Ovation Abdominal Stent Graft Research Articles

The Impact of Proximal Neck Anatomy on the 5-Year Outcomes Following Endovascular Aortic Aneurysm Repair With the Ovation Stent Graft.

Hostile proximal neck anatomy has historically been associated with worse outcomes for endovascular aortic aneurysm repair (EVAR) of abdominal aortic aneurysms (AAA). We investigated the impact of proximal neck anatomy on the outcomes following EVAR with the Ovation abdominal stent graft (Endologix, Irving, Calif). We used prospectively collected data from the Effectiveness of Custom Seal with Ovation: Review of the Evidence database, compromised of pooled data from 6 clinical trials and the European Post-Market Registry of patients undergoing elective infrarenal EVAR (2009-2017). We investigated the impact of short neck length (<10 mm), wide neck diameter (≥28 mm), reverse taper shape (>10%), and neck angulation (>45°) on the outcomes. The primary outcome was type IA endoleak. Secondary outcomes included any type I/III endoleak, sac expansion, aneurysm-related reinterventions, and all-cause and aneurysm-related mortality, and a combined endpoint of type IA endoleak, graft migration, AAA-related reintervention, conversion, and aneurysm rupture. We used Kaplan-Meier analysis and Cox proportional hazards models to estimate the 30 day and 5 year rates and assess univariate and risk-adjusted differences. Of the 1020 patients, 60 patients had a short neck, 113 had a wide neck diameter, 279 were reverse taper shaped, and 99 had neck angulation >45°. Wide proximal neck was associated with higher 5 year type IA endoleak estimates compared with favorable neck anatomy (7.1% vs 4.3%; p=0.02). No association with 5 year type IA endoleak was found for short neck length (1.7% vs 4.3%; p=0.52), reverse taper shape (3.2% vs 4.3%; p=0.99), or neck angulation (6.1% vs 4.3%; p=0.13). A wide neck diameter compared with favorable anatomy was also associated with higher 5 year estimates of graft migration (3.8% vs 0.4%; p=0.03) and the combined neck-related adverse outcome endpoint (16% vs 9.5%; p=0.002). The estimates of aneurysm sac expansion, rupture, and overall and aneurysm-related mortality were similar between the hostile proximal neck anatomy cohorts and favorable anatomy. Wide proximal neck is associated with higher 5 year type IA endoleak rates for patients treated with the Ovation stent graft. However, short neck length, reverse taper shape, and neck angulation are not associated with higher 5 year type IA endoleak rates. Hostile proximal neck anatomy has historically been associated with worse outcomes for endovascular aortic aneurysm repair of abdominal aortic aneurysms. The Ovation stent graft platform uses a different proximal sealing method using a polymer inflatable ring, aiming to improve sealing between the graft and aortic wall. This study demonstrated that short, angulated, and reverse taper-shaped neck anatomy did not result in increased type IA endoleak estimates in patients treated with the Ovation stent graft platform. Potentially, the different sealing mechanisms played a role in mitigating the historically worse outcomes in patients with short, angulated, and reverse taper-shaped neck anatomy.

Endovascular Abdominal Aortic Aneurysm Repair With Ovation Alto Stent Graft: Protocol for the ALTAIR (ALTo endogrAft Italian Registry) Study.

