Comparative analysis of carotid artery stenting practice and outcomes across operator specialties: insights from a prespecified subanalysis of a large real-world patient cohort (ROADSAVER Study).

BACKGROUND: In contemporary clinical practice, carotid artery stenting (CAS) is increasingly becoming a multispecialty field, joining operators of various training backgrounds, which bring forth their unique expertise, patient management philosophies, and procedural preferences. The best practices and approaches, however, are still debated. Therefore, real-world insights on different operator preferences and related outcomes are of utmost value, yet still rather scarce in the available literature. METHODS: Using the data collected in the ROADSAVER observational, European multicenter CAS study, a prespecified comparative analysis evaluating the impact of the operator's specialization was performed. We used major adverse event (MAE) rate at 30-day follow-up, defined as the cumulative incidence of any death or stroke, and its components as outcome measures. RESULTS: A total of 1965 procedures were analyzed; almost half 878 (44.7%) were performed by radiologists (interventional/neuro), 717 (36.5%) by cardiologists or angiologists, and 370 (18.8%) by surgeons (vascular/neuro). Patients treated by surgeons were the oldest (72.9±8.5), while radiologists treated most symptomatic patients (58.1%) and more often used radial access (37.2%). The 30-day MAE incidence achieved by cardiologists/angiologists was 2.0%, radiologists 2.5%, and surgeons 1.9%; the observed differences in rates were statistically not-significant (P=0.7027), even when adjusted for baseline patient/lesion and procedural disparities across groups. The corresponding incidence rates for death from any cause were 1.0%, 0.8%, and 0.3%, P=0.4880, and for any stroke: 1.4%, 2.3%, and 1.9%, P=0.4477, respectively. CONCLUSIONS: Despite the disparities in patient selection and procedural preferences, the outcomes achieved by different specialties in real-world, contemporary CAS practice remain similar when using modern devices and techniques.

A single-center experience of type B aortic intramural hematoma.

OBJECTIVE: The outcomes of the best medical treatment (BMT) and intervention treatment (INT) in a single-center experience were reported in type B intramural hematoma (IMH). METHODS: From February 2015 to February 2021, a total of 195 consecutive patients with type B IMH were enrolled in the study. The primary end point was mortality, and the secondary end points included clinical and imaging outcomes. The clinical outcomes were aortic-related death, retrograde type A aortic dissection, stent graft-induced new entry tear, endoleak, and reintervention. The imaging outcome was evaluated through the latest follow-up computed tomography angiography, which included aortic rupture, aortic dissection, aortic aneurysm, rapid growth of aortic diameter, newly developed or enlarged penetrating aortic ulcer or ulcer-like projection (ULP) and increased aortic wall thickness. Kaplan-Meier curves were used to assess the association between different treatments. RESULTS: Among the enrolled patients, 115 received BMT, and 80 received INT. There was no significant difference in early (1.7% vs 2.5%; P = 1.00) and midterm all-cause death (8.3% vs 5.2%; P = .42) between the BMT and INT groups. However, patients who underwent INT were at risk of procedure-related complications such as stent graft-induced new entry tear and endoleaks. The INT group was associated with a profound decrease in the risk of ULP, including newly developed ULP (4.3% vs 26.9%; P < .05), ULP enlargement (6.4% vs 31.3%; P < .05), and a lower proportion of high-risk ULP (10.9% vs 45.6%; P < .05). Although there was no significant difference in the incidence of IMH regression between the two groups, the maximum diameter of the descending aorta in patients receiving INT was larger compared with those treated with BMT. CONCLUSIONS: Based on our limited experience, patients with type B IMH treated with BMT or INT shared similar midterm clinical outcome. Patients who underwent INT may have a decreased risk of ULPs, but a higher risk of procedure-related events and patients on BMT should be closely monitored for ULP progression.

Midterm survival after aortic repair versus conservative treatment in patients with penetrating aortic ulcer.

Background: The clinical outcomes and survival of patients with penetrating aortic ulcers (PAU) were evaluated in a tertiary care hospital, comparing those who underwent aortic repair to those treated conservatively. Patients and methods: A retrospective single-centre analysis included all patients that underwent a computed tomography angiography (CT-A) scan with the diagnosis of a PAU between January 2009 and May 2019. "PAU" was identified in 1,493 of 112,506 CT-A scan reports in 576 patients. Clinical and angiomorphological data were collected. The primary outcome was overall survival (OS), with secondary outcomes focusing on identifying risk factors for poor OS. Survival probabilities were analysed by the Kaplan-Meier method using the log-rank test. A Cox hazard model using survival as dependent variable with stepwise backward eliminations based on the likelihood ratios was employed. Results: 315 PAUs were identified in 278 patients. The prevalence in the cohort was 0.8%. The mean age of the patients was 74.4 years, and they were predominantly male (n = 208, 74.8%). The mean ulcer depth was 11.8 mm (range 2-50 mm). Out of the patients, 232 were asymptomatic (83.5%). Among 178 PAUs (56.5%), high-risk factors, such as ulcer depth >10 mm, aortic diameter >40 mm, and ulcer length >20 mm, were observed. Aortic repair was associated with a better mean OS compared to conservatively managed patients (72.6 versus 32.2 months, p = 0.001). The Cox hazard model showed that ulcer depth >1 mm was associated with poor OS (HR 0.67, p = 0.048), while aortic repair was related to a better OS (HR 4.365, p<0.013). Conclusions: Aortic repair is associated with better OS, but this finding should be interpreted with caution because of differences in age and comorbidities between the groups. Further evaluation is warranted through prospective studies with randomized groups. Further assessment for angiomorphological parameters is recommended to identify patients at increased risk for poor OS.

