Publications by Year: 2025

OBJECTIVE: Socioeconomic disparities are known to contribute to adverse outcomes after surgery; however, the role of individual wealth and neighborhood environment on both follow-up and outcomes following EVAR are not well understood.

METHODS: We included all fee-for-service Medicare beneficiaries ≥66 years who underwent infrarenal EVAR with a bifurcated endograft for intact AAA from 2011-2019. Patients were divided into cohorts using dual enrollment in Medicare/Medicaid (vs. Medicare only) as a measure of individual wealth and residence in a distressed community (vs. non-distressed community) as a measure of regional wealth (as defined by the Distressed Community Index, DCI). The primary outcome was the composite of late aneurysm rupture, aortic reintervention, conversion to open repair, or all-cause mortality at 9 years. The cumulative incidence of the primary composite outcome was determined using Kaplan Meier methods and compared across groups using log-rank tests.

RESULTS: Of 111,381 patients who underwent EVAR, 9,991 (9.0%) were dual-enrolled in Medicare/Medicaid, and 22,902 (21%) lived in distressed communities. A higher incidence of the primary outcome was observed in dual-enrolled vs. Medicare-only patients (83% vs 72%, hazard ratio (HR) 1.42[95% Confidence interval (CI) 1.38, 1.47] p<.01) and in those living in distressed vs. non-distressed communities (75% vs 72%, HR 1.09[1.06,1.11] p<.01). After adjustment for comorbidities and other disparity measures, the association between dual enrollment or DCI and the primary outcome was attenuated but remained significant (aHR 1.19 [95%CI 1.15, 1.23], aHR 1.03 [95%CI 1.00,1.05], respectively). When mortality was removed from the primary outcome, the relationships between dual enrollment or DCI and the composite outcome were no longer significant after adjustment (aHR 1.02, [0.93, 1.13], aHR 0.95, [0.89, 1.05]). Among EVAR-specific secondary outcomes, rates of 9-year all-cause mortality and late rupture were higher in dual-enrolled vs. Medicare-only patients, and mortality rates were higher in distressed vs. non-distressed patients. In addition, both dual-enrolled and residents of distressed communities had lower rates of EVAR-related office visits and AAA-related imaging in follow-up and higher rates of emergency department visits.

CONCLUSION: Among Medicare beneficiaries who underwent EVAR for AAA, socioeconomically disadvantaged beneficiaries had a higher incidence of the primary composite outcome, driven primarily by higher all-cause mortality. This study highlights the need for interventions targeted at improving access to appropriate disease surveillance and management of comorbidities for patients who are most vulnerable.

BACKGROUND: The Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial reported the superiority of surgical bypass compared with endovascular intervention for the treatment of chronic limb-threatening ischemia (CLTI) in patients deemed suitable for either; however, the generalizability of these findings to the broader CLTI population is in question. Herein, we analyzed perioperative (30-day) outcomes from the National Surgical Quality Improvement Project (NSQIP) for CLTI interventions.

METHODS: The NSQIP-Vascular targeted database was queried from 2014 to 2019, contemporaneous with BEST-CLI, for patients undergoing CLTI intervention. Surgical bypass groups included saphenous vein (OPEN-GSV) or alternative conduit (OPEN-Other) and were compared to the endovascular (intervention group) (ENDO). Inverse Probability weighting with regression adjustment assessed 30-day outcomes including perioperative death (POD), major amputation, major adverse limb events (MALE, major reintervention and/or amputation), composite MALE or POD, and major adverse cardiovascular events (MACE, myocardial infarction, or stroke). Results were provided as risk ratio (RR).

RESULTS: Of the total cohort, 6780 (34.1%) were in the OPEN-GSV group, 4201 (21.1%) in OPEN-Other, and 8887 (44.7%) in ENDO. Compared to OPEN-GSV, ENDO exhibited a higher risk for major amputation (RR, 1.38; P = .002), higher risk of MALE (RR, 1.23; P = .004), lower risk of MACE (RR, 0.48; P < .001), and similar risk for all other outcomes. Compared to OPEN-Other, ENDO exhibited a lower risk of MACE (RR, 0.49; P < .001) and POD (RR, 0.76; P = .040) and was similar for all other outcomes.

