Results of chimney endovascular aneurysm repair as used in the PERICLES Registry to treat patients with suprarenal aortic pathologies.

BACKGROUND: The prevailing evidence calls for using chimney/snorkel endovascular repair (ch-EVAR) with one or two chimney grafts. No studies up to now focus on its applicability and results for the treatment of suprarenal aortic pathologies (SRAP). Hence, we evaluated the clinical and radiologic results of ch-EVAR treatment for SRAP placing three or more chimney grafts within the PERICLES Registry. METHODS: Data from 517 patients suffering complex aortic pathologies treated by ch-EVAR between 2008 and 2014 at 13 European and U.S. centers were retrospectively reviewed and analyzed. RESULTS: Sixty-seven ch-EVAR-treated patients (12.9% of the entire PERICLES cohort) presented SRAP (83.5% elective, 16.5% urgent). The majority of patients (95.5%) received three chimney grafts; four patients received four chimney grafts. The Endurant device was the most commonly used (35.8%) followed by the Zenith abdominal endograft (19.4%). Overall, 204 chimney grafts were placed (56.7% covered self-expandable, 40.3% covered balloon-expandable stents, and 10.4% bare metal balloon-expandable stents). At a median follow-up of 24 months (range, 0.1-67.0 days), 30-day mortality was 6.1% (4 patients), and the overall mortality was 16.4% (11 patients). Overall survival was 87.4% (range, 79.5%-96.0%) at 1 year, 81.8% (range, 72.2%-92.2%) at 2 years and thereafter. Type IA endoleak was noted in nine patients (13.4%) intraoperatively and successfully treated in seven cases (97.1% technical success). Aneurysm sac diameter significantly decreased from 70.5 ± 19.3 mm to 66.9 ± 20.6 mm (P < .001) at last follow-up. Ischemic stroke or transient ischemic attack were noted in two patients (2.9%). Chimney occlusion was detected in six renal arteries (9.5%) and two superior mesenteric arteries (3.2%). No patients required chronic hemodialysis. All occluded superior mesenteric artery grafts were successfully rescued using endovascular approaches. CONCLUSIONS: The midterm use of ch-EVAR for the treatment SRAP seems to be safe, highlighting its applicability for the treatment of rupture threatening pathologies and seal zone lengthening as in type IA endoleaks after EVAR. However, the incidence of type IA endoleaks, chimney graft occlusions, and ischemic stroke rates is higher compared with the prevailing single chimney evidence. Longer follow-up with more cases is needed to establish the exact performance of this treatment in SRAP.

CTA Assessment of Midterm Morphological Changes to Chimney Grafts Used in the Treatment of Juxtarenal Aortic Aneurysms.

Purpose: To evaluate chimney stent-graft position and morphological changes of the aneurysm sac as visualized by postoperative computed tomography angiography (CTA) over a minimum 24-month follow-up period. Materials and Methods: Twenty-one patients (mean age 75.7±8.6 years; 20 men) with juxtarenal aortic aneurysms who underwent successful chimney endovascular aneurysm repair (ch-EVAR) with the Endurant stent-graft and had 2 postoperative CTAs separated by at least 24 months were included in the study. CTA-based measurements of aortic stent-graft migration, target vessel angle, and chimney angle were compared between the serial scans. Results: During a mean follow-up of 34.9 months (range 24-69.2), the mean migration of the aortic stent-grafts was under 5 mm (2.76±2.4 mm). The average migration distance per year was 1.15 mm. The aneurysm diameter reduced a mean 3.25 mm (p=0.048). The right renal artery angle moved significantly upward 6.72° (p=0.025), while the right renal chimney stent-graft moved significantly downward 7.83° (p=0.042). The left renal artery angle also moved upward 1.87° (p=0.388) and the corresponding chimney moved downward 5.68° (p=0.133). During the study period, no type I/III endoleak or chimney occlusion was observed. Conclusion: Midterm morphometric assessment of ch-EVAR using CTA showed significant aneurysm sac shrinkage and a stable 3-year position of the abdominal devices, with the mean downward migration of the aortic stent-graft being <5 mm in the majority of cases. The chimney grafts seem to be prone to take an oblique rather than parallel configuration during follow-up. However, there was no relevant clinical consequence related to this phenomenon.

Patient-Specific Rehearsal Feasibility Before Endovascular Repair of Ruptured Abdominal Aortic Aneurysm.

