Time Dependent Correlation Between Sac Behaviour and Re-intervention after Endovascular Aneurysm Repair.

OBJECTIVE: This study aimed to investigate the correlation between aneurysm sac behaviour and time to re-intervention after endovascular aneurysm repair (EVAR). METHODS: A retrospective observational cohort study of patients who underwent EVAR at a single centre between January 2008 and November 2011 and who were followed up for a mean of 6.6 ± 2.9 years was conducted. Based on sac appearances on pre-operative imaging and imaging at the end of follow up, patients were stratified into two groups: (1) sac regression; and (2) no sac regression. The no sac regression group was further subdivided into stable sac group and sac expansion group. Sac regression and expansion throughout follow up were defined as a decrease or increase in the abdominal aortic aneurysm sac diameter of ≥ 5 mm compared with the pre-operative size. A Cox proportional hazards model using multiple failure per subject data was used to identify sac behaviour as a predictor of re-intervention free time. RESULTS: Patients with sac regression had a higher probability of freedom from re-intervention compared with those with a stable or expanding aneurysm sac (94%, 57%, and 16% at 12 years, respectively; log rank, p < .001). Mean time to re-intervention was 11.3 years for the sac regression group, 8.8 years for the stable sac group, and 5.0 years for the sac expansion group (p < .001). In the stable sac group, the risk of re-intervention increased sharply six years after EVAR, whereas in the sac expansion group a sharp rise in re-intervention was noted 3.5 years after EVAR, reaching a plateau after year 6. CONCLUSION: A time dependent correlation between aneurysm sac behaviour and re-intervention was found. Such findings have implications for surveillance strategies.

Covered Stents Versus Bare Metal Stents in the Treatment of Aorto-iliac Disease: A Systematic Review and Individual Participant Data Meta-analysis.

OBJECTIVE: To assess the comparative safety and efficacy of covered stents (CS) and bare metal stents (BMS) in endovascular treatment of aorto-iliac disease in patients with peripheral arterial disease. DATA SOURCES: A systematic review was conducted adhering to the PRISMA 2020 and PRISMA for Individual Participant Data 2015 guidelines. REVIEW METHODS: A search of PubMed, Scopus, and Web of Science for articles published by December 2023 was performed. The primary endpoint was primary patency. Certainty of evidence was assessed via the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework. RESULTS: Eleven studies, comprising 1 896 patients and 2 092 lesions, were included. Of these, nine studies reported on patients' clinical status, with 35.5% classified as Rutherford 4 - 6. Overall primary patency for CS and BMS at 48 months was 91.2% (95% confidence interval [CI] 84.1 - 99.0%) (GRADE, moderate) and 83.5% (95% CI 70.9 - 98.3%) (GRADE, low). The one-stage individual participant data meta-analyses indicated a significant risk reduction for primary patency loss favouring CS (hazard ratio [HR] 0.58, 95% CI 0.35 - 0.95) (GRADE, very low). The 48 month primary patency for CS and BMS when treating TransAtlantic InterSociety Consensus (TASC) C and D lesions was 92.4% (95% CI 84.7 - 100%) (GRADE, moderate) and 80.8% (95% CI 64.5 - 100%) (GRADE, low), with CS displaying a decreased risk for patency loss (HR 0.39, 95% 0.27 - 0.57) (GRADE, moderate). While statistically non-significant differences were identified between CS and BMS regarding technical success, 30 day mortality, intra-operative and immediate post-operative procedure related complications, and major amputation, CS displayed a decreased re-intervention risk (risk ratio 0.59, 95% CI 0.40 - 0.87) (GRADE, low). CONCLUSION: This review has illustrated the improved patency of CS compared with BMS in the treatment of TASC C and D lesions. Caution is advised in interpreting overall primary patency outcomes given the substantial inclusion of TASC C and D lesions into the analysis. Ultimately, both stent types have demonstrated comparable safety profiles.

A Greek Multicentre Study Assessing the Outcome of Late Rupture After Endovascular Abdominal Aortic Aneurysm Repair.

OBJECTIVE: Late rupture after endovascular aortic aneurysm repair (EVAR) for an abdominal aortic aneurysm (AAA) is an increasing complication associated with a high mortality rate. This study aimed to analyse the causes and outcomes in patients with AAA rupture after EVAR. METHODS: A multi-institutional Greek study of late ruptures after EVAR between 2008 - 2022 was performed. Primary outcomes were intra-operative and in hospital death. RESULTS: A total of 70 patients presented with late rupture after EVAR (proportion of ruptured EVARs among all EVARs, 0.6%; 69 males; mean age 77.2 ± 6.7 years). The mean time interval between EVAR and late rupture was 72.3 months (range 6 - 180 months). In all cases the cause of rupture was the presence of an endoleak (type I, 73%) with sac enlargement. Moreover, 34% of subjects with rupture after EVAR had been lost to follow up and 32% underwent a secondary intervention. Additionally, 57 patients (81%) were treated by conversion to open surgical repair (COSR) and the remainder by endovascular correction of endoleak (ECE). Eleven intra-operative deaths (16%) were recorded. The overall in hospital mortality rate was 41% (23% ECE vs. 46% COSR; p = .21). Of the patients who presented as initially haemodynamically stable, 23% died during hospitalisation, while the respective mortality rate for patients who presented as unstable was 78% (odds ratio [OR] 11.8, 95% confidence interval [CI] 3.6 - 39.1; p < .001). Multivariable logistic regression analysis revealed that severity of haemodynamic shock was the most significant risk factor for intra-operative (OR 7.15, 95% CI 1.58 - 32.40; p = .010) and in hospital death (OR 9.53, 95% CI 2.79 - 32.58; p < .001). CONCLUSION: These data underline the devastating prognosis of late rupture after EVAR. Haemodynamic status at presentation was an important predictive factor for death both in the ECE and COSR groups. Rigorous follow up and prompt evaluation of an unstable patient in case of rupture after EVAR is recommended.