CONCLUSIONS: These data demonstrate a higher rate of early amputation and MALE among those who underwent ENDO vs OPEN-GSV. Conversely, early limb events were similar between ENDO and OPEN-Other. Both OPEN-GSV and OPEN-Other were associated with a higher risk of 30-day MACE. OPEN-Other was associated with a higher risk of MACE. These data highlight the importance of patient selection to optimize overall patient outcomes in CLTI.

BACKGROUND: Symptomatic peripheral artery disease (PAD) is prevalent and guideline-recommended therapies include optimal medical therapy (OMT), supervised exercise therapy (SET), and revascularization (stenting). The Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) trial examined longitudinal patient-reported outcomes to assess response to OMT, SET, and stenting. The predictors of symptomatic improvement have not been fully assessed.

METHODS: This is a secondary analysis of the CLEVER trial, which randomized patients with claudication to OMT alone, OMT plus SET, or OMT plus stenting. The primary outcome was a change in the Peripheral Artery Questionnaire (PAQ) summary score by 10 points or more from baseline to 6 and 18 months. Multivariate logistic regression was used to identify predictors of response.

RESULTS: Of the 103 participants (66 men, median age 63 years), 65 (63%) had a response to therapy at 6 months. Of 98 participants who completed the 18-month PAQ, 52 (53%) had a symptomatic response. On binary logistic regression, when compared to OMT, SET (6 months: odds ratio [OR] 4.25, 95% CI: 1.33-13.58; 18 months: OR 3.92, 95% CI: 1.04-14.70) and ST (6 months: OR 5.19, 95% CI: 1.58-17.03; 18 months: OR 11.50, 95% CI: 2.89-45.72) were associated with an increase in PAQ at 6 and 18 months.

CONCLUSION: Among randomized patients in the CLEVER trial, treatment with either SET or stenting was predictive of clinically meaningful change in the PAQ summary score from baseline to 6 and 18 months. These interventions, with a prioritization of SET, should be more widely available to patients with PAD. This study adds to the findings of the CLEVER trial by denoting that SET and stenting are beneficial in patients with PAD, independent of comorbidities.

Endovascular renal denervation (RDN) is a catheter-based, procedural therapy for the treatment of hypertension that was approved by the US Food and Drug Administration (FDA) in November 2023. Early studies suggest that endovascular RDN reduces blood pressure (BP) in patients with hypertension. However, BP response to RDN is highly variable, optimal patient selection remains uncertain, and the procedure's high cost remains a significant challenge. The purpose of this review is to comprehensively examine the literature regarding the mechanism by which endovascular RDN reduces BP and the safety and effectiveness of RDN, and to discuss key considerations for selecting appropriate patients for endovascular RDN. Relevant studies in the field were identified from PubMed using search terms including 'renal denervation' and 'renal denervation for hypertension.' In conclusion, clinical trials have demonstrated a statistically significant BP-lowering effect of endovascular RDN, which based on multiple trials with long-term follow-up, appears to persist over several years with low complication rates. More research is needed to understand which patients benefit most from endovascular RDN and to evaluate the long-term outcomes, including the impact of endovascular RDN on cardiovascular events.

Although transcatheter aortic valve replacement (TAVR) devices can impair coronary access, there are limited real-world data comparing outcomes of percutaneous coronary intervention (PCI) in post-TAVR vs. non-TAVR patients. In this study, we compare procedural characteristics and outcomes between patients with vs. without a history of TAVR who undergo PCI. We used claims data for the Medicare population to evaluate the incidence of PCI after TAVR between 2011-2017. Then, using the CathPCI Registry, we compared PCI outcomes between patients with a history of TAVR vs. propensity score-matched non-TAVR patients. Of the 52,780 Medicare patients who underwent TAVR between 2011-2017, the incidence of acute myocardial infarction (AMI) was 10.2% and of PCI was 5.1% at 5 years. At five years, the incidence of stroke was 5.0% and of death was 64.0%. In the CathPCI Registry, procedural success for PCI was similar between 1,309 post-TAVR patients vs. 5,236 propensity-score matched patients without prior TAVR. However, post-TAVR patients required greater fluoroscopic time (21.9 vs 17.7 mins, p<0.001) and had higher rates of post-procedural stroke (0.8% vs 0.4%, p=0.02) and bleeding (5.1% vs 2.9%, p<0.001). Post-TAVR patients were more likely to have repeat PCI in the 3 years post-PCI (HR: 1.36, 95% C.I: 1.09, 1.70) and had higher rates of stroke (HR: 1.65, C.I.: 1.07-2.56, p=0.023) and death (HR: 1.23, C.I.: 1.11-1.38, p<0.001) compared to non-TAVR patients. In conclusion, in the CathPCI Registry, patients with a history of TAVR appeared to have similar procedural success but longer fluoroscopic times, more frequent post-procedural bleeding and stroke, and a higher likelihood of a repeat PCI compared with matched patients without a history of TAVR.