BackgroundSince 2010, the Ovation Abdominal Stent Graft System has offered an innovative sealing option for abdominal aortic aneurysm (AAA) by including a sealing ring filled with polymer 13 mm from the renal arteries. In August 2020, the redesigned Ovation Alto, with a sealing ring 6 mm closer to the top of the fabric, received CE Mark approval.ObjectiveThis registry study aims to evaluate intraoperative, perioperative, and postoperative results in patients treated by the Alto stent graft (Endologix Inc.) for elective AAA repair in a multicentric consecutive experience.MethodsAll consecutive eligible patients submitted to endovascular aneurysm repair (EVAR) by Alto Endovascular AAA implantation will be included in this analysis. Patients will be submitted to EVAR procedures based on their own preferences, anatomical features, and operators experience. An estimated number of 300 patients submitted to EVAR with Alto stent graft should be enrolled. It is estimated that the inclusion period will be 24 months. The follow-up period is set to be 5 years. Full data sets and cross-sectional images of contrast-enhanced computed tomography scan performed before EVAR, at the first postoperative month, at 24 or 36 months, and at 5-year follow-up interval will be reported in the central database for a centralized core laboratory review of morphological changes. The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with the Alto stent graft in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will be also addressed: operative time; intraoperative radiation exposure; contrast medium usage; AAA sac shrinkage at 12-month and 5-year follow-up; any potential role of patients’ baseline characteristics, valuated on preoperative computed tomography angiographic study, and of device configuration (number of component) in the primary endpoint.ResultsThe study is currently in the recruitment phase and the final patient is expected to be treated by the end of 2023 and then followed up for 5 years. A total of 300 patients will be recruited. Analyses will focus on primary and secondary endpoints. Updated results will be shared at 1- and 3-5-year follow-ups.ConclusionsThe results from this registry study could validate the safety and effectiveness of the new design of the Ovation Alto Stent Graft. The technical modifications to the endograft could allow for accommodation of a more comprehensive range of anatomies on-label.Trial RegistrationClinicalTrials.gov NCT05234892; https://clinicaltrials.gov/ct2/show/NCT05234892International Registered Report Identifier (IRRID)PRR1-10.2196/36995

Early Experience with the New Ovation Alto Stent Graft in Endovascular Abdominal Aortic Aneurysm Repair

IntroductionSince 2010, the Ovation Abdominal Stent Graft System has offered a new sealing concept, achieved by a sealing ring filled with polymer 13 mm from the renal arteries. In the latest version, called Ovation Alto, the sealing ring is relocated 6 mm closer to the top of the fabric. This study describes the early clinical outcomes, after CE Mark approval in August 2020, of endovascular aneurysm repair with the Alto endograft.ReportEleven patients underwent endovascular aneurysm repair with implantation of Ovation Alto endografts. All patients were male, and the median age was 75 (IQR 5.5) years. Hostile proximal aortic neck (<10 mm) was identified in six cases (54.5%). All procedures were performed using bilateral percutaneous approaches with no groin complications. The median procedure time was 58 (IQR 7.2) minutes, the median contrast volume used was 65 (IQR 4.2) mL, and the median blood loss 40 (IQR 12.4) mL. Technical success was achieved in all cases. The median stent graft landing distance between the top of the fabric and the lowest renal artery was 1.4 (IQR 0.8) mm. No intra-operative high flow endoleaks were registered. At one and six month follow up, there was 100% clinical success (no type I/III endoleak, sac enlargement, stent graft migration, polymer leakage, abdominal aortic aneurysm related mortality, or secondary intervention).DiscussionInitial experience confirms the early technical and clinical success of the new Ovation Alto stent graft. Technical modifications to the endograft could allow for accommodation of a more comprehensive range of anatomies on label. Further studies are needed to evaluate long term durability outcomes.

Similar 5-year outcomes between female and male patients undergoing elective endovascular abdominal aortic aneurysm repair with the Ovation stent graft

