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OBJECTIVE: Treatment goals of prophylactic endovascular aortic repair of complex aneurysms involving the renal-mesenteric arteries (complex endovascular aortic repair [cEVAR]) include achieving both technical success and long-term survival benefit. Mortality within the first year after cEVAR likely indicates treatment failure owing to associated costs and procedural complexity. Notably, no validated clinical decision aid tools exist that reliably predict mortality after cEVAR. The purpose of this study was to derive and validate a preoperative prediction model of 1-year mortality after elective cEVAR. METHODS: All elective cEVARs including fenestrated, branched, and/or chimney procedures for aortic disease extent confined proximally to Ishimaru landing zones 6 to 9 in the Society for Vascular Surgery Vascular Quality Initiative were identified (January 2012 to August 2023). Patients (n = 4053) were randomly divided into training (n = 3039) and validation (n = 1014) datasets. A logistic regression model for 1-year mortality was created and internally validated by bootstrapping the AUC and calibration intercept and slope, and by using the model to predict 1-year mortality in the validation dataset. Independent predictors were assigned an integer score, based on model beta-coefficients, to generate a simplified scoring system to categorize patient risk. RESULTS: The overall crude 1-year mortality rate after elective cEVAR was 11.3% (n = 456/4053). Independent preoperative predictors of 1-year mortality included chronic obstructive pulmonary disease, chronic renal insufficiency (creatinine >1.8 mg/dL or dialysis dependence), hemoglobin <12 g/dL, decreasing body mass index, congestive heart failure, increasing age, American Society of Anesthesiologists class ≥IV, current tobacco use, history of peripheral vascular intervention, and increasing extent of aortic disease. The 1-year mortality rate varied from 4% among the 23% of patients classified as low risk to 23% for the 24% classified as high risk. Performance of the model in validation was comparable with performance in the training data. The internally validated scoring system classified patients roughly into quartiles of risk (low, low/medium, medium/high and high), with 52% of patients categorized as medium/high to high risk, which had corresponding 1-year mortality rates of 11% and 23%, respectively. Aneurysm diameter was below Society for Vascular Surgery recommended treatment thresholds (<5.0 cm in females, <5.5 cm in males) in 17% of patients (n = 679/3961), 41% of whom were categorized as medium/high or high risk. This subgroup had significantly increased in-hospital complication rates (18% vs 12%; P = .02) and 1-year mortality (13% vs 5%; P < .0001) compared with patients in the low- or low/medium-risk groups with guideline-compliant aneurysm diameters (≥5.0 cm in females, ≥5.5 cm in males). CONCLUSIONS: This validated preoperative prediction model for 1-year mortality after cEVAR incorporates physiological, functional, and anatomical variables. This novel and simplified scoring system can effectively discriminate mortality risk and, when applied prospectively, may facilitate improved preoperative decision-making, complex aneurysm care delivery, and resource allocation.
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Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Masculino , Feminino , Humanos , Medição de Risco , Aneurisma da Aorta Abdominal/cirurgia , Resultado do Tratamento , Fatores de Risco , Estudos Retrospectivos , Complicações Pós-Operatórias/etiologiaRESUMO
BACKGROUND: Early survival (1-year) after elective repair of complex abdominal aortic aneurysms (AAA) or thoracoabdominal aortic aneurysms (TAAA) can be used as an indicator of successful repair and provides a reasonable countermeasure to the annual rupture risk based on diameter. We aimed to identify preoperative factors associated with 1-year mortality after fenestrated or branched endovascular aortic repair (F/BEVAR) and develop a predictive model for 1-year mortality based on patient-specific risk profiles. METHODS: The US-Aortic Research Consortium database was queried for all patients undergoing elective F/BEVAR for complex AAA (cAAA) or TAAA from 2005 to 2022. The primary outcome was 1-year survival based on preoperative risk profile. Multivariable Cox regression was used to determine preoperative variables associated with 1-year mortality overall and by extent of aortic pathology. Logistic regression was performed to build a predictive model for 1-year mortality based on number of risk factors present. RESULTS: A total of 2099 patients met the inclusion criteria for this study (cAAA: n = 709 [34.3%]; type 1-3 TAAA: n = 777 [37.6%]; type 4-5 TAAA: n = 580 [28.1%]). Multivariable Cox regression identified the following significant risk factors associated with 1-year mortality: current smoker, chronic obstructive pulmonary disease, congestive heart failure (CHF), aortic diameter >7 cm, age >75 years, extent 1-3, creatinine >1.7 mg/dL, and hematocrit <36%. When stratified by extent of aortic involvement, multivariable Cox regression revealed risk factors for 1-year mortality in cAAA (CHF maximum aortic diameter >7 cm, hematocrit <36 mg/dL, and current smoking status), type 1-3 TAAA (chronic obstructive pulmonary disease, CHF, and age >75 years), and type 4-5 TAAA (age >75 years, creatinine >1.7 mg/dL, and hematocrit <36 mg/dL). Logistic regression was then used to develop a predictive model for 1-year mortality based on patient risk profile. Appraisal of the model revealed an area under the curve of 0.64 (P < .001), and an observed to expected ratio of 0.85. CONCLUSIONS: This study describes multiple risk factors associated with an increase in 1-year mortality after F/BEVAR. Given that elective repair of cAAA or TAAA is offered to some patients in whom future rupture risk outweighs operative risk, these findings suggest that highly comorbid patients with smaller aneurysms may not benefit from repair. Descriptive and predictive models for 1-year mortality based on patient risk profiles can serve as an adjunct in clinical decision-making when considering elective F/BEVAR.
