Aortic neck dilatation (AND) occurs after endovascular aneurysm repair (EVAR) with self expanding stent grafts (SESs). Whether it continues, ultimately exceeding the endograft diameter leading to ...abdominal aortic aneurysm (AAA) rupture, remains uncertain. Dynamics, risk factors, and clinical relevance of AND were investigated after EVAR with standard SESs.
All intact EVAR patients treated from 2000 to 2015 at a tertiary institution were included. Demographic, anatomical, and device related characteristics were investigated as risk factors for AND. Outer to outer diameters were measured at a single standardised aortic level on reconstructed computed tomography (CT) images.
A total of 460 patients were included (median follow up 5.2 years, interquartile range IQR 3.0, 7.7 years; CT imaging follow up 3.3 years, IQR 1.3, 5.4). Baseline neck diameter was 24 mm (IQR 22, 26) and increased 11.1% (IQR 1.5%, 21.9%) at last CT imaging. Endograft oversizing was 20.0% (IQR 13.6, 28.0). AND was greater during the first year (5.2% IQR 0, 11.7) decreasing subsequently (two to four years to 1.4%/year IQR 0.0, 4.5%, p ≤ .001) and was associated with suprarenal fixation endografts (t value = 7.9, p < .001) and oversizing (t value = 4.4, p < .001). AND exceeding the endograft was 3.5% (95% CI 2.2% – 4.8%) and 14.4% (95% CI 11.0% – 17.8%) at five and eight years, respectively. Excessive AND was associated with baseline neck diameter (OR 1.2/mm, 95% CI 1.05 – 1.41) while the Excluder endograft had a protective effect (OR 0.15, 95% CI 0.04 – 0.58). Excessive AND was associated with type 1A endoleak (HR 3.3, 95% CI 1.1 – 9.7) and endograft migration > 5 mm (HR 3.1, 95% CI 1.4 – 6.9).
AND after EVAR with SES is associated with endograft oversizing and radial force but decelerates after the first post-operative year. Baseline aortic neck diameter and suprarenal stent bearing endografts were associated with an increased risk of AND beyond nominal stent graft diameter. However, it remains unclear whether patient selection, differences in endograft radial force or the suprarenal stent are accountable for this difference.
Many endografts are currently available for standard endovascular repair of infrarenal abdominal aortic aneurysms. Comparison of long-term outcomes between devices might aid in this decision process, ...but comparative data are scarce. The purpose of this study was to report long-term clinical outcomes of two commercially available endoprosthesis, the Endurant (Medtronic Vascular, Inc, Minneapolis, Minn) and the Excluder (W. L. Gore & Associates, Flagstaff, Ariz) stent grafts.
Patients undergoing standard endovascular repair from July 2004 to December 2011 in a single institution with the Endurant or the Low-Porosity Excluder endografts were eligible. Only patients treated for intact degenerative abdominal infrarenal aneurysms were included. All measurements were performed on center-lumen line reconstructions obtained on dedicated software. The primary end point was primary clinical success, defined as clinical success without the need for an additional or secondary surgical or endovascular procedure. Neck-related events (a composite of type IA endoleak, neck-related secondary intervention, or migration of >5 mm), neck morphology changes, renal function, and overall survival were secondary end points.
