EVAS Sealing Technology: The new paradigm in AAA therapy

Transcription

1 June 2016 EDUCATIONAL SUPPLEMENT EVAS Sealing Technology: The new paradigm in AAA therapy This educational supplement has been supported by an unrestricted educational grant from Endologix MM1398 Rev 01

2 Endologix: The power of choice Endologix, Inc. is uniquely positioned to offer vascular specialists the power of choice for treating abdominal aortic aneurysms (AAA). This choice includes the Nellix, AFX and Ovation platforms that allow physicians to confidently treat more patients even more effectively. This supplement highlights how the power of choice is transforming AAA treatment in Europe. It also underscores the impact that EndoVascular Aneurysm Sealing (EVAS) has had on AAA treatment, and shows why the new Nellix device has the potential to become a workhorse device with promising results when treating patients within the instructions for use (IFU). It additionally explores the use of EVAS in iliac artery aneurysms, and presents an update on the EVAS FORWARD Global Registry, showing continued positive clinical outcomes with Nellix in an all-comer patient population. In this supplement: 2 The power of choice transforming AAA treatment 4 Enhancements make the next-generation Nellix a potential workhorse device: More patients within IFU 5 EVAS for concomitant and isolated iliac artery aneurysms 7 EVAS FORWARD Global Registry continues to show positive clinical data with Nellix in an all-comers study INTERVIEW: PIOTR SZOPINSKI The power of choice transforming AAA treatment Piotr Szopinski and his team at the Clinic of Vascular Surgery, Institute of Haematology and Transfusion Medicine, Warsaw, Poland, have 14 years of experience performing endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAA). In this interview, Szopinski speaks about his device choices and how the use of EndoVascular Aneurysm Sealing (EVAS) has impacted his approach to aneurysm repair. How many abdominal aortic aneurysms do you treat per year and which devices do you currently use in your institution? At the Clinic of Vascular Surgery at the Institute of Haematology and Transfusion Medicine in Warsaw, we perform about 80 endovascular repairs of abdominal aortic aneurysms every year, with different devices. Some of these belong to the old generation of stent graft systems, which rely on some form of proximal fixation (infra- or suprarenal), i.e. Endurant (Medtronic), Zenith (Cook), Jotec endografts, Aorfix (Lombard) and Excluder (Gore), or are based on anatomical fixation such as AFX (Endologix). We started using endovascular polymer-based devices such as Ovation and Nellix (both from Endologix) in Of course we also operate on abdominal aortic aneurysm patients using open repair as this remains an extremely important and useful technique. How do you choose your device for each patient? Our team is very skilled in endovascular techniques for abdominal aortic aneurysm repair. We performed the first EVAR in 2002 and since then we have carried out over 1,000 procedures. We have had the opportunity to become familiar with all systems available on the market. In my opinion it is not acceptable to use only one or two systems to treat all patients with abdominal aortic aneurysm, which is a relatively common practice in other hospitals. My personal experience is that we quite often encounter challenging anatomies in relation to the available endovascular therapeutic techniques. This particularly applies to difficult access because of narrow, tortuous or calcified iliac arteries. Short or tapered proximal necks are particularly a challenge for stent graft placement. Also a small diameter in the distal neck can be overlooked, which can lead to late complications. Finally, the risk of type II endoleaks originating from patent large lumbar arteries, accessory renal arteries or a patent inferior mesenteric artery may lead to sac expansion and need for secondary intervention. Another challenging group of patients are those with late complications following previous open or endovascular aortic repair. Being a referral centre, our clinic is also specialised in EVAR revisions. All factors mentioned above are taken into account, but the main criterion is the aneurysm anatomy assessed on the basis of computed tomography with the use of dedicated programmes such as Osirix, TeraRecon or Intelix (Endologix). 2