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PURPOSE: This single-center study aimed to assess patients who underwent intentional percutaneous endovascular aortic aneurysm repair (pEVAR) with Hybrid Technique combining a single Perclose (Abbott, Abbott Park, Illinois) Suture-Mediated Closure Device + single Angio-Seal VIP 8F (Terumo, Tokyo, Japan) and compare outcomes with the standard Dual Perclose technique. Materials and Methods: Consecutive elective pEVAR patients treated from November 2022 to November 2023, with healthy femoral accesses and introducer sheaths ≤20 French (F) outer diameter, were included. Coin-toss randomization determined whether a combination of single Perclose Device + single Angio-Seal VIP 8F (Hybrid Technique) or the standard double Perclose Devices (Dual Perclose) was used. In Hybrid Technique, a single Perclose device was positioned at 12 o'clock; a single Angio-Seal VIP 8F was placed after sheaths removal. Dual Perclose followed standard procedure. Primary endpoints included immediate hemostasis, sheath diameter differences, access conversion rate, technical success, and cost analysis. RESULTS: The study involved 60 pEVAR patients (median age=78, interquartile range [IQR]=72-85 years) within the inclusion criteria. In 14 (24%) cases, only 1 femoral access was studied. There were 106 pEVAR accesses, with 58 (54.7%) in the Hybrid Technique group and 48 (45.3%) in the Dual Perclose group. Both groups exhibited homogeneity in pre-operative characteristics and sheath diameter (Hybrid Technique-16F vs Dual Perclose-18F; p=0.202). Immediate hemostasis was achieved in 100% of the Hybrid Technique group vs 87.5% for the Dual Perclose group (p=0.006). Surgical access conversion was unnecessary. Technical success was 100%, with all 6 femoral bleeding cases after Dual Perclose resolved endovascularly, using additional devices. Cost analysis showed a median cost of 330 euros (IQR=0) for the Hybrid Technique group vs 384 euros (IQR=360-456) for the Dual Perclose group (p<0.001). Thirty-day mortality was 3%, in 2 fragile patients, without access-related complications. Multivariate analysis identified Dual Perclose access (odds ratio [OR]=35.6; 95% confidence interval [CI]=18.3-36.8; p<0.001) and obesity (OR=19.7; 95% CI=1.4-23.9.5; p<0.001) as independent risk factors for immediate hemostasis failure. Median follow-up was 134 days (IQR=41-227), with 1 Hybrid Technique case (2%) successfully treated with thrombin injection for a small femoral pseudoaneurysm after 62 days. CONCLUSIONS: The elective Hybrid Technique with combination of single Perclose Device + single Angio-Seal VIP 8F during pEVAR in selected patients appears to be non-inferior to the standard Dual Perclose procedure. It demonstrates a positive trend in reducing immediate hemostasis failure and costs. Both procedures achieved technical success and avoiding surgical access conversions. CLINICAL IMPACT: This study introduces a novel elective hybrid technique combining a single Perclose device with a single Angio-Seal VIP 8Fr for percutaneous endovascular abdominal aortic interventions. Results for hybrid technique showed 100% technical success and efficient immediate hemostasis, while costing less than standard dual Perclose procedure. Both procedures did not require surgical conversions. Despite being a single-center study, it demonstrates potential benefits of the intentional application of this hybrid technique towards minimally invasiveness. Obesity and dual Perclose technique were identified as independent risk factors for hemostasis failure, reaffirming the hybrid technique procedure's efficacy as well as and non-inferiority to standard procedure.
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OBJECTIVE: To compare and evaluate early and midterm outcomes of a novel no cross approach with short tip vs. standard tip introducer systems for all distal components to prevent target vessel bridging stent kink or collapse during fenestrated endovascular aortic repair (FEVAR). METHODS: A retrospective analysis was conducted on all patients who underwent FEVAR at a tertiary referral centre between October 2016 and July 2022. The inclusion criterion was the use of renal artery fenestrations. Patients who had chronic dissections were included. Endpoints were analysed in two groups comprising the no cross group and the standard group, with all cases being consecutive in their respective groups. Cone beam computed tomography was used intra-operatively in all cases, and post-operative computed tomography angiograms and re-interventions were reviewed. Primary endpoints included technical success, intra-operative adjunctive procedures, adverse events related to the fenestration, and re-interventions, while secondary endpoints were secondary interventions and overall mortality rate. RESULTS: Seventy patients (35 in each group) were enrolled in the study, with 64 (91%) having juxtarenal aneurysms. There were no differences in demographics, cardiovascular risk factors, or aneurysm characteristics between the two groups. The no cross group demonstrated a significantly higher technical success rate (100% in all cases) compared with the standard group (29 cases, 83%; p = .010). Additionally, there were statistically significantly fewer intra-operative adjunctive procedures required in the no cross group (1.5% of fenestrations) compared with the standard group (8.2% of fenestrations) (p = .013). The overall median follow up was 32 months (interquartile range 22, 62 months). CONCLUSION: Implementation of a novel no cross concept during FEVAR, using a short dilator introducer tip on the distal bifurcated component and iliac extensions, significantly reduced intra-operative fenestration related adverse events and enhanced technical success. Further studies with larger patient populations and longer follow up are needed to confirm these findings.
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OBJECTIVE: To provide an updated systematic literature review summarizing current evidence on aortic neck dilatation (AND) after endovascular aortic aneurysm repair (EVAR) in patients with infrarenal abdominal aortic aneurysm. METHODS: An extensive electronic search in major electronic databases was conducted between January 2000 and December 2021. Eligible for inclusion were observational studies that followed up with patients (n ≥ 20) undergoing EVAR with self-expanding endografts, for 12 or more months, evaluated AND with computed tomography angiography and provided data on relevant outcomes. The primary end point was the incidence of AND after EVAR, and the secondary end points were the occurrence of type Ia endoleak, stent graft migration, secondary rupture, and reintervention. RESULTS: We included 34 studies with a total sample of 12,038 patients (10,413 men; median age, 71 years). AND was defined clearly in 18 studies, but significant differences in AND definition were evidenced. The pooled incidence of AND based on quantitative analysis of 16 studies with a total of 9201 patients (7961 men; median age, 72 years) was calculated at 22.9% (95% confidence interval [CI], 14.4-34.4) over a follow-up period ranging from 12 months to 14 years. The risk of a type Ia endoleak was significantly higher in AND patients compared with those without AND (odds ratio, 2.95; 95% CI, 1.10-7.93; P = .030). Similarly, endograft migration was more common in the AND group compared with the non-AND group (odds ratio, 5.95; 95% CI, 1.80-19.69; P = .004). The combined incidence of secondary rupture and reintervention did not differ significantly between the two groups, even though the combined effect was in favor of the non-AND group. CONCLUSIONS: Proximal AND after EVAR is common and occurs in a large proportion of patients with infrarenal abdominal aortic aneurysm. AND can influence the long-term durability of proximal endograft fixation and is significantly related to adverse outcomes, often leading to reinterventions.
