Background Vascular prosthetic graft infection is a severe complication after open aortic aneurysm repair. Reports of infected endografts are scarce. General treatment consensus with infected graft ...material is that it should be removed completely. The objective of this study was to describe the incidence of endograft infection after endovascular repair of abdominal (EVAR) and thoracic aortic aneurysm (TEVAR) and to report treatment options and their outcome. Methods A retrospective cohort study was performed of patients endovascularly operated for abdominal and thoracic aortic aneurysm in two large hospitals (one tertiary referral center and one large community hospital) between March 1996 and June 2009. Diagnosis of infected endograft was made based on clinical findings, blood tests and cultures, imaging studies (computed tomography, fludeoxyglucose positron emission tomography), and intraoperative findings at reoperation. Results Eleven patients with an infected endograft were identified in 1431 endovascular procedures. One other patient was referred from another hospital. Patients were aged 68 ± 9 years, and all but one were male. The median time from initial TEVAR/EVAR to the diagnosis of infection was 115 days (range, 7-3748 days), with 42% of patients presenting within 3 months after TEVAR/EVAR. Seven patients were diagnosed with endograft infection after elective TEVAR/EVAR and five after emergency TEVAR/EVAR. The incidence was significantly higher in patients that were treated in an emergency setting (0.56% vs 2.79%; P = .002), while there was no significant difference between TEVAR and EVAR procedures (1.37% vs 0.77%). All patients were initially treated with antibiotic therapy, which was complemented with surgical intervention in six patients. In four patients, the infected graft material was completely explanted. Isolated microorganisms included Staphylococcus species (n = 4), Streptococcus species (n = 4), Enterobacter cloacae (n = 1), Escherichia coli (n = 1), Pseudomonas aeruginosa (n = 1), and Listeria monocytogenes (n = 1). Median time of follow-up was 201 days (range, 6-2023 days). During the study period, three out of 12 patients died, of which two were treated conservatively ( P = ns). At their last follow-up visit, seven of nine patients still used antimicrobial therapy. Conclusions The incidence of endograft infection is below 1%, with a mortality rate of 25%. Although consensus is that infected graft material should always be removed, this study shows no significant difference in mortality between the conservatively- and the surgically-managed group, possibly related to the small sample size. There may be a role for conservative treatment in selected cases of patients with an infected endograft.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Objective In this study the first results are presented of a new endovascular technique using covered stents to reconstruct the aortic bifurcation in patients with aortoiliac occlusive disease. With ...the “Covered Endovascular Reconstruction of the Aortic Bifurcation” (CERAB) technique, the anatomy and physiology of the aortic bifurcation is mimicked. Material and methods Between 2009 and March 2014, 103 patients (51 male, 52 female) suffering from obstructive lesions at the level of the aortic bifurcation were treated with CERAB in two clinics. The median age was 61 years (range 36–85 years). Lesion morphology was evaluated by CT angiography. Six TASC-II B lesions, nine TASC-II C lesions, and 88 TASC-II D lesions were treated. Follow up was a median 12 months (range 0–49 months) and consisted of clinical examination, ankle brachial indices, and duplex ultrasound examination. Results Technical success was obtained in 98 procedures (95.1%). In five cases lesions could not be recanalized. Primary patency was 87.3% at 1 year and 82.3% at 2 years, while secondary patency was 95.0% at 1 year and 95.0% at 2 years. Mean ankle brachial indices improved significantly from 0.64 ± 0.21 before to 0.91 ± 014, after the procedure ( p < .001). The overall 30 day complication rate was 23.3%, including 22 minor complications and two major complications (1.9%). There was no 30 day mortality. Median hospital stay was 2 days (range 1–16 days). Conclusions The CERAB technique appears to be a safe and feasible alternative to open surgical reconstruction of the aortic bifurcation in complex occlusive disease. Comparative studies with the current gold standards are indicated.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Isolated iliac artery aneurysms (IAAs), accounting for 2% to 7% of all abdominal aneurysms, are often treated with the use of iliac branched endografts. Although outside the manufacturer's ...instructions for use, iliac branched devices can be used solely, without the adjunctive placement of an endovascular aneurysm repair device, for the treatment of an isolated IAA. In the present study, we have described the outcomes of the use of the Gore iliac branched endoprosthesis (IBE; W.L. Gore & Associates, Flagstaff, Ariz), without the support of an infrarenal endovascular aneurysm repair device, for the exclusion of an isolated IAA. The present study was an international multicenter retrospective cohort analysis.
