Treatment Of Complex Aortic Pathologies Research Articles

Staging TEVAR after FET — an exception or the rule?

PurposeFrozen elephant trunk (FET) was born as an ideal one-step procedure to treat complex arch and descending thoracic aorta pathology. It was then proved that it frequently needs reintervention, which can often be performed by thoracic endovascular aortic repair (TEVAR) extension since FET provides a safe proximal landing zone. We hereby describe our experience in TEVAR extension after FET, its main indications, technique, and outcomes.MethodsBetween 2007 and 2022, 371 patients underwent FET at our center. Of these, 119 needed TEVAR extension. Some required more than one TEVAR, with a total of 154 procedures. The preoperative characteristics, indications, and outcomes were analyzed retrospectively.ResultsOf 154 TEVAR procedures, 15 were performed in an urgent setting. Mean time from FET to TEVAR was 22,2 ± 28,73 months. Two patients died in the operating room; no others died during the hospital stay. Survival after 1, 2, 5, and 10 years was 96.2%, 93.9%, 90.1%, and 70.5% respectively. There was no statistically significant difference in the rates of TEVAR extension for patients in which a Thoraflex™ vs E-vita™ graft was used, nor for zone 2 vs zone 3 anastomosis and stent length.ConclusionThough TEVAR extension is often required after FET, it is a safe and effective procedure with excellent post-operative outcomes in the short-, mid-, and long-term and allows successful treatment of complex aortic pathologies. Rigorous and specialized follow-up after FET is central to identify the right moment to intervene.

Combined Endovascular Treatment of Complex Aortic Pathologies.

Multisegmented aortic pathologies present challenging issues independent of the treatment chosen. Whether open or endovascular, staged, or simultaneous, every treatment modality has its own pros and cons. We revealed our patients retrospectively with early and midterm results who had simultaneous endovascular thoracic and abdominal aortic repair for thoracic aortic pathologies and infrarenal abdominal aortic aneurysm (iAAA) as a single-center experience. Between January 2016 and January 2021, 16 patients were diagnosed with thoracic aortic pathology and iAAA was simultaneously repaired in an endovascular manner. All patients were operated on with the same cardiovascular surgeon team. The average age of the patients were 76.9 ± 6.2 (64-86) years. There was no early mortality. The technical success was 100%. In total, 18 thoracic endografts were deployed in 16 patients for thoracic aortic pathologies. Follow-up period was 21.85 ± 8.96 months, and in the follow-up period, two patients had a secondary intervention. One cardiac and one coronavirus disease 2019 mortality was detected in the follow-up period. There was no aneurysm-related mortality. The postoperative first-year survival was 84.6 ± 10.0. Simultaneous endovascular solution for complex multisegmented aortic pathologies provides a rapid, less-invasive approach with successful early and midterm morbidity, mortality with short intensive care unit period, and length of hospital stay. A combination of endovascular aortic aneurysm repair and thoracic endovascular aortic repair where anatomic suitability exists is a strong alternative over staged and hybrid therapies. Contrast-induced nephropathy, postimplantation syndrome, and spinal cord ischemia should be carefully monitored with this strategy.

Early Outcomes of a Novel Off the Shelf Preloaded Inner Branch Endograft for the Treatment of Complex Aortic Pathologies in the ItaliaN Branched Registry of E-nside EnDograft (INBREED)

Early Outcomes of a Novel Off the Shelf Preloaded Inner Branch Endograft for the Treatment of Complex Aortic Pathologies in the ItaliaN Branched Registry of E-nside EnDograft (INBREED)

Single-center initial experience with inner-branch complex EVAR in 44 patients.

