[Endovascular Repair of Aortic Injury Caused by Esophageal Foreign Body:Report of a Case].

A 51-year-old man visited to our hospital because of chest discomfort and hematemesis. He was diagnosed with Mallory-Weiss syndrome and followed in outpatient clinic. One week later, he visited our hospital again for fever and discomfort. Chest computed tomography (CT) showed a foreign body perforated in the mediastinum in the upper esophagus, and he was urgently hospitalized for surgical removal of esophageal foreign body. Before surgery he vomited the esophageal foreign body with a lot of blood. Hematemesis was stopped spontaneously and contrast-enhanced CT revealed a pseudoaneurysm in the distal aortic arch, so thoracic endovascular aortic repair (TEVAR) was performed to prevent rupture. Esophageal endoscopy found that the site of esophageal injury healed spontaneously, so the patient was followed conservatively with antibiotics. He was discharged on postoperative day 18 uneventfully. TEVAR was an effective treatment for aortic injury caused by esophageal foreign body in our case.

Treatment of secondary mitral regurgitation by transcatheter edge-to-edge repair using MitraClip.

Transcatheter edge-to-edge repair (TEER) is becoming the standard invasive treatment for ventricular functional mitral regurgitation (MR). It is necessary to determine the severity of MR before treatment with MitraClip; however, the severity of secondary MR is usually underestimated compared with that of primary MR and varies temporally. Therefore, to accurately determine the severity of MR, it is important to correctly use the algorithm of the guidelines for valvular heart disease and aggressively perform stress echocardiography. Before performing TEER, the difficulty of the procedure should be evaluated. First, morphological features that make TEER unsuitable, such as cleft of the mitral leaflet, mitral stenosis (MS), or perforation of the mitral leaflet, should be checked. The mitral valve orifice area, transmitral valve pressure gradient, coaptation depth, coaptation length, and posterior leaflet length should be measured to determine the difficulty of the procedure based on the inclusion criteria of Endovascular Valve Edge-to-Edge Repair Study II and the German consensus. After MitraClip implantation, in addition to assessing the severity of MS and residual MR, the pulmonary venous flow pattern and stroke volume should be evaluated to comprehensively assess whether TEER improves the hemodynamics. MitraClip has also been used to treat atrial functional MR, another type of secondary MR. Several reports suggest that MitraClip is effective for atrial functional MR; however, evidence is still being accumulated.

Open Surgical Repair for a Giant Common Hepatic Artery Aneurysm with Difficulty in Proximal Arterial Clamping: A Case Report.

Hepatic artery aneurysm has been considered as a rare, life-threatening disease. In this study, we report on a patient requiring surgical treatment for a giant hepatic artery aneurysm by aneurysmectomy without revascularization. A 70-year-old woman who complained of epigastric pain was referred to our hospital. Enhanced computed tomography scan has revealed a giant (11×9 cm) common hepatic artery aneurysm. She then underwent emergency surgery; the intra-aortic balloon occlusion technique was applied in order to control the blood inflow into the aneurysm. The aneurysm was then incised, and direct closure of the inflow and outflow orifices was performed safely without evidence of ischemic change in the liver.

Learning Curve for Transcatheter Aortic Valve Implantation Under a Controlled Introduction System　- Initial Analysis of a Japanese Nationwide Registry.

BACKGROUND: The introduction of transcatheter aortic valve implantation (TAVI) into Japan was strictly controlled to optimize patient outcomes. The goal of this study was to assess if increasing experience during the introduction of this procedure was associated with outcomes.Methods and Results:The initial 1,752 patients registered in the Japanese national TAVI registry were included in the study. The association between operator procedure number and incidence of the early safety endpoint at 30 days (ESE30) as defined in the Valve Academic Research Consortium-2 consensus document was evaluated. Patients were divided into 4 groups by quartiles of procedure count (Groups I-IV in order of increasing number of procedures). Median patient age was 85 years, and 30.5% were male. The 30-day mortality rate was 1.4% (n=24), and 78 patients (7.9%) experienced 95 ESE30. Among the variables included in the model, ESE30 was associated with non-transfemoral approach (P=0.004), renal dysfunction (Cr >2.0 mg/dL) (P=0.01) and NYHA class III/IV (P=0.04). ESE30 incidence was not significantly different between Groups I-III and Group IV. Spline plots demonstrated that experience of 15-20 cases in total was needed to achieve a consistent low risk of ESE30. CONCLUSIONS: Increasing experience was associated with better outcomes, but to a lesser degree than in previous reports. Our findings suggested that the risks associated with the learning curve process were appropriately mitigated.