Temporal Trends and Outcomes of Abdominal Aortic Aneurysm Care in the United States.

BACKGROUND: Endovascular aortic aneurysm repair (EVAR) has had a dynamic impact on abdominal aortic aneurysm (AAA) care, often supplanting open AAA repair (OAR). Accordingly, US AAA management is often highlighted by disparities in patient selection and guideline compliance. The purpose of this analysis was to define secular trends in AAA care. METHODS: The Society for Vascular Surgery Vascular Quality Initiative was queried for all EVARs and OARs (2011-2021). End points included procedure utilization, change in mortality, patient risk profile, Society for Vascular Surgery-endorsed diameter compliance, off-label EVAR use, cross-clamp location, blood loss, in-hospital complications, and post-EVAR surveillance missingness. Linear regression was used without risk adjustment for all end points except for mortality and complications, for which logistic regression with risk adjustment was used. RESULTS: In all, 66 609 EVARs (elective, 85% [n=55 805] and nonelective, 15% [n=9976]) and 13 818 OARs (elective, 70% [n=9706] and nonelective, 30% [n=4081]) were analyzed. Elective EVAR:OAR ratios were increased (0.2 per year [95% CI, 0.01-0.32]), while nonelective ratios were unchanged. Elective diameter threshold noncompliance decreased for OAR (24%→17%; P=0.01) but not EVAR (mean, 37%). Low-risk patients increasingly underwent elective repairs (EVAR, +0.4%per year [95% CI, 0.2-0.6]; OAR, +0.6 points per year [95% CI, 0.2-1.0]). Off-label EVAR frequency was unchanged (mean, 39%) but intraoperative complications decreased (0.5% per year [95% CI, 0.2-0.9]). OAR complexity increased reflecting greater suprarenal cross-clamp rates (0.4% per year [95% CI, 0.1-0.8]) and blood loss (33 mL/y [95% CI, 19-47]). In-hospital complications decreased for elective (0.7% per year [95% CI, 0.4-0.9]) and nonelective EVAR (1.7% per year [95% CI, 1.1-2.3]) but not OAR (mean, 42%). A 30-day mortality was unchanged for both elective OAR (mean, 4%) and EVAR (mean, 1%). Among nonelective OARs, an increase in both 30-day (0.8% per year [95% CI, 0.1-1.5]) and 1-year mortality (0.8% per year [95% CI, 0.3-1.6]) was observed. Postoperative EVAR surveillance acquisition decreased (67%→49%), while 1-year mortality among patients without imaging was 4-fold greater (9.2% versus imaging, 2.0%; odds ratio, 4.1 [95% CI, 3.8-4.3]; P<0.0001). CONCLUSIONS: There has been an increase in EVAR and a corresponding reduction in OAR across the United States, despite established concerns surrounding guideline adherence, reintervention, follow-up, and cost. Although EVAR morbidity has declined, OAR complication rates remain unchanged and unexpectedly high. Opportunities remain for improving AAA care delivery, patient and procedure selection, guideline compliance, and surveillance.

Midterm outcomes of "wide neck" abdominal aortic aneurysm after open or endovascular repair in two European centers: a propensity score matching analysis.

BACKGROUND: The aim of this study was to compare mid-term clinical and morphological outcomes in patients undergoing open (OR) and endovascular aortic repair (EVAR) with a proximal wide neck abdominal aortic aneurysm (WN-AAA). METHODS: Between 2009 and 2014 data of all patients undergoing OR at IRCCS San Raffaele Hospital and EVAR at German Aortic Center Hamburg were retrospectively analyzed. Primary endpoints were aneurysm-related mortality at 5 years, reintervention, and overall mortality. Secondary endpoint was proximal neck enlargement. A 1:1 propensity score matching (PSM) was performed. Survival and freedom from AAA-related reintervention were investigated in matched OR and EVAR group by Kaplan-Meier analysis. RESULTS: Of all OR performed at IRCCS San Raffaele Hospital 70 were found to have a proximal neck >28 mm (mean age: 69.8±7.2 years, 67 [95.71%] male); of all consecutive EVAR performed at German Aortic Center Hamburg, 52 required an endograft size of at least 32 mm (mean age of 73.1±8.7 years, 49 [94.2%] male). After PSM, the study cohort consisted of 30 OR and EVAR. One early mortality was registered in both groups (P=NS). Mid-term freedom from reintervention compared in OR and EVAR, with no statistically significant differences (P=0.979). Eight (15.4%) patients treated with EVAR developed a significant proximal diameter enlargement (≥3 mm) while only 1 (1.4%) patient in the OR group had the same evolution (P<0.01). CONCLUSIONS: In WN-AAA neck enlargement is observed more frequently in patients undergoing EVAR, but reintervention rate was similar in the 2 groups, demonstrating that both options were safe and effective.

Phase-specific survival after endovascular versus open surgical repair of descending thoracic aortic aneurysm.