The use of inner-branch aortic stent grafts in the treatment of complex aortic pathologies aims at broad applicability and stable bridging stent sealing compared to other endovascular technologies. The objective of this study was to evaluate the early outcomes with a single manufacturer custom-made and off-the-shelf inner-branched endograft in a mixed patient cohort. This retrospective, monocentric study between 2019 and 2022 included 44 patients treated with inner-branched aortic stent grafts (iBEVAR) as custom-made device (CMD) or off-the-shelf device (E-nside) with at least four inner branches. The primary endpoints were technical and clinical success. Overall, 77% (n = 34) and 23% (n = 10) of the patients (mean age 77 ± 6.5 years, n = 36 male) were treated with a custom-made iBEVAR with at least four inner branches and an off-the-shelf graft, respectively. Treatment indications were thoracoabdominal pathologies in 52.2% (n = 23), complex abdominal aneurysms in 25% (n = 11), and type Ia endoleaks in 22.7% (n = 10). Preoperative spinal catheter placement was performed in 27% (n = 12) of patients. Implantation was entirely percutaneous in 75% (n = 33). Technical success was 100%. Target vessel success manifested at 99% (178/180). There was no in-hospital mortality. Permanent paraplegia developed in 6.8% (n = 3) of patients. The mean follow-up was 12 months (range 0-52 months). Three late deaths (6.8%) occurred, one related to an aortic graft infection. Kaplan-Meier estimated 1-year survival manifested at 95% and branch patency at 98% (177/180). Re-intervention was necessary for a total of six patients (13.6%). Inner-branch aortic stent grafts provide a feasible option for the treatment of complex aortic pathologies, both elective (custom-made) and urgent (off-the-shelf). The technical success rate is high with acceptable short-term outcomes and moderate re-intervention rates comparable to existing platforms. Further follow-up will evaluate long-term outcomes.

Distal stent graft-induced new entry (dSINE) after frozen elephant trunk: a scoping review.

The introduction of hybrid total arch replacement with the frozen elephant trunk (FET) technique has improved the field of aortic surgery by allowing single-stage treatment of complex aortic pathologies. Although FET has been associated with favorable aortic remodeling, it is also associated with the potential development of distal stent graft-induced new entries (dSINEs). The aim of our review is to collect data about the incidence and the supposed conditions for the occurrence of dSINE after total hybrid arch replacement with FET technique. The literature review was performed using PubMed databases from inception to January 2022. A descriptive approach to detect and display supposed risk factors and predictors for dSINE occurrence has been adopted. Eight studies summarized the state-of-the-art of dSINE in a total number of 544 FET procedures performed to treat acute and chronic aortic dissections. The scoping review showed dSINEs occurrence in 69 patients (12.7%). The mean time between surgery and the diagnosis ranged from 12.6 to 30.6 months. Most patients that developed dSINE received endovascular treatment, whereas a couple of them needed open surgery. According to our experience, from January 2007 to December 2021, in 225 FET procedures a total of 54 cases of dSINE, both with Thoraflex and E-vita grafts have been detected. The mean time between the surgical procedure and the diagnosis was 27.2±33.6 months. dSINEs are frequent complications after FET. Although not emergent, they require proper treatment. Due to dSINE's asymptomatic nature and potential harm, a rigorous follow-up including angio-computed tomography (CT) should be planned.

A Giant Thoracic Aortic Aneurysm Treated by Frozen Elephant Trunk Technique

The treatment of complex aortic pathologies involving the ascending aorta, the aortic arch, and the descending aorta continues to be a challenging situation in aortic surgery. The frozen elephant trunk technique has been increasingly used but there still is an ongoing discussion within the surgical community about the optimal indications. We present herein a patient with a complex aortic aneurysm involving all three segments of the thoracic aorta. The device used is a hybrid prosthesis consisting of a proximal woven polyester graft and a distal self-expanding nitinol stent graft, which can be delivered antegrade into the descending aorta.

Editor's Choice – Early Outcomes of a Novel Off the Shelf Preloaded Inner Branch Endograft for the Treatment of Complex Aortic Pathologies in the ItaliaN Branched Registry of E-nside EnDograft (INBREED)

