Multicentre experience of antegrade thoracic endovascular aortic repair for the treatment of thoracic aortic diseases.

OBJECTIVES: The goal of this multicentre retrospective cohort study was to evaluate technical success and early and late outcomes of thoracic endovascular repair (TEVAR) with grafts deployed upside down through antegrade access, to treat thoracic aortic diseases. METHODS: Antegrade TEVAR operations performed between January 2010 and December 2021 were collected and analysed. Both elective and urgent procedures were included. Exclusion criteria were endografts deployed in previous or concomitant surgical or endovascular repairs. RESULTS: Fourteen patients were enrolled; 13 were males (94%) with a mean age of 71 years (interquartile range 62; 78). Five patients underwent urgent procedures (2 ruptured aortas and 3 symptomatic patients). Indications for treatment were 8 (57%) aneurysms/pseudoaneurysms, 3 (21%) dissections and 3 (21%) penetrating aortic ulcers. Technical success was achieved in all procedures. Early mortality occurred in 4 (28%) cases, all urgent procedures. Median follow-up was 13 months (interquartile range 1; 44). Late deaths occurred in 2 (20%) patients, both operated on in elective settings. The first died at 19 months of aortic-related reintervention; the second died at 34 months of a non-aortic-related cause. Two patients (14%) underwent aortic-related reinterventions for late type I endoleak. The survival rate of those having the elective procedures was 100%, 84% and 67% at 12, 24 and 36 months, respectively. Freedom from reintervention was 92%, 56% and 56% at 12, 24 and 36 months, respectively. CONCLUSIONS: Antegrade TEVAR can seldom be considered an alternative when traditional retrograde approach is not feasible. Despite good technical success and few access-site complications, this study demonstrates high rates of late type I endoleak and aortic-related reinterventions.

Inflow Artery Aneurysmal Degeneration After Long Term Native Arteriovenous Fistula for Haemodialysis.

OBJECTIVE: Inflow arterial aneurysms are a rare but serious complication after long term arteriovenous fistulae (AVF), probably due to arterial wall remodelling after an increase in flow and shear stress, and kidney transplantation with immunosuppressive therapy. This study aimed to describe the outcomes of surgical treatment and long term follow up in a large cohort. METHODS: This prospective cohort study collected data from patients with a true inflow artery aneurysm after AVF creation that was surgically repaired between 2010 and 2022. Anastomotic and infected aneurysms or post-puncture pseudoaneurysms were excluded. Demographic data, access characteristics, symptoms, treatment strategies, and long term follow up were recorded; patency was estimated using Kaplan-Meier survival analysis. RESULTS: During the study period, 28 patients (64% men, mean age 60.1 years) were treated surgically for aneurysmal degeneration of the axillary or brachial (n = 23) or radial (n = 5) artery after an AVF (10 distal, 18 proximal) performed a mean of 18.3 ± SD 7.9 years previously. Most AVFs were ligated or thrombosed, while all patients except one had previously received kidney transplants. Most of the cases (n = 18) were symptomatic: 13 with pain or swelling, four with distal embolisation, and one rupture. They were repaired by aneurysm partial excision and graft interposition (11 great saphenous vein, six ipsilateral basilic vein, three cephalic vein, and two PTFE graft), ligation (n = 3), or direct end to end anastomosis (n = 3). No major complications occurred before discharge, after a mean hospital stay of 2.4 days. After a mean follow up of 4.8 ± 3.3 years, three cases presented complications: two recurrent proximal brachial aneurysms were repaired with an additional proximal interposition graft (one with further late infected pseudoaneurysm) and an asymptomatic post-traumatic graft thrombosis. Five year primary and secondary patency was 84% and 96%, respectively. CONCLUSION: Aneurysmal degeneration of the inflow artery is an unusual complication during long term follow up of AVFs. Aneurysm excision and, in general, autogenous graft interposition using the saphenous or ipsilateral arm vein is a safe and effective strategy.

