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TAVR vs. SAVR for severe aortic stenosis in the low and intermediate surgical risk population: An updated meta-analysis, meta-regression, and trial sequential analysis
No full textBackground: Guidelines recommend transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for patients of age \u3e 65 years. The relative risks and benefits of TAVR vs. SAVR in low and intermediate surgical risk remain incompletely described.
Methods: A systematic search of PubMed, Scopus, and Cochrane Central databases identified randomized controlled trials (RCTs) comparing clinical outcomes of TAVR vs. SAVR in low and intermediate surgical risk.
Results: Ten RCTs (9239 patients, TAVR 50.8 %) were included. TAVR was associated with lower rates of all-cause death or stroke at 30-day (rate ratio [RR] 0.70; 95%CI 0.55-0.89; p = 0.003; I2 = 26 %) and 1-year (RR 0.77; 95%CI 0.60-0.98; p = 0.033; I2 = 54 %) follow-up. Bleeding complications, new-onset atrial fibrillation (AF), acute kidney injury (AKI), and severe patient-prosthesis mismatch (PPM) were lower with TAVR at 30 days and 1-year. Permanent pacemaker implantation, aortic valve reintervention, major vascular complications, and paravalvular leak (PVL) were significantly higher with TAVR at 30-day and 1-year follow-ups. Rates of all-cause death, stroke, MI, endocarditis, and rehospitalization were comparable between the groups at 30-day and 1-year follow-up.
Conclusion: In patients with severe AS and low to intermediate surgical risk, TAVR is associated with reduced rates of all-cause death or stroke, bleeding, new-onset AF, AKI, and severe PPM compared to SAVR. However, despite these short-term benefits, higher rates of permanent pacemaker implantation, PVL, and reintervention raise significant concerns about the long-term safety of TAVR, particularly for younger, lower-risk patients.
Keywords: Aortic stenosis; Low and intermediate surgical risk; Surgical aortic valve replacement; Transcatheter aortic valve replacement; Trial sequential analysis; meta-regression
Evaluation of an integrated digital and mobile intervention to improve outcomes for patients with moderate to severe COPD
No full textChronic obstructive pulmonary disease (COPD) leads to high rates of emergency department (ED) visits and hospitalizations. This study evaluated a community-based digital health intervention\u27s association with acute care utilization among patients with moderate to severe COPD. In a decentralized, nonrandomized trial, participants received biometric monitoring, symptom tracking, on-demand paramedic services, and digital pulmonary rehabilitation for 6 months. Outcomes were compared to a synthetic control group using weighted optimal matching and multivariable-adjusted regression. The primary outcome was hospitalization; secondary outcomes included readmission rates, ED visits, length of stay, and mortality. Eighty-eight intervention participants (mean age 67 (SD 10)) were compared to a weighted control group of 14,492 (mean age 69 (SD 11)). Intervention participants had lower odds of hospitalization (OR 0.67, 95% CI: 0.46-0.98) and 30-day readmission (OR 0.38, 95% CI: 0.17-0.84). This digital and mobile intervention was associated with reduced acute care use and supports further evaluation of hybrid care models for COPD
Comprehensive Care Approach to Drug-Related Tricuspid Valve Endocarditis Using Percutaneous Vegectomy
No full textBackground: Tricuspid valve endocarditis is more prevalent in the population of patients who inject intravenous drugs. The comorbidity of active addiction significantly complicates treatment in this population and multidisciplinary management is required.
Case summary: A young man with a history of active injection drug use presented with isolated tricuspid valve endocarditis. The patient was deemed a poor surgical candidate because of active addiction. The patient underwent percutaneous vegectomy with successful aspiration of vegetation.
Discussion: Multidisciplinary management played a critical role in the patient\u27s recovery and eventual surgical intervention. Although tricuspid valve endocarditis is common, management of active addiction complicates management. Currently no guidelines exist for management of infective endocarditis in intravenous drug use.
