Cavoatrial junction stenting in vascular hemodialysis catheter malfunction.

In patients undergoing hemodialytic treatment via intravascular catheters, stenosis or occlusion of central veins is common. Despite an extensive characterization of Superior Vena Cava Syndrome (SVCS) no data is available about CavoAtrial Junction (CAJ) stenosis. We report the case of two patients with a story of multiple catheter failures due to thrombosis or infection. Computed tomography (CT) showed radiological signs of CAJ stenosis confirmed at the following venography. In absence of other feasible options to place a vascular access, the two underwent stenting with Gore Viabahn VBX balloon expandable endoprosthesis (W.L. Gore & Associates, Flagstaff, AZ, USA) of the CAJ stenosis. Completion venography showed complete resolution of the stenosis in both patients. No complications occurred during the procedures. At a mean follow-up of 878 ± 559 days no signs of in-stent restenosis or recoil were found. The present cases emphasize the feasibility and safety of CAJ stenting, underlining the importance of preserving CAJ and upper veins patency in hemodialysis access.

Proposal of a classification of cannulation damage in vascular access grafts based on clinical, ultrasound, and microscopic observations.

INTRODUCTION: Arteriovenous grafts (AVGs) serve as an alternative to native arteriovenous fistulas (AVFs) in the context of hemodialysis patient life planning. AVGs are more susceptible to developing outflow stenosis (due to intimal hyperplasia), thrombosis, and infections. However, an often overlooked contributor to AVG failure is cannulation damage. The objective of this paper is to assess the impact of cannulations on AVGs. We aim to establish a classification of AVG damage by comparing clinical data and ultrasound images with microscopic morphological findings obtained from explanted grafts. MATERIALS AND METHODS: This study is conducted at a single center. We included all patients who underwent AVG creation between 2011 and 2019. Comprehensive data on clinical history, follow-up, and complications were collected and reviewed. Duplex ultrasound (DUS) characteristics were documented, and all grafts explanted during the analysis period underwent optical microscopy evaluation. Finally, clinical data, along with DUS and microscopic findings, were integrated to derive a damage classification. RESULTS: During the study period, 247 patients underwent 334 early cannulation AVGs. The median follow-up duration was 714 days (IQR 392, 1195). One hundred eleven (33%) grafts were explanted. Clinical data and DUS findings were utilized to formulate a four-grade classification system indicating increasing damage. CONCLUSION: Cannulation damage alone does not solely account for AVG failure. It results from a biological host-mediated process that promotes the growth of intimal hyperplasia at the cannulation sites. This process is not clinically significant within the initial 2 years after AVG creation.

Quality assurance in surgical trials of arteriovenous grafts for haemodialysis: A systematic review, a narrative exploration and expert recommendations.

BACKGROUND: Introducing new procedures and challenging established paradigms requires well-designed randomised controlled trials (RCT). However, RCT in surgery present unique challenges with much of treatment tailored to the individual patient circumstances, refined by experience and limited by organisational factors. There has been considerable debate over the outcomes of arteriovenous grafts (AVG) compared to AVF, but any differences may reflect differing practice and potential variability. It is essential, therefore, when considering an RCT of a novel surgical procedure or device that quality assurance (QA) is defined for both the new approach and the comparator. The aim of this systematic review was to evaluate the QA standards performed in RCT of AVG using a multi-national, multi-disciplinary approach and propose an approach for future RCT. METHOD: The methods of this have been previously registered (PROSPERO: CRD420234284280) and published. In summary, a four-stage review was performed: identification of RCT of AVG, initial review, multidisciplinary appraisal of QA methods and reconciliation. QA measures were sought in four areas - generic, credentialing, standardisation and monitoring, with data abstracted by a multi-national, multi-speciality review body. RESULTS: QA in RCT involving AVG in all four domains is highly variable, often sub-optimally described and has not improved over the past three decades. Few RCT established or defined a pre-RCT level of experience, none documented a pre-trial education programme, or had minimal standards of peri-operative management, no study had a defined pre-trial monitoring programme, and none assessed technical performance. CONCLUSION: QA in RCT is a relatively new area that is expanding to ensure evidence is reliable and reproducible. This review demonstrates that QA has not previously been detailed, but can be measured in surgical RCT of vascular access, and that a four-domain approach can easily be implemented into future RCT.