Outcomes After Endovascular Aortic Intervention in Patients With Connective Tissue Disease.

Importance: Endovascular treatment is not recommended for aortic pathologies in patients with connective tissue diseases (CTDs) other than in redo operations and as bridging procedures in emergencies. However, recent developments in endovascular technology may challenge this dogma. Objective: To assess the midterm outcomes of endovascular aortic repair in patients with CTD. Design, Setting, and Participants: For this descriptive retrospective study, data on demographics, interventions, and short-term and midterm outcomes were collected from 18 aortic centers in Europe, Asia, North America, and New Zealand. Patients with CTD who had undergone endovascular aortic repair from 2005 to 2020 were included. Data were analyzed from December 2021 to November 2022. Exposure: All principal endovascular aortic repairs, including redo surgery and complex repairs of the aortic arch and visceral aorta. Main Outcomes and Measures: Short-term and midterm survival, rates of secondary procedures, and conversion to open repair. Results: In total, 171 patients were included: 142 with Marfan syndrome, 17 with Loeys-Dietz syndrome, and 12 with vascular Ehlers-Danlos syndrome (vEDS). Median (IQR) age was 49.9 years (37.9-59.0), and 107 patients (62.6%) were male. One hundred fifty-two (88.9%) were treated for aortic dissections and 19 (11.1%) for degenerative aneurysms. One hundred thirty-six patients (79.5%) had undergone open aortic surgery before the index endovascular repair. In 74 patients (43.3%), arch and/or visceral branches were included in the repair. Primary technical success was achieved in 168 patients (98.2%), and 30-day mortality was 2.9% (5 patients). Survival at 1 and 5 years was 96.2% and 80.6% for Marfan syndrome, 93.8% and 85.2% for Loeys-Dietz syndrome, and 75.0% and 43.8% for vEDS, respectively. After a median (IQR) follow-up of 4.7 years (1.9-9.2), 91 patients (53.2%) had undergone secondary procedures, of which 14 (8.2%) were open conversions. Conclusions and Relevance: This study found that endovascular aortic interventions, including redo procedures and complex repairs of the aortic arch and visceral aorta, in patients with CTD had a high rate of early technical success, low perioperative mortality, and a midterm survival rate comparable with reports of open aortic surgery in patients with CTD. The rate of secondary procedures was high, but few patients required conversion to open repair. Improvements in devices and techniques, as well as ongoing follow-up, may result in endovascular treatment for patients with CTD being included in guideline recommendations.

European Expert Opinion on Infrarenal Sealing Zone Definition and Management in Endovascular Aortic Repair Patients: A Delphi Consensus.

PURPOSE: The purpose of the study was to provide a consensus definition of the infrarenal sealing zone and develop an algorithm to determine when and if adjunctive procedure(s) or reintervention should be considered in managing patients undergoing endovascular aortic repair (EVAR) for infrarenal abdominal aortic aneurysm (AAA). METHODS: A European Advisory Board (AB), made up of 11 vascular surgeons with expertise in EVAR for AAA, was assembled to share their opinion regarding the definition of preoperative and postoperative infrarenal sealing zone. Information on their current clinical practice and level of agreement on proposed reintervention paths was used to develop an algorithm. The process included 2 virtual meetings and 2 rounds of online surveys completed by the AB (Delphi method). Consensus was defined as reached when ≥ 8 of 11 (73%) respondents agreed or were neutral. RESULTS: The AB reached complete consensus on definitions and measurement of the pre-EVAR target anticipated sealing zone (TASZ) and the post-EVAR real achieved sealing zone (RASZ), namely, the shortest length between the proximal and distal reference points as defined by the AB, in case of patients with challenging anatomies. Also, agreement was achieved on a list of 4 anatomic parameters and 3 prosthesis-/procedure-related parameters, considered to have the most significant impact on preoperative and postoperative sealing zones. Furthermore, the agreement was reached that in the presence of visible neck-related complications, both adjunctive procedure(s) and reintervention should be contemplated (100% consensus). In addition, adjunctive procedure(s) or reintervention can be considered in the following cases (% consensus): insufficient sealing zone on completion imaging (91%) or on the first postoperative computed tomography (CT) scan (91%), suboptimal sealing zone on completion imaging (73%) or postoperative CT scan (82%), and negative evolution of the actual sealing zone over time (91%), even in the absence of visible complications. CONCLUSIONS: AB members agreed on definitions of the pre- and post-EVAR infrarenal sealing zone, as well as factors of influence. Furthermore, a clinical decision algorithm was proposed to determine the timing and necessity of adjunctive procedure(s) and reinterventions.

