Infrapopliteal Endovascular Interventions for Claudication Are Associated with Poor Long-Term Outcomes in Medicare-Matched Registry Patients.

BACKGROUND: There are limited data supporting or opposing the use of infrapopliteal peripheral vascular interventions (PVI) for the treatment of claudication. OBJECTIVES: We aimed to evaluate the association of infrapopliteal PVI with long-term outcomes compared with isolated femoropopliteal PVI for the treatment of claudication. METHODS: We conducted a retrospective analysis of all patients in the Medicare-matched Vascular Quality Initiative database who underwent an index infrainguinal PVI for claudication from January 2004-December 2019 using Cox proportional hazards models. RESULTS: Of 14,261 patients (39.9% female; 85.6% age ≥65 years, 87.7% non-Hispanic white) who underwent an index infrainguinal PVI for claudication, 16.6% (N=2,369) received an infrapopliteal PVI. The median follow-up after index PVI was 3.7 years (IQR 2.1-6.1). Compared to patients who underwent isolated femoropopliteal PVI, patients receiving any infrapopliteal PVI had a higher 3-year cumulative incidence of conversion to CLTI (33.3% vs. 23.8%; P<0.001); repeat PVI (41.0% vs. 38.2%; P<0.01); and amputation (8.1% vs. 2.8%; P<0.001). After risk-adjustment, patients undergoing infrapopliteal PVI had a higher risk of conversion to CLTI (aHR 1.39, 95% CI, 1.25-1.53); repeat PVI (aHR 1.10, 95% CI, 1.01-1.19); and amputation (aHR 2.18, 95% CI, 1.77-2.67). Findings were consistent after adjusting for competing risk of death; in a 1:1 propensity-matched analysis; and in subgroup analyses stratified by TASC disease, diabetes, and end-stage kidney disease. CONCLUSIONS: Infrapopliteal PVI is associated with worse long-term outcomes than femoropopliteal PVI for claudication. These risks should be discussed with patients.

Utility of motor-evoked potentials in contemporary open thoracoabdominal aortic repair.

OBJECTIVE: Paraplegia remains one of the major complications of contemporary open thoracoabdominal aortic aneurysm (TAAA) repair. Intraoperative motor-evoked potentials (MEPs) act as a surrogate measure for spinal cord homeostasis. The purpose of this study was to evaluate the results of intraoperative neuromonitoring in contemporary TAAA repair and its association with postoperative spinal cord ischemia (SCI). METHODS: Patients who underwent open type 2 or 3 TAAA or completion aortic repair using intraoperative neuromonitoring were identified between May 2006 and November 2023. Patient demographics, comorbidities, indication for the procedure, procedural details, and outcomes were recorded. The groups were divided based on type of repair, and univariate statistics were then used to evaluate the association of these metrics vs the type of repair. RESULTS: Seventy-nine patients underwent open type 2 (N = 41) and 3 (N = 23) TAAA and completion aortic (N = 15; open in 14 and endovascular in 1) repairs by a single surgeon. The cohort was predominantly male (N = 48, 60.8%) with a mean age of 52.5 ± 16.2 years. There was a high incidence of hypertension (N = 53, 67.1%), smoking history (N = 42, 53.1%), and connective tissue disorders (N = 37, 46.8%). Operative indications included dissection-related (N = 50, 63.3%) and degenerative (N = 26, 32.9%) TAAA and dissection-related malperfusion (N = 3, 3.8%). Left heart bypass was often (N = 73, 92.4%) used for distal aortic perfusion, and cerebrospinal fluid drainage (N = 77, 97.5%) was a common adjunct. MEPs were classified as no change (N = 43, 54.4%), reversible change (N = 26, 32.9%), irreversible change (N = 4, 5.1%), and unreliable (N = 6, 7.6%). MEP changes were predominantly bilateral (N = 70, 88.6%) and occurred most often during repair of the abdominal aortic segment (N = 13, 16.5%). The median number of replaced vertebral levels was associated with MEP changes (P = .013). SCI was only observed in repairs greater than 6 replaced vertebral levels with an overall frequency of 17.7%. It was most prevalent in completion aortic repairs (26.7%). Immediate and delayed SCI occurred in 10.1% and 7.6% of patients, respectively; it was most commonly (71.8%) reversible. Permanent paraplegia occurred in four patients (5.1%), with equal immediate and delayed onsets. MEPs demonstrated poor sensitivity (53.9%) and specificity (62.3%) for SCI; however, there was a high negative predictive value (86.4%) in this population. In-hospital mortality occurred in five (6.3%) patients. CONCLUSIONS: No changes in intraoperative MEPs are highly predictive of spinal cord homeostasis. The number of replaced vertebral levels and previous aortic repair should guide intraoperative neuroprotective measures including intercostal reimplantation and should take precedence over intraoperative monitoring, especially when MEP changes occur.

Practice Patterns of Peripheral Vascular Interventions for Peripheral Artery Disease in the Office-Based Laboratory Setting versus Outpatient Hospital.

