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.