A systematic review of the surgical management of secondary aortoduodenal fistula.

OBJECTIVE: Secondary aortoduodenal fistulae (SADF) are uncommon but life-threatening conditions that occur as complications of aortic reconstructive surgery. Data on the mortality and morbidity of procedures associated with SADF remain scarce. METHODS: Comprehensive literature search was conducted on the MedLine, Scopus, Embase, and Web of Knowledge databases for cases of SADF. Data regarding patient demographics, fistula anatomy and treatment interventions performed were extracted for further analysis. RESULTS: The study pool consisted of 127 case reports, 28 case series and 1 retrospective study published between 1973 and 2021. A total of 189 patients were operated for SADF. Among the 189 patients, 141 patients (74.6%) had aortic graft excision, 26 (13.8%) aortic primary repair, and 22 (11.6%) EVAR. Although patients undergoing EVAR were older with higher Charlson Comorbidity Index, compared with patients who had graft excision and primary aortic repair these differences were not statistically significant (P = .12 and P = .22, respectively). Primary bowel repair was performed in 145 patients (76.7%), duodenectomy in 25 (13.2%), and no bowel repair in 19 (10.1%). Additional omentoplasty was performed in 65 patients (34.6%). Mortality was comparable with respect to the type of aortic and bowel repair, with no statistically significant differences recorded (P = .54 and P = .77, respectively). Omentoplasty significantly decreased the risk of death (odds ratio, 0.4; 95% confidence interval, 0.2-0.8, P = .01). CONCLUSIONS: Optimal operative management should address both the aortic and duodenal defects and be complemented with appropriate reconstructive procedures. Endovascular aortic approaches seem feasible in carefully select patients in whom duodenal repair may be omitted.

A Systematic Review Network Meta-Analysis and Meta-Regression on Surgical and Endovenous Interventions for the Treatment of Lower Limb Venous Ulcer Disease.

BACKGROUND: Venous leg ulcer (VLU) disease constitutes the most severe form of chronic venous insufficiency. We performed a network meta-analysis and meta-regression to investigate the efficacy and safety of the various available interventions in the treatment of VLU. METHODS: We conducted a systematic research corresponding to the instructions by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement for studies reporting on surgical or endovenous interventions for the treatment of VLU. Following data extraction, we performed a Bayesian network meta-analysis and meta-regression. Primary endpoints included VLU healing and recurrence. The secondary endpoint was postintervention complications. RESULTS: Seventeen studies evaluating the impact of compression monotherapy, radiofrequency ablation (RFA), endovenous laser ablation (EVLA), sclerotherapy, and saphenous vein surgery on VLU treatment, consisting of 2156 patients (2186 VLU) were included. When compared to compression monotherapy, RFA was the only treatment displaying a statistically-significant impact on ulcer healing, odds ratio (OR) 5.80 (95% credibility interval (CI): 1.08-35.07), while EVLA, RR 0.06 (95% CI: 0.00-0.57), sclerotherapy, RR 0.07 (95% CI: 0.00-0.68) and RFA, RR 0.12 (95% CI: 0.01-0.91) were the 3 interventions reducing VLU recurrence. EVLA (SUCRA, 69.65) ranked as the most efficient intervention concerning ulcer recurrence reduction. Regarding postintervention complications, EVLA was the only intervention displaying a statistically-significant increased risk compared to compression monotherapy, RR 14.3 (95% CI: 2.03-172.56). Meta-regression analysis exploring the impact of perforator treatment on VLU failed to predict healing, ß = -0.27 (95% CI: -2.55 to 1.85), recurrence, ß = -0.02 (95% CI: -2.96 to 2.75) and complication outcomes, ß = -0.089 (95% CI: -3.13 to 2.85). During sensitivity analysis, RFA and sclerotherapy failed to sustain their effects on ulcer healing and ulcer recurrence, respectively. In addition, sclerotherapy displayed statistically-significant inferior outcomes compared to both EVLA and RFA regarding ulcer recurrence. CONCLUSION: This is the first network meta-analysis examining the effect of various interventions on VLU disease. While we have demonstrated the efficacy of RFA and ELVA in ulcer recurrence prevention, our results regarding the impact of RFA and sclerotherapy on VLU healing and recurrence, respectively, should be interpreted with caution. In addition, this review raises questions concerning the value of surgery and perforator interventions in the treatment of VLU. Further research through randomized controlled trials is required. CLINICAL IMPACT: Our review has revealed the significant efficacy of endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) in effectively reducing the incidence of ulcer recurrence when compared to compression monotherapy. These outcomes hold the potential to provide relevant insights to both medical practitioners and patients, thereby informing a more prudent and enlightened decision-making approach. Such informed decisions, aimed at mitigating the recurring occurrence of venous leg ulcers, carry profound significance given the considerable socioeconomic implications associated with this medical condition.

