Revascularization with BYCROSS atherectomy device- protocol of a prospective multicenter observational study.

BACKGROUND: The BYCROSS™ device is a novel device intended for use in atherectomy of the peripheral arterial disease (PAD). With the BYCROSS™ atherectomy system, also prolonged calcifying lesions can be treated in a minimally invasive manner, which was previously reserved for bypass surgery. The aim of this study is to collect additional clinical data on safety and performance of the BYCROSS™ from patients undergoing revascularization of severely stenotic or occluded peripheral arterial vessels with the BYCROSS™. METHODS AND DESIGN: This is an investigator-initiated national prospective multicenter observational study in patients with PAD. Sixty patients (20 per center) with PAD with stenosis higher than 80% or complete occlusion (de novo or recurrent stenosis) of vessels below the aortic bifurcation (min 3 mm vessel diameter) will be recruited. Three vascular surgery centers are participating in the study. The primary efficacy endpoint is procedural success, defined as passage of the occlusion through the BYCROSS device, and safety outcomes, explicated as freedom from device-related serious adverse events (SADEs). Secondary endpoints include primary and secondary patency rates, change in Rutherford classification, and freedom from amputation at 3 and 12 months. DISCUSSION: The BYCROSS atherectomy system may be a novel device for the minimally invasive treatment of prolonged calcified lesions previously reserved for bypass surgery. This national prospective multicenter observational study could represent another step in demonstrating the efficancy and safety of this device for treatment of PAD. TRIAL REGISTRATION: #DRKS00029947 (who.int). PROTOCOL APPROVAL ID: #22-0047(Ethics Committee at Ludwig-Maximilians-University Munich).

German nation-wide in-patient treatment of abdominal aortic aneurysm-trends between 2005 and 2019 and impact of the SARS-CoV-2 pandemic.

PURPOSE: Aim of this study was to analyze hospitalizations due to ruptured and non-ruptured abdominal aortic aneurysms (rAAA, nrAAA) in Germany between 2005 and 2021 to determine long-term trends in treatment and the impact of the SARS-CoV-2 pandemic. MATERIALS AND METHODS: Fully anonymized data were available from the research data center (RDC) of the German Federal Statistical Office (Destatis). All German hospitalizations with the ICD-10 code "I71.3, rAAA" and "I71.4, nrAAA" in 2005 and 2010-2021 were analyzed. RESULTS: We report data of a total of 202,951 hospitalizations. The number of hospitalizations increased from 2005 to 2019 (14,075 to 16,051, + 14.0%). The rate of open repair (OR) constantly decreased, whereas the rate of endovascular aortic repair (EVAR) increased until 2019. During the pandemic, the number of hospitalizations due to nrAAA dropped from 13,887 (86.5%) in 2019 to 11,278 (85.0%) in 2021. The strongest decrease of hospitalizations for AAA was observed during the first wave of the SARS-CoV-2-pandemic in spring 2020 (-25.5%). CONCLUSION: Over the past decades, we observed an increasing number of hospitalizations due to AAA accompanied by a shift from OR to EVAR especially for nrAAA. During the lockdown measures due to the SARS-CoV-2-pandemic, a decrease in hospitalizations for nrAAA (but not for rAAA) was shown in 2020 and furthermore in 2021 with no rebound of treatment of nrAAA suggesting an accumulation of untreated AAA with a potentially increased risk of rupture.

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

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

Technical aspects of percutaneous endovascular arteriovenous fistula creation with the Ellipsys® Vascular Access System. Preliminary results after 16 patients.