A novel method for prevention of stent graft-induced distal re-dissection after thoracic endovascular aortic repair for Type B aortic dissection.

OBJECTIVES: Stent graft-induced distal re-dissection (SIDR) is a burdensome complication after thoracic endovascular aortic repair (TEVAR) for Type B aortic dissection. We developed a novel method to prevent SIDR by placing a small-diameter short stent graft [Excluder Aortic Extender (Cuff)] at the distal landing zone (DLZ) and reviewed its effectiveness in this study. METHODS: Ninety patients who underwent TEVAR for Type B aortic dissection using commercially available devices between January 2008 and September 2016 were retrospectively reviewed. Among them, TEVAR with the Cuff technique was performed in 36 (40%) cases, in which a Cuff was placed at the DLZ in the descending aorta prior to the main stent graft deployment to avoid excessive stent graft oversizing at the distal end. The effectiveness of the Cuff technique was assessed by evaluating mid-term clinical results, including the incidence of SIDR. RESULTS: Technical success was achieved in all 90 cases. During a median follow-up time of 40.4 months (range 0.2-90.6 months), 8 SIDRs were documented using multidetector computed tomography images. Freedom from SIDR was significantly lower in the Cuff group (Cuff: 100%/5 years vs non-Cuff: 84.6%/5 years; P = 0.04), whereas no difference was observed between both groups in the oversizing rate at the DLZ (19.9 ± 8.5% vs 17.8 ± 9.9%; P = 0.29). CONCLUSIONS: Placement of a small-diameter short stent graft at the DLZ (Cuff technique) in TEVAR for aortic dissection is an easy procedure that may reduce the incidence of SIDR.

Type 1a endoleak following Zone 1 and Zone 2 thoracic endovascular aortic repair: effect of bird-beak configuration.

OBJECTIVES: Type 1a endoleak is one of the most severe complications after thoracic endovascular aortic repair (TEVAR), because it carries the risk of aortic rupture. The association between bird-beak configuration and Type 1a endoleak remains unclear. The purpose of this study was to analyse the predictors of Type 1a endoleak following Zone 1 and Zone 2 TEVAR, with a particular focus on the effect of bird-beak configuration. METHODS: From April 2008 to July 2015, 105 patients (mean age 68.6 years) who underwent Zone 1 and 2 landing TEVAR were enrolled, with a mean follow-up period of 4.3 years. The patients were categorized into 2 groups, according to the presence (Group B, n = 32) or the absence (Group N, n = 73) of bird-beak configuration on the first postoperative multidetector computed tomography. RESULTS: The Kaplan-Meier event-free rate curve showed that Type 1a endoleak and bird-beak progression occurred less frequently in Group N than in Group B. Five-year freedom from Type 1a endoleak rates were 79.7% and 100% for Groups B and N, respectively (P = 0.007). Multivariable logistic regression analysis showed that dissecting aortic aneurysm (odds ratio 3.72, 95% confidence interval 1.30-11.0; P = 0.014) and shorter radius of inner curvature (odds ratio 1.09, 95% confidence interval 0.85-0.99; P = 0.025) were significant risk factors for bird-beak configuration. Multivariable Cox proportional hazard regression showed that Z-type stent graft (hazard ratio 2.69, 95% confidence interval 1.11-6.51; P = 0.030) was a significant risk factor for bird-beak progression. CONCLUSIONS: Appropriate stent grafts need to be chosen carefully to prevent Type 1a endoleak and bird-beak configuration after landing Zone 1 and 2 TEVAR. Patients with bird-beak configuration on early postoperative multidetector computed tomography require closer follow-up to screen for Type 1a endoleak.