OBJECTIVE: Controversy exists regarding the value and limitations of different sites of service for peripheral artery disease (PAD) treatment. We aimed to examine practice patterns associated with peripheral vascular interventions (PVI) performed in the office-based laboratory (OBL) vs. outpatient hospital site of service using a nationally representative database. METHODS: Using 100% Medicare fee-for-service claims data, we identified all patients undergoing PVI for claudication or chronic limb-threatening ischemia (CLTI) between 01/2017 and 12/2022. We evaluated the associations of patient and procedure characteristics with site of service using multivariable hierarchical logistic regression. We used multinomial regression models to estimate the relative risk ratios (RRR) of site of service and intervention type (angioplasty, stent, atherectomy) and intervention level (iliac, femoropopliteal, tibial) after adjusting for baseline patient characteristics and clustering by physician. RESULTS: Of 848,526 PVI, 485,942 (57.3%) were performed in an OBL. OBL use increased significantly over time from 48.3% in 2017 to 65.5% in 2022 (P<0.001). Patients treated in OBLs were more likely to be Black (aOR 1.14, 95%CI 1.11-1.18) or other non-white race (aOR 1.13, 95%CI 1.08-1.18), have fewer comorbidities, and receive treatment for claudication vs. CLTI (aOR 1.30, 95%CI 1.26-1.33) compared to patients treated in outpatient hospital settings. Physicians with majority practice (>50% procedures) in an OBL were more likely to practice in urban settings (aOR 21.58, 95%CI 9.31-50.02), specialize in radiology (aOR 18.15, 95%CI 8.92- 36.92), and have high-volume PVI practices (aOR 2.15, 95%CI 2.10-2.29). The median time from diagnosis to treatment was shorter in OBLs, particularly for patients with CLTI (29 vs. 39 days, P<0.001). The OBL setting was the strongest predictor of patients receiving an atherectomy alone (aRRR 6.67, 95%CI 6.59-6.76) or atherectomy+stent (aRRR 10.84, 95%CI 10.64-11.05), and these findings were consistent in subgroup analyses stratified by PVI indication. OBL setting was also associated with higher risk of tibial interventions for both claudication (aRRR 3.18, 95%CI 3.11-3.25) and CLTI (aRRR 1.89, 95%CI 1.86-1.92). Average reimbursement (including procedure and facility fees) was slightly higher for OBLs compared to the hospital ($8,742/case vs. $8,459/case; P<0.001). However, in a simulated cohort resetting the OBL's intervention type distribution to that of the hospital, OBLs were associated with a hypothetical cost savings of $221,219,803 overall and $2,602 per case. CONCLUSION: The OBL site of service was associated with greater access to care for non-white patients and shorter time from diagnosis to treatment, but more frequently performed high-cost interventions compared to the outpatient hospital setting. The benefit to patients from improved access to PAD care in OBL settings must be balanced with the potential limitations of receiving differential care.

National registry insights on genetic aortopathies and thoracic endovascular aortic interventions.

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) in patients with genetic aortopathies (GA) is controversial, given concerns of durability. We describe characteristics and outcomes after TEVAR in patients with GA. METHODS: All patients undergoing TEVAR between 2010 and 2023 in the Vascular Quality Iniatitive were identified and categorized as having a GA or not. Demographics, baseline, and procedural characteristics were compared among groups. Multivariable logistic regression was used to evaluate the independent association of GA with postoperative outcomes. Kaplan-Meier methods and multivariable Cox regression analyses were used to evaluate 5-year survival and 2-year reinterventions. RESULTS: Of 19,340 patients, 304 (1.6%) had GA (87% Marfan syndrome, 9% Loeys-Dietz syndrome, and 4% vascular Ehlers-Danlos syndrome). Compared with patients without GA, patients with GA were younger (50 years [interquartile range, 37-72 years] vs 70 years [interquartile range, 61-77 years]), more often presented with acute dissection (28% vs 18%), postdissection aneurysm (48% vs 17%), had a symptomatic presentation (50% vs 39%), and were less likely to have degenerative aneurysms (18% vs 47%) or penetrating aortic ulcer (and intramural hematoma) (3% vs 13%) (all P < .001). Patients with GA were more likely to have prior repair of the ascending aorta/arch (open, 56% vs 11% [P < .001]; endovascular, 5.6% vs 2.1% [P = .017]) or the descending thoracic aorta (open, 12% vs 2% [P = .007]; endovascular, 8.2% vs 3.6% [P = .011]). No significant differences were found in prior abdominal suprarenal repairs; however, patients with GA had more prior open infrarenal repairs (5.3% vs 3.2%), but fewer prior endovascular infrarenal repairs (3.3% vs 5.5%) (all P < .05). After adjusting for demographics, comorbidities, and disease characteristics, patients with GA had similar odds of perioperative mortality (4.6% vs 7.0%; adjusted odds ratio [aOR], 1.1; 95% confidence interval [CI], 0.57-1.9; P = .75), any in-hospital complication (26% vs 23%; aOR, 1.24; 95% CI, 0.92-1.6; P = .14), or in-hospital reintervention (13% vs 8.3%; aOR, 1.25; 95% CI, 0.84-1.80; P = .25) compared with patients without GA. However, patients with GA had a higher likelihood of postoperative vasopressors (33% vs 27%; aOR, 1.44; 95% CI, 1.1-1.9; P = .006) and transfusion (25% vs 23%; aOR, 1.39; 95% CI, 1.03-1.9; P = .006). The 2-year reintervention rates were higher in patients with GA (25% vs 13%; adjusted hazard ratio, 1.99; 95% CI, 1.4-2.9; P < .001), but 5-year survival was similar (81% vs 74%; adjusted hazard ratio, 1.02; 95% CI, 0.70-1.50; P = .1). CONCLUSIONS: TEVAR for patients with GA seemed to be safe initially, with similar odds for in-hospital complications, in-hospital reinterventions, and perioperative mortality, as well as similar hazards for 5-year mortality compared with patients without GA. However, patients with GA had higher 2-year reintervention rates. Future studies should assess long-term durability after TEVAR compared with the recommended open repair to appropriately weigh the risks and benefits of endovascular treatment in patients with GA.

Infrapopliteal Peripheral Vascular Interventions for Claudication are Performed Frequently in the USA and Are Associated with Poor Long Term Outcomes.