PURPOSE: Technical aspects are crucial for planning and performing endovascular arteriovenous fistula (AVF) creation. The Ellipsys® Vascular Access System represents a minimal invasive method for the creation of a proximal forearm fistula. This report summarizes the essential elements for AVF creation with the Ellipsys® Vascular Access System and investigates feasibility, efficacy, and safety procedures conducted on 16 patients. MATERIALS AND METHODS: We performed a retrospective analysis of patients who underwent endovascular AVF creation with the Ellipsys® Vascular Access System between May 2020 and March 2022 at a tertiary referral center. RESULTS: The median age was 67.5 years (47-86 years). The mean BMI was 31.4 kg/m2. AV fistula was created on 15/16 patients on their left arm. The technical success was 100%. The mean operation time was 24.2 min. There were no complications associated with the procedure. All patients were examined after 30 days (± 5 days). Primary patency after 30 days was 94% (15/16). The mean fistula flow was 681.1 mL/min and the mean AVF diameter was 6.1 mm. Thirteen out of 15 patients met the criteria for potential hemodialysis. CONCLUSION: With the Ellipsys Vascular Access System exist an additional possibility of an AV fistula creation. Based on above findings, the Ellipsys® Vascular Access System represents a feasible, safe, and effective method for AVF creation.

Iatrogenic injury of the popliteal artery in orthopedic knee surgery: clinical results and development of a therapeutic algorithm.

PURPOSE: Intraoperative injury to the popliteal artery is a rare complication of orthopedic surgery, however, it can have serious consequences, including major amputation. Recommendations for a standard approach are lacking. The aim of this study was to develop an interdisciplinary therapeutic algorithm to assist in complication management. METHODS: From 01/11 to 12/20, 16 arterial injuries after knee surgery were analyzed in a retrospective single-center study. Four cases involved recurrent orthopedic surgery. Procedures performed included eleven total knee arthoplasties (TKA), two TKA replacements, one arthroscopy, and two high tibial osteotomies. Clinical presentation of patients was hemorrhage (n = 2), ischemia (n = 7), the combination of both (n = 4), or pseudoaneurysm formation (n = 3). RESULTS: Ten patients underwent endovascular treatment, some as combined procedures: (stent)-PTA (n = 6), aspiration thrombectomy (n = 5), thrombin injection (n = 1), and embolization (n = 1). Six patients were treated surgically: four with bypass/interposition and one with a patch plasty and one as a hybrid procedure, respectively. Only autologous great saphenous vein was used. All extremities could be preserved. Functional impairment remained in six cases. CONCLUSION: Both endovascular and surgical procedures can be used to treat arterial injuries after knee surgery. Efficient standardized diagnosis and the involvement of vascular expertise are essential to prevent functional impairment or limb loss, as suggested in the algorithms.

[Deep Vein Thrombosis in Intensive Care Patients with COVID-19 Infection - Impact of a Standardised Therapeutic Regimen]. / Tiefe Beinvenenthrombosen bei Intensivpatienten mit COVID-19-Infektion ­ Einfluss eines standardisierten Therapieregimes.

BACKGROUND AND OBJECTIVES: It has been reported that the risk of deep vein thrombosis is greater in patients with COVID-19 infection. We have now investigated whether a standardised therapy can reduce the risk of DVT. MATERIALS AND METHODS: After establishing standard therapy with anticoagulation, steroids and convalescent plasma, we screened 20 patients with COVID-19 pneumonia for DVT by ultrasound examination. The comparison group contained 20 COVID patients with inconsistent therapy, who were examined for the presence of thrombosis during the first wave. RESULTS: In the current patient population with standard therapy, we could not detect any thrombosis, and in the prior patients group only 25% of patients developed DVT. Pulmonary embolism was found in one patient in the first cohort and two in the second. CONCLUSION: The risk of DVT could be reduced through anticoagulation, and administration of steroids and convalescent plasma. The specific significance of the individual components has not yet been clarified. Since bleeding is a rarely observed in SARS-CoV-2 infections, a generous indication for anticoagulation seems to be justified.

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

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

[Increased risk of deep vein thrombosis in intensive care unit patients with CoViD-19 infections?-Preliminary data]. / Erhöhtes Risiko für tiefe Beinvenenthrombosen bei Intensivpatienten mit CoViD-19-Infektion? ­ Erste Daten.

