior enlisted, P=0.369). On multivariate analysis, parameters such as leukocytosis and temperature, as well as race and rank were not associated with perforation (P=0.7). Only age had a correlation, with individuals aged 66-75 y having higher perforation rates (odds ratio, 1.04; 95% confidence interval, 1.02-1.05; P<0.001). CONCLUSIONS: In an equal-access health care system, older age, not socioeconomic factors, correlated with increased appendiceal perforation rates.

Factors associated with the occurrence and treatment of supraventricular tachycardia in a pediatric congenital heart disease cohort.

In patients with congenital heart disease (CHD), the association between supraventricular tachycardia (SVT), type of pathophysiology, and therapeutic interventions in a population-based cohort warrants further examination. A retrospective, longitudinal 15-year data set (1996-2010) was analyzed. Inclusion criteria included age ≤17 years, enrolled in South Carolina State Medicaid, and diagnosed as having one or more CHDs as well as SVT. SVT was diagnosed in 6.5 % of CHD patients (N = 1,169) during the 15-year epoch investigated. SVT was less likely to occur in African-American (hazard ratio [HR] = 0.76) or male patients (HR = 0.88), but it was significantly more likely to occur in patients age ≤12 months or in adolescents ≥13 years in those undergoing multiple surgeries/medical interventions for their CHD (HR = 1.14), those receiving antiarrhythmic/diuretic/preload-/afterload-reducing medications (HR = 5.46), and those with severe/cyanotic CHDs (HR = 1.52) or chromosomal abnormalities (HR = 1.64). Children who had an atrial septal defect secundum (adjusted odds ratio [aOR] = 3.03) and those treated with diuretic or antiarrhythmic medication (aOR = 1.80) were significantly more likely to undergo SVT ablation, whereas those with late-onset pulmonary hypertension (ages 6-12 years old) were significantly less likely to undergo SVT ablation. SVT recurred in only 14 of 166 patients who underwent SVT ablation. Multiple medical interventions at an early age may increase the risk of SVT occurrence in young CHD patients regardless of the severity/complexity of the CHD.

Electrocardiographic predictors of atrial mechanical sensing in leadless pacemakers.

BACKGROUND: Leadless pacemakers (LPs) capable of VDD pacing allow for atrioventricular synchrony through mechanical sensing of atrial contraction. However, mechanical sensing is less reliable and less predictable than electrical sensing. OBJECTIVE: The purpose of this study was to evaluate P-wave amplitude during sinus rhythm from preoperative 12-lead electrocardiograms (ECGs) as a predictor for atrial mechanical sensing in patients undergoing VDD LP implantation. METHODS: Consecutive patients undergoing VDD LP implantation were included in this 2-center prospective cohort study. ECG parameters were evaluated separately and in combination for association with the signal amplitude of atrial mechanical contraction (A4). RESULTS: Eighty patients (median age 82 years; female 55%; mean body mass index [BMI] 25.8 kg/m2) were included in the study and 61 patients in the A4 signal analysis (19 patients in VVI mode during follow-up). Absolute (aVL, aVF, V1, V2) and BMI-adjusted (I, II, aVL, aVF, aVR, V1, V2) P-wave amplitudes from baseline ECGs demonstrated a statistically significant positive correlation with A4 signal amplitude (all P <.05). A combined P-wave signal amplitude of at least 0.2 mV in V1 and aVL was predictive, with specificity of 83% (95% confidence interval 67%-100%) for A4 signal ≥1 m/s2. We found a significant correlation of A4 signal amplitude and overall atrioventricular synchrony (P = .013). CONCLUSION: P-wave amplitudes in ECG leads aVL and V1 can predict A4 signal amplitude in patients with VDD LP and therefore the probability of successful AV synchronous pacing.

Population-based treated prevalence of congenital heart disease in a pediatric cohort.