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Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Masculino , Humanos , Idoso , Implante de Prótese Vascular/efeitos adversos , Endoleak/etiologia , Resultado do Tratamento , Dilatação/efeitos adversos , Fatores de Risco , Procedimentos Endovasculares/efeitos adversos , Estudos Retrospectivos , Aneurisma da Aorta Abdominal/cirurgia , Prótese Vascular/efeitos adversosRESUMO
OBJECTIVE: Mental illness can be a debilitating chronic disease associated with a higher likelihood of preexisting medical comorbidities and postoperative morbidity and mortality. Given the relative prevalence of mental health disorders among the veteran population, we sought to examine postoperative outcomes in patients undergoing endovascular aortic aneurysm repair (EVAR). METHODS: Retrospective review of a single institution Veterans Administration Hospital operative database was used to identify patients who underwent EVAR from January 2010 to December 2021. Patients' demographics, comorbidities, medications, and intraoperative variables were collected. In addition, mental illness status was evaluated to stratify patients based on preexisting anxiety, depression, posttraumatic stress disorder, substance abuse disorder, or major psychiatric illness. The study's primary outcomes were postoperative complications, mortality, and follow-up rates. Secondary outcomes included hospital length of stay, readmission rates, and intervention rates. RESULTS: A total of 241 patients underwent infrarenal EVARs at our institution. One hundred forty patients (58.1%) were diagnosed with mental illness, whereas 101 (41.9%) had no prior diagnosis of mental illness. Of the 241 patients, 65.7% had a history of substance abuse disorder, 38.6% depression, 29.3% post-traumatic stress disorder, 19.3% anxiety, and 3.6% major psychiatric illness. There was no statistical difference in the number of medical comorbidities, race, smoking status, or medications compared with patients without mental illness. We found no statistical difference in access type, wound infection rates, hypogastric coiling, estimated blood loss, and operating time. χ2 analysis demonstrated a statistically significant lower overall postoperative complication rate (28.6% vs 32.7%; P = .05) and decreased loss to follow-up (8.6% vs 15.8%; P = .05) among patients with a preexisting mental illness diagnosis. There were no statistically significant differences in readmission rate, length of stay, or 30-day mortality. When stratified by type of mental illness, binary logistic regression demonstrated no statistically significant differences in primary outcomes of postoperative complications, readmission rates, loss to follow-up, and 1-year mortality. Cox proportional hazards modeling demonstrated no significant difference in cumulative survival in patients diagnosed with a mental illness (0.56; 95% confidence interval, 0.29-0.107; P = .08). CONCLUSIONS: There was no association between the presence of a prior mental health diagnosis and adverse outcomes following EVAR. Preceding mental illness did not correlate with an increased rate of complications, readmission, length of stay, or 30-day mortality in a veteran population. Lower loss to follow-up rates in patients with mental illness may reflect overall Veterans Health Administration expansion in resources and surveillance of these at-risk individuals. Further research is needed to assess the association between postoperative outcomes and mental illness.
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OBJECTIVE: The aim of this study was to compare midterm results of EndoAnchors in EndoSuture aneurysm repair (ESAR) versus fenestrated endovascular aneurysm repair (FEVAR) in short neck abdominal aortic aneurysm (AAA). METHODS: All patients who underwent an ESAR procedure for a short neck AAA at our center between September 2017 and May 2020 were considered for analysis. To form the control group, preoperative computed tomography angiography of patients who underwent FEVAR for juxtarenal AAA between April 2012 and May 2020 were reviewed and patients who met short neck criteria selected. A propensity-matched score on neck length and neck diameter was calculated, resulting in 18 matched pairs. AAA shrinkage, type Ia endoleaks (EL), AAA-related reinterventions, and AAA-related deaths were compared. RESULTS: The median AAA diameter was 54 mm (interquartile range [IQR], 52-61 mm) versus 58 mm (IQR, 53-63 mm) with a median neck length of 8 mm (IQR, 6-12 mm) vs 10 mm (IQR, 6-13 mm) in ESAR and FEVAR patients, respectively. Technical success was 100% in both groups. Procedural success was 94% in the ESAR group versus 100% in the FEVAR group. The median procedure duration was 138 mm (IQR, 113-182 mm) vs 240 mm (IQR, 199-293 mm) ( P < .001) and the median length of stay was 2 days (IQR, 2-3 days) vs 7 days (IQR, 6-7 days) (P < .001) in ESAR and FEVAR patients, respectively. No major hospital complications were observed in ESAR patients compared with two in FEVAR patients (11%) with one transient acute kidney injury and one transient paraplegia. The median follow-up was 23 months (IQR, 19-33 months) vs 36 months (IQR, 22-57 months) with 67% versus 61% AAA shrinkage in the ESAR and FEVAR groups, respectively (P = .73). No type Ia EL, proximal neck-related reinterventions, or AAA-related deaths were observed in either group. No AAA-related reintervention was observed in the ESAR group versus three reinterventions in the FEVAR group (P = .23). CONCLUSIONS: ESAR seems to be a safe technique with no major postoperative complications or reinterventions observed during follow-up. It seems to offer similar midterm results as FEVAR in terms of type Ia EL, aneurysm shrinkage, and aneurysm-related mortality. ESAR seems to be a good off-the-shelf alternative to FEVAR in case of technical constraints.