INTRODUCTION: Thoracic endovascular aortic repair (TEVAR) has gained preference over open surgical repair (OSR) as the intervention of choice for patients with descending thoracic aortic aneurysm (DTA). This study aimed to compare the outcomes of patients with DTA undergoing OSR and TEVAR with contemporary findings. EVIDENCE ACQUISITION: A comprehensive search of MEDLINE and EMBASE databases was conducted to identify relevant randomized controlled trials or studies utilizing propensity-score analysis or reporting risk-adjusted outcomes. The search was performed up until March 2023. EVIDENCE SYNTHESIS: Eight studies met the inclusion criteria, including 4 studies using propensity-score matching and four studies reporting risk-adjusted outcomes, comprising 14,873 patients with DTA undergoing OSR (N.=10,882) and TEVAR (N.=3991). Operative mortality was similar between the two interventions (odds ratio 0.92, 95% CI 0.70-1.21, P=0.57, I2=0%). However, overall long-term mortality was significantly higher after TEVAR compared to OSR (Hazard Ratio [HR] 1.30, 95% CI 1.05-1.59, P=0.01, I2=0%). Phase-specific analysis revealed comparable risks of mortality within 1 year and between one and two years after interventions, while the risk of mortality was significantly higher after TEVAR compared to OSR beyond two years (HR 1.77, 95% CI, 1.19-2.63, P=0.01. I2=0%). CONCLUSIONS: This study demonstrated comparable operative mortality between OSR and TEVAR, but higher long-term mortality associated with TEVAR in patients with DTA. The phase-specific analysis highlighted the survival advantage of OSR beyond 2 years. These findings suggest a need for reconsidering OSR indications in the management of DTA.

Real-World Outcomes of Carotid Artery Stenting in Symptomatic and Asymptomatic Patients With Carotid Artery Stenosis.

BACKGROUND: The effectiveness and safety of carotid artery stenting (CAS) are comparable to those of carotid endarterectomy in both symptomatic and asymptomatic patients with carotid artery stenosis, but real-world outcomes are not well-known. OBJECTIVES: The purpose of this study was to investigate the real-world clinical outcomes of CAS in symptomatic and asymptomatic patients with carotid artery stenosis. METHODS: We conducted a nationwide retrospective registry study of 156 centers between January 2015 and December 2019. We enrolled consecutive patients with CAS managed by certified specialists from the Japanese Society of Neuroendovascular Therapy. Outcomes between symptomatic and asymptomatic patients were compared. The primary outcome was a composite of ischemic stroke and all-cause death at 30 days after CAS. Secondary outcomes were ischemic stroke, all-cause death, intracranial hemorrhage (ICH), and procedural complications. RESULTS: We analyzed 9,792 patients (symptomatic, n = 5,351; asymptomatic, n = 4,441). The mean age was 73.5 years, and men were dominant (86.4%). Embolism protection devices were used in 99% of patients. The primary outcome was not significantly different between the symptomatic and asymptomatic groups (120 [2.2%] vs 65 [1.5%]; adjusted OR: 1.30; 95% CI: 0.92-1.83). The incidences of symptomatic ICH, any ICH, acute in-stent occlusion, and hyperperfusion syndrome were significantly more prevalent in the symptomatic group (47 [0.9%] vs 8 [0.2%], aOR: 4.41 [95% CI: 1.68-11.6]; 73 [1.4%] vs 12 [0.3%], aOR: 3.56 [95% CI: 1.71-7.39]; 45 [0.8%] vs 19 [0.4%], aOR: 2.18 [95% CI: 1.08-4.40]; and 102 [1.9%] vs 36 [0.8%], aOR: 1.78 [95% CI: 1.17-2.71], respectively). Other secondary outcomes were not significantly different between the 2 groups. CONCLUSIONS: The complication rate after specialist-involved CAS at 30 days was low in real-world practice.

A comparison of endovascular therapy and medical management in patients with large vessel occlusion mild stroke treated between 2015 and 2023: a systematic review and meta-analysis.

OBJECTIVE: Endovascular therapy (EVT) is recommended for patients with acute large-vessel occlusion (LVO) However, its efficacy and safety compared to medical management (MM) in patients with a National Institutes of Health Stroke Scale (NIHSS) score of ≤6 remains unclear. This meta-analysis compared EVT with medical MM in patients with large vessel occlusion mild stroke treated between 2015 and 2023, following the publication of the first randomized controlled trial. MATERIALS AND METHODS: Biomedical database searches (inception to March 21, 2023) retrieved articles reporting favorable functional outcome(modified Rankin Scale [mRS] 0-1) and functional independence (mRS 0-2), 90-day mortality and symptomatic intracranial hemorrhage (sICH). We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PRISMA) to maintain methodological rigor and transparency in our meta-analysis. RESULTS: We conducted a meta-analysis of 22 studies (4,985 patients) to reveal no significant differences in favorable functional outcomes and independence across all groups. However, in patients treated between 2015 and 2023, EVT exhibited a higher risk of 90-day mortality (Odds Ratio [OR] = 1.84, 95% Confidence Interval [CI] [1.10, 3.07], p = 0.02) and sICH (OR = 3.36, 95% CI [1.96, 6.66], p < 0.01). EVT correlated with elevated sICH in the anterior circulation (OR=2.94, 95%CI [1.82, 4.74], p<0.01) regardless of the proximal (OR=2.20, 95%CI [1.04, 4.69], p=0.04) or distal (OR=3.44, 95%CI [1.43, 8.32], p<0.01) location of the occlusion. EVT correlated with elevated sICH rates in patients treated within 6 hours of symptom onset or those with NHISS≤5. CONCLUSION: In patients treated between 2015 and 2023, EVT and MM did not differ in efficacy in acute LVO mild stroke; MM associated with better safety outcomes. Rigorous randomized controlled trials are warranted.

