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Back to Journal »Medical Devices: Evidence and Research» Volume 12

Nellix Endovascular Aneurysm Sealing System: Current Prospects

Author Choo XY, Hajibandeh S, Hajibandeh S, Antoniou GA 

The 2019 volume will be published on February 19, 2019: 12 pages 65-79

DOI https://doi.org/10.2147/MDER.S155300

Single anonymous peer review

Editor approved for publication: Dr. Scott Fraser

Xin Y Choo,1 Shahab Hajibandeh,1 Shahin Hajibandeh,1 George A Antoniou1,2 1 Vascular and Endovascular Surgery, Royal Oldham Hospital, Pennine Acute Hospital NHS Trust, Manchester, UK; 2 Cardiovascular Medicine, University of Manchester Medical School, UK Science background: The Nellix Endovascular Aneurysm Sealing (EVAS) system is a new method for the treatment of abdominal aortic aneurysms (AAA). We aim to evaluate the efficacy of EVAS in the management of AAA patients. Materials and methods: We searched PubMed/MEDLINE, CINAHL, and bibliography to find studies reporting the clinical results of Evas treatment using the Nellix device in asymptomatic, unruptured AAA patients. We combined the dichotomous outcome data using a random effects model. Results: We identified 14 single-arm observational studies, reporting a total of 1,510 patients. The aggregate estimate of technical success is 99% (95% CI = 98-100; heterogeneity: P=0.869, I2=0%). 39% of patients underwent auxiliary surgery (95% CI = 19-63; heterogeneity: P<0.0001, I2=88%). Two cases of aneurysm rupture were reported within 30 days after treatment (0.7%, 95% CI = 0.3-1.6; heterogeneity: P=0.923, I2=0%), and another 5 cases of rupture occurred during follow-up (0.8%, 95%). % CI =0.4-1.6; heterogeneity: P=0.958, I2=0%). The combined estimates of early (within 30 days) and late (during follow-up) type I endoleaks are 2.8% (95% CI =1.8–4.2; heterogeneity: P=0.254, I2=18%) and 1.9% (95%) ) CI = 1.3-2.8; heterogeneity: P=0.887, I2=0%). 3.1% (95% CI =1.8-5.4; heterogeneity: P=0.419, I2=0%) and 2.1% (95% CI =0.8-5.3; heterogeneity: P=0.004, I2=65%). The early and late reintervention rates were 2.7% (95% CI =1.7-4.2; heterogeneity: P=0.183, I2=27%) and 3.5% (95% CI =2.3-5.5; heterogeneity: P= 0.061, I2=42%), respectively. The pooled estimate of 30-day mortality was 1.5% (95% CI = 0.9-2.6; heterogeneity: P=0.559, I2=0%), and the pooled estimate of aneurysm-related death during follow-up was 1.0% (95% CI = 0.6-1.9; heterogeneity: P=0.872, I2=0%). Conclusion: The results reported by EVAS are acceptable. Type I endoleaks, sac enlargement, device displacement, and aneurysm rupture are recognized complications. High-level research is needed to investigate the potential advantages of EVAS over traditional treatments. Keywords: intravascular aneurysm closure, Nellix, aortic aneurysm, EVAS, AAA, endovascular aneurysm repair, EVAR

The Nellix system (Endologix Inc., Irvine, CA, USA) for endovascular aneurysm closure (EVAS) is a new method for the treatment of abdominal aortic aneurysms (AAA), which is conceptually different from endovascular aneurysm repair ( EVAR). 1 EVAR is developing rapidly in 2,3 technology and equipment, and its application range has been significantly expanded. 4,5

EVAR surgery involves a stent graft, which is designed to exclude aneurysms from the systemic circulation. The stent is made of a metal skeleton and covered with polytetrafluoroethylene (PTFE) or polyester fabric to keep the stent impermeable. Use the fluoroscopy guide to push the device through the femoral artery to the aneurysm, and then deploy it. Isolate the aneurysm by sealing the proximal and distal ends of the aneurysm to prevent subsequent rupture. 6

