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Nationwide Experience with EVAS Relining of Previous Open or Endovascular AAA Treatment in The Netherlands

Open AccessPublished:January 05, 2022DOI:https://doi.org/10.1016/j.avsg.2021.12.077

      Objective

      Relining of a previously placed surgical graft or endograft for an abdominal aortic aneurysm (AAA) is a reintervention to treat progression of disease or failure of the primary (endo)graft. Endovascular Aneurysm Sealing (EVAS) relining is a technique with potential advantages due to the absence of a bifurcation, the possibility for a unilateral approach, and sealing concept of the endobags. The purpose of this study was to describe the nationwide experience with EVAS relining of previous AAA repair in the Netherlands.

      Methods

      A retrospective analysis of all patients who underwent EVAS relining in 7 high volume vascular centres in the Netherlands between 2014 and 2019 was performed. Primary outcomes were technical and clinical success. Secondary outcomes were perioperative outcomes, complications and survival.

      Results

      Thirty-three patients underwent EVAS relining of open (n = 10) or endovascular (n = 23) repair. 26 were elective cases, 5 were urgent and 2 were acute (ruptured). Mean time between primary treatment and EVAS relining was 99 ± 74 months. Indications after open repair were proximal progression of disease (n = 7) and graft defect (n = 3). Indications after EVAR were type IA (n = 10), type IB (n = 3), type IIIA (n = 4), type IIIB (n = 3) endoleak, and endotension (n = 3). 18 patients underwent regular EVAS, 4 unilateral EVAS and 11 chimney-EVAS. In-hospital mortality was 6% (both patients with rAAA). Technical success was achieved in 97%. Median follow-up after EVAS relining was 20 months (range 0-43). Freedom from reintervention at 1-year and 2-year were 83% and 61% and the estimated survival 79% and 71%, respectively. EVAS relining after open repair had a clinical success of 90% at 1-year and of 70% at latest follow-up, while after EVAR clinical success rates were 70% and 52%, respectively.

      Conclusion

      EVAS relining of previous AAA repair is associated with high technical success, however with limited clinical success at median follow-up of 20 months. Clinical success was higher in patients with EVAS relining after open repair than after EVAR. In patients with failed AAA repair, EVAS relining should only be considered, when established techniques such as fenestrated repair or open conversion are not available or indicated.
      What this paper adds
      This Dutch nationwide study reports outcomes of 33 patients with EVAS relining of failed previous open or endovascular abdominal aortic aneurysm repair and demonstrates a high technical success, however a limited clinical success rate at median follow-up of 20 months. In patients with failed AAA repair, EVAS relining could be considered, when other more established techniques such as fenestrated repair or open conversion are not available or indicated.

      INTRODUCTION

      Endovascular Aneurysm Repair (EVAR) has become the most frequently used procedure for the treatment of an abdominal aortic aneurysm (AAA) with favourable perioperative morbidity and mortality rates in comparison to open repair.
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      although the latter is outside the instruction (IFU) for use of the device. After its commercial release, the short-term outcome showed high technical success and low reintervention rates compared to EVAR. However mid- and long-term results were less favourable because of complications such as type I endoleaks and particularly stent graft migration and displacement.
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      Concerns about these results initially led to a refinement of the IFU and a temporary recall of the device. Thereafter, the technique is no longer being used in Europe except for compassionate cases. In the US, a confirmatory safety and effectiveness trial (EVAS 2) is currently in the follow-up phase. According to the IFU, EVAS is not designed for secondary aortic procedures.

      Endologix. My EndNote Library. Doi: {, #12;, #26;, 1999 #37;Barkley, 1997 #30;Chacko, 2013 #1;Chacko, 2014 #4;Chronis, 2004 #31;Fossum, 2009 #22;Heath, 2014 #14;Hinshaw, 2000 #32;Hoza, 2000 #33;Lavigne, 2010 #21;March, 2000 #35;Meftagh, 2014 #36;Parent, 2011 #3;Pelham, 2008 #39;Rajwan, 2014.

      However, recent reports have described EVAS and chimney-EVAS (ch-EVAS) as a potentially useful technique for the management of failing EVAR due to type IA or type III endoleaks.
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      Endovascular Aneurysm Sealing (EVAS) Alone or in Combination with Chimney Grafts (chEVAS) for Treating Complications of Previous Endovascular Aneurysm Repair (EVAR) Procedures.
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      Endovascular Aneurysm Sealing (EVAS) and Chimney EVAS in the Treatment of Failed Endovascular Aneurysm Repairs.
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      Treatment of Type IIIb Endoleaks After EVAR Using the Nellix EndoVascular Aneurysm Sealing System.
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      An alternative approach for treating a type ia endoleak after conventional evar using the nellix endovascular aneurysm sealing.
      The advantage of EVAS compared to other endovascular techniques (such as fenestrated endovascular aneurysm repair (FEVAR) or proximal cuff placement with or without endoanchors) is that it may offer an off-the-shelf solution and is associated with fewer anatomical constraints. Also, the possibility for a unilateral approach, the absence of a flow-divider and efficient seal with use of endobags are potential advantages.
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      The objective of the current study is to describe the nationwide Dutch experience with relining of a previous open or endovascular AAA repair using EVAS.

