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.

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.

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.

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.

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.

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.

Development of a Risk Score to Predict New Pacemaker Implantation After Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aim of this study was to define risk factors and develop a predictive risk score for new pacemaker implantation (PMI) after transcatheter aortic valve replacement (TAVR). BACKGROUND: TAVR has become an accepted treatment alternative for patients with severe aortic stenosis at elevated surgical risk. New PMI is a common occurrence after TAVR and is associated with poorer outcomes. METHODS: All patients without prior valve procedures undergoing elective TAVR with the Edwards SAPIEN 3 at a single institution (n = 1,266) were evaluated. Multivariate analysis was performed to evaluate for predictors of PMI in this population in a derivation cohort of patients with complete data (n = 778), and this model was used to develop the Emory risk score (ERS), which was tested in a validation cohort (n = 367). RESULTS: Fifty-seven patients (7.3%) in the derivation cohort required PMI. In a regression model, history of syncope (odds ratio [OR]: 2.5; p = 0.026), baseline right bundle branch block (OR: 4.3; p < 0.001), QRS duration ≥138 ms (OR: 2.5; p = 0.017), and valve oversizing >15.6% (OR: 1.9; p = 0.041) remained independent predictors of PMI and were included in the ERS. The ERS was strongly associated with PMI (per point increase OR: 2.2; p < 0.001) with an area under the receiver-operating characteristic curve of 0.778 (p < 0.001), which was similar to its performance in the derivation cohort. CONCLUSIONS: A history of syncope, right bundle branch block, longer QRS duration, and higher degree of oversizing are predictive of the need for PMI after TAVR. Additionally, the ERS for PMI was developed and validated, representing a simple bedside tool to aid in risk stratification for patients for undergoing TAVR.

Long-Term Neurodevelopmental Outcomes in Children and Adolescents With Congenital Heart Disease.

BACKGROUND: Effective medical and surgical management of pediatric congenital heart disease (CHD) to reduce long-term adverse neurodevelopmental outcomes is an important clinical objective in primary and specialty health care. We identify clinical predictors associated with an increased risk of 6 long-term neurodevelopmental outcomes in children with CHD compared to the general pediatric Medicaid population. METHOD: South Carolina's retrospective, 15-year Medicaid data set (January 1, 1996-December 31, 2010) for 19,947 patients aged ≤ 17 years diagnosed with ≥ 1 CHD lesions (on the basis of International Classification of Diseases, Ninth Revision, Clinical Modification codes) were compared to 19,948 patients without CHD matched on age at entry into and duration in Medicaid using logistic and Cox proportional hazards regression. RESULTS: The CHD cohort was significantly less likely to have incident neurologic or psychiatric disorders, mental retardation, developmental delays, or inattention/hyperactivity (adjusted odds ratios [ORs] = 0.34, 0.56, 0.03, 0.01, 0.004, respectively) but was more likely to have incident seizures (OR = 2.00) compared to controls. Exposure to both cardiac and noncardiac surgical intervention was associated with a significantly increased risk of developing neurologic or psychiatric disorders, mental retardation, developmental delays, or inattention/hyperactivity (cardiac ORs = 1.66, 2.00, 1.67, 1.43, 1.76, respectively) (noncardiac ORs = 2.25, 1.59, 1.48, 1.29, 1.36, 2.46, respectively). Any documented hypoxemia was associated with a significantly increased risk of developing 5 of the neurodevelopmental conditions (neurologic OR = 4.52, psychiatric OR = 1.60, mental retardation OR = 2.90, developmental delay OR = 2.12, seizures OR = 4.23). CONCLUSION: Practitioners should maintain vigilant surveillance of all CHD patients, especially those exposed to surgical procedures or experiencing hypoxemia, to identify any neurodevelopmental issues early and address them promptly.

Prevalence and management of patent ductus arteriosus in a pediatric medicaid cohort.

BACKGROUND: Widespread use of echocardiography has made earlier diagnosis of patent ductus arteriosus (PDA) possible, but pharmacological or surgical intervention is highly variable. Herein, we investigate the prevalence of PDA and its management in a routine care system. METHODS: A 15-year retrospective dataset (1996-2010) was analyzed. Selection criteria included age ≤17 years, enrollees in South Carolina State Medicaid, and diagnosed as having PDA on 1 or more service visits to a pediatrician or pediatric cardiologist. RESULTS: The 15-year treated prevalence rate of PDA was 0.25/1000 pediatric cases of congenital heart disease (CHD). PDA was more prevalent in non-African American patients (adjusted odds ratio [aOR]: 1.12), but not in females after controlling for all other CHDs diagnosed in the cohort. Associated CHDs were present in 57.6% of the cases, primarily atrial or ventricular septal defects, and fewer patients (5.5%) developed pulmonary hypertension. Of 3627 PDA cases examined, 70.0% received no medications or PDA repair. Therapeutic ibuprofen was used for closure in 24.4% of the cases, and a PDA repair was performed in 7.8%. Younger children (aOR: 0.82), those who received an atrial septal defect closure (aOR: 5.18), and those who were treated with digoxin (aOR: 1.86) or with diuretics or preload/afterload reducing agents (ie, calcium channel blockers or angiotensin-converting enzyme inhibitors) (aOR: 5.72) were significantly more likely to have a PDA repair procedure. CONCLUSIONS: The majority of diagnosed PDA cases did not require pharmacological or surgical intervention. Those receiving pharmacological or surgical intervention were treated conservatively in relation to the presence of distress symptoms or concomitant CHDs requiring intervention.

Economic grand rounds: economic costs of failure to monitor adverse effects of second-generation antipsychotics: an underestimated factor.

Since 2003, the U.S. Food and Drug Administration as well as the American Diabetes Association, the American Psychiatric Association, and others have called for routine monitoring of cardiometabolic risk factors for patients of all ages prescribed second-generation antipsychotic medications. This survey of major public and private mental health treatment systems in 2010 found that adherence to such guidelines was limited. The authors describe some of the impediments to widespread monitoring of cardiometabolic risk factors among psychiatric patients taking second-generation antipsychotics and advocate for a nationwide commitment to providing the organizational and financial supports necessary to ensure systematic screening of cardiometabolic health among such patients.