Publications

Hypertension is a primary contributor to cardiovascular disease, and the leading risk factor for loss of quality adjusted life years. Up to 50% of the cases of hypertension in the United States remain uncontrolled. Additionally, 8%-18% of the hypertensive population have resistant hypertension; uncontrolled pressure despite 3 different antihypertensive agents. Recently, catheter-based percutaneous renal denervation emerged as a method for ablating renal sympathetic nerves for difficult-to-control hypertension. Initial randomized (non-sham) trials and registry analyses showed impressive benefit, but the first sham-controlled randomized controlled trial using monopolar radiofrequency ablation showed limited benefit. With refinement of techniques to include multipolar radiofrequency, ultrasound denervation, and direct ethanol injection, randomized controlled trials demonstrated significant blood pressure improvement, leading to US Food and Drug Administration approval of radiofrequency- and ultrasound-based denervation technologies. In this review article, we summarize the major randomized sham-controlled trials and societal guidelines regarding the efficacy and safety of renal artery denervation for the treatment of uncontrolled hypertension.

Balancing the safety and efficacy of antithrombotic agents in patients with gastrointestinal disorders is challenging because of the potential for interference with the absorption of antithrombotic drugs and for an increased risk of bleeding. In this Review, we address considerations for enteral antithrombotic therapy in patients with cardiovascular disease and gastrointestinal comorbidities. For those with gastrointestinal bleeding (GIB), we summarize a general scheme for risk stratification and clinical evidence on risk reduction approaches, such as limiting the use of concomitant medications that increase the risk of GIB and the potential utility of gastrointestinal protection strategies (such as proton pump inhibitors or histamine type 2 receptor antagonists). Furthermore, we summarize the best available evidence and potential gaps in our knowledge on tailoring antithrombotic therapy in patients with active or recent GIB and in those at high risk of GIB but without active or recent GIB. Finally, we review the recommendations provided by major medical societies, highlighting the crucial role of teamwork and multidisciplinary discussions to customize the antithrombotic regimen in patients with coexisting cardiovascular and gastrointestinal diseases.

INTRODUCTION: Two of the main reasons recent guidelines do not recommend routine population-wide screening programs for asymptomatic carotid artery stenosis (AsxCS) is that screening could lead to an increase of carotid revascularization procedures and that such mass screening programs may not be cost-effective. Nevertheless, selective screening for AsxCS could have several benefits. This article presents the rationale for such a program.

AREAS COVERED: The benefits of selective screening for AsxCS include early recognition of AsxCS allowing timely initiation of preventive measures to reduce future myocardial infarction (MI), stroke, cardiac death and cardiovascular (CV) event rates.

EXPERT OPINION: Mass screening programs for AsxCS are neither clinically effective nor cost-effective. Nevertheless, targeted screening of populations at high risk for AsxCS provides an opportunity to identify these individuals earlier rather than later and to initiate a number of lifestyle measures, risk factor modifications, and intensive medical therapy in order to prevent future strokes and CV events. For patients at 'higher risk of stroke' on best medical treatment, a prophylactic carotid intervention may be considered.

BACKGROUND: The role of advanced therapies (systemic thrombolysis, catheter-based treatment, and surgical thrombectomy) for the management of right heart thrombus is poorly defined. In this study, we assessed the clinical predictors and outcomes of advanced therapy compared with anticoagulation alone for the acute management of right heart thrombus.

METHODS: In this observational cohort study, we analyzed consecutive patients who were treated for right heart thrombus. The primary end point was 90-day all-cause mortality. Clinical predictors of utilizing advanced therapy were assessed with multivariable logistic regression. Propensity score matching was utilized to compare adjusted outcomes between patients receiving advanced therapies versus anticoagulation alone.

RESULTS: A total of 345 patients were included in the study. Advanced therapy was utilized in 13.6% (N=47) of patients, of which 25.5% (N=12/47) was systemic thrombolysis, 23.4% (N=11/47) was endovascular thrombectomy, and 53.2% (N=25/47) was surgical thrombectomy. Younger age (odds ratio, 0.98 [95% CI, 0.96-0.99]) and concurrent pulmonary embolism (odds ratio, 5.36 [95% CI, 2.48-12.1]) predicted utilization of advanced therapy. In propensity score-matched analysis, there was no difference in 90-day mortality (hazard ratio, 0.46 [95% CI, 0.17-1.22]), in-hospital mortality (odds ratio, 0.64 [95% CI, 0.17-2.19]), or length of stay (β, -4.39 [95% CI, -14.0 to 5.22]) between advanced therapy and anticoagulation.

CONCLUSIONS: Among a diverse cohort of patients with right heart thrombus, outcomes did not differ between those who underwent advanced therapy and anticoagulation alone. Important predictors for utilizing advanced treatment included younger age and the presence of a concurrent pulmonary embolism. Future studies assessing advanced therapy in larger and broader patient populations are necessary.

AIMS: Catheter-directed treatment (CDT) of acute pulmonary embolism (PE) is entering a growth phase in Europe following a steady increase in the USA in the past decade, but the potential economic impact on European healthcare systems remains unknown.

