Implications of the Centers for Medicare and Medicaid Services (CMS) decision to expand indications for carotid artery stenting.

OBJECTIVE: On October 11, 2023, the Centers for Medicare and Medicaid Services (CMS) expanded the indications for carotid artery stenting (CAS) to include patients with ≥50% symptomatic or ≥70% asymptomatic carotid stenosis. The aim of this article was to investigate the implications of this decision. METHODS: The reasons behind the increased coverage for CAS are analyzed and discussed, as well as the various Societies supporting or opposing the expansion of indications for CAS. RESULTS: The benefits associated with expanding CAS indications include providing an additional therapeutic option to patients and enabling individualization of treatment according to patient-specific characteristics. The drawbacks of expanding CAS indications include a possible bias in decision-making and an increase in inappropriate CAS procedures. CONCLUSIONS: The purpose of the CMS recommendation to expand indications for CAS is to improve the available therapeutic options for patients. Hopefully this decision will not be misinterpreted and will be used to improve patient options and patient outcomes.

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.

Recent advances and controversial issues in the optimal management of asymptomatic carotid stenosis.

OBJECTIVE: The optimal management of patients with asymptomatic carotid stenosis (AsxCS) is enduringly controversial. We updated our 2021 Expert Review and Position Statement, focusing on recent advances in the diagnosis and management of patients with AsxCS. METHODS: A systematic review of the literature was performed up to August 1, 2023, using PubMed/PubMed Central, EMBASE and Scopus. The following keywords were used in various combinations: "asymptomatic carotid stenosis," "carotid endarterectomy" (CEA), "carotid artery stenting" (CAS), and "transcarotid artery revascularization" (TCAR). Areas covered included (i) improvements in best medical treatment (BMT) for patients with AsxCS and declining stroke risk, (ii) technological advances in surgical/endovascular skills/techniques and outcomes, (iii) risk factors, clinical/imaging characteristics and risk prediction models for the identification of high-risk AsxCS patient subgroups, and (iv) the association between cognitive dysfunction and AsxCS. RESULTS: BMT is essential for all patients with AsxCS, regardless of whether they will eventually be offered CEA, CAS, or TCAR. Specific patient subgroups at high risk for stroke despite BMT should be considered for a carotid revascularization procedure. These patients include those with severe (≥80%) AsxCS, transcranial Doppler-detected microemboli, plaque echolucency on Duplex ultrasound examination, silent infarcts on brain computed tomography or magnetic resonance angiography scans, decreased cerebrovascular reserve, increased size of juxtaluminal hypoechoic area, AsxCS progression, carotid plaque ulceration, and intraplaque hemorrhage. Treatment of patients with AsxCS should be individualized, taking into consideration individual patient preferences and needs, clinical and imaging characteristics, and cultural, ethnic, and social factors. Solid evidence supporting or refuting an association between AsxCS and cognitive dysfunction is lacking. CONCLUSIONS: The optimal management of patients with AsxCS should include BMT for all individuals and a prophylactic carotid revascularization procedure (CEA, CAS, or TCAR) for some asymptomatic patient subgroups, additionally taking into consideration individual patient needs and preference, clinical and imaging characteristics, social and cultural factors, and the available stroke risk prediction models. Future studies should investigate the association between AsxCS with cognitive function and the role of carotid revascularization procedures in the progression or reversal of cognitive dysfunction.

An international, multispecialty, expert-based Delphi Consensus document on controversial issues in the management of patients with asymptomatic and symptomatic carotid stenosis.

OBJECTIVE: Despite the publication of various national/international guidelines, several questions concerning the management of patients with asymptomatic (AsxCS) and symptomatic (SxCS) carotid stenosis remain unanswered. The aim of this international, multi-specialty, expert-based Delphi Consensus document was to address these issues to help clinicians make decisions when guidelines are unclear. METHODS: Fourteen controversial topics were identified. A three-round Delphi Consensus process was performed including 61 experts. The aim of Round 1 was to investigate the differing views and opinions regarding these unresolved topics. In Round 2, clarifications were asked from each participant. In Round 3, the questionnaire was resent to all participants for their final vote. Consensus was reached when ≥75% of experts agreed on a specific response. RESULTS: Most experts agreed that: (1) the current periprocedural/in-hospital stroke/death thresholds for performing a carotid intervention should be lowered from 6% to 4% in patients with SxCS and from 3% to 2% in patients with AsxCS; (2) the time threshold for a patient being considered "recently symptomatic" should be reduced from the current definition of "6 months" to 3 months or less; (3) 80% to 99% AsxCS carries a higher risk of stroke compared with 60% to 79% AsxCS; (4) factors beyond the grade of stenosis and symptoms should be added to the indications for revascularization in AsxCS patients (eg, plaque features of vulnerability and silent infarctions on brain computed tomography scans); and (5) shunting should be used selectively, rather than always or never. Consensus could not be reached on the remaining topics due to conflicting, inadequate, or controversial evidence. CONCLUSIONS: The present international, multi-specialty expert-based Delphi Consensus document attempted to provide responses to several unanswered/unresolved issues. However, consensus could not be achieved on some topics, highlighting areas requiring future research.