Extant epidemiologic results for pediatric congenital heart disease (CHD) are dated. Given the degree of variability in previous prevalence estimates and the rapid changes in pediatric cardiology diagnostic and treatment procedures, a reexamination of these rates represents a potentially important update in this area of inquiry. This report characterizes the prevalence rates of children with CHD in one state's treated pediatric population by type of lesion and in comparison with published rates from previous studies. Two 15-year data sets (1996-2010) are analyzed. The inclusion criteria for the study required the participants to be 17 years or younger, enrollees in the South Carolina State Medicaid or State Health Plan, and recipients of a CHD diagnosis on one or more service visits to a pediatrician or pediatric cardiologist. A 15-year accrued prevalence rate for pediatric CHD of 16.7 per 1,000 was found among 1,145,364 unduplicated children served. The annual incidence rates varied from 6.3 to 8.6 per 1,000, with an initial downward trend from 1996 to 2002 followed by an upward trend from 2003 to 2008. A higher prevalence of atrioventricular canal/endocardial cushion defects, common/single ventricle, double-outlet right ventricle, tetralogy of Fallot, and truncus arteriosus and a lower prevalence of dextro-transposition of the great arteries were diagnosed in South Carolina than in other states and countries according to published results. The study results underscore the need for periodic updating of prevalence data for pediatric CHD, both in total and for specific lesions, to anticipate and provide more specialized care to young patients with CHD, especially in the more rare and complex cases.

Prevalence of treatment, risk factors, and management of atrial septal defects in a pediatric Medicaid cohort.

Atrial septal defects (ASDs) vary greatly depending on their size, age at closure, and clinical management. This report characterizes the prevalence, complexity, and clinical management of these lesions in a statewide pediatric cohort and examines predictors for receiving closures. A 15-year Medicaid data set (1996-2010) from one state was analyzed. The selection criteria specified patients 17 years of age or younger with a diagnosis of ASD primum, secundum, or sinus venosus on one or more service visits to a pediatrician or pediatric cardiologist. During the 15-year period, ASDs represented a prevalence rate for treatment of 0.47/1000 CHDs identified, with 61 % presenting as complex lesions. Concomitant cardiac anomalies that might have a negative impact on prognosis were present including patent ductus arteriosus (26.1 %), pulmonary hypertension (3.8 %), and supraventricular tachycardia (2.4 %). Pharmacologic treatments, predominantly diuretics, were prescribed for 21 % of the cohort. Both surgical closures (6.3 %) and transcatheter closures (1.4 %) were used for ASD secundum cases, whereas surgical closures predominated for ASD primum (25.6 %) and sinus venosus (13.5 %) lesions. The postoperative follow-up period was two to three times longer for children with ASD primum or sinus venosus than for those with ASD secundum (average, ~1 year). Factors predicting the likelihood of having ASD closure were older age, having a concomitant patent ductus arteriosus (PDA) repair, treatment with ibuprofen, having two or more concomitant CHDs, and receiving diuretics or preload/afterload-reducing agents. Care of ASDs in routine practice settings involves more complications and appears to be more conservative than portrayed in previous investigations of isolated ASDs.

Individual risk factors and complexity associated with congenital heart disease in a pediatric medicaid cohort.

OBJECTIVES: To determine the sex and race differences associated with specific congenital heart diseases (CHDs) and the patterns of concomitant conditions associated with eight severe, complex lesions. METHODS: A 15-year Medicaid dataset (1996-2010) from one state was analyzed for 14,496 patients aged 17 years and younger and diagnosed as having a CHD on one or more service visits to a pediatrician or pediatric cardiologist. RESULTS: Controlling for all other diagnosed CHDs, boys were more likely to be diagnosed as having transposition of the great arteries, hypoplastic left heart syndrome, aortic stenosis, and coarctation of the aorta, whereas African Americans were more likely to be diagnosed as having tricuspid regurgitation, atrial septal defect sinus venosus, coronary artery anomaly, and pulmonary stenosis. Ventricular septal defects, atrial septal defects secundum, patent ductus arteriosus, and pulmonary stenosis were the most prevalent isolated CHDs, whereas tetralogy of Fallot, atrioventricular canal/endocardial cushion defect, common/single ventricle, double outlet right ventricle, and transposition of the great arteries were the most prevalent severe, complex lesions. The complexity of some severe cardiac anomalies appears to be increasing over time. CONCLUSIONS: Changes over time in pediatric CHD caseload mix may affect care management and result in prognosis or outcome differences. These changes present important opportunities for pediatricians and pediatric cardiologists to collaborate, especially in the care of the most severe anomalies.