Pulmonary embolism (PE) is a life-threatening condition characterised by occlusion of the pulmonary vasculature, with a global incidence of approximately 1 in 1,000 patients. While pharmacological therapy remains the cornerstone of PE management, selected patients may benefit from catheter-directed treatments due to their potential for rapid symptom relief and swift haemodynamic stabilisation. Catheter-directed thrombolysis and catheter-directed mechanical thrombectomy are current treatment options, though their availability is still limited. This review provides a practical outlook on catheter-directed therapies for PE, outlining optimal procedural planning, device selection, technical execution, evaluation of results, and management of complications.

BACKGROUND: Use of a nitinol extravascular support implanted during AVF (arteriovenous fistula) creation has been gaining traction due to its potential to improve functional success and reduce interventions; however, comparative effectiveness data with traditional unsupported AVFs are lacking. The objective of this study was to compare outcomes of AVFs created with a vascular support device versus traditional unsupported AVFs in patients with advanced kidney disease.

METHODS: This was a comparative effectiveness retrospective observational cohort study conducted using data from the prospective, multi-center, single-arm VasQ US Pivotal trial (extravascular support AVF group) matched with an unsupported AVF control group developed using Medicare claims data from the same surgeons that participated in the trial. Eligible control participants were Medicare fee-for-service beneficiaries who underwent AVF creation (2017-2019). Endpoints included 6-month primary patency (primary endpoint), intervention rate, and functional success. Propensity score methods using inverse probability treatment weighting were used to examine the association between supported device use and outcomes.

RESULTS: A total of 782 unsupported AVF patients were compared to the 144 supported AVF patients from the Pivotal study. Compared with unsupported AVFs, primary patency at 180 days was superior for supported AVFs (66% vs 36% for control; OR, 3.27; 95% CI, 2.15-5.17; p < 0.0001). Intervention rate for supported AVFs (0.97 per patient-year; 95% CI, 0.71-1.28) was nearly half of unsupported AVFs (1.91 per patient-year; 1.58-2.07; p < 0.0001). Functional success for supported AVF patients was significantly greater than unsupported AVFs at 90 days (43.4% vs 26.7%, respectively; p = 0.005) and 180 days (72.5% vs 53.7%, respectively; p = 0.004).

CONCLUSIONS: AVFs created with extravascular support maintained higher primary patency, improved functional success, and had less reinterventions than unsupported AVFs. More patients may begin using their AVF for dialysis sooner with a lower risk of requiring a maturation procedure if created with extravascular support.

BACKGROUND: Transcarotid artery revascularization (TCAR) has emerged as an alternative therapeutic modality to carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TFCAS) for the management of patients with carotid artery stenosis. However, certain issues regarding the indications and contraindications of TCAR remain unanswered or unresolved. The aim of this international, expert-based Delphi consensus document was to attempt to provide some guidance on these topics.

METHODS: A 3-round Delphi consensus process was performed, including 29 experts. The aim of round 1 was to investigate the differing views and opinions of the participants. Round 2 was carried out after the results from the literature on each topic were provided to the participants. During round 3, the participants had the opportunity to finalize their vote.

