Three-Dimensional Geometric Analysis of Viabahn VBX Bridging Stent Grafts in Fenestrated Endovascular Aortic Repair: A Multicenter, Retrospective Cohort Study.

PURPOSE: The primary aim of this study was to assess the 3-dimensional flare geometry of the Gore Viabahn VBX balloon-expandable covered stent (BECS) after fenestrated endovascular aortic repair (FEVAR) and to determine and visualize BECS-associated complications. METHODS: This multicenter retrospective study included patients who underwent FEVAR between 2018 and 2022 in 3 vascular centers participating in the VBX Expand Registry. Patients with at least one visceral artery treated with the VBX and with availability of 2 post-FEVAR computed tomography angiography (CTA) scans (follow-up [FU] 1: 0-6 months; FU2: 9-24 months) were included. The flare geometry of the VBX, including flare-to-fenestration distance, flare-to-fenestration diameter ratio, flare angle, and apposition with the target artery were assessed using a vascular workstation and dedicated CTA applied software. RESULTS: In total, 90 VBX BECS were analyzed in 43 FEVAR patients. The median CTA FU for FU1 and FU2 was 35 days (interquartile range [IQR], 29-51 days) and 14 months (IQR, 13-15 months), respectively. The mean flare-to-fenestration distance was 5.6±2.0 mm on FU1 and remained unchanged at 5.7±2.0 mm on FU2 (p=.417). The flare-to-fenestration diameter ratio was 1.19±0.17 on FU1 and remained unchanged at 1.21±0.19 (p=.206). The mean apposition length was 18.6±5.3 mm on FU1 and remained 18.6±5.3 mm (p=.550). The flare angle was 31°±15° on FU1 and changed to 33°±16° (p=.009). On FU1, the BECS-associated complication rate was 1%, and the BECS-associated reintervention rate was 0%. On FU2, the BECS-associated complication rate was 3%, and the BECS-associated reintervention rate was 1%. CONCLUSIONS: The flare geometry of the VBX bridging stent did not change significantly during 14 months follow-up in this study. Three-dimensional geometric analysis of the flare may contribute to identify the origin of endoleaks and occlusions, but this should be confirmed in a larger study including enough patients and BECS to compare complicated and uncomplicated cases. CLINICAL IMPACT: The three-dimensional flare geometry of the Gore Viabahn VBX BECS was assessed on the first and second postoperative CTA scans, and geometrical changes during this period were identified. For BECS that were diagnosed with a type 3c endoleak or occlusion, the BECS geometry was analyzed to detect geometrical components that were related to the complication. Geometric analysis of the flare may help to better detect and identify the cause of such complications.

One-year results of a balloon expandable endoprosthesis as a bridging stent for branched endovascular aortic repair.

OBJECTIVE: This post-market multicenter registry aimed to evaluate the safety and performance of the GORE VIABAHN VBX balloon expandable endoprosthesis (VBX stent) implanted in peripheral vessels. In this subgroup analysis, we assessed the outcomes of the VBX stent as a bridging stent graft for visceral vessels during branched endovascular aortic repair at 1 year. METHODS: A single cohort from a prospective, multicenter, observational, 16-site European registry. Patients were enrolled from November 2018 to March 2022. Endpoints included 1-year primary patency (PP), primary assisted patency (PAP), and secondary patency (SP), stent graft-related death and serious adverse events through 30 days. RESULTS: Seventy-three patients were enrolled in this registry sub-cohort, 57 (78.1%) were male, and the mean age was 73 ± 8.1 years. Thoracoabdominal aneurysms predominated the cohort with 68 patients (93.2%), followed by five patients (6.8%) with pararenal and infrarenal aneurysms. Overall, 233 target vessels were treated with the index bridging graft. The overall per stent graft analysis demonstrated a PP of 95.8% at 1 year; PAP was 95.8%, and SP reached 97.9%. The per-target vessel analysis demonstrated a PP, PAP, and SP in the celiac trunk of 100%, 100%, and 100%; in the superior mesenteric artery of 96.0%, 96.0%, and 100%, and in the renal arteries of 94.2%, 94.2%, and 95.1%, respectively. Four patients (5%) died at 1 year; none of the deaths were device-related. The composite endpoint of target vessel technical success and freedom from VBX stent-related serious adverse events through 30 days was achieved in 98.6% of patients. CONCLUSIONS: In this prospective post-market multicenter registry, the VBX stent demonstrated excellent results at 1 year, with almost 96% primary patency and 98% secondary patency. Patency in the renal arteries seems to be lower. Nevertheless, the VBX stent appears to be a reliable bridging stent for branched endovascular aortic repair.

Relining of a Bridging Covered Stent to Treat a Rare Cause of Type IIIc Endoleak Following Fenestrated Endovascular Aneurysm Repair.

