Incidence of and outcomes after misaligned deployment of the Talent Thoracic Stent Graft System

ObjectiveVarious types of device-specific adverse events can occur during deployment of thoracic stent grafts due to the high flow rate and severe aortic angulation that is often encountered in the thoracic aorta. This study assessed the incidence, etiology, and overall effect of misaligned deployment of the Talent Thoracic Stent Graft (TSG) System. Techniques to predict and avoid this complication are discussed.MethodsData collection included pivotal-trial follow-up, direct surveys of centers inside and outside the United States and principal investigators, a targeted literature search, and review of complaint files. Misaligned deployment was considered to occur when the proximal covered or uncovered stent apices of a thoracic stent graft folded back on itself and remained nonparallel to the wall of the aorta after deployment had been completed.ResultsOf about 20,305 deployments to date of the Talent TSG, 24 misaligned deployments were identified for an incidence of 0.1%. Nineteen (79%) events occurred during treatment of degenerative aneurysms or penetrating ulcers, four (17%) during treatment of dissections, and the underlying pathology could not be determined for one patient. The misalignment was noted at the proximal end of the stent graft in 15 patients (63%), and the other 9 events (37%) occurred at the graft overlap junction. Two events were treated intraoperatively, with a second overlapping device placed in one patient and a snare used to reposition the proximal stent in another. Adverse clinical events occurred in three patients and included a persistent type I endoleak, continued false lumen perfusion in a patient with dissection, and delayed retrograde type A dissection in a patient undergoing total arch repair. No intraoperative contrast extravasation or computed tomography evidence of perforation was noted. There were no perioperative deaths or cerebrovascular events, with one report of paraplegia among the 24 patients in this series.ConclusionMisaligned deployment is an unusual phenomenon that tends to occur in the context of certain well-defined anatomic conditions in the thoracic aorta. To date, most of these events have not led to significant adverse sequelae. However, careful patient selection, periprocedural imaging, and case planning can help to identify anatomies in which misaligned opening is likely to occur, allowing physicians to avoid this complication

Gender analysis of the pivotal results of the Medtronic Talent Thoracic Stent Graft System (VALOR) trial

PurposeThis study evaluated the differences between male and female patients undergoing thoracic endovascular aneurysm repair (TEVAR) in a pivotal Food and Drug Administration (FDA)-approved trial.MethodsThe Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms (VALOR) study was a prospective, nonrandomized, multicenter, pivotal trial conducted in the United States. Patients were enrolled between December 2003 and June 2005. Follow-up was conducted at 30 and 365 days.ResultsVALOR enrolled 115 men (58.9%; 69.3 ± 11.7 years old), and 80 women (41.1%; 71.6 ± 10.1 years old). Iliac conduits were used more often in women, who had smaller diameter external iliac arteries, than in men (38.8% vs 8.8%, P < .001). Women required more blood transfusions and had a longer hospital length of stay. At 30 days, more major adverse events occurred in women than in men (52.5% vs 33.0%, P = .008), with more vascular access-related and respiratory complications. No gender-based differences were seen in all-cause mortality or in aneurysm-related death. The composite end point of 365-day “successful aneurysm treatment,” defined as no aneurysm growth >5 mm at the 365-day follow-up visit compared with the 30-day follow-up visit and absence of any type I endoleak requiring a secondary procedure, favored women over men (98.2% vs 82.4%, P = .004).ConclusionsTEVAR with the Talent device provided similar rates of 365-day mortality and morbidity for men and women. Although female patients had higher rates of periprocedural complications, they also more often had successful aneurysm treatment at the 1-year follow-up

Aortic Pathology Determines Midterm Outcome After Endovascular Repair of the Thoracic Aorta Report From the Medtronic Thoracic Endovascular Registry (MOTHER) Database

Background—Endovascular repair of the thoracic aorta has become an increasingly utilized therapy. Although the short-term mortality advantage over open surgery is well documented, late mortality and the impact of presenting pathology on long-term outcomes remain poorly reported. Methods and Results—A database was built from 5 prospective studies and a single institutional series. Rates of perioperative adverse events were calculated, as were midterm death and reintervention rates. Multivariate analysis was performed with the use of logistic regression modeling. Kaplan-Meier survival curves were drawn for midterm outcomes. The database contained 1010 patients: 670 patients with thoracic aortic aneurysm, 195 with chronic type B aortic dissection, and 114 with acute type B aortic dissection. Lower elective mortality was observed in patients with chronic dissections (3%) compared with patients with aneurysms (5%). Multivariate analysis identified age, mode of admission, American Society of Anesthesiologists grade, and pathology as independent predictors of 30-day death (P < 0.05). In the midterm, the all-cause mortality rate was 8, 4.9, and 3.2 deaths per 100 patient-years for thoracic aortic aneurysm, acute type B aortic dissection, and chronic type B aortic dissection, respectively. The rates of aortic-related death were 0.6, 1.2, and 0.4 deaths per 100 patient-years for thoracic aortic aneurysm, acute type B aortic dissection, and chronic type B aortic dissection, respectively. Conclusions—This study indicated that the midterm outcomes of endovascular repair of the thoracic aorta are defined by presenting pathology, associated comorbidities, and mode of admission. Nonaortic mortality is high in the midterm for patients with thoracic aortic aneurysm, and managing modifiable risk factors appears vital. Endovascular repair of the thoracic aorta results in excellent midterm protection from aortic-related mortality, regardless of presenting pathology

