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).

SPOT GRADE II: Clinical Validation of a New Method for Reproducibly Quantifying Surgical Wound Bleeding: Prospective, Multicenter, Multispecialty, Single-Arm Study.

The SPOT GRADE (SG), a Surface Bleeding Severity Scale, is a unique visual method for assessing bleeding severity based on quantitative determinations of blood flow. This study assessed the reliability of the SG scale in a clinical setting and collected initial data on the safety and efficacy of HEMOBLAST Bellows (HB), a hemostatic agent, in abdominal and orthopedic operations. Twenty-seven patients were enrolled across 3 centers and received the investigational device.

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).

An immediate access dialysis graft designed to prevent needle-related complications: Results from the initial pre-clinical studies.

Introduction: No technology has been specifically developed with the intent to reduce needle-related vascular access injuries; a significant source of complications and abandonment. We present the initial pre-clinical study results of a novel, self-sealing, immediate cannulation dialysis graft that aims to prevent needle-related complications; to promote safe, reliable needle access; to reduce catheter use; and could facilitate home hemodialyisis.

Methods: The innovative graft design consists of two cannulation chambers with self-sealing properties and materials that prevent side and back wall needle puncture.

Thromboembolic Events with Enterprise Versus Pipeline: Porcine In Vivo Experiment.

Background: Thromboembolic complications are serious adverse events associated with stenting of intracranial aneurysms. For the development of novel devices, currently no practical model exists to evaluate distal embolic events. The purpose of the current study was 2-fold: 1) assess the feasibility of a porcine carotid bifurcation model for in vivo testing of stent thrombogenicity and 2) compare the thrombogenicity of the Enterprise vascular reconstruction device versus the Pipeline embolization device (PED).

Sample Entropy of Speed Power Spectrum as a Measure of Laparoscopic Surgical Instrument Trajectory Smoothness.

In this study the complexity of the speed power spectrum is assessed as a metric for measuring trajectory smoothness. There are a variety of published methods for analyzing trajectory smoothness but many lack validity. This preliminary study took an information theoretic approach to assess trajectory smoothness by applying the sample entropy measure to the speed power spectrum of simulated and experimental trajectories.

Objective Assessment of the Early Stages of the Learning Curve for the Senhance Surgical Robotic System.

Objective: The purpose of this research is to study the early stages of the Senhance learning curve to report how force feedback impacts learning rate. This serves as an exploratory investigation into assumptions that fellows and faculty will adjust faster to the Senhance in comparison with residents, and that force feedback will not hinder skill acquisition.

Design: In this study, participants completed the peg transfer and precision cutting task from the Fundamentals of Laparoscopic Surgery (FLS) manual skills assessment five times each using the Senhance while instrument motion was tracked.

A novel paraplegia model in awake behaving macaques.

Lower limb paralysis from spinal cord injury (SCI) or neurological disease carries a poor prognosis for recovery and remains a large societal burden. Neurophysiological and neuroprosthetic research have the potential to improve quality of life for these patients; however, the lack of an ethical and sustainable nonhuman primate model for paraplegia hinders their advancement. Therefore, our multidisciplinary team developed a way to induce temporary paralysis in awake behaving macaques by creating a fully implantable lumbar epidural catheter-subcutaneous port system that enables easy and reliable targeted drug delivery for sensorimotor blockade.

Tissue engineered vascular grafts: Origins, development, and current strategies for clinical application.

Since the development of a dependable and durable synthetic non-autogenous vascular conduit in the mid-twentieth century, the field of vascular surgery has experienced tremendous growth. Concomitant with this growth, development in the field of bioengineering and the development of different tissue engineering techniques have expanded the armamentarium of the surgeon for treating a variety of complex cardiovascular diseases. The recent development of completely tissue engineered vascular conduits that can be implanted for clinical application is a particularly exciting development in this field.

Tissue-engineered vascular grafts: autologous off-the-shelf vascular access?

Dialysis grafts have provided reliable access for millions of patients in need of renal replacement therapy. However, regardless of the material used for artificial dialysis grafts their mean patency remains generally poor and infection rates are greater than native arteriovenous fistulas. The need for superior alternatives to conventional synthetic materials used for vascular access has been an area of investigation for more than 25 years and recently there has been a great deal of progress in the field of tissue-engineered vascular grafts.

Arteriovenous fistula creation using the Optiflow vascular anastomosis device: a first in man pilot study.

Although arteriovenous fistulae are the preferred form of dialysis vascular access they continue to have significant problems with maturation failure. The Optiflow device is a sutureless anastomotic conduit which could potentially reduce surgical time and also standardize the surgical procedure. We report herein on the "First in Man" experience with the Optiflow device.

An early study on the mechanisms that allow tissue-engineered vascular grafts to resist intimal hyperplasia.

Intimal hyperplasia is one of the prominent failure mechanisms for arteriovenous fistulas and arteriovenous access grafts. Human tissue-engineered vascular grafts (TEVGs) were implanted as arteriovenous grafts in a novel baboon model. Ultrasound was used to monitor flow rates and vascular diameters throughout the study.

Decellularized tissue-engineered blood vessel as an arterial conduit.

Arterial tissue-engineering techniques that have been reported previously typically involve long waiting times of several months while cells from the recipient are cultured to create the engineered vessel. In this study, we developed a different approach to arterial tissue engineering that can substantially reduce the waiting time for a graft. Tissue-engineered vessels (TEVs) were grown from banked porcine smooth muscle cells that were allogeneic to the intended recipient, using a biomimetic perfusion system.

