Thoracic Endoprosthesis Research Articles

Outcomes of thoracic endovascular aortic repair for complicated type B acute aortic dissection from a multicenter Japanese post-market surveillance study.

A primary goal of thoracic endovascular aortic repair (TEVAR) for type B acute aortic dissection (BAAD) is exclusion of the primary entry tear with a suitable stent graft (SG) to reestablish true lumen flow and promote aortic remodeling. This study aimed to determine the safety and efficacy of a conformable thoracic SG in a Japanese population with complicated BAAD. Between 2016 and 2017, 43 patients with complicated BAAD were enrolled in this prospective, nonrandomized, multicenter post-market surveillance study at 27 sites in Japan. All patients underwent TEVAR using the Gore TAG Conformable Thoracic Endoprosthesis (CTAG) (W.L. Gore and Associates, Flagstaff, AZ). The most common TEVAR indication for complicated BAAD was malperfusion (41.9%; 24 out of 43) and aortic rupture was observed in 32.5% of patients (14 out of 43). All SG implants were successfully completed and there was no patient with surgical conversion. Thirty-day mortality was 7.0% (3 out of 43) and one patient (2.3%) experienced spinal cord ischemia during hospitalization. Entry tear exclusion was achieved in 91.3% of patients at 1month, and 95.7% at 24months. Through 24months after TEVAR, no retrograde type A aortic dissection was observed and distal stent graft induced new entry was observed in two patients (4.7%). TEVAR utilizing the CTAG device for complicated BAAD in Japan demonstrated a low incidence of perioperative mortality and complications. Complications directly attributed to the SG including RTAD and dSINE were uncommon and the midterm outcomes were deemed satisfactory.

A Multicenter Clinical Trial on the Five-Year Outcomes Following Treatment of Acute, Complicated Type B Aortic Dissection With a Conformable Stent Graft.

Thoracic endovascular aortic repair (TEVAR) has become the treatment of choice for acute, complicated type B aortic dissections. The purpose of this study was to evaluate the 5-year outcomes of the GORE thoracic aortic graft (TAG) 08-01 study on TEVAR for acute, complicated type B aortic dissections using the GORE conformable TAG thoracic endoprosthesis (CTAG) and to establish if late aortic complications are avoided and remodeling is sustained. From January 2010 to February 2017, 50 patients with acute, complicated type B aortic dissections were enrolled from 26 sites in the United States in this prospective, nonrandomized study. Patients underwent follow-up assessments postprocedure, at 1month, 6months, 1year, and then yearly through 5years. Device-related events, false lumen thrombosis, and aortic remodeling were assessed from computed tomography (CT) scans by a core laboratory. The all-cause mortality rate through 5years was 26%. 4% of patients experienced late (>30day) deaths that were attributable to aortic pathology. Secondary interventions were required in 22% of patients. In 87% of patients, complete false lumen thrombosis in the portion of the false lumen parallel to the stent-graft was observed. There was a significant 11mm increase in the maximum true lumen diameter (P<0.0001) and a 22mm decrease in the maximum false lumen diameter (P<0.0001) over 5years. True lumen area was also increased by 221mm2(P=0.0003) over 5 years. There was no significant change in the false lumen area. There were no associations observed between patient outcomes and pretreatment indication for treatment (i.e., rupture with or without malperfusion or malperfusion alone). Treatment of patients with advanced pathophysiology with the CTAG device resulted in favorable long-term clinical and anatomic outcomes. Complete thrombosis of the false lumen and positive aortic remodeling was sustained throughout the study. The low rate of late aortic events observed in this study demonstrates the safety, effectiveness, and the long-term durability of the CTAG device.

Five-year outcomes of endovascular treatment for aortic dissection from the Global Registry for Endovascular Aortic Treatment