Upside-Down Gore Excluder as an Endoprosthesis for Aortoiliac Aneurysm Exclusion: A Retrospective Multicenter Study.

OBJECTIVE: The upside-down configuration of a Gore Excluder contralateral leg endoprosthesis has been used to overcome diameter differences in the endovascular treatment of aortoiliac aneurysms. Our goal was not to describe the technique but to study the applicability and safety. MATERIAL AND METHODS: Patients were retrospectively enrolled. The indication and details of the procedure were at the discretion of the treating physicians. A case report form was completed including baseline characteristics, indication for treatment, procedural data, and outcomes during follow-up. RESULTS: A total of 31 subjects were enrolled with a range of indications, including 3 patients treated in the emergency setting (9.7%). In 64.5% (n=20), it was a primary intervention for a common iliac aneurysm (n=10), internal iliac aneurysm (n=4), or abdominal aortic aneurysm (n=6). In 11 subjects (35.5%), treatment was performed after previous aortoiliac interventions, including anastomotic iliac artery aneurysm (n=5), type III endoleak (n=3), and endograft thrombus (n=3). Median follow-up was 13 months (range=1-142 months). During follow-up, 2 patients required an upside-down contralateral leg-related secondary intervention, one for an occlusion and another for a type Ia endoleak. There was no type Ib or III endoleak, and no migration, kinking/stenosis, or conversion to open repair was observed. The aneurysm-related mortality was 3.3% (n=1). CONCLUSION: An upside-down contralateral leg is a valuable technique that can be used to achieve adequate aneurysm exclusion or resolve complications. It is associated with a limited number of complications. CLINICAL IMPACT: This article studies the use of an upside-down iliac endograft. We describe a wide range of indications in which this previously published technique has been applied. In elective and acute settings and as primary and revision intervention an upside-down iliac endograft was performed successfully. Furthermore, follow-up data is presented showing the effectiveness of the technique. Knowledge of this procedure is a valuable addition to the skillset of every interventionalist.

Impact on Hospital Resource Utilization of Endoluminal Bypass Using the Viabahn Endoprosthesis with Heparin Bioactive Surface Compared With Surgical Femoropopliteal Bypass.

OBJECTIVE: To assess the impact of heparin-bonded endoprosthesis compared with femoropopliteal bypass on key hospital resources and revenues up to 1-year follow-up. DESIGN: A 2-arm scenario resource consumption data analysis was modeled based on a multicentre prospective randomized controlled trial. SETTING: Six centers in the Netherlands. PARTICIPANTS: A total of 100 patients were assigned to 2 arms (50 each arm). The first arm evaluated endovascular treatment using the heparin-bonded Viabahn endoprosthesis and the second the femoropopliteal bypass. Resource consumption rates were compared between arms. PRIMARY AND SECONDARY OUTCOMES MEASURES: Resource consumption rates, including hospital stay for bypass procedure, operating room time, type of anesthesia, number of used (endo)grafts, use of different types of bed locations (vascular ward, medium or intensive care), readmission for wound infections, and reinterventions over a period of 12 months. RESULTS: Endovascular repair used fewer hospital resources, with an overall difference of €149.983. Hospital stay was 118 days less (261 vs 379), including 21 fewer days in medium/intensive care (5 vs 26) and 50 fewer operating room hours (100 vs 150). Fewer patients required general anesthesia (31 vs 39), and there were less surgical site infections (3 vs 12). In the surgical bypass group, there were 18 fewer days of hospital stay related to reinterventions (80 vs 62), and the cost of the devices was €309.996, cheaper. The total monetary difference was € 160.013, in favor of the femoropopliteal bypass (€3.200, per patient). CONCLUSIONS: Endovascular repair of the superficial femoral artery reduces the use of valuable hospital resources. Its major limitation is the cost of the devices, which should be balanced against the reduction in peri-procedural morbidity and faster recovery. In the context of shortage of hospital beds, it offers capacity benefits, allowing for the treatment of more patients overall. These benefits may outweigh the fewer reinterventions in the surgical bypass group. REGISTRATION: The SuperB Trial was registered in clinicaltrials.gov; NCT-ID: NCT01220245. CLINICAL IMPACT: Modeling is a useful technique to predict the impact of treatment modalities on hospital resources and revenue. This study uses real-world data from the SuperB Trial to compare two treatment strategies of superficial femoral artery disease, reflecting actual clinical practice and patient outcomes. The analysis focused on direct costs associated with hospital resources and device usage without considering indirect costs or long-term cost-effectiveness. The analysis showed that endovascular repair reduces the use of valuable hospital resources. Its major limitation is device costs, which should be balanced against the reduction in peri-procedural morbidity and faster recovery. In the context of shortage of hospital beds, it offers capacity benefits, allowing for the treatment of more patients overall.