Take-home messages: Percutaneous vegectomy can be a useful tool to reduce morbidity and mortality in patients with drug use-related infective endocarditis. Multidisciplinary management is critical for success in these high-risk patients.
Keywords: drug abuse; endocarditis; tricuspid valve
Surgical synergy: Assessing care coordination in pediatric surgical referral programs
No full textBackground: Specialized pediatric surgical referral programs (PSPs) for complex conditions are increasing across the United States, resulting in care rendered geographically distant from patients\u27 homes. We explored care coordination gaps across differing stakeholder perspectives to identify opportunities to optimize post-discharge practices in this evolving landscape.
Methods: We reviewed published literature for guidelines and consensus statements on ideal care coordination practices. Qualitative interviews were conducted with three PSPs examining themes and gaps in their care coordination workflows. Surveys were distributed to an established family support network to assess patient/family perspectives on post-discharge care. To explore communication bias across practice settings, surveys were provided to American Pediatric Surgical Association (APSA) members.
Results: Eight thematic domains for an ideal care coordination framework were identified. Effective PSP practices included identifying local physician contacts, providing thorough pre-discharge patient/family education, and ensuring reliable post-discharge PSP access. PSPs reported challenges in ensuring patient access to medication/devices, variability in discharge documentation, and lack of closed-loop feedback. Fifty-two family support network surveys (13 % response) revealed PSPs frequently fulfilled medication/device safety, but demonstrated gaps in medication/device receipt confirmation, insurance coverage for medications/devices, and assessment of discharge readiness. In 239 APSA responses (17 % response), local surgeons perceived bias against non-academic practice environments as a barrier to effective post-discharge PSP care coordination.
Conclusion: PSPs implement care coordination practices that inconsistently address the core domains of a standardized framework. These findings provide guidance for improved alignment between PSPs, families, and local surgeons to optimize pediatric surgical post-discharge care coordination independent of geography.
Keywords: Care coordination; Pediatric surgery; Post-discharge care; Referral program; Transition of care
Dual-vector rAAVrh8 gene therapy for GM2 gangliosidosis: a phase 1/2 trial
No full textThe dual rAAVrh8-HEXA and rAAVrh8-HEXB vector can restore central nervous system hexosaminidase (Hex) enzyme activity, decrease GM2 levels in cerebrospinal fluid and rescue phenotypic consequences of GM2 gangliosidosis, Tay-Sachs and Sandhoff diseases in animal models following simultaneous bi-thalamic (BiT) injections. Following up on an n = 2 expanded access trial, we initiated a phase 1/2, single-dose, dose-escalation of combined BiT, intra-cisterna magna and intrathecal infusion in children with Tay-Sachs and Sandhoff diseases (six infantile, three juvenile). The BiT injection volume and vector dose were doubled between four cohorts, with the lowest dose matching the earlier expanded access trial. Cerebrospinal fluid HexA enzyme activity, serum total Hex activity and GM2 levels showed a dose-dependent biochemical correction of the disease. Serum Hex activity surpassed 40 nmol h-1 ml-1, two times the lower limit of normal, and neuroimaging demonstrated increased fiber tracts. Correction was greatest at 12 weeks, but in decline by 24 weeks postdosing. Infantile patients experienced global clinical stabilization and prolonged oral feeding without aspiration until 3-3.5 years. Seizures had a later onset, were less frequent, less severe and more responsive to anti-convulsant medication. Adverse events were rare in infantile patients, but worsening dystonia was observed in juvenile patients, who were excluded from ongoing enrollment. ClinicalTrials.gov registration: NCT04669535 and NCT0661456
Analysis of the 2024 Breast Surgical Oncology Fellowship Match: Survey of Applicants\u27 and Program Directors\u27 Preferences Regarding In-Person Versus Virtual Interviews
No full textBackground: In 2020, in response to the coronavirus disease 2019 (COVID-19) pandemic, Breast Surgical Oncology (BSO) fellowship programs transitioned to virtual interviews; however, for the 2024 cycle, programs selected either virtual or in-person interviews with applicants participating in potentially both formats. Following the match, a survey was performed to evaluate experiences among applicants and program directors (PDs).
