Higher 30 Day Mortality in Patients with Familial Abdominal Aortic Aneurysm after EVAR.

OBJECTIVES: To determine the influence of a positive family history for aneurysms on clinical success and mortality after endovascular aneurysm repair (EVAR). METHODS: From 2009 to 2011, 1262 patients with abdominal aortic aneurysms (AAA) treated by EVAR were enrolled in a prospective, industry sponsored clinical registry ENGAGE. Patients were classified into familial and sporadic AAA patients according to baseline clinical reports. Clinical characteristics, aneurysm morphology, and follow-up were registered. The primary endpoint was clinical success after EVAR, a composite of technical success and freedom from the following complications: AAA increase >5 mm, type I and III endoleak, rupture, conversion, secondary procedures, migration, and occlusion. Secondary endpoints were the individual components of clinical success, 30 day mortality, and aneurysm related and all cause mortality. RESULTS: Of the 1262 AAA patients (89.5% male and mean age 73.1 years), 86 patients (6.8%) reported a positive family history and were classified as familial AAA. Duration of follow-up was 4.4 ± 1.7 years. Patients with familial AAA were more often female (18.6% vs. 9.9%, p = .012). No difference was observed in aneurysm morphology. There was no significant difference in clinical success between patients with familial and sporadic AAA (72.1% vs. 79.3%, p=.116). Familial AAA patients had a higher 30 day mortality after EVAR (4.7% vs. 1.0%, adjusted HR 5.7, 1.8-17.9, p = .003) as well as aneurysm related mortality (5.8% vs. 1.3%, adjusted HR 5.4, 1.9-14.9, p = .001), while no difference was observed in all cause mortality (19.8% vs. 24.3%, adjusted HR 0.8, 0.5-1.4, p = .501). CONCLUSIONS: The current study shows a higher 30 day mortality after EVAR in familial AAA patients. Future studies should determine the role of family history in AAA treatment, suitability for endovascular or open repair, and on adaptation of post-operative surveillance. For the time being, patients with familial forms of AAA should be considered at higher risk for EVAR and warrant extra vigilance.

Iliac Seal Zone Dynamics and Clinical Consequences After Endovascular Aneurysm Repair.

OBJECTIVE: To evaluate the dynamics of the iliac attachment zone after EVAR, and the association with clinical events. METHODS: A tertiary institution's prospective EVAR database was searched to identify common iliac arteries at risk. Internally validated measurements were made, using centre lumen line reconstructions. Iliac dilatation and endograft limb retraction were the main endpoints. Associations between dilatation, retraction, oversizing, and distal seal length were investigated. Association with clinical events (sealing or occlusion) was also explored. RESULTS: Of 452 primary EVAR patients treated from 2004 to 2012, 341 were included (mean age 72 years, 12% female, 597 common iliac arteries). Median follow-up was 4.7 years. At 30 days, the mean iliac diameter increased from 14 mm to 15 mm (p < .001). Over follow-up, it increased to 18 mm (p < .001). Iliac dilatation ≥20% occurred in 295 cases (49.4%) and exceeded the implanted endograft diameter in 170 (28.7%). Limb retraction ≥5 mm was identified in 54 patients (9.1%) and was associated with iliac seal complications (p < 0.001). Iliac endograft extension diameter ≥24 mm (OR 3.3, 95% CI 1.7-6.4) and iliac artery dilatation beyond the endograft (OR 2.1, 95% CI 1.2-3.8) were independent risk factors. Overall, there were 34 (5.7%) iliac seal complications. Retraction of the iliac endograft (OR 1.17 per mm, 95% CI 1.10-1.24) and baseline AAA diameter (1.04 per mm, 95% CI 1.01-1.07) were independent risk factors for seal related complications. Greater initial post-operative iliac seal length was protective (OR 0.94 per mm, 95% CI 0.90-0.97). CONCLUSIONS: Iliac dilatation and endograft retraction are common findings during follow-up, potentially leading to adverse clinical events. Optimisation of the iliac seal zone providing a long distal seal length and added attention to patients with large aneurysms or receiving ≥24 mm diameter iliac extensions are recommended. Also, long-term surveillance including CTA is advised to reveal and correct loss of seal at the iliac attachments before adverse clinical events occur.