3 EVAS Sealing Technology: The new paradigm in AAA therapy June 2016 After detailed analysis of preoperative data, the appropriate endograft for each respective patient is ultimately chosen. Which benefits do sealing technologies have compared to traditional EVAR? Our point of view on abdominal aortic aneurysm repair has changed with the introduction of sealing technologies. The number of reinterventions after EVAR procedures varies between 25% and 40% depending on the device used and the site s experience. Now, EVAS technology has the potential to reduce it. Significant reduction in type II endoleaks can decrease the risk of reinterventions due to sac enlargement and potentially surveillance costs. The non-modular design of the Nellix system eliminates the risk of type III endoleak, a complication associated with modular endograft component separation. The overall rate of persistent endoleak (1.9%) is the lowest seen in endovascular treatment of AAA, as reported in the EVAS FOR- WARD Global Registry results presented at the recent Charing Cross Symposium. In our practice, we also have observed a significant decrease in contrast medium for reduced risk of renal impairment, and a reduction in fluoroscopy time, an important benefit to both the patient and the operating staff. How important is it to treat patients according to the instructions for use? The implantation of the new endografts in accordance with the manufacturer s instructions for use (IFU) is very important for our patients safety. Compliance with IFU enables quick and safe aneurysm exclusion with low radiation dose. At our clinic, the learning curve with the Nellix device was steep. Initially, we qualified patients with friendly anatomy to familiarise ourselves with the implantation technique, delivery system and console, and to recognise the accurate pressure in the EndoBags during prefilling and then in the course of polymer injection. It is mandatory to know the tips and tricks in case something does not go as planned. Such an attitude allowed us to start qualifying patients outside IFU, mainly because of the length, shape and angulation of the aneurysm neck. We presented our results at the ESVS Meeting in Porto in 2015 and at the Charing Cross Symposium in Our special attention is still given to patients with pararenal aneurysms treated with the chimney Nellix technique. Our data were included in the ASCEND Registry and the results are very promising. I Today, Endologix offers three product platforms two based on polymer technology and one on anatomical fixation. We are familiar with all three devices and in our opinion they cover the majority of anatomical variations. would like to emphasise that performing this kind of procedure requires very good team collaboration and proper planning and they should be carried out in a well-equipped hybrid room as unexpected complications may occur and ways of treating them are limited. The implantation of chimneys with Nellix by an unskilled team may lead to type Ia endoleak and other complications. What is the value of having one company with the ability to provide multiple technology platforms? With the merger of two innovative companies (Endologix and TriVascular), clinicians have a comprehensive range of endografts with broad applicability across a majority of aneurysm anatomies. Today, Endologix offers three product platforms two based on polymer technology and one on anatomical fixation. We are familiar with all three devices and in our opinion they cover the majority of anatomical variations. Ovation offers an ultra-low profile, highly flexible delivery system with proximal fixation and a polymer sealing ring. At our institution, Ovation is the most frequently chosen device for percutaneous EVAR procedures. AFX allows for preservation of the aortic bifurcation and due to its unique structure gives the ability to perform the procedure with minimal volume of contrast medium. This is particularly important in patients with renal failure. Finally, Nellix represents a completely new technology. Nevertheless, we mastered it in a relatively short time, which encouraged us to change our approach to the treatment of pararenal and suprarenal aneurysms. In some of these clinical scenarios we implant chimneys into all visceral arteries instead of branched or fenestrated devices, which has simplified the treatment of this particular group of patients. Observing the development of this method I believe that chimney EVAS will become an off-the-shelf technique in the near future; however, we ought to remember that it is still outside of the IFU. How do you decide whether or not a device will become your workhorse device? We are currently using almost all endografts available on the market. Since the introduction of Endologix products we have changed the percentage rate of the devices in use and now the ones from Endologix comprise more than half of all the implanted stent grafts. This gives us a lot of comfort in everyday practice, having good products and getting excellent cooperation and support from the company. It is more like having a tool kit from one company! n Endologix: EVAS and EVAR solutions OVATION Proximal fixation Polymer sealing ring Ultra-low profile AFX Bifurcation preservation Proximal extended seal zones Anatomical versatility NELLIX Complete aneurysm sealing Lowest endoleak rate Simplified procedure & planning Endologix: The power of choice 3

