Endovascular repair of pararenal and thoracoabdominal aortic aneurysms with inner and outer off-the-shelf multibranched endografts: A systematic review and meta-analysis.

During the last years a great progress has been noted in device technology and operator experience in treating complex aortic aneurysms. Fenestrated and branched custom-made devices require detailed preoperative planning and production time that can take ≤12 weeks. During this awaiting period, aortic-related mortality is increased. To overcome this limitation, off-the-shelf standardized multibranched devices were launched in the market for the treatment of pararenal and thoracoabdominal aortic aneurysms (TAAAs). Our aim was to evaluate systematically all the published studies of off-the-shelf endografts for the treatment of pararenal and TAAAs. We performed a systematic review to identify all the eligible studies that reported outcomes to the off-the-shelf with inner or outer multibranched devices and then conducted a qualitative synthesis and meta-analysis of the results. The main outcomes were technical success, mortality, target visceral vessel instability, major adverse events, and reintervention rates. We estimated pooled proportions and 95% confidence intervals (CIs). A total of 1605 study titles were identified by the initial search strategy, of which 13 (8 t-Branch, 3 E-nside, 1 We-Flow, and 1 TAMBE) were considered eligible for inclusion in the meta-analysis. A total of 595 patients (70% male) were identified among the eligible studies. In terms of procedures, 64.4% were elective, 19.2% (13.4% outer multibranched group [OMG]; 6.1% inner multibranched group [IMG]) were emergent, and 16.4% (15.6% OMG; 0.8% IMG) were urgent. The pooled technical success was 92.1% (95% CI, 83.8%-96.4%) and 96.9% (95% CI, 92.5%-98.8%) for the outer and inner multibranched endografts, respectively. The pooled 30-day mortality was 10.4 % (95% CI, 6.6%-16.1%,) and 4.2% (95% CI, 2.0%-8.6%) for the OMG and IMG, respectively. The pooled 30-day and late target visceral vessel instability for the OMG was 3.5% (95% CI, 2.0%-6.1%) and 6.2% (95% CI, 4.7%-8.0%) and for the IMG 10.4% (95% CI, 4.5%-22.5%) and 1.6% (95% CI, 0.7%-3.3%) respectively. This pooled analysis indicated good technical success and mortality rates for both devices despite the high rate of urgent procedures. Pararenal and TAAAs can be treated safely using the included devices. However, further studies are required to draw additional conclusions for the IMG owing to the small sample size.

Karaolanis GI ，Makaloski V ，Jungi S ，Weiss S ，Kotopoulos K ，Chaikhouni B ，Becker D ，Kotelis D ，Bosiers MJ ... -  《-》

Early Results of Fenestrated and Branched Endovascular Repair of Complex Aortic Aneurysms with a Custom-made National Device Available in the Brazilian Public Health System.

Multicenter studies conducted in developed countries demonstrated that custom-made devices are safe, effective, and durable for treating complex abdominal aneurysms. However, the situation in developing countries, such as Brazil, is different. Funding and time to have the endoprosthesis delivered are the major concerns. In order to overcome these conditions, high-volume Brazilian university hospitals started gaining experience with a custom-made device produced in the country. The present study aimed to describe the practice of 2 tertiary centers and report the early results of fenestrated and branched endovascular repair of complex aortic aneurysms with a custom-made national device available in the Brazilian public health system. Retrospective analysis of all consecutive patients that underwent fenestrated and branched endovascular aneurysm repair (F/BEVAR) of complex aortic aneurysms using custom-made manufactured endoprosthesis in 2 tertiary centers from January 2020 to July 2022. Thirteen cases were included (10 male, mean age 69 ± 9 years). 70% were complex abdominal aneurysms, and 30% were type II, III, and IV thoracoabdominal aneurysms (mean aneurysm diameter 69.2 ± 8.12 mm). F/BEVAR included 33 visceral arteries. The Apolo® device was used in all cases. Technical success was achieved in 12 out of 13 patients (92.3%). Thirty-day major adverse events included one death (7.7%), 5 acute renal failure (38.4%), 2 spinal cord ischemia (15.4%). The 1-year survival rate was 92.3%. Fenestrated and branched endovascular repair of complex aortic aneurysms with the custom-made Apolo® device has proven safe and effective in high-volume tertiary centers in the Brazilian public health system. Considering the complexity of the cases, the early patency of vessels and low initial mortality support this device continuation and expansion to treat complex aortic aneurysms in a developing country.

Domingues BS ，Dalio MB ，Miquelin DG ，Neto FR ，Reis LF ，Miquelin AR ，Godoy JMP ，Joviliano EE ... -  《-》

Outcomes using inverted iliac limb bifurcate components in fenestrated/branched endografting.