      MATERIAL AND METHODS

      Study Design/Setting

      This study is a nationwide multicentre retrospective case series. EVAS relining was performed in 7 centres in the Netherlands (St. Antonius Hospital Nieuwegein, Rijnstate Hospital Arnhem, Maastricht University Medical Center, Erasmus Medical Center Rotterdam, Amsterdam University Medical Center location VUMC, Elisabeth-TweeSteden Hospital Tilburg, and Dijklander Hospital Hoorn). The study was conducted in conformity with the Declaration of Helsinki and approved by the Institutional Review Board of Maastricht University Medical Centre. A waiver for informed consent from the patients was provided by the appropriate local Medical Ethical committees. The STROBE guidelines for cohort studies (STrengthening the Reporting of OBservational studies in Epidemiology STROBE) were applied.

      Study Population and Data Collection

      Between October 2014 and October 2018 all patients who underwent EVAS as a secondary intervention after previous EVAR or open AAA repair were included. All patients were reviewed by a multidisciplinary team consisting of vascular surgeons and interventional radiologists prior to recommending EVAS or ch-EVAS. The decision to perform EVAS or ch-EVAS relining instead of more conventional methods such as FEVAR or open repair was made in this multidisciplinary meeting but could have been based on different criteria in each centre. In general, only patients unfit for open conversion would be evaluated for an endovascular treatment. Subsequently, EVAS relining was offered as an alternative to FEVAR when there were anatomical restraints for FEVAR, such as narrow visceral aortic segment, visceral thrombus, hampered access, and target vessel restrictions, or when the timing of the procedure (acute or urgent aneurysm, large aneurysm with rapid growth) requested an off-the-shelf solution. Data was collected retrospectively from the hospital records in the respective centres. Patient demographics, peri-operative and follow-up data concerning both the primary and secondary endpoints were obtained.

      EVAS Relining Procedure

      For EVAS relining the Nellix® Endovascular Aneurysm Sealing system was used, if needed in combination with balloon expandable covered stents (BECS) as chimney grafts. All interventions were performed under general anaesthesia in fully equipped hybrid operating rooms. Experienced vascular surgeons, familiar with the EVAS technique, performed the interventions. Open or percutaneous access was gained via the common femoral arteries and the Nellix stent grafts were deployed infrarenal extending into the iliac limbs as described before.
      • Donayre CE
      • Zarins CK
      • Krievins DK
      • et al.
      Initial clinical experience with a sac-anchoring endoprosthesis for aortic aneurysm repair.
      ,
      • Batagini NC
      • Hardy D
      • Clair DG
      • et al.
      Nellix EndoVascular Aneurysm Sealing System: Device description, technique of implantation, and literature review.
      Unilateral EVAS was performed in patients with a unilateral type IB or type III endoleak. Ch-EVAS was performed when a suprarenal seal was necessary. For ch-EVAS, upper extremity access was gained via open approach of either the left or right brachial or axillary artery. Renal and/or visceral arteries were cannulated and BECS and the Nellix grafts were simultaneously deployed. After filling the endobags with polymer a completion angiogram was performed to assess the position and patency of the Nellix stent frames and BECS and to check for endoleak. Patients underwent computed tomography (CT) angiography imaging and/or duplex ultrasound before discharge and then surveillance with clinical and imaging assessment according to local protocol.

      Study Endpoints

      The primary outcomes of this study were technical and clinical success, defined according to the reporting standards of endovascular aortic aneurysm repair.
      • Chaikof EL
      • Blankensteijn JD
      • Harris PL
      • et al.
      Reporting standards for endovascular aortic aneurysm repair.
      Technical success was defined as a complete exclusion of the AAA (absence of type I/III endoleak) with patent endografts and side branches at completion angiography. Clinical success was defined as absence of aneurysm-related reintervention and -mortality, absence of endoleak (type I and III) and absence of AAA growth at 1 year, 2 year and last follow-up. The secondary outcomes investigated were perioperative results, complications and survival at the same time points, including at 30 days after procedure.
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      • Blankensteijn JD
      • Harris PL
      • et al.
      Reporting standards for endovascular aortic aneurysm repair.

