Publications

BACKGROUND: Stroke is a recognized complication following transcatheter aortic valve replacement (TAVR). Although women have historically had a higher rate of bleeding and vascular complications after TAVR, contemporary data on sex differences in post-TAVR stroke and stroke severity are lacking. Disabling strokes significantly affect quality of life and outcomes, underscoring the need to explore sex-specific variations in post-TAVR stroke risk.

METHODS: In this retrospective cohort study, we included all patients who underwent TAVR in the National Inpatient Sample from 2016 to 2021. Stroke and stroke severity were ascertained using validated claims-based algorithms. Disabling strokes were defined as those resulting in death or discharge to a nonhome location. We used multivariable logistic regression to evaluate the association between sex and stroke while adjusting for covariates, including cerebral embolic protection use, and accounting for survey weights.

RESULTS: Among our weighted sample of 379 410 patients (43.9% female), women demonstrated higher overall in-hospital stroke incidence compared with men (2.31% versus 1.69%; adjusted odds ratio [aOR], 1.208 [95% CI, 1.082-1.350]). This difference was driven primarily by disabling strokes, which were more common in women (1.61% versus 1.01%; aOR, 1.327 [95% CI, 1.158-1.520]). Conversely, the incidence of nondisabling stroke was not statistically different between sexes (0.70% versus 0.67%;( aOR, 1.013 [95% CI, 0.844-1.215]).

CONCLUSIONS: Among patients undergoing TAVR in contemporary practice, women had a higher rate of any stroke and disabling strokes compared with men. These findings emphasize the need for tailored strategies to mitigate stroke risk and improve outcomes for female TAVR patients.

BACKGROUND: Racial differences in the use and outcomes of intravascular imaging (IVI) and invasive physiology (IP) during percutaneous coronary intervention (PCI) are underreported in the United States.

METHODS: Medicare Fee-For-Service claims data were used to examine the use and outcomes of IVI- and IP-guided PCI by Black versus White race (2016-2023). Multivariable logistic regression was used to assess the association between race and IVI/IP use. The primary outcome was major adverse cardiovascular events, which included myocardial infarction, repeat revascularization, and death. Outcomes were compared by race according to the device used (IVI versus none; IP versus none; and among all IVI/IP recipients). Cox regression was used to estimate the association between race and 2-year outcomes, adjusting for all baseline characteristics.

RESULTS: The study included 1 481 343 PCI patients (5.9% Black patients, 63.6% male, mean age 75.3±7.0 years). IVI was used in 17.6% of PCIs in White patients and 15.0% in Black patients; IP use was 7.1% and 5.7%, respectively. After adjustment, Black adults were less likely to receive IVI (odds ratio, 0.94 [95% CI, 0.93-0.96]) or IP (odds ratio, 0.83 [95% CI, 0.81-0.85]). IVI- and IP-guided PCI had lower major adverse cardiovascular event risk at 2-years in both racial groups compared with angiography alone: IVI (White patients: hazard ratio [HR], 0.93 [95% CI, 0.92-0.94]; Black patients: HR, 0.85 [95% CI, 0.84-0.87]) and IP (White patients: HR, 0.95 [95% CI, 0.92-0.98]); Black patients: HR, 0.87 [95% CI, 0.83-0.91]). However, despite global benefits with IVI/IP, Black adults had a higher adjusted risk of major adverse cardiovascular events compared with White adults (HR, 1.02 [95% CI, 1.01-1.03]).

CONCLUSIONS: IVI- and IP-guided PCI were associated with improved outcomes in both Black and White beneficiaries, yet these technologies were less frequently used in Black adults, and overall PCI outcomes remained worse for this group.

BACKGROUND AND AIMS: Femoropopliteal artery disease is associated with high rates of post-revascularization restenosis. Drug-coated devices (DCD), including drug-coated balloons (DCBs) and drug-eluting stents (DES), have demonstrated efficacy in reducing restenosis rates compared to non-drug-coated devices (NDCDs). However, concerns about potential long-term mortality risks have led to regulatory scrutiny. This study represents the final report from the Safety Assessment of Femoropopliteal Endovascular Treatment with Paclitaxel-Coated Devices (SAFE-PAD) study, a pre-specified analysis designed with the US Food and Drug Administration to evaluate the long-term mortality associated with femoropopliteal DCD use.

