Publications

OBJECTIVE: The optimal management of patients with asymptomatic carotid stenosis (AsxCS) is enduringly controversial. We updated our 2021 Expert Review and Position Statement, focusing on recent advances in the diagnosis and management of patients with AsxCS.

METHODS: A systematic review of the literature was performed up to August 1, 2023, using PubMed/PubMed Central, EMBASE and Scopus. The following keywords were used in various combinations: "asymptomatic carotid stenosis," "carotid endarterectomy" (CEA), "carotid artery stenting" (CAS), and "transcarotid artery revascularization" (TCAR). Areas covered included (i) improvements in best medical treatment (BMT) for patients with AsxCS and declining stroke risk, (ii) technological advances in surgical/endovascular skills/techniques and outcomes, (iii) risk factors, clinical/imaging characteristics and risk prediction models for the identification of high-risk AsxCS patient subgroups, and (iv) the association between cognitive dysfunction and AsxCS.

RESULTS: BMT is essential for all patients with AsxCS, regardless of whether they will eventually be offered CEA, CAS, or TCAR. Specific patient subgroups at high risk for stroke despite BMT should be considered for a carotid revascularization procedure. These patients include those with severe (≥80%) AsxCS, transcranial Doppler-detected microemboli, plaque echolucency on Duplex ultrasound examination, silent infarcts on brain computed tomography or magnetic resonance angiography scans, decreased cerebrovascular reserve, increased size of juxtaluminal hypoechoic area, AsxCS progression, carotid plaque ulceration, and intraplaque hemorrhage. Treatment of patients with AsxCS should be individualized, taking into consideration individual patient preferences and needs, clinical and imaging characteristics, and cultural, ethnic, and social factors. Solid evidence supporting or refuting an association between AsxCS and cognitive dysfunction is lacking.

CONCLUSIONS: The optimal management of patients with AsxCS should include BMT for all individuals and a prophylactic carotid revascularization procedure (CEA, CAS, or TCAR) for some asymptomatic patient subgroups, additionally taking into consideration individual patient needs and preference, clinical and imaging characteristics, social and cultural factors, and the available stroke risk prediction models. Future studies should investigate the association between AsxCS with cognitive function and the role of carotid revascularization procedures in the progression or reversal of cognitive dysfunction.

OBJECTIVE: Despite the publication of various national/international guidelines, several questions concerning the management of patients with asymptomatic (AsxCS) and symptomatic (SxCS) carotid stenosis remain unanswered. The aim of this international, multi-specialty, expert-based Delphi Consensus document was to address these issues to help clinicians make decisions when guidelines are unclear.

METHODS: Fourteen controversial topics were identified. A three-round Delphi Consensus process was performed including 61 experts. The aim of Round 1 was to investigate the differing views and opinions regarding these unresolved topics. In Round 2, clarifications were asked from each participant. In Round 3, the questionnaire was resent to all participants for their final vote. Consensus was reached when ≥75% of experts agreed on a specific response.

RESULTS: Most experts agreed that: (1) the current periprocedural/in-hospital stroke/death thresholds for performing a carotid intervention should be lowered from 6% to 4% in patients with SxCS and from 3% to 2% in patients with AsxCS; (2) the time threshold for a patient being considered "recently symptomatic" should be reduced from the current definition of "6 months" to 3 months or less; (3) 80% to 99% AsxCS carries a higher risk of stroke compared with 60% to 79% AsxCS; (4) factors beyond the grade of stenosis and symptoms should be added to the indications for revascularization in AsxCS patients (eg, plaque features of vulnerability and silent infarctions on brain computed tomography scans); and (5) shunting should be used selectively, rather than always or never. Consensus could not be reached on the remaining topics due to conflicting, inadequate, or controversial evidence.

CONCLUSIONS: The present international, multi-specialty expert-based Delphi Consensus document attempted to provide responses to several unanswered/unresolved issues. However, consensus could not be achieved on some topics, highlighting areas requiring future research.

BACKGROUND: Lower-limb amputation rates in patients with chronic limb-threatening ischemia vary across the United States, with marked disparities in amputation rates by gender, race, and income status. We evaluated the association of patient, hospital, and geographic characteristics with the intensity of vascular care received the year before a major lower-limb amputation and how intensity of care associates with outcomes after amputation.

