Endovascular Aortic Arch Research Articles

Preclinical Evaluation of a Non-Customized Modular Inner Branched Stent Graft for Total Endovascular Aortic Arch Repair in a Porcine Model

Objectives: The aim of this study was to evaluate the feasibility and safety of a non-customized modular inner branched stent graft for total endovascular aortic arch repair in a porcine model. Methods: The modular inner branched stent graft system with a split main body design included 1 proximal main component, 1 distal main component, and 1 branched covered stent. The gutter in the proximal main component was sealed with sutured membrane. Fatigue testing was performed to evaluate the durability of the stent graft. Fifteen pigs were used in this study. In each pig, a stent graft was delivered and deployed to the aortic arch through the femoral arterial access and right carotid arterial access. Angiography and computed tomography angiography were used to evaluate the morphological features before euthanasia. After euthanasia, the implanted device, surrounding tissue, and major organs were harvested for gross and histological examination. Results: There were no collapses and no stent graft fractures detected after fatigue testing. The technical success rate was 14/15, and the incidence of major adverse cardiovascular events was 2/15. Angiography performed at the end of follow-up revealed no endoleaks and no device migration. Histological examination demonstrated excellent biocompatibility of the stent graft. Conclusions: The non-customized modular inner branched stent graft system is safe and feasible for the endovascular reconstruction of the aortic arch in a porcine model.

In Vivo Quantification of Cardiac-Pulsatility-Induced Motion Before and After Double-Branched Endovascular Aortic Arch Repair

The Relay®Branch stent-graft (Terumo Aortic, Sunrise, FL, USA) offers a custom-made endovascular solution for complex aortic arch pathologies. In this technical note, a modified electrocardiography (ECG)-gated computed tomography (CT)-based algorithm was applied to quantify cardiac-pulsatility-induced changes of the aortic arch geometry and motion before and after double-branched endovascular repair (bTEVAR) of an aortic arch aneurysm. This software algorithm has the potential to provide novel and clinically relevant insights in the influence of bTEVAR on aortic anatomy, arterial compliance, and stent-graft dynamics.

The End of Wire Wrapping: A Technique to Avoid Intertwining Preloaded Guidewires for Endovascular Aortic Arch Repair

The development of new endografts and techniques has improved the results of endovascular aortic arch repair in recent years. Fenestrated endovascular repair is now the new frontier to be crossed. However, certain technical barriers have prevented further progress in endovascular arch repair. The purpose of this study was to present a new technique for endovascular aortic arch repair for one, two, or three vessels using preloaded wires and precannulated target vessels without wire wrapping.

Total Endovascular Aortic Arch Repair: From Dream to Reality.

The gold-standard therapy for the treatment of aortic arch pathologies is conventional open surgery. Recently, total endovascular aortic arch replacement with branched stent-grafts has been introduced into clinical practice with the aim of reducing invasiveness especially in selected high-risk patients. The aim of this review is to describe the two most commonly used branched devices for endovascular arch stent-grafting: Nexus (Endospan, Herzlia, Israle) and RelayBranch (Terumo Aortic, Glasgow, United Kingdom). Nexus is a CE-certified off-the-shelf, single branch, double stent graft system. It consists of two different components: a main module for the aortic arch and the descending aorta with a side-branch for the brachiocephalic artery (BCA), and a curved module for the ascending aorta that lands into the sino-tubular junction and connects to the main module through a side-facing self-protecting sleeve. Nexus may be used in urgent-emergency cases and also in patients with only one suitable supra-aortic target vessel but, on the other hand, it makes cerebral blood flow dependent on one source vessel only. The RelayBranch Thoracic Stent-Graft System is a custom made, double branched endograft with a wide window on its superior portion to accommodate two inner tunnels for BCA and left common carotid artery connection; bilateral cervical accesses are generally used to advance guidewires for catheterization of the inner tunnels in a retrograde fashion. RelayBranch can be customized on every patient’s specific anatomy and provides a double blood source for the brain, but it cannot be used in urgent-emergency conditions. Therefore, in order to optimize outcomes, the choice of the most appropriate device should be made considering pros and cons of each system and patient’s anatomy by an experienced aortic team. In conclusion, total endovascular aortic arch exclusion is a promising reality in selected high-risk patients.