BACKGROUND: The incidence of deep vein thrombosis (DVT) in CoViD-19 patients in intensive care units (ICU) has so far been investigated in only a few studies. Prospective comparative studies with non-CoViD-19 ICU patients are completely lacking. OBJECTIVE: Evaluation of the incidence of DVT in ICU patients with CoViD-19 compared to non-CoViD-19 ICU patients who were treated in the University Hospital Augsburg during the same period. In addition, the aim was to investigate what type of anticoagulation was present in CoViD-19 patients at the time the DVT occurred and to what extent DVT is associated with increased mortality in this patient population. MATERIAL AND METHODS: In this prospective single center study, which was conducted between 18 April 2020 and 30 April 2020, 20 SARS-CoV2 positive patients were compared with 20 non-CoVid-19 patients in the ICU with respect to the occurrence of DVT. For this purpose, demographic data, laboratory parameters, and clinical outcomes were recorded and evaluated. RESULTS: The rate of DVT in the investigated patient collective was markedly higher in patients with SARS-CoV2 (CoViD-19 patients 20% vs. non-CoViD-19 patients 5%). Both DVT and elevated D­dimer levels were associated with increased mortality in the present study. CONCLUSION: We recommend the determination of D­dimer levels and, in the case of elevated levels, the broad indication for compression sonography of the deep leg veins on admission of patients with suspected or confirmed SARS-CoV2. In this way DVT in the setting of CoViD-19 can be recognized early and therapeutic anticoagulation can be started. All inpatient CoViD-19 patients should receive thrombosis prophylaxis with low molecular weight heparin. Further studies on point of care methods (TEG®, ROTEM®) for the detection of hypercoagulability in SARS-CoV2 are necessary.

Preliminary outcome of Nellix-in-Nellix extensions in patients treated with failed endovascular aneurysm sealing.

BACKGROUND: The 1-year results of the use of the Nellix (Endologix Inc, Irvine, Calif) endovascular aneurysm sealing (EVAS) device were initially promising. However, midterm complications including migration and aneurysm growth occurred more frequently than expected, which provided an incentive to refine the instructions for use. Strategies for the management of complications arising after endovascular aneurysm repair are often not applicable for EVAS, given the unique configuration of the Nellix device, and new techniques are needed. This study analyzes the clinical outcomes of both elective and emergency deployment of a new Nellix device within a primarily placed device, for failure of EVAS, which we refer to as a Nellix-in-Nellix application (NINA). METHODS: This is a global, retrospective, observational cohort study focusing on the early outcome of NINA for failed EVAS, including data from 11 European institutions and 1 hospital in New Zealand. RESULTS: A total of 41 patients were identified who underwent a NINA procedure. Of these, 32 (78%) were placed electively and 9 (22%) were placed on an emergency basis. Seven patients were initially treated with chimney EVAS (n = 5 in the elective NINA group and n = 2 in the emergency NINA group). The average time between the primary EVAS procedure and NINA was 573 days (interquartile range, [IQR] 397-1078 days) and 478 days (IQR, 120-806) for the elective and emergency groups, respectively. The indication for elective NINA was endoleak with migration (50%), endoleak without migration (25%), migration without endoleak (16%), and other (9%). Chimney grafts were used in 21 of 32 patients in the elective group and 3 of 9 patients in the emergency group. Technical success was achieved in 94% of patients in the elective group and 100% of patients in the emergency group. At latest follow-up (median, 104 days; IQR, 49-328 days), there were three aneurysm-related deaths (9%), no ruptures, and five device-related reinterventions (16%) within the elective group. In the emergency group (median follow-up, 23 days; IQR, 7-61 days), there were four aneurysm-related deaths and three aneurysm-related reinterventions. CONCLUSIONS: In conclusion, a NINA can be used to treat late failures of EVAS with an acceptable technical success rate and can be used when more established treatment options are unfeasible or contraindicated. The durability of this technique needs to be further reviewed.

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

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

Early Experience With Endovascular Aneurysm Sealing in Combination With Parallel Grafts for the Treatment of Complex Abdominal Aneurysms: The ASCEND Registry.

