BACKGROUND:Mesenchymal precursor cells (MPCs) are allogeneic, immunoselected cells with anti-inflammatory properties that could improve outcomes in heart failure with reduced ejection fraction (HFrEF). OBJECTIVES:This study assessed the efficacy and safety of MPCs in patients with high-risk HFrEF. METHODS:This randomized, double-blind, multicenter study evaluated a single transendocardial administration procedure of MPCs or sham-control in 565 intention-to-treat patients with HFrEF on guideline-directed therapies. The primary endpoint was time-to-recurrent events caused by decompensated HFrEF or successfully resuscitated symptomatic ventricular arrhythmias. Hierarchical secondary endpoints included components of the primary endpoint, time-to-first terminal cardiac events, and all-cause death. Separate and composite major adverse cardiovascular events analyses were performed for myocardial infarction or stroke or cardiovascular death. Baseline and 12-month echocardiography was performed. Baseline plasma high-sensitivity C-reactive protein levels were evaluated for disease severity. RESULTS:The primary endpoint was similar between treatment groups (HR: 1.17; 95% CI: 0.81-1.69; P = 0.41) as were terminal cardiac events and secondary endpoints. Compared with control subjects, MPCs increased left ventricular ejection fraction from baseline to 12 months, especially in patients with inflammation. MPCs decreased the risk of myocardial infarction or stroke by 58% (HR: 0.42; 95% CI: 0.23-0.76) and the risk of 3-point major adverse cardiovascular events by 28% (HR: 0.72; 95% CI: 0.51-1.03) in the analysis population (n = 537), and by 75% (HR: 0.25; 95% CI: 0.09-0.66) and 38% (HR: 0.62; 95% CI: 0.39-1.00), respectively, in patients with inflammation (baseline high-sensitivity C-reactive protein ≥2 mg/L). CONCLUSIONS:The primary and secondary endpoints of the trial were negative. Positive signals in prespecified, and post hoc exploratory analyses suggest MPCs may improve outcomes, especially in patients with inflammation.

•Cor triatriatum dexter (CTD) can complicate percutaneous atrial septal interventions.•Clinically silent (forme fruste) CTD is detectable by new echocardiography techniques.•Using these techniques could improve patient selection and guide interventions.

T he prevalence of senile calcific aortic stenosis, a degenerative disease, mirrors the portion of the population that survives other processes to reach an advanced age. Thus, because of longer life expectancy, increasing numbers of women are candidates for aortic valve replacement (AVR). In current cardiovascular medicine, transcatheter AVR (TAVR) has proved to be suitable in the elderly and in those otherwise at high risk for surgical AVR (SAVR). Early TAVR trials appeared to harbor a recruitment bias against women—related, in part, to the use of large-profile devices, which precluded insertion in smaller femoral arteries. Even so, sex-specific examination of TAVR in early cohorts suggested distinct profiles of outcome for men and women, including an apparent survival advantage for women. In the Partner high-risk trial, sex-specific all-cause mortality rates at 2 years were reported. The investigators concluded that early and late mortality rates in women were better with TAVR than with SAVR; in contrast, there was no late survival benefit with TAVR in men, although their general clinical outcomes from both methods were similar. Thus, in the high-risk cohort, late mortality rates with TAVR were lower in women than in men, especially in women who underwent transfemoral TAVR. In a patient-level meta-analysis that included 47,188 subjects, women who underwent TAVR had more strokes, major bleeding, vascular complications, and need for transfusion within 30 days than did men, but lower mortality rates at one year. Likely factors contributing to complications were older age, lower body surface area, and vessels of smaller diameter. Increased occurrences of bleeding and vascular complications in women did not negatively affect their long-term survival benefit. Women had a lower risk of permanent pacemaker placement after TAVR; however, their increased 30-day risk of stroke and transient ischemic attack remained significantly higher after one year. The investigators concluded that women had better one-year and long-term survival prospects (mean follow-up duration, 3.28 ± 1.4 yr) than did men, despite more risk of early (30-d) postoperative bleeding and vascular complications and a greater long-term risk of stroke. The long-term survival advantage in women was consistently observed in multiple sensitivity and subgroup analyses of the cohorts, vascular access methods, geographic variations, and valve types. Smaller annular size in the women probably reduced the incidence of prosthesis undersizing. In comparison, the men tended to receive undersized valves, which resulted in more paravalvular leaks. In addition, the men had markedly worse baseline vascular disease and comorbidities than did the women, including hypertension, diabetes mellitus, coronary artery disease, prior revascularization, lower left ventricular ejection fraction, and higher risk scores. Of note, women’s hearts may exhibit more favorable remodeling when hemodynamically stressed by aortic stenosis, mainly through less fibrosis and collagen deposition, thus enabling the reversal of cardiac remodeling after TAVR. One-year outcomes were recently reported in the Women’s International Transcatheter Aortic Valve Implantation Registry. The investigators noted that baseline characteristics differ in men and women who undergo TAVR, and that these can affect shortand long-term events. Women have smaller peripheral vessels and aortic valve annuli, lower origins of the coronary arteries, more prevalent osteoporosis and frailty, greater risk of bleeding, and more prevalent concomitant valve disease and heart failure. 8th Annual Women’s Heart & Vascular Symposium

We describe transcatheter aortic valve implantation in a patient who had severe peripheral artery disease. The patient's vascular condition required additional preliminary peripheral intervention to enable adequate vascular access. A 78-year-old man with severe aortic stenosis, substantial comorbidities, and severe heart failure symptoms was referred for aortic valve replacement. The patient's 20-mm aortic annulus necessitated the use of a 23-mm Edwards Sapien valve inserted through a 22F sheath, which itself needed a vessel diameter of at least 7 mm for percutaneous delivery. The left common femoral artery was selected for valve delivery. The left iliac artery and infrarenal aorta underwent extensive intervention to achieve an intraluminal diameter larger than 7 mm. After aortic valvuloplasty, valve deployment was successful, and the transaortic gradient decreased from 40 mmHg to less than 5 mmHg. The patient was discharged from the hospital 4 days postoperatively. We conclude that transcatheter aortic valve implantation can be successfully performed in patients with obstructed vascular access, including stenosis of the infrarenal aorta and the subclavian and coronary arteries.