OBJECTIVE: Infrapopliteal peripheral vascular interventions (PVIs) for claudication are still performed in the USA. This study aimed to evaluate whether infrapopliteal PVI is associated with worse long term outcomes than isolated femoropopliteal PVI for treatment of claudication. METHODS: A retrospective analysis of fee for service claims in a national administrative database was conducted using 100% of the Medicare fee for service claims between 2017 and 2019 to capture all Medicare beneficiaries who underwent an index infra-inguinal PVI for claudication. Hierarchical Cox proportional hazards models were performed to assess the association of infrapopliteal PVI with conversion to chronic limb threatening ischaemia (CLTI), repeat PVI, and major amputation. RESULTS: In total, 36 147 patients (41.1% female; 89.7% age ≥ 65 years; 79.0% non-Hispanic White race) underwent an index PVI for claudication, of whom 32.6% (n = 11 790) received an infrapopliteal PVI. Of these, 61.4% (n = 7 245) received a concomitant femoropopliteal PVI and 38.6% (n = 4 545) received an isolated infrapopliteal PVI. The median follow up time was 3.5 years (interquartile range 2.7, 4.3). Patients receiving infrapopliteal PVI had a higher three year cumulative incidence of conversion to CLTI (26.0%; 95% confidence interval [CI] 24.9 - 27.2% vs. 19.9%; 95% CI 19.1 - 20.7%), repeat PVI (56.0%; 95% CI 54.8 - 57.3% vs. 45.7%; 95% CI 44.9 - 46.6%), and major amputation (2.2%; 95% CI 1.8 - 2.6% vs. 1.3%; 95% CI 1.1 - 1.5%) compared with patients receiving isolated femoropopliteal PVI. After adjusting for patient and physician level characteristics, the risk of conversion to CLTI (adjusted hazard ratio [aHR] 1.31, 95% CI 1.23 - 1.39), repeat PVI (aHR 1.12, 95% CI 1.05 - 1.20), and major amputation (aHR 1.72, 95% CI 1.42 - 2.07) remained significantly higher for patients receiving infrapopliteal PVI. An increasing number of infrapopliteal vessels treated during the index intervention was associated with increasingly poor outcomes (p < .001 for trend). CONCLUSION: Infrapopliteal PVI for claudication is associated with worse long term outcomes relative to isolated femoropopliteal PVI.

Results of the North American Complex Abdominal Aortic Debranching (NACAAD) Registry.

BACKGROUND: Hybrid debranching repair of pararenal and thoracoabdominal aortic aneurysms was initially designed as a better alternative to standard open repair, addressing the limitations of endovascular repair involving the visceral aorta. We reviewed the collective outcomes of hybrid debranching repairs using extra-anatomic, open surgical debranching of the renal-mesenteric arteries, followed by endovascular aortic stenting. METHODS: Data from patients who underwent hybrid repair in 14 North American institutions during 10 years were retrospectively reviewed. Society of Vascular Surgery scores were used to assess comorbidity risk. Early and late outcomes, including mortality, morbidity, reintervention, and patency were analyzed. RESULTS: A total of 208 patients (118 male; mean age, 71±8 years old) were treated by hybrid repair with extraanatomic reconstruction of 657 renal and mesenteric arteries (mean 3.2 vessels/patient). Mean aneurysm diameter was 6.6±1.3 cm. Thoracoabdominal aortic aneurysms were identified in 163 (78%) patients and pararenal aneurysms in 45 (22%). A single-stage repair was performed in 92 (44%) patients. The iliac arteries were the most common source of inflow (n=132; 63%), and most (n=150; 72%) had 3 or more bypasses. There were 30 (14%) early deaths, ranging widely across sites (0%-21%). A Society of Vascular Surgery comorbidity score >15 was the primary predictor of early mortality (P<0.01), whereas mortality was 3% in a score ≤9. Early complications occurred in 140 (73%) patients and included respiratory complications in 45 patients (22%) and spinal cord ischemia in 22 (11%), of whom 10 (45%) fully recovered. At 5 years, survival was 61±5%, primary graft patency was 90±2%, and secondary patency was 93±2%. The most significant predictor of late mortality was renal insufficiency (P<0.0001). CONCLUSIONS: Mortality after hybrid repair and visceral debranching is highly variable by center, but strongly affected by preoperative comorbidities and the centers' experience with the technique. With excellent graft patency at 5 years, the outcomes of hybrid repair done at centers of excellence and in carefully selected patients may be comparable (or better) than traditional open or even totally endovascular approaches. However, in patients already considered as high-risk for surgery, it may not offer better outcomes.

Midterm outcomes of isolated thoracic aortic replacement in congenital versus degenerative aortopathy in a 15-year institutional cohort.

BACKGROUND: Open aortic replacement represents the only approved option to address thoracic aortopathy among patients with connective tissue disorders (CTD). The aim of our study was to investigate contemporary midterm outcomes of isolated thoracic aortic replacement in patients with CTD versus degenerative pathology in a large institutional cohort. METHODS: All patients undergoing isolated open thoracic aortic replacement at a single academic center from 2005 to 2020 were included. Patients were classified as having CTD or not having CTD based on documented genetic mutations associated with congenital aortopathy. In-hospital and midterm outcomes, including mortality, paraplegia, development of new arterial pathology on surveillance imaging, and the need for future operations, were compared between groups using descriptive statistics and Kaplan-Meier survival analysis. RESULTS: Overall, 62 patients were included with a median follow-up of 58 months (range, 19-81 months) (59 months for those with CTD vs 51.5 months for those without CTD). CTD was present in 18 patients (29%), with 16 having Marfan syndrome (77.8%). Patients with CTD were younger than patients without CTD (45.8 years vs 60.9 years) and had lower rates of smoking (5.6% vs 56.8%) and hypertension (97.7% vs 72.2%; all P < .01). Patients with CTD were more likely to have a dissection component at the time of repair compared with patients without CTD (100% vs 59.1%) and underwent repair at smaller aortic diameters (5.9 cm vs 6.6 cm; both P < .05). There were no differences in in-hospital outcomes between the two groups, including mortality (4.5% vs 5.6%) and paraplegia (2.3% vs 0%; both P > .05). At 5 years, patients with CTD were more likely to have developed aneurysmal changes distal to their thoracic repair (88.9% vs 47.7%) and extra-aortic arterial aneurysms (41.2% vs 2.3%; both P < .05). However, on survival analysis, there were no differences in freedom from additional vascular procedures (hazard ratio,1.76; P = .333) or, specifically, additional aortic procedures (hazard ratio, 1.81; P = .380) between the two groups. There was only one anastomotic complication identified on longitudinal follow-up, which occurred in a patient without CTD 8 years after the index operation. CONCLUSIONS: Although carrying significant operative risks and the potential for morbidity, open thoracic aortic replacement represents a well-tolerated, durable treatment option for patients with congenitally mediated thoracic aortic disease. Because both patients with and without CTD who required thoracic aortic replacement often need future aortic intervention, vigilant surveillance is warranted. Equivalent intervention rates between the two groups suggest remodeling of the CTD aorta is almost universally characterized by initial postrepair dilation, but the majority of these changes successfully stabilize and do not progress to higher rates of intervention.