The study included 277 patients (156 Endurants; 121 Excluders). The median follow-up was 5.8 years (range, 0.1-12.4 years) and did not differ between groups (P = .18). Patients treated with the Endurant stent graft had wider (neck diameter of >28 mm, 27.3% vs 1.7% P < .001; neck diameter of 27 mm, interquartile range (IQR), 24-29 mm for Endurant and 24 mm IQR, 22-25 mm for Excluder; P < .001) and more angulated necks (β-angle of >60°, 26.7% vs 12.5%; P = .004). Oversizing was greater in the Endurant group (16% IQR, 12%-22% vs 13% IQR, 8%-17%, respectively; P < .001). Patients were treated outside device instructions for use regarding proximal neck: 16.7% in the Endurant and 17.3% in the Excluder group (P = .720). The 7-year primary clinical success was 54.7% for the Endurant and 58.1% for the Excluder groups (P = .53). Freedom from neck-related events at 7 years was 76.7% for the Endurant and 78.8% for Excluder group (P = .94). The Endurant stent graft (hazard ratio HR, 2.7; 95% confidence interval CI, 1.3-5.8; P = .009) was an independent predictor of significant renal function decline. Neck dilatation was greater in Endurant-implanted patients (13% 95% CI, 2%-22% vs 4% 95% CI, 0%-10%; P < .001). Overall survival at 7 years was 61.4% in the Endurant and 50.3% (n = 50; standard error, 0.047) in the Excluder group (P = .39).
This study reveals that durable and sustainable results can be obtained with either of these late generation devices. This finding suggests that careful planning and a tailored device selection taking into account the patient's anatomy are more relevant determinants than the graft model itself to obtain clinical success. The Endurant endoprosthesis seems to be associated with a higher rate of neck dilatation and faster decrease in the estimated glomerular filtration rate, but further studies with longer follow-up are necessary to determine the clinical relevance of these findings.
Endovascular aneurysm repair (EVAR) became an increasingly preferred modality for abdominal aortic aneurysm (AAA) repair both in elective AAA repair (el-EVAR) and EVAR of a ruptured AAA (r-EVAR) ...setting. Ruptured AAAs usually have more hostile anatomies and less time for planning. Consequently, more complications may arise after r-EVAR. The purpose of this study was to compare mi-term outcomes between r-EVAR and el-EVAR.
A retrospective cohort analysis of patients undergoing EVAR from 2000 to 2015 at a tertiary institution was performed. Patients with previous aortic surgery, nonatherosclerotic AAA and isolated iliac aneurysms were excluded. In-hospital casualties or patients who were intraoperatively converted to open repair were also excluded. For the midterm outcome analysis, only patients with at least two postoperative examinations (a 30-day computed tomography scan and a second postoperative examination performed 6 months or later) were considered. The primary end point was freedom from aneurysm-related complications (a composite of type I or III endoleak, aneurysm sac growth, migration of more than 5 mm, device integrity failure, AAA-related death, late postimplant rupture, or AAA-related secondary intervention). Freedom from secondary interventions, neck-related events (defined as a composite of type IA endoleak, migration of more than 5 mm, or preemptive neck-related secondary intervention) and late survival were secondary end points. The impact of device instructions for use (IFU) compliance on neck events was also assessed.
The study included 565 patients (65 r-EVAR and 500 el-EVAR). Eighty-two patients were treated outside proximal neck IFU, 13 in the r-EVAR group (21.3%) and 69 (14.5%) in the el-EVAR (P = .16). During the index hospitalization, there were more complications (12.3% vs 3.2%; P = .001) and reinterventions (12.3% vs 2.8%; P < .001) in the r-EVAR group. After discharge, median clinical follow-up time was 4.3 years (interquartile range, 2.1-7.0 years) without differences between both groups. Five-year freedom from AAA-related complications was 53.9% in the r-EVAR group and 65.4% in the el-EVAR (P = .21). In multivariable analysis the r-EVAR group was not at increased risk for late complications (hazard ratio HR, 0.94; 95% confidence interval CI, 0.54-1.61; P = .81). Five-year freedom from neck-related events was 74% in r-EVAR and 82% in the el-EVAR group (P = .345). Patients treated outside neck IFU were at greater risk for neck-related events both in r-EVAR (HR, 6.5; 95% CI, 1.8-22.9; P = .004) and el-EVAR group (HR, 2.6; 95% CI, 1.5-4.5; P < .001). Freedom from secondary interventions at 5 years was 63.0% for r-EVAR and 76.9% for el-EVAR (P = .16). Survival at 5 years was 68.8% in the r-EVAR group and 73.3% in the el-EVAR group (P = .30).
