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1.
Eur J Vasc Endovasc Surg ; 67(2): 192-331, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38307694

ABSTRACT

OBJECTIVE: The European Society for Vascular Surgery (ESVS) has developed clinical practice guidelines for the care of patients with aneurysms of the abdominal aorta and iliac arteries in succession to the 2011 and 2019 versions, with the aim of assisting physicians and patients in selecting the best management strategy. METHODS: The guideline is based on scientific evidence completed with expert opinion on the matter. By summarising and evaluating the best available evidence, recommendations for the evaluation and treatment of patients have been formulated. The recommendations are graded according to a modified European Society of Cardiology grading system, where the strength (class) of each recommendation is graded from I to III and the letters A to C mark the level of evidence. RESULTS: A total of 160 recommendations have been issued on the following topics: Service standards, including surgical volume and training; Epidemiology, diagnosis, and screening; Management of patients with small abdominal aortic aneurysm (AAA), including surveillance, cardiovascular risk reduction, and indication for repair; Elective AAA repair, including operative risk assessment, open and endovascular repair, and early complications; Ruptured and symptomatic AAA, including peri-operative management, such as permissive hypotension and use of aortic occlusion balloon, open and endovascular repair, and early complications, such as abdominal compartment syndrome and colonic ischaemia; Long term outcome and follow up after AAA repair, including graft infection, endoleaks and follow up routines; Management of complex AAA, including open and endovascular repair; Management of iliac artery aneurysm, including indication for repair and open and endovascular repair; and Miscellaneous aortic problems, including mycotic, inflammatory, and saccular aortic aneurysm. In addition, Shared decision making is being addressed, with supporting information for patients, and Unresolved issues are discussed. CONCLUSION: The ESVS Clinical Practice Guidelines provide the most comprehensive, up to date, and unbiased advice to clinicians and patients on the management of abdominal aorto-iliac artery aneurysms.

2.
Eur J Vasc Endovasc Surg ; 66(5): 632-643, 2023 11.
Article in English | MEDLINE | ID: mdl-37451604

ABSTRACT

OBJECTIVE: Chronic mesenteric ischaemia (CMI) treatment focuses on symptom relief and prevention of disease progression. Endovascular repair represents the main treatment modality, while data on the associated antiplatelet regimen are scarce. The aim of this meta-analysis was to assess the early and midterm outcomes of endovascular repair in patients with CMI. DATA SOURCES: Randomised controlled trials and observational studies (1990 - 2022) reporting on early and midterm endovascular repair outcomes in patients with atherosclerotic CMI. REVIEW METHODS: The PRISMA guidelines and PICO model were followed. The protocol was registered to PROSPERO (CRD42023401685). Medline, Embase (via Ovid), and Cochrane databases were searched (end date 21 February 2023). The Newcastle-Ottawa Scale was used for risk of bias assessment, and GRADE for evidence quality assessment. Primary outcomes were technical success, 30 day mortality, and symptom relief, assessed using prevalence meta-analysis. The role of dual antiplatelet therapy (DAPT) was investigated using meta-regression analysis. RESULTS: Sixteen retrospective studies (1 224 patients; mean age 69.8 ± 10.6 years; 60.3% female) reporting on 1 368 target vessels (57.8% superior mesenteric arteries) were included. Technical success was 95.0% (95% CI 93 - 97%, p = .28, I2 19%, low certainty), the 30 day mortality rate was 2.0% (95% CI 2 - 4%, p = .93, I2 36%, low certainty), and immediate symptom relief was 87.0% (95% CI 80 - 92%, p < .010, I2 85%, very low certainty). At mean follow up of 28 months, the mortality rate was 15.0% (95% CI 9 - 25%, p = .010, I2 86%, very low certainty), symptom recurrence 25.0% (95% CI 21 - 31%, p < .010, I2 68%, very low certainty) and re-intervention rate 26.0% (95% CI 17 - 37%, p < .010, I2 92%, very low certainty). Single antiplatelet therapy (SAPT) and DAPT performed similarly in the investigated outcomes. CONCLUSION: Endovascular repair for CMI appears to be safe as first line treatment, with a low peri-operative mortality rate and acceptable immediate symptom relief. During midterm follow up, symptom recurrence and need for re-intervention are not uncommon. SAPT appears to be equal to DAPT in post-operative outcomes.


Subject(s)
Atherosclerosis , Endovascular Procedures , Mesenteric Ischemia , Humans , Female , Middle Aged , Aged , Aged, 80 and over , Male , Mesenteric Ischemia/diagnostic imaging , Mesenteric Ischemia/surgery , Mesenteric Ischemia/etiology , Retrospective Studies , Platelet Aggregation Inhibitors/therapeutic use , Atherosclerosis/complications , Atherosclerosis/surgery , Chronic Disease , Endovascular Procedures/adverse effects
3.
Ann Surg ; 275(3): 609-616, 2022 03 01.
Article in English | MEDLINE | ID: mdl-32740230