ObjectiveThe Global Registry for Endovascular Aortic Treatment (GREAT) is an International prospective multicenter registry collecting real-world data on performance of Gore aortic endografts. The purpose was to analyze the long-term outcomes and patient survival rates, as well as device performance in patients undergoing thoracic endovascular aortic repair for acute and chronic and complicated or uncomplicated type B aortic dissection (TBAD). MethodsFrom August 2010 to October 2016, 5014 patients were enrolled in the GREAT registry. The study population were patients treated with thoracic endovascular aortic repair for TBAD through 5-year follow-up (days 0-2006). The primary outcomes for this analysis were all-cause and aortic-related mortality, stroke, aortic rupture, endoleaks, migration, fracture, compression, and any reintervention through 5 years. ResultsWe identified 265 patients. The mean age was 60.9 ± 11.9 years (range, 19-84 years; 211 males [79.6%]). Devices used were the Gore TAG and Conformable Gore TAG Thoracic Endoprosthesis. There were 228 patients (86.0%) who underwent primary endovascular treatment (144 off-label [54.3%]); 22 (8.3%) underwent reintervention after prior endovascular procedure and 15 (5.7%) underwent reintervention after prior open procedure. Kaplan-Meier estimated freedom from all-cause mortality at 5 years was 71.1%. Freedom from aortic-related mortality through 5 years was 95.8%. There was no significant difference in freedom from all-cause mortality during the follow-up period in complicated or uncomplicated disease. At 30 days and through 5 years, respectively, for all the following outcomes, the aortic rupture rate was 1.1% (n = 3) and 1.9% (n = 5). The stroke rate was 1.1% (n = 3) and 4.2% (n = 11). The spinal cord ischemic event rate was 1.5% (n = 4) and 2.6% (n = 7). Reinterventions were required in 6.4% (n = 17) and 21.1% (n = 56) of patients. The need for conversion to open repair was 0.4% (n = 1) and 2.6% (n = 7). Additional graft placement was required in 3 patients (1.1%) and 16 patients (6.0%). The endoleak rate at 30 days was 3.4% (n = 9); type IA (n = 1 [0.4%]), type IB (n = 4 [1.5%]), type II (n = 1 [0.4%]), type III (n = 1 [0.4%]), and unspecified (n = 4 [1.6%]). Through 5 years, the endoleak rate was 12.1% (n = 32); type IA (n = 7 [2.6%]), type IB (n = 10 [3.8%]), type II (n = 9 [3.4%]), type III (n = 2 [0.8%]), and unspecified (n = 12 [4.5%]). There were no cases of stent migration, compression or fracture through 5 years. ConclusionsResults at the 5-year follow-up demonstrate that the use of the Gore TAG and Conformable Gore TAG Thoracic Endoprosthesis can be supported in treatment of TBAD (acute, chronic, complicated, and uncomplicated). These data demonstrate strong device durability, beneficial patient outcomes, and support for the treatment of thoracic aortic dissection with an endovascular approach. Complete 10-year follow-up in GREAT as planned will be advantageous.

The efficacy and safety of Gore conformable thoracic stent graft and Valiant Captivia thoracic stent graft for acute type B aortic dissection

BackgroundTo evaluate the safety and efficacy of the conformable thoracic aortic endograft (Conformable TAG Thoracic Endoprosthesis [CTAG]; W. L. Gore & Associates, Flagstaff, Ariz) and Valiant Captivia thoracic stent graft (Medtronic Inc., Santa Rosa, CA) for acute type B aortic dissection (TBAD). MethodsThe early and mid-term outcomes were analyzed for 413 patients undergoing TEVAR using conformable TAG thoracic endoprosthesis and Valiant Captivia thoracic stent graft for acute TBAD. 100 propensity-matched pairs of patients were generated, including 100 patients in the CTAG group and 200 patients in the Valiant Captivia group. ResultsOperative mortality were 2.33% (3 of 129) in the CTAG group and 1.76% (5 of 284) in the Valiant Captivia group. The median follow-up was 41.67 (26.00–60.67) months. No significant difference in mortality (9 [7.00%] vs. 36 [12.68%], P = 0.95) or re-intervention rate (3 [2.33%] vs. 20 [7.04%], P = 0.29) was observed between two groups. CTAG group have a lower incidence rate of distal stent graft-induced new entry tear than Valiant Captivia group (2.33% vs. 9.86%, P = 0.045). Lower incidence of type Ia endoleak was identified in the CTAG group (2.22%) than the Valiant Captivia group (14.41%) in patients with type III arch (P = 0.039). ConclusionsBoth Valiant Captivia thoracic stent graft and CTAG thoracic endoprosthesis can be safely performed for acute TBAD with low operative mortality, favorable mid-term survival and freedom from reintervention. CTAG thoracic endoprosthesis had fewer dSINE even with larger oversizing and potentially suitable for type III arch with fewer type Ia endoleaks.

Thoracic endovascular repair for blunt traumatic thoracic aortic injury: Long-term results.

