Preliminary outcome of Nellix-in-Nellix extensions in patients treated with failed endovascular aneurysm sealing.

BACKGROUND: The 1-year results of the use of the Nellix (Endologix Inc, Irvine, Calif) endovascular aneurysm sealing (EVAS) device were initially promising. However, midterm complications including migration and aneurysm growth occurred more frequently than expected, which provided an incentive to refine the instructions for use. Strategies for the management of complications arising after endovascular aneurysm repair are often not applicable for EVAS, given the unique configuration of the Nellix device, and new techniques are needed. This study analyzes the clinical outcomes of both elective and emergency deployment of a new Nellix device within a primarily placed device, for failure of EVAS, which we refer to as a Nellix-in-Nellix application (NINA). METHODS: This is a global, retrospective, observational cohort study focusing on the early outcome of NINA for failed EVAS, including data from 11 European institutions and 1 hospital in New Zealand. RESULTS: A total of 41 patients were identified who underwent a NINA procedure. Of these, 32 (78%) were placed electively and 9 (22%) were placed on an emergency basis. Seven patients were initially treated with chimney EVAS (n = 5 in the elective NINA group and n = 2 in the emergency NINA group). The average time between the primary EVAS procedure and NINA was 573 days (interquartile range, [IQR] 397-1078 days) and 478 days (IQR, 120-806) for the elective and emergency groups, respectively. The indication for elective NINA was endoleak with migration (50%), endoleak without migration (25%), migration without endoleak (16%), and other (9%). Chimney grafts were used in 21 of 32 patients in the elective group and 3 of 9 patients in the emergency group. Technical success was achieved in 94% of patients in the elective group and 100% of patients in the emergency group. At latest follow-up (median, 104 days; IQR, 49-328 days), there were three aneurysm-related deaths (9%), no ruptures, and five device-related reinterventions (16%) within the elective group. In the emergency group (median follow-up, 23 days; IQR, 7-61 days), there were four aneurysm-related deaths and three aneurysm-related reinterventions. CONCLUSIONS: In conclusion, a NINA can be used to treat late failures of EVAS with an acceptable technical success rate and can be used when more established treatment options are unfeasible or contraindicated. The durability of this technique needs to be further reviewed.

Red cell distribution width at hospital discharge and out-of hospital outcomes in critically ill non-cardiac vascular surgery patients.

OBJECTIVE: Red cell distribution width (RDW) is associated with mortality and bloodstream infection risk in the critically ill. In vascular surgery patients surviving critical care it is not known if RDW can predict subsequent risk of all-cause mortality following hospital discharge. We hypothesized that an increase in RDW at hospital discharge in vascular surgery patients who received critical care would be associated with increased mortality following hospital discharge. DESIGN, SETTING, AND PARTICIPANTS: We performed a two-center observational cohort study of critically ill non-cardiac vascular surgery patients surviving admission 18 years or older treated between November, 1997, and December 2012 in Boston, Massachusetts. EXPOSURES: RDW measured within 24 hours of hospital discharge and categorized a priori as ≤13.3%, 13.3-14.0%, 14.0-14.7%, 14.7-15.8%, >15.8%. MAIN OUTCOMES AND MEASURES: The primary outcome was all cause mortality in the 90 days following hospital discharge. RESULTS: The cohort included 4,715 patients (male 58%; white 83%; mean age 62.9 years). 90 and 365-day post discharge mortality was 7.5% and 14.4% respectively. In the cohort, 47.3% were discharged to a care facility and 14.8% of patients were readmitted within 30 days. After adjustment for age, gender, race, Deyo-Charlson comorbidity Index, patient type, acute organ failures, prior vascular surgery and vascular surgery category, patients with a discharge RDW 14.7-15.8% or >15.8% have an adjusted OR of 90-day post discharge mortality of 2.52 (95%CI, 1.29-4.90; P = 0.007) or 5.13 (95%CI, 2.70-9.75; P <0.001) relative to patients with a discharge RDW ≤13.3%. The adjusted odds of 30-day readmission in the RDW >15.8% group was 1.52 (95%CI, 1.12-2.07; P = 0.007) relative to patients with a discharge RDW ≤13.3%. Similar adjusted discharge RDW-outcome associations are present at 365 days following hospital discharge and for discharge to a care facility. CONCLUSIONS: In critically ill vascular surgery patients who survive hospitalization, an elevated RDW at hospital discharge is a strong predictor of subsequent mortality, hospital readmission and placement in a care facility. Patients with elevated RDW are at high risk for adverse out of hospital outcomes and may benefit from closer post discharge follow-up and higher intensity rehabilitation.

Two-Year Outcomes of the Nellix EndoVascular Aneurysm Sealing System for Treatment of Abdominal Aortic Aneurysms.