ABSTRACT

OBJECTIVE: To assess whether level of arterial obstruction determines the effectiveness of SET in patients with IC. BACKGROUND DATA: Guidelines advocate SET before invasive treatment for IC, but early revascularization remains widespread, especially in patients with aortoiliac disease. METHODS: Patients were recruited from 10 Dutch centers between October 2017 and October 2018. Participants received SET first, followed by endovascular or open revascularization in case of insufficient effect. They were grouped according to level of stenosis (aortoiliac, femoropopliteal, multilevel, or rest group with no significant stenosis). Changes from baseline walking performance (maximal and functional walking distance on a treadmill test, 6-minute walk test) and vascular quality of life questionnaire-6 at 3 and 6 months were compared, after multivariate adjustment for possible confounders. Freedom from revascularization was estimated with Kaplan-Meier analysis. RESULTS: Some 267 patients were eligible for analysis (aortoiliac n = 70, 26%; femoropopliteal n = 115, 43%; multilevel n = 69, 26%; rest n = 13, 5%). No between group differences in walking performance or vascular quality of life questionnaire-6 were found. Mean improvement in maximal walking distance after 6 months was 439 m [99% confidence interval (CI) 297-581], 466 m (99% CI 359-574), 353 m (99% CI 210-496), and 403 m (99% CI 58-749), respectively (P = 0.40). Freedom from intervention was 73.9% for aortoiliac disease and 88.6% for femoropopliteal disease (hazard ratio 2.46, 99% CI 0.96 - 6.30, P = 0.013). CONCLUSIONS: Short-term effectiveness of SET for IC is not determined by the location of stenosis. Although aortoiliac disease patients improved walking performance and health-related quality of life similarly compared to other arterial disease level groups, they underwent revascularization more often.


Subject(s)
Exercise Therapy/methods , Intermittent Claudication/etiology , Intermittent Claudication/therapy , Peripheral Arterial Disease/complications , Aged , Cohort Studies , Female , Humans , Male , Middle Aged , Peripheral Arterial Disease/diagnosis , Prospective Studies , Treatment Outcome
4.
Eur J Vasc Endovasc Surg ; 64(6): 602-608, 2022 12.
Article in English | MEDLINE | ID: mdl-36089184

ABSTRACT

OBJECTIVE: The Observing a Decade of Yearly Standardised Surveillance in EVAR patients with Ultrasound or CT Scan (ODYSSEUS) study was conducted to assess differences in outcomes of patients with continued or discontinued yearly follow up after endovascular abdominal aortic aneurysm repair (EVAR). Earlier results of this study showed that discontinued follow up was not associated with poor outcomes. Therefore, an incremental cost analysis and budget impact analysis of de-implementation of yearly imaging following EVAR was performed. METHODS: In total, 1 596 patients from the ODYSSEUS study were included. The expected cost savings were assessed if yearly imaging was reduced in patients with a post-operative computed tomography angiogram without abnormalities made around 30 days after EVAR. Costs were derived from the Dutch costs manual, benchmark cost prices, and literature review. Costs were expressed in euros (€) and displayed at 2019 prices. Sensitivity analysis was performed by varying costs. RESULTS: A difference of 24% in cost was found between patients with continued and discontinued imaging follow up. The cost per patient was €1 935 in the continued group vs. €1 603 per patient in the discontinued group at five years post-EVAR, with a mean difference of €332 (95% bias corrected and accelerated bootstrap confidence interval -741 to 114). De-implementation of yearly imaging would result in an annual nationwide cost saving of €678 471. Sensitivity analysis with variation in adherence rates, imaging, or secondary intervention costs resulted in a saving of at least €271 388 per year. CONCLUSION: This study provided an in depth analysis of hospital costs for post-EVAR patients in the Netherlands with a modest impact on the Dutch healthcare budget.


Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Endovascular Procedures/methods , Cost-Benefit Analysis , Tomography, X-Ray Computed , Angiography , Blood Vessel Prosthesis Implantation/adverse effects , Treatment Outcome , Retrospective Studies
5.
Eur J Vasc Endovasc Surg ; 63(3): 430-437, 2022 03.
Article in English | MEDLINE | ID: mdl-35148946

ABSTRACT

OBJECTIVE: To compare cost effectiveness of endovascular revascularisation (ER) and supervised exercise therapy (SET) as primary treatment for patients with intermittent claudication (IC) due to iliac artery obstruction. METHODS: Cost utility analysis from a restricted societal perspective and time horizon of 12 months. Patients were included in a multicentre randomised controlled trial (SUPER study, NCT01385774, NTR2648) which compared effectiveness of ER and SET. Health status and health related quality of life (HRQOL) were measured using the Euroqol 5 dimensions 3 levels (EQ5D-3L) and VascuQol-25-NL. Incremental costs were determined per allocated treatment and use of healthcare during follow up. Effectiveness of treatment was determined in quality adjusted life years (QALYs). The difference between treatment groups was calculated by an incremental cost utility ratio (ICER). RESULTS: Some 240 patients were included, and complete follow up was available for 206 patients (ER 111 , SET 95). The mean costs for patients allocated to ER were €4 031 and €2 179 for SET, a mean difference of €1 852 (95% bias corrected and accelerated [bca] bootstrap confidence interval 1 185 - 2 646). The difference in QALYs during follow up was 0.09 (95% bcaCI 0.04 - 0.13) in favour of ER. The ICER per QALY was €20 805 (95% bcaCI 11 053 - 45 561). The difference in VascuQol sumscore was 0.64 (95% bcaCI 0.39 - 0.91), again in favour of ER. CONCLUSION: ER as a primary treatment, results in slightly better health outcome and higher QALYs and HRQOL during 12 months of follow up. Although these differences are statistically significant, clinical relevance must be discussed due to the small differences and relatively high cost of ER as primary treatment.


