HB-0014 Bruckner et al 2019 PDF - Application Techniques of Novel Hemostat in Cardiac Operations

DOI: 10.1111/jocs.14171 SURGICAL TECHNIQUE Application techniques of a novel hemostat in cardiac operations: HEMOBLAST Brian A. Bruckner MD1 | Uy Ngo PA1 | Mahesh Ramchandani MD1 | Erik Suarez MD1 | Samir Awad MD...

DOI: 10.1111/jocs.14171 SURGICAL TECHNIQUE Application techniques of a novel hemostat in cardiac operations: HEMOBLAST Brian A. Bruckner MD1 | Uy Ngo PA1 | Mahesh Ramchandani MD1 | Erik Suarez MD1 | Samir Awad MD 2 | Michael Reardon MD 1 1 Houston Methodist Hospital, Methodist DeBakey Heart & Vascular Center, Houston, Abstract Texas Background: Postoperative bleeding complications are associated with less favorable 2 Department of Surgery, Michael E. DeBakey outcomes in cardiac surgery and contribute to excessive overall healthcare costs. Veterans Affairs Medical Center, Houston, Texas 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 Correspondence Brian A. Bruckner, MD, 6550 Fannin, Suite plasma thrombin that may help reduce surgical bleeding. 1401, Houston, TX 77030. Aims: The aim of this study was to describe the techniques of application for this new Email: [email protected] combination powder‐based hemostat, HB, and demonstrate its use employing Funding information photographs of application methods during cardiac procedures. Biom'up, Lyon, France 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. KEYWORDS cardiac, collagen, hemostat, hemostatic powder, thrombin 1 | INTRODUCTION postoperative blood product administration is also associated with potential risks including adverse reactions, transfusion‐related Postoperative bleeding complications are associated with less injuries, or transmission of infectious diseases that are significant favorable outcomes in cardiac surgery and contribute to excessive factors for morbidity or mortality.2 In a study examining open heart 1 overall health care costs. The need for intraoperative and procedures requiring re‐exploration for bleeding, it was described --------------------------------------------------------------------------------------------------------------------------- This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. © 2019 The Authors. Journal of Cardiac Surgery Published by Wiley Periodicals, Inc. J Card Surg. 2019;1-5. wileyonlinelibrary.com/journal/jocs | 1 2 | BRUCKNER ET AL. F I G U R E 1 A, HEMOBLAST shown with cap. B, HEMOBLAST shown without cap that 66% of such cases were from surgical bleeding vs 34% attributed heart, including the great vessels. Several applications may be used, 3 to coagulopathy where no surgical bleeding site could be found. especially in revision cardiac cases where dissection of adhesions from Topical hemostatic agents have been developed to reduce blood loss previous surgery may lead to diffuse bleeding. After the application of within the surgical field and when used as an adjuvant measure in the the hemostatic powder, a saline‐soaked laparotomy pad/sponge is operating room, may reduce overall bleeding during the postoperative then applied and wound appropriate pressure is held for 3 minutes. period.4 Topical hemostatic agents are usually applied to the bleeding After pressure is applied, the laparotomy pad is carefully removed to area and pressure is applied to promote clotting and stop active bleeding. re‐evaluate the surgical field. Gentle irrigation with saline may be used A novel combination powder‐based agent HEMOBLAST Bellows to separate the laparotomy pad from the powder. When applying (HEMOBLAST; Biom’up, Lyon, France) has now become commercially HEMOBLAST to a vertical surface such as the sternal edge, the available and is similar to other powdered hemostats with regard to being laparotomy pad can be placed below the bleeding site to catch falling readily available and easy to use, but has additional hemostatic properties powder. This powder can then be approximated to the bleeding site as it is the only available agent containing chondroitin sulfate and when pressure is held with the saline‐soaked pad. If there continues to thrombin.5 The aim of this study was to describe the techniques of be bleeding (not controllable by conventional surgical techniques), an application and use of the new combination powder‐based hemostat additional application of HEMOBLAST can be repeated with the same (HEMOBLAST) and demonstrate its use employing photographs of steps as described above. application techniques during cardiac procedures. HEMOBLAST is a combination agent consisting of porcine‐ derived collagen, bovine‐derived chondroitin sulfate, and human‐ 3 | C L I N I C A L E XP E R IE N C E derived thrombin. The bellows, (Figure 1A and 1B) which contains the hemostat, includes 1.65 g of powder. This device has been This study was approved by the Institutional Review Board at the