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    Contribution margins and utilization of transcatheter aortic valve replacement versus surgical aortic valve replacement in the Medicare population.

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    BACKGROUND: Hospitals and health systems must balance the demand for transcatheter aortic valve replacement (TAVR) against financial sustainability. Patients may be eligible for both TAVR and surgical aortic valve replacement (SAVR), but financial realities for hospitals may affect differential access to those therapies. We sought to understand the landscape of costs and reimbursement for TAVR and SAVR in the US and to understand the association of procedural reimbursement with receipt of either. METHODS: We included fee-for-service Medicare beneficiaries undergoing isolated TAVR or SAVR in 2016-2019. For each TAVR and SAVR, inpatient revenues and direct costs were calculated at the claim level. The contribution margin (CM) for each TAVR or SAVR was then calculated as total revenues minus total direct costs, which defines the net profit for the procedure for the hospital. Multivariate logistic regressions were used to identify hospital characteristics associated with positive TAVR CMs. Multivariate linear regression was used to assess the relationship between relative volume of TAVR cases and relative differences in TAVR versus SAVR CMs at the hospital level. RESULTS: Of 542 sites, 377 (69.6%) had positive CMs, and 165 (30.4%) had negative CMs for TAVR; 505 (93.2%) had positive CMs for SAVR. Median revenues, costs, and CMs for TAVR decreased between 2016 and 2019. The median (IQR) total CM per hospital for TAVR decreased from 10,574(10,574 (1,331-22,259)in2016to22,259) in 2016 to 6,744 (6,0996,099-17,511) in 2019 (P \u3c 0.001). Teaching hospital status (aOR 1.77, 95% CI 1.07-2.93) and for-profit status (aOR 3.7, 95% CI 1.8-7.6) were associated with increased odds of positive TAVR CMs relative to nonteaching hospital status and nonprofit status, respectively, in multivariate logistic regression models. The median (IQR) proportion of TAVR of total AVR was 76.67% (69.6%-82.5%) compared with 74.6% (66.9%-80.4%) at hospitals with negative TAVR CMs (P = .04). There was no significant linear relationship between hospital-level difference in median TAVR and SAVR CMs and hospital-level proportion of TAVR of total AVR in multivariate models. CONCLUSIONS: Most hospitals had positive CMs for TAVR and nearly all had positive CMs for SAVR. Positive CMs for TAVR for individual hospitals were associated with a significant increase in the utilization of TAVR. However, the magnitude of difference in TAVR versus SAVR CM was not associated with differential procedural use

    Large-Bore Mechanical Thrombectomy Versus Catheter-Directed Thrombolysis in the Management of Intermediate-Risk Pulmonary Embolism: Primary Results of the PEERLESS Randomized Controlled Trial.

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    BACKGROUND: There are a lack of randomized controlled trial data comparing outcomes of different catheter-based interventions for intermediate-risk pulmonary embolism. METHODS: PEERLESS is a prospective, multicenter, randomized controlled trial that enrolled 550 patients with intermediate-risk pulmonary embolism with right ventricular dilatation and additional clinical risk factors randomized 1:1 to treatment with large-bore mechanical thrombectomy (LBMT) or catheter-directed thrombolysis (CDT). The primary end point was a hierarchal win ratio composite of the following (assessed at the sooner of hospital discharge or 7 days after the procedure): (1) all-cause mortality, (2) intracranial hemorrhage, (3) major bleeding, (4) clinical deterioration and/or escalation to bailout, and (5) postprocedural intensive care unit admission and length of stay. Assessments at the 24-hour visit included respiratory rate, modified Medical Research Council dyspnea score, New York Heart Association classification, right ventricle/left ventricle ratio reduction, and right ventricular function. End points through 30 days included total hospital stay, all-cause readmission, and all-cause mortality. RESULTS: The primary end point occurred significantly less frequently with LBMT compared with CDT (win ratio, 5.01 [95% CI, 3.68-6.97]; CONCLUSIONS: PEERLESS met its primary end point in favor of LBMT compared with CDT in treatment of intermediate-risk pulmonary embolism. LBMT had lower rates of clinical deterioration and/or bailout and postprocedural intensive care unit use compared with CDT, with no difference in mortality or bleeding. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05111613

    Comfort Behavioral Scale in PICU

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    Effects of Kilohertz Frequency on Paresthesia Perception Thresholds in Spinal Cord Stimulation.