Outcomes of endovascular thrombectomy for ischaemic stroke among nonagenarians with and without pre-existing dependency.

BACKGROUND: Our aim was to compare the outcomes of treatment with endovascular thrombectomy for pre-stroke dependent versus pre-stroke independent among the very elderly ≥90 years. METHODS: A retrospective cohort study was performed on 106 patients ≥90 years who underwent endovascular thrombectomy for ischaemic stroke in Western Australia between June 2016 and September 2021. Patient, stroke and procedural details along with inpatient progress and outcome at 90 days were recorded. Patients were divided into Group A (pre-stroke modified Rankin Scale 0-2) and Group B (pre-stroke modified Rankin Scale >2). Primary outcome measure was functional status at 90 days post-stroke, with favourable clinical outcome defined as a 90-day mRS category equal to the patients' respective pre-stroke mRS category. Secondary outcome measures include successful reperfusion, symptomatic intracranial haemorrhage, hospital length-of-stay, change in accommodation to an aged care facility, and mortality during admission, at 90 days and one year. RESULTS: 61 patients were allocated to Group A and 45 to Group B. There was none with pre-stroke mRS 5. Group B had more pre-existing cognitive impairment, aged care facility residents, higher median age and lower Alberta Stroke Program Early CT Score. For primary outcome measure, 38 % of patients in Group A and 49 % in Group B achieved a favourable clinical outcome. The difference was not significant (p=0.3408). For secondary outcome measures, Group B had a significantly higher 90-day mortality rate at 47 % versus 24 % in Group A (p=0.03). All other secondary outcome measures were similar between the two groups. These include the rate of successful reperfusion and symptomatic intracranial haemorrhage, hospital length-of-stay, new transition into an aged care facility, inpatient mortality rate and 1-year mortality rate. CONCLUSION: When treated with endovascular thrombectomy for ischaemic stroke, nonagenarians with pre-existing dependency achieved a rate of favourable functional outcome comparable with their independent peers, although they also had higher 90-day mortality rate.

Popliteal-to-Distal Extreme Bypass in Endovascular Era.

BACKGROUND: Chronic limb-threatening ischemia (CLTI) is characterized by rest pain and tissue loss, with an annual mortality rate of 20% and amputation rate of 40%, if not treated. Open bypass surgery is recommended in CLTI, depending on the availability of good quality venous material, outflow artery patency, and surgical expertise. The aim of the study is to analyze primary patency, limb salvage, and survival rate in patients undergoing popliteal-to-distal bypass. METHODS: All consecutive patients who underwent popliteal-to-distal bypass surgery between January 2016 and December 2021 were enrolled in the study. Primary outcomes were primary patency, limb salvage, and overall survival. Secondary outcomes included amputation-free survival and secondary patency. RESULTS: Forty-nine patients were included during the study. Technical success was achieved in 100% of cases. Target outflow artery was in 27% (n. 13) of cases the anterior tibial artery, in 27% (n. 13) the dorsalis pedis, in 2% (n. 1) the peroneal artery, in 30% (n. 15) the retromalleolar tibial artery, in 10% (n. 5) the medial plantar artery, and in 4% (n. 2) the tarsal artery. Two-year primary patency was 85% ± 5. Secondary patency rates were 86% ± 3 at 2 years. The overall survival was 81% ± 6 at 2 years, the amputation-free survival was 70% ± 9, and the limb salvage rate was 81% ± 6. CONCLUSIONS: Popliteal-to-distal bypass requires high technical expertise to be performed. When a good autologous vein and adequate outflow artery are present, they can be feasible with good patency rates and overall survival.

A Multicenter Study of the Mid-term Outcomes of Patients with Uncomplicated Type B Aortic Dissection After Distal Porous Talos Stent-Graft Implantation.

BACKGROUND: The Talos stent-graft has extended length to improve aortic remodeling, and distal porous design to decrease the rate of spinal cord ischemia (SCI). This study retrospectively analyzed its mid-term outcomes for uncomplicated type B aortic dissection in a multicenter study. METHODS: The primary safety end point was 30-day major adverse events, including all-cause mortality, dissection-related mortality, conversion to open surgery, and device-related adverse events. The primary efficacy end point was treatment success at 12 months postoperation, defined as no technical failure or secondary dissection-related reintervention. The survival status of the patients was visualized using the Kaplan-Meier curve. Aortic growth was assessed at 4 levels, and SCI was evaluated at 12 months. RESULTS: 113 patients participated with a mean age of 54.4 (11.1) years and 71.7% (81/113) were male. The 30-day mortality was 0.9% (1/113), no conversions to open surgery or device-related adverse events were recorded. The 12-month treatment success rate was 99.1% (112/113), with no dissection-related reinterventions. There was no spinal cord or visceral ischemia at 12 months. At a median of 34 months follow-up, 9 further deaths were recorded and the 3-year survival rate was 91.7%. The percentage of aortic growth was 1.8% (2/111) at the tracheal bifurcation, 3.6% (4/111) below the left atrium, 6.0% (5/83) above the celiac artery, and 12.1% (9/74) below the lower renal artery. The total thrombosis rate of the false lumen at the stented segment was 80.5% (91/113). CONCLUSIONS: The results showed satisfactory results of Talos stent-graft in terms of safety and efficacy. More data are needed to confirm the long-term performance.