The use of standard bifurcate pieces in fenestrated/branched endovascular aortic repair (F/BEVAR) requires adequate length from the lowest branch or fenestration to the aortic bifurcation. In patients with prior aortic surgery, the aortic bifurcation is often artificially established in a more proximal position, compromising the infrarenal length, which hinders the placement of a standard bifurcate component below the fenestrated/branched component. Short bifurcate bodies using an inverted contralateral limb have been purpose-built to address this challenge. However, reported outcomes for this device remain limited, with specific concerns about the durability of the inverted iliac limb sealing region. We sought to evaluate outcomes of F/BEVAR using an investigational inverted iliac limb bifurcate, manufactured by Cook Medical. This study was a retrospective review of prospectively maintained data from the US-Aortic Research Consortium from 2005 to 2022. Patients were included if they underwent F/BEVAR for thoracoabdominal or complex abdominal aortic aneurysms. Patients were excluded if they did not have a bifurcate device placed. Patients were then compared based on the use of an inverted iliac limb or standard bifurcate component. The primary outcome for this study was technical success. Secondary outcomes included 30-day mortality, freedom from ischemic leg complications, freedom from type I endoleaks (TIELs), freedom from type II endoleaks (TIIELs), freedom from type III endoleaks (TIIIELs), and graft component separations. A total of 1944 patients met study criteria with 442 (22.8%) inverted iliac limb bifurcates and 1502 (77.2%) standard bifurcates. Patients who received inverted iliac limbs were more likely to have had prior aortic surgery (63.8% vs 28.5%; P < .001). Patients receiving inverted iliac limbs had longer procedure times (265 minutes; interquartile range [IQR], 201-342 minutes vs 241 minutes; IQR, 186-313 minutes; P < .001), more contrast use (89 mL [IQR, 55-135 mL] vs 109 mL [IQR, 75-156 mL]; P < .001), and higher estimated blood loss (250 mL [IQR, 150-500 mL] vs 250 mL [IQR, 110-400 mL]; P = .042). There were no differences in rates of technical success (97.3% vs 96.1%; P = .310), rates of endoleaks upon completion of the case (18.0% vs 21.4%; P = .123), or 30-day mortality rates (1.8% vs 2.5%; P = .466) between patients receiving inverted iliac limb and standard bifurcated components. There were no differences in cumulative survival, freedom from limb ischemia, freedom from aneurysm rupture, and freedom from TIIIELs over the course of 5 years between patients receiving inverted bifurcates and standard bifurcated components. Patients with inverted iliac limb bifurcate components had decreased freedom from reinterventions, TIELs, and TIIELs. After adjustment for potential confounders, the use of an inverted iliac limb was not associated with reinterventions (hazard ratio,1.044; 95% confidence interval, 0.849-1.285; P = .682). There was a total of 2 component separations (0.1%) of the bifurcate component from the fenestrated/branched component over the study period, both of which occurred in the standard bifurcate components. The use of investigational inverted iliac limb bifurcate components is a safe option with favorable mid-term outcomes in patients who are not anatomical candidates for standard bifurcate components. Patients undergoing investigational inverted iliac limb bifurcate component implantation had decreased freedom from reinterventions, which likely corresponds with the complexity of repair associated with them.

Khoury MK ，Beck AW ，Farber MA ，Gasper W ，Lee WA ，Oderich G ，Parodi FE ，Schanzer A ，Schneider D ，Sweet M ，Timaran CH ，Eagleton MJ ... -  《-》

Effect of narrow paravisceral aorta on target vessel instability after fenestrated and branched endovascular aortic repair.

