Pulsed Transcranial Red/Near-Infrared Light Therapy Using Light-Emitting Diodes Improves Cerebral Blood Flow and Cognitive Function in Veterans with Chronic Traumatic Brain Injury: A Case Series.

Objective: This study explored the outcome of applying red/near-infrared light therapy using light-emitting diodes (LEDs) pulsed with three different frequencies transcranially to treat traumatic brain injury (TBI) in Veterans. Background: Photobiomodulation therapy (PBMT) using LEDs has been shown to have positive effects on TBI in humans and animal models. Materials and methods: Twelve symptomatic military Veterans diagnosed with chronic TBI >18 months post-trauma received pulsed transcranial PBMT (tPBMT) using two neoprene therapy pads containing 220 infrared and 180 red LEDs, generating a power output of 3.3 W and an average power density of 6.4 mW/cm2 for 20 min, thrice per week over 6 weeks. Outcome measures included standardized neuropsychological test scores and qualitative and quantitative single photon emission computed tomography (SPECT) measures of regional cerebral blood flow (rCBF). Results: Pulsed tPBMT significantly improved neuropsychological scores in 6 of 15 subscales (40.0%; p < 0.05; two tailed). SPECT analysis showed increase in rCBF in 8 of 12 (66.7%) study participants. Quantitative SPECT analysis revealed a significant increase in rCBF in this subgroup of study participants and a significant difference between pre-treatment and post-treatment gamma ray counts per cubic centimeter [t = 3.77, df = 7, p = 0.007, 95% confidence interval (95,543.21-21,931.82)]. This is the first study to report quantitative SPECT analysis of rCBF in regions of interest following pulsed tPBMT with LEDs in TBI. Conclusions: Pulsed tPBMT using LEDs shows promise in improving cognitive function and rCBF several years after TBI. Larger, controlled studies are indicated.

Pulsed Transcranial Red/Near-Infrared Light Therapy Using Light-Emitting Diodes Improves Cerebral Blood Flow and Cognitive Function in Veterans with Chronic Traumatic Brain Injury: A Case Series.

OBJECTIVE: This study explored the outcome of applying red/near-infrared light therapy using light-emitting diodes (LEDs) pulsed with three different frequencies transcranially to treat traumatic brain injury (TBI) in Veterans. BACKGROUND: Photobiomodulation therapy (PBMT) using LEDs has been shown to have positive effects on TBI in humans and animal models. MATERIALS AND METHODS: Twelve symptomatic military Veterans diagnosed with chronic TBI >18 months post-trauma received pulsed transcranial PBMT (tPBMT) using two neoprene therapy pads containing 220 infrared and 180 red LEDs, generating a power output of 3.3 W and an average power density of 6.4 mW/cm2 for 20 min, thrice per week over 6 weeks. Outcome measures included standardized neuropsychological test scores and qualitative and quantitative single photon emission computed tomography (SPECT) measures of regional cerebral blood flow (rCBF). RESULTS: Pulsed tPBMT significantly improved neuropsychological scores in 6 of 15 subscales (40.0%; p < 0.05; two tailed). SPECT analysis showed increase in rCBF in 8 of 12 (66.7%) study participants. Quantitative SPECT analysis revealed a significant increase in rCBF in this subgroup of study participants and a significant difference between pre-treatment and post-treatment gamma ray counts per cubic centimeter [t = 3.77, df = 7, p = 0.007, 95% confidence interval (95,543.21-21,931.82)]. This is the first study to report quantitative SPECT analysis of rCBF in regions of interest following pulsed tPBMT with LEDs in TBI. CONCLUSIONS: Pulsed tPBMT using LEDs shows promise in improving cognitive function and rCBF several years after TBI. Larger, controlled studies are indicated.

Inclusion of Functional Status Measures in the Risk Adjustment of 30-Day Mortality After Transcatheter Aortic Valve Replacement: A Report From the Society of Thoracic Surgeons/American College of Cardiology TVT Registry.