      Statistics

      Continuous data were reported as mean with the standard deviation or median with the interquartile range. Frequency and percentages were reported for categorical variables. Categorical variables were compared using Pearson's chi-squared test. Continuous variables were compared using the independent t-test for nonparametric data. For the assessment of survival and reinterventions Kaplan-Meier analysis was used. All statistical analyses were performed using IBM Statistics SPSS version 25.0.

      RESULTS

      Thirty three patients from 7 centres in the Netherlands who underwent an EVAS relining of a previous open or endovascular AAA repair were identified. The majority of patients was male (31/33) with a mean age of 74 ± 5.5 years. Patient characteristics are summarised in Table I. The primary AAA procedures were performed between 1993 and 2015 (open: between 1993–2011; EVAR: between 2001–2015). Mean time between the primary intervention and EVAS relining was 99 ± 74 months. Ten patients underwent EVAS relining after open repair of which 7 for progression of disease (5 para-anastomotic aneurysms and 2 true proximal aneurysms) and 3 for a tear or defect in the surgical graft. The remaining 23 patients were treated for EVAR failure due to type IA endoleak (n = 10), type IB endoleak (n = 3), type IIIA endoleak (n = 4; Fig. 1), type IIIB endoleak (n = 3) or endotension (n = 3). 26 of the EVAS relinings were elective, 5 were urgent interventions for a symptomatic AAA and 2 were acute for a ruptured AAA (rAAA) (Table I).
      Table IDemographics
      Patient CharacteristicsTotal, N(%)Previous openPrevious EVAR
      Total331023
      Male31 (94%)1021
      Mean age (yr)74.4 ± 5.574.9 ± 6.374.8 ± 5.6
      Hypertension26 (78%)719
      Dyslipidemia23 (69%)518
      Diabetes8 (24%)26
      History of MI15 (45%)510
      History of CVA4 (12%)13
      Active smoker5 (15%)05
      Former smoker12 (36%)57
      ASA ≥ 329 (88%)821
      Timing EVAS
      rAAA211
      sAAA523
      Elective26719
      Mean time primary repair – EVAS (months)99 ± 74175 ± 7162 ± 43
      Indications EVAS
      Progression of disease (7)Type IA EL (10)
      Graft defect/tear (3)Type IB EL (3)
      Type IIIA EL (4)

      Type IIIB EL (3)
      Endotension (3)
      Table I: Demographics. This table summarizes all patient characteristics, timing of the EVAS procedure and indications for EVAS procedure. The characteristics are presented as number of patients having this characteristic unless otherwise specified. Means are presented with their respective standard deviation.
      N, number of patients; MI, myocardial infarction; CVA, cerebrovascular accident; EL, endoleak; rAAA, ruptured abdominal aneurysm; sAAA, symptomatic abdominal aneurysm.
      Fig 1
      Fig. 1EVAS relining for type III endoleak Axial (A) and coronal (B) CT angiogram images of type III endoleak (arrow) after EVAR. Axial (C) and MPR coronal (D) CT angiogram images of succesfull EVAS relining. There is no endoleak anymore on the postoperative imaging studies. Question: Could panel C be made a little less dark? To compare with A.
      Eighteen patients were treated with a regular bilateral EVAS procedure, 4 underwent a unilateral EVAS procedure and 11 patients were treated with ch-EVAS (3 patients with 1 chimney, 5 patients with 2 chimneys and 3 patients with 3 chimneys). The mean polymer volume per procedure was 46 ± 24 mL and the mean polymer filling pressure was 203±28 mmHg. The mean procedure time was 131 ± 66 min. The mean hospital stay was 5.5 ± 8.3 days (Table II).
      Table IIOperative details
      Operative DetailsOverallPrevious openPrevious EVAR
      Intervention, n
      EVAS-bilateral18711
      EVAS-unilateral413
      Ch-EVAS1129
      Adjunctive Procedures, n
      Femoral endarterectomy413
      Iliac endoprosthesis extension312
      Embolization IIA101
      Stent popliteal aneurysm110
      Mean operative time, min131 ( ± 65.7)109 ( ± 60.1)142 ( ± 67.0)
      Mean polymer filling pressure, mmHg204 (± 28.2)210 (± 26.7)201 (± 29.1)
      Mean polymer volume, ml46 (± 23.6)54 (± 16.8)41 (± 26.1)
      Pre-fill, n231013
      Secondary fill, n1046
      Table II: Operative details. This table summarizes relevant operative details from all 33 patients that underwent EVAS-relining. Primary and secondary interventions are present as number of patients that received the respective treatment. Adjunctive procedures are presented as the number of procedures. Some patients received more than one adjunctive procedure. Means are presented with their respective standard deviations. Ch-EVAS, chimney EVAS; IIA, internal iliac artery.