This study aims to evaluate the endoprosthesis complications in patients undergoing TEVAR for blunt traumatic thoracic aortic injury, through long-term clinical and diagnostic follow-up. During the study interval (November 2000-October 2020), a total of 38 patients (63% male; average age 37.5years) with thoracic aortic injury underwent thoracic endovascular aortic repair. Patients underwent routine follow-up with clinical examination and radiological evaluation (CT-angiography or MRI-angiography plus chest radiograph), scheduled at 1month, at 6months (only in the cases of thoracic aortic dissection), at 1year after the procedure and every 1year thereafter. Technical success was achieved in 38 procedures (100%). The TEVAR-related mortality rate was 0%. No immediate major complications related to the endovascular procedure were observed. The median duration of diagnostic follow-up was 80months. A total of four procedure-related complications (10.5%) were identified at the follow-up. Three (7.9%) distal infoldings and collapses of the thoracic endoprosthesis and one (2.6%) type Ia endoleak were observed. No thrombosis of the prosthesis, nor signs of aortic pseudocoarctation were identified. No further complications related to endograft (endoleaks, infections, rupture, partial or complete thrombosis) occurred. No changes in the native aorta, stenosis, or increases in the endograft's diameters were observed. A total of 20 patients (52.6%) underwent MRI-angiography examinations, while a total of 34 patients (89.5%) underwent chest radiographs at the follow-up. In all cases, CT-angiography examinations were performed at the follow-up. Procedure-related complications were observed within one year of TEVAR, limiting concerns related to the durability of the prosthesis. No morphological changes in the aorta were observed despite long-term follow-up. The consequences of lifelong surveillance in terms of radiation exposure deserve special consideration, especially in younger patients treated for TAI.

Uncommon indication for an Octopus technique in a symptomatic infected thoracoabdominal aneurysm after thoracic endoprosthesis

Emergent thoraco-abdominal aneurysms (TAAA) repair remains challenging. Endovascular treatment should be considered in patients unfit for open surgery. Octopus technique is an off-the-shelf solution suitable for selected situations. We describe the successful treatment of a symptomatic and infected TAAA. A 66-year-old man presented to the emergency department with an infected 92mm TAAA with impending rupture due to Type 1b endoleak following previous TEVAR. 18FDG-PET-CT ruled out an endograft infection but diagnosed an aortitis.. Considering the emergent setting and his comorbidities, the patient was treated with the Octopus technique. Both renals were sacrificed and the celiac trunk was previously occluded, leaving the superior mesenteric artery the only target vessel. Treatment was successful and patient went home with a lifelong oral antibiotherapy. The 6-months angio-CT confirmed the absence of endoleak and patent superior mesenteric artery. The Octopus procedure can be used in selected cases for urgent endovascular TAAA repair in patients who are unfit for open repair.

Type 1A Endoleak after TEVAR in the Aortic Arch: A Review of the Literature.

Aortic arch repair is a challenging intervention. Open surgical repair is still considered the gold standard, but in high-risk patients, it is not always a reasonable option, making endovascular approaches an enticing, when not the only available, alternative for treatment. The strategies more commonly adopted are surgical supra-aortic trunk (SAT) rerouting followed by deployment of a standard thoracic endoprosthesis, chimney techniques, custom-made scalloped, fenestrated, and branched devices, and in situ or physician-modified fenestrations. If we excluded techniques involving SAT rerouting where the arch anatomy is surgically modified in order to make deployment in the aortic arch of a standard thoracic endoprosthesis possible, in the other techniques, one or more SATs are incorporated in the thoracic endoprosthesis. In these cases, no matter what solution is adopted, because of the morphology of the aorta at this level, achieving an ideal sealing is extremely difficult, and endovascular treatments of the arch are burdened by an increased risk of type IA endoleaks. PubMed, EMBASE, and Cochrane Library were searched. We identified 1277 records. After reading titles, abstracts, and full texts, we excluded 1231 records. Exclusion criteria were low-quality evidence, abstracts, case reports, conference presentations, reviews, editorials, and expert opinions. A total of 48 studies were included, for a total of 3114 patients. A type IA endoleak occurred in 248 patients (7.7%) with a mean incidence of 18.8% in chimney procedures, 4.8% and 3%, respectively, in fenestrated and branched devices, and 2.2% in in situ fenestration. We excluded from our analysis scalloped technology that is used when the target vessel originates from a healthy landing zone and represents a different anatomical setting. Type IA endoleaks are a concern with all types of endovascular aortic arch repair, and they can compromise the outcomes of the procedure. The rate of type IA endoleaks appears to be significantly higher in chimney procedures. In order to maximize sealing, whenever possible, endovascular repair of the arch should be achieved with custom-made fenestrated devices. However, chimney configurations are still a valuable solution particularly in the emergency setting, although in such a procedure, to guarantee accurate postoperative management and follow-up, an imaging protocol could be useful.