Durable and sustainable midterm outcomes were found for both r-EVAR and el-EVAR patients who survived the postoperative period. Patients treated outside the IFU are at greater risk for late complications. Surveillance protocols may be tailored according to individual anatomy and IFU compliance rather than timing of repair.
Abstract Objective Endovascular aneurysm repair (EVAR) has progressively expanded to treat more challenging anatomies. Although EVAR in patients with wide infrarenal necks has been reported with ...acceptable results, there is still controversy regarding the longer-term outcomes. Our aim is to determine the impact of infrarenal neck diameter on midterm outcome following EVAR with a single endograft with suprarenal fixation. Methods A retrospective case-control study was designed using data from a prospective multicenter database. Patients who electively underwent standard EVAR with an Endurant stent graft (Medtronic Ave, Santa Rosa, Calif) for a degenerative abdominal aortic aneurysm from January 2008 to December 2012 in three high-volume centers in The Netherlands were included. All measurements were obtained using dedicated reconstruction software and center-lumen line reconstruction. Patients with an infrarenal neck diameter of ≥30 mm were compared with patients with a neck diameter of <30 mm. The primary end point was freedom from neck-related adverse events (a composite of type Ia endoleak, neck-related secondary intervention, and endograft migration). Secondary end points were primary clinical success, type Ia endoleak, neck-related reinterventions, endoleaks, and aneurysm-related secondary interventions. Results Four-hundred twenty-seven patients were included. Seventy-four patients (17.3%) with a neck diameter of ≥30 mm were compared with a control group of 353 patients. There were no significant differences at baseline between groups including demographics, comorbidities, baseline aneurysm diameter, infrarenal neck length, suprarenal angulation, or infrarenal neck angulation. Median stent graft oversizing was 12.5% (7.9-16.1) and 16.6% (12.0-23.1) in the ≥30-mm neck-diameter and control groups, respectively ( P < .001). Median follow-up was 3.1 years (1.2-4.7) and 4.1 years (2.7-5.6) for the large neck and control groups, respectively ( P < .001). Type Ia endoleaks occurred in 17 patients (4.0%) and were significantly more frequent in patients with ≥30-mm neck diameter (9.5% vs 2.8%; P = .005). Neck-related secondary interventions were performed in 20 patients (4.7%) and were also more common among patients with neck diameters of ≥30 mm (9.5% vs 3.7%; P = .04). The 4-year freedom from neck-related adverse events were 75% and 95% for the large neck and control groups, respectively ( P < .001). On multivariable regression analysis, infrarenal neck diameter of ≥30 mm was an independent risk factor for neck-related adverse events (odds ratio OR, 3.8; 95% confidence interval CI, 1.6-9.1), type Ia endoleak (OR, 2.7; 95% CI, 1.0-8.3), and neck-related secondary interventions (OR, 3.2, 95% CI, 1.1-9.2). Conclusions EVAR in patients with large diameter necks is associated with an increased risk of neck-related adverse events in midterm follow-up. This may influence the clinical decision regarding choice of repair and toward a more intensive surveillance following EVAR in these patients in the long term.
The aim of this study was to investigate the association between post-implantation syndrome (PIS) and long term outcomes, with emphasis on cardiovascular prognosis.
One hundred and forty-nine ...consecutive patients undergoing EVAR in a tertiary institution were previously included in a study investigating the risk factors and short term consequences of PIS (defined as tympanic temperature ≥ 38°C and CRP > 10 mg/L, after excluding complications with an effect on inflammatory markers). This study was based on a prospectively maintained database. Survival status was derived from inquiry of civil registry database information and causes of death from the Dutch Central Bureau of Statistics. The primary endpoint was cardiovascular events. Secondary endpoints were overall and specific cause mortality (cardiovascular, ischaemic heart disease, AAA, and cancer related mortality). Aneurysm sac dynamics and occurrence of endoleaks were also analysed. Survival estimates were obtained using Kaplan–Meier plots and a multivariable model was constructed to correct for confounders.