      Study Endpoints

      Technical success was achieved in 32 of 33 patients (97%). In 1 patient with a 2-vessel ch-EVAS, a type IA endoleak persisted on the completion angiography, which was successfully treated 2 months later using vascular plugs and coils to fill the gutters and the endoleak itself (Fig. 2). Perioperative mortality (30-day and in-hospital) was 6%, due to the death of both patients who were treated for a rAAA on postoperative day 4 and 24, respectively. There were no deaths in the elective or urgently treated group. Perioperative complications were observed in 8 patients, one in the open group and 7 in the EVAR group. 5 patients developed a groin hematoma which was treated conservatively. 3 patients had a postoperative infection (2 wound infections and 1 patient with fever of unknown origin) successfully treated with antibiotics (Table III). 1 patient, who underwent elective EVAS relining for a type IIIA EL, needed a reintervention within 30 days; he was treated with right iliac limb extension for a type IB endoleak.
      Fig 2
      Fig. 2Ch-EVAS relining for type IA endoleak. Coronal (A) and Axial (B) CT angiogram images of type IA endoleak (arrow) after EVAR. MPR coronal CT angiogram images from ch-EVAS in EVAR (C). Control CT angiogram demonstrating persistent type IA endoleak (arrows, D). Control CT angiogram after extensive coil embolization (arrow) of gutter leak from ch-EVAS (E). There is no type IA endoleak anymore on the postoperative imaging studies. Question: could panel E be made a little less dark? To compare with D.
      Table IIIOutcomes and complications
      Total(n = 33)Previous open(n = 10)Previous EVAR(n = 23)P-value
      Early outcome
      Technical success32 (97%)1022
      Mean hospital stay, days5.5 ± 83 ± 26 ± 10
      Complications
      Perioperative complications1028.396
      Hematoma/bleeding514
      Infection
      These infections were treated with antibiotics. MOF, multi organ failure; AB, antibiotics; EL, endoleak; SMA, superior mesenteric artery.
      303
      Wound infection202
      Fever101
      Post-op MOF211
      Early mortality211
      Aneurysm related211
      Reinterventions (<30 days)101
      Late outcome
      Mean follow-up (months)21 ± 1322 ± 1320 ± 13
      Clinical success19 (58%)712
      Overall mortality14 (42%)311.341
      Aneurysm related6 (18%)15.422
      Estimated survival 1yr78.5 ± 7.2%80 ± 12.6%78.3 ± 8.6%.484
      Number at risk24818
      Estimated survival 2yr70.6 ± 8.4%80 ± 12.6%67.4 ±10.3%
      Number at risk17812
      Freedom of reintervention1yr: 82.7 ± 7.1%1yr: 77.8 ± 13.9%1yr: 85.8 ± 7.6%.363
      2yr: 61.2 ± 10.7%2yr: 77.8 ± 13.9%2yr: 53.1 ± 14.4%
      Late complications
      Complications (≥ 30 days)17215.026
      Endoleak13112.023
      Type IA EL615
      Type IB EL101
      Type II EL303
      Type IIIA EL202
      Type IIIB EL101
      Limb stenosis211
      Crushed stent SMA101
      Gluteal claudication303
      Reinterventions (≥30 days)12210.198
      Table III: Outcomes and complications. This table summarizes surgical outcomes and complications of the patient sample. Means are presented with their respective SD.
      low asterisk These infections were treated with antibiotics. MOF, multi organ failure; AB, antibiotics; EL, endoleak; SMA, superior mesenteric artery.
      During a median follow-up time of 20 months (range 0–43), clinical success was achieved in 19 patients (58%, Table IV). In the group with previous open repair 9 patients (90%) had clinical success at 1-year follow-up versus 16 patients (70%) in the group with previous EVAR. At the end of follow-up clinical success was 70% in the open group and 52% in the patients with a previous EVAR. In the open group, 5 of 7 elective EVAS relinings achieved clinical success and both symptomatic patients had clinical success. With EVAS relining after EVAR, clinical success was achieved in 11 of 19 electively treated patients and in 1 of 3 symptomatic, not ruptured, patients. 1 of 2 ch-EVAS relinings in the open group had clinical success, while 4 of 9 ch-EVAS relinings after EVAR had clinical success (Table IV).
      Table IVSummary of all patients including indications and outcomes
      PatientSettingIndicationInterventionTechnical successClinical successEndoleakAneurysm growthReinterventionTime between EVAS and reintervention in monthsResult reinterventionMortalityAneurysm related mortalityTotal follow-up in months
      1ElectiveProgression of diseasech-EVASYesYes-NoNo--No-27
      2ElectiveProgression of diseasech-EVASYesNo-YesYes Revision ch-EVAS with chimney to RRA, SMA and celiac trunk for stenosis SMA and aneurysm growth11Successful Good position stents, no growth, no ELNo-15
      3ElectiveProgression of diseaseEVASYesYes-NoNo--No-32
      4ElectiveProgression of diseaseEVASYesYes-NoNo--No-36
      5ElectiveProgression of diseaseu-EVASYesNoIAYesNo (due to palliative setting)--Yes, unknown cause of death outside hospitalNo28
      6ElectiveProgression of diseaseEVASYesYes-NoNo--Yes, gastric cancerNo12
      7sAAAProgression of diseaseEVASYesYes-NoNo--No-13
      8ElectiveGraft defectEVASYesYesNoNo--No-43
      9sAAAGraft defectEVASYesYes-NoYes PTA+stent both Nellix limbs for stenosis of right limb2Successful No re-stenosisNo-19
      10rAAAGraft defectEVASYesNo-NoNo--Yes, postoperative shock, MOF (4 days after EVAS)Yes0
