National Action Plan for Adverse Drug Event Prevention: Recommendations for Safer Outpatient Opioid Use.

INTRODUCTION: Adverse drug events (ADEs) have been highlighted as a major patient safety and public health challenge by the National Action Plan for Adverse Drug Event Prevention (ADE Action Plan), which was released by the Office of Disease Prevention and Health Promotion (ODPHP) in August 2014. The ADE Action Plan focuses on surveillance, evidence-based prevention, incentives, and oversights, additional research needs as well as possible measures and metrics to track progress of ADE prevention within three drug classes: anticoagulants, diabetes agents, and opioids.Objectives and Recommendations. With outpatient opioid prescriptions being a great concern among many healthcare providers, this article focuses on recommendations from the ADE Action Plan to help guide safer opioid use in healthcare delivery settings. Its aim is to discuss current federal methods in place to prevent opioid ADEs while also providing evidence to encourage providers and hospitals to innovate new systems and practices to increase prevention.

Posterior lumbar fusion: choice of approach and adjunct techniques.

The choice among the many options of approach and adjunct techniques in planning a posterior lumbar fusion can be problematic. Debates remain as to whether solid fusion has an advantage over pseudarthrosis regarding long-term symptom deterioration and whether an instrumented or a noninstrumented approach will best serve clinically and/or cost effectively, particularly in elderly patients. Increased motion resulting in higher rates of nonunion and the use of nonsteroidal anti-inflammatory drugs have been studied in animal models and are presumed risk factors, despite the lack of clinical investigation. Smoking is a proven risk factor for pseudarthrosis in both animal models and level III clinical studies. Recent long-term studies and image/clinical assessment of lumbar fusions and pseudarthrosis show that, although imaging remains a key area of difficulty in assessment, including an instrumented approach and a well-selected biologic adjunct, as well as achieving a solid fusion, all carry important long-term clinical advantages in avoiding revision surgery for nonunion.

Episode Care Costs Following Catheter-Directed Reperfusion Therapies for Pulmonary Embolism: A Literature-Based Comparative Cohort Analysis.

This analysis aimed to estimate 30-day episode care costs associated with 3 contemporary endovascular therapies indicated for treatment of pulmonary embolism (PE). Systematic literature review was used to identify clinical research reporting costs associated with invasive PE care and outcomes for ultrasound-accelerated thrombolysis (USAT), continuous-aspiration mechanical thrombectomy (CAMT), and volume-controlled-aspiration mechanical thrombectomy (VAMT). Total episode variable care costs were defined as the sum of device costs, variable acute care costs, and contingent costs. Variable acute care costs were estimated using methodology sensitive to periprocedural and postprocedural resource allocation unique to the 3 therapies. Contingent costs included expenses for thrombolytics, postprocedure bleeding events, and readmissions through 30 days. Through February 28, 2023, 70 sources were identified and used to inform estimates of 30-day total episode variable costs. Device costs for USAT, CAMT, and VAMT were the most expensive single component of total episode variable costs, estimated at $5,965, $10,279, and $11,901, respectively. Costs associated with catheterization suite utilization, intensive care, and hospital length of stay, along with contingent costs, were important drivers of total episode costs. Total episode variable care costs through 30 days were $19,146, $20,938, and $17,290 for USAT, CAMT, and VAMT, respectively. In conclusion, estimated total episode care costs after invasive treatment for PE are heavily influenced by device expense, in-hospital care, and postacute care complications. Regardless of device cost, strategies that avoid thrombolytics, reduce the need for intensive care unit care, shorten length of stay, and reduce postprocedure bleeding and 30-day readmissions contributed to the lowest episode costs.

Best practices for vascular arterial access and closure: a contemporary guide for the cardiac catheterization laboratory.

More than 1 million transcatheter-based cardiovascular procedures across the spectrum of interventional cardiology are performed annually in the United States. With the expanded indications for and increased complexities associated with these procedures, interventional cardiologists are expected to possess the requisite expertise to complete these interventions safely and effectively. While the art of vascular access and closure remains a prerequisite and critical skillset in contemporary practice, there remain significant variations in the techniques employed, resulting in the bleeding and vascular complications encountered in clinical practice. With an increasing recognition of the potential merits to standardized approaches to vascular access and closure, cardiovascular societies have put forth recommendations around best practices for performing these procedures in the cardiac catheterization laboratories. In this review, we aim to: (1) Examine the evolving definitions of bleeding and vascular complications; (2) Review best practices for transradial and transfemoral access and closure, including for large bore procedures; and (3) Highlight knowledge gaps and proposed areas of clinical research pertaining to vascular access which may inform clinical practice and potentially optimize the outcomes of patients undergoing transcatheter-based cardiac and vascular interventions.

Mechanical Thrombectomy for High-Risk Pulmonary Embolism: Insights From the US Cohort of the FLASH Registry.