Position Paper on Young Vascular Surgeons Training of the Mediterranean Federation for the Advancing of Vascular Surgery (MeFAVS): State of the Art and Perspectives.

The Mediterranean Federation for the Advancing of Vascular Surgery (MeFAVS) was founded in 2018, with the aim to promote cooperation among vascular professionals within Mediterranean countries. Due to its prominent social and economic impact on national health systems, diabetic peripheral artery was selected as the very first topic to be investigated by the federation. In this second paper, different experiences from delegates of participating countries were shared to define common strategies to harmonize, standardize, and optimize education and training in the Vascular Surgery specialty.

The Initial Experience on Branched and Fenestrated Endografts in the Aortic Arch. A Systematic Review.

OBJECTIVE: Branched and fenestrated endografts (fEVAR/bEVAR) are complex techniques used to treat thoracic aorta pathologies involving the aortic arch. This systematic review aims to determine all the reported results regarding these techniques in the aortic arch, in order to describe their clinical outcomes. METHODS: A systematic review of the literature was performed, considering all articles published until October 2019. PubMed, Cochrane database resources were used. The protocol of the study was previously registered in the Prospero database (CRD42020147037). Primary exclusion criteria included opinion articles, merely technique descriptions, articles without the follow-up of at least 1 month, studies conducted on animals, mixed treatments, and ongoing trials without published data. Included variables were study design, aortic pathology, type of endovascular technique (fEVAR/bEVAR), endograft manufacturing, number of fenestrations/branches and type of bridge stents. Technical success, complications during surgery and follow-up were also described. RESULTS: From a total of 164 articles, 29 (28 retrospective, 1 prospective) were analyzed with a total of 693 cases (341 fEVAR and 352 bEVAR). The most common indications for repair were aneurysm (54.8%) and dissection (40%). Only fEVAR and bEVAR were considered, but different endograft materials and techniques were used and, therefore, reported upon in the current review. Zenith Alpha Thoracic Endovascular Graft was the most representative (24% of cases). Custom made, off-the-shelf, physician modified and in situ fenestrated endografts were also used in 39%, 22.4%, 18.6% and 18.9% of cases, respectively. Bridge stents were implanted in the 50.5% of cases. Technical success rate was 96%. The main intraoperative complication was the endoleak (5.2%) followed by stroke (4.8%). The in-hospital mortality was 2.5%. The mean follow-up was 18.5 months. The mortality related to the main operation during follow-up was 3.2% and not directly related to the main operation was 11.3%. During the follow-up, 92 cases (13.3%) in total had to undergo through a reintervention, 46.7% with endovascular repair and 26.1% with open surgical repair (the rest were not specified). CONCLUSION: published experience with bEVAR and fEVAR in the aortic arch showed acceptable short-term effectiveness and safety. More well-conducted prospective clinical studies with long term follow-up, combined with comparative meta-analysis, are needed to elucidate the real benefit of those endovascular techniques in the aortic arch pathology.

Total endovascular treatment for thoraco-abdominal aortic aneurysm in a patient with Behçet's disease: Case report and literature review.

