Volumetric analysis in primary and residual type B aortic dissection treated with stented-assisted balloon-induced intimal disruption and relamination technique can predict aortic reintervention.

OBJECTIVE: The aim of this study was to investigate the mid-term results of stented-assisted balloon-induced intimal disruption and relamination (STABILISE) in patients with aortic dissection with the implementation of volumetric analysis. METHODS: This was a single-center retrospective analysis of prospectively collected data. From May 2017 to September 2022, 42 patients underwent STABILISE for acute complicated or subacute high-risk aortic dissection. STABILISE was completed with distal extended endovascular aortic repair in 24 patients. A computed tomography scan was performed at baseline, before hospital discharge, and at 1, 3, and 5 years. Perfused total aortic, true lumen, and false lumen volumes were assessed for thoracic, visceral, and aorto-iliac segment. The ratio between false lumen and total volume was named perfusion dissection index (PDI). Complete remodeling was defined as PDI = 0, and positive remodeling as PDI ≤0.1. RESULTS: Technical success was 97.6%. No 30-day deaths, spinal cord injuries, or retrograde dissections were observed. Mean follow-up was 44 ± 19.4 months. Thoracic diameter was lower at last available computed tomography scan (36.7 vs 33.0 mm; P = .01). Aortic growth >5 mm was observed in 9.5% of the patients. Thoracic and visceral aortic complete remodeling were 92.8% and 83.3%, respectively, with no difference between acute and subacute group. Distal extended endovascular aortic repair significantly increased complete remodeling in the aorto-iliac segment, compared with STABILISE alone (69.6% vs 21.4%; P < .001). Freedom from vascular reinterventions at 3 years was 83.1% (95% confidence interval, 71.5%-96.6%). Total PDI ≤0.1 at first postoperative control was a predictor of vascular reinterventions (P < .0001). CONCLUSIONS: STABILISE is a safe and feasible technique associated with high mid-term rates of complete remodeling in the thoracic and visceral aorta. Volumetric analysis allows the quantification of aortic remodeling and represents a predictor of aortic reinterventions.

Proximal sealing in the aortic arch for inner curve disease using the custom Relay scalloped and fenestrated stent graft.

OBJECTIVE: This study aimed to analyze early and midterm results of custom-made proximal scallop and fenestrated stent grafts for thoracic endovascular aortic repair (TEVAR) with a proximal landing zone (PLZ) in the aortic arch. METHODS: All consecutive patients treated with the custom made proximal scalloped and fenestrated Relay stent grafts (Terumo Aortic Bolton Medical Inc.) in 10 Italian centers between January 2014 and December 2022 were included. The primary end points were technical success, incidence of intraoperative major adverse events, deployment accuracy, and rate of early neurological complications, endoleaks (ELs) and retrograde aortic dissection. RESULTS: During the study period, 49 patients received TEVAR with Relay custom-made endograft in Italy were enrolled. The median patient age was 70.1 years (interquartile range, 23-86 years) and 65.3% were male. The indication for treatment was atherosclerotic aneurysms in 59.2% of cases and penetrating aortic ulcer in 22.4%. The endograft configuration was proximal fenestration in 55.1% and scallop in 44.9%. The proximal landing zone was zone 0 in 25 cases (51%), zone 1 in 14 cases (28.6%), and zone 2 in 10 cases (20.4%). The supra-aortic debranching procedures were 38 (77.5%). Technical success was 97.9% (48/49) owing to one case (2.0%) of inaccurate deployment. Intraoperatively, one (2.0%) type Ia and one (2.0%) type III EL were detected. There were no cases of in-hospital mortality, major adverse events, or retrograde dissection. Three minor strokes (6.1%) (National Institutes of Health Stroke Scale score of ≤4) were observed. At a mean follow-up time of 36.3 ± 21.3 months the rate of types I to III ELs and reintervention was 4.1%, respectively. Four patients (8.2%) died during the follow-up period, one (2.1%) from abdominal aortic rupture and three (6.1%) from nonaortic causes. CONCLUSIONS: Our early and midterm outcomes suggest that scalloped and fenestrated TEVAR may provide an acceptable alternative treatment option for aortic arch pathologies. Large-scale studies are needed to assess the long-term durability of this technique.

Long-Term Propensity-Matched Comparison of Fenestrated Endovascular Aneurysm Repair and Open Surgical Repair of Complex Abdominal Aortic Aneurysms.