Five-Year Outcomes of the SuperB Trial: A Multicenter Randomized Controlled Trial Comparing Heparin-Bonded Endograft to Surgical Femoropopliteal Bypass.

OBJECTIVE: This study aims to compare the 5-year outcomes of endoluminal bypass (EB) using heparin-bonded self-expanding covered stents versus bypass surgery for extensive femoropopliteal disease, including technical and clinical outcomes and health status. BACKGROUND: The surgical femoropopliteal bypass was the gold standard to treat peripheral arterial disease (PAD) for decades; however, endovascular treatment modalities are now recommended for most femoropopliteal lesions. One-year data of a randomized controlled trial comparing EB with surgical bypass (SB) have shown a faster recovery, less morbidity, and comparable patency rates between the two techniques. To date, long-term randomized controlled data regarding both techniques are lacking. METHODS: Five-year results of a multicenter randomized controlled trial comparing EB with SB in patients with femoropopliteal artery disease were evaluated based on intention-to-treat and per-protocol analyses. RESULTS: At 5-year follow-up, primary, primary-assisted, and secondary patency rates were 36.2%, 52.4%, and 68.1% for EB and 49.4%, 72.2%, and 77.8% for SB, respectively (p=0.608). Freedom from target lesion revascularization (fTLR) was 34.1% for EB and 57.6% for SB (p=0.365). In both groups, the ankle-brachial index, Rutherford classification, and walking distance significantly improved compared with baseline without differences between groups at follow-up. Freedom from major amputation rate was 92.6% in the EB group and 96.2% in the SB group (p=0.361). The 36-Item Short-Form Health Survey showed no significant differences between groups. CONCLUSION: Treatment of extensive femoropopliteal disease with self-expanding covered stents provides comparable clinical-related and health-related questionnaire outcomes when compared with SB through 5 years of follow-up. However, the EB is related to a higher number of reinterventions. CLINICAL IMPACT: This present study is the first to report five-year outcomes comparing an endoluminal (EB) using heparin-bonded self-expanding covered stents with surgical bypass (SB) for long and complex femoropopliteal disease. Although the advantages of treatment with EB are mostly seen in the early period after treatment, the outcomes support the use of EB for this indication and seems to be a valid and safe alternative for bypass surgery. Future trials comparing various endovascular strategies may provide further guidance for the development of an evidence-based treatment algorithm.

Three-Dimensional Geometric Analysis of Viabahn VBX Bridging Stent Grafts in Fenestrated Endovascular Aortic Repair: A Multicenter, Retrospective Cohort Study.

PURPOSE: The primary aim of this study was to assess the 3-dimensional flare geometry of the Gore Viabahn VBX balloon-expandable covered stent (BECS) after fenestrated endovascular aortic repair (FEVAR) and to determine and visualize BECS-associated complications. METHODS: This multicenter retrospective study included patients who underwent FEVAR between 2018 and 2022 in 3 vascular centers participating in the VBX Expand Registry. Patients with at least one visceral artery treated with the VBX and with availability of 2 post-FEVAR computed tomography angiography (CTA) scans (follow-up [FU] 1: 0-6 months; FU2: 9-24 months) were included. The flare geometry of the VBX, including flare-to-fenestration distance, flare-to-fenestration diameter ratio, flare angle, and apposition with the target artery were assessed using a vascular workstation and dedicated CTA applied software. RESULTS: In total, 90 VBX BECS were analyzed in 43 FEVAR patients. The median CTA FU for FU1 and FU2 was 35 days (interquartile range [IQR], 29-51 days) and 14 months (IQR, 13-15 months), respectively. The mean flare-to-fenestration distance was 5.6±2.0 mm on FU1 and remained unchanged at 5.7±2.0 mm on FU2 (p=.417). The flare-to-fenestration diameter ratio was 1.19±0.17 on FU1 and remained unchanged at 1.21±0.19 (p=.206). The mean apposition length was 18.6±5.3 mm on FU1 and remained 18.6±5.3 mm (p=.550). The flare angle was 31°±15° on FU1 and changed to 33°±16° (p=.009). On FU1, the BECS-associated complication rate was 1%, and the BECS-associated reintervention rate was 0%. On FU2, the BECS-associated complication rate was 3%, and the BECS-associated reintervention rate was 1%. CONCLUSIONS: The flare geometry of the VBX bridging stent did not change significantly during 14 months follow-up in this study. Three-dimensional geometric analysis of the flare may contribute to identify the origin of endoleaks and occlusions, but this should be confirmed in a larger study including enough patients and BECS to compare complicated and uncomplicated cases. CLINICAL IMPACT: The three-dimensional flare geometry of the Gore Viabahn VBX BECS was assessed on the first and second postoperative CTA scans, and geometrical changes during this period were identified. For BECS that were diagnosed with a type 3c endoleak or occlusion, the BECS geometry was analyzed to detect geometrical components that were related to the complication. Geometric analysis of the flare may help to better detect and identify the cause of such complications.