The aim of this study was to investigate the early outcomes of a novel off the shelf pre-loaded inner branched thoraco-abdominal endograft (E-nside) in the treatment of aortic pathologies. Data from a physician initiated national multicentre registry on patients treated with the E-nside endograft, were prospectively collected and analysed. Pre-operative clinical and anatomical characteristics, procedural data, and early outcomes (90 days) were recorded in a dedicated electronic data capture system. The primary endpoint was technical success. Secondary endpoints were early mortality (90 days), procedural metrics, target vessel patency, endoleak rate, and major adverse events (MAEs) at 90 days. In total, 116 patients from 31 Italian centres were included. Mean ± standard deviation (SD) patient age was 73 ± 8 years and 76 (65.5%) were male. Aortic pathologies included degenerative aneurysm in 98 (84.5%), post-dissection aneurysm in five (4.3%), pseudoaneurysm in six (5.2%), penetrating aortic ulcer or intramural haematoma in four (3.4%), and subacute dissection in three (2.6%). Mean ± SD aneurysm diameter was 66 ± 17 mm; aneurysm extent was Crawford I - III in 55 (50.4%), IV in 21 (19.2%), pararenal in 29 (26.7%), and juxtarenal in four (3.7%). The procedure setting was urgent in 25 (21.5%) patients. Median procedural time was 240 minutes (interquartile range [IQR] 195, 303), with a median contrast volume of 175 mL (IQR 120, 235). The endograft's technical success rate was 98.2% and the 90 day mortality rate was 5.2% (n= 6; 2.1% for elective repair and 16% for urgent repair). The 90-days cumulative MAE rate was 24.1% (n= 28). At 90 days, there were 10 (2.3%) target vessel related events (nine occlusions and one type IC endoleak) and one type 1A endoleak requiring re-intervention. In this real life, non-sponsored registry, the E-nside endograft was used for the treatment of a broad spectrum of aortic pathologies, including urgent cases and different anatomies. The results showed excellent technical implantation safety and efficacy, as well as early outcomes. Longer term follow up is needed to better define the clinical role of this novel endograft.

1124 THORAFLEX HYBRID AS FROZEN ELEPHANT TRUNK

Abstract Introduction Dissection and aneurysms of the aorta are pathologies that greatly compromise the prognosis of patients. By examining these pathologies in the area under consideration, knowing that they also subject the epiacortic arterial structures to this dilation, an endovascular solution was sought that would reduce the long and risky times of surgery. A hybrid operation that is implemented is that of the Thoraflex™ implant. During cardiac surgery, the replacement of the ascending aorta, whether by dissection or aneurysm, is incorporated with the endovascular implant with this state-of-the-art prosthesis that can circumscribe the problem to the descending thoracic aorta. This device has three outlets that will play the role of the supraortic arteries. Purpose Assessment of patients for the treatment of aneurysms and chronic thrombosed dissections of the aortic arch and describe the effectiveness of this treatment. Method A Pubmed search related to clinical data and field experience was performed. Results Patients with different aortic pathology were treated and evaluated. The recovery, compared to the classic surgery, was faster due to the lower exposure to extra-body circulation and a reduced surgical time. Conclusions Thoraflex™ hybrid as frozen elephant trunk presents a cutting-edge option and a valid alternative for the treatment of complex aortic pathologies. It is clear how much, despite the surgery, the risks of stroke, of infections due to the procrastination of the operation are considerably reduced and above all how the mortality rate has been reduced, making the approach to a pathology that is usually treated less complex in an emergency.

Cloud-based fusion imaging improves operative metrics during fenestrated endovascular aneurysm repair

ObjectiveEndovascular treatment of complex aortic pathology has been associated with increases in procedural-related metrics, including the operative time and radiation exposure. Three-dimensional fusion imaging technology has decreased the radiation dose and iodinated contrast use during endovascular aneurysm repair. The aim of the present study was to report our institutional experience with the use of a cloud-based fusion imaging platform during fenestrated endovascular aneurysm repair (FEVAR). MethodsA retrospective review of a prospectively maintained aortic database was performed to identify all patients who had undergone FEVAR with commercially available devices (Zenith Fenestrated; Cook Medical Inc, Bloomington, IN) between 2013 and 2020 and all endovascular aneurysm repairs performed using Cydar EV Intelligent Maps (Cydar Medical, Cambridge, UK). The Cydar EV cohort was reviewed further to select all FEVARs performed with overlay map guidance. The patient demographic, clinical, and procedure metrics were analyzed, with a comparative analysis of FEVAR performed without and with the Cydar EV imaging platform. Patients were excluded from comparative analysis if the data were incomplete in the dataset or they had a documented history of prior open or endovascular abdominal aortic aneurysm repair. ResultsDuring the 7-year study period, 191 FEVARs had been performed. The Cydar EV imaging platform was implemented in 2018 and used in 124 complex endovascular aneurysm repairs, including 69 consecutive FEVARs. A complete dataset was available for 137 FEVARs. With exclusion to select for de novo FEVAR, a comparative analysis was performed of 53 FEVAR without and 63 with Cydar EV imaging guidance. The cohorts were similar in patient demographics, medical comorbidities, and aortic aneurysm characteristics. No significant difference was noted between the two groups for major adverse postoperative events, length of stay, or length of intensive care unit stay. The use of Cydar EV resulted in nonsignificant decreases in the mean fluoroscopy time (69.3 ± 28 minutes vs 66.2 ± 33 minutes; P = .598) and operative time (204.4 ± 64 minutes vs 186 ± 105 minutes; P = .278). A statistically significant decrease was found in the iodinated contrast volume (105 ± 44 mL vs 83 ± 32 mL; P = .005), patient radiation exposure using the dose area product (1,049,841 mGy/cm2 vs 630,990 mGy/cm2; P < .001) and cumulative air kerma levels (4518 mGy vs 3084 mGy; P = .02) for patients undergoing FEVAR with Cydar EV guidance. ConclusionsAt our aortic center, we have observed a trend toward shorter operative times and significant reductions in both iodinated contrast use and radiation exposure during FEVAR using the Cydar EV intelligent maps. Intelligent map guidance improved the efficiency of complex endovascular aneurysm repair, providing a safer intervention for both patient and practitioner.

