Publications

IMPORTANCE: Recent studies have produced inconsistent findings regarding the outcomes of the percutaneous microaxial left ventricular assist device (LVAD) during acute myocardial infarction with cardiogenic shock (AMICS).

OBJECTIVE: To compare the percutaneous microaxial LVAD vs alternative treatments among patients presenting with AMICS using observational analyses of administrative data.

DESIGN, SETTING, AND PARTICIPANTS: This comparative effectiveness research study used Medicare fee-for-service claims of patients admitted with AMICS undergoing percutaneous coronary intervention from October 1, 2015, through December 31, 2019. Treatment strategies were compared using (1) inverse probability of treatment weighting to estimate the effect of different baseline treatments in the overall population; (2) instrumental variable analysis to determine the effectiveness of the percutaneous microaxial LVAD among patients whose treatment was influenced by cross-sectional institutional practice patterns; (3) an instrumented difference-in-differences analysis to determine the effectiveness of treatment among patients whose treatment was influenced by longitudinal changes in institutional practice patterns; and (4) a grace period approach to determine the effectiveness of initiating the percutaneous microaxial LVAD within 2 days of percutaneous coronary intervention. Analysis took place between March 2021 and December 2022.

INTERVENTIONS: Percutaneous microaxial LVAD vs alternative treatments (including medical therapy and intra-aortic balloon pump).

MAIN OUTCOMES AND MEASURES: Thirty-day all-cause mortality and readmissions.

RESULTS: Of 23 478 patients, 14 264 (60.8%) were male and the mean (SD) age was 73.9 (9.8) years. In the inverse probability of treatment weighting analysis and grace period approaches, treatment with percutaneous microaxial LVAD was associated with a higher risk-adjusted 30-day mortality (risk difference, 14.9%; 95% CI, 12.9%-17.0%). However, patients receiving the percutaneous microaxial LVAD had a higher frequency of factors associated with severe illness, suggesting possible confounding by measures of illness severity not available in the data. In the instrumental variable analysis, 30-day mortality was also higher with percutaneous microaxial LVAD, but patient and hospital characteristics differed across levels of the instrumental variable, suggesting possible confounding by unmeasured variables (risk difference, 13.5%; 95% CI, 3.9%-23.2%). In the instrumented difference-in-differences analysis, the association between the percutaneous microaxial LVAD and mortality was imprecise, and differences in trends in characteristics between hospitals with different percutaneous microaxial LVAD use suggested potential assumption violations.

CONCLUSIONS: In observational analyses comparing the percutaneous microaxial LVAD to alternative treatments among patients with AMICS, the percutaneous microaxial LVAD was associated with worse outcomes in some analyses, while in other analyses, the association was too imprecise to draw meaningful conclusions. However, the distribution of patient and institutional characteristics between treatment groups or groups defined by institutional differences in treatment use, including changes in use over time, combined with clinical knowledge of illness severity factors not captured in the data, suggested violations of key assumptions that are needed for valid causal inference with different observational analyses. Randomized clinical trials of mechanical support devices will allow valid comparisons across candidate treatment strategies and help resolve ongoing controversies.

PURPOSE: To investigate the real-world safety of paclitaxel (PTX)-coated devices for treating lower extremity peripheral artery disease using a commercial claims database.

MATERIALS AND METHODS: Data from FAIR Health, the largest commercial claims data warehouse in the United States, were used for this study. The study consisted of patients who underwent femoropopliteal revascularization procedures between January 1, 2015, and December 31, 2019, with PTX and non-PTX devices. The primary outcome was 4-year survival following treatment. The secondary outcomes included 2-year survival, 2- and 4-year freedom from amputation, and repeat revascularization. Propensity score matching was used to minimize confounding, and the Kaplan-Meier methods were used to estimate survival.

RESULTS: A total of 10,832 procedures were included in the analysis, including 4,962 involving PTX devices and 5,870 involving non-PTX devices. PTX devices were associated with a reduced hazard of death following treatment at 2 and 4 years (hazard ratio [HR], 0.74 [95% confidence interval {CI}, 0.69-0.79]; P <.05, and HR, 0.89 [95% CI, 0.77-1.02]; log-rank P =.018, respectively). The risk of amputation was also lower following treatment with PTX devices than with non-PTX devices at 2 and 4 years (HR, 0.82 [95% CI, 0.76-0.87]; P =.02, and HR, 0.77 [95% CI, 0.67-0.89]; log-rank P =.01, respectively). In addition, the odds of repeat revascularization were similar with PTX and non-PTX devices at 2 and 4 years.

