Proximal Stent Graft Research Articles

Hybrid Stent Graft Technique in Bridging Hostile Renal Arteries in Thoraco-abdominal Branched Endografting

Patency of target arteries is crucial for fenestrated and branched endovascular aortic repair (F/B-EVAR) in thoracoabdominal aortic aneurysms (TAAAs). Occlusions more frequently occur in renal arteries (RAs) than in coeliac and superior mesenteric arteries, especially in patients with hostile anatomy treated by BEVAR. This study aimed to report RA outcomes using a hybrid bridging stent graft technique with distal self expandable (SE) combined with proximal balloon expandable (BE) stent graft during BEVAR with hostile RA anatomies. Clinical data from consecutive patients treated for TAAA by F/B-EVAR in three aortic centres (two in the USA, one in Europe) from 2016 to 2022 were prospectively collected. Renal artery orientation was defined as hostile in case of upward (type B) or downward + upward (type D) orientation. Hostile RAs accommodated by BEVAR and combination of SE + BE stent grafts were retrospectively evaluated. Intra-operative RA related complications, technical success, and branch occlusions were assessed as early outcomes. Primary and secondary RA patency, freedom from RA related re-interventions, and freedom from RA instability were assessed during follow up. Of 584 TAAAs managed by F/B-EVAR, 83 patients (14.2%) had 125 hostile RAs (type B, 45.6%; type D, 54.4%) managed by BEVAR with hybrid SE + BE stent grafts. Intra-operative complications occurred in three RAs (2.4%), including two dissections and one disconnection, all successfully managed with additional stent. Technical success was achieved in all cases, with no RA occlusions at 30 days. The median follow up was 21 (interquartile range 4, 38) months. Estimated three year RA primary patency was 97 ± 2%. Re-interventions were performed in five RAs (4.0%), including two RA branch embolisations for bleeding, two catheter thrombectomies with stent relining (bilateral occlusion in one patient), and one revision of type Ic endoleak. Freedom from RA related re-interventions and RA instability was 95 ± 2% and 91 ± 3% at three years, respectively. Renal artery secondary patency was 99 ± 1% at three years. In hostile RA anatomies, a combination of distal SE and proximal BE stent grafts as bridging stenting in BEVAR is safe and effective, with low rates of occlusion, re-interventions, and branch instability at midterm follow up.

Urgent Thoracic Endovascular Aortic Repair for Type-B0,D Acute Aortic Dissection

The objective of the present study is to clarify safety and efficacy of thoracic endovascular aortic repair (TEVAR), excluding the primary entry in the descending aorta, for type-B0,D acute aortic dissection (TB0,DAAD) (so-called retrograde type-A acute aortic dissection). Forty-six patients with hyperacute-phase (within 2days after the onset) type-A acute aortic dissection (TAAAD) and TB0,DAAD underwent urgent (on the admission or next day) intervention (TEVAR or conventional surgical aortic repair [CSAR]) for 2years. Results of TEVAR for TB0,DAAD were compared with those of CSAR for TAAAD. Outcomes included 30-day mortality, aortic reintervention, and major complications (stroke and paraplegia/paraparesis). Details of TEVAR were also analyzed. Seven patients with TB0,DAAD and 39 patients with TAAAD underwent respectively urgent TEVAR and CSAR. Aortic reintervention was significantly more frequent in the TEVAR than CSAR group (28.6% vs. 0%, P<0.01). There was no difference in incidence of death and stroke between the TEVAR and CSAR group. All the 7 patients survived and 5 of the 7 (71.4%) patients were relieved of aortic reintervention for 30days following TEVAR. One patient, however, underwent aortic arch replacement on postoperative day (POD) 1 owing to the patent and nonshrinking ascending false lumen (FL). The entry existed in the aortic arch. Another patient underwent ascending and transverse aortic replacement with frozen elephant trunk on POD13 due to proximal stent graft-induced new entry irrespective of the thrombosed and shrinking ascending FL. Because of the patent and nonshrinking ascending FL, 1 patient underwent additional TEVAR for the residual entry in the distal descending thoracic aorta on POD33 and subsequently ascending aortic replacement 4months later. No entry was detected in the ascending or transverse aorta. The ascending FL in the other 4 patients was thrombosed early, shrinking gradually, and disappeared at last following TEVAR. Urgent TEVAR for TB0,DAAD may be alternative to CSAR in selected cases. Accurate diagnosis of the primary entry location on preinterventional computed tomography scans for exclusion of the entry and cautious selection and delivery of a stent graft to prevent stent graft-induced new entry or endoleak are requisite for success of the procedure, remodeling of the FL, and satisfactory prognosis.

Multicentric Use of Commercially Available Infrarenal Endografts During Fenestrated Endovascular Aortic Repair: A Feasibility Study.