Purpose: To evaluate the feasibility of a patient-specific rehearsal (PsR) before emergency endovascular aneurysm repairs (eEVAR) and its influence on the operation. Materials and Methods: From February 2016 to October 2016, 10 consecutive patients (mean age 75±7.4 years; 9 men) presenting with a ruptured abdominal aortic aneurysm (rAAA) suitable for standard EVAR were enrolled in the study. A 3-dimensional (3D) model of the abdominal aorta was generated on a virtual reality simulator based on the patient's computed tomography (CT) images. Following the patient-specific simulation setup, PsR was conducted during patient admission or in parallel with the preoperative eEVAR workup. Measured outcomes were PsR feasibility only in the first 4 patients and impact on operative performance thereafter (changes in device selection, the planning process, clinical outcomes, perioperative mortality, and complication rates). Technical metrics and timing of system setup, rehearsal, interval from patient arrival to the actual procedure, and eEVAR were recorded. Results: Mean time for 3D model creation was 21.3±7.8 minutes (range 13-37); there was a significant positive relationship between aortic neck diameter and segmentation time (p=0.003). The overall mean time for simulator setup and PsR was 54±14 minutes (range 37-80); PsR alone was completed in a mean 31±40 minutes (95% confidence interval -60 to -2.2). The actual eEVAR procedure duration was 69±16 minutes (range 45-90). No delay in the actual eEVAR procedure was registered owing to the PsR pathway. In 6 patients, preprocedure rehearsal induced changes in operative strategy, including device selection, main body introduction side, and/or deployment configuration. In 4 cases, rehearsal was performed twice to achieve optimal performance. Conclusion: PsR before eEVAR was feasible in all cases and caused no time delays in the actual eEVAR procedure. PsR optimized eEVAR planning by identifying optimal strategy for stent-graft component selection and deployment.

Impact of aortic stent-graft oversizing on outcomes of the chimney endovascular technique based on a new analysis of the PERICLES Registry.

OBJECTIVE: Chimney endovascular aortic aneurysm repair is gaining ever greater acceptance. However, persistent gutters leading to type IA endoleaks represent an unsolved issue. The aim of the current study was to analyze the impact of abdominal endograft oversizing to the occurrence of this phenomenon. METHODS: The PERformance of the snorkel/chImney endovascular teChnique in the treatment of compLex aortic PathologiesES registry includes the largest experience with chimney endovascular aortic aneurysm repair from 13 vascular centers in Europe and the U.S. Prospectively collected data from centers with standard use of the Endurant stent-graft and balloon-expandable covered stents as chimney grafts only were included in the present analysis. The parameter which varied was the degree of oversizing of the aortic stent-graft classifying the cohort in two groups, group A (20% and less oversizing) and group B (>20% of oversizing). The primary endpoint was the incidence of persistent type IA endoleak needed reintervention. Secondary endpoints were all-cause mortality and freedom from reintervention. RESULTS: Group A included 21 patients while group B 144. The mean preoperative pathology's neck length and diameter was 5.8 mm (±4.4) versus 4.9 mm (±3.8) and 27.6 mm (±4.7) versus 24.9 mm (±3.7) for group A and group B, respectively. The mean length of the new sealing zone after chimney graft placement was similar for both groups (group A versus group B; 17.9 mm versus 18.3 mm, respectively, P = .21). The percentage of oversizing of the aortic stent-graft ranged between 13.8 and 20% versus 22.2 and 30%, for group A and group B, respectively. Patients of group A had more type 1A endoleaks, (14.3%) versus patients of group B (2.1%) based on the first follow-up imaging, P = .02. The incidence of persistent type IA endoleaks needing a reintervention was 14.3 and 1.4% for the group A and group B, respectively, P = .01. The mean volume of contrast medium used was greater in group A versus group B with 239 ml versus150 ml, P = .05. Additionally, 14.3% of patients of group A experienced acute renal failure compared to those in group B which was 1.0%, P = .01. CONCLUSIONS: Oversizing of ideally 30% of the Endurant stent-graft is associated with significant lower incidence of type IA endoleaks requiring reintervention for patients treated by chimney endovascular aortic aneurysm repair.

Comparison of Two Different Techniques for Isolated Left Subclavian Artery Revascularization During Thoracic Endovascular Aortic Repair in Zone 2.

