Safety and Feasibility of the BYCROSS® Atherectomy Device for the Treatment of Femoropopliteal Arterial Obstructions: Single-Center Short-Term Outcomes.

Background: Endovascular techniques have gained preference over peripheral arterial bypass surgery due to their minimally invasive nature; however, endovascular treatments often show limited efficacy in arterial segments with a high atherosclerotic load. The use of atherectomy devices enables the removal of calcified plaque material and may promote arterial wall remodeling. This study assessed the technical success, safety, and feasibility of the BYCROSS® atherectomy device in femoropopliteal lesions. Methods: This single-center, retrospective cohort study analyzed elective patients undergoing BYCROSS® atherectomy for chronic peripheral arterial disease from March 2022 to May 2023. Patient data, procedural details, and outcomes were retrospectively collected from electronic patient records. The primary performance endpoints of this study were technical success, complications, and patency rates. Primary safety endpoints included 30-day and short-term major adverse limb events (MALEs), major adverse cardiovascular events (MACEs), and mortality rate. Results: The study included 19 patients (median age, 71 years; 63% male) with Fontaine class IIb (26%), III (21%), or IV (53%). The BYCROSS® atherectomy device was used to treat 22 limbs in the femoropopliteal tract, of which 11 lesions (50%) were occlusions and 11 were stenoses, with a median length of 24 cm (interquartile range: 17-38). Technical success was achieved in all cases: 4.5% required atherectomy only, 50% required additional balloon angioplasties, 41% required balloon angioplasties and stenting, and 4.5% required segments only stenting. Additional treatment of below-the-knee arteries was performed in 12 patients. Procedurally related complications (not limited to the use of the BYCROSS® device) occurred in 23% of limbs, including distal embolization and laceration. At 30 days, mortality was 5%, the MACE rate was 11%, and the MALE rate was 0%. The observed mortality rate was not directly related to the procedure. Patency (<50% restenosis at duplex ultrasound) was 83% at 30 days. Conclusions: The use of the BYCROSS® atherectomy device for the treatment of femoropopliteal lesions appears to be safe and feasible, with high technical success and low MALE and MACE rates in a challenging population with long-segment femoropopliteal lesions. Long-term follow-up in larger patient series is needed to confirm these findings and to determine the durability of this technique.

Importance of sac regression after EVAR and the role of EndoAnchors.

The initial success and widespread adoption of endovascular aneurysm repair (EVAR) for the treatment of abdominal aortic aneurysms have been tempered by numerous reports of secondary interventions and increased long-term mortality compared with open repair. Over the past decade, several studies on postoperative sac dynamics after EVAR have suggested that the presence of sac regression is a benign feature with a favorable prognosis. Conversely, increasing sacs and even stable sacs can be indicators of more unstable sac behavior with worse outcomes in the long-term. Endoleaks were initially perceived as the main drivers of sac behavior. However, the observation that sac regression can occur in the presence of endoleaks, and vice versa - increasing sacs without evidence of endoleak - on imaging studies, suggests the involvement of other contributing factors. These factors can be divided into anatomical factors, patient characteristics, sac thrombus composition, and device-related factors. The shift of interest away from especially type 2 endoleaks is further supported by promising results with the use of EndoAnchors regarding postoperative sac behavior. This review provides an overview of the existing literature on the implications and known risk factors of post-EVAR sac behavior, describes the accurate measurement of sac behavior, and discusses the use of EndoAnchors to promote sac regression.

Outcomes and Patency of Endovascular Infrapopliteal Reinterventions in Patients With Chronic Limb-Threatening Ischemia.

