RESUMO
BACKGROUND: In this study, we systematically reviewed late open conversions after failed endovascular aneurysm repair (EVAR), assessed the methodologic quality of the included studies, and performed a meta-analysis on the 30-day mortality rates for urgent and elective late conversions. METHODS: Electronic databases were systematically searched for studies published up to June 2018 that focused on late open conversion of failed EVAR (ie, >30 days after the initial EVAR), reported the primary outcome of 30-day mortality rate, and distinguished the 30-day mortality rate between urgent and elective late conversions. Two independent reviewers assessed the methodologic quality of the included studies with the Methodological Index for Non-Randomized Studies. Data on baseline demographics, indication for conversion, surgical approach, and early and late mortality rates were recorded. Reported data correspond to the average or range of the means reported in the individual studies. A random-effects model was used to pool 30-day mortality rates for urgent and elective late conversion. RESULTS: There were 27 retrospective studies with a total of 791 patients available for analysis, with 617 elective and 174 urgent late conversions. The methodologic quality was mostly poor (median, 6; interquartile range, 5-7). The mean time from primary EVAR to conversion was 35.1 months (95% confidence interval [CI], 30.4-39.8 months). The most commonly explanted endografts were Excluder (W. L. Gore & Associates, Flagstaff, Ariz) in 16.2%, Talent (Medtronic, Minneapolis, Minn) in 14.5%, and AneuRx (Medtronic) in 13.7%. Nineteen other types of endografts were used in 43.3%; the type of endograft was not reported in 12.3%. A transperitoneal approach was used in a mean 74.0% of conversions (95% CI, 70.9%-77.0%), and complete endograft explantation was performed in 478 (60.4%) patients (95% CI, 57.0%-63.8%). The complication rate was 36.7% (95% CI, 27.0%-46.4%). Temporary or permanent hemodialysis after conversion was required in 3.9% of patients (95% CI, 2.6%-5.2%). The pooled estimate for the 30-day mortality rate was 2.8% (95% CI, 1.5%-4.0%; P = .726) for elective late conversions and 28.1% (95% CI, 18.9%-37.3%; P < .001) for urgent late conversions. CONCLUSIONS: Type I endoleak and rupture are the most common indications for, respectively, elective and urgent conversions. A 10 times higher 30-day mortality rate was observed for patients treated with late open conversion in an urgent vs elective setting. The 30-day mortality rate of elective late open conversions is almost comparable to that of primary elective open abdominal aortic aneurysm repair procedures. For the interpretation of the outcomes of the review, however, the methodologic quality of the available literature should be considered.
Assuntos
Aneurisma/cirurgia , Ruptura Aórtica/cirurgia , Implante de Prótese Vascular , Conversão para Cirurgia Aberta , Endoleak/cirurgia , Procedimentos Endovasculares , Idoso , Idoso de 80 Anos ou mais , Aneurisma/mortalidade , Ruptura Aórtica/etiologia , Ruptura Aórtica/mortalidade , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/mortalidade , Conversão para Cirurgia Aberta/efeitos adversos , Conversão para Cirurgia Aberta/mortalidade , Procedimentos Cirúrgicos Eletivos , Endoleak/etiologia , Endoleak/mortalidade , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição de Risco , Fatores de Risco , Fatores de Tempo , Falha de TratamentoRESUMO
OBJECTIVE: The aim of this study was to analyze the penetration depth, angles, distribution, and location of deployment of individual EndoAnchor (Medtronic Vascular, Santa Rosa, Calif) implants. METHODS: Eighty-six primary and revision arm patients (procedural success, 53; persistent type IA endoleak, 33) treated for type IA endoleaks with a total of 580 EndoAnchor implants from a subset of the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR) were included in this study. Procedural success was defined as the absence of a type IA endoleak on the first postprocedural computed tomography scan after the EndoAnchor implantation procedure. Endograft malapposition along the circumference was assessed at the first postoperative computed tomography scans and expressed as clock-face range and width in degrees and normalized such that the center