Subject(s)
Intermittent Claudication , Quality of Life , Cost-Benefit Analysis , Exercise Therapy/methods , Humans , Iliac Artery , Intermittent Claudication/etiology , Intermittent Claudication/therapy , Quality-Adjusted Life Years , Treatment Outcome
6.
Eur J Vasc Endovasc Surg ; 63(3): 421-429, 2022 03.
Article in English | MEDLINE | ID: mdl-35151572

ABSTRACT

OBJECTIVE: International guidelines recommend supervised exercise therapy (SET) as primary treatment for all patients with intermittent claudication (IC), yet primary endovascular revascularisation (ER) might be more effective in patients with iliac artery obstruction. METHODS: This was a multicentre RCT including patients with IC caused by iliac artery stenosis or occlusion (NCT01385774). Patients were allocated randomly to SET or ER stratified for maximum walking distance (MWD) and concomitant SFA disease. Primary endpoints were MWD on a treadmill (3.2 km/h, 10% incline) and disease specific quality of life (VascuQol) after one year. Additional interventions during a mean follow up of 5.5 years were recorded. RESULTS: Between November 2010 and May 2015, 114 patients were allocated to SET, and 126 to ER. The trial was terminated prematurely after 240 patients were included. Compliance with SET was 57/114 (50%) after six months. Ten patients allocated to ER (8%) did not receive this intervention. One year follow up was complete for 90/114 (79%) SET patients and for 104/126 (83%) ER patients. The mean MWD improved from 187 to 561 m in SET patients and from 196 to 574 m in ER patients (p = .69). VascuQol sumscore improved from 4.24 to 5.58 in SET patients, and from 4.28 to 5.88 in ER patients (p = .048). Some 33/114 (29%) SET patients had an ER within one year, and 2/114 (2%) surgical revascularisation (SR). Some 10/126 (8%) ER patients had additional ER within one year and 10/126 (8%) SR. After a mean of 5.5 years, 49% of SET patients and 27% of ER patients underwent an additional intervention for IC. CONCLUSION: Taking into account the many limitations of the SUPER study, both a strategy of primary SET and primary ER improve MWD on a treadmill and disease specific Qol of patients with IC caused by an iliac artery obstruction. It seems reasonable to start with SET in these patients and accept a 30% failure rate, which, of course, must be discussed with the patient. Patients continue to have interventions beyond one year.


Subject(s)
Intermittent Claudication , Peripheral Arterial Disease , Exercise Therapy , Humans , Iliac Artery , Intermittent Claudication/etiology , Intermittent Claudication/therapy , Peripheral Arterial Disease/complications , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/therapy , Quality of Life , Treatment Outcome , Walking
7.
Eur J Vasc Endovasc Surg ; 63(3): 390-399, 2022 03.
Article in English | MEDLINE | ID: mdl-35181224

ABSTRACT

OBJECTIVE: Lifelong imaging surveillance is recommended following endovascular aneurysm repair (EVAR). This study aimed to examine the association between adherence to post-operative surveillance and survival and secondary interventions in patients with an initial post-operative computed tomography angiogram (CTA) without abnormalities. METHODS: All consecutive patients undergoing EVAR for intact abdominal aortic aneurysm (AAA) in 16 hospitals between 2007 and 2012 were identified retrospectively, with follow up until December 2018. Patients were included if the initial post-operative CTA showed no types I - III endoleak, kinking, infection, or limb occlusion. Discontinued follow up was defined as at least one 16 month period in which no imaging surveillance was performed. Primary outcomes were aneurysm related mortality and secondary interventions, and secondary outcome all cause mortality. Kaplan-Meier analysis was used to estimate survival, and Cox regression analyses to identify the association between independent variables and outcome. Sensitivity analyses were performed by varying the definition of continued yearly follow up. The study protocol was published (bmjopen-2019-033584). RESULTS: 1 596 patients (552 continued, 1 044 discontinued follow up) were included with a median (interquartile range) follow up of 89.1 months (52.6). Cumulative aneurysm related, overall, and intervention free survival was 99.4/94.8/96.1%, 98.5/72.9/85.9%, and 96.3/45.4/71.1% at 1, 5, and 10 years, respectively. American Society of Anesthesiologists (ASA) classification (ASA IV hazard ratio [HR] 3.810, 95% confidence interval [CI] 1.296 - 11.198), increase in AAA diameter (HR 3.299, 95% CI 1.408 - 7.729), and continued follow up (HR 3.611, 95% CI 1.780 - 7.323) were independently associated with aneurysm related mortality. The same variables and age (HR 1.063 per year, 95% CI 1.052 - 1.074) were significantly associated with all cause mortality. No difference in secondary interventions was observed between patients with continued vs. discontinued follow up (89/552; 16% vs. 136/1044; 13%; p = .091). Sensitivity analyses showed worse aneurysm related and overall survival in patients with continued follow up. CONCLUSION: Discontinued follow up is not associated with poor outcomes. Future prospective studies are indicated to determine in which patients imaging follow up can be safely reduced.


Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Angiography/adverse effects , Aortic Aneurysm, Abdominal/complications , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/methods , Endoleak/etiology , Endovascular Procedures/methods , Humans , Prospective Studies , Retrospective Studies , Risk Factors , Tomography, X-Ray Computed , Treatment Outcome
8.
J Endovasc Ther ; 28(6): 878-887, 2021 12.
Article in English | MEDLINE | ID: mdl-34315298

ABSTRACT

PURPOSE: Lifelong follow-up after endovascular abdominal aortic aneurysm repair (EVAR) is recommended due to a continued risk of complications, especially if the first postoperative imaging shows abnormal findings. We studied the long-term outcomes in patients with abnormalities on the first postoperative computed tomography angiography (CTA) following EVAR. MATERIALS AND METHODS: This is a retrospective study of all consecutive patients who underwent elective EVAR for nonruptured abdominal aortic aneurysm (AAA) between January 2007 and January 2012 in 16 Dutch hospitals with follow-up until December 2018. Patients were included if the first postoperative CTA showed one of the following abnormal findings: endoleak type I-IV, endograft kinking, infection, or limb occlusion. AAA diameter, complications, and secondary interventions during follow-up were registered. Primary endpoint was overall survival, and other endpoints were secondary interventions and intervention-free survival. Kaplan-Meier analyses were used to estimate overall and intervention-free survival. Cox regression analyses were used to identify the association of independent determinants with survival and secondary interventions. RESULTS: A total of 502 patients had abnormal findings on the first postoperative CTA after EVAR and had a median follow-up (interquartile range IQR) of 83.0 months (59.0). The estimated overall survival rate at 1, 5, and 10 years was 84.7%, 51.0%, and 30.8%, respectively. Age [hazard ratio (HR) 1.06, 95% confidence interval (CI) 1.05 to 1.10] and American Society of Anesthesiologists (ASA) classification (ASA IV HR 3.20, 95% CI 1.99 to 5.15) were significantly associated with all-cause mortality. Overall, 167 of the 502 patients (33.3%) underwent 238 secondary interventions in total. Fifty-eight patients (12%) underwent an intervention based on a finding on the first postoperative CTA. Overall survival was 38.4% for patients with secondary interventions and 44.5% for patients without (log rank; p=0.166). The intervention-free survival rate at 1, 5, and 10 years was 82.9%, 61.3%, and 45.6%, respectively. CONCLUSIONS: Patients with abnormalities on the first postoperative CTA after elective EVAR for infrarenal AAA cannot be discharged from regular imaging follow-up due to a high risk of secondary interventions. Patients who had a secondary intervention had similar overall survival as those without secondary interventions.


Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/adverse effects , Computed Tomography Angiography , Endoleak , Endovascular Procedures/adverse effects , Humans , Retrospective Studies , Risk Factors , Treatment Outcome
9.
Eur J Vasc Endovasc Surg ; 61(5): 779-786, 2021 05.
Article in English | MEDLINE | ID: mdl-33632609

ABSTRACT

OBJECTIVE: The aims of the present study were to examine the impact of type 2 endoleaks (T2EL) on overall survival and to determine the need for secondary intervention after endovascular aneurysm repair (EVAR). METHODS: A multicentre retrospective cohort study in the Netherlands was conducted among patients with an infrarenal abdominal aortic aneurysm (AAA) who underwent EVAR between 2007 and 2012. The primary endpoint was overall survival for patients with (T2EL+) or without (T2EL-) a T2EL. Secondary endpoints were sac growth, AAA rupture, and secondary intervention. Kaplan-Meier survival and multivariable Cox regression analysis were used. RESULTS: A total of 2 018 patients were included. The median follow up was 62.1 (range 0.1 - 146.2) months. No difference in overall survival was found between T2EL+ (n = 388) and T2EL- patients (n = 1630) (p = .54). The overall survival estimates at five and 10 years were 73.3%/69.4% and 45.9%/44.1% for T2EL+/T2EL- patients, respectively. Eighty-five of 388 (21.9%) T2EL+ patients underwent a secondary intervention. There was no difference in overall survival between T2EL+ patients who underwent a secondary intervention and those who were treated conservatively (p = .081). Sac growth was observed in 89 T2EL+ patients and 44/89 patients (49.4%) underwent a secondary intervention. In 41/44 cases (93.1%), sac growth was still observed after the intervention, but was left untreated. Aneurysm rupture occurred in 4/388 T2EL patients. In Cox regression analysis, higher age, ASA classification, and maximum iliac diameter were significantly associated with worse overall survival. CONCLUSION: No difference in overall survival was found between T2EL+ and T2EL- patients. Also, patients who underwent a secondary intervention did not have better survival compared with those who did not undergo a secondary intervention. This study reinforces the need for conservative treatment of an isolated T2EL and the importance of a prospective study to determine possible advantages of the intervention.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Rupture/epidemiology , Conservative Treatment/statistics & numerical data , Endoleak/epidemiology , Endovascular Procedures/adverse effects , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/complications , Aortic Aneurysm, Abdominal/mortality , Aortic Rupture/etiology , Aortic Rupture/prevention & control , Endoleak/etiology , Endoleak/therapy , Endovascular Procedures/statistics & numerical data , Female , Follow-Up Studies , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Netherlands/epidemiology , Reoperation/statistics & numerical data , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome
10.
Eur J Vasc Endovasc Surg ; 62(2): 214-224, 2021 08.
Article in English | MEDLINE | ID: mdl-33674157

ABSTRACT

OBJECTIVE: Chronic limb threatening ischaemia (CLTI) is the most severe form of peripheral arterial disease. International guidelines recommend arterial revascularisation in patients with CLTI. However, these patients are often fragile elderly people with significant comorbidities, whose vascular anatomy is not always suitable for open or endovascular revascularisation. Recent studies have suggested acceptable outcomes of conservative treatment. A systematic review of the available literature was conducted to obtain best estimates of outcomes of conservative treatment in patients with CLTI. DATA SOURCES: MEDLINE, Embase, and Cochrane Central. REVIEW METHODS: A systematic review and meta-analysis was carried out following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. MEDLINE, Embase, and Cochrane Central were searched from inception until September 2019. All studies reporting on outcomes of conservative treatment for CLTI were considered. Study selection, data extraction, and risk of bias assessment were done by two investigators independently. Risk of bias was evaluated with a modified version of the Cochrane tool for observational studies. Outcomes of interest were all cause mortality, major amputation, and amputation free survival (AFS) after at least 12 months of follow up. A random effects model was used for meta-analyses. RESULTS: Twenty-seven publications were included, consisting of 12 observational studies and 15 placebo arms from randomised clinical trials, totalling 1 642 patients. Most studies included patients with non-reconstructable CLTI. Overall study quality was moderate. The pooled 12 month all cause mortality rate in 14 studies comprising 1 003 patients was 18% (95% confidence interval [CI] 13 - 25, I2 = 73%). The pooled major amputation rate from 14 studies comprising 755 patients was 27% (95% CI 20 - 36, I2 = 65%) after one year, and pooled AFS rate after 12 months in 11 studies with 970 patients was 60% (95% CI 52 - 67, I2 = 75%). CONCLUSION: Conservative treatment for patients with CLTI may be considered and does not always result in loss of limb or patient demise. The results of this review can be used to inform patients with CLTI about conservative treatment as part of a shared decision making process.