CONCLUSIONS: In the real-world commercial claims database, no short- or long-term signal for increased mortality or amputations was observed following treatment with PTX devices.

BACKGROUND: Multiple interventions, including catheter-directed therapy (CDT), systemic thrombolysis (ST), surgical embolectomy (SE), and therapeutic anticoagulation (AC) have been used to treat intermediate to high-risk pulmonary embolism (PE), but the most effective and safest treatment remains unclear. Our study aimed to investigate the efficacy and safety outcomes of each intervention.

METHODS: We queried PubMed and EMBASE in January 2023 and performed a network meta-analysis of observational studies and randomized controlled trials (RCT), including high or intermediate-risk PE patients, and comparing AC, CDT, SE, and ST. The primary outcomes were in-hospital mortality and major bleeding. The secondary outcomes included long-term mortality (≥6 months), recurrent PE, minor bleeding, and intracranial hemorrhage.

RESULTS: We identified 11 RCTs and 42 observational studies involving 157,454 patients. CDT was associated with lower in-hospital mortality than ST (odds ratio [OR] [95% confidence interval (CI)]: 0.41 [0.31-0.55]), AC (OR [95% CI]: 0.33 [0.20-0.53]), and SE (OR [95% CI]: 0.61 [0.39-0.96]). Recurrent PE in CDT was lower than ST (OR [95% CI]: 0.66 [0.50-0.87]), AC (OR [95% CI]: 0.36 [0.20-0.66]), and trended lower than SE (OR [95% CI]: 0.71 [0.40-1.26]). Notably, ST had higher major bleeding risks than CDT (OR [95% CI]: 1.51 [1.19-1.91]) and AC (OR [95% CI]: 2.21 [1.53-3.19]). By rankogram analysis, CDT presented the highest p-score in in-hospital mortality, long-term mortality, and recurrent PE.

CONCLUSION: In this network meta-analysis of observational studies and RCTs involving patients with intermediate to high-risk PE, CDT was associated with improved mortality outcomes compared to other therapies, without significant additional bleeding risk.

IMPORTANCE: Carotid artery stenting has been limited to use in patients with high surgical risk; outcomes in patients with standard surgical risk are not well known.

OBJECTIVE: To compare stroke, death, and myocardial infarction outcomes following transcarotid artery revascularization vs carotid endarterectomy in patients with standard surgical risk.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective propensity-matched cohort study was conducted from August 2016 to August 2019 with follow-up until August 31, 2020, using data from the multicenter Vascular Quality Initiative Carotid Artery Stent and Carotid Endarterectomy registries. Patients with standard surgical risk, defined as those lacking Medicare-defined high medical or surgical risk characteristics and undergoing transcarotid artery revascularization (n = 2962) or carotid endarterectomy (n = 35 063) for atherosclerotic carotid disease. In total, 760 patients were excluded for treatment of multiple lesions or in conjunction with other procedures.

EXPOSURES: Transcarotid artery revascularization vs carotid endarterectomy.

MAIN OUTCOMES AND MEASURES: The primary outcome was a composite end point of 30-day stroke, death, or myocardial infarction or 1-year ipsilateral stroke.

RESULTS: After 1:3 matching, 2962 patients undergoing transcarotid artery revascularization (mean [SD] age, 70.4 [6.9] years; 1910 [64.5%] male) and 8886 undergoing endarterectomy (mean [SD] age, 70.0 [6.5] years; 5777 [65.0%] male) were identified. There was no statistically significant difference in the risk of the primary composite end point between the 2 cohorts (transcarotid 3.0% vs endarterectomy 2.6%; absolute difference, 0.40% [95% CI, -0.43% to 1.24%]; relative risk [RR], 1.14 [95% CI, 0.87 to 1.50]; P = .34). Transcarotid artery revascularization was associated with a higher risk of 1-year ipsilateral stroke (1.6% vs 1.1%; absolute difference, 0.52% [95% CI, 0.03 to 1.08]; RR, 1.49 [95% CI, 1.05 to 2.11%]; P = .02) but no difference in 1-year all-cause mortality (2.6% vs 2.5%; absolute difference, -0.13% [95% CI, -0.18% to 0.33%]; RR, 1.04 [95% CI, 0.78 to 1.39]; P = .67).

CONCLUSIONS AND RELEVANCE: In this study, the risk of 30-day stroke, death, or myocardial infarction or 1-year ipsilateral stroke was similar in patients undergoing transcarotid artery revascularization compared with those undergoing endarterectomy for carotid stenosis.

