Prospective, multicenter, randomized, controlled trial evaluating the performance of a novel combination powder vs hemostatic matrix in cardiothoracic operations.

AIM: This trial compared the hemostatic performance of a novel combination powder (CP) to a control hemostatic matrix (HM) in cardiothoracic operations. METHODS: Patients meeting eligibility criteria were enrolled after providing informed consent. Subjects were randomized intraoperatively to receive CP (HEMOBLAST Bellows; Biom'up, France) or HM (FLOSEAL Hemostatic Matrix; Baxter Healthcare Corporation, Hayward, CA). Bleeding was assessed using a clinically validated, quantitative bleeding severity scale. The primary endpoint was total time to hemostasis (TTTH), from the start of device preparation, as an indicator of when a surgeon asks for a surgical hemostat until hemostasis was achieved. TTTH at 3 minutes was utilized for the primary analysis, while TTTH at 5 minutes was considered as a secondary endpoint. RESULTS: A total of 105 subjects were enrolled across four institutions. The primary efficacy endpoint for the superiority of CP relative to HM for success at achieving hemostasis within 3 minutes was met, with 64.2% of the CP group achieving hemostasis compared with 9.6% of the HM group, a difference of 54.54% (37.4%-71.6%; P < .001 for superiority). The secondary efficacy endpoint was also met, with 92.5% of the CP group achieving hemostasis at 5 minutes versus 44.2% in the HM group, a difference of 48.2% (31.1%-65.4%; P < .001 for noninferiority). There were no device-related adverse events. CONCLUSIONS: In this multicenter, randomized, controlled trial, comparison of CP to HM revealed CP superiority and noninferiority for TTTH at 3 and 5 minutes, respectively.

Preoperative Vitamin K Reduces Blood Transfusions at Time of Left Ventricular Assist Device Implant.

BACKGROUND: Congestive heart failure patients have hepatic congestion and abnormal coagulation profiles, increasing perioperative bleeding at time of ventricular assist device implantation. This study examined the impact of the preoperative administration of vitamin K on perioperative blood transfusion requirements. METHODS: Retrospectively, 190 patients met inclusion criteria. Patients received no vitamin K (n = 62) or two 10-mg doses of intravenous vitamin K (n = 128) in the 24 hours before assist device implantation. Primary end points included transfusion requirements and reexploration rates for bleeding. Secondary outcomes were pump thrombosis and in-hospital mortality. RESULTS: Baseline characteristics were similar between the 2 groups, with slight differences (not statistically significant) noted in the Interagency Registry for Mechanically Assisted Circulatory Support profile and total bilirubin levels. The only significant difference noted was the year of implantation (P < .001). Blood product usage was significantly lower in the vitamin K group compared to the no vitamin K group (P < .001). Higher rates of reexploration for bleeding (29.7% vs 13.6%, P = .023) and death at hospital discharge (16.2% vs 2.8%, P = .004) were noted for the no vitamin K group compared with the vitamin K group. After adjusting for age, sex, race, body mass index, Interagency Registry for Mechanically Assisted Circulatory Support profile, total bilirubin, surgeon, and year of operation, reexploration rates and death did not achieve statistical significance. No statistically significant difference was observed in stroke and pump thrombosis rates between the 2 groups. CONCLUSIONS: Preoperative vitamin K administration may help reduce blood product use without any increased risk for strokes or pump thrombosis.

Median Sternotomy for Lung Transplantation: Techniques and Advantages.

Lung transplantation is traditionally performed with a clamshell thoracotomy or bilateral anterior thoracotomy incisions. We have performed 121 lung transplants with a median sternotomy incision from 2013-2017. We present our technique for lung transplantation utilizing cardiopulmonary bypass with a median sternotomy, and discuss the potential advantages of this technique.

Echocardiographic Assessment of Degenerative Mitral Stenosis: A Diagnostic Challenge of an Emerging Cardiac Disease.