Long Term Outcomes of the Gore Excluder Low Permeability Endoprosthesis for the Treatment of Infrarenal Aortic Aneurysms.

OBJECTIVE: This study evaluated the long term outcomes of endovascular aneurysm repair using the Gore Excluder Low Permeability (LP) endoprosthesis across high volume Dutch hospitals. METHODS: A retrospective analysis was conducted of patients treated with the Excluder LP for infrarenal abdominal aortic aneurysm (AAA) in four hospitals between 2004 and 2017. Primary outcomes were overall survival, freedom from re-interventions (overall, inside and outside instructions for use, IFU), and AAA sac dynamics: growth (> 5 mm), stabilisation, and regression (< 5 mm). Secondary outcomes were technical success (device deployment), procedural parameters, and re-interventions. Follow up visits were extracted from patient files, with imaging assessed for complications and AAA diameter. RESULTS: Five hundred and fourteen patients were enrolled, with a median (IQR) follow up of 5.0 (2.9, 6.9) years. Survival rates were 94.0% at one year, 73.0% at five years, and 37.0% at 10 years, with freedom from re-interventions of 89.0%, 79.0%, and 71.0%, respectively. 37.9% were treated outside IFU, leading to significantly more re-interventions over 10 years compared with those treated inside IFU (36.0% vs. 25.0%, respectively; p = .044). The aneurysm sac regressed by 53.5% at one year, 65.8% at five years, and 77.8% at 10 years, and grew by 9.8%, 14.3%, and 22.2%, respectively. Patients with one year sac growth had significantly worse survival (p = .047). Seven patients (1.4%) had a ruptured aneurysm during follow up. Over 15 years, type 1a endoleak occurred in 5.3%, type 1b in 3.1%, type 3 in 1.9%, type 4 in 0.2%, and type 2 in 35.6% of patients. CONCLUSION: This multicentre study of real world endovascular aneurysm repair data using the Gore Excluder LP endoprosthesis demonstrated robust long term survival and re-intervention rates, despite 37.9% of patients being treated outside IFU, with type 4 endoleak being rare. Treatment outside IFU significantly increased re-intervention rates and one year sac growth was associated with statistically significantly worse survival.

Similar long-term outcomes for venous, bovine pericardial, and polyester patches for primary carotid endarterectomy.

BACKGROUND: Currently, the type of patch used for carotid endarterectomy closure depends on the preference of the operating surgeon. Various materials are available, including autologous venous patches, bovine pericardial patches (BPP), and synthetic patches. The purpose of this study was to compare the long-term outcomes. METHODS: All patients who underwent primary carotid endarterectomy with patch angioplasty using a venous, bovine, or polyester patch between 2010 and 2020 at two high-volume medical centers were included in this retrospective analysis on largely prospectively collected data. Study endpoints included long-term ipsilateral transient ischemic attack or cerebrovascular accident, restenosis, reintervention, and all-cause mortality. Cox proportional hazard models were fitted to assess the effect of patch type to each outcome. RESULTS: In total, 1481 CEAs were performed with a follow-up of 32 (13-65) months. Venous patch was used in 309 patients (20.9%), BPP in 1000 patients (67.5%), and polyester patch in 172 patients (11.6%). A preoperative symptomatic carotid artery stenosis of >50% was observed in 91.9% (n = 284) of the patients who received a venous patch, 92.1% (n = 921) of the patients who received BPP, and 90.7% (n = 156) of the patients who received a polyester patch (p = 0.799). Only in selected patients with an asymptomatic stenosis of >70% surgery was considered. Multivariable analyses showed no significant differences between the three patch types regarding long-term outcomes after adjusting for confounders. CONCLUSIONS: In patients undergoing primary carotid endarterectomy, the use of venous, bovine pericardial, or polyester patches seems equally safe and durable in terms of comparability in long-term outcomes.

Comparison of Various Functional Assessment Tools to Identify Older Patients Undergoing Aortic Aneurysm Repair at Risk for Postoperative Complications.

BACKGROUND: To estimate whether the benefits of aortic aneurysm repair will outweigh the risks, determining individual risks is essential. This single-center prospective cohort study aimed to compare the association of functional tools with postoperative complications in older patients undergoing aortic aneurysm repair. METHODS: Ninety-eight patients (≥65 years) who underwent aortic aneurysm repair were included. Four functional tools were administered: the Montreal Cognitive Assessment (MoCA); the 4-Meter Walk Test (4-MWT); handgrip strength; and the Groningen Frailty Indicator (GFI). Primary outcome was the association between all tests and 30-day postoperative complications. RESULTS: After adjusting for confounders, the odds ratio for MoCA was 1.39 (95% confidence interval [CI] 0.450; 3.157; P = 0.723), for 4-MWT 0.63 (95% CI 0.242; 1.650; P = 0.348), for GFI 1.82 (95% CI 0.783; 4.323, P = 0.162), and for weak handgrip strength 4.78 (95% CI 1.338; 17.096, P = 0.016). CONCLUSIONS: Weak handgrip strength is significantly associated with the development of postoperative complications after aortic aneurysm repair. This study strengthens the idea that implementing a quick screening tool for risk assessment at the outpatient clinic, such as handgrip strength, identifies patients who may benefit from preoperative enhancement with help from, for example, Comprehensive Geriatric Assessment, eventually leading to better outcomes for this patient group.