Reprint of: Early peripheral vascular interventions for claudication are associated with higher rates of late interventions and progression to chronic limb threatening ischemia.

OBJECTIVE: Despite societal guidelines that peripheral vascular intervention (PVI) should not be the first-line therapy for intermittent claudication, a significant number of patients will undergo PVI for claudication within 6 months of diagnosis. The aim of the present study was to investigate the association of early PVI for claudication with subsequent interventions. METHODS: We evaluated 100% of Medicare fee-for-service claims to identify all beneficiaries with a new diagnosis of claudication from January 1, 2015 to December 31, 2017. The primary outcome was late intervention, defined as any femoropopliteal PVI performed >6 months after the claudication diagnosis (through June 30, 2021). Kaplan-Meier curves were used to compare the cumulative incidence of late PVI for claudication patients with early (≤6 months) PVI vs those without early PVI. A hierarchical Cox proportional hazards model was used to evaluate the patient- and physician-level characteristics associated with late PVIs. RESULTS: A total of 187,442 patients had a new diagnosis of claudication during the study period, of whom 6069 (3.2%) had undergone early PVI. After a median follow-up of 4.39 years (interquartile range, 3.62-5.17 years), 22.5% of the early PVI patients had undergone late PVI vs 3.6% of those without early PVI (P < .001). Patients treated by high use physicians of early PVI (≥2 standard deviations; physician outliers) were more likely to have received late PVI than were patients treated by standard use physician of early PVI (9.8% vs 3.9%; P < .001). Patients who had undergone early PVI (16.4% vs 7.8%) and patients treated by outlier physicians (9.7% vs 8.0%) were more likely to have developed CLTI (P < .001 for both). After adjustment, the patient factors associated with late PVI included receipt of early PVI (adjusted hazard ratio [aHR], 6.89; 95% confidence interval [CI], 6.42-7.40) and Black race (vs White; aHR, 1.19; 95% CI, 1.10-1.30). The only physician factor associated with late PVI was a majority of practice in an ambulatory surgery center or office-based laboratory, with an increasing proportion of ambulatory surgery center or office-based laboratory services associated with significantly increased rates of late PVI (quartile 4 vs quartile 1; aHR, 1.57; 95% CI, 1.41-1.75). CONCLUSIONS: Early PVI after the diagnosis of claudication was associated with higher late PVI rates compared with early nonoperative management. High use physicians of early PVI for claudication performed more late PVIs than did their peers, especially those primarily delivering care in high reimbursement settings. The appropriateness of early PVI for claudication needs critical evaluation, as do the incentives surrounding the delivery of these interventions in ambulatory intervention suites.

Early peripheral vascular interventions for claudication are associated with higher rates of late interventions and progression to chronic limb threatening ischemia.

OBJECTIVE: Despite societal guidelines that peripheral vascular intervention (PVI) should not be the first-line therapy for intermittent claudication, a significant number of patients will undergo PVI for claudication within 6 months of diagnosis. The aim of the present study was to investigate the association of early PVI for claudication with subsequent interventions. METHODS: We evaluated 100% of Medicare fee-for-service claims to identify all beneficiaries with a new diagnosis of claudication from January 1, 2015 to December 31, 2017. The primary outcome was late intervention, defined as any femoropopliteal PVI performed >6 months after the claudication diagnosis (through June 30, 2021). Kaplan-Meier curves were used to compare the cumulative incidence of late PVI for claudication patients with early (≤6 months) PVI vs those without early PVI. A hierarchical Cox proportional hazards model was used to evaluate the patient- and physician-level characteristics associated with late PVIs. RESULTS: A total of 187,442 patients had a new diagnosis of claudication during the study period, of whom 6069 (3.2%) had undergone early PVI. After a median follow-up of 4.39 years (interquartile range, 3.62-5.17 years), 22.5% of the early PVI patients had undergone late PVI vs 3.6% of those without early PVI (P < .001). Patients treated by high use physicians of early PVI (≥2 standard deviations; physician outliers) were more likely to have received late PVI than were patients treated by standard use physician of early PVI (9.8% vs 3.9%; P < .001). Patients who had undergone early PVI (16.4% vs 7.8%) and patients treated by outlier physicians (9.7% vs 8.0%) were more likely to have developed CLTI (P < .001 for both). After adjustment, the patient factors associated with late PVI included receipt of early PVI (adjusted hazard ratio [aHR], 6.89; 95% confidence interval [CI], 6.42-7.40) and Black race (vs White; aHR, 1.19; 95% CI, 1.10-1.30). The only physician factor associated with late PVI was a majority of practice in an ambulatory surgery center or office-based laboratory, with an increasing proportion of ambulatory surgery center or office-based laboratory services associated with significantly increased rates of late PVI (quartile 4 vs quartile 1; aHR, 1.57; 95% CI, 1.41-1.75). CONCLUSIONS: Early PVI after the diagnosis of claudication was associated with higher late PVI rates compared with early nonoperative management. High use physicians of early PVI for claudication performed more late PVIs than did their peers, especially those primarily delivering care in high reimbursement settings. The appropriateness of early PVI for claudication needs critical evaluation, as do the incentives surrounding the delivery of these interventions in ambulatory intervention suites.