      11ElectiveType IA ELch-EVASYesNoIAYesYes Proximal extension and covered stents in both Nellix limbs, embolization IA EL and coiling lumbar artery21Successful. No growth, no more ELNo-34
      12ElectiveType IA ELch-EVASYesNoIINoYes Relining crushed SMA-stent3Successful. Stent SMA patentYes, unknown cause of death.outside hospitalNo29
      13ElectiveType IA ELch-EVASNoNo(Persistent) IAYesYes Coiling IA EL2Successful. In FU type II EL (IMA), no growthNo-25
      Thrombectomy (left) Nellix limb and fasciotomy for lower limb ischemia7Successful. Ischemia resolved, Nellix patent. However, aneurysm infection, started on lifelong AB
      14ElectiveType IA ELEVASYesNoIAYesYes Explantation Nellix16SuccessfulNo-19
      15ElectiveType IA ELch-EVASYesYes-NoNo--Yes, unknown cause of death outside hospitalNo1
      16ElectiveType IA ELEVASYesYes-NoNo--Yes, breast cancerNo2
      17ElectiveType IA ELch-EVASYesYes-NoNo--No-23
      18ElectiveType IA ELch-EVASYesYes-NoNo--No-20
      19ElectiveType IA ELEVASYesNoIAYesYes Explantation Nellix for aneurysm growth and migration25Unsuccessful, resulting in deadYes, postoperative bowelischemiaYes27
      20sAAAType IA ELch-EVASYesNoIIIYesNo--Yes, rupture due to type III ELYes4
      21ElectiveType IB ELu-EVASYesYes-NoNo--No-38
      22ElectiveType IB ELu-EVASYesYesIIINoNo (unknown cause of death outside hospital)--Yes, unknown cause of deathNo20
      23ElectiveType IB ELEVASYesYes-NoNo--No-33
      24ElectiveType IIIA ELu-EVASYesNoIBNoYes Right iliac limb extension for IB EL<1 weekSuccessfulYes, postop after rupture rightYes34
      Intervention for ruptured aneurysm right iliac artery34Dead (2 weeks after reintervention)iliac artery, exact cause unknown
      25ElectiveType IIIA ELEVASYesYes-NoNo--No-7
      26ElectiveType IIIB ELEVASYesYes-NoNo--No-14
      27ElectiveType IIIB ELEVASYesYes-NoNo--No-38
      28sAAAType IIIA ELEVASYesYesIIYesNo--Yes, poor cardiac condition, exact cause unknownNo34
      29sAAAType IIIB ELEVASYesNoIINoNo--No-10
      30rAAAType IIIB ELEVASYesNo-NoNo--Yes, postoperative shock, MOFYes0
      31ElectiveEndotensionEVASYesNoIIIYesYes Covered bridging stents distal from Nellix for type III EL33Successful. No EL, no growth, patent stentsNo-35
      32ElectiveEndotensionch-EVASYesYes-NoNo--Yes, melanomaNo4
      33ElectiveEndotensionch-EVASYesNoIAYesYes Explantation Nellix for EL and growth19Unsuccessful, resulting in deathYes, Postop bowel-ischemiaYes19
      Table IV. Summary of all patients including indications and outcomes.
      Patients 1-10 underwent EVAS relining after previous open AAA repair. Patients 11-33 had a previous EVAR.
      rAAA, ruptured abdominal aortic aneurysm; sAAA symptomatic abdominal aortic aneurysm; Ch-EVAS, chimney-EVAS; u-EVAS, unilateral EVAS; RRA, right renal artery; SMA, superior mesenteric artery; EL, endoleak; MOF, multi organ failure; IMA, inferior mesenteric artery.
      There were 14 additional deaths (42%). 6 deaths during follow-up were AAA-related (18%). The 2 patients with rAAA died on postoperative day 4 and 24, respectively. 1 patient who had an urgent ch-EVAS for a type IA EL had a fatal rAAA at 4 months follow-up (rupture of type III EL). 2 patients died after conversion to open procedure for explantation due to renewed EL (1 type IA, 1 type III), both originally underwent an elective relining procedure and 1 had a ch-EVAS. Another patient who had an elective unilateral EVAS relining died during follow-up after a reintervention for a ruptured aneurysm of the right iliac artery. The remaining 7 deaths were caused by cancer (1 gastric cancer, 1 melanoma, 1 breast cancer) or had an unknown cause of death (n = 4; Table IV). The estimated Kaplan Meier survival was 78.5 ± 7.2% at 1-year follow-up (24 patients at risk) and 70.6±8.4% at 2-years follow-up (17 patients at risk; Fig. 3). The survival at 1-year follow-up was not significantly different between the relining after open and relining after EVAR group (P=.484).
      Fig 3
      Fig. 3A. Kaplan-Meier survival curve for EVAS relining for previous open and endovascular aneurysm repair. . B. Kaplan-Meier curve for freedom from aneurysm related mortality after EVAS relining of previous open and endovascular aneurysm repair.
      Overall, significantly more complications occurred during follow-up in the EVAR group (15 versus 2 in the open group; P = 0.026). 10 patients experienced growth of the aneurysm sac during follow-up. Endoleaks were present in 13 patients, this was significantly higher in the EVAR group (12 versus 1 in the open group; P = 0.023). 7 patients had a type I EL (5 renewed IA EL, 1 persistent IA EL and 1 IB EL within 30 days, not seen on completion angiography). 3 patients had a persistent type II EL and 3 patients developed a renewed type III EL. In 1 patient a crushed chimney graft in the superior mesenteric artery was relined 3 months after ch-EVAS. In 2 patients a unilateral stenosis of the Nellix-system was successfully treated with PTA. 3 patients suffered from gluteal claudication (Table III). A total of 12 (36%) reinterventions were performed during the follow-up. Table IV shows an overview of results and reinterventions for all patients. Freedom from reintervention was 82.7 ± 7.1% after 1-year follow-up and 61.2 ± 10.7% after 2-years follow-up. At 1-year follow-up no significant difference was found in the amount of reinterventions after EVAS relining for failing open repair versus EVAR (P = 0.198). Subgroups divided per indication for relining of EVAR were too small for statistical analysis.

