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1.
J Vasc Surg ; 79(2): 229-239.e3, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38148614

RESUMO

OBJECTIVE: Current societal recommendations regarding the timing of thoracic endovascular aortic repair (TEVAR) for blunt thoracic aortic injury (BTAI) vary. Prior studies have shown that elective repair was associated with lower mortality after TEVAR for BTAI. However, these studies lacked data such as Society for Vascular Surgery (SVS) aortic injury grades and TEVAR-related postoperative outcomes. Therefore, we used the Vascular Quality Initiative registry, which includes relevant anatomic and outcome data, to examine the outcomes following urgent/emergent (≤ 24 hours) vs elective TEVAR for BTAI. METHODS: Patients undergoing TEVAR for BTAI between 2013 and 2022 were included, excluding those with SVS grade 4 aortic injuries. We included covariates such as age, sex, race, transfer status, body mass index, preoperative hemoglobin, comorbidities, medication use, SVS aortic injury grade, coexisting injuries, Glasgow Coma Scale, and prior aortic surgery in a regression model to compute propensity scores for assignment to urgent/emergent or elective TEVAR. Perioperative outcomes and 5-year mortality were evaluated using inverse probability-weighted logistic regression and Cox regression, also adjusting for left subclavian artery revascularization/occlusion and annual center and physician volumes. RESULTS: Of 1016 patients, 102 (10%) underwent elective TEVAR. Patients who underwent elective repair were more likely to undergo revascularization of the left subclavian artery (31% vs 7.5%; P < .001) and receive intraoperative heparin (94% vs 82%; P = .002). After inverse probability weighting, there was no association between TEVAR timing and perioperative mortality (elective vs urgent/emergent: 3.9% vs 6.6%; odds ratio [OR], 1.1; 95% confidence interval [CI], 0.27-4.7; P = .90) and 5-year mortality (5.8% vs 12%; hazard ratio [HR], 0.95; 95% CI, 0.21-4.3; P > .9).Compared with urgent/emergent TEVAR, elective repair was associated with lower postoperative stroke (1.0% vs 2.1%; adjusted OR [aOR], 0.12; 95% CI, 0.02-0.94; P = .044), even after adjusting for intraoperative heparin use (aOR, 0.12; 95% CI, 0.02-0.92; P = .042). Elective TEVAR was also associated with lower odds of failure of extubation immediately after surgery (39% vs 65%; aOR, 0.18; 95% CI, 0.09-0.35; P < .001) and postoperative pneumonia (4.9% vs 11%; aOR, 0.34; 95% CI, 0.13-0.91; P = .031), but comparable odds of any postoperative complication as a composite outcome and reintervention during index admission. CONCLUSIONS: Patients with BTAI who underwent elective TEVAR were more likely to receive intraoperative heparin. Perioperative mortality and 5-year mortality rates were similar between the elective and emergent/urgent TEVAR groups. Postoperatively, elective TEVAR was associated with lower ischemic stroke, pulmonary complications, and prolonged hospitalization. Future modifications in society guidelines should incorporate the current evidence supporting the use of elective TEVAR for BTAI. The optimal timing of TEVAR in patients with BTAI and the factors determining it should be the subject of future study to facilitate personalized decision-making.


Assuntos
Implante de Prótese Vascular , Procedimentos Endovasculares , Traumatismos Torácicos , Lesões do Sistema Vascular , Ferimentos não Penetrantes , Humanos , Correção Endovascular de Aneurisma , Procedimentos Endovasculares/efeitos adversos , Fatores de Risco , Aorta/cirurgia , Aorta Torácica/diagnóstico por imagem , Aorta Torácica/cirurgia , Aorta Torácica/lesões , Heparina , Ferimentos não Penetrantes/diagnóstico por imagem , Ferimentos não Penetrantes/cirurgia , Traumatismos Torácicos/cirurgia , Lesões do Sistema Vascular/diagnóstico por imagem , Lesões do Sistema Vascular/cirurgia , Resultado do Tratamento , Estudos Retrospectivos , Implante de Prótese Vascular/efeitos adversos
2.
J Vasc Surg ; 80(3): 678-684.e1, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-38677660