Feasibility and results of secondary endovascular connections in hybrid prostheses of the aortic arch

The evolution of the treatment of complex aortic pathologies was revolutionized by the use of hybrid prostheses, and the Frozen Elephant Trump (FET) technique offers a landing zone for a secondary procedure. The aim of our study was to evaluate the technical feasibility and the mid and long term results of the connection between the Thoraflex module and a thoracic stentgraft.

Abdominal aortic aneurysms-open vs. endovascular treatment : Decision-making from the perspective of the vascular surgeon

In the last 20years, the treatment of abdominal aortic aneurysms has essentially evolved from surgical to minimally invasive endovascular treatment. There are still anumber of clinical situations that make surgical intervention useful or even necessary. This underlines the importance of interdisciplinary vascular centers for the treatment of complex aortic pathologies and their sequelae. In the following article, the arguments for the choice of procedure for the treatment of infrarenal aortic aneurysms are discussed and the recommendations of various guidelines are compared.

Early Outcomes of a Novel Off-the-shelf Preloaded Inner Branch Endograft for the Treatment of Complex Aortic Pathologies in the ItaliaN Branched Registry of E-nside EnDograft (INBREED)

Early Outcomes of a Novel Off-the-shelf Preloaded Inner Branch Endograft for the Treatment of Complex Aortic Pathologies in the ItaliaN Branched Registry of E-nside EnDograft (INBREED)

Single-center Experience With the Femoral-to-brachial Preloaded Delivery System for Fenestrated-branched Endovascular Repair of Complex Aortic Aneurysms

The role of fenestrated-branched endovascular aortic repair (FB-EVAR) in the treatment of complex aortic pathology has evolved rapidly over the last two decades. Much of this is due to the development and selective use of procedural adjuncts, such as low-profile devices, upper extremity access, and preloaded delivery systems (PDS). Our experience with femoral-to-brachial (FTB) PDS has advanced over the years. The aim of this study was to assess technical aspects and outcomes of FB-EVAR using FTB-PDS with two separate configurations.

Cloud-based Fusion Imaging Improves Operative Metrics During Fenestrated Endovascular Aneurysm Repair