Readily available tissue-engineered vascular grafts.

Autologous or synthetic vascular grafts are used routinely for providing access in hemodialysis or for arterial bypass in patients with cardiovascular disease. However, some patients either lack suitable autologous tissue or cannot receive synthetic grafts. Such patients could benefit from a vascular graft produced by tissue engineering.

Neoadjuvant chemoradiation for rectal cancer reduces lymph node harvest in proctectomy specimens.

Purpose: The purpose of this study was to compare the number of lymph nodes retrieved following proctectomy for rectal cancer in patients either receiving no neoadjuvant therapy versus those treated with standard preoperative chemoradiation.

Methods: A retrospective review was performed of all consecutive patients that underwent proctectomy for rectal cancer from 1997-2006. Specimens from patients that received neoadjuvant therapy were compared to patients that did not receive preoperative chemoradiation.

Genomic modeling of atherosclerosis in peripheral arterial disease and its variant phenotype in patients with diabetes.

Microarrays can be used to discover candidate genes associated with peripheral arterial disease (PAD) and develop models that predict patient clinical status. We hypothesize that multiple phenotypes of PAD with distinct patterns of gene expression exist. We histologically characterized and extracted ribonucleic acid from 31 arterial samples collected from the lower extremities of patients undergoing amputation or free fibular grafting.

Acute in-vivo evaluation of bleeding with Gelfoam plus saline and Gelfoam plus human thrombin using a liver square lesion model in swine.

Background: Management of post-operative bleeding has historically used topical bovine thrombin. However, possible harm through activation of coagulation inhibitors has encouraged investigation with other hemostatic agents. This study utilized a novel ordinal bleeding model to test whether a Gelfoam + human thrombin solution is superior at controlling bleeding when compared to Gelfoam + saline solution at different time intervals.

Bipolar sealing increases mesenteric reach during bowel transection compared with stapled division: clinical evidence and laboratory support in a porcine model.

Background: The ideal technique for mesenteric division to create tension-free anastomoses has not been defined. For patients undergoing Roux-en-Y gastric bypass (RYGB), the mesenteric division technique was changed from stapler to bipolar sealing using LigaSure for cost reasons. This study aimed objectively to assess the impact of the mesenteric division method on mobilization length of the Roux limb in an animal model.

Effectiveness of Glycerol Mono-oleate as a Biosealant.

Background: The number of femoral artery catheterizations will increase over the next decade to more than 9 million worldwide. Accordingly, a new era of access site management with vascular closure techniques utilizing biologics are being developed and implemented. Glycerol mono-oleate (GMO) is one such biologic - a biodegradable compound that changes from a solid phase to a bioadhesive swollen semisolid phase when exposed to aqueous solutions and heat.

Management of hemostasis in vascular surgery.

The fate of the circulatory system in response to vascular injury is governed by a series of complex biochemical reactions involving cellular elements and plasma proteins. Alteration of this hemostatic balance can result in excessive bleeding or procoagulant complications. In the field of vascular surgery, modulation of this process can have severe implications with respect to the maintenance of vascular conduit patency by avoiding thromboembolic events and the prevention of excess bleeding in the operative setting.

Adventitial endothelial implants reduce matrix metalloproteinase-2 expression and increase luminal diameter in porcine arteriovenous grafts.

Objective: Vascular access dysfunction is a major problem in hemodialysis patients. Only 50% of arteriovenous grafts (AVGs) will remain patent 1 year after surgery. AVGs frequently develop stenoses and occlusions at the venous anastomoses in the venous outflow tract.

The balance of thrombosis and hemorrhage in surgery.

Postoperative hemorrhage and thrombosis is a significant problem during the perioperative period. Understanding the complex and dynamic interplay of factors, proteins, and enzymes during coagulation is imperative to maintain balance between hemostasis and thrombosis. To improve patient outcome, each patient should be risk stratified for bleeding or thrombosis during the preoperative examination.

A description of the preterm fetal sheep systemic and central responses to maternal general anesthesia.

Background: The second trimester is recommended as the optimal time to conduct a surgical procedure on pregnant patients, even though the fetal responses to anesthesia at this age are not known. Here we assessed the responses of preterm fetal sheep to a standard anesthetic regimen of midazolam, thiopental, and isoflurane.

Methods: Variables were monitored in previously instrumented preterm pregnant sheep before, during, and after 4 h of general anesthesia.

General anesthesia improves fetal cerebral oxygenation without evidence of subsequent neuronal injury.

Anesthetic exposure during pregnancy is viewed as a relatively routine medical practice. However, recent rodent studies have suggested that common anesthetic agents can damage the developing brain. Here we assessed this claim in a higher order species by exposing previously instrumented near-term pregnant sheep at gestational day 122 (+/-1) to a combination of midazolam, sodium thiopental, and isoflurane at clinically relevant doses and means of anesthetic delivery (i.

Maternal insufflation during the second trimester equivalent produces hypercapnia, acidosis, and prolonged hypoxia in fetal sheep.

Background: Anecdotal reports suggest that the second trimester is the safest time to conduct a laparoscopic procedure on a pregnant patient, but this supposition has not been tested empirically.

Methods: Previously instrumented preterm sheep (total n = 8) at gestational day 90 (term, 145 days) were anesthetized and then insufflated with carbon dioxide for 60 min at a pressure of 15 mmHg. Cardiovascular parameters were continuously recorded while blood gas status was determined before and at 15-min intervals during and up to 2 h after insufflation.