evaluated in a recent prospective, randomized, controlled trial, and Houston Methodist Hospital and patient confidentiality was assured. received the U.S. Food and Drug Administration approval for use in Patient consent was also obtained for the use of the intraoperative 6 minimal, mild, and moderate bleeding. photographs in the manuscript. For the consented patients undergoing cardiac procedures, the procedures (coronary artery bypass and left ventricular assist device 2 | SU R GI CA L TECH NI QUE (LVAD) implantation) were performed with the use of full cardiopul- monary bypass which included aortic and atrial cannulation. The Applying HEMOBLAST first involves quickly blotting excess blood at patients underwent heparinization and reversal with protamine sulfate the target site with a dry pad, sponge, or suction. HEMOBLAST is then at the conclusion of the procedure. HEMOBLAST was applied after rapidly applied to the target site to ensure complete coverage. The protamine administration to the indicated area(s) of the surgical field. powder may be used at a focal bleeding area such as a peripheral The initial 24 procedures in which HEMOBLAST was used at our vessel, or large diffuse bleeding field such as the mediastinum and institution included: LVAD insertions, lung transplants, heart BRUCKNER ET AL. | 3 F I G U R E 2 A, Redo sternotomy revealing mediastinal bleeding/oozing. B, HEMOBLAST application to mediastinal bleeding sites. C, Wet lap application to apply pressure. D, Gentle removal of lap pad reveals reduction in bleeding transplants, aortic valve replacements, coronary artery bypass dissection of adhesions from the previous bypass procedure and grafting, and mitral valve repair. With regard to complications eventually resulted in successful revascularization which included two occurring in the first 30 days following these cases, no instances of new saphenous vein grafts to the left‐sided circulation in addition to mediastinitis, sternal infections, or allergic reaction were observed. the already patent left internal artery mammary graft. The case was There was no 30‐day mortality in this group of patients. done utilizing full cardiopulmonary bypass and cardioplegia. After revascularization, the patient was weaned from cardiopulmonary bypass and heparin was reversed with protamine sulfate. The cannulas 3.1 | Bleeding during coronary artery bypass used for the bypass procedure were removed and the field was surgery inspected for surgical hemostasis, ie, need for polypropylene sutures. A 73‐year‐old male underwent a redo coronary artery bypass After surgical hemostasis had been achieved, diffuse “oozing” in the procedure and had been on preoperative antiplatelet agents including superior mediastinal area was still noted despite multiple attempts of aspirin and clopidogrel. The operative course required extensive holding pressure (Figure 2A). HEMOBLAST was applied to this F I G U R E 3 A, Sternal bleeding after LVAD procedure is shown. B, HEMOBLAST applied to bleeding sites on the sternum. C, Wet lap sponge applied for 3 minutes to powder. D, After sponge has been removed significant improvement in hemostasis noted. LVAD, left ventricular assist device 4 | BRUCKNER ET AL. localized area of bleeding where adhesions from a previous advantage of the ease of use and can cover broad surgical fields or thoracotomy were taken down and possibly platelet dysfunction small areas without the need for additional applicators or pressurized occurred related to preoperative medication and cardiopulmonary gases. These agents are easy to dispense to the surgeon in a matter bypass. As shown in Figure 2B, once HEMOBLAST was fully applied to of seconds and do not require refrigeration or mixing.6 From a clinical the bleeding area, it was followed by the rapid placement of a soaking application prospective, we have used the product in over 60 open wet lap pad (Figure 2C). After approximately 3 minutes of gentle cardiothoracic and vascular procedures since late 2018. Improve- manual pressure on the lap pad, HEMOBLAST was slowly removed ments in the field of hemostasis have been noted in the majority of and gently irrigated. Hemostasis was achieved after removal of the these high‐risk patients prone to bleeding (ie, cardiac surgery pad (Figure 2D). On closer inspection, it is apparent that there was a revisions, LVAD patients, patients on platelet inhibitors, etc.). transparent adherent layer that had formed over the bleeding site, In conclusion, HEMOBLAST is a novel powder‐based multiple which resulted in cessation of bleeding/oozing from this area. component hemostatic agent that promotes focal or large area hemostasis. We have presented the techniques of use which are important to the successful application of HEMOBLAST to assist with 3.2 | Sternal bleeding following LVAD placement hemostasis. Additional