Endovascular treatment of complex aortic pathology is associated with increases in procedural-related metrics including operative time and radiation exposure. Three-dimensional fusion imaging technology has decreased radiation dose and iodinated contrast use in endovascular aneurysm repair. The aim of this study is to report our institutional experience with use of a cloud-based fusion imaging platform in fenestrated endovascular aneurysm repair (FEVAR). A retrospective review of a prospectively maintained aortic database was performed to identify all patients who underwent commercially-available FEVAR (Zenith Fenestrated, Cook Medical, Bloomington, Ind) between 2013 and 2020, as well as all endovascular aneurysm repairs performed using Cydar EV Intelligent Maps (Cydar Medical, Cambridge, UK). The Cydar EV cohort was reviewed further to select all FEVAR performed with intelligent map guidance. Patient demographics, clinical, and procedural-related metrics were analyzed, with comparative analysis of FEVAR performed without and with the Cydar EV imaging platform. Patients were excluded from the comparative analysis if incomplete in the data set, or if documented history of prior open or endovascular abdominal aortic aneurysm repair. Over the 7-year study period 191 FEVAR were performed. The Cydar EV imaging platform was implemented in 2018 and used in 124 complex endovascular aneurysm repairs, including 69 consecutive FEVAR. A complete dataset was available on 137 FEVAR. With exclusions to select for de novo FEVAR, comparative analysis was performed on 53 FEVAR without and 63 with Cydar EV. Cohorts were similar with respect to patient demographics, medical comorbidities, and aortic aneurysm characteristics. No significant difference was noted between groups on major adverse postoperative events, length of stay, or length of intensive care unit stay. Use of the Cydar EV resulted in nonsignificant decreases in mean fluoroscopy time (69.3 minutes vs 66.2 minutes; P = .598), and a positive trend toward shorter operative times (204.4 minutes vs 186 minutes; P = .278). Notably, a statistically significant decrease in both iodinated contrast volume (104.7 mL vs 83.8 mL; P = .005), and patient radiation exposure via dose-area product (1,049,841 mGy/cm2 vs 630,990; P < .001) was observed in patients undergoing FEVAR with Cydar EV Intelligent Maps. Our aortic center has observed a trend toward shorter operative times, and significant decreased in both iodinated contrast use and radiation exposure during FEVAR with the use of Cydar EV Intelligent Maps. Intelligent map guidance improves the efficiency of complex endovascular aneurysm repair, providing a safer intervention for both patient and practitioner.

Early and Mid-Term Durability of Surgeon-Modified and Custom-Made Fenestrated Devices for the Treatment of Complex Aortic Pathology

Fenestrated endovascular aneurysm repair (F-EVAR) has allowed successful treatment of patients with complex aortic aneurysms. Custom-made devices (CMDs) are manufactured by companies and tailored to the patient's anatomy to incorporate target vessels, while there is also the "off label" alternative with the devices modified by a surgeon in the operating room: surgeon-modified FEVAR (sm-FEVAR). This study aims to present and compare technical durability of CMDs- and sm-FEVAR for complex abdominal and thoracoabdominal aortic pathologies. A retrospective cohort study was undertaken including all consecutive patients treated with sm- or CMD-FEVAR during a 3-year period in a single center. Only cases with at least 3 reno-visceral target vessels were included. Primary outcomes were technical success, and freedom from endoleak (EL) (Ia or III; all branch related) and re-intervention during follow-up period. Mortality and morbidity were also recorded. Thirty-two sm-FEVAR patients (81,3% male) and 79 CMD-FEVAR patients (77,2% male) were included. Indication for sm-FEVAR was exclusively urgent, while all CMD- FEVAR were elective. Technical success was similar in sm-FEVAR (100%) and CMD-FEVAR (98,7%) (P=0.523). Mean follow-up was 16.3 ± 13 and 20 ± 17.3 months for sm-FEVAR and CMD- FEVAR, respectively (P=0.28). The freedom from EL Ia rate was 91.7% [standard error (SE) 5.7%] at 12 months in sm-FEVAR, while it was 97.7% (SE 2.2%) and 92.3% (SE 4.3%) at 12 and 24 months, respectively in CMD-FEVAR (P=0.69). The freedom from EL III rate was 95.5% (SE 4.4%) and 88% (SE 8.2%) at 12 and 24 months, respectively in sm-FEVAR, while it was 92.1% (SE 3.8%) and 89.2% (SE 4.7%) at 12 and 24 months, respectively in CMD-FEVAR (P=0.68). The freedom from re-intervention rate was 91.6% (SE 5.7%) and 84.6% (SE 8.6%) at 12 and 24 months, respectively in sm-FEVAR, while it was 91.7% (SE 4%) and 83.4% (SE 5.9%) at 12 and 24 months, respectively in CMD-FEVAR (P=0.90). The survival rate was 87.5% (5.8%) and 76.3% (7.9%) at 1 and 12 months, respectively in sm-FEVAR, while it was 93.7% (2.7%) at 1 month in CMD-FEVAR without any other death during FU period. No bridging stent occlusions were noted during follow-up period in any patient. Sm-FEVAR offers good technical success and mid-term clinical outcomes in urgent cases of complex aortic pathologies. Its durability is acceptable and comparable to CMD-FEVAR with a relatively low re-intervention rate.

Surgeon-modified Stentgrafts für komplexe Aortenrekonstruktionen – was ist möglich?

