Urgent Candy-Plug Technique for Distal False Lumen Occlusion in Chronic Aortic Dissection.

INTRODUCTION: This study aimed to assess the impact of urgency on early and midterm outcomes of the Candy-Plug (CP) technique for distal false lumen (FL) occlusion in thoracic endovascular aortic repair (TEVAR) for aortic dissection (AD). METHODS: The CP registry was reviewed, and patients were categorized into elective and urgent/emergent groups for analysis. Endpoints included technical success, clinical success, early (30-day) computed tomography angiography (CTA) findings, early (30-day) mortality, adverse events, aortic remodeling in patients with available CTA follow-up and re-intervention. RESULTS: A total of 155 patients received a custom-made Candy-Plug with 32 patients (44% males, mean age 61±9 years) were treated urgently vs. 123 patients (63% males, mean age 62±11 years) electively. The primary CP rate was higher in the urgent group; (28/32, (88%) in the urgent group vs. 96/123 (78%) in the elective group, p=051). The mean contrast volume was higher in the urgent group; (157±56ml in the urgent group vs. 130±71ml in the elective group, p=.017). Technical success was achieved in all patients in both groups. Clinical success was achieved in 25/32 (78%) patients in the urgent group vs. 113/123 (92%) in the elective group, p=.159. The early mortality rate was 4/32, (13%) patients in the urgent group vs. 1/123 (1%) in the elective group, p=.120). There was no statistically significant difference regarding the early adverse events between the urgent and elective CP groups. Early aortic-related re-interventions were required in 6/32 (19%) patients in the urgent group vs. 6/123 (5%) in the elective group, p=.094. Thoracic aortic aneurysm sac regression was lower in the urgent group (5/28, (18%) in the urgent group vs. 63/114 (55%) in the elective group, p=001). Stable thoracic aortic aneurysm sac was higher in the urgent group (22/28, (79%) in the urgent group vs. 47/114 (41%) in the elective group, p=000). An increase in thoracic aortic aneurysm sac occurred in 1/28 (4%) patient in the urgent group vs. 4/114 (4%) patients in the elective group, p=.096. CONCLUSION: The urgent use of the CP technique for distal FL occlusion in AD was feasible and effective. The decrease in aortic FL sac diameter may be affected by the urgent use of CP due to limited sizing availability. However, it achieved high rate of aortic remodeling.

Prolonged Impella 5.0/5.5 support within different pathways of care for cardiogenic shock: the experience of a referral center.

Aims: Impella 5.0 and 5.5 are promising low-invasive left ventricle (LV) temporary mechanical circulatory supports (tMCS) for cardiogenic shock due to LV mechanical unloading and are paired with powerful hemodynamic support. This study aimed to analyze data and destinies of patients supported with Impella 5.0/5.5 at a national referral center for cardiogenic shock and to assess the parameters associated with myocardial recovery and successful weaning. Methods: A single-center observational study was conducted on all patients treated with Impella 5.0 or 5.5 from March 2018 to July 2023. Results: A total of 59 patients underwent Impella 5.0/5.5 implantation due to profound cardiogenic shock, with acute myocardial infarction being the most frequent cause of shock (42 patients, 71%). The median duration of Impella support was 13 days (maximum duration of 52 days). Axillary cannulation was feasible in almost all patients, and 36% were mobilized during support. A total of 44 patients (75%) survived to the next therapy/recovery: 21 patients experienced recovery and 15 and 8 were bridged to long-term LVAD and heart transplantation, respectively. The global survival rate was 66%. The predictors of native heart recovery at multivariate analysis were the number of days on tMCS before upgrade to Impella 5.0/5.5 [hazard ratio (HR) 0.68 (0.51-9) p = 0.0068] and improvement of LVEF within the first 7-10 days of support [HR 4.72 (1.34-16.7), p = 0.016]. Conclusions: Transcatheter systems such as Impella 5.0/5.5 revolutionized the field of tMCS. Myocardial recovery is the primary clinical target. Its prognostication and promotion are key to ensure the most proficuous course for each patient from cardiogenic shock to long-term event-free survival.

Multicenter Study on Physician-Modified Endografts for Thoracoabdominal and Complex Abdominal Aortic Aneurysm Repair.