Socioeconomic status fails to account for worse outcomes in non-Hispanic black patients undergoing carotid revascularization.

OBJECTIVE: Previous studies have reported an association of Black race with worse carotid revascularization outcomes, but rarely include socioeconomic status as a confounding covariate. We aimed to assess the association of race and ethnicity with in-hospital and long-term outcomes following carotid revascularization before and after accounting for socioeconomic status. METHODS: We identified non-Hispanic Black and non-Hispanic white patients who underwent carotid endarterectomy, transfemoral carotid stenting, or transcarotid artery revascularization between 2003 and 2022 in the Vascular Quality Initiative. Primary outcomes were in-hospital stroke/death and long-term stroke/death. Multivariable logistic regression and Cox proportional hazards models were used to assess the association of race with perioperative and long-term outcomes after adjusting for baseline characteristics using a sequential model approach without and with consideration of Area Deprivation Index (ADI), a validated composite marker of socioeconomic status. RESULTS: Of 201,395 patients, 5.1% (n = 10,195) were non-Hispanic Black, and 94.9% (n = 191,200) were non-Hispanic white. Mean follow-up time was 3.4±0.01 years. A disproportionately high percentage of Black patients were living in more socioeconomically deprived neighborhoods relative to their white counterparts (67.5% vs 54.2%; P < .001). After adjusting for demographic, comorbidity, and disease characteristics, Black race was associated with greater odds of in-hospital (adjusted odds ratio [aOR], 1.24; 95% confidence interval [CI], 1.10-1.40) and long-term stroke/death (adjusted hazard ratio [aHR], 1.13; 95% CI, 1.04-1.23). These associations did not substantially change after additionally adjusting for ADI; Black race was persistently associated with greater odds of in-hospital (aOR, 1.23; 95% CI, 1.09-1.39) and long-term stroke/death (aHR, 1.12; 95% CI, 1.03-1.21). Patients living in the most deprived neighborhoods were at greater risk of long-term stroke/death compared with patients living in the least deprived neighborhoods (aHR, 1.19; 95% CI, 1.05-1.35). CONCLUSIONS: Non-Hispanic Black race is associated with worse in-hospital and long-term outcomes following carotid revascularization despite accounting for neighborhood socioeconomic deprivation. There appears to be unrecognized gaps in care that prevent Black patients from experiencing equitable outcomes following carotid artery revascularization.

Practice patterns surrounding the use of tibial interventions for claudication in the Medicare population.

OBJECTIVE: At present, no data are available to support the use of tibial interventions in the treatment of claudication. We characterized the practice patterns surrounding tibial peripheral vascular interventions (PVIs) for patients with claudication in the United States. METHODS: Using 100% Medicare fee-for-service claims from 2017 to 2019, we conducted a retrospective analysis of all patients who underwent an index PVI for claudication. Patients with any previous PVI, acute limb ischemia, or chronic limb-threatening ischemia in the preceding 12 months were excluded. The primary outcome was the receipt or delivery of tibial revascularization during an index PVI for claudication, defined as tibial PVI with or without concomitant femoropopliteal PVI. Univariable comparisons and multivariable hierarchical logistic regression were used to assess the patient and physician characteristics associated with the use of tibial PVI for claudication. RESULTS: Of 59,930 Medicare patients who underwent an index PVI for claudication between 2017 and 2019, 16,594 (27.7%) underwent a tibial PVI (isolated tibial PVI, 38.5%; tibial PVI with concomitant femoropopliteal PVI, 61.5%). Of the 1542 physicians included in our analysis, the median physician-level tibial PVI rate was 20.0% (interquartile range, 9.1%-37.5%). Hierarchical logistic regression suggested that patient-level characteristics associated with tibial PVI for claudication included male sex (adjusted odds ratio [aOR], 1.23), increasing age (aOR, 1.30-1.96), Black race (aOR, 1.47), Hispanic ethnicity (aOR, 1.86), diabetes (aOR, 1.36), no history of hypertension (aOR, 1.12), and never-smoking status (aOR, 1.64; P < .05 for all). Physician-level characteristics associated with tibial PVI for claudication included early-career status (aOR, 2.97), practice location in the West (aOR, 1.75), high-volume PVI practice (aOR, 1.87), majority of practice in an ambulatory surgery center or office-based laboratory setting (aOR, 2.37), and physician specialty. The odds of vascular surgeons performing tibial PVI were significantly lower compared with radiologists (aOR, 2.98) and cardiologists (aOR, 1.67; P < .05 for all). The average Medicare reimbursement per patient was dramatically higher for physicians performing high rates of tibial PVI (quartile 4 vs quartile 1-3, $12,023.96 vs $692.31 per patient; P < .001). CONCLUSIONS: Tibial PVI for claudication was performed more often by nonvascular surgeons in high-volume practices and high-reimbursement settings. Thus, a critical need exists to reevaluate the indications, education, and reimbursement policies surrounding these procedures.

A systematic review supporting the Society for Vascular Surgery guidelines on the management of heritable aortopathies.

BACKGROUND: To support the development of clinical practice guidelines on the management of patients with genetic aortopathies and arteriopathies, a writing committee from the Society for Vascular Surgery has commissioned this systematic review. METHODS: We conducted a systematic review and searched multiple databases for studies addressing six questions identified by the Society for Vascular Surgery guideline committee about evaluating and managing patients with genetic aortopathies and arteriopathies. Studies were selected and appraised by pairs of independent reviewers. RESULTS: We included 12 studies in this systematic review. We did not identify studies about the long-term outcomes of endovascular repair for aortic aneurysm in patients with heritable aortopathy or about new aortic events in pregnant women with a history of aortic dissection (AD) or aneurysm. A small case series demonstrated a 100% survival rate and 100% aortic intervention-free survival at 15 months (range, 7-28 months) after endograft repair for type B AD. A positive genetic diagnosis was discovered in 36% of patients with aortic aneurysms and dissections who had no risk factors for hereditary aortopathies, and these patients had a mortality rate of 11% at a median follow-up duration of 5 months. Black patients had lower 30-day mortality than White patients (5.6% vs 9.0%, respectively), but they had a higher overall aortic reintervention rate at 30 days after AD repair (47% vs 27%, respectively). Aortic reinterventions owing to aneurysmal expansion and endoleak at 30 days were higher in Black patients than White patients. The certainty of evidence was judged to be very low across all the outcomes evaluated in this systematic review. CONCLUSIONS: The available evidence suggests high survival after thoracic endovascular aortic repair for type B AD in young patients with heritable aortopathies, but with limited long-term follow-up. Genetic testing in patients with acute aortic aneurysms and dissections had a high yield. It was positive for most patients with risk factors for hereditary aortopathies and in more than one-third for all other patients, and was associated with new aortic events within 15 years.