This study aimed to assess the feasibility and short-term outcomes of different manufactured proximal and distal stent graft components during fenestrated endovascular aortic repair (FEVAR). A multicenter retrospective review was conducted at 3 aortic centers, involving all consecutive patients who underwent FEVAR utilizing a customized Dacron-based tubular proximal and a distal bifurcated polytetrafluoreten (PTFE)-based commercially available stent grafts. Primary outcomes were 30 day mortality, major adverse events, and technical and clinical success. Secondary outcomes assessed stent graft migration, occurrence of types I/III endoleak, and reintervention. A total of 23 FEVAR cases across all centers were included in this study. Technical success was achieved in all cases, with a median procedure time of 183 (153-244) minutes. There were no major adverse events, except for 1 transient acute renal failure. The median follow-up period was 23 (17-28) months. All target vessels retained patent with the exception of 1 right renal fenestration that showed signs of kinking at the first follow-up, and despite secondary intervention with relining and distal extension, there was an occlusion afterward and 1 hepatic artery with a separate fenestration. This and 1 successful relining of a superior mesenteric artery kink were the only reinterventions in this cohort. One case of persistent type 1b endoleak was reported in a patient with chronic type B aortic dissection, which resolved with distal extension on the external iliac artery 5 months after the index procedure. No deaths occurred throughout the follow-up with, and there were no signs of stent graft migration or type 3 endoleak. The use of commercially available PTFE-based bifurcated stent grafts to extend distally the tubular graft appears to be a feasible approach during FEVAR, with promising short-term outcomes. Further studies are necessary to define the applicability of this solution and evaluate long-term outcomes. This multicentric study on fenestrated endovascular aortic repair (FEVAR) demonstrates the feasibility and good short-term outcomes of utilizing a PTFE-based commercially available stent graft to extend the proximal tubular custom-made fenestrated stent graft. The high technical success rate, absence of major adverse events, and low occurrence of complications such as stent graft migration and endoleaks highlight the potential clinical benefits of this approach with an off-the-shelf distal extension whose delivery system does not cross the fenestrations intraoperatively.

Oversizing Consideration of Proximal Stent Graft in Hemodynamically Stable and Unstable Patients Undergoing Emergent Endovascular Aortic Repair

Consideration for oversizing the proximal stent graft is suggested in endovascular aortic repair. However, a special recommendation for the proximal oversizing ratio (OSR) in patients with ruptured abdominal aortic aneurysm (rAAA) is ambiguous. This study aims to evaluate the effect of different degrees of the proximal oversizing ratio (OSR) on risk of type IA endoleak (TIAEL) in hemodynamically stable and unstable patients with rAAA undergoing emergency endovascular aortic repair (EVAR). Our study included 134 rAAA patients undergoing emergent EVAR, and we did not observe a significant association between hemodynamic instability and risk of T1AEL (HR 3.89, 95%CI 0.40–37.75, p = 0.24). All three T1AELs in the hemodynamically unstable subgroup were observed in patients with OSR ≤ 30%, but no significant difference was found regarding T1AEL between patients with OSR &gt; 30% and OSR ≤ 30% (0.00% vs. 11.11%, p = 0.19). As for hemodynamically stable patients, OSR &gt; 20% was associated with a significantly decreased risk of T1AEL (HR 0.03, 95%CI 0.01–0.53, p = 0.016). In conclusion, a proximal OSR &gt; 20% is associated with a decreased risk of T1AEL in hemodynamically stable patients, while an OSR &gt; 30% did not add an additional advantage of lowering the risk of T1AEL in hemodynamically unstable patients.

Off-the-Shelf Single-Fenestrated Endograft for Emergent Juxtarenal and Pararenal Abdominal Aortic Aneurysm.