Subject(s)
Conservative Treatment , Extremities/blood supply , Ischemia/therapy , Peripheral Arterial Disease/therapy , Amputation, Surgical/statistics & numerical data , Chronic Disease , Humans , Ischemia/etiology , Ischemia/surgery , Mortality , Peripheral Arterial Disease/complications , Treatment Outcome
11.
Ann Vasc Surg ; 71: 381-391, 2021 Feb.
Article in English | MEDLINE | ID: mdl-32768546

ABSTRACT

BACKGROUND: Early morbidity and mortality are low after endovascular abdominal aneurysm repair (EVAR), but secondary interventions and late complications are common. The aim of the present multicenter cohort study is to detail the frequency and indication for interventions after EVAR and the impact on long-term survival. METHODS: A retrospective multicenter cohort study of secondary interventions after elective EVAR for an infrarenal abdominal aortic aneurysm was conducted. Consecutive patients (n = 349) undergoing EVAR between January 2007 and January 2012 were analyzed, with long-term follow-up until December 2018. Those requiring intervention were classified in accordance with the indications and specific nature of the intervention and treatment. The primary study end point was overall survival classified for patients with and without intervention. Kaplan-Meier analysis was used to estimate overall survival for those who did and who did not undergo secondary interventions. Univariable and multivariable Cox regression were performed to identify independent variables associated with mortality. RESULTS: Some 56 patients (16%) underwent 72 secondary interventions after EVAR during a median (interquartile range) follow-up period of 53.2 months (60.1). Some 45 patients (80.4%) underwent one intervention. Indications for intervention included mainly endograft kinking/outflow obstruction and type II endoleak. An endovascular technique was used in 40.3% of interventions. Median time to secondary intervention was 24.1 months. In 93 patients with abnormalities on imaging, no intervention was performed mainly because the abnormality had disappeared on follow-up imaging (43%). Kaplan-Meier curves showed no difference in survival for patients with and without secondary interventions (P = 0.153). Age (hazard ratio [HR]: 1.089, 95% confidence interval [CI]: 1.063-1.116), ASA classification (ASA III, IV HR: 1.517, 95% CI: 1.056-2.178) were significantly related to mortality. CONCLUSIONS: Secondary intervention rates are still considerable after EVAR. Endograft kinking/outflow obstruction and endoleak type II are the most common indications for a secondary intervention. Secondary interventions did not adversely affect long-term overall survival after EVAR.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/adverse effects , Endoleak/surgery , Endovascular Procedures/adverse effects , Graft Occlusion, Vascular/surgery , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/mortality , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/mortality , Endoleak/diagnostic imaging , Endoleak/etiology , Endoleak/mortality , Endovascular Procedures/instrumentation , Endovascular Procedures/mortality , Female , Graft Occlusion, Vascular/diagnostic imaging , Graft Occlusion, Vascular/etiology , Graft Occlusion, Vascular/mortality , Humans , Incidence , Male , Netherlands/epidemiology , Reoperation , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome
12.
Eur J Vasc Endovasc Surg ; 60(1): 49-55, 2020 Jul.
Article in English | MEDLINE | ID: mdl-32331994

ABSTRACT

OBJECTIVE: The new 2019 guideline of the European Society for Vascular Surgery (ESVS) recommends consideration for elective iliac artery aneurysm (eIAA) repair when the iliac diameter exceeds 3.5 cm, as opposed to 3.0 cm previously. The current study assessed diameters at time of eIAA repair and ruptured IAA (rIAA) repair and compared clinical outcomes after open surgical repair (OSR) and endovascular aneurysm repair (EVAR). METHODS: This retrospective observational study used the nationwide Dutch Surgical Aneurysm Audit (DSAA) registry that includes all patients who undergo aorto-iliac aneurysm repair in the Netherlands. All patients who underwent primary IAA repair between 1 January 2014 and 1 January 2018 were included. Diameters at time of eIAA and rIAA repair were compared in a descriptive fashion. The anatomical location of the IAA was not registered in the registry. Patient characteristics and outcomes of OSR and EVAR were compared with appropriate statistical tests. RESULTS: The DSAA registry comprised 974 patients who underwent IAA repair. A total of 851 patients were included after exclusion of patients undergoing revision surgery and patients with missing essential variables. eIAA repair was carried out in 713 patients, rIAA repair in 102, and symptomatic IAA repair in 36. OSR was performed in 205, EVAR in 618, and hybrid repairs and conversions in 28. The median maximum IAA diameter at the time of eIAA and rIAA repair was 43 (IQR 38-50) mm and 68 (IQR 58-85) mm, respectively. Mortality was 1.3% (95% CI 0.7-2.4) after eIAA repair and 25.5% (95% CI 18.0-34.7) after rIAA repair. Mortality was not significantly different between the OSR and EVAR subgroups. Elective OSR was associated with significantly more complications than EVAR (intra-operative: 9.8% vs. 3.6%, post-operative: 34.0% vs. 13.8%, respectively). CONCLUSION: In the Netherlands, most eIAA repairs are performed at diameters larger than recommended by the ESVS guideline. These findings appear to support the recent increase in the threshold diameter for eIAA repair.