was translated to 0 degrees. The position and penetration of each EndoAnchor implant were measured as the clock-face orientation. EndoAnchor implant penetration into the aortic wall was categorized as follows: good penetration, ≥2 mm; borderline penetration, <2 mm or ≥2-mm gap between the endograft and aortic wall; or no penetration. The orthogonal and longitudinal angles between the EndoAnchor implant and the interface plane of the aortic wall were determined. Location of deployment was investigated for each EndoAnchor implant and classified as maldeployed when it was above the fabric or in a gap >2 mm between the endograft and aortic wall due to >2-mm thrombus or positioning of the EndoAnchor implant below the aortic neck. RESULTS: A total of 170 (29%) EndoAnchor implants had maldeployment and were therefore beyond recommended use and not useful. After EndoAnchor implantation, the procedural success and persistent type IA endoleak groups had 3 (1%) and 4 (2%) EndoAnchor implants positioned above the fabric as well as 60 (18%) and 103 (42%) placed in a gap >2 mm, respectively. The amount of EndoAnchor implants with good, borderline, and no penetration was significantly different between both groups (success vs type IA endoleak) after exclusion of maldeployed EndoAnchor implants (235 [87.4%], 14 [5.2%], and 20 [7.4%] vs 97 [68.8%], 18 [12.8%], and 26 [18.4%], respectively; P < .001). Good penetration EndoAnchor implants were more closely aligned with a 90-degree orthogonal angle than the borderline penetration and nonpenetrating EndoAnchor implants. The longitudinal angle was more distributed, which was observed through all three penetration groups. CONCLUSIONS: In this subcohort of ANCHOR patients, almost 30% of the EndoAnchor implants had maldeployment, which may be prevented by careful preoperative planning and measured intraoperative deployment. If endoleaks are due to >2-mm gaps, EndoAnchor implants alone may not provide the intended sealing, and additional devices should be considered.
Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Endoleak/cirurgia , Procedimentos Endovasculares/instrumentação , Migração de Corpo Estranho/cirurgia , Stents , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Implante de Prótese Vascular/efeitos adversos , Endoleak/diagnóstico por imagem , Endoleak/etiologia , Procedimentos Endovasculares/efeitos adversos , Feminino , Migração de Corpo Estranho/diagnóstico por imagem , Migração de Corpo Estranho/etiologia , Humanos , Masculino , Desenho de Prótese , Sistema de Registros , Reoperação , Estudos Retrospectivos , Fatores de Risco , Resultado do TratamentoRESUMO
BACKGROUND: Chimney endovascular aneurysm sealing (ch-EVAS) could potentially minimize gutter-associated endoleaks in patients with juxtarenal abdominal aortic aneurysms resulting from the use of the conformable endobags surrounding the chimney stent grafts (ch-SGs). The aim of the present study was to quantify the (non)apposition of the endobags in the proximal aortic neck, migration of the endograft stent frames, and changes in geometry of the ch-SGs during the follow-up period. METHODS: The prospective data from 20 patients undergoing elective ch-EVAS were retrospectively reviewed. The aortic anatomy was analyzed on preoperative and postoperative computed tomography scans. The (non)apposition of the endobags in the aortic neck, Nellix (Endologix, Irvine, Calif) stent frame migration, and chimney graft geometry and migration were assessed. RESULTS: The median preoperative infrarenal neck length was 4.0 mm (interquartile range [IQR], 0-6.0 mm). The median seal length in the juxtarenal aortic neck at the first follow-up was 23.0 mm (IQR 18.0-30.8 mm). Five type IA endoleaks were identified on postoperative imaging; one at 1 month and four newly diagnosed at 1 year. Of these five type IA endoleaks, two were type Is1 (not extending into the aneurysm sac) and did not need reintervention and other three were type Is2 (extending into the aneurysm sac). One of these patients died of malignancy before reintervention could be performed. Bilateral ch-SG occlusions in one patient were documented at the 1-month follow-up (patient needed hemodialysis) and two patients with a new single ch-SG occlusion were found at the 1-year follow-up. No reinterventions were performed