Three-Year Results of the Nellix Endovascular Aneurysm Sealing System for Treatment of Abdominal Aortic Aneurysms in Frail Patients with Poor Anatomical Features.

INTRODUCTION: Endovascular aneurysm sealing represents an alternative to advanced technology devices for compromised patients with abdominal aortic aneurysms. We report our results of 15 fragile patients with very low-quality infrarenal necks treated with endovascular aneurysm sealing. MATERIAL AND METHODS: All patients treated with Nellix device in our hospital between June 2015 and October 2016 were retrospectively reviewed. The primary endpoints are the following: overall survival and freedom from reintervention rates. The secondary endpoints are the following: technical success; 30-day mortality; abdominal aortic aneurysm-related mortality; and freedom from endoleak rate, complications, and surgical conversion rate. RESULTS: Nellix was used in 15 patients, median age 75.5 years, of which 67% were unfit for open surgery. Mean aneurysm diameter was 60 mm. One-third (5/15) of the patients were inside the Nellix instructions for use. Technical success rate was 93.3%. No perioperative complications existed, and 30-day mortality was 0%. Median follow-up was 35 (interquartile range: 11-37) months. Survival rates at 1 and 3 years were 80% and 59.3%. Abdominal aortic aneurysm-related mortality occurred in 3 of 15 cases. Freedom from rupture rates at 1 and 3 years were 92.9% and 66%. Freedom from endoleak rates at 1 and 3 years were 92.9% and 74.5%. Freedom from reintervention rates at 1 and 3 years were 86.7% and 70.6%, with a dramatic drop to 37.1% at 4 years of follow-up. Three open surgery conversions were needed. There were no statistically significant differences in results between patients treated inside and outside instructions for use. CONCLUSION: The endovascular aneurysm sealing has shown encouraging short-term results, but its safety and effectiveness during time is questionable, because this system still carries high rates of reintervention, conversions for type IA endoleaks, and secondary aneurysm ruptures.

Predicting risk of rupture and rupture-preventing reinterventions following endovascular abdominal aortic aneurysm repair.

BACKGROUND: Clinical and imaging surveillance practices following endovascular aneurysm repair (EVAR) for intact abdominal aortic aneurysm (AAA) vary considerably and compliance with recommended lifelong surveillance is poor. The aim of this study was to develop a dynamic prognostic model to enable stratification of patients at risk of future secondary aortic rupture or the need for intervention to prevent rupture (rupture-preventing reintervention) to enable the development of personalized surveillance intervals. METHODS: Baseline data and repeat measurements of postoperative aneurysm sac diameter from the EVAR-1 and EVAR-2 trials were used to develop the model, with external validation in a cohort from a single-centre vascular database. Longitudinal mixed-effects models were fitted to trajectories of sac diameter, and model-predicted sac diameter and rate of growth were used in prognostic Cox proportional hazards models. RESULTS: Some 785 patients from the EVAR trials were included, of whom 155 (19·7 per cent) experienced at least one rupture or required a rupture-preventing reintervention during follow-up. An increased risk was associated with preoperative AAA size, rate of sac growth and the number of previously detected complications. A prognostic model using predicted sac growth alone had good discrimination at 2 years (C-index 0·68), 3 years (C-index 0·72) and 5 years (C-index 0·75) after operation and had excellent external validation (C-index 0·76-0·79). More than 5 years after operation, growth rates above 1 mm/year had a sensitivity of over 80 per cent and specificity over 50 per cent in identifying events occurring within 2 years. CONCLUSION: Secondary sac growth is an important predictor of rupture or rupture-preventing reintervention to enable the development of personalized surveillance intervals. A dynamic prognostic model has the potential to tailor surveillance by identifying a large proportion of patients who may require less intensive follow-up.

Population-based study of ruptured abdominal aortic aneurysm.

BACKGROUND: The incidence of abdominal aortic aneurysms (AAAs) and their rupture has been reported to be decreasing. The aim was to evaluate trends in ruptured AAA (rAAA) incidence in the hospital district of Helsinki and Uusimaa (HUS) in southern Finland. This was a population-based retrospective review of all patients with rAAA in this well defined geographical area during 2003-2013. METHODS: Data for all patients treated for rAAA at Helsinki University Hospital, the only vascular surgery centre in an area of 1·5 million inhabitants, were collected from local vascular registry. All deaths attributed to rAAA were obtained from the cause of death registry of Statistics Finland. RESULTS: The mean(s.d.) age of the 712 patients with rAAA was 76·5(9·6) years; 76·7 per cent of them were men. Only 330 patients (46·3 per cent of those with rAAA) arrived alive at Helsinki University Hospital. The turn-down rate for surgical treatment was 10·3 per cent. Of the 296 patients operated on, 199 (67·2 per cent) were alive at 30 days. Only 27·9 per cent of all patients were alive 30 days after rupture of the AAA. The incidence of rAAA was 4·3 per 100 000 inhabitants and the mortality rate was 3·2 per 100 000 inhabitants. A decreasing trend was seen in incidence and mortality during the 11-year study interval. CONCLUSION: The incidence of rAAA is decreasing in the HUS district. Mortality from rAAA remains very high, because half of the patients die before reaching the hospital.