METHODS: SAFE-PAD was a retrospective cohort study of 168 553 Medicare fee-for-service beneficiaries (≥66 years) who underwent femoropopliteal artery revascularization between 2015 and 2018. Device exposure (DCDs vs. NDCDs) was identified using Medicare claims data. The primary outcome was all-cause mortality, assessed between treatment groups using inverse probability treatment weighting. Secondary outcomes included all-cause hospitalizations, repeat revascularization, major amputation, and cardiovascular medication use. Sensitivity analyses included instrumental variable methods, falsification endpoints, and simulation of hypothetical unmeasured confounders. Subgroup analyses examined outcomes in inpatient vs outpatient settings, in younger/low-risk populations, and in high-risk chronic limb-threatening ischaemia patients.

RESULTS: At a median follow-up of 4.3 years (maximum: 9.0 years), DCD use was not associated with increased mortality (adjusted hazard ratio: 0.98; 95% confidence interval: 0.97, 0.99), meeting the pre-specified 5% non-inferiority relative margin. Sensitivity analyses supported the validity of the primary result. Secondary outcomes showed similar hospitalization and amputation rates between groups but an increase in repeat revascularization with DCDs. Subgroup analyses confirmed safety findings across high/low-risk subgroups and across clinical settings.

CONCLUSIONS: In this final report from the SAFE-PAD study, there was no evidence of long-term mortality risk associated with DCDs used for femoropopliteal revascularization. The SAFE-PAD study helped inform the reversal of regulatory warnings against routine DCD use.

BACKGROUND: In recent years, there has been increasing utilization of catheter-based interventions (CBI) for the treatment of acute pulmonary embolism (PE). We aimed to investigate the trends and practice patterns associated with the utilization of CBI among older patients hospitalized with a PE in US hospitals.

METHODS: All Medicare fee-for-service beneficiaries hospitalized with a PE from June 1, 2018, to September 30, 2023, were identified. For outcomes analysis, a subset of patients hospitalized between June 1, 2018, and December 31, 2021, was identified to allow for follow-up to occur.

RESULTS: In total, 313,522 patients were hospitalized with a concomitant PE; of which, 9.12% (n = 28,597) underwent a CBI (4.76% [n = 14,914] catheter-directed thrombolysis and 4.76% [n = 14,918] mechanical thrombectomy). Utilization of CBI increased over time from 5.92% in 2018 to 14.1% in 2023, attributed to increases in mechanical thrombectomy. CBI was used more frequently at teaching hospitals (adjusted OR, 1.10; 95% CI, 1.04-1.15) and in male patients (adjusted OR, 1.15; 95% CI, 1.10-1.21), while less frequently at smaller institutions (adjusted OR, 0.14; 95% CI, 0.09-0.22) and in patients with Black race (adjusted OR, 0.90; 95% CI, 0.85-0.95) or dual enrollment (adjusted OR, 0.80; 95% CI, 0.76-0.86). Older age, Black race, geographic region, and distressed communities were associated with higher rates of death or periprocedural complications.

CONCLUSIONS: In this contemporary nationwide analysis of hospitalized patients with PE, we found that rates of CBI increased over time, although uptake of CBI remains heterogeneous. Our findings suggest that there are differences in access to advanced therapies and outcomes among particular populations following CBI for PE management.

OBJECTIVE: Centralized aortic hubs frequently exist in competitive markets, which have at times demonstrated inferior surgical outcomes. Here we evaluate the impact of local market competition specifically on complex aortic surgical outcomes.

METHODS: A retrospective review included all Vascular Quality Initiative (VQI) patients between 2013 and 2022 undergoing index complex endovascular aortic repair, thoracic endovascular aortic repair, or open aortic repair. Market competition was defined by the Herfindahl-Hirschman index (HHI), using surgeon-level market share within blinded VQI regions or metropolitan statistical areas (MSAs). A higher HHI indicates lower competition. Multivariable logistic 30-day mortality models and Cox survival models were used to examine the association between HHI and outcomes. A sensitivity analysis further adjusted for complexity among all complex and routine aortic surgical patients in the Vascular Implant Surveillance and Interventional Outcomes Network from 2017 to 2019, using generalized estimating equations with MSA-level clustering.

RESULTS: The VQI contained 10,868 complex aortic surgical patients, with 4372 additional patients in MSA-based Vascular Implant Surveillance and Interventional Outcomes Network sensitivity analysis. The median patient age was 75 years. Of these patients, 68.4% were male, with a greater number of patients in high competition regions (51.3%) and MSAs (34.6%) vs medium and low competition locales. Comorbidities and aneurysm diameter were broadly similar across HHI intervals. Lower 30-day mortality was observed in high competition regions (high, 23.7%; medium, 25.9%; low, 25.9%; P = .03). In multivariable logistic models, medium regional competition was associated with greater 30-day mortality odds vs high competition (odds ratio [OR], 1.39; 95% CI, 1.21-1.60; P < .001), with a trend toward increased mortality for low competition (OR, 1.20; 95% CI, 0.98-1.45; P = .07). MSA-based sensitivity analyses demonstrated a similar trend for medium competition MSAs (OR, 1.25; 95% CI, 0.98-1.58; P = .07), without significant relationship for low-competition MSAs. Regional interval was not associated with any long-term mortality difference.

