Talent Endograft Research Articles

Infrarenal endovascular aneurysm repair with large device (34- to 36-mm) diameters is associated with higher risk of proximal fixation failure

ObjectiveEndovascular aneurysm repair (EVAR) has become the standard of care for infrarenal aneurysms. Endografts are commercially available in proximal diameters up to 36 mm, allowing proximal seal in necks up to 32 mm. We sought to further investigate clinical outcomes after standard EVAR in patients requiring large main body devices. MethodsWe performed a retrospective review of a prospectively maintained database for all patients undergoing elective EVAR for infrarenal abdominal aortic aneurysms at a single institution from 2000 to 2016. Only endografts with the option of a 34- to 36-mm proximal diameter were included. Requisite patient demographics, anatomic and device-related variables, and relevant clinical outcomes and imaging were reviewed. The primary outcome in this study was proximal fixation failure, which was a composite of type IA endoleak and stent graft migration >10 mm after EVAR. Outcomes were stratified by device diameter for the large-diameter device cohort (34-36 mm) and the normal-diameter device cohort (<34 mm). ResultsThere were 500 patients treated with EVAR who met the inclusion criteria. A total of 108 (21.6%) patients received large-diameter devices. There was no difference between the large-diameter cohort and the normal-diameter cohort in terms of 30-day (0.9% vs 0.95%; P = .960) or 1-year mortality (9.0% vs 6.2%; P = .920). Proximal fixation failure occurred in 24 of 392 (6.1%) patients in the normal-diameter cohort and 26 of 108 (24%) patients in the large-diameter cohort (P < .001). There were 13 (3.3%) type IA endoleaks in the normal-diameter cohort and 16 (14.8%) in the large-diameter cohort (P < .001). Stent graft migration (>10 mm) occurred in 15 (3.8%) in the normal-diameter cohort and 16 (14.8%) in the large-diameter cohort (P < .001). After multivariate analysis, only the use of Talent (Medtronic, Minneapolis, Minn) endografts (odds ratio [OR], 4.50; 95% confidence interval [CI], 1.18-17.21) and neck diameter ≥29 mm (OR, 2.50; 95% CI, 1.12-5.08) remained significant independent risk factors for development of proximal fixation failure (OR, 3.99; 95% CI, 1.75-9.11). ConclusionsStandard EVAR in patients with large infrarenal necks ≥29 mm requiring a 34- to 36-mm-diameter endograft is independently associated with an increased rate of proximal fixation failure. This group of patients should be considered for more proximal seal strategies with fenestrated or branched devices vs open repair. Also, this group likely needs more stringent radiographic follow-up.

Laser Fenestration of Aortic Stent-Grafts Followed by Noncompliant vs Cutting Balloon Dilation: A Scanning Electron Microscopy Study

Purpose: To examine the effects of in situ laser fenestration and subsequent balloon dilation (noncompliant vs cutting) on the graft fabric of 4 aortic stent-graft models. Method: In an in vitro setup, the Zenith TX2, Talent, Endurant, and Anaconda aortic stent-grafts (all made of polyester graft material) were subjected to laser fenestration with a 2.3-mm-diameter probe at low and high energy in a physiologic saline solution followed by balloon dilation of the hole. For the first series of tests, 6-mm-diameter noncompliant balloons were used and replaced for the second series by 6-mm-diameter cutting balloons. Each procedure was performed 5 times (5 fenestrations per balloon type). The fenestrations were examined visually and with light and scanning electron microscopy. Results: Each fenestration demonstrated various degrees of fraying and/or tearing regardless of the device. The monofilament twill weave of the Talent endograft tore in the warp direction up to 7.09±0.46 mm at high energy compared with 2.41±0.26 mm for the Endurant multifilament device. The fenestrations of the 3 endografts with multifilament weave (Zenith, Anaconda, and Endurant) showed more fraying; fenestration areas in the multifilament Endurant were >10 mm2 at low and high energy. The fenestrations were free of melted fibers, but minor blackening of the filaments was observed in all devices. Overall, the cutting balloons resulted in worse tearing and damage. Of note, the edges of the dilated laser-formed fenestrations of the Talent and the Endurant grafts demonstrated evidence of additional shredded yarns. Conclusion: In situ fenestration does not cause any melting of the polyester; however, the observed structural damage to the fabric construction must be carefully considered. Cutting balloons caused various levels of tearing compared to the noncompliant balloons and cannot be recommended for use in this application. Rather, noncompliant balloons should be employed, but only with endografts constructed from multifilament yarns. The use of in situ fenestration must be restricted to urgent and emergent cases until long-term durability can be determined.

