Transcatheter Mitral Valve Replacement With the Transseptal EVOQUE System

ObjectivesThe aim of this study was to examine the initial experience with a novel transseptal transcatheter mitral valve replacement (TMVR) system.BackgroundTransseptal TMVR may offer a less invasive option than surgery for mitral regurgitation (MR) with greater efficacy and fewer anatomic limitations than transcatheter repair.MethodsPatients were treated with the EVOQUE TMVR system from September 2018 to October 2019. Key inclusion criteria were moderate or greater MR, New York Heart Association functional class ≥II, and high or prohibitive surgical risk. The primary outcome was technical success, defined by Mitral Valve Academic Research Consortium criteria.ResultsFourteen patients were treated, all with at least moderate to severe MR. The median age was 84 years, and the median Society of Thoracic Surgeons score was 4.6%. MR was degenerative in 4 (28.6%), functional in 3 (21.4%), and mixed in 7 (50%). Technical success was achieved in 13 patients (92.9%), and 1 patient was converted to surgery. At 30 days there was 1 noncardiovascular mortality (7.1%), 2 strokes (14.3%), no myocardial infarctions, and no rehospitalizations. Two patients (14.3%) underwent paravalvular leak closure. One patient (7.1%) underwent alcohol septal ablation for left ventricular outflow tract obstruction. Including the 2 patients with paravalvular leak closure, MR was mild or less in all implanted patients at 30 days, with no MR in 10 (83.3%). Mean mitral gradient was 5.8 mm Hg (median). New York Heart Association functional class improved to ≤II in 9 patients (81.8%).ConclusionsThis first-in-human experience has demonstrated the feasibility of the transseptal EVOQUE TMVR system. Further clinical studies are required to establish safety and clinical outcomes.     

Pre-Hospital Administration of Epinephrine in Pediatric Patients With Out-of-Hospital Cardiac Arrest

BackgroundThere is little evidence about pre-hospital advanced life support including epinephrine administration for pediatric out-of-hospital cardiac arrests (OHCAs).ObjectivesThis study aimed to assess the effect of pre-hospital epinephrine administration by emergency-medical-service (EMS) personnel for pediatric OHCA.MethodsThis nationwide population-based observational study in Japan enrolled pediatric patients age 8 to 17 years with OHCA between January 2007 and December 2016. Patients were sequentially matched with or without epinephrine during cardiac arrest using a risk-set matching based on time-dependent propensity score (probability of receiving epinephrine) calculated at each minute after initiation of cardiopulmonary resuscitation by EMS personnel. The primary endpoint was 1-month survival. Secondary endpoints were 1-month survival with favorable neurological outcome, defined as the cerebral performance category scale of 1 or 2, and pre-hospital return of spontaneous circulation (ROSC).ResultsDuring the study period, a total of 1,214,658 OHCA patients were registered, and 3,961 pediatric OHCAs were eligible for analyses. Of these, 306 (7.7%) patients received epinephrine and 3,655 (92.3%) did not receive epinephrine. After time-dependent propensity score-sequential matching, 608 patients were included in the matched cohort. In the matched cohort, there were no significant differences between the epinephrine and no epinephrine groups in 1-month survival (epinephrine: 10.2% [31 of 304] vs. no epinephrine: 7.9% [24 of 304]; risk ratio [RR]: 1.13 [95% confidence interval (CI): 0.67 to 1.93]) and favorable neurological outcome (epinephrine: 3.6% [11 of 304] vs. no epinephrine: 2.6% [8 of 304]; RR: 1.56 [95% CI: 0.61 to 3.96]), whereas the epinephrine group had a higher likelihood of achieving pre-hospital ROSC (epinephrine: 11.2% [34 of 304] vs. no epinephrine: 3.3% [10 of 304]; RR: 3.17 [95% CI: 1.54 to 6.54]).ConclusionsIn this study, pre-hospital epinephrine administration was associated with ROSC, whereas there were no significant differences in 1-month survival and favorable neurological outcome between those with and without epinephrine.     

Intravascular Polarimetry in Patients With Coronary Artery Disease

ObjectivesThe aims of this first-in-human pilot study of intravascular polarimetry were to investigate polarization properties of coronary plaques in patients and to examine the relationship of these features with established structural characteristics available to conventional optical frequency domain imaging (OFDI) and with clinical presentation.BackgroundPolarization-sensitive OFDI measures birefringence and depolarization of tissue together with conventional cross-sectional optical frequency domain images of subsurface microstructure.MethodsThirty patients undergoing polarization-sensitive OFDI (acute coronary syndrome, n = 12; stable angina pectoris, n = 18) participated in this study. Three hundred forty-two cross-sectional images evenly distributed along all imaged coronary arteries were classified into 1 of 7 plaque categories according to conventional OFDI. Polarization features averaged over the entire intimal area of each cross section were compared among plaque types and with structural parameters. Furthermore, the polarization properties in cross sections (n = 244) of the fibrous caps of acute coronary syndrome and stable angina pectoris culprit lesions were assessed and compared with structural features using a generalized linear model.ResultsThe median birefringence and depolarization showed statistically significant differences among plaque types (p < 0.001 for both, one-way analysis of variance). Depolarization differed significantly among individual plaque types (p < 0.05), except between normal arteries and fibrous plaques and between fibrofatty and fibrocalcified plaques. Caps of acute coronary syndrome lesions and ruptured caps exhibited lower birefringence than caps of stable angina pectoris lesions (p < 0.01). In addition to clinical presentation, cap birefringence was also associated with macrophage accumulation as assessed using normalized SD.ConclusionsIntravascular polarimetry provides quantitative metrics that help characterize coronary arterial tissues and may offer refined insight into coronary arterial atherosclerotic lesions in patients.     