PURPOSE: Endovascular revascularization is the preferred treatment to improve perfusion of the lower extremity in patients with chronic limb-threatening ischemia (CLTI). Patients with CLTI often present with stenotic-occlusive lesions involving the infrapopliteal arteries. Although the frequency of treating infrapopliteal lesions is increasing, the reintervention rates remain high. This study aimed to determine the outcomes and patency of infrapopliteal endovascular reinterventions. METHODS: This retrospective, multicenter cohort study of 3 Dutch hospitals included patients who underwent an endovascular infrapopliteal reintervention in 2015 up to 2021 after a primary infrapopliteal intervention for CLTI. The outcome measures after the reintervention procedures included technical success rate, the mortality rate and complication rate (any deviation from the normal postinterventional course) at 30 days, overall survival, amputation-free survival (AFS), freedom from major amputation, major adverse limb event (MALE), and recurrent reinterventions (a reintervention following the infrapopliteal reintervention). Cox proportional hazard models were used to determine risk factors for AFS and freedom from major amputation or recurrent reintervention. RESULTS: Eighty-one patients with CLTI were included. A total of 87 limbs underwent an infrapopliteal reintervention in which 122 lesions were treated. Technical success was achieved in 99 lesions (81%). The 30-day mortality rate was 1%, and the complication rate was 13%. Overall survival and AFS at 1 year were 69% (95% confidence interval [CI], 55%-79%) and 54% (95% CI, 37%-67%), respectively, and those at 2.5 years were 45% (95% CI, 33%-56%) and 21% (95% CI, 11%-33%), respectively. Freedom from major amputation, MALE, and recurrent reinterventions at 1 year and 2.5 years were 59% (95% CI, 46%-70%) and 41% (95% CI, 25%-56%); 54% (95% CI, 41%-65%) and 36% (95% CI, 21%-51%); and 68% (95% CI, 55%-78%) and 51% (95% CI, 33%-66%), respectively. A Global Limb Anatomic Staging System score of III showed an increased hazard ratio of 2.559 (95% CI, 1.078-6.072; p=0.033) for freedom of major amputation or recurrent reintervention. CONCLUSIONS: The results of this study indicate that endovascular infrapopliteal reinterventions can be performed with acceptable 30-day mortality and complication rates. However, outcomes and patency were moderate to poor, with low AFS, high rates of major amputations, and recurrent reinterventions. CLINICAL IMPACT: This multicenter retrospective study evaluating outcome and patency of endovascular infrapopliteal reinterventions for CLTI, shows that endovascular infrapopliteal reinterventions can be performed with acceptable 30-day mortality and complication rates. However, the short- and mid-term outcomes of the infrapopliteal reinterventions were moderate to poor, with low rates of AFS and a high need for recurrent reinterventions. While the frequency of performing infrapopliteal reinterventions is increasing with additional growing complexity of the disease, alternative treatment options such as venous bypass grafting or deep venous arterialization may be considered and should be studied in randomized controlled trials.

Three cases of spontaneous major bleeding in patients with a COVID-19 infection.

In addition to the respiratory compromise typical for COVID-19 many papers reported on the thromboembolic complications in these often critically ill patients. In this report, three cases of patients that developed spontaneous major bleeding following treatment with therapeutic anticoagulation for thromboembolic complications of COVID-19 were described. Two cases were treated with coil-embolization and one patient could be treated conservatively. These cases illustrate the presence of a relevant bleeding risk against the background of the well-known thromboembolic complications associated with COVID-19. The increased risks of thromboembolic complications in COVID-19 warrant adequate prophylactic anticoagulation. The optimal dose to obtain a significant risk reduction without a significant increase in the incidence of major bleeding requires further research.

A Systematic Review and Meta-Analysis on Perioperative Cerebral and Hemodynamic Monitoring Methods during Carotid Endarterectomy.