Evaluation of endovascular abdominal aortic aneurysm repair in nonagenarians

The aim of this study was to investigate the safety and efficacy of endovascular abdominal aortic aneurysm repair (EVAR) in nonagenarians. From May 2003 to March 2011, 12 nonagenarian abdominal aortic aneurysm patients were treated with endovascular repair including two emergencies. The mean age of patients was 92.5 ± 1.6 years (range: 90-95 years), and 11 of the patients (91.7%) were men. Technical success, perioperative complications, and mortality were evaluated. The follow-up protocol consisted of computed tomography angiograms or ultrasounds performed at 3, 6, 9, and 12 months, and annually thereafter. Seven patients were operated under general anesthesia and five under local anesthesia. There was 100% technical success with no need for open conversion. The endografts used included two Endurant endografts, four Talent endografts, and six Zenith endografts. The mean operative time was 3.4 ± 1.3 h, mean procedural blood loss was 150.5 ± 60.5 mL, and mean postoperative length of stay was 8.4 ± 2.3 days. Mortality rates were 8.3% at 30 days, 16.7% at 1 year, 41.7% at 3 years, and 75% at 5 years. The mean survival of the 11 patients who expired beyond the first 30 days was 28.5 months (range: 9-73 months). Overall, EVAR in nonagenarians was associated with acceptable procedural success and perioperative morbidity and mortality. The medium and long-term results suggested that EVAR may be of limited benefit in some patients who are aged >90 years. Therefore, individual patient selection is very important.

Treatment of a type IIIb endoleak in a Talent endograft using telescoping cuffs and two parallel upside-down excluder contralateral legs

We describe a case of a type IIIb endoleak arising from the main body of a Talent endograft that was treated using two telescoping cuffs and two parallel upside-down inserted Excluder contralateral legs, thereby creating a new bifurcating endograft. First, a 23-mm cuff was deployed onto the flow divider of the Talent endograft, followed by a second 28-mm cuff below the renal arteries creating a tapering lumen. Two 20-mm Excluder contralateral limbs were then positioned upside-down in the 23-mm cuff and deployed simultaneously, creating a new bifurcated prosthesis. Control computed tomography (CT) scan at 6 weeks showed a good position of the endografts without signs of an endoleak. In conclusion, a type IIIb endoleak at the level of the flow divider may successfully be excluded using two telescoping cuffs and two parallel upside-down contralateral Excluder limbs. Due to the rarity of this complication, the treatment will always have to be tailor-made.

Technical and Clinical Outcome of Talent versus Endurant Endografts for Endovascular Aortic Aneurysm Repair

ObjectiveThe technical evolution of endografts for the interventional management of infrarenal abdominal aortic aneurysms (AAA) has allowed a continuous expansion of indications. This study compares the established Talent endograft with its successor, the Endurant endograft, taking individual aortoiliac anatomy into account.MethodsFrom June 2007 to December 2010, 35 patients with AAA were treated with a Talent endograft (33 men) and 36 patients with an Endurant endograft (34 men). Aortoiliac anatomy was evaluated in detail using preinterventional computed tomography angiography. The 30-day outcome of both groups were compared regarding technical and clinical success as well as complications including endoleaks.ResultsThe Endurant group included more patients with unfavorable anatomy (kinking of pelvic arteries, p = 0.017; shorter proximal neck, p = 0.084). Primary technical success was 91.4% in the Talent group and 100% in the Endurant group (p = 0.115). Type 1 endoleaks occurred in 5.7% of patients in the Talent group and in 2.8% of those in the Endurant group (p = 0.614). Type 3 endoleaks only occurred in the Talent group (2.9% of patients; p = 0.493). Type 2 endoleaks were significantly less common in the Endurant group than in the Talent group (8.3% versus 28.6%; p = 0.035). Rates of major and minor complications were not significantly different between both groups. Primary clinical success was significantly better in the Endurant group (97.2%) than in the Talent group (80.0%) (p = 0.028).ConclusionEndurant endografts appear to have better technical and clinical outcome in patients with difficult aortoiliac anatomy, significantly reducing the occurrence of type 2 endoleaks.