IMPORTANCE: Thoracic endovascular aortic repair (TEVAR) has increasingly been used for uncomplicated type B aortic dissection (uTBAD) despite limited supporting data.

OBJECTIVE: To assess whether initial TEVAR following uTBAD is associated with reduced mortality or morbidity compared with medical therapy alone.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study included Centers for Medicare & Medicaid Services inpatient claims data for adults aged 65 years or older with index admissions for acute uTBAD from January 1, 2011, to December 31, 2018, with follow-up available through December 31, 2019.

EXPOSURES: Initial TEVAR was defined as TEVAR within 30 days of admission for acute uTBAD.

MAIN OUTCOMES AND MEASURES: Outcomes included all-cause mortality, cardiovascular hospitalizations, aorta-related and repeated aorta-related hospitalizations, and aortic interventions associated with initial TEVAR vs medical therapy. Propensity score inverse probability weighting was used.

RESULTS: Of 7105 patients with eligible index admissions for acute uTBAD, 1140 (16.0%) underwent initial TEVAR (623 [54.6%] female; median age, 74 years [IQR, 68-80 years]) and 5965 (84.0%) did not undergo TEVAR (3344 [56.1%] female; median age, 76 years [IQR, 69-83 years]). Receipt of TEVAR was associated with region (vs South; Midwest: adjusted odds ratio [aOR], 0.66 [95% CI, 0.53-0.81]; P < .001; Northeast: aOR, 0.63 [95% CI, 0.50-0.79]; P < .001), Medicaid dual eligibility (aOR, 0.76; 95% CI, 0.63-0.91; P = .003), hypertension (aOR, 1.26; 95% CI, 1.03-1.54; P = .03), peripheral vascular disease (aOR, 1.24; 95% CI, 1.02-1.49; P = .03), and year of admission (2012, 2013, 2014, and 2015 were associated with greater odds of TEVAR compared with 2011). After inverse probability weighting, mortality was similar for the 2 strategies up to 5 years (hazard ratio [HR], 0.95; 95% CI, 0.85-1.06), as were aorta-related hospitalizations (HR, 1.12; 95% CI, 0.99-1.27), aortic interventions (HR, 1.01; 95% CI, 0.84-1.20), and cardiovascular hospitalizations (HR, 1.05; 95% CI, 0.93-1.20). In a sensitivity analysis that included deaths within the first 30 days, initial TEVAR was associated with lower mortality over a period of 1 year (adjusted HR [aHR], 0.86; 95% CI, 0.75-0.99; P = .03), 2 years (aHR, 0.85; 95% CI, 0.75-0.96; P = .008), and 5 years (aHR, 0.87; 95% CI, 0.80-0.96; P = .004).

CONCLUSIONS AND RELEVANCE: In this study, 16.0% of patients underwent initial TEVAR within 30 days of uTBAD, and receipt of initial TEVAR was associated with hypertension, peripheral vascular disease, region, Medicaid dual eligibility, and year of admission. Initial TEVAR was not associated with improved mortality or reduced hospitalizations or aortic interventions over a period of 5 years, but in a sensitivity analysis that included deaths within the first 30 days, initial TEVAR was associated with lower mortality. These findings, along with cost-effectiveness and quality of life, should be assessed in a prospective trial in the US population.

OBJECTIVE: To quantify contemporary outcomes following elective ascending aortic aneurysm repair, to determine risk factors for adverse events and to evaluate difference by institutional surgical volume.

METHODS: We included all elective hospitalisations of adult patients with an ascending aortic aneurysm who underwent aneurysm repair in the Nationwide Readmissions Database between 2016 and 2019. The primary outcome was a composite of in-hospital mortality, stroke (ischaemic and non-ischaemic) and myocardial infarction (MI). We identified independent predictor of adverse events and investigated outcomes by institutional volume.

RESULTS: Among 12 043 patients (mean 62.8 years of age, 28.0% female), MI, stroke or in-hospital death occurred in 598 (4.9%) patients during the index admission (acute stroke: 2.7%, MI: 0.7%, in-hospital death: 2.0%). The strongest predictors of in-hospital death, stroke or MI were chronic weight loss, pulmonary circulation disorder and concomitant descending aortic surgery. Higher procedural volume was associated with a lower incidence of in-hospital death, stroke or MI (OR comparing the highest with the lowest tertile 0.71, 95% CI 0.57 to 0.87; p=0.001) and in-hospital death (OR 0.51, 95% CI 0.37 to 0.72; p<0.001), but no difference in 30-day readmissions.