All the patients who had undergone treatment with a solitary IBE for IAA exclusion from January 11, 2013 to December 31, 2018 were retrospectively reviewed. The primary outcome was technical success. The secondary outcomes included mortality, intraoperative and postoperative complications, and reintervention.
A total of 18 European and American centers participated, with a total of 51 patients in whom 54 IAAs were excluded. The technical success rate was 94.1%, with an assisted technical success rate of 96.1%. No 30-day mortality occurred, with 98.1% patency of the internal and external iliac artery found at 24 months of follow-up. At 24 months of follow-up, 81.5% of the patients were free of complications and 90% were free of a secondary intervention.
Treatment with a solitary IBE is a safe and, at midterm, an effective treatment strategy for selected patients with a solitary IAA.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Abstract Objective The Nellix EndoVascular Aneurysm Sealing (EVAS) System (Endologix, Inc, Irvine, Calif) is a novel approach to abdominal aortic aneurysm (AAA) treatment whereby polymer is used to ...fill the AAA sac. We report 1-year results of the investigational device exemption pivotal trial. Methods Eligible patients were treated at 30 sites in the United States and Europe. Inclusion criteria required an asymptomatic infrarenal AAA, with a neck length ≥10 mm and ≤60° angle, iliac artery blood lumen diameter 9 to 35 mm, access artery diameter ≥6 mm, and serum creatinine ≤2 mg/dL. Follow-up included computed tomography angiography scans at 30 days, 6 months, and 1 year that were evaluated by a core laboratory. The primary safety end point was 30-day major adverse events (MAEs), which were compared with a performance goal of <56% (the Society for Vascular Surgery open repair control group rate). The primary effectiveness end point was treatment success at 1 year, which was compared with a performance goal of >80%. Treatment success required procedural technical success and absence of AAA rupture during follow-up, conversion to open surgical repair, endoleak (type I or III) at 1 year, migration >10 mm causing complications or requiring secondary intervention, aneurysm enlargement, or secondary procedures through 1 year for resolution of endoleak, device obstruction or occlusion, or device defect. Results Of 150 treated patients, 149 (99.3%) completed 1-year follow-up. The MAEs rate at 30 days was 2.7% (95% confidence interval, 0.7%-6.7%), satisfying the primary safety end point (<56%). The 1-year treatment success was 94% (95% confidence interval, 88.6%-97.4%), achieving the primary effectiveness endpoint (>80%). At 1 year, key secondary outcomes included 6.7% MAEs, 4.7% serious device-related events, 1.3% AAA-related mortality, 3.7% secondary interventions, and 0.7% surgical conversions. MAEs through 1 year included death (n = 6), stroke (n = 3), bowel ischemia (n = 2), renal failure (n = 2), respiratory failure (n = 2), and myocardial infarction (n =1). One iatrogenic AAA rupture occurred and one AAA rupture was reported during follow-up. AAA sac enlargement (>5 mm) was 1.5% at 1 year. Endoleaks were present in four patients (3.1%) at 1 year (1 type Ib and 3 type II). Migration >10 mm occurred in three patients (2.3%), but none required secondary intervention. Conclusions Outcomes with this novel endovascular therapy for AAA, the Nellix EVAS System, are encouraging. The primary safety and effectiveness end points have been met. Low morbidity, low mortality, and high procedural and treatment success were achieved despite the inevitability of a learning curve and unique risks associated with a new device and technique. Long-term follow-up is in progress.