Individual Patient Data Meta-Analysis of 10-Year Follow-Up after Endovascular and Open Repair for Ruptured Abdominal AorticAneurysms.

BACKGROUND: Endovascular aortic repair (EVAR) has conferred an early survival advantage compared to an open surgical repair (OSR) in patients with ruptured abdominal aortic aneurysms (rAAA). However, the long-term survival benefit after EVAR was not displayed among randomized controlled trials (RCTs), whereas many non-RCTs have provided conflicting results. We conducted a time-to-event individual patient data (IPD) meta-analysis on long-term rAAA data. METHODS: All studies comparing mortality after EVAR versus OSR for rAAA were included. We used restricted mean survival times (RMSTs) as a measure of life expectancy for EVAR and OSR. RESULTS: A total of 21 studies, including 12,187 patients (4952 EVAR and 7235 OSR) were finally deemed eligible. A secondary IPD analysis included 725 (372 EVAR and 353 OSR) patients only from the 3 RCTs (Immediate Management of the Patient With Rupture : Open Versus Endovascular Repair, Endovasculaire ou Chirurgie dans les Anévrysmes aorto-iliaques Rompus and Amsterdam Acute Aneurysm Trial trials). Among all studies, the median survival was 4.20 (95% confidence interval [CI]: 3.70-4.58) years for EVAR and 1.91 (95% CI: 1.57-2.39) years for OSR. Although EVAR presented with increased hazard risk from 4 to 7 years, which peaked at 6 years after the operation, the RMST difference was 0.54 (95% CI: 0.35-0.73; P < 0.001) years gained with EVAR at the end of the 10-year follow-up. IPD meta-analysis of RCTs did not demonstrate significant differences. CONCLUSIONS: At 10-years follow-up, EVAR was associated with a 6.5 month increase in life expectancy when compared to OSR after analyzing all eligible studies. Evidence from our study suggests that a strict follow-up program would be desirable, especially for patients with long-life expectancy.

Ascending Aorta Dissection Before 5.5 cm Diameter; "It Wasn't Raining When Noah Built the Ark".

INTRODUCTION: The aim of this study was to compare mean maximum ascending aortic diameter at the time of acute aortic dissection with the current surgical threshold for elective ascending aortic operations on non-syndromic thoracic aortic aneurysms. MATERIAL AND METHODS: All consecutive non-syndromic adult patients admitted for acute type A aortic dissection in a single tertiary centre were prospectively enrolled from April 2020 to March 2021. The primary endpoint was the difference between mean maximum aortic diameter at the time of dissection and the 5.5 cm threshold for elective repair. Secondary endpoints included 30-day/in-hospital mortality, aortic length and comparison with normal controls, length/height ratio index, "actual" preoperative Euroscore II and "predicted" Euroscore II if electively operated. RESULTS: Among 31 patients ageing 67.3±12.03 years on average, mean maximum aortic diameter at the time of dissection was 5.13±0.66 cm, significantly lower than the guidelines-derived surgical threshold of 5.5 cm (p=0.004). Mean aortic length was 11±1.47 cm, also significantly longer compared normal controls reported in the literature (p<0.001). The 30-day/in-hospital mortality was 35.5%. Mean length/height ratio index was 6.18±0.76 cm/m. Finally, mean "actual" preoperative Euroscore II was 10.43±4.07 which was significantly higher than the 1.47±0.57 "predicted" Euroscore II (p<0.05). CONCLUSIONS: The maximum aortic diameter at the time of acute type A aortic dissection of non-syndromic cases was significantly lower than the current recommendation for elective repair. Lowering of the current diameter-based surgical threshold of 5.5 cm may be profitable in terms of prevention, but further investigations should be undertaken. Length-based thresholds could also add to timely aortic dissection prevention.

A systematic review and meta-analysis of stroke rates in patients undergoing thoracic endovascular aortic repair for descending thoracic aortic aneurysm and type B dissection.

OBJECTIVE: We performed a systematic review and meta-analysis to assess the stroke rates after thoracic endovascular aortic repair (TEVAR) for descending thoracic aortic aneurysms and/or dissections. METHODS: A systematic search of all the literature reported until September 2021 was performed according to the PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines. The pooled perioperative stroke rates and corresponding 95% confidence intervals (CIs) were estimated using fixed or random effect methods. RESULTS: A total of 878 study titles were identified by the initial search strategy, of which 43 were considered eligible for inclusion in the meta-analysis. A total of 5764 patients (63.5% male) were identified among the eligible studies. The pooled any stroke rate was 4.4% (95% CI, 3.60%-5.28%). However, after procedures without left subclavian artery (LSA) ostial coverage (eg, TEVAR deployed within or distal to zone ≥3), the stroke rate was 3.15% (95% CI, 2.21%-4.22%). For the patients with LSA coverage, the pooled stroke rate was 2.8% (95% CI, 1.69%-4.14%) for patients receiving left subclavian artery revascularization. However, the patients without LSA revascularization had a pooled estimated stroke incidence of 11.8% (95% CI, 5.85%-19.12%). CONCLUSIONS: Stroke has been a common finding after TEVAR, especially with LSA coverage without revascularization, validating current clinical practice guidelines recommending routine revascularization, when feasible. Additional studies with larger patient numbers that provide separate data regarding the aortic pathology treated, the anatomic location of the stroke and their association with functional recovery and survival are needed.