METHODS AND RESULTS: We built two statistical models for the monthly trend of proportion of CDT among patients with severe (intermediate- or high-risk) PE in the USA. The conservative model was based on admission data from the National Inpatient Sample (NIS) 2016-20 and the model reflecting increasing access to advanced treatment from the PERT™ national quality assurance database registry 2018-21. By applying these models to the forecast of annual PE-related hospitalizations in Germany, we calculated the annual number of severe PE cases and the expected increase in CDT use for the period 2025-30. The NIS-based model yielded a slow increase, reaching 3.1% (95% confidence interval 3.0-3.2%) among all hospitalizations with PE in 2030; in the PERT-based model, increase would be steeper, reaching 8.7% (8.3-9.2%). Based on current reimbursement rates, we estimated an increase of annual costs for PE-related hospitalizations in Germany ranging from 15.3 to 49.8 million euros by 2030. This calculation does not account for potential cost savings, including those from reduced length of hospital stay.

CONCLUSION: Our approach and results, which may be adapted to other European healthcare systems, provide a benchmark for healthcare costs expected to result from CDT. Data from ongoing trials on clinical benefits and cost savings are needed to determine cost-effectiveness and inform reimbursement decisions.

BACKGROUND: Outpatient management of select patients with low-risk acute pulmonary embolism (PE) has been proven to be safe and effective, yet recent evidence suggests that patients are still managed with hospitalization. Few studies have assessed contemporary real-world trends in discharge rates from U.S. emergency departments (EDs) for acute PE.

OBJECTIVE: To evaluate whether the proportion of discharges from EDs for acute PE changed between 2012 and 2020 and which baseline characteristics are associated with ED discharge.

DESIGN: Serial cross-sectional analysis.

SETTING: U.S. EDs participating in the National Hospital Ambulatory Medical Care Survey.

PATIENTS: Patients with ED visits for acute PE between 2012 and 2020.

MEASUREMENTS: National trends in the proportion of discharges for acute PE and factors associated with ED discharge.

RESULTS: Between 2012 and 2020, there were approximately 1 635 300 visits for acute PE. Overall, ED discharge rates remained constant over time, with rates of 38.2% (95% CI, 17.9% to 64.0%) between 2012 and 2014 and 33.4% (CI, 21.0% to 49.0%) between 2018 and 2020 (adjusted risk ratio, 1.01 per year [CI, 0.89 to 1.14]). No baseline characteristics, including established risk stratification scores, were predictive of an increased likelihood of ED discharge; however, patients at teaching hospitals and those with private insurance were more likely to receive oral anticoagulation at discharge. Only 35.9% (CI, 23.9% to 50.0%) of patients who were considered low-risk according to their Pulmonary Embolism Severity Index (PESI) class, 33.1% (CI, 21.6% to 47.0%) according to simplified PESI score, and 34.8% (CI, 23.3% to 48.0%) according to hemodynamic stability were discharged from the ED setting.

LIMITATIONS: Cross-sectional survey design and inability to adjudicate diagnoses.

CONCLUSION: In a representative nationwide sample, rates of discharge from the ED for acute PE appear to have remained constant between 2012 and 2020. Only one third of low-risk patients were discharged for outpatient management, and rates seem to have stabilized. Outpatient management of low-risk acute PE may still be largely underutilized in the United States.

PRIMARY FUNDING SOURCE: None.

BACKGROUND: As a key treatment goal for patients with symptomatic peripheral artery disease (PAD), improving health status has also become an important end point for clinical trials and performance-based care. An understanding of patient factors associated with 1-year PAD health status is lacking in patients with PAD.

METHODS: The health status of 1073 consecutive patients with symptomatic PAD in the international multicenter PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry was measured at baseline and 1 year with the Peripheral Artery Questionnaire (PAQ). The association of 47 patient characteristics with 1-year PAQ scores was assessed using a random forest algorithm. Variables of clinical significance were retained and included in a hierarchical multivariable linear regression model predicting 1-year PAQ summary scores.

RESULTS: The mean age of patients was 67.7 ± 9.3 years, and 37% were female. Variables with the highest importance ranking in predicting 1-year PAQ summary score were baseline PAQ summary score, Patient Health Questionnaire-8 depression score, Generalized Anxiety Disorder-2 anxiety score, new onset symptom presentation, insurance status, current or prior diagnosis of depression, low social support, initial invasive treatment, duration of symptoms, and race. The addition of 19 clinical variables in an extended model marginally improved the explained variance in 1-year health status (from R2 0.312 to 0.335).

CONCLUSIONS: Patients' 1-year PAD-specific health status, as measured by the PAQ, can be predicted from 10 mostly psychosocial and socioeconomic patient characteristics including depression, anxiety, insurance status, social support, and symptoms. These characteristics should be validated and tested in other PAD cohorts so that this model can inform risk adjustment and prediction of PAD health status in comparative effectiveness research and performance-based care.