Evaluation of the Safety and Efficacy of a Novel Thrombin Containing Combination Hemostatic Powder Using a Historical Control.

This clinical study compares 2 hemostatic agents, a novel combination powder (CP) (HEMOBLAST™ Bellows) and an established polysaccharide starch powder (PP) (Arista™ AH) to assess the usefulness of CP. Retrospective comparative analysis of CP (July 2018 to July 2019, 68 patients) to PP (January 2011 to January 2013, 94 patients) in cardiothoracic patients was performed using linear regression models adjusting for age, sex, and procedure type for the endpoints: blood loss; protamine to skin closure time (hemostasis time); chest tube output and blood products required 48 hours postoperatively; ICU stay; postoperative comorbidities; and 30 day mortality. 162 patients (108 M: 54 F) underwent 162 cardiothoracic surgical procedures including: transplantation (n = 44), placement of ventricular assist device (n = 87), and others (n = 31). Use of CP compared to PP (Estimated Mean Difference [95% CI], P-value) produced significant reductions: blood loss (mL) (-886.51 [-1457.76, -312.26], P = 0.003); protamine to skin closure time (min) (-16.81 [-28.03, -5.59], P = 0.004); chest tube output (48 hrs, mL) (-445.76 [-669.38, -222.14], P < 0.001); packed red blood cell transfusions (units) (-0.98 [-1.56, -0.4], P = 0.001); and postoperative comorbidities (-0.31 [-0.55, -0.07], P = 0.012). There were no differences in the ICU stay (4.07 [-2.01, 10.15], P = 0.188) or 30-day mortality (0.57 [0.20, 1.63], P = 0.291). The use of CP in complex cardiothoracic operations resulted in improved hemostasis and significant clinical benefits in blood loss, transfusion requirements, morbidity, and time in operating room.

Percutaneous Left Axillary Artery Placement of Intra-Aortic Balloon Pump in Advanced Heart Failure Patients.

OBJECTIVES: This study presents the largest clinical experience of percutaneously placed axillary intra-aortic balloon pump (IABP) in patients with advanced heart failure. BACKGROUND: Transfemoral placement of IABP limits mobility and recuperation in patients who need prolonged support. We had previously reported a novel percutaneous method of IABP placement in the axillary artery and now present our expanded experience with this technique. METHODS: We performed a retrospective chart review of patients with advanced heart failure with percutaneous axillary IABP placement from November 2007 to June 2018 at Houston Methodist Hospital. We defined successful cardiac replacement therapy as heart transplant or left ventricular assist device implantation. We compared patients who had successful cardiac replacement with those who died and those who needed unplanned escalation of mechanical circulatory support. RESULTS: Of the 195 patients identified, 133 (68%) underwent successful cardiac replacement (120 transplants and 13 left ventricular assist device) as planned. End-organ function improved on IABP support in patients bridged to next therapy. There were 16 patients that died while on IABP support and 18 needed escalation of support. Higher right atrial/wedge ratio, higher right atrial pressure, smaller left ventricular end diastolic dimension, and ischemic cardiomyopathy were associated with death on the IABP in multivariate analysis. Post-transplant and post left ventricular assist device survival for those bridged successfully was 87% and 62%, respectively. Although bedside repositioning was frequent, 37% needed replacement for malfunction. Vascular complications occurred in a minority. CONCLUSIONS: Percutaneous axillary approach for IABP placement is a feasible strategy for prolonged mechanical circulatory support in patients with advanced heart failure.

Application techniques of a novel hemostat in cardiac operations: HEMOBLAST.

BACKGROUND: Postoperative bleeding complications are associated with less favorable outcomes in cardiac surgery and contribute to excessive overall healthcare costs. HEMOBLAST (Biom'up, Lyon, France) (HB) is a novel ready-to-use hemostatic powder that consists of porcine collagen, bovine chondroitin sulfate, and human pooled plasma thrombin that may help reduce surgical bleeding. AIMS: The aim of this study was to describe the techniques of application for this new combination powder-based hemostat, HB, and demonstrate its use employing photographs of application methods during cardiac procedures. MATERIALS AND METHODS: The initial 24 procedures in which HB was used at our institution included: left ventricular assist device (LVAD) insertions, lung transplants, heart transplants, aortic valve replacements, coronary artery bypass grafting, and mitral valve repair. RESULTS: Hemostasis was achieved in all cases and there were no instances of mediastinitis, sternal infections, allergic reactions, or 30-day mortality. DISCUSSION: This report describes the best methods of application of HB including use for treatment of mediastinal bleeding in a re-operative procedure in a patient on antiplatelet agents and sternal bleeding during an LVAD insertion. Proper application can facilitate excellent hemostasis using this powder. CONCLUSION: HB is a novel powder-based multiple component hemostatic agent that promotes focal or large area hemostasis. We have presented the techniques of use that are important to the successful application of HB to facilitate hemostasis.