Systematic Review and Meta-Analysis of Outcomes After Operative Treatment of Aberrant Subclavian Artery Pathologies and Suggested Reporting Items.

OBJECTIVE: To synthesise and present all available evidence regarding the surgical treatment of patients with aberrant subclavian artery (aSA) pathologies during the last 30 years. The study also aimed to create a checklist of suggested reporting items to help increase reporting homogeneity. METHODS: A systematic search of medical databases was performed to identify all studies published between 1990 and 2020 reporting on the outcomes of patients undergoing surgery for an aSA pathology. Patients were divided into two groups; Group A included patients undergoing open or hybrid surgery through sternotomy/thoracotomy and Group B included patients undergoing endovascular or hybrid treatment without chest access. The % crude rates (CR) of all variables of interest were calculated. A proportion meta-analysis was performed reporting pooled rates with 95% confidence intervals (CIs). RESULTS: Three hundred and fourteen studies were identified reporting on the surgical outcomes of 732 patients (60.1% males; 440/732). The quality of evidence was generally low, with 286 studies including fewer than four patients and 28 studies with five or more cases. Aberrant right subclavian artery (aRSA) in a left sided aortic arch was present in 71.4% of the patients and a Kommerell's diverticulum was present in 50.1% of the cases. A total of 68% of the patients were symptomatic on presentation, with the majority complaining of dysphagia (49.6%). Group A included 453 and Group B 279 patients. Studies reporting on five or more patients were included in the main meta-analysis. The pooled early mortality rate was 1.62% (95% CI 0.05% - 4.53%) in Group A and 1.96% (95% CI 0 - 6.34%) in Group B. Pooled rates of symptom relief were 99.52% (95% CI 92.05% - 100.00%) in Group A and 95.79% (95% CI 83.96% - 100.00%) in Group B. CONCLUSION: The surgical techniques used to treat aSA and aortic pathologies involving an aSA had remarkably low mortality rates and high clinical success, regardless of the technique used.

A Systematic Review and Meta-Analysis of Carotid Artery Stenting for the Treatment of Cervical Carotid Artery Dissection.

OBJECTIVE: To assess the efficacy and safety of carotid artery stenting for the treatment of extracranial carotid artery dissection (CAD). DATA SOURCES: Systematic review using Medline, Scopus, EMBASE, and the Cochrane Library. REVIEW METHODS: A systematic search was performed according to the Preferred Reporting Items for Systematic reviews and Meta-analysis statement. Data from the eligible studies were extracted and meta-analysed. Primary endpoints included post-operative mortality, cerebrovascular events (CEs), and modified Rankin Score for neurological disability (mRS) at 90 days. Subgroup analyses were performed between stenting of spontaneous and traumatic CAD, primary stenting vs. stenting after failed medical therapy (FMT), and stenting of CAD in the presence of tandem occlusions vs. stenting of isolated extracranial CAD. RESULTS: Twenty-four studies with 1 224 patients were included. Pooled post-operative mortality, CE, and mRS 0 - 2 rates were 1.71% (95% confidence interval [CI] 0.83 - 2.80), 6.45% (95% CI 2.80 - 11.10), and 76.13% (95% CI 64.15 - 86.50), respectively. The pooled stroke rate was 2.16% (95% CI 0.0 - 6.64). Spontaneous vs. traumatic CAD mortality rates were 3.20% (95% CI 1.80 - 4.88) and 0.00% (95% CI 0.00 - 1.59) while CE rates were 14.26% (95% CI 6.28 - 24.36) and 1.64% (95% CI 0.0 - 6.08). Primary stenting and stenting after FMT mortality rates were 0.63% (95% CI 0.0 - 5.63) and 0.0% (95% CI 0.0 - 2.24), while CE rates were 5.02% (95% CI 0.38 - 12.63) and 3.33% (95% CI 0.12 - 9.03). Mortality rates for tandem occlusions and isolated extracranial CAD were 5.62% (95% CI 1.76 - 10.83) and 0.23% (95% CI 0.0 - 1.88), respectively, while CE rates were 15.28% (95% CI 6.23 - 26.64) and 1.88% (95% CI 0.23 - 4.51). The methodological index for non-randomised studies score was 8.66 (low). CONCLUSION: Both primary stenting and stenting of spontaneous CAD yielded unfavourable results with respect to stent thrombosis and stroke rates. Conversely, stenting following FMT had acceptable mortality and complication rates corroborating the use of stenting in the setting of CAD as a second line treatment. Due to the low quality of the included studies, definite conclusions cannot be drawn necessitating further research.

E-Vita OPEN NEO Hybrid Stent Graft: A New Frontier for Total Arch Replacement.