Contemporary Revascularization Strategies and Outcomes Among Patients With Diabetes With Critical Limb Ischemia: Insights From the National Inpatient Sample

ObjectivesThe purpose of this study was to evaluate temporal trends in the frequency of revascularization and associated outcomes in patients with diabetes mellitus and critical limb ischemia (CLI).BackgroundLittle is known about outcomes following revascularization for CLI in patients with diabetes mellitus.MethodsTemporal trends in hospitalization for CLI among patients with diabetes were determined using the 2002–2015 National Inpatient Sample database. Propensity score matching was used to compare patients who underwent revascularization with those who did not and, separately, to compare those who underwent endovascular versus surgical revascularization. The main study outcome was in-hospital mortality.ResultsThe analysis included 1,222,324 hospitalizations. The number of hospitalizations for CLI among patients with diabetes increased over time (p_trend < 0.001). There was an increase in the use of lower extremity revascularization, paralleled by a decline in in-hospital mortality during the study period. In the matched cohort, patients who were revascularized had lower in-hospital mortality (odds ratio [OR]: 0.68; 95% confidence interval [CI]: 0.63 to 0.72) and major amputation (OR: 0.25; 95% CI: 0.24 to 0.27) compared with those who were treated medically. Compared with endovascular revascularization, those who underwent surgical revascularization had higher rates of in-hospital mortality (OR: 1.18; 95% CI: 1.04 to 1.35) but lower rates of major amputation (OR: 0.75; 95% CI: 0.70 to 0.81). Major bleeding, blood transfusion, post-operative infection, respiratory complications, discharges to nursing facility, and longer length of hospital stay were also more common among those who underwent surgery.ConclusionsIn this national analysis of patients with DM and CLI, we demonstrated an increase in hospitalization for CLI among patients with diabetes in the United States. Although in-hospital mortality decreased over time regardless of the treatment strategy used, this outcome occurred less frequently among those who underwent revascularization than not. Compared with surgical revascularization, endovascular revascularization was associated with lower in-hospital mortality but higher rates of major amputation.     

Incidence of Malignancies in Patients Treated With Sirolimus Following Heart Transplantation

BackgroundMalignancy is a major cause of late post-heart transplantation (HT) mortality. Sirolimus (SRL) exerts antiproliferative properties and its long-term use in HT as primary immunosuppression (IS) is associated with decreased mortality risk that is not fully explained by attenuation of cardiac allograft vasculopathy progression.ObjectivesThis study sought to examine whether conversion from calcineurin inhibitor (CNI)-based to SRL-based IS was associated with decreased risk of malignancy post-HT.MethodsOverall, 523 patients underwent HT between 1994 and 2016 at a single institution. The main outcomes included incidence of overall de novo malignancies (excluding non-melanoma skin cancers [NMSCs]), post-transplantation lymphoproliferative disorders (PTLD), and first and subsequent primary occurrences of NMSC post-HT.ResultsThe study identified 307 patients on SRL-based and 216 on CNI-based maintenance IS. Over a median follow-up of 10 years after HT, overall de novo malignancies (non-NMSC) occurred in 31% of CNI patients and in 13% of SRL patients (adjusted hazard ratio [HR]: 0.34; 95% confidence interval [CI]: 0.18 to 0.62; p < 0.001). The incidence of the first NMSC was similar in the SRL and CNI groups (HR: 0.92; 95% CI: 0.66 to 1.28; p = 0.62). However, conversion to SRL was significantly associated with a decreased risk of subsequent primary occurrences of NMSC compared with that of CNI (adjusted HR: 0.44; 95% CI: 0.28 to 0.69; p < 0.001). The adjusted PTLD risk was significantly decreased in the SRL group (HR: 0.13; 95% CI: 0.03 to 0.59; p = 0.009). Late survival post-HT was markedly decreased in patients who developed non-NMSC, PTLD, or non-PTLD compared with patients who did not develop these malignancies, whereas NMSC had no significant effect on survival.ConclusionsConversion to SRL was associated with a decreased risk of all de novo malignancies, PTLD, and subsequent primary occurrences of NMSC after HT. These findings provided further explanation of the late survival benefit with long-term SRL use.     

Maintenance of Remission With Tofacitinib Therapy in Patients With Ulcerative Colitis

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