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OBJECTIVE: As a result of conflicting, inadequate or controversial data in the literature, several issues concerning the management of patients with abdominal aortic aneurysms (AAAs) remain unanswered. The aim of this international, expert-based Delphi Consensus document was to provide some guidance for clinicians on these controversial topics. METHODS: A 3-Round Delphi Consensus document was produced with 44 experts on 6 pre-specified topics regarding the management of AAAs. All answers were provided anonymously. The response rate for each round was 100%. RESULTS: Most participants (42 of 44; 95.4%) agreed that a minimum case volume/year is essential (or probably essential) for a center to offer open/endovascular AAA repair (EVAR). Furthermore, 33 of 44 (75.0%) believed that AAA screening programs are (probably) still clinically effective and cost-effective. Additionally, most panelists (36 of 44; 81.9%) voted that surveillance after EVAR should be (or should probably be) lifelong. Finally, 35 of 44 (79.7%) participants thought that women smokers should (or should probably/possibly) be considered for screening at 65 years of age similar to men. No consensus was achieved regarding lowering the threshold for AAA repair and the need for deep venous thrombosis prophylaxis in patients undergoing EVAR. CONCLUSIONS: This expert-based Delphi Consensus document provides guidance for clinicians regarding specific unresolved issues. Consensus could not be achieved in some topics, highlighting the need for further research in those areas.
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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.
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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.
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Aterosclerosis , Procedimientos Endovasculares , Isquemia Mesentérica , Humanos , Femenino , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Masculino , Isquemia Mesentérica/diagnóstico por imagen , Isquemia Mesentérica/cirugía , Isquemia Mesentérica/etiología , Estudios Retrospectivos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Aterosclerosis/complicaciones , Aterosclerosis/cirugía , Enfermedad Crónica , Procedimientos Endovasculares/efectos adversosRESUMEN
OBJECTIVES: The Hyperview® is a hyperspectral camera, which can be used to assess the microcirculation of patients with peripheral arterial disease (PAD) and/or diabetes mellitus (DM). It measures local tissue oxygenation in concentrations of oxyhemoblobin (OXY), deoxyhemoglobin (DEOXY), and O2-saturation (O2-SAT) in arbitrary units. The aim of this validation study is to assess whether the Hyperview® is able to monitor microcirculatory changes after revascularization in patients with PAD. METHODS: In this prospective observational cohort study, 50 patients with PAD were included who were scheduled for endovascular, hybrid, or open revascularization. The ankle-brachial index (ABI), systolic toe pressure (TP) (in case of DM), and a set of Hyperview® measurements of the plantar region were recorded before and after treatment. Changes in pre- and postoperative measurements were assessed with the paired t-test. RESULTS: Some 38 patients underwent endovascular revascularization and eight patients underwent hybrid or open vascular surgical revascularization. After revascularization, the ABI improved from 0.58 to 0.80 (p < 0.001). OXY increased from 72.6 to 77.8 (p = 0.134). DEOXY decreased from 69.1 to 55.0 (p < 0.001). O2-SAT increased from 51.3 to 58.1 (p < 0.001). TP improved from 50.6 to 61.9 mmHg (p = 0.065) but was measured in only 16 patients. CONCLUSION: The Hyperview® is able to observe changes in the microcirculation after revascularization in terms of DEOXY and O2-SAT. The results of this study are a promising step into the validation of the Hyperview®.
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Imágenes Hiperespectrales , Enfermedad Arterial Periférica , Humanos , Microcirculación , Estudios Prospectivos , Extremidad Inferior/irrigación sanguínea , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/cirugía , Índice Tobillo BraquialRESUMEN
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.
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Terapia por Ejercicio/métodos , Claudicación Intermitente/etiología , Claudicación Intermitente/terapia , Enfermedad Arterial Periférica/complicaciones , Anciano , Estudios de Cohortes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/diagnóstico , Estudios Prospectivos , Resultado del TratamientoRESUMEN
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.