Methods: Surveys were developed within the BSO Fellowship Program Directors Committee and distributed via email to matched applicants and PDs from 18 July 2024 to 9 August 2024. Descriptive statistics were conducted.
Results: Of the 89 matched applicants, 60 completed the survey (response rate 67.4%). Most applicants (76.7%, n = 46) preferred in-person over virtual interviews. The top reason for preferring in-person was \u27to see the program in person\u27 (56.7%, n = 34). Nearly half of applicants (48.3%, n = 29) estimated spending ≥$5000 on interviews, and 78.3% (n = 47) indicated the cost was \u27worth it\u27. Over half of applicants (51.7%, n = 31) reported interview style had an impact on their match. Of the 64 PDs, 38 completed the survey (response rate 59.4%). Virtual interviews were the most common format (65.8%, n = 25). The most important factor reported by most programs regarding the interview approach was cost to applicants (42.1%, n = 16). Over half of PDs (52.6%, n = 20) felt the interview approach influenced the match.
Conclusions: The majority of 2024 BSO fellowship matched applicants preferred in-person interviews, noting the importance of location, faculty, and culture to their decision making. This data may assist PDs in choosing the interview approach best suited for their programs and guide training programs more broadly.
Keywords: Breast fellowship; Fellowship interviews; Match; Program directors
Developing an approach to enhance recruitment for a cluster-randomised implementation trial: leveraging deliberative participation and credible messengers
No full textObjectives: To evaluate an innovative approach to recruit 40 hospitals to a cluster randomised controlled trial (RCT) to improve discharge antibiotic prescribing.
Design: This study describes the design, implementation and impact of a theory-informed recruitment approach for hospitals participating in the Reducing Overuse of Antibiotics at Discharge (ROAD) Home trial.
Setting: An inperson meeting of a quality improvement collaborative of acute care hospitals in the state of Michigan.
Participants: Representatives from acute care hospitals that are part of the Michigan Hospital Medicine Safety Consortium.
Interventions: Small group recruitment sessions that combined deliberative participation and credible messengers to recruit hospitals to participate in a cluster RCT on a single date (1 November 2023).
Primary and secondary outcomes: The primary outcome was the number of hospitals which agreed to participate in the trial. We also assessed participant feedback, effectiveness of recruitment methods and resources required for implementation of this approach.
Results: We recruited 51 (74%) of 69 eligible hospitals. Survey participants reported: sessions made clear the purpose of the trial (94%, 64/68) and time commitment required (87%, 59/68); agreed deliberative participation was helpful (82%, 56/68) and were \u27very satisfied\u27 with the session (82%, 56/68). Investigators largely reported credible messengers were a positive influence, though this varied across sessions. Hospital recruitment was time intensive, taking 179.5 total person hours. The recruitment process involved 3 months of preparation for the sessions and 2 months of follow-up prior to closing recruitment.
Conclusions: We demonstrated the feasibility and impact of a novel approach to recruit hospitals from an existing collaborative to a cluster RCT using the principles of deliberative participation and credible messengers. While the approach was time-consuming, we achieved success at over-recruiting hospitals in a relatively short period of time. Strategies presented here may assist future trial organisers in implementing hospital-based cluster RCTs.
Trial registration number: The ROAD Home trial is registered on Clinical.
Trials: gov (NCT06106204).
Keywords: Clinical Trial; Hospitals; Implementation Science; Quality in health care
Medications for Opioid Use Disorder in County Jails - Outcomes after Release
No full textBackground: In 2019, seven county correctional facilities (jails) in Massachusetts initiated pilot programs to provide all Food and Drug Administration-approved medications for opioid use disorder (MOUD).
Methods: This observational study used linked state data to examine postrelease MOUD receipt, overdose, death, and reincarceration among persons with probable opioid use disorder (OUD) in carceral settings who did or did not receive MOUD from these programs from September 1, 2019, through December 31, 2020. Log-binomial and proportional-hazards models were adjusted for propensity-score weights and baseline covariates that remained imbalanced after propensity-score weighting.