BACKGROUND: To compare outcomes between different strategies of perioperative cerebral and hemodynamic monitoring during carotid endarterectomy. DATA SOURCES: MEDLINE, EMBASE, CINAHL, and Cochrane CENTRAL databases were searched. METHODS: This review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and prospectively registered in the international prospective register of systematic reviews (CRD42021241891). The Grading of Recommendations, Assessment, Development and Evaluation approach was used to describe the methodological quality of the studies and certainty of the evidence. The primary outcome was 30-day stroke rate. Secondary outcomes measures are 30-day ipsilateral stroke, 30-day mortality, shunt rate, and complication rates. RESULTS: The search identified 3,460 articles. Seventeen randomized controlled trials (RCTs), three prospective observational studies and seven registries were included, reporting on 236,983 patients. The overall pooled 30-day stroke rate is 1.8% (95% CI 1.4-2.2%), ranging from 0 to 12.6%. In RCT's the pooled 30-day stroke rate is 2.7% (95% CI 1.6-3.7%) compared to 1.3% (95% CI 0.8-1.8%) in the registries. The overall stroke risk decreased from 3.7% before the year 2000 to 1.6% after 2000. No significant differences could be identified between different monitoring and shunting strategies, although a trend to higher stroke rates in routine no shunting arms of RCTs was observed. Overall, 30-day mortality, myocardial infarction and nerve injury rates are 0.6% (95% CI 0.4-0.8), 0.8% (95% CI 0.6-1.0) and 1.3% (95% CI 0.4-2.2), respectively. CONCLUSIONS: No significant differences between the compared shunting and monitoring strategies are found. However, routine no shunting is not recommended. The available data are too limited to prefer 1 method of neuromonitoring over another method when selective shunting is applied.

Outcomes of open repair of postdissection abdominal aortic aneurysms.

BACKGROUND: Evidence to guide management of postdissection abdominal aortic aneurysms (PDAAA) is lacking. This study describes the outcomes of open repair of PDAAA. METHODS: A retrospective cohort study was conducted of all consecutive patients treated with open repair for PDAAA after a Stanford type A or type B thoracic aortic dissection between January 2006 and December 2017 in two vascular referral centers. Preceding type B dissection treatment could include conservative or surgical management. Primary outcomes were 30-day mortality, complication rates, survival, and reintervention-free survival. Survival and reintervention-free survival were analyzed using the Kaplan-Meier method. Reintervention was defined as any endovascular or surgical intervention after the index procedure. RESULTS: Included were 36 patients (27 men [75%]) with a median age of 64 years (range, 35-81 years). The 30-day mortality was 2.7%. The median follow-up was 16 months (range, 0-88 months). The postoperative course was uneventful in 21 patients (58%). The most frequent complications were postoperative bleeding requiring repeat laparotomy (n = 4), pneumonia (n = 3), congestive heart failure (n = 2), new-onset atrial fibrillation (n = 2), mesenteric ischemia requiring left hemicolectomy (n=1), and ischemic cerebrovascular accident (n = 1). Renal failure requiring hemodialysis developed in one patient. The overall survival at 1 year was 88.8%. Reintervention-free survival was 95.5% after 1 year and 88.6% after 2 years. CONCLUSIONS: Open repair of PDAAA can be performed with a low mortality rate and an acceptable complication rate, comparable with elective open repair of abdominal aortic aneurysms without dissection.

Telemedicine in patients with peripheral arterial disease: is it worth the effort?

Introduction: For patients with peripheral arterial disease (PAD), the various components of telemedicine, such as telemonitoring, telecoaching, and teleconsultation, could be valuable in daily management. The objective of this review was to give an overview of the current use of telemedicine interventions in PAD. Areas covered: A literature search was performed for studies that evaluated patients with PAD of the aorto-pedal trajectory, who were monitored by telemedicine and acted upon accordingly. The primary outcome was health-related outcomes. The studies that were found focused mainly on wearable activity monitoring and telecoaching in PAD (n = 4) or wound monitoring after vascular surgery (n = 2). Main results indicate that telemedicine interventions are able to detect (post-operative) complications early, improve functional capacity and claudication onset time, and improve PAD patients' quality of life. Expert opinion: The use of telemedicine in PAD patients is still an under-explored area. Studies investigating the use of telemedicine in PAD are very limited and show varying results. Owing to its high potential in improving physical ability, lifestyle coaching, and timely detection of deterioration, future research should focus on proper implementation of telemedicine in PAD patients, including clinical and feasibility outcomes, effect on workload of nurses, and cost-efficiency.

A systematic review of standardized methods for assessment of endograft sealing on computed tomography angiography post-endovascular aortic repair, and its influence on endograft-associated complications.