Clinical observation of endovascular thoracic aortic prosthetics in a patient with distal anastomosis aneurysm of a vascular prosthesis formed "end-to-side" after extraanatomic prosthetics

A clinical observation of successful prosthetics of an aneurysm of distal anastomosis of a vascular prosthesis of the thoracic aorta with a stent graft in a patient 24 years after extraanatomic bypass surgery with an end-to-side anastomosis for aortic coarctation is presented. During a routine examination, an aneurysm of the distal anastomosis of the vascular prosthesis was revealed in the patient. After further examination, thoracic aorta endoprosthesis was performed from vascular prosthesis to native aorta with Ankura 2020B120 stent graft (Lifetech Scientific Co., LTD. Shenzhen, China). Intraoperative results of endoprosthetics were assessed as good. The aneurysm of the distal anastomosis was not contrasted, the patency of the vessels of the aortic arch was preserved. According to the control computed tomography study performed 3 months after the operation, the aneurysm of the distal anastomosis is not contrasted, there is no dislocation of the prosthesis, there are no endolics. The above clinical observation demonstrates the effectiveness and safety of thoracic aortic endoprosthesis from a vascular prosthesis to a native aorta with anastomosis aneurysms of a vascular prosthesis, which allows avoiding complex and traumatic repeated open surgical intervention on the aorta and achieving good immediate and long-term treatment results. Received 25 November 2021. Revised 29 December 2021. Accepted 31 January 2022. Informed consent: The patient’s informed consent to use the records for medical purposes is obtained. Funding: The study did not have sponsorship. Conflict of interest: Authors declare no conflict of interest. Contribution of the authors Literature review: N.S. GorshkovDrafting the article: N.S. Gorshkov, N.R. ChernayaCritical revision of the article: R.Sh. Muslimov, L.S. KokovSurgical treatment: N.S. Gorshkov, N.R. Chernaya, M.V. Parhomenko, V.S. SelyaevFinal approval of the version to be published: N.S. Gorshkov, N.R. Chernaya, M.V. Parhomenko, V.S. Selyaev, L.S. Kokov

Retrograde type A dissection in the Vascular Quality Initiative thoracic endovascular aortic repair for dissection postapproval project: Presented at the Forty-fifth Annual Meeting of the Southern Association for Vascular Surgery (Virtual), Scottsdale, Ariz, January 27-30, 2021.

Background Retrograde dissection (RD) can be a serious complication after thoracic endovascular aortic repair (TEVAR), with retrograde type A dissection (RTAD) particularly life-threatening. Prior studies have suggested that treatment timing, anatomic characteristics, device selection, and procedural conduct of TEVAR performed for type B aortic dissection could mitigate the occurrence of RD. The Vascular Quality Initiative TEVAR for Dissection Registry is an ongoing project meant to satisfy Food and Drug Administration requirements for postmarket approval surveillance of the Gore conformable TAG thoracic endoprosthesis (W.L.

Retrograde type A dissection in the Vascular Quality Initiative thoracic endovascular aortic repair for dissection postapproval project

BackgroundRetrograde dissection (RD) can be a serious complication after thoracic endovascular aortic repair (TEVAR), with retrograde type A dissection (RTAD) particularly life-threatening. Prior studies have suggested that treatment timing, anatomic characteristics, device selection, and procedural conduct of TEVAR performed for type B aortic dissection could mitigate the occurrence of RD. The Vascular Quality Initiative TEVAR for Dissection Registry is an ongoing project meant to satisfy Food and Drug Administration requirements for postmarket approval surveillance of the Gore conformable TAG thoracic endoprosthesis (W.L. Gore & Associates, Flagstaff, Ariz), Medtronic Valiant thoracic stent graft (Medtronic, Santa Rosa, Calif), and Cook Medical dissection devices (Cook Medical, Bloomington, Ind) and provides a unique source of evaluation for RTAD in a prospectively collected real-world registry. MethodsA total of 588 consecutive patients at 49 institutions had undergone TEVAR for acute (<30 days; n = 336) and chronic (≥30 days; n = 252) type B aortic dissection were included. The occurrence of RD as reported by the participating centers and de-identified source documents were reviewed and confirmed independently by two of us (A.W.B. and G.W.). The demographics, procedural and device data, and anatomic considerations were evaluated, and the devices were grouped in a de-identified manner as Gore, Medtronic, and other. ResultsThe mean follow-up was 889 days (median, 658 days), and 408 patients had completed follow-up data available for >1 year. A total of 19 patients with RD (3.2%) were identified, 9 of whom had been treated for acute and 10 for chronic dissection, a 2.7% and 4.0% incidence, respectively (P = .48, acute vs chronic). Of the 19 RD cases, 15 were RTAD, 6 after treatment of acute and 9 after treatment of chronic dissection, a 1.8% and 3.6% incidence, respectively (P = .19, acute vs chronic). Five cases of RD had occurred intraoperatively (four of which were RTAD). The median time to RD and RTAD was 62 and 69 days, respectively (range, 0 to 1600 days). Of the 15 patients with RTAD, 12 had undergone surgical repair and 2 had not undergone repair; the treatment of one was unknown. The overall mortality was 33.3% (5 of 15). The factors associated with RTAD included more extensive dissection (mean, 5.6 zones without RTAD vs 8.5 zones with RTAD; P = .001), female sex (28.3% female without RTAD vs 53.3% with RTAD; P = .04), and non-White race (62.7% White without RTAD vs 33.3% White with RTAD; P = .05). Mean oversizing was not significantly different for those without RTAD compared with that for those with RTAD (14.0% vs 14.2%; P = .92). The device type was anonymized in this project; however, we found no significant differences between the Gore, Medtronic, and all other devices. ConclusionsThe rate of RD in the present real-world postapproval project was consistent with that from previously reported studies, including highly controlled pivotal studies. Device type was not predictive of RD, and the newly identified risk factors for RTAD include more extensive dissection and a trend toward a greater risk for female sex and non-White race.