PURPOSE: To present a rare cause of type III endoleak via the left renal artery (LRA) fenestration following fenestrated endovascular aneurysm repair (FEVAR) and to describe a successful reintervention for treating this endoleak. TECHNIQUE: The patient presented with a type IIIc endoleak following FEVAR, due to inadvertent placement of the LRA bridging balloon expandable covered stent (BECS) via the superior mesenteric artery (SMA) fenestration, but deployed outside the SMA fenestration. The proximal part of the BECS was positioned outside of the main body. This caused a type IIIc endoleak via the open LRA fenestration. Reintervention was performed by relining the LRA with a new BECS. First, access to the lumen of the previously placed BECS was gained using a re-entry catheter, followed by placement of a new BECS via the LRA fenestration. Completion angiography, and computerized tomography angiography (CTA) at 3 months follow-up showed total obliteration of the endoleak and patency of the LRA. CONCLUSION: Placement of a bridging stent via an incorrect fenestration during FEVAR is a rare cause of type III endoleak. In certain cases, successful treatment of such an endoleak could be achieved by perforation and relining of the misplaced BECS via the correct fenestration of the target vessel. CLINICAL IMPACT: To our best knowledge, a type IIIc endoleak following fenestrated endovascular aneurysm repair, due to placement of a bridging covered stent through an incorrect fenestration and deployed short of the fenestration, has not been described before. Reintervention was performed with perforation of the previously placed covered stent and relining using a new bridging covered stent. The technique presented here was successful for treating the endoleak in this case and could help guide clinicians when dealing with this or similar complications.

In Vitro Geometry Analysis of Fenestrations in Endovascular Aneurysm Repair.

PURPOSE: Changes in the flared end of balloon-expandable covered stent (BECS) may precede BECS-associated complications but are not regularly assessed with computed tomographic angiography (CTA) after fenestrated endovascular aneurysm repair (FEVAR). Validation of the flare geometric analysis (FGA) and assessment of intraobserver and interobserver variability are investigated in this study. METHODS: Two series of 3 BeGraft BECSs (Bentley InnoMed GmbH, Hechingen, Germany) and 1 series of 3 Advanta V12 BECSs (Getinge AB, Göteborg, Sweden) were deployed in 3 side branches (45°, 60°, and 90° aortic branch angles) of an aorta phantom model. A standard post-FEVAR CTA scan was acquired. Computed tomographic angiography-derived measurements consisted of centerline reconstructions and placement of 3-dimensional coordinate markers by 2 observers in a vascular workstation. Flare geometric analysis calculates 3 BECS parameters: the circumferential flare-to-fenestration distance (FFD), which is the distance from the proximal end of the flare to fenestration, and diameters at the proximal end of the flare (Dflare) and at the fenestration (Dfenestration). Computed tomographic angiography-derived measurements were validated against microscopy measurements. Bland-Altman plots were used to determine the intraobserver and interobserver variability of the BECS parameters and intraclass correlation coefficient (ICC). RESULTS: For each BECS, the FFD at 4 equidistant quadrants of the circumference, Dflare, and Dfenestration were calculated. The mean difference and repeatability coefficient (RC) of the validation were 0.8 (2.1) mm for FFD, 0.4 (1.0) mm for Dflare, and -0.2 (1.2) mm for Dfenestration. The mean intraobserver and interobserver difference (RC) was 0.5 (1.6) mm and 0.7 (2.6) mm for FFD, 0.1 (0.6) mm and 0.1 (0.7) mm for Dflare, and -0.1 (0.8) mm and -0.8 (1.0) mm for Dfenestration. The mean ICC of intraobserver variability was 0.86 for FFD, 0.94 for Dflare, and 0.78 for Dfenestration. The mean ICC of interobserver variability was 0.77 for FFD, 0.92 for Dflare, and 0.48 for Dfenestration. CONCLUSION: This study showed that FGA of the flared ends of BECS can be performed with high accuracy in a phantom model, with good intraobserver and interobserver variability. Flare geometric analysis can be used to determine flare geometry of the BECS on standard post-FEVAR CTA scans.

Outcomes of Advanta V12 Covered Stents After Fenestrated Endovascular Aneurysm Repair.

