Real world experience with the TREO device in standard EVAR: Mid-term results of 150 cases from a German Multicenter study.

Background: The objective of the study was to analyze mid-term results of unselected patients treated with the TREO (Terumo Aortic, Florida, USA) device at six German hospital sites. Methods: A multicenter, retrospective analysis of patients treated within and outside instructions for use (IFU) from January 2017 to November 2020 was performed. Primary outcomes were technical success, mortality and endograft related complications according to IFU status. Secondary outcomes were aneurysm/procedure related re-interventions. Results: 150 patients (92% male, mean age 73 ±8 years) were treated (within IFU 84% vs. outside IFU 16%) with the TREO device for abdominal aortic aneurysms (n=127 intact, n=17 symptomatic and n=6 ruptured; p=0.30). Technical success was achieved in 147/150 (within IFU 99% vs. outside IFU 92%, p=0.08). 30-day mortality was 2%, one year and overall mortality was 3% and 5%. During a mean follow-up of 28.4 months (range: 1-67.4 months), 35 (25%; within IFU 23% vs. outside IFU 35%, p=0.23) patients suffered from endoleaks. The majority were endoleaks type II (n=33), the remaining type Ia (n=5) and type Ib (n=3). No endoleaks type III-V, migrations or aneurysm ruptures occurred. Overall, 19 patients (13%; within IFU 13% vs. 15% outside IFU, p=0.70) received a secondary intervention: nine endoleak related endovascular procedures, three open conversions, two endograft limb related interventions, four surgical revisions of the femoral access sites and two bowl ischemia related procedures, respectively. Conclusions: This non industry-sponsored, multicenter trial indicates that using the TREO device in a real-world setting (both within and outside IFU) seems feasible in the treatment of patients suffering from AAA. While the rate of complications and secondary interventions is in line with previously published data, the findings highlight the fact that standard EVAR is associated with serious adverse events.

Combining Endovascular Aneurysm Sealing with Chimney Grafts - 5 Year Follow-Up after 47 Procedures.

BACKGROUND: To evaluate longer-term results of a cohort treated with primary chimney endovascular aneurysm sealing (ChEVAS) for complex abdominal aortic aneurysms or secondary ChEVAS after failed endovascular aneurysm repair/endovascular aneurysm sealing. METHODS: A single-center study was conducted of 47 consecutive patients (mean age 72 ± 8 years, range 50-91; 38 men) treated with ChEVAS from February 2014 to November 2016 and followed through December 2021. The main outcome measures were all-cause mortality (ACM), aneurysm-related mortality, occurrence of secondary complications and conversion to open surgery. Data are presented as the median (interquartile range [IQR]) and absolute range. RESULTS: 35 patients received a primary ChEVAS (=group I) and 12 patients a secondary ChEVAS (=group II). Technical success was 97% (group I) and 92% (group II); 30-day mortality was 3% and 8%, respectively. The median proximal sealing zone length was 20.5 mm (IQR 16, 24; range 10-48) in group I and 26 mm (IQR 17.5, 30; range 8-45) in group II, respectively. During a median time of follow-up of 62 months (range 0-88), ACM amounted to 60% (group I) and 58% (group II); aneurysm mortality was 29% and 8%, respectively. An endoleak was seen in 57% (group I: 15 type Ia endoleaks, four isolated type Ib, and 1 endoleak type V) and 25% (group II: 1 endoleak type Ia, one type II, and 2 type V), aneurysm growth in 40% and 17%, migration in 40% and 17%, resulting in 20% and 25% conversions in group I and II, respectively. Overall a secondary intervention was performed in 51% (group I) and 25% (group II), respectively. The occurrence of complications did not significantly differ between the 2 groups. Neither the number of chimney grafts, nor the thrombus ratio significantly affected the occurrence of abovementioned complications. CONCLUSIONS: While initially delivering a high technical success rate, ChEVAS fails to provide acceptable longer-term results both in primary and secondary ChEVAS, resulting in high rates of complications, secondary interventions and open conversions.

Open Conversion After Endovascular Aneurysm Sealing: Technical Features and Clinical Outcomes in 44 Patients.

PURPOSE: To evaluate the technical features and clinical results after open conversion for complications following endovascular aneurysm sealing (EVAS). MATERIALS AND METHODS: From July 2013 to February 2020, 44 patients (mean age 72±8 years; 36 men) underwent an open conversion due to EVAS complications in a single center. Data were collected on patient characteristics, reasons for conversion, characteristics and duration of the procedure, condition of the polymer, blood loss, time in the intensive care unit (ICU), and intra/postoperative complications. The main outcome measure was mortality at 30 days and in follow-up. Data are presented as the median (IQR) and absolute range. RESULTS: On average, the open conversion took place 3 years after the initial EVAS implantation [median 37 months (IQR 23, 50); range 0-64]. Most patients were converted due migration (82%), aneurysm growth (77%), and/or endoleak (75%), with 21 patients (48%) having all 3 events. Less frequent diagnoses were aneurysm rupture (n=7), aortic infection (n=3), technical failure during implantation (n=2), and graft thrombosis (n=1). The majority of patients (n=26) were asymptomatic and converted electively, but 9 were operated on urgently and 9 emergently (7 late rupture and 2 due to technical failure). The median procedure duration was 178 minutes (IQR 149, 223; range 87-417), the median blood loss was 1100 mL (IQR 600, 2600; range 300-5000). Polymer degradation was mentioned in the operative reports of 18 cases (41%). Patients stayed a median of 3 days (IQR 2, 7; range 1-35) in the ICU, while the median length of stay in the hospital was 14 days (IQR 10, 20; range 0-93). The 30-day mortality was 23% (n=10). During a median follow-up of 3 months (IQR 0, 11; range 0-38), no additional deaths occurred, but 12 patients suffered from an adverse event. There were 3 cases of wound dehiscence after laparotomy, 2 cases of leg ischemia, 2 cases of renal failure, and individual cases of urinary obstruction, urinoma, paralytic ileus, gastrointestinal bleeding, and postoperative delirium. A non-elective setting was associated with a significantly increased mortality of 33% in urgent cases and 56% in emergent cases (p=0.007). Based on these results an algorithm for the management of EVAS complications was developed. CONCLUSION: The significantly increased mortality associated with nonelective conversions highlights the need for active surveillance. The presented algorithm offers a structured tool to avoid emergency conversions.