Efficacy and Durability of Percutaneous Deep Vein Arterialization: A Systematic Review.

BACKGROUND: Endovascular deep vein arteriaization (DVA) is a novel technique aimed at salvaging peripheral arterial disease unamenable to conventional surgical intervention. This study aims to review contemporary literature on the efficacy, safety, and durability of DVA on patients with no-option critical limb ischemia (NO-CLI). METHODS: The study was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, using predefined search terms of "percutaneous deep vein arterialization" or "percutaneous deep venous arterialization" in PubMed, Web of Sciences, OvidSP, and Embase. Only studies with 5 or more patients were included, and studies involving open or hybrid DVA were excluded. The primary outcomes included technical success and primary amputation rates. Secondary outcomes included rates of wound healing, complication, reintervention, and all-cause mortality. RESULTS: Ten studies encompassing a total of 233 patients were included. Patients were primarily those deemed to have NO-CLI. The median follow-up period was 12 months (range 1-63 months). The technical success rate was 97% (95% confidence interval [CI] 96.2%-97.9%) and the major amputation rate was 21.8% (95% 21.1%-22.4%). The wound healing rate was 69.5% (95% CI 67.9-71.0%), complication rate was 13.8% (95% CI 11.7%-15.9%), reintervention rate was 37.4% (95% CI 34.9%-39.9%), and all-cause mortality rate was 15.7% (95% CI 14.1%-17.2%). CONCLUSIONS: Our study showed that endovascular DVA is safe for patients with NO-CLI. Nonetheless, studies were small with follow-up period of less than 1 year. There is currently lack of level 1 evidence to recommend routine use in patients with NO-CLI.

Differences in In-Hospital and Follow-Up Outcomes Between Non-A Non-B Aortic Dissection and Type B Aortic Dissection Treated by Endovascular Based Treatment.

OBJECTIVES: Non-A non-B aortic dissection (AD) is a rare and life-threatening medical emergency, and it has been controversial whether it should be managed as type B aortic dissection (TBAD). The study aims to compare in-hospital and follow-up outcomes between patients with non-A non-B AD and those with TBAD treated by endovascular based treatment (EBT). METHODS: From January 2017 to December 2021, 96 consecutive patients with non-A non-B AD met the inclusion criteria and underwent EBT. Patients with TBAD were matched to patients with non-A non-B AD at a 1:1 ratio using propensity score matching analysis to correct for baseline confounding factors. The primary endpoint was all-cause mortality. Aortic-related events were defined as dissection-related death, aortic rupture, retrograde type A aortic dissection, reintervention, and type Ia endoleak. RESULTS: Patients with non-A non-B AD required more TEVAR-related adjunctive procedures compared to TBAD patients during EBT and they required a longer ICU length of stay (36.0 vs 24.0 hours, P < .05) as well as a longer hospitalization (8.0 vs 7.0 days, P < .05) after EBT. There was no statistical difference in overall survival after EBT for patients with TBAD and non-A non-B AD. However, compared to patients with TBAD, non-A non-B AD patients had a higher rate of reintervention and experienced more aortic-related late events during follow-up. CONCLUSION: Patients with non-A non-B acute AD who are treated with EBT do not have higher in-hospital or follow-up mortality rates compared to patients with type B AD. However, there is an increased risk of reintervention and aortic-related late events after the intervention during follow-up.

Systematic review and meta-analysis of cerebrospinal fluid drain-related mortality and morbidity after fenestrated-branched endovascular aortic repair.

OBJECTIVE: This study aimed to investigate the incidence of cerebrospinal fluid drainage (CSFD)-related complications specifically in patients who underwent fenestrated and branched endovascular aortic repair (F/B-EVAR). This objective was chosen considering the limitations and uncertainties surrounding its efficacy in preventing spinal cord injury. METHODS: A systematic review following Cochrane Handbook and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines was conducted (PROSPERO; #CRD42022359223). Literature searches of MEDLINE, Embase, and Scopus were performed until May 1, 2023, focusing on studies published after January 1, 2000. The inclusion criteria encompassed studies reporting on F/B-EVAR, CSFD, and drain-related complications. Data extraction and quality assessment using the Newcastle-Ottawa Scale were performed by multiple reviewers to ensure accuracy and reliability. A proportion meta-analysis was conducted to calculate the pooled rate and 95% confidence interval (CI). The primary and secondary outcomes were CSFD-related mortality and morbidity, respectively. RESULTS: Six retrospective, observational, single-center studies were included, totaling 1079 patients and 730 CSFD placements (all prophylactic except for one). The Newcastle-Ottawa Scale showed a high to moderate risk of bias. The analysis revealed a CSFD-related mortality rate of 1.4% (95% CI: 0.0-4.8; I2 = 67.7%) and an overall morbidity rate of 25.6% (95% CI: 13.6-39.7; I2 = 83.2%). The overall major, moderate, and minor estimated complication rates were 6.1% (95% CI: 4.1-8.5; I2 = 0%), 4.6% (95% CI: 2.4-7.3; I2 = 33.5%), and 26.4% (95% CI: 16.5-37.7; I2 = 84.9%), respectively. Severe complications included intracranial hemorrhage (2.8%), spinal hematoma (1.4%), subarachnoid hemorrhage (1.4%), and CSFD-related neurological deficits (1.1%). A pooled estimate of 11.4% for nonfunctioning drainage was found. CONCLUSIONS: F/B-EVAR patients showed a notable incidence of CSFD-related death and substantial morbidity. This study highlights the limitations of the available data, the high prevalence of complications associated with CSFD, and the need for further research to better understand the risks and benefits of CSFD in F/B-EVAR. This calls for careful consideration regarding the routine use of prophylactic drainage due to the accumulating evidence of the risks associated with CSFD without proven benefit in this specific context.