Not all traumatic brain injury patients on preinjury anticoagulation are the same.

BACKGROUND: Prognostic significance of different anticoagulants in TBI patients remains unanswered. We aimed to compare effects of different anticoagulants on outcomes of TBI patients. METHODS: A secondary analysis of AAST BIG MIT. Blunt TBI patients ≥50 years using anticoagulants presenting ICH were identified. Outcomes were progression of ICH and need for neurosurgical intervention (NSI). RESULTS: 393 patients were identified. Mean age was 74 and most common anticoagulant was aspirin (30%), followed by Plavix (28%), and coumadin (20%). 20% had progression of ICH and 10% underwent NSI. On multivariate regression for ICH progression, warfarin, SDH, IPH, SAH, alcohol intoxication and neurologic exam deterioration were associated with increased odds. Warfarin, abnormal neurologic exam on presentation, and SDH were independent predictors of NSI. CONCLUSIONS: Our findings reflect a dynamic interaction between type of anticoagulants, bleeding pattern & outcomes. Future modifications of BIG may need to take the type of anticoagulant into consideration.

Resuscitative endovascular balloon occlusion of the aorta: simulation improves performance but may require interval training to prevent skill degradation.

PURPOSE: Surgical trainees are exposed to less procedures with increasing need for simulation. Resuscitative endovascular balloon occlusion of the aorta (REBOA) has become increasingly implemented for hemorrhage control, yet most courses are catered to faculty level with little data on trainees. We propose that routine training in this critical procedure will improve trainee performance over time. METHODS: This is a prospective, observational study at a level I trauma center involving a monthly trauma procedural program. Early in the month, trainees received hands-on REBOA training; at the end, trainees underwent standardized, class-based evaluation on a perfused trainer. Score percentages were recorded (0-100%). Endpoints included early, mid and late performance (2-12 months). Paired T-test and Pearson's coefficient were used to evaluate differences and strength of association between time between training and performance. RESULTS: 25 trainees participated with 5 and 11 repeat learners in the PGY-2 and PGY-3 classes, respectively. Median early performance score was 62.5% (IQR 56-81) for PGY-2s and 91.6% (IQR 75-100) in PGY-3s. Pearson's coefficient between time between and training and score demonstrated a weak correlation in the PGY-2s (r2 = - 0.13), but was more pronounced in the PGY-3s (r2 = - 0.44) with an inflection point at 5 months. CONCLUSIONS: Routine REBOA training in trainees is associated with improvement in performance within a short period of time. Skill degradation was most pronounced in trainees who did not receive training for more than 5 months. Trainees can be successfully trained in REBOA; however, this should be done at shorter intervals to prevent skill degradation.

Validating the Brain Injury Guidelines: Results of an American Association for the Surgery of Trauma prospective multi-institutional trial.