Carotid stenosis in logistic restraints Optimizing treatment of significant carotid artery stenosis in times of logistic restraints as a result of COVID-19 pandemic.

BACKGROUND: COVID-19 confronted medical care with many challenges. During the pandemic, several resources were limited resulting in renouncing or postponing medical care like carotid endarterectomy (CEA) for patients with significant carotid artery stenosis. Although according to international guidelines CEA is the first choice, carotid artery stenting (CAS) could potentially be a reasonable alternative especially during logistical restraints. PURPOSE: To evaluate outcomes of CAS versus CEA before, during and after the COVID-19 pandemic. Our hypothesis was that a CAS first approach yielded comparable outcomes compared to a CEA first approach. METHODS: Retrospective analysis of consecutive patients with significant carotid artery stenosis treated with CEA or CAS between September 2018 and March 2023. Each consecutive period of 1.5 year marked a new (treatment) period: pre-COVID (CEA first strategy), during COVID (CAS first strategy) and post COVID (patient tailored approach). Primary outcome was the composite endpoint of stroke, TIA or death within 30 days. Secondary outcome consisted of the rate of technical success, cerebral hyperperfusion syndrome, myocardial infarction or other cardiac complications needing intervention, bleeding of the surgical site needing intervention, nerve palsy, unintended IC admission, pseudoaneurysm, restenosis or occlusion. RESULTS: A total of 318 patients were included. Out of 137 patients treated with CEA, 55, 36 and 46 were treated pre-COVID, during COVID and post-COVID, respectively. Out of 181 CAS procedures, 38, 59 and 84, respectively, were performed in each time period. Primary outcome occurred in 5.5%, 0% and 2.2% in the CEA group and 0%, 1.7% and 3.6% in the CAS group (p = .27; p = 1.00; p = 1.00, respectively). Overall technical success was 100% for CEA and 99.4% for CAS (p = 1.00). Rate of restenosis was the only secondary outcome measure which was significantly better after CAS compared to CEA in the pre- and post-COVID period (CEA vs CAS, 12.7% vs 7.9% and 23.9% vs 4.8% with a p-value of .03 and .03, respectively). Hospital presentation to treatment interval did not differ significantly during the pandemic. CONCLUSION: Outcomes were comparable between CAS versus CEA in patients with significant carotid artery stenosis before, during and after the COVID-19 pandemic. CAS showed better results in terms of other complications (i.e., restenosis rate) in the pre- and post-COVID period compared to CEA. Our results may support a CAS first approach when no relevant contra-indications exist without exposing the patient to complications associated with an open surgical approach. Discussion in a multidisciplinary team is advised.

Patch angioplasty during carotid endarterectomy using different materials has similar clinical outcomes.

OBJECTIVE: Patch angioplasty during carotid endarterectomy (CEA) is commonly used to treat carotid artery stenosis. However, the choice of which patch to use remains a matter of debate. Autologous venous material has disadvantages such as wound-related problems at the harvest site and a prolonged intervention time. These limitations can be bypassed when synthetic or biological patches are used. Both materials have been associated with divergent advantages and disadvantages. Therefore, the aim of our study was to compare the long-term follow-up outcomes in patients who underwent CEA and closure with either a bovine pericardial patch (BPP) or polyester patch. METHODS: A retrospective cohort study was conducted including all patients who underwent primary CEA and closure with a BPP or a polyester patch between January 2010 and December 2020 at our tertiary referral center. In 2015, the BPP was introduced as an alternative for polyester. The primary outcome was the occurrence of transient ischemic attack (TIA) or cerebrovascular accident (CVA) during follow-up and secondary outcomes included restenosis, reintervention, all-cause mortality, and patch infection. Cox proportional hazard models were used and hazard ratios with 95% confidence intervals were used to predict these outcomes. RESULTS: We included 417 CEA patients; 254 patients (61%) received a BPP and 163 received (39%) a polyester patch. The mean age was 70.2 ± 8.7 years and 67% were male. The median follow-up time was 15 months (range, 12-27 months) for BPP and 42 months (range, 16-60 months) for polyester (P < .001). Postoperative hematoma (≤30 days) was significantly lower in the BPP cohort (2% BPP vs 6% polyester; P = .047). No other significant differences on short-term outcomes were found. Univariable Cox regression analyses showed no significant differences between the effect estimates of polyester and BPP on TIA or CVA (P = .106), restenosis (P = .211), reintervention (P = .549), or all-cause mortality (P = .158). No significant differences were found after adjusting for confounders in the multivariable analyses: TIA or CVA (P = .939), restenosis (P = .057), reintervention (P = .193) and all-cause mortality (P = .742). Three patients with a polyester patch had patch infection compared with none of the patients in the group who received a BPP. CONCLUSIONS: This large retrospective study showed comparable safety and durability of both BPP and polyester suggesting that both patch types can be safely applied for CEA with patch angioplasty. Patch infection was rare and was absent in the BPP group.