ObjectiveFemale patients undergoing endovascular aneurysm repair (EVAR) for infrarenal abdominal aortic aneurysms present with more challenging anatomy and historically have worse outcomes compared with men. The Ovation Abdominal Stent Graft platform (Endologix, Irving, Calif) contains a polymer-filled proximal sealing ring and has a low-profile delivery system, potentially beneficial in female patients. We therefore investigated differences in long-term outcomes between men and women treated with this device. MethodsWe used data collected prospectively in the Effectiveness of Custom Seal with Ovation: Review of the Evidence (ENCORE) database, comprising five trials and the European Post-Market Registry. Anatomic characteristics of the proximal aneurysm neck and iliac arteries were compared between male and female patients. Outcomes were 5-year freedom from type IA and type I/III endoleaks, abdominal aortic aneurysm-related reinterventions, and overall survival. We used Kaplan-Meier analysis to estimate survival proportions and tested univariate differences in survival using log-rank tests. Cox proportional hazards modeling was used to adjust for baseline differences. ResultsWe identified 1045 (81%) male and 251 (19%) female patients undergoing EVAR. Female patients were older (mean age, 75 ± 8.4 years vs 73 ± 8.1 years; P < .006). Aneurysm diameter (52 ± 7.5 mm vs 55 ± 9.2 mm; P < .001) and proximal neck diameter (21 ± 3.3 mm vs 23 ± 2.9 mm; P < .001) were smaller in female patients, but adjusted for body surface area, female patients had relatively larger aneurysms and aneurysm necks. Furthermore, female patients presented with shorter proximal necks, smaller iliac artery diameters, more angulated necks, and higher rates of reverse-tapered necks. Five-year freedom from type IA endoleak was similar between men and women (97% vs 96%; P = .38), as was freedom from type I/III endoleaks (91% vs 94%; P = .37) and reinterventions (91% vs 93%; P = .67). Five-year survival was 81% for female patients, similar to the 79% in male patients (P = .55), with one aneurysm-related death in female patients (0.4%) and five in male patients (0.8%; P = .76). Risk-adjusted analyses showed no association between sex and type IA endoleak (hazard ratio [HR], 1.4; 95% confidence interval [CI], 0.6-3.1; P = .41), type I/III endoleak (HR, 1.4; 95% CI, 0.7-2.8; P = .33), reintervention (HR, 1.0; 95% CI, 0.6-2.0; P = .77), and overall mortality (HR, 0.7; 95% CI, 0.4-1.1; P = .14). ConclusionsFemale patients undergoing EVAR with the Ovation platform presented with substantially more adverse proximal neck characteristics. Despite these differences, 5-year freedom from endoleaks and overall survival did not differ between sexes.

Five-year results of endovascular abdominal aortic aneurysm repair with the Ovation abdominal stent graft

ObjectiveEndovascular abdominal aortic aneurysm repair (EVAR) has been rigorously compared with open repair for the treatment of abdominal aortic aneurysms in randomized trials and observational studies, but a comparison of individual devices is lacking, and single-device registries and trials are limited by small sample size. Here we report a descriptive analysis of the Effectiveness of Custom Seal with Ovation: Review of the Evidence (ENCORE) database, pooled results of multiple studies evaluating the midterm results of EVAR with the Ovation Abdominal Stent Graft Platform. MethodsThis is a retrospective analysis of the ENCORE database, a cohort of patients undergoing EVAR with the Ovation platform composed of pooled, prospectively collected data from 1296 patients from five clinical trials and the prospectively maintained European Union Post-Market Registry. The primary outcomes were 5-year rates of type IA and type I or III endoleak. Secondary outcomes included were 30-day mortality, 30-day major adverse event, technical success (successful deployment of the aortic body and iliac limbs), as well as 5-year survival, and freedom from aneurysm-related mortality, type II endoleak, device-related intervention, aneurysm rupture, sac expansion, and conversion to open repair. ResultsA total of 1296 patients were included in the analysis. The average age was 73 ± 8 years and 81% of patients were male. Fifty percent of patients had complex aortic anatomy, (neck length <10 mm, neck diameter >28 mm, neck angle >60°, reverse neck taper >10%, distal common iliac artery diameter <10 mm, or external iliac artery diameter <6 mm). Technical success was 99.7%. Thirty-day mortality was 0.3%, 30-day rate of major adverse event was 1.6%, and polymer leak rate was 0.2%. Freedom from type IA endoleak at 1, 3, and 5 years was 97.6%, 97.1%, and 95.8%, respectively; type I or III endoleak at 1, 3, and 5 years was 96.9%, 95.7%, and 94.0%, respectively. Freedom from device-related reintervention at 1, 3, and 5 years was 96.2%, 94.4%, and 92.4% and primary freedom from sac expansion was 97.0% at 1 year, 90.3% at 3 years, and 84.9% at 5 years. Freedom from all-cause mortality and aneurysm-related mortality at 5 years were 78.9% and 99.3%, respectively. ConclusionsThis analysis of the ENCORE database demonstrates that EVAR with the Ovation platform has favorable midterm durability evidenced by successful aneurysm exclusion and 5-year freedom from aneurysm-related mortality.