INTRODUCTION: To report total endovascular treatment for a rare case of Crawford extent IV thoraco-abdominal aortic aneurysm (TAAA) using custom-designed branched device in a patient with Behçet's disease. METHODS: A 50 years' old man with history of BD was accidentally diagnosed Crawford extent IV TAAA during computed tomography follow-up after left nephrectomy of renal carcinoma. The aneurysm extended from descending aorta to right common iliac artery with a maximum diameter of 6.2 cm. RESULTS: The endovascular procedure wassuccessfully performed using custom-designed branched component to cannulate visceral arteries, bifurcated endograft and iliac legs to exclude the aneurysm sac in abdominal aorta and an iliac branched device to preserve the right internal iliac artery. The patient was discharged without any complication. Computed tomography angiogram at one month after endovascular repair demonstrated total exclusion of the aneurysm, patent visceral branches and right internal iliac artery. No complication occurred to six-month follow-up. CONCLUSION: Endovascular treatment of stable TAAA in patients with Behc?et's disease using custom-designed branched device is feasible, microinvasive and safe. The long-term efficacy needs to be observed.

Reducing residual thrombotic risk in patients with peripheral artery disease: impact of the COMPASS trial.

Patients with peripheral artery disease (PAD) are at a high risk not only for the classical cardiovascular (CV) outcomes (major adverse cardiovascular events; MACE) but also for vascular limb events (major adverse limb events; MALE). Therefore, a comprehensive approach for these patients should include both goals. However, the traditional antithrombotic approach with only antiplatelet agents (single or dual antiplatelet therapy) does not sufficiently reduce the risk of recurrent thrombotic events. Importantly, the underlying cause of atherosclerosis in patients with PAD implies both platelet activation and the initiation and promotion of coagulation cascade, in which Factor Xa plays a key role. Therefore, to reduce residual vascular risk, it is necessary to address both targets. In the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial that included patients with stable atherosclerotic vascular disease, the rivaroxaban plus aspirin strategy (versus aspirin) markedly reduced the risk of both CV and limb outcomes, and related complications, with a good safety profile. In fact, the net clinical benefit outcome composed of MACE; MALE, including major amputation, and fatal or critical organ bleeding was significantly reduced by 28% with the COMPASS strategy, (hazard ratio: 0.72; 95% confidence interval: 0.59-0.87). Therefore, the rivaroxaban plus aspirin approach provides comprehensive protection and should be considered for most patients with PAD at high risk of such events.

Climatic influence on the risk of abdominal aortic aneurysm rupture.

Our aim is to examine the effects of climatic conditions on the incidence of ruptured abdominal aortic aneurysms (rAAA) in Catalonia, Spain. We combined clinical data from the Public Health official registries in Catalonia, Spain (HD-MBDS) of all rAAA with local climatic data obtained from the closest meteorological station (69 stations, National Meteorological Service: MeteoCat) from 2008 to 2017. We analyzed the median, maximum, minimum, and variability of atmospheric pressure (hPa) and air temperature (°C), solar irradiation (MJ/m2), humidity (%), accumulated precipitation (mm), median wind, and maximum flaw direction and velocity (°, m/s), recorded on the days of events, the previous day, and mean results for 3, 7, and 30 days before, as well as seasonality. Seventy-five control days were randomly selected in a 1-year period around every rAAA day at the same meteorological station, and compared. A total of 717 days and locations with rAAA were identified, and 53,775 controls were randomly selected. For the rAAA days, there were significantly lower temperatures, lower solar global irradiation, and higher mean humidity levels in all time periods (p < 0.001, p < 0.001, p < 0.05); higher atmospheric pressure variability during 1 week and 1 month before (p = 0.011, p = 0.007); and they often occurred during autumn/winter (57.6%, p < 0.001). Logistic regression identified low mean temperatures on the days of ruptures and high mean humidity the week before as independent rupture predictors. In conclusion, low median temperatures the same day and high humidity during 1 week before were identified as independent predictors of rAAA occurrence. The role of climate on pathophysiologic mechanisms may require further investigation.