Efficacy of intentional undersized thoracic endovascular repair for Stanford type B aortic dissection.

OBJECTIVE: Thoracic endovascular aneurysm repair (TEVAR) is widely used for the treatment of aortic dissection. Endograft oversizing is a risk factor for stent graft-induced new entry tears and retrograde type A aortic dissection. However, there is no clear consensus on the optimal graft size selection for Stanford type B acute or subacute aortic dissection (TBAD). Herein, we examined the safety and efficacy of TEVAR using an intentionally undersized endograft to treat TBAD. METHODS: This retrospective chart review study included 82 patients who underwent TEVAR for acute or subacute Stanford TBAD between 2015 and 2022. We measured the true lumen diameter just distal to the subclavian artery and opted for a stent graft of the same diameter. In instances where deformation resulting from false lumen pressure displacement was pronounced, we measured the diameter at the site just proximal to the subclavian artery. Patients' characteristics, procedural, in-hospital, and follow-up data, and aortic remodeling were analyzed. The aortic diameter was analyzed using one-way analysis of variance followed by Dunnett's test. Survival and freedom from reintervention were estimated using Kaplan-Meier curves. RESULTS: The follow-up rate was 98.4%. The mean age was 58.3 ± 12.3 years, and 76 were men (92.7%). The mean diameters of the stent graft and native proximal landing zone were 30.9 ± 3.2 mm and 30.8 ± 3.0 mm, respectively. The oversize rate of the stent graft in relation to the native proximal aortic diameter was 0.3% ± 4.7%. In-hospital mortality was observed in one patient, retrograde type A aortic dissection in one patient, distal stent graft-induced new entry tear in zero patients, and type 1a endoleak in 22 patients (26.8%). Type 1a endoleaks, characterized by antegrade false lumen blood flow originating from the primary entry, in 12 patients spontaneously disappeared within 1 year of follow-up. According to aortic remodeling, 59 patients (86.8%) achieved complete aortic remodeling at the aortic arch level and 51 (75.0%) at the eighth thoracic vertebral level. The diameters of the aortic arch and descending aorta were significantly reduced compared with the postoperative measurements (P <.001). Survival rates were 97.5% and 93.6% at 1 and 3 years, respectively. Freedom from reintervention was 84.7% and 84.7% at 1 and 3 years, respectively. CONCLUSIONS: Intentionally undersized TEVAR was safe and achieved acceptable aortic remodeling despite a high rate of type 1a endoleaks. A type 1a endoleak was acceptable as it primarily diminished during the mid-term follow-up.

Editor's Choice - Outcomes of Off the Shelf Outer Branched Versus Inner Branched Endografts in the Treatment of Thoraco-Abdominal Aortic Aneurysm in the B.R.I.O. (BRanched Inner - Outer) Study Group.

OBJECTIVE: This study aimed to compare two commercially available off the shelf branched endografts for thoraco-abdominal aortic aneurysm (TAAA) repair, namely the E-nside (Artivion) and Zenith t-Branch (Cook Medical) devices. METHODS: This multicentre retrospective study (2020 - 2023) included patients treated by branched endovascular aortic repair (BEVAR) for TAAA using the inner branched E-nside or the outer branched t-Branch. Endpoints were 30 day technical success and major adverse events (MAEs) as well as one year freedom from target vessel instability and main endograft instability. RESULTS: The study included 163 patients: 79 (307 target vessels) treated with E-nside and 84 (325 target vessels) with t-branch. Aneurysm extent was I - III in 91 patients (55.8%; 47% of E-nside and 66% of t-Branch) and IV in 72 patients (44.2%; 53% of E-nside and 34% of t-Branch) (p = .011). An adjunctive proximal thoracic endograft was used in 43% of E-nside vs. 69% of t-Branch (p < .001), with less frequent thoracic endografting (14% vs. 76%; p < .001) and shorter length of coverage (p = .024) in extent IV TAAA treated by E-nside. E-nside cases had shorter renal artery bridging lengths (66 ± 17 mm vs. 76 ± 20 mm; p < .010) and less frequent use of a distal bifurcated endograft (53% vs. 80%; p < .001). Comparing 30 day results, the mortality rate was 1% vs. 2% (p = .62), any MAE occurred in 18% vs. 21% (p = .55), the stroke rate was 3% vs. 0% (p = .23), and the elective spinal cord ischaemia rate was 5% vs. 8% (p = .40) for E-nside and t-Branch, respectively. At one year, freedom from target vessel instability was 96 ± 3% for E-nside and 95 ± 3% for t-Branch (p = .58), and freedom from endograft instability was 98 ± 2% vs. 97 ± 3% (p = .46), respectively. CONCLUSION: Both off the shelf devices provided excellent early and one year results. The E-nside may require shorter thoracic aortic coverage and bridging length for the renal arteries, and less frequent implantation of a concomitant proximal thoracic or distal abdominal bifurcated endograft. However, these aspects did not determine significant differences in clinical outcomes.