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Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Procedimientos Endovasculares/métodos , Análisis Costo-Beneficio , Tomografía Computarizada por Rayos X , Angiografía , Implantación de Prótesis Vascular/efectos adversos , Resultado del Tratamiento , Estudios RetrospectivosRESUMEN
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.
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Claudicación Intermitente , Enfermedad Arterial Periférica , Terapia por Ejercicio , Humanos , Arteria Ilíaca , Claudicación Intermitente/etiología , Claudicación Intermitente/terapia , Enfermedad Arterial Periférica/complicaciones , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/terapia , Calidad de Vida , Resultado del Tratamiento , CaminataRESUMEN
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.
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Claudicación Intermitente , Calidad de Vida , Análisis Costo-Beneficio , Terapia por Ejercicio/métodos , Humanos , Arteria Ilíaca , Claudicación Intermitente/etiología , Claudicación Intermitente/terapia , Años de Vida Ajustados por Calidad de Vida , Resultado del TratamientoRESUMEN
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.
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Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Angiografía/efectos adversos , Aneurisma de la Aorta Abdominal/complicaciones , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/métodos , Endofuga/etiología , Procedimientos Endovasculares/métodos , Humanos , Estudios Prospectivos , Estudios Retrospectivos , Factores de Riesgo , Tomografía Computarizada por Rayos X , Resultado del TratamientoRESUMEN
OBJECTIVES: The Hyperview® is a novel camera that applies hyperspectral imaging to project local concentrations of oxyhaemoglobin (OXY), deoxyhaemoglobin (DEOXY) and O2-saturation (O2-SAT) in a map. In this pilot validation study, we assessed inter - and intra-observer agreement for measuring OXY, DEOXY and O2-SAT in healthy participants. METHODS: The plantar region of the right foot was assessed with the Hyperview® in 50 healthy participants. Two consecutive pictures were taken by the same observer, followed by two images by a second observer. Measurements were performed without and with standardization (a static device for both the foot and the Hyperview camera). Inter- and intra-observer agreements were expressed as Intraclass Correlation coefficients (ICC) with their 95% confidence interval (CI). A score <0.40 indicates poor agreement, 0.40-0.59 fair, 0.60-0.74 good and 0.75-1.00 excellent agreement. Bland and Altman plots were also generated. RESULTS: Without standardization, the ICC values between the observers for OXY, DEOXY and O2-SAT ranged from 0.70 to 0.83. The intra-observer agreement of both observers ranged from 0.36 to 0.83. With standardization, the ICC values between the observers ranged from 0.80 to 0.82 and intra-observer agreement varied from 0.75 to 0.92. Four Bland and Altman plots were generated of the measurements of OXY by observers 1 and 2. CONCLUSIONS: When standardization is used, the Hyperview® camera is a reliable device with excellent intra- and inter-observer agreements for the assessment of OXY, DEOXY and O2-SAT. In future research, the inter- and intra-observer agreements of the camera should be investigated in patients with diabetes and/or peripheral arterial disease.
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Enfermedad Arterial Periférica , Voluntarios Sanos , Humanos , Variaciones Dependientes del Observador , Proyectos Piloto , Reproducibilidad de los ResultadosRESUMEN
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.
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Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/efectos adversos , Angiografía por Tomografía Computarizada , Endofuga , Procedimientos Endovasculares/efectos adversos , Humanos , Estudios Retrospectivos , Factores de Riesgo , Resultado del TratamientoRESUMEN
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.
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Aneurisma de la Aorta Abdominal/cirugía , Rotura de la Aorta/epidemiología , Tratamiento Conservador/estadística & datos numéricos , Endofuga/epidemiología , Procedimientos Endovasculares/efectos adversos , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/complicaciones , Aneurisma de la Aorta Abdominal/mortalidad , Rotura de la Aorta/etiología , Rotura de la Aorta/prevención & control , Endofuga/etiología , Endofuga/terapia , Procedimientos Endovasculares/estadística & datos numéricos , Femenino , Estudios de Seguimiento , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Países Bajos/epidemiología , Reoperación/estadística & datos numéricos , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
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.