RESUMO

OBJECTIVE: The aim of this study was to demonstrate the safety and effectiveness of a low-profile thoracic endograft (19-23 French) in subjects with blunt traumatic aortic injury. METHODS: A prospective, multicenter study assessed the RelayPro thoracic endograft for the treatment of traumatic aortic injury. Fifty patients were enrolled at 16 centers in the United States between 2017 and 2021. The primary endpoint was 30-day all-cause mortality. RESULTS: The cohort was mostly male (74%), with a mean age of 42.4 ± 17.2 years, and treated for traumatic injuries (4% Grade 1, 8% Grade 2, 76% Grade 3, and 12% Grade 4) due to motor vehicle collision (80%). The proximal landing zone was proximal to the left subclavian artery in 42%, and access was primarily percutaneous (80%). Most (71%) were treated with a non-bare stent endograft. Technical success was 98% (one early type Ia endoleak). All-cause 30-day mortality was 2% (compared with an expected rate of 8%), with an exact two-sided 95% confidence interval [CI] of 0.1%, 10.6% below the performance goal upper limit of 25%. Kaplan-Meier analysis estimated freedom from all-cause mortality to be 98% at 30 days through 4 years (95% CI, 86.6%-99.7%). Kaplan-Meier estimated freedom from major adverse events, all-cause mortality, paralysis, and stroke, was 98.0% at 30 days and 95.8% from 6 months to 4 years (95% CI, 84.3%-98.9%). There were no strokes and one case of paraplegia (2%) during follow-up. CONCLUSIONS: RelayPro was safe and effective and may provide an early survival benefit in the treatment of blunt traumatic aortic injury.


Assuntos
Implante de Prótese Vascular , Prótese Vascular , Procedimentos Endovasculares , Desenho de Prótese , Lesões do Sistema Vascular , Ferimentos não Penetrantes , Humanos , Masculino , Ferimentos não Penetrantes/cirurgia , Ferimentos não Penetrantes/mortalidade , Ferimentos não Penetrantes/diagnóstico por imagem , Feminino , Adulto , Pessoa de Meia-Idade , Procedimentos Endovasculares/instrumentação , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Implante de Prótese Vascular/instrumentação , Implante de Prótese Vascular/mortalidade , Implante de Prótese Vascular/efeitos adversos , Estudos Prospectivos , Lesões do Sistema Vascular/cirurgia , Lesões do Sistema Vascular/mortalidade , Lesões do Sistema Vascular/diagnóstico por imagem , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Aorta Torácica/cirurgia , Aorta Torácica/lesões , Aorta Torácica/diagnóstico por imagem , Stents , Fatores de Risco , Idoso , Adulto Jovem , Medição de Risco , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/etiologia
3.
J Vasc Surg ; 80(1): 53-63.e3, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38431064

RESUMO

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) for blunt thoracic aortic injury (BTAI) at high-volume hospitals has previously been associated with lower perioperative mortality, but the impact of annual surgeon volume on outcomes following TEVAR for BTAI remains unknown. METHODS: We analyzed Vascular Quality Initiative (VQI) data from patients with BTAI that underwent TEVAR between 2013 and 2023. Annual surgeon volumes were computed as the number of TEVARs (for any pathology) performed over a 1-year period preceding each procedure and were further categorized into quintiles. Surgeons in the first volume quintile were categorized as low volume (LV), the highest quintile as high volume (HV), and the middle three quintiles as medium volume (MV). TEVAR procedures performed by surgeons with less than 1-year enrollment in the VQI were excluded. Using multilevel logistic regression models, we evaluated associations between surgeon volume and perioperative outcomes, accounting for annual center volumes and adjusting for potential confounders, including aortic injury grade and severity of coexisting injuries. Multilevel models accounted for the nested clustering of patients and surgeons within the same center. Sensitivity analysis excluding patients with grade IV BTAI was performed. RESULTS: We studied 1321 patients who underwent TEVAR for BTAI (28% by LV surgeons [0-1 procedures per year], 52% by MV surgeons [2-8 procedures per year], 20% by HV surgeons [≥9 procedures per year]). With higher surgeon volume, TEVAR was delayed more (in <4 hours: LV: 68%, MV: 54%, HV: 46%; P < .001; elective (>24 hours): LV: 5.1%; MV: 8.9%: HV: 14%), heparin administered more (LV: 80%, MV: 81%, HV: 87%; P = .007), perioperative mortality appears lower (LV: 11%, MV: 7.3%, HV: 6.5%; P = .095), and ischemic/hemorrhagic stroke was lower (LV: 6.5%, MV: 3.6%, HV: 1.5%; P = .006). After adjustment, compared with LV surgeons, higher volume surgeons had lower odds of perioperative mortality (MV: 0.49; 95% confidence interval [CI], 0.25-0.97; P = .039; HV: 0.45; 95% CI, 0.16-1.22; P = .12; MV/HV: 0.50; 95% CI, 0.26-0.96; P = .038) and ischemic/hemorrhagic stroke (MV: 0.38; 95% CI, 0.18-0.81; P = .011; HV: 0.16; 95% CI, 0.04-0.61; P = .008). Sensitivity analysis found lower adjusted odds for perioperative mortality (although not significant) and ischemic/hemorrhagic stroke for higher volume surgeons. CONCLUSIONS: In patients undergoing TEVAR for BTAI, higher surgeon volume is independently associated with lower perioperative mortality and postoperative stroke, regardless of hospital volume. Future studies could elucidate if TEVAR for non-ruptured BTAI might be delayed and allow stabilization, heparinization, and involvement of a higher TEVAR volume surgeon.