BACKGROUND: The ever-changing landscape of aortic arch surgery necessitates a constant update on the available devices and technologies for the contemporary management of complex aortic diseases. The E-Vita OPEN NEO hybrid stent graft system offers a unique approach for aortic arch replacement with the frozen elephant trunk technique. In contrast to its predecessors and other commercially available devices, it fits to each individual patient's needs by allowing for more proximal graft anastomosis. We sought to present our initial experience with the novel E-Vita OPEN NEO hybrid stent graft system focusing on its description, optimal graft selection, operative technique, and results in a clinical setting. METHODS: We prospectively collected data on all patients in whom the E-Vita OPEN NEO device was used between October 2020 and May 2021. The primary outcome was perioperative or with 30-day mortality. Secondary outcomes were the incidence of neurologic complications (stroke and spinal cord ischemia) and endoleak on a postoperative computed tomography angiography. RESULTS: During the study period, six patients received the novel hybrid stent device. The mean patient age was 59.3 ± 13.3 years and 83% were male. Two patients were operated on an emergent setting due to acute Stanford type A aortic dissection and there were two reoperations in patients with a history of previous repaired type A dissection. There was no perioperative or 30-day mortality and none of the patients exhibited adverse neurologic events. Two patients required completion thoracic endovascular repair due to type Ib endoleak. One patient died after a prolonged stay in the intensive care unit due to pneumonia and multiorgan failure. CONCLUSIONS: This novel device adapts to each patient's characteristics and offers a curative option for acute and chronic aortic arch and descending aortic conditions such as aneurysmal disease and aortic dissection. In addition, it offers an excellent landing station for potential endovascular therapies and allows for complete aortic remodeling.

Autologous Platelet Rich Plasma Promotes the Healing of Non-Ischemic Diabetic Foot Ulcers. A Randomized Controlled Trial.

BACKGROUND: DFU (diabetic foot ulcer) represents a major global health and socioeconomic problem and a leading cause of lower limb amputation. Although many therapies have been tested, none has been proposed as a dominant wound healing treatment. We performed a prospective randomized controlled study in order to assess the role of autologous platelet rich plasma (PRP) for the promotion of non-ischemic DFU healing. METHODS: After full vascular assessment, a total of 80 patients were randomized in 1:1 ratio to receive either PRP injection in the healing edge and the floor of the targeted DFU (Group A), or have usual standard care with moist dressing with or without collagenase ointment (Group B). We calculated the total surface area (TSA) for the ulcer in both groups (cm2) before, after treatment and every week up to 12 weeks of follow-up. RESULTS: A total of 4 patients (10%) experienced major amputation in group B, while no major amputation was performed in patients of Group A (P< 0.001). A ≥ 50% reduction in TSA occurred earlier in Group A (at 2.5 weeks), compared to Group B (4.5 weeks); P < 0.001. Complete wound healing rate was 95% (n = 38) and it was achieved earlier (6th week) for patients of group A, contrary to 77.8% (n = 28) of patients (9th week) for Group B (P < 0.001). Superficial wound infection was noted in 10% (n = 4) of the cases in the PRP arm, while in group B, 45% (n = 18) of cases had a variable degree of infection ranging from superficial to deep wound infection and cellulites (P < 0.001). PRP treatment was cost-effective, with 247.50$ vs. 437.50$ for the total cost of treatment for patients of Group B. CONCLUSION: PRP is a cost-beneficial novel modality of treatment that can accelerate wound healing and decrease the rate of local infection in DFU, compared to other conventional treatment modalities.

Systematic review with pooled data analysis reveals the need for a standardized reporting protocol including the visceral vessels during fenestrated endovascular aortic repair (FEVAR).

OBJECTIVES: To collect and analyse the available evidence in the outcomes of patients treated with fenestrated endovascular aortic repair (f-EVAR) technique focusing specifically on visceral vessel outcomes. METHODS: The current meta-analysis was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. All the studies reporting the f-EVAR technique for the management of degenerative pararenal and/or type IV thoracoabdominal aortic aneurysms (TAAA) were considered eligible for inclusion in the study. The main study outcomes (technical success, type I endoleaks, fracture or occlusion of the bridging stents, overall aneurysm-related mortality, and the reintervention rate) were subsequently expressed as proportions and 95% confidence intervals. RESULTS: Fourteen studies with a total of 1804 patients were included in a pooled analysis. The technical success of the procedure was 95.97% (95%CI = 92.35-98.60). Intraoperatively, the pooled proportion of reported type I endoleak was 7.6% (95%CI = 2.52-14.60) while during a median follow-up of 41 months (range 11-96) follow-up period the pooled rate of fracture and occlusion of the bridging stents was 2.79% (95%CI = 0.00-8.52) and 4.46% (95%CI = 1.93-7.77), respectively. The overall aneurysm-related mortality was detected to be 0.63% (95%CI = 0.04-1.63), and the pooled estimate for re-intervention rate was 15.69%. CONCLUSIONS: Fenestrated endovascular repair for p-AAA is an effective and safe treatment. Target vessel complications and endoleaks remain the two most important concerns for fenestrated endovascular procedures, contributing to most of the secondary interventions. The lack of computed tomography angiography follow-up evaluation does not allow us to draw robust conclusions about the complication rates for the superior mesenteric artery during f-EVAR. Due to the potential implications of SMA complications on aneurysm-related mortality, standardized reporting of short- and long-term target visceral vessel outcomes is required.