PURPOSE: Fenestrated endovascular aneurysm repair (FEVAR) is a well-established endovascular treatment option for pararenal abdominal aortic aneurysms in which balloon-expandable covered stents (BECS) are used to bridge the fenestration to the target vessels. This study presents midterm clinical outcomes and patency rates of the Advanta V12 BECS used as a bridging stent. METHODS: All patients treated with FEVAR with at least 1 Advanta V12 BECS were included from 2 large-volume vascular centers between January 2012 and December 2015. Primary endpoints were freedom from all-cause reintervention, and freedom from BECS-associated complications and reintervention. BECS-associated complications included significant stenosis, occlusion, type 3 endoleak, or stent fracture. Secondary endpoints included all-cause mortality in-hospital and during follow-up. RESULTS: This retrospective study included 194 FEVAR patients with a mean age of 72.2±8.0 years. A total of 457 visceral arteries were stented with an Advanta V12 BECS. Median (interquartile range) follow-up time was 24.6 (1.6, 49.9) months. The FEVAR procedure was technically successful in 93% of the patients. Five patients (3%) died in-hospital. Patient survival was 77% (95% CI 69% to 84%) at 3 years. Freedom from all-cause reintervention was 70% (95% CI 61% to 78%) at 3 years, and 33% of all-cause reinterventions were BECS associated. Complications were seen in 24 of 457 Advanta V12 BECSs: type 3 endoleak in 8 BECSs, significant stenosis in 4 BECSs, occlusion in 6 BECSs, and stent fractures in 3 BECSs. A combination of complications occurred in 3 BECSs: type 3 endoleak and stenosis, stent fracture and stenosis, and stent fracture and occlusion. The freedom from BECS-associated complications for Advanta V12 BECSs was 98% (95% CI 96% to 99%) at 1 year and 92% (95% CI 88% to 95%) at 3 years. The freedom from BECS-associated reinterventions was 98% (95% CI 95% to 100%) at 1 year and 94% (95% CI 91% to 97%) at 3 years. CONCLUSION: The Advanta V12 BECS used as bridging stent in FEVAR showed low complication and reintervention rates at 3 years. A substantial number of FEVAR patients required a reintervention, but most were not BECS related.

Endograft Conformability in Fenestrated Endovascular Aneurysm Repair for Complex Abdominal Aortic Aneurysms.

Purpose: To compare the impact of 2 commercially available custom-made fenestrated endografts on patient anatomy. Materials and Methods: The records of 234 patients who underwent fenestrated endovascular aneurysm repair for abdominal aortic aneurysm from March 2002 to July 2016 in 2 hospitals were screened to identify those who had pre- and postoperative computed tomography angiography assessments with a slice thickness of ≤2 mm. The search identified 145 patients for further analysis: 110 patients (mean age 72.4±7.1 years; 94 men) who had been treated with the Zenith Fenestrated (ZF) endograft and 35 patients (mean age 72.3±7.3 years; 30 men) treated with the Fenestrated Anaconda (FA) endograft. Measurements included aortic diameters at the level of the superior mesenteric artery (SMA) and renal arteries, target vessel angles, target vessel clock positions, and the target vessel tortuosity index. Variables were tested for inter- and intraobserver agreement. Results: There was a good agreement between observers in all tested variables. The native anatomy changed in both groups after endograft implantation. In the ZF group, changes were seen in the angles of the celiac artery (p=0.012), SMA (p=0.022), left renal artery (LRA) (p<0.001), and the right renal artery (RRA) (p<0.001); the aortic diameter at the SMA level (p<0.001); and the LRA (p<0.001) and RRA (p<0.001) clock positions. In the FA group, changes were seen in the angles of the LRA (p=0.001) and RRA (p<0.001) and in the SMA tortuosity index (p=0.044). Between group differences in changes were seen for the aortic diameters at the SMA and renal artery levels (p<0.001 for both) and the LRA clock position (p=0.019). Conclusion: Both custom-made fenestrated endografts altered vascular anatomy. The data suggest a higher conformability of the Fenestrated Anaconda endograft compared with the Zenith Fenestrated.

Outcome of Fenestrated Endovascular Aneurysm Repair in Octogenarians: A Retrospective Multicentre Analysis.

OBJECTIVE: An ageing population leads to more age related diseases, such as complex abdominal aortic aneurysms (AAA). Patients with complex AAAs and multiple comorbidities benefit from fenestrated endovascular aneurysm repair (FEVAR), but for the elderly this benefit is not completely clear. METHODS: Between 2001 and 2016 all patients treated for complex AAA by FEVAR at two tertiary referral centres were screened for inclusion. Group 1 consisted of patients aged 80 years and older and group 2 of patients younger than 80 years of age. The groups were compared for peri-operative outcome, as well as patient and re-intervention free survival, and target vessel patency during follow up. RESULTS: Group 1 consisted of 42 patients (median age 82 years; interquartile range [IQR] 81-83 years) and group 2 of 230 patients (median age 72 years; IQR 67-77 years). No differences were seen in pre-operative comorbidities, except for age and renal function. Renal function was 61.4 mL/min/1.73 m2vs.74.5 mL/min/1.73 m2 (p < .01). No differences were seen between procedures, except for a slightly longer operation time in group two. Median follow up was 26 and 32 months, respectively. No difference was seen between the groups for estimated cumulative overall survival (p = .08) at one, three, and five years, being 95%, 58%, and 42% for group 1, and 88%, 75%, and 61% for group 2, respectively. There was no difference seen between groups for the estimated cumulative re-intervention free survival (p = .95) at one, three, and five years, being 84%, 84%, and 84% in group 1, respectively, and 88%, 84%, and 82% in group 2, respectively. Ultimately, no difference was seen between groups for the estimated cumulative target vessel patency (p = .56) at one, three, and five years, being 100%, 100%, and 90% for group 1, and 96%, 93% and 92% for group 2, respectively. CONCLUSION: Age itself is not a reason to withhold FEVAR in the elderly, and choice of treatment should be based on the patient's comorbidities and preferences.