First-in-human feasibility study of the aXess graft (aXess-FIH): 6-Month results.

OBJECTIVE: The creation of an arteriovenous fistula (AVF) is considered the most effective hemodialysis (HD) vascular access. For patients who are not suitable for AVF, arteriovenous grafts (AVGs) are the best access option for chronic HD. However, conventional AVGs are prone to intimal hyperplasia, stenosis, thrombosis, and infection. Xeltis has developed an AVG as a potential alternative to currently available AVGs based on the concept of endogenous tissue restoration. The results of the first 6-month follow-up are presented here. METHODS: The aXess first-in-human (FIH) study [NCT04898153] is a prospective, single-arm, multicenter feasibility study that evaluates the early safety and performance of the aXess Hemodialysis Graft. A total of 20 patients with end-stage renal disease were enrolled across six European investigational sites. RESULTS: At 6-months follow-up, all grafts were patent with primary and secondary patency rates were 80% and 100%, respectively. Three patients required a re-intervention to maintain graft patency, while one re-intervention was required to restore patency. One graft thrombosis and zero infections were reported. CONCLUSION: The expected advantages of the novel aXess Hemodialysis Graft over conventional AVGs would be evaluated by the analysis on long-term safety and effectiveness during the 5-year follow-up of the currently ongoing trial.

Implanted blood vessel external support device for the treatment of distal hypoperfusion ischemic syndrome in arteriovenous fistulas and high-frame-rate Vector Flow quality assessment.

INTRODUCTION: Distal hypoperfusion ischemic syndrome (DHIS) is a complication occurring after arteriovenous fistula (AVF) creation. Different surgical alternatives haves been proposed in case of severe DHIS. Aim of the present paper is to present a new technique for DHIS treatment. MATERIAL AND METHODS: Between the 1st of January 2021 and the 31st December 2021 all the patients referred to our center for DHIS grade 2-4 were treated with a new surgical technique. It consists of AVF remodeling using an external nitinol support (VasQ®) to reduce the risk of outflow vein enlargement and DHIS recurrence. To better appreciate the hemodynamic effects of the surgery, a new ultrasound technique called high-frame-rate Vector Flow (HiFR-VF) was used. RESULTS: Seven patients (M:F 1:3; mean age 43 ± 12 years, range 29-65) were included in this study. Central line was never necessary, and technical success was 100% at 12 months. The comparison with historical data demonstrated lower recurrence of symptoms in comparison to simple artery-to-vein redo (p 0.50). The HiFR-VF showed flow with limited turbulent characteristics at the anastomosis site. DISCUSSION AND CONCLUSION: The new technique proposed demonstrated to be safe and effective for treatment of DHIS, preventing symptoms recurrence. Ultrasound examination and HiFR-VF can be considered a valuable method to evaluate complex flows at the levels of vascular anastomosis.

Effects of the New COVID-19-Induced Rule on Substitutions and Performance in Italian Elite Soccer.

COVID-19 has resulted in widespread changes, including within the realm of sports. Professional soccer has adapted by allowing more substitutions, leading to tactical adjustments and potential physical benefits. Accordingly, this study analyzed the impact of the new rule in Italian top-level soccer, focusing on substitution patterns and performance differences between the pre-COVID (2017-2018, 2018-2019 seasons) and post COVID (2020-2021, 2021-2022 seasons) eras. As such, publicly available data from 1520 matches (760 matches per era) were recorded. The sample included matches played from 40 Italian top division teams in both the pre- and post-COVID eras. Analyses confirmed substitutions follow a consistent temporal pattern throughout the match in both eras, highlighting a slight difference in second-half management, and showed the new rule is still not used to its full potential, thus raising concerns about teams' financial strength, as not all managers possess "deep benches" (i.e., a large number of top-level players available to play). Further analyses revealed a statistically significant increment (p = 0.002) in the quantity of collectively produced sprints in the post-COVID era compared to the pre-COVID one. The results from this study emphasize the need to carefully address sprint preparation and repeated sprint abilities, also considering factors such as the number of substitutes and their skill level.