Tratamiento endovascular del arco aórtico con la prótesis NEXUS™: experiencia inicial de un centro

Introduction and objectivesThe treatment of aortic arch pathology is highly complex. Most of the open techniques are performed with circulatory arrest, and consequently there are patients who, due to their comorbidities, are not candidates for this approach. Recently, the endovascular treatment of the arch has opened a therapeutic window for them. The NEXUS™ prosthesis (Endospan Ltd/Jotec GmbH) is developed to cover the aortic arch. This article presents the initial experience at our center. MethodsBetween August 2020 and July 2021 two patients were treated with the NEXUS™ prosthesis in our center. Retrospectively, the technical and postoperative results, as well as the clinical and radiological follow-up, were collected in accordance with the current reporting standards. ResultsWe performed the intervention in two surgical stages, using the first for the debranching of the supraaortic trunks, and the second to implant the NEXUS™ device from zone 0B to zone 4 of the aorta.No patient presented temporary or permanent neurological deficits. They also did not present complications of vascular access or postoperative bleeding. In the postoperative control and follow-up CT we did not observe type I or III endoleaks. Follow-up is 14.7 and 3.3 months. ConclusionsThe results of endovascular aortic arch repair with the NEXUS™ System with respect to technical success are promising. In our experience, we did not find in-hospital complications. To obtain more robust results we need a larger sample volume and carry out a more extensive follow-up.

Mid-term outcomes of hybrid debranching endovascular aortic arch repair in landing zones 0-2.

The aim of this study is to summarize a single-center experience of hybrid debranching endovascular repair of the aortic arch and proximal descending thoracic aorta (DTA) with regard to the mid-term outcomes with highlighting the difference between the landing zones 0-2. A retrospective review of data from a prospectively collected registry (Gangnam Severance Endovascular Aortic Registry) was performed. From among 332 patients whose aortic pathology was managed with TEVAR, 112 patients who underwent hybrid arch repair during the study period between 2012 and 2016 were identified. The patients were grouped into three cohorts according to the proximal landing zones (0, 1, and 2) of Ishimaru. The early outcome (30-days) in terms of mortality, morbidity, supra-aortic vessels patency, and presence of endoleak were analyzed. The survival, freedom from re-intervention, and major complications during follow-up were demonstrated. During the study period. 112 patients (mean age 65±7, 79% males) were included. The patients were distributed in three cohorts: 8 (7%) patients with proximal landing zone 0, 20 (18%) with zone 1, and 80 (75%) with zone 2 hybrid aortic arch repair. Technical success was achieved in 7 (88%), 19 (90%), and 79 (94%) patients for zones 0, 1, and 2, respectively. The mean intensive care unit (ICU) stay was shorter in zone 2 (p = .005). The mean total hospital stay was shorter in zone 2 (p = .03). The overall in-hospital mortality rate was 5% (4/112). There was no spinal cord ischemia or early surgical conversion. Renal function deterioration was seen more but not significantly in zone 0 patients (p = .08). Respiratory failure was seen significantly in zone 0 patients (p = .01). Stroke occurred in 6/44 (14%) patients with degenerative aneurysm versus 1/60 (2%) patients with aortic dissection (p =.06). Early CTA showed 100% patency of the supra-aortic vessels. The early endoleak rate was significant in zone 0 patients (p = .008). The mean follow-up period was (32±19months). The survival rates and freedom from re-intervention were not statistically significant among the three zones. However, the survival rate and freedom from intervention tend to be higher in zone 2 versus zone 0 (p = .07 and .09), respectively. Hybrid debranching endovascular aortic arch repair is feasible and relatively safe with acceptable mid-term outcomes. Zone 0 patients has worse early and late outcomes in comparison to other zones. Careful patient selection and improved endovascular technology may be the key to improve the outcomes.