PURPOSE: To report the results of the ASCEND Registry of cases involving endovascular aneurysm sealing (EVAS) in combination with chimney grafts (chEVAS) for the treatment of para- and juxtarenal aortic aneurysms (AAA). METHODS: A retrospective, multicenter registry established in 8 vascular centers between 2013 and 2016 recorded the treatment results and follow-up of chEVAS procedures for nonruptured AAAs; data were analyzed using standardized outcome measures. In the observation period, 154 patients (mean age 72.3±7.7 years; 124 men) underwent elective treatment for de novo juxtarenal and pararenal aneurysms and formed the study group. RESULTS: Sixty-two (40.3%) of the cohort were treated using a single parallel graft, 54 (35.1%) with double chimneys, 27 (17.5%) with triple chimneys, and 11 (7.1%) with 4 chimneys. The 30-day mortality was 2.8%, and there were 4 perioperative strokes (1 fatal). At 1 year, the freedom from all-cause mortality was 89.8% and the freedom from aneurysm-related mortality was 94.3%. There were 3 endoleaks within 90 days of the procedure, one type Ia and 2 type Ib. The freedom from type Ia endoleaks was 95.7% at 1 year. There were no types II or III endoleaks in this series; the freedom from all endoleaks was 94.2% at 1 year. Freedom from reintervention at 1 year was 89.2%. Target vessel patency rates at 1 year were 97.7%, 99.3%, 100%, and 100% for the left renal, right renal, superior mesenteric artery, and celiac axis stents, respectively. CONCLUSION: The ASCEND Registry supports a proof of concept for the use of polymer technology and EVAS with parallel grafts in managing patients with complex aortic disease. The future role of chEVAS will be defined by studies that assess mid- to long-term durability.

Anatomical Applicability of Endovascular Aneurysm Sealing Techniques in a Consecutive Cohort of Fenestrated Endovascular Aneurysm Repairs.

PURPOSE: To determine how many endovascular aneurysm sealing (EVAS) procedures with/without off-label use of chimneys (ChEVAS) could have been performed in a cohort of patients who had undergone fenestrated endovascular aneurysm repair (FEVAR). METHODS: Sixty patients (median age 76.3 years; 54 men) who underwent FEVAR in our institution between 2013 and 2015 were selected for the study. The median aneurysm diameter was 62.0 mm (interquartile range 59.3, 69.0). Preoperative computed tomography angiograms (CTA) were anonymized and sent to 2 physicians with experience of more than 40 ChEVAS interventions. These ChEVAS planners were blinded to the study purpose and asked to agree upon an EVAS/ChEVAS plan. The primary outcome was the percentage of the FEVAR patients in whom an EVAS/ChEVAS was technically possible. The secondary outcomes were a comparison of seal zones, number of target vessels, and device cost. RESULTS: An EVAS-based intervention would have been technically possible in 56 (93.3%) of the FEVAR patients. The median proximal aortic seal zone was significantly more distal in the EVAS/ChEVAS procedures vs the FEVAR cases (zone 8 vs zone 7, p<0.001) and fewer target vessels were involved (median 2 vs 3, p<0.001). The cost of the EVAS/ChEVAS device was 66% of the FEVAR device. Planners would not currently advocate an EVAS-based intervention in 43 (76.8%) of these 56 patients due to concerns regarding the risk of migration associated with the lumen thrombus ratios observed. CONCLUSION: EVAS is technically feasible in the majority of patients undergoing FEVAR in our institution but currently advocated in only 23.2%. The seal zone was more distal, fewer target vessels were involved, and the device cost was lower in the planned EVAS/ChEVAS interventions.

Endovascular Aneurysm Sealing (EVAS) and Chimney EVAS in the Treatment of Failed Endovascular Aneurysm Repairs.