Introduction: Although there is much attention for proper sizing of pre-operative anatomy before (thoracic) endovascular aneurysm repair ([T]EVAR), standardized assessment of endograft position and apposition at postoperative imaging is seldom addressed in the international guidelines. The highly detailed three-dimensional computed tomography angiography (CTA) volumes contain valuable information about the apposition of the endograft with the arterial wall and the position of the device relative to anatomical landmarks in the proximal and distal landing zones, which is currently hardly used. With proper assessment on CTA of the endograft after EVAR, the risk for future endograft-related complications may be determined, allowing patient-tailored, risk-stratified surveillance. Areas covered: This systematic review identified three standardized methods for assessing apposition or position of the endograft in the proximal or distal landing zone on CTA after (T)EVAR. Quantification of apposition and position, validation of measurement precision, and association with endograft-related complications were extracted. Short (<10 mm apposition length) and decreasing (>0 mm) apposition were associated with endograft-associated complications. Expert commentary: Standardized assessment of apposition and position of the endograft in the proximal and distal landing zones on CTA should be incorporated in post-(T)EVAR surveillance. A risk-stratified CTA surveillance protocol is proposed.

Systematic Review and Meta-Analysis on the Management of Open Abdominal Aortic Graft Infections.

OBJECTIVE: Aortic graft infection (AGI) is a disastrous complication with an incidence of 0.2-6% in operated patients. With little or no high quality evidence, the best treatment option remains unclear. Therefore, the literature on the management of open abdominal AGI was systematically reviewed to determine optimal treatment. METHODS: In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a systematic review and meta-analysis was conducted for AGI. MEDLINE, Embase, and the Cochrane Database of Systematic Reviews were searched. Methodological quality was assessed using the Methodological Index for Non-randomised Studies (MINORS) score. Primary outcomes were 30 day mortality and one year survival. Secondary outcomes were survival, infection recurrence, limb salvage, and graft patency. RESULTS: Of 1574 studies identified, 32 papers were included in the study. The overall quality of the studies was moderate, with an average MINORS score of 11.9. Pooled overall 30 day mortality and one year survival were 13.5% (95% CI 10.5-16.4) and 73.6% (95% CI 68.8-78.4), respectively. The lowest 30 day mortality and highest one year survival were found for in situ repair compared with extra-anatomic repair and for prosthetic grafts compared with venous grafts or arterial allografts. The infection recurrence rate was highest for prosthetic grafts. CONCLUSIONS: There is a lack of well designed, qualitative comparative studies making conclusive recommendations impossible. The current best available data suggests that partial graft removal should be avoided and the lowest 30 day mortality and best one year survival are achieved with in situ repair using prosthetic grafts. Initiatives such as the MAGIC database to collaboratively collect prospective data are an important step forward in obtaining more solid answers on this topic.

A systematic review of patch angioplasty versus primary closure for carotid endarterectomy.

BACKGROUND: Guidelines recommend routine patching after carotid endarterectomy (CEA) on the basis of a lower restenosis rate and presumed lower procedural stroke rate than with primary repair. Underlying evidence is based on studies performed decades ago with perioperative care that significantly differed from current standards. Recent studies raise doubt about routine patching and have suggested that a more selective approach to patch closure (PAC) might be noninferior for procedural safety and long-term stroke prevention. The objective was to review the literature on the procedural safety and perioperative stroke prevention of PAC compared with primary closure (PRC) after CEA. METHODS: MEDLINE, Embase, and Cochrane Central Register of Controlled Trials databases were searched from January 1966 to September 2017. Two authors independently performed the search, study selection, assessment of methodologic quality, and data extraction. Articles were eligible if they compared PAC and PRC after CEA, were published in English, included human studies, and had a full text available. Methodologic quality for nonrandomized studies was assessed using the Methodological Index for Non-Randomized Studies score; randomized controlled trials were assessed using Grading of Recommendations Assessment, Development, and Evaluation. Nonrandomized studies with a score ≤15 were excluded. The primary outcome measure was 30-day stroke risk. Secondary outcome measures were long-term restenosis (>50%) and postoperative bleeding. RESULTS: Twenty-nine articles met the inclusion criteria, 9 randomized studies and 20 nonrandomized studies, for a total of 12,696 patients and 13,219 CEAs. Overall 30-day stroke risk was higher in the PRC group (odds ratio [OR], 1.9; 95% confidence interval [CI], 1.2-2.9). After exclusion of nonrandomized studies, this difference was not statistically significant anymore (OR, 1.8; 95% CI, 0.8-3.9). The restenosis rate was higher after PRC (OR, 2.2; 95% CI, 1.4-3.4). There were no differences in bleeding complications. Methodologic quality of the nonrandomized studies was moderate, and seven were excluded. Quality of the evidence according to Grading of Recommendations Assessment, Development, and Evaluation was moderate for restenosis, 30-day stroke, and bleeding. CONCLUSIONS: In this systematic review, on the basis of moderate-quality evidence, perioperative stroke rate was lower after PAC compared with PRC. The rate of restenosis was higher after PRC, although the clinical significance of this finding in terms of long-term stroke prevention remained unclear.