BACKGROUND: Physician modified endografts (PMEGs) have been widely used in the treatment of complex abdominal aortic aneurysm and thoracoabdominal aortic aneurysm, however, previous data are limited to small single center studies and robust data on safety and effectiveness of PMEGs are lacking. We aimed to perform an international multicenter study analyzing the outcomes of PMEGs in complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. METHODS: An international multicenter single-arm cohort study was performed analyzing the outcomes of PMEGs in the treatment of elective, symptomatic, and ruptured complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. Variables and outcomes were defined according to the Society for Vascular Surgery reporting standards. Device modification and procedure details were collected and analyzed. Efficacy outcomes included technical success and safety outcomes included major adverse events and 30-day mortality. Follow-up outcomes included reinterventions, endoleaks, target vessel patency rates and overall and aortic-related mortality. Multivariable analysis was performed aiming at identifying predictors of technical success, 30-day mortality, and major adverse events. RESULTS: Overall, 1274 patients were included in the study from 19 centers. Median age was 74 (IQR, 68-79), and 75.7% were men; 45.7% were complex abdominal aortic aneurysms, and 54.3% were thoracoabdominal aortic aneurysms; 65.5% patients presented electively, 24.6% were symptomatic, and 9.9% were ruptured. Most patients (83.1%) were submitted to a fenestrated repair, 3.6% to branched repair, and 13.4% to a combined fenestrated and branched repair. Most patients (85.8%) had ≥3 target vessels included. The overall technical success was 94% (94% in elective, 93.4% in symptomatic, and 95.1% in ruptured cases). Thirty-day mortality was 5.8% (4.1% in elective, 7.6% in symptomatic, and 12.7% in ruptured aneurysms). Major adverse events occurred in 25.2% of cases (23.1% in elective, 27.8% in symptomatic, and 30.3% in ruptured aneurysms). Median follow-up was 21 months (5.6-50.6). Freedom from reintervention was 73.8%, 61.8%, and 51.4% at 1, 3, and 5 years; primary target vessel patency was 96.9%, 93.6%, and 90.3%. Overall survival and freedom from aortic-related mortality was 82.4%/92.9%, 69.9%/91.6%, and 55.0%/89.1% at 1, 3, and 5 years. CONCLUSIONS: PMEGs were a safe and effective treatment option for elective, symptomatic, and ruptured complex aortic aneurysms. Long-term data and future prospective studies are needed for more robust and detailed analysis.

Advanced Imaging Techniques for Complex Endovascular Aortic Repair: Pre-Operative, Intra-Operative and Post-Operative Advancements.

OBJECTIVES: Endovascular aortic repair requires extensive preoperative, intraoperative, and postoperative imaging for planning, surveillance, and detection of endo-leaks. There have been many advancements in imaging modalities to achieve this purpose. This review discussed different imaging modalities used at different stages of treatment of complex endovascular aortic repair. METHODS: We conducted a literature review of all the imaging modalities utilized in endovascular aortic repair by searching various databases. RESULTS: Pre-operative techniques include analysis of images obtained via modified central line using analysis software and intravascular ultrasound. Fusion imaging, CO2 angiography, intravascular ultrasound, and Fiber Optic RealShape technology have been crucial in obtaining real-time imaging for the detection of endo-leaks during operative procedures. Conventional imaging modalities like CT Angiography and MR Angiography are still employed for post-operative surveillance along with computational fluid dynamics and contrast-enhanced ultrasound. The advancements in artificial intelligence have been the breakthrough in developing robust imaging applications. CONCLUSIONS: This review explains the advantages, disadvantages, and side-effect profile of the abovementioned imaging modalities.

Design, evolution, and experience with the candy plug device for endovascular false lumen occlusion of chronic aortic dissections.

INTRODUCTION: The management of the false lumen (FL) when dealing with aortic dissection is a crucial aspect since inducing its thrombosis is necessary in order to achieve aortic remodeling. One of the pitfalls of endovascular treatment of aortic dissection (AD) is retrograde distal FL perfusion and pressurization, which prevents FL thrombosis and thus aortic remodeling, while being associated with aneurysmal degeneration of the FL and poor long-term outcomes. AREAS COVERED: Currently, there is no CE/FDA approved device for FL closure, however different techniques and devices have been proposed to overcome this challenge, the most known of which is the Candy Plug (CP). This review aims to describe the CP device, its implantation technique, and the available data in the literature (PubMed, Cochrane, and EMBASE databases; last queried, December 31, 2023). EXPERT OPINIONS: While the treatment of AD remains technically challenging, the use of the CP technique to close any distal FL reperfusion proved to be feasible and safe with excellent rates of both technical and clinical success. Furthermore, recent studies have shown a quick learning curve with this technique.

Plug-Based Embolization Techniques of Aortic Side Branches during Standard and Complex Endovascular Aortic Repair.

