Sebastian Zerwes

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.

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 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.

Clinical outcomes in hybrid repair procedures for pathologies involving the aortic arch

Objective Fifty patients with complex aortic disease, who received hybrid treatment of the aortic arch with supra-aortic debranching and endovascular stent-graft repair, were evaluated in regard to events of primary (survival and technical success) and secondary (procedure-related complications) interest. Methods The single-center study was conducted over an eight-year period from December 2004 to December 2012. Treated medical conditions included 23 aortic aneurysms (46%), 21 aortic dissections (42%), and six penetrating aortic ulcers (12%). Procedures were divided into groups of elective, urgent, and emergent. Results Twenty-eight (56%) patients were operated electively, 15 (30%) urgently, and seven (14%) emergently. Sternotomy, cardiopulmonary bypass, and deep hypothermic circulatory arrest were required in 12 (24%) patients. The primary technical success rate was 86% and raised to 92% (n = 46) of secondary technical success rate after therapy of three type I endoleaks. The 30-day mortality added up to 16.0%, and the mean time of survival was 49.3 months. In a total of eight (16%) patients, an endoleak occurred (five endoleaks type I, three endoleaks type II), while nine (18%) of patients suffered a perioperative stroke. Conclusions In severely ill patients with complex aortic diseases, hybrid therapy may offer a promising alternative to conventional open repair.

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.

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.

Seduction and Its Impact on Instructions for Use.

In the October 2016 issue of the JEVT, Thompson et al report the early and midterm results of the EVAS FORWARD Global Registry. In this multicenter experience, 277 patients were treated with the Nellix Endovascular Aneurysm Sealing System (Endologix Inc, Irvine, CA, USA). The authors observed a persistent endoleak rate of 0.7% (1 type Ia and 1 type II) at 1 year, with freedom from types I and II endoleaks of 96.3% and 98.2%, respectively. Those results are particularly interesting as the registry contained an anatomically more challenging cohort compared to the GREAT and ENGAGE registries. What attracts even more attention, though, is a closer look at the percentages of patients treated beyond the instructions for use (IFU). In that regard, both the GREAT and the ENGAGE registries share similar numbers of patients (17% and 18%, respectively) treated beyond the IFU. In the EVAS FORWARD registry, however, close to 37% of patients were treated beyond the IFU, more than double the rates of GREAT and ENGAGE. This finding leads to an obvious question: Why is it that Nellix was implanted so many times beyond the IFU? Shouldn’t one be extremely cautious with a new stent-graft that is still lacking long-term results? Even more so, given the fact that said stent-graft employs a quite different method of excluding the aneurysm? The answer appears to be seduction. The “sealing the entire aneurysm” idea of the Nellix system quite simply represents a very seductive concept that seems to lure vascular surgeons to go beyond the IFU. Little to no neck? Angulated necks? Large necks? Large concomitant iliac artery aneurysms? All not a problem, the endobags will take care of it. Add the “one size fits all” component (after all, the only alternating variables are stent length and polymer amount with its associated pressure), and the sky seems the limit. This is precisely what happened in our service when we started using Nellix 3 years ago. We thought we could treat anybody and any given anatomy. After well over 200 cases, we are now beyond the initial “honeymoon phase” of a new relationship and have dropped our rose-colored glasses. The reality is that just like with any other (new) stent-graft, preoperative planning and careful operative execution are key. At the beginning, too little attention was paid to proximal neck length, resulting in either landing too low, giving away precious proximal landing zone, or implanting Nellix in <10mm proximal necks; we now take a very close look at the proximal neck. As suggested by Thompson and colleagues after analyzing the type Ia endoleaks in the EVAS FORWARD registry, technical errors, such as low landing, seem to be responsible, an observation with which we agree. Hence, in order to avoid type Ia endoleak, it appears to be important to land as closely as possible to the renal arteries. We believe that this is likely to result in a different scenario of flow dynamics, potentially lowering the pressure burden exerted by the pulse wave onto the endobags. In necks <10 mm and/ or highly laden with thrombus, we prefer to combine Nellix with renovisceral chimney grafts to create a sufficient landing zone of at least 10 mm. As for the treatment of type I endoleaks, Thompson et al report 4 early and 4 late type I endoleaks treated with coil embolization and liquid embolic agents to create a proximal seal between the aortic wall and the endobags. Taking into account the likely underlying pathogenesis of type I endoleaks, namely, low stent-graft deployment, this approach seems questionable, since it fixes only the symptoms and not the pathology apparently responsible for it. In the abovementioned scenarios, we prefer the Nellix-in-Nellix application (NINA) to liquidate the endoleak. Using NINA, one creates the landing zone that should have been achieved in the primary implantation. Once again, if necessary, we combine NINA with renovisceral chimney grafts. While our initial and midterm results with NINA are promising, long-term 664652 JETXXX10.1177/1526602816664652Journal of Endovascular TherapyZerwes research-article2016

Persistierende V. cava superior links und die Auswirkung auf die Anlage eines Dialyseshunts

Ein 24-jähriger Patient war aufgrund einer kongenitalen Nierenhypoplasie dialysepflichtig geworden. Nach Anlage einer proximalen AV-Fistel auf die V. cephalica rechts bei Linkshändigkeit konnte erfolgreich über den Shunt dialysiert werden. Circa ein Jahr nach Shuntanlage wurde der Patient erneut in der Shuntsprechstunde vorgestellt. Auffällig waren hohe venöse Drücke bei der Dialyse (250mmHg bei Fluss 320ml/min) und die Ausbildung eines langstreckigen Shuntaneurysmas am rechten Oberarm (. Abb. 1).

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.