Incidence, Clinical Correlates, and Outcomes of Pulmonary Hypertension After Kidney Transplantation: Analysis of Linked US Registry and Medicare Billing Claims.

BACKGROUND: The incidence, risks, and outcomes associated with pulmonary hypertension (P-HTN) in the kidney transplant (KTx) population are not well described. METHODS: We linked US transplant registry data with Medicare claims (2006-2016) to investigate P-HTN diagnoses among Medicare-insured KTx recipients (N = 35 512) using billing claims. Cox regression was applied to identify independent correlates and outcomes of P-HTN (adjusted hazard ratio [aHR] 95%LCLaHR95%UCL) and to examine P-HTN diagnoses as time-dependent mortality predictors. RESULTS: Overall, 8.2% of recipients had a diagnostic code for P-HTN within 2 y preceding transplant. By 3 y posttransplant, P-HTN was diagnosed in 10.310.6%11.0 of the study cohort. After adjustment, posttransplant P-HTN was more likely in KTx recipients who were older (age ≥60 versus 18-30 y a HR, 1.912.403.01) or female (aHR, 1.151.241.34), who had pretransplant P-HTN (aHR, 4.384.795.24), coronary artery disease (aHR, 1.051.151.27), valvular heart disease (aHR, 1.221.321.43), peripheral vascular disease (aHR, 1.051.181.33), chronic pulmonary disease (aHR, 1.201.311.43), obstructive sleep apnea (aHR, 1.151.281.43), longer dialysis duration, pretransplant hemodialysis (aHR, 1.171.371.59), or who underwent transplant in the more recent era (2012-2016 versus 2006-2011: aHR, 1.291.391.51). Posttransplant P-HTN was associated with >2.5-fold increased risk of mortality (aHR, 2.572.843.14) and all-cause graft failure (aHR, 2.422.642.88) within 3 y posttransplant. Outcome associations of newly diagnosed posttransplant P-HTN were similar. CONCLUSIONS: Posttransplant P-HTN is diagnosed in 1 in 10 KTx recipients and is associated with an increased risk of death and graft failure. Future research is needed to refine diagnostic, classification, and management strategies to improve outcomes in KTx recipients who develop P-HTN.

Focused, low tube potential, coronary calcium assessment prior to coronary CT angiography: A prospective, randomized clinical trial.

BACKGROUND: Coronary artery calcium (CAC) scanning is commonly performed before coronary CT angiography (CTA) based partly on its potential to influence CTA scan parameters. Encompassing the whole heart and performed at high tube potential (120 â€‹kVp), standard (Agatston) CAC scanning adds to patient radiation exposure. Most CAC exists in the proximal and mid coronary segments and is easily visualized at low kVp. METHODS: We tested the impact of a modified calcium scan on coronary CTA acquisition decision-making and image quality in a randomized clinical trial. Providers documented planned CTA acquisition parameters prior to CAC scanning in a blinded manner. Standard Agatston CAC scans proceeded in typical fashion whereas modified scans utilized 80 â€‹kVp and reduced z-axis length focused on the proximal-to-mid coronary arteries. CTA providers reviewed the CAC burden then documented final acquisition parameters. RESULTS: The study included 172 patients (48% female; mean age 59 â€‹± â€‹6.7). As planned, the calcium scan effective dose was significantly lower in the modified CAC scan group (0.14 vs. 0.74 â€‹mSv using a 0.014 k-factor or 0.26 vs. 1.38 â€‹mSv using a 0.026 k-factor; both p â€‹< â€‹0.001). Initially selected CTA parameters were changed at an identical rate following visual CAC assessment (59%). There was no significant difference in coronary CTA image quality (median quality score â€‹= â€‹4 in both groups, p â€‹= â€‹0.26), noise (31.0 vs 31.4 HU; p â€‹= â€‹0.81), or signal/noise ratio (17.9 vs 16.8; p â€‹= â€‹0.26). CONCLUSIONS: A low-kVp scan with focused field-of-view provides actionable information regarding the presence and severity of CAC prior to coronary CTA. Coronary CTA parameters based on patient variables are frequently modified after assessing CAC burden in the CTA suite. CLINICALTRIALS. GOV REGISTRATION NUMBER: NCT02972242.