Vascular plugs are an evolving family of vessel occluders providing a single-device embolization system for large, high-flow arteries. Nitinol mesh plugs and polytetrafluoroethylene membrane plugs are available in different configurations and sizes to occlude arteries from 3 to 20 mm in diameter. Possible applications during complex endovascular aortic procedures are aortic branch embolization to prevent endoleak or to gain an adequate landing zone, directional branch occlusion, and false lumen embolization in aortic dissection. Plugs are delivered through catheters or introducers, and their technical and clinical results are comparable to those of coil embolization. Plugs are more accurate than coils as repositionable devices, less prone to migration, and have fewer blooming artifacts on postoperative computed tomography imaging. Their main drawback is the need for larger delivery systems. This narrative review describes up-to-date techniques and technology for plug embolization in complex aortic repair.

Efficacy and Safety of Endovascular Fenestrated and Branched Grafts Versus Open Surgery in Thoracoabdominal Aortic Aneurysm Repair: An Updated Systematic Review, Meta-analysis, and Meta-regression.

OBJECTIVE: To provide an updated systematic review and meta-analysis with meta-regression of efficacy and safety of fenestrated/branched endovascular repair of thoracoabdominal aortic aneurysms (TAAAs) compared with open repair. BACKGROUND: Endovascular repair of TAAAs may be a promising alternative to open surgery by reducing invasiveness and expanding the eligible population, but evidence remains limited. METHODS: We applied "Prepared Items for Systematic Reviews and Meta-analysis" guidelines to retrieve, quantitatively pool, and critically evaluate the efficacy and safety (including 30-day mortality, reintervention, spinal cord injury [SCI], and renal injury) of both approaches. Original studies were retrieved from PubMed, Embase, and Cochrane Library until April 20, 2022, excluding papers reporting <10 patients. Pooled proportions and means were determined using a random-effect model. Heterogeneity between studies was evaluated with I2 statistics. RESULTS: Sixty-four studies met the predefined inclusion criteria. Endovascular cohort patients were older and had higher rates of comorbidities. Endovascular repair was associated with similar proportions of mortality (0.07, 95% confidence intervals [CI]: 0.06-0.08) compared with open repair (0.09, 95% CI: 0.08-0.12; P = 0.22), higher proportions of reintervention (0.19, 95% CI: 0.13-0.26 vs 0.06, 95% CI: 0.04-0.10; P < 0.01), similar proportions of transient SCI (0.07, 95% CI: 0.05-0.09 vs 0.06, 95% CI: 0.05-0.08; P = 0.28), lower proportions of permanent SCI (0.04, 95% CI: 0.03-0.05 vs 0.06, 95% CI: 0.05-0.07; P < 0.01), and renal injury (0.08, 95% CI: 0.06-0.10 vs 0.13, 95% CI: 0.09-0.17; P = 0.02). Results were affected by high heterogeneity and potential publication bias. CONCLUSIONS: Despite these limitations and the lack of randomized trials, this meta-analysis suggests that endovascular TAAA repair could be a safer alternative to the open approach.

An International Expert-Based CONsensus on Indications and Techniques for aoRtic balloOn occLusion in the Management of Ruptured Abdominal Aortic Aneurysms (CONTROL-RAAA).

OBJECTIVE: To report on the recommendations of an expert-based consensus on the indications, timing, and techniques of aortic balloon occlusion (ABO) in the management of ruptured abdominal aortic aneurysms (rAAA). METHODS: Eleven facilitators created appropriate statements regarding the study issues that were voted on using a 4-point Likert scale with open-comment fields, by a selected panel of international experts (vascular surgeons and interventional radiologists) using a 3-round modified Delphi consensus procedure (study period: January-April 2023). Based on the experts' responses, only the statements reaching grade A (full agreement ≥75%) or B (overall agreement ≥80% and full disagreement <5%) were included in the final study report. The consistency of each round's answers was also graded using Cohen's kappa, the intraclass correlation coefficient, and, in case of double resubmission, Fleiss kappa. RESULTS: Sixty-three experts were included in the final analysis and voted on 25 statements related to indication and timing (n=6), and techniques (n=19) of ABO in the setting of rAAA. Femoral sheath or ABO should be preferably placed in the operating room, via a percutaneous transfemoral access, on a stiff wire (grade B, consistency I), ABO placement should be suprarenal and last less than 30 minutes (grade B, consistency II), postoperative peripheral vascular status (grade A, consistency II) and laboratory testing every 6 to 12 hours (grade B, consistency) should be assessed to detect complications. Formal training for ABO should be implemented (grade B, consistency I). Most of the statements in this international expert-based Delphi consensus study might guide current choices for indications, timing, and techniques of ABO in the management of rAAA. Clinical practice guidelines should incorporate dedicated statements that can guide clinicians in decision-making. CONCLUSIONS: At arrival and during both open or endovascular procedures for rAAA, selective use of intra-aortic balloon occlusion is recommended, and it should be performed preferably by the treating physician in aortic pathology. CLINICAL IMPACT: This is the first consensus study of international vascular experts aimed at defining the indications, timing, and techniques of optimal use of ABO in the clinical setting of rAAA. Aortic occlusion by endovascular means (or ABO) is a quick procedure in properly trained hands that may play an important role as a temporizing measure until the definitive aortic repair is achieved, whether by endovascular or open means. Since data on its use in hemodynamically unstable patients are limited in the literature, owing to practical challenges in the performance of well-conducted prospective studies, understanding real-world use by experts is of importance in addressing critical issues and identifying main gaps in knowledge.