Update on the Talent aortic stent-graft: A preliminary report from United States phase I and II trials

AbstractPurpose: Phase I and phase II trials were conducted to determine the safety and efficacy of the Talent aortic stent-graft (Medtronic World Medical, Sunrise, Fla) in the treatment of infrarenal abdominal aortic aneurysms (AAA). This is a preliminary report of the technical results and 30-day clinical outcome of these trials. Methods: Multicenter prospective trials were conducted to test the Talent stent-graft in high-risk and low-risk patient populations with AAA, including phase I feasibility and phase II clinical trials. The low-risk study included concurrent surgical controls. Results: In the phase I trial, deployment success was achieved in 92% (23/25 patients), and initial technical success was 78% (18/23 implants without endoleak). The 30-day technical success rate was 96%, with six endoleaks that resolved spontaneously (without need for further intervention); and the 30-day mortality rate was 12% (3/25 patients). The phase II high-risk trial demonstrated a deployment success of 94% (119/127 patients) and an initial technical success of 86% (102/119 implants). The 30-day technical success rate was 96%, and the 30-day mortality rate was 1.5% (2/127 patients). The phase II low-risk trial included a first-generation and a second-generation Talent stent-graft. Deployment success rates were 97% and 99%, respectively, and technical success rates at 30 days were 97% and 96%, respectively. The 30-day mortality rate was 2% in the phase II low-risk first-generation device trial, and the adverse-event rate was 20%. Corresponding figures for the second-generation device were 0% and 1.8%, respectively. Conclusion: The Talent stent-graft can be deployed successfully and achieves endovascular exclusion in a large proportion of patients with AAA. Morbidity and mortality rates are acceptable. One-year clinical results and the comparison with concurrent surgical control subjects remain to be evaluated. (J Vasc Surg 2001;33:S146-9.

Propensity-matched cohort validates findings of the VALOR trial

IntroductionThe Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms (VALOR) trial findings noted superior 30-day and 1-year outcomes of the Talent thoracic endograft (Medtronic Vascular, Santa Rosa, Calif) compared with surgical repair of descending thoracic aneurysms (DTAs). Data from 195 prospective thoracic endovascular aneurysm repair (TEVAR) patients treated with the Talent device and 189 retrospective controls undergoing open surgical repair (OSR) from three centers of excellence were included in the trial after completion of TEVAR enrollment and compared. Such comparisons are biased by baseline differences among TEVAR vs OSR, however, propensity score (PS) analysis can reduce bias and validate such comparisons.MethodsLogistic regression was used to generate a PS (range, 0-1) to identify baseline characteristics more likely in TEVAR. The PS estimated the probability that any patient would undergo TEVAR (eg, a PS of 0.99 represents a 99% chance a patient belongs to TEVAR). PSs were then generated for all patients, and TEVAR and OSR patients were divided into tertiles based on the PS to reduce up to 80% of inherent bias. Outcomes from the middle tertile (T2), patients equally likely (midrange PS) to be in TEVAR or OSR and therefore best matched, were compared using regression analysis and were also compared with the outcomes in the overall trial group.ResultsCorrelates of membership in TEVAR were smaller aneurysm (P < .001), anticoagulants (P < .01), no previous abdominal aortic aneurysm (AAA) repair (P < .01), no peripheral vascular disease (P = .001), statin use (P = .002), aspirin use (P = .002), older age (P = .028), race (P = .007), male gender (P = .02), and heart failure (P = .035). T2 included 68 TEVAR (PS, 0.58 ± 0.2) and 67 OSR patients (PS, 0.46 ± 0.2). VALOR overall reported differences in aneurysm size (56 mm TEVAR vs 69 mm open) and prior AAA repair (19% TEVAR vs 37% open), and this adjusted to no differences in T2 patients. In the well-matched T2 cohort, TEVAR patients had similar 30-day mortality (0% vs 3% OSR; P = .2) and improved 1-year aneurysm-related mortality rates (0% TEVAR vs 8% OSR; P = .05) compared with the OSR patients. This finding was in concurrence with the VALOR trial reporting similar benefit in TEVAR patients. The all-cause 1-year mortality showed a favorable trend for TEVAR in the VALOR trial; however, in T2 patients, 1-year all-cause mortality was similar in both groups of patients (17% TEVAR vs 15% OSR; P = .8). Age (P = .01), history of cerebrovascular accident (P < .05), antiarrhythmia medication (P = .04), and renal disease (P < .03) independently predicted all-cause and aneurysm-related mortality by regression analysis.ConclusionsPS analysis is an important tool for elimination of bias inherent when retrospective controls are used. Its application to VALOR validates the long-term benefit in aneurysm-related mortality conferred by TEVAR in patients undergoing endovascular DTA repair