INTRODUCTION: Brain Injury Guidelines (BIG) was developed to effectively use health care resources including repeat head computed tomography (RHCT) scan and neurosurgical consultation in traumatic brain injury (TBI) patients. The aim of this study was to prospectively validate BIG at a multi-institutional level. METHODS: This is a prospective, observational, multi-institutional trial across nine Levels I and II trauma centers. Adult (16 years or older) blunt TBI patients with a positive initial head computed tomography (CT) scan were identified and categorized into BIG 1, 2, and 3 based on their neurologic examination, alcohol intoxication, antiplatelet/anticoagulant use, and head CT scan findings. The primary outcome was neurosurgical intervention. The secondary outcomes were neurologic worsening, RHCT progression, postdischarge emergency department visit, and 30-day readmission. RESULTS: A total of 2,432 patients met the inclusion criteria, of which 2,033 had no missing information and were categorized into BIG 1 (301 [14.8%]), BIG 2 (295 [14.5%]), and BIG 3 (1,437 [70.7%]). In BIG 1, no patient worsened clinically, 4 of 301 patients (1.3%) had progression on RHCT with no change in management, and none required neurosurgical intervention. In BIG 2, 2 of 295 patients (0.7%) worsened clinically, and 21 of 295 patients (7.1%) had progression on RHCT. Overall, 7 of 295 patients (2.4%) would have required upgrade from BIG 2 to 3 because of neurologic examination worsening or progression on RHCT, but no patient required neurosurgical intervention. There were no TBI-related postdischarge emergency department visits or 30-day readmissions in BIG 1 and 2 patients. All patients who required neurosurgical intervention were BIG 3 (280 of 1,437 patients [19.5%]). Agreement between assigned and final BIG categories was excellent ( κ = 99%). In this cohort, implementing BIG would have decreased CT scan utilization and neurosurgical consultation by 29% overall, with a 100% reduction in BIG 1 patients and a 98% reduction in BIG 2 patients. CONCLUSION: Brain Injury Guidelines is safe and defines the management of TBI patients by trauma and acute care surgeons without the routine need for RHCT and neurosurgical consultation. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level III.

Ablation of manifest septal accessory pathways: a single-center experience.

BACKGROUND: Ablation of septal accessory pathways (SAPs) is associated with an increased risk of heart block. Data on outcomes of SAP ablation in adults are limited. OBJECTIVES: To describe outcomes of SAP ablation in our center. METHODS: Patients with Wolff-Parkinson-White syndrome (WPW) undergoing an EP study at our center between January 2008 and August 2019 were identified from our institutional database. Location of the pathway was noted as anteroseptal (AS), midseptal (MS), or posteroseptal (PS). Outcomes of the ablation including success, complication rates, and recurrences were also recorded. RESULTS: Thirty-three patients with SAP underwent 35 EP studies: AS (n = 13), MS (n = 5), and PS (n = 15). Thirty pathways were targeted for ablation, two of which required a 2nd procedure resulting in 32 attempts at ablation in 30 patients. In the remaining 3 patients, SAP did not have malignant features and were not targeted for ablation. Single-procedure success rate was 28/30 (93.33%): 9/10 AS, 5/5 MS, and 14/15 PS ablations. One AS pathway was successfully ablated during a 2nd procedure. Two complications were observed: 1 pericardial effusion in a patient who underwent epicardial mapping and ablation of both PS and right free wall APs. Additionally, transient 2:1 AV block occurred during an MS pathway ablation that recovered during follow-up and did not require permanent pacing procedure. CONCLUSION: In this single-center experience, ablation of manifest SAP was associated with high success rates and low complication rates. No instances of permanent heart block requiring pacing occurred.

Outcomes Of Manifest Right Free Wall Accessory Pathway Ablation: Data From A Single Center.

BACKGROUND: Right free wall (RFW) accessory pathways (AP) typically present anatomical challenges to ablation leading to high rates of procedural failure and recovery of AP conduction. METHODS: Patients with a diagnosis of Wolff-Parkinson-White Syndrome (WPW) and a manifest RFW AP undergoing an electrophysiology study (EPS) or an ablation at our center between 01/01/2008 and 08/01/2019 were identified from our databases using diagnosis codes and manual chart review. RESULTS: Twenty-one patients with manifest RFW AP underwent EPS, all of which were targeted for ablation. Single procedure success rate was 19 / 21 (90.5%). Of the 19 successful cases, 4 (17.4%) patients were found to have recurrent right free wall pathway conduction at follow-up and each underwent a successful 2nd procedure (9.5%). Fluoroscopic and 3D electroanatomic mapping software was used in all cases to guide ablation. A 4 mm or 8 mm non-irrigated radiofrequency (RF) ablation catheter was used in 76% of cases while an 8 mm cryo-catheter was used in one case. More than one type of ablation catheter was used in four cases (16%). A steerable sheath was used in 68% of cases. CONCLUSIONS: In a tertiary center, RFW AP ablation has high acute success (>90%) but approximately 21% of patients with initially successful ablation required a 2nd procedure for recurrence of pathway conduction. A combination of a large tip ablation catheter and a steerable sheath were used in most cases.