studies underway will address its effect on A 57‐year‐old woman with a significant history of end‐stage heart failure surgical blood loss, morbidity, and blood conservation. underwent LVAD placement. The case was performed utilizing full cardiopulmonary bypass and heparinization. After the device had been AC KNO WL EDG M EN T placed, the patient was weaned from bypass and the temporary bypass cannulas were removed. Systemic protamine sulfate was given to reverse The development of this manuscript was supported by Biom’up. the heparinization. Before closing the sternal incision, oozing was noted from the sternum and HEMOBLAST was applied for hemostasis. As CON F LI CT OF IN TE RES T S depicted in Figure 3A, there is an area of “oozing” from the sternal surface. HEMOBLAST was applied in Figure 3B to the sternal surface Dr Bruckner and Dr Awad are consultants of Biom’up. No other followed by a soaking wet laparotomy pad (Figure 3C). After 3 minutes of authors have relevant conflict of interests to disclose. wound appropriate pressure on the wet laparotomy pad, it was removed to reveal improved hemostasis (less oozing of blood from the sternal ORCI D bone) as demonstrated in Figure 3D. Brian A. Bruckner http://orcid.org/0000-0002-0263-5128 4 | COMMENT R E F E R E N CE S Attaining hemostasis during surgery is paramount, whether bleeding 1. Christensen MC, Krapf S, Kempel A, von Heymann C. Costs of is surgical or from an existing coagulopathy, especially during cardiac excessive postoperative hemorrhage in cardiac surgery. J Thorac Cardiovasc Surg. 2009;138(3):687‐693. procedures. Retrospective studies have shown that perioperative red 2. Vamvakas EC, Blajchman MA. Transfusion‐related mortality: blood cell transfusion is associated with a dose‐dependent increased the ongoing risks of allogeneic blood transfusion and the risk of postoperative cardiac complications, overall morbidity, and in‐ available strategies for their prevention. Blood. 2009;113(15): hospital mortality.7 Additionally, these studies have shown that 3406‐3417. 3. Hall TS, Brevetti GR, Skoultchi AJ, Sines JC, Gregory P, Spotnitz AJ. decreasing the need for transfusions in the perioperative period can Re‐exploration for hemorrhage following open heart surgery differ- lessen the length of intensive care unit stay for patients.8 The use of entiation on the causes of bleeding and the impact on patient intraoperative hemostatic agents has become increasingly important outcomes. Ann Thorac Cardiovasc Surg. 2001;7(6):352‐357. as they aid with hemostasis and can potentially decrease operating 4. Nasso G, Piancone F, Bonifazi R, et al. Prospective, randomized clinical trial of the FloSeal matrix sealant in cardiac surgery. Ann room times, and the need for blood transfusions.4,9 The beneficial Thorac Surg. 2009;88(5):1520‐1526. effects of these agents can contribute to improved patient outcomes 5. Bruckner BA, Blau LN, Rodriguez L, et al. Microporous polysaccharide and overall health care savings.4,10 hemosphere absorbable hemostat use in cardiothoracic surgical In this paper, we demonstrate the use of the novel hemostat procedures. J Cardiothorac Surg. 2014;9:134. HEMOBLAST on patients undergoing cardiac surgical procedures. 6. Ardehali A, Spotnitz WD, Hoffman RW, et al. Evaluation of the safety and efficacy of a new hemostatic powder using a quantitative surface Unlike other powder‐based agents available from our observations in bleeding severity scale. J Card Surg. 2019;34(1):50‐62. the operative field, the multiple component HEMOBLAST appears to 7. Koch CG, Li L, Duncan AI, et al. Morbidity and mortality risk have more adherence properties and actually “sticks” to the field and associated with red blood cell and blood‐component transfusion in turns into a thin transparent layer that covers the bleeding site. In isolated coronary artery bypass grafting. Crit Care Med. 2006;34(6): 1608‐1616. addition, the collagen and thrombin would appear to provide strong 8. Galas FR, Almeida JP, Fukushima JT, et al. Blood transfusion in properties that facilitate platelet aggregation and conversion of cardiac surgery is a risk factor for increased hospital length of stay in fibrinogen to fibrin. Powder‐based hemostatic agents offer the adult patients. J Cardiothorac Surg. 2013;8:54. BRUCKNER ET AL. | 5 9. Wallace DG, Cruise GM, Rhee WM, et al. A tissue sealant based on reactive multifunctional polyethylene glycol. J Biomed Mater Res. How to cite this article: Bruckner BA, Ngo U, Ramchandani 2001;58(5):545‐555. M, Suarez E, Awad S, Reardon M. Application techniques of a 10. Ikeme S, Weltert L, Lewis KM, et al. Cost‐effectiveness analysis of a novel hemostat in cardiac operations: HEMOBLAST. J Card sealing hemostat patch (HEMOPATCH) vs standard of care in cardiac surgery. J Med Econ. 2018;21(3):273‐281. Surg. 2019;1‐5. https://doi.org/10.1111/jocs.14171