Three-Year Safety and Efficacy of the INCRAFT Endograft for Treatment of Abdominal Aortic Aneurysms: Results of the INSIGHT Study.

PURPOSE: Preliminary results of the INSIGHT study showed that the low-profile INCRAFT Abdominal Aortic Aneurysm (AAA) Stent-Graft System was safe and effective in the endovascular aneurysm repair (EVAR). This study aimed to assess the durability and the midterm effectiveness of EVAR using the INCRAFT System in the framework of a multicenter, prospective, open-label, post-approval study. MATERIALS AND METHODS: Between 2015 and 2016, 150 subjects from 23 European centers treated with the INCRAFT System for an infrarenal AAA were included. Clinical and radiologic data were prospectively collected and analyzed using protocol-specified, monitored follow-up clinic visits at 1, 6, and 12 months post-implantation and annually after that. The clinical success at 3 years was determined. Freedom from overall and aneurysm-related mortality, type I endoleak, secondary interventions, and aneurysm sac enlargement through 3 years were evaluated. Kaplan-Meier estimates were used for late outcomes. An independent clinical events committee reviewed all events. The CT (computed tomography) scans through 1 year were reviewed by an independent core laboratory. RESULTS: The primary clinical success rate at 3 years was 84.0% (126/150). There were no aneurysm-related deaths, endograft migration, or aneurysm-related ruptures through 3 years. Stent fracture was detected in 2 subjects (1.3%) without clinical sequelae. Over 3 years, freedom from overall mortality was 89.4%, freedom from secondary interventions was 80%, and freedom from aneurysm sac enlargement was 96.5%. The 3-year freedom from type IA and IB endoleaks was 93.3% and 98.6%, respectively. CONCLUSIONS.: In a multicenter real-world study setting, the use of a low-profile INCRAFT device for AAA is associated with sustained clinical success and low rates of reinterventions through 3 years. CLINICAL IMPACT: Low-profile endografts have broadened the spectrum of patients with anatomic suitability for endovascular repair of abdominal aortic aneurysms (AAA). However, questions remain regarding the durability of the repair. The INSIGHT study evaluated the use of the INCRAFT System in routine real-world clinical practice, including patients with complex anatomies. The treatment was safe and effective. The results showed sustained clinical success over 3 years, with no aneurysm-related deaths or ruptures, and a high rate of intervention-free survival at 3 years. Despite the low-profile design of the endograft, the midterm results demonstrate the durability of AAA repair using the INCRAFT System.ClinicalTrials.gov Identifier: NCT02477111.

Risk Prediction Models for Peri-Operative Mortality in Patients Undergoing Major Vascular Surgery with Particular Focus on Ruptured Abdominal Aortic Aneurysms: A Scoping Review.