The BeGraft Balloon Expandable Covered Stent as a Proximal Extension to an Iliac Branch Device for Endovascular Repair of Isolated Common Iliac Artery Aneurysms.

INTRODUCTION: Isolated common iliac artery aneurysms (CIAA) are rare and can be treated by endovascular exclusion using iliac branch devices (IBD). The use of a balloon expandable covered stent as a proximal extension to an IBD to allow adequate sealing in the proximal common iliac artery (CIA) for exclusion of isolated CIAA is demonstrated. REPORT: Two patients with isolated CIAA of ≥4.5 cm with a proximal neck length of ≥20 mm (patient A: 26 mm; patient B: 24 mm) and a neck diameter of ≤20 mm (patient A: 16.4 mm; patient B: 15.6 mm) were treated by combining a Zenith IBD with an aortic BeGraft balloon expandable covered stent. After deploying the BeGraft covered stent at 12 mm a second balloon was used to further dilate the proximal part of the stent outside the IBD to allow adequate sealing in the CIA. Completion angiography and follow up computed tomography angiography 1 month post-operatively showed adequate sealing and no endoleaks. DISCUSSION: The feasibility of the application of a balloon expandable covered stent as a proximal extension to an IBD for isolated CIAA was demonstrated. It is not necessary to insert an aortic bifurcation endograft, thus reducing procedure time, radiation exposure, contrast use, and cost. A patent inferior mesenteric artery and lumbar arteries can be spared and procedures that require crossing over the aortic bifurcation remain possible. Comorbidity, prior interventions, and disease extension can make this endovascular approach preferred over open repair. Isolated CIAA can be efficiently treated combining the BeGraft balloon expandable covered stent and IBD, which allows proximal sealing in the CIA.

Patch Angioplasty or Primary Closure Following Carotid Endarterectomy for Symptomatic Carotid Artery Stenosis.

Objectives Guidelines recommend routine patching to prevent restenosis following carotid endarterectomy, mainly based on studies performed many years ago with different perioperative care and medical treatment compared with current standards. Aim of the present study was to compare primary closure (PRC) versus patch closure (PAC) in a contemporary cohort of patients. Methods Consecutive patients treated by carotid endarterectomy for symptomatic stenosis between January 2006 and April 2016 were retrospectively analyzed. Primary outcome was restenosis at 6 weeks and 1 year and occurrence of ipsilateral stroke. Secondary outcomes were mortality, complications, and reintervention rates. Results Five hundred carotid artery endarterectomies were performed. Fifty-nine patients were excluded because eversion endarterectomy was performed or because they were asymptomatic. PRC was performed in 349 and PAC in 92 patients. Restenosis at 6 weeks was 6.0% in the PAC group versus 3.0% in the PRC group ( p = 0.200). Restenosis at 1 year was 31.6 versus 14.1%, respectively ( p = 0.104). No difference was found for stroke (3.4 vs 1.1%, p = 0.319), death (1.1 vs 0.0%, p = 0.584), or other complications (1.1 vs 0.0%, p = 0.584), respectively. Conclusions It remains unclear whether routine patching should be recommended for all patients. A strategy of selective patching compared with routine patching, based on internal carotid artery diameter and other patient characteristics, deserves further investigation.