Evaluation of Patient Renal Function Following Endovascular Aneurysm Repair with Suprarenal Fixation

This study aimed to assess the mid-term renal function of abdominal aortic aneurysm patients following suprarenal endovascular repair. From March 2005 to December 2009, 290 abdominal aortic aneurysm patients were included in the study and grouped according to whether they had received infrarenal or suprarenal endovascular aneurysm repair. Suprarenal endovascular aneurysm repair was performed in 173 patients, with a mean age of 72(±8) years (85.0% male). Infrarenal endovascular aneurysm repair was performed in 117 patients, with a mean age of 71(±9) years (90.6% male). Preoperative and one week, 1-, 3-, 6- and 12-month postoperative serum creatinine and cystatin C values were recorded. Estimated glomerular filtration rate was calculated by cystatin-based formula and Cr-based Cockcroft formula. The t-test was used to determine statistical differences between or within groups. All patients received Talent or Zenith endograft. Patients’ characteristics and operative files in the two groups were well matched. Preoperative serum creatinine and cystatin C were 82 (±8) mmol/L and 0.89 (±0.11) mg/L for suprarenal endovascular aneurysm repair, respectively, and 81 (±11) mmol/L and 0.87 (±0.15) mg/L, respectively, for infrarenal endovascular aneurysm repair; no differences were observed between the two groups. Compared to preoperative renal markers within each group, a deterioration in serum creatinine, cystatin C and estimated glomerular filtration rate values was found at one week and 12 months after surgery（p &lt; 0.05). A deterioration in cystatin C [SR:(0.93 ± 0.17) mg/L, IR: (0.92 ± 0.31) mg/L] and estimated glomerular filtration rate by cystatin C was also found at six months after surgery（p &lt; 0.05). However, no differences in patient serum creatinine, cystatin C and estimated glomerular filtration rate values were observed between groups at each follow-up time interval. There was no greater significant difference in the association of the use of suprarenal fixation with midterm postoperative renal injury than with infrarenal fixation.

Long-term outcomes of endovascular aneurysm repair for challenging aortic necks using the Talent endograft

The aim of the present paper is to evaluate the long-term outcomes of endovascular aneurysm repair (EVAR) for challenging aortic necks. Subgroup analyses were performed on 156 patients from the prospective multicenter Talent eLPS (enhanced Low Profile Stent Graft System) trial. Patients with high-risk aortic necks (length < 15 mm or diameter ≥28 mm) were compared with the remaining patients. Patients with high-risk (n = 86) and low-risk necks (n = 70) had similar age and gender distribution. Despite similar prevalences of co-morbidities, the high-risk group had higher Society for Vascular Surgery scores. The high-risk group also had larger maximum aneurysm diameters (56.6 versus 53.0 mm, P < 0.02). There were lower freedoms from major adverse events (MAEs) for the high-risk group at 30 days (84.9 versus 95.7%; P < 0.04) and 365 days (73.4 versus 89.2%; P = 0.02). Effectiveness endpoints at 12 m showed no significant differences. Freedom from all-cause mortality at 30 days (96.5 versus 100%) and aneurysm-related mortality at 365 days (96.0 versus 100%) were similar. At five years, there were no differences in endoleaks or change in aneurysm diameter. All migrations occurred in the high-risk group. The five-year freedom from aneurysm-related mortality for the high- and low-risk groups was 93.2 and 100%, respectively. In conclusion, despite a higher rate of MAEs within the first year and higher migration rates at five years, EVAR in aneurysms with challenging aortic necks can be treated with acceptable long-term results.

Endovascular debranching of the aortic arch during thoracic endograft repair

Treatment of complex thoracic aortic pathology increasingly requires coverage of one or more aortic arch vessels. Endovascular debranching with a chimney technique can reduce or eliminate the need for surgical bypass. In this study, we evaluate our initial experience with planned endovascular debranching of the aortic arch. During a 13-month period, nine patients were treated with endovascular debranching during thoracic endograft placement. Balloon expandable (n = 7) or self-expanding stents (n = 2) were deployed (innominate, n = 2; left common carotid, n = 2; left subclavian, n = 5) along with either TAG (W. L. Gore, Flagstaff, Ariz; n = 8) or Talent (Medtronic, Minneapolis, Minn; n = 1) endografts. Four patients required six surgical bypasses to additional arch vessels (right to left common carotid artery, n = 2; left common carotid to subclavian artery, n = 4). Indications for thoracic endograft placement were aortic transection (n = 4), aortic aneurysm (n = 2), aortotracheal fistula (n = 1), contained aortic aneurysm rupture (n = 1), and acute aortic dissection (n = 1). Endografts were deployed into zones 0 (n = 2), 1 (n = 2), and 2 (n = 5). Technical success of endovascular debranching was attained in eight of nine patients, with maintenance of branch perfusion and absence of endoleak. Perioperative morbidity included one myocardial infarction and one stroke that resulted in the patient's death. During subsequent follow-up (range, 2-25 months), there were no instances of endoleak secondary to chimney stents. All debranched vessels maintained primary patency. Endovascular debranching permits planned extension of the thoracic endograft over arch vessels while further minimizing the need for open reconstruction. Short-term results indicate technical feasibility of this approach. Long-term outcomes remain undefined.