Rupture of Abdominal Aortic Aneurysms in Patients Under Screening Age and Elective Repair Threshold.

OBJECTIVES: The objective of this study was to identify the proportion of abdominal aortic aneurysm ruptures that occur before the screening age or threshold diameter for operative repair is reached. METHODS: The study was a retrospective analysis of RAAA patients including all RAAA patients admitted to Helsinki (HUH) and Tampere University Hospitals (TaUH) during 2002-2013. The data for age, gender, and comorbidities were collected from vascular registry and patient records. Computed tomography images taken at the time of admission were used for the measurement of maximum anteroposterior (AP) aneurysm diameter at the time of rupture. Age and diameter data were compared with risk factors. RESULTS: A total of 585 patients diagnosed with RAAA were admitted to the two hospitals during the 12 year period. The mean age at the time of rupture was 73.6 years (SD 9.5, range 42-96 years). 18.3% of patients were under 65: 21.4% of men and 3.0% of women. Men were on average 8 years younger than women. The odds ratio (OR) for rupture before 65 years of age for smokers was 2.1 compared with non-smokers, and 28.4% of smokers were under 65 at the time of rupture. Of all RAAA patients, 327 had a computed tomography scan confirming rupture. The mean AP diameter of the aneurysm was 75.6 mm (SD 15.8, range 32-155 mm). The mean size was significantly lower in women than in men (70.5 vs. 76.8, p = .005). CONCLUSIONS: The data from this study show that a fifth of men would not make it to the screening age of 65 before AAA rupture, the proportion being even larger in active smokers. The data from this study also supports the previous finding that aneurysm size at the time of rupture is significantly smaller in women.

Duplex surveillance after endovascular revascularisation for critical limb ischaemia.

OBJECTIVE: Despite the popularity of endovascular therapy (EVT) for critical limb ischaemia (CLI), there are few studies investigating the efficacy of duplex ultrasound (DUS) surveillance after endovascular interventions. The aim of this study was to evaluate DUS surveillance after EVT for CLI. METHODS: 146 endovascular procedures in 134 consecutive patients with CLI between 2011 and 2012 were included. Follow-up visits with ankle-brachial index (ABI), toe pressure, and target vessel DUS were performed at 1, 3, and 6 months after revascularisation. RESULTS: The median age of the study population was 79 years, 58% were males, and 55% had diabetes. The target artery was at the iliac, femoro-popliteal, and infrapopliteal level in 2%, 54%, and 44% of cases, respectively. There were 282 follow-up visits. In 15 (5.3%) DUS examinations, the target vessel was not seen properly. In the remaining 267 DUS, the majority of the target arteries were patent with no or mild restenosis (n = 169, 63.3%), but in 98 (36.7%) examinations, the target artery was stenosed or occluded. When DUS was compared with the clinical presentation, there was no correlation in 30% and when DUS and toe pressure were compared, discrepancy was seen in 29%. A re-angiogram was performed for 29 patients, and the DUS finding was verified in each case. During the mean follow-up of 11 months, a new endovascular intervention was performed on 37 (25.3%) limbs, and 4 (2.7%) underwent surgical bypass. Four (3.0%) patients died and 6 (4.5%) underwent major amputation. CONCLUSION: Clinical status or toe pressure alone were adequate markers of endovascular revascularisation failure in the majority of the patients, but would have missed up to one-third of the clinically significant re-stenoses or occlusions. DUS is therefore a valuable aid in surveillance after EVT for CLI, especially for patients with an ischaemic tissue lesion.

Doppler ultrasound examination of multiple sclerosis patients and control participants: inter-observer agreement and association with disease.