CONCLUSIONS: More competitive regions demonstrate lower 30-day mortality after complex aortic surgery but equivalent long-term survival. Further efforts should focus on drivers of this difference to widen access to high-quality complex aortic care.

We discuss generalizability analyses under a partially nested trial design, where part of the trial is nested within a cohort of trial-eligible individuals, while the rest of the trial is not nested. This design arises, for example, when only some centers participating in a trial are able to collect data on nonrandomized individuals, or when data on nonrandomized individuals cannot be collected for the full duration of the trial. Our work is motivated by the Necrotizing Enterocolitis Surgery Trial, which compared initial laparotomy versus peritoneal drain for infants with necrotizing enterocolitis or spontaneous intestinal perforation. During the first phase of the study, data were collected from randomized individuals as well as consenting nonrandomized individuals; during the second phase of the study, however, data were only collected from randomized individuals, resulting in a partially nested trial design. We propose methods for generalizability analyses with partially nested trial designs. We describe identification conditions and propose estimators for causal estimands in the target population of all trial-eligible individuals, both randomized and nonrandomized, in the part of the data where the trial is nested while using trial information spanning both parts. We evaluate the estimators in a simulation study and provide an illustration using the Necrotizing Enterocolitis Surgery Trial study.

The optimal treatment of patients with diffuse large B-cell lymphoma (DLBCL) or Hodgkin lymphoma (HL) with preexisting cardiomyopathy is uncertain. An anonymous, electronic survey was distributed by e-mail to three US lymphoma cooperative groups, two community hospitals, and twelve academic medical systems, and distributed at one international lymphoma meeting. Fifty hematology-oncology providers caring for patients with lymphoma were included. In response to a vignette of a 67-yo with Stage III DLBCL with LVEF of 40-45%, 15 (30%) would use non-anthracycline regimens, 13 (26%) R-CHOP with liposomal doxorubicin instead of doxorubicin, 11 (22%) R-CHOP without modification and 6 (12%) R-CHOP with a continuous doxorubicin infusion. In a second vignette of a patient with HL in remission after frontline treatment with doxorubicin cumulative dose 300 mg/m2, 16 (32%) would order an echocardiogram after treatment. There was substantial variability in preferred treatment regimens with preexisting cardiomyopathy and in cardiac monitoring after anthracycline.

OBJECTIVE: Despite advances in the management of chronic limb-threatening ischemia (CLTI), a large proportion of these patients are not candidates for traditional revascularization and may be destined for major amputation. Given this medically complex and no-option patient population, deep venous arterialization (DVA) has been recently revitalized as a limb salvage technique, whereby an arteriovenous fistula in the lower leg is created to supply more oxygenated blood via the venous system to the foot. Recently, PROMISE II (Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia) demonstrated a 6-month amputation-free survival (AFS) rate of 66% after DVA. With this trial in mind, our study aimed to evaluate the real-world outcomes of this procedure.

METHODS: The study population included all patients undergoing a DVA from January 1, 2021, through December 31, 2023 among fee-for-service beneficiaries identified in the Medicare Fee-for-Service Carrier Claims file. DVA procedures were identified using Current Procedural Terminology code 0620T. Outcomes included limb salvage, freedom from major adverse limb events (defined as major amputation or ipsilateral reintervention), survival, and AFS. Cumulative incidences for outcomes that include death were estimated from traditional Kaplan-Meier methods; for non-death end points, outcomes were estimated from the cumulative incidence function, accounting for the competing risk of death.

RESULTS: Between 2021 and 2023, 134 patients underwent a DVA for CLTI. Among these, the median age was 70 years and the majority of patients were male (66%), White (63%), and had tissue loss (72%), hypertension (99%), hyperlipidemia (96%), chronic kidney disease (89%), and diabetes (83%). After a DVA for CLTI, the 6-month and 1-year AFS incidences were 42% and 33%, respectively. One-year incidences of limb salvage, freedom from major adverse limb events, and survival were 53%, 36%, and 65%, respectively.

CONCLUSIONS: Among patients with no traditional options for revascularization, our data demonstrate that DVA is a procedure that is, by its nature, performed on high-risk individuals who continue to have a high risk of limb loss and mortality. Importantly, AFS in our analysis was notably worse than that reported in PROMISE II and, as such, raises questions about the generalizability of this procedure in real world practice. Further investigation is needed regarding patient selection criteria for and the clinical usefulness of the DVA procedure.