Current Opinions in Open and Endovascular Treatment of Major Arterial Injuries in Pediatric Patient.

Pediatric major arterial vascular injuries may belong to the same principal categories as adults, but have been poorly documented, with an estimated overall incidence of <2% of all vascular traumas. Open surgery has been the mainstay of treatment, but no clear guidelines have been developed to recommend the best practice patterns in terms of strategy or repair as well as postoperative pharmacological regimen. Herein, we report three cases and a narrative review of the available literature regarding the main aspects when dealing with pediatric arterial injuries based on the predominant series available from the most recent published literature.

Quality assurance in surgical trials of arteriovenous grafts for haemodialysis: protocol for a systematic review.

INTRODUCTION: Decisions regarding the optimal vascular access for haemodialysis patients are becoming increasingly complex, and the provision of vascular access is open to variations in systems of care as well as surgical experience and practice. Two main surgical options are recognised: arteriovenous fistula and arteriovenous graft (AVG). All recommendations regarding AVG are based on a limited number of randomised controlled trials (RCTs). It is essential that when considering an RCT of a surgical procedure, an appropriate definition of quality assurance (QA) is made for both the new approach and the comparator, otherwise replication of results or implementation into clinical practice may differ from published results. The aim of this systematic review will be to assess the methodological quality of RCT involving AVG, and the QA measures implemented in delivering interventions in these trials. METHODS AND ANALYSIS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be followed. A systematic search will be performed of the MEDLINE, Embase and Cochrane databases to identify relevant literature. Studies will be selected by title and abstract review, followed by a full-text review using inclusion and exclusion criteria. Data collected will pertain to generic measures of QA, credentialing of investigators, procedural standardisation and performance monitoring. Trial methodology will be compared against a standardised template developed by a multinational, multispecialty review body with experience in vascular access. A narrative approach will be taken to synthesise and report data. ETHICS AND DISSEMINATION: Ethical approval is not required as it is a protocol for a systematic review. Findings will be disseminated through peer-reviewed publications and conference presentations, with the ultimate aim of providing recommendations for future RCT of AVG design.

Pulmonary Artery Pseudoaneurysms Embolization: Bicentric Experience and Review of the Literature.

The purpose of this bicentric case series was to report the safety, efficacy, and clinical outcome of transcatheter embolization in pulmonary artery pseudoaneurysms (PAPAs). Between January 2016 and June 2021, eight patients with PAPA were subjected to transcatheter embolization. The total number of patients was eight, of which five were female, with a mean age of 62 ± 14 years (average ± standard deviation). Etiology was traumatic in 2/8 cases and iatrogenic in 6/8 cases (after positioning a Swan-Ganz catheter in 5/6 cases and a temporary pacemaker in the latter case). In a single case, the PAPA was incidentally discovered during a routine X-ray, in the remaining 7 cases, the procedure was performed in emergency settings. PAPA embolization was performed using detachable coils alone in 3 cases; coils and glue in 1 case; coils, glue, and vascular plug in 1 case; coils and non-adhesive liquid embolic agents (Onyx and Squid respectively) in 2 cases; and non-adhesive liquid embolic agent alone (Onyx) in 1 case. No peri-procedural or post-procedural complications were recorded. Both the technical and clinical success rates were 100.0%. In conclusion, endovascular embolization is a technically feasible and safe therapeutic option for patients with PAPAs.

Acute problems of hemodialysis access: Thrombosis, aneurysms, symptomatic high-flow fistulas, and complications related to central lines.