Midterm Outcomes With a Self-Expandable Transcatheter Heart Valve in Japanese Patients With Symptomatic Severe Aortic Stenosis.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a viable alternative to surgical aortic valve replacement in high-risk or inoperable patients with aortic stenosis (AS). Here we report the midterm outcomes of high-risk Japanese patients with severe AS who underwent TAVI with a self-expandable TAV.Methods and Results:The CoreValve Japan Trial was a prospective, multicenter trial of the CoreValve System. A group of 55 patients (mean age 82.5±5.5 years, 30.9% male, 100% NYHA class III/IV, STS 8.0±4.2%) were enrolled in the 26-mm/29-mm CoreValve study, and 20 patients (mean age 81.0±6.6 years, 5.0% male, 100% NYHA class III/IV, STS 7.0±3.3%) were enrolled in the 23-mm CoreValve study, which started 1 year later. For the 26-mm/29-mm cohort, the 3-year all-cause mortality rate was 32.6%; major stroke was 15.4%. Mean pressure gradient (MPG), effective orifice area (EOA), and NYHA class showed sustained improvement. Paravalvular regurgitation (PVR) at 3 years was 28.6% (none), 25.7% (trace), 40.0% (mild), 5.7% (moderate), and 0.0% (severe). For the 23-mm cohort, the 2-year all-cause mortality rate was 5.0%; major stroke was 5.0%. MPG, EOA, and NYHA class showed sustained improvement. PVR at 2 years was 16.7% (none), 33.3% (trace), 44.4% (mild), 5.6% (moderate), and 0.0% (severe). CONCLUSIONS: TAVI with the CoreValve System was associated with sustained clinical and functional cardiac improvement in high surgical risk Japanese patients with severe AS. (Clinicaltrials.gov Identifiers: NCT01437098 and NCT01634269.).

Clinical Outcomes and Bioprosthetic Valve Function After Transcatheter Aortic Valve Implantation Under Dual Antiplatelet Therapy vs. Aspirin Alone.

BACKGROUND: Dual antiplatelet therapy (DAPT) is commonly used after transcatheter aortic valve implantation (TAVI); however, the supporting evidence is limited. To determine if aspirin alone is a better alternative to DAPT, we compared the outcomes of patients treated with DAPT or aspirin alone after TAVI.Methods and Results:We analyzed a total of 144 consecutive patients (92 females, mean age 83±6 years) who underwent implantation of a balloon-expandable transcatheter valve (SAPIEN or SAPIEN XT, Edwards Lifesciences). Patients were divided into DAPT (n=66) or aspirin-alone treatment groups (n=78). At 1 year after TAVI, the composite endpoint, which consisted of all-cause death, myocardial infarction, stroke, and major or life-threatening bleeding complications, occurred significantly less frequently (Kaplan-Meier analysis) in the aspirin-alone group (15.4%) than in the DAPT group (30.3%; P=0.031). Valve function assessed by echocardiography was similar between the 2 treatment groups with respect to effective orifice area (1.78±0.43 cm2in DAPT vs. 1.91±0.46 cm2in aspirin-alone group; P=0.13) and transvalvular pressure gradient (11.1±3.5 mmHg in DAPT vs. 10.3±4.1 mmHg in aspirin-alone group; P=0.31). CONCLUSIONS: Treatment with aspirin alone after TAVI had greater safety benefits and was associated with similar valve function as DAPT. These results suggest that treatment with aspirin alone is an acceptable regimen for TAVI patients.

Thoracic endovascular aortic repair for degenerative distal arch aneurysm can be used as a standard procedure in high-risk patients.

OBJECTIVES: In recent years, supra-aortic rerouting and thoracic endovascular aortic repair (TEVAR) for treating aortic arch pathology have emerged as a less invasive option for high-risk patients. This study aimed to assess our strategy for preventing stroke and improving late outcomes after supra-aortic rerouting and TEVAR. METHODS: Between July 2008 and July 2015, we performed 280 cases of TEVAR for arch pathologies, using manufactured stent grafts. This study reviewed 101 patients who underwent supra-aortic rerouting and TEVAR for degenerative distal arch aneurysms (80 men, mean age 73.1 years, Zone 1/Zone 2 = 48/53). Since 2011, we have routinely used the brain protection method, which comprises blocking native forward flow from the left common carotid artery (LCA) and left subclavian artery (LSA) for zone 1 cases and the LSA for zone 2 cases before TEVAR. RESULTS: The mean operation time was 178 ± 65 min. The stroke and 30-day death rates were 3 and 1%, respectively. Before the brain protection method was introduced, the perioperative risk factor for stroke was atheroma Grade ≥III (P = 0.035). Proximal landing zone (P = 0.58) and LSA sacrifice (P = 1.00) were not risk factors for stroke. No strokes occurred after using the brain protection method (before protection: 6% and after protection: 0%). Regarding late results, the rate of freedom from aorta-related death at 1 and 4 years was 97 and 95%, respectively. The rate of freedom from aortic events at 1 and 4 years was 91 and 86%, respectively. During follow-up, no type Ia endoleak developed and one type A dissection was observed. CONCLUSIONS: Our strategy for supra-aortic rerouting and TEVAR showed satisfactory early and late results. The chief risk factor for perioperative stroke was atheroma, and blocking native forward flow from the LCA and the LSA prior to the TEVAR procedure helped prevent stroke.

