Kimberly M Brayton's research while affiliated with Stanford University and other places

Lymphedema is a common complication of cancer therapeutics; its prevalence, treatment outcomes, and costs have been poorly defined. The objective of this study was to examine lymphedema prevalence among cancer survivors and to characterize changes in clinical outcomes and costs associated with a defined therapeutic intervention (use of a pneumatic compression devices [PCD]) in a representative, privately insured population. Retrospective analysis of de-identified health claims data from a large national insurer for calendar years 2007 through 2013. Patients were required to have 12 months of continuous insurance coverage prior to PCD receipt (baseline), as well as a 12-month follow-up period. Analyses were performed for individuals with cancer-related lymphedema (n = 1,065). Lymphedema prevalence was calculated: number of patients with a lymphedema claim in a calendar year divided by total number of enrollees. The impact of PCD use was evaluated by comparing rates of a pre-specified set of health outcomes and costs for the 12 months before and after, respectively, PCD receipt. Lymphedema prevalence among cancer survivors increased from 0.95% in 2007 to 1.24% in 2013. PCD use was associated with decreases in rates of hospitalizations (45% to 32%, p<0.0001), outpatient hospital visits (95% to 90%, p<0.0001), cellulitis diagnoses (28% to 22%, p = 0.003), and physical therapy use (50% to 41%, p<0.0001). The average baseline health care costs were high ($53,422) but decreased in the year after PCD acquisition (-$11,833, p<0.0001). Lymphedema is a prevalent medical condition that is often a defining attribute of cancer survivorship. The problem is associated with high health care costs; Treatment (in this instance, use of PCD) is associated with significant decreases in adverse clinical outcomes and costs.

To identify clinical, angiographic, and procedural factors associated with increased risk of periprocedural complications during chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Successful CTO PCI can provide significant clinical benefit; however, procedural risks have received limited study. We sought to identify factors associated with increased CTO PCI periprocedural risk that could be utilized to guide patient and lesion selection. The clinical, angiographic, and procedural records of 336 consecutive CTO PCI procedures performed at a single center from May 2005 through 2012 were reviewed, and data on periprocedural complications were recorded. Logistic regression was performed to identify independent predictors of periprocedural complications during CTO PCI. The incidence of major and minor complications was 3.9% and 10.4%, respectively. Minor bleeding and vascular events were the most common complications (4.8%), followed by perforation (2.4%), contrast-induced nephropathy (1.8%), and transient hypotension (0.6%). Major complications were uncommon: death (0.3%); emergency coronary artery bypass grafting (0.6%); stroke (0.3%); tamponade (0.3%); clinical myocardial infarction (0.9%); donor vessel injury (0.6%); and major bleeding or vascular events (0.9%). Patients who experienced any complication had higher preprocedure troponin levels and were more likely to undergo treatment using the retrograde approach. In multivariable analysis, use of the retrograde approach was independently associated with increased risk of periprocedural complications (odds ratio, 2.057; 95% confidence interval, 1.045-4.051; P=.04). Major complications of CTO PCI are infrequent, but are more common with use of the retrograde approach.

Objective: Same-day discharge (SDD) appears to be safe in highly selected patients undergoing PCI, however the economic impact of SDD compared to overnight observation has not been comprehensively assessed. Methods: We developed a decision-analytic Markov model to compare SDD to overnight observation post-PCI (Figure). Patients were followed from index PCI over remaining lifetime, including the possibility of future revascularizations. Inputs were derived from registries, RCTs, and meta-analyses. We adjusted mortality rates for having had a prior adverse procedural outcome. Costs were estimated using micro-costing (2012 USD), and outcomes were measured in QALYs, both considered from a societal perspective and discounted at 3% annually. Results: Base case analysis demonstrated that SDD cost $1,639 less but delivered 0.0028 fewer QALYs ($585,000 saved per QALY lost) compared to overnight observation. This result was sensitive to adverse outcome probabilities. SDD cost less and provided more QALYs when the probabilities of adverse outcomes for SDD were lower (<0.57% death, <0.60% major bleeding, or <2.32% MI) or when the probabilities of adverse outcomes for overnight observation were higher (>0.63% death, >0.90% major bleeding, or >2.89% MI). However, SDD cost more and was less effective if rates of SDD adverse events were substantially higher (>6.46% for MI) but still within the 95% confidence interval. Probabilistic sensitivity analyses revealed that SDD was frequently cost-effective even at high willingness-to-pay thresholds. Conclusion: SDD appears to be cost-effective if its safety profile is confirmed to be nearly identical to overnight observation. The attractiveness of SDD may depend on the ability of health systems to re-allocate resources to achieve anticipated cost savings, and to monitor and respond to adverse events out of the hospital.