PC048. Incidence and Outcomes of Anaphylactic Reaction Related to Polymer Leak With the Ovation Abdominal Stent Graft System

PC048. Incidence and Outcomes of Anaphylactic Reaction Related to Polymer Leak With the Ovation Abdominal Stent Graft System

The role of ethylene-vinyl alcohol copolymer in association with other embolic agents for the percutaneous and endovascular treatment of type Ia endoleak.

To evaluate safety, technical and clinical success of embolization of type Ia endoleak (T1a EL) using ethylene-vinyl alcohol copolymer as embolic agent alone or in combination with other materials. Five patients presented T1a EL after endovascular repair of aortic aneurysms (EVAR) with radiological evidence of expanding sac size; in particular, three had contained rupture. In one patient, proximal cuff insertion was previously performed, in three patients proximal cuff was urgently inserted but T1a EL persisted; one patient, previously treated with Ovation Abdominal Stent Graft System, was directly proposed for endovascular treatment. In all cases, endovascular embolization was successfully performed and the transfemoral approach was always chosen; in one case it failed and translumbar approach by direct puncture of the sac was required. Used embolization agents were glue, ethylene-vinyl alcohol copolymer (Onyx) and coils in three cases, n-butyl cyanoacrylate and Onyx in one case, Onyx and coils in the last case. Technical success rate was 100% as well as clinical success. No major or minor complication, including non-target embolization, was registered. Clinical success was 100% until today and the sac diameter remained stable in four patients and decreased in one. Onyx may be considered a suitable embolic agent in the treatment of patients with type Ia endoleaks after EVAR, after failure of conventional treatments such as prolonged balloon inflation of the aortic neck or deployment of large bare stent.

Endovascular Treatment of Infrarenal Aortic Aneurism with Ovation Abdominal Stent Graft System

Purpose: This case reports and describes an endovascular aneurysm repair treated with Ovation® abdominal stent graft system (Tri Vascular Inc, Santa Rosa, Calif). A seventy-four-year-old male checked in at our hospital complaining of severe abdominal pain. On his physical exam and initial image study no gastro-intestinal anomalies were found that justified the complaint. The patient was then submitted to an abdominal-pelvic computed tomography angiography where was confirmed our previous conjecture of an infrarenal aortic aneurysm. The patient was forwarded for endovascular treatment using endoprosthesis (current generation stent grafts) with an ultra-low-profile delivery system, with excellent conformability, and kink resistant iliac limbs. The patient’s development following treatment was beyond expectations with radical clinical improvement and complete relief of symptoms. The results acquired in this case supports the viability an efficiency of abdominal aortic aneurysm endovascular treatment with the ovation stent graft system to treat a wide range of anatomies, especially in difficult anatomies, such as it is in this particular case.

Endovascular aneurysm repair with the Ovation TriVascular Stent Graft System utilizing a predominantly percutaneous approach under local anaesthesia.