Development and External Validation of a Model Predicting Death After Surgery in Patients With a Ruptured Abdominal Aortic Aneurysm: The Dutch Aneurysm Score.

OBJECTIVE: The decision whether or not to proceed with surgical intervention of a patient with a ruptured abdominal aortic aneurysm (rAAA) is very difficult in daily practice. The primary objective of the present study was to develop and to externally validate a new prediction model: the Dutch Aneurysm Score (DAS). METHODS: With a prospective cohort of 10 hospitals (n = 508) the DAS was developed using a multivariate logistic regression model. Two retrospective cohorts with rAAA patients from two hospitals (n = 373) were used for external validation. The primary outcome was the combined 30 day and in-hospital death rate. Discrimination (AUC), calibration plots, and the ability to identify high risk patients were compared with the more commonly used Glasgow Aneurysm Score (GAS). RESULTS: After multivariate logistic regression, four pre-operative variables were identified: age, lowest in hospital systolic blood pressure, cardiopulmonary resuscitation, and haemoglobin level. The area under the receiver operating curve (AUC) for the DAS was 0.77 (95% CI 0.72-0.82) compared with the GAS with an AUC of 0.72 (95% CI 0.67-0.77). The DAS showed a death rate in patients with a predicted death rate ≥80% of 83%. CONCLUSIONS: The present study shows that the DAS has a higher discriminative performance (AUC) compared with the GAS. All clinical variables used for the DAS are easy to obtain. Identification of low risk patients with the DAS can potentially reduce turndown rates. The DAS can reliably be used by clinicians to make a more informed decision in dialogue with the patient and their family whether or not to proceed with surgical intervention.

Perioperative Complications are Associated With Adverse Long-Term Prognosis and Affect the Cause of Death After General Surgery.

BACKGROUND: It is unclear how mortality and causes of death vary between patients and surgical procedures and how occurrence of postoperative complications is associated with prognosis. This study describes long-term mortality rates and causes of death in a general surgical population. Furthermore, we explore the effect of postoperative complications on mortality. METHODS: A single-centre analysis of postoperative complications, with mortality as primary endpoint, was conducted in 4479 patients undergoing surgery. We applied univariate and multivariable regression models to analyse the effect of risk factors, including surgical risk and postoperative complications, on mortality. Causes of death were also explored. RESULTS: 75 patients (1.7 %) died within 30 days after surgery and 730 patients (16.3 %) died during a median follow-up of 6.3 years (IQR 5.8-6.8). Significant differences in long-term mortality were observed with worst outcome for patients undergoing high-risk vascular surgery (HR 1.5; 95 % CI 1.2-1.9). When looking at causes of death, high-risk surgery was associated with a twofold higher risk of cardiovascular death (HR 1.9; 95 % CI 1.2-3.1), whereas the intermediate-risk group had a higher risk of dying from cancer-related causes (HR 1.5; 95 % CI 1.1-2.0). Occurrence of complications-particularly of cardiovascular nature- was associated with worse survival (HR 1.9; 95 % CI 1.3-2.7). CONCLUSION: High-risk vascular surgery and occurrence of postoperative complications are important predictors of late mortality. Further focus on these groups of patients can contribute to reduced morbidity. Improvement in quality of care should be aimed at preventing postoperative complications and thus a better outcome in a general surgical population.

Low Socioeconomic Status is an Independent Risk Factor for Survival After Abdominal Aortic Aneurysm Repair and Open Surgery for Peripheral Artery Disease.