      DISCUSSION

      Reinterventions for failing previous open or endovascular aneurysm repair are often challenging procedures. Relining the (endo) graft using the EVAS technique can be advantageous because it offers an off-the-shelf solution and is aimed to provide circumferential seal with the endobags. Overall, this nationwide study of EVAS relining of failing open and endovascular aneurysm repair demonstrates a high technical success of 97% and after a mean follow-up of almost 2 years a clinical success rate of only 58%.
      The high technical success rate in our study is in line with previous studies on regular EVAS and EVAS relining.
      • Paraskevas KI
      • Karouki M
      • Rehman A
      • et al.
      Endovascular Aneurysm Sealing (EVAS) Alone or in Combination with Chimney Grafts (chEVAS) for Treating Complications of Previous Endovascular Aneurysm Repair (EVAR) Procedures.
      • Youssef M
      • Zerwes S
      • Jakob R
      • et al.
      Endovascular Aneurysm Sealing (EVAS) and Chimney EVAS in the Treatment of Failed Endovascular Aneurysm Repairs.
      • van den Ham LH
      • Wiersema AM
      • Kievit JK
      • et al.
      Treatment of Type IIIb Endoleaks After EVAR Using the Nellix EndoVascular Aneurysm Sealing System.
      • Bockler D
      • Reijnen MMPJ
      • Krievins D
      • et al.
      Use of the Nellix EVAS system to treat post-EVAR complications and to treat challenging infrarenal necks.
      • Lareyre F
      • Mialhe C
      • Dommerc C
      • et al.
      Endovascular aneurysm sealing (EVAS) and chimney EVAS in the treatment of type Ia and type III endoleaks after endovascular aneurysm repair (EVAR).
      These studies on EVAS relining also reported promising clinical results, however only with a short follow-up period.
      • Paraskevas KI
      • Karouki M
      • Rehman A
      • et al.
      Endovascular Aneurysm Sealing (EVAS) Alone or in Combination with Chimney Grafts (chEVAS) for Treating Complications of Previous Endovascular Aneurysm Repair (EVAR) Procedures.
      ,
      • Youssef M
      • Zerwes S
      • Jakob R
      • et al.
      Endovascular Aneurysm Sealing (EVAS) and Chimney EVAS in the Treatment of Failed Endovascular Aneurysm Repairs.
      ,
      • Bockler D
      • Reijnen MMPJ
      • Krievins D
      • et al.
      Use of the Nellix EVAS system to treat post-EVAR complications and to treat challenging infrarenal necks.
      • Lareyre F
      • Mialhe C
      • Dommerc C
      • et al.
      Endovascular aneurysm sealing (EVAS) and chimney EVAS in the treatment of type Ia and type III endoleaks after endovascular aneurysm repair (EVAR).
      • Martinelli O
      • Fresilli M
      • Irace L
      • et al.
      An alternative approach for treating a type ia endoleak after conventional evar using the nellix endovascular aneurysm sealing.
      Recent studies on regular EVAS with mid- and long-term follow-up periods report high failure rates and are more in line with the findings in our study.
      • Mortola L
      • Ferrero E
      • Quaglino S
      • et al.
      Management of Nellix migration and type Ia endoleak from proximal endovascular aneurysm sealing relining to late open conversion.
      • Hatzl J
      • Peters AS
      • Pfeiffer S
      • et al.
      Midterm single-center results after endovascular aneurysm sealing reveal a high rate of stent graft migration, secondary aneurysm ruptures, and device-related reinterventions.
      • Singh AA
      • Benaragama KS
      • Pope T
      • et al.
      Progressive device failure at long term follow up of the nellix endovascular aneurysm sealing (EVAS) System.
      There are several possible explanations for the limited clinical results in the current study. First, the patient population was heterogeneous and challenging including a substantial number of urgent and acute relinings as well as chimney repairs. Secondly, a technical explanation for the achievement of an initially adequate, however not durable sealing could be a low and/or insufficient volume of polymer inside the endobags. This could be caused by a limited space inside the pre-existing (endo) graft or by inadequate prefill to completely unfold the endobags. Moreover, a rapid rise in filling pressure due to the position of the distal ends of the endobags inside the narrow bifurcation or limbs of the previously placed (endo) graft was observed, possible leading to underfilling of the endobags. Another technical explanation is the fact that the chosen Nellix system could have been too short to reline the entire endograft, leaving a possibility for development of an endoleak distal from the EVAS, which was seen in 2 patients. Also, in 1 patient, the distal bare stent of the Nellix system caused a fabric rupture of the original EVAR stent graft and a fatal rupture. Thirdly, the absence of an active fixation of the endobags may hamper a durable outcome to rescue EVAR with a type IA endoleak, because the EVAS relining will not prevent persistent migration. Obviously, the relining does not reinforce the fixation and seal capacity of the original EVAR devices itself. The adjunctive use of endoanchors could be helpful in this perspective. Finally, the presence of gutter leaks after ch-EVAS resulting in continuous pressurization of the aneurysm sac, would be an indication for reinterventions. These gutter leaks can be difficult to treat and often need extensive coil embolization.