PURPOSE: This study investigated the long-term outcomes of patients treated with fenestrated and branched endovascular aneurysm repair (F-BEVAR) or open surgical repair (OSR) for complex abdominal aortic aneurysms (c-AAAs). Complex abdominal aortic aneurysms are defined as aneurysms that involve the renal or mesenteric arteries and extend up to the level of the celiac axis or diaphragmatic hiatus but do not extend into the thoracic aorta. This study compares with a propensity-score matching the outcome of these procedures from 2 high-volume aortic centers. MATERIALS AND METHODS: All patients with c-AAAs undergoing repair at 2 centers between January 2010 and June 2016 were included. The long-term imaging follow-up consisted in a yearly computed tomography angiography (CTA) in the F-BEVAR group. Yearly abdominal ultrasound examination and 5-year CTA were performed in the OSR group. The primary endpoints were long-term mortality, aneurysm-related mortality, and chronic renal decline (CRD), defined as estimated glomerular filtration rate reduction to <60 mL/min/1.73 m2 or >20%/de novo dependence on permanent dialysis in patients with normal or abnormal preoperative renal function, respectively. Secondary endpoints included aortic-related reinterventions, target vessel occlusion, proximal aorta degeneration, access-related complications, graft infection, and the composite endpoint of clinical failure during follow-up. RESULTS: After 1:1 propensity matching, 102 consecutive patients who underwent F-BEVAR and OSR, respectively, were included. The median follow-up was 67 months. There was no significant difference in long-term overall mortality (40.2% vs 36.3%; p=0.40) and aneurysm-related mortality (6.8% vs 5.8%; p=0.30), in the F-BEVAR and OSR groups, respectively. During follow-up, late renal function decline occurred in 27 (27.8%) versus 46 patients (47.4%) in the F-BEVAR and OSR groups, respectively (p<0.01). During follow-up, 23 reinterventions (23.5%) were performed in the F-BEVAR group, and 5 (5.1%) in the OSR group (p<0.01). CONCLUSIONS: No differences in overall and aneurysm-related mortality were observed. Chronic renal decline was significantly higher after OSR, while the reintervention rate was higher in the F-BEVAR group. These long-term results reflect the outcomes of a complex procedure performed by a single experienced operator in 2 high-volume centers, and followed with a strict surveillance imaging follow-up. CLINICAL IMPACT: Nowadays, F-BEVAR and OSR are considered two established techniques for the treatment of c-AAA. However, long-term comparative outcomes are not well studied, and concerns may rise in terms of durability of the repair, risk of reinterventions and late chronic renal decline. The present study showed, with a median follow-up > 5 years, no differences in overall and aneurysm-related mortality. Chronic renal decline was significantly higher after OSR, while the reintervention rate was higher in the endovascular group. To achieve the best possible long-term outcomes, both techniques should be performed in high volume aortic centres, tailored to the patient, and with an adequate surveillance imaging.

Short Term Outcomes of Distal Extended EndoVascular Aortic Repair (DEEVAR) Petticoat in Acute and Subacute Complicated Type B Aortic Dissection.

OBJECTIVE: The aim of this study was to evaluate the peri-operative and short term results of institutional experience with the Distal Extended EndoVascular Aortic Repair PETTICOAT (DEEVAR PETTICOAT) procedure. METHODS: This was a single centre, observational study. From January 2015 to December 2019, 53 patients were admitted to the institution for treatment of acute and subacute complicated type B aortic dissection. Among them, data on 16 patients deemed suitable for a PETTICOAT procedure extended at infrarenal and iliac level by means of a bifurcated endograft were prospectively collected. Patients with persistent pain, visceral or lower limb malperfusion, true lumen collapse, and distal extension with computed tomography angiography (CTA) evidence of entry tears in the infrarenal or iliac zone were included. A CTA scan was performed in all patients at the baseline, before hospital discharge and then at six and 12 months post-operatively to assess aortic remodelling. Complete aortic remodelling was defined as stable aortic size (maximum enlargement < 5 mm) with complete true lumen re-expansion and complete false lumen exclusion or disappearance. RESULTS: Technical success was obtained in all patients. One patient (7%) had intra-operative infrarenal aortic rupture during balloon dilation of the distal end of the bare stent, successfully treated by deployment of a bifurcated endograft. Additional covered stenting of the visceral arteries was necessary in nine patients (56%) and malperfusion resolved immediately in all cases. There were no spinal cord ischaemia or other peri-procedural complications, and no post-operative death, stroke, paraplegia/paraparesis, or acute renal failure was observed. Follow up ranged from one month to 24 months (median 7.5 months). One patient (7%) with a history of drug abuse died from sepsis. At the last CTA check, all patients showed complete remodelling of the thoraco-abdominal aorta and iliac arteries without vessel enlargement. CONCLUSION: The present findings suggest that the DEEVAR PETTICOAT procedure provides effective sealing of all distal tears without increased risk of major peri-procedural complications. Further studies with larger number of patients and longer follow up are needed to confirm the safety and durability of this technique.