Hemodynamic complications frequently affect vascular access and are important causes of morbidity and mortality. We present a review of acute complications affecting vascular accesses, focusing on classical and new treatments. Acute complications in hemodialysis vascular access are often underestimated and undertreated, and can present a challenge for both vascular surgeons and anesthesiologists. Accordingly, we considered different anesthesiologic approaches to both hemorrhagic and nonhemorrhagic patients. A strict collaboration among nephrologists, surgeons, and anesthesiologists can potentially improve prevention and management of acute complications and quality of life.

Study protocol of a prospective single-arm multicenter clinical study to assess the safety and performance of the aXess hemodialysis graft: The pivotal study.

BACKGROUND: Arteriovenous grafts (AVGs) are used for patients deemed unsuitable for the creation of an autogenous arteriovenous fistula (AVF) or unable to await maturation of the AVF before starting hemodialysis. However, AVGs are prone to infection and thrombosis resulting in low long-term patency rates. The novel aXess Hemodialysis Graft consists of porous polymeric biomaterial allowing the infiltration by cells and the growth of neotissue, while the graft itself is gradually absorbed, ultimately resulting in a fully functional natural blood vessel. The Pivotal Study will examine the long-term effectiveness and safety of the aXess Hemodialysis Graft. METHODS: The Pivotal Study is a prospective, single-arm, multicenter study that will be conducted in 110 subjects with end-stage renal disease who are not deemed suitable for the creation of an autogenous vascular access. The primary efficacy endpoint will be the primary patency rate at 6 months. The primary safety endpoint will be the freedom from device-related serious adverse events at 6 months. The secondary endpoints will include the procedural success rate, time to first cannulation, patency rates, the rate of access-related interventions to maintain patency, the freedom from device-related serious adverse events and the rate of access site infections. Patients will be followed for 60 months. An exploratory Health Economic and Outcomes Research sub-study will determine potential additional benefits of the aXess graft to patients, health care institutions, and reimbursement programs. DISCUSSION: The Pivotal study will examine the long-term performance and safety of the aXess Hemodialysis Graft and compare the outcome measures with historical data obtained with other graft types and autogenous AVFs. Potential advantages may include superior long-term patency rates and lower infection rates versus currently available AVGs and a shorter time to first cannulation compared to an autologous AVF. As such, the aXess Hemodialysis Graft may fulfill an unmet clinical need in the field of hemodialysis access.

Recruitment into randomised trials of arteriovenous grafts: A systematic review.

Although randomised controlled trials (RCT) are considered the optimal form of evidence, there are relatively few in surgery. Surgical RCT are particularly likely to be discontinued with poor recruitment cited as a leading reason. Surgical RCT present challenges over and above those seen in drug trials as the treatment under study may vary between procedures, between surgeons in one unit, and between units in multi-centred RCT. The most contentious and debated area of vascular access remains the role of arteriovenous grafts, and thus the quality of the data that is used to support opinions, guidelines and recommendations is critical. The aim of this review was to determine the extent of variation in the planning and recruitment in all RCT involving AVG. The findings of this are stark: there have been only 31 RCT performed in 31 years, the vast majority of which exhibited major limitations severe enough to undermine the results. This underlines the need for better quality RCT and data, and further inform the design of future studies. Perhaps most fundamental is the planning for a RCT that accounts for the intended population, the uptake of a RCT and the attrition for the significant co-morbidity in this population.

Indocyanine Green Angiography for Quality Assessment of Renal Graft Before Transplantation: A Pilot Study.