      Indeed, when comparing the results after EVAS relining of failing open repair versus EVAR, our results suggest better outcomes in the group of patients with previous open repair. There were more reinterventions, endoleaks, AAA growth and mid-term complications in the EVAR group. Apart from the technical possible explanations mentioned above, 1 other explanation could be that the Nellix system is better protected from distal migration by the usually narrower surrounding surgical graft, compared to a wider endograft. Finally, the continuing presence of a biologically active aneurysm sac, which was able to cause endoleaks in the EVAR group, could also have contributed to the decreased clinical success. However, subgroups divided per indication for relining or type of previous repair were too small for statistical analysis.
      Several studies on endovascular treatment (such as ch-EVAR, FEVAR and BEVAR) of para-anastomotic aneurysms after previous open infrarenal AAA repair have demonstrated safety and efficacy, with high technical success (92V100%), a low reintervention rate during up to 3-year follow-up (0–18%) and 1 -year survival of 79–96%.
      • Wu Z
      • Xu L
      • Raithel D
      • et al.
      Endovascular repair of proximal para-anastomotic aneurysms after previous open abdominal aortic aneurysm reconstruction.
      • Karaolanis GI
      • Pipitone MD
      • Torsello G
      • et al.
      Endovascular treatment of proximal para-anastomotic aneurysms after previous surgical repair of infrarenal aortic aneurysms by the chimney technique.
      • Katsargyris A
      • Oikonomou K
      • Spinelli D
      • et al.
      Fenestrated and branched stent-grafting after previous open or endovascular aortic surgery.
      • Oikonomou K
      • Katsargyris A
      • Bekkema F
      • et al.
      Fenestrated endografting of juxtarenal aneurysms after open aortic surgery.
      • Reyes A
      • Donas KP
      • Pitoulias G
      • et al.
      Complementary role of fenestrated/branched endografting and the chimney technique in the treatment of pararenal aneurysms after open abdominal aortic repair.
      • Katsargyris A
      • Yazar O
      • Oikonomou K
      • et al.
      Fenestrated stent-grafts for salvage of prior endovascular abdominal aortic aneurysm repair.
      • Marques de Marino P
      • Malgor RD
      • Verhoeven EL
      • et al.
      Rescue of proximal failure of endovascular abdominal aortic aneurysm repair with standard and fenestrated grafts.
      Equally, there are reports on endovascular treatment with FEVAR or BEVAR of failing EVAR demonstrating good clinical outcomes during up to 2-year follow-up with high technical success rates (85–100%), low reintervention rates (15–18%) and low AAA-related mortality (2–4%).
      • Katsargyris A
      • Yazar O
      • Oikonomou K
      • et al.
      Fenestrated stent-grafts for salvage of prior endovascular abdominal aortic aneurysm repair.
      • Marques de Marino P
      • Malgor RD
      • Verhoeven EL
      • et al.
      Rescue of proximal failure of endovascular abdominal aortic aneurysm repair with standard and fenestrated grafts.
      • Wang SK
      • Drucker NA
      • Sawchuk AP
      • et al.
      Use of the Zenith Fenestrated platform to rescue failing endovascular and open aortic reconstructions is safe and technically feasible.
      • Martin Z
      • Greenberg RK
      • Mastracci TM
      • et al.
      Late rescue of proximal endograft failure using fenestrated and branched devices.
      Finally, in a recent systematic review on conversion for failing EVAR, pooled mortality of elective conversion was 2.8%, complication rate was 37% and overall mortality at a mean follow-up of 28 months was 17%.
      • Goudeketting SR
      • Fung Kon Jin PHP
      • Unlu C
      • et al.
      Systematic review and meta-analysis of elective and urgent late open conversion after failed endovascular aneurysm repair.
      When comparing the above results with the current experience of EVAS relining, EVAS relining in the Netherlands resulted in less favorable outcomes (45% complications, 36% reinterventions and overall mortality of 48% at 21 months follow-up). Our group, however, was rather heterogeneous with both acute and elective cases and a variety of indications, rendering a comparison with the studies above complex. The estimated survival in our series was 53% at 2 years, which is low and reflects a patient cohort with severe comorbidities and 29 of 33 patients ASA ≥3. The majority of these patients were judged to be too high-risk for open conversion and potentially even for a fenestrated repair, however the decision to perform EVAS relining could have been based on different criteria in each centre. It is likely that high volume EVAS centres would have been more inclined to offer EVAS relining, while other centres, with usually more extensive experience in fenestrated and branched aortic repair, would have only used this technique if other options, such as complex fenestrated repair was not available. This makes our series a reflection of a real-world experience in EVAS relining.