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Tratamiento Conservador , Extremidades/irrigación sanguínea , Isquemia/terapia , Enfermedad Arterial Periférica/terapia , Amputación Quirúrgica/estadística & datos numéricos , Enfermedad Crónica , Humanos , Isquemia/etiología , Isquemia/cirugía , Mortalidad , Enfermedad Arterial Periférica/complicaciones , Resultado del TratamientoRESUMEN
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.
Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/efectos adversos , Endofuga/cirugía , Procedimientos Endovasculares/efectos adversos , Oclusión de Injerto Vascular/cirugía , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/mortalidad , Prótesis Vascular , Implantación de Prótesis Vascular/instrumentación , Implantación de Prótesis Vascular/mortalidad , Endofuga/diagnóstico por imagen , Endofuga/etiología , Endofuga/mortalidad , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/mortalidad , Femenino , Oclusión de Injerto Vascular/diagnóstico por imagen , Oclusión de Injerto Vascular/etiología , Oclusión de Injerto Vascular/mortalidad , Humanos , Incidencia , Masculino , Países Bajos/epidemiología , Reoperación , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
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.
Asunto(s)
Aneurisma Ilíaco/cirugía , Anciano , Anciano de 80 o más Años , Procedimientos Endovasculares/métodos , Procedimientos Endovasculares/mortalidad , Procedimientos Endovasculares/estadística & datos numéricos , Femenino , Adhesión a Directriz/estadística & datos numéricos , Humanos , Aneurisma Ilíaco/epidemiología , Aneurisma Ilíaco/mortalidad , Aneurisma Ilíaco/patología , Arteria Ilíaca/patología , Arteria Ilíaca/cirugía , Masculino , Países Bajos/epidemiología , Sistema de Registros , Estudios Retrospectivos , Factores Sexuales , Resultado del TratamientoRESUMEN
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.
Asunto(s)
Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Rotura de la Aorta/etiología , Aortografía/métodos , Angiografía por Tomografía Computarizada , Tomografía Computarizada Multidetector , Anciano , Anciano de 80 o más Años , Aorta Abdominal/fisiopatología , Aneurisma de la Aorta Abdominal/complicaciones , Aneurisma de la Aorta Abdominal/fisiopatología , Rotura de la Aorta/diagnóstico por imagen , Rotura de la Aorta/fisiopatología , Fenómenos Biomecánicos , Bases de Datos Factuales , Femenino , Humanos , Masculino , Países Bajos , Modelación Específica para el Paciente , Valor Predictivo de las Pruebas , Pronóstico , Interpretación de Imagen Radiográfica Asistida por Computador , Flujo Sanguíneo Regional , Reproducibilidad de los Resultados , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Estrés MecánicoRESUMEN
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.
Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Procedimientos Quirúrgicos Electivos/efectos adversos , Procedimientos Endovasculares/efectos adversos , Periodo Perioperatorio/estadística & datos numéricos , Injerto Vascular/efectos adversos , Anciano , Anciano de 80 o más Años , Aorta Abdominal/trasplante , Aneurisma de la Aorta Abdominal/mortalidad , Rotura de la Aorta , Enfermedades Asintomáticas/mortalidad , Enfermedades Asintomáticas/terapia , Procedimientos Quirúrgicos Electivos/métodos , Procedimientos Endovasculares/métodos , Femenino , Disparidades en el Estado de Salud , Mortalidad Hospitalaria , Humanos , Masculino , Persona de Mediana Edad , Países Bajos/epidemiología , Selección de Paciente , Sistema de Registros/estadística & datos numéricos , Estudios Retrospectivos , Factores de Riesgo , Factores Sexuales , Resultado del Tratamiento , Injerto Vascular/métodosRESUMEN
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.
Asunto(s)
Redes de Comunicación de Computadores , Isquemia/clasificación , Extremidad Inferior/irrigación sanguínea , Medición de Riesgo/métodos , Amputación Quirúrgica/tendencias , Enfermedad Crónica , Humanos , Isquemia/diagnóstico , Isquemia/cirugía , Pronóstico , Índice de Severidad de la EnfermedadRESUMEN
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.