Outcomes of Total Endovascular Aortic Arch Repair With Surgeon-Modified Fenestrated Stent-Grafts on Zone 0 Landing for Aortic Arch Pathologies

Outcomes of Total Endovascular Aortic Arch Repair With Surgeon-Modified Fenestrated Stent-Grafts on Zone 0 Landing for Aortic Arch Pathologies

Early Results and Feasibility of Total Endovascular Aortic Arch Repair Using Three-Vessel Company-manufactured and Physician-modified Stent Grafts

Total endovascular repair of aortic arch aneurysms is feasible in select patients. Unfortunately, and because of anatomic constraints, some patients are ineligible for company-manufactured devices. This study aims to evaluate the feasibility and early outcomes of total endovascular arch repair using three-vessel company-manufactured and physician-modified stent grafts.

Modular Endo-Bentall Procedure Using a “Rendez-Vous Access”

Purpose: The concept of a single endovascular valve-carrying conduit device was designated endo-Bentall, but published experience is limited to a single case. This technical note describes an alternative modular endo-Bentall technique and a novel access technique to implant it. Technique: A 82-year-old woman with chest pain referred for a 10 cm symptomatic aneurysm of the distal arch and descending aorta. An ascending aortic aneurysm of 5.5 cm prevented endovascular aortic arch repair due to lack of a proximal landing zone. The technique is a modular approach combining a physician-modified endograft (PMEG) with 3 large fenestrations for coronary artery perfusion and a transcatheter aortic valve implantation (TAVI). A “rendez-vous access” with a transapical and transfemoral through-and-through wire offered rapid sequential deployment in a modular fashion of both components. The PMEG was deployed first, landing 5 mm deep in the left ventricular outflow tract (LVOT) and the transcatheter aortic valve was implanted few millimeters below. The endo-Bentall procedure was combined with endovascular aortic arch repair. Conclusion: A modular endo-Bentall procedure combining a PMEG and TAVI is feasible and adaptable to emergent setting using the “rendez-vous access.”

Comparison of the Outcomes of Total Endovascular Aortic Arch Repair Between Branched Endograft and Chimney Endograft Technique in Zone 0 Landing

Purpose: Zone 0 landing in thoracic endovascular aortic repair (TEVAR) has recently gained increasing attention for the treatment of high-risk patients. The aim of this study was to compare the outcomes of total endovascular aortic arch repair between branched TEVAR (bTEVAR) and chimney TEVAR (cTEVAR) in the landing zone (LZ) 0. Materials and Methods: This was a single-center, retrospective, and observational cohort study. From January 2010 to March 2020, 40 patients (bTEVAR, n=25; cTEVAR, n=15; median age: 79 years) were enrolled in this study, with a median follow-up period of 4.1 years. These patients were considered unsuitable for open surgical treatment. Results: All procedures were successful and no cases of conversion to open repair were noted during the 30-day postoperative period. The 30-day mortality was 2.5% (n=1; bTEVAR [0 of 25, 0%] vs cTEVAR [1 of 15, 6.7%]; p=0.375), the perioperative stroke rate was 10.0% (n=4; bTEVAR [4 of 25, 16.0%] vs cTEVAR [0 of 15, 0%], p=0.278), and type 1a endoleak rate was 15.0% (n=6; bTEVAR [0 of 25, 0%] vs cTEVAR [6 of 15, 40.0%], p=0.001). The risk factor for stroke was atheroma grade of ≥2 in the brachiocephalic artery (p<0.001). The risk factor for type 1a endoleak was cTEVAR (p=0.001). The 8-year survival rate was 49.9%. The aorta-related death-free rate and aortic event-free rate at 8 years were 94.4% (bTEVAR: 95.5% vs cTEVAR: 93.3%, p=0.504) and 60.7% (bTEVAR: 70.7% vs cTEVAR: 40.0%, p=0.048), respectively. Conclusions: Total endovascular aortic arch repair using bTEVAR and cTEVAR is feasible for the treatment of aortic arch diseases in high-risk patients who are unsuitable for open surgery. However, as the rate of stroke is high, strict preoperative evaluation to prevent stroke is needed. No rupture of the aneurysm was observed in cTEVAR, but patients should be selected carefully because of the high incidence of type 1a endoleak.

Morphology of the left subclavian artery: implications for single-branched endovascular aortic arch repair.