OBJECTIVE/BACKGROUND: The association between socioeconomic status (SES), presentation, and outcome after vascular surgery is largely unknown. This study aimed to determine the influence of SES on post-operative survival and severity of disease at presentation among vascular surgery patients in the Dutch setting of equal access to and provision of care. METHODS: Patients undergoing surgical treatment for peripheral artery disease (PAD), abdominal aortic aneurysm (AAA), or carotid artery stenosis between January 2003 and December 2011 were retrospectively included. The association between SES, quantified by household income, disease severity at presentation, and survival was studied using logistic and Cox regression analysis adjusted for demographics, and medical and behavioral risk factors. RESULTS: A total of 1,178 patients were included. Low income was associated with worse post-operative survival in the PAD cohort (n = 324, hazard ratio 1.05, 95% confidence interval [CI] 1.00-1.10, per 5,000 Euro decrease) and the AAA cohort (n = 440, quadratic relation, p = .01). AAA patients in the lowest income quartile were more likely to present with a ruptured aneurysm (odds ratio [OR] 2.12, 95% CI 1.08-4.17). Lowest income quartile PAD patients presented more frequently with symptoms of critical limb ischemia, although no significant association could be established (OR 2.02, 95% CI 0.96-4.26). CONCLUSIONS: The increased health hazards observed in this study are caused by patient related factors rather than differences in medical care, considering the equality of care provided by the study setting. Although the exact mechanism driving the association between SES and worse outcome remains elusive, consideration of SES as a risk factor in pre-operative decision making and focus on treatment of known SES related behavioral and psychosocial risk factors may improve the outcome of patients with vascular disease.

Risk factors for proximal neck complications after endovascular aneurysm repair using the endurant stentgraft.

OBJECTIVE: To assess the incidence and risk factors for proximal aneurysm neck related complications with a late generation device for endovascular abdominal aneurysm repair (EVAR). METHODS: Data were retrieved from a prospective registry (Endurant Stent Graft Natural Selection Global Postmarket Registry) involving 79 institutions worldwide. The risk factors tested were age, gender, surgical risk profile, proximal neck length (<10 mm), diameter (>30 mm), supra- and infrarenal angulation (>60° and 75°), mural thrombus/calcification (>50%) and taper (>10%), and AAA diameter (>65 mm). Two neck related composite endpoints were used, for intra-operative (type-1a endoleak, conversion, deployment/retrieval complication or unintentional renal coverage) and post-operative (type-1a endoleak or migration) adverse events. Independent risk factors were identified using multivariable backwards modeling. RESULTS: The study included 1263 patients (mean age 73, 10.3% female) from March 2009 to May 2011. Twenty three (1.8%) intra-operative adverse events occurred. Neck length <10 mm (OR 4.9, 95% CI 1.1-22.6) and neck thrombus/calcification >50% (OR 4.8, 95% CI 1.7-13.5) were risk factors for intra-operative events. The planned 1 year follow up visit was reached for the entire cohort, and the 2 year visit for 431 patients. During this time, 99 (7.8%) events occurred. Female gender (HR 1.9, 95% CI 1.1-3.2), aneurysm diameter >65 mm (HR 2.8, 95% CI 1.9-4.2), and neck length <10 mm (HR 2.8, 95% CI 1.1-6.9) were significant post-operative risk factors. Neck angulation, neck taper, large diameter neck, and presence of thrombus/calcification were not predictors of adverse outcome in this study. CONCLUSION: These results support the adequacy of this device in the face of adverse neck anatomy, and confirm neck length as the most relevant anatomical limitation for EVAR. Additionally, the study confirms the decline in early to mid-term intervention rates with a newer generation device in a large patient sample. Lastly, it suggests that neck related risk factors affect outcome and impact on prognosis in varying degrees.

Mid-Term Results of EVAR in Severe Proximal Aneurysm Neck Angulation.