Surgical Decision Making in Uncomplicated Type B Aortic Dissection: A Survey of Australian/New Zealand and European Surgeons.

OBJECTIVE: There is controversy about the role of pre-emptive thoracic endovascular aortic repair (TEVAR) in uncomplicated type B aortic dissection (TBAD). The aim was to understand expert opinions and the factors influencing decision making. METHODS: In 2018, surgeons from Australia/New Zealand (ANZ) and Europe (EUR) were contacted to participate in an online survey which comprised questions about preferences for pre-emptive TEVAR, followed by five case scenarios, and two ranking questions for anatomical and technical risk factors respectively. Case 1 was designed to favour TEVAR in a hypertensive patient with partial false lumen thrombosis and large diameter (aortic ≥ 40 mm, false lumen ≥ 22 mm). Case 2 had no risk factors mandating TEVAR, according to current evidence. Cases 3, 4, and 5 were designed to test one risk factor respectively, large entry tear on the inner aortic curvature (≥10 mm), partial false lumen thrombosis, and large diameter alone. RESULTS: There were 75 responses, 42 from EUR and 33 from ANZ. Almost half of surgeons (49.3%) endorsed pre-emptive TEVAR with 82.3% preferring to perform TEVAR in the subacute phase. In Case 1 and 5, 58.3% and 52.8% of surgeons respectively chose TEVAR, the highest rates obtained in the survey. Cases 1 and 5 included large diameters ≥40 mm, which were ranked the highest in importance when surgeons considered anatomical risk factors. Surgeons who recommend pre-emptive TEVAR were more likely to choose TEVAR in both Case 1 (83.3% vs. 33.3%, p < .001, 95% CI 27.6%-65.8%) and Case 5 (69.4% vs. 38.2%, p = .008, 95% CI 8.2%-50.0%). CONCLUSION: In this survey about uncomplicated TBAD, about half of surgeons recommended pre-emptive TEVAR in selected cases. The surgeon's predisposition towards intervention and large diameters appear to be the most influential factors in decision making. These findings underline the uncertainty in today's practice and emphasise the need for better predictive tools.

Residual risk reduction opportunities in patients with chronic coronary syndrome. Role of dual pathway inhibition.

INTRODUCTION: In this review, the role of the rivaroxaban-plus-aspirin approach (dual pathway inhibition - DPI) in patients with chronic coronary syndrome (CCS) and to perform practical recommendations about its use was updated. AREAS COVERED: The contents of this review were proposed in an expert meeting. To identify relevant articles, a systematic search of Medline/Embase was performed (to July 2019), using the key words 'rivaroxaban', 'vascular dose', 'COMPASS' and 'coronary artery disease' in the search strategy. EXPERT OPINION: Despite current antithrombotic strategies (single/dual antiplatelet therapy) have decreased rates of recurrent cardiovascular events among patients with CCS, residual risk remains unacceptably high. The COMPASS trial showed in CCS patients that compared with aspirin 100 mg rivaroxaban 2.5 mg bid plus aspirin 100 mg reduced the risk of major cardiac events, cardiovascular hospitalization and mortality, without an increase of intracranial or fatal bleedings. Importantly, residual risk with the rivaroxaban plus aspirin approach was lower than with different dual antiplatelet therapy regimens. The rivaroxaban plus aspirin strategy is of particular benefit in patients with CCS and high-risk cardiovascular feature (i.e. ≥2 vascular beds, heart failure, renal insufficiency, peripheral artery disease, previous stroke or diabetes) and should be considered in these populations.

Improved Remodeling With TEVAR and Distal Bare-Metal Stent in Acute Complicated Type B Dissection.