A systematic review and meta-analysis of the streamliner multilayer flow modulator stent for treatment of complex aortic lesions.

OBJECTIVE: We evaluated the safety and efficacy of multilayer flow modulator (MFM) stents (Cardiatis, Isnes, Belgium) for the treatment of complex aortic lesions. METHODS: A systematic electronic research was conducted for studies reported from December 2008 to May 2020. Data extracted from 15 eligible case series (CS) were appropriately pooled and analyzed in a meta-analysis. The patient baseline characteristics were recorded, and 16 outcomes of interest were studied. The primary end points included 30-day all-cause and aneurysm-related mortality, aneurysm-related mortality at 1 year, vessel patency, and any endoleaks, ruptures, reinterventions, and aneurysm exclusion at the end of follow-up. RESULTS: A total of 39 studies (15 CS and 24 case reports), involving 429 patients, met the inclusion criteria. Overall, 436 lesions were treated, and 1521 aortic branches were covered by the multilayer stent. The mean follow-up for the 15 CS with 404 patients was 14.6 months. Compliance with the instructions for use was reported by eight CS, with 75% of the procedures performed within the instructions for use. However, 41% of the patients reported by 12 CS had undergone a previous aortic intervention. The pooled 30-day all-cause and 30-day aneurysm-related mortality rates were 0.56% (95% confidence interval [CI], 0.00%-2.54%) and 0.00% (95% CI, 0.00%-0.80%), respectively. The pooled aneurysm-related mortality at 1 year of follow-up was 5.25% (95% CI, 0.07%-14.91%). The pooled vessel patency at the end of follow-up was 99.12% (95% CI, 97.73%-99.93%). The pooled reintervention and endoleak rates at the end of follow-up were 10.94% (95% CI, 3.64%-20.67%) and 10.70% (95% CI, 4.45%-18.66%), respectively. The crude spinal cord ischemia and renal failure rates were 0.69% and 1.8%, respectively. CONCLUSIONS: The results from the present review and meta-analysis have indicated the safety and efficacy of MFM stents for treating challenging aortic pathologic lesions when used as first-line treatment and within the instructions for use. The almost zero pooled 30-day all-cause and aneurysm-related mortality rates combined with the low crude spinal cord ischemia and renal failure rates indicate the use of MFM stents is a good treatment option for complex aortic lesions in the short- and mid-term periods. The lack of long-term follow-up warrants further research concerning the efficacy of the device in the long term.

An updated systematic review and meta-analysis of results of transcervical carotid artery stenting with flow reversal.

OBJECTIVE: Transcervical carotid artery stenting (CAS) has emerged as an alternative to transfemoral CAS. An earlier systematic review from our group (n = 12 studies; 739 transcervical CAS procedures [489/739 with flow reversal]) demonstrated that transcervical CAS is a safe procedure associated with a low incidence of stroke and complications. Since then, new studies have been published adding nearly 1600 patients to the literature. We aimed to update our early systematic review and also to perform a meta-analysis to investigate outcomes specifically after transcervical CAS with flow reversal. METHODS: An electronic search of PubMed/MEDLINE, Embase, and the Cochrane databases was carried out to identify studies reporting outcomes after transcervical CAS with flow reversal. Crude event rates for outcomes of interest were estimated by simple pooling of data. A proportion meta-analysis was also performed to estimate pooled outcome rates. RESULTS: A total of 18 studies (n = 2110 transcervical CAS procedures with flow reversal) were identified. A high technical success (98.25%) and a low mortality rate (0.48%) were recorded. The crude rates of major stroke, minor stroke, transient ischemic attack, and myocardial infarction (MI) were 0.71%, 0.90%, 0.57%, and 0.57%, respectively; a cranial nerve injury occurred in 0.28% of the procedures. A neck hematoma was reported in 1.04% of the procedures, and a carotid artery dissection occurred in 0.76% of the interventions; in 1.09% of the cases, conversion to carotid endarterectomy was required. After a meta-analysis was undertaken, the pooled technical success rate was 98.69% (95% confidence interval [CI], 97.19-99.70). A pooled mortality rate of 0.04% (95% CI, 0.00-0.29) was recorded. The pooled rate of any type of neurologic complications was 1.88 (95% CI, 1.24-2.61), whereas the pooled rates of major stroke, minor stroke, and transient ischemic attack were 0.12% (95% CI, 0.00-0.46), 0.15% (95% CI, 0.00-0.50), and 0.01% (95% CI, 0.00-0.22), respectively. The pooled rate of bradycardia/hypotension was 10.21% (95% CI, 3.99-18.51), whereas the pooled rate of MI was 0.08% (95% CI, 0.00-0.39). A neck hematoma after transcervical CAS was recorded in 1.51% (95% CI, 0.22-3.54) of the procedures; in 0.74% (95% CI, 0.05-1.95) of the interventions, conversion to CEA was required. Finally, a carotid artery dissection during transcervical CAS occurred in 0.47% (95% CI, 0.00-1.38) of the procedures. CONCLUSIONS: This updated systematic review and meta-analysis demonstrated that transcervical CAS with flow reversal is associated with high technical success, almost zero mortality, and low rates of major stroke, minor stroke, MI, and complications.

Systematic review and meta-analysis of published studies on endovascular repair of thoracoabdominal aortic aneurysms with the t-Branch off-the-shelf multibranched endograft.