Preliminary results of endurant stent grafts and comparison with talent stent grafts

Background: In the present study, we compared early results of Endurant (Medtronic) stent grafts used in the treatment of abdominal aortic aneurysms with Talent (Medtronic) endografts. Methods: In 12 patients (1 female, 11 males; mean age 74 years; range 59 to 86 years) treated with the Endurant stent grafts between January 2009 and February 2010, the outcomes of technical success, endoleak and perioperative mortality rates were documented. These patients were treated with indications of infrarenal aneurysms (n=10), penetrating atherosclerotic ulcer (n=1) or ruptured iliac aneurysm (n=1). These results were compared with 23 patiens (2 females, 21 males; mean age 72; years; range 61 to 82 years) whose abdominal aortic aneurysms were treated with the Talent endografts between November 1994 and January 2009. Results: Technical success was achieved in the 12 patients with the Endurant stent grafts. In nine of these 12 patients aortobiiliac tube grafts and in the remaning three patients tube grafts were used. No endoleak was detected at the early postoperative control computed tomography angiography. Aneurysm diameters were 51-72 mm, aneurysm necks were 10-20 mm and aneurysms neck angulations were measured as 0-90 degrees. Neither aneurysmal nor conversion to open repair-related deaths have been observed over 30 days. In the Talent group, the aneurysm diameters were 50-80 mm, aneurysm necks were 8-25 mm and aneursym angulations were measured as 0-60 degrees. In the Talent group four aortouniiliac and 19 aortobiiliac grafts were used. In these 23 patients two type 1 leaks were treated with a proximal cuff and two type 2 leaks disappeared during the follow-up. Conclusion: The newly developed Endurant stent graft with a low profile can be delivered and deployed in angulated necks and stenotic iliac vessels. However, it should be assessed with long-term follow-ups in terms of graft migration and patency.

Total percutaneous endovascular abdominal aortic aneurysm repair

To determine the safety and efficacy of total percutaneous endovascular abdominal aortic aneurysm repair using the Perclose ProGlide suture-mediated closure system. From May 2008 to April 2010, 36 abdominal aortic aneurysm patients were undergone total percutaneous endovascular repair. There were 30 male and 6 female patients with a mean age of 68 years. Endografts used included 3 Endurant endografts, 13 Talent endografts, and 20 Zenith endografts. Prior to insertion of the introducer sheath, two ProGlides were pre-set to 18 to 24 F access sites and one to 14 to 16 F access sites. At last, suture the arteriotomy by tying down knots of the ProGlide following removal of the sheath. Technical success, complications, and procedure and access closure times were evaluated. Follow-up protocol consisted of computed tomography angiograms performed at 3, 6, 9, 12 months, and annually thereafter. Twenty patients were operated under local anesthesia and 16 patients under general anesthesia. A total of 68 femoral arteries were closed with 128 devices. Thirty-eight vessels were with 2 devices, while 8 arteries required 3 devices and 2 arteries required 4 devices for hemostasis and an additional 20 vessels only required a single device. Sixty-three (63/68, 92.6%) vessels were closed successfully. Two vessels converted to open closure. Three vessels complicated with hematomas without surgical procedure. The mean follow-up was (12±3) months. There was one asymptomatic femoral artery dissection 3 months after operation. Total percutaneous endovascular abdominal aortic aneurysm repair is safe and effective. But it should be performed at hybrid operating room where can convert to open procedure if necessary.

Long-term results of Talent endografts for endovascular abdominal aortic aneurysm repair