Cost effectiveness and clinical efficacy of patent foramen ovale closure as compared to medical therapy in cryptogenic stroke patients: A detailed cost analysis and meta-analysis of randomized controlled trials.

BACKGROUND: Up to half the patients with cryptogenic stroke under the age of 55 years have been found to have a PFO. Observational studies have demonstrated a benefit from closure of PFO and several RCTs have shown a trend toward benefit. The cost and clinical effectiveness of PFO closure is unclear. METHODS AND RESULTS: We searched for RCTs of PFO closure in patients with cryptogenic stroke and performed a detailed cost analysis and meta-analysis of treatment outcomes based on the results of the meta-analysis. Five RCTs containing 3404 patients with cryptogenic stroke were included. Of these 1829 underwent PFO closure and 1611 received medical therapy. Mean follow-up was 4.0 years. PFO closure achieved cost effectiveness (<$50,000/Quality-adjusted life-year gained) 2.7 years (95% Confidence Interval (CI) 2.2-3.4) after closure. The incremental cost to prevent one combined end point (CEP, combined transient ischemic attack (TIA), stroke, and death) by PFO closure was $535,655(95% CI $458,329-$642,674). After 55.4 years (95%CI 51.1-60.5) of follow-up, the per patient total cost of medical therapy exceeded that of PFO closure. PFO closure demonstrated clinical efficacy with a decreased risk of CEP (pooled hazard ratio (HR = 0.43(95%CI 0.27-0.59))) and a decreased risk of stroke (HR = 0.29(95%CI 0.02-0.57)). CONCLUSIONS: In comparison to medical therapy alone, PFO closure appears to be cost-effective and clinically efficacious.

Implications of New Cholesterol Treatment Guidelines on Statin Utilization, Intensity, and Costs in Active Duty Service Members.

Background: The recommendations in the 2013 American College of Cardiology/American Heart Association (ACC/AHA) blood cholesterol guidelines expanded the indications and level of intensity of statin therapy for the primary prevention of cardiovascular disease. We assessed the treatment and cost implications of theseguidelines within a cohort of active duty service members. Methods: Using the military electronic medical record system, the Armed Forces Health Longitudinal Technology Application, we randomly selected 1,000 active duty persons aged 40 yr or older and reviewed their lipid profiles and medical records to identify risk factors for atherosclerotic cardiovascular disease. We compared the recommended cholesterol treatment under the new ACC/AHA guidelines versus the Third Adult Treatment Panel of the National Cholesterol Education Program. Findings: The mean age was 49 ± 7 yr, 36% were female, 22% were on baseline statin therapy (4% high intensity), and 13% were not at Third Adult Treatment Panel cholesterol goal. There was no difference in the proportion eligible for statin therapy between ACC/AHA and Third Adult Treatment Panel guidelines. Statin treatment under the ACC/AHA guideline resulted in a mean statin dose increase from 25 ± 20 mg to 36 ± 25 mg (p < 0.001) with an increase in those eligible for high-intensity statin therapy, 6% to 11% (p < 0.001). These changes translated to higher estimated yearly statin acquisition costs, $40,197 versus $52,527 per 1,000 patient-years of treatment (p < 0.001). Discussion: Within a low-risk active duty population over 40 yr, application of the 2013 ACC/AHA cholesterol treatment guidelines may not significantly increase those eligible for statins, but may increase statin treatment intensity and costs.

Healthcare Policy Statement on the Utility of Coronary Computed Tomography for Evaluation of Cardiovascular Conditions and Preventive Healthcare: From the Health Policy Working Group of the Society of Cardiovascular Computed Tomography.