BACKGROUND: Endovascular treatment of thoracoabdominal aortic aneurysms is becoming increasingly popular in clinical practice, mainly because of its reduced perioperative mortality and morbidity. However, the custom-made stent graft platform that companies offer requires detailed preoperative planning and production time that can take up to 12 weeks. This may delay surgery in elective patients and is not an option for urgent or emergent cases. To surpass this limitation, the t-Branch (Cook Medical, Bloomington, Ind) was launched in 2012 in Europe as the first off-the-shelf standardized multibranched endograft for the endovascular treatment of thoracoabdominal aneurysms. Our aim was to systematically evaluate all published experience with this commercially available off-the-shelf thoracoabdominal stent graft. METHODS: We performed a systematic inquiry of the medical databases to identify all published studies that reported on the outcomes of patients treated with the t-Branch stent graft and then conducted a qualitative synthesis and meta-analysis of the results. The main end points studied were technical success, mortality, major stroke, spinal cord ischemia, primary branch patency, and renal insufficiency during the first 30 days along with midterm mortality and reintervention rate. We estimated pooled proportions and 95% confidence intervals (CIs). RESULTS: We identified seven retrospective studies published between 2014 and 2018, with a total of 197 patients (mean age, 72.3 ± 7 years; 70% male). Among 165 patients, 45% were symptomatic and 19% were treated for a ruptured aortic aneurysm. In 197 patients, pooled technical success was 92.75% (95% CI, 83.9%-98.7%), and in 10% of the cases, an early endoleak was detected (95% CI, 0%-43.7%). Early mortality was 5.8% (95% CI, 2.5%-10%), and major stroke was observed in 4% of the patients (95% CI, 0.96%-8.40%). The rate of spinal cord ischemia was 12.2% (95% CI, 4.1%-23.2%), with the rate of permanent paraplegia at 1.3% (95% CI, 0%-8.7%). Acute renal failure was 18.7% (95% CI, 9.1%-30.4%), whereas primary branch patency was calculated at 98.2% (95% CI, 96.7%-99.2%). Mean follow-up was 15 ± 7 months. During this time, midterm mortality (after 30 days) was 6.9% (95% CI, 2.44%-12.8%) and pooled reintervention rate was 5.7% (95% CI, 1.70%-11.4%). CONCLUSIONS: This pooled analysis indicated good technical success rate after t-Branch endograft implantation, with acceptable mortality and neurologic complications despite a high rate of urgent procedures. Thoracoabdominal endovascular repair with the t-Branch endograft is a feasible and safe therapeutic option for elective and urgent patients.

The use of iliac branch devices for preservation of flow in internal iliac artery during endovascular aortic aneurysm repair.

OBJECTIVE: Common iliac artery aneurysms are present in more than a third of patients with abdominal aortic aneurysm and may pose a challenge during open and endovascular repair. Although embolization of the internal iliac artery is an established method, it may be complicated with buttock claudication, erectile dysfunction, colon ischemia, and pelvic necrosis. Iliac branch devices (IBDs), which permit preservation of the hypogastric artery, have been used to prevent these complications. We conducted a meta-analysis to assess the safety and outcomes of IBDs and to explore potential differences between the commercially available types of IBDs. METHODS: The meta-analysis was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. After review of the literature, 36 eligible studies with a total of 1502 patients were included in our study. A meta-analysis was performed with investigation of the following outcomes: technical success rate, 30-day mortality, 30-day patency, follow-up patency, endoleak, buttock claudication, and IBD-associated reintervention. Furthermore, we conducted a subgroup meta-analysis by commercial type of endograft among the outcomes of interest. RESULTS: Among all eligible studies, technical success of the method was 97.35% (95% confidence interval [CI], 96.27-98.29). The endoleak rate postoperatively and during the follow-up period was 12.68% (95% CI, 8.80-17.07). The 30-day patency of IBDs was estimated at 97.59% (95% CI, 96.49-98.54), whereas follow-up patency was 94.32% (95% CI, 91.70-96.54). Furthermore, reintervention rate associated with IBDs was 6.96% (95% CI, 5.10-9.03), and buttock claudication during the follow-up period was 2.15% (95% CI, 1.25-3.22). CONCLUSIONS: IBD seems to be a safe, feasible, and effective technique for the treatment of aortoiliac aneurysms in select patients with suitable anatomy. Further results are awaited to explore the long-term efficacy and durability of these devices.

Outcomes of endosutured aneurysm repair with the Heli-FX EndoAnchor implants.