OBJECTIVES: Criteria for donation have been expanded to meet the great demand for organ transplant, resulting in different tools and classifications to help physicians to better assess the quality of the transplanted kidney. In this study, we evaluated the use of indocyanine green angiography as an additional tool to evaluate the renal microcirculation and the quality of the potential kidney graft. MATERIALS AND METHODS: All kidneys from extended criteria donors or donors after cardiac death available for transplant underwent indocyanine green angiog-raphy before implantation and after reconditioning, when hypothermic perfusion was required. We performed fluorescent angiography with a 10-mm-view laparoscope connected to a high-definition camera system while a solution of indocyanine green and Celsior was injected into the renal artery. We compared fluorescence intensities with postoperative graft function and then analyzed increases in fluorescence intensity before and after hypothermic machine perfusion treatment. RESULTS: In transplanted kidneys preserved in traditional cold storage, we found a statistically significant difference in fluorescence intensity values between groups with early graft function and delayed graft function. Fluorescence intensity increased significantly in all perfused kidneys after hypothermic machine perfusion treatment, indicating that intensity was directly proportional to improved renal microcirculation. Among 21 kidneys retrieved for transplant that adhered to the inclusion criteria, 11 were examined histopathologically, with a Karpinski score ranging from 2 to 7. The kidney that scored 7 was immediately discarded. Five underwent hypothermic pulsatile perfusion since they came from donors after cardiac death. Fluorescence intensity increased significantly in all perfused kidneys (4/5 were closest to doubling). Histopathological evaluations and Karpinski scores of the grafts indicated that all 5 were considered suitable for transplant. CONCLUSIONS: Indocyanine green angiography can be used in the future as an additional useful tool to help physicians to assess graft quality before implantation.

Internal Iliac Artery Embolization within EVAR Procedure: Safety, Feasibility, and Outcome.

BACKGROUND: This study is focused on Internal Iliac Artery (IIA) embolization in patients undergoing Endovascular Aneurysm Repair (EVAR). Our aims were: to establish the feasibility of the procedure; to assess the presence of endoleak (EL) and increase in the size of the sac at follow-up; to define the need for reintervention; and to evaluate mortality rate. METHODS: In this retrospective single-center study, EVAR-treated patients with an embolization of IIA were chosen. Coils and vascular plug were used as embolizing agents. RESULTS: A total of 49 participants were enrolled in the study (48 men and one woman) with a median age of 76 ± 12 years. Patients had no early EL in 87.75% of cases, 8.16% had type 1a EL, 2.04% type 1b EL, and 2.04% type 2 EL, with a comprehensive technical success of 95.91%. In the follow-up, at 1 month 72.22% remained without EL, at 6 months 70.97%, and at 1 year 81.48%. In the same period, the trend of type 1 EL was 5.56% (1 month), 3.23% (6 months), and 0% (1 year). For EL type 2: 22.22% at 1 month, 25.81% at 6 months, and 16.7% at 1 year. The overall mortality was 35.58% and the re-intervention rate was 16.33%. CONCLUSIONS: IIA embolization is a feasible and safe procedure. The presence of EL is not superior to EVAR procedures that do not involve embolization.

Carbon dioxide automated digital subtraction angiography for endovascular arteriovenous fistulas creation.

Recent literature shows how residual renal function (RKF), defined as the urinary clearance of urea and creatinine, is associated with a lower mortality risk in HD patients. The use of non-nephrotoxic contrast media during radiological procedure, may be useful for preservation of RKF in patients with chronic kidney disease not yet in haemodialysis. We describe the case of a 51-year-old male suffering from chronic kidney disease from 2018, due to a right nephrectomy for an adenocarcinoma, who was considered for an endovascular arteriovenous fistula (endoAVF) creation (WavelinQ endoAVF System, Becton Dickinson, Franklin Lakes, New Jersey, US), using Carbon Dioxide as contrast media instead of conventional iodinated ones, with optimal results. CO2 DSA permits to well recognize the patency of target vein, its connection to the perforator vein and finally the endoAVF creation without requiring supplemental iodate contrast medium. We propose, CO2 automated digital subtraction angiography (DSA) as a safer technique that could be substitutive of the standard iodinated ones, in the creation of endo AVF.

Hemodialysis patients and complications management costs in Italy: Plastic cannulae a potentially cost-effective strategy.