Drag Forces after Thoracic Endovascular Aortic Repair. General Review of the Literature.

BACKGROUND: Despite the great evolution of endograft devices for thoracic endovascular aortic repair (TEVAR), threatening related complication such as graft migration and endoleaks still occur during follow up. The Drag Forces (DF), that is the displacement forces that play a role in graft migration and endoleaks caused by the blood flow against the thoracic graft, can be studied by means of Computational Fluid Dynamics (CFD). METHOD: A general review of papers found in current literature was performed. CFD studies available on the topic of thoracic aortic diseases and DF were analyzed. All anatomic, hemodynamics or graft related factors which could have an impact on DF were reported. RESULTS: Different factors deeply influence DF magnitude in the different site of the Ishimaru's zones classification: angulation, tortuosity and length of the landing zone, graft diameter, length and deployment position, blood pressure, pulse waveform, blood viscosity and patient heart rate have been related to the magnitude of DF. Moreover, also the three-dimensional orientation of DF is emerging as a fundamental issue from CFD studies. DF can be divided in sideways and upward components. The former, even of higher magnitude in zone 0, maintain always an orthogonal orientation and does not change in any type of aortic arch; the latter result strictly related to the anatomic complexity of the aortic arch with values up to four times higher in zone 3. CONCLUSION: Different DF magnitude and orientation could explain how TEVAR have higher rate of migration and endoleaks when we face with more complex aortic anatomies. All these aspects should be foreseen during the planning of TEVAR procedure. In this field, collaboration between physicians and engineers is crucial, as both parts have a primary role in understanding and describing hidden aspects involved in TEVAR procedures.

Long-term results of hybrid repair techniques for Kommerell's diverticulum.

OBJECTIVE: The aim of this study was to evaluate early and late results of hybrid repair techniques for Kommerell's diverticulum (KD). METHODS: All patients who underwent hybrid repair (thoracic endovascular aortic repair + supra-aortic debranching) for KD between 2009 and 2018 were included in this retrospective multicenter study (three Italian centers). A proximal landing zone (PLZ) of at least 2 cm of healthy aorta was considered adequate for the deployment of a standard thoracic stent graft. The early end points were technical success, in-hospital mortality, and cerebrovascular events. Late outcomes included survival, reintervention, and patency of supra-aortic debranching. We used an embryogenetic anomaly based aortic arch classification for PLZ evaluation to identify the most appropriate hybrid adjunct. RESULTS: Sixteen patients with KD were included. According to the aforementioned classification, stent graft deployment was required in six patients (37.5%) in PLZ 0, nine patients (56.3%) in PLZ 1, and one patient (6.3%) in PLZ 2. Technical success was achieved in all patients. One patient (6.3%) died in the hospital because of posterior cerebral hemorrhage after total debranching (PLZ 0). No further cerebrovascular events were observed. One patient (6.3%) had an asymptomatic left subclavian artery-right left subclavian artery bypass occlusion and required early reintervention. The 30-day secondary patency of supra-aortic debranching was 100%. Two type II endoleaks (12.5%) were detected at 1 month through computed tomography angiography. Further transient complications were found in three cases: hemidiaphragm paralysis in one patient and recurrent laryngeal nerve paralysis in two patients. At a mean follow-up of 48 months, four patients had died because of nonaortic reasons, and one RCCA-right subclavian artery bypass had lost its patency. None of the patients reported any growth of KD after hybrid repair. Ten patients (62.5%) showed aneurysmal sac shrinkage of at least 5 mm. CONCLUSIONS: Hybrid repair is confirmed to be a safe and effective approach for KD. Operative risk is associated primarily with the invasiveness of the hybrid adjunct.

Distal Extended Endovascular Aortic Repair PETTICOAT: A Modified Technique to Improve False Lumen Remodeling in Acute Type B Aortic Dissection.