Since the introduction of endovascular aneurysm repair (EVAR), long-term follow-up studies reporting single-device results are scarce. In this study, we focus on EVAR repair with the Talent stent graft (Medtronic, Santa Rosa, Calif). Between July 2000 and December 2007, 365 patients underwent elective EVAR with a Talent device. Patient data were gathered prospectively and evaluated retrospectively. By American Society of Anesthesiologists category, 74% were categories III and IV. Postoperative computed tomography (CT) scanning was performed before discharge, at 3, 12 months, and yearly thereafter. Data are presented according to reporting standards for EVAR. The mean proximal aortic neck diameter was 27 mm (range, 16-36 mm), with a neck length <15 mm in 31% (data available for 193 patients). Deployment of endografts was successful in 361 of 365 patients (99%). Initially, conversion to laparotomy was necessary in four patients. Primary technical success determined by results from computed tomography (CT) scans before discharge was achieved in 333 patients (91%). Proximal type I endoleaks were present in 28 patients (8%) during follow-up, and 14 of these patients needed additional treatment for type I endoleak. The 30-day mortality for the whole Talent group was 1.1% (4 of 365). Follow-up to 84 months is reported for 24 patients. During follow-up, 122 (33%) patients died; in nine, death was abdominal aortic aneurysm (AAA)-related (including 30-day mortality). Kaplan-Meier estimates revealed primary clinical success rates of 98% at 1 year, 93% at 2 years, 88% at 3 years, 79% at 4 years, 64% at 5 years, 51% at 6 years, and 48% at 7 years. Secondary interventions were performed in 73 of 365 patients (20%). Ten conversions for failed endografts were performed. Life-table yearly risk for AAA-related reintervention was 6%, yearly risk for conversion to open repair was 1.1%, yearly risk for total mortality was 8.9%, and yearly risk for AAA-related mortality was 0.8%. Initially, technical success of endovascular aneurysm repair (EVAR) using the Talent endograft is high, with acceptable yearly risk for AAA-related mortality and conversion. However, a substantial amount of mainly endovascular reinterventions is necessary during long-term follow-up to achieve these results.

A 5-Year Comparison of EVAR for Large and Small Aortic Necks

To compare the long-term outcomes of endovascular aneurysm repair (EVAR) using the Talent endograft for abdominal aortic aneurysms (AAAs) with large and small aortic necks. Data on 156 patients (142 men; mean age 74.1 years, range 41-89) with adequate preoperative imaging were obtained from the prospective, nonrandomized, multicenter Talent eLPS trial, which enrolled patients from February 2002 to April 2003. Subgroup analyses were performed for AAAs with a large aortic neck diameter (≥28 mm; n=53, group 1) and those with smaller necks (<28 mm; n=103, group 2). Safety and effectiveness endpoints were evaluated at 30 days, 1 year, and 5 years post procedure. Patients in both groups had similar gender and risk factor profiles. However, group 1 was significantly older (mean age 76.5 versus 72.9 years; p<0.01). Aside from neck diameter, the 2 groups had similar mean neck length and angulation. Group 1 also had a larger maximum aneurysm diameter (mean 58.2 versus 53.4 mm; p<0.01). At 1 year, the 2 groups had similar effectiveness endpoint results. There was a significantly lower freedom from major adverse events (MAEs) for group 1 at 30 days (79.2% versus 95.1%; p<0.01). While this trend continued to 1 year, the difference lost statistical significance (72.0% versus 85.1%; p=0.08). Freedom from all-cause mortality at 30 days (94.4% versus 100%; p<0.04) and aneurysm-related death at 1 year (93.3 versus 100%; p<0.04) also was significantly lower for group 1. At 5 years, there were no significant differences in the rates of endoleaks or aneurysm changes. The 5-year rates for freedom from aneurysm-related mortality for groups 1 and 2 were 91.2% and 98.7% (p=NS), respectively. There were 5 instances of migration in this study, all occurring in group 1 patients. AAAs with aortic necks ≥28 mm can be treated with endovascular devices with acceptable results at 5 years. However, these patients have a higher rate of MAEs within the first year and higher migration rates at 5 years. In addition, they have a lower freedom from all-cause mortality at 30 days and aneurysm-related death at 1 year. Careful patient selection, accurate device deployment, and continued follow-up are necessary to optimize long-term results in this patient population.

Significance of Initial Aortic Aneurysm Pressure Sensor Readings Varies with Aortic Endograft Design

The differences in implantable pressure sensor aneurysm sac readings were compared following endovascular aneurysm repair (EVAR) among three different stent grafts. From January 2006 to March 2009, 51 aortic stent grafts were implanted along with the Endosure sensor. Grafts used were Zenith, Talent, and Excluder. In the present retrospective study, pulse ratios were measured intraoperatively before and after aneurysm sac exclusion and in follow-up (within 30days). Analysis of variance was used to determine significance. The average aneurysm size that was repaired was 5.75cm (range: 4-8.5cm); 41 patients (80.4%) being male with an average age of 76.3years (range: 58-90years). Thirty-four grafts were Zenith, 9 were Talent, and 8 were Excluder. The average pre-aneurysm exclusion pulse ratios for the Zenith, Talent, and Excluder were 1.00, 1.08, and 0.95 (p=0.18), respectively. The average post-aneurysm exclusion pulse ratios were 0.34, 0.67, and 0.35, respectively (p=0.003). Pulse ratios at the time of follow-up (within 30days) were 0.17, 0.22, and 0.11, respectively (p=0.44). Nine of 51 (17.6%) patients had a reduction of pulse ratio of less than 30% after endograft implantation. Five of those 9 patients (55.5%) had the Talent endograft, although there was no angiographic evidence of endoleak. The Talent graft has significantly higher pulse ratios following endograft implantation despite having no angiographic evidence of endoleak when compared to the Zenith and Excluder grafts. However, the pulse ratios decreased to levels similar to Zenith and Excluder within 30days of endograft implantation. This suggests that the Talent endograft may have increased porosity initially. If pulse ratios do not appropriately decrease immediately after device implantation, further angiographic imaging may not be necessary if no obvious endoleak is seen.