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    BACKGROUND: Paresthesia-based spinal cord stimulation (SCS) depends upon dorsal column (DC) fiber activation to engage pain-relieving neural mechanisms. However, the mechanisms for 10-kHz paresthesia-free SCS have not been fully elucidated. Preclinical work has shown selective drive of inhibitory dorsal horn neurons, while other hypotheses suggest that DC fibers may be activated. To provide clinical data for guiding mechanism work, we analyzed paresthesia perception thresholds (PPT) over a range of low to high kHz frequency and compared those values to the stimulation parameters from the therapeutic 10-kHz SCS programs used by patients. OBJECTIVE: The goal of this study was to provide clinically relevant stimulation parameters for translational mechanism work. STUDY DESIGN: Retrospective chart review of technical data collected during baseline evaluation from two prospective clinical studies. SETTING: Acute outpatient follow-up. METHODS: Data were extracted from study files of enrolled patients who had used fully implanted SCS for at least 3 months with leads positioned in the epidural space at the T8-T11 vertebral levels to treat their chronic intractable back and/or leg pain. PPTs had been measured using a bipole program at 10 kHz at pulse width (PW) = 30 µs, and at 50 Hz, 500 Hz, 1 kHz, and 5 kHz at PW = 80 µs. Therapeutic stimulation amplitudes for 10 kHz at 30 µs were obtained from patients\u27 IPG log files at the time of study enrollment. RESULTS: PPTs were obtained from 23 patients with failed back surgery syndrome (11 M/ 12 F; 60 ± 15 years old). PPTs at PW = 80 µs were PPT (50 Hz) = 7.9 (5.7 - 9.7) mA, PPT (500 Hz) = 7.0 (5.2 - 9.1) mA, PPT(1 kHz) = 7.0 (5.5 --8.5) mA, and PPT (5 kHz) = 6.1 (4.1- 7.9) mA; all higher frequencies had statistically significantly lower PPTs than PPT(50 Hz at 80 µs). For 10 kHz at 30 µs, the PPT was higher than 15 mA for 13 (56%) of the subjects; for the remaining 44%, the PPT = 8.3 ± 4.0 mA was statistically significantly larger than the therapeutic stimulation pulse amplitudes = 2.4 ± 0.4 mA. LIMITATIONS: Retrospective chart review, small number of patients. CONCLUSIONS: Therapeutic 10-kHz SCS uses stimulation amplitudes far lower than the PPT, providing evidence that therapeutic 10-kHz SCS does not activate dorsal column axons. Additionally, the PPT decreases with increasing kHz frequency, suggesting that a presumed asynchronous pattern of activation from kHz stimulation does not raise the threshold at which sensation occurs

    A Systematic Literature Review to Determine Gaps in Diagnosing Suspected Infection in Solid Organ Transplant Recipients.

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    BACKGROUND: Improved diagnostic testing (DT) of infections may optimize outcomes for solid organ transplant recipients (SOTR), but a comprehensive analysis is lacking. METHODS: We conducted a systematic literature review across multiple databases, including EMBASE and MEDLINE(R), of studies published between 1 January 2012-11 June 2022, to examine the evidence behind DT in SOTR. Eligibility criteria included the use of conventional diagnostic methods (culture, biomarkers, directed-polymerase chain reaction [PCR]) or advanced molecular diagnostics (broad-range PCR, metagenomics) to diagnose infections in hospitalized SOTR. Bias was assessed using tools such as the Cochrane Handbook and PRISMA 2020. RESULTS: Of 2362 studies, 72 were eligible and evaluated heterogeneous SOT populations, infections, biospecimens, DT, and outcomes. All studies exhibited bias, mainly in reporting quality. Median study sample size was 102 (range, 11-1307). Culture was the most common DT studied (N = 45 studies, 62.5%), with positive results in a median of 27.7% (range, 0%-88.3%). Biomarkers, PCR, and metagenomics were evaluated in 7, 19, and 3 studies, respectively; only 6 reported sensitivity, specificity, and positive/negative predictive values. Directed-PCR performed well for targeted pathogens, but only 1 study evaluated broad-range PCR. Metagenomics approaches detected numerous organisms but required clinical adjudication, with too few studies (N = 3) to draw conclusions. Turnaround time was shorter for PCR/metagenomics than conventional diagnostic methods (N = 4 studies, 5.6%). Only 6 studies reported the impact of DT on outcomes like antimicrobial use and length of stay. CONCLUSIONS: We identified considerable evidence gaps in infection-related DT among SOT, particularly molecular DT, highlighting the need for further research

    “Diabetes and Kidneys: Unraveling T2D’s Silent Threat”

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    “Celebrating Dr. Steven Packer with those who know him well”

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    Radiation: Keep it Simple

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