Novant Health is a four-state integrated network of physician clinics, outpatient centers and hospitals. Its network consists of more than 1,600 physicians and 29,000 employees at more than 640 locations, including 15 medical centers and hundreds of outpatient facilities and physician clinics. The organization was formed on 1 July 1997 by the merger of Carolina Medicorp of Winston-Salem, North Carolina and Presbyterian Health Services of Charlotte, North Carolina. Headquartered in Winston-Salem, North Carolina, Novant Health serves more than 4 million patients annually. In 2019, Novant Health was ranked #38 in Forbes' annual ranking of America's Best Employers for Diversity, #3 in Diversity MBA Magazine's annual ranking of Best Places to Work for Women & Diverse Managers, and #6 in North Carolina in Forbes' annual ranking of America's Best Employers by State.
BACKGROUND:For patients with atrial fibrillation, the use of oral anticoagulant therapy to prevent stroke is limited by the risk of bleeding. Left atrial appendage closure is considered for patients who are unsuitable candidates for long-term anticoagulation, but its role in patients who are eligible for anticoagulants has not been established. METHODS:In this ongoing, prospective, international, randomized trial involving patients with atrial fibrillation who were suitable candidates for anticoagulation, we randomly assigned patients in a 1:1 ratio to receive either device-based left atrial appendage closure (device group) or non-vitamin K antagonist oral anticoagulant (NOAC) therapy (anticoagulation group). The primary efficacy end point - a composite of death from cardiovascular causes, stroke, or systemic embolism - was tested for noninferiority (noninferiority margin, 4.8 percentage points) after 3 years of follow-up. The primary safety end point, non-procedure-related bleeding, was tested for superiority. RESULTS:Of the 3000 patients who underwent randomization, 1499 were assigned to the device group and 1501 to the anticoagulation group. The mean (±SD) age of the patients was 71.7±7.5 years, 31.9% of the patients were women, and the mean CHA2DS2-VASc score was 3.5±1.3. At 3 years, a primary efficacy end-point event had occurred in 81 patients (Kaplan-Meier estimate, 5.7%) in the device group and in 65 patients (Kaplan-Meier estimate, 4.8%) in the anticoagulation group (difference, 0.9 percentage points; 95% confidence interval [CI], -0.8 to 2.6; P<0.001 for noninferiority). Non-procedure-related bleeding occurred in 154 patients (Kaplan-Meier estimate, 10.9%) in the device group and in 260 patients (Kaplan-Meier estimate, 19.0%) in the anticoagulation group (hazard ratio, 0.55; 95% CI, 0.45 to 0.67; P<0.001 for superiority). CONCLUSIONS:Among patients with atrial fibrillation who were candidates for anticoagulation, device-based left atrial appendage closure was noninferior to NOAC therapy with respect to a composite of death from cardiovascular causes, stroke, or systemic embolism and was superior to NOAC therapy for non-procedure-related bleeding at 3 years. (Funded by Boston Scientific; CHAMPION-AF ClinicalTrials.gov number, NCT04394546.).
