A 2015-2016 Survey of American Board of Cardiovascular Perfusion Certified Clinical Perfusionists: Perfusion Profile and Clinical Trends.

To document the current perfusion workforce status and to anticipate the future demands of an ever-changing perfusion workplace environment, a valid survey is needed to help guide the future of the perfusion workforce. The American Board of Cardiovascular Perfusion (ABCP) sponsored a survey of Certified Clinical Perfusionist (CCP) demographic and clinical trends that was linked electronically to the 2015-2016 ABCP online recertification process. Of 3,875 eligible CCP's, 3,056 (78.9%) responded to the survey. The 12 survey questions covered the topics of gender, age, education levels, years of clinical experience, annual clinical activity exposure, high fidelity simulation experience, recertification requirement satisfaction and professional activity requirement contentment. The results of the ABCP annual survey are being published in accordance with the ABCP's commitment to establish and maintain interactive communication with the community of CCPs. The goal of this survey is to present the perfusion and health-care community with important statistics related to the current field of perfusion and establish trends to guide the future of perfusion.

Rethinking the Paradigm: Modern Approach to Proximal Aortic Reconstruction Demonstrates Excellent Outcomes.

BACKGROUND: Techniques for aortic surgery continue to evolve. A real-world snapshot of patients undergoing elective surgery for aneurysm in the modern era is helpful to assist in deciding the appropriate timing for intervention. We herein describe our experience with 100 consecutive patients who underwent primary elective surgery for aneurysm of the proximal thoracic aorta over a two-year period at a single institution. METHODS: The majority of our patients were male, mean age 61.19 ± 13.33 years. Two patients had Marfan syndrome. Twenty-eight patients had bicuspid aortic valve. Thirty-four patients underwent aortic root replacement utilizing a composite valve/graft conduit; 23 had valve-sparing root replacements. The ascending aorta was replaced in 89 patients; 80 (89.9%) of these included a period of circulatory arrest at moderate hypothermia utilizing unilateral selective antegrade cerebral perfusion. RESULTS: Thirty-day mortality was zero. Perioperative stroke occurred in 2 patients, both of whom completely recovered prior to discharge. No patients required re-exploration for bleeding. One patient developed a sternal wound infection. Fifteen patients required readmission to hospital within thirty days of discharge. CONCLUSION: Elective surgery for aneurysm of the proximal aorta is safe, reproducible, and is associated with outcomes that are superior to those seen in an acute aortic syndrome. It may be appropriate to offer surgery to younger patients with proximal aortic aneurysms at smaller diameters, even if their aortic dimensions do not yet meet traditional guidelines for surgical intervention.

Right Atrial Vacuum-Assisted Thrombectomy: Single-Center Experience.

BACKGROUND: Right heart thrombus in the absence of structural heart disease, atrial fibrillation, or intracardiac catheter is rare. It typically represents a thrombus migrating from the venous system to the lung, known as thrombi-in-transit, and can lead to a life-threatening pulmonary embolism. The optimal therapy for thrombi-in-transit remains controversial. We report our experience using percutaneous removal of right heart thrombus using vacuum aspiration. METHODS: Patients with right atrial mass who were hemodynamically stable and underwent vacuum thombectomy using the AngioVac system (AngioDynamics) at our institution were included in this analysis. Between December 2012 and August 2014, a total of 7 patients (2 men, 5 women) with a mean age of 51.5 years (range, 20-83 years) underwent right atrial thrombectomy. Data during the procedure and follow-up period were collected and analyzed. RESULTS: All patients were hemodynamically stable before the procedure. The procedure was considered successful in 6 patients. All patients survived through hospitalization. No periprocedural bleeding, stroke, or myocardial infarction occurred. One patient developed cardiogenic shock after the procedure that required extracorporeal membrane oxygenation support for <24 hours. There was no recurrent venous thromboembolism at a mean follow-up of 9 months. CONCLUSION: Vacuum-assisted thrombectomy can be a potential treatment option for hemodynamically stable patients with large right-sided intracardiac thrombus who are not surgical candidates.

Hybrid minimally invasive extraction of atrial clot avoids redo sternotomy in Jehovah's Witness.

We report the novel use of the AngioVac device in a percutaneous hybrid approach to remove a large right atrial clot as an effective and potentially lifesaving alternative to a very high-risk redo-sternotomy in a Jehovah's Witness patient.

An impact analysis of the application of the threshold of toxicological concern concept to pharmaceuticals.

The recent application of the threshold of toxicological concern (TTC) concept to the regulation of pharmaceuticals in the European Union is analyzed. The derivation of TTC and the threshold of regulation that followed it were originally intended to provide makers of food contact materials greater flexibility with their products, while allowing the CFSAN branch of FDA to conserve its resources for more important issues. A reanalysis of the scientific data employed by EMEA regulators to rationalize its 1.5 mcg default genotoxic impurity limit is presented to demonstrate (a) that direct translation of conclusions relevant to food consumption are unduly influenced by many classes of potent carcinogens of historic concern which would be impossible to generate unknowingly as pharmaceutical impurities, and (b) that the majority of reactive chemicals that would be useful to synthetic chemists are among the least potent carcinogens in the underpinning supportive analyses. Evidence is further presented to show that implementation and acceptance of a 1.5 mcg TTC-based total limit on such impurities can be expected to impede pharmaceutical research and development efficiency while providing an insignificant cancer risk-avoidance benefit to patients who require pharmaceutical treatments. The conclusion drawn is that a significantly higher default limit can readily be defended that would be both in keeping with TTC principles and the best interest of patients.

A 21st century HPLC workflow for process R&D.

A unique high-performance liquid chromatographic (HPLC) workflow specifically designed for the rigors of process development has been developed. A key feature of the workflow is the creation of an HPLC software-hardware platform designed to automatically and systematically screen samples using a matrix of columns and eluents to aggressively search for impurities. The workflow platform was assembled from commercial hardware components and both custom and commercial HPLC software. The platform can be used to challenge existing HPLC methods or to develop new methods. Three real world examples are provided to illustrate the utility of the platform to rigorously assess the complexity of samples and to develop new and improved HPLC methods.

Synthesis of Z-5-carboxymethylene-1,3-dioxolan-4-ones: a better way.

The title compounds were prepared by a straightforward two-step procedure. Tartaric acid was first protected as either a bis(ketal) or a bis(acetal). This intermediate was then treated with potassium tert-butoxide at reduced temperature to effect a stereoselective elimination leading to the Z diastereomer of the alpha,beta-unsaturated acid. This protocol is useful for the laboratory-scale synthesis of these compounds but can also be scaled up to produce kilogram quantities of the material.