BACKGROUND: The ASSIST (A multicentre Study in Survivors of type B aortic dissection undergoing Stenting) study compared both 1-year outcomes and evolution of true and false lumen (eg, remodeling) in patients with complicated type B aortic dissection subjected to thoracic endovascular aortic repair (TEVAR) with distal true lumen scaffolding by self-expanding nitinol open stent in comparison with TEVAR alone. METHODS: The ASSIST study was a multicenter prospective single-arm study comparing clinical and imaging data from 39 consecutive patients (59.4 ± 13 years of age) who received TEVAR and the JOTEC E-XL open stent with data from matched control subjects treated with TEVAR alone based on 1:1 propensity score matching. Clinical data were collected by an independent Contract Research Organization (CRO) and computed tomography images were subjected to blinded core-lab analysis. RESULTS: There were no differences in baseline demographics, clinical profiles, morphological data, procedural details, and in-hospital and 1-year outcomes between groups. Differences emerged with regard to evolution of both true lumen distal to stent graft, false lumen over the entire length of dissection, and remodeling (P < .001). At 1 year, TEVAR with the E-XL stent revealed false lumen thrombosis at the level of celiac trunk in 53.8% vs 17.9% with TEVAR alone (P = .004). Kaplan-Meier survival analysis indicated favorable clinical outcomes with the additional E-XL stent. CONCLUSIONS: TEVAR for acute complicated type B aortic dissection proved to be safe and promoted remodeling of the stent grafted thoracic aorta. Additional scaffolding of the true lumen distal to TEVAR with a self-expanding stent supported distal true lumen expansion, false lumen regression, and thrombosis, with evidence of improved distal remodeling at 1 year.

Review of serum biomarkers in carotid atherosclerosis.

BACKGROUND: Carotid artery atherosclerotic stenosis is a preventable major cause of stroke, but there is still a need for definition of high-risk plaque in asymptomatic patients who might benefit from interventional therapies. Several image markers are recommended to characterize unstable plaques. The measurement of serum biomarkers is a promising method to assist in decision making, but the lack of robust evidence in the carotid environment burdens their potential as a standard of care. The goal of this review was to offer an updated state-of-the-art study of available serum biomarkers with clinical implications, with focus on those that may predict carotid symptom development. METHODS: The Cochrane Library and MEDLINE databases were searched (all until September 2018) for studies on carotid plaque and serum biomarkers of atherosclerosis. Nonhuman, basic science, and histology studies were excluded, focusing on clinical studies. Selected abstracts were screened to include the most relevant articles on atherosclerotic plaque presence, progression, instability or symptom development. RESULTS: Some well-established biomarkers for coronary disease are not relevant to carotid atherosclerosis and other inflammatory biomarkers, lipids, interleukins, homocysteine, and adipokines may be useful in quantifying carotid disease-related risk. Some serum biomarkers combined with image features may assist vascular specialists in selecting patients at high risk for stroke and in need of intervention. CONCLUSIONS: Prospective studies applying a combination of biomarkers are essential to prove clinical usefulness.

Influence of On-Call Vascular Surgery Team and Off-Hour Effect on Survival after Ruptured Abdominal Aortic Aneurysm.