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Objective In this study, we analyzed the procedural success and early outcome of endovascular treatment of a multicenter cohort of patients with common iliac artery (CIA) aneurysms treated with the ...new GORE EXCLUDER (W. L. Gore & Associates, Flagstaff, Ariz) iliac branch endoprosthesis (IBE). Methods A retrospective cohort analysis was performed in 13 sites in The Netherlands. Anatomic, demographic, procedural, and follow-up data were assessed from hospital records. Results From November 2013 to December 2014, 51 CIA aneurysms were treated with an IBE in 46 patients. The median diameter of the treated aneurysm was 40.5 (range, 25.0-90.0) mm. The mean procedural time was 198 ± 56 minutes. All but one implantation were successful; two type Ib endoleaks were noticed, resulting in a procedural success rate of 93.5%. The two type Ib endoleaks spontaneously disappeared at 30 days. There was no 30-day mortality. Ipsilateral buttock claudication was present in only two cases at 30 days and disappeared during follow-up. The incidence of reported erectile dysfunction was low and severe ischemic complications were absent. After a mean follow-up of 6 months, data on 17 treated aneurysms were available. Two showed a stable diameter, whereas 15 showed a mean decrease of 3.9 ± 2.2 mm ( P < .001). Reinterventions were performed in two patients (7.1%). The 6-month primary patency of the internal component of the IBE device was 94%. Conclusions The use of the GORE EXCLUDER IBE device for CIA aneurysms is related to high procedural success, high patency rates, and low reintervention rates at short-term follow-up. Prospective data with longer follow-up are awaited to establish the role of the device in the treatment algorithm of CIA aneurysms.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Primary antibody deficiencies (PADs) without an identified monogenetic origin form the largest and most heterogeneous group of primary immunodeficiencies. These patients often remain undiagnosed for ...years and many present to medical attention in adulthood after several infections risking structural complications. Not much is known about their treatment, comorbidities, or prognosis, nor whether the various immunological forms (decreased total IgG, IgG subclass(es), IgM, IgA, specific antibody responses, alone or in combination(s)) should be considered as separate, clearly definable subgroups. The unclassified primary antibody deficiency (unPAD) study aims to describe in detail all PAD patients without an identified specific monogenetic defect regarding their demographical, clinical, and immunological characteristics at presentation and during follow-up. In constructing these patterns, the unPAD study aims to reduce the number of missed and unidentified PAD patients in the future. In addition, this study will focus on subclassifying unPAD to support the identification of patients at higher risk for infection or immune dysregulation related complications, enabling the development of personalized follow-up and treatment plans.
We present a protocol for a multicenter observational cohort study using the ESID online Registry. Patients of all ages who have given informed consent for participation in the ESID online Registry and fulfill the ESID Clinical Working Definitions for 'unclassified antibody deficiency', 'deficiency of specific IgG', 'IgA with IgG subclass deficiency', 'isolated IgG subclass deficiency', 'selective IgM deficiency', 'selective IgA deficiency' or 'common variable immunodeficiency' will be included. For all patients, basic characteristics can be registered at first registration and yearly thereafter in level 1 forms. Detailed characteristics of the patients can be registered in level 2 forms. Consecutive follow-up forms can be added indefinitely. To ensure the quality of the collected data, all data will be fully monitored before they are exported from the ESID online Registry for analysis. Outcomes will be the clinical and immunological characteristics of unPAD at presentation and during follow-up. Subgroup analyses will be made based on demographical, clinical and immunological characteristics.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Accurate determination of probable surgical outcomes is fundamental in decision-making regarding appropriate abdominal aortic aneurysm treatment. These outcomes depend, among other factors, on ...patient-related factors such as physical fitness. The primary aim of this study was to evaluate the correlation between physical fitness, measured by the metabolic equivalent of task (MET) score and the five-factor Modified Frailty Index (MFI-5), and all-cause mortality.