The Nellix device is designed to seal and eliminate the aneurysm cavity. 1 It consists of two balloon expandable stents to support the aortic flow channel. The system is introduced into the aorta in a manner similar to EVAR; using a guide wire, the system enters the aorta through the femoral artery. The catheter sheath is then pulled back and the device expanded from the proximal end of the non-aneurysmal aorta to the distal iliac artery is deployed. The PTFE-based non-porous inner bag will then be filled with a biocompatible polyethylene glycol polymer, which can be adjusted to fit the aneurysm sac cavity. This allows the aneurysm to be sealed and prevents displacement. 1

EVAS aims to overcome the shortcomings of EVAR and provide better clinical results. The Nellix device has recently received European CE mark approval and is currently monitoring its efficacy. 7 We aim to conduct a comprehensive literature search and systematic review of published evidence to evaluate the efficacy of EVAS in the management of patients with AAA.

A preset plan for the goals and methods of the current system review has been formulated. We report this system evaluation based on the PRISMA statement standard.

Study selection and eligibility criteria for patient inclusion

Outcome parameters include technical success, operation time, fluoroscopy time, need for auxiliary surgery, mortality, postoperative complications, AAA rupture, endoleak, device displacement, capsule expansion, re-intervention and hospital stay.

The studies included in this review were identified through a focused search of the electronic databases PubMed/MEDLINE and CINAHL. The key words used are "Nellix" and "intravascular aneurysm seal". The last search was conducted in April 2018. We also searched the bibliographic list of related articles and reviews to obtain further studies that may be eligible. Finally, we manually searched the following leading journals in the field of Vascular and Endovascular Surgery: Journal of Vascular Surgery, European Journal of Vascular and Endovascular Surgery and Journal of Endovascular Therapy.

We created an electronic data extraction spreadsheet, conducted a pilot test on randomly selected articles, and adjusted accordingly. Our data extraction spreadsheet contains the following information:

The two authors independently collected and recorded data in the data extraction spreadsheet. Disagreements are resolved through discussion. If no agreement can be reached, the third author is consulted.

We use simple descriptive statistics to present demographic and clinical data. We used the method of converting from median to mean recommended by Hozo et al. 38 We used meta-analysis of data from individual studies to aggregate the classification results of the entire evaluation population. The combined ratio is calculated as the reverse conversion of the weighted average of the conversion ratio. We anticipated considerable heterogeneity between clinical studies, so a random effects model was applied. We combined Cochran's Q (χ2) test and I2 statistic to check the heterogeneity. We used comprehensive meta-analysis software (Biostat, Englewood, NJ, USA).

A total of 634 articles were retrieved from the electronic database search (Figure 1). After evaluating the title and abstract, 395 articles were excluded because they were not related to the subject of the study. After further evaluation, 201 articles were excluded. Obtained the full texts of the remaining 38 articles and evaluated their qualifications. 14 studies met the inclusion criteria of our study and were included in qualitative and quantitative synthesis. 8-21

Figure 1 shows the flow chart of the literature search strategy.

Table 1 lists information related to the research. Table 2 summarizes the baseline demographic and clinical characteristics of the study population. All 14 articles are single-arm observational studies, published after 2011. With the exception of one study, the recruitment period for all studies was 1 year or longer. 17 Four studies 10, 12, 13, 16 reported 1-year results, while the remaining studies reported longer follow-up results. The weighted average follow-up time of 8,9,11,14,15,18-21 was 11.6±5.4 months. Nine studies 8,9,11,13,16-19,21 are multi-center studies, and the remaining five are single-center studies. 10,12,14,15,20

Note: The data reported in Table 2-6 is the result of the cohort in accordance with IFU 2013.

Abbreviations: AAA, abdominal aortic aneurysm; CI, contraindications; CT, computed tomography; CVA, cerebrovascular accident; EVAS, intravascular aneurysm closure; IFU, instructions for use; M, multicenter; MI, myocardial infarction ; NR, not reported; P, quasi; R, review; S, single.

Table 2 Baseline demographic and clinical characteristics of the study population​​

Abbreviations: AR, arrhythmia; ASA, American Association of Anesthesiologists classification of physical conditions; CAD, coronary artery disease; CHF, congestive heart failure; CKD, chronic kidney disease; cardiovascular disease, cerebrovascular disease; DM, diabetes; HTN, high Blood pressure; MI, myocardial infarction; NR, not reported.