Endovascular solutions to emergent juxtarenal and pararenal abdominal aortic aneurysms (AAAs) are complicated. Endovascular aortic repair (EVAR) with in situ laser fenestration (ISLF) is promising but requires a period of visceral ischemia. With an off-the-shelf, single superior mesenteric artery (SMA)-fenestrated device mesenteric ischemia is avoided and renal ischemia decreased. The aim was to develop an optimized design of such an endograft suitable for >90% of juxtarenal and pararenal AAAs. Single-center analysis on 44 consecutive preoperative CTs for previously elective fenestrated EVARs for juxtarenal and pararenal aneurysms. Anatomical characteristics were analyzed to define: (1) shortest aortic coverage above SMA fenestration to achieve ≥4 cm seal; (2) feasibility of a scallop for the celiac artery; (3) shortest distance between the SMA and lowest renal, to facilitate renal ISLF in a straight endograft; (4) distance from the lowest renal to the aortic bifurcation, to allow an overlapping zone >40 mm with a bifurcated stent graft; (5) aortic diameter in the sealing zone, for optimal proximal stent graft diameter with 10% to 30% oversizing; (6) the final design was then tested on individual level. (1) The stent graft needs to start 40 mm above the SMA fenestration to achieve a 4 cm sealing zone in >90% of cases. (2) A proximal sealing zone of 40 mm without a scallop covers 77% of celiac arteries. With an addition of a 20 mm deep, 20 mm wide scallop at 12:30, the stent graft still covers 27% of celiacs. This suggests that a scallop would not be practically feasible. (3) In >90% of cases, the lowest renal was <31 mm from the SMA, suggesting that the tapering should start 30 mm below the SMA. (4) The distance from the lowest renal to the aortic bifurcation ranged from 82 to 166 mm. This allows for a 20 mm tapering and 50 mm straight part in all cases. (5) The 5th and 95th percentile of the aortic diameter in the sealing zone was 22 and 31 mm, respectively. Thus, 2 different stent graft diameters (28 and 34 mm) would fit >90% of cases. (6) The final design was suitable in 91% cases. Two sizes of a single-fenestrated aortic stent graft without scallop cover >90% of juxtarenal and pararenal anatomies. Emergent juxta- and pararenal aortic aneurysms is a difficult clinical scenario that continuously challenges physicians. An endovascular option is in situ laser fenestrated endografts. One risk with these is the complete visceral ischemia occurring before the fenestrations are completed. An off-the-shelf single-fenestrated stent graft facilitates the treatment by removing the ischemia time for the SMA and reducing the ischemia time for the celiac and renal arteries thus decreasing the risk of visceral ischemia complications.

Long-Term Outcomes in Thoracic Endovascular Aortic Repair for Complicated Type B Aortic Dissection or Intramural Hematoma Depending on Proximal Landing Zone.

Thoracic endovascular aortic repair (TEVAR) is the preferred treatment for complicated type B aortic dissection (TBAD) or intramural hematoma (IMH). This study aimed to investigate the association of the proximal landing zone and its morphology with long-term outcomes in patients with TBAD or IMH. A total of 94 patients who underwent TEVAR for TBAD or IMH between 10/2003 and 01/2020 were included. The cohort was divided according to the proximal landing in Ishimaru zone 2 or 3 and the presence of a healthy landing zone (HLZ; non-dissected or aneurysmatic, ≥2 cm length). Primary outcome was freedom from aortic reintervention. Secondary endpoints were freedom from aortic growth, stroke, spinal cord ischemia, retrograde dissection, proximal stent-graft induced new entry (pSINE), debranching failure, and mortality. Outcomes were assessed using Cox proportional hazard models with mortality as a competing risk. A proximal TEVAR landing in zone 2 was associated with higher rates of reinterventions compared to zone 3 (33% vs. 15%, p = 0.031), spinal cord ischemia (8% vs. 0%, p = 0.037), and pSINE (13% vs. 2%, p = 0.032). No difference was found for the other outcomes, including mortality. Landing in dissected segments was not associated with impaired results. Proximal TEVAR landing in zone 3 may be preferable with regard to long-term aortic reintervention in patients with TBAD or IMH.

Assessment of Thoracic Endovascular Aortic Repair Using Relay Proximal Scallop: Results of a French Prospective Multicentre Study

A proximal scallop design allows aortic arch repair without complex endovascular manipulation in theaortic arch. The aim was to assess the safety and efficacy at one year of the Relay proximal scallop stent graft. A prospective multicentre study evaluated consecutive patients treated with the Relay proximal scallop stent graft in 10 French aortic centres. All consecutive patients eligible for elective thoracic endovascular repair with proximal scallop in the 10 participating centres between January 2015 and July 2018 were included. Primary endpoints were 30 day mortality, stroke, and spinal cord ischaemia (SCI) rates. Outcomes including safety and efficacy, technical and clinical success, all cause death, neurological events, vessel patency, and device specific complications were analysed. Survival and survival without severe complications were estimated using Kaplan-Meier estimates. Ten aortic centres treated 40 patients for thoracic aortic aneurysm (45%), penetrating atherosclerotic aneurysm (30%), and dissection (25%). Half of the procedures (50%) targeted zone 0 of the aortic arch (zone 0 in 17.5% and zones 0/1 in 32.5%), 37.5% targeted zone 2 (35% zone 2 alone; 2.5% zones 1/2), and 15% targeted zone 1 (12.5% zone 1 alone). Median follow up was one year. Thirty day mortality, stroke, and SCI rates were 10%, 5%, and 0% respectively. Primary technical success was 95%. Type Ia, Ib, and III endoleaks rates were 5.4%, 0%, and 0% respectively at one month. The overall mortality rate at one year was 17.5%. Aneurysm expansion was > 5 mm in one case at one year associated with type Ia endoleak (3%). There was no supra-aortic trunk thrombosis, one (2%) graft kink, and no migration. One year outcomes showed that the Relay proximal scallop stent graft is an acceptable answer to thoracic aortic disease to deal with short proximal landing zones.