The rising cost of healthcare is prompting numerous policy and advocacy discussions regarding strategies for constraining growth and creating a more efficient and effective healthcare system. Cardiovascular imaging is central to the care of patients at risk of, and living with, heart disease. Estimates are that utilization of cardiovascular imaging exceeds 20 million studies per year. The Society of Cardiovascular CT (SCCT), alongside Rush University Medical Center, and in collaboration with government agencies, regional payers, and industry healthcare experts met in November 2016 in Chicago, IL to evaluate obstacles and hurdles facing the cardiovascular imaging community and how they can contribute to efficacy while maintaining or even improving outcomes and quality. The summit incorporated inputs from payers, providers, and patients' perspectives, providing a platform for all voices to be heard, allowing for a constructive dialogue with potential solutions moving forward. This article outlines the proceedings from the summit, with a detailed review of past hurdles, current status, and potential solutions as we move forward in an ever-changing healthcare landscape.

Prognostic Significance of Nonobstructive Left Main Coronary Artery Disease in Women Versus Men: Long-Term Outcomes From the CONFIRM (Coronary CT Angiography Evaluation For Clinical Outcomes: An International Multicenter) Registry.

BACKGROUND: Patients with obstructive (≥50% stenosis) left main (LM) coronary artery disease (CAD) are at high risk for adverse events; prior studies have also documented worse outcomes among women than men with severe multivessel/LM CAD. However, the prognostic significance of nonobstructive (1%-49% stenosis) LM CAD, including sex-specific differences, has not been previously examined. METHODS AND RESULTS: In the long-term CONFIRM (Coronary CT Angiography Evaluation For Clinical Outcomes: An International Multicenter) registry, patients underwent elective coronary computed tomographic angiography for suspected CAD and were followed for 5 years. After excluding those with obstructive LM CAD, 5166 patients were categorized as having normal LM or nonobstructive LM (18% of cohort). Cumulative 5-year incidence of death, myocardial infarction, or revascularization was higher among patients with nonobstructive LM than normal LM in both women and men: women (34.3% versus 15.4%; P<0.0001); men (24.6% versus 18.2%; P<0.0001). A significant interaction existed between sex and LM status for the composite outcome (P=0.001). In multivariable Cox regression, the presence of nonobstructive LM plaque increased the risk for the composite outcome in women (adjusted hazard ratio, 1.48; P=0.005) but not in men (adjusted hazard ratio, 0.98, P=0.806). In subgroup analysis, women with nonobstructive LM CAD had a nearly 80% higher risk for events than men with nonobstructive LM CAD (adjusted hazard ratio, 1.78; P=0.017); sex-specific interactions were not observed across other patterns (eg, location or extent) of nonobstructive plaque. CONCLUSION: Nonobstructive LM CAD was frequently detected on coronary computed tomographic angiography and strongly associated with adverse events among women. Recognizing the sex-specific prognostic significance of nonobstructive LM plaque may augment risk stratification efforts.

A comparison of the safety and effectiveness of dabigatran and warfarin in non-valvular atrial fibrillation patients in a large healthcare system.

Dabigatran is approved for stroke risk reduction in patients with nonvalvular atrial fibrillation (NVAF). Data from diverse clinical practice settings will help establish whether the risk:benefit ratio seen in clinical trials is comparable with routine clinical care. This study aimed to compare the safety and effectiveness of dabigatran and warfarin in clinical practice. We undertook a propensity score-matched (PSM) cohort study (N=12,793 per group; mean age 74) comparing treatment with dabigatran or warfarin in the US Department of Defense claims database, October 2009 to July 2013. Treatment-naïve patients with first prescription claim for dabigatran (either FDA-approved dose) or warfarin between October 2010 and July 2012 (index) and a diagnosis of NVAF during the 12 months before index date were included. Primary outcomes were stroke and major bleeding. Secondary outcomes included ischaemic and haemorrhagic stroke, major gastrointestinal (GI), urogenital or other bleeding, myocardial infarction (MI) and death. Time-to-event was investigated using Kaplan-Meier survival analyses. Outcomes comparisons were made utilising Cox-proportional hazards models of PSM groups. Dabigatran users experienced fewer strokes (adjusted hazard ratio [95 % confidence intervals] 0.73 [0.55-0.97]), major intracranial (0.49 [0.30-0.79]), urogenital (0.36 [0.18-0.74]) and other (0.38 [0.22-0.66]) bleeding, MI (0.65 [0.45-0.95]) and deaths (0.64 [0.55-0.74]) than the warfarin group. Major bleeding (0.87 [0.74-1.03]) and major GI bleeding (1.13 [0.94-1.37]) was similar between groups and major lower GI bleeding events were more frequent (1.30 [1.04-1.62]) with dabigatran. In conclusion, compared with warfarin, dabigatran treatment was associated with a lower risk of stroke and most outcomes measured, but increased incidence of major lower GI bleeding.