PURPOSE: To analyze the results of isolated left subclavian artery (LSA) revascularization during thoracic endovascular aortic repair (TEVAR) using carotid-subclavian bypass (CSbp) or chimney grafts (CGs). METHODS: A retrospective multicenter, observational study identified 73 patients (mean age 68±13 years, range 22-87; 56 men) with acute or chronic thoracic aortic lesions who underwent TEVAR with isolated LSA revascularization using either CSbp (n=42) or CGs (n=31) from January 2010 and February 2017. Primary endpoints were TEVAR-related mortality, postoperative stroke, freedom from type Ia endoleak, and LSA patency. RESULTS: Primary technical success was achieved in all cases. Early TEVAR-related mortality was 4.2% (CSbp 2% vs CG 6%, p=0.571). Two (3%) patients had major ischemic strokes (one in each group). Mean follow-up was 24±21 months (range 1-72; median 15). Estimated freedom from TEVAR-related mortality was 93%±3% (95% CI 84.3% to 97.0%) at 12 and 36 months, with no significant difference between CSbp and CG (p=0.258). Aortic reintervention did not differ between the groups (CSbp 5% vs CG 6%, p=0.356); nor did freedom from type Ia endoleak (CSbp 98% vs CG 87%, p=0.134). Gutter-related endoleaks occurred in 4 (13%) CG patients, but none of the patients experienced sac enlargement or the need for reintervention and none died. Primary patency of the LSA was 100% for the entire group during the observation period. CONCLUSION: In our experience, LSA revascularization proved most satisfactory and equally effective with both the CSbp and CG techniques, without discernible differences at midterm follow-up.

Importance of Early Aortic Surveillance after Endovascular Treatment of Type B Aortic Dissection with Malperfusion Syndrome.

BACKGROUND: The aim of the study was to assess the incidence and timing of adverse events and complications occurring after endovascular treatment of type B aortic dissection (TBAD) complicated with malperfusion syndrome (MPS). METHODS: Twenty-eight patients with TBAD and MPS treated endovascularly at our center from January 2006 to January 2015 were evaluated through a retrospective scrutiny of the medical records. The primary end point of the study was aorta-related reintervention. The secondary end point was all-cause mortality. RESULTS: The MPS included the mesenteric and renal arteries in 14 (50%) and 21 (75%) patients, respectively, the lower extremities in 14 (50%) patients and the spinal cord in 3 (10.7%). The 1-year and 5-year freedom of reintervention rate were 86.2% and 74.7%, respectively. The median time to reintervention was 4.5 months. The main reason for reintervention was type I proximal endoleak which was treated by proximal endograft extensions and appropriate arch-branch management. The perioperative mortality was 14.3% (4 of 28). The mean follow-up was 61.7 months (range, 2-96 months). The short-term and long-term survivals were 82.1% at 1 and 5 years, respectively. CONCLUSIONS: The results suggest that closer follow-up and imaging surveillance of the aorta are warranted after thoracic endovascular aortic repair treatment of TBAD and MPS. And especially so during the first 6 months to enable timely detection and correction of potential complications.

Periscope endograft technique to revascularize the left subclavian artery during thoracic endovascular aortic repair.

PURPOSE: To present early and midterm results of the periscope endograft (PG) technique to maintain left subclavian artery (LSA) blood flow in thoracic endovascular aortic repairs (TEVAR) involving zone 3. METHODS: From April 2010 to January 2013, 14 consecutive high-risk patients (11 men; mean age 70±8 years, range 56-87) underwent TEVAR with the PG technique for 10 thoracic aortic aneurysms (TAA), 2 traumatic aortic ruptures, and 2 aortic dissections without a suitable landing zone (>2 cm distal to the LSA). Five procedures were performed emergently for rupture (3 TAAs and the 2 trauma cases). Two patients had a periscope deployed in an aberrant right subclavian artery. The periscope endografts were sized 1 to 2 mm larger than the branch artery at the intended landing zone. The caudal end was extended distal to the intended distal landing site of the thoracic stent-graft, which was usually deployed after the PG. Both the PG and thoracic stent-grafts were generally molded using the kissing balloon technique. Outcomes analyzed were immediate technical success, perioperative mortality and morbidity, aneurysm diameter change, and periscope endograft patency. RESULTS: Immediate technical success was 100%, with all procedures completed as planned. Perioperatively, one periscope occluded and one of the ruptured TAA patients died. One percutaneous access site hematoma required only conservative management. At a mean follow-up of 26±9 months (range 9-37), there was no additional PG occlusion. The Kaplan-Meier estimate of PG patency was 93% at 2 years. CONCLUSION: The periscope endograft is a simple technique to maintain perfusion to the LSA in cases where the aortic stent-graft crosses its ostium. The PG technique can be performed transfemorally and even percutaneously, and it can be applied to all supra-aortic branches. Early and midterm results are encouraging, but more experience and long-term results are mandatory before this technique can be widely recommended.