Analysis of the factors related to the early outcomes of Type B Acute Aortic Syndromes

Objective: To determine the outcomes of endovascular treatment (ET) of Type B Acute Aortic Syndrome (AAS) and factors related to mortality and Spinal Cord ischemia. Methods: This was a retrospective cohort of complicated AAS patients who underwent endovascular treatment. The primary outcome variable was mortality rate and clinical outcomes. The secondary outcome variable was SCI. Results: Overall, 32 patients were evaluated, 10 patients submitted to CM and 22 patients ET. 100% of the patients had arterial hypertension, with a higher prevalence of male gender (53.1%). There was a higher prevalence of acute aortic dissection Stanford B with 19 cases (59.4%). Among the 22 patients submitted to interventional therapy, most of them thoracic endoprosthesis (TEVAR), with 16 patients (72.7%). A logistic regression showed that refractory chest pain (HR = 9,57; p = 0.005), aortic diameter higher than 40mm (HR = 16.65; p &lt; 0.001), chronic renal failure (CRF) (HR = 5.2; p = 0.009) and SCI (HR = 1.89; p = 0.029) were related to increased mortality rate. Otherwise, male gender (MG) (HR = 17.20; p &lt; 0.001), concomitant TEVAR + EVAR (HR = 3.88; p = 0.048), malperfusion (HR = 3.88; p = 0.038) and number of internal iliac patency (IIP) (HR = 6.52; p = 0.016) were associated to SCI. Conclusion: This study concluded that refractory chest pain, aortic diameter higher than 40mm, CRF and SCI were related to increased mortality rate. MG, concomitant TEVAR + EVAR, malperfusion and number of IIP were associated to SCI.

Penetrating aortic ulcer post migration of thoracic aortic endoprosthesis: Case report

IntroductionThoracic endovascular aortic repair (TEVAR) is the first treatment option for many thoracic aortic pathologies. Especially after aortic dissections, it is possible to have progression during follow-up with appearance of new lesions on arterial wall. Herein, we report a case of Penetrating Aortic Ulcer (PAU) post release of Thoracic endoprosthesis.Presentation of caseA 67-years-old male with hypertension and diabetes mellitus was followed at our hospital after an emergency procedure for Type B aortic dissection (TBAD) complicated by symptomatic large infrarenal AAA and treated with a proximal TEVAR plus chimney for left subclavian artery and PETTICOAT with EVAR for abdominal aortic disease. Follow up at 15 months showed a deep PAU with partial crush of stent in Left Subclavian Artery. Thus, we performed a left carotid-subclavian bypass and subsequently a TEVAR procedure with release of Bolton Relay endoprosthesis (Terumo Aortic, Sunrise, Florida, United States).DiscussionIn literature there are few studeis that focus on migration after TEVAR during follow-up. Elongation, changes of tortuosity on thoracic aorta after TEVAR, can help to determine a migration of prosthesis. In this case Bolton Relay endoprosthesis (Terumo Aortic, Sunrise, Florida, United States) has permitted to improve precision and quality of procedure.ConclusionIn literature there are few studies reporting complications of TEVAR post prosthesis migration. In this case, Bolton Relay endoprosthesis was useful and safe.