Carotid calcium burden derived from computed tomography angiography as a predictor of all-cause mortality after carotid endarterectomy.

OBJECTIVE: Carotid endarterectomy (CEA) aims to reduce the risk of stroke in patients with atherosclerotic carotid disease. Preoperative risk assessments that predict complications are needed to optimize the care in this patient group. The current approach, namely relying solely on symptomatology and degree of stenosis, is outdated and calls for innovation. The Agatston calcium score was applied in several vascular specialties to assess cardiovascular risk profile but has been little studied in carotid surgery. It is hypothesized that a higher calcium burden at initial presentation equates to a worse prognosis attributable to an increased cerebrovascular and cardiovascular risk profile. The aim was to investigate the association between preoperative ipsilateral calcium score and postoperative all-cause mortality in patients undergoing CEA. METHODS: This single-center retrospective cohort study included 89 patients who underwent CEA at a tertiary referral center between 2010 and 2018. Preoperative calcium scores were measured on contrast-enhanced computed tomography images with patient-specific Hounsfield thresholds at the level of the carotid bifurcation. The association between these calcium scores and all-cause mortality was analyzed using multivariable adjusted Cox proportional hazard analysis. RESULTS: Cox proportional hazard analysis demonstrated a significant association between preoperative ipsilateral carotid calcium score and all-cause mortality (hazard ratio, 1.10; 95% confidence interval, 1.03-1.16; P = .003). After adjusting for age, preoperative estimated glomerular filtration rate, and diabetes mellitus, a significant association remained (hazard ratio, 1.07; 95% confidence interval, 1.00-1.15; P = .05). CONCLUSIONS: A higher calcium burden was predictive of worse outcome, which might be explained by an overall poorer health status. These results highlight the potential of calcium measurements in combination with other traditional risk factors, for preoperative risk assessment and thus for improved patient education and care.

Variability of [18F]FDG-PET/LDCT reporting in vascular graft and endograft infection.

PURPOSE: 18F-fluoro-D-deoxyglucose positron emission tomography with low dose and/or contrast enhanced computed tomography ([18F]FDG-PET/CT) scan reveals high sensitivity for the diagnosis of vascular graft and endograft infection (VGEI), but lower specificity. Reporting [18F]FDG-PET/CT scans of suspected VGEI is challenging, reader dependent, and reporting standards are lacking. The aim of this study was to evaluate variability of [18F]FDG-PET/low dose CT (LDCT) reporting of suspected VGEI using a proposed standard reporting format. METHODS: A retrospective cohort study was conducted including all patients with a suspected VGEI (according to the MAGIC criteria) without need for urgent surgical treatment who underwent an additional [18F]FDG-PET/LDCT scan between 2006 and 2022 at a tertiary referral centre. All [18F]FDG-PET/LDCT reports were scored following pre-selected criteria that were formulated based on literature and experts in the field. The aim was to investigate the completeness of [18F]FDG-PET/LDCT reports for diagnosing VGEI (proven according to the MAGIC criteria) and to evaluate if incompleteness of reports influenced the diagnostic accuracy. RESULTS: Hundred-fifty-two patients were included. Median diagnostic interval from the index vascular surgical procedure until [18F]FDG-PET/LDCT scan was 35.5 (7.3-73.3) months. Grafts were in 65.1% located centrally and 34.9% peripherally. Based on the pre-selected reporting criteria, 45.7% of the reports included all items. The least frequently assessed criterion was FDG-uptake pattern (40.6%). Overall, [18F]FDG-PET/LDCT showed a sensitivity of 91%, a specificity of 72%, and an accuracy of 88% when compared to the gold standard (diagnosed VGEI). Lower sensitivity and specificity in reports including ≤ 8 criteria compared to completely evaluated reports were found (83% and 50% vs. 92% and 77%, respectively). CONCLUSION: Less than half of the [18F]FDG-PET/LDCT reports of suspected VGEI met all pre-selected criteria. Incompleteness of reports led to lower sensitivity and specificity. Implementing a recommendation with specific criteria for VGEI reporting is needed in the VGEI-guideline update. This study provides a first recommendation for a concise and complete [18F]FDG-PET/LDCT report in patients with suspected VGEI.

Relining of a Bridging Covered Stent to Treat a Rare Cause of Type IIIc Endoleak Following Fenestrated Endovascular Aneurysm Repair.