Objectives: To assess the risk of stroke after transradial (TR) versus transfemoral (TF) artery cardiac catheterization. Background: TR catheterization is gaining popularity due to its association with lower bleeding and access site complications, improved patient comfort, and lower costs compared to TF catheterization; however, there is concern that TR catheterization may be associated with an increased risk of neurological complications. Methods: We conducted a meta-analysis of randomized studies published until 2013 reporting risk of stroke in TR vs. TF catheterization. Results: Data from 11,273 patients in 13 studies were collated. The majority of patients were men, and 8,987 (79.7%) were enrolled in acute coronary syndrome trials. Very few patients had a history of prior coronary artery bypass grafting, and approximately 2/3 of patients underwent percutaneous coronary intervention. Stroke occurred in 25 of 5,659 patients in the TR group, vs. 24 of 5,614 patients in the TF group. There was no difference in stroke rates between the TR and TF groups ( Figure , risk difference 0.00%, 95% confidence interval -0.29% - 0.25%, p=0.88). This finding was consistent in a number of sensitivity analyses (excluding non-ST elevation acute coronary syndrome (ACS) trials, non-ACS trials, trials reporting in-hospital events or 30-day events, trials requiring radial expertise). Conclusions: TR catheterization is not associated with a significant increase in stroke compared to TF catheterization.

The incidence of periprocedural myocardial infarction (MI) after percutaneous coronary intervention (PCI) ranges from 2% to 50%, depending on the clinical presentation, type of procedure, choice of biomarker (creatine kinase [CK]-MB or troponin), and the threshold used to qualify the diagnosis.1 Because of this heterogeneity of definition, the prognostic implications of periprocedural MI are controversial.2 However, several studies have demonstrated that periprocedural MI is associated with worse in-hospital, short-term, and long-term clinical outcomes, including death, recurrent MI, and need for revascularization.3–5 Various mechanisms can lead to periprocedural MI, such as side branch occlusion or vessel spasm; however, distal embolization of atheroma or thrombus seems to be a dominant cause.6 In a cardiac MRI (cMRI) study of patients undergoing complex native coronary PCI, elevated troponin levels post-PCI correlated with new myocardial enhancement because of side branch occlusion in 43% of cases and in the apical myocardium distal to the stent in 57% of cases, as would be expected with distal embolization.7 Numerous studies have documented the occurrence of distal embolization during both elective and urgent PCI and have characterized its histopathologic substrate. In an analysis of catheter-retrieved materials from human studies of patients undergoing PCI for acute coronary syndrome (ACS),8 those with no-reflow had significantly higher amounts of visible atheroma and microscopic components such as platelet–fibrin complexes, cholesterol crystals, and macrophages.8 In another study of 37 lesions in 35 patients undergoing elective PCI, microscopic particles were captured by embolic protection devices (EPDs) in 28 (75.6%) lesions.9 Thrombotic components (fibrin strand–entrapped platelets, leukocytes, and red cells) accounted for the majority (≈75%) of captured debris, whereas plaque components (fibrous tissue, calcium spots, acellular amorphous material, macrophages, foam cells, and cholesterol clefts) accounted for the minority (≈25%).9 Similar findings were demonstrated among 33 …