for the ch-SG occlusions. An occluded Nellix stent frame in one patient was treated with femorofemoral crossover bypass. Kaplan-Meier estimate of reintervention-free survival was 85.0% after 1 year. Migration ≥5 mm of the proximal end of the Nellix stent frames was observed in 20.0% of the patients, but no reintervention was performed at the 1-year follow-up. Imaging showed 20.1% of the available sealing surface was not used, and the nonapposition surface increased to 30.6% of the preoperative aortic neck surface at 1 year. Median migration was 3.5 mm (IQR, 2.4-5.0 mm) and 3.1 mm (IQR, 2.0-4.8 mm) for the left and right proximal end of the Nellix stent frames, respectively, and was 3.0 mm (IQR, 2.2-4.8 mm) for the proximal end of the ch-SGs at 1 year of follow-up. CONCLUSIONS: Substantial distal migration of the Nellix endograft and positional changes of the ch-SGs in the juxtarenal aortic neck were observed at 1 year of follow-up, resulting in a 25.0% type IA endoleak rate, with three of these type IA endoleaks extending into the aneurysm sac. The reintervention-free survival rate was 85.0% at 1 year in this cohort of 20 patients. Careful follow-up after ch-EVAS is advised because changes are often subtle. The authors have stopped the ch-EVAS procedure so far. Long-term follow-up data on the stability of the Nellix endograft and the consequences of migration on ch-SGs is required before this technique should be used in clinical practice.
Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Procedimentos Endovasculares , Complicações Pós-Operatórias/diagnóstico , Stents , Idoso , Idoso de 80 Anos ou mais , Endoleak/diagnóstico , Feminino , Migração de Corpo Estranho/diagnóstico , Migração de Corpo Estranho/etiologia , Humanos , Masculino , Falha de Prótese , Estudos Retrospectivos , Stents/efeitos adversosRESUMO
Purpose: To validate new computed tomography (CT)-applied software used to determine endograft limb position and apposition after endovascular aneurysm repair (EVAR). Materials and Methods: Twelve EVAR patients (mean age 81±6 years; 10 men) with distal stent-graft extensions for 15 (3 bilateral) type Ib endoleaks during follow-up were selected based on the availability of the following CT studies: pre-EVAR, 1 month, and the penultimate scan prior to the scan disclosing the type Ib endoleak. Twelve patients (mean age 82±7 years; 11 men) without endoleak and a similar interval between the primary EVAR procedure and the penultimate CT scan of the endoleak group were selected as controls using measurements from both endograft limbs (n=21, 3 excluded). Prototype Vascular Imaging Analysis software was adapted to calculate 6 parameters for the distal apposition zone: fabric distance, shortest apposition length, endograft diameter, iliac seal surface (ISS), iliac endograft apposition surface (IEAS), and percentage of iliac surface coverage (IEAS/ISS × 100). Measurements were performed on the preoperative, first postoperative, and penultimate/matched follow-up CT scans. Interobserver variability was assessed with the intraclass correlation coefficient (ICC). Continuous data are presented as the median [interquartile range (IQR) Q1, Q3]. Results: CTA follow-up was not significantly different between the endoleak and control groups [30 months (IQR 18, 58) vs 36 months (IQR 21, 59), p=0.843]. Interobserver agreement was good to excellent for all parameters (ICC 0.879-0.985). Preoperative anatomy and endograft dimensions on the first follow-up CTA scan did not differ significantly between the groups. When the penultimate CTA scan was compared with the first postoperative CT scan, endograft dimensions had significantly changed in the endoleak group; importantly, apposition was significantly decreased, and fabric distance was significantly increased, indicating limb retraction. Differences in changes in endograft dimensions were significant between the groups. Conclusion: New CT-applied software was introduced to visualize apposition and position changes of endograft limbs during follow-up. The software demonstrated good-to-excellent interobserver agreement and enabled accurate analysis of post-EVAR endograft dimensions. Significant changes in apposition and position were observed with the software on the penultimate CT scan prior to diagnosis of type Ib endoleak.