Our goal was to evaluate the morphology of the aortic arch, focusing on the left subclavian artery (LSA), and to anticipate implications for single-branched endovascular aortic arch repair. We performed a morphological analysis of computed tomography angiography scans of 322 patients between January 2002 and December 2018. Arch type and distance between arch vessels on the convexity were evaluated. We defined 3 morphological types: U-type distance between the left common carotid artery (LCCA) and LSA offspring >10 mm; V-type distance between the LCCA and LSA offspring <10 mm and W-type isolated left vertebral artery offspring from the aortic arch. Most patients presented a type III arch [50% (n = 161)]. The median distance from the brachiocephalic trunk offspring to the LCCA offspring measured 2.5 mm (2.0-3.0 mm) and that between the LCCA offspring and the LSA offspring was 6.5 mm (4.0-11.0 mm). We observed no significant difference based on the morphological type (V versus U versus W) in the brachiocephalic trunk-LCCA distance, but there were significant differences in the LCCA-LSA distance between types V and U (P < 0.001) and between types V and W (P < 0.001). Interestingly, we found no significant difference in the LCCA-LSA distance between types U and W. We noted a significant difference in the median diameter of the LSA according to U, V and W types: V type versus U type, 12.5 vs 13.5 mm (P = 0.033) as well as U type versus W type, 13.5 vs 10.5 mm (P < 0.001) and V type versus W type, 12.5 vs 10.5 mm (P < 0.002). The distances between the LSA offspring and left vertebral artery offspring between types U and V did not differ significantly. Our categorization of the U, V and W types of the LSA can help us anticipate shapes and distances and thereby function as an initial evaluation tool for predicting single branched endovascular aortic arch repair involving the LSA.

Short-Term Outcomes of In Situ Fenestration in Total Endovascular Aortic Arch Treatment

The aim of this study was to analyze the short-term outcomes of in situ fenestration and discuss its feasibility and safety for the treatment of aortic dissection or aneurysm involving aortic arch. A retrospective single-center review was conducted on patients who were treated with ISF technique to revascularize supra-arch branches from Jun 2017 to Oct 2019. Computed tomographic angiography was performed to assess the patency of bridging stents, endoleaks and prognosis prior to discharge, after 3 months, 6 months, 12 months and yearly thereafter. Patient demographics, operative details, clinical outcomes, and complications were analyzed and then discussed in this paper. A total of 21 patients were diagnosed with arch pathologies, 5 type A aortic dissections, 12 type B aortic dissections and 4 thoracic aortic aneurysms. There were 19 men and 2 women (mean age 60.7 ± 15.3). 8 cases were treated with three-fenestration stent grafts, 1 case with two-fenestration stent graft, and 12 cases with single-fenestration stent grafts. Overall technical success rate was 95.2%. Mean operation time was 227.4 ± 143.8 minutes. Complications were intraoperative hemorrhage (>1000 ml, 2), stroke (2), hydropericardium (1) and endoleaks (2 type Ⅲ, 1 type Ⅰ). There was no aorta-related mortality or late endoleaks during the mean follow-up of 25.5 ± 6.2 months. All the bridging stents remained patent and there was no migration according to follow-up Computed tomographic angiography. With low complication and mortality rate, ISF is an effective and feasible method for the total endovascular aortic arch repair. Long-term follow-up study is needed to evaluate its durability.

The End of Wire Wrapping: A Technique to Avoid Intertwining Preloaded Guidewires for Endovascular Aortic Arch Repair

Purpose: The purpose of this study was to present a new technique for endovascular aortic arch repair for 1, 2, or 3 vessels using preloaded wires and precannulated target vessels without wire wrapping. Technique: This technique uses a prototype catheter with 2 parallel lumens to position through-and-through guidewires in the supra-aortic branches and an extra-stiff guidewire in the ascending aorta with no wrapping. This allows the introduction and advancement of the device with the already precannulated target vessels. The endograft is advanced to the aortic arch without twisting or wrapping. Covered stents are deployed to align the graft and target vessels. Conclusion: To our knowledge, a technique that avoids wire wrapping has not been previously described. This technique allows safer and faster endovascular arch procedures and opens up new possibilities by enabling multi-vessel endovascular aortic arch repair with all precannulated target vessels.