Note: aMean ± SD (range). b These data are reported as median with range and/or IQR. The values ​​shown in the table are the average values ​​after converting the median to an average value using the method suggested by Hozo et al. 38

Abbreviations: IFU, instructions for use; NR, not reported.

Note: Unless otherwise specified, aMean ± SD (range). b These data are reported as median with range and/or IQR. The values ​​shown in the table are the average values ​​after converting the median to an average value using the method suggested by Hozo et al. 38

Abbreviations: GA, general anesthesia; LA, local anesthesia; NR, not reported; RA, regional anesthesia; T1RF, type 1 respiratory failure.

Table 5 Early clinical results (within 30 days)

Note: Unless otherwise specified, aMean ± SD (range). b These data are reported as median with range and/or IQR. The values ​​shown in the table are the average values ​​after converting the median to an average value using the method suggested by Hozo et al. 38

Table 6 Late clinical results (during follow-up)

Note: Unless otherwise specified, aMean ± SD (range). b These data are reported as median with range and/or IQR. The values ​​shown in the table are the average values ​​after converting the median to an average value using the method suggested by Hozo et al. 38

Abbreviations: CT, computed tomography; CTA, computed tomography angiography; NR, not reported.

The included studies reported a total of 1,510 asymptomatic, unruptured AAA patients using Nellix equipment for Evas treatment. The weighted average age of the included patients was 74 ± 2 years, and 89% of the patients were male. Hypertension is the most common comorbidity (74%), followed by heart disease (coronary artery disease 40%, myocardial infarction 28%, arrhythmia 21%, angina 19%, congestive heart failure 8%), respiratory diseases ( 32%), kidney disease (19%), diabetes (17%) and cerebrovascular disease (12%). 58% of patients smoked.

The inclusion criteria vary from study to study. Table 1 summarizes the specific inclusion criteria for each selected study. Van Sterkenburg et al. described the results of Evas in patients with related iliac artery occlusive disease using the Nellix device. 15 Youssef et al. studied the results of Evas using Nellix for endoprostheses in patients with AAA and/or common iliac aneurysm. 18 Zoethout et al. reported the patient's results based on the recommended IFU 2013 and IFU 2016.21

Table 3 shows the anatomical features of aneurysms. Most authors report the anatomical data of the aneurysm and whether the aneurysm was treated in IFU 2013. 80% of the aneurysms of the included patients were treated in the IFU of the Nellix device. The weighted average diameter of the largest aneurysm is 60±6 mm. The weighted average diameter and length of the aortic neck were 24±2 and 25±4 mm, respectively. The average angle of the aortic neck is 32°±9°.

The result data is shown in Table 4-6.

Thirteen studies (1,233 patients) reported technical success. 8-15, 17-21 The technical success rate varies from 98% to 100%. Technical success was achieved in 1,226 of 1,233 patients, and the combined estimate was 99% (95% CI = 98–100; heterogeneity: P=0.869, I2=0%).

Eleven studies (1,335 patients) reported operating times ranging from 70 to 151 minutes. The weighted average operation time of 8-11, 13, 16-21 was 106±24 minutes.

The fluoroscopy time range for 6 studies (717 patients) was 8 to 33 minutes. The weighted average of 8, 9, 11, 13, 16, and 17 is 17±12 minutes.

Five studies reported data on auxiliary surgery. 12,14,15,18,20 assisted surgery was performed on 105 of 240 patients (pooled estimate 39%, 95% CI = 19–63; heterogeneity: P<0.0001, I2=88%), proportion It ranges from 7.7% to 60%. Including 97 cases of auxiliary iliac stent placement, 4 cases of femoral endarterectomy, 2 cases of chimney transplantation, 1 case of internal iliac artery coil embolization, and 1 case of additional proximal stent placement.