Purpose: For patients undergoing elective percutaneous coronary intervention (PCI), shortening hospitalization has important cost implications and safety considerations. In studies of same-day discharge (SDD) compared to routine overnight observation in highly selected PCI populations, the overall safety profile is uncertain as some outcome were better with SDD and others were not. We assessed the cost-effectiveness of SDD for all eligible PCI patients. Method: We developed a decision-analytic Markov model of patients post PCI to compare same-day discharge to routine overnight observation. Patients were followed from their index PCI over their remaining lifetime, including the possibility of repeat coronary procedures. We derived inputs from registries, randomized trials, and meta-analyses. The probabilities for SDD adverse outcomes were death (0.6%), major bleed (MB) (0.9%), myocardial infarction (MI) (2.6%), and target vessel revascularization (1.1%); overnight observation outcomes differed only for MI, at 0.6%. We adjusted mortality rates for previous adverse procedure outcomes. We estimated costs using micro-costing methods (2012 USD) and measured outcomes in QALYs, both considered from a societal perspective and discounted at 3% annually. Result: Compared to current practice (routine overnight observation), same-day discharge costs $1,639 less but delivers 0.0028 fewer QALYs ($585,000 saved per QALY lost). This finding is sensitive to adverse outcome probabilities. SDD costs less and provides more QALYs for values of safety measures within the 95% confidence intervals when the probabilities of adverse outcomes for SDD patients are lower (<0.57% for death, <0.60% for MB, or <2.32% for MI) or when the probabilities of adverse outcomes for overnight observation are higher (>0.63% for death, >0.90% for major bleeding events, or >2.89% for MI). In contrast, SDD costs more and is less effective if risks of SDD adverse events are substantially higher (>6.46% for MI) but still within the 95% confidence interval. Probabilistic sensitivity analyses reveal that SDD is frequently cost-effective even at higher willingness-to-pay thresholds (see figure). Conclusion: While same-day discharge can likely reduce costs in many health systems, its health benefits relative to overnight observation appear close and uncertain. The attractiveness of same-day discharge may depend on the ability of particular systems to monitor and quickly respond to adverse events out of the hospital. Research in this area should prioritize establishing the safety profile of same-day discharge in representative patient populations.

Transradial (TR) catheterization is gaining popularity due to its association with lower bleeding and access site complications, improved patient comfort, and lower costs compared to transfemoral (TF) catheterization; however, there is concern that TR catheterization may be associated with an increased risk of neurological complications. New randomized data has emerged since the publication of the last meta-analysis evaluating the risk of stroke between TR and TF catheterization in 2009. We conducted a meta-analysis of randomized studies published until 2013 reporting risk of stroke in TR vs. TF catheterization. Data from 11,273 patients in 13 studies were collated. The majority of patients were men, and 8987 (79.7%) were enrolled in acute coronary syndrome trials. Very few patients had a history of prior coronary artery bypass grafting, and approximately 2/3 of patients underwent percutaneous coronary intervention. Stroke occurred in 25 of 5659 patients in the TR group, vs. 24 of 5614 patients in the TF group. There was no difference in stroke rates between the TR and TF groups (risk difference 0.00%, 95% confidence interval -0.29%-0.25%, p=0.88). TR catheterization is not associated with a significant increase in stroke compared to TF catheterization.

Objectives: This study sought to assess the safety of same-day discharge in patients undergoing percutaneous coronary intervention (PCI). Background: The safety of same-day discharge has previously been evaluated primarily in small, single-center studies. Methods: We conducted a meta-analysis of studies reporting outcomes of patients discharged on the same day as PCI. Demographic data, procedural characteristics, and adverse outcomes were collected. Two composite outcomes were pre-specified: 1) death, myocardial infarction (MI), or target lesion revascularization (TLR); and 2) major bleeding or vascular complications. Results: Data from 12,803 patients in 37 studies were collated, including 7 randomized controlled trials (RCTs) (n = 2,738) and 30 observational studies (n = 10,065). The majority of patients in both cohorts underwent PCI for stable angina. The vascular access site was predominantly transradial in the randomized cohort (60.8%) and transfemoral in the observational cohort (70.0%). In the RCTs, no difference was seen between same-day discharge and routine overnight observation with regard to death/MI/TLR (odds ratio [OR]: 0.90; 95% confidence interval [CI]: 0.43 to 1.87; p = 0.78) or for major bleeding/vascular complications (OR: 1.69; 95% CI: 0.84 to 3.40; p = 0.15). In observational studies, the primary outcome of death/MI/TLR occurred at a pooled rate of 1.00% (95% CI: 0.58% to 1.68%), and major bleeding/vascular complications occurred at a pooled rate of 0.68% (95% CI: 0.35% to 1.32%). Conclusions: In selected patients undergoing largely elective PCI, same-day discharge was associated with a low rate of major complications and appeared to be as safe as routine overnight observation.