Contemporary US Practice Research Articles

Managing the Costs of Kidney Paired Donation: A Survey of Contemporary US Practice and Challenges

Managing the Costs of Kidney Paired Donation: A Survey of Contemporary US Practice and Challenges

Contemporary trends of leadless pacemaker implantation in the United States.

Leadless pacemakers (LPM) have established themselves as the important therapeutic modality in management of selected patients with symptomatic bradycardia. To determine real-world utilization and in-hospital outcomes of LPM implantation since its approval by the Food and Drug Administration in 2016. For this retrospective cohort study, data were extracted from the National Inpatient Sample database from the years 2016-2020. The outcomes analyzed in our study included implantation trends of LPM over study years, mortality, major complications (defined as pericardial effusion requiring intervention, any vascular complication, or acute kidney injury), length of stay, and cost of hospitalization. Implantation trends of LPM were assessed using linear regression. Using years 2016-2017 as a reference, adjusted outcomes of mortality, major complications, prolonged length of stay (defined as >6 days), and increased hospitalization cost (defined as median cost >34 098$) were analyzed for subsequent years using a multivariable logistic regression model. There was a gradual increased trend of LPM implantation over our study years (3230 devices in years 2016-2017 to 11 815 devices in year 2020, p for trend <.01). The adjusted mortality improved significantly after LPM implantation in subsequent years compared to the reference years 2016-2017 (aOR for the year 2018: 0.61, 95% CI: 0.51-0.73; aOR for the year 2019: 0.49, 95% CI: 0.41-0.59; and aOR for the year 2020: 0.52, 95% CI: 0.44-0.62). No differences in adjusted rates of major complications were demonstrated over the subsequent years. The adjusted cost of hospitalization was higher for the years 2019 (aOR: 1.33, 95% CI: 1.22-1.46) and 2020 (aOR: 1.69, 95% CI: 1.55-1.84). The contemporary US practice has shown significantly increased implantation rates of LPM since its approval with reduced rates of inpatient mortality.

Effectiveness of Transcatheter Closure of Patent Foramen Ovale in Clinical Practice.

Background Transcatheter closure of patent foramen ovale (PFO) has reduced the risk of recurrent stroke in patients with cryptogenic strokes in randomized clinical trials. Whether PFO closure in clinical practice is associated with similar benefit remains unknown. Methods and Results We identified patients with PFO and a history of ischemic stroke or transient ischemic attack who were treated with PFO closure or medical therapy in the OptumLabs database. The primary end point was recurrent ischemic stroke or systemic embolization. Secondary outcomes included mortality, all stroke, transient ischemic attack, and major bleeding. A total of 6668 propensity-matched patients were included (PFO closure n=4111; medical therapy n=2557). The incidence of stroke or systemic embolization per 100 person-years was 2.38 after PFO cohort and 2.99 with medical therapy (hazard ratio [HR], 0.85 [95% CI, 0.68-1.05], P=0.13). Mortality was lower in the PFO closure cohort (1.78 versus 2.59 per 100 person-years: HR, 0.69 [95% CI, 0.55-0.87], P=0.002). Falsification end points showed that this difference is unlikely to be completely explained by residual confounders. There were no significant differences between the groups in secondary end points including intracranial hemorrhage and major bleeding except for an increase in nonintracranial hemorrhage bleeding among patients treated with oral anticoagulation (1.42 versus 2.16 per 100 person-years: HR, 0.69 [95% CI, 0.48-0.99], P=0.043). The main end point was consistent in subanalyses including patients <60 years of age, patients with prior stroke, and those treated after the publication of the positive PFO trials in 2017. Conclusions In contemporary US practice, PFO closure is not associated with lower rates of recurrent ischemic stroke or systemic embolization compared with medical therapy. Potential reasons for this discrepancy warrant further investigation.