Multicenter Experience With Large Diameter Balloon-Expandable Stent-Grafts for the Treatment of Infrarenal Penetrating Aortic Ulcers

Purpose To describe the use of large-diameter balloon-expandable stent-grafts (BeGraft aortic stent-graft, Bentley InnoMed GmbH, Hechingen, Germany) in the treatment of infrarenal penetrating aortic ulcer (iPAU). Materials and Methods Retrospective analysis of patients undergoing endovascular treatment with the BeGraft aortic stent-graft in 8 European centers from January 2017 to October 2020. Demographics, perioperative data, and midterm outcomes were collected. Endpoints of the study were technical feasibility, early mortality, and morbidity. Results A total of 40 patients were included. The mean age was 73.9±7.05 years and 63.2% were male. Indications for treatment included size and morphology (65%), presence of symptoms (29.5%), and contained ruptures (5.5%). Urgent treatment was performed in 5% of cases. Technical success was 97.5%. Median operation time was 58 minutes (19–170 minutes), with 27.5% of patients having additional procedures during the main intervention (1 additional repair with a C-TAG (W.L. Gore & Associates, Inc, Flagstaff, AZ, USA) thoracic endoprosthesis, 5 covered endovascular reconstruction of aortic bifurcation procedures, 3 extensions with proximal cuffs, and 2 percutaneous angioplasties of the common iliac arteries). Percutaneous femoral access was used in 72.5%, while groin cut-down was performed in 27.5%. Repair was successful with only 1 stent in 45% of cases, while 37.5% required 2 stents and nearly 17.5% required 3/4 stent-grafts. The 30-day mortality was 0%, with a 2.5% reintervention rate (1 patient required evacuation of an intra-abdominal hematoma). Median follow-up was 13.9 months (2–39 months), during which no vascular-related reinterventions or deaths were reported. In 4 patients, a type II endoleak was observed. No cases of graft migration, thrombosis, or stent-fracture were observed. Conclusions The treatment of iPAU with the BeGraft aortic stent-graft in a selective patient group is feasible with low rate of perioperative morbidity and mortality. Balloon-expandable stent-grafts offer the option to repair iPAUs with a shorter coverage of the aorta using low-profile sheath, that enables treatment in the presence of calcified access vessels and small diameter aortic bifurcations.

Five-year Outcomes With Conformable GORE TAG Endoprosthesis Used in Traumatic Aortic Transections

BackgroundThe Conformable GORE TAG thoracic endoprosthesis (CTAG) device (W.L. Gore and Associates, Flagstaff, AZ) seeks to optimize thoracic endovascular repair of blunt aortic injuries by better apposition to the aortic arch. The Evaluation of the GORE Conformable TAG Thoracic Endoprosthesis for Treatment of Traumatic Transection (TAG 08-02) study assessed the safety and effectiveness of the CTAG device in the 5 years after treatment. MethodsThis prospective, single-arm study was conducted at 30 US sites with follow-up through 5 years. Patients were evaluated for all-cause mortality and device events through follow-up. An independent core laboratory reviewed pretreatment and posttreatment images. ResultsA total of 51 initial cohort patients and 50 continued access patients were enrolled and underwent placement of a total of 111 CTAG devices (mean, 1.1/subject; range, 1.0 to 3.0) during initial treatment. On average, patients were 42.7 ± 19.5 years old, with a mean Injury Severity Score of 31.5 ± 14.5, and most presented with polytraumatic injuries. The median time between injury and treatment was 21.0 hours (range, 3.2 to 334.4 hours). A total of 60 patients had partial or complete left subclavian artery coverage, but only 1 patient had a stroke that was unable to be attributed to the device or procedure. The freedom from all-cause mortality was 95% and 89% at 1 month and 5 years after the procedure, respectively. There were 2 minor endoleaks. No aortic ruptures, wire frame fractures, erosions, lumen obstructions, device compressions, or thrombus-related events were reported. ConclusionsThe 5-year outcomes verify that the CTAG device is a safe, effective, and durable option for patients with blunt aortic injuries who are undergoing thoracic endovascular aortic repair.

Long-term outcomes of the conformable TAG thoracic endoprosthesis in a prospective multicenter trial