OBJECTIVES: The aim of this study was to develop and validate a risk adjustment model for 30-day mortality after transcatheter aortic valve replacement (TAVR) that accounted for both standard clinical factors and pre-procedural health status and frailty. BACKGROUND: Assessment of risk for TAVR is important both for patient selection and provider comparisons. Prior efforts for risk adjustment have focused on in-hospital mortality, which is easily obtainable but can be biased because of early discharge of ill patients. METHODS: Using data from patients who underwent TAVR as part of the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry (June 2013 to May 2016), a hierarchical logistic regression model to estimate risk for 30-day mortality after TAVR based only on pre-procedural factors and access site was developed and internally validated. The model included factors from the original TVT Registry in-hospital mortality model but added the Kansas City Cardiomyopathy Questionnaire (health status) and gait speed (5-m walk test). RESULTS: Among 21,661 TAVR patients at 188 sites, 1,025 (4.7%) died within 30 days. Independent predictors of 30-day death included older age, low body weight, worse renal function, peripheral artery disease, home oxygen, prior myocardial infarction, left main coronary artery disease, tricuspid regurgitation, nonfemoral access, worse baseline health status, and inability to walk. The predicted 30-day mortality risk ranged from 1.1% (lowest decile of risk) to 13.8% (highest decile of risk). The model was able to stratify risk on the basis of patient factors with good discrimination (C = 0.71 [derivation], C = 0.70 [split-sample validation]) and excellent calibration, both overall and in key patient subgroups. CONCLUSIONS: A clinical risk model was developed for 30-day death after TAVR that included clinical data as well as health status and frailty. This model will facilitate tracking outcomes over time as TAVR expands to lower risk patients and to less experienced sites and will allow an objective comparison of short-term mortality rates across centers.

Valve hemodynamic deterioration and cardiovascular outcomes in TAVR: A report from the STS/ACC TVT Registry.

BACKGROUND: Recent reports of leaflet abnormalities (detected using advanced imaging) have raised questions regarding transcatheter aortic valve replacement (TAVR) durability. We sought to determine the incidence of valve hemodynamic deterioration (VHD) and its association with cardiovascular outcomes. METHODS AND RESULTS: Consecutive cases with paired postimplant and follow-up echocardiograms from November 2011 to March 2015 in the STS/ACC TVT Registry were allocated into 2 overlapping cohorts: early (paired echocardiograms at 0 and 30 days) and late (paired echocardiograms at 30 days and 1 year). VHD was defined as an increase in mean aortic valve gradient ≥10 mm Hg. Eighteen-month cardiovascular outcomes were determined via linkage with Centers for Medicare & Medicaid Services claims. Backwards selection logistic regression was performed to determine predictors of VHD. Among 10,099 TAVRs with paired echocardiograms, the median age was 84 years and 48.7% were female, with Society of Thoracic Surgeons score distributions of <8% (61.7%), 8%-15% (28.8%), and >15% (9.5%). The incidence of VHD was 2.1% in the early cohort and 2.5% in the late cohort. There was no significant difference between those with and without VHD in either cohort in the combined end point of death/stroke/aortic valve reintervention or heart failure hospitalization or myocardial infarction. Independent predictors of VHD included chronic lung disease, valve-in-valve procedure, 23-mm TAVR valve, severe patient-prosthesis mismatch, increasing body mass index, and increasing baseline aortic valve gradient. CONCLUSIONS: The incidence of VHD in US clinical practice is low, and VHD is not associated with increased cardiovascular events at 18 months. Patient and procedural predictors may help to identify patients at risk for VHD in whom surveillance or preventive strategies may be considered.

The association of transcatheter aortic valve replacement availability and hospital aortic valve replacement volume and mortality in the United States.

BACKGROUND: Whether the introduction of transcatheter aortic valve replacement (TAVR) has affected hospitals' surgical aortic valve replacement (SAVR) and overall aortic valve replacement (AVR) case volumes and outcomes in the United States is unknown. METHODS: We utilized data from The Society of Thoracic Surgeons (STS) adult cardiac surgery database and the STS/American College of Cardiology (ACC) transcatheter valve therapies registry to examine SAVR and TAVR procedures. Temporal trends in total case volume (SAVR plus TAVR), and observed and risk-adjusted in-hospital mortality rates were assessed among low-risk cases (STS predicted risk of operative mortality < 4%), intermediate-risk cases (4% to 8%), and high-risk cases (> 8%). A contemporary control was provided by non-TAVR centers. RESULTS: From 2008 to 2013, the total annual volume of AVR among 246 TAVR-performing hospitals increased from 19,578 to 33,004, with a 22% growth in SAVR volumes; non-TAVR hospital (n = 555) increases were more modest (16,563 to 19,134; 16% growth). Expanded volumes at TAVR hospitals included increased SAVR use in low- and intermediate-risk cases, and TAVR use in high-risk cases. In parallel, in-hospital mortality for all AVR procedures at TAVR sites declined from 3.4% to 2.9% (observed to expected [O:E] ratio 0.75 to 0.58, p < 0.001); the greatest declines were among intermediate- and high-risk SAVR patients. Owing to reduced SAVR mortality, TAVR centers experienced a significantly greater decline in O:E ratio for high-risk patient in-hospital mortality than non-TAVR centers (TAVR center O:E ratio, 0.81 to 0.61; non-TAVR center O:E ratio, 0.85 to 0.76; p < 0.001). After approval of TAVR for clinical use, a trend toward higher in-hospital mortality rates and O:E ratios for TAVR procedures was observed at new (but not at established) TAVR centers (O:E ratio, 0.41 to 0.67; p = 0.08). CONCLUSIONS: Since the introduction of TAVR, the total volume of AVR procedures, including higher overall use of SAVR, at TAVR sites has significantly increased in the United States. Overall, in-hospital survival of patients undergoing treatment for aortic valve stenosis continues to improve.