Outcomes of Total Endovascular Aortic Arch Repair with Surgeon-Modified Fenestrated Stent-Grafts on Zone 0 Landing for Aortic Arch Pathologies

Objectives This study evaluated the feasibility and safety of total endovascular aortic arch repair with surgeon-modified fenestrated stent-graft on zone 0 landing for aortic arch pathologies. Methods Between June 2016 and October 2019, 37 consecutive patients underwent total endovascular arch repair with surgeon-modified fenestrated stent-grafts on zone 0 landing. Outcomes included technical success, perioperative and follow-up morbidity and mortality, and branch artery patency. Results During the study period, 37 patients were treated with total endovascular aortic arch repair with surgeon-modified fenestrated stent-graft. Twenty-one (56.8%) patients were diagnosed with aortic dissections, 15 (40.5%) patients with aneurysms, and 1 (2.7%) patient required reintervention due to endoleak and sac expansion from previous thoracic endovascular aortic repair for thoracoabdominal aneurysm. The proximal landing zone for all patients were in zone 0, and all branch arteries of aortic arch were reconstructed. Technical success was achieved in 34 cases (91.9%). Three (8.1%) patients had fenestrations misaligned with target arteries, and the chimney technique was applied as a complementary measure. Thirty-day mortality rate was 5.4% (n=2). Thirty-day stroke rate was 5.4% (n=2). Thirty-day reintervention rate was 2.7% (n=1). At a median follow-up of 20 months (range, 3–49 months), 5 (13.5%) patients died, including 2 aortic-related deaths, 1 nonaortic-related death, and 2 deaths of unknown reason. One (2.7%) patient had stroke. Four patients (10.8%) had reintervention during the follow-up, including 2 cases of left subclavian artery occlusion and 2 cases of type II endoleak. The estimated survival (±SE) at 2 years was 72.4%±9.7% (95% CI 53.4%–91.4%). The estimated freedom from reintervention (±SE) at 2 years was 87.4%±5.9% (95% CI 75.84%–98.96%). Conclusions Total endovascular aortic arch repair with surgeon-modified fenestrated stent-grafts on zone 0 landing is an alternate option for the treatment of aortic arch pathologies in experienced centers.

Endovascular aortic arch repair with a pre-cannulated double-fenestrated physician-modified stent graft: a benchtop experiment.

The critical step in total endovascular aortic arch repair is to ensure alignment of fenestrations with, and thus maintenance of flow to, supra-aortic trunks. This experimental study evaluates the feasibility and accuracy of a double-fenestrated physician-modified endovascular graft [single common large fenestration for the brachiocephalic trunk and left common carotid artery and a distal small fenestration for left subclavian artery (LSA) with a preloaded guidewire for the LSA] for total endovascular aortic arch repair. Eight fresh human cadaveric thoracic aortas were harvested. Thoracic endografts with a physician-modified double fenestration were deployed for total endovascular aortic arch repair in a bench test model. A guidewire was preloaded through the distal fenestration for the LSA. All experiments were undertaken in a hybrid room under fluoroscopic guidance with subsequent angioscopy and open evaluation for assessment. Mean aortic diameter in zone 0 was 31.3 ± 3.33 mm. Mean duration for stent graft modification was 20.1 ± 5.8 min. Mean duration of the procedure was 24 ± 8.6 min. The Medtronic Valiant Captivia stent graft was used in 6 and the Cook Alpha Zenith thoracic stent graft in 2 cases. LSA catheterization was technically successful with supra-aortic trunk patency in 100% of cases. The use of a double-fenestrated stent graft with a preloaded guidewire appears to be a useful technical addition to facilitate easy and correct alignment of stent graft fenestrations with supra-aortic trunk origins.