Degenerative mitral stenosis (DMS) is characterized by decreased mitral valve (MV) orifice area and increased transmitral pressure gradient due to chronic noninflammatory degeneration and subsequent calcification of the fibrous mitral annulus and the MV leaflets. The "true" prevalence of DMS in the general population is unknown. DMS predominantly affects elderly individuals, many of whom have multiple other comorbidities. Transcatheter MV replacement techniques, although their long-term outcomes are yet to be tested, have been gaining popularity and may emerge as more effective and relatively safer treatment option for patients with DMS. Echocardiography is the primary imaging modality for evaluation of DMS and related hemodynamic abnormalities such as increased transmitral pressure gradient and pulmonary arterial pressure. Classic echocardiographic techniques used for evaluation of mitral stenosis (pressure half time, proximal isovelocity surface area, continuity equation, and MV area planimetry) lack validation for DMS. Direct planimetry with 3-dimensional echocardiography and color flow Doppler is a reasonable technique for determining MV area in DMS. Cardiac computed tomography is an essential tool for planning potential interventions or surgeries for DMS. This article reviews the current concepts on mitral annular calcification and its role in DMS. We then discuss the epidemiology, natural history, differential diagnosis, mechanisms, and echocardiographic assessment of DMS.

Elevation of miR-221 and -222 in the internal mammary arteries of diabetic subjects and normalization with metformin.

Diabetes is a major risk factor for cardiovascular disease and is associated with increased intimal thickening and accelerated vascular smooth muscle cell (VSMC) proliferation. We measured the expression of two microRNAs that promote intimal thickening, miR-221/222, and mRNA encoding a downstream target, p27(Kip1), in internal mammary artery (IMA) segments collected from 37 subjects undergoing coronary artery bypass grafting. The segments were stratified into three groups: non-diabetic subjects (ND), diabetic subjects not on metformin (DMMet-), and diabetic subjects on metformin (DMMet+). The DMMet- group exhibited a significant increase in miR-221/222 and decrease in p27(Kip1) mRNA compared to both the ND and DMMet+ groups. miR-221/222 levels inversely correlated with metformin dose. VSMCs isolated from the IMAs of the DMMet- group proliferate at a faster rate than those of the ND and DMMet+ groups. Further studies into the importance of miR-221/222 in the increased intimal thickening observed in diabetic subjects is warranted.

Isolation of endothelial cells and vascular smooth muscle cells from internal mammary artery tissue.

Analyses of vascular smooth muscle cell and endothelial cell function through tissue culture techniques are often employed to investigate the underlying mechanisms regulating cardiovascular disease. As diseases such as diabetes mellitus and chronic kidney disease increase a patient's risk of cardiovascular disease, the development of methods for examining the effects of these diseases on vascular smooth muscle cells and endothelial cells is needed. Commercial sources of endothelial cells and vascular smooth muscle cells generally provide minimal donor information and are in limited supply. This study was designed to determine if vascular smooth muscle cells and endothelial cells could be isolated from human internal mammary arteries obtained from donors undergoing coronary artery bypass graft surgery. As coronary artery bypass graft surgery is a commonly performed procedure, this method would provide a new source for these cells that when combined with the donor's medical history will greatly enhance our studies of the effects of complicating diseases on vascular biology. Internal mammary artery tissue was obtained from patients undergoing coronary artery bypass graft surgery. Through a simple method employing two separate tissue digestions, vascular smooth muscle cells and endothelial cells were isolated and characterized. The isolated vascular smooth muscle cells and endothelial cells exhibited the expected morphology and were able to be passaged for further analysis. The vascular smooth muscle cells exhibited positive staining for α-smooth muscle actin and the endothelial cells exhibited positive staining for CD31. The overall purity of the isolations was > 95%. This method allows for the isolation of endothelial cells and vascular smooth muscle cells from internal mammary arteries, providing a new tool for investigations into the interplay of vascular diseases and complicating diseases such as diabetes and kidney disease.