Results with the Talent thoracic stent graft in the VALOR trial.

OBJECTIVE: We report the 5-year outcomes of thoracic endovascular aneurysm repair (TEVAR) using the Medtronic Vascular Talent Thoracic Stent Graft System (Medtronic Vascular, Santa Rosa, Calif) in patients considered low or moderate risk for open surgical repair. METHODS: The Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms (VALOR) trial was a prospective, nonrandomized, multicenter, pivotal study conducted at 38 U.S. sites. Between December 2003 and June 2005, VALOR enrolled 195 patients who were low or moderate risk (0, 1, and 2) per the modified Society for Vascular Surgery and American Association for Vascular Surgery criteria. The patients had fusiform thoracic aortic aneurysms (TAAs) and/or focal saccular TAAs/penetrating atherosclerotic ulcers. Standard follow-up interval examinations were conducted at 1 month, 6 months, 1 year, and annually thereafter. RESULTS: Over the 5-year follow-up, 76 deaths occurred (43.9%). Freedom from all-cause mortality was 83.9% at 1 year and 58.5% at 5 years. Most deaths were due to cardiac, pulmonary or cancer-related causes. Freedom from aneurysm-related mortality (ARM) was 96.9% at 1 year and 96.1% at 5 years. There was only 1 case of ARM after the first year of follow-up. Over the 5-year follow-up period, four patients were converted to open surgery and four patients experienced aneurysm rupture. The 5-year freedom from aneurysm rupture was 97.1% and the 5-year freedom from conversion to surgery was 97.1%. The incidence of stent graft migration (>10 mm) was ≤ 1.8% in each year of follow-up. The rate of type I endoleak was 4.6% at 1 month, 6.3% from 1 month to 1 year, and 3.8% during year 5. The rate of type III endoleak was 1.3% at 1 month, 1.9% from 1 month to 1 year, and 1.9% during year 5. Through 5 years, 28 patients (14.4%) underwent 31 additional endovascular procedures on the original target lesion. The 5-year freedom from secondary endovascular procedures was 81.5%. CONCLUSIONS: Through 5-year follow-up in patients who were candidates for open surgical repair, TEVAR using the Talent Thoracic Stent Graft System has demonstrated sustained protection from ARM, aneurysm rupture, and conversion to surgery, and durable stent graft performance. Close patient follow-up remains essential after TEVAR.

Report on the results of thoracic endovascular aortic repair for acute, complicated, type B aortic dissection at 30 days and 1 year from a multidisciplinary subcommittee of the Society for Vascular Surgery Outcomes Committee.

OBJECTIVE: This study analyzed 1-year outcome after thoracic endovascular aortic repair (TEVAR) in patients with complicated type B aortic dissection (cTBAoD) who had rupture or malperfusion and symptom onset ≤14 days (acute), 15 to 30 days (subacute), and 31 to 90 days (chronic) until required intervention. The main focus of this report is primarily on the acute cohort. METHODS: Clinical data were systematically collected from five physician-sponsored investigational device exemption (IDE) clinical trials between 2000 and 2008 using standardized definitions and forms. Adverse events were reported early (≤30 days) and late (>30 days) by body system. Major adverse events included death, stroke, myocardial infarction, renal failure, respiratory failure, paralysis, and bowel ischemia. RESULTS: There were 99 cTBAoD patients: 85 were acute, 11 were subacute, and 3 were chronic. Among the acute patients, 31.8% had rupture and 71.8% had malperfusion, including 55.7% lower extremity, 36.1% renal, 19.7% visceral, 8.2% other, and 3.3% spinal cord (patients may have more than one source). Rupture and malperfusion were both reported for three acute patients. Additional findings for the acute cohort included pain (76.5%), hypertension (43.5%), and bleeding (8.2%); comorbidities included hypertension (83.5%), current/past smoking history (69.8%), and diabetes (12.9%). The main focus of this analysis was the acute cohort (n = 85). Age averaged 59 years (72.9% male). Early adverse events included pulmonary (36.5%), vascular (28.2%), renal (25.9%), and neurologic (23.5%). Early major adverse events occurred in 37.6% of patients, including death (10.6%), stroke (9.4%), renal failure (9.4%), and paralysis (9.4%); late adverse events included vascular (15.8%), cardiac (10.5%), gastrointestinal (6.6%), and hemorrhage (5.3%). The point-estimate mortality rate was 10.8 (95% confidence interval [CI], 4.1-17.5) at 30 days and 29.4 (95% CI, 18.4-40.4) at 1 year, when 34 patients remained at risk. CONCLUSIONS: Emergency TEVAR for patients with cTBAoD (malperfusion or rupture) provided acceptable mortality and morbidity results out to 1 year. Manufacturers can use this 30-day mortality point-estimate of 10.8 (95% CI, 4.1-17.5) for the acute cohort to establish a performance goal for use in single-arm commercial IDE trials if the Food and Drug Administration and other regulatory bodies concur.