The PIS incidence was 39% (58/149). At the time of surgery, patients had a mean age of 73 ± 7 years and were predominantly male. There were no baseline differences between the PIS and non-PIS groups. The median follow up was 6.4 years (3.2 – 8.3), similar in both groups (p = .81). There was no difference in cardiovascular events for PIS and non-PIS patients (p = .63). However, Kaplan–Meier plots suggest a trend towards a higher rate of cardiovascular events in PIS patients during the first years: freedom from cardiovascular events at one year was 94% vs. 89% and at three years 90% vs. 82%. No differences were found in overall and specific cause mortality. There was a higher rate of type II endoleaks for non-PIS patients (28% vs. 9%, p = .005). Sac dynamics were similar in both groups.
The results suggest that PIS is not associated with a statistically significantly higher risk of cardiovascular events. PIS had no impact on mortality. Lastly, PIS patients had fewer type II endoleaks, but sac dynamics were analogous.
Standard endovascular aneurysm repair (EVAR) is the most common treatment of abdominal aortic aneurysms (AAAs). EVAR has been increasingly used in patients with hostile neck features. This study ...investigated the outcomes of EVAR in patients with neck diameters ≥30 mm in the prospectively maintained Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE).
This is a retrospective study comparing patients with neck diameters ≥30 mm with patients with neck diameters <30 mm. The primary end point was type IA endoleak (EL1A). Secondary end points included secondary interventions to correct EL1A, aneurysm rupture, and survival.
This study included 1257 patients (mean age, 73.1 years; 89.4% male) observed for a median 4.0 years (interquartile range, 2.7-4.8 years). A total of 97 (7.7%) patients had infrarenal neck diameters ≥30 mm and were compared with the remaining 1160 (92.3%) with neck diameters <30 mm. At baseline, there were no differences between groups regarding demographics and comorbidities other than cardiac disease, which was more frequent in the ≥30-mm neck diameter group (P = .037). There were no significant differences between the groups regarding neck length, angulation, thrombus, or calcification. Mean preoperative AAA diameter was 64.6 ± 11.3 mm in the ≥30-mm neck diameter group and 60.0 ± 11.6 mm in the <30-mm neck diameter group (P < .001). Stent graft oversizing was significantly less in the ≥30-mm neck diameter group (12.2% ± 8.9% vs 22.1% ± 11.9%; P <. 001). Five patients (5.2%) in the ≥30-mm neck diameter group and 30 (2.6%) with neck diameters <30 mm developed EL1A, yielding a 4-year freedom from EL1A of 92.4% vs 96.6%, respectively (P = .09). Oversizing was 21.8% ± 13.0% for patients developing EL1A and 21.3% ± 12.4% for the remaining cohort (P = .99). In adjusting for neck length, AAA diameter, and device oversizing, patients with neck diameter ≥30 mm were at greater risk for development of EL1A (hazard ratio, 3.0; 95% confidence interval, 1.0-9.3; P = .05). Secondary interventions due to EL1A did not differ between groups (P = .36). AAA rupture occurred in three patients with neck diameter ≥30 mm (3.1%) and in eight patients with neck diameter <30 mm (0.7%; hazard ratio, 5.1; 95% confidence interval, 1.4-19.2; P = .016); two cases were EL1A related in each group. At 4 years, overall survival was 61.6% for the ≥30-mm neck diameter group and 75.2% for the <30-mm neck diameter group (P = .009), which remained significant on correcting for sex and AAA diameter (P = .016).
In this study, patients with infrarenal neck diameter ≥30 mm had a threefold increased risk of EL1A and fivefold risk of aneurysm rupture after EVAR as well as worse overall survival. This may influence the choice of AAA repair and underlines the need for regular computed tomography-based imaging surveillance in this subset of patients. Furthermore, these results can serve as standards with which new, possibly improved technology, such as EndoAnchors (Medtronic, Santa Rosa, Calif), can be compared.