RESULTS: Most participants agreed that TCAR can or can probably or possibly be performed within 14 days of a cerebrovascular event, but it is best to avoid it in the first 48 hr. It was felt that TCAR cannot or should not replace TFCAS or CEA, as each procedure has specific indications and contraindications. Symptomatic patients >80 years should probably be treated with TCAR rather than with TFCAS. TCAR can or can probably be used for the treatment of restenosis following CEA or TFCAS. Finally, there is a need for a randomized controlled trial (RCT) to provide better evidence for the unresolved issues.

CONCLUSIONS: This Delphi consensus document attempted to assist the decision-making of physicians or interventionalists or vascular surgeons involved in the management of carotid stenosis patients. Furthermore, areas requiring additional research were identified. Future studies and RCTs should provide more evidence to address the unanswered questions regarding TCAR.

The objective of this study was to measure the contemporary patency rates and frequency of interventions required for arteriovenous fistula (AVF) care in a representative US population of patients with end-stage kidney disease, including by age, race, and gender. All Medicare beneficiaries aged >20 years who underwent AVF graft creation for end-stage kidney disease between 2017 and 2019 were included for analysis. The primary end points included primary patency, primary assisted patency, postintervention patency, and fistula functionality up to 1 year after AVF placement. The secondary end point included admission for an associated adverse event after AVF creation. Multivariate analysis of patency rates was also assessed. Of 43,457 patients included in the analysis, the cumulative primary patency at 90 days was 68.4% and at 1 year, 31.5%. At 1 year, the primary assisted patency rate, postintervention patency, and fistula use were 70.4%, 30.2%, and 59.1%, respectively. There was no difference in primary patency rates when comparing age groups (age 40 to 59 years: hazard ratio [HR] 1.01, 95% confidence interval [CI] 0.95 to 1.06, p = 0.84 or age ≥60 years: HR 0.99, 95% CI 0.93 to 1.04, p = 0.61) with the reference of age group 20 to 39 years. Women were at greater risk of experiencing primary patency failure than were men (HR 1.16, 95% CI 1.14 to 1.20, p <0.001), and Black patients were at greater risk of experiencing primary patency failure than were White patients (HR 1.34, 95% CI 1.31 to 1.38, p <0.001). The cumulative incidence of admissions for adverse events was 32.6% at 1 year. In conclusion, our findings suggest that the real-world AVF patency rates remain low, with disproportionately low rates in women and Black patients.

BACKGROUND: Intravascular ultrasound (IVUS) use in aortic endovascular interventions, including thoracic endovascular aneurysm repair (TEVAR) and endovascular aneurysm repair (EVAR), may have similar benefits to those seen in coronary and peripheral interventions, but limited utilization and outcome data exist.

METHODS: Centers for Medicare and Medicaid Services claims data were used to identify patients undergoing TEVAR and EVAR from 2016 to 2023. Utilization trends were stratified by region, urbanicity, distressed communities index, community versus academic center, Medicare versus dual enrollment status, indication, urgency, and presence of dissection with malperfusion. Inverse probability weighting was used to assess the impact of IVUS on a composite outcome of repeat aortic intervention or death. Cox regression was used to estimate weighted hazard ratios.

RESULTS: A total of 136 540 patients underwent TEVAR and EVAR, of which 9.8% (13 364) used IVUS. IVUS use increased slightly from 2016 to 2023, driven more by use in TEVAR compared with EVAR, and was higher in academic settings, with Medicare and Medicaid dual enrollment, in the West, with dissections, with malperfusion and for elective procedures. IVUS was associated with a lower risk of the primary outcome at 30-days (hazard ratio, 0.80 [95% CI, 0.73-0.89]; P<0.001) and 6-months (hazard ratio, 0.93 [95% CI, 0.87-0.99]; P=0.022) for all-comers. Subgroup analysis suggested lower risks of the primary outcome with IVUS use for aneurysm driven by the abdominal segment, malperfusion, thoracoabdominal dissection with malperfusion, thoracoabdominal repair, and chronic kidney disease.

CONCLUSIONS: IVUS use has increased slightly in TEVAR and EVAR with heterogeneity in use. IVUS implementation during TEVAR and EVAR was associated with improved early and mid-term outcomes, particularly in certain subsets.