Effectiveness of Proximal Landing Zone 1 and 2 Thoracic Endovascular Aortic Repair for Type B Aortic Dissection by Comparing Outcomes With Thoracic Arch Aneurysm.

Hybrid thoracic endovascular aortic repair (TEVAR) for aortic arch aneurysms is a minimally invasive procedure with improved results. This study aimed to clarify the effectiveness and expand the possibilities of zone 1 and 2 landing TEVAR for type B aortic dissection (TBAD) using our treatment strategy. This retrospective, single-center, observational cohort study included 213 patients (TBAD, n=69; thoracic arch aneurysm [TAA], n=144; median age, 72 years; median follow-up period, 6 years) from May 2008 to February 2020. The following conditions were satisfied before performing zone 1 and 2 landing TEVAR: TBAD; proximal landing zone (LZ): diameter <37 mm, length >15 mm, and nondissection area, proximal stent-graft: size ≤40 mm and oversizing rate: 10% to 20%, and TAA; proximal LZ: diameter ≤42 mm and length >15 mm, proximal stent-graft: size ≤46 mm and oversizing rate: 10% to 20%. Of the 69 patients in the TBAD group, 34 (49.3%) had patent false lumen (PFL), and 35 (50.7%) had false lumen partial thrombosis (FLPT), including ulcer-like projections. Emergency procedures were performed in 33 (15.5%) patients. There were no significant differences in the in-hospital mortality (TBAD: 1.5% vs TAA: 0.7%, p=0.544) or the in-hospital aortic complications (TBAD: n=1 vs TAA: n=5, p=0.666). Retrograde type A dissection was not observed in the TBAD group. The aortic event-free rates at 10 years were 89.7% (95% confidence interval [CI]: 78.7%-95.3%) and 87.9% (95% CI: 80.3%-92.8%) in the TBAD and TAA groups, respectively (log-rank p=0.636). In the TBAD group, the early and late outcomes were not significantly different between the PFL and FLPT groups. Satisfactory early and long-term results were obtained with zone 1 and 2 landing TEVAR. The TBAD cases had the same good results as the TAA cases. Using our strategy, we especially might reduce complications and be an effective treatment for acute complicated TBAD. This study aimed to clarify the effectiveness and expand the possibilities of zones 1 and 2 landing TEVAR for type B aortic dissection (TBAD) using our treatment strategy. Satisfactory early and long-term results in the TBAD and thoracic arch aneurysm (TAA) groups were obtained with zones 1 and 2 landing TEVAR. The TBAD cases had the same good results as the TAA cases. Using our strategy, we especially might reduce complications and be an effective treatment for acute complicated TBAD.

Outcomes of Patients With Type B Aortic Dissections Repaired With the Zenith Dissection Endovascular System Compared With Aortic Stentgraft

This study aims to evaluate the safety and effectiveness of the Zenith Dissection Endovascular System (ZDES; Zenith TX2 Dissection Endovascular Graft with Pro-Form and Zenith Dissection Endovascular Stent), which uses a proximal stentgraft along with a distal bare metal stent compared with traditional stentgrafts alone in the repair of acute, complicated type B aortic dissection (TBAD). This institutional review board-approved, single-center retrospective study reviews the medical charts of 32 patients with acute, complicated TBAD repaired at an urban academic medical center. Sixteen of these TBAD cases were repaired with the dissection stent (62.5% male; mean age, 60.3 years), and 16 were repaired with a stentgraft (87.5% male; mean age, 63.1 years). Primary outcomes evaluated include 30-day and 3-year mortality, 30-day morbidity outcomes, false lumen thrombosis, and aneurysmal degeneration. A total of 12 postoperative major adverse events occurred in the ZDES group compared with 37 events in the stentgraft group (P = .0087). Most notable major adverse events included myocardial infarction (0 of 16 ZDES; 2 of 16 stentgraft), renal ischemia (0 of 16 ZDES; 5 of 16 stentgraft), stroke and spinal cord ischemia (2 of 16 ZDES; 5 of 16 stentgraft), transient extremity ischemia (1 of 16 ZDES; 5 of 16 stentgraft), and refractory pain (0 of 16 ZDES; 8 of 16 stentgraft). At the 6-month follow-up, complete or partial thrombosis of the false lumen was noted in 100% of patients (16 of 16) in the ZDES group and in 56.3% of patients (9 of 16) in the stentgraft group. At the 12-month follow-up, complete or partial thrombosis of the false lumen was noted in three additional patients in the stentgraft group for a total of 75% of patients (12 of 16). Growth (>5 mm) of the maximum transaortic diameter was noted in 33.3% of patients (5 of 15) in the ZDES group and in 54% of patients (7 of 13) in the stentgraft group at 12 months. Thirty-day mortality occurred in one patient (6.3%) in the ZDES group, and there was no 30-day mortality in the stentgraft group. This death was related to dissection repair. Three-year mortality occurred in four patients (25%) in the stentgraft group, and there was no 3-year mortality in the ZDES group. These deaths were related to aneurysmal degeneration of the repaired aorta. This study suggests that patients with TBAD repaired with the ZDES had better aortic remodeling and false lumen thrombosis as well as decreased aneurysmal degeneration than patients treated with the stentgraft alone.