The Emergency Surgery Score accurately predicts the need for postdischarge respiratory and renal support after emergent laparotomies: A prospective EAST multicenter study.

BACKGROUND: The Emergency Surgery Score (ESS) was recently validated as an accurate mortality risk calculator for emergency general surgery. We sought to prospectively evaluate whether ESS can predict the need for respiratory and/or renal support (RRS) at discharge after emergent laparotomies (EL). METHODS: This is a post hoc analysis of a 19-center prospective observational study. Between April 2018 and June 2019, all adult patients undergoing EL were enrolled. Preoperative, intraoperative, and postoperative variables were systematically collected. In this analysis, patients were excluded if they died during the index hospitalization, were discharged to hospice, or transferred to other hospitals. A composite variable, the need for RRS, was defined as the need for one or more of the following at hospital discharge: tracheostomy, ventilator dependence, or dialysis. Emergency Surgery Score was calculated for all patients, and the correlation between ESS and RRS was examined using the c-statistics method. RESULTS: From a total of 1,649 patients, 1,347 were included. Median age was 60 years, 49.4% were men, and 70.9% were White. The most common diagnoses were hollow viscus organ perforation (28.1%) and small bowel obstruction (24.5%); 87 patients (6.5%) had a need for RRS (4.7% tracheostomy, 2.7% dialysis, and 1.3% ventilator dependence). Emergency Surgery Score predicted the need for RRS in a stepwise fashion; for example, 0.7%, 26.2%, and 85.7% of patients required RRS at an ESS of 2, 12, and 16, respectively. The c-statistics for the need for RRS, the need for tracheostomy, ventilator dependence, or dialysis at discharge were 0.84, 0.82, 0.79, and 0.88, respectively. CONCLUSION: Emergency Surgery Score accurately predicts the need for RRS at discharge in EL patients and could be used for preoperative patient counseling and for quality of care benchmarking. LEVEL OF EVIDENCE: Prognostic and epidemiological, level III.

The emergency surgery score (ESS) and outcomes in elderly patients undergoing emergency laparotomy: A post-hoc analysis of an EAST multicenter study.

INTRODUCTION: We sought to evaluate whether the Emergency Surgery Score (ESS) can accurately predict outcomes in elderly patients undergoing emergent laparotomy (EL). METHODS: This is a post-hoc analysis of an EAST multicenter study. Between April 2018 and June 2019, all adult patients undergoing EL in 19 participating hospitals were prospectively enrolled, and ESS was calculated for each patient. Using the c-statistic, the correlation between ESS and mortality, morbidity, and need for ICU admission was assessed in three patient age cohorts (65-74, 75-84, ≥85 years old). RESULTS: 715 patients were included, of which 52% were 65-74, 34% were 75-84, and 14% were ≥85 years old; 51% were female, and 77% were white. ESS strongly correlated with postoperative mortality (c-statistic:0.81). Mortality gradually increased from 0% to 20%-60% at ESS of 2, 10 and 16 points, respectively. ESS predicted mortality, morbidity, and need for ICU best in patients 65-74 years old (c-statistic:0.81, 0.75, 0.83 respectively), but its performance significantly decreased in patients ≥85 years (c-statistic:0.72, 0.64, 0.67 respectively). CONCLUSION: ESS is an accurate predictor of outcome in the elderly EL patient 65-85 years old, but its performance decreases for patients ≥85. Consideration should be given to modify ESS to better predict outcomes in the very elderly patient population.

Prospective validation of the Emergency Surgery Score in emergency general surgery: An Eastern Association for the Surgery of Trauma multicenter study.