BACKGROUND: Data from the literature suggest that in patients with acute, complicated type B aortic dissection (cTBAD), initial successful treatment with thoracic endovascular aneurysm repair (TEVAR) is not necessarily associated with favorable remodeling of the dissected aorta during follow-up, and long-term results indicate that TEVAR failed to completely suppress false lumen patency. Sealing of all relevant distal reentries, infrarenal and/or iliac, seems to be the key issue to induce total false lumen thrombosis in abdominal aorta as well as the iliac arteries, especially in complicated patients presenting with malperfusion or complete true lumen collapse. MATERIALS AND METHODS: Of the 34 consecutive patients diagnosed with cTBAD at our hospital from January 2015 to April 2018, 30 had complicated dissections receiving endovascular treatment according to the standard Provisional ExTension To Induce COmplete ATtachment (PETTICOAT) technique and were excluded from this study, whereas 4 patients with radiologic evidence of multiple reentry tears at detached lumbar arteries and iliac bifurcation with complete true lumen collapse and clinical evidence of malperfusion were treated with a modified PETTICOAT technique with distal extension of the aortic stent, balloon expansion of the stented true lumen, and use of the AFX bifurcated endograft system to preserve the natural aortic bifurcation and provide complete distal sealing of reentry tears. RESULTS: Primary technical success was achieved in all patients. No postoperative deaths were observed, but 1 patient experienced an hemorrhagic shock on the second postoperative day. No patient suffered postoperative stroke, paraplegia, paraparesis, or acute renal failure. CONCLUSIONS: Using an abdominal aortic bifurcated endograft with PETTICOAT to treat acute cTBAD seems to be a feasible approach in high-risk patients to improve aortic remodeling. The AFX bifurcated endograft system meets the requirements of anatomical fixation and sealing of distal tears.

Endovascular repair of ascending aortic pathologies in patients unfit for open surgery: case series and literature review.

The number of vascular centers performing endovascular repair of ascending aortic disease is constantly increasing. Accordingly to the guidelines, open surgical repair remains the gold standard for these pathologies. However, approximately one quarter of patients are deemed unfit for open surgery. In this study, we describe three cases of ascending thoracic endovascular aortic repair (TEVAR) performed at our center. All the patients were deemed unfit for open surgery by the aortic team. Two patients had an ascending aortic pseudoaneurysm, and the third had a focal type A aortic dissection. In two cases, we used two abdominal aortic cuffs deployed from zone 0B to zone 0C, with no need for supra-aortic trunk debranching. In one case, we performed a "reverse" extrathoracic debranching, and we deployed a thoracic endograft from zone 0B to zone 2. Complications included one minor stroke and one inguinal hematoma. In one patient with an infected pseudoaneurysm, we performed ascending TEVAR as a bridge strategy for open repair. This patient developed a type Ia endoleak; however, clinical stabilization and infection control were obtained, and he was able to undergo heart surgery successfully. He underwent a second reintervention to treat superior mesenteric embolic occlusion. At 2 years of follow-up, all three patients were alive. Our preliminary experience demonstrates the technical feasibility and clinical appropriateness of ascending TEVAR using standard, commercially available endografts. However, no consensus has been reached regarding some critical aspects, such as the development of a standardized technique or the efficacy of the currently available devices. The improvements in graft design and the adoption of the "aortic team" approach could help in the near future to standardize the procedure, establish appropriate indications, and ensure good clinical outcomes.

Long-Term Results of Complex Abdominal Aortic Aneurysm Open Repair.

This study investigated the long-term outcomes of patients treated with open surgical repair for complex abdominal aortic aneurysms (c-AAAs). A total of 119 patients with c-AAAs undergoing repair between January 2010 and June 2016 in a high-volume aortic center were included. The long-term imaging follow-up consisted of yearly abdominal ultrasound examinations and 5-year computed tomography angiography. At a median follow-up of 76 months (IQR 38 months), forty-three deaths (37%) and three (2.5%) aortic-related deaths were observed. Long-term chronic renal decline was observed in fifty (43.8%) patients, significantly correlated with post-operative acute kidney injury. During the follow-up, five reinterventions (4.3%) were performed. The present study suggests that open c-AAA repair can be performed with acceptable operative risk with durable results. To achieve the best possible long-term outcome, the open surgery repair of complex AAA should be performed in high-volume aortic centers and tailored to the patient.