A 5-Year Evaluation Using the Talent Endovascular Graft for Endovascular Aneurysm Repair in Short Aortic Necks

Although endovascular aneurysm repair has been shown to be an effective way to treat abdominal aortic aneurysm (AAA), certain anatomic characteristics such as a short aortic neck, limit its applicability. Initially, commercially available devices were approved only for the treatment of AAA with an aortic neck length ≥ 15 mm. The purpose of this study was to evaluate the outcomes of the recently approved Talent endograft for AAAs with a short aortic neck length (10-15 mm). Data were obtained from the prospective, nonrandomized, multicenter Talent enhanced Low Profile Stent Graft System trial which enrolled patients between February 2002 and April 2003. A total of 154 patients with adequate preoperative imaging were identified for this study. Subgroup analyses were performed for AAA with 10-15 mm aortic neck and those with >15 mm neck. Safety and effectiveness endpoints were evaluated at 30 days, 1 year, and 5 years postprocedure. Patients treated with aortic neck lengths of 10-15 mm (n = 35) and those with >15 mm (n = 102) had similar age, gender, and risk factor profile. Both groups had similar preoperative aneurysm morphology in terms of maximum aneurysm size, degree of neck angulation, or proximal neck diameter. There were no statistically significant differences in freedom from major adverse events and mortality rates at 30 and 365 days. Similarly, there was no difference in the effectiveness endpoints at 12 months. At 5 years, there was no difference in migration rate, endoleaks, or change in aneurysm diameter from baseline. In addition, there is no difference in freedom from aneurysm-related mortality (94% vs. 99%). AAAs with short aortic necks (10-15 mm) and otherwise suitable anatomy for endovascular repair can be safely and effectively treated with the Talent endograft with excellent 1 and 5 year outcomes.

PS20. Long-term Results of Talent Endografts for Endovascular Abdominal Aortic Aneurysm Repair

Since introduction of EVAR, long-term follow-up studies reporting single device results are scarce. In this study we focus on the Talent® endograft. Between July 2000 and December 2007 366 patients underwent elective EVAR repair. Patient data were gathered prospectively and retrospectively evaluated. 74% of the patients were diagnosed ASA III and IV. Postoperative CT-scanning was performed before discharge, 6, 12 months and yearly thereafter. Data are presented according to reporting standards for EVAR (Chaikof et.al, J VS 2002) Mean proximal aortic neck diameter was 27 mm, with a neck length ≤15 mm in 31% (data available for 193 cases). Deployment of endografts was successful in 99% (362/366) of patients. Initially conversion to laparotomy was necessary in 4 cases. Primary technical success based upon results from CT-scans before discharge was achieved in 91% (332/366). 8% (28/366) patients had proximal type 1 endoleaks; during follow-up 14/28 patients needed additional treatment. 30-day mortality was 1.4% (5/366). Follow-up is reported till 84 months (n = 24 at 84 months). 34% (123/366) patients died during follow-up. In five patients mortality was AAA related (2 ruptured). Kaplan Meier estimates revealed primary clinical success rates of 98% at 1 year, 93% at 2 years, 88% at 3 years, 79% at 4, 64 % at 5 years, 51% at 6 years and 48% at 7 years, respectively. Secondary interventions had to be performed in 18% (66/366) of patients. Ten open conversions for failed endografts were performed. Life table yearly risk for AAA related reintervention was 6%, yearly risk for conversion 1.1%, and yearly risk for AAA-related mortality was 0.8%. Initially technical success of EVAR using the Talent endograft is high, with low yearly risk for AAA-related mortality and conversion. However, a substantial amount of -mainly endovascular- reinterventions is necessary during long-term follow-up to achieve these results

Twelve-year outcomes after endovascular aneurysm repair using earliest available endograft components from a single center