To present our experience with the Ovation Abdominal Stent Graft System (TriVascular Inc., Santa Rosa, CA) during endovascular aneurysm repair (EVAR) and compare results according to the type of anaesthesia. We conducted a single-centre retrospective study including patients who underwent EVAR using the Ovation endograft between May 2011 and July 2014. Outcome was evaluated regarding pre-, peri- and immediate postoperative and follow-up measures. Overall results are reported, while additional analysis was performed to compare the outcome between groups of patients undertaking either local or regional/general anaesthesia (LA vs RGA). 66 patients were included. Median follow-up was 13 months (range, 1-39 months). Median age was 72 years and median abdominal aortic aneurysm diameter was 58 mm (range, 54-100 mm). Technical success was 63 (95%), while there were 2 (3%) conversions to open surgery. A total percutaneous approach was used in 50/66 (76%) cases. Overall, 9/66 (14%) subjects suffered from any kind of morbidity. Median hospitalization was 3 days (range, 1-16 days). Immediate and midterm mortality rate was 0%. No endoleak Type I, III, IV or stent migration was observed. There were 8 (13%) Type II endoleaks. Overall, additional endovascular procedures were required in 6 (9%), while surgery was performed in 4 (6%) patients. 44 (67%) patients underwent LA and 22 (23%) RGA. Differences between groups were significant for procedural time (85 vs 107 min; p < 0.001), percutaneous access (91% vs 45%; p < 0.001) and systematic complications (2.3% vs 14%; p = 0.05). EVAR with the use of the Ovation endograft shows promising short-term and midterm results regarding safety and effectiveness. Completion of the procedures under LA using a total percutaneous approach seems advantageous and may be used in routine practice. The Ovation Abdominal Stent Graft System is an ultra-low profile stent graft system that allows percutaneous deployment for EVAR and offers excellent overall efficacy and safety. Totally percutaneous EVAR under LA seems advantageous and may be used as a routine with this specific endograft.

Inexplicable Late Type Ia Endoleak Associated With the Low-Profile Ovation Endograft in a Patient With Favorable Neck Anatomy

Purpose: To report an unusual late type Ia endoleak after endovascular aneurysm repair with a low-profile sealing ring endograft and its treatment with transcaval sac embolization. Case Report: An 82-year-old man was treated for a 47-mm abdominal aortic aneurysm associated with a 35-mm left common iliac artery aneurysm using an Ovation Abdominal Stent Graft System. Correct endograft placement was documented at 3-month follow-up. Seven months after the repair, the patient was admitted to the emergency department with acute left inguinal pain. Computed tomography showed aneurysm sac enlargement (57 mm) and a contained rupture of the left common iliac artery due to a late type Ia endoleak. The endoleak was embolized with coils and thrombin via a transcaval approach. Sac shrinkage without signs of endoleak was observed at 12-month follow-up. Conclusion: In this case, late endograft failure with sealing ring collapse created an inflow channel into the aneurysm sac, with massive type Ia endoleak.

Ultra-low profile polymer-filled stent graft for abdominal aortic aneurysm treatment: a two-year follow-up.

This study evaluated 2years of follow-up of the Ovation Abdominal Stent Graft System (TriVascular Inc., Santa Rosa, CA, USA) for endovascular repair (EVAR) of abdominal aortic aneurysms (AAAs). This retrospective multicentre study included 36 patients (median age, 73.6year) with AAAs (mean diameter, 5.65cm) treated with the Ovation stent graft and followed up for at least 2years. Safety and effectiveness of the Ovation stent graft were evaluated. Indications for EVAR were the following: AAA ≥5cm, neck length ≥7mm, angulation ≤60° and diameter <30mm; the presence of neck calcification and thrombosis was not considered a contraindication; distal iliac landing zone length of 10mm, and diameter between 5 and 20mm. Patients were treated under a common protocol, including clinical and imaging follow-up at discharge, 30days, 6months, and annually for 5years. Adverse events, clinical and imaging data and possible re-intervention were recorded. The Ovation stent graft was implanted successfully in 36 patients (100%). None of the patients required conversion to open surgery, and none presented with an aneurysm rupture. Endograft stent fracture or migration was not observed in any case. No type I, III or IV endoleaks were observed; in 12 patients (33.3%), a type II endoleak was noted, in one case with sac enlargement but not treated due to concomitant comorbidities and the patient's decision. The 2-year results of the Ovation Abdominal Stent Graft System demonstrate excellent safety and effectiveness in the treatment of patients with AAAs, particularly in those with challenging anatomical characteristics.