Consensus minimum core data elements adapted to peripheral vascular intervention in the drug-eluting era: Consensus report from the Registry Assessment of Peripheral Interventional Devices (RAPID) Pathways "LEAN" working group.

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.

Connective tissue disease type mediates branch patency of grafts in open thoracoabdominal aortic reconstruction.

OBJECTIVE: Despite a shared degenerative vascular phenotype, Marfan syndrome (MFS), Loeys-Dietz syndrome (LDS), and other genetically distinct connective tissue diseases (CTDs) have unique extravascular pathologies that impact the outcomes of aortic replacement. The aim of our study was to investigate the association of CTD genotype with postoperative outcomes and branch patency following open thoracoabdominal aortic replacement in a large institutional cohort. METHODS: All patients undergoing open branched thoracoabdominal aortic replacement at a single academic center from 2006 to 2020 were included and classified as CTD or non-CTD based on the presence of genotypic documentation. Outcomes were compared using analysis of variance and χ2 testing for continuous and discrete variables, respectively. Kaplan-Meier curves were utilized to examine patency of graft branches over time. RESULTS: Overall, 172 patients were included, with a mean follow-up of 30.5 ± 34.9 months. CTD was present in 45 patients (26%); specifically, 32 had MFS, five had LDS, and eight had another CTD. Patients with CTDs had more extent II thoracoabdominal aneurysms (40% vs 15%), more reconstructed branches (3.5 vs 1.8), more frequently reconstructed visceral branches (86.7% vs 22.7%), and higher intraoperative blood loss (13.3 vs 6.8 L; all P < .05) compared with non-CTD patients. Patients with MFS were more frequently systemically anticoagulated preoperatively (50% vs 5%) and demonstrated higher rates of postoperative deep vein thrombosis/pulmonary embolism compared with non-CTD patients (9% vs 2%; both P < .05). Five-year renal branch patency was decreased among all patients compared with visceral branches (87.3% vs 95.6%; P = .05), but there were no individual branch patency differences between patients with and without CTDs (P = .086). Overall branch patency at 1 and 5 years was significantly higher in patients with MFS than in non-CTD patients (98.9% vs 89.1% at 5 years); there were no significant patency differences between non-CTD patients and any other CTD subgroup, mostly due to early patency loss. CONCLUSIONS: Open thoracoabdominal reconstruction in patients with CTD is technically challenging and associated with increased transfusion and postoperative thromboembolic events when compared with non-CTD patients. Technical outcomes of the procedure are excellent and are differentially associated with genotype, with patients with MFS experiencing significantly improved branch patency over both non-CTD patients and patients with other CTDs, a finding which has multifactorial drivers.

Patient-centered clinical success after lower extremity revascularization for complex diabetic foot wounds treated in a multidisciplinary setting.

OBJECTIVE: Physician-oriented outcomes, such as patency and amputation-free survival (AFS), have traditionally been markers of success after lower extremity revascularization. Previous studies have defined clinical success based on a composite of patient-centered outcomes and have shown this outcome to be achieved in less than 50% of patients, far lower than standard physician-oriented outcomes. The purpose of this study is to evaluate clinical success after lower extremity bypass (LEB) or peripheral vascular intervention (PVI) for tissue loss in diabetic patients treated in a multidisciplinary setting to better understand what factors are associated with success from a patient's perspective. METHODS: All patients presenting to our multidisciplinary diabetic limb preservation service from July 2012 to January 2020 were enrolled in a prospective database. Patients who underwent either LEB or PVI for ulcer or gangrene were included in the analysis. Clinical success was defined as the composite outcome of secondary patency to the point of wound healing, limb salvage for 1 year, maintenance of ambulatory status for 1 year, and survival for 6 months. Secondary outcomes included 1-year wound healing, patency, and AFS. RESULTS: A total of 134 revascularizations were performed in 131 patients, including 91 (68%) PVI and 43 (32%) LEB. Patients were more frequently male (64%) and black (61%), and 16% were dialysis-dependent. All patients had tissue loss (53% ulcer, 47% gangrene). There were 5 (3.7%) wound, ischemia, and foot infection stage 1, 6 (6.0%) stage 2, 29 (22%) stage 3, and 92 (69%) stage 4 limbs at the time of revascularization. Overall, 76.9% of patients preserved secondary patency to the point of wound healing, 92.5% had limb salvage for 1 year, 90.3% had maintenance of ambulatory status for 1 year, and 96.3% survived for 6 months. The clinical success composite outcome was achieved in 71.6% of patients and was not statistically different between those undergoing PVI vs LEB (69.2% vs 76.7%, P = .37). Secondary patency, limb salvage, and AFS at 1 year were 80.8% ± 3.6%, 91.8% ± 2.3%, and 83.3% ± 3.1%, respectively. Wound healing at 1 year was 84.3% ± 3.4%. The only covariate associated with clinical failure on multivariable analysis was increased age (odds ratio, 0.95; 95% confidence interval, 0.91-0.99; P = .008). CONCLUSIONS: Among diabetic patients presenting with tissue loss, the composite outcome of patient-centered clinical success is lower than traditional physician-centered outcomes after lower extremity revascularization, mostly due to low rates of secondary patency to the point of wound healing. In the current study, clinical failure was only associated with older age and was no different after PVI compared with LEB.