PURPOSE: To analyze the 2-year outcomes of endovascular aneurysm sealing (EVAS) according to 2 versions of the instructions for use (IFU). METHODS: A retrospective study was conducted involving 355 consecutive patients treated with the first-generation EVAS device from April 2013 to December 31, 2015, at 3 high-volume centers. Out of 355 patients treated with EVAS, 264 were elective asymptomatic infrarenal EVAS procedures suitable for analysis. In this cohort, 168 (63.3%) patients were treated within the IFU 2013 criteria; of these 48 (18.2%) were in compliance with the revised IFU 2016 version. RESULTS: Overall technical success was 98.2% (165/168) in the IFU 2013 group and 97.9% (47/48) in the IFU 2016 subgroup (p=0.428). The 2-year freedom from reintervention estimates were 89.7% (IFU 2013) and 95.7% (IFU 2016), with significantly more reinterventions in the first 45 cases (p=0.005). The stenosis/occlusion estimates were 6.5% (IFU 2013) and 4.2% (IFU 2016; p=0.705). Nine (5.4%) endoleaks (8 type Ia and 1 type Ib) were observed within the IFU 2013 cohort; 3 (2.1%) were in the IFU 2016 subgroup (p=0.583). Migration ≥10 mm or ≥5 mm requiring intervention was reported in 12 (7.1%) patients in the IFU 2013 cohort but none within the IFU 2016 subgroup. Ten (6.0%) patients demonstrated aneurysm growth in the IFU 2013 cohort, of which 2 (4.2%) were in the IFU 2016 subgroup. Overall survival and freedom from aneurysm-related death estimates at 2 years were 90.9% and 97.6% in the IFU 2013 cohort (IFU 2016: 95.5% and 100.0%). The prevalence of complications seemed lower within IFU 2016 without significant differences. CONCLUSION: This study shows acceptable 2-year results of EVAS used within the IFU, without significant differences between the 2 IFU versions, though longer follow-up is indicated. The refined IFU significantly reduced the applicability of the technique.

Genome-wide association study identifies a sequence variant within the DAB2IP gene conferring susceptibility to abdominal aortic aneurysm.

We performed a genome-wide association study on 1,292 individuals with abdominal aortic aneurysms (AAAs) and 30,503 controls from Iceland and The Netherlands, with a follow-up of top markers in up to 3,267 individuals with AAAs and 7,451 controls. The A allele of rs7025486 on 9q33 was found to associate with AAA, with an odds ratio (OR) of 1.21 and P = 4.6 x 10(-10). In tests for association with other vascular diseases, we found that rs7025486[A] is associated with early onset myocardial infarction (OR = 1.18, P = 3.1 x 10(-5)), peripheral arterial disease (OR = 1.14, P = 3.9 x 10(-5)) and pulmonary embolism (OR = 1.20, P = 0.00030), but not with intracranial aneurysm or ischemic stroke. No association was observed between rs7025486[A] and common risk factors for arterial and venous diseases-that is, smoking, lipid levels, obesity, type 2 diabetes and hypertension. Rs7025486 is located within DAB2IP, which encodes an inhibitor of cell growth and survival.

Ischemic patterns assessed by positron emission tomography predict adverse outcome in patients with idiopathic dilated cardiomyopathy.

BACKGROUND: Although patients with idiopathic dilated cardiomyopathy (DCM) have no coronary artery disease, regional impairment of myocardial perfusion combined with preserved metabolism has been found using positron emission tomography (PET). Our aim was to assess the prognostic relevance of PET-mismatch between stress myocardial perfusion and glucose uptake on clinical outcome in DCM. METHODS: In 24 patients with DCM who underwent both myocardial perfusion and metabolism PET scanning, "mismatch" was assessed and the association with clinical outcome (hospitalization, mortality, and heart transplantation) was investigated. RESULTS: Mismatch was found in 16 patients (66.7%). Univariate analysis showed that the presence of mismatch was associated with adverse outcome (P = 0.03). After adjustment for sex and age, the association remained significant with an adjusted relative risk of 10.4 (95% CI 1.1-103; P = 0.04) for death, heart transplant, or hospitalization. Univariate analysis also showed that a higher extent of mismatch was significantly associated with adverse outcome (P = 0.02). After adjusting for sex and age, the association remained significant with an adjusted relative risk of 6.5 [95% CI 1.2-36; P = 0.03] for death, heart transplantation, or hospitalization. CONCLUSION: PET stress perfusion-metabolism mismatch, indicative for ischemia, is frequently found in DCM patients and related to a poorer outcome.

Emergency endovascular stent grafting for thoracic aortic pathology.

Our aim was to report single-center results of emergency endovascular treatment for thoracic aortic disease. From March 1998 to January 2006, 30 acute thoracic EVAR procedures were carried out in 29 patients. One patient received two procedures in different settings. Four patients died before treatment could be initiated. The pathology of aortic lesions included atherosclerotic aneurysm (n = 13), pseudoaneurysm (n = 6), aortic rupture (n = 5), type B dissection (n = 5), aortobronchial or aortoesophageal fistula (n = 4), and intramural hematoma (n = 1). The surgical mortality rate was 21%. Three patients died as a result of technical complications, and three patients died after technically successful procedures. The mean follow-up was 31 +/- 23 months. The late mortality rate was 40% (8 of 20). Four patients died of causes unrelated to the procedure; two patients died at home without autopsy. Two patients died as a consequence of graft infections. Three late nonfatal complications occurred. Two of these resulted in additional treatment: one patient developed a mycotic aneurysm that was treated with additional stent grafting, and one patient developed a type 3 endoleak after 6 years of follow-up and was successfully treated with a bridging stent graft. Endovascular treatment for acute thoracic disease is feasible and associated with a reasonable outcome. In selected cases, it may be considered as a first option.