4 Introducing the Next-Generation Nellix EVAS Sealing Technology: The new paradigm in AAA therapy June 2016 NEXT GENERATION Enhancements make the next-generation Nellix a potential workhorse device: More patients within IFU The next-generation Nellix EndoVascular Aneurysm Sealing (EVAS) System, which received the CE mark on 11 April 2016, incorporates design improvements to enhance ease of use and offers physicians the ability to treat a wider range of abdominal aortic aneurysm anatomies and, therefore, more patients. The new system offers two additional stent lengths of 190mm and 200mm and an expanded indication for a maximum treatable blood flow lumen diameter of 70mm. The EndoBag is now sutured distally, which will improve the predictability of the distal seal performance. The delivery system has several new features that include a flexible inner core, a simplified console, and new angiographic holes in the nosecone. With the new Nellix, I can treat more patients within the IFU. Jan Heyligers Jan Heyligers, Elisabeth TweeSteden Hospital, Tilburg, The Netherlands, performed the first case with the device post-ce marking. He explained to Vascular News, The patient needed a long stent, making him a perfect candidate. New longer Nellix stent lengths mean that more patients can be treated more effectively. Because the distal end of the EndoBag is now attached to the stent, it allows for more precise and effective deployment, a design feature that is especially beneficial in the treatment of iliac artery aneurysms. Importantly, the indication for maximum flow lumen diameter has increased from 60mm to 70mm, further broadening the range of anatomic applicability. With the new Nellix, I can treat more patients within the IFU. Michelangelo Ferri, Vascular and Endovascular Surgery Unit, Mauriziano Umberto I Hospital, Turin, Italy, started using the Nellix system three years ago and since then has performed over 100 EVAS procedures. At my centre Nellix has revolutionised abdominal aortic aneurysm treatment. It has enabled streamlined planning and procedures and has delivered good clinical results. Moreover, we have noticed that a vast proportion of patients are morphologically more suitable for treatment with Nellix compared with traditional EVAR devices, he said. Ferri believes the next-generation Nellix system will have further impact on the EVAS experience, and added, We will be able to treat more patients (for example, those with abdominal aortic aneurysms and concomitant iliac artery aneurysms) and more aneurysm anatomies (those with aneurysms presenting large blood flow lumen). The added flexibility to the delivery system will enhance device performance in tortuous anatomies. The new system is more predictable in the exclusion of iliac aneurysms and provides intuitive management, with shorter connection lines (less air bubbles in the lines). It also makes angiography more effective and enables precise positioning of the stent at the level of the renal arteries. Among these important improvements, I find the new stent lengths and the attached distal part of the EndoBags particularly beneficial. He explained that with the attachment of the EndoBags now being so close to the distal end of the stent graft, it is possible to seal the entire length of the aneurysmal aortoiliac anatomy and added, With this we avoid type Ib endoleaks and are able to deploy the device just above the iliac Michelangelo Ferri bifurcation, avoiding hypogastric occlusion or the need for a branched graft. With the new generation Nellix we will be able to treat more patients and more effectively. When deciding if an endograft can be adopted as his team s workhorse device, Ferri notes that he first wants to be sure that it can improve outcomes. After considering the morphological applicability of an AAA device, if it shows ease of use and ability for precise deployment, it has the potential to become my workhorse device, as Nellix is at the moment, he said. The next-generation Nellix Expanded blood lumen diameter indications increased to 70mm Distal EndoBag attachment allows predictable seal performance Additional stent lengths (190mm and 200mm) offer more treatment options New console design simplifies implant procedure Integrated angiography holes in the nosecone enhance visualisation of the AAA anatomy 4