PURPOSE: The present scoping review aims to describe and analyze available clinical data on the most commonly reported risk prediction indices in vascular surgery for perioperative mortality, with a particular focus on ruptured abdominal aortic aneurysm (rAAA). MATERIALS AND METHODS: A scoping review following the PRISMA Protocols Extension for Scoping Reviews was performed. Available full-text studies published in English in PubMed, Cochrane and EMBASE databases (last queried, 30 March 2023) were systematically reviewed and analyzed. The Population, Intervention, Comparison, Outcome (PICO) framework used to construct the search strings was the following: in patients with aortic pathologies, in particular rAAA (population), undergoing open or endovascular surgery (intervention), what different risk prediction models exist (comparison), and how well do they predict post-operative mortality (outcomes)? RESULTS: The literature search and screening of all relevant abstracts revealed a total of 56 studies in the final qualitative synthesis. The main findings of the scoping review, grouped by the risk score that was investigated in the original studies, were synthetized without performing any formal meta-analysis. A total of nine risk scores for major vascular surgery or elective AAA, and 10 scores focusing on rAAA, were identified. Whilst there were several validation studies suggesting that most risk scores performed adequately in the setting of rAAA, none reached 100% accuracy. The Glasgow aneurysm score, ERAS and Vancouver score risk scores were more frequently included in validation studies and were more often used in secondary studies. Unfortunately, the published literature presents a heterogenicity of results in the validation studies comparing the different risk scores. To date, no risk score has been endorsed by any of the vascular surgery societies. CONCLUSIONS: The use of risk scores in any complex surgery can have multiple advantages, especially when dealing with emergent cases, since they can inform perioperative decision making, patient and family discussions, and post hoc case-mix adjustments. Although a variety of different rAAA risk prediction tools have been published to date, none are superior to others based on this review. The heterogeneity of the variables used in the different scores impairs comparative analysis which represents a major limitation to understanding which risk score may be the "best" in contemporary practice. Future developments in artificial intelligence may further assist surgical decision making in predicting post-operative adverse events.

Outcomes of Percutaneous Access to the First Versus Third Segment of Axillary Artery During Aortic Procedures.

PURPOSE: This article aims at investigating the outcomes of percutaneous access via the first versus third axillary artery (AXA) segments with closure devices during aortic procedures. MATERIALS AND METHODS: All patients receiving percutaneous AXA access closed with Perclose ProGlide device (Abbott, Santa Clara, California) from 2008 to 2021 were included in a retrospective multicenter registry (NCT: 04589962). Efficacy endpoint was the technically successful percutaneous procedure (no open conversion). Safety endpoints were stroke and access complications according to the Valve Academic Research Consortium-3 reporting standards. The first (AXA1) or third (AXA3) axillary puncture sites were compared. RESULTS: A total of 412 percutaneous AXA accesses were included: 172 (42%) in AXA1 and 240 (58%) in AXA3. Left AXA was catheterized in 363 cases (76% of AXA1 vs 97% of AXA3, p<0.001) and 91% of fenestrated/branched endovascular repair (F/BEVAR) procedures were conducted from the left. A ≥12F internal diameter (ID) sheath was used in 49% of procedures. Open conversion rate was 1%, no major vascular complications occurred, and only one major non-vascular complication was recorded. Primary closure failure occurred in 18 AXA1 (11%) and 32 AXA3 accesses (13%), treated by covered (8.3%) or bare-metal (2.7%) stenting. Bailout stent patency was 100% at median follow-up of 12 months, with 6 of 6 stents still patent after >36 months of follow-up. Stroke rate was 4.4%. An introducer sheath >12F was independently associated with both access complications (p<0.001) and stroke (p=0.005), while a right-side access was associated with stroke only (p=0.034). Even after adjustment for covariates, AXA1 versus AXA3 showed an equal success rate (odds ratio [OR]=0.537, 95% confidence interval [CI]=0.011-1.22 for AXA3, p=0.104). The combination of AXA3 and a >10F introducer sheath provided worse outcomes compared with >10F sheaths through AXA1 (OR for success=0.367, 95% CI=0.176-0.767, p=0.008). This was not confirmed for >12F sheaths, associated with similar outcomes (p=0.31 AXA 1 vs AXA 3). CONCLUSION: Major local complications with the percutaneous axillary approach and ≤12F sheaths are infrequent and solvable by complementary endovascular interventions. Stroke risk remains an issue. First and third AXA segments are both amenable for access with good results, but larger sheaths (12F) perform better in AXA1. CLINICAL IMPACT: Percutaneous access with vascular closure devices at the first or third axillary artery (AXA) segments during aortic procedures is burdened by a negligible risk of open conversion. Local complications with the percutaneous axillary approach are infrequent and solvable by complementary endovascular interventions. First and third AXA segments are both amenable to access with excellent results, but larger sheaths (12F) perform better in the wider first AXA segment. In this setting, bailout stenting does not appear to be associated with mid-term stent occlusion.

Outcomes of Elective and Non-elective Fenestrated-branched Endovascular Aortic Repair for Treatment of Thoracoabdominal Aortic Aneurysms.