Early Outcomes in Japanese Dialysis Patients Treated With Transcatheter Aortic Valve Implantation.

BACKGROUND: Although transcatheter aortic valve implantation (TAVI) is a new alternative treatment with acceptable midterm results for high surgical risk patients, at present performing the procedure in dialysis patients is not reimbursed in Japan. METHODS AND RESULTS: The study group of 17 dialysis patients (mean age, 76.7±5.0 years) underwent TAVI with the SAPIEN/SAPIEN XT. EuroSCORE and STS score were 25.0±19.0% and 15.4±12.3%, respectively. Transiliofemoral and transapical approaches were performed in 7 (41.2%) and 10 patients (58.8%), respectively. ICU and hospital stays after TAVI were 1.8±1.6 and 12.9±12.7 days, respectively. Mean transvalvular gradients at discharge significantly decreased from 45.9±13.3 mmHg to 10.7±4.3 mmHg (P<0.0001) and effective orifice area significantly increased from 0.78±0.17 to 1.69±0.37 cm(2)(P<0.0001). Device success was 87.5%. One patient required a valve-in-valve procedure on 187-postoperative-day for an acute increase in paravalvular leakage caused by initial lower implantation of the device. The overall mortality at 1 year was 0% and clinical efficacies at 30 days, 6 months, and 1 year were 93.8%, 83.3%, and 69.2%, respectively. CONCLUSIONS: Satisfactory early results were achieved with TAVI in Japanese dialysis patients with a high surgical risk, indicating it is a safe and effective alternative for the treatment of aortic valve stenosis in such patients.

Predictors of Prolonged Hemodynamic Compromise After Valve Deployment During Transcatheter Aortic Valve Implantation.

OBJECTIVE: To identify the risk factors of prolonged hemodynamic compromise caused by rapid pacing for valve deployment during transcatheter aortic valve implantation. DESIGN: A retrospective study. SETTING: Academic hospital. PARTICIPANTS: Forty-seven patients with severe aortic stenosis who underwent transcatheter aortic valve implantation. INTERVENTIONS: The time after the end of rapid pacing until systolic arterial pressure and SvO2 recovery (systolic arterial pressure>90 mmHg and SvO2>65%) was defined as "the hemodynamic recovery time" and was measured from online anesthetic charts. The total study population was divided into 2 groups according to the recovery time (third quartile in all patients; 33 and 14 patients in the early and delayed recovery groups, respectively). Subsequently, the factors associated with prolonged hemodynamic compromise after rapid pacing for valve deployment were identified by univariate and multivariate analyses. MEASUREMENTS AND MAIN RESULTS: Multivariate analysis identified left ventricular end-diastolic diameter (odds ratio, 0.774; 95% confidence interval, 0.608-0.915) and SvO2 (odds ratio, 0.748; 95% confidence interval, 0.590-0.868) as independent factors associated with prolonged hemodynamic compromise after rapid pacing for valve deployment. CONCLUSIONS: SvO2 and left ventricular end-diastolic diameter were found to be significant independent predictors of prolonged hemodynamic compromise immediately after rapid pacing for valve deployment during transcatheter aortic valve implantation.

New Self-Expanding Transcatheter Aortic Valve Device for Transfemoral Implantation- Early Results of the First-in-Asia Implantation of the ACURATE Neo/TF(TM) System.

