Background The Surgical Treatment for Ischemic Heart Failure (STICH) randomized trial was designed to identify an optimal management strategy for patients with ischemic cardiomyopathy. Baseline echocardiographic (Echo) examination was required for all patients. Aims The primary aim of this report is to describe the baseline STICH Echo Core Lab data. The secondary aim is to provide recommendations regarding how Echo should be used in clinical practice and research based on the experience gained from Echo in STICH. Method Between September 2002 and January 2006, 2,136 patients with an ejection fraction (EF) ≤ 35% and coronary artery disease amenable to coronary artery bypass grafting were enrolled. Echo was acquired by 122 clinical enrolling sites and measurements were performed by the Echo Core Lab after a certification process for all clinical sites. Results Echo was available for analysis in 2,006 (93.9%) patients; 1734 (86.4%) were men and mean (SD) age was 60.9 (9.5) years. Mean left ventricular (LV) end-systolic volume index measureable in 72.8% was 84.0 (30.9) mL/m2, and EF was 28.9 (8.3) % with 18.5% of patients having EF >35%. Single plane measurement of LV and left atrial volume was similar to their volume by biplane measurement (r= 0.97 and 0.92, respectively). Mitral regurgitation severity by visual assessment was associated with a wide range of effective regurgitant orifice area (ERO), while ERO ≥ 0.2 cm2 indicated at least moderate mitral regurgitation by visual assessment. . Deceleration time (DT) of mitral inflow velocity had a weak correlation with EF (r=0.25), but was inversely related to estimated pulmonary artery systolic pressure (r = −0.49). Conclusion In STICH patients with ischemic cardiomyopathy, Core Lab analysis of baseline Echo demonstrated a wide spectrum of LV shape, function, and hemodynamics as well as feasibility and limitations of obtaining essential Echo measurements. It is critical that utilization of Echo parameters in clinical practice and research needs to balance the strengths and weaknesses of the technique.
A double-blind, cross-over study was designed to evaluate the effects of L-carnitine in patients with peripheral vascular disease. After drug washout, 20 patients were randomly assigned to receive placebo or L-carnitine (2 g bid, orally) for a period of 3 weeks and were then crossed over to the other treatment for an additional 3 weeks. The effect on walking distance at the end of each treatment period was measured by treadmill test. Absolute walking distance rose from 174 + 63 m with placebo to 306 122 m (p < .01) with carnitine. Biopsy of the ischemic muscle, carried out before and after 15 days of L-carnitine administration in four additional patients, showed that treatment significantly increased total carnitine levels. An additional goal of this study was to ascertain the elfects of L-carnitine on the metabolic changes induced by exercise in the affected limb. In six patients under control conditions, arterial and popliteal venous lactate and pyruvate concentrations were determined at rest, when the maximal walking distance was reached, and 5 min after the walking test. Twenty-four hours later, L-carnitine was administered intravenously (3 g as a bolus followed by an infusion of 2 mg/kg/min for 30 min) and metabolic assessments were repeated. Five minutes after the walking test, popliteal venous lactate concentration increased by 107 + 16% before treatment and by only 54 + 32% (p < .01) after carnitine. Furthermore, carnitine induced a more rapid recovery to the resting value of the lactate/pyruvate ratio. These data suggest that carnitine improves pyruvate utilization and oxidative phosphorylation efficiency in the skeletal muscle of the ischemic leg. L-Carnitine, administered intravenously to 18 patients at the same dosage as above, did not modify blood flow or the ankle/arm systolic blood pressure ratio. In an additional eight patients, this intravenous dose produced an increase in walking distance similar to that observed with oral treatment. In conclusion, this study demonstrates that L-carnitine, although not affecting the general or regional hemodynamics, improves the walking capacity of patients with intermittent claudication, probably through a metabolic mechanism. Circulation 77, No. 4, 767-773, 1988. THE MOST IMPORTANT problem in the treatment of obstructive vascular disease is to make the energy supply adequate to the metabolic demand in the hypoxic area. In peripheral vascular disease, this goal is sought only by interventions aimed at increasing blood flow to the ischemic muscle. Many reports on ischemic heart-disease, however, suggest that a metabolic agent such as carnitine (3-hydroxy-4N-trimethylaminobutyrate) may protect the ischemic myocardium' and improve the stress tolerance of the heart2-4 by increasFrom the