Subject(s)
Iliac Aneurysm/surgery , Aged , Aged, 80 and over , Endovascular Procedures/methods , Endovascular Procedures/mortality , Endovascular Procedures/statistics & numerical data , Female , Guideline Adherence/statistics & numerical data , Humans , Iliac Aneurysm/epidemiology , Iliac Aneurysm/mortality , Iliac Aneurysm/pathology , Iliac Artery/pathology , Iliac Artery/surgery , Male , Netherlands/epidemiology , Registries , Retrospective Studies , Sex Factors , Treatment Outcome
13.
J Vasc Interv Radiol ; 30(7): 987-994.e4, 2019 Jul.
Article in English | MEDLINE | ID: mdl-31109852

ABSTRACT

PURPOSE: To evaluate whether the biomechanical marker known as rupture risk equivalent diameter (RRED) was superior to the actual abdominal aortic aneurysm (AAA) diameter in estimating future rupture risk in patients who had undergone pre-rupture computed tomography (CT) angiography. MATERIALS AND METHODS: A retrospective study was conducted in 13 patients with ruptured AAAs who had undergone CT angiography before and after rupture between 2001 and 2015. The median time between the 2 scans was 731 days. Biomechanical and geometrical markers such as maximal AAA diameter, peak wall stress (PWS), and RRED were calculated with AAA-dedicated software. The main analyses determined whether RRED was higher than the actual diameter and the threshold diameter for elective surgery (55 mm for men, 50 mm for women) in AAAs before and after rupture. Differences between diameter and biomechanical markers before and after rupture were tested with appropriate statistical tests. RESULTS: RRED before and after rupture was smaller than the actual diameter in 7 of 13 cases. Post-rupture RRED was estimated to be smaller than the threshold diameter for elective repair in 4 cases, again suggesting a low rupture risk. The median PWS before and after rupture was 181.7 kPa (interquartile range [IQR], 152.1-244.2 kPa) and 274.1 kPa (IQR, 172.2-377.2 kPa), respectively. CONCLUSIONS: RRED was smaller than the actual diameter in more than half of pre-rupture AAAs, suggesting a lower rupture risk than estimated with the actual diameter. The results suggest that the currently available biomechanical imaging markers might not be ready for use in clinical practice.


Subject(s)
Aorta, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Rupture/etiology , Aortography/methods , Computed Tomography Angiography , Multidetector Computed Tomography , Aged , Aged, 80 and over , Aorta, Abdominal/physiopathology , Aortic Aneurysm, Abdominal/complications , Aortic Aneurysm, Abdominal/physiopathology , Aortic Rupture/diagnostic imaging , Aortic Rupture/physiopathology , Biomechanical Phenomena , Databases, Factual , Female , Humans , Male , Netherlands , Patient-Specific Modeling , Predictive Value of Tests , Prognosis , Radiographic Image Interpretation, Computer-Assisted , Regional Blood Flow , Reproducibility of Results , Retrospective Studies , Risk Assessment , Risk Factors , Stress, Mechanical
15.
Eur J Vasc Endovasc Surg ; 58(6): 813-820, 2019 Dec.
Article in English | MEDLINE | ID: mdl-31706741

ABSTRACT

OBJECTIVE: The aim was to compare peri-operative (30 day and/or in hospital) mortality between women and men in the Netherlands after elective repair of an asymptomatic abdominal aortic aneurysm (AAA). METHODS: This was a retrospective study using data from the Dutch Surgical Aneurysm Audit (DSAA), a mandatory nationwide registry of patients undergoing AAA repair in the Netherlands. Patients who underwent elective open surgical (OSR) or endovascular aneurysm repair (EVAR) of an asymptomatic abdominal aortic aneurysm (AAA) between 2013 and 2018 were included. Absolute risk differences (ARDs) with 95% confidence intervals (CIs) in peri-operative mortality between women and men were estimated. Logistic regression analyses were performed to estimate adjusted odds ratios (ORs) for mortality. Confounders included pre-operative cardiac and pulmonary comorbidity, serum haemoglobin, serum creatinine, type of AAA repair, and AAA diameter. RESULTS: Some 1662 women and 9637 men were included, of whom 507 (30.5%) women and 2056 (21.3%) men underwent OSR (p < .001). Crude peri-operative mortality was 3.01% in women and 1.60% in men (ARD = 1.41%, 95% CI 0.64-2.37). This significant difference was also observed for OSR (ARD = 2.63%, 95% CI 0.43-5.36), but not for EVAR (ARD = 0.36%, 95% CI -0.16 to 1.17). Female sex remained associated with peri-operative mortality after adjusting for confounders (OR = 1.79, 95% CI 1.20-2.65, p = .004), which was similarly observed for OSR (OR = 1.85, 95% CI 1.16-2.94, p = .01), but not for EVAR (OR = 1.46, 95% CI 0.72-2.95, p = .29). CONCLUSIONS: Peri-operative mortality after elective repair of an asymptomatic AAA in the Netherlands is higher in women than in men. This disparity might be explained by the higher peri-operative mortality in women undergoing OSR, because no such difference was found in patients undergoing EVAR. Yet, it is likely that there are unaccounted factors at play since female sex remained significantly associated with mortality after adjusting for type of repair.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Elective Surgical Procedures/adverse effects , Endovascular Procedures/adverse effects , Perioperative Period/statistics & numerical data , Vascular Grafting/adverse effects , Aged , Aged, 80 and over , Aorta, Abdominal/transplantation , Aortic Aneurysm, Abdominal/mortality , Aortic Rupture , Asymptomatic Diseases/mortality , Asymptomatic Diseases/therapy , Elective Surgical Procedures/methods , Endovascular Procedures/methods , Female , Health Status Disparities , Hospital Mortality , Humans , Male , Middle Aged , Netherlands/epidemiology , Patient Selection , Registries/statistics & numerical data , Retrospective Studies , Risk Factors , Sex Factors , Treatment Outcome , Vascular Grafting/methods
16.
Eur J Vasc Endovasc Surg ; 58(3): 362-371, 2019 09.
Article in English | MEDLINE | ID: mdl-31230866