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Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Humanos , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/complicações , Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/efeitos adversos , Fatores de Risco , Resultado do Tratamento , Procedimentos Endovasculares/efeitos adversos , Fatores de Tempo , Estudos Retrospectivos , Desenho de Prótese , Endoleak/etiologia , Endoleak/cirurgiaRESUMO
OBJECTIVES: An abdominal aortic aneurysm (AAA) is a potentially life-threatening condition, the management of which has dramatically evolved over the past 2 decades with an increasing tendency toward endovascular repair (EVAR) rather than open surgical repair. Classically, contrast-enhanced multislice computed tomography (CT) angiography (CTA) is performed preoperatively for procedure sizing and EVAR planning. This entails voluminous contrast injection with risk of allergic reaction, nephropathy, and radiation exposure. Intra-vascular ultrasound (IVUS) has been increasingly used to guide EVAR procedures intraoperatively. The aim of this study is to investigate the accuracy of IVUS in sizing AAAs, device selection, and EVAR planning compared to the gold standard CTA. DESIGN: This is a prospective observational study enrolling 10 patients who underwent standard infrarenal EVAR procedures performed for unruptured infrarenal AAAs over the course of 1 year. All patients had a preoperative CTA done upon which aneurysm sizing and device planning were performed, and the measurements obtained were compared to those obtained from intraoperative IVUS. METHODS: All participating patients had unruptured infrarenal AAA, had no renal impairment, and had anatomical suitability for EVAR according to the instructions for use (IFU) of the device manufacturer. Primary endpoint was comparing anatomical measurements recorded by IVUS with those obtained from the preoperative CTA. RESULTS: Mean age was 65.6 (±6.19), all patients were males and hypertensives and 4 (40%) had a positive family history for AAA. On comparing mean measurements taken by CTA and IVUS, there was no statistically significant differences with exception of maximal aortic diameter and aortic diameter at site of bifurcation (both p-values <.001). There were no statistically significant differences in length measurements between the 2 imaging modalities. Computed tomography angiography was more associated with neck thrombus detection, and IVUS was more associated with calcification detection. CONCLUSION: Although CT angiography is still the gold standard imaging modality for AAA, IVUS use is very beneficial in EVAR sizing and planning, in addition to intra-operative guidance of the procedure, saving the patient significant time, contrast administration, and radiation exposure, especially in patients with renal impairment and contrast allergy. CLINICAL IMPACT: A preoperative CT angiogram is the gold standard required investigation for planning and sizing EVARs, with subsequent contrast injection entailing a risk of contrast induced nephropathy and allergic reactions. IVUS has been used as an adjuvant technique to guide EVAR stent graft deployment. However, our study concluded that it can also be reliably used in sizing and planning of the EVAR stent graft along with complementary non contrast imaging, especially in patients with high risk for contrast induced nephropathy and contrast allergy.
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PURPOSE: To measure the long-term proximal aortic neck dilatation (AND) after elective endovascular aortic aneurysm repair (EVAR) with a variety of contemporary, third-generation, endograft devices. MATERIALS AND METHODS: This is a noninterventional prospective cohort study of 157 patients that underwent standard EVAR with self-expanding abdominal endografts. Patients' recruitment lasted from 2013 to 2017, and postoperative follow-up was up to 5 years. A computed tomography angiography (CTA) was performed at the first month and then at 1, 2, and 5 years. Proximal aortic neck's (PAN) basic morphological characteristics (diameter, length, angulation) were measured based on the analysis of CTA in a standardized fashion. Neck-related adverse events, such as migration, endoleak or rupture, and reinterventions were recorded. RESULTS: Significant straightening of the PAN was evident even in the first-month CTA with concurrent neck shortening that became significant at 5 years. Both the suprarenal aorta and the PAN significantly dilated overtime, with PAN dilating more progressively. Mean neck dilatation at the juxtarenal level was 0.8±0.4 mm at 1 year, 1.8±0.8 mm at 2 years, and 3.9±1.7 mm at 5 years, with a mean neck dilatation rate of 0.07 mm/month overall. The incidence of AND ≥2.5 mm was 37.2% at 2 years and 58.1% at 5 years after EVAR and was considered important (≥5 mm) in 11.5% of patients at 2 years and 30.6% of patients at 5 years. A multivariate analysis performed showed that the endograft oversizing, the preoperative neck diameter, and the preoperative abdominal aortic aneurysm sac diameter served as independent predictors of AND at 5 years. At the 5-year follow-up, 8 late type Ia endoleaks (6.5%) and 7 caudal migrations (5.6%) were identified, while no late ruptures were reported. In total, 11 late endovascular reinterventions (8.9%) were performed. Overall, proximal neck-related adverse outcomes (5/7 migrations and 5/8 endoleaks) and reinterventions (7/11) were significantly associated with the presence of important late AND. CONCLUSION: Proximal AND after EVAR is common. It can influence the long-term durability of proximal endograft fixation and is significantly associated with adverse outcomes, often leading to reinterventions. A systemic and extended surveillance protocol is needed for maintenance of good long-term results. CLINICAL IMPACT: This is a thorough and systematic analysis of the long-term geometric remodeling of the proximal aortic neck after EVAR, that highlights the importance of a strict, and extended surveillance protocol for maintenance of good long-term results of EVAR.