Assuntos
Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/cirurgia , Aortografia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Angiografia por Tomografia Computadorizada , Endoleak/diagnóstico por imagem , Procedimentos Endovasculares/instrumentação , Artéria Ilíaca/cirurgia , Software , Stents , Idoso , Idoso de 80 Anos ou mais , Aorta Abdominal/diagnóstico por imagem , Aorta Abdominal/fisiopatologia , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/fisiopatologia , Implante de Prótese Vascular/efeitos adversos , Endoleak/etiologia , Endoleak/fisiopatologia , Procedimentos Endovasculares/efeitos adversos , Feminino , Humanos , Artéria Ilíaca/diagnóstico por imagem , Artéria Ilíaca/fisiopatologia , Masculino , Variações Dependentes do Observador , Valor Preditivo dos Testes , Desenho de Prótese , Interpretação de Imagem Radiográfica Assistida por Computador , Reprodutibilidade dos Testes , Estudos Retrospectivos , Fatores de Tempo , Resultado do TratamentoRESUMO
PURPOSE: To review midterm clinical outcomes of EndoAnchor placement during or after endovascular aneurysm repair (EVAR) or chimney EVAR (ch-EVAR). MATERIALS AND METHODS: A retrospective analysis was conducted of 51 consecutive patients [median age 75 years; 38 men] who underwent EVAR/ch-EVAR with EndoAnchor placement between June 2010 and December 2016 to prevent seal failures (31, 61%) or to treat type Ia endoleak and/or migration (20, 39%). Median aortic neck diameter was 27.7 mm and median neck length was 9.0 mm. Thirty-three (65%) had a conical neck; 48 (94%) had at least 1 hostile neck characteristic. Thirty-two (63%) patients had severe comorbidities (ASA score ⩾III). Eight patients had a single ch-EVAR procedure. Baseline patient characteristics, anatomic variables, procedure details, early and late complications, reinterventions, and aneurysm-related and all-cause mortality rates were recorded. Follow-up imaging was performed with computed tomography angiography (CTA) or duplex ultrasonography. RESULTS: Median procedure time was 100 minutes; a median of 6 EndoAnchors were implanted. There were 10 (10%) residual type Ia endoleaks at the end of the procedure; 9 had resolved by the first postoperative CTA. One residual and 2 new type Ia endoleaks were identified at the first postoperative imaging. Median follow-up for the entire cohort was 24.0 months, during which 3 new type Ia endoleaks were identified. Five of the 6 type Ia endoleaks were treated, 1 resolved spontaneously. There was 1 endograft limb occlusion without clinical consequences, 1 chimney graft occlusion without possibilities for a reintervention, 1 rupture after type IV endoleak (a Nellix device was successfully deployed within the main device), and 1 complete graft explantation for infection. There was no new-onset hemodialysis. Kaplan-Meier estimates of freedom from type Ia endoleak, proximal neck-related reinterventions, and aneurysm-related mortality at 2 years were 87.3%, 92.2%, and 94.0%, respectively. CONCLUSION: EndoAnchors are helpful in the endovascular treatment of unfavorable proximal aortic necks, with fair midterm results.
Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Procedimentos Endovasculares/instrumentação , Stents , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/mortalidade , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/mortalidade , Endoleak/etiologia , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos , Intervalo Livre de Progressão , Estudos Retrospectivos , Fatores de Risco , Fatores de TempoRESUMO
PURPOSE: To investigate changes in penetration depths and angles of EndoAnchor implants with initially good penetration after therapeutic use in endovascular aneurysm repair. MATERIALS AND METHODS: Patients were selected from the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR; ClinicalTrials.gov identifier NCT01534819). Inclusion criteria were (1) EndoAnchor implantation to treat intraoperative or late type Ia endoleak and (2) at least 2 postoperative computed tomography angiography (CTA) scans. Exclusion criteria were the use of adjunct procedures. Based on these criteria, 54 patients (44 men) with 360 EndoAnchor implants were eligible for this analysis. Penetration depth of each EndoAnchor implant into the aortic wall was judged as (1) good (≥2-mm penetration), (2) borderline (<2 mm or when there was a gap between the endograft and the aortic wall), or (3) no penetration. The penetration depth and longitudinal angles of EndoAnchors with good penetration were investigated on the last available postprocedure CTA scan. Endoleaks were also analyzed. RESULTS: EndoAnchor penetration on the first postprocedure CTA scan was good in 187 (51.9%), borderline in 69 (19.2%), and missing in 104 (28.9%). On the last CTA scan, 182 (97.4%) of the 187 initially well-positioned EndoAnchors remained good. Five (2.6%) EndoAnchors in 4 patients changed configuration over time (4 became borderline and 1 became nonpenetrating), all without any clinical sequelae. The median orthogonal angles of the EndoAnchor implants with good penetration on the first and last CTA scans were 92° [interquartile range (IQR) 85, 98] and 90° (IQR 84, 97), respectively (p=0.822); for longitudinal angles, medians of 85° (IQR 71, 96) and 84° (IQR 70, 96) were found (p=0.043). Of the 18 (33%) patients who had a type Ia endoleak on the first postprocedure CTA, 6 resolved over time. Median follow-up was 13 months, during which no new type Ia endoleak was found. CONCLUSION: Despite the small number of EndoAnchors analyzed, this study showed that the sustainability of EndoAnchor implants with initially good penetration is satisfactory at 1-year follow-up. The vast majority of EndoAnchor implants with good penetration initially remained in good position; <3% of implants became borderline or nonpenetrating, without any clinical consequence.
Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/efeitos adversos , Endoleak/cirurgia , Aneurisma da Aorta Abdominal/fisiopatologia , Prótese Vascular , Implante de Prótese Vascular/instrumentação , Bases de Dados Factuais , Endoleak/diagnóstico por imagem , Endoleak/etiologia , Endoleak/fisiopatologia , Feminino , Humanos , Masculino , Sistema de Registros , Reoperação , Stents , Fatores de Tempo , Resultado do TratamentoRESUMO
Purpose: This study investigated the effect of different EndoAnchor configurations on aortic endograft displacement resistance in an in vitro model. Materials and Methods: An in vitro model was developed and validated to perform displacement force measurements on different EndoAnchor configurations within an endograft and silicone tube. Five EndoAnchor configurations were created: (1) 6 circumferentially deployed EndoAnchors, (2) 5 EndoAnchors within 120° of the circumference and 1 additional, contralateral EndoAnchor, (3) 4 circumferentially deployed EndoAnchors, (4) 2 rows of 4 circumferentially deployed EndoAnchors, and (5) a configuration of 2 columns of 3 EndoAnchors. An experienced vascular surgeon deployed EndoAnchors under C-arm guidance at the proximal sealing zone of the endograft. A constant force with increments of 1 newton (N) was applied to the distal end of the endograft. The force necessary to displace a part of the endograft by 3 mm was defined as the endograft displacement force (EDF). Two video cameras recorded the measurements. Videos were examined to determine the exact moment 3-mm migration had occurred at part of the endograft. Five measurements were performed after each deployed EndoAnchor for each configuration. Measurements are given as the median and interquartile range (IQR) Q1, Q3. Results: Baseline displacement force measurement of the endograft without EndoAnchors resulted in a median EDF of 5.1 N (IQR 4.8, 5.2). The circumferential distribution of 6 EndoAnchors resulted in a median EDF of 53.7 N (IQR 49.0, 59.0), whereas configurations 2 through 5 demonstrated substantially lower EDFs of 29.0 N (IQR 28.5, 30.1), 24.6 N (IQR 21.9, 27.2), 36.7 N, and 9.6 N (IQR 9.4, 10.0), respectively. Decreasing the distance between the EndoAnchors over the circumference of the endograft increased the displacement resistance. Conclusion: This in vitro study demonstrates the influence EndoAnchor configurations have on the displacement resistance of an aortic endograft. Parts of the endograft where no EndoAnchor has been deployed remain sensitive to migration. In the current model, the only configuration that rivaled a hand-sewn anastomosis was the one with 6 EndoAnchors. A circumferential distribution of EndoAnchors with small distances between EndoAnchors should be pursued, if possible. This study provides a quantification of different EndoAnchor configurations that clinicians may have to adopt in clinical practice, which can help them make a measured decision on where to deploy EndoAnchors to ensure good endograft fixation.