Nine studies (902 patients) reported data on postoperative complications. 10,13–15,17–21 In nine studies, the incidence of postoperative complications was 0% to 60%, and the pooled estimate was 5.6% (95% CI = 1.9 – 15.2; heterogeneity: P< 0.0001, I2=86%). Complications include endoleaks, 10, 21 wound infections, 18 thrombosis in grafts, 10 inguinal hematoma, 14, 15, 18 femoral artery 15 or inferior abdominal artery occlusion, 19 embolism, 14 duodenal hemorrhage, 15 and respiratory failure 14. ,18,20 Karouki et al. reported 1 case of lower extremity paresis. 14 Jeffrey Hing et al. reported 5 cases of post-implantation syndrome. 20

Eight studies (916 patients) reported AAA rupture within 30 days after surgery, with an incidence of 0% to 2%, and a pooled estimate of 0.7% (95% CI = 0.3-1.6; heterogeneity: P = 0.923, I2) =0%).8,10-14,16,17 In two studies, only two ruptures within 30 days were found, with 1 case in each study. 10,16 During the follow-up period from 1 to 23 months, 12 studies reported 5 cases of AAA rupture (1,455 patients in total), the incidence ranged from 0% to 1.3%, and the pooled estimate was 0.8% (95% CI = 0.4-1.6; Heterogeneity: P=0.958, I2=0% ).8-14,16,17,19-21

Eight studies (616 patients) reported data on length of stay in the hospital, ranging from 1 to 9 days. 8-10,12,16-18,20 The weighted average length of hospital stay is 5±3 days.

All included studies reported endoleak as a result. Forty-nine of 1,510 patients reported endoleak within 30 days after surgery, and the incidence in all studies ranged from 0% to 9.6%. 8–13,16,19,21 Approximately half of the endoleaks (29, 59%) were noticed as type I, and the rest were type II. The aggregate estimate of type I endoleak in the early stage (within 30 days) was 2.8% (95% CI =1.8-4.2; heterogeneity: P=0.254, I2=18%), and the early type II endoleak was 1.9% (95% CI) =1.2-3.0; heterogeneity: P=0.266, I2=17%). During the follow-up period of 1 to 23 months, all 14 studies (1,510 patients) reported cases of endoleak, with an incidence of 0% to 3.1%. In 6 studies, no endoleaks were found during the follow-up period. 9,10,12,14,15,18 The remaining 8 studies found 31 endoleaks. 8,11,13,16,17,19-21 The most common type of endoleak is type I (22), followed by type II (8) and type III (1). The pooled estimate for type I endoleak is 1.9% (95% CI = 1.3-2.8; heterogeneity: P=0.887, I2=0%), and the pooled estimate for type II endoleak is 1.1% (95% CI = 0.7-2.0; Heterogeneity: P=0.871, I2=0%), the aggregate estimate of type III endoleak is 0.7 (95% CI =0.4-1.5; Heterogeneity: P=0.847, I2=0%) .

Five studies (302 patients) reported cyst enlargement within 30 days. 10,15-17,20 None of the studies found that cyst enlargement occurred within 30 days after surgery. During a follow-up period of 12 to 23 months, six studies evaluated aneurysm sac enlargement with an incidence ranging from 0% to 5%. 8,10,13,17,20,21 Note that there are a total of 10 patients with 481 aneurysm sac enlargements shared between two studies, one study reported 2 cases of cyst enlargement, and the other reported 8 cases . 13,21 The remaining four studies did not find any enlargement of the cyst during the follow-up period. 8,10,17,20 The collective estimate of the incidence of cyst enlargement was 3.1% (95% CI =1.8-5.4; heterogeneity: P=0.419, I2=0%).

Five studies reported data on device migration that occurred within 30 days after surgery. The rates for all studies ranged from 0% to 6.7%, with a pooled estimate of 0.9% (95% CI = 0.3-3.3; heterogeneity: P=0.211, I2=32%).10,11,17,19,20 Only 2 out of 635 patients experienced device migration within 30 days. During the 5- to 23-month follow-up period, 9 studies reported the incidence of device migration, ranging from 0% to 13%, with a pooled estimate of 2.1% (95% CI = 0.8-5.3; heterogeneity: P = 0.004, I2=65%).8–11,13,17,19–21 19 out of a total of 1,008 patients found that the Nellix device was displaced during the follow-up period. 13,19–21

Twenty-nine out of 1,260 patients reported re-intervention within 30 days after surgery. The ratio of 11 studies ranged from 0% to 6.4%, and the pooled estimate was 2.7% (95% CI = 1.7-4.2; heterogeneity: P =0.183, I2=27%).8,9,11,12,14–17,19–21 During the 5–23 month follow-up period, 47 out of 1,355 patients underwent re-intervention, with an incidence ranging from 0 % To 9.5% in 12 studies, and the pooled estimate is 3.5% (95% CI = 2.3–5.5; heterogeneity: P = 0.061, I2 = 42%). 8,9,11,13–21