OBJECTIVE: To describe outcomes after elective and non-elective fenestrated-branched endovascular aortic repair (FB-EVAR) for thoracoabdominal aortic aneurysms (TAAAs). BACKGROUND: FB-EVAR has been increasingly utilized to treat TAAAs; however, outcomes after non-elective versus elective repair are not well described. METHODS: Clinical data of consecutive patients undergoing FB-EVAR for TAAAs at 24 centers (2006-2021) were reviewed. Endpoints including early mortality and major adverse events (MAEs), all-cause mortality, and aortic-related mortality (ARM), were analyzed and compared in patients who had non-elective versus elective repair. RESULTS: A total of 2603 patients (69% males; mean age 72±10 year old) underwent FB-EVAR for TAAAs. Elective repair was performed in 2187 patients (84%) and non-elective repair in 416 patients [16%; 268 (64%) symptomatic, 148 (36%) ruptured]. Non-elective FB-EVAR was associated with higher early mortality (17% vs 5%, P <0.001) and rates of MAEs (34% vs 20%, P <0.001). Median follow-up was 15 months (interquartile range, 7-37 months). Survival and cumulative incidence of ARM at 3 years were both lower for non-elective versus elective patients (50±4% vs 70±1% and 21±3% vs 7±1%, P <0.001). On multivariable analysis, non-elective repair was associated with increased risk of all-cause mortality (hazard ratio, 1.92; 95% CI] 1.50-2.44; P <0.001) and ARM (hazard ratio, 2.43; 95% CI, 1.63-3.62; P <0.001). CONCLUSIONS: Non-elective FB-EVAR of symptomatic or ruptured TAAAs is feasible, but carries higher incidence of early MAEs and increased all-cause mortality and ARM than elective repair. Long-term follow-up is warranted to justify the treatment.

Radial access for peripheral vascular intervention: the S.M.A.R.T. RADIANZ Vascular Stent System.

INTRODUCTION: Radial access is the standard of care for nearly all cardiac catheterization procedures. It improves patient satisfaction, reduces the length of stay, and is associated with fewer complications. However, few devices and tools are available for the treatment of peripheral arterial disease via a transradial approach (TRA). The S.M.A.R.T. RADIANZ Vascular Stent System is among the RADIANZ suite of products, which is aimed at expanding the portfolio of devices to treat peripheral arterial disease. AREAS COVERED: In this Expert review, the following areas will be covered: (1) Current Landscape of peripheral vascular intervention (PVI) using TRA (2) Detailed description of the S.M.A.R.T. RADIANZ Vascular Stent System. (3) Ongoing clinical trials to evaluate safety of this approach. (4) Future directions and current regulatory status. EXPERT OPINION: TRA for PVI is a promising approach. It holds the possibility of substantially improving the care of patients with peripheral arterial disease (PAD). Numerous challenges must be overcome to realize the full potential of a radial-to-peripheral (RTP) approach. The length of devices and the small sheath size are the main constraints of this approach. The results of the ongoing RADIANCY trial will demonstrate the safety, in selected patients, of the RADIANZ suite of products.

Emergent endovascular treatment options for thoracoabdominal aortic aneurysm.

For a long time, parallel grafting, physician-modified endografts, and, more recently, in situ fenestration were the only go-to endovascular options for ruptured thoracoabdominal aortic aneurysm, offered mixed results, and depended mainly on the operator's and center's experience. As custom-made devices have become an established endovascular treatment option for elective thoracoabdominal aortic aneurysm, they are not a viable option in the emergency setting, as endograft production can take up to 4 months. The development of off-the-shelf (OTS) multibranched devices with a standardized configuration has allowed the treatment of ruptured thoracoabdominal aortic aneurysm with emergent branched endovascular procedures. The Zenith t-Branch device (Cook Medical) was the first readily available graft outside the United States to receive the CE mark (in 2012) and is currently the most studied device for those indications. A new device, the E-nside thoracoabdominal branch endoprosthesis OTS multibranched endograft (Artivion), has been made commercially available, and the GORE EXCLUDER thoracoabdominal branch endoprosthesis OTS multibranched endograft (W. L. Gore and Associates) is expected to be released in 2023. Due to the lack of guidelines on ruptured thoracoabdominal aortic aneurysm, this review summarizes the available treatment options (ie, parallel grafts, physician-modified endografts, in situ fenestrations, and OTS multibranched devices), compares the indications and contraindications, and points out the evidence gaps that should be filled in the next decade.

Transatlantic multicenter study on the use of a modified preloaded delivery system for fenestrated endovascular aortic repair.