Assuntos
Aorta/cirurgia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Procedimentos Endovasculares/instrumentação , Hemodinâmica , Aorta/fisiopatologia , Implante de Prótese Vascular/efeitos adversos , Endoleak/etiologia , Endoleak/fisiopatologia , Procedimentos Endovasculares/efeitos adversos , Migração de Corpo Estranho/etiologia , Migração de Corpo Estranho/fisiopatologia , Humanos , Teste de Materiais , Modelos Anatômicos , Modelos Cardiovasculares , Desenho de Prótese , Fluxo Sanguíneo Regional , Estresse Mecânico , Gravação em VídeoRESUMO
OBJECTIVE: This study sought to quantify EndoAnchor (Medtronic Vascular, Santa Rosa, Calif) penetration into the aortic wall in patients undergoing endovascular abdominal aortic aneurysm repair and to assess predictors of successful penetration and its relationship to postprocedural type IA endoleak. METHODS: A subset of patients from the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR) were included if they met the following criteria: the indication for EndoAnchor use was to treat a type IA endoleak, and postprocedure contrast-enhanced computed tomography (CT) scans of sufficient quality were available for core laboratory review. Patients undergoing implantation of cuffs or stents during the EndoAnchor implantation procedure were excluded. Baseline anatomic characteristics were recorded. The cohort was divided into patients with and without persistent type IA endoleaks at the first postoperative CT scan. Penetration of each EndoAnchor measured on this CT scan was defined as good penetration when the EndoAnchor penetrated ≥2 mm into the aortic wall, borderline penetration when EndoAnchor penetration was <2 mm or a gap remained between the endograft and aortic wall, or no penetration when the EndoAnchor did not penetrate into the aortic wall. Differences between the groups were analyzed with the Mann-Whitney U test or Fisher exact test. Multivariate analyses were performed to identify independent predictors of EndoAnchor penetration, and procedural success was defined by absence of type IA endoleak. RESULTS: Eighty-six patients of the primary (n = 61 [71%]) and revision (n = 25 [29%]) arms of the ANCHOR registry were included. There were 53 (62%) without and 33 (38%) with persistent type IA endoleaks on the first postprocedural CT scan. The median number of EndoAnchors with good penetration was significantly greater in the cohort without endoleaks, 4 (interquartile range, 3-5) vs 3 (interquartile range, 1.5-4), respectively (P = .002). A multivariate model for EndoAnchor penetration identified use of a Medtronic Endurant endograft as a factor associated with good penetration (P = .001), whereas poor penetration was associated with a larger aortic neck diameter 10 mm distal to the lowest renal artery (P < .001) and greater proximal neck calcium thickness (P = .004). EndoAnchor penetration was the only variable that attained significance (P < .001) in the multivariate model for successful treatment of a type IA endoleak. CONCLUSIONS: Adequate EndoAnchor penetration into the aortic wall is less likely when the aortic neck diameter is large or when the neck contains significant mural calcium. No penetration of the EndoAnchor was the only factor predictive of postprocedural type IA endoleak. This study stresses the importance of careful selection of patients based on preoperative assessment of the infrarenal neck on CT angiography and emphasizes careful deployment of EndoAnchors into the aortic wall to improve successful treatment of type IA endoleaks.
Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/instrumentação , Procedimentos Endovasculares/instrumentação , Âncoras de Sutura , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aortografia/métodos , Prótese Vascular , Implante de Prótese Vascular/efeitos adversos , Angiografia por Tomografia Computadorizada , Endoleak/diagnóstico por imagem , Endoleak/etiologia , Procedimentos Endovasculares/efeitos adversos , Feminino , Migração de Corpo Estranho/diagnóstico por imagem , Migração de Corpo Estranho/etiologia , Humanos , Modelos Logísticos , Masculino , Análise Multivariada , Desenho de Prótese , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Resultado do TratamentoRESUMO
PURPOSE: To systematically review and meta-analyze the added value of 3-dimensional (3D) image fusion technology in endovascular aortic repair for its potential to reduce contrast media volume, radiation dose, procedure time, and fluoroscopy time. METHODS: Electronic databases were systematically searched for studies published between January 2010 and March 2016 that included a control group describing 3D fusion imaging in endovascular aortic procedures. Two independent reviewers assessed the methodological quality of the included studies and extracted data on iodinated contrast volume, radiation dose, procedure time, and fluoroscopy time. The contrast use for standard and complex endovascular aortic repairs (fenestrated, branched, and chimney) were pooled using a random-effects model; outcomes are reported as the mean difference with 95% confidence intervals (CIs). RESULTS: Seven studies, 5 retrospective and 2 prospective, involving 921 patients were selected for analysis. The methodological quality of the studies was moderate (median 17, range 15-18). The use of fusion imaging led to an estimated mean reduction in iodinated contrast of 40.1 mL (95% CI 16.4 to 63.7, p=0.002) for standard procedures and a mean 70.7 mL (95% CI 44.8 to 96.6, p<0.001) for complex repairs. Secondary outcome measures were not pooled because of potential bias in nonrandomized data, but radiation doses, procedure times, and fluoroscopy times were lower, although not always significantly, in the fusion group in 6 of the 7 studies. CONCLUSION: Compared with the control group, 3D fusion imaging is associated with a significant reduction in the volume of contrast employed for standard and complex endovascular aortic procedures, which can be particularly important in patients with renal failure. Radiation doses, procedure times, and fluoroscopy times were reduced when 3D fusion was used.
Assuntos
Aneurisma Aórtico/cirurgia , Aortografia/métodos , Implante de Prótese Vascular/métodos , Angiografia por Tomografia Computadorizada/métodos , Procedimentos Endovasculares/métodos , Imageamento Tridimensional/métodos , Angiografia por Ressonância Magnética/métodos , Interpretação de Imagem Radiográfica Assistida por Computador/métodos , Aneurisma Aórtico/diagnóstico por imagem , Aneurisma Aórtico/fisiopatologia , Implante de Prótese Vascular/efeitos adversos , Meios de Contraste/administração & dosagem , Procedimentos Endovasculares/efeitos adversos , Humanos , Duração da Cirurgia , Valor Preditivo dos Testes , Doses de Radiação , Exposição à Radiação , Radiografia Intervencionista , Fatores de Tempo , Resultado do TratamentoRESUMO
INTRODUCTION: Endovascular revascularization has become the preferred treatment for most patients with iliac artery obstructions, with a high rate of clinical and technical success. AREAS COVERED: This review will describe novel developments in the diagnosis and treatment of iliac artery obstructions including the augmentation of preprocedural imaging with advanced flow models, image fusion techniques, and state-of-the-art device-tracking capabilities. EXPERT OPINION: The combination of these developments will change the endovascular field within the next 5 years, allowing targeted iliac treatment without the need for radiographic imaging or iodinated contrast media.