Influence of the Revised Nellix Instructions for Use on Outcomes After Endovascular Aneurysm Sealing.

PURPOSE: To evaluate the impact of the revised Nellix instructions for use (IFU) from 2016 on clinical outcomes and anatomic applicability by retrospectively applying them to a cohort treated with endovascular aneurysm sealing according to the original IFU 2013. METHODS: A single-center study was conducted of 100 consecutive patients (mean age 72±8 years, range 46-91; 89 men) treated electively with standard bilateral EVAS from July 2013 to August 2015 and followed through December 2017. Procedures previously classified within and outside the original IFU from 2013 (75 and 25, respectively) were reclassified according to the revised IFU 2016 (34 and 66, respectively). Stepwise backward logistic regression analysis was performed to evaluate the prognostic value of specific anatomic features for the development of endoleak and/or migration. RESULTS: The single most important morphologic feature disqualifying patients from being within IFU 2016 was a thrombus ratio >1.4 (36 of 41 reclassified patients). Overall technical success was 98% (100% within vs 97% outside IFU 2016, p=0.323) and 30-day mortality was 3% (0% within vs 5% outside IFU 2016, p=0.251). During a median follow-up of 31 months (range 0-53), overall mortality was 21% (15% within vs 24% outside IFU 2016, p=0.469); aneurysm-related mortality was 8% (3% within vs 11% outside IFU 2016, p=0.533). Twenty-six patients developed an endoleak (6 within vs 20 outside IFU 2016, p=0.172) and 23 had migration (4 within vs 19 outside IFU 2016, p=0.088). Both proximal neck length <10 mm and neck angulation >60° were positive predictors for the development of endoleak and/or migration. A reintervention was performed in 26 patients (7 within vs 19 outside IFU 2016, p=0.376). While a significant difference was found between the within vs outside IFU 2016 groups with regard to freedom from migration (p=0.026) and the composite freedom from endoleak and/or migration (p=0.021), there were no significant differences in survival (p=0.201) or freedom from reintervention (p=0.505), suggesting a limited effectiveness of the new IFU 2016. CONCLUSION: The IFU 2016 reduced the anatomic applicability to 34% from 75% for the original IFU 2013. The lack of significant intergroup differences in terms of survival and reinterventions suggests a limited effectiveness of the new IFU 2016.

Early experience with the new endovascular aneurysm sealing system Nellix: First clinical results after 50 implantations.

OBJECTIVE: In the present study, 50 EVAS procedures were evaluated in regard to primary (survival and technical success) and secondary (device-related complications) events of interest. METHODS: The single center study was conducted from July 2013 to August 2014 with prospective collection of the clinical data. The clinical results were controlled by CT angiography and contrast-enhanced ultrasound. RESULTS: The technical success was 98% and the 30-day mortality 4%. One (2%) patient died from multisystem organ failure and another patient from an intracranial bleeding, respectively. One patient (2%) suffered from a device-related aneurysm rupture. During early follow-up, one (2%) patient developed an endoleak type II, while three (6%) patients suffered from a partial endograft limb thrombosis. Overall, a secondary intervention was necessary in six (12%) patients. CONCLUSIONS: With the Nellix EVAS system, a high primary technical success of 98% was achieved; one (2%) patient developed an endoleak type II which did not require secondary intervention. Those promising results are contrasted by a substantial rate of endograft limb thromboses (8%) and one (2%) intraoperative aneurysm rupture. Further studies are needed to assess the durability of the Nellix stentgraft and the occurrence of device-related complications.

Clinical outcomes in hybrid repair procedures for pathologies involving the aortic arch.

OBJECTIVE: Fifty patients with complex aortic disease, who received hybrid treatment of the aortic arch with supra-aortic debranching and endovascular stent-graft repair, were evaluated in regard to events of primary (survival and technical success) and secondary (procedure-related complications) interest. METHODS: The single-center study was conducted over an eight-year period from December 2004 to December 2012. Treated medical conditions included 23 aortic aneurysms (46%), 21 aortic dissections (42%), and six penetrating aortic ulcers (12%). Procedures were divided into groups of elective, urgent, and emergent. RESULTS: Twenty-eight (56%) patients were operated electively, 15 (30%) urgently, and seven (14%) emergently. Sternotomy, cardiopulmonary bypass, and deep hypothermic circulatory arrest were required in 12 (24%) patients. The primary technical success rate was 86% and raised to 92% (n=46) of secondary technical success rate after therapy of three type I endoleaks. The 30-day mortality added up to 16.0%, and the mean time of survival was 49.3 months. In a total of eight (16%) patients, an endoleak occurred (five endoleaks type I, three endoleaks type II), while nine (18%) of patients suffered a perioperative stroke. CONCLUSIONS: In severely ill patients with complex aortic diseases, hybrid therapy may offer a promising alternative to conventional open repair.