Geometric changes over time in bridging stents after branched and fenestrated endovascular repair for thoracoabdominal aneurysm.

OBJECTIVE: The objective of this study was to assess long-term durability of bridging stents in branched and combined branched and fenestrated endovascular aneurysm repair (B/F-EVAR) for thoracoabdominal aortic aneurysm (TAAA) and pararenal abdominal aortic aneurysm. METHODS: A retrospective database analysis was performed of patients treated by B/F-EVAR for TAAA. Computed tomography angiography images were analyzed to assess patency, bridging stent angulation and migration, aneurysm diameter, and migration of the endograft. RESULTS: Twenty-eight patients with a median age of 70 years (interquartile range [IQR], 67-77 years) were included. Assisted technical success was 89%. Within 30 days postoperatively, five patients died. In the remaining 23 patients, median follow-up was 5.3 years (IQR, 2.9-7.2 years), and 1-, 3-, and 5-year estimated overall survival was 69%, 65%, and 44%, respectively. During follow-up, 12 of 47 (26%) branches occluded and 5 of 47 (11%) branches developed a 70% to 99% stenosis. The 1-, 3-, and 5-year estimated freedom from adverse events was 78%, 76%, and 59% for branch stents and 100%, 96%, and 90% for fenestration stents, respectively. The median distal bridging stent migration was 0.5 mm (IQR, -1.9 to 1.4; P > .05 mm). In 10 branches, migration >10 mm was seen, ranging from 14.1 mm sliding in to 23.0 mm sliding out. The angulation between branch and stent became 4 degrees more angulated (IQR, -14 to +2 degrees). In 23 branches, the angulation changed 10 degrees or more, leading to an occlusion in 7 branches, a 70% to 99% stenosis in 3 branches, and a 50% to 70% stenosis in 4 branches. In three cases, the endograft migrated >5 mm caudally, with a breach in a fenestration stent in one and a breach in a branch stent in another. CONCLUSIONS: The anatomic configuration of branches in B/F-EVAR of TAAAs and pararenal abdominal aortic aneurysms changes over time. The change in angle of branches and the bridging stent influences the likelihood of stenosis and occlusion. Follow-up of B/F-EVAR should include computed tomography angiography measurements of aortic diameter, endograft migration, target vessel stent length, and angulation to detect disconnection, stenosis, and occlusion.

Long-term outcome of endovascular popliteal artery aneurysm repair.

OBJECTIVE: The position of endovascular treatment in the algorithm of popliteal artery aneurysm (PAA) repair is still a matter of debate. Although several studies have described results similar to those of open surgery, follow-up of the endovascular group has been relatively short so far. The aim of this study was to describe the long-term outcome of endovascular repair of PAA with endografts. METHODS: All patients with a PAA treated with an expanded polytetrafluoroethylene stent graft between June 1998 and November 2014 in a tertiary referral center were prospectively gathered in a database and retrospectively analyzed. The primary end point of this study was primary patency. Secondary end points included primary assisted and secondary patency, survival of the patient, stent fractures, secondary interventions, and limb loss. RESULTS: A total of 75 PAAs were treated in 64 patients with a mean age of 68.1 ± 9.4 years. Unilateral PAA was present in 39 patients (61%) and bilateral PAAs in 25 patients (39%), of which 11 (17%) were treated bilaterally. Median follow-up was 68 months (range, 2-187 months). Primary patency at 1 year, 5 years, and 10 years was 84%, 60%, and 51%, respectively; primary assisted patency, 84%, 65%, and 57%; and secondary patency, 89%, 71%, and 60%. Stent fractures occurred in 28% of the cases (n = 21) in a median follow-up time of 47 months (range, 14-187 months). One-third of the fractures were associated with an occlusion that mainly presented with claudication, and only one was associated with acute ischemia. Reinterventions were performed in 12 cases (16%) during a median follow-up of 14 months (range, 1-47 months). The reintervention-free survival after 1 year, 5 years, and 10 years was 93%, 79%, and 79%, respectively. No major amputations were performed. The overall survival rate after 5 years and 10 years was 78% and 46%, respectively. CONCLUSIONS: Endovascular repair has established a definitive role in the treatment protocol for PAAs. It is associated with acceptable long-term patency rates. Stent fractures occurred in almost one-third of cases but never led to limb loss. Future developments should focus on the design of more dedicated and durable stents for this specific indication.

Mid- and Long-Term Outcome of Currently Available Endografts for the Treatment of Infrarenal Abdominal Aortic Aneurysm.