CONCLUSIONS: The overall rate of in-hospital death, stroke and MI is nearly 5% in patients undergoing elective ascending aortic aneurysm repair. Among several predictors, chronic weight loss is associated with the largest increase in the risk of poor outcomes. Higher hospital volume is associated with a lower in-hospital mortality, highlighting the importance to refer patients to high-volume centres while discussing the risks and benefits of proceeding with repair.

BACKGROUND: Balloon pulmonary angioplasty (BPA) was introduced as a treatment modality for patients with inoperable, medically refractory chronic thromboembolic pulmonary hypertension decades ago; however, reports of high rates of pulmonary vascular injury have led to considerable refinement in procedural technique.

OBJECTIVES: The authors sought to better understand the evolution of BPA procedure-related complications over time.

METHODS: The authors conducted a systematic review of original articles published by pulmonary hypertension centers globally and performed a pooled cohort analysis of procedure-related outcomes with BPA.

RESULTS: This systematic review identified 26 published articles from 18 countries worldwide from 2013 to 2022. A total of 1,714 patients underwent 7,561 total BPA procedures with an average follow up of 7.3 months. From the first period (2013-2017) to the second period (2018-2022), the cumulative incidence of hemoptysis/vascular injury decreased from 14.1% (474/3,351) to 7.7% (233/3,029) (P < 0.01); lung injury/reperfusion edema decreased from 11.3% (377/3,351) to 1.4% (57/3,943) (P < 0.01); invasive mechanical ventilation decreased from 0.7% (23/3,195) to 0.1% (4/3,062) (P < 0.01); and mortality decreased from 2.0% (13/636) to 0.8% (8/1,071) (P < 0.01).

CONCLUSIONS: Procedure-related complications with BPA, including hemoptysis/vascular injury, lung injury/reperfusion edema, mechanical ventilation, and death, were less common in the second period (2018-2022), compared with first period (2013-2017), likely from refinement in patient and lesion selection and procedural technique over time.

Registry Assessment of Peripheral Interventional Devices (RAPID) initiated the Pathways Program to provide a transparent, collaborative forum in which to pursue insights into multiple unresolved questions on benefit-risk of paclitaxel-coated devices, including understanding the basis of the mortality signal, without a demonstrable potential biological mechanism, and whether the late mortality signal could be artifact intrinsic to multiple independent prospective randomized data sources that did not prespecify death as a long-term end point. In response to the directive, the LEAN-Case Report Form working group focused on enhancements to the RAPID Phase I Minimum Core Data set through the addition of key clinical modifiers that would be more strongly linked to longer-term mortality outcomes after peripheral arterial disease intervention in the drug-eluting device era, with the goal to have future mortality signals more accurately examined.

BACKGROUND: Meningioma resection is associated with the risk of venous thromboembolism (VTE).

OBJECTIVES: To determine the incidence and risk factors for VTE following meningioma resection and VTE outcomes based on the type and timing of anticoagulation.

METHODS: From 2011 to 2019, 901 consecutive patients underwent meningioma resection. We retrospectively evaluated the postoperative incidence of VTE and bleeding. For VTE, we determined the treatment strategy and rate of VTE complications and bleeding.

RESULTS: Pharmacologic prophylaxis was administered to 665 (73.8%) patients. The cumulative incidence for total postoperative VTE was 8.7% (95% CI: 6.9%-10.6%), and for symptomatic VTE was 6.0% (95% CI: 4.6%-7.7%). A multivariable model identified the following independent predictors of symptomatic VTE: history of VTE, obesity, and lack of pharmacologic prophylaxis. Following postoperative VTE, 58 (74.3%) patients received therapeutic anticoagulation either initially (33.3%) or after a median delay of 23.5 days (41.0%). Symptomatic recurrent VTE occurred in 13 (16.6%) patients. Following VTE, the use of subtherapeutic anticoagulation was associated with a lower rate of total VTE extension than no anticoagulation (17.5% vs 42.9%, OR 0.28, 95% CI: 0.09-0.93). In total, 14 patients (1.6%) experienced clinically relevant bleeding: 4 received therapeutic anticoagulants, 8 received prophylactic anticoagulation, and 2 received no anticoagulation. Among patients with VTE, 4 (5.1%) experienced bleeding.

CONCLUSION: Recognition of risk factors for VTE following meningioma resection may help improve approaches to thromboprophylaxis. The management of postoperative VTE is highly variable, but most VTE patients are ultimately treated with therapeutic anticoagulants.