Safe and rapid disposition of low-to-intermediate risk patients presenting to the emergency department with chest pain: a 1-year high-volume single-center experience.

BACKGROUND: Coronary CT angiography (CTA) is a powerful tool for the evaluation of chest pain in the emergency department (ED). Some debate persists regarding its cost-effectiveness in a low-to-intermediate risk population. OBJECTIVE: This study sought to evaluate the safety and cost-effectiveness of coronary CTA for low-to-intermediate risk patients presenting to the ED with chest pain in a closed-loop referral system. METHODS: Chest pain patients were evaluated in the ED via a local rapid coronary CTA protocol and tracked prospectively for ED throughput, disposition, chest pain recidivism, and cost utilization as compared with an age-matched cohort evaluated for chest pain treated with usual care. RESULTS: One hundred eighty-three patients underwent the rapid coronary CTA protocol compared with an age-matched cohort of 184 patients treated with usual care. The median follow-up period for major adverse cardiovascular events in the coronary CTA group was 9.0 months (range, 1.8-14.5 months) and 11.1 months (range, 0-14.0 months) for the age-matched cohort. The median ED length of stay (LOS) was 5.8 hours (range, 2.6-12.3 hours) for the rapid coronary CTA cohort and 12.2 hours (range, 1.7-40.3 hours) for the age-matched cohort (P < .001). The median time to performance of coronary CTA was 2.5 hours (range, 0.4-8.7 hours) with a median time from coronary CTA performance to disposition of 2.9 hours (range, 0.8-8.6 hours). Total median hospital LOS was 5.9 hours (range, 2.7-124 hours) in the rapid coronary CTA cohort compared with 25.0 hours (range, 1.2-208 hours) in the age-matched cohort (P < .001). Hospital admission was more common in the age-matched cohort (98.9% vs 9.3%; P < .001). There was a significant reduction in total payer cost in coronary CTA group when compared to usual care ($182,064.55 vs $685,190.77; P < .001). CONCLUSIONS: Coronary CTA for ED risk stratification and disposition within a closed referral system resulted in the shortest ED LOS published to date while being safe and cost-effective.

Cost effectiveness of percutaneous closure versus medical therapy for cryptogenic stroke in patients with a patent foramen ovale.

In patients with patent foramen ovales (PFOs) and cryptogenic stroke, observational studies have demonstrated reductions in recurrent neurologic events with transcatheter PFO closure compared with medical therapy. Randomized controlled trials and meta-analyses have shown a trend toward benefit with device closure. The cost-effectiveness of PFO closure has not been described. Therefore, a detailed cost analysis was performed using pooled weighted outcome and complication rates from published randomized controlled trials, Medicare cost tables, and wholesale medication prices. Incremental cost per life-year gained and per quality-adjusted life-year (QALY) gained by PFO closure was calculated. The commonly accepted cost-effectiveness threshold of <$50,000/quality-adjusted life-year gained was used. At 2.6 years (the mean duration of randomized controlled trial follow-up), PFO closure was more costly ($16,213, 95% confidence interval [CI] $15,753 to $16,749) per patient, with a cost of $103,607 (95% CI $5,826 to $2,544,750) per life-year gained. The expenditure to prevent 1 combined end point (transient ischemic attack, stroke, and death) at 2.6 years was $1.09 million (95% CI $1.04 million to $1.20 million). Modeling the costs of medical treatment prospectively, PFO closure reached cost-effectiveness (<$50,000/quality-adjusted life-year gained) at 2.6 years (95% CI 1.5 to 44.2). At 30.2 years (95% CI 28.2 to 36.2), the per patient mean cost of medical therapy exceeded that of PFO closure. In conclusion, PFO closure is associated with higher expenditures related to procedural costs; however, this increase may be offset over time by reduced event rates and costs of long-term medical treatment in patients who undergo transcatheter PFO closure. In younger patients typical of cryptogenic stroke, PFO closure may be cost effective in the long term.