A multicenter "real-world" study of the valiant NAVION stent graft.

BACKGROUND: The aim of the present study was to evaluate early results of thoracic endovascular aortic repair (TEVAR) using the Valiant Navion™ stent graft in a "real-world" scenario. METHODS: All patients who underwent TEVAR with the Valiant Navion™ endograft between November 2018 and November 2019 were included in this retrospective multicenter study (six European centers). The primary endpoints were technical success, incidence of major adverse events (MAEs), access failure, deployment failure, deployment accuracy, and rate of intraoperative endoleaks (ELs). RESULTS: One hundred-sixteen patients with varying thoracic aortic diseases were included. Eighteen patients (15.5%) were treated for an off-label condition. The technical success rate was 100%, without any access or deployment failures. The proximal and distal deployment accuracy rates were 99.1% and 97.4%, respectively. There were no intraoperative MAEs, including death. Two (1.7%) type Ib ELs were detected at the first postoperative CTA, all of which were in off-label procedures and related to the short length of the sealing neck. No type III ELs were detected. The median hospitalization time was 8 days (IQR 4-12), including a median intensive care unit stay of 1 day (IQR 1-2). The in-hospital mortality rate was 4.3%. At a median follow-up time of 98 days (IQR 39-187), there were no aortic-related mortalities or new onset of endoleaks. CONCLUSION: Our initial experience with the Valiant Navion™ endograft in a wide variety of aortic diseases showed safe early outcomes, especially for on-label procedures.

Aortic treatment in connective tissue disease.

Connective tissue disease (CTD) represents a group of genetic conditions characterized by disruptive matrix remodeling. When this process involves aortic and vascular wall, patients with CTD have a high risk of developing arterial aneurysms, dissections and ruptures. Open surgical repair is still the gold standard therapy for patients with CTD with reasonable morbidity and mortality risk. The surgical treatment of CTD often requires multiple operations. In the endovascular era, fenestrated and branched stent grafts may play a role in reducing the complications of multiple open operations. Although the long-term results of endovascular treatment in the setting of CTD are unknown, it is generally accepted that endovascular treatment is restricted to selected patients with high surgical risk. In an emergency setting, endovascular intervention can serve as a lifesaving bridge to elective open aortic repair. Aortic centers performing a large volume of complex open and endovascular aortic repairs have started to combine these two techniques in a staged fashion. The goal is to reduce the morbidity and mortality associated with extensive aortic repairs in CTD patients. For this reason, recommend endovascular therapy when a "graft-to-graft" approach is possible. In this scenario, the surgeon who performs the open repair must take into consideration future interventions. Surgical repair in any aortic segment should allow creation of proximal and distal landing zones over 4 cm to secure the sealing of a future stent graft. Connective tissue disease should be treated with a multidisciplinary approach, in high volume centers. Endovascular treatment represents a potential option in patients at high risk for open repair. Staged hybrid procedures have emerged as a way to reduce spinal cord ischemia and avoid multiple open surgeries. The aim of this article is to discuss the management of aortic diseases in CTD, focusing on to the role of standard open surgery and emerging endovascular treatment, and to give an overview of the few series published regarding this topic with a small number of patients.

Frozen elephant trunk and arch endografts for chronic thoracoabdominal aortic dissections.

Chronic aortic dissecting aneurysms (TAAD) presenting after acute Stanford type A or B dissection includes both arch and/or thoracoabdominal aortic aneurysms (TAAA). Approximately 60% of patients who survive surgical treatment of acute type A aortic dissections will require another aortic procedure. Similarly, more than 70% of patients with chronic type B aortic dissections will experience false lumen dilation at 5-year follow-up, often requiring intervention. Open or hybrid aortic repairs of complex TAAD involving the arch and the TAAA are very demanding procedures for both patients and clinicians. Open surgery remains the first line therapy in fit patients. Recent development of branched arch devices has offered an alternative option for high-risk patients. Technical challenges associated with the endovascular management of these complex aneurysms include proximal sealing zone often located in the aortic arch or the ascending aorta, narrow true lumen working space, and aortic branch perfusion by either the true or false lumen, or both. Recent studies have reported encouraging results with endovascular treatment of these complex dissecting aneurysms, especially following open ascending aortic repair. The aim of this review was to describe the available strategies for arch repair in the setting of a chronic TAAD and to determine the subset of patients that can benefit from of a totally endovascular approach.