The close anatomical relationship to the visceral vessels renders the treatment of complex throacoabdominal aortic pathologies challenging. In emergent cases, off-the-shelf stent grafts and parallel techniques are feasible treatment options. Alternatively, the treating surgeon can alter a conventional stent graft, creating a so-called surgeon-modified stent graft (SMSG) to adapt it to the complex aortic pathology. The aim of this publication is to present the possibilities and results of this method. The location of SMSG's fenestrations can be determined after manual measurements of the centerline of flow reconstructions of the aortic computed tomography-angiography. The planning of the SMSG can be simplified and standardized by creating personalized 3D aortic models, and by using algorithms for the automated determination of the ideal fenestration positions. Most approved stent grafts can be used as platforms for SMSG. Different manufacturing techniques have been described. In addition to simple fenestrations, mini-cuffs, directional branches, and inner branches are used. Furthermore, diameter reducing ties and preloaded catheters could facilitate the implantation. The treatment of complex aortic pathologies using SMSG has achieved good results, with high technical success rate of 90-100%, and low 30-day mortality, especially when compared to open surgical treatment of similar patients. The rate of endoleak of 0-14% was also acceptable. Long-term durability results after treatment with SMSG are not yet available. Surgeon-modified stent grafts are safe and feasible for the endovascular treatment of patients with urgent complex thoracoabdominal aortic pathologies. They represent compassionate use and show promising results in the published literature.

Correlation of coagulopathy and frozen elephant trunk use in aortic arch surgery: A systematic review and meta-analysis.

The advent of frozen elephant trunk (FET) for reconstruction of elective and nonelective aortic arch surgery has augmented the treatment of complex aortic pathologies in a single-stage operation. To date, no studies have been focused on the prevalence and predictors of coagulopathy potentiated by FET procedure. In a systematic review, we searched databases up to June 2020 to find studies reporting coagulopathy complications after FET procedure. A proportional meta-analysis was carried out using STATA software (StataCorp). A total of 46 studies consisting of 6313 patients were eligible. The pooled estimation of reoperation for postoperative bleeding was 7% (95% confidence interval [CI:] 5-8; I2 = 84.73%; reported by 39 studies including 4796 patients). The mean volume of transfused packed blood cells and fresh frozen plasma was 1677 ml (95% CI: 1066.4-2287.6) and 1016.5 ml (95% CI: 450.7-1582.3). The subgroup by the stent type showed a decrease in the heterogeneity (I2 = 0.01%, I2 = 53.95%, I2 = 0.01%, and I2 = 54.41% for Thoraflex® Hybrid, E-vita®, Frozenix®, and Cronus®, respectively). The subgroup by the chronicity of operation resulted in less heterogeneity among patients undergoing elective compared with nonelective operation (I2 = 29.22% vs. I2 = 80.56% in nonelective). Meta-regression analysis showed that age and male gender significantly impacted on the reoperation for postoperative bleeding. The FET procedure for arch replacement is associated with coagulopathy complications and the transfusion of blood products. Male, age, and selective choice of FET use were found to be the heterogeneity sources of reoperation for postoperative bleeding.

"Proximalization is Advancement"-Zone 3 Frozen Elephant Trunk vs Zone 2 Frozen Elephant Trunk: A Literature Review.

Over the decades, the Frozen Elephant Trunk (FET) technique has gained immense popularity allowing simplified treatment of complex aortic pathologies. FET is frequently used to treat aortic conditions involving the distal aortic arch and the proximal descending aorta in a single stage. Surgical preference has recently changed from FET procedures being performed at Zone 3 to Zone 2. There are several advantages of Zone 2 FET over Zone 3 FET including reduction in spinal cord injury, visceral ischemia, neurological and cardiovascular sequelae. In addition, Zone 2 FET is a technically less complicated procedure. Literature on the comparison between Zone 3 and Zone 2 FET is scarce and primarily observational and anecdotal. Therefore, further research is warranted in this paradigm to substantiate current surgical treatment options for complex aortic pathologies. In this review, we explore literature surrounding FET and the reasons for the shift in surgical preference from Zone 3 to Zone 2.