Chamber dimensions and functional assessment with coronary computed tomographic angiography as compared to echocardiography using American Society of Echocardiography guidelines.

BACKGROUND: The correlation between normal cardiac chamber linear dimensions measured during retrospective coronary computed tomographic angiography as compared to transthoracic echocardiography using the American Society of Echocardiography guidelines is not well established. METHODS: We performed a review from January 2005 to July 2011 to identify subjects with retrospective electrocardiogram-gated coronary computed tomographic angiography scans for chest pain and transthoracic echocardiography with normal cardiac structures performed within 90 days. Dimensions were manually calculated in both imaging modalities in accordance with the American Society of Echocardiography published guidelines. Left ventricular ejection fraction was calculated on echocardiography manually using the Simpson's formula and by coronary computed tomographic angiography using the end-systolic and end-diastolic volumes. RESULTS: We reviewed 532 studies, rejected 412 and had 120 cases for review with a median time between studies of 7 days (interquartile range (IQR25,75) = 0-22 days) with no correlation between the measurements made by coronary computed tomographic angiography and transthoracic echocardiography using Bland-Altman analysis. We generated coronary computed tomographic angiography cardiac dimension reference ranges for both genders for our population. CONCLUSION: Our findings represent a step towards generating cardiac chamber dimensions' reference ranges for coronary computed tomographic angiography as compared to transthoracic echocardiography in patients with normal cardiac morphology and function using the American Society of Echocardiography guideline measurements that are commonly used by cardiologists.

Assessment of major adverse cardiovascular events and ischemic stroke with coronary computed tomography angiography based upon angiographic diagnosis in a high-volume single center.

BACKGROUND: Patient prognosis has been shown to directly correlate with the severity of coronary artery disease diagnosed by coronary computed tomography angiography (CCTA). Although the presence of coronary artery calcium has been associated with increased incidence of ischemic stroke, there are no data on the incidence of ischemic stroke based upon the severity of coronary artery disease by CCTA. Therefore, we sought to investigate the rate of major adverse cardiovascular events, including ischemic stroke, based upon the severity of coronary artery disease by CCTA over a 6-year period in a high-volume single military center. METHODS: We performed a retrospective chart review of all CCTA studies to evaluate the incidence of all-cause mortality, non-fatal myocardial infarction, ischemic stroke, and late revascularization (>90 days following CCTA) from January 2005 until July 2012. We reviewed 1518 CCTA reports, dividing patients into groups with obstructive (≥50% stenosis), non-obstructive (<50% stenosis), and no coronary artery disease (no angiographic disease). Subsequent major adverse cardiovascular events data (incidence of all-cause mortality, ischemic stroke, non-fatal myocardial infarction, and late revascularization) were obtained. RESULTS: Over a review period of 6 years with a resultant median follow-up period of 22 months (interquartile range = 13-34 months), the major adverse cardiovascular events rate was significantly higher with obstructive coronary artery disease compared to both non-obstructive coronary artery disease and no coronary artery disease (8.9% vs 0.7%, p < 0.001; 8.9% vs 1.6%, p < 0.001). The incidence of ischemic stroke alone was also significantly higher in those with obstructive coronary artery disease compared to those with no coronary artery disease (3.8% vs 0.4%, p < 0.001). CONCLUSION: Being free of disease on CCTA was associated with excellent cardiovascular prognosis. Obstructive coronary artery disease was associated with a significantly increased incidence of ischemic stroke. There was also a direct correlation between the severity of coronary artery disease on CCTA and cardiovascular prognosis over the follow-up period of 24 months.

Outcomes after coronary computed tomography angiography in the emergency department: a systematic review and meta-analysis of randomized, controlled trials.