OBJECTIVE: To determine if mid-term outcome following endovascular aneurysm repair (EVAR) with the Endurant Stent Graft (Medtronic, Santa Rosa, CA, USA) is influenced by severe proximal neck angulation. METHODS: A retrospective case-control study was performed using data from a prospective multicenter database. All measurements were obtained using dedicated reconstruction software and center-lumen line reconstruction. Patients with neck length >15 mm, infrarenal angle ß > 75°, and/or suprarenal angle α > 60°, or neck length >10 mm with ß > 60°, and/or α > 45° were compared with a matched control group. Primary endpoint was primary clinical success. Secondary endpoints were freedom from rupture, type 1A endoleak, stent fractures, freedom from neck-related reinterventions, and aneurysm-related adverse events. Morphological neck variation over time was also assessed. RESULTS: Forty-five patients were included in the study group and were compared with a matched control group with 65 patients. Median follow-up time was 49.5 months (range 30.5-58.4). The 4-year primary clinical success estimates were 83% and 80% for the angulated and nonangulated groups (p = .42). Proximal neck angulation did not affect primary clinical success in a multivariate model (hazard ratio 1.56, 95% confidence interval 0.55-4.41).Groups did not differ significantly in regard to freedom from rupture (p =.79), freedom from type 1A endoleak (p = .79), freedom from neck-related adverse events (p = .68), and neck-related reinterventions (p = .68). Neck angle reduction was more pronounced in patients with severe proximal neck angulation (mean deltaα -15.6°, mean deltaß -30.6°) than in the control group (mean deltaα -0.39°, mean deltaß -5.9°) (p < .001). CONCLUSION: Mid-term outcomes following EVAR with the Endurant Stent Graft were not influenced by severe proximal neck angulation in our population. Despite the conformability of the device, moderate aortic neck remodeling was identified in the group of patients with angulated neck anatomy on the first computed tomography scan after implantation with no important further remodeling afterwards. No device integrity failures were encountered.

Early sac shrinkage predicts a low risk of late complications after endovascular aortic aneurysm repair.

BACKGROUND: Aneurysm shrinkage has been proposed as a marker of successful endovascular aneurysm repair (EVAR). Patients with early postoperative shrinkage may experience fewer subsequent complications, and consequently require less intensive surveillance. METHODS: Patients undergoing EVAR from 2000 to 2011 at three vascular centres (in 2 countries), who had two imaging examinations (postoperative and after 6-18 months), were included. Maximum diameter, complications and secondary interventions during follow-up were registered. Patients were categorized according to early sac dynamics. The primary endpoint was freedom from late complications. Secondary endpoints were freedom from secondary intervention, postimplant rupture and direct (type I/III) endoleaks. RESULTS: Some 597 EVARs (71.1 per cent of all EVARs) were included. No shrinkage was observed in 284 patients (47.6 per cent), moderate shrinkage (5-9 mm) in 142 (23.8 per cent) and major shrinkage (at least 10 mm) in 171 patients (28.6 per cent). Four years after the index imaging, the rate of freedom from complications was 84.3 (95 per cent confidence interval 78.7 to 89.8), 88.1 (80.6 to 95.5) and 94.4 (90.1 to 98.7) per cent respectively. No shrinkage was an independent risk factor for late complications compared with major shrinkage (hazard ratio (HR) 3.11; P < 0.001). Moderate compared with major shrinkage (HR 2.10; P = 0.022), early postoperative complications (HR 3.34; P < 0.001) and increasing abdominal aortic aneurysm baseline diameter (HR 1.02; P = 0.001) were also risk factors for late complications. Freedom from secondary interventions and direct endoleaks was greater for patients with major sac shrinkage. CONCLUSION: Early change in aneurysm sac diameter is a strong predictor of late complications after EVAR. Patients with major sac shrinkage have a very low risk of complications for up to 5 years. This parameter may be used to tailor postoperative surveillance.

Spontaneous delayed sealing in selected patients with a primary type-Ia endoleak after endovascular aneurysm repair.