Predictors of early and late mortality following open extent IV thoracoabdominal aortic aneurysm repair in a large contemporary single-center experience

ObjectiveThe primary purpose of this study was to examine outcomes following open repair of extent IV thoracoabdominal aortic aneurysms (TAAAs) at a single university hospital. As a secondary aim, comparison was made to patients who underwent open abdominal aortic aneurysm (AAA) repair with supraceliac clamping but without left renal artery bypass to assess the effect of left renal artery bypass on outcomes.MethodsPatients undergoing open extent IV TAAA repair from 1998 to 2008 were identified (n = 108). Primary outcomes were 30-day and long-term survival. Secondary outcomes were major complication, renal failure, and postoperative change in renal function. A second analysis was performed, comparing patients undergoing extent IV TAAA repair with patients undergoing AAA repair with supraceliac clamping but without left renal artery bypass (n = 50).ResultsEighty-three men (76.9%) and 25 women (23.1%), with a mean age of 72.9 years, underwent open extent IV TAAA repair. Nine patients (8.3%) were ruptured. Mean aneurysm maximal diameter was 6.5 ± 1.3 cm. Supraceliac and left renal ischemic times were 22.9 ± 9.3 and 40.6 ± 16.2 minutes, respectively. Six patients (5.6%) died at 30 days. The only predictor of 30-day mortality was decreased preoperative estimated glomerular filtration rate (eGFR) (P = .044 by multivariate analysis; and P = .011 by univariate analysis). One-year and 5-year survival rates were 87% and 50%, respectively. Patients with a history of cerebrovascular disease (P = .001) and postoperative renal insufficiency (P = .034) had increased long-term mortality by log-rank test. Twenty-five (25.3%) patients sustained a postoperative decrease in renal function, while 19 (19.2%) patients had an improvement in renal function. There was no difference in 30-day mortality (5.6% vs 6.0%; P = 1.000), 5-year survival (50% vs 48%; P = .886), major complications (37.0% vs 38.0%; P = 1.000), renal failure (6.1% vs 0%; P = .215), or postoperative change in renal function, in patients undergoing extent IV TAAA repair vs AAA repair with supraceliac clamping but without left renal artery bypass.ConclusionsOpen extent IV TAAA repair can be performed with low morbidity and mortality rates. The performance of left renal artery bypass does not appear to contribute to the morbidity and mortality of extent IV TAAA repair. While decreased preoperative eGFR appears to increase the risk of 30-day mortality, a history of cerebrovascular disease and postoperative renal insufficiency appear to increase the risk of long-term mortality. Finally, open extent IV TAAA repair not uncommonly improves renal function

Outcome of the pivotal study of the Aptus endovascular abdominal aortic aneurysms repair system