Report on endograft management of traumatic thoracic aortic transections at 30 days and 1 year from a multidisciplinary subcommittee of the Society for Vascular Surgery Outcomes Committee.

OBJECTIVES: The Society for Vascular Surgery Outcomes Committee, including ad hoc members from Society of Thoracic Surgeons, American Association of Thoracic Surgery, and Society for Interventional Radiology, collected outcomes of patients with traumatic thoracic aortic transections treated with endovascular grafts. Results through 1 year of follow-up are reported. METHODS: Data from five physician-sponsored investigational device exemption clinical trials from 2000 to 2008 were entered using standardized forms and definitions. Adverse events were reported early (≤30 days) and late (>30 days) by body system. Major adverse events included one or more of the following: death, stroke, myocardial infarction, renal failure, respiratory failure, paralysis, or bowel ischemia. RESULTS: There were 60 symptomatic patients (68.3% men; mean age, 46 years) with traumatic aortic transections, of which 97% were due to a motor vehicle accident and 3% were related to other blunt trauma. The average total injury severity score was 39, most with involvement of the chest and abdomen. The average surgical time was 125 minutes. The mean hospital length of stay was 17 days. Associated procedures for the management of nonaortic injuries occurred in 51.7%. All-cause mortality was 9.1% at 30 days and 14.4% at 1 year. One or more major adverse events occurred in 23.3% of the patients, major adverse events occurred early in 20.0% and late in 3.6%. Death accounted for 41.7% of the early and all of the late major adverse events. Early adverse events included 16.7% pulmonary, 13.3% neurologic, and 11.7% vascular complications. Late adverse events included one patient (1.8%) with pulmonary failure and one patient (1.8%) who died of an unknown cause. CONCLUSIONS: One-year results of endograft placement for the management of patients with traumatic aortic injury are acceptable. Most cases treated were due to motor vehicle accident and associated with multiple coexisting injuries. Approximately three-quarters of the deaths occurred ≤30 days, indicating the acute severity of the condition. Although the relatively low rates of adverse and major adverse events are consistent with what is anticipated in an otherwise healthy population, future device and procedural developments may facilitate improved outcomes in the future.

Outcome of endovascular repair of small and large abdominal aortic aneurysms.