Comprehensive long-term outcome data after endovascular aneurysm repair (EVAR) are scarce, although anecdotes of endograft failure in the early 1990s abound. The objective of this report is to provide comprehensive outcomes after EVAR performed with the earliest available endograft components. These were a home-made endograft (pre-expanded polytetrafluoroethylene [PTFE] fixed with giant Palmaz stents) and first-generation Talent endografts (World Medical, Sunrise, Fla). A prospectively recorded database of all cases undertaken at a tertiary referral center was retrospectively interrogated. Sex, age, types of endograft used, and fate of patient and endografts implanted between 10 and 15 years previously were studied. A literature search was undertaken to obtain data for long-term survival after EVAR and open surgery (OR). There were 50 patients in total operated on between 1994 and 1998 of whom 43 were male. The median age was 73 years (54-93) at time of EVAR and 85 years (67-100) in the survivors at a median of 12 years later. There were 26 home-made (PTFE fixed with Palmaz stents) and 24 Talent endografts (World Medical). Thirty-day mortality was 4%, one death in a ruptured abdominal aortic aneurysm. Twenty-one (42%) survived for 12 years to the time of reporting. Of these, 6 have functioning home-made endografts, 8 have Talent endografts, and 8 (5 home-made and 3 Talent) survive after conversion to OR. Secondary interventions took place in 9 further patients. Of 27 late deaths, 1 suffered endograft sepsis, 20 died of cardio-respiratory causes and 6 died of cancer. The only report of more than a 10-year survival after OR was found in an e-publication from Sweden. The projected survival after 10 years was 40% for unruptured aneurysms. However, survival in the general population was higher at 60%. Ten-year survival after EVAR parallels that of elective OR but is less than the general population. Although the rate of eventual conversion to open repair was high using this earliest available endograft technology, the aneurysm-related mortality was low, and both endografts remain functional for more than 10 years after placement.

Aortic Compliance Following EVAR and the Influence of Different Endografts:Determination Using Dynamic MRA

To utilize dynamic magnetic resonance angiography (MRA) to characterize aortic stiffness (beta) and elastic modulus (Ep) as indexes of wall compliance during the cardiac cycle and determine any influence of different endograft designs or the presence of endoleaks on these indexes. Eleven consecutive patients (11 men; median age 74 years, range 63-78) with abdominal aortic aneurysm (AAA) selected for endovascular repair were scanned pre- and postoperatively. Aortic area and diameter changes during the cardiac cycle were determined using dynamic MRA at 4 levels: 3 cm above the renal arteries, between the renal arteries, 1 cm below the renal arteries, and at the level of maximum aneurysm sac diameter. Ep and beta were calculated. Data are presented as median (range); p<0.05 was considered significant. Preoperatively, Ep and beta were significantly higher at the level of the aneurysm sac compared to all other levels (p<0.05). Following EVAR, stiffness increased at this level (p<0.05). After implantation, patients with an Excluder endograft demonstrated Ep and beta measurements at the aneurysm neck that were 94% and 60% higher, respectively, compared to those with a Talent (p<0.05) endograft. The presence of an endoleak had no effect on Ep or beta. This study introduces the feasibility of dynamic MRA imaging-based calculations of aortic elastic modulus and stiffness. AAA patients demonstrate increased Ep and beta at the level of the aneurysm sac. EVAR results in increased aneurysm sac Ep and beta. Stent-graft design seems to alter Ep and beta within the aneurysm neck, which may have consequences for endograft durability. The presence of an endoleak does not seem to have an effect on Ep or beta.

Long-term outcome after Talent endograft implantation for aneurysms of the abdominal aorta: A multicenter retrospective study