Aortobifemoral bypass vs covered endovascular reconstruction of aortic bifurcation.

BACKGROUND: Covered endovascular reconstruction of aortic bifurcation (CERAB) is increasingly used as a first line-treatment in patients with aortoiliac occlusive disease (AIOD). We sought to compare the outcomes of patients who underwent CERAB compared with the gold standard of aortobifemoral bypass (ABF). METHODS: The Vascular Quality Initiative was queried for patients who underwent ABF or CERAB from 2009 to 2021. Propensity scores were generated using demographics, comorbidities, Rutherford class, and urgency. The two groups were matched using 5-to-1 nearest-neighbor match. Our primary outcomes were 1-year estimates of primary patency, major adverse limb events (MALEs), MALE-free survival, reintervention-free survival, and amputation-free survival. Standard statistical methods were used. RESULTS: A total of 3944 ABF and 281 CERAB cases were identified. Of all patients with AIOD, the proportion of CERAB increased from 0% to 17.9% between 2009 and 2021. Compared with ABF, patients who underwent CERAB were more likely to be older (64.7 vs 60.2; P < .001) and more often had diabetes (40.9% vs 24.1%; P < .001) and end-stage renal disease (1.1% vs 0.3%; P = .03). In the matched analysis (229 CERAB vs 929 ABF), ABF patients had improved MALE-free survival (93.2% [±0.9%] vs 83.2% [±3%]; P < .001) and lower rates of MALE (5.2% [±0.9%] vs 14.1% [±3%]; P < .001), with comparable primary patency rates (98.3% [±0.3%] vs 96.6% [±1%]; P = .6) and amputation-free survival (99.3% [±0.3%] vs 99.4% [±0.6%]; P = .9). Patients in the CERAB group had significantly lower reintervention-free survival (62.5% [±6%] vs 92.9% [±0.9%]; P < .001). Matched analysis also revealed shorter length of stay (1 vs 7 days; P < .001), as well as lower pulmonary (1.2% vs 6.6%; P = .01), renal (1.8% vs 10%; P < .001), and cardiac (1.8% vs 12.8%; P < .001) complications among CERAB patients. CONCLUSIONS: CERAB had lower perioperative morbidity compared with ABF with a similar primary patency 1-year estimates. However, patients who underwent CERAB experienced more major adverse limb events and reinterventions. Although CERAB is an effective treatment for patients with AIOD, further studies are needed to determine the long-term outcomes of CERAB compared with the established durability of ABF and further define the role of CEARB in the treatment of AIOD.

Impact of head and neck radiation on long-term outcomes after carotid revascularization.

OBJECTIVE: Radiation-induced carotid artery stenosis (RICS) is a well-described phenomenon seen after head and neck cancer radiation. Previously published literature suggests that, compared with atherosclerotic disease, RICS may result in worse long-term outcomes and early restenosis. This study aims to evaluate the effect of radiation on long-term outcomes after various carotid revascularization techniques using a multi-center registry database. METHODS: Patients in the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) registry for carotid artery intervention (carotid endarterectomy [CEA]; transfemoral carotid artery stenting [CAS]; transcarotid artery revascularization [TCAR]), who are 65 years or older were included in the study. VQI Vascular Implant Surveillance and Interventional Outcomes Network (VISION) Medicare-linked database was used to obtain long-term procedure-specific outcomes. Primary endpoints were 3-year death, stroke, and reintervention. We performed propensity matching between patients with prior radiation and those without. Kaplan-Meier analysis and a multivariate logistic regression model were used to analyze the outcome variables. RESULTS: A total of 56,472 patients had undergone carotid revascularization (CEA, n = 48,307; TCAR, n = 4593; CAS, n = 3572), 1244 patients with prior radiation and 54,925 patients without prior radiation. The prior radiation group was more likely to be male (71.9% vs 60.3%; P < .01), to receive a stent (47.5% vs 13.5%; P < .01), and to be on P2Y12 inhibitor (55.2% vs 38.3%; P < .01). Propensity matching was performed on 1223 patients (CEA, n = 655; TCAR, n = 292; CAS, n = 287). There were no significant differences in 30-day outcomes for death, stroke, or major adverse cardiovascular events for all three procedures. The prior radiation group had higher rates of cranial nerve injury (3.7% vs 1.8%; P = .04) and 90-day readmission (23.5% vs 18.3%; P = .01) after CEA. For long-term outcomes, prior radiation significantly increased mortality risk for CEA and CAS (hazard ratio [HR], 1.77; 95% confidence interval [CI], 1.38-2.27 and HR, 1.56; 95% CI, 1.02-2.36, respectively). The 3-year risk of stroke for CEA in radiated patients was also significantly higher (HR, 1.47; 95% CI, 1.03-2.09) compared with non-radiated patients. Prior radiation did not significantly affect death and stroke in patients undergoing TCAR. Prior radiation also did not impact the rates of short and long-term reintervention after CEA, CAS, or TCAR. CONCLUSIONS: Prior head and neck radiation significantly increases the risk for mortality and stroke for CEA and the risk for mortality after CAS. Long-term outcomes for TCAR are not significantly affected by prior radiation. TCAR may be the preferred treatment modality for patients with radiation-induced carotid stenosis.