Abstract 9818: Use of Outpatient Intravenous Diuretic Therapy Among Patients With Heart Failure in the United States

Introduction: Select centers have published local experiences with outpatient (OP) intravenous (IV) diuretic clinics to treat worsening heart failure (HF) and prevent hospitalization. Little is known regarding widespread use of this care strategy in contemporary US practice, including the potential impact of the COVID-19 pandemic. Methods: Inpatient (IP) and OP claims from Optum (April 2018-March 2021) were utilized to identify instances where patients with HF with reduced ejection fraction (HFrEF) received ≥1 administration of IV diuretic. Episodes of care were categorized into hierarchical mutually exclusive groups defined by intensity of care setting, including IP hospitalization, critical care (without IP hospitalization), emergency department (without IP hospitalization), observation unit, nursing facility, and outpatient clinic. Analyses were stratified across pre-pandemic (4/2018-3/2019, 4/2019-3/2020) and COVID-19 pandemic periods (4/2020-3/2021). Results: Among 302,397 patients with HFrEF, 56,213 (19%) patients received IV diuretic therapy during the study period, accounting for 94,865 total IV diuretic episodes. Of patients receiving IV diuretics, 44% were female and 20% were Black. Among 85,827 (90%) IV diuretic episodes with available data on location of care, 14% were outpatient clinic visits, 60% were IP hospitalizations, and 21% were ED visits. Critical care, observation unit, and nursing facility locations each constituted ~1-2% of IV diuretic episodes. The proportion of outpatient IV diuretic visits and the overall distribution of IV diuretic episodes was similar over time, spanning the pre-pandemic and COVID-19 pandemic periods (Figure) . Conclusions: In this cohort of US patients with HFrEF, approximately 1 in 7 care episodes involving IV diuretic therapy occurred in outpatient clinic. The relative proportion of outpatient IV diuretic visits did not meaningfully change during the first year of the COVID-19 pandemic.

TCT-274 Differences in Risk Profile, Management, and Outcomes of STEMI Among Asian vs White Patients in Contemporary US Practice

TCT-274 Differences in Risk Profile, Management, and Outcomes of STEMI Among Asian vs White Patients in Contemporary US Practice

Treatment Effect of Percutaneous Coronary Intervention in Men Versus Women With ST-Segment-Elevation Myocardial Infarction.

BackgroundWomen are less likely to receive primary percutaneous coronary intervention (pPCI) than men. A potential reason is risk aversion because of the worse outcomes with pPCI among women. However, whether pPCI is associated with a comparable mortality benefit in men and women remains unknown.Methods and ResultsWe selected patients admitted with a principal diagnosis of ST‐segment–elevation myocardial infarction in the National Inpatient Sample (2016–2018). We used propensity‐score matching to calculate average treatment effects of pPCI for in‐hospital mortality, major complications, length of stay, and cost. As a sensitivity analysis, we used logit models followed by a marginal command to calculate the average marginal effect. We included 413 500 weighted hospitalizations (30.7% women, 69.3% men). Women had more comorbidities except smoking and prior sternotomy. Compared with men, women were less likely to undergo angiography (81.0% versus 87.0%; adjusted odds ratio [OR], 0.77; 95% CI, 0.74–0.81; P<0.001) or pPCI (74.0% versus 82.0%; adjusted OR, 0.76; 95% CI, 0.73–0.79; P<0.001). There were no significant differences in average treatment effects of pPCI on mortality between men (−8.4% [−9.3% to −7.6%], P<0.001), and women (−9.5% [−10.8% to −8.3%], P<0.001) (P interaction=0.16). This persisted in age‐stratified analyses (≥85, 65–84, 45–64, <45 years) and sensitivity analysis, excluding emergent admissions. The average treatment effects of pPCI on major complications were comparable except for acute stroke, leaving against medical advice, and palliative encounter. There were no differences in the average treatment effects of pPCI on length of stay, but the proportional increase in cost with pPCI was higher in women.ConclusionspPCI results in a comparable reduction in in‐hospital mortality in men and women. Nonetheless, risk‐adjusted rates of pPCI remain lower in women in contemporary US practice.