OBJECTIVE: Analyze the outcomes of endovascular complex abdominal and thoracoabdominal aortic aneurysm repair using the Cook fenestrated device with the modified preloaded delivery system (MPDS) with a biport handle and preloaded catheters. METHODS: A multicenter retrospective single arm cohort study was performed, including all consecutive patients with complex abdominal aortic aneurysm repair and thoracoabdominal aortic aneurysms treated with the MPDS fenestrated device (Cook Medical). Patient clinical characteristics, anatomy, and indications for device use were collected. Outcomes, classified according to the Society for Vascular Surgery reporting standards, were collected at discharge, 30 days, 6 months, and annually thereafter. RESULTS: Overall, 712 patients (median age, 73 years; interquartile range [IQR], 68-78 years; 83% male) from 16 centers in Europe and the United States treated electively were included: 35.4% (n = 252) presented with thoracoabdominal aortic aneurysms and 64.6% (n = 460) with complex abdominal aortic aneurysm repair. Overall, 2755 target vessels were included (mean ,3.9 per patient). Of these, 1628 were incorporated via ipsilateral preloads using the MPDS (1440 accessed from the biport handle and 188 from above). The mean size of the contralateral femoral sheath during target vessel catheterization was 15F ± 4, and in 41 patients (6.7%) the sheath size was ≤8F. Technical success was 96.1%. Median procedural time was 209 minutes (IQR, 161-270 minutes), contrast volume was 100 mL (IQR, 70-150mL), fluoroscopy time was 63.9 minutes (IQR, 49.7-80.4 minutes) and median cumulative air kerma radiation dose was 2630 mGy (IQR, 838-5251 mGy). Thirty-day mortality was 4.8% (n = 34). Access complications occurred in 6.8% (n = 48) and 30-day reintervention in 7% (n = 50; 18 branch related). Follow-up of >30 days was available for 628 patients (88%), with a median follow-up of 19 months (IQR, 8-39 months). Branch-related endoleaks (type Ic/IIIc) were observed in 15 patients (2.6%) and aneurysm growth of >5 mm was observed in 54 (9.5%). Freedom from reintervention at 12 and 24 months was 87.1% (standard error [SE],1.5%) and 79.2% (SE, 2.0%), respectively. Overall target vessel patency at 12 and 24 months was 98.6% (SE, 0.3%) and 96.8% (SE, 0.4%), respectively, and was 97.9% (SE, 0.4%) and 95.3% (SE, 0.8%) for arteries stented from below using the MPDS, respectively. CONCLUSIONS: The MPDS is safe and effective. Overall benefits include a decrease in contralateral sheath size in the treatment of complex anatomies with favorable results.

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.

Practice of neuromonitoring in open and endovascular thoracoabdominal aortic repair-an international expert-based modified Delphi consensus study.

OBJECTIVES: Spinal cord injury is detrimental for patients undergoing open or endovascular thoracoabdominal aortic aneurysm (TAAA) repair. The aim of this survey and of the modified Delphi consensus was to gather information on current practices and standards in neuroprotection in patients undergoing open and endovascular TAAA. METHODS: The Aortic Association conducted an international online survey on neuromonitoring in open and endovascular TAAA repair. In a first round an expert panel put together a survey on different aspects of neuromonitoring. Based on the answers from the first round of the survey, 18 Delphi consensus questions were formulated. RESULTS: A total of 56 physicians completed the survey. Of these, 45 perform open and endovascular TAAA repair, 3 do open TAAA repair and 8 do endovascular TAAA repair. At least 1 neuromonitoring or protection modality is utilized during open TAAA surgery. Cerebrospinal fluid (CSF) drainage was used in 97.9%, near infrared spectroscopy in 70.8% and motor evoked potentials or somatosensory evoked potentials in 60.4%. Three of 53 centres do not utilize any form of neuromonitoring or protection during endovascular TAAA repair: 92.5% use CSF drainage; 35.8%, cerebral or paravertebral near infrared spectroscopy; and 24.5% motor evoked potentials or somatosensory evoked potentials. The utilization of CSF drainage and neuromonitoring varies depending on the extent of the TAAA repair. CONCLUSIONS: The results of this survey and of the Delphi consensus show that there is broad consensus on the importance of protecting the spinal cord to avoid spinal cord injury in patients undergoing open TAAA repair. Those measures are less frequently utilized in patients undergoing endovascular TAAA repair but should be considered, especially in patients who require extensive coverage of the thoracoabdominal aorta.

Fate of target visceral vessels in fenestrated and branched complex endovascular aortic repair.