Currently, there is a wide range of commercially available endografts for infrarenal abdominal aortic aneurysm (AAA) repair. Results of long-term follow up after endovascular aneurysm repair (EVAR) are limited. Thereby, the durability of these endografts and the difference between manufacturers is not fully clear. In this review, studies with mid- and long-term results, with a minimum median follow up of 36 months per endograft, were included describing results with Cook Zenith? Flex? endograft (Cook Medical Inc., Bloomington, Indiana) (n=6), Cordis Corporate INCRAFT? (Cordis Corporation, Freemont, California) (n=1), Gore? EXCLUDER? (W.L. Gore & Associates Inc., Flagstaff, Arizona) (n=3), Medtronic Endurant? (Medtronic plc, Santa Rosa, California) (n= 6), and Vascutek Anaconda? (Vascutek Ltd., Inchinnan, Scotland) (n=2). The assisted technical success varied between 83% and 100%, and the perioperative mortality, early reintervention, and early conversion rates were comparable for the studied endografts. At three-year follow up, the freedom from AAA-rupture and AAA-related death varied between 98% and 100%. The results demonstrated an increasing complication and reintervention rate over time. When adhering to the instruction for use, minor differences were seen during follow up between the endografts. Latest generation endografts continue to have good postoperative results, the reintervention-rate of 10-20% over time mandates an ongoing close patient follow up. The choice of a specific design depends on native patient anatomy and the experience of the implanting surgeon.

Midterm results of the fenestrated Anaconda endograft for short-neck infrarenal and juxtarenal abdominal aortic aneurysm repair.

OBJECTIVE: The fenestrated Anaconda endograft (Vascutek, Renfrewshire, Scotland) was introduced in 2010 and showed promising short-term results with high technical success and low morbidity rates. The aim of this study was to present the midterm results, with a minimum of 12 months follow-up, for all patients treated with the fenestrated Anaconda endograft in The Netherlands. METHODS: Patients treated with the fenestrated Anaconda endograft between May 2011 and February 2015 were included. Follow-up consisted of computed tomography angiography at 1 month and 1 year, and duplex ultrasound yearly thereafter with additional computed tomography angiography if indicated using a standard protocol. RESULTS: A total of 60 patients were included; 48 patients (80.0%) were treated for juxtarenal aneurysms, and 12 (20.0%) were short-neck infrarenal aneurysms. Mean aneurysm size was 64 ± 9 mm. A total of 140 fenestrations were incorporated. Median follow-up was 16.4 months (interquartile range, 11.9-27.4). The 30-day mortality was 3.4% (n = 2). Kaplan-Meier estimates for 1-year, 2-year, and 3-year survival were 91.4%, 89.5%, and 86.3%, respectively, without aneurysm-related mortality during follow-up. Main body primary and secondary endograft patencies were 98.3% and 100%, respectively. Target vessel primary and secondary patencies were 95.0% and 98.6%, respectively. Early type IA endoleaks occurred in seven patients (11.7%) and spontaneously resolved in all patients. At 1-year follow-up 4 (6.7%) type II endoleaks persisted. One patient experienced aneurysm rupture because of a late type III endoleak attributable to a dislodged renal stent and subsequently underwent successful conversion to open surgery. CONCLUSIONS: The fenestrated Anaconda is a viable treatment option for complex abdominal aortic aneurysms. Acceptable mortality and morbidity and low reintervention rates contribute to good midterm results. Occurrence of early type I endoleak was relatively common, but these resolved spontaneously in all patients.

Results From a Nationwide Registry on Scalloped Thoracic Stent-Grafts for Short Landing Zones.

PURPOSE: To report the perioperative results and short-term follow-up of patients treated with scalloped thoracic stent-grafts. METHODS: A multicenter registry in the Netherlands captured data on 30 patients (mean age 68 years; 17 men) with thoracic aortic pathology and a short (<20 mm) proximal or distal landing zone who received a custom-made scalloped stent-graft between January 2013 and February 2016. Patients were treated for saccular (n=13) aneurysms, fusiform (n=9) aneurysms, pseudoaneurysms (n=4), or chronic type B dissections (n=4). The scallop was used to preserve flow in the left subclavian artery (LSA) (n=17), left common carotid artery (n=5), innominate artery (n=1), and celiac trunk (n=7). In 7 (23%) patients, the scallop also included the adjacent artery. RESULTS: Technical success was achieved in 28 (93%) patients. In 1 patient, a minor type Ia endoleak was observed intraoperatively, which was no longer visible on computed tomography angiography at 3 months. In another patient, the LSA was unintentionally obstructed due to migration of the stent-graft on deployment. Concomitant carotid-carotid or carotid-subclavian bypass was performed in 4 patients. There was no retrograde type A dissection or conversion to open surgery. In-hospital mortality was 3%, and the perioperative ischemic stroke rate was 3%. At a mean follow-up of 9.7 months (range <1 to 31), 29 of 30 target vessels were patent. CONCLUSION: The scalloped stent-graft appears to be a safe and relatively simple alternative for the treatment of thoracic aortic lesions with short landing zones. Larger patient series and long-term follow-up are required to confirm these early results.

Long-Term Outcome of the GORE EXCLUDER AAA Endoprosthesis for Treatment of Infrarenal Aortic Aneurysms.