We describe transcatheter aortic valve implantation in a patient who had severe peripheral artery disease. The patient's vascular condition required additional preliminary peripheral intervention to enable adequate vascular access. A 78-year-old man with severe aortic stenosis, substantial comorbidities, and severe heart failure symptoms was referred for aortic valve replacement. The patient's 20-mm aortic annulus necessitated the use of a 23-mm Edwards Sapien valve inserted through a 22F sheath, which itself needed a vessel diameter of at least 7 mm for percutaneous delivery. The left common femoral artery was selected for valve delivery. The left iliac artery and infrarenal aorta underwent extensive intervention to achieve an intraluminal diameter larger than 7 mm. After aortic valvuloplasty, valve deployment was successful, and the transaortic gradient decreased from 40 mmHg to less than 5 mmHg. The patient was discharged from the hospital 4 days postoperatively. We conclude that transcatheter aortic valve implantation can be successfully performed in patients with obstructed vascular access, including stenosis of the infrarenal aorta and the subclavian and coronary arteries.

Introduction The native heart valves and, in particular, the aortic valve have a complex geometry that provides both ideal opening and closing geometries through an anatomic joining of a tubular inflow structure of the left ventricular outflow tract and an expansion of the valve sinuses above the hinging point of the valve leaflets defined by the aortic valve annular ring (Online Figure 1). A central challenge to the formation of a transcatheter heart valve (THV) is the confinement of the operating leaflets within a partially sealed tubular structure while preserving effective opening and closing valve behaviour without the benefit of the natural mechanism of the sinuses of Valsalva in a single valve and leaflet geometry. The compromises reflected in the available THV designs have produced THVs that require large delivery catheters which impose technical difficulties and clinical risks on the patient. The Colibri heart valve (CHV) was designed to address these shortcomings.

We sought to evaluate the restoration of microcirculatory patency after primary percutaneous coronary intervention (PCI) in an unselected cohort of patients at a tertiary center.We retrospectively evaluated distributions of the Thrombolysis in Myocardial Infarction (TIMI) myocardial perfusion grade (TMPG) and the myocardial blush grade (MBG) in all primary PCI procedures performed at our institution during 2008. We defined optimal microvascular perfusion as simultaneous TMPG 3 and MBG 3 at procedure's end.Ninety-nine patients (mean age, 61.5 ± 12.7 yr; 64 men) underwent primary PCI. Microvascular perfusion was optimal in 69 patients (69.7%) and was associated with lower peaks of enzymes than those occurring in patients with suboptimal perfusion. When optimal microvascular perfusion was achieved, early spontaneous recanalization was more frequently observed, as expressed by a higher frequency of TIMI-3 flow (34.8% vs 10%; P=0.006), TMPG 3 (26% vs 3.3%; P=0.004), and MBG 3 (24.6% vs 3.3%; P=0.004) on the initial angiogram before primary PCI. A higher frequency of MBG 3 (50% vs 20%; P=0.005) was seen after initial recanalization in patients with optimal microvascular perfusion. Multiple regression analysis showed that MBG after initial recanalization and the use of drug-eluting stents were associated with optimal perfusion.Despite successful recanalization of the culprit coronary artery, optimal microvascular perfusion was achieved in less than 75% of the patients. Restoration of the microvasculature was associated with smaller infarcts. Procedure-related variables associated with suboptimal perfusion were unlikely to be causative.

The mechanical behavior of endovascular coronary stents influences their therapeutic efficacy. Through computational studies, researchers can analyze device performance and improve designs. We developed a 1-dimensional finite element method, net-based algorithm and used it to analyze the effects of radial loading and bending in commercially available stents. Our computational study included designs modeled on the Express, Cypher, Xience, and Palmaz stents.We found that stents that did not fully expand were less rigid than the fully expanded stents and, therefore, exhibited larger displacement. Stents with an open-cell design, such as Express-like or Xience-like stents, had a higher bending flexibility. Stents with in-phase circumferential rings, such as the Xience-like stent, had the smallest longitudinal extension when exposed to radial compression forces. Thus, the open-cell model that had in-phase circumferential rings connected by straight horizontal struts exhibited radial stiffness, bending flexibility, and the smallest change in stent length during radial forcing. The Palmaz-like stent was the most rigid of all. These findings are supported by clinical experience.Computer simulations of the mechanical properties of endovascular stents offer sophisticated insights into the mechanical behavior of different stent designs and should be used whenever possible to help physicians decide which stent is best for treating a given lesion. Our 1-dimensional finite element method model is incomparably simpler, faster, and more accurate than the classical 3-dimensional approaches. It can facilitate stent design and may aid in stent selection in the clinical setting.