BACKGROUND: Feasibility and early results of transfemoral aortic valve implantation using the ACURATE neo/TF(TM)self-expanding stent are reported. METHODS AND RESULTS: The study group of 15 patients (mean age 83.3±6.0) was enrolled with a mean EuroSCORE and STS score of 21.9±11.6% and 7.5±3.1%, respectively. Clinical and echocardiographic evaluations were performed at baseline, discharge, 30 days and 6 months. The primary endpoint was all-cause mortality at 30 days. Transcatheter aortic valve implantation (TAVI) using the ACURATE neo/TF device was successful in 14 patients; 1 patient underwent valve-in-valve implantation because the prosthetic valve embolized during withdrawal of the delivery system. Conversion to surgery, coronary obstruction, peri-operative stroke, and pacemaker implantation did not occur at 30 days. Mean transvalvular gradients at discharge significantly decreased from 44.2±10.5 mmHg (preprocedural) to 7.7±3.1 mmHg (P<0.0001) and effective orifice area significantly increased from 0.77±0.12 to 1.69±0.25 cm(2)(P<0.0001). None or trace paravalvular leak was revealed in 50.0%, and no patient exhibited moderate or higher paravalvular leak. The overall mortality at 30 days and 6 months was 0% and 6.7%, respectively. CONCLUSIONS: A new self-expanding TF TAVI device, ACURATE neo/TF, is safe and effective in the treatment of severe aortic stenosis in elderly patients at high risk for surgery.

The assessment of collateral communication after hybrid repair for Crawford extent II thoraco-abdominal aortic aneurysms.

OBJECTIVES: The repair of extensive thoraco-abdominal aortic aneurysms (TAAAs) is invasive and carries a high risk for spinal cord injury (SCI). The aim of this study was to assess the early results and collateral circulation to the spinal cord after hybrid repair for Crawford extent II aortic aneurysms. METHODS: Between 1997 and 2013, we performed 128 thoracic endovascular aortic repair (TEVAR) procedures for TAAAs. This study reviews 12 patients who underwent hybrid TEVAR for a Crawford extent II aortic aneurysm (mean age: 56 years, 6 men, chronic dissection: 10). Aortic arch repair was performed to create a proximal landing zone and visceral debranching bypass was performed to create a distal landing zone at separate stages prior to TEVAR. Subsequently, a stent graft was deployed to cover the residual downstream aorta. TEVAR was generally performed the day after the final debranching procedure. Cerebrospinal fluid drainage was performed, and the mean blood pressure was maintained at >90 mmHg in all cases. RESULTS: The median operation time for TEVAR was 94 min (range: 71-421 min) and the mean blood loss was 300 ml (range: 130-1350 ml). No SCI or in-hospital death was observed after TEVAR. Multidetector computed tomography identified three arteries (subclavian artery, external iliac artery and internal iliac artery) providing collateral circulation to spinal segmental arteries (SAs). In all cases, mid-thoracic SAs (Th5-8) and low lumbar SAs (L2-5) were fed by the subclavian artery and the internal iliac artery, respectively. Additionally, low thoracic to high lumbar SAs (Th9-L1) communicated with the subclavian artery via the lateral thoracic wall and/or the external iliac artery via the abdominal wall. CONCLUSIONS: We achieved satisfactory early and mid-term outcomes with hybrid repair for Crawford extent II TAAAs. Furthermore, collateral circulation to SAs was maintained during and after TEVAR regardless of the extent of the aortic repair.

Urgent transcatheter aortic valve replacement for severe aortic valve stenosis with acute decompensated heart failure: report of a case.

Recent evidence suggests that transcatheter aortic valve replacement (TAVR) is feasible for treating severe aortic valve stenosis (AS) in patients who are considered high risk for elective surgery. However, it is still unclear whether TAVR is a better option than surgical aortic valve replacement for severe AS with acute decompensated heart failure. We report a case of severe AS with acute heart failure, which was treated successfully by urgent TAVR, with cardiopulmonary support.

Mid-term results of endovascular treatment with the Gore TAG device for degenerative descending thoracic aortic aneurysms.

PURPOSE: To confirm the validity of using Gore TAG for degenerative descending thoracic aneurysm repair, we evaluated the mid-term clinical outcomes in our single-center experience. METHODS: From May 2008 to April 2011, elective thoracic endovascular aortic repair (TEVAR) with Gore TAG without left subclavian artery (LSA) coverage for a degenerative descending thoracic aneurysm was performed in 36 consecutive cases. RESULTS: The procedural success rate was 100%, and no patient died within 30 days of the operation. We observed no cases of paraplegia or stroke. The mean follow-up was 33.2 ± 13.0 months (the maximum follow-up was 58.0 months). The actuarial survival rate was 100, 97.2 and 94.4% at 1, 2 and 3 years. There was no aorta-related death at 3 years. Two (5.6%) late distal Type I endoleaks were observed. Freedom form aortic events rate was 97.2, 97.2, and 97.2% at 1, 2, and 3 years respectively. In six cases with bird-beak configurations at the 2-year follow-up, the bird-beak length and angle had increased gradually. CONCLUSIONS: Elective TEVAR using the Gore TAG for degenerative descending thoracic aortic aneurysms without LSA coverage is effective and provides satisfactory early and mid-term outcomes. However, since the bird-beak configurations progressed, a conformable and flexible device for the next generation of procedures will be needed.