5 COMMON ILIAC ARTERY ANEURYSMS EVAS for concomitant and isolated iliac artery aneurysms Jean-Paul PM de Vries, Department of Vascular Surgery, St Antonius Hospital, Nieuwegein,The Netherlands, presented results of a multicentre experience with Endovascular Aneurysm Sealing (EVAS) and the Nellix device in the treatment of iliac artery aneurysms at the Charing Cross Symposium (26 29 April, London, UK). The use of Nellix in iliac artery aneurysms also has been reported in two studies recently published in peer-reviewed journals. In his presentation at the CX Innovation Showcase session, De Vries noted that one in four patients undergoing endovascular aneurysm repair (EVAR) suffers from a concomitant common iliac artery aneurysm, and that this concomitant aneurysm increases the risk of type Ib and II endoleaks, secondary interventions and aneurysm ruptures. He pointed out that while iliac branched devices are important for preservation of the hypogastric arteries, these devices are limited to a narrow range of vascular anatomies, are associated with complex cases, and can nearly double the cost of the intervention. The use of parallel stent grafts for hypogastric preservation is an alternative endovascular option but is associated with higher risk of occlusion and long-term durability. De Vries commented that his team adopted EndoVascular Aneurysm Sealing (EVAS) to treat abdominal aortic aneurysm (AAA) patients with concomitant common iliac artery aneurysms. Traditional EVAR devices are only indicated to treat iliac artery diameters up to 25mm, whereas Nellix is indicated for treatment of iliac artery blood flow lumens up to 35mm. If the patient suffers from a concomitant iliac artery aneurysm we can preserve flow to the internal iliac artery, with no additional costs or adjunctive devices to the internal and external iliac arteries. Furthermore, if needed, he said, it is possible to extend the Nellix device into the external iliac artery without embolising the internal iliac artery. As the Endo- Bag in the common iliac artery will seal the entire landing zone, there is minimal risk of types Ib and II endoleaks. In his presentation, De Vries referred to the work of Dainis Krievins and colleagues in Riga, Latvia. 1 Krievins et al reported their experience with Nellix in 48 AAA patients with 54 concomitant common iliac artery aneurysms treated between 2008 and In all cases, the internal iliac artery was preserved. With a mean follow-up of 3.2 years (1 5 years), the study showed no aneurysm enlargement when the common iliac artery aneurysm was completely excluded. De Vries then presented data of 72 patients with common iliac artery aneurysms treated with EVAS in a multicentre Jean-Paul de Vries Marwan Youssef Dainis Krievins study (Europe and New Zealand). The mean age was 74.3 years, 98.9% of patients were male, and 41.7% were treated within the instructions for use. Mean left common iliac artery aneurysm diameter was 28.9±12.7mm, mean right common iliac artery aneurysm diameter was 34.5±12.9mm, and 69.4% of patients had a concomitant infrarenal aortic aneurysm and 26.4% had bilateral iliac aneurysms. Mean procedure time was 107.7±36.1 minutes. The procedural results showed one type Ib endoleak on completion angiogram this was a patient with a Nellix device and periscope stent to the internal iliac artery who was successfully treated with a covered stent. Sixty-day follow-up showed two stent graft occlusions (2.8%), both of which were treated with thrombectomy and relining with a covered stent (both patients had isolated common iliac artery aneurysms where the distal end of the The short-term results of this multicentre experience are very encouraging, with low rates of endoleak, a low incidence of graft occlusions, and an overall reduction in secondary interventions compared to iliac branched devices and parallel grafts. Nellix device had to be extended to the external iliac artery). Two type II endoleaks were seen with no expansion and were, therefore, placed under surveillance. The most recent follow-up (mean 13.1±9 months) included two stent graft occlusions, both treated with thrombolysis, one stent graft stenosis treated with PTA, and no stent graft