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.

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.

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.

European Multicenter Registry for the Performance of the Chimney/Snorkel Technique in the Treatment of Aortic Arch Pathologic Conditions.

BACKGROUND: To study the performance of the chimney technique in the treatment of aortic arch pathologic conditions. METHODS: We retrospectively evaluated the clinical and procedural outcome data of patients undergoing endovascular treatment in the aortic arch by use of the chimney technique at four European centers between June 2002 and December 2014. The primary endpoint was technical success. The secondary endpoints were type I endoleak, 30-day mortality, stroke, primary patency of the chimney graft, and freedom from reintervention. RESULTS: Ninety-five patients were included in the study. The underlying pathologic conditions were degenerative aneurysm (n = 45, 47.4%), type B aortic dissection (n = 30, 31.6%), dissecting aneurysm (n = 6, 6.5%), penetrating atherosclerotic ulcer (n = 5, 5.3%), type I endoleak after previous thoracic endovascular aortic repair (n = 6, 6.3%), and aortic embolic disease (n = 3, 3.2%). Twenty-one patients (22%) underwent arch-branch debranching before chimney graft implantation. The majority of patients were treated electively (n = 49, 51.6%). Forty-six patients (48.4%) underwent urgent placement of chimney grafts because of their symptoms (n = 25) or rupture (n = 21). Technical success was 89.5%. The 30-day mortality was 9.5% (9 patients). No aorta-related death was observed. A type Ia endoleak occurred in 10 patients (10.5%) intraoperatively, resolving spontaneously within the first 30 days in 50% of these cases. Major stroke was diagnosed in 2 patients (2%). Primary patency of the chimney grafts was 98%, and 5 patients (5.2%) required a reintervention. CONCLUSIONS: The chimney technique in the aortic arch proved highly and predictably successful, with a low rate of reinterventions.

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.

Aortic dissection: a 250-year perspective.

Two hundred fifty years have passed since Frank Nicholls' history-making, accurate observations on the anatomic findings and cause of death of King George II were published. Several decades later, the disease was named, using--for the first time--the terms dissection and dissecting attached to an aortic disease process. Another century went by before effective surgical treatment was developed. In sharp contrast, the evolution of the last 20 years has been nothing short of amazing. Our understanding of AD, while not yet complete, has improved dramatically. In addition, the introduction of nonsurgical endovascular therapy has had a profoundly transformative impact--and we are just at the beginning! It would not be unreasonable to predict that stent-graft repair will likely replace (or nearly replace) open surgery in the treatment of complicated type B dissection in the near future, especially as technologies continue to improve and indication-specific designs are developed and tested in the clinical setting. Moreover, it is predictable that endovascular solutions for some patients with type A aortic dissection will become available in the years to come as surgical results continue to be suboptimal. Finally, and amidst this plethora of "good news," it is appropriate to reflect on the formidable challenge that endovascular therapies face as they gear to "compete" with optimal medical therapy in the management of patients with acute uncomplicated type B dissection, because it will obviously be difficult (if not impossible) to improve on the already-achieved 30-day mortality rate of less than 10%. Long-term gains may well become the winning card when and if the late results of TEVAR can be shown to improve on the rather compromised outlook of medically treated dissection patients. Stay tuned.

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.

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.

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.

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

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.