Thirteen studies reported mortality within 30 days after surgery. The mortality of all studies ranged from 0% to 4.8%, with a pooled estimate of 1.5% (95% CI = 0.9-2.6; heterogeneity: P = 0.559, I2 =0 %). 8-20 10 of the 1,342 patients died within 30 days. Seven out of ten deaths (70%) are not related to aneurysms/devices. Seven of the 13 studies reported zero mortality at 30 days. 11,14,15,17-20 All 14 studies reported mortality during follow-up. The 8-21 follow-up period is from 1 to 23 months. Overall, 67 deaths were reported during follow-up (1,510 patients in total), and mortality rates for all studies ranged from 0% to 20%. The pooled estimate of mortality during follow-up was 5.2% (95% CI = 3.7–7.3; heterogeneity: P=0.076, I2=38%). It was found that 6 of the 67 deaths (9%) were related to aneurysms. The aggregate estimate of aneurysm-related death during follow-up was 1.0% (95% CI = 0.6–1.9; heterogeneity: P = 0.872, I2 = 0%).

We conducted a systematic review and identified 14 single-arm observational studies, reporting a total of 1,510 patients who used Nellix equipment and EVAS for asymptomatic, non-ruptured AAA repair. Our review showed that despite the wide range of aneurysm morphologies included between and within the studies, the technical success rate of treatment with the Nellix device is high, ranging from 98% to 100%. Most authors define technical success as the successful deployment of the device to exclude aneurysm blood flow at the completion of angiography, and no endoleaks or stent thrombosis. 8-15,17-19,21 Interestingly, the technical success of an aneurysm with an angled proximal neck was reported by a patient treated with the Nellix device outside the IFU of 80°. 20 The incidence of postoperative complications in the nine studies ranged from 0% to 60%, reflecting the difference in perioperative morbidity reported by these studies. 10,13-15,17-21 We found that the weighted average operation time and hospital stay were 106±24 minutes and 5±3 days, respectively. These values ​​are comparable to the operating time and hospital stay reported in the EVAR trial. twenty two

The EVAS with Nellix device is designed to reduce complications, especially endoleaks, and subsequent re-intervention during follow-up. 23 We found that the use of the Nellix device is associated with a low endoleak rate, which is comparable to the reported endoleak rate. EVAR.24 Type I endoleak is the most common type of endoleak included in the study report. In our study, the reported re-intervention rate was very low. During the 5--23 month follow-up period, the re-intervention rate of 12 studies ranged from 0% to 9.5%.

Based on available evidence, the effects of the EVAS and Nellix devices on preventing the expansion of the aneurysm sac are promising. During the 12 to 23 months follow-up period, 10 of 481 patients reported cyst enlargement (incidence rate 0% to 5%). The incidence of aneurysm sac enlargement is generally lower than that reported after EVAR; within 5 years after EVAR, 21%–42% of patients have observed aneurysm sac enlargement. 25,26 However, the difference in the incidence of capsular enlargement between the studies reporting ENAS and the studies reporting EVAR may be related to the difference in follow-up. Further research is needed to directly compare the results between Evas and EVAR.

Device migration is one of the significant complications that may occur after EVAS. 27 England et al. reported a migration rate as high as 28%, none of which has relevant clinical significance. 27 In addition, Antoniou et al. described the case of Nellix endograft.28 In our study, we found that the migration rate ranged from 0% to 13% during the follow-up period of 5 to 23 months, highlighting the effects of post-EVAS monitoring. importance.

Most of the included patients had their aneurysms treated in the IFU 2013 of the Nellix device. Some studies have reported the clinical results of IFU treatment of internal and external aneurysms in 2013. Zerwes et al. found that there was no significant difference in technical success between patients treated within and outside IFU. 10 Gossetti et al. reported that the incidence of patients treated outside of the IFU was statistically higher. 19 Comparative evidence suggests that the requirement for a robust evaluation of the complications associated with the Evas IFU recommended by the Nellix device is not complied with.