To investigate the effect of narrow paravisceral aorta (NPA) on target vessel instability (TVI) after fenestrated-branched endovascular aortic repair. We conducted a single-center retrospective study (2014-2023) of patients treated by fenestrated-branched endovascular aortic repair for thoracoabdominal aortic aneurysms (TAAA) or pararenal aortic aneurysms. The paravisceral aorta was defined as the aortic segment limited by the diaphragmatic hiatus proximally and the emergence of lower renal artery distally, and was considered "narrow" in case of a minimum inner diameter of <25 mm. The minimum aortic diameter, location, longitudinal extension, angulation, calcification, and thrombus thickness of NPA were evaluated at the preoperative computed tomography angiogram. End points were 30-day technical success and freedom from TVI. There were 142 patients with JRAA/pararenal aortic aneurysm (n = 85 [59%]) and extent IV (n = 24 [17%]) or extent I-III (n = 33 [23%]) TAAA, with 513 target arteries successfully incorporated through a fenestration (n = 294 [57%]) or directional branch (n = 219 [43%]). A NPA was present in 95 patients (70%), 73 (86%) treated by fenestrated endovascular aortic repair (FEVAR) and 22 (39%) by branched endovascular aortic repair (BEVAR). The overall 30-day mortality was 2% and technical success was 99%, without differences between NPA and non-NPA (P = .99). Kaplan-Meier estimated freedom from TVI at 4 years was 82%, 81% (95% CI, 75-95) in patients with a NPA and 80% (95% CI, 68-94) and in those without NPA (P = .220). The result was maintained for both FEVAR (NPA: 81% [95% CI, 62-88]; non-NPA: 76% [95% CI, 60-99]; P = .870) and BEVAR (NPA: 77% [95% CI, 69-99]; non-NPA: 80% [95% confidence interval (CI) 66-99]; P = .100). After multivariate analysis, the concomitant presence of a NPA <20 mm and angulation of >30° was significantly associated with TVI in FEVAR (HR, 3.21; 95% CI, 1.03-48.70; P = .036), being the result mostly driven by target vessel occlusion. In BEVAR, a NPA diameter of <25 mm was not associated with TVI (HR, 2.02; 95% CI, 0.59-5.23; P = .948); after multivariate analysis, the use of outer branches in case of a NPA longitudinal extension of >25 mm (hazard ratio [HR], 3.02; 95% CI, 1.01-36.33; P = .040) and NPA severe calcification (HR, 1.70; 95% CI, 1.00-22.42; P = .048) were associated with a higher chance for TVI. FEVAR and BEVAR are both feasible in cases of NPA and provide satisfactory target vessels durability. The use of outer branches should be avoided in cases with an inner aortic diameter of <25 mm with a longitudinal extension of >25 mm or moderate to severe NPA calcifications. In FEVAR, bridging stent patency may be negatively influenced by NPA of <20 mm in association with aortic angulation of >30°.

Piazza M ，Squizzato F ，Forcella E ，Bilato MJ ，Colacchio EC ，Grego F ，Antonello M ... -  《-》

Ten years of physician-modified endografts.

Physician-modified endografts (PMEGs) have expanded the scope of endovascular abdominal aortic repair beyond the infrarenal aorta. Patients with prohibitively high surgical risk and visceral segment disease are often candidates for this intervention, which mitigates much of the morbidity and mortality associated with conventional open repair. Here we present the institutional PMEG experience of a high-volume aortic center. We studied all PMEGs performed at our institution from 2012 to 2023. We included cases that were submitted to the US Food sand Drug Administration in support of an investigational device exemption (IDE) trial, as well as those in the subsequently approved IDE trial. Over this 11-year period, we assessed the changes in operative characteristics and perioperative outcomes over time. Additionally, we compared the outcomes from PMEG cases to those of Zenith fenestrated (ZFEN) grafts (done by the surgeon with the PMEG IDE), an alternative device used for aneurysms involving the lower visceral segment. Here we assessed operative characteristics, perioperative outcomes, and 5-year survival and reintervention rates. When assessing the change over time for PMEG operative characteristics, we found a trend toward decreased fluoroscopy time and decreased proportions of completion type I and type III endoleaks (all P < .05). Perioperative outcomes have remained stable over this period, with an overall perioperative mortality rate of 4.9% (noting that this registry also includes cases that were urgent and emergent). Despite the increased complexity of PMEGs relative to ZFENs, we found comparable perioperative outcomes with regard to mortality (4.9% vs 4.3%; P = .86), permanent spinal cord ischemia (1.1% vs 0%; P = .38), postoperative myocardial infarction (4.3% vs 2.9%; P = .60), postoperative respiratory failure (7.1% vs 4.3%; P = .43), and new dialysis use (2.2% vs 4.3%; P = .35). Additionally, 5-year survival (PMEG 54% vs ZFEN 65%; P = .15) and freedom from reintervention (63% vs 74%; P = .07) were similar between these cohorts. Throughout our >10-year experience with PMEGs, we have noted improvements in operative outcomes, which can likely be attributed to technological advances and increased physician experience. Additionally, we have found that PMEGs perform well when compared with ZFENs, despite being a more complicated repair that is able to treat a larger segment of the aorta. PMEGs are crucial for the comprehensive care of vascular patients with complex aortic disease. As further operative advancements are made, we only expect the use of this intervention to increase.

Sanders AP ，Gomez-Mayorga J ，Manchella MK ，Swerdlow NJ ，Schermerhorn ML ... -  《-》