Comparison of Outcomes of Coronary Revascularization for Acute Myocardial Infarction in Men Versus Women

This study sought to examine the differences in the characteristics and outcomes between men and women who underwent percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for acute myocardial infarction (AMI) in contemporary US practice. The Nationwide Inpatient Sample was used to identify patients who underwent revascularization for AMI between January 1, 2003 and December 31, 2016. The primary outcome was in-hospital mortality. Propensity score matching was utilized to account for differences in baseline characteristics. In total, 3,603,142 patients were included, of whom only 1,180,436 (33%) were women. Compared with men, women were older and had higher prevalence of key co-morbidities including diabetes, hypertension, congestive heart failure, and chronic kidney and lung disease (p <0.001). In the PCI cohort, women were significantly less likely to undergo multivessel PCI, to receive mechanical circulatory support, or to undergo atherectomy. In the CABG group, women were more likely to have concomitant valve surgery. In the propensity-matched cohorts, in-hospital mortality was higher for women than men regardless of revascularization strategy: 7.6% versus 6.6% for PCI in ST-elevation myocardial infarction, 2.0% versus 1.9% for PCI in non-ST-elevation myocardial infarction, and 5.7% versus 4.3% for CABG in any AMI (p <0.001). Women also had higher rates of major complications, longer hospitalizations, higher costs, and were less likely to be discharged home (vs nursing facility). These sex-based differences persisted over the study 14-year period. In conclusion, in a contemporary nationwide analysis of propensity score-matched patients, women who undergo revascularization for AMI have worse in-hospital outcomes than men regardless of revascularization mode.

Reperfusion of ST-Segment-Elevation Myocardial Infarction in the COVID-19 Era: Business as Usual?

Reperfusion of ST-Segment-Elevation Myocardial Infarction in the COVID-19 Era: Business as Usual?

The Role of Reciprocity in International Humanitarian Law Training: Examples from Historical and Contemporary US Practice

While scholars assert that reciprocity is a force that influences international humanitarian law, the literature has yet to include a detailed analysis of its role in military training. This presents two limitations. First, a substantial quantity of primary source material pertaining to state practice goes underutilized. Second, the methods by which international humanitarian law are promulgated and disseminated to soldiers during training are overlooked. Thus, a potentially important factor in adherence remains under-examined. This article analyzes historical and contemporary military training material including manuals, pamphlets, circulars, and films. Research results suggest that reciprocity impacts international humanitarian law training in varied, nuanced, and dynamic ways. In particular, an emphasis on reciprocity remains a consistent message in post–Vietnam War training. Furthermore, positive reciprocity in the form of a golden rule rationale is often used to justify adherence and remains prevalent in post-9/11 training material.1

NAFTA 2.0: The Greenest Trade Agreement Ever?

AbstractThe renegotiation of what US President Trump called ‘the worst trade deal ever’ has resulted in the most detailed environmental chapter in any trade agreement in history. The USMCA mentions dozens of environmental issues that its predecessor, the North American Free Trade Agreement (NAFTA), overlooked, and in line with contemporary US practice, brings the vast majority of environmental provisions into the core of the agreement, and subjects these provisions to a sanction-based dispute settlement mechanism. It also jettisons two controversial NAFTA measures potentially harmful to the environment. However, this paper argues that the USMCA only makes limited contributions to environmental protection. It primarily replicates most of the environmental provisions included in recent agreements, and only introduces three unprecedented environmental provisions. Moreover, it avoids important issues such as climate change, it does not mention the precautionary principle, and it scales back some environmental provisions related to multilateral environmental agreements.

LONGITUDINAL CHANGES IN MEDICATION DOSING AMONG PATIENTS WITH HEART FAILURE WITH REDUCED EJECTION FRACTION: FROM THE CHAMP-HF REGISTRY

Guidelines recommend titration of medical therapy for heart failure with reduced ejection fraction (HFrEF) to target doses derived from clinical trials, as tolerated. The degree to which such titration occurs in contemporary US practice is unclear. Among 2,588 US outpatients with chronic HFrEF in

CONTEMPORARY INCIDENCE OF RECURRENT CARDIOVASCULAR EVENTS 1 TO 3 YEARS AFTER MYOCARDIAL INFARCTION: LONGITUDINAL US ANALYSIS FROM NCDR REGISTRIES LINKED WITH ALL-PAYER CLAIMS DATABASE