BACKGROUND: Ruptured abdominal aortic aneurysms (rAAAs) represent a life-threatening emergency and carry a high community and in-hospital mortality, despite treatment and protocol advances. Identifying prognostic factors like the presence of on-call vascular surgery teams at first hospital admissions or times of hospital admissions can modify hospital protocols and mechanisms to ameliorate general outcomes. The aim of this study is to analyze the influence of on-call vascular surgery teams and off-hour admissions on survival after rAAAs in Catalonia, Spain. METHODS: We used data from public health official registries (based on registration of the minimum basic data set) to collect diagnosed cases of rAAAs (ICD-9-CM [International Classification of Diseases, Ninth Revision, Clinical Modification] 441.3) between January 2008 and December 2017. Variables included patient comorbidities, aneurysm treatment and type (endovascular treatment: ICD-9-CM 39.7 or open surgery: ICD-9-CM 398.44 and 39.25), in-hospital mortality, initial hospital admissions and transfers, days and times of admission, and final treatment received. We compared intervention rates and mortalities in all samples and operated cases, in patients initially admitted into tertiary vascular centers (with on-call vascular surgery teams) and community centers (without on-call vascular surgery teams), and the "off-hour effect" (night [22:00 hr to 8:00 hr] or weekend admissions [Friday to Sunday]) in mortality and type of surgery (open or endovascular repair). RESULTS: Of 717 patients with rAAAs (92% men), 561 (78.2%) were initially admitted into tertiary vascular centers and 156 (21.8%) into community centers. The rate of operated cases and global mortality was higher when cases were initially admitted into tertiary vascular centers (388, 69.2% vs. 46, 29.5%; P < 0.001 and 63.6% vs. 88.5%, P < 0.001, respectively), but when surgery was performed (excluding palliative nonoperated cases), the postoperative mortality in both groups was comparable (47.4% vs. 60.9%, P = 0.085), in both univariate and multivariate analysis. On the other hand, patients admitted during night hours (210, 29.3%) did not reveal noteworthy differences in the overall mortality (68.6% vs. 69.2%, P = 0.860) or postoperative mortality compared to those admitted during day hours (61.0% vs. 60.4%, P = 0.880). Weekend admissions neither showed worse results (280, 39.1%, admitted during weekend: overall mortality 70.4% vs. 68.2%, P = 0.541 and postoperative mortality 51.2% vs. 47.3%, P = 0.436). No significant dissimilarities were seen either in the use of endovascular or open repair at night (42.2% vs. 46.1%, P = 0.457) or weekend (41.8% vs. 47%, P = 0.287). CONCLUSIONS: Patients with rAAAs initially admitted into tertiary vascular centers have better overall survival rates than those initially admitted into community centers, mainly because of higher rates of rejected cases in community centers. No differences were seen in terms of mortality or type of surgery in the off-hour admitted cases (night hours or during weekends).

FEVAR/BEVAR have limitations and do not always represent the preferred option for juxtarenal reconstruction.

Following the definition given by the recent ESVS guidelines, juxtarenal abdominal aortic aneurysm (JAAA) is defined as an aneurysm extending up to but not involving the renal arteries, necessitating suprarenal aortic clamping for open surgery, i.e. a short neck (<10 mm). JAAA repair always represents a challenge intervention, either by open or endovascular means, mostly related to the renal arteries involvement. Concerning endovascular repair, different options can be considered. Among them, fenestrated endografts (FEVAR) should be considered as a first option1, due to their reported safety and efficacy. However, when the anatomy is not favorable or when FEVAR devices are not available in an emergency setting for instance, other alternatives can be considered like parallel graft or chimney technique (ChEVAR). Do nothing is the last alternative when medical and anatomical circumstances are absolutely poor. In the following pages, we will review the limitations of FEVAR and branched endografts, the better indications and anatomical conditions for a successful repair with ChEVAR technique and its current clinical results reported in the literature.

Research methodology and practical issues relating to the conduct of a medical device registry.

BACKGROUND: The postmarket research goal is to assess "generalizability" or "external validity" to see if the early results of clinical trials with investigational devices are reproducible in everyday practice in the real world and the longer term. Registries have an important but ambivalent role in achieving this goal. METHODS: Although registries are common, in practice they follow the regulatory processes that appear designed primarily for pharmaceutical clinical trials and confirmatory studies. We review the literature to assess different definitions and the role of registries in the hierarchy of scientific evidence. We analyze common characteristics affecting registry design, implementation, and governance as well as safety reporting and off-label use while describing the experience of setting up an international, prospective registry for an endovascular device used to treat abdominal aortic aneurysms. RESULTS: Key areas in which to distinguish registries from trials are as follows: eligibility, setting (patients and institutions), device configurations and iterations, the use of design and quality "spaces," a focus on systematic quality checks (rather than source data monitoring), open-ended follow-up, flexibility in the definition of end points and sample sizes, data sharing, and publishing commitments. CONCLUSION: Both clinical trials and registries are essential and complementary research methods and the strengths and weaknesses of each need to be recognized. The specific characteristics of registry research deserve to be acknowledged and safeguarded in the regulations governing clinical investigations with medical devices.