PURPOSE: To assess the technical success and clinical outcome of reinterventions using the Nellix Endovascular Aneurysm Sealing (EVAS) System to treat complications after endovascular aneurysm repair (EVAR). METHODS: Fifteen consecutive patients (mean age 79 years; 14 men) with prior EVAR were treated with EVAS between March 2014 and December 2015 at 2 institutions. The failed prior EVARs included 13 bifurcated endografts, 1 bifurcated graft plus fenestrated cuff, and 1 tube endograft. Endoleaks were the predominant indications: type Ia in 10 and type III in 5 (3 type IIIa and 2 type IIIb). All patients presented with progressive aortic aneurysms (median 7.85-cm diameter; range 6.5-11). Eight patients were treated on an urgent or emergency basis (6 symptomatic aneurysms and 2 contained ruptures). All patients underwent Nellix relining of the failed stent-graft; 10 had chimney (Ch) procedures in combination with EVAS (chEVAS) because the proximal landing zones were inadequate. RESULTS: Technical success was 100%. All endoleaks were successfully sealed, and no additional intervention was required. No further endoleak after EVAS or chEVAS was recorded. Endobag protrusion occurred in 1 case without sequelae. One elderly patient with ruptured aneurysm died from multiple organ failure 2 months postoperatively. One renal artery guidewire injury led to nephrectomy because of active bleeding. No reinterventions, aneurysm-related mortalities, graft thrombosis, endoleaks, or chimney graft occlusions were observed during a median follow-up of 8 months (range 3-24). CONCLUSION: The present preliminary experience demonstrates that the use of EVAS/chEVAS is feasible for treatment of failed EVAR. This technique may be used as bailout or an alternative treatment when other established methods are infeasible or not available.

Treating iliac aneurysm using the Nellix Endovascular Sac Sealing System.

As endovascular treatment of abdominal aortic aneurysms has become established, there has been growing focus on treatment of the aneurysmal iliac artery. Isolated, large iliac aneurysms >30 mm pose a risk of rupture, but, in addition, 20% to 30% of abdominal aortic aneurysms are associated with iliac aneurysmal dilatation, which can compromise long-term outcomes. Endovascular solutions are evolving and until recently have utilized standard stent graft technology. The endovascular aortic sealing system was introduced as a new, effective method for the treatment of infrarenal aortic aneurysms. In this article, we present our recent extended use of the Nellix system, with or without a combination of adjuvant endovascular techniques, in the treatment of 84 common iliac artery aneurysms. The results support the use of endovascular aortic sealing system in endovascular therapy for aneurysmal iliac pathologies. Different endovascular sealing techniques for the treatment of common iliac artery aneurysms, re-interventions, and extended follow-up are also discussed.

Initial Experience in the Treatment of Extensive Iliac Artery Aneurysms With the Nellix Aneurysm Sealing System.

PURPOSE: To assess the feasibility and effectiveness of the Nellix prosthesis in the treatment of common iliac artery aneurysms. METHODS: Between May 2013 and June 2015, 230 patients underwent implantation of the Nellix device at 2 institutions. Fifty of these patients (mean age 76 years; 35 men) were identified as having 60 common iliac artery aneurysms (CIAAs) with a median diameter of 4 cm (range 3.5-7). The majority of patients had aortoiliac aneurysms (5, 70%), 10 (20%) had isolated CIAAs, and 5 (10%) had iliac anastomotic aneurysms after aortoiliac bypass. In 20 patients, the iliac aneurysm was the indication for the intervention; in the other 30 patients, the endovascular iliac repair was an adjunct procedure to endovascular aneurysm sealing (EVAS). An iliac branch device (IBD) was used when feasible to preserve flow to the internal iliac artery. RESULTS: Seventeen (34%) patients underwent elective implantation of the Nellix graft in combination with an IBD, 33 (66%) patients underwent Nellix sealing of the CIAA using 1 (n=5), 2 (n=22), or 3 Nellix grafts (2 bilateral grafts and 1 graft as an extension to the external iliac artery in 6 patients). The technical success rate was 100%, and no graft-related complications were reported postoperatively. No buttock claudication, reinterventions, graft thrombosis, or endoleaks were observed during a mean follow-up of 12 months. CONCLUSION: Our initial experience demonstrates that Nellix grafts are feasible and safe for the treatment of extensive iliac artery aneurysms. The long-term durability of these grafts should be validated in larger patient cohorts before this promising alternative endovascular technique can gain widespread acceptance.

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

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