Long-term risks of myocardial infarction (MI) survivors in contemporary US practice remains severely under recognized. Using a unique linkage of national cardiovascular registries and claims, we examined the longitudinal risks and the impact of a patient's comorbidity burden on risk. Patients were

Variation in type of adjuvant chemotherapy received among patients with stage I breast cancer: A multi-institutional Portuguese cohort study

BackgroundA contemporary US study showed an increase in the use of chemotherapy in the last decade for some patients with stage-I breast cancer; with a rise in more intensive regimens, and declining use of anthracyclines. Nevertheless, there is still uncertainty on the absolute benefit of chemotherapy for these patients and the optimal regimen. In this study we compare those findings with the patterns of care among a Portuguese cohort of stage-I breast cancers. MethodsRetrospective cohort study of patients with stage-I breast cancer diagnosed from 2006 to 2008 at four Portuguese institutions. The use and type of chemotherapy was evaluated. ResultsAmong patients with stage I–III breast cancer 39.4% (n = 682) had stage I disease. Of the 595 eligible patients, 22.4% were treated with chemotherapy, 33.9% aged <55 years vs. 12.7% aged >65 years (p < 0.001). Thirteen percent of patients with hormone receptor (HR)+/HER2− tumors, 52.7% of patients with HER2+ and 66.0% of patients with HR-/HER2− received chemotherapy (p < 0.001). In addition, we found inter-institutional variability, with the use of chemotherapy ranging from 0.0% to 43.4% (p < 0.001). Eighty-five percent of patients treated with chemotherapy received less-intensive regimens with anthracycline-based regimens, such as doxorubicin and cyclophosphamide, being the most frequently used, while docetaxel and cyclophosphamide was only used in 1.5% of cases. ConclusionsOverall, almost one-quarter of patients received chemotherapy with institutional variability. When treated, mostly less-intensive associations including anthracyclines were used, which contrasts with contemporary US practice. This study highlights the need for health-services research to understand local practices and tailor quality improvement interventions.

Trends in P2Y12 Inhibitor Use in Patients Referred for Invasive Evaluation of Coronary Artery Disease in Contemporary US Practice

Practice in patients undergoing invasive evaluation for coronary artery disease is variable regarding choice of P2Y12 inhibitor and timing of treatment initiation and is usually dictated by institutional or even individual operator preference. Limited data are available on the actual patterns of P2Y12 inhibitor use in contemporary practice in the United States. We used electronic medical records from the Cerner "Health Facts" database of adults who underwent coronary angiography with or without percutaneous coronary intervention (PCI) from January 2008 to June 2013 and who received a loading dose of clopidogrel, prasugrel, or ticagrelor at any time from 48 hours before the start of procedure up to 6 hours after. Timing of P2Y12 inhibitor administration was categorized as >2 hours before, 0 to 2 hours before (pretreatment groups), or after the start of procedure. Results were also evaluated according to type of P2Y12 inhibitor and patient clinical presentation. A total of 37,964 patients underwent coronary angiography, and 28,306 proceeded to PCI. Pretreatment with a P2Y12 inhibitor was observed in 28% and 23% in the overall and PCI populations, respectively. Moderate variability of pretreatment rates was noted relative to clinical presentation and P2Y12 inhibitor type. Pretreatment rates remained fairly constant over time with the exception of a decreasing trend with prasugrel. In conclusion, among patients referred for invasive evaluation of coronary artery disease, P2Y12 inhibitor pretreatment was low in contemporary US practice, an observation consistent over time and for all available agents and clinical presentations.