BACKGROUND: The treatment of end-stage chronic renal failure involves substantial costs for health care, which could be higher considering hemodialysis access complications management costs. Complications could be addressed by cannulation technique, but also by the needle. In particular, the use of a metal needle for cannulation is responsible for several complications that compromise dialysis delivery and require interventions. This analysis aims to evaluate, from a hospital perspective, the direct costs related to complications that may occur in hemodialysis patients in Italy. METHODS: To identify the main complications to consider in our analysis and related patient pathway for their management, we conducted an international literature search on PubMed and validated the data for Italy with an Italian Key Opinion Leader (KOL). A micro-costing analysis was developed to precisely assess the economic costs of healthcare interventions to manage complications due to vascular access cannulation. RESULTS: The major complications identified, and the average cost/per episode for their management are the following ones: Local infection € 1455 (min € 745 and max € 2160); Sepsis, that requires hospitalization in ward € 4401 (min € 3693 and max € 4623); Sepsis (ICU) € 17,190; Hematoma € 304 (min € 252 and max € 728); Aneurysm € 3632 (min € 3139 and max € 4014); Pseudoaneurysm € 3695 (min € 3615 and max € 4014); Stenosis € 2229 (min € 1874 and max € 4857); Thrombosis € 2151 (min € 1941 and max € 3395). CONCLUSIONS: In making decisions, hospital administration, and payer should take into consideration, not just the price of devices, but the entire patient's pathway. The use of plastic cannulae in hemodialysis patients shows improved outcomes compared to traditional metal needles. Furthermore, combining it with accurate and efficient cannulation techniques reduces complication rates, improves patients' quality of life, and reduces healthcare resource consumption.

Stent migration as complication of endovascular treatment of vascular access stenosis: A systemic review.

Outflow vein stenosis is one of the commonest complications of both native and prosthetic vascular access. Together with angioplasty, first-line treatment is stenting. Although it has been described as a uncommon complication, the risk of stent migration should be always considered. We aimed to conduct a systematic review of literature concerning stents migration in vascular access, the possible outcomes and treatments. This study was performed applying Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Searches were conducted in PubMed/Medline, Scopus, and Google scholar databases. Studies selection, data abstraction was done by two different reviewers. We identified 17 studies, comprising 18 cases (M:F 1:1, mean age 56 ± 18 (range 33-88)). All the patients underwent stenting for vascular access outflow stenosis. The commonest type of device reported was self expandible bare-metal stent. Intraoperative evidence of stent migration occurred in six cases at the final quality control, or for intraprocedure dyspnea onset. In two patients it was a incidental diagnosis. In the remaining cases, chest pain or dyspnea were the common delayed presentation symptoms. Even if stent migration is an uncommon event, it is burdened with low mortality and morbidity. Literature provide only few and frequently inadequate data. Stent removal is the treatment of choice when severe symptoms or cardiopulmonary complication are present. Endovascular procedures demonstrated to be an effective and safe alternative, while open surgical treatment is preferred whenever endovascular therapy failed or in selected cases.

Systemic inflammation index as useful tool to predict arteriovenous graft stenosis: Our experience and literature review.

OBJECTIVE: Many studies show that settings of severe inflammatory stress might be responsible for changes in circulating blood cells count. Effective inflammation indices are created calculating the quantitative relationship between these cells. No previous studies have been proposed on hemodialysis patients exploring the association between arteriovenous graft (AVG) stenosis and systemic inflammation markers, such as Neutrophil-lymphocyte ratio (NLR), platelet-lymphocyte ratio (PLR), and systemic-immune-inflammation index (SII). METHODS: Patients undergone surgery for AVG creation in a 2-year period are examined. Examining their full blood count, we have established the value of inflammatory indices (NLR, PLR, SII) and we have compared their mean values in patients who have developed significant stenosis or not. Finally, we have considered the connection between those values and stenosis onset and recurrence in AVG. RESULTS: Fifty-two patients are included in the study [male: 40%, mean age 70 ± 15 years (range 55-86)]. We have found out there is not statistical significance in preoperative values of inflammatory index (NLR p 0.33, PLR p 0.15, SII p 0.98) Otherwise NLR and SII indices were statistically significant 3 months after surgery (NLR 2.04 ± 0.98 vs 3.91 ± 2.10, p < 0.001; SII 415.32 ± 255.15 vs 636.91 ± 349.01, p 0.014). CONCLUSIONS: Increased post-operative values of NLR and SII have proved a strong association with AVG outflow stenosis onset and recurrence.