Application of "Fabulous" stent system to improve aortic remodeling after TEVAR for type B aortic dissection.

Application of "Fabulous" stent system to improve aortic remodeling after TEVAR for type B aortic dissection.

Prediction of bird-beak configuration in thoracic endovascular aortic repair preoperatively using patient-specific finite element simulations

ObjectivesFormation of bird-beak configuration in thoracic endovascular aortic repair (TEVAR) has been shown to be correlated with the risk of complications such as type Ia endoleaks, stent graft migration, and collapse. The aim of this study was to use patient-specific computational simulations of TEVAR to predict the formation of bird-beak configuration preoperatively. MethodsPatient-specific TEVAR computational simulations are developed using a retrospective cohort of patients treated for thoracic aortic aneurysm. The preoperative computed tomography images were segmented to develop three-dimensional geometry of the thoracic aorta. These geometries were used in finite element simulations of stent graft deployment during TEVAR. Simulated results were compared against the postoperative computed tomography images to assess the accuracy of simulations in predicting the proximal position of a deployed stent graft and presence of bird-beak. In cases with a bird-beak configuration, the length and angle of the bird-beak were measured and compared between the simulated and postoperative results. ResultsTwelve TEVAR patient cases were simulated. Computational simulations were able to accurately predict whether the proximal stent graft was fully apposed, proximal bare stents were protruded, or bird-beak configuration was present. In three cases with bird-beak configuration, simulations predicted the length and angle of the bird-beak with less than 10% and 24% error, respectively. Other factors such as a small aortic arch angle, small oversizing value, and landing zones close to the arch apex may have played a role in formation of bird-beak in these patients. ConclusionsComputational simulations of TEVAR accurately predicted the proximal position of a deployed stent graft and the presence of bird-beak preoperatively. The computational models were able to predict the length and angle of bird-beak configurations with good accuracy. These simulations can provide insight into the surgical planning process with the goal of minimizing bird-beak occurrence.

First in Human Implantation of the Thoracoflo Graft: A New Hybrid Device for Thoraco-Abdominal Aortic Repair

Despite a high rate of success when performed in specialised centres, current techniques for thoraco-abdominal aortic repair are associated with serious complications. The problem of spinal cord ischaemia remains unsolved. The new hybrid graft for thoraco-abdominal aortic repair was developed based on the frozen elephant trunk principle. The device consists of a proximal stent graft for transabdominal retrograde delivery to the descending thoracic aorta, combined with a distal six branched abdominal device for open aortic repair. An additional seventh branch is provided for possible lumbar artery re-implantation. Because the stent graft is implanted via a transabdominal approach, it avoids the need for thoracotomy and extracorporeal circulation. A 56 year old patient with Loeys-Dietz syndrome was placed in a supine position. The aorto-iliac axis was exposed via a midline transperitoneal approach. Following an end to side anastomosis of the iliac branch to the left common iliac artery, the stent graft portion was inserted into the thoracic aorta via the coeliac trunk ostium. After stent implantation and graft de-airing by needle puncture, retrograde blood flow to the abdominal aortic segment, and the lumbar and visceral arteries was established via the end to side iliac anastomosis creating an extra-anatomic bypass. Subsequently, the visceral and renal arteries were anastomosed to the branches. Finally, the aorta was opened and surgical graft attached via the collar. The reconstruction ended with end to end anastomoses of both common iliac arteries to the graft branches. The first and successful implantation of the new Thoracoflo hybrid device via a novel surgical technique is reported, eliminating the need for thoracotomy and extracorporeal circulation for thoraco-abdominal aortic repair.