OBJECTIVES: The aim of the study was to systematically review and perform a meta-analysis of randomized, controlled trials of coronary computed tomography angiography (CCTA) versus usual care (UC) triage of acute chest pain in the emergency department (ED). BACKGROUND: CCTA allows rapid evaluation of patients presenting to the ED with acute chest pain syndromes; however, the impact of such testing on patient management and downstream testing has emerged as a concern. METHODS: We systematically searched for randomized, controlled trials of CCTA in the ED and performed a meta-analysis of clinical outcomes. RESULTS: Four randomized, controlled trials were included, with 1,869 patients undergoing CCTA and 1,397 undergoing UC. There were no deaths and no difference in the incidence of myocardial infarction, post-discharge ED visits, or rehospitalizations. Four studies reported decreased length of stay with CCTA and 3 reported cost savings; 8.4% of patients undergoing CCTA versus 6.3% of those receiving UC underwent invasive coronary angiography (ICA), whereas 4.6% of patients undergoing CCTA versus 2.6% of those receiving UC underwent coronary revascularization. The odds ratio of ICA for CCTA patients versus UC patients was 1.36 (95% confidence interval [CI]: 1.03 to 1.80, p = 0.030), and for revascularization, it was 1.81 (95% CI: 1.20 to 2.72, p = 0.004). The absolute increase in ICA after CCTA was 21 per 1,000 CCTA patients (95% CI: 1.8 to 44.9), and the number needed to scan was 48. The absolute increase in revascularization after CCTA was 20 per 1,000 patients (95% CI: 5.0 to 41.4); the number needed to scan was 50. Both percutaneous coronary intervention and coronary artery bypass graft surgery independently contributed to the significant increase in revascularization. CONCLUSIONS: Compared with UC, the use of CCTA in the ED is associated with decreased ED cost and length of stay but increased ICA and revascularization.

Prognostic value of coronary computed tomographic angiography among 1,125 consecutive military health care beneficiaries without known coronary artery disease.

We sought to assess the prognostic value of coronary computed tomography angiography (CCTA) among military health care system beneficiaries. We identified 1,125 consecutive symptomatic patients without known coronary artery disease (CAD) referred for 64-slice CCTA (2006-2010) at a single center. CAD was assessed as none, < 50%, or > or = 50% (obstructive) coronary stenosis. A combined endpoint of major adverse events (death, myocardial infarction [MI], coronary revascularization > 90 days after CCTA) was assessed by Kaplan-Meier and Cox proportional hazards. The mean age was 50 +/- 12 years, 59% were male, and 617 (55%) had no CAD, 411 (37%) nonobstructive CAD, and 97 (9%) obstructive CAD on CCTA. During 2.0 +/- 1.1-year follow-up, there were 6 deaths, 3 MIs, and 6 revascularizations. There was 1 event in the no-CAD group (0.08%/year), 4 events in the nonobstructive group (0.5%/year), and 9 events in patients with obstructive CAD (4.5%/year) (p < 0.001). Patients with obstructive CAD had significantly increased combined adverse events. Increasing angina typicality and risk factors (hazard ratio [HR] 1.24, 95% confidence interval [CI] 1.05-1.46; p = 0.01) and obstructive CAD (HR 12.1, 95% CI 3.99-36.9; p < 0.001) were independently predictive of events. Absence of CAD was associated with very low event rates, providing military health care system patients and providers confidence in regards to cardiovascular risk, future deployments, and occupational assignments.

The prognostic significance of coronary CT angiography.

Coronary computed tomography angiography (CTA) is an increasingly utilized, highly accurate noninvasive test for the diagnosis of coronary artery disease. Accumulating data have convincingly demonstrated that the presence, extent, and location of both obstructive and nonobstructive coronary atherosclerosis visualized on coronary CTA conveys powerful prognostic information, incremental to that provided by clinical variables and coronary calcium scoring. Proposed markers of future plaque instability and coronary risk, such as the degree of vessel remodeling and low-attenuation plaque volume, as well as measures of CT myocardial perfusion, may further improve the prognostic value of CTA. Ultimately, studies are needed to assess whether the prognostic information provided by coronary CTA testing results in sustained changes in patient and provider behaviors that cost effectively improve patient outcomes.