Cardiac arrest and clinical characteristics, treatments and outcomes among patients hospitalized with ST-elevation myocardial infarction in contemporary practice: A report from the National Cardiovascular Data Registry

Cardiac arrest (CA) is a major complication of patients with ST-elevation myocardial infarction (STEMI). Its prevalence and prognostic impact in contemporary US practice has not been well assessed. We evaluated STEMI patients included in the National Cardiovascular Data Registry (NCDR) Acute Coronary Treatment Intervention Outcomes Network Registry-Get With the Guidelines (ACTION Registry-GWTG) from 4/1/11 to 6/30/12. Patient clinical characteristics, treatments, and inhospital outcomes were compared by the presence or absence of CA on first medical contact-either before hospital arrival or upon presentation to the ACTION hospital. Of the 49,279 STEMI patients included, 3,716 (7.5%) had CA. Cardiac arrest patients were more likely to have heart failure (15.5% vs 6.9%) and shock (42.9% vs 4.9%) on presentation and higher median (25th and 75th percentiles) ACTION Registry-GWTG mortality risk scores (42 [32, 54] vs 32 [26, 38]) than non-CA patients (all P < .001). Primary percutaneous coronary intervention was performed in most patients with and without CA (76.7% vs 79.1%). Inhospital mortality was significantly higher in patients with than without CA (28.8% vs 4.0%; P < .001), both in patients who presented with cardiogenic shock (46.9% vs 27.1%; P < .001) and those without shock (15.4% vs 2.9%; P < .001). The ACTION Registry-GWTG inhospital mortality model underestimated mortality risk in CA patients; however, prediction significantly improved after adding CA to the model. Almost 8% of STEMI patients present with CA. More than 25% die during the hospitalization, despite high use of primary percutaneous coronary intervention. Cardiogenic shock and CA frequently coexist. Our results suggest that development of systems of care and treatments for both STEMI and CA is needed to reduce the high mortality in these patients.

In-hospital switching between clopidogrel and prasugrel among patients with acute myocardial infarction treated with percutaneous coronary intervention: insights into contemporary practice from the national cardiovascular data registry.

Although randomized clinical trials have compared clopidogrel with higher potency ADP receptor inhibitors (ADPris) among patients with myocardial infarction, little is known about the frequency and factors associated with switching between ADPris in clinical practice. We studied 47 040 patients with myocardial infarction treated with percutaneous coronary intervention, who received either clopidogrel or prasugrel within 24 hours of admission at 361 US hospitals from July 2009 to June 2011 using the merged Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With the Guidelines and CathPCI Registry database. Hierarchical logistic regression modeling was used to determine factors independently associated with in-hospital ADPri switching. Among 40 531 patients treated initially in-hospital with clopidogrel, 2125 (5.2%) were discharged on prasugrel; this frequency steadily increased from 0% to 7% during the study period. Among 6509 patients treated initially in-hospital with prasugrel, 751 (11.5%) were discharged on clopidogrel. The frequency of this switch increased from 6% to 18% during the first 2 quarters of the study period and decreased to 9% by the end. Switching clopidogrel to prasugrel was associated with high-risk angiographic characteristics (thrombotic, long, and bifurcating lesions), reinfarction in-hospital, and private health insurance coverage. Older age, previous cerebrovascular event, in-hospital coronary artery bypass grafting, in-hospital bleeding, and warfarin use at discharge were associated with switching prasugrel to clopidogrel. Clopidogrel and prasugrel are not uncommonly switched in-hospital in patients with myocardial infarction undergoing percutaneous coronary intervention. In contemporary US practice, in addition to risk for bleeding and recurrent ischemic events, medical drug coverage is a major determinant of ADPri selection.

Operator learning curve for transradial percutaneous coronary interventions: implications for the initiation of a transradial access program in contemporary US practice

