Effects of RBT-1 on preconditioning response biomarkers in patients undergoing coronary artery bypass graft or heart valve surgery: a multicentre, double-blind, randomised, placebo-controlled phase 2 trial.

Background: RBT-1 is a combination drug of stannic protoporfin (SnPP) and iron sucrose (FeS) that elicits a preconditioning response through activation of antioxidant, anti-inflammatory, and iron-scavenging pathways, as measured by heme oxygenase-1 (HO-1), interleukin-10 (IL-10), and ferritin, respectively. Our primary aim was to determine whether RBT-1 administered before surgery would safely and effectively elicit a preconditioning response in patients undergoing cardiac surgery.

Methods: This phase 2, double-blind, randomised, placebo-controlled, parallel-group, adaptive trial, conducted in 19 centres across the USA, Canada, and Australia, enrolled patients scheduled to undergo non-emergent coronary artery bypass graft (CABG) and/or heart valve surgery with cardiopulmonary bypass.

Intimal hyperplasia, saphenous vein graft disease, and clinical outcomes: Insights from the CTSN VEST randomized trial.

Background: Diffuse intimal hyperplasia and graft irregularity adversely affect the long-term patency of saphenous vein grafts (SVGs) and clinical outcomes of patients undergoing coronary artery bypass grafting (CABG). The VEST trial evaluated the efficacy of external graft support in limiting the development of intimal hyperplasia (IH) at 1 year postsurgery. In the present secondary analysis, we explored the associations between graft disease and IH and clinical events.

External Support for Saphenous Vein Grafts in Coronary Artery Bypass Surgery: A Randomized Clinical Trial.

Importance: Intimal hyperplasia and subsequent saphenous vein graft failure may have significant adverse clinical effects in patients undergoing coronary artery bypass surgery. External support of saphenous vein grafts has the potential to prevent vein graft dilation and hence slow the rate of intimal hyperplasia and increase long-term vein patency.

Objective: To determine efficacy, as measured by intimal hyperplasia, and safety of an external saphenous vein graft support device in patients undergoing a coronary bypass graft procedure.

Rationale and design of a randomized trial evaluating an external support device for saphenous vein coronary grafts.

Background: Coronary artery bypass grafting (CABG) is the most common revascularization approach for the treatment of multi-vessel coronary artery disease. While the internal mammary artery is nearly universally used to bypass the left anterior descending coronary artery, autologous saphenous vein grafts (SVGs) are still the most frequently used conduits to grafts the remaining coronary artery targets. Long-term failure of these grafts, however, continues to limit the benefits of surgery.

PATENCY-2 trial of vonapanitase to promote radiocephalic fistula use for hemodialysis and secondary patency.

Objective: Arteriovenous fistulas created for hemodialysis often fail to become usable and are frequently abandoned. This prospective trial evaluated the efficacy of vonapanitase, a recombinant human elastase, in increasing radiocephalic fistula use for hemodialysis and secondary patency.

Methods: PATENCY-2 was a randomized, double-blind, placebo-controlled trial in patients on or approaching the need for hemodialysis undergoing radiocephalic arteriovenous fistula creation.

POST-CONCUSSIVE CHANGES IN BALANCE AND POSTURAL STABILITY MEASURED WITH CANESENSE™ AND THE BALANCE ERROR SCORING SYSTEM (BESS) IN DIVISION I COLLEGIATE FOOTBALL PLAYERS: A CASE SERIES.

Introduction: Impairments in postural stability have been identified following sports-related concussion. CaneSense™ is a recently developed mobile lower limb motion capture system and mobile application for movement assessment which provides an objective measure of postural stability. One of the components within CaneSense™ is the Post-Concussive Excursion Index (PCEI), a measure of postural stability expressed as a percentage of symmetry between lower limbs.

A randomized trial of vonapanitase (PATENCY-1) to promote radiocephalic fistula patency and use for hemodialysis.

Objective: Arteriovenous fistulas created in patients with chronic kidney disease often lose patency and fail to become usable. This prospective trial evaluated the efficacy of vonapanitase, a recombinant human elastase, in promoting radiocephalic fistula patency and use for hemodialysis.

Methods: PATENCY-1 was a double-blind, placebo-controlled trial that enrolled 349 patients on or approaching hemodialysis and being evaluated for radiocephalic arteriovenous fistula creation.

A MULTIDISCIPLINARY APPROACH TO THE REHABILITATION OF A COLLEGIATE FOOTBALL PLAYER FOLLOWING ANKLE FRACTURE: A CASE REPORT.

Background And Purpose: Multiple rehabilitation factors including overall wellness need to be considered when an athlete returns to sport after an injury. The purpose of this case report is to describe a multidisciplinary approach for return to sport of a Division I collegiate football player following a traumatic ankle fracture requiring surgical repair. The assessment and treatment approach included the use of a performance-based physical therapy outcome measure, self-reported functional abilities, body composition assessments, and nutritional counseling.

Effects of red-cell storage duration on patients undergoing cardiac surgery.

Background: Some observational studies have reported that transfusion of red-cell units that have been stored for more than 2 to 3 weeks is associated with serious, even fatal, adverse events. Patients undergoing cardiac surgery may be especially vulnerable to the adverse effects of transfusion.

Methods: We conducted a randomized trial at multiple sites from 2010 to 2014.

Return to Sport Following Surgery for a Complicated Tibia and Fibula Fracture in a Collegiate Women's Soccer Player with a Low Level of Kinesiophobia.

Background & Purpose: Much attention has been solely paid to physical outcome measures for return to sport after injury in the past. However, current research shows that the psychological component of these injuries can be more predictive of return to sport than physical outcome measures. The purpose of this case report is to describe the successful return to sport following surgery of a complicated tibia and fibula fracture of a Division I collegiate women's soccer player with a low level of kinesiophobia.

Application of human type I pancreatic elastase (PRT-201) to the venous anastomosis of arteriovenous grafts in patients with chronic kidney disease.

Purpose: To explore the safety and efficacy of PRT-201 applied to the outflow vein of a newly created arteriovenous graft (AVG).

Methods: Randomized, double-blind, placebo-controlled, single-dose escalation study of PRT-201 (0.01 to 9 mg) applied to the graft-vein anastomosis and adjacent outflow vein immediately after AVG placement.

Effect of an implantable gentamicin-collagen sponge on sternal wound infections following cardiac surgery: a randomized trial.

Context: Despite the routine use of prophylactic systemic antibiotics, sternal wound infection still occurs in 5% or more of cardiac surgical patients and is associated with significant excess morbidity, mortality, and cost. The gentamicin-collagen sponge, a surgically implantable topical antibiotic, is currently approved in 54 countries. A large, 2-center, randomized trial in Sweden reported in 2005 that the sponge reduced surgical site infection by 50% in cardiac patients.