Endovascular Solutions for Aortic Arch Diseases: Total and Hybrid

Although the endovascular approach is the therapeutic option of choice for thoracic and abdominal aortic diseases, open surgery is still the treatment of choice for aortic arch diseases. While open surgical repair remains the gold standard treatment for complete aortic arch replacement, it continues to be burdened by high mortality and neurologic complications, especially for patients who require redo surgery. Therefore, in the era of endovascular surgery, it is not surprising that hybrid operating rooms, new technologies, and new approaches are strongly challenging open surgery. Less-invasive endovascular procedures, when used to treat aortic arch diseases, when feasible and indicated, have clear advantages over open surgery, primarily because there is no need for cardiopulmonary bypass, hypothermic circulatory arrest, or cerebral protection. Moreover, patients who have already been treated for acute type A aortic dissection continue to have a considerable risk for future aortic reintervention, which is associated with increased risk for short- and long-term mortality. In light of these advantages, it is clear how selected high-risk patients with aortic arch disease could benefit from the endovascular approach. However, the hemodynamic and anatomic characteristics of the aortic arch make the endovascular approach in this region challenging. In fact, uncorrected stent-graft placement can have fatal consequences for the patient and increase the risk of endoleaks and stroke. To minimize these potential risks, precise and accurate preoperative planning to achieve optimal stent-graft dimensions and implantation is essential together with careful patient selection. Endovascular options for the treatment of aortic arch disease include both hybrid procedures and total endovascular solutions. This manuscript provides an overview of the current strategies for endovascular aortic arch treatment, including the most recent available series on this topic. In addition, a literature search offers insight into the current state of the art.

Results of endovascular aortic arch repair using the Relay Branch system.

Our goal was to evaluate results of endovascular aortic arch repair using the Relay Branch system. Forty-three patients with thoracic aortic pathology involving the aortic arch have been treated with the Relay Branch system (Terumo Aortic, Sunrise, FL, USA) in 10 centres. We assessed in-hospital mortality, neurological injury, treatment success according to current reporting standards and the need for secondary interventions. In addition, outcome was analysed according to the underlying pathology: non-dissective disease versus residual aortic dissection (RAD) (defined as remaining dissection after previous type A repair, chronic type B aortic dissections). In-hospital mortality was 9% (0% in patients with RAD). Disabling stroke occurred in 7% (0% in patients with RAD); non-disabling stroke occurred in 19% (7% in patients with RAD). Early type IA and B endoleak formation occurred in 4%. Median follow-up was 16 ± 18 months. During the follow-up period, 23% of the patients died. Aortic-related deaths were low (3% in patients with RAD). The results of endovascular aortic arch repair using the Relay Branch system in a selected patient population with regard to technical success are good. In-hospital mortality is acceptable, the number of disabling strokes is low and technical success is high. Non-disabling stroke is a major concern, and every effort has to be taken to reduce this to a minimum. The best outcome is seen in patients with underlying RAD. Finally, more data are needed.

The current status of endovascular aortic arch repair

Endovascular aortic arch repair provides treatment opportunity for patients with aortic arch dissection and aneurysm who are intolerant to open surgery. The aortic arch branches provide the blood flow for brain, the revascularization of these branches is part and parcel of the endovascular aortic arch repair. The anatomical configuration, high-speed blood flow and long access from femoral artery increase the difficulty of endovascular aortic arch repair. Debranch technique, combined with chimney, scallop, and fenestration, have partially simplified the endovascular aortic arch repair. The dedicated endografts for aortic arch is becoming a research focus. In the design of aortic arch endografts, fenestrated and branched stent-grafts are the two main strategies. A variety of innovative concepts have been applied in the design of aortic arch endografts, including modular and integrated design, inner branch and outer branch design, single branch and multi-branch design, etc. Today, these procedures of complex endovascular aortic arch repair still need to be limited to experienced centers. Endovascular aortic arch repair showed favorable short-term outcomes through the development of strict surgical plans, as well as effective teamwork. Long-term efficacy and safety in larger participants need further investigation.

Multicenter global early feasibility study to evaluate total endovascular arch repair using three-vessel inner branch stent-grafts for aneurysms and dissections