Fenestrated/branched endovascular aortic repair using unilateral femoral access in patients with iliac occlusive disease

ObjectiveFenestrated/branched endovascular aortic repair (F/BEVAR) in patients with occluded iliac arteries is challenging owing to limited access for branch vessel catheterization and increased risk for leg and spinal ischemic complications. The aim of this study was to analyze technical strategies and outcomes of F/BEVAR in patients with unilateral iliofemoral occlusive disease. MethodsWe performed a retrospective review of all consecutive patients treated by F/BEVAR in two institutions (2003-2021). Patients with unilateral iliofemoral occlusive disease were included in the analysis. All patients had one patent iliac artery that was used for advancement of the fenestrated-branch component. Preloaded catheter/guidewire systems or steerable sheaths were used as adjuncts to facilitate catheterization. Primary endpoints were technical success, mortality, major adverse events (stroke, spinal cord injury, dialysis or decrease in the glomerular filtration rate of more than 50%, bowel ischemia, myocardial infarction, or respiratory failure), primary iliac patency, and freedom from reinterventions. ResultsThere were 959 patients treated with F/BEVAR. Of these, 15 patients (1.56%; mean age, 74 years; 80% male) had occluded iliac arteries and 1 patent iliofemoral access and were treated for a thoracoabdominal aortic aneurysm (n = 8) or juxtarenal abdominal aortic aneurysm (n = 7). Brachial access was used in 14 of the 15 patients and preloaded systems in 7 of the 15 patients (47%). The remaining 53% had staggered deployment of stent grafts. There were seven physician-modified endovascular grafts, seven custom-made devices, and one off-the-shelf device used. Thirteen patients (87%) had distal seal using aortouni-iliac stent grafts and two (13%) had distal seal in the infrarenal aorta. Concomitant femoral crossover bypass (FCB) was performed in two patients and six patients had a prior FCB. Technical success was 100%. There were no intraoperative complications or early lower extremity ischemic complications, and all FCB were preserved. There was one mortality (7%) within 30 days owing to retrograde type A dissection. Major adverse events occurred in 20% of patients. The median follow-up was 12 months (range, 0-85 months). Two patients (13%) required three reinterventions. One patient required proximal stent graft extension for an acute type B dissection (3 months) and another required iliac extension for type Ib endoleak of an aortouni-iliac graft (21 months) and thrombolysis of that extension (50 months). At last follow-up, all patients had primary graft patency except one with secondary graft patency without new claudication. One patient had a single renal artery stent occlusion at follow-up with no r-intervention. The overall survival rate was 60%, without aortic-related deaths. ConclusionsAlthough challenging, F/BEVAR with unilateral femoral/brachial approach is feasible in patients with occluded iliac limbs, with an important rate of ischemic complications, but satisfactory outcomes.

Five-year results of the STABLE II study for the endovascular treatment of complicated, acute type B aortic dissection with a composite device design

To provide the 5-year outcomes of the use of a composite device (proximal covered stent graft+ distal bare stent) for endovascular repair of patients with acute, type B aortic dissection complicated by aortic rupture and/or malperfusion. Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE) II was a prospective, multicenter study of the Zenith Dissection Endovascular System (William Cook Europe). Patients were enrolled between August 2012 and January 2015 at sites in the United States and Japan. Five-year follow-up was completed by January2020. In total, 73 patients (mean age: 60.7± 10.9years; 65.8% male) with acute type B dissection complicated by malperfusion (72.6%), rupture (21.9%), or both (5.5%) were enrolled. Patients were treated with either a composite device (79.5%) or the proximal stent graft alone (no distal bare stent, 20.5%). Dissections were more extensive in patients who received the composite device (408.9± 121.3mm) than in patients who did not receive a bare stent (315.9± 100.1mm). The mean follow-up was 1209.4± 754.6days. Freedom from all-cause mortality was 80.3%± 4.7% at 1year and 68.9%± 7.3% at 5years. Freedom from dissection-related mortality remained at 97.1%± 2.1% from 1-year through 5-year follow-up. Within the stent-graft region, the rate of either complete thrombosis or elimination of the false lumen increased over time (82.1% of all patients at 5years vs 55.7% at first postprocedure computed tomography), with a higher rate at 5years in patients who received the composite device (90.5%) compared with patients without the bare stent (57.1%). Throughout the follow-up, overall true lumen diameter increased within the stent-graft region, and overall false lumen diameter decreased. At 5years, 20.7% of patients experienced a decrease in maximum transaortic diameter within the stent-graft region, 17.2% experienced an increase, and 62.1% experienced no change. Distal to the treated segment (but within the dissected aorta), 23.1% of patients experience no change in transaortic diameter at 5years; a bare stent was deployed in all these patients at the procedure. Five-year freedom from all secondary intervention was 70.7%± 7.2%. These 5-year outcomes indicate a low rate of dissection-related mortality for the Zenith Dissection Endovascular System in the treatment of patients with acute, complicated type B aortic dissection. Further, these data suggest a positive influence of composite device use on false lumen thrombosis. Continuous monitoring for distal aortic growth is necessary in all patients.

Concomitant distal bare-metal stenting for residual true lumen stenosis in a frozen elephant trunk technique for acute type A aortic dissection.