Multicenter experience in revascularization of very elderly patients.

BACKGROUND: Very elderly patients are increasingly referred for revascularization yet have been underrepresented in both prior percutaneous coronary intervention (PCI) and coronary bypass surgery (CABG) clinical trials. We pooled the largest PCI and CABG clinical registries in the United States to better understand revascularization procedure use, risks and outcomes in patients aged > or =75 years. METHODS: Six PCI registries (n = 48,439) and 8 CABG registries (n = 180,709) voluntarily contributed all procedural data in patients aged > or =75 years from 1990 through 1999. Patient characteristics, procedural process, and inhospital mortality and morbidity outcomes were evaluated. Risk factors for mortality in elderly patients were identified and compared across registries using standardized multivariable logistic regression. RESULTS: Between the years 1991 and 1999, the proportion of patients aged > or =75 years undergoing revascularization was on the rise (10% increase). Pooled estimates of inhospital mortality following PCI during this decade was 3.0% (range 1.5%-5.2% among databases), and following CABG was 5.9% (range 4.9%-8.4% among databases). Mortality rates declined significantly in older patients for both PCI and CABG over this decade. While process measures varied across registries, the most significant predictors of inhospital death (procedural urgency, left ventricular dysfunction, prior CABG) seemed consistent across all sites. CONCLUSION: Over the last decade, the use of coronary revascularization in elderly patients increased and outcomes improved. While age remains a determinant of procedural risk, this risk varies markedly among elderly patients, emphasizing the need for individualized risk assessments.

Hospital variability in length of stay after coronary artery bypass surgery: results from the Society of Thoracic Surgeon's National Cardiac Database.

BACKGROUND: There is growing interest in comparing resource, as well as patient outcome metrics among coronary artery bypass graft surgery (CABG) providers, yet few tools exist for adjusting these provider comparisons for patient case-mix. In this study, we aimed to define the magnitude of hospital variability in postoperative length of stay (PLOS) in contemporary practice and to determine the degree to which this variability was accounted for by differences in patient case-mix. We also sought to determine the relationship between hospitals' risk-adjusted PLOS and mortality outcomes. METHODS: We analyzed 496,797 isolated CABG procedures performed between January 1997 to January 2001 at 587 US hospitals participating in the Society of Thoracic Surgeon's National Cardiac Database. Logistic and linear regression were used to identify independent preoperative factors affecting a patient's likelihood for early discharge (PLOS < or = 5 day), prolonged stay (> 14 days), and overall PLOS. Hierarchical models were used to determine the degree to which hospital factors influenced PLOS beyond patient factors. RESULTS: Overall, 53% of CABG patients were discharged within 5 days of CABG, whereas 5% required prolonged (> 14 days) stays. More than 25 preoperative patient factors were independently associated with a patients' likelihood for early discharge and prolonged stay (model C index 0.70 and 0.75, respectively). After adjusting for patient factors, however, there remained wide unexplained variability among hospitals in PLOS and limited correlation between these PLOS metrics and hospitals' risk-adjusted mortality results (Spearman correlation coefficient -0.15 and 0.35). CONCLUSIONS: Our study provides a method for institutions to receive meaningful risk-adjusted bypass PLOS information. Given the marked variability among hospitals in CABG PLOS, institutions should consider benchmarking metrics of efficiency, as well as patient outcomes.