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PURPOSE: Zenith Alpha Abdominal (Cook Medical, Bloomington, IN, USA) is one of the new-generation low-profile stent-grafts with demonstrated satisfactory early and midterm clinical outcomes for endovascular treatment of abdominal aortic aneurysms (AAAs). The aim was to evaluate early and midterm results of this device in the framework of a multicenter regional retrospective registry, with the analysis of morphological factors affecting outcomes, including different limb configurations. MATERIALS AND METHODS: Between January 2016 and November 2021, 202 patients with AAA underwent elective endovascular aneurysm repair (EVAR) with implantation of a Zenith Alpha Abdominal in 7 centers. Early (30 day) outcomes in terms of technical and clinical success were assessed. Estimated 5 year outcomes were evaluated in terms of survival, freedom from type I/III endoleak, freedom from surgical conversion, freedom from limb graft occlusion, freedom from any device-related reintervention, and graft infection evaluation by life-table analysis (Kaplan-Meier test). A comparative analysis between different limb configurations (Zenith Spiral Z AAA iliac legs, codes ZISL vs ZSLE) was performed in terms of limb graft occlusion. RESULTS: The 30 day technical and clinical success rates were 97.5% and 99.5%, respectively. Median follow-up period was 25.5 months (interquartile range [IQR]: 12-43.25). The 5 year survival rate was 73.6%. The estimated 5 year outcomes in terms of freedom from type I/III endoleak, freedom from surgical conversion, freedom from limb graft occlusion, freedom from any device-related reintervention, and freedom from graft infection were 88.6% (95% CI [confidence interval]: 83.4%-93.1%), 95.8% (95% CI: 92.7%-97.1%), 93.6% (95% CI: 90.2%-96.8%), 87% (95% CI: 83.3%-91.6%), and 97.7% (95% CI: 95.1%-98.9%), respectively. About limb configuration, no differences were found in terms of 5 year freedom from limb graft occlusion (ZSLE 93.4% [95% CI: 89.8%-95.5%] vs ZISL 94.3% [95% CI: 90.1%-95.9%], p=0.342; log-rank 0.903). CONCLUSION: Zenith Alpha Abdominal in elective EVAR offered satisfactory early and 5 year outcomes with low complication rates. Limb graft occlusion continued to be an issue. Limb configuration did not affect outcomes. CLINICAL IMPACT: The authors describe satisfactory early and 5 year outcomes of Zenith Alpha Abdominal in elective endovascular aortic repair in the framework of a multicenter regional retrospective registry. At 5 years freedom from type I endoleak was 88.6%, and rate of endograft infections and conversions to open repair were very low. in the present study. Hot topic about about Zenith stent-graft still remains the limb graft occlusion with a 30-day overall rate of 2%, and estimated 5-year freedom from limb graft occlusion of 93.6%. Limb graft configuration did not affect limb graft occlusion rate. A standardized protocol including iliac stenting should be adopted to reduce kimb graft occlusion.
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PURPOSE: The aim of this study is to report an Italian multicenter experience analyzing the incidence and the risk factors associated with spinal cord ischemia (SCI) in a large cohort of thoracoabdominal aortic aneurysms (TAAAs) treated by fenestrated-branched endovascular aneurysm repair (F-/B-EVAR). MATERIALS AND METHODS: All consecutive patients undergoing F-/B-EVAR in 4 Italian university centers between 2008 and 2019 were prospectively recorded and retrospectively analyzed. Spinal cord ischemia, 30 day/in-hospital adverse events, and mortality were assessed as early outcomes. Risk factors for SCI were determined by multivariable analysis. RESULTS: A total of 351 patients received F-/B-EVAR for a TAAA. Twenty-eight (8.0%) patients died within 30 postoperative days or during the hospitalization. Regarding SCI, 47 patients (13.4%) developed neurological symptoms related to spinal cord impaired perfusion. Among them, 17 (4.8%) had a major permanent impairment. The multivariable analysis identified that SCI was associated with Crawford extent I to III (odds ratio [OR]: 20.90, p=0.004, 95% confidence interval [CI]=2.69-162.57), and with endovascular procedures performed for ruptured TAAA (OR: 5.74, p=0.010, 95% CI=1.53-21.57). Spinal cord ischemia was also significantly associated with a grade 3 bleeding during the visceral stage (OR: 4.34, p=0.005, 95% CI=1.55-12.16) and a grade 2 renal insufficiency at 30 days (OR: 7.45, p=0.002, 95% CI=2.12-26.18). CONCLUSION: The present study indicates that SCI is still an open issue after extent I to III TAAA endovascular repair, while its incidence in extent IV TAAA and pararenal/juxtarenal aneurysms is rare. Thoracoabdominal aortic aneurysms extension, urgent TAAA repair for rupture, severe bleeding, and 30 day renal insufficiency have been identified as significant risk factors for SCI. In the presence of such factors, adjunctive strategies may be considered to reduce SCI rates, while in low-risk patients invasive or potentially-risky maneuvers might not be justified.
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Aneurisma da Aorta Abdominal , Aneurisma da Aorta Torácica , Aneurisma da Aorta Toracoabdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Insuficiência Renal , Isquemia do Cordão Espinal , Humanos , Prótese Vascular/efeitos adversos , Correção Endovascular de Aneurisma , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/cirurgia , Estudos Retrospectivos , Resultado do Tratamento , Isquemia do Cordão Espinal/diagnóstico por imagem , Isquemia do Cordão Espinal/epidemiologia , Isquemia do Cordão Espinal/etiologia , Fatores de Risco , Insuficiência Renal/complicações , Insuficiência Renal/cirurgia , Sistema de RegistrosRESUMO
OBJECTIVE: The performance of fenestrated endovascular aortic aneurysm repair (FEVAR) may be compromised by complications related to the dynamic vascular environment. The aim of this study was to analyze the behavior of FEVAR bridging stent configurations during the cardiac cycle and during follow-up to improve our understanding on treatment durability. DESIGN: Twenty-one patients presenting with complex abdominal aortic aneurysms (AAAs; 9 juxtarenal/6 pararenal/3 paravisceral/1 thoracoabdominal aortic aneurysm type IV), treated with a fenestrated Anaconda (Terumo Aortic, Inchinnan, Scotland, UK) with Advanta V12 bridging stents (Getinge, Merrimack, NH, USA), were prospectively enrolled in a multicenter observational cohort study and underwent electrocardiogram (ECG)-gated computed tomographic angiography (CTA) preoperatively, at discharge, 7-week, and 12-month follow-ups. METHODS: Fenestrated endovascular aortic aneurysm repair stability was assessed considering the following variables: branch angle as the angle between the aorta and the target artery, end-stent angle as the angle between the end of the bridging stent and the native artery downstream from it, curvature and tortuosity index (TI) to describe the bending of the target artery. Body-bridging stent stability was assessed considering bridging stent flare lengths, the distances between the proximal sealing stent-ring and fenestrations and the distance between the fenestration and first apposition in the target artery. RESULTS: Renal branch angles significantly increased after FEVAR toward a perpendicular position (right renal artery from median 60.9°, inter quartile range [IQR]=44.2-84.9° preoperatively to 94.4°, IQR=72.6-99.8°, p=0.001 at 12-month follow-up; left renal artery [LRA], from 63.7°, IQR=55.0-73.0° to 94.3°, IQR=68.2-105.6°, p<0.001), while visceral branch angles did not. The mean dynamic curvature only decreased for the LRA from preoperative (3.0, IQR=2.2-3.8 m-1) to 12-month follow-up (1.9, IQR=1.4-2.6 m-1, p=0.027). The remaining investigated variables did not seem to show any changes over time in this cohort. CONCLUSIONS: Fenestrated endovascular aortic aneurysm repair for complex AAAs using the Anaconda fenestrated stent-graft and balloon-expandable Advanta V12 bridging stents demonstrated stable configurations up to 12-month follow-up, except for increasing renal branch angles toward perpendicular orientation to the aorta, yet without apparent clinical consequences in this cohort. CLINICAL IMPACT: This study provides detailed information on the cardiac-pulsatility-induced (dynamic) and longitudinal geometry deformations of the target arteries and bridging stents after fenestrated endovascular aortic aneurysm repair (FEVAR) up to 12-month follow-up. The configuration demonstrated limited dynamic and longitudinal deformations in terms of branch angle, end-stent angle, curvature, and tortuosity index (TI), except for the increasing renal branch angles that go toward a perpendicular orientation to the aorta. Overall, the results suggest that the investigated FEVAR configurations are stable and durable, though careful consideration of increasing renal branch angles and significant geometry alterations is advised.