BACKGROUND: The Emergency Surgery Score (ESS) was recently developed and retrospectively validated as an accurate mortality risk calculator for emergency general surgery. We sought to prospectively validate ESS, specifically in the high-risk nontrauma emergency laparotomy (EL) patient. METHODS: This is an Eastern Association for the Surgery of Trauma multicenter prospective observational study. Between April 2018 and June 2019, 19 centers enrolled all adults (aged >18 years) undergoing EL. Preoperative, intraoperative, and postoperative variables were prospectively and systematically collected. Emergency Surgery Score was calculated for each patient and validated using c-statistic methodology by correlating it with three postoperative outcomes: (1) 30-day mortality, (2) 30-day complications (e.g., respiratory/renal failure, infection), and (3) postoperative intensive care unit (ICU) admission. RESULTS: A total of 1,649 patients were included. The mean age was 60.5 years, 50.3% were female, and 71.4% were white. The mean ESS was 6, and the most common indication for EL was hollow viscus perforation. The 30-day mortality and complication rates were 14.8% and 53.3%; 57.0% of patients required ICU admission. Emergency Surgery Score gradually and accurately predicted 30-day mortality; 3.5%, 50.0%, and 85.7% of patients with ESS of 3, 12, and 17 died after surgery, respectively, with a c-statistic of 0.84. Similarly, ESS gradually and accurately predicted complications; 21.0%, 57.1%, and 88.9% of patients with ESS of 1, 6, and 13 developed postoperative complications, with a c-statistic of 0.74. Emergency Surgery Score also accurately predicted which patients required intensive care unit admission (c-statistic, 0.80). CONCLUSION: This is the first prospective multicenter study to validate ESS as an accurate predictor of outcome in the EL patient. Emergency Surgery Score can prove useful for (1) perioperative patient and family counseling, (2) triaging patients to the intensive care unit, and (3) benchmarking the quality of emergency general surgery care. LEVEL OF EVIDENCE: Prognostic study, level III.

Minimally invasive preperitoneal balloon tamponade and abdominal aortic junctional tourniquet versus open packing for pelvic fracture-associated hemorrhage: Not all extrinsic compression is equal.

BACKGROUND: Minimally invasive preperitoneal balloon tamponade (PPB) and abdominal aortic junctional tourniquets (AAJT) have been proposed as alternatives to open preperitoneal packing (OP) for the management of pelvic fracture-associated hemorrhage. We hypothesized that the PPB (SpaceMaker Pro) and AAJT would result in similar rates of survival and blood loss versus OP. METHODS: Thirty-two swine underwent creation of a combined open-book pelvic fracture and major iliac vascular injuries. Animals were randomized to no intervention (n = 7), OP (n = 10), PPB (n = 9), or AAJT (n = 6) at a mean arterial pressure <40 mm Hg following initiation of uncontrolled hemorrhage. Survival (up to 60 minutes + 10 minutes after intervention reversal), hemodynamics, extraperitoneal pressures, blood loss, and associated complications were compared between groups. RESULTS: Prior to injury, no difference was measured between groups for weight, hemodynamics, lactate, and hematocrit (all p > 0.05). The injury was uniformly lethal without intervention, with survival time (mean) of 5 minutes, peak preperitoneal pressure (PP) of 14 mm Hg, blood loss of 960 g, and peak lactate of 2.6 mmol/L. Survival time was 44 minutes with OP versus 60 minutes with PPB and AAJT (p < 0.01). Peak PP (mm Hg) was 19 with OP, 23 with PPB, and 23 with AAJT (p > 0.05). Blood loss (g) was 850 with OP, 930 with PPB, and 600 with AAJT (p > 0.05). Peak lactate (mmol/L) was 3.3 with OP, 4.3 with PPB, and 6.3 with AAJT (p < 0.01). Only 33% of AAJT animals survived intervention reversal versus 60% for OP and 67% for PPB (p < 0.01). Necropsy revealed bowel/bladder injury in 50% of AAJT subjects versus 0% in all other arms (p < 0.01). CONCLUSION: Preperitoneal balloon tamponade is a safe and potentially effective alternative to OP for the management of lethal pelvic fracture-associated hemorrhage. Abdominal aortic junctional tourniquet offers a similar survival benefit to PPB but has concerning rates of ischemia-reperfusion and compressive abdominal organ injury.