Assuntos
Aorta Torácica , Competência Clínica , Correção Endovascular de Aneurisma , Hospitais com Alto Volume de Atendimentos , Cirurgiões , Lesões do Sistema Vascular , Ferimentos não Penetrantes , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Aorta Torácica/cirurgia , Aorta Torácica/lesões , Aorta Torácica/diagnóstico por imagem , Bases de Dados Factuais , Correção Endovascular de Aneurisma/efeitos adversos , Correção Endovascular de Aneurisma/mortalidade , Hospitais com Baixo Volume de Atendimentos , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/cirurgia , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Traumatismos Torácicos/cirurgia , Traumatismos Torácicos/mortalidade , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Lesões do Sistema Vascular/cirurgia , Lesões do Sistema Vascular/mortalidade , Lesões do Sistema Vascular/diagnóstico por imagem , Ferimentos não Penetrantes/cirurgia , Ferimentos não Penetrantes/mortalidade
4.
J Endovasc Ther ; : 15266028241245326, 2024 Apr 11.
Artigo em Inglês | MEDLINE | ID: mdl-38605568

RESUMO

OBJECTIVE: This study aimed to assess the long-term outcomes in patients treated by thoracic endovascular aortic repair (TEVAR) for blunt thoracic aortic injuries (BTAI). MATERIALS AND METHODS: From January 2010 to December 2019, this retrospective observational study was conducted at 3 centers, involving 62 consecutive BTAI patients who underwent TEVAR. Computed tomography angiography scans were planned to be conducted at 6 months post-procedure, and annually thereafter. RESULTS: Technical success was achieved in all 62 procedures (100%), which included cases of dissection (n=35, 56.45%), pseudoaneurysm (n=20, 32.26%), and rupture (n=7, 11.29%). Mean injury severity score was 31.66±8.30. A total of 21 supra-arch branches were revascularized by chimney technique, with 12 cases involving the left subclavian artery (LSA) and 9 cases involving the left common carotid artery. In addition, 11 LSAs were covered during the procedure. The in-hospital mortality rate was 1.61% (n=1). The mean follow-up time was 86.82±30.58 months. The all-cause follow-up mortality rate was 3.28% (n=2). Stenosis or occlusion of 3 supra-arch branches (4.92%) was identified at follow-up, with 2 cases (3.28%) requiring re-intervention. No spinal cord ischemia, endoleak, or migration was observed. CONCLUSIONS: Despite only including patients with long-term follow-up, this study confirms the long-term safety and effectiveness of TEVAR for BTAI. For young BTAI patients, as the thoracic aorta increases with age, longer follow-up is needed to observe the potential mismatch between the endograft and the aorta. CLINICAL IMPACT: This study confirms the long-term safety and effectiveness of endovascular treatment for blunt thoracic aortic injury (BTAI). For young BTAI patients, as the thoracic aorta increases with age, longer follow-up is needed to observe the potential mismatch between the endograft and the aorta. Through a remarkably extended follow-up period (86.82±30.58 months) conducted at multiple centers in China, this study confirms the long-term safety and effectiveness of endovascular treatment for BTAI.

5.
J Endovasc Ther ; : 15266028241283324, 2024 Sep 29.
Artigo em Inglês | MEDLINE | ID: mdl-39342458

RESUMO

OBJECTIVES: Stent graft-