ObjectiveWe evaluated the outcomes of total endovascular aortic arch repair using three-vessel inner branch stent-grafts for aneurysms and chronic dissections. MethodsWe reviewed the clinical data and outcomes of consecutive patients treated by total endovascular aortic arch repair at eight academic centers using three-vessel inner branch stent-grafts (William Cook Europe, Bjaeverskov, Denmark) from 2016 to 2019. All patients received three-vessel designs with two antegrade and one retrograde inner branch, which was used to incorporate the innominate, left common carotid, and left subclavian arteries. The antegrade inner branches were accessed via a carotid or an upper extremity approach. A preloaded catheter was used for access to the retrograde left subclavian artery branch via a transfemoral approach. The endpoints were technical success, mortality, major adverse events, any stroke (minor or major) or transient ischemia attack, secondary interventions, target vessel patency, target vessel instability, aneurysm-related mortality, and patient survival. ResultsA total of 39 patients (31 men [79%]; mean age, 70 ± 7 years) had undergone treatment of 14 degenerative (36%) and 25 chronic (64%) postdissection arch aneurysms. The clinical characteristics included American Society of Anesthesiologists class ≥III in 28 patients (95%) and previous median sternotomy for ascending aortic repair in 28 patients (72%). The technical success rate was 100%. Two patients had died in-hospital or within 30 days (5%), and two patients had experienced a stroke (one minor). The combined mortality and any stroke rate was 8% (n = 3). Major adverse events occurred in 10 patients (26%), including respiratory failure in 4 (10%) and estimated blood loss >1 L, myocardial infarction, and acute kidney injury in 2 patients each (5%). The median follow-up was 3.2 months (interquartile range, 1-14 months). Of the 39 patients, 12 (31%) required secondary interventions to treat vascular access complications in 5, endoleak in 6 (three type II, one type Ic, one type Ia/Ib, one type IIIa), and target vessel stenosis in 1 patient. At 1 year, the primary and secondary patency rates and freedom from target vessel instability were 95% ± 5%, 100%, and 91% ± 5%, respectively. Freedom from aortic-related mortality and patient survival was 94% ± 4% and 90% ± 6%, respectively. ConclusionsThe findings from the present multicenter global experience have demonstrated the technical feasibility and safety of total endovascular aortic arch repair for aneurysms and chronic dissections using three-vessel inner branch stent-grafts. The mortality and stroke rates compare favorably with those after open surgical repair in a higher risk group of patients. However, the rate of secondary interventions was high (31%), emphasizing need for greater experience and longer follow-up.

Double fenestrated physician-modified stent-grafts for total aortic arch repair in 50 patients

ObjectiveOur aim was to evaluate the early- and medium-term outcomes of using double fenestrated physician-modified endovascular grafts (PMEGs) for total endovascular aortic arch repair. MethodsThe present single-center retrospective analysis of prospectively collected data included 50 patients from January 2017 through October 2019, who had undergone thoracic endovascular aortic repair (TEVAR). The fenestrations were a proximal larger fenestration that incorporated the brachiocephalic trunk and left common carotid artery and a distal smaller fenestration for the left subclavian artery (LSA). Only the LSA fenestration was stented. ResultsThe median duration for stent graft modification was 26 ± 6 minutes. Of the 50 patients, 41 were men. The mean patient age was 68 ± 11.5 years. The indications for treatment included degenerative aortic arch aneurysm (n = 17), dissecting aortic arch aneurysm after type A dissection (n = 13), type B dissection (n = 13), aortic ulcer (n = 3), and other pathologies (n = 4). The technical success rate was 94% (47 of 50) overall, and 100% (28 of 28) after a technical modification incorporating a preloaded guide wire for the LSA fenestration (P < .05). The 30-day mortality was 2% (n = 1). Two patients (4%) had a minor stroke with full recovery. One patient (2%) had a type IB and two patients (4%) had a type II endoleak from the LSA. Four patients (8%) required reintervention: one because of a type IB endoleak and three because of access-related complications. All supra-aortic trunks were patent. During a mean follow-up of 16 ± 8.3 months, no conversions to open surgical repair were required and no aortic rupture, paraplegia, or retrograde dissection occurred. ConclusionsUsing double fenestrated PMEGs for TEVAR is both feasible and effective for total endovascular aortic arch repair, avoiding the need for anatomic and extra-anatomic surgical revascularization. The absence of brachiocephalic trunk stenting was not associated with endoleaks or treatment failure and resulted in a lower stroke risk than alternative strategies. The midterm results suggest that stenting of the brachiocephalic trunk and right common carotid artery might not be necessary for a large proportion of patients undergoing total endovascular aortic arch repair. The persistence of the seal and ongoing durability require assessment in studies with long-term follow-up data available.