The Influence of 3D Printed Aortic Models on the Evolution of Physician Modified Stent Grafts for the Urgent Treatment of Thoraco-abdominal and Pararenal Aortic Pathologies

The aim was to describe the outcomes of high risk patients with symptomatic or contained rupture of pararenal (PRAs) and thoraco-abdominal aortic aneurysms (TAAAs) with anatomy unsuitable for commercially available stent grafts who underwent fenestrated endovascular aneurysm repair (FEVAR) using physician modified stent grafts (PMSGs) planned with 3D image analysis software (3DIMAS), and 3D printed aortic models (3DAMs). Nineteen consecutive patients (17 male; mean age, 70±9 years) underwent PMSG-FEVAR between 2015 and 2019. 3DAMs to plan the PMSGs were introduced in 2018. End points were all cause mortality, freedom from any endoleak, target vessel patency, and re-intervention. Seven patients (36.8%) were treated with PMSGs using 3DIMAS (three PRAs, three type IV, and one type III TAAAs), and 12 patients (63.2%) received PMSGs using 3DAMs (five PRAs, seven type IV TAAAs). Six patients presented with contained aortic rupture and 13 patients were treated for symptomatic aortic aneurysm. Mean aortic diameter was 72±10mm. The choice of stent graft for fenestration was the Valiant Captivia Closed Web (Medtronic), except for one patient. Sixteen (84.2%) stent grafts were manufactured with four fenestrations. Technical success was 100%. Seventy-one renovisceral branch vessels were targeted with fenestrations. Mean length of hospital stay was 17.3±10.4 days. Thirty day mortality was 0%. Two patients developed reversible spinal cord injury. Mean follow up was 14.4 months (range 1-52 months). During follow up one non-aneurysm related death occurred, and two successful re-interventions were performed: one to re-establish renal artery patency, and one to treat a type 1c endoleak. PMSGs for urgent treatment of pararenal and thoraco-abdominal aortic aneurysms in high risk patients unsuitable for commercially available stent grafts are feasible and safe. 3D printing technology may improve urgent construction of patient specific devices for treatment of complex aortic pathologies and improve outcomes.

Long-term chimney/snorkel endovascular aortic aneurysm repair experience for complex abdominal aortic pathologies within the PERICLES registry

ObjectiveThe early and short-term efficacy of the snorkel/chimney technique for endovascular aortic aneurysm repair (ch-EVAR) have been previously reported. However, long-term ch-EVAR performance, vessel patency, and patient survival remain unknown. Our study evaluated the late outcomes to identify possible predictors of failure within the PERICLES (performance of the chimney technique for the treatment of complex aortic pathologies) registry. MethodsClinical and radiographic data from patients who had undergone ch-EVAR from 2008 to 2014 in the PERICLES registry were updated with an extension of the follow-up. Regression models were used to evaluate the relevant anatomic and operative characteristics as factors influencing the late results. We focused on patients with ≥30 months of follow-up (mean, 46.6 months; range, 30-120 months). ResultsA total of 517 patients from the initial PERICLES registry were included in the present analysis, from which the mean follow-up was updated from 17.1 months to 28.2 months (range, 1-120 months). All-cause mortality at the latest follow-up was 25.5% (n = 132), with an estimated patient survival of 87.6%, 74.4%, and 66.1% at 1, 3, and 5 years, respectively. A subgroup of 244 patients with 387 chimney grafts placed (335 renal arteries, 42 superior mesenteric arteries, 10 celiac arteries) and follow-up for ≥30 months was used to analyze specific anatomic and device predictors of adverse events. In the subgroup, the technical success was 88.9%, and the primary patency was 94%, 92.8%, 92%, and 90.5% at 2.5, 3, 4, and 5 years, respectively. The mean aneurysm sac regression was 7.8 ± 11.4 mm (P < .0001). Chimney graft occlusion had occurred in 24 target vessels (6.2%). Late open conversion was required in 5 patients for endograft infection in 2, persistent type Ia endoleak in 2, and endotension in 1 patient. The absence of an infrarenal neck (odds ratio, 2.86; 95% confidence interval, 1.32-6.19; P = .007) was significantly associated with long-term device-related complications. A sealing zone diameter >30 mm was significantly associated with persistent or late type Ia endoleak (odds ratio, 4.86; 95% confidence interval, 1.42-16.59; P = .012). ConclusionsThe present analysis of the PERICLES registry has provided the missing long-term experience for the ch-EVAR technique, showing favorable results with more than one half of the patients surviving for >5 years and a chimney graft branch vessel patency of 92%. The absence of an infrarenal neck and treatment with a sealing zone diameter >30 mm were the main anatomic long-term limits of the technique, requiring adequate preoperative planning and determination of the appropriate indication.