Index atherectomy peripheral vascular interventions performed for claudication are associated with more reinterventions than nonatherectomy interventions.

OBJECTIVE: Despite limited evidence supporting atherectomy alone over stenting/angioplasty as the index peripheral vascular intervention (PVI), the use of atherectomy has rapidly increased in recent years. We previously identified a wide distribution of atherectomy practice patterns among US physicians. The aim of this study was to investigate the association of index atherectomy with reintervention. METHODS: We used 100% Medicare fee-for-service claims to identify all beneficiaries who underwent elective first-time femoropopliteal PVI for claudication between January 1, 2019, and December 31, 2019. Subsequent PVI reinterventions were examined through June 30, 2021. Kaplan-Meier curves were used to compare rates of PVI reinterventions for patients who received index atherectomy versus nonatherectomy procedures. Reintervention rates were also described for physicians by their overall atherectomy use (by quartile). A hierarchical Cox proportional hazard model was used to evaluate patient and physician-level characteristics associated with reinterventions. RESULTS: A total of 15,246 patients underwent an index PVI for claudication in 2019, of which 59.7% were atherectomy. After a median of 603 days (interquartile range, 77-784 days) of follow-up, 41.2% of patients underwent a PVI reintervention, including 48.9% of patients who underwent index atherectomy versus 29.8% of patients who underwent index nonatherectomy (P < .001). Patients treated by high physician users of atherectomy (quartile 4) received more reinterventions than patients treated by standard physician users (quartiles 1-3) (56.8% vs 39.6%; P < .001). After adjustment, patient factors association with PVI reintervention included receipt of index atherectomy (adjusted hazard ratio [aHR], 1.33; 95% confidence interval [CI], 1.21-1.46), Black race (vs White; aHR; 1.18; 95% CI, 1.03-1.34), diabetes (aHR, 1.13; 95% CI, 1.07-1.21), and urban residence (aHR, 1.11; 95% CI, 1.01-1.22). Physician factors associated with reintervention included male sex (aHR, 1.52; 95% CI, 1.12-2.04), high-volume PVI practices (aHR, 1.23; 95% CI, 1.10-1.37), and physicians with a high use of index atherectomy (aHR, 1.49; 95% CI, 1.27-1.74). Vascular surgeons had a lower risk of PVI reintervention than cardiologists (vs vascular; aHR, 1.22; 95% CI, 1.09-1.38), radiologists (aHR, 1.55; 95% CI, 1.31-1.83), and other specialties (aHR, 1.59; 95% CI, 1.20-2.11). The location of services delivered was not associated with reintervention (P > .05). CONCLUSIONS: The use of atherectomy as an index PVI for claudication is associated with higher PVI reintervention rates compared with nonatherectomy procedures. Similarly, high physician users of atherectomy perform more PVI reinterventions than their peers. The appropriateness of using atherectomy for initial treatment of claudication needs critical reevaluation.

Surgical and endovascular treatment of late postcoarctation repair aortic aneurysms: Results from an international multicenter study.

OBJECTIVE: The formation of postaortic coarctation aneurysms (pCoAA) is well-described in the literature and carries a significant risk of rupture and death. Treatment strategies include open surgical, hybrid, and endovascular repair, depending on the clinical presentation, risk assessment, and anatomy. The aim of this study was to report the early and midterm results of open surgical and endovascular repair of pCoAA. METHODS: This is an international multicenter retrospective study including patients who underwent open surgical or endovascular repair for pCoAA between 2000 and 2021 at 14 highly specialized academic cardiovascular centers. The preoperative, intraoperative, and postoperative data were recorded and analyzed. RESULTS: A total of 74 patients (46 male; median age, 44 years; interquartile range [IQR], 35-53 years) underwent pCoAA repair. All patients had previously undergone surgical repair of aortic coarctation at a median age of 11 years for the index procedure (IQR, 7-17 years). The most common first surgical correction was synthetic patch aortoplasty in 48 patients, followed by graft interposition in 11. The median pCoAA diameter was 54 mm (IQR, 44-63 mm). The median time from the aortic coarctation repair to the pCoAA diagnosis was 33 years (IQR, 25-40 years). A total of 33 patients had symptoms at presentation, including thoracic or back pain in 8 patients. Open surgical repair was performed in 28 patients, including four frozen elephant trunk procedures and one Bentall. The remaining 46 patients underwent endovascular repair of the pCoAA. Two in-hospital deaths were observed (one frozen elephant trunk and one endovascular). After a median follow-up of 50 months (IQR, 14-127 months), there were a total of seven reinterventions. CONCLUSIONS: This international multicenter study demonstrates that patients with pCoAA can be safely treated with either open surgical or endovascular interventions. Because the median time between the coarctation repair and the aneurysm formation was more than 30 years, life-long surveillance of these patients is warranted.

In-situ bypass is associated with superior infection-free survival compared with extra-anatomic bypass for the management of secondary aortic graft infections without enteric involvement.