The development of newer-generation endografts for the endovascular treatment of abdominal aortic aneurysms has resulted in considerable improvements in clinical performance. However, long-term outcome data are still scarce. To assess long-term clinical and radiographic outcomes after use of the Talent stent graft, a retrospective analysis was performed that was based on 165 patients treated with this endograft in Germany between October 1996 and December 1998. Data were collected according to the recommendation of the ad hoc committee for standardized reporting practices in vascular surgery and were evaluated statistically by using univariate and multivariate analyses. A total of 165 patients were treated with a Talent endograft in 9 German centers before December 31, 1998. Most were asymptomatic (94.5%), male (97.6%), and treated with a bifurcated graft (86.7%). Two patients (1.2%) died within 30 days, and 28 (17%) died during the follow-up period. The cause of death was aneurysm rupture in one case. Survival was 95.4% +/- 1.7% at 1 year, 89% +/- 2.6% at 2 years, 78.1% +/- 3.6% at 5 years, and 76.2% +/- 4.1% at 7 years. Patients classified as American Society of Anesthesiologists grade IV had a significantly lower survival rate (24.9%) than those classified as American Society of Anesthesiologists grade II and III (91.9% and 77.3%). During a mean follow-up period of 53.2 +/- 20.1 months (range, 1-84 months), 47 secondary procedures were performed in 31 patients (18.8%). Kaplan-Meier estimates showed a freedom from secondary intervention of 94.7% +/- 1.8%, 81.7% +/- 3.3%, and 77.4% +/- 3.6% at 1, 3, and 7 years, respectively. The reason for secondary treatment was endograft thrombosis in 10 patients (6.1%), persisting primary endoleak in 9 (5.5%), late secondary endoleak in 6 (3.6%), graft migration in 3 (1.8%), aneurysm rupture in 2 (1.2%), and graft infection in 1 (0.6%). Device migration (> or =10 mm) occurred in seven patients (4.2%). Other graft changes, such as graft kinking (n = 4; 2.4%), fracture of metallic stents (n = 2; 1.2%), erosion of the longitudinal bar (n = 2; 1.2%), or modular component separation (n = 1; 0.6%), were rare. Follow-up computed tomographic imaging revealed a decrease of the maximum aneurysm sac diameter (>5 mm) in 106 (64.2%) patients and an increase in 14 (8.5%) patients. The mean aneurysm diameter significantly decreased (P < .001). Of the factors recorded at baseline, only endoleaks showed a significant correlation with the risk of aneurysm increase during follow-up (P < .001). Adverse anatomy (neck diameter >28 mm, neck length <15 mm, and '5 patent aortic branches) did not adversely influence the aneurysm shrinkage rate, the risk for a secondary procedure, or the clinical success rate. A significantly higher rate of clinical success (P < .05) was observed in patients older than 65 years of age. Implantation of the Talent endograft device is a safe and effective alternative to open surgery for exclusion of abdominal aortic aneurysm. In comparison with first-generation grafts, the device showed superior durability for as long as 5 to 7 years after implantation. Even if prototypes of the Talent device were implanted in this study, the graft was also successfully used in most patients, even in those with adverse anatomy. Because improvements of the endograft have been made to address connecting bar breaks, a lower incidence of graft limb occlusion can be expected in the future.

Detection of endograft fractures with multidetector row computed tomography

Delayed endograft metallic strut failures detected in vivo with multidetector row computed tomography (MDCT) are reported in two patients who underwent endovascular abdominal aortic aneurysm repair with AneuRx and Talent endografts. In both instances, nitinol fractures were associated with proximal migration and type I endoleak. In both cases, the metallic strut fractures were detected with transverse sections from 16-channel MDCT angiograms and confirmed by using volume rendering. These cases highlight the previously unreported ability of thin-section, high-resolution MDCT angiography to detect endograft strut fractures.

Suprarenal Endograft Fixation Avoids Adverse Outcomes Associated with Aortic Neck Angulation

The advent of endovascular therapy has had a profound impact on repair of abdominal aortic aneurysms (AAA). Prudent patient selection, particularly in regard to unfavorable anatomy, is emerging as perhaps the most important determinant of endovascular abdominal aortic aneurysm repair (EVAR) outcome. The aim of this study was to examine the association of one such anatomic factor, proximal aortic neck angulation, with the incidence of adverse events following EVAR. Prospectively collected data on 289 EVAR repairs with the Talent endograft (Medtronic, Inc., Minneapolis, MN) from March 1998 to June 2000 were analyzed. Stent graft-specific adverse events studied were migration, endoleak, kinking, thrombosis, and AAA expansion. Computed tomography (CT) scanning with three-dimensional post-processing and/or aortography was used to measure aortic neck angle. Patients were categorized into one of four groups according to their neck angle: I (0-10 degrees); II (11-39 degrees); III (40-59 degrees); or IV (60-85 degrees). Outcomes were evaluated by chi-squared analysis and ANOVA. There was a direct correlation between AAA diameter and neck angle (p = 0.002). There was no difference in endoleak rate (p = 0.877), stent migration (p = 0.850), or AAA expansion rate (p = 0.599) between groups. Device kinking >45 degrees was associated with neck angulation > or = 60 degrees (p = 0.013), but not with other adverse outcomes. The average neck angle was 30 degrees in patients with endoleaks and 31 degrees in patients without endoleaks. Increasing aortic neck angulation was not associated with the selected adverse outcomes within 1 year following EVAR with the Talent stent graft using suprarenal fixation with the exception of graft kinking. This may be related to the graft design that permits suprarenal aortic fixatiou of the proximal stent graft, Whether severe degrees of angulation of 60 degrees or greater can be safely treated with suprarenal fixation requires further study.