Assuntos
Arteriopatias Oclusivas/cirurgia , Procedimentos Endovasculares/métodos , Artéria Ilíaca/cirurgia , Meios de Contraste , Humanos , Resultado do TratamentoRESUMO
BACKGROUND: Endovascular iliac artery interventions rely on the use of two-dimensional digital subtraction angiographies with an iodinated contrast agent and ionizing radiation. The amount of iodinated contrast agent should be limited because of its potentially nephrotoxic effects. Three-dimensional (3D) image fusion requires registration of a preprocedural magnetic resonance angiogram (MRA) or computed tomography (CT) angiogram to a perprocedurally acquired cone-beam CT or two fluoroscopic orthogonal projections. After registration, the 3D angiography images can be overlaid on the fluoroscopy screen and will follow table and C-arm movements. This study will assess the added value of the 3D image fusion technique in iliac artery interventions regarding the amount of the iodinated contrast agent administered. METHODS/DESIGN: The study cohort will comprise 106 patients (> 18 years) with symptomatic common and/or external iliac artery stenoses or occlusions and a recent (< 6 months) diagnostic MRA from the pelvis through the lower extremities, for which an endovascular intervention is indicated. Patients will be randomized into the control or study group (i.e. treatment without or with 3D image fusion guidance). The primary endpoint is the amount of administered iodinated contrast agent (mL). Secondary outcomes are technical success of the procedure, defined as < 30% residual stenosis over the treated lesion, fluoroscopy time, and radiation dose as dose area product (mGycm2). Patient participation in the study will be completed after hospital discharge. DISCUSSION: This study is a randomized controlled multicenter trial to provide evidence on the effect of the 3D image fusion technique on the amount of administered iodinated contrast during endovascular common and/or external iliac artery interventions. TRIAL REGISTRATION: Nederlands Trial Register, NTR5008 . Registered on 16 December 2014.
Assuntos
Procedimentos Endovasculares/métodos , Fluoroscopia/métodos , Artéria Ilíaca/cirurgia , Imageamento Tridimensional/métodos , Angiografia por Ressonância Magnética/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto , Cirurgia Assistida por Computador/métodos , Tomografia Computadorizada de Feixe Cônico , Meios de Contraste , Humanos , Estudos Multicêntricos como Assunto , Tamanho da AmostraRESUMO
INTRODUCTION: The effect of the insertion of guidewires and catheters on fusion accuracy of the three-dimensional (3D) image fusion technique during iliac percutaneous transluminal angioplasty (PTA) procedures has not yet been investigated. EVIDENCE ACQUISITION: Technical validation of the 3D fusion technique was evaluated in 11 patients with common and/or external iliac artery lesions. A preprocedural contrast-enhanced magnetic resonance angiogram (CE-MRA) was segmented and manually registered to a cone-beam computed tomography image created at the beginning of the procedure for each patient. The treating physician visually scored the fusion accuracy (i.e., accurate [<2 mm], mismatch [2-5 mm], or inaccurate [>5 mm]) of the entire vasculature of the overlay with respect to the digital subtraction angiography (DSA) directly after the first obtained DSA. Contours of the vasculature of the fusion images and DSAs were drawn after the procedure. The cranial-caudal, lateral-medial, and absolute displacement were calculated between the vessel centerlines. To determine the influence of the catheters, displacement of the catheterized iliac trajectories were compared with the noncatheterized trajectories. Electronic databases were systematically searched for available literature published between January 2010 till August 2017. EVIDENCE SYNTHESIS: The mean registration error for all iliac trajectories (N.=20) was small (4.0±2.5 mm). No significant difference in fusion displacement was observed between catheterized (N.=11) and noncatheterized (N.=9) iliac arteries. The systematic literature search yielded 2 manuscripts with a total of 22 patients. The methodological quality of these studies was poor (≤11 MINORS Score), mainly due to a lack of a control group. CONCLUSIONS: Accurate image fusion based on preprocedural CE-MRA is possible and could potentially be of help in iliac PTA procedures. The flexible guidewires and angiographic catheters, routinely used during endovascular procedures of iliac arteries, did not cause significant displacement that influenced the image fusion. Current literature on 3D image fusion in iliac PTA procedures is of limited methodological quality.