OBJECTIVE: Direct additional therapy is advised for type-Ia endoleaks detected on completion angiography after endovascular aneurysm repair (EVAR). Additional intraoperative endovascular procedures are, however, often challenging or not possible, and direct open conversion is unattractive. The results of a selective, conservative strategy for patients with primary type-Ia endoleak has been analysed. METHODS: This was a retrospective, single-centre study (UMC, Utrecht, NL). From 2004 to 2008, all patients with a primary type-Ia endoleak and suitable anatomy for EVAR, stentgraft oversizing ≥15%, and optimal deployment were included. Complications during follow-up were studied and all sequential CTA scans were reviewed. These were compared with the remaining patients, treated during the same period. RESULTS: Fifteen patients were included (14 male, median age 77, range 67-85) with a median aneurysm diameter of 60 mm (48-80), an aneurysm neck diameter of 26 mm (21-32), a neck length of 29 mm (11-39), and infrarenal angulation of 49° (31-90). One patient suffered rupture 2 days after EVAR - leading to the only AAA-related death. Eight of the 15 type-Ia endoleaks disappeared spontaneously on the first postoperative CTA, obtained within 1 week of EVAR. On the second postoperative CTA, obtained a median of 5 months (1-12) after EVAR, all remaining endoleaks had sealed. One recurrence occurred at 4.85 years. During a median follow-up of 3.3 years, there were five secondary interventions. Compared with controls, there were more secondary (or recurrent) type-1a endoleaks (13% vs. 4%), endograft migrations (13% vs. 3%), sac growths (33% vs. 16%), and secondary interventions (33% vs. 23%). None of these differences however, were statistically significant. CONCLUSIONS: All but one of the primary type-Ia endoleaks sealed spontaneously. Until sealing, the risk of rupture persisted, but subsequently only one recurrence of type-Ia endoleak was seen. In selected patients, a conservative approach for primary type-Ia endoleaks may be justified.

Differences in mortality, risk factors, and complications after open and endovascular repair of ruptured abdominal aortic aneurysms.

OBJECTIVE/BACKGROUND: Endovascular aneurysm repair (EVAR) for ruptured abdominal aortic aneurysm (rAAA) has faced resistance owing to the marginal evidence of benefit over open surgical repair (OSR). This study aims to determine the impact of treatment modality on early mortality after rAAA, and to assess differences in postoperative complications and long-term survival. METHODS: Patients treated between January 2000 and June 2013 were identified. The primary endpoint was early mortality. Secondary endpoints were postoperative complications and long-term survival. Independent risk factors for early mortality were calculated using multivariate logistic regression. Survival estimates were obtained by means of Kaplan-Meier curves. RESULTS: Two hundred and twenty-one patients were treated (age 72 ± 8 years, 90% male), 83 (38%) by EVAR and 138 (62%) by OSR. There were no differences between groups at the time of admission. Early mortality was significantly lower for EVAR compared with OSR (odds ratio [OR]: 0.45, 95% confidence interval [CI]: 0.21-0.97). Similarly, EVAR was associated with a threefold risk reduction in major complications (OR: 0.33, 95%CI: 0.15-0.71). Hemoglobin level <11 mg/dL was predictive of early death for patients in both groups. Age greater than 75 years and the presence of shock were significant risk factors for early death after OSR, but not after EVAR. The early survival benefit of EVAR over OSR persisted for up to 3 years. CONCLUSION: This study shows an early mortality benefit after EVAR, which persists over the mid-term. It also suggests different prognostic significance for preoperative variables according to the type of repair. Age and the presence of shock were risk factors for early death after OSR, while hemoglobin level on admission was a risk factor for both groups. This information may contribute to repair-specific risk prediction and improved patient selection.

Treatment of post-implantation aneurysm growth by laparoscopic sac fenestration: long-term results.

OBJECTIVES: Sac growth after endovascular aneurysm repair (EVAR) is an important finding, which may influence prognosis. In case of a type II endoleak or endotension, clipping of side branches and subsequent sac fenestration has been presented as a therapeutic alternative. The long-term clinical efficacy of this procedure is unknown. METHODS: The study included eight patients who underwent laparoscopic aortic collateral clipping and sac fenestration for enlarging aneurysms following EVAR. Secondary interventions and clinical outcome were retrieved from hospital records. Sac behaviour was evaluated measuring volumes on periodical computed tomography angiography (CTA) imaging using dedicated software. RESULTS: Follow-up had a median length of 6.6 (range 0.6-8.6) years. During this time, only three patients successfully achieved durable aneurysm shrinkage (n = 2) or stability (n = 1). The remaining patients suffered persistent (n = 2) or recurrent sac growth (n = 3), all regarded as failure of fenestration. A total of six additional interventions were performed, comprising open conversion (n = 2), relining (n = 1) and implantation of iliac extensions (n = 3). All additional interventions were successful at arresting further sac growth during the remainder of follow-up. CONCLUSIONS: Despite being a less invasive alternative to conversion and open repair, the long-term outcome of sac fenestration is unpredictable and additional major procedures were often necessary to arrest sac growth.