PURPOSE: To evaluate long-term outcome of GORE EXCLUDER AAA Endoprosthesis (W.L. Gore & Associates, Inc, Flagstaff, Arizona) for elective treatment of infrarenal aortic aneurysms and to evaluate performance of different generations of the device. MATERIALS AND METHODS: A retrospective analysis was performed of 248 patients undergoing elective endovascular aneurysm repair with the GORE EXCLUDER between January 2000 and December 2015 in 2 hospitals. Primary endpoint was reintervention-free survival. Secondary endpoints were technical success, overall survival, rupture-free survival, endoleaks, sac diameter change (> 5 mm), limb occlusion, and migration (> 5 mm). Median follow-up time was 26 months (range, 1-190 months). RESULTS: Assisted primary technical success was 96.8%. Reintervention-free survival for 5 and 10 years was 85.2% and 75.6%, respectively. Independent risk factors for reintervention were technical success (P < .001), type I endoleak (P < .001), and type II endoleak (P = .003). Late adverse events requiring reintervention included rupture (0.4%), limb occlusion (0.4%), and stent migration (0.4%). Type Ia (4.8%), Ib (2.8%), II (35.9%), and V (6.5%) endoleaks were reported throughout follow-up. Sac growth was more prevalent with the original GORE EXCLUDER compared with the low permeability GORE EXCLUDER (P = .001) and in the presence of type I, II, and V endoleaks (P < .05). Three conversions (1.2%) were performed. Overall survival at 5 and 10 years was 68.4% and 49.0%, with no reported aneurysm-related deaths. CONCLUSIONS: Treatment with the GORE EXCLUDER is effective with acceptable reintervention rates in the long-term and few device-related adverse events or ruptures up to 10 years. Observed late adverse events and new-onset endoleaks emphasize the need for long-term surveillance.

Fenestrated Endografts for Complex Abdominal Aortic Aneurysm Repair.

Since the introduction of fenestrated endovascular aneurysm repair (FEVAR) in 1996, great advances have been made in endograft development. Custom-made and off-the-shelf fenestrated and branched endografts have been used to treat patients with complex abdominal aortic and thoraco-abdominal aneurysms. Most experience has been gained with the Cook Zenith® fenestrated endograft (Cook Medical Inc., Limerick, Ireland). The Cook Zenith® endograft is customized with fenestrations, (fixed) inner or outer branches, or a combination of them, to cover a wide range of complex aneurysms. There are limitations to the number, location, and size of the fenestrations and to the maximal angulation of the aorta. Because the production of a custom-made fenestrated endograft takes several weeks, and is therefore not available for emergency cases, off-the-shelf fenestrated endograft were developed. One of these grafts was the Endologix Ventana™ (Endologix, Inc., Irvine, California). This endograft was withdrawn from enrollment due to a high reintervention rate. Vascutek Ltd. developed the custom-made Vascutek Fenestrated Anaconda™ endograft (Vascutek Ltd., Inchinnan, Scotland) to treat patients where other endografts were not suitable-like in a more tortuous aorta with an angulation up to 90°. Additionally, the unsupported proximal body enables a high number and large size of fenestrations if needed. First reports of custom-made fenestrated and (inner and outer) branched JOTEC E-xtra DESIGN ENGINEERING (JOTEC GmbH, Hechingen, Germany) for aortic aneurysms seem promising, but larger series need to be reported to be able to draw conclusions. Both custom-made Cook Zenith® and Vascutek Fenestrated Anaconda™ endografts have good reported clinical outcomes with a perioperative mortality between 4.1 and 6.7% and a reintervention rate of <10% at one year. Knowledge on the long-term outcome of both devices is still limited.

Fenestrated endografting of juxtarenal aneurysms after open aortic surgery.

INTRODUCTION: Juxtarenal aneurysms after previous surgical aortic reconstruction constitute a complex clinical scenario. Open redo surgery is technically demanding and usually requires suprarenal or supraceliac clamping. Standard endovascular repair is prohibited due to the lack of a proximal landing zone. We present our experience with fenestrated endovascular aneurysm repair (F-EVAR) in the treatment of juxtarenal aneurysms after previous open surgery. METHODS: A prospectively maintained database including all patients with juxtarenal abdominal aortic aneurysm after previous surgical reconstruction that underwent F-EVAR within the period from November 2003 to February 2013 under the instruction of the senior author. Evaluated outcomes included initial technical success and operative mortality and morbidity as well as late survival, target vessel patency, aneurysm diameter regression, renal function, and reintervention. RESULTS: A total of 35 patients (33 male; mean age, 71.5 ± 6.2 years) were treated. Median interval from the primary surgical reconstruction was 126 months (range, 48-223 months). All patients had proximal anatomies precluding standard endovascular techniques and were considered high risk for open repair due to their comorbidities and redo nature of the operation. In total, 111 vessels were targeted: 77 with small fenestrations, 33 with scallops, and 1 vessel with a downward branch. The operation was completed by totally endovascular means in 34 patients (97.1%). In one patient, a retroperitoneal approach was needed to gain retrograde access to a renal artery. Operative target vessel perfusion success rate was 100%. Operative mortality was 0% and median hospital stay 6 days (range, 2-40 days). Mean follow-up (FU) was 37.5 ± 25 months. Mean aneurysm maximal diameter decreased from 60 ± 4 mm to 47 ± 8 mm (P < .05). No type I endoleak was diagnosed, and no reintervention was required during FU. There were eight late deaths, all unrelated to the aneurysm. Estimated survival rates at 1, 2, and 4 years were 92.0% ± 5.5%, 82.8% ± 7.9% and 76.9% ± 9.3%, respectively. Three target vessel occlusions occurred during FU. One patient suffered a bilateral renal artery occlusion resulting in dialysis. In a second patient, one renal artery occluded without clinical symptoms. No other cases of renal function deterioration were observed. CONCLUSIONS: F-EVAR is a valid treatment option for juxtarenal aneurysms after previous surgical reconstruction. F-EVAR represents a less morbid alternative to redo open surgery, has a high technical success rate, and shows durability in mid-term FU.