BackgroundThe Gore conformable TAG thoracic endoprosthesis (CTAG) was engineered to enhance conformability in the thoracic aorta and has demonstrated greater deployment accuracy and wall apposition than the original TAG device. The Food and Drug Administration approved the CTAG in 2011 based on the 1-year results of the pivotal trial for the CTAG device. In the present report, we have documented the outcomes for those patients through 5 years. MethodsThe CTAG aneurysm study was a prospective, multicenter trial that assessed the safety and effectiveness of the CTAG device as treatment of descending thoracic aortic aneurysms. Follow-up imaging assessments consisted of radiographs and computed tomography at annual intervals through 5 years. A core imaging laboratory was used to assess the aneurysm size, device integrity, and endoleaks. ResultsA total of 66 patients were enrolled (51 pivotal arm patients and 15 continued access patients) from October 2009 through September 2011. The baseline characteristics, procedural characteristics, and outcomes through 2 years were reported previously. Through 5 years, five patients (7.6%) had required device-related reintervention (one type Ia endoleak or contained rupture of the descending thoracic aorta, one type Ib endoleak, two indeterminate endoleaks, and one thoracic aortic pseudoaneurysm). Four patients (6.1%) had died of aneurysm-related causes, with one death occurring within 30 days of the index procedure. A total of 24 patients (36.3%) had died during the 5-year study period. Seven patients (10.6%) had experienced stroke or transient ischemic attack through 5 years, with one early stroke (postoperative day 28). Prosthesis or intercomponent migration was observed in six patients (9.1%) through 5 years; however, no patient had developed a type III junctional endoleak. No stent-graft fracture or compression was observed through 5 years. At 5 years, 14 patients (50.0%) showed sac regression, 5 (17.9%) showed sac expansion, and 9 (32.1%) showed sac stability using on a 5-mm threshold for change. ConclusionsThoracic endovascular aortic repair with the CTAG device was associated with low rates of aneurysm-related mortality and reintervention through 5 years. Proximal endoleak was rare, and most patients showed sac regression or stability at 5 years after the initial thoracic endovascular aortic repair.

Alternative treatment for patent ductus arteriosus: a therapeutic challenge.

The ductus arteriosus is a fetal structure that spontaneously closes in 90% of newborns. Patency 3 months after birth is considered a congenital heart disease that, if untreated, can progress to serious cardiovascular complications. This report aims to review an alternative treatment with an aortic endoprosthesis in a 49-year-old man who presented with dyspnea on moderate exertion associated with a heart murmur. He was diagnosed with persistent ductus arteriosus (PDA) with cardiac complications. Clinical management was unsuccessful and surgical treatment was indicated. Endovascular treatment with a thoracic endoprosthesis was indicated and performed successfully. Percutaneous closure is the preferred method in adult patients. Endovascular intervention using an endoprosthesis is a safe and effective option, in addition to being applicable regardless of the anatomy of the PDA. This case demonstrates the natural history of the pathology and presents a safe and effective alternative for its management.

Gender Related Access Complications After TEVAR: Analysis from the Retrospective Multicentre Cohort GORE® GREAT Registry Study

The Global Registry for Endovascular Aortic Treatment (GREAT), a retrospective sponsored registry, was queried to determine the incidence and identify potential predictors of access related complications after TEVAR. This is a multicentre, observational cohort study. For the current study, all patients were treated only with the Conformable GORE® TAG® Thoracic Endoprosthesis and GORE® TAG® Thoracic Endoprosthesis devices for any kind of thoracic aortic disease. All serious adverse events within 30 days of the procedure were documented by sites. The following were considered access related complications: surgical site infection, pseudoaneurysm, avulsion, dissection, arterial bleeding, access vessel thrombosis/occlusion, seroma, and lymphocoele. A total of 887 patients was analysed: most of the cases had an operative indication for TEVAR of degenerative atherosclerotic aneurysm (n = 414, 46.7%) and type B dissection (n = 270, 30.4% either complicated or uncomplicated). Two hundred and ninety-five patients (33.3%) were female. The overall access related complication rate was 2.8% (n = 25): 4.7% (n = 14) in women and 1.8% (n = 11) in men (p = .013). After adjustment for age, urgency, device diameter, introducer sheath (≥24Fr vs. ≤ 24Fr), access vessel diameters, and access method, female gender was significantly associated with the risk of access complications (OR 2.85; p = .038). Brachial artery for access was also found to be an independent predictor of access related complications (OR 8.32; p < .001). This analysis suggests that women may have a higher access related complication rate after TEVAR, irrespective of the clinical setting, type of aortic disease, and device sizing.

Gender Related Access Complications After TEVAR: Analysis from the Retrospective Multicentre Cohort GORE® GREAT Registry Study

The Global Registry for Endovascular Aortic Treatment (GREAT), a retrospective sponsored registry, was queried to determine the incidence and identify potential predictors of access related complications after TEVAR. This is a multicentre, observational cohort study. For the current study, all patients were treated only with the Conformable GORE® TAG® Thoracic Endoprosthesis and GORE® TAG® Thoracic Endoprosthesis devices for any kind of thoracic aortic disease. All serious adverse events within 30 days of the procedure were documented by sites. The following were considered access related complications: surgical site infection, pseudoaneurysm, avulsion, dissection, arterial bleeding, access vessel thrombosis/occlusion, seroma, and lymphocoele. A total of 887 patients was analysed: most of the cases had an operative indication for TEVAR of degenerative atherosclerotic aneurysm (n=414, 46.7%) and type B dissection (n=270, 30.4% either complicated or uncomplicated). Two hundred and ninety-five patients (33.3%) were female. The overall access related complication rate was 2.8% (n=25): 4.7% (n=14) in women and 1.8% (n=11) in men (p=.013). After adjustment for age, urgency, device diameter, introducer sheath (≥24Fr vs.≤24Fr), access vessel diameters, and access method, female gender was significantly associated with the risk of access complications (OR 2.85; p=.038). Brachial artery for access was also found to be an independent predictor of access related complications (OR 8.32; p<.001). This analysis suggests that women may have a higher access related complication rate after TEVAR, irrespective of the clinical setting, type of aortic disease, and device sizing.