For acute type A aortic dissection (TAAD), we have performed aortic arch repair using a frozen elephant trunk (FET) since 20141 and observed that aortic remodeling was limited at the level below the FET stent end postoperatively.2 For acute type B aortic dissection (TBAD), the PETTICOAT (provisional extension to induce complete attachment) technique has been an option to reopen the residual true lumen (TL) collapse after thoracic endovascular aortic repair (TEVAR).3 Similarly, proximal stent grafting with distal bare-metal stenting in a 2-staged manner has been reported in repair of acute DeBakey type I aortic dissection.

Invivo evaluation of a new hybrid graft using retrograde visceral perfusion for thoracoabdominal aortic repair in an animal model.

ObjectivesThe SPIDER technique for hybrid thoracoabdominal aortic aneurysm repair can avoid thoracotomy and extracorporeal circulation. To improve technical feasibility and safety, the new Thoracoflo graft, consisting of a proximal stent graft connected to a 7-branched abdominal prosthesis, was evaluated in a pig model for technical feasibility testing, before implantation in humans.MethodsRetroperitoneal exposure of the infradiaphragmatic aorta, including visceral and renal arteries, was performed in 7 pigs (75-85 kg). One iliac branch was temporarily attached to the distal aorta to maintain retrograde visceral and antegrade iliac perfusion after deployment of the thoracic stent graft segment (SPIDER technique). The proximal stent-grafted segment was deployed in the thoracic aorta via direct aortic puncture over the wire without fluoroscopy. The graft was deaired before flow via the iliac side branch to the visceral and iliac arteries was established. Visceral, renal, and lumbar arteries were subsequently sutured to the corresponding side branches of the graft. Technical feasibility, operating and clamping time, blood flow, and tissue perfusion in the related organs were evaluated before implantation and after 3 and 6 hours using transit-time flow measurement and fluorescent microspheres. Final angiography or postprocedural computed tomography angiography were performed.ResultsOver-the-wire graft deployment was successful in 6 animals without hemodynamic alteration (P = n.s.). In 1 pig, the proximal stent graft section migrated as the guidewire was not removed, as recommended, before release of the proximal fixation wire. Angiography and computed tomography scan confirmed successful graft implantation and transit-time flow measurement confirmed good visceral and iliac blood flow. Fluorescent microspheres confirmed good spinal cord perfusion.ConclusionsOver-the-wire implantation of the Thoracoflo graft using the SPIDER technique is feasible in a pig model. No fluoroscopy was required. For safe implantation, it is mandatory to follow the single steps of implantation.

Long-term outcome of patients treated by TEVAR for type B aortic dissection or intramural hematoma depending on a healthy vs non-healthy proximal landing zone

Abstract Objective Thoracic endovascular aortic repair (TEVAR) is the first-line therapy for complicated type B aortic dissection (TBAD) or intramural hematoma (IMH). However, depending on the location of the primary entry tear, there is paucity of data as to whether the proximal landing zone (PLZ) of the stent prosthesis must be in a non-dissected healthy part (healthy landing zone = HLZ) or in the dissected aorta (non-healthy landing zone= non-HLZ). Methods Retrospective analysis of patients who underwent TEVAR for acute (&amp;lt;14 days) or subacute (&amp;lt;3 months) TBAD or IMH from 2003–2020 at a single center. A HLZ was defined as a non-dissected aortic segment (length ≥2 cm). Primary endpoints were freedom from aortic reintervention and -growth (≥5 mm). Secondary endpoints involved stroke, retrograde type A aortic dissection, proximal stent graft induced new entry (pSINE), debranching failure, 30-day and overall mortality. Results 94 patients (age 70 years (interquartile-range (IQR): 59 to 78) were included. 84 (89%) presented with a TBAD and only ten (11%) with an IMH. CTA analysis revealed a HLZ in 62 (66%) patients. Debranching of the left subclavian artery was performed in 21 (22%) patients to extend the PLZ. The median follow-up time was 20 (IQR: 4.6 to 72.9) months. The overall aortic reintervention rate was 22%. Estimated re-intervention rate at 12 months was 13.1% for HLZ vs. 16.1% for non-HLZ and at 5 years 16.8% for HLZ 29.9% vs. for non-HLZ (P=0.187). Aortic growth was observed in 12 patients after 2.2 years (IQR: 0.8 to 5.9), with no significant difference in patients with HLZ vs. non-HLZ (11% vs 16%,P=0.535). No significant differences were observed for the secondary endpoints. 30-day mortality was 10% in both groups, P=1.0. Overall survival was 47% in the HLZ group vs. 41% in the non-HLZ group, P=0.663. A Cox proportional hazard model for reintervention with mortality as a competing risk showed a trend towards better long-term outcome for patients with a HLZ, hazard ratio 0.451 (95%-CI: 0.186–1.09, P=0.078). Conclusion In the majority of patients, it was possible to land in a HLZ. Consistently, reintervention rates, aortic growth, and mortality were higher in patients with non-HLZ compared with HLZ over the mid- and long-term. However, these differences were not statistically significant. Therefore, larger studies are urgently needed.