Dutch experience with the fenestrated Anaconda endograft for short-neck infrarenal and juxtarenal abdominal aortic aneurysm repair.

OBJECTIVE: In the past decennium, the management of short-neck infrarenal and juxtarenal aortic aneurysms with fenestrated endovascular aneurysm repair (FEVAR) has been shown to be successful, with good early and midterm results. Recently, a new fenestrated device, the fenestrated Anaconda (Vascutek, Renfrewshire, Scotland), was introduced. The aim of this study was to present the current Dutch experience with this device. METHODS: A prospectively held database of patients treated with the fenestrated Anaconda endograft was analyzed. Decision to treat was based on current international guidelines. Indications for FEVAR included an abdominal aortic aneurysm (AAA) with unsuitable neck anatomy for EVAR. Planning was performed on computed tomography angiography images using a three-dimensional workstation. RESULTS: Between May 2011 and September 2013, 25 patients were treated in eight institutions for juxtarenal (n = 23) and short-neck AAA (n = 2). Median AAA size was 61 mm (59-68.5 mm). All procedures except one were performed with bifurcated devices. A total of 56 fenestrations were incorporated, and 53 (94.6%) were successfully cannulated and stented. One patient died of bowel ischemia caused by occlusion of the superior mesenteric artery. On completion angiography, three type I endoleaks and seven type II endoleaks were observed. At 1 month of follow-up, all endoleaks had spontaneously resolved. Median follow-up was 11 months (range, 1-29 months). There were no aneurysm ruptures or aneurysm-related deaths and no reinterventions to date. Primary patency at 1 month of cannulated and stented target vessels was 96%. CONCLUSIONS: Initial and short-term results of FEVAR using the fenestrated Anaconda endograft are promising, with acceptable technical success and short-term complication rates. Growing experience and long-term results are needed to support these findings.

Visceral stent patency in fenestrated stent grafting for abdominal aortic aneurysm repair.

OBJECTIVE: Fenestrated endovascular abdominal aortic aneurysm repair (F-EVAR) has been introduced for treatment of aneurysms in which visceral arteries are incorporated. Patency of target vessels has been reported to be excellent. Results of the use of stent grafts to accommodate visceral arteries in F-EVAR are presented in this study, including an overview of factors that affect outcome. METHODS: All patients treated with fenestrated stent grafts in a single center between November 2001 and October 2011 were reviewed. Patients treated for suprarenal, juxtarenal, and infrarenal short-necked aortic aneurysms were included. Patients with thoraco-abdominal aneurysms or aneurysms treated with grafts with fixed side branches were excluded. Polytetrafluoroethylene covered stents were used routinely since June 2005. Target vessels and stents were examined using computed tomography angiography reconstructions. Primary end points were primary patency, defined as the absence of occlusion, and loss of renal function. Secondary end points were technical success, stenosis (defined as a ≥50% angiographic diameter reduction), stent fracture, and mortality. RESULTS: A total of 138 patients with a median age of 73 years (range, 50-91 years) met the inclusion criteria. Median computed tomography angiography follow-up was 13 months (range, 1-97 months). In total, 392 target vessels were provided with 140 scallops and 252 fenestrations. Visceral stents (-grafts) were placed in 254 target vessels. Technical success was obtained in 249 arteries (98.0%). Overall stent patency of target vessels was 95.7% at 1 year and 88.6% at 4 years. Renal artery stent patency was 97.4% at 1 year and 91.2% at 4 years (96.8% and 89.1% for uncovered stents; 97.3% and 92.4% for covered stents, respectively). There was no significant difference in patency between covered and uncovered stents in renal arteries (P = .71). Renal artery stenosis occurred in 26 stented arteries (11.3%) and occlusion in seven arteries. Renal artery stent stenosis occurred significantly more in uncovered than in covered stents (P = .04). Stent fractures occurred more in uncovered than in covered stents (P = .01) and was associated with a significantly lower visceral stent patency rate (P < .01). During follow-up, 13 patients developed permanent renal function impairment (9.4%), of which two required permanent dialysis (1.4%). Renal dysfunction was significantly associated with renal stent occlusion or stenosis (P < .01). CONCLUSIONS: Patency rates of visceral artery stent (-grafts) in F-EVAR were 95.7% at 1 year and 88.6% at 4 years. Patency rates were affected by stent fractures, which occurred more in uncovered compared with covered stents. Renal artery stent stenosis occurred more in uncovered compared with covered stents. Renal dysfunction was significantly associated with renal stent occlusion or stenosis.

