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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.  相似文献   

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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.  相似文献   

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Current guidelines recommend that clinical surveillance for patients with moderate aortic stenosis (AS) and aortic valve replacement (AVR) may be considered if there is an indication for coronary revascularization. Recent observational studies, however, have shown that moderate AS is associated with an increased risk of cardiovascular events and mortality. Whether the increased risk of adverse events is caused by associated comorbidities, or to the underlying moderate AS itself, is incompletely understood. Similarly, which patients with moderate AS need close follow-up or could potentially benefit from early AVR is also unknown. In this review, the authors provide a comprehensive overview of the current published reports on moderate AS. They first provide an algorithm that helps to diagnose moderate AS correctly, especially when discordant grading is observed. Although the traditional focus of AS assessment has been on the valve, it is increasingly acknowledged that AS is not only a disease of the aortic valve but also of the ventricle. The authors therefore discuss how multimodality imaging can help to evaluate the left ventricular remodeling response and improve risk stratification in patients with moderate AS. Finally, they summarize current evidence on the management of moderate AS and highlight ongoing trials on AVR in moderate AS.  相似文献   

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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 (ptrend < 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.  相似文献   

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