Preperitoneal balloon tamponade and resuscitative endovascular balloon occlusion of the aorta: Alternatives to open packing for pelvic fracture-associated hemorrhage.

BACKGROUND: The objective of this study was to compare the efficacy of preperitoneal balloon tamponade (PPB), resuscitative endovascular balloon occlusion of the orta (REBOA), and open preperitoneal packing (OP) in a realistic animal model of pelvic fracture-associated hemorrhage. METHODS: Thirty-nine swine underwent creation of open-book pelvic fracture and iliac vascular injury. Animals were randomized to no intervention (n = 7), OP (n = 10), PPB (n = 9), zone 1 REBOA (n = 7), and zone 3 REBOA (n = 6) at a mean arterial pressure less than 40 mm Hg from uncontrolled hemorrhage. Primary outcome was survival at 1 hour. Secondary outcomes included survival in the immediate 10 m following intervention reversal, peak preperitoneal pressure (PP), blood loss, bleed rate, and peak lactate. RESULTS: Prior to injury, no difference was measured between groups for weight, hemodynamics, lactate, and hematocrit (all p = NS). The injury was uniformly lethal without intervention, with survival time (mean) of 5 m, peak PP of 14 mm Hg, blood loss of 960 g, bleed rate of 450 g/m, and peak lactate of 2.6 mmol/L. Survival time (m) was extended to 44 with OP, 60 with PPB, and 60 with REBOA (p < 0.01). Peak PP (mm Hg) was 19 with OP, 23 with PPB, 10 with zone 1 REBOA, and 6 with zone 3 REBOA (p < 0.05). Blood loss (g) was 850 with OP, 930 with PPB, 610 with zone 1 REBOA, and 370 with zone 3 REBOA (p < 0.01). Peak lactate (mmol/L) was 3.3 with OP, 4.3 with PPB, 13.4 with zone 1 REBOA, and 5.3 with zone 3 REBOA (p < 0.01). Only 33% of zone 1 REBOA animals survived the initial 10 m after balloon deflation, compared to 60% for OP, 67% for PPB, and 100% for zone 3 REBOA (p < 0.01). CONCLUSION: Preperitoneal balloon tamponade and zone 3 REBOA are effective alternatives to OP in this animal model of lethal pelvic fracture-associated hemorrhage. Zone 1 REBOA extends survival time but with high mortality upon reversal.

The Safety and Feasibility of Same-Day Discharge After Implantation of MICRA Transcatheter Leadless Pacemaker System.

BACKGROUND: Data suggests that same day discharge after implantation of trans-venous pacemakers is safe and feasible. We sought to determine whether same day discharge was feasible and safe following implantation of Medtronic MICRA leadless pacemakers. METHODS: We retrospectively identified all patients undergoing MICRA placement at our institution between April 2014 to August 2018 (n=167). Patients were stratified into two groups: those discharged on the same day as their procedure (SD, n=25), and those observed for at least one night in the hospital (HD, n=142). The primary endpoint included a composite of major complications including: access site complications, new pericardial effusion, device dislodgement, and need for device revision up to approximately 45 days of follow up. RESULTS: SD and HD had similar age (75±13 vs. 75±13 years, p=0.923), prevalence of male sex (49 vs. 44%, p=0.669), and frequency of high-grade heart block as an indication for pacing (38 vs. 32%, p=0.596). There were more Caucasians in the SD group (72 vs. 66%, p=0.038). The rate of the composite endpoint was statistically non-significantly higher in the HD group (3.5% vs. 0.0%, p=1.00). The rates of each individual components comprising the composite endpoint were similar between groups. CONCLUSIONS: Our data suggest that in appropriately selected patients, same day discharge can occur safely following Micra leadless pacemaker implantation.