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PURPOSE: To present a rare cause of type III endoleak via the left renal artery (LRA) fenestration following fenestrated endovascular aneurysm repair (FEVAR) and to describe a successful reintervention for treating this endoleak. TECHNIQUE: The patient presented with a type IIIc endoleak following FEVAR, due to inadvertent placement of the LRA bridging balloon expandable covered stent (BECS) via the superior mesenteric artery (SMA) fenestration, but deployed outside the SMA fenestration. The proximal part of the BECS was positioned outside of the main body. This caused a type IIIc endoleak via the open LRA fenestration. Reintervention was performed by relining the LRA with a new BECS. First, access to the lumen of the previously placed BECS was gained using a re-entry catheter, followed by placement of a new BECS via the LRA fenestration. Completion angiography, and computerized tomography angiography (CTA) at 3 months follow-up showed total obliteration of the endoleak and patency of the LRA. CONCLUSION: Placement of a bridging stent via an incorrect fenestration during FEVAR is a rare cause of type III endoleak. In certain cases, successful treatment of such an endoleak could be achieved by perforation and relining of the misplaced BECS via the correct fenestration of the target vessel. CLINICAL IMPACT: To our best knowledge, a type IIIc endoleak following fenestrated endovascular aneurysm repair, due to placement of a bridging covered stent through an incorrect fenestration and deployed short of the fenestration, has not been described before. Reintervention was performed with perforation of the previously placed covered stent and relining using a new bridging covered stent. The technique presented here was successful for treating the endoleak in this case and could help guide clinicians when dealing with this or similar complications.
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OBJECTIVE: The purpose of this study was to evaluate the technical feasibility, safety, and early outcomes of a snare-less, endovascular abdominal aortic aneurysm repair (EVAR)-first technique (SET) for iliac branch endoprosthesis (IBE) placement. METHODS: We retrospectively reviewed all patients who received IBEs between July 2018 and March 2022. Patients were divided into 2 categories based on method of IBE deployment: SET or Standard. Primary endpoints were technical success, major adverse events, mortality, reintervention, internal iliac artery (IIA) patency, and freedom from IIA branch instability. Technical success was defined by successful deployment of both the EVAR and the IBE with maintained patency of the IIA and no stent graft migration. RESULTS: There were 20 patients (90% male, median age 72 [65.4-74.5] years) who underwent IBE placement. Among these, 5 (33.3%) underwent SET to treat 5 common iliac artery (CIA)/IIA aneurysms, while the remaining 15 (66.7%) underwent standard IBE deployment with through-and-through femoral access (n=13) or trans-brachial access (n=2) to treat 19 CIA/IIA aneurysms. Overall median renal to iliac bifurcation length was 169 (152-177) mm, with 9 patients falling short of the minimum of 165 mm for on-label IBE placement. Median contrast used was 148 (120-201) mL, fluoroscopy time 42.8 (35.0-49.8) minutes, estimated blood loss 200 (100-275) mL, and procedure time 192 (167-246) minutes, with no significant differences between the 2 groups. Technical success was achieved in 100% of cases. At 30 days, there were no mortalities or major adverse events in either group; there were 100% IIA patency, no IIA instability, and no reinterventions in both groups. Median follow-up in the SET group was 5.7 (5.5-6.2) months, with 1 death at 6 months and 1 type 1B endoleak at 6 months requiring reintervention. Median follow-up for the Standard group was 1.6 (0.8-2.1) years with 2 non-aneurysm-related deaths and no reinterventions at 1 year. CONCLUSIONS: SET for IBE is a safe and effective approach that decreases technical complexity and mitigates anatomic barriers to IBE placement. CLINICAL IMPACT: SET for IBE is a safe and effective approach to IBE placement that decreases technical complexity. A critical component to this technique is a large bore sheath with a stiff steerable tip. Importantly, this approach also mitigates anatomic barriers to IBE placement, expanding applicability of IBE technology to patients who may be otherwise ineligible.
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OBJECTIVE: This study aimed to investigate the impact of the number of patent lumbar arteries (LAs) on sac enlargement after endovascular aneurysm repair (EVAR). METHODS: This was a retrospective cohort single centre registry study. Between January 2006 and December 2019, 336 EVARs were reviewed using a commercially available device excluding type I or type III endoleaks during a follow up of ≥ 12 months. Patients were divided into four groups based on the pre-operative patency of the inferior mesenteric artery (IMA) and high (≥ 4) or low (≤ 3) number of patent LAs: Group 1, patent IMA and high number of patent LAs; Group 2, patent IMA and low number of patent LAs; Group 3, occluded IMA and a high number of patent LAs; Group 4, occluded IMA and low number of patent LAs. RESULTS: Groups 1, 2, 3, and 4 included 124, 104, 45, and 63 patients, respectively. The median follow up duration was 65.1 months. Significant differences in the incidence of overall type II endoleak (T2EL) at discharge between Group 1 and Group 2 (59.7% vs. 36.5%, p < .001) and between Group 3 and Group 4 (33.3% vs. 4.8%, p < .001) were observed. In patients with a pre-operatively patent IMA, the rate of freedom from aneurysm sac enlargement was significantly lower in Group 1 than in Group 2 (69.0% vs. 81.7% five years after EVAR, p < .001). In patients with a pre-operatively occluded IMA, the freedom rate from aneurysm sac enlargement was not significantly different between Groups 3 and Group 4 (95.0% vs. 100% five years after EVAR, p = .075). CONCLUSION: A high number of patent LAs seemed to have a significant role in sac enlargement with T2EL when the IMA was patent pre-operatively, whereas a high number of patent LAs seemed to have limited influence on sac enlargement when the IMA was occluded pre-operatively.