ABSTRACT

OBJECTIVES: The Society for Vascular Surgery has proposed the Wound, Ischaemia, and foot Infection (WIfI) classification system as a prognostic tool for the one year amputation risk and the added value of revascularisation in patients with chronic limb threatening ischaemia (CLTI). This systematic review summarises the current evidence on the prognostic value of the WIfI classification system in clinical practice. DESIGN: Systematic review and meta-analysis following the PRISMA guidelines. MATERIALS: The Embase, MEDLINE, and Cochrane databases were searched up to June 2018. METHODS: All studies using the WIfI classification for patients with CLTI were eligible. Outcomes of interest were major amputation, limb salvage, and amputation free survival in relation to WIfI clinical stage. The methodological quality of studies was appraised with the Quality in Prognosis Studies (QUIPS) tool. If possible, data were pooled and analysed using a random effects model. Study selection, quality assessment, and data extraction were carried out by two authors independently. RESULTS: The search yielded 12 studies comprising 2669 patients, most of whom underwent endovascular or open revascularisation. Overall study quality was moderate. All but one were retrospective studies, including a variety of subpopulations of patients with CLTI, such as only haemodialysis dependent, diabetic or non-diabetic patients. The WIfI classification was derived from chart data or prospectively maintained databases, both documented before the WIfI classification was published. Estimated one year major amputation rates from four studies comprising 569 patients were 0%, 8% (95% CI 3-21%), 11% (95% CI 6-18%) and 38% (95% CI 21-58%), for WIfI stages I-IV, respectively. CONCLUSIONS: The likelihood of an amputation after one year in patients with CLTI increases with higher WIfI stages, which is important prognostic information. Prospective evaluations are needed to determine its role in clinical practice.


Subject(s)
Computer Communication Networks , Ischemia/classification , Lower Extremity/blood supply , Risk Assessment/methods , Amputation, Surgical/trends , Chronic Disease , Humans , Ischemia/diagnosis , Ischemia/surgery , Prognosis , Severity of Illness Index
17.
Eur J Vasc Endovasc Surg ; 57(2): 229-237, 2019 02.
Article in English | MEDLINE | ID: mdl-30318394

ABSTRACT

OBJECTIVES: Diagnosing colonic ischaemia (CI) after ruptured abdominal aortic aneurysm (RAAA) repair is challenging. This study determined the diagnostic value of sigmoidoscopy in patients suspected of CI after RAAA repair. METHODS: This was a retrospective multicentre cohort study. Patients who underwent RAAA repair in three hospitals in Amsterdam, the Netherlands, between 2004 and 2011 (AJAX cohort) were included. Sigmoidoscopies were carried out based on clinical judgment. Endoscopy results were classified as "no ischaemia," "mild CI," or "moderate to severe CI." The surgical diagnosis was classified as "transmural" or "no transmural" CI. The value of sigmoidoscopy was assessed with calculation of positive and negative predictive values (PPV, NPV) with 95% CI for transmural CI. Logistic regression analysis was used to express the association of risk factors with CI as adjusted OR. RESULTS: Transmural CI was diagnosed in 23 of 351 patients (6.6%). Thirteen of sixteen patients (81%) who underwent direct laparotomy for high suspicion of CI indeed had transmural CI. Forty-six patients (13%) underwent sigmoidoscopy. The prevalence of transmural CI was 22% (10/46; 95% CI 12-36%) in these patients. The PPV for transmural CI of "moderate to severe CI" on sigmoidoscopy was 73% (8/11; 95% CI 43-90%). The PPV of "mild CI" on sigmoidoscopy was 11% (2/19; 95% CI 2.9-31%). The NPV of "no ischaemia" on sigmoidoscopy was 100% (95% CI 78-100%). Cardiac comorbidity (OR 3.1, 95% CI 1.19-7.97), low first haemoglobin (OR 0.6, 95% CI 0.47-0.87), and high vasopressor administration (OR 9.4, 95% CI 1.99-44.46) were independently associated with CI. CONCLUSIONS: Sigmoidoscopy increases the likelihood of correctly identifying the presence or absence of transmural CI, especially in patients with a moderate clinical suspicion for CI after RAAA repair.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Rupture/surgery , Colitis, Ischemic/diagnosis , Sigmoidoscopy , Vascular Surgical Procedures/adverse effects , Aged , Aged, 80 and over , Colitis, Ischemic/etiology , Endovascular Procedures/adverse effects , Female , Humans , Male , Postoperative Complications/diagnosis , Retrospective Studies , Risk Factors
18.
J Vasc Surg ; 68(3): 900-915, 2018 09.
Article in English | MEDLINE | ID: mdl-30146037

ABSTRACT

OBJECTIVE: Outcomes after repair of ruptured abdominal aortic aneurysm (RAAA) have improved in the last decade. It is unknown whether this has resulted in a reduction of postoperative bowel ischemia (BI). The primary objective was to determine BI prevalence after RAAA repair. Secondary objectives were to determine its major sequelae and differences between open repair (OR) and endovascular aneurysm repair (EVAR). METHODS: This systematic review (PROSPERO CRD42017055920) followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Meta-analysis Of Observational Studies in Epidemiology (MOOSE) guidelines. MEDLINE and Embase were searched for studies published from 2005 until 2018. The methodologic quality of observational studies was assessed with the Methodological Index for Non-Randomized Studies (MINORS) tool. The quality of the randomized controlled trials (RCTs) was assessed with the Cochrane Collaboration's tool for assessing risk of bias. BI prevalence and rates of BI as cause of death, reoperation, and bowel resection were estimated with meta-analyses with a random-effects model. Differences between OR and EVAR were estimated with pooled risk ratios with 95% confidence intervals (CIs). Changes over time were assessed with Spearman rank test (ρ). Publication bias was assessed with a funnel plot analysis. RESULTS: A total of 101 studies with 52,670 patients were included; 72 studies were retrospective cohort studies, 14 studies were prospective cohort studies, 12 studies were retrospective administrative database studies, and 3 studies were RCTs. The overall methodologic quality of the RCTs was high, but that of observational studies was low. The pooled prevalence of BI ranged from of 0.08 (95% CI, 0.07-0.09) in database studies to 0.10 (95% CI, 0.08-0.12) in cohort studies. The risk of BI was higher after OR than after EVAR (risk ratio, 1.79; 95% CI, 1.25-2.57). The pooled rate of BI as cause of death was 0.04 (95% CI, 0.03-0.05), and that of BI as cause of reoperation and bowel resection ranged between 0.05 and 0.07. BI prevalence did not change over time (ρ, -0.01; P = .93). The funnel plot analysis was highly suggestive of publication bias. CONCLUSIONS: The prevalence of clinically relevant BI after RAAA repair is approximately 10%. Approximately 5% of patients undergoing RAAA repair suffer from severe consequences of BI. BI is less prevalent after EVAR than after OR.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Rupture/surgery , Intestines/blood supply , Ischemia/etiology , Postoperative Complications/etiology , Humans , Risk Factors
19.
Eur J Vasc Endovasc Surg ; 56(1): 120-128, 2018 07.
Article in English | MEDLINE | ID: mdl-29685678

