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In 2022 and 2023, Medtronic recalled implantable defibrillators because they may deliver less than full-energy shocks. The 2022 problem truncates the second phase of the waveform (SCP-T2), resulting in ∼32-J shocks, and is mitigated by downloadable software. The 2023 malfunction truncates the first phase of the waveform, resulting in 0- to 12-J shocks due to a glassed feedthrough problem (GFT-T1) that might be avoided by programming B>AX shock polarity. The purpose of this study was to assess the consequences of GFT-T1 and SCP-T2 shocks in the Food and Drug Administration's Manufacturers and User Facility Device Experience (MAUDE) database and to estimate the incidences of GFT-T1 and SCP-T2. We analyzed MAUDE reports supplemented by Medtronic data; lead failures were excluded. The incidences of SCP-T2 and GFT-T1 were estimated using USA volumes for devices with glassed feedthroughs. One hundred thirty-two devices delivered truncated shocks: 27 (20.5%) were GFT-T1; 103 (78.0%) were SCP-T2; and 2 (1.5%) truncated both phases (BOTH-T1&2). Of 54 ventricular fibrillation (VF) patients, 21 (38.9%) were not defibrillated by truncated shocks: 8 (38.1%) received GFT-T1 shocks, 12 (57.1%) received SCP-T2 shocks, and 1 received a BOTH-T1&2 shock; 2 patients suffered unrelated deaths; 1 was externally rescued; 1 outcome was unknown; the others were defibrillated by subsequent shocks or terminated spontaneously. The majority of patients (79.1%) shocked for ventricular tachycardia (VT) were converted, primarily (94.1%) by SCP-T2 shocks. Estimated incidences of GFT-T1 and SCP-T2 were 0.0078%–0.0088% and 0.1062%–0.1110%. GFT-T1 and SCP-T2 shocks can result in failure to terminate VF/VT, but they may be preventable. Although the incidences of these truncated shocks are very low, heightened surveillance is warranted. [ABSTRACT FROM AUTHOR]

Cardiac computed tomography (CT) is increasingly used in pediatric patients with congenital heart disease (CHD). Variability of practice and of comprehensive diagnostic risk across institutions is not known. Four centers prospectively enrolled consecutive pediatric CHD patients <18 years of age undergoing cardiac CT from January 6, 2017 to 1/30/2020. Patient characteristics, cardiac CT data and comprehensive diagnostic risk were compared by age and institutions. Risk categories included sedation and anesthesia use, vascular access, contrast exposure, cardiovascular medication, adverse events (AEs), and estimated radiation dose. Cardiac CT was performed in 1045 pediatric patients at a median (interquartile range, IQR) age of 1.7 years (0.3, 11.0). The most common indications were arterial abnormalities, suspected coronary artery anomalies, functionally single ventricle heart disease, and tetralogy of Fallot/pulmonary atresia. Sedation was used in 8% and anesthesia in 11% of patients. Peripheral vascular access was utilized for 93%. Median contrast volume was 2 ​ml/kg. Beta blockers were administered in 11% of cases and nitroglycerin in 2% of cases. The median (IQR) total procedural dose length product (DLP) was 20 ​mGy∗cm (10, 50). Sedation, vascular access, contrast exposure, use of cardiovascular medications and radiation dose estimates varied significantly by institution and age (p ​< ​0.001). Seven minor adverse events (0.7%) and no major adverse events were reported. Cardiac CT for CHD is safe in pediatric patients when appropriate CT technology and expertise are available. Scans can be acquired at relatively low radiation exposure with few minor adverse events. We conducted a prospective multi-institutional evaluation of variability of practice and comprehensive diagnostic risk for cardiac CT in pediatric CHD patients. 1329 scans were performed in 1045 patients at four institutions from January 6, 2017 to 1/30/2020 in patients from 1 day to <18 years of age. Anesthesia and sedation were required in a minority of cases, with a very low rate of adverse events and low radiation exposure (median procedural DLP 20 ​mGy∗cm). However, variation exists between institutions, warranting future exploration and quality improvement initiatives to develop best practice guidelines and reduced practice variability. [ABSTRACT FROM AUTHOR]

Background Hypercholesterolemia is a major risk factor for cardiovascular disease. Women with hypercholesterolemia and familial hypercholesterolemia (FH) are a high-risk group often underdiagnosed, undertreated, and unaware of the need for cascade screening. Objectives The objectives were to identify the prevalence of hypercholesterolemia and FH in 2 national databases, explore lifestyle/medication adherence, and examine rates of cascade screening (lipid testing in all first-degree relatives) among those with FH. Methods This was a cross-sectional study of women who completed an online survey in 2014. Outcomes were examined for 3 groups: diagnosed, probable, and no FH. For FH, multivariable logistic regression was used to examine the association between family member screening for FH and sociodemographic and/or clinical characteristics. Results There were 761 respondents with a mean (±standard deviation) age of 59 ± 10.1 years; 26% reported FH, 22% probable FH, and 51% no FH. Eighty-three percent of the total sample and 95% with FH take a statin. In those with hypercholesterolemia and FH, 65% and 58% reported high medication adherence, respectively. Women with probable FH consumed significantly fewer fruits/vegetables and were less active. FH cascade screening was: siblings 54%, parents 37%, and children 34%. Marital status, annual household income, and diabetes were significantly associated with cascade screening. Conclusion In a survey of informed women with hypercholesterolemia and FH, cascade screening is underused. Our findings warrant increased efforts to identify cascade screening barriers. Early detection and treatment of hypercholesterolemia/FH is a priority for women, and their first-degree relatives, as this may dramatically reduce cardiovascular disease impact. [ABSTRACT FROM AUTHOR]