Results: The study cohort included 6400 persons with probable OUD: 2711 (42.4%) received MOUD in jail and 3689 (57.6%) did not. Among persons treated with MOUD in jail, 67.9% received buprenorphine, 25.7% received methadone, and 6.5% received naltrexone. Treated persons were more likely than those not treated to be White (75.4% vs. 58.1%), to be sentenced (31.6% vs. 13.2%), to be receiving MOUD at jail entry (73.7% vs. 17.1%), and to receive MOUD during the first 30 days after community release (60.2% vs. 17.6%; adjusted relative risk, 1.44; 95% confidence interval [CI], 1.38 to 1.50). Only 50.4% of MOUD recipients engaged in MOUD treatment for 75% of the first 90 days after release, and 57.5% were receiving MOUD at 180 days. Receipt of MOUD in jail, as compared with no such receipt, was associated with lower postrelease risks of fatal overdose (adjusted hazard ratio, 0.48; 95% CI, 0.36 to 0.64), nonfatal overdose (adjusted hazard ratio, 0.76; 95% CI, 0.68 to 0.85), death from any cause (adjusted hazard ratio, 0.44; 95% CI, 0.35 to 0.56), and reincarceration (adjusted hazard ratio, 0.88; 95% CI, 0.81 to 0.94). The incidence of hospitalizations did not differ substantially between the two groups.
Conclusions: Receipt of MOUD in jail was associated with an increased likelihood of postrelease MOUD initiation and decreased risks of overdose, death from any cause, and reincarceration. (Funded by the National Institutes of Health and others.)
Factors in Initial Anticoagulation Choice in Hospitalized Patients With Pulmonary Embolism
No full textImportance: Despite guideline recommendations to use low-molecular-weight heparins (LMWHs) or direct oral anticoagulants in the treatment of most patients with acute pulmonary embolism (PE), US-based studies have found increasing use of unfractionated heparin (UFH) in hospitalized patients.
Objective: To identify barriers and facilitators of guideline-concordant anticoagulation in patients hospitalized with acute PE.
Design, setting, and participants: This qualitative study conducted semistructured interviews from February 1 to June 3, 2024, that were recorded, transcribed, and analyzed in an iterative process using reflexive thematic analysis. Interview participants were physicians in emergency medicine, hospital medicine (hospitalist), interventional cardiology, and interventional radiology. Participants were recruited using maximum variation sampling targeting UFH-dominant vs LMWH-dominant approaches in hospitalized patients with acute PE. We triangulated results with a group of interventional cardiologists and radiologists (interventionalists).
Main outcomes and measures: Common themes and factors associated with anticoagulant selection for hospitalized patients with acute PE. Reflexive thematic analysis was used to identify these themes and factors.
Results: Of the 46 interviewees (median [IQR] age, 43 [36-50] years; 33 who identified as men [71.7%]), 25 (54.3%) were emergency physicians, 17 (37.0%) were hospitalists, and 4 (8.7%) were interventionalists. Each interview lasted a median (IQR) of 29 (25-32) minutes. Prominent themes associated with anticoagulant selection included agnosticism regarding choice of anticoagulant, the inertia of learned practice, and therapeutic momentum after anticoagulation initiation. Institutional culture and support were factors associated with choice of the dominant anticoagulation strategy. Additionally, factors associated with UFH use were fear of decompensation and misperceptions regarding the pharmacology of anticoagulants and catheter-directed treatments.
Conclusions and relevance: In this qualitative study, physicians across a spectrum of specialties and geographical settings reported common barriers and facilitators to the use of guideline-concordant anticoagulation in patients hospitalized with acute PE, particularly agnosticism regarding choice of anticoagulant, inertia of learned practice, therapeutic momentum after anticoagulation initiation, and institutional culture and support. Future implementation efforts may consider targeting these domains