METHODS: Using Medicare claims data (2016-2019), beneficiaries diagnosed with chronic limb-threatening ischemia who underwent a major lower-limb amputation were identified. We examined patient, hospital, and geographic characteristics associated with the intensity of vascular care received the year before amputation. Secondary objectives evaluated all-cause mortality and adverse events following amputation.

RESULTS: Of 33 036 total Medicare beneficiaries undergoing major amputation, 7885 (23.9%) were due to chronic limb-threatening ischemia; of these, 4988 (63.3%) received low-intensity and 2897 (36.7%) received high-intensity vascular care. Mean age, 76.6 years; women, 38.9%; Black adults, 24.5%; and of low income, 35.2%. After multivariable adjustment, those of low income (odds ratio, 0.65 [95% CI, 0.58-0.72]; P<0.001), and to a lesser extent, men (odds ratio, 0.89 [95% CI, 0.81-0.98]; P=0.019), and those who received care at a safety-net hospital (odds ratio, 0.87 [95% CI, 0.78-0.97]; P=0.012) were most likely to receive low intensity of care before amputation. High-intensity care was associated with a lower risk of all-cause mortality 2 years following amputation (hazard ratio, 0.79 [95% CI, 0.74-0.85]; P<0.001).

CONCLUSIONS: Patients who were of low-income status, and to a lesser extent, men, or those cared for at safety-net hospitals were most likely to receive low-intensity vascular care. Low-intensity care was associated with worse long-term event-free survival. These data emphasize the continued disparities that exist in contemporary vascular practice.

BACKGROUND: Little is known about treatment variability across US hospitals for patients with chronic limb-threatening ischemia (CLTI).

METHODS AND RESULTS: Data were collected from the 2016 to 2018 National Inpatient Sample. All patients aged ≥18 years, admitted to nonfederal US hospitals with a primary diagnosis of CLTI, were identified. Patients were classified according to their clinical presentation (rest pain, skin ulceration, or gangrene) and were further characterized according to the treatment strategy used. The primary outcome of interest was variability in CLTI treatment, as characterized by the median odds ratio. The median odds ratio is defined as the likelihood that 2 similar patients would be treated with a given modality at 1 versus another randomly selected hospital. There were 15 896 (weighted n=79 480) hospitalizations identified where CLTI was the primary diagnosis. Medical therapy alone, endovascular revascularization ± amputation, surgical revascularization ± amputation, and amputation alone were used in 4057 (25%), 5390 (34%), 3733 (24%), and 2716 (17%) patients, respectively. After adjusting for both patient- and hospital-related factors, the median odds ratio (95% CI) for medical therapy alone, endovascular revascularization ± amputation, surgical revascularization ± amputation, any revascularization, and amputation alone were 1.28 (1.19-1.38), 1.86 (1.77-1.95), 1.65 (1.55-1.74), 1.37 (1.28-1.45), and 1.42 (1.27-1.55), respectively.

CONCLUSIONS: Significant variability in CLTI treatment exists across US hospitals and is not fully explained by patient or hospital characteristics.

Percutaneous revascularization is the primary strategy for treating lower extremity venous and arterial disease. Angiography is limited by its ability to accurately size vessels, precisely determine the degree of stenosis and length of lesions, characterize lesion morphology, or correctly diagnose postintervention complications. These limitations are overcome with use of intravascular ultrasound (IVUS). IVUS has demonstrated the ability to improve outcomes following percutaneous coronary intervention, and there is increasing evidence to support its benefits in the setting of peripheral vascular intervention. At this stage in its evolution, there remains a need to standardize the use and approach to peripheral vascular IVUS imaging. This manuscript represents considerations and consensus perspectives that emerged from a roundtable discussion including 15 physicians with expertise in interventional cardiology, interventional radiology, and vascular surgery, representing 6 cardiovascular specialty societies, held on February 3, 2023. The roundtable's aims were to assess the current state of lower extremity revascularization, identify knowledge gaps and need for evidence, and determine how IVUS can improve care and outcomes for patients with peripheral arterial and deep venous pathology.

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: Catheter-directed treatment (CDT) of acute pulmonary embolism (PE) is entering a growth phase in Europe following a steady increase in the United States (US) 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 US. The conservative model was based on admission data from the National Inpatient Sample (NIS) 2016-2020, and the model reflecting increasing access to advanced treatment from the PERTTM national quality assurance database registry 2018-2021. 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 2025-2030. The NIS-based model yielded a slow increase, reaching 3.1% (95% CI 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: 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.