Our study aimed to assess the characteristics and outcomes of transfemoral approach (TFA) versus the initial steps of a transradial approach (TRA) program and to assess the learning curve of TRA in contemporary, US practice. When compared to TFA, TRA has been shown to lower bleeding and vascular complications during percutaneous coronary intervention (PCI). However, use of TRA is still low. There are limited data regarding the characteristics of TRA learning curve, especially in an era with designated TRA equipment. Consecutive patients undergoing PCI in a single US center were divided into two cohorts according to vascular access approach: the last 250 TFA patients prior to the establishment of a TRA program and the initial 239 TRA patients following the establishment of a TRA program. Subgroup analysis of the TRA group, which was divided into five sequential case groups of 50 cases per group, was performed in order to assess TRA learning curve. Overall, the baseline characteristics of TFA vs. TRA groups were comparable. Fluoroscopy time was significantly longer during TRA procedures (18±11 vs. 15±8min, respectively, p=0.002); however, contrast use was lower during TRA procedures (161±72 vs. 180±63ml, respectively, p=0.002). In-hospital outcomes were similar between the two groups, with low frequencies of mortality, myocardial infarction, and stent thrombosis. Subanalysis of TRA group for learning curve assessment showed no major differences in patient demographics among the five subgroups. In the initial cases, more PCI was performed among non-acute cases (62% in patients 1-50 vs. 8-27% in patients 51-239, p<0.001). Despite these differences, characteristics of the treated vessels were similar between groups. There was no significant change in fluoroscopy time or in the amount of iodinated contrast volume delivered. Similarly, no differences in procedural, in-hospital, and long-term outcomes were documented. Adopting TRA as a default is feasible for high-volume operators without significant learning curve effects.

FREQUENCY, TREATMENT AND IMPACT OF PREHOSPITAL CARDIAC ARREST AMONG PATIENTS WITH STEMI: A REPORT FROM THE ACTION REGISTRY-GWTG™ AND MISSION: LIFELINE

The presence of cardiac arrest (CA) in patients (pts) with ST elevation MI (STEMI) is associated with worse outcomes, but the processes of care and outcomes for these pts have not been assessed in contemporary US practice. We evaluated STEMI pts enrolled in the ACTION Registry®-GWTG™ from 4/1/11

Abstract P111: Revascularization in Perioperative Myocardial Infarction After High Risk Surgery is Associated With Reduced Mortality

Background: The incidence of perioperative myocardial infarction (PMI) is 5-35% after high-risk vascular surgeries, and increases mortality. We sought to determine the incidence of PMI after abdominal aortic aneurysm (AAA) and lower extremity revascularization (LE) procedures in current practice and describe the potential benefit of coronary revascularization. Methods: We analyzed the Nationwide Inpatient Sample from 1998 - 2006. Adult records were selected for indicating AAA and LE procedures. This group was queried for acute myocardial infarction and either percutaneous coronary intervention or coronary artery bypass grafting. In-hospital mortality was determined. We compared categorical data using the Chi-square test. Results: The incidence of PMI was 2.4% (6755/269100) overall, in-hospital mortality increased with PMI. Revascularization was associated with decreased mortality. Conclusion: In contemporary US practice, PMI appears to be under-diagnosed in this sample compared to previous prospective studies, and continues to be associated with increased in-hospital mortality. The utilization of coronary revascularization was associated with decreased mortality. Due to the retrospective nature of this study, causation cannot be determined.

War as an Institution of International Hierarchy: Carl Schmitt’s Theory of the Partisan and Contemporary US Practice

The purpose of this article is to consider what war might look like as an institution of international hierarchy. This might not seem all that challenging because we have a long history of pre-Westphalian warfare to draw on. The first section of the article examines that history to demonstrate how war was gradually transformed from an institution of hierarchy to an institution of international society. The second and third sections of the article are perhaps more challenging because they unsettle English School perspectives on war. This is not simply a reference to the use in the third section of Carl Schmitt to help us understand the evolution of irregular warfare and what that means for normative relationships between combatants. It is also a reference to the argument of the fourth section, which is that the legal regime advanced by the United States in the war on terror in effect globalises the legal hierarchy of civil war. This argument is made with reference to the Military Commissions Act and the case of Omar Khadr and Mohamed Jawad. The article concludes by noting that it is, under Obama, more likely that al Qaeda operatives will be tried in a civilian court and less likely that the detainee will be subjected to aggressive interrogation techniques. Yet to the extent that the 2009 Military Commissions Act holds open the possibility of prosecuting enemy combatants simply for engaging in hostilities, contemporary US practice continues to challenge our understanding of war as an institution of anarchical society.