ABSTRACT

OBJECTIVE/BACKGROUND: Incisional hernia is a frequent late complication after open abdominal aortic aneurysm (AAA) repair. We aimed to determine whether prophylactic mesh reinforcement of the abdominal wall at open AAA repair via midline laparotomy reduces the rate of incisional hernia compared to standard sutured closure. METHODS: A systematic review and meta-analysis was carried out in accordance with the PRISMA statement (PROSPERO registration CRD42017072508). Randomised controlled trials (RCTs) comparing prophylactic mesh reinforcement with standard sutured closure were eligible for inclusion. MEDLINE, Embase, and the Cochrane Library were searched. A meta-analysis with a random effects model was carried out to estimate pooled risk ratios (RR) with 95% confidence intervals (CIs) for the incidence of, and re-operation rate for, incisional hernias. Assessments of methodological quality, quality of evidence, and strength of recommendations were done with the Cochrane Collaboration's tool for assessing risk of bias and the GRADE approach. RESULTS: Four RCTs with a total of 388 patients were included in the meta-analysis. Pooled analysis showed that mesh reinforcement significantly reduced the risk of incisional hernia after AAA repair compared with standard sutured closure (RR 0.27, 95% CI 0.11-0.66). The pooled rate of re-operations was not different between groups (RR 0.23, 95% CI 0.11-1.05). Mesh reinforcement did not cause more intra-operative or post-operative complications than sutured closure. The risk of bias in studies was low and the quality of evidence was rated as moderate. CONCLUSION: Prophylactic mesh reinforcement of the abdominal wall after open AAA repair via midline laparotomy significantly reduces the risk of incisional hernia. However, no significant difference in re-operation for incisional hernia was found.


Subject(s)
Abdominal Wound Closure Techniques/instrumentation , Aortic Aneurysm, Abdominal/surgery , Hernia, Abdominal/prevention & control , Incisional Hernia/prevention & control , Surgical Mesh , Suture Techniques , Vascular Surgical Procedures , Abdominal Wound Closure Techniques/adverse effects , Chi-Square Distribution , Hernia, Abdominal/diagnosis , Hernia, Abdominal/etiology , Humans , Incisional Hernia/diagnosis , Incisional Hernia/etiology , Odds Ratio , Quality of Life , Randomized Controlled Trials as Topic , Risk Factors , Suture Techniques/adverse effects , Treatment Outcome , Vascular Surgical Procedures/adverse effects
20.
Eur J Vasc Endovasc Surg ; 55(1): 83-91, 2018 Jan.
Article in English | MEDLINE | ID: mdl-29158067

ABSTRACT

OBJECTIVES: Loss of muscle mass has been associated with poor survival in several surgical patient populations, including those with an abdominal aortic aneurysm (AAA). We wanted to replicate these findings and assess the association between psoas muscle area (PMA) and survival in patients with an asymptomatic AAA. METHODS: Patients with an asymptomatic infrarenal AAA who underwent computed tomography (CT) scanning between January 1, 2007, and December 31, 2013, were included in this single-centre retrospective cohort study. PMA was measured with thresholding on an axial image at the centre level of the third lumbar vertebra. The lowest tertile of PMA in all patients was used as a cutoff value for a low PMA. Then, in separate analyses for conservatively and surgically managed patients, survival was estimated with the Kaplan-Meier method. Differences in survival between patients with and without a low PMA were tested with the log-rank test. RESULTS: Of 228 patients, 104 were managed conservatively and 124 underwent AAA repair. Seventy-seven patients (62%) had an endovascular repair. In these 228 patients, the median PMA was 16.83 cm2, while the cutoff value for low PMA was 14.56 cm2. Patients who were managed conservatively were more often classified as having low PMA (45/104, 43%, vs. 31/124, 25%; p = .004) and were significantly older (mean 73.44 ± 9.05 years vs. 69.03 ± 7.46 years; p < .001). Low PMA was not associated with survival, either in patients managed conservatively, or in those who underwent AAA repair (p = .512 and p = .311, respectively). CONCLUSIONS: The association between low PMA and poor survival could not be replicated; in this study, low PMA was not associated with survival in patients with an asymptomatic AAA. Further research is recommended before PMA can be used for pre-operative risk stratification.


Subject(s)
Aorta, Abdominal/surgery , Aortic Aneurysm, Abdominal/mortality , Asymptomatic Diseases/mortality , Psoas Muscles/diagnostic imaging , Age Factors , Aged , Aged, 80 and over , Aorta, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/therapy , Elective Surgical Procedures/methods , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Prognosis , Psoas Muscles/anatomy & histology , Retrospective Studies , Risk Assessment/methods , Risk Factors , Tomography, X-Ray Computed , Vascular Surgical Procedures/methods
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