Large aneurysm diameter represents a well known predictor of late complications after endovascular aneurysm repair (EVAR). However, the role of the thrombus free lumen inside the abdominal aortic ...aneurysm (AAA) sac is not clear. It was hypothesised that greater luminal volume represents a relevant risk factor for late complications after EVAR.
A retrospective cohort analysis was performed including all patients undergoing EVAR from 2005 to 2016 at a tertiary referral institution. Pre-operative AAA lumen volume was measured in centre lumen line reconstructions and patients were stratified into quartiles according to luminal volume. The primary endpoint was freedom from AAA related complications. Secondary endpoints were freedom from neck events (type 1A endoleak, migration >5 mm or any pre-emptive neck related intervention), iliac related events (type 1B endoleak or pre-emptive iliac related intervention), and overall survival.
Four hundred and four patients were included: 101 in the first quartile (Q1; <61 cm3). Patients with higher luminal volumes had wider, shorter, and more angulated proximal necks. There were more ruptured AAAs, more aorto-uni-iliac implanted devices and patients outside neck instructions for use in the 4th quartile. Five year freedom from AAA related complications was 79%, 66%, 58% and 56%, respectively (p = .007). At five years, freedom from neck related events was 86%, 84%, 73%, and 71%, respectively, for the four groups (p = .009), and freedom from iliac related events was 96%, 91%, 88%, and 88%, respectively (p = .335). On multivariable analysis, luminal volume was an independent predictor of late complications (Q4 vs. Q1 – hazard ratio: 1.91, 95% confidence interval 1.01–3.6, p = .046). Overall survival at five years was not affected by lumen volume (p = .75).
AAA luminal volume represents an important risk factor for AAA related complications. This information may be considered when deciding tailoring surveillance protocols after EVAR. However, larger studies are needed to validate this hypothesis.
Purpose
To compare changes in abdominal aortic aneurysm (AAA) sac volume between endovascular aneurysm repairs (EVAR) performed for ruptured (rEVAR) vs intact (iEVAR) AAAs and to determine the impact ...of early volume shrinkage on future complications.
Materials and Methods
A retrospective analysis was performed of all patients undergoing standard infrarenal EVAR from 2002 to 2016 at a tertiary referral institution. Only patients with degenerative AAAs and with 30-day and 1-year computed tomography angiography (CTA) imaging were included. Early sac shrinkage was defined as a volume sac reduction >10% between the first (<30-day) and the 1-year CTA. The primary endpoint was to compare AAA sac volume changes between patients undergoing rEVAR (n=51; mean age 71.0±8.5 years; 46 men) vs iEVAR (n=393; mean age 72.3±7.5 years; 350 men). Results are reported as the mean difference with the interquartile range (IQR Q1, Q3). The secondary endpoint was freedom from aneurysm-related complications after 1 year as determined by regression analysis; the results are presented as the hazard ratio (HR) and 95% confidence interval (CI).
Results
At baseline, the rEVAR group had larger aneurysms (p<0.001) and shorter (p<0.001) and more angulated (p=0.028) necks. Aneurysm sac volume decreased more in the rEVAR group during the first year −26.3% (IQR −38.8%, −12.5%) vs the iEVAR group −11.9% (IQR −27.5%, 0); p<0.001. However, after the first year, the change in sac volume was similar between the groups −3.8% (IQR −32.9%, 31.9%) for rEVAR and −1.5% (IQR −20.9%, 13.6%) for iEVAR, p=0.74. Endoleak occurrence during follow-up was similar between the groups. In the overall population, patients with early sac shrinkage had a lower incidence of complications after the 1-year examination (adjusted HR 0.59, 95% CI 0.39 to 0.89, p=0.01).
Conclusion
EVAR patients treated for rupture have more pronounced aneurysm sac shrinkage compared with iEVAR patients during the first year after EVAR. Patients presenting with early shrinkage are less likely to encounter late complications. These parameters may be considered when tailoring surveillance protocols.
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