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Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Embolização Terapêutica , Procedimentos Endovasculares , Humanos , Endoleak/diagnóstico por imagem , Endoleak/etiologia , Endoleak/epidemiologia , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/complicações , Correção Endovascular de Aneurisma , Estudos Retrospectivos , Implante de Prótese Vascular/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Aorta Abdominal/cirurgia , Resultado do Tratamento , Embolização Terapêutica/efeitos adversos , Fatores de RiscoRESUMO
BACKGROUND: Recent guidelines state that improving the survival rate of patients with ruptured abdominal aortic aneurysm (rAAA) requires a protocol or algorithm for the emergency management of these patients. We aimed to investigate whether introducing a protocol treatment for rAAA improves clinical outcomes compared with the pre-protocol strategy. METHODS: At our institution, 92 patients treated for rAAA between June 2008 and August 2022 were retrospectively analyzed. In 2014, the protocol-based treatment was introduced comprising a transfer algorithm to shorten the time to proximal control, use of an endovascular occlusion balloon, strict indications for endovascular aortic aneurysm repair (EVAR) or open surgical repair, and perioperative care, including for abdominal compartment syndrome (ACS). Clinical outcomes were compared between the protocol and pre-protocol group, including operative status, all-cause mortality, and rAAA-related death at 30-day, in-hospital, and 1-year postoperative follow-ups. RESULTS: Overall, 52 and 40 patients received the protocol-based and pre-protocol treatments, respectively. EVAR was more frequently performed in the protocol group. The rate of achieving time to proximal control was significantly faster, and the transfusion volume was lower in the protocol group. ACS occurred more frequently in the protocol group with a higher EVAR. No difference was found in all-cause mortality between the two groups. The protocol group exhibited fewer rAAA-related deaths than the pre-protocol group during the following time points: 30 days (9.6% vs. 22.5%), during the hospital stay (11.5% vs. 30.0%), and 1 year (14.5% vs. 31.5%). CONCLUSIONS: The protocol-based treatment improved the survival rate of patients with rAAA.
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Aneurisma da Aorta Abdominal , Ruptura Aórtica , Humanos , Estudos Retrospectivos , Algoritmos , Aorta , Ruptura Aórtica/diagnóstico por imagem , Ruptura Aórtica/cirurgia , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgiaRESUMO
Despite advancements in surgical and postoperative management, spinal cord injury has been a persistent complication of both open and endovascular repair of thoracoabdominal and descending thoracic aortic aneurysm. Spinal cord injury can be explained with an ischemia-infarction model which results in local edema of the spinal cord, damaging its structure and leading to reversible or irreversible loss of its function. Perfusion of the spinal cord during aortic procedures can be enhanced by several adjuncts which have been described with a broad variety of evidence in their support. These adjuncts include systemic hypothermia, cerebrospinal fluid drainage, extracorporeal circulation and distal aortic perfusion, segmental arteries reimplantation, left subclavian artery revascularization, and staged aortic repair. The Authors here reviewed and discussed the role of such adjuncts in preventing spinal cord injury from occurring, pinpointing current evidence and outlining future perspectives.
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Aneurisma da Aorta Abdominal , Aneurisma da Aorta Torácica , Aneurisma da Aorta Toracoabdominal , Procedimentos Endovasculares , Traumatismos da Medula Espinal , Isquemia do Cordão Espinal , Humanos , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/cirurgia , Aneurisma da Aorta Torácica/complicações , Isquemia do Cordão Espinal/etiologia , Isquemia do Cordão Espinal/prevenção & controle , Resultado do Tratamento , Medula Espinal/irrigação sanguínea , Traumatismos da Medula Espinal/complicações , Traumatismos da Medula Espinal/prevenção & controle , Procedimentos Endovasculares/efeitos adversos , Aneurisma da Aorta Abdominal/complicaçõesRESUMO
OBJECTIVE: Open or endovascular repair of abdominal aortic aneurysms (AAAs) can involve sacrifice of the internal iliac artery (IIA). In the present study, we investigated the effect of IIA exclusion on ischemic complications and overall mortality. METHODS: The data from 326 patients who had undergone elective open surgical or endovascular treatment of a nonruptured AAA from January 2010 to December 2019 in a tertiary hospital were retrospectively reviewed. Ischemic complications included buttock claudication, spinal ischemia (including paraparesis), ischemic colitis, lower limb paresthesia, and skin necrosis. Their duration and mortality during the study period were investigated. RESULTS: Nearly 50% of patients (148; 45.4%) had undergone endovascular aortic aneurysm repair and 178 (54.6%) had undergone open surgery. The median patient age was 78 years (range, 31-94 years). The median follow-up period was 1140 days (range, 0-4757 days). Of the 326 patients, 50 (15.3%) had died during follow-up. The bilateral IIAs were preserved in 187 patients (57.4%), a single IIA in 86 patients (26.4%), and no IIA in 53 patients (16.3%). Ischemic complications occurred in 57 patients (17.5%). Multivariable analysis revealed failure to preserve the bilateral IIAs (hazard ratio [HR], 8.65; 95% confidence interval [CI], 4.31-17.36; P < .01), management of the IIA (HR, 3.05, 95% CI, 2.17-4.28; P < .01), and hyperlipidemia (HR, 2.09; 95% CI, 1.04-4.17; P = .04) affected the occurrence of ischemic complications. Furthermore, univariable analysis revealed that patients had experienced more ischemic complications when a single IIA (HR, 6.97; 95% CI, 3.74-13.02; P < .01) or none of the IIAs had been preserved (HR, 8.88; 95% CI, 4.12-19.16; P < .01) than when both IIAs were preserved. Moreover, multivariable analysis revealed that stage 5 chronic kidney disease (HR, 2.7; 95% CI, 1.09-6.14; P = .03), age >75 years (HR, 2.48; 95% CI, 1.12-5.49; P = .03), cerebrovascular accident (HR, 1.95; 95% CI, 1.00-3.78; P = .05), and failure to preserve the bilateral IIAs (HR, 1.91; 95% CI, 1.02-3.46; P = .04) were associated with higher mortality after AAA repair. CONCLUSIONS: IIA exclusion is a risk factor for ischemic complications and overall mortality. Thus, preservation of the IIA as much as possible during AAA repair is recommended.