fracture. Three late endoleaks were observed one type Ia successfully treated with transcatheter embolisation, and two persistent type II. The advantages of treating concomitant common iliac artery aneurysms with EVAS are that the techique: Excludes the common iliac artery aneurysm with minimal distal neck Treats blood flow lumen diameters 9 35mm Allows for preservation of the internal iliac artery In case of aneurysm extension to the external iliac artery, occlusion of the internal iliac artery can be achieved with the Nellix EndoBag alone, eliminating the need for adjunctive coils or plugs. The short-term results of this multicentre experience are very encouraging, with low rates of endoleak, a low incidence of graft occlusions, and an overall reduction in secondary interventions compared to iliac branched devices and parallel grafts, De Vries concluded. German experience Another experience with the use of Nellix in the treatment of common iliac artery aneurysms was conducted by Marwan Youssef and colleagues from the Department of Cardiothoracic and Vascular Surgery, Medi- Continued on page 6 EVAS for Concomitant and Isolated Iliac Aneurysms 5

6 EVAS for Concomitant and Isolated Iliac Aneurysms EVAS Sealing Technology: The new paradigm in AAA therapy June 2016 COMMON ILIAC ARTERY ANEURYSMS Continued from page 5 cal Center of the Johannes Gutenberg-University Mainz, Germany, and Department of Vascular Surgery, Hospital of Augsburg, Germany. 2 Between May 2013 and June 2015, 230 patients underwent implantation of the Nellix device, and 50 of these patients (mean age 76 years; 35 men) presented with 60 common iliac artery aneurysms (median diameter 4cm). The majority of patients, 35 (70%), had aortoiliac aneurysms, 10 (20%) had isolated common iliac artery aneurysms, and 5 (10%) had iliac anastomotic aneurysms after aortoiliac bypass. In 20 patients, the iliac aneurysm was the indication for the intervention; in the remaining 30 patients, the endovascular iliac repair was an adjunct procedure to EVAS. An iliac branch device was used when feasible to preserve flow to the internal iliac artery. The results showed that 17 (34%) patients were treated with the Nellix graft in combination with an iliac branch device, and 33 (66%) patients were treated with the implantation of the Nellix graft in the common iliac artery aneurysm using one (n=5), two (n=22), or three (n=6) Nellix stents (two bilateral stents and one stent as an extension to the external iliac artery). 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. Youssef, who has performed over 60 iliac sealing procedures either with Nellix grafts alone or in combination with an iliac branch device for hypogastric preservation told Vascular News: This initial experience demonstrates that Nellix grafts are feasible and safe for the treatment of concomitant and isolated iliac artery aneurysms. Iliac aneurysm sealing appears to be a promising application of EVAS in this complex patient population. However, further follow-up and additional multicentre studies are warranted to corroborate these results. Long-term results: Latvia and New Zealand Additional data on the application of EVAS for the treatment of iliac artery aneurysms have been recently reported in the Journal of Vascular Surgery by Dainis Krievins, Pauls Stradins Clinical University Hospital in Riga, Latvia, and Andrew Holden, Auckland City Hospital, Auckland, New Zealand. 3 This multicentre, prospective study evaluated the long-term effectiveness of EVAS in the treatment of complex aortoiliac aneurysms with preservation of hypogastric artery flow. Krievins et al reported, Among 125 patients with EVAS, 68 patients (mean age 75+8 years, 79% men) had both AAA (mean diameter 55.8±2mm) and common iliac artery aneurysms (CIA; median diameter 23.4, IQR mm) with bilateral CIA in 33 patients. Treatment of 101 CIA included: complete CIA exclusion in 40 (39.6%), partial CIA exclusion in 33 (32.7%) and no CIA treatment in 28 (27.7%) with successful AAA exclusion in all patients. Internal iliac flow was preserved in all 122 hypogastric arteries that were patent prior to treatment (14 hypogastric arteries were occluded at baseline). During the five-year follow-up period (median follow-up 24.7 months, range 11.5 to 61.7 months), three patients required secondary treatment with hypogastric occlusion and graft extension to the external iliac. Thus, internal iliac flow was maintained in 98% of at-risk hypogastric arteries. There were no type Ib endoleaks or aneurysmrelated clinical events, except for the three secondary treatments. Further, they