Center-level outcomes following elective fenestrated endovascular aortic aneurysm repair in the Vascular Quality Initiative database.

OBJECTIVE: Hospital volume is associated with mortality after open aortic aneurysm repair. Fenestrated and branched endovascular aortic repair (B-FEVAR) has been increasingly used for repair of complex thoracoabdominal and juxtarenal aneurysms, but evidence of a center-volume relationship is limited. We aimed to measure the association of center volume with in-hospital mortality, postoperative outcomes, and 1-year survival following B-FEVAR. METHODS: Patients undergoing elective endovascular thoracoabdominal and complex abdominal aneurysm repair with branch intervention (2014-2021) listed within the national Vascular Quality Initiative Thoracic Endovascular Aortic Repair/Complex EVAR database were analyzed. Centers were grouped into quartiles by mean annual procedure volume. Multivariable regression was used to evaluate the effect of center volume on in-hospital mortality adjusting for baseline and procedural characteristics. Kaplan-Meier estimation, log rank test, and mixed effects Cox regression were used to evaluate 1-year survival. RESULTS: A total of 4302 adult elective F-BEVAR procedures were identified at a total of 163 centers. In-hospital mortality did not differ by hospital volume (quartile [Q]1 = 35/1059 [3.3%]; Q2 = 30/1063 [2.8%]; Q3 = 33/1120 [2.9%]; and Q4 = 44/1060 [4.2%]; P = .308). The high volume group had a higher rate of major complication (Q1 = 14.9%; Q2 = 12.8%; Q3 = 13.3%; and Q4 = 20.1%; adjusted P < .001). Physician-modified grafts were more frequently employed in high-volume centers (Q1 = 4.5%; Q2 = 18.7%; Q3 = 11.3%; and Q4 = 19.2%; P < .001), with a decreased incidence of any endoleak noted at the end of the procedure (Q1 = 34.9%; Q2 = 32.8%; Q3 = 30.0%; and Q4 = 29.0%; P = .003). In the multivariable analysis, in-hospital mortality was not associated with center volume, comparing very low volume to medium- and high-volume centers (odds ratio [95% confidence interval] vs Q4: Q1 = 1.1 [0.6-1.9], Q2 = 0.6 [0.4-1.1], and Q3 = 0.9 [0.5-1.5]; all P > .05). No significant difference was found in 1-year survival between center volume groups. CONCLUSIONS: In-hospital mortality is not associated with procedure volume within centers performing complex endovascular aortic repair. However, complication rates and endoleak may be associated with procedure volume. Long-term outcomes by annualized procedure volume, specifically graft durability and sac expansion, should be investigated.

Post hoc analysis of the SuperB and Zilverpass trials for treatment of long and complex superficial femoral artery lesions.

OBJECTIVE: In two randomized controlled trials, the outcomes of endovascular treatment of complex femoropopliteal arterial lesions were compared with bypass surgery and considered a valid alternative treatment. The aim of this study was to compare both endovascular treatment options with the hypothesis that implantation of heparin-bonded self-expanding covered stents (Viabahn [SECS]) or drug-eluting stents (ZilverPTX [DES]) are related to similar clinical outcomes at 1-year follow-up. METHODS: In a post-hoc analysis, the SuperB trial and Zilverpass databases were merged. Patients in the endovascular treatment arms were included, and data was analyzed in an intention-to-treat (ITT) and a per-protocol (PP) fashion. Data included baseline and lesion characteristics, procedural details, and follow-up data. The primary endpoint of this study was primary patency at 1-year follow-up. The secondary endpoints were secondary patency, target lesion revascularization (TLR), limb loss, and all-cause mortality. RESULTS: A total of 176 patients were included; 63 in the SECS arm and 113 in the DES arm. Through 1-year follow-up, there were no significant differences in primary patency (ITT: 63.4% vs 71.1%: P = .183 and PP: 60.8% vs 71.1%; P = .100). Secondary patency rates were not significantly different in the ITT analysis (86.5% vs 95.1%; P = .054), but in the PP analysis, there was a significant difference in favor of the DES group (SECS, 85.6% vs DES, 95.1%; P = .038). There was no significant difference in freedom from TLR between groups (79.6% vs 77.0%; P = .481). No major amputations were performed in the SECS group, and two were performed in the DES group (1.8%). Survival rate was 98.2% in the SECS group, and 91.3% in the DES group after 1-year follow-up (P = .106). Based on diagnosis (intermittent claudication vs chronic limb-threatening ischemia) no differences between patients with intermittent claudication and chronic limb-threatening ischemia were observed in primary patency, secondary patency and freedom from TLR. CONCLUSIONS: Treatment of complex femoropopliteal arterial disease with the heparin-bonded Viabahn endoprosthesis and the Zilver PTX drug-eluting stent are related to similar primary and secondary patency, and TLR rates at 1 year, except for secondary patency in the PP analysis. This study further supports the endovascular treatment of long complex lesions in the femoropopliteal artery.