Severe proximal aneurysm neck angulation: early results using the Endurant stentgraft system.

OBJECTIVE: Angulation of the proximal aneurysm neck has been associated with adverse outcome after EVAR. We aim to investigate the influence of angulation on early results when using the Endurant Stentgraft System. METHODS: A retrospective analysis of a prospective multicentre database identified 45 elective patients treated with the Endurant stentgraft with severe angulation of the proximal neck, which were compared to a control group without significant angulation. Endpoints were early technical and clinical success, deployment accuracy and differences in operative details. RESULTS: Mean age was 74 with 86.4% males. Mean infrarenal angle (ß) was 80.8° ± 16 and mean suprarenal angle (α) was 51.4° ± 21. Patients in the angulated group had larger aneurysms (mean 309 cc vs. 187 cc), shorter necks (mean 27 mm ± 14 vs. 32.6 mm ± 13) and 74% (vs. 56%) were ASA III/IV. Technical success was 100%, with one patient requiring an unplanned proximal extension. No differences were found regarding early type-I endoleaks (0% vs. 0%), major postoperative complications (6.7% vs. 6.2%; p = 0.77) or early survival (97.8% vs. 96.9%, p = 0.79). Distance from lowest renal artery to prosthesis was 2.4 mm ± 2.7 vs. 2.3 mm ± 4.8, p = 0.9. Operative details were equivalent for both groups. CONCLUSIONS: Treatment with the Endurant stentgraft is technically feasible and safe, with satisfactory results in angulated and non-angulated anatomies alike. No sealing length was lost in extremely angulated cases, confirming the device's high conformability. Mid- and long-term data are awaited to verify durability, but early results are promising and challenge current opinion concerning neck angulation.

Decision-making in type-B dissection: current evidence and future perspectives.

Aortic dissection is a devastating cardiovascular condition with an incidence of 3,5:100 000. It is classified according to anatomic extent, mechanism of lesion, duration from index event and course (uncomplicated vs. complicated). Intramural hematoma and penetrating aortic ulcers share many of the features of classic dissections, but tend to occur in older patients with advanced atherosclerosis. In uncomplicated type-B dissection, conservative treatment with tight blood pressure and heart rate control is safe and effective. Early stent-graft implantation may, however, result in more favorable aortic remodeling and reduced late complications. For acute complicated cases intervention is usually required. Stent-graft coverage of the entry tear frequently resolves malperfusion, but the role of the false lumen in organ perfusion must be assessed and endovascular revascularization performed if necessary. In chronic type-B dissections, coverage of the entry tear likely results in continued pressurization of the false lumen due to rigidity of the dissecting membrane and distal fenestrations. Better understanding of the different disease mechanisms involved, imaging advances and introduction of dedicated stent-grafts are expected to further improve patient outcomes in the future. Primary and secondary pharmacological prevention, stricter follow-up protocols and screening of family members may also prove valuable. Better patient selection will allow preventive treatment with low morbidity for those at higher risk of complications.

Device-specific outcomes after endovascular abdominal aortic aneurysm repair.

Over the last decade, endovascular aneurysm repair (EVAR) has been used extensively for the elective treatment of infra-renal abdominal aneurysms. However, it remains unclear how specific devices perform and how they compare to others. We provide an overview of currently used endografts, and discuss the current evidence regarding device-specific outcomes. Published literature confirms differences in results according to endograft selection. These differences were more pronounced with older generations of devices, in comparison to newer models. Contemporary results are generally good and one should remember that no randomized data exist regarding individual device performance. Moreover, by the time there is enough follow-up to draw conclusions, the data is relatively obsolete due to constant improvements in endograft technology and design. Results from EVAR have been steadily improving and individualized device selection has shown to be valuable. It appears that patients with favorable anatomy do well with most modern endografts. Those with challenging anatomies may benefit more from a particular design, delivery and deployment feature requiring greater knowledge and experience for adequate device selection.