Survival after endovascular therapy in patients with ruptured thoracic aortic diseases: Results from the Global Registry for Endovascular Aortic Treatment Registry

ObjectiveThe Global Registry for Endovascular Aortic Treatment is a prospective observational multicenter cohort registry of all Gore aortic endografts for a variety of aortic pathologies. The purpose of this study was to evaluate the outcome of the Conformable GORE TAG Thoracic Endoprosthesis and GORE TAG Thoracic Endoprosthesis devices for ruptured thoracic aortic syndromes. MethodsBetween December 2010 and October 2016, a total of 5018 patients were enrolled from 114 international sites in this registry. The database was queried for patients with at least one of the following pathologies: descending thoracic aortic aneurysm with rupture, thoracoabdominal aortic aneurysm rupture, descending aortic dissection rupture, and aortic arch aneurysm rupture. Patient demographics, operative details, and clinical outcomes were analyzed. ResultsA total of 40 patients were treated with a ruptured thoracic aortic disease (62.5% male; mean age, 67.5 ± 14.1 years). Nineteen patients were treated for descending thoracic aneurysm rupture, 9 for thoracoabdominal aneurysm rupture, 7 for descending aortic dissection rupture, and 5 for aortic arch aneurysm rupture. Technical success was achieved in 40 of 40 patients (100%). There were no intraoperative mortalities and no conversions to an open procedure. A total of 12 patients (30.0%) required intervention for involvement of at least one aortic branch vessel (4 covered, 5 surgically debranched, 1 stented, and 6 chimney technique). The 30-day mortality was four patients (10.0%). Early reintervention (≤30 days) was required in seven patients (17.5%), five of which were device related. There was a total of five endoleaks and all five required a reintervention. The median follow-up duration was 14.7 months (range, 1-57 months). Freedom from device-related intervention at 1 year was 87.1% (95% confidence interval, [CI], 0.716-0.944), at 2 years was 81.3% (95% CI 0.607-0.917) and at 3 years was 73.1% (95% CI, 0.47-0.878). Freedom from all-cause mortality at 1 year was 65.0% (95% CI, 0.474-0.780), at 2 years was 61.2% (95% CI, 0.431-0.751), and at 3 years was 56.1% (95% CI, 0.369-0.715). ConclusionsThe Conformable GORE TAG Thoracic Endoprosthesis and GORE TAG Thoracic Endoprosthesis thoracic endografts provide an effective treatment for ruptured thoracic aortic diseases. Adjunctive coverage or revascularization of an aortic branch vessel may be necessary. Longer follow-up and larger studies are needed to determine durability of these repairs.

Laparoscopic Sleeve Gastrectomy Leakage: Case Report of A Rare Complication Management

Introduction: Laparoscopic sleeve gastrectomy (SG) is an effective method for the treatment of obesity. Leakage is the most common and unfavorable complication of SG. Use of self-expandable metal stents (SEMS) has become the gold standard management. Aortoesophageal fistula (AEF) is a rare and life-threatening complication that can result from SEMS placement. Case Presentation: A 52 year old woman underwent laparoscopic SG for morbid obesity. Eight days after an esophagogastric SEMS placement was required for gastric leakage. Twenty two days later she presented massive hematemesis and active AEF was diagnosed requiring endovascular placement of thoracic endoprosthesis. SG conversion into Roux en Y gastric bypass (RYGB) with double pigtail stent placement was necessary for the persistence of gastric fistula. 45 days after, EGD revealed the aortic prosthesis at the distal portion of esophagus. For this reason, she underwent a thoracic aorta reconstruction and an esophago jejunal anastomosis. Discussion: Esophageal ulceration is a possible complication of SEMS placement and can lead to an AEF. In order to promptly identify and treat rare and fatal complications as AEF, it is important to always keep a high index of suspicion. Conclusion: The awareness of rare complications as AEF after SEMS placement is important in order to facilitate immediate surgical treatment and to raise survival possibility. It is important to be familiar with all different treatment options, as well as being updated on the latest Guidelines. A good knowledge of timing and best treatment option, depending on the leak and patient clinical status, are mandatories.