ObjectiveEndovascular treatment of abdominal aortic aneurysm (AAA) is associated with benefits over open surgery, yet limitations remain with current endovascular devices. This study was performed to assess outcomes of AAA repair with the Aptus endograft and EndoAnchors (Aptus Endosystems, Sunnyvale, Calif).MethodsThis prospective, multicenter, single-arm investigational device exemption trial was conducted at 25 sites in the United States. A total of 155 patients were enrolled in the trial (mean age, 73 ± 8 years; male, 93.5%; mean AAA diameter, 53.6 ± 7.9 mm). The Aptus endograft is a two-component system: a multilumen, modular endograft with two docking limbs (Aptus Endograft System) and the Heli-FX Aortic Securement System comprising an electronically controlled applier (Heli-FX Applier) with helical EndoAnchors provided in a cassette and a deflectable sheath (Heli-FX Guide) designed for delivery of the applier to the target location for EndoAnchor implantation. The main eligibility criteria included proximal neck length of ≥12 mm, diameter of 19 to 29 mm, and infrarenal angulation of ≤60 degrees. The primary safety end point was freedom from major adverse events at 30 days, and the primary effectiveness end point was successful aneurysm treatment at 12 months. Thrombus-related events (TRE) were defined as limb occlusion or thromboembolism from the endograft. Subjects were observed for a median of 4.2 years, with imaging end points analyzed by a core laboratory and adverse events adjudicated by a clinical events committee.ResultsAmong 155 enrolled subjects, 153 (98.7%) underwent successful implantation of the Aptus endograft and a median of five EndoAnchors; two subjects were converted to open surgical repair during the initial procedure. Overall, the primary safety and effectiveness end points were met in 98.1% and 97.4% of the subjects, respectively. Aneurysm-related mortality was 0.6%, with one postdischarge cardiac death 18 days after implantation. There were no AAA ruptures. There were no fractures of stents or EndoAnchors. There was one type I endoleak and one type III endoleak. Stent graft migration was noted in five subjects, none associated with sac enlargement, type I endoleak, or EndoAnchor dislocation from the endograft. AAA sac shrinkage of ≥5 mm at 1, 2, and 3 years was observed in 60.3%, 72.9%, and 81.7%, respectively. Sixty-one subjects (39.4%) experienced 113 TRE, associated with 80 reinterventions (in 58 subjects) unassociated with limb loss or death. A root cause analysis of TRE identified small, out-of-specification docking limbs with graft infolding and high local shear, resulting in thrombus formation within the endograft with subsequent distal embolization in some cases.ConclusionsEarly results of the Aptus endograft trial met its safety and effectiveness end points; however, a high rate of TRE was observed because of manufacturing discrepancies. The findings confirm a low rate of type I and type III endoleaks, migration, and non-TRE reintervention with a high rate of aneurysm sac regression during midterm follow-up

Limb interventions in patients undergoing treatment with an unsupported bifurcated aortic endograft system: A review of the Phase II EVT Trial

AbstractIntroduction: Both supported and unsupported bifurcated endograft limbs develop flow-restricting lesions, including kinks, stenoses, and occlusions, which can be identified during or after surgery. Recognition and intervention are essential to achieve long-term graft patency and a satisfactory functional result. This report represents a comprehensive retrospective review of graft limb interventions from the Phase II EVT Trial with the Endovascular Grafting System unsupported bifurcated endograft (Guidant/EVT, Menlo Park, Calif). Methods: The study population consists of 242 patients who underwent treatment with bifurcated endografts implanted during the EVT Phase II Trial. Graft limb interventions have been divided into two groups: those in whom the intervention occurred during surgery versus those in whom the intervention occurred after surgery. Parameters studied included type, incidence, and timing of graft limb intervention, indications for intervention, procedures performed, and overall patient outcome. Results: The mean follow-up period was 31 months. Primary, primary assisted, and secondary limb patency rates were 61.6%, 93.7%, and 97.1%, respectively. Technical success rate at case completion was 97.5%. In 68 of the 242 cases, limb interventions were performed during surgery to assure patency (28.1%). In 28 cases, interventions were performed after surgery (11.6%). Of these postoperative limb problems, 82% occurred during the first 6 months. Repeat limb interventions were necessitated in three patients (1.2%). Within the intraoperative intervention group, perceived indications included kinks (15%), stenosis (57%), dissection (6%), graft redundancy (12%), and instances of twists, thrombosis, and pressure gradients (10%). These findings were successfully managed with percutaneous transluminal angioplasty only (41%), percutaneous transluminal angioplasty and stent (50%), and various combined interventions. Within the postoperative intervention group, symptomatic indications included stenosis (46%) and thrombosis/occlusion (54%). These postoperative limb events were successfully managed with stent (64%), thrombolysis (32%), and femoral-femoral bypass (21%). When limb dysfunction developed in the postoperative setting, it most often occurred within the first 6 months of implantation. Only one patient in this Phase II cohort had a lower extremity amputation unrelated to a graft limb abnormality. Conclusion: The unsupported bifurcated limbs of this endograft necessitated primary adjunctive intervention in 40% of cases. Primary intervention was two times more likely to be performed at the time of the implant rather than after surgery. Repeat limb interventions were not common. Endograft limb flow problems were successfully treated with standard endovascular or surgical interventions or both. These data may support prophylactic stenting of unsupported Ancure graft limbs. A strategy that includes both intraoperative and early postoperative graft limb surveillance is essential to detect reduced limb flow. (J Vasc Surg 2002;36:118-26.