Four hundred twenty-nine patients undergoing elective endovascular treatment of an infrarenal aortic aneurysm (EVAR) from January 2011 to September 2018 were identified in an existing local abdominal aortic aneurysm database. Physical fitness was measured by the MFI-5 and the METs as registered during preoperative screening. The primary end point was 1-year all-cause mortality and secondary end points included 5-year all-cause mortality, freedom from aneurysm-related mortality and aneurysm-related reinterventions. Correlations were analyzed using Spearman's rho and survival was analyzed using Kaplan-Meier analyses. The effect of physical fitness on mortality was assessed by binary logistics regression analyses.
There was a positive correlation between the MFI-5 and 1-year all-cause mortality (Rho = 0.163; P = .001), but not between the METs and 1-year all-cause mortality (Rho = –0.083; P = .124). A significant correlation between both MFI-5 and METs and 5-year all-cause mortality was observed (Rho = 0.255; P < .001 and Rho = –0.154; P = .004). When stratified by the MFI-5, the 1- and 5-year follow-up survival rates were 95.1% and 85.9%, respectively, in the group with the lowest MFI-5 and 74.5% and 33.1% in the group with the highest MFI-5 score (P = .007 and P < .001). When stratified by METs categories for 1-year follow-up, no significant differences in survival between the groups were observed (P = .090). The 5-year follow-up survival rate was 39.4% in the lowest METs category and 76.3% in the highest METs category (P = .039). Logistic regression analysis, assessing the impact of age, sex, METs, and the MFI-5 on the risk of all-cause mortality, showed that only age and the MFI-5 made a significant contribution.
There is a significant positive association between the MFI-5 and both the 1- and 5-year all-cause mortality rates after EVAR; METs only correlated with the 5-year all-cause mortality. Only age and the MFI-5 contributed to predicting overall survival after EVAR; therefore, it could be recommended to add the MFI-5 for guidance in preoperative counselling.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Objective Despite improvements in endograft devices, operator technique, and patient selection, endovascular repair has not achieved the long-term durability of open surgical aneurysm repair. ...Persistent or recurrent aneurysm sac flow from failed proximal sealing, component failure, or branch vessel flow underpins a significant rate of reintervention after endovascular repair. The Nellix device (Endologix, Irvine, Calif) employs a unique design with deployment of polymer-filled EndoBags surrounding the endograft flow lumens, sealing the aneurysm sac space and potentially reducing complications from persistent sac flow. This retrospective analysis represents the initial experience in consecutive patients treated with the device in real-world practice. Methods This study was performed at six clinical centers in Europe and one in New Zealand during the initial period after commercialization of the Nellix device. Patients underwent evaluation with computed tomography and other imaging modalities following local standards of care. Patients were selected for treatment with Nellix and treated by each institution according to its endovascular repair protocol. Clinical and imaging end points included technical success (successful device deployment and absence of any endoleak at completion angiography), freedom from all-cause and aneurysm-related mortality, endoleak by type, limb occlusion, aneurysm rupture, and reintervention. Results During a 17-month period, 171 patients with abdominal aortic aneurysms were treated with the Nellix device and observed for a median of 5 months (range, 0-14 months). The 153 male and 18 female patients with mean age of 74 ± 7 years had aneurysms 61 ± 9 mm in diameter with an average infrarenal neck length of 28 ± 15 mm and infrarenal angulation of 37 ± 22 degrees. Technical success was achieved in all but two patients (99%); one patient had a type Ib endoleak and another had a type II endoleak. Through the last available follow-up, type Ia endoleak was observed in five patients (3%), type Ib endoleak in four patients (2%), and type II endoleak in four patients (2%). There were eight limb occlusions (5%), among which seven were evident at the 1-month follow-up visit. Aneurysm-related reinterventions were performed in 15 patients (9%). There were no aneurysm ruptures or open surgical conversions. Conclusions This first multicenter postmarket report of the Nellix device for infrarenal abdominal aortic aneurysm repair demonstrates satisfactory results during the initial learning phase of this new technology. The rate of aneurysm exclusion was high, and frequency of complications was low. More definitive conclusions on the value of this novel device await the results of the ongoing Nellix EVAS FORWARD Global Registry and the EVAS FORWARD investigational device exemption trial.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
The objective of this study was to demonstrate the 3-year outcome of the covered endovascular reconstruction of the aortic bifurcation (CERAB) technique for the treatment of extensive aortoiliac ...occlusive disease (AIOD).