OBJECTIVE: Chronic cerebrospinal venous insufficiency (CCSVI) has been proposed as a major risk factor for multiple sclerosis (MS). The aim of this study was to assess inter-observer agreement between two ultrasound examiners and to compare findings in MS patients and control participants. METHODS: A prospective, blinded, controlled study of MS patients diagnosed within 2 years (MS ≤ 2, n = 39), patients diagnosed more than 10 years ago (MS > 10, n = 43) and age- and sex-matched control participants (n = 40). Ultrasound examinations were performed by two independent examiners. CCSVI criteria 1, 3, 4 and 5 as proposed by Zamboni were explored: (1) reflux in the internal jugular (IJV) and vertebral veins (VV), (3) IJV cross-sectional area (CSA) ≤0.3 cm(2), (4) absence of flow in IJV and VV, and (5) reverted postural control of venous outflow. RESULTS: Criteria 1, 4 and 5 were met in less than 10% of the MS patients and control participants as studied by both examiners. The level of inter-observer agreement was poor for all parameters except assessment of the CSA of IJV at the thyroid level. Findings meeting CCSVI criterion 3 (CSA ≤ 0.3 cm(2)) were observed in 18/40 (45%) of the control participants, in 24/37 (65%) of MS ≤ 2 patients (p = 0.09 vs. control participants) and in 30/43 (70%) of the MS > 10 patients (p = 0.022 vs. control participants). CONCLUSIONS: The feasibility of the CCSVI criteria for common use is questionable because of low inter-observer agreement. Small-calibre IJVs meeting the CCSVI criterion 3 appear common in both Finnish control participants and MS patients, but the clinical significance of this finding is questionable.

The natural course of abdominal aortic aneurysms that meet the treatment criteria but not the operative requirements.

INTRODUCTION: Abdominal aortic aneurysms (AAAs) of 55 mm diameter or growth >5 mm in 6 months are commonly accepted treatment criteria. The aim of this study was to establish the outcome of aneurysms that met the treatment criteria but not the operative requirements. MATERIAL AND METHODS: Patients (n = 154) who were declined from operative care of AAA in Helsinki University Central Hospital (HUCH) during 2000-2010 were retrospectively analysed. Reasons for exclusion were identified. The follow-up period extended until the end of April 2012. The rupture rate and mortality were determined. The patients were analysed according to the aneurysm diameter: 55-60, 61-70 and >70 mm. RESULTS: The reasons for exclusion from operative treatment were cardiorespiratory co-morbidities in 33%, cancer in 8%, overall condition in 33% and patient's choice in 21% of the patients. Regardless of the size of the aneurysm, the cause of death was aneurysm rupture in 43%, which was confirmed either in hospital or in autopsy for 76% of the patients. Of the ruptured aneurysms, 12 were operated of which five survived. CONCLUSIONS: A ruptured aneurysm is the most common cause of death among patients unfit for surgery; this should be considered in the preoperative evaluation process, especially since 5 of the 12 patients survived the ruptured AAA (RAAA) operation.

The role of vascular registries in improving the management of abdominal aortic aneurysm.

Treatment of abdominal aortic aneurysm (AAA) is one of the vascular surgical index procedures and an important part of the total workload. Whichever way treated, it typically has high mortality and morbidity. Furthermore, endovascular repair is still a relatively new treatment method and under evolution. Therefore continuous quality control with subsequent outcome analysis, benchmarking, intervention and reassessment are mandatory to achieve high level aneurysm care. Vascular registries are tools for this audit. The aim of this review is to focus on the problems and solutions related to attempts to improve the management of abdominal aortic aneurysm with emphasis on the experience gathered in Finland. This includes great variations in dynamics over time in Southern Finland. To control the influence of patient selection and case-mix, total hospital mortality is emphasized as the most appropriate outcome measure of the level of treatment of ruptured abdominal aortic aneurysm (RAAA). Total aneurysm mortality (including total hospital mortality of RAAA and other AAA surgery) is introduced as an outcome measure of vascular service.

Prediction of survival after 48-h of intensive care following open surgical repair of ruptured abdominal aortic aneurysm.

OBJECTIVE: To identify predictive factors for 30-day mortality after 48 h of maximal treatment in intensive care unit (ICU) after repair for ruptured abdominal aortic aneurysm (RAAA). DESIGN: Retrospective study in the ICU of the university central hospital. MATERIALS AND METHODS: Between 1999 and 2003, a total of 197 patients were admitted to emergency unit due to RAAA, and 185 of them underwent open surgical repair. A total of 138 patients survived at least 48-h and were included in a study to identify factors predictive of 30-day mortality by logistic regression analysis. RESULTS: Thirty-day mortality of all RAAA patients was 46% (87/197) whereas the 30-day mortality for those alive at 48 h was 22% (31/138). Forward stepwise multivariate logistic regression analysis revealed that only organ dysfunction by SOFA score (sequential organ failure assessment) at 48-h, preoperative Glasgow Aneurysm Score, and supra-renal clamping in operation were independent predictors of death. CONCLUSIONS: Degree of organ dysfunction by SOFA score was the best predictor of 30-day mortality in RAAA patients alive at 48-h after open surgical repair.