The most relevant unmet needs in endovascular management of descending thoracic aorta.

Endovascular repair of descending thoracic aorta (DTA) is considered as first interventional option for most part of the aortic disorders. However, many unmet needs and issues are still limiting its applicability. One of the major limitations is related to the existing gaps in evidence. Clear and robust evidence is still needed in many aspects of the management of DTA pathologies. In numerous clinical scenarios, adequate trials are lacking. Besides those gaps in evidence, it is well recognized that thoracic endografting (TEVAR) is technically evolving in order to overcome technical and device-related complications and limitations. We can deploy endografts in any aortic segment: in the descending, in the ascending, in the arch, even preserving aortic branches. Nevertheless, from the pure technical point of view, current generations of endografts still need more development and improvement. Durability remains the major concern for any endovascular treatment, and thoracic endografting is not an exception. As Galenus said, the physician is only nature's assistant, thoracic endograft should also follow the natural anatomy instead of fighting against it. We will focus the following pages on the graft conformability and compliance, both related to durability and safety of thoracic endografting. We will review the current knowledge and concerns associated with the anatomical and hemodynamic modifications induced by the thoracic endograft strength, stiffness and straightness and their implications for the future thoracic endograft designs.

Aortic Curvature Remodeling after Thoracic Endovascular Aortic Repair: Assessing Device Conformability, Using Image Vector Analysis.

BACKGROUND: Aortic arch curvature can be straightened by endograft placement. However, different measurement methods with dissimilar follow-up and endografts have been published. The aim of this study was to corroborate, for the first time, the pliability of the Conformable Gore TAG Thoracic Endoprosthesis (W.L. Gore and Associates, Flagstaff, AZ, USA) into the aortic arch, using different image vector analysis. MATERIAL AND METHODS: We, retrospectively, analyzed patients primarily treated for thoracic aortic aneurysms and blunt traumatic aortic injuries by means of a Conformable Gore TAG Thoracic Endoprosthesis endograft proximally sealed into the aortic arch (zones Z1-Z3) in five different Spanish centers, between 2010 and 2017. The preoperative, one-month and six-month postoperative, computed tomography angiographies (CTAs) were obtained, creating accurate 3D center lumen line and external lumen line from the aortic valve to the renal arteries. Three different image analysis methods were used to compare modifications of the aortic curvature: first, segment analysis (angulations of the center lumen line when divided into seven precise segments, examining anterior-posterior, right-left, and cranial-caudal displacement), second, center lumen line analysis (bending of the center lumen line itself in seven definite points), and third, expected behavior (length of the endograft in the external lumen line). Two independent observers performed a blind analysis of all CTAs. Changes between preoperative and postoperative CTAs at one and six months are compared, and differences are viewed between cases sealed proximally (Z1-Z2) and distally (Z3) into the aortic arch. RESULTS: We analyzed 37 cases. At 1- and 6-month follow-ups, minimal changes occurred first in segment analysis (only a slight decrease of -2.0° in the XY plane at 10 cm from the brachiocephalic trunk at six-month follow-up was seen, P = 0.027). Second, center lumen line analysis again only showed negligible aortic curvature straightening (+3.5° at 10 cm from the brachiocephalic trunk at one month, P = 0.006, disappearing at six-month follow-up). Finally, good device length predictability was shown (interclass correlation coefficients: 0.995 and 0.994 at one and six months, P > 0.001). No differences were seen between cases proximally sealed into the proximal and distal aortic arch. CONCLUSIONS: Conformable Gore TAG Thoracic Endoprosthesis thoracic endograft showed a good pliability into the aortic arch and proximal thoracic aorta, with minimal changes in the aortic curvature after endograft placement in the short-term follow-up (up to six months). In addition, final endograft length into outer aortic curvature is highly predictable.