OBJECTIVE: To assess branch vessel outcomes after endovascular repair of complex aortic aneurysms analyzing possible factors influencing early and long-term results. METHODS: The Italian Multicentre Fenestrated and Branched registry enrolled 596 consecutive patients treated with fenestrated and branched endografts for complex aortic disease from January 2008 to December 2019 by four Italian academic centers. The primary end points of the study were technical success (defined as target visceral vessel [TVV] patency and absence of bridging device-related endoleak at final intraoperative control), and freedom from TVV instability (defined as the combined results of type IC/IIIC endoleaks and patency loss) during follow-up. Secondary end points were overall survival and TVV-related reinterventions. RESULTS: We excluded 591 patients (3 patients with a surgical debranching and 2 patients who died before completion from the study cohort) were treated for a total of 1991 visceral vessels targeted by either a directional branch or a fenestration. The overall technical success rate was 98.4%. Failure was related to the use of an off-the-shelf (OTS) device (custom-made device vs OTS, HR, 0.220; P = .007) and a preoperative TVV stenosis of >50% (HR, 12.460; P < .001). The mean follow-up time was 25.1 months (interquartile range, 3-39 months). The overall estimated survival rates were 87%, 77.4%, and 67.8% at 1, 3, and 5 years, respectively (standard error [SE], 0.015, 0.022, and 0.032). During follow-up, TVV branch instability was observed in 91 vessels (5%): 48 type IC/IIIC endoleaks (2.6%) and 43 stenoses-thromboses (2.4%). The extent of aneurysm disease (thoracoabdominal aortic aneurysm [TAAA] types I-III vs TAAA type IV/juxtarenal aortic aneurysm/pararenal aortic aneurysm) was the only independent predictor for developing a TVV-related type IC/IIIC endoleak (HR, 3.899; 95% confidence interval [CI]:, 1.924-7.900; P < .001). Risk of patency loss was independently associated with branch configuration (HR, 8.883; P < .001; 95% CI, 3.750-21.043) and renal arteries (HR, 2.848; P = .030; 95% CI, 1.108-7.319). Estimated rates at 1, 3, and 5 years of freedom from TVV instability and freedom from TVV-related reintervention were 96.6%, 93.8%, and 90% (SE, 0.005, 0.007, and 0.014) and 97.4%, 95.0%, and 91.6% (SE, 0.004, 0.007, and 0.013), respectively. CONCLUSIONS: Intraoperative failure to bridge a TVV was associated with a preoperative TVV stenosis of >50% and the use of OTS devices. Midterm outcomes were satisfying, with an estimated 5-year freedom from TVV instability and reintervention of 90.0% and 91.6%, respectively. During follow-up, the larger extent of aneurysm disease was associated with an increased risk of TVV-related endoleaks, whereas a branch configuration and renal arteries were more prone to patency loss.

In-hospital cost-effectiveness analysis of open versus staged fenestrated/branched endovascular elective repair of thoracoabdominal aneurysms.

OBJECTIVE: To compare costs and effectiveness of elective open (OR) vs fenestrated/branched endovascular (ER) repair of thoracoabdominal aneurysms (TAAAs) in a high-volume center. METHODS: This single-center retrospective observational study (PRO-ENDO TAAA Study, NCT05266781) was designed as part of a larger health technology assessment analysis. All electively treated TAAAs between 2013 and 2021 were analyzed and propensity-matched. End points were clinical success, major adverse events (MAEs), hospital direct costs, and freedom from all causes and aneurysm-related mortality and reinterventions. Risk factors and outcomes were homogeneously classified according to the Society of Vascular Surgery reporting standards. Cost-effectiveness value and incremental cost-effectiveness ratio were calculated, considering the absence of MAEs as a measure of effectiveness. RESULTS: Propensity matching identified 102 pairs of patients out of 789 TAAAs. Mortality, MAE, permanent spinal cord ischemia rates, respiratory complications, cardiac complications, and renal injury were higher for OR (13% vs 5%, P = .048; 60% vs 17%, P < .001; 10% vs 3%, P = .045; 91% vs 18%, P < .001; 16% vs 6%, P = .024; 27% vs 6%, P < .001, respectively). Access complication rate (6% vs 27%; P < .001) was higher in the ER group. Intensive care unit stay was longer (P < .001) for OR, and ER patients were discharged home more frequently (3% vs 94%; P < .001). No differences in midterm end points were observed at 2 years. Despite ER reducing all the hospital cost items (-42% to -88%, P < .001), the higher expenses (P < .001) of the endovascular devices increased the overall cost of ER by 80%. Cost-effectiveness value for ER was favorable to OR (56,365 vs 64,903 €/patient) with an incremental cost-effectiveness ratio of 48,409 € per MAE saved. CONCLUSIONS: ER of TAAA reduces perioperative mortality and morbidity compared with OR, with no differences in reinterventions and survival rates at midterm follow-up. Despite the expenses for endovascular grafts, ER was found to be more cost-effective in preventing MAEs.