A Case of Difficult Catheterization of the Contralateral Limb of the Ovation Abdominal Stent Graft System in Challenging Aortoiliac Anatomy, Facilitated through the Brachial Access: A Word of Caution

The Ovation Stent Graft System is a new trimodular endoprosthesis for the treatment of abdominal aortic aneurysms. A long nitinol stent with anchors serves the suprarenal fixation, whereas inflatable rings in the main body achieve sealing. This dissociation precludes the presence of a nitinol skeleton in the endograft, thus, avoiding competing for the same space within the delivery system, enabling the latter to achieve ultra-low profiles. However, the lack of nitinol support may render the endograft's docking limb prone to collapse in cases of narrow aortoiliac anatomy. We present a case of challenging contralateral limb catheterization, facilitated effectively through the brachial access. Preparing for the brachial route remains a useful and time-sparing adjunctive measure that guarantees the device's safety and effectiveness in challenging anatomies.

One-year outcomes from an international study of the Ovation Abdominal Stent Graft System for endovascular aneurysm repair

This study evaluated 1-year safety and effectiveness outcomes of the United States regulatory trial for the Ovation Abdominal Stent Graft System (TriVascular Inc, Santa Rosa, Calif) for endovascular repair of abdominal aortic aneurysms (AAAs). This prospective, multicenter, single-arm trial was conducted at 36 sites in the United States, Germany, and Chile to evaluate the safety and effectiveness of the Ovation stent graft. From November 2009 to May 2011, 161 patients (88% males; mean age, 73 ± 8 years) with AAAs (mean diameter, 54 ± 9 mm) were treated with the Ovation stent graft. The main body is a modular two-docking limb device with a 14F outer diameter delivery system, active suprarenal fixation, and polymer-filled proximal rings that accommodate the aortic neck for seal. Main inclusion criteria included proximal aortic neck length ≥ 7 mm, inner neck diameter between 16 and 30 mm, distal iliac landing zones length ≥ 10 mm, and diameter between 8 and 20 mm. Patients were treated under a common protocol, including clinical and imaging follow-up at discharge, 30 days, 6 months, and annually through 5 years. A Clinical Events Committee adjudicated adverse events, an independent imaging core laboratory analyzed imaging, and a Data Safety and Monitoring Board provided study oversight. Complete 1-year follow-up data were available for this report. The Ovation stent graft was implanted successfully in 161 patients (100%), including 69 (42.9%) by percutaneous access. General anesthesia was used in 106 patients (65.8%). Technical success was 100%, and mean procedure time was 110 minutes. Median procedural blood loss was 150 mL, and median hospital stay was 1 day. The 30-day major adverse event rate was 2.5%. At 1 year, AAA-related and all-cause mortality were 0.6% and 2.5%, respectively. Major adverse event and serious adverse event rates through 1 year were 6.2% and 38.5%, respectively. The 1-year treatment success rate was 99.3%. The imaging core laboratory reported no stent graft migration or type I, III, or IV endoleaks. At 1 year, type II endoleaks were identified in 34% of patients, and AAA enlargement was identified in one patient (0.7%). No AAA rupture or conversion to open surgery was reported. AAA-related secondary procedures were performed in 10 patients (6.2%) for 12 findings, including endoleak (six), aortic main body stenosis (three), and iliac limb stenosis or occlusion (three). The 1-year results of the Ovation Abdominal Stent Graft System demonstrate excellent safety and effectiveness in treatment of patients with AAAs, particularly in patients with challenging anatomic characteristics, including short aortic necks and narrow iliac arteries. Longer-term follow-up is needed.