Background Transcatheter aortic valve replacement (TAVR) requires large‐bore access, which is associated with bleeding and vascular complications. ProGlide and Prostar XL are vascular closure devices widely used in clinical practice, but their comparative efficacy and safety in TAVR is a subject of debate, owing to conflicting results among published studies. We aimed to compare outcomes with Proglide versus Prostar XL vascular closure devices after TAVR. Methods and Results This large‐scale analysis was conducted using RISPEVA, a multicenter national prospective database of patients undergoing transfemoral TAVR treated with ProGlide versus Prostar XL vascular closure devices. Both multivariate and propensity score adjustments were performed. A total of 2583 patients were selected. Among them, 1361 received ProGlide and 1222 Prostar XL. The predefined primary end point was a composite of cardiovascular mortality, bleeding, and vascular complications assessed at 30 days and 1‐year follow‐up. At 30 days, there was a significantly greater reduction of the primary end point with ProGlide versus Prostar XL (13.8% versus 20.5%, respectively; multivariate adjusted odds ratio, 0.80 [95% CI, 0.65–0.99]; P =0.043), driven by a reduction of bleeding complications (9.1% versus 11.7%, respectively; multivariate adjusted odds ratio, 0.76 [95% CI, 0.58–0.98]; P =0.046). Propensity score analysis confirmed the significant reduction of major adverse cardiovascular events and bleeding risk with ProGlide. No significant differences in the primary end point were found between the 2 vascular closure devices at 1 year of follow‐up (multivariate adjusted hazard ratio, 0.88 [95% CI, 0.72–1.10]; P =0.902). Comparable results were obtained by propensity score analysis. During the procedure, compared with Prostar XL, ProGlide yielded significant higher device success (99.2% versus 97.5%, respectively; P =0.001). Conclusions ProGlide has superior efficacy as compared with Prostar XL in TAVR procedures and is associated with a greater reduction of composite adverse events at short‐term, driven by lower bleeding complications. Registration Information URL: clinicaltrials.gov ; Unique identifier: NCT02713932.
Coronary artery ectasia (CAE) is defined as a diffuse or focal dilation of an epicardial coronary artery, which diameter exceeds by at least 1. 5 times the normal adjacent segment. The term ectasia refers to a diffuse dilation, involving more than 50% of the length of the vessel, while the term aneurysm defines a focal vessel dilation. CAE is a relatively uncommon angiographic finding and its prevalence ranges between 0.3 and 5% of patients undergoing coronary angiography. Although its pathophysiology is still unclear, atherosclerosis seems to be the underlying mechanism in most cases. The prognostic role of CAE is also controversial, but previous studies reported a high risk of cardiovascular events and mortality in these patients after percutaneous coronary intervention. Despite the availability of different options for the interventional management of patients with CAE, including covered stent implantation and stent-assisted coil embolization, there is no one standard approach, as therapy is tailored to the individual patient. The abnormal coronary dilation, often associated with high thrombus burden in the setting of acute coronary syndromes, makes the interventional treatment of CAE patients challenging and often complicated by distal thrombus embolization and stent malapposition. Moreover, the optimal antithrombotic therapy is debated and includes dual antiplatelet therapy, anticoagulation, or a combination of them. In this review we aimed to provide an overview of the pathophysiology, classification, clinical presentation, natural history, and management of patients with CAE, with a focus on the challenges for both clinical and interventional cardiologists in daily clinical practice.
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