Staphylococcus aureus continues to be a main cause of bloodstream infections (BSI) with an annual incidence rate of fifty cases per 100,000 person-years and mortality rates up to 30%. Methicillin-susceptible strains are frequently considered less complicated, however, pose just as high mortality rates and therapeutic challenges as methicillin-resistant cases. First-line treatment continues to be anti-staphylococcal penicillins, like nafcillin or oxacillin, and first generation cephalosporins, such as cefazolin. In cases of persistent bacteremia, newer in vitro studies and small case series have shown possible synergistic activity when cefazolin and ertapenem are combined. The purpose of this study is to describe the use of combination cefazolin and ertapenem in the treatment of persistent BSIs due to methicillin-susceptible Staphylococcus aureus (MSSA).Table 1.Baseline DemographicsTable 2.Results This case series was conducted through an electronic medical record report identifying patients ≥18 years old with MSSA BSI who received concomitantly at least one dose of both cefazolin and ertapenem at Novant Health acute care facilities from January 1, 2021, through July 31, 2024. Twenty-three patients were included. The most common sources of BSI included pulmonary, skin and skin structure with abscess, bone and joint, and implanted device-related infections. The median blood culture clearance was seen after 2 days of combination cefazolin and ertapenem. The average days of monotherapy was 3.5 days and the median days from the initial positive blood culture to combination therapy initiation was 6 days. 30-day all-cause mortality occurred in 5 patients (21.7%), which was consistent with mortality rates previously reported for persistent Staphylococcus aureus BSI. In the data-lacking clinical challenge of persistent MSSA BSI, combination cefazolin and ertapenem may serve as a safe and effective way to improve the time to clearance of blood cultures. This is the largest study to date summarizing the clinical success of this novel combination strategy. Additional data is needed to compare this regimen to standard of therapy; however, clinicians can consider utilizing this combination strategy in patients with persistent MSSA BSI. All Authors: No reported disclosures
IntroductionSacituzumab govitecan is approved for the treatment of triple-negative advanced/metastatic breast cancer and hormone-receptor positive, HER2-negative advanced/metastatic breast cancer. Clinical trials show favorable improvements in progression-free survival (PFS) and overall survival (OS). However, they report a large percentage of patients experiencing hypersensitivity reactions. It has been observed that use of sacituzumab govitecan at [redacted institution] may have a lower rate of hypersensitivity reactions than seen in clinical trials.MethodsThis study aimed to determine the real-world data of PFS and OS of sacituzumab govitecan while evaluating the incidence and severity of hypersensitivity reactions. It was a retrospective, single-center, multi-site study conducted across [redacted], which included adult patients who received at least one dose of sacituzumab govitecan from April 1, 2020 to July 31, 2024 for an FDA-approved breast cancer indication.ResultsA total of 75 patients met the inclusion criteria for assessment. The median PFS was 2.8 months (95% CI, 0.0-14.4) and the median OS was 7.2 months (95% CI, 0.0-19.3). No hypersensitivity reactions were reported, hence reaction severity was not assessed nor associated with treatment discontinuation.Conclusion and RelevanceThis study demonstrated that PFS and OS may be shorter than estimated in clinical trials. However, baseline performance status and previous lines of therapy were not evaluated and thus may have impacted the results. Additionally, no hypersensitivity reactions were observed. From review of this data, the low risk of reactions helps justify future research to assess the necessity of certain premedications and/or elimination of observation times.
Background Left atrial appendage closure (LAAC) is a proven strategy for stroke prevention in patients with atrial fibrillation, yet procedural challenges and postimplant considerations remain key barriers to optimal outcomes. The next-generation WATCHMAN FLX Pro device introduces 3 significant advances: 1) enhanced visualization through radiopaque markers; 2) a novel fluoropolymer coating designed to facilitate endothelization; and 3) expanded anatomical coverage with a 40-mm size option. Objectives The HEAL-LAA (Post-Market Real World Outcomes in WATCHMAN FLX Pro Left Atrial Appendage Closure Device) is a prospective, multicenter, post-market-approval study designed to assess the safety and effectiveness of the novel device. Methods This study enrolled 500 patients indicated for LAAC across 32 centers in the United States. The primary effectiveness endpoint was peridevice leak >5 millimeters at 45 days on transesophageal echocardiography, with a performance goal of <5%. The primary safety endpoint was the composite rate of all-cause mortality, stroke, systemic embolism, or major bleeding within 6 months after the index procedure, with a performance goal of <21%. Device seal and safety outcomes were also assessed at 12 months. Results Postprocedure antithrombotic regimens included direct oral anticoagulants with or without aspirin in over 50% of patients, whereas 33% received dual antiplatelet therapy. The primary effectiveness endpoint was reached with 0 cases of peridevice leak >5 millimeters at 45-day follow-up and 82.7% achieving complete seal. At 45 days, the rate of patients either having complete seal or small leak ≤3 mm was 99.8%, and at 12 months, this rate was 98.8%. The composite primary safety endpoint was 11.1% at 6 months and 15.3% at 12 months. Conclusions The HEAL-LAA study demonstrates that the novel device achieves excellent early closure at 45 days and favorable 6-month clinical outcomes, supporting its safety and effectiveness for LAAC. Safety and effectiveness was sustained through 12 months. Overall, results are similar to the predecessor device, and more targeted studies are needed to assess incremental value of the coating.