PURPOSE: To present a rare cause of type III endoleak via the left renal artery (LRA) fenestration following fenestrated endovascular aneurysm repair (FEVAR) and to describe a successful reintervention for treating this endoleak. TECHNIQUE: The patient presented with a type IIIc endoleak following FEVAR, due to inadvertent placement of the LRA bridging balloon expandable covered stent (BECS) via the superior mesenteric artery (SMA) fenestration, but deployed outside the SMA fenestration. The proximal part of the BECS was positioned outside of the main body. This caused a type IIIc endoleak via the open LRA fenestration. Reintervention was performed by relining the LRA with a new BECS. First, access to the lumen of the previously placed BECS was gained using a re-entry catheter, followed by placement of a new BECS via the LRA fenestration. Completion angiography, and computerized tomography angiography (CTA) at 3 months follow-up showed total obliteration of the endoleak and patency of the LRA. CONCLUSION: Placement of a bridging stent via an incorrect fenestration during FEVAR is a rare cause of type III endoleak. In certain cases, successful treatment of such an endoleak could be achieved by perforation and relining of the misplaced BECS via the correct fenestration of the target vessel. CLINICAL IMPACT: To our best knowledge, a type IIIc endoleak following fenestrated endovascular aneurysm repair, due to placement of a bridging covered stent through an incorrect fenestration and deployed short of the fenestration, has not been described before. Reintervention was performed with perforation of the previously placed covered stent and relining using a new bridging covered stent. The technique presented here was successful for treating the endoleak in this case and could help guide clinicians when dealing with this or similar complications.

In Vivo Quantification of Cardiac-Pulsatility-Induced Motion Before and After Double-Branched Endovascular Aortic Arch Repair.

The Relay®Branch stent-graft (Terumo Aortic, Sunrise, FL, USA) offers a custom-made endovascular solution for complex aortic arch pathologies. In this technical note, a modified electrocardiography (ECG)-gated computed tomography (CT)-based algorithm was applied to quantify cardiac-pulsatility-induced changes of the aortic arch geometry and motion before and after double-branched endovascular repair (bTEVAR) of an aortic arch aneurysm. This software algorithm has the potential to provide novel and clinically relevant insights in the influence of bTEVAR on aortic anatomy, arterial compliance, and stent-graft dynamics.

Renal and Visceral Artery Configuration During the First Year of Follow-Up After Fenestrated Aortic Aneurysm Repair Using the Anaconda Stent-graft: A Prospective Longitudinal Multicenter Study With ECG-Gated CTA Scans.

OBJECTIVE: The performance of fenestrated endovascular aortic aneurysm repair (FEVAR) may be compromised by complications related to the dynamic vascular environment. The aim of this study was to analyze the behavior of FEVAR bridging stent configurations during the cardiac cycle and during follow-up to improve our understanding on treatment durability. DESIGN: Twenty-one patients presenting with complex abdominal aortic aneurysms (AAAs; 9 juxtarenal/6 pararenal/3 paravisceral/1 thoracoabdominal aortic aneurysm type IV), treated with a fenestrated Anaconda (Terumo Aortic, Inchinnan, Scotland, UK) with Advanta V12 bridging stents (Getinge, Merrimack, NH, USA), were prospectively enrolled in a multicenter observational cohort study and underwent electrocardiogram (ECG)-gated computed tomographic angiography (CTA) preoperatively, at discharge, 7-week, and 12-month follow-ups. METHODS: Fenestrated endovascular aortic aneurysm repair stability was assessed considering the following variables: branch angle as the angle between the aorta and the target artery, end-stent angle as the angle between the end of the bridging stent and the native artery downstream from it, curvature and tortuosity index (TI) to describe the bending of the target artery. Body-bridging stent stability was assessed considering bridging stent flare lengths, the distances between the proximal sealing stent-ring and fenestrations and the distance between the fenestration and first apposition in the target artery. RESULTS: Renal branch angles significantly increased after FEVAR toward a perpendicular position (right renal artery from median 60.9°, inter quartile range [IQR]=44.2-84.9° preoperatively to 94.4°, IQR=72.6-99.8°, p=0.001 at 12-month follow-up; left renal artery [LRA], from 63.7°, IQR=55.0-73.0° to 94.3°, IQR=68.2-105.6°, p<0.001), while visceral branch angles did not. The mean dynamic curvature only decreased for the LRA from preoperative (3.0, IQR=2.2-3.8 m-1) to 12-month follow-up (1.9, IQR=1.4-2.6 m-1, p=0.027). The remaining investigated variables did not seem to show any changes over time in this cohort. CONCLUSIONS: Fenestrated endovascular aortic aneurysm repair for complex AAAs using the Anaconda fenestrated stent-graft and balloon-expandable Advanta V12 bridging stents demonstrated stable configurations up to 12-month follow-up, except for increasing renal branch angles toward perpendicular orientation to the aorta, yet without apparent clinical consequences in this cohort. CLINICAL IMPACT: This study provides detailed information on the cardiac-pulsatility-induced (dynamic) and longitudinal geometry deformations of the target arteries and bridging stents after fenestrated endovascular aortic aneurysm repair (FEVAR) up to 12-month follow-up. The configuration demonstrated limited dynamic and longitudinal deformations in terms of branch angle, end-stent angle, curvature, and tortuosity index (TI), except for the increasing renal branch angles that go toward a perpendicular orientation to the aorta. Overall, the results suggest that the investigated FEVAR configurations are stable and durable, though careful consideration of increasing renal branch angles and significant geometry alterations is advised.