OBJECTIVE: The optimal revascularization modality following complete resection of aortic graft infection (AGI) without enteric involvement remains unclear. The purpose of this investigation is to determine the revascularization approach associated with the lowest morbidity and mortality using real-world data in patients undergoing complete excision of AGI. METHODS: A retrospective, multi-institutional study of AGI from 2002 to 2014 was performed using a standardized database. Baseline demographics, comorbidities, and perioperative variables were recorded. The primary outcome was infection-free survival. Descriptive statistics, Kaplan-Meier survival analysis, and univariate and multivariable analyses were performed. RESULTS: A total of 241 patients at 34 institutions from seven countries presented with AGI during the study period (median age, 68 years; 75% male). The initial aortic procedures that resulted in AGI were 172 surgical grafts (71%), 66 endografts (27%), and three unknown (2%). Of the patients, 172 (71%) underwent complete excision of infected aortic graft material followed by in situ (in-line) bypass (ISB), including antibiotic-treated prosthetic graft (35%), autogenous femoral vein (neo-aortoiliac surgery) (24%), and cryopreserved allograft (41%). Sixty-nine patients (29%) underwent extra-anatomic bypass (EAB). Overall median Kaplan-Meier estimated survival was 5.8 years. Perioperative mortality was 16%. When stratified by ISB vs EAB, there was a significant difference in Kaplan-Meier estimated infection-free survival (2910 days; interquartile range, 391-3771 days vs 180 days; interquartile range, 27-3750 days; P < .001). There were otherwise no significant differences in presentation, comorbidities, or perioperative variables. Multivariable Cox regression showed lower infection-free survival among patients with EAB (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.6-3.6; P < .001), polymicrobial infection (HR, 2.2; 95% CI, 1.4-3.5; P = .001), methicillin-resistant Staphylococcus aureus infection (HR, 1.7; 95% CI, 1.1-2.7; P = .02), as well as the protective effect of omental/muscle flap coverage (HR, 0.59; 95% CI, 0.37-0.92; P = .02). CONCLUSIONS: After complete resection of AGI, perioperative mortality is 16% and median overall survival is 5.8 years. EAB is associated with nearly a two and one-half-fold higher reinfection/mortality compared with ISB. Omental and/or muscle flap coverage of the repair appear protective.

Use of Intravascular Ultrasound During First-Time Femoropopliteal Peripheral Vascular Interventions Among Medicare Beneficiaries.

BACKGROUND: Intravascular ultrasound (IVUS) may be a useful adjunct to lower extremity peripheral vascular interventions (PVI) in certain clinical scenarios. We aimed to identify patient- and physician-level characteristics associated with the use of IVUS during first-time femoropopliteal PVI. METHODS: We included all Medicare beneficiaries undergoing elective femoropopliteal PVI for claudication or chronic limb-threatening ischemia between 01/01/2019 and 12/31/2019. We excluded patients with prior open or endovascular femoropopliteal intervention and all physicians performing ≤10 PVI during the study period. We calculated the proportion of patients who had IVUS performed as part of their index PVI for each physician. Hierarchical logistic regression was used to evaluate patient- and physician-level factors associated with use of IVUS. RESULTS: We identified 58,552 patients who underwent index femoropopliteal PVI, of whom 11,394 (19%) received IVUS. A total of 1,628 physicians performed >10 procedures during the study period, with IVUS utilization ranging from 0-100%. After hierarchical regression, claudication (versus chronic limb-threatening ischemia: OR 1.23, 95% CI 1.11-1.36), stenting (versus angioplasty alone: OR 1.57, 1.33-1.86) and atherectomy (versus angioplasty alone: OR 2.09, 1.83-2.39) were associated with higher odds of IVUS utilization. Higher-volume providers (tertile 3 vs. tertile 1: OR 3.78, 2.43-5.90) and those with high rates of service provided in an office-based laboratory (tertile 3 vs. tertile 1: OR 10.72, 6.78-19.93) were more likely to utilize IVUS. Radiologists (OR 11.23, 5.96-21.17) and cardiologists (OR 1.97, 1.32-2.93) used IVUS more frequently than vascular surgeons. CONCLUSIONS: Wide variability exists in the use of IVUS for first-time femoropopliteal PVI. The association of IVUS with claudication, atherectomy, and office-based laboratories raises concern about its potential overuse by some physicians.

Drug-Eluting Stents are Associated with Superior Mid-Term Outcomes for the Treatment of Infrainguinal Bypass Graft Stenoses.

BACKGROUND: We previously demonstrated that everolimus drug-eluting stents (eDES) have reasonable short-term patency for the treatment of infrainguinal bypass stenoses. The aim of this study is to compare mid-term outcomes of eDES, plain balloon angioplasty (PTA), percutaneous cutting balloon (PCB), and drug-coated balloon (DCB) interventions for failing infrainguinal bypasses. METHODS: We conducted a retrospective review of patients with infrainguinal bypass stenoses treated by endovascular intervention (August 2010-August 2021). The primary outcome was primary patency (PP). Secondary outcomes were primary-assisted patency (PAP), secondary patency (SP), limb salvage (LS), and mortality. Outcomes were compared by treatment using Kaplan-Meier curves with log-rank tests and Cox proportional hazards models adjusting for baseline differences between groups. RESULTS: Seventy-two consecutive patients with 152 discrete infrainguinal bypass graft stenoses were identified. Mean age was 65.1 ± 10.6 years, 55.6% were male, and 48.6% were Black. In total, 81.9% of patients were originally treated for chronic limb-threatening ischemia, and 57.2% of distal anastomoses were to tibial or pedal targets. Of 152 lesions, 44.1% (n = 67) were treated with PTA, 17.8% (n = 27) with PCB, 20.4% (n = 31) with DCB, and 17.8% (n = 27) with eDES. Median follow-up was 28.5 months (interquartile range 11.5-51.9). There was no difference in bypass configuration, conduit choice, or stenosis location (proximal anastomosis, mid-bypass, distal anastomosis) between groups. At 24 months postintervention, PP was significantly better for eDES (72.9%, 95% confidence interval [CI] 49.8-85.6), followed by PCB (55.9%, 95% CI 34.2-72.9), PTA (34.4%, 95% CI 21.7-47.4), and DCB (33.6%, 95% CI 14.5-53.9) (P = 0.03). PAP, LS, and mortality did not significantly differ between modalities (P > 0.05). After risk adjustment, eDES was associated with the lowest risk of PP loss (hazard ratio versus PTA 0.15, 95% CI 0.05-0.47). CONCLUSIONS: eDES is associated with superior 24-month patency rates compared to other endovascular technologies, and should be considered a primary therapy modality for the treatment of infrainguinal bypass graft stenoses.