Between February 2009 and July 2016, all patients treated with the CERAB technique for AIOD were identified in the local databases of two centers and analyzed. Demographics and lesion characteristics were scored. Follow-up consisted of clinical assessment, duplex ultrasound, and ankle-brachial indices. Patency rates and clinically driven target lesion revascularization were calculated by Kaplan-Meier analysis.
Of 130 patients (69 male and 61 female) treated, 68% were diagnosed with intermittent claudication and 32% suffered from critical limb ischemia. The majority (89%) were TransAtlantic Inter-Society Consensus II D lesions, and the remaining were B and C lesions (both 5%). Median follow-up was 24 months (range, 0-67 months). The technical success rate was 97%, and 67% of cases were performed completely percutaneously. The ankle-brachial index improved significantly from 0.65 ± 0.22 preoperatively to 0.88 ± 0.15 after the procedure. The 30-day minor and major complication rate was 33% and 7%. The median hospital stay was 2 days (range, 1-76 days). At 1 year and 3 years of follow-up, 94% and 96% of the patients clinically improved at least one Rutherford category (2% and 0% unchanged, 4% and 4% worsened). Limb salvage rate was 98% at 1 year and 97% at 3 years of follow-up. Primary, primary assisted, and secondary patency was 86%, 91%, and 97% at 1 year; 84%, 89%, and 97% at 2 years; and 82%, 87%, and 97% at 3 years. Freedom from clinically driven target lesion revascularization was 87% at 1-year follow-up and 86% at both 2-year and 3-year follow-up.
The CERAB technique is a safe and feasible technique for the treatment of extensive AIOD with good 3-year results regarding patency and clinical improvement.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Objective The Nellix EndoVascular Aneurysm Sealing system (Endologix, Inc, Irvine, Calif) is a novel approach to abdominal aortic aneurysm (AAA) endovascular repair whereby biocompatible polymer is ...employed to exclude and to seal the AAA sac. We report 30-day results of the U.S. pivotal trial. Methods Consecutive, eligible, consenting patients were enrolled at 29 sites in the United States and Europe. Inclusion criteria required an asymptomatic infrarenal AAA, with aortic neck length ≥10 mm and angle to the sac ≤60 degrees, aortic neck diameter of 18 to 32 mm, aneurysm blood lumen diameter ≤6 cm, common iliac artery lumen diameter of 9 to 35 mm, access artery diameter ≥6 mm, and serum creatinine level ≤2 mg/dL. Follow-up at 30 days included clinical assessment and computed tomography angiography evaluation of endoleaks and device integrity as assessed by a core laboratory. The primary safety end point is the incidence of independently adjudicated 30-day major adverse events (MAEs), with success defined as superiority with reference to the Society for Vascular Surgery open repair control group (56%). Results Between January and November 2014, 150 trial patients having a mean AAA diameter of 5.8 cm were enrolled and treated with the Nellix system with 100% procedural success. One early death (0.7%) occurred secondary to multisystem organ failure. All 149 surviving patients completed 30-day follow-up. There were no aneurysm ruptures, conversions, limb thromboses, stent fractures, or stent kinking. Five early MAEs occurred in four patients (2.7%) and included one death, bowel ischemia (1), renal failure (2), and respiratory failure (1). One (0.7%) secondary intervention to treat inadvertent coverage of a renal artery was performed. The core laboratory identified nine (6%) endoleaks (one type I, eight type II) on 30-day computed tomography angiography. Freedom from MAE was 97.3% (95% confidence interval, 93.3%-99.0%). Conclusions In selected patients, perioperative outcomes with the Nellix system for endovascular aneurysm sealing are encouraging, with very low 30-day morbidity and mortality and high procedural success. The primary safety end point has been achieved. Longer term follow-up is in progress.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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