Citations

Abstract Since its introduction in 2002, left atrial appendage closure (LAAC) has rapidly expanded as an alternative to anticoagulation in patients with atrial fibrillation at high risk of stroke. Harmonized processes for data collection, analysis, and reporting in LAAC trials are essential to enhance research quality and improve clinical practice. The Left Atrial Appendage Academic Research Consortium (LAARC) initiative is an independent collaboration of academic research organizations, cardiology and neurology experts, clinical trialists, and regulatory authorities from the USA, Europe, and Asia. The consortium engaged clinical experts, regulators—including the US Food and Drug Administration (FDA), European Notified Bodies, and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)—and industry leaders to define standardized study elements and endpoints for LAAC trials. Key considerations included alignment with prior Academic Research Consortium initiatives, procedural and mechanistic insights, and clinical relevance. Consensus definitions were proposed for mortality, stroke, bleeding, and device performance, along with composite endpoints for safety and effectiveness. The proposed LAARC consensus definitions aim to standardize endpoint reporting, improve comparability across studies, and support regulatory and clinical trial applications for this evolving therapy through broad dissemination in the peer-reviewed literature.

Objective: To evaluate access, clinical outcomes, engagement, and satisfaction associated with an advanced musculoskeletal virtual care model. Design: Retrospective cohort study of adults with musculoskeletal complaints referred to advanced orthopedic virtual physical therapy by Physical Medicine and Rehabilitation providers between July 2024 and April 2025. Outcomes included access to care, patient-reported outcome measures, pain intensity, plan-of-care completion, and patient satisfaction. Results: Of 137 referred patients, 86 (62.8%) completed evaluations; 70.9% of those (n=61) completed full care episodes — exceeding national completion benchmarks (71% vs. 43%). Among completers, 96% achieved Minimal Clinically Important Differences. Functional improvements were significant: Oswestry Disability Index −32.4, Neck Disability Index −29.5, Lower Extremity Functional Scale +26.6 (all P <.001). Pain decreased from 6.1 to 0.9 (−85%). Average care required 5.6 visits versus national benchmarks of 6–10. Patient satisfaction was exceptional (Net Promoter Score=100). Conclusion: Among patients who completed a full episode of care, this advanced virtual musculoskeletal model was associated with substantial functional improvement, pain reduction, and high satisfaction while requiring fewer visits than national averages. Because outcome analyses were limited to completers, these findings may not represent all referred patients. Prospective controlled studies are needed to evaluate effectiveness and scalability.

Abstract Background Deep brain stimulation (DBS) is a widely used therapy for neurologic and psychiatric disorders. Conventional DBS delivers highly regular stimulation patterns that suppress pathological activity but can induce stimulation-related side effects, limiting the therapeutic window. Introducing controlled temporal variability through stochastic pulse timing may represent an alternative programming dimension to improve tolerability while preserving clinical benefit. Methods An adult in their 60’s with bilateral Vim DBS underwent evaluation of tonic, pink-noise, and white-noise stimulation patterns delivered through his chronically implanted Boston Scientific Genus system using the Chronos research platform. We assessed tremor and stimulation-induced side effects using accelerometry, spiral drawing tasks, standardized speech recordings, and patient-reported paresthesias. Results Pink noise stimulation preserved meaningful tremor suppression while improving tolerability compared with conventional tonic 130 Hz stimulation. Under tonic stimulation, dysarthria and paresthesias were prominent at 2.0 mA, narrowing the usable therapeutic window. In contrast, pink noise maintained tremor control across the same amplitude range with reduced side-effect burden. White noise stimulation demonstrated intermediate effects, providing improved tolerability relative to tonic stimulation but less tremor suppression than pink noise. Findings were consistent across accelerometry and functional drawing tasks. Conclusion This study provides first-in-human evidence that temporally structured stochastic pulse timing can preserve therapeutic benefit while expanding the tolerable stimulation range relative to tonic DBS. These findings suggest that temporal structure represents a clinically meaningful programming dimension that may broaden the DBS therapeutic window using software based updates to existing hardware. Further evaluation in larger cohorts is warranted.