In 2016, an improved version of the recommended IFU for Nellix devices was introduced. 39 Zoethout et al. compared the 2-year clinical results of patients treated in IFU 2013 and IFU 2016; 21 they found that compared with the IFU 2013 group, the IFU 2016 group had fewer complications, although the difference was not significant. 21 The author believes that compared with IFU 2013, the improved IFU 2016 does not clearly show better results of the EVAS procedure. In addition, the applicability of Nellix is ​​significantly reduced with IFU 2016. Since the improved IFU is relatively new, further analysis and follow-up will help determine the impact of the new IFU on clinical outcomes.

Radiation exposure during EVAR poses a potential hazard to patient safety. 29,30 Compared with EVAR, Evas may benefit by exposing patients to less radiation. The studies included in our review report fluoroscopy times; however, there are no data on radiation exposure. Ockert et al.31 and Antoniou et al.32 compared the radiation exposure during EVAR and EVAS. These studies report similar results in the reduction of radiation exposure in ENAS compared to EVAR. Given the recognized carcinogenic risk of radiation exposure, this is beneficial to both the patient and the surgical team; therefore, it is worthy of further analysis. 31

Aneurysm rupture after EVAS is a well-described complication. Antoniou et al. reviewed late aneurysm rupture after EVAR, and pointed out that graft-related endoleaks were the main cause of rupture. 33 In our study, a total of 7 AAA ruptures were reported. Zerwes et al. reported the early rupture of the aneurysm sac due to iatrogenic causes. 10 The filling of the inner bag apparently caused the rupture of the aorta. This was not noticed during the operation. A computed tomography scan a week later showed retroperitoneal hematoma and type Ia endoleak, which was treated by implanting two additional Nellix endografts together with chimney grafts into the two renal arteries. This allows the endoleak to be successfully treated. 10 Carpenter et al. reported two cases of advanced aneurysm rupture, one was iatrogenic and the other was related to type Ia endoleak. 13 The first patient experienced multiple infections and rectal bleeding after surgery. The clinical event committee ruled that the event was device-related intestinal ischemia. 13 The latter patient developed type Ia endoleak 7 months after the operation. 13 The patient found the contained aneurysm ruptured during the open transition and unfortunately died one month later. 13 Thompson et al. reported three aortic ruptures; one early rupture was caused by type Ib endoleak, and two late ruptures were caused by untreated type Ia endoleak. 16 These ruptures were treated with distal extension and two conversions, respectively. 16 Zoethout et al. reported a previously unsuccessful Nellix-in-Nellix operation. 21 The aneurysm rupture found in our study is related to iatrogenicity and endoleak, which is consistent with the findings of Antoniou et al. 33 This further emphasizes the importance of monitoring and follow-up after EVAR.

Chimney EVAS (Ch-EVAS) is a newly described technique that was mentioned as an auxiliary surgery in two included studies. 15,20 In both cases, Ch-EVAS was used to extend the proximal landing zone. Several studies have reported cases of patients treated with Ch-EVAS and analyzed the clinical results with encouraging results. Torella et al. reported two cases where Ch-EVAS was successfully used to treat failed EVAR and pararenal aneurysms. 34 Youssef et al. reported that Ch-EVAS is a wise treatment for EVAR failure caused by endoleak, which further strengthened their research. 35 de Bruin et al. also reported on Ch-EVAS as a viable solution for proximal and suprarenal aneurysms with poor morphology, and pointed out that the endoleak rate was low during a short-term follow-up of 123 days. 36 In a larger cohort study, Thompson et al. reported the results of Ch-EVAS from the ASCEND Registry and supported the use of Ch-EVAS in patients with complex aortic disease. 37 Although recent studies have shown that Ch-EVAS has achieved encouraging results in the treatment of complex aneurysm morphology and persistent endoleaks. Compared with previous EVARs, further studies with larger patient cohorts and longer follow-up periods It is important to understand the durability of Ch-EVAS and possible complications​​.

The result of EVAS is acceptable. Type I endoleaks, sac enlargement, device displacement, and aneurysm rupture are recognized complications. High-level research is needed to investigate the potential advantages of EVAS over traditional treatments.

The authors report no conflicts of interest in this work.

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