Fixing Bridge Technique Combining Distal Covered Self-Expandable With Proximal Balloon-Expandable Stent-Graft in Case of Branched Endografting

The aim of the study was to describe the early and midterm results of the fixing bridge technique—a combination of a distal covered self-expandable with proximal balloon expandable stent graft—during branched thoracoabdominal aneurysm (TAAA) repair to limit the incidence of type IIIc endoleak (∼2%).

Type B aortic dissection residual after proximal aortic repair: an innovative open surgical approach in patients not eligible for endovascular treatment.

Residual type B aortic dissection (R-TBAD) is a challenging kind of disease affecting an increasing number of patients. Management of R-TBAD has not been specifically addressed in current literature and many of those patients are not eligible for endovascular treatment. Aim of the study was to evaluate the efficacy and feasibility of a specifically conceived procedure the "saguaro branched graft technique" to treat R-TBAD distal to a proximal stent-graft. Data of patients treated between 2015 and 2019 were prospectively collected and retrospectively analyzed. Indication for surgery was R-TBAD with chronic malperfusion, aortic enlargement >55 mm or rapid growth, and symptomatic aortic enlargement. A Dacron graft with four branches has been tailored on the back table by implanting two bifurcated grafts to a tube or bifurcated graft. After left thoracoabdominal incision the proximal endograft has been used as a solid starting point for the distal branched graft. Sequential revascularization of the visceral vessels was performed step by step by suturing each artery outside the aneurysm before opening the distal aorta, while a continued retrograde aortic and visceral perfusion was maintained by a left pump atrio-femoral bypass. After that all visceral branches had been regularly perfused from above, the thoraco-abdominal aorta was open and repaired. Outcome measures were 30-day mortality and 30-day major complications as were long-term all-cause mortality, aorta-related mortality, reintervention and patency rates of the branches. Thirteen patients with R-TBAD were treated during the study period. Indication for surgery was chronic malperfusion in one patient (7.7%), aortic enlargement >55 mm or rapid growth in 9 patients (69.2%), persistent pain with aortic enlargement ≥50 mm in 3 patients (23.1%). All patients were considered not eligible for endovascular repair. At 30-days no deaths or re-interventions occurred and major complications including acute cardiovascular events and renal function impairment were not reported; one patient (7.7%) developed postoperative paraplegia. At a mean follow-up period of 19.6±10.2 (range, 8-48) months, reintervention and mortality rates were null. Visceral malperfusion and late-onset renal failure were not reported, and all visceral branches were still patent. Despite the potential high risk of open surgery, the "saguaro branched graft technique" appears to be a safe surgical solution for R-TBAD.

The PETTICOAT-Snowshoe Technique Prevents Distal Stent Graft-Induced New Entry in Patients with Aortic Dissection

Distal stent graft-induced new entry (SINE) is a serious complication of thoracic endovascular aortic repair (TEVAR) for Stanford type B aortic dissection (TBAD). The PETTICOAT-snowshoe technique was developed to prevent distal SINE for double-barrel TBAD. Initially, a proximal stent-graft (SG) is deployed, followed by the extension of a bare stent above the celiac artery and deployment of a second SG within the bare stent. This study examined whether the PETTICOAT-snowshoe technique prevents distal SINE. This was a single-center, retrospective study comparing 2 groups that underwent conventional standard TEVAR between January 2013 and September 2018 and TEVAR using the PETTICOAT-snowshoe technique after October 2018 for double-barrel TBAD. Twenty-seven patients (74% male) underwent standard TEVAR (group A), while another 27 (78% male) underwent the PETTICOAT-snowshoe technique (group B). TEVAR was performed in the chronic phase on 15 patients (55.6%) in group A and on 16 (59.2%) in group B. Aorta-related mortality occurred in 1 patient in group A (3.7%). Oversizing ratios at the distal edge of the SG diameter to the major axis of the true lumen were 25% ± 26% and 25% ± 21% in groups A and B, respectively. During the follow-up period, 5 patients (18.5%) in group A and none in group B (P=0.02) developed distal SINE. 3 of 5 patients with distal SINE in group A were treated with additional TEVAR, one with thoracoabdominal aortic replacement, and one with conservative observation. The freedom from distal SINE rate was significantly higher in group B than in group A (P=0.04). The PETTICOAT-snowshoe technique significantly prevented distal SINE during the mid-term period even with the same distal SG oversizing as conventional standard TEVAR.