A limited and customized follow-up seems justified after endovascular abdominal aneurysm repair in octogenarians.

OBJECTIVE: The objective of this study was to determine whether long-term follow-up after endovascular aneurysm repair (EVAR) is justified in octogenarians. METHODS: Between September 1996 and October 2011, all patients, including octogenarians, treated for an abdominal aortic aneurysm (AAA) by EVAR were included in a prospective database. Patients older than 80 years and with a nonruptured infrarenal aneurysm treated electively or urgently were included in the study (study group [SG]). Patients with ruptured aneurysms and patients who died during surgery or within the first postoperative month were excluded from further analysis. The control group (CG) consisted of patients younger than 80 years, matched for gender and AAA diameter. All patients were evaluated 4 to 8 weeks after EVAR and then annually thereafter. Follow-up data were complemented by review of the computerized hospital registry and charts and by contact of the patient's general practitioner or referring hospital. Primary outcomes were stent- or aneurysm-related complications and interventions. Secondary outcomes were additional surgical complications and patient survival. RESULTS: A total number of 193 patients (SG, n = 97; CG, n = 96) were included for analysis. Median age was 80 years, and 88.6% were male. Median follow-up time was 33.6 months (interquartile range [IQR], 12.9-68.3). Stent- and procedure-related postoperative complications were comparable between groups (SG, 41.2%; CG, 39.6%; P = .82). Median time to complication was 2.3 months (IQR, 0.2-19.4) in the SG compared with 18.1 months (IQR, 6.8-50.5) in the CG. The 2-year complication-free survival rates were 58% (SG) and 60% (CG). Interventions were performed significantly less frequently in octogenarians (SG, 8.2%; CG, 19.8%; P < .05). Median time to intervention was 11.1 months (IQR, 2.0-31.0) in the SG compared with 54.3 months (IQR, 15.0-93.2) in the CG. The 2-year intervention-free survival rates were 90% (SG) and 92% (CG). During follow-up, 98 patients died (SG, n = 54; CG, n = 44); median time to death was 31.8 months (IQR, 13.3-66.0) in the SG compared with 44.4 months (IQR, 15.0-77.7) in the CG. One aneurysm-related death occurred in the CG. The 2- and 5-year survival rates were 71% and 32% for the SG compared with 77% and 66% for the CG (P < .05). CONCLUSIONS: Because of the low incidence of secondary procedures and AAA-related deaths in octogenarians, long-term and frequent follow-up after EVAR seems questionable. An adapted and shortened follow-up seems warranted in this patient group.

C-reactive protein predicts postoperative delirium following vascular surgery.

BACKGROUND: The etiology of postoperative delirium (POD) following vascular surgery is generally unknown. The incidence, however, can be as high as 35%. A possible neuroinflammatory basis for delirium is likely and C-reactive protein (CRP) as a marker for inflammation can possibly play a predictive role. METHODS: Between March 2010 and September 2012, 277 consecutive elective vascular surgery patients were prospectively evaluated for the diagnosis of POD. Various potential risk factors, including postoperative CRP values, were collected. RESULTS: The mean age of the patients was 69 ± 11 years (range 21-92). The mean hospital length of stay was 6 ± 4 days (range 1-33). Sixteen patients (6%) developed POD during hospital stay. Univariate analysis revealed multiple comorbidities (P = 0.001), postoperative elevated CRP levels (P = 0.001), intensive care unit admittance (P = 0.01), and open aortic surgery or amputation procedures (P = 0.0001) to be significantly related to the diagnosis POD. Multivariate logistic regression analysis confirmed the relationship between an elevated CRP value and POD (odds ratio [OR] 1.01, 95% confidence interval 1.00-1.03, P = 0.04). The sensitivity analyses yielded essentially similar results. Based on OR, it can be calculated that the risk of POD is increased by approximately 35% if the CRP concentration is 50 mg/L, and by approximately 90% if the CRP concentration is 100 mg/L (compared with a CRP concentration of 5 mg/L). Thirty-one percent (5/16) of patients with POD needed a long-stay care facility after discharge (P = 0.0001). CONCLUSIONS: In this study, CRP can be used as a marker for an increased risk of POD after vascular surgery. In addition, it was found that POD was associated with a 10-fold increase in the need of long-stay care after discharge.