Background: Acute mortality for high-risk, or massive, pulmonary embolism (PE) is almost 30% even when treated using advanced therapies. This analysis assessed the safety and effectiveness of mechanical thrombectomy (MT) for high-risk PE. Methods: The prospective, multicenter FlowTriever All-comer Registry for Patient Safety and Hemodynamics (FLASH) study is designed to evaluate real-world PE patient outcomes after MT with the FlowTriever System (Inari Medical). In this study, acute outcomes through 30 days were evaluated for the subset of patients with high-risk PE as determined by the sites and following European Society of Cardiology guidelines. An independent medical monitor adjudicated adverse events (AEs), including major AEs: device-related mortality, major bleeding, or intraprocedural device-related or procedure-related AEs. Results: Of the 799 patients in the US cohort, 63 (7.9%) were diagnosed with high-risk PE; 30 (47.6%) patients showed a systolic blood pressure <90 mm Hg, 29 (46.0%) required vasopressors, and 4 (6.3%) experienced cardiac arrest. The mean age of patients with high-risk PE was 59.4 ± 15.6 years, and 34 (54.0%) were women. At baseline, 45 (72.6%) patients were tachycardic, 18 (54.5%) showed elevated lactate levels of ≥2.5 mM, and 21 (42.9%) demonstrated depressed cardiac index of <2 L/min/m2. Immediately after MT, heart rate improved to 93.5 ± 17.9 bpm. Twenty-five (42.4%) patients did not require an overnight stay in the intensive care unit, and no mortalities or major AEs occurred through 48 hours. Moreover, no mortalities occurred in 61 (96.8%) patients followed up through the 30-day visit. Conclusions: In this cohort of 63 patients with high-risk PE, MT was safe and effective, with no acute mortalities reported. Further prospective data are needed in this population.

Choosing fusion levels in adolescent idiopathic scoliosis.

Correct identification of fusion levels in surgical planning for the management of adolescent idiopathic scoliosis is a complex task. Several classification systems and algorithms exist to assist surgeons in determining the appropriate levels to be instrumented. The Lenke classification is the benchmark system. Among the many factors and measurements that are taken into account when selecting the proper upper instrumented vertebra and lower instrumented vertebra are planning for selective fusion; preserving motion segments; preventing proximal and/or distal junctional kyphosis, shoulder imbalance, and neck pain; and maintaining short fusion lengths. Existing treatment algorithms do not account for every exception, and further research is required to improve long-term surgical outcomes.

Endovascular Plug for Endobronchial Management of an Expectorated Pulmonary Artery Embolization Coil: A Case Report.

Pulmonary artery aneurysms are frequently managed with endovascular embolization. Rare but serious complications of coil embolization are erosion and migration of the coils into the adjacent airways, posing a risk for massive hemoptysis. We report the case of a medically complex patient with a left main pulmonary artery aneurysm treated with coil embolization who ultimately experienced transbronchial migration and expectoration of the coil. We discuss the challenging anesthetic and surgical management of these serious complications, including the use of an endovascular plug to occlude the erosion site and distal airways.

Outcomes in High-Risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy or Other Contemporary Therapies: Results From the FLAME Study.

BACKGROUND: Hemodynamically unstable high-risk, or massive, pulmonary embolism (PE) has a reported in-hospital mortality of over 25%. Systemic thrombolysis is the guideline-recommended treatment despite limited evidence. The FLAME study (FlowTriever for Acute Massive PE) was designed to generate evidence for interventional treatments in high-risk PE. METHODS: The FLAME study was a prospective, multicenter, nonrandomized, parallel group, observational study of high-risk PE. Eligible patients were treated with FlowTriever mechanical thrombectomy (FlowTriever Arm) or with other contemporary therapies (Context Arm). The primary end point was an in-hospital composite of all-cause mortality, bailout to an alternate thrombus removal strategy, clinical deterioration, and major bleeding. This was compared in the FlowTriever Arm to a prespecified performance goal derived from a contemporary systematic review and meta-analysis. RESULTS: A total of 53 patients were enrolled in the FlowTriever Arm and 61 in the Context Arm. Context Arm patients were primarily treated with systemic thrombolysis (68.9%) or anticoagulation alone (23.0%). The primary end point was reached in 9/53 (17.0%) FlowTriever Arm patients, significantly lower than the 32.0% performance goal (P<0.01). The primary end point was reached in 39/61 (63.9%) Context Arm patients. In-hospital mortality occurred in 1/53 (1.9%) patients in the FlowTriever Arm and in 18/61 (29.5%) patients in the Context Arm. CONCLUSIONS: Among patients selected for mechanical thrombectomy with the FlowTriever System, a significantly lower associated rate of in-hospital adverse clinical outcomes was observed compared with a prespecified performance goal, primarily driven by low all-cause mortality of 1.9%. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04795167.

Racial and ethnic disparities in health care-associated Clostridium difficile infections in the United States: State of the science.

BACKGROUND: Among health care-associated infections (HAIs), Clostridium difficile infections (CDIs) are a major cause of morbidity and mortality in the United States. As national progress toward CDI prevention continues, it will be critical to ensure that the benefits from CDI prevention are realized across different patient demographic groups, including any targeted interventions. METHODS: Through a comprehensive review of existing evidence for racial/ethnic and other disparities in CDIs, we identified a few general trends, but the results were heterogeneous and highlight significant gaps in the literature. RESULTS: The majority of analyzed studies identified white patients as at increased risk of CDIs, although there is a very limited literature base, and many studies had significant methodological limitations. CONCLUSION: Key recommendations for future research are provided to address antimicrobial stewardship programs and populations that may be at increased risk for CDIs.

Adverse Drug Event Prevention: 2014 Action Plan Conference.

Adverse drug events (ADEs) have been highlighted as a national patient safety and public health challenge by the National Action Plan for Adverse Drug Event Prevention (ADE Action Plan), which was released by the Office of Disease Prevention and Health Promotion in August 2014. The following October, the ADE Prevention: 2014 Action Plan Conference provided an opportunity for federal agencies, national experts, and stakeholders to coordinate and collaborate in the initiative to reduce preventable ADEs. The single-day conference included morning plenary sessions focused on the surveillance, evidence-based prevention, incentives and oversights, and additional research needs of the drug classes highlighted in the ADE Action Plan: anticoagulants, diabetes agents, and opioids. Afternoon breakout sessions allowed for facilitated discussions on measures for tracking national progress in ADE prevention and the identification of opportunities to ensure safe and high-quality health care and medication use.