Performance of the BioIntegral Bovine Pericardial Graft in Vascular Infections: VASCular No-REact Graft Against INfection Study.

BACKGROUND: Vascular graft and endograft infections (VGEI) and native vessel infections (NVI) remain considerable challenges in vascular surgery, leading to high mortality and morbidity rates. Although in situ reconstruction is the preferred treatment, the material of choice is still a source of debate. Autologous veins are considered the first choice; however, xenografts may be an acceptable alternative. The performance of a biomodified bovine pericardial graft is assessed when implemented in an infected vascular area. METHODS: This is a prospective multicenter cohort study. Patients who underwent reconstruction for VGEI or NVI with a biomodified bovine pericardial bifurcated or straight tube graft were included from December 2017 until June 2021. The primary outcome measure was reinfection at mid-term follow-up. Secondary outcome measures included mortality, patency, and amputation rate. RESULTS: Thirty-four patients with vascular infections were included, of which 23 (68%) had an infected Dacron prosthesis after primary open repair and 8 (24%) had an infected endovascular graft. The remaining 3 (9%) had infected native vessels. At secondary repair, 3 (7%) patients had an in situ aortic tube reconstruction, 29 (66%) had an aortic bifurcated reconstruction, and 2 (5%) had an iliac-femoral reconstruction. At 1-year follow-up after the BioIntegral bovine pericardial graft reconstruction, the reinfection rate was 9%. The 1-year infection-related and procedure-related mortality rate was 16%. The occlusion rate was 6% and in total 3 patients underwent a lower limb amputation during the 1-year follow-up period. CONCLUSIONS: In situ reconstruction as treatment of (endo)graft and native vessel infections remains a challenge and reinfection looms as a potential consequence. In cases where time is of essence or when autologous venous repair is not feasible, a swift available solution is needed. The BioIntegral biomodified bovine pericardial graft may be an option as it shows reasonable results in terms of reinfection, in aortic tube and bifurcated grafts.

Use of Omniflow® II Biosynthetic Graft for the Treatment of Vascular Graft and Endograft Infections.

BACKGROUND: Vascular graft/endograft infection is a rare but life-threatening complication of cardiovascular surgery and remains a surgical challenge. Several different graft materials are available for the treatment of vascular graft/endograft infection, each having its own advantages and disadvantages. Biosynthetic vascular grafts have shown low reinfection rates and could be a potential second best after autologous veins in the treatment of vascular graft/endograft infection. Therefore, the aim of our study was to evaluate the efficacy and morbidity of Omniflow® II for the treatment of vascular graft/endograft infection. METHODS: A multicenter retrospective cohort study was performed to evaluate the use of Omniflow® II in the abdominal and peripheral region to treat vascular graft/endograft infection between January 2014 and December 2021. Primary outcome was recurrent vascular graft infection. Secondary outcomes included primary patency, primary assisted patency, secondary patency, all-cause mortality, and major amputation. RESULTS: Fifty-two patients were included with a median follow-up duration of 26.5 (10.8-54.8) months. Nine (17%) grafts were implanted in intracavitary position and 43 (83%) in peripheral position. Most grafts were used as femoral interposition (n = 12, 23%), femoro-femoral crossover (n = 10, 19%), femoro-popliteal (n = 8, 15%), and aorto-bifemoral (n = 8, 15%) graft. Fifteen (29%) grafts were implanted extra-anatomically and 37 (71%) in situ. Eight patients (15%) presented with reinfection during follow-up, most of these patients received an aorto-bifemoral graft (n = 3, 38%). Intracavitary vascular grafting had a 33% (n = 3) reinfection rate and peripheral grafting 12% (n = 5; P = 0.025). The estimated primary patencies at 1, 2, and 3 years were 75%, 72%, and 72% for peripherally located grafts and 58% (at all timepoints) for intracavitary grafts (P = 0.815). Secondary patencies at 1, 2, and 3 years were 77% (at all timepoints) for peripherally located prostheses and 75% (at all timepoints) for intracavitary prostheses (P = 0.731). A significantly higher mortality during follow-up was observed in patients who received an intracavitary graft compared to patients with a peripheral graft (P = 0.003). CONCLUSIONS: This study highlights the efficacy and safety of the Omniflow® II biosynthetic prosthesis for the treatment of vascular graft/endograft infection, in absence of suitable venous material, with acceptable reinfection, patency, and freedom of amputation prevalences, especially in replacing peripheral vascular graft/endograft infection. However, a control group with either venous reconstruction or another alternative graft is needed to make firmer conclusions.