OBJECTIVE: Endovascular aneurysm repair has gained field over open surgery for the treatment of abdominal aortic aneurysm. However, type Ia endoleak represents a common complication especially in hostile neck anatomy that is recently faced using endoanchors. We conducted a systematic review and meta-analysis to collect and analyse all the available comparative evidence on the outcomes of the endosuture aneurysm repair in patients with or without hostile neck in standard endovascular aneurysm repair. METHODS: The current meta-analysis was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. All the prospective and retrospective studies reporting primary use of the Heli-FX EndoAnchor implants were considered eligible for inclusion in this study. The main study outcomes (technical success of endoanchor implantation, incidence of type Ia endoleak, aortic stent graft migration and the percentage of patients who presented regression or expansion of aneurysm sac throughout the follow-up) were subsequently expressed as proportions and 95% confidence intervals. RESULTS: Eight studies with a total of 968 patients were included in a pooled analysis. The technical success of the primary endoanchor fixation was 97.12% (95%CI: 92.98-99.67). During a mean six months follow-up period, a pooled rate of 6.23% (95%CI: 0.83-15.25) of the patients developed a persistent type Ia endoleak despite the primary implantation. Migration of the main graft was reported in five studies, in which a 0.26% (95%CI = 0.00-1.54) of the patients required an additional proximal aortic cuff. Regression of the aneurysm sac was observed at 68.82% (95%CI: 51.02-84.21). An expansion of the aneurysm sac was found in 1.93% (95%CI: 0.91-3.24) of the participants. The overall survival rate was 93.43% (95%CI: 89.97-96.29) at a mean six months follow-up period. CONCLUSIONS: Endosuture aneurysm repair with the Heli-FX EndoAnchor implants seems to be technically feasible and safe either for prevention or for repair of intraoperative type Ia endoleak. Despite the primary implants of endoanchors, few cases of persistent type Ia endoleak and migration are still conspicuous. Long-term follow up is needed to determinate the role of this therapeutic option in the treatment of aortic aneurysms.

Repair of descending thoracic aortic aneurysms with Ankura Thoracic Stent Graft.

OBJECTIVE: The aim of the study was to present the results for patients with atherosclerotic aneurysm of the descending thoracic aorta (DTA) treated with a novel thoracic stent graft. METHODS: A single-center retrospective review of prospectively collected data was performed. We extracted demographic variables as well as atherosclerotic comorbidities and operation-related and imaging-related data from patients' medical records. We estimated technical success rate, in-hospital and 30-day mortality, and mortality at the end of follow-up as well as complication and reintervention rate in our study cohort. Follow-up computed tomography angiography was performed after 1 month and 6 months and yearly thereafter. RESULTS: A total of 30 patients (80% male; mean age, 73.7 ± 6.33 years) were treated with Ankura Thoracic Stent Graft (Lifetech, Shenzhen, China) for DTA aneurysm from February 2014 until June 2017. Technical success of the thoracic endovascular aortic repair (TEVAR) was 97% (29/30 patients). A surgical conduit was required in one patient; in three patients, we intentionally covered the left subclavian artery because of insufficient proximal landing zone. No aorta-related deaths were recorded during follow-up. During the early postoperative period, two patients (7%) with long DTA coverage developed paralysis or paraparesis, which immediately resolved after lumbar drainage. No renal complications requiring dialysis were observed. One patient (3%) developed postoperative pulmonary infection, whereas access site complications were 7%. Two symptomatic patients treated outside instructions for use (7%) developed early type IA endoleak and one patient (3%) developed type IB endoleak; type II endoleak was recorded in 3% of the study cohort. During the 30-day postoperative period, two patients died of non-TEVAR-related causes, one of gastrointestinal bleeding and the other of pulmonary infection. During a median follow-up of 31.7 (range, 38.4) months, two more patients also died of non-TEVAR-related causes, one of stroke from carotid artery disease and the other of motor vehicle trauma. In the rest of the cohort, no other adverse events were noted. CONCLUSIONS: This novel endograft showed early evidence of a safe, effective, and durable endoprosthesis for the treatment of DTA aneurysms.

Editor's Choice - Cryopreserved Allografts for Arterial Reconstruction after Aorto-Iliac Infection: A Systematic Review and Meta-Analysis.

OBJECTIVE: Native and aortic graft infections are rare, but they represent one of the most life threatening complications of vascular surgery. Several materials and surgical approaches have been developed so far. Among them, cryopreserved allografts have been proposed as a treatment option. A systematic review and meta-analysis was conducted to investigate the role of cryopreserved allografts for arterial reconstruction after aorto-iliac infection. METHODS: The current meta-analysis was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Patient baseline characteristics were investigated, along with 30 outcomes after use of cryopreserved arterial allografts for reconstruction after aorto-iliac infection. Pooled proportions with 95% CIs of outcome rates were calculated. RESULTS: A total of 31 studies, including 1,377 patients, finally participated in the meta-analysis. Among the early outcomes, 30 day mortality was 14.91% (95% CI 11.78-18.31). Peri-anastomotic rupture/allograft disruption rate was 5.90% (95% CI 2.77-9.88), while pooled aneurysmal degeneration/allograft dilatation was 4.99% (95% CI 1.60-9.68). A pooled rate of 3.11% (95% CI 1.60-4.98) was estimated for pseudoaneurysm formation after the use of cryopreserved arterial allografts, while the allograft thrombotic/stenotic complication rate and peri-anastomotic infection were 12.19% (95% CI 7.90-17.15) and 3.32% (95% CI 1.90-5.03), respectively. Mortality during follow up was 19.24% (95% CI 11.97-27.58), while allograft related mortality during follow up was 3.58% (95% CI 1.56-6.15). A pooled allograft related re-operation rate was estimated at 24.87% (95% CI 17.89-32.51). CONCLUSIONS: The use of cryopreserved allograft seems to be a safe and durable option with acceptable outcomes for treatment of aorto-iliac infection.