BACKGROUND: To evaluate the outcomes of endovascular aneurysm repair (EVAR) in patients with small (≤5.4 cm) and large (≥5.5 cm) abdominal aortic aneurysms (AAAs). METHOD: Data for this study were obtained from the prospective, nonrandomized, multicenter Talent enhanced Low Profile Stent trial that enrolled patients between February 2002 and April 2003. A total of 156 patients with adequate preoperative imaging were identified for this study. Subgroup analyses were performed for patients with small (≤5.4 cm) and large (≥5.5 cm) AAAs. Demographics, aneurysm morphology, and perioperative endpoints were assessed. Safety and effectiveness endpoints were evaluated at 30 days, 1 year, and 5 years postprocedure. RESULTS: Patients with small AAAs (n = 85) had similar age, gender, and medical risk profile compared with those for larger AAAs (n = 71). The proximal aortic necks in small AAAs were longer (24.7 mm vs. 20.7 mm, p = 0.05), less angulated (27.2° vs. 34.2°, p = 0.01), and smaller (24.6 mm vs. 26.1 mm, p = 0.01). Patients with small AAAs spent less time in intensive care (8.1 hour vs. 26.3 hour, p = 0.03); however, other perioperative endpoints were similar. Although the group with small AAAs had a statistically significant higher rate of successful aneurysm treatment (96.8% vs. 84.9%, p = 0.04), no difference was observed in all other effectiveness endpoints at 12 months. No differences in freedom from major adverse events at 30 days and 365 days were reported. At 5 years, no differences in rates of migration, endoleaks, change in aneurysm diameter, or freedom from aneurysm-related mortality were found. Further subgroup analyses segregating patients with very small (≤5.0 cm, n = 55), small (5.1-5.4 cm, n = 30), and larger (≥5.5 cm) AAAs also showed no statistically significant differences in postoperative outcomes. CONCLUSIONS: In a prospective clinical trial setting with long-term follow-up, patients with small (≤5.4 cm) AAAs had aortic neck characteristics which were more favorable for EVAR. Despite these anatomic differences, clinical outcomes were similar to patients with large AAAs. Thus, we conclude that EVAR for small AAA should not be routinely recommended for patients on the basis of the assumption of improved outcomes.

Periscope graft to extend distal landing zone in ruptured thoracoabdominal aneurysms with short distal necks.

Endovascular aneurysm repair (EVAR) of ruptured thoracoabdominal aortic aneurysms may be compromised or even impossible due to short proximal and/or distal necks or landing zones, respectively. Supra-aortic branches may limit the proximal anchorage and visceral or renal arteries the distal anchorage of endografts. While solutions have been proposed to overcome the problem of a short proximal neck, no technique has been described that solves the problem of a short distal neck. We present the "periscope technique," which allows extension of the distal landing zone and complete endovascular treatment of ruptured thoracoabdominal aneurysms with short distal necks using devices already stocked in most centers performing EVAR procedures.

Five-year results for the Talent enhanced Low Profile System abdominal stent graft pivotal trial including early and long-term safety and efficacy.

OBJECTIVES: The pivotal trial of the Talent enhanced Low Profile System (eLPS; Medtronic Vascular, Santa Rosa, Calif) stent graft evaluated short and long-term safety and efficacy of endovascular aneurysm repair (EVAR). These data and a confirmatory group assessing the performance of the CoilTrac delivery system supported the United States premarket approval application for the device. METHODS: The pivotal trial was a prospective, nonrandomized study conducted at 13 sites from February 2002 to April 2003. The study group (n = 166) underwent EVAR using the Talent eLPS stent graft. The control group (n = 243) underwent open surgical AAA repair. Data for this group were obtained from the Society for Vascular Surgery Endovascular AAA Surgical Controls project. Outcomes were compared at 30 days and 12 months. Additional 5-year follow-up was obtained for the eLPS group. A single-center cohort of 137 patients was the confirmatory group for the assessment of the clinical performance of the CoilTrac delivery system, with analysis of outcomes

A 5-year comparison of EVAR for large and small aortic necks.

PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

A 5-year evaluation using the talent endovascular graft for endovascular aneurysm repair in short aortic necks.

BACKGROUND: 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). METHOD: 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. RESULTS: 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%). CONCLUSIONS: 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.

Technical solutions for common problems in TEVAR: managing access and aortic branches.

Thoracic endovascular aortic repair (TEVAR) is rapidly emerging as an important treatment option for several indications, and it would not be unreasonable to predict that endograft treatment may well become the predominant form of therapy for many, if not the majority, of patients. However, several unresolved issues remain, and the need for further improvements and technological refinements will not cease any time soon. Ranking high among these issues are the challenges related to endovascular access and aortic branch management, which constitute the main focus of this review. Achieving safe and successful endovascular access for introduction and deployment of the stent-graft device is a crucially important and often challenging step during TEVAR, but arterial injury has been, and continues to be, an all-too-common occurrence to this day. A clear understanding of the relevant issues and available technical solutions can go a long way toward preventing such catastrophes. A preponderance of thoracic aortic pathologies tend to develop adjacent to or within the branched segments. It is therefore not surprising that branch management issues have risen to the top of the entire TEVAR field. Debranching and vessel relocation techniques have added a whole new dimension to the therapy because they can expand or create suitable landing zones proximally and distally, thereby broadening the applicability of endograft technologies to a much larger number of patients.