found that totally excluded iliac aneurysms did not change in diameter over time (p=0.85), whereas untreated CIA enlarged at a rate of 0.16mm/year (95% CI , p<0.0001). Partially excluded CIA enlarged at a higher rate of 0.59mm/ year (95% CI , p<0.0001). Enlargement 3mm occurred only in partially treated CIA larger than 3cm. Krievins told Vascular News, The EVAS system is a new approach to the treatment of aortoiliac aneurysms which provides a more elegant solution to the CIA Latest Clinical patients follow-up events Multicentre study ±9 months 2 occlusions, of EVAS in CIA 1 no fracture, 23 late endoleaks (1 type Ia and 12 persistent type II) Youssef et al months No buttock claudication, reinterventions, occlusion or endoleaks reported Krievins et al years 3 reinterventions with hypogastric occlusion Patients with aorto-iliac aneurysms can be successfully treated using the EVAS endograft with long-term preservation of internal iliac artery patency in 98% of patients. problem of preserving flow to the internal iliac artery. This is achieved by two-stent supported flow channels which are surrounded by polymer-filled EndoBags that fill and seal both the abdominal and common iliac aneurysm. The polymer-filled EndoBags provide positional fixation of the endograft and seal of the aneurysm proximally, distally and throughout its length. Distal sealing can be achieved in common iliac aneurysms with blood flow lumen diameters up to 35mm, thus preserving patency of the hypogastric artery. EVAS has shown promising results in treating patients with both simple and complex anatomy and may streamline the treatment of aortoiliac aneurysms. Krievins noted that in this study, the effectiveness of EVAS in preventing common iliac aneurysm enlargement depended on the completeness of coverage of the aneurysm. Iliac aneurysms that were totally covered by the endograft were stable through five years of follow-up and there were no late adverse events. In the early experience we partially treated iliac aneurysms with the assumption that it will not result in a distal endoleak and may, in fact, thrombose and resolve. However, our data now show that leaving iliac aneurysms partially treated results in worse outcomes. Therefore, we have adjusted our practice and we aim for complete seal of the iliac aneurysm with Nellix, he said. Krievins and colleagues concluded, Patients with aorto-iliac aneurysms can be successfully treated using the EVAS endograft with long-term preservation of internal iliac artery patency in 98% of patients. Complete common iliac aneurysm exclusion appears to prevent continued CIA enlargement whereas partial exclusion may allow continued CIA enlargement over time. References: 1. ESVS Annual Meeting M Youssef, Z Nurzai, S Zerwes, R Jakob, et al. J Endovasc Ther 2016; 23(2): DK Krievins, J Savlovskis, A Holden, K Kisis, et al. J Vasc Surg

7 GLOBAL REGISTRY EVAS FORWARD Global Registry continues to show positive clinical data with Nellix in an all-comers study The first-ever prospective, all-comers clinical study of EndoVascular Aneurysm Sealing (EVAS) shows encouraging results, with durable aneurysm exclusion at 18 months. Matt Thompson, St George s Vascular Institute, London, UK, who presented an update of the EVAS FORWARD Global Registry at the Charing Cross Symposium on 27 April 2016, said that aneurysm sealing with the Nellix system demonstrated low endoleak and reintervention rates in a complex abdominal aortic aneurysm patient population. Furthermore, the data showed improved clinical outcomes when patients are treated within instructions for use (IFU). The EVAS FORWARD Global Registry includes up to 300 patients who were enrolled at up to 30 centres and will be followed for five years. The study principal investigators are Thompson and Andrew Holden, Auckland, New Zealand. The dataset presented at Charing Cross had a mean follow-up of 20 months. The patients were divided into four cohorts, according to the challenging nature of the morphology: cohort 1 were patients treated with neck length 10mm and infrarenal angle 60 degrees (n=200, 69%); cohort 2 had neck length 5 10mm and infrarenal angle degrees (n=39, 13%); cohort 3 included patients with juxtarenal/ pararenal aneurysms neck length <5mm and/or infrarenal angle >90 degrees (n=38, 12.7%); and cohort 4 included patients with ruptured aneurysms, EVAR revisions, aorto-uni-iliac aneurysms and isolated iliac aneurysms (n=22, 7.4%). At Charing Cross, Thompson focused on the infrarenal aneurysm cohorts (groups 1, 2 and 3). He showed a graph comparing EVAS FORWARD and two EVAR registries (ENGAGE and GREAT), noting that EVAS FORWARD has enrolled a larger number of patients with challenging anatomies, including aneurysm necks <10mm (17% vs. 2% in ENGAGE and 1.5% in GREAT), conical necks (51%), and a larger number of patients with high neck angulation (>60 degrees), iliac diameters >25mm, or requiring chimney procedures. The latest results showed that, at 18 months, freedom from persistent type Ia endoleak was 98.5% (four cases) and from all endoleaks was 98.1% (there was one endoleak of unknown type). By treatment within and outside of IFU, the freedom from type Ia endoleak was 96.4% in patients on-ifu and 85.6% in those treated off-ifu (p=0.0011). If you go outside of the IFU with challenging proximal aortic or distal Matt Thompson The EVAS FORWARD Global Registry results are encouraging, with low endoleak and reintervention rates in a complex patient population, and also excellent aneurysmrelated and overall survival trends through the latest follow-up. iliac anatomy the risk of endoleak increases, Thompson said. In addition, in the majority of patients with a type Ia endoleak, you see that the Nellix stents were either misaligned or deployed too low within the infrarenal neck. It is important to land the Nellix stents as close to the most caudal renal artery as possible to maximise the sealing zone. He continued to comment on the options for treatment of type Ia endoleak with Nellix. Transcatheter embolisation with coils and a liquid embolic agent do very well. In the EVAS FORWARD Global Registry, 95% of patients treated with embolisation did not present with a recurrent endoleak. Thompson expressed to delegates that the 98.2% freedom from type II endoleak and 100% freedom from persistent type II endoleak were impressive. He explained that the core laboratory described these endoleaks as very small and that they spontaneously thrombosed during the study period. He then summarised his overall impression of the endoleak results. The composite endoleak rate remains low (1.9%) through the latest follow-up, he said. The second outcome Thompson shared with the audience was freedom from secondary intervention. Overall, the freedom from secondary intervention rate was 89.6% at 18 months. When looking at endoleaks and occlusions, the freedom from secondary intervention was 93.9% for endoleaks and 97.8% for occlusion. When you look at the EVAS FORWARD Global Registry, ENGAGE, and GREAT, all three registries report similar secondary intervention rates, despite EVAS registry presenting a more complex patient cohort, he said. With regard to mortality, Thompson pointed out that freedom from aneurysmrelated mortality was 97.8%, and similar to that reported in the other EVAR registries. However, one point of interest in the EVAS FORWARD Global Registry is related to freedom from all-cause mortality (92.7% at 18 months), which is trending better than you might have imagined based on what has been reported in EVAR studies. Thompson concluded by saying that the results are encouraging, with low endoleak and reintervention rates in a complex patient population, and also excellent aneurysmrelated and overall survival trends through the latest follow-up. ASCEND study Data from the new ASCEND Registry (Aneurysm Study for Complex AAA: Evaluation of Nellix Durability), a physicianinitiated retrospective registry of Nellix in conjunction with aortic branch stent grafts for the treatment of patients with complex abdominal aortic aneurysms, were presented at Charing Cross. Matt Thompson, co-principal investigator of the registry alongside Andrew Holden, presented the results. The data included one-year outcomes from the first 154 patients enrolled in the registry. In the study, patients were successfully treated with single, double, triple and quadruple branches. Outcomes included 1.3% serious renal complications at 30 days, target vessel patency of %, no persistent endoleaks, 94.3% aneurysmrelated and 89.8% overall survival through one-year follow-up. Thompson said, Early data from the ASCEND Registry reveal a promising use of polymer-based sealing to address a therapeutic gap. Long-term follow-up is needed to assess the durability of this potential first-line therapy for patients with complex AAA. The ASCEND Registry is an open-label, single-arm, observational real-world registry with no prospective screening. The study will enrol 200 patients with juxtarenal and pararenal aortic aneurysms at up to 10 international centres. EVAS FORWARD Global Registry 18-Month Data MM1398 Rev 01 7

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