EVAR Follow-Up with Ultrasound Superb Microvascular Imaging (SMI) Compared to CEUS and CT Angiography for Detection of Type II Endoleak.

The aim of this study was to evaluate the usefulness of superb microvascular imaging (SMI) versus contrast-enhanced ultrasound (CEUS) and compared to computed tomography angiography (CTA) as a reference standard, for detection of type II endoleak during follow-up of endovascular abdominal aortic aneurysm repair (EVAR). Between April 2017 and September 2020, 122 patients underwent post-EVAR follow-up with CTA at 3 months and with ultrasound SMI and CEUS at 4 months from the EVAR procedure. Aneurysmal sac diameter and graft patency were evaluated; endoleaks were assessed and classified. Sensitivity, specificity, positive and negative predictive values, and diagnostic accuracy were calculated both for SMI and CEUS and compared to CTA. Furthermore, the percentage of agreement and Cohen's Kappa coefficient were calculated. CTA revealed 54 type II endoleaks. Ultrasound SMI and CEUS presented the same sensitivity (91.5%), specificity (100%), positive (100%), and negative (92.8%) predictive and accuracy (95.9%) value for detecting type II endoleak. The same percentage of agreement of 94.9% was found between SMI/CEUS, and CTA with a Cohen's Kappa coefficient of 0.89. The diagnostic accuracy of SMI is comparable with CEUS in the identification of type II endoleaks after EVAR. Since SMI is less invasive, less expensive, and less time-consuming, this method may be considered to be a potential tool for monitoring patients after EVAR implantation.

Long-term results of treatment of infrarenal aortic aneurysms with low-profile stent grafts in a multicenter registry.

OBJECTIVE: In recent years, manufacturers have developed new stent grafts with lower profiles to increase the endovascular aneurysm repair applicability. As reported by the current European Society for Vascular Surgery guidelines, long-term evaluation of such low-profile platforms is strongly recommended. This study aims to report outcomes beyond 5 years from a multicenter registry, including a real-world cohort of patients electively treated with low-profile stent grafts. METHODS: A retrospective data collection of patients who had undergone elective implantation of low-profile endograft ≤16 Fr. (Zenith LP, Ovation, Incraft) was performed in nine centers. The primary endpoint was a long-term primary clinical success. Secondary endpoints were survival rate, freedom from abdominal aortic aneurysm (AAA)-related death, freedom from type I to III endoleak, limb patency, and freedom from all reinterventions. The Kaplan-Meier curves were stratified for investigative devices. A multivariate analysis evaluated predictors of primary clinical success and reintervention rate. RESULTS: A total of 619 patients were enrolled (Ovation, n = 373; Incraft, n = 111; and Zenith LP, n = 135), with a mean follow-up of 56.8 ± 22.8 months. The overall primary and the secondary clinical success rate at 8 years was 72.1% and 93.8%, respectively. At 8 years, overall survival was 53.2%, freedom from AAA-related death was 94.4%, freedom from reintervention was 74%, freedom from type I/III endoleak was 86.9%, and limb patency was 90.4%. A significantly worse primary clinical success of the Zenith LP was recorded as dependent on more limb-related events. No differences between platforms were registered in the rate of AAA-related deaths, open conversion, sac enlargement, and type I/III endoleaks (P = .26). Multivariate analysis identified iliac tortuosity (hazard ratio, 2.053) and Zenith LP (hazard ratio, 3.818) as significant independent predictors of clinical failure and reintervention. CONCLUSIONS: Low-profile stent grafts have acceptable long-term outcomes. Overall survival and AAA-related death were in line with those reported for traditional devices. Long-term surveillance and reintervention, when necessary, remain crucial to guarantee durability.