      Limitations

      Limitations of this study are the small sample size, the heterogeneity of the study population and the heterogenous indications for EVAS relining. The results of our study are definitely influenced by the inclusion of both elective as well as urgent and acute cases and a mixture of infrarenal EVAS relining as well as ch-EVAS relinings. Moreover, despite the multidisciplinary approach in each centre, criteria to perform EVAS relining and not FEVAR or open conversion, would have differed between centres resulting in a selection bias. The patients in our study were treated in high volume centres by experienced vascular surgeons, however not all centres were high volume EVAS centres, therefore the experience with the device would have differed. Finally, the use of EVAS as a secondary procedure was outside the IFU.

      CONCLUSION

      EVAS relining of previous open and endovascular AAA repair in the Netherlands was performed with a high technical success rate in a challenging and heterogeneous patient population. With a median follow-up of 20 months, EVAS relining was associated with a high number of reinterventions, (persistent) endoleaks and continuing aneurysm growth, leading to a 58% clinical success rate. Higher success was reported for EVAS relining of previous open AAA repair compared to relining to rescue a failed EVAR. The high technical success rate argues in favour of EVAS as a secondary approach in patients with failed AAA repair. However, caution is advised due to low clinical success and high reintervention rate. EVAS relining has the potential to be an appropriate technique to treat patients with failed AAA repair. Further development and more research are necessary for this technique to be considered over more established techniques in the future. In patients with failed AAA repair, EVAS relining should only be considered, when established techniques such as fenestrated repair or open conversion are not available or indicated.
      This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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