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Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Aneurisma Ilíaco , Adulto , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/complicações , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Humanos , Aneurisma Ilíaco/cirurgia , Artéria Ilíaca/cirurgia , Isquemia/diagnóstico por imagem , Isquemia/etiologia , Isquemia/cirurgia , Pessoa de Meia-Idade , Complicações Pós-Operatórias/cirurgia , Estudos Retrospectivos , Fatores de Risco , Resultado do TratamentoRESUMO
OBJECTIVE: Varying opinions on optimal elective and emergent surgical management of infrarenal abdominal aortic aneurysms are expressed by the most recent Society for Vascular Surgery (SVS), European Society for Vascular Surgery, vs UK National Institutes for Health and Care Excellence guidelines. The UK National Institutes for Health and Care Excellence guidelines propose that open surgical repair serve as the default treatment for infrarenal abdominal aortic aneurysm. The rationale for this approach relied on data from the early era of endovascular aneurysm repair (EVAR) and are in contrast to the more balanced approaches of the SVS and European Society for Vascular Surgery. We hypothesize that significant differences in patient selection, management, and postoperative outcome are related to the era in which treatment was undertaken, contextualizing the outcomes reported in early-era EVAR randomized controlled trials. METHODS: Retrospectively, two cohorts representing all EVAR patients from "early" (n = 167; 2008-2010) and "late" (n = 129; 2015-2017) periods at a single treating institution were assembled. Primary outcomes of era-related changes in preoperative demographics, anatomy, and intraoperative events were assessed; anatomy was compared using the SVS anatomic severity grading system. These era-related differences were then placed in the context of early perioperative outcomes and at follow-up to 1 year. RESULTS: Choice of surgical strategy differed by era, despite the same patient preoperative comorbidities between EVAR groups. Preoperative anatomic severity was significantly worse in the early cohort (P < .001), with adverse proximal and distal seal zone features (P < .001). Technical success was 16.2% higher in the late cohort, with significantly fewer type 1A/B endoleaks perioperatively (P < .001). In-hospital complications, driven by higher acute kidney injury and surgical site complications in the early cohort, resulted in a 16.5% difference between cohorts (P < .05). At 1 year of follow-up, outcome differences persisted; late-era patients had fewer 1A endoleaks, fewer graft complications, and better reintervention-free survival. CONCLUSIONS: From a granular dataset of EVAR patients, we found an impact of EVAR repair era on early clinical outcomes; late cohort infrarenal EVAR patients had less severe preoperative anatomy and improved perioperative and follow-up outcomes to 1 year, suggesting that the results of early EVAR randomized controlled trials may no longer be generalizable to modern practice.
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Injúria Renal Aguda/epidemiologia , Aneurisma da Aorta Abdominal/cirurgia , Endoleak/epidemiologia , Procedimentos Endovasculares/efeitos adversos , Injúria Renal Aguda/etiologia , Idoso , Aorta Abdominal/diagnóstico por imagem , Aorta Abdominal/patologia , Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/complicações , Aneurisma da Aorta Abdominal/diagnóstico , Endoleak/etiologia , Procedimentos Endovasculares/métodos , Procedimentos Endovasculares/normas , Feminino , Seguimentos , Humanos , Rim/irrigação sanguínea , Masculino , Guias de Prática Clínica como Assunto , Estudos Retrospectivos , Medição de Risco/estatística & dados numéricos , Fatores de Risco , Índice de Gravidade de Doença , Sociedades Médicas/normas , Fatores de Tempo , Resultado do TratamentoRESUMO
INTRODUCTION: Clinical trials at the advent of endovascular aortic aneurysm repairs (EVARs) demonstrated improved early survival with EVAR compared to open repairs; however, characterizations of routine contemporary care have been limited. This study compares postoperative survival among Veterans in clinical care following abdominal aortic aneurysm (AAA) repair with EVAR versus open repairs since the widespread adoption of EVAR. MATERIALS AND METHODS: This retrospective cohort analysis of Veterans with AAA repairs from 2007 to 2020 at Veterans Affairs (VA) facilities evaluated survival by a repair method. Administrative International Classification of Diseases 9/10 codes and sociodemographic characteristics from structured charting were used for characterization and adjusted analyses. Demographics were compared via Chi-squared and Wilcoxon rank-sum testing and mortality evaluated using Kaplan-Meier and Cox proportional hazard analyses. RESULTS: Among 15,480 AAA repairs (3566 open, and 11,914 EVAR), patients receiving open repairs were younger with lower Charlson scores compared to EVARs. EVAR was associated with better survival until 2.4 y post-procedure. Mean long-term survival, however, was higher for open surgery (6.3 ± 3.8 versus 5.8 ± 3.1 y in EVAR). After adjustment for gender, race, and ethnicity, EVAR was associated with worse survival (mortality hazard ratio [HR] 1.17; 95% confidence interval [CI], 1.11-1.24) as was each increment in Charlson score (HR 1.11; CI 1.10-1.12), whereas service-connected care (HR 0.73; CI, 0.70-0.77) and age (HR 0.99; CI, 0.98-0.99) were associated with better survival. CONCLUSIONS: In contemporary Veteran aneurysm repairs, although a higher early survival rate was observed in EVAR repairs, long-term survival was higher for open repairs. Service-connected care was independently associated with greater survival after aneurysm repair.