Microporous polysaccharide hemosphere absorbable hemostat use in cardiothoracic surgical procedures.

BACKGROUND: Topical hemostatic agents are used to reduce bleeding and transfusion need during cardiothoracic surgery. We report our experience with Arista® AH Absorbable Hemostatic Particles (Arista® AH), a novel plant-based microporous polysaccharide hemostatic powder. METHODS: Data were retrospectively collected for patients (n = 240) that received cardiothoracic surgery at our institution from January 2009 to January 2013 with (n = 103) or without (n = 137) the use of Arista® AH. Endpoints included protamine to skin closure time (hemostasis time), cardiopulmonary bypass time, quantity of Arista® AH applied, intraoperative blood product usage, intraoperative blood loss, chest tube output 48 hours postoperatively, blood products required 48 hours postoperatively, length of stay in the intensive care unit, 30-day morbidity, and 30-day mortality. RESULTS: 240 patients (176 M: 64 F) underwent 240 cardiothoracic procedures including heart transplantation (n = 53), cardiac assist devices (n = 113), coronary artery bypass grafts (n = 20), valve procedures (n = 19), lung transplantation (n = 17), aortic dissection (n = 8), and other (n = 10). Application of Arista® AH led to significant reduction in hemostasis time versus the untreated control group (Arista® AH: 93.4 ± 41 min. vs. CONTROL: 107.6 ± 56 min., p = 0.02). Postoperative chest tube output in the first 48 hours was also significantly reduced (Arista® AH: 1594 ± 949 mL vs. CONTROL: 2112 ± 1437 mL, p < 0.001), as well as transfusion of packed red blood cells (Arista® AH: 2.4 ± 2.5 units vs. CONTROL: 4.0 ± 5.1 units, p < 0.001). There was no significant difference in 30-day mortality or postoperative complications. CONCLUSION: Use of Arista® AH in complex cardiothoracic surgery resulted in a significant reduction in hemostasis time, postoperative chest tube output, and need for postoperative blood transfusion.

Experience of sternal secondary closure by means of a titanium fixation system after transverse thoracosternotomy.

Sternal dehiscence is a common complication after transverse thoracosternotomy in patients undergoing bilateral sequential lung transplantation (BSLT). These patients can be treated with conservative therapy, but severe dehiscence requires surgical reapproximation and secondary closure of the sternum. Seventy-one cases of patients who underwent BSLT between January 2007 and May 2009 were reviewed retrospectively. Out of 71 patients, the sternum was intact in two cases due to the use of bilateral anterolateral thoracotomy, and a clamshell incision had been utilized in 69 patients. Four patients (6.8%) presented with persistent chest pain with severe sternal dehiscence diagnosed by chest X-ray and/or chest computed tomography, and underwent sternal reapproximation using the Synthes Titanium Sternal Fixation System for longitudinal sternal plating. All four patients had successful sternal realignment and resolution of their preoperative clinical symptoms. No perioperative or postoperative complications were observed. The Synthes Titanium Sternal Fixation System is an appropriate and effective method for internal fixation of the sternum when used for symptomatic severe sternal dehiscence after sequential BSLT via transverse thoracosternotomy.

Recurrent device thrombi during mechanical circulatory support with an axial-flow pump is a treatable condition and does not preclude successful long-term support.

The formation of pump thrombus after implantation of axial-flow ventricular assist devices has been described previously. We report a case of recurrent pump thrombus formation in a 63-year-old man who was bridged to heart transplantation with a MicroMed DeBakey ventricular assist device. He was treated with a low, dose-adjusted thrombolytic treatment protocol, and was subsequently successfully bridged to transplantation. Transient pump thrombus formation does not preclude safe long-term support with an axial-flow pump when diagnosed and treated appropriately.