Transcatheter aortic valve replacement for patients with aortic valve stenosis complicated with moyamoya disease.

Moyamoya disease (MMD) is a rare disease characterized by occlusive intracranial arteriopathy with formation of abnormal cerebrovascular collateral networks. Conventional cardiovascular surgical procedures using cardiopulmonary bypass for patients with MMD is challenging because low cerebral perfusion pressure and nonpulsatile (continuous) flow during cardiopulmonary bypass can cause severe cerebral ischemia. We successfully performed transcatheter aortic valve replacement in 3 women with severe aortic valve stenosis complicated with MMD. Transcatheter aortic valve replacement may be useful for patients with severe aortic valve stenosis complicated with severe cerebral ischemia, including MMD.

Aortic remodeling as a prognostic factor for late aortic events after thoracic endovascular aortic repair in type B aortic dissection with patent false lumen.

PURPOSE: To assess the significance of aortic remodeling in the prevention of the late aortic events after thoracic endovascular aortic repair (TEVAR) for aortic dissection. METHODS: The study involved 52 patients (41 men; mean age was 59.7±13.3 years) with type B aortic dissections and patent false lumens treated with TEVAR between 2004 and 2011. Of the 52 patients, 18 were treated in the acute phase for rupture (n=1), malperfusion (n=10), aortic diameter over 40 mm at onset (n=3), and rapid enlargement of the false lumen (n=4). In the chronic setting, the indications for TEVAR were rupture (n=1), malperfusion (n=2), aortic diameter >50 mm (n=18), and rapid enlargement of the false lumen (n=13). Aortic remodeling was evaluated at 6 months postoperatively, and risk factors for late aortic events were evaluated in multivariate analysis using aortic remodeling and other pre-, peri-, and postoperative factors. RESULTS: Over a mean 36.0±18.9 months, 19 aortic events were documented: enlargement of the false lumen (n=4), type I endoleak (n=2), and erosion at the stent-graft edges (n=13). Multivariate analysis revealed that failure to achieve aortic remodeling at 6 months postoperatively was the only significant risk factor for late aortic events (hazard ratio 0.20, p=0.037). Patients with aortic remodeling had a higher rate of freedom from aortic events compared with those without aortic remodeling (100% vs. 81.5% at 1 year and 79.3% vs. 48.4% at 3 years, respectively). CONCLUSION: Aortic remodeling after TEVAR is a significant prognostic factor for better long-term results for type B aortic dissection.

Clinical experience with the RELAY NBS PLUS stent-graft for aortic arch pathology.

PURPOSE: To assess the safety, efficacy and performance of the RELAY NBS PLUS stent-graft in patients with aortic arch pathology. METHODS: From July 2010 to December 2011, the RELAY NBS PLUS was used to treat 13 patients (eight males; mean age 59.8 years, range 29-78 years) suffering from aortic arch pathology. The distribution of the proximal landing zone was Zone 0 in one case, Zone 1 in three cases and Zone 2 in nine cases. Bypass of the cervical branches was performed in 11 patients. RESULTS: The surgery-related mortality within 30 days and postoperative morbidity were 0%. Postoperative computed tomography at discharge confirmed 100% clinical success without any endoleaks. The mean radius of the inner curve in the aortic arch was 16.2 mm (range 5.8-25.7 mm). We detected two bird-beak configurations with a severely angulated aortic arch with a radius of the inner curve <15 mm. At the mid-term follow-up (mean 22.1 months; range 13.8-28.2 months), all patients were alive without aorta- or device-related complications. CONCLUSIONS: RELAY NBS PLUS stent-grafts can be safely and effectively implanted with controlled deployment to satisfactorily repair aortic arch pathology, even in the cases considered to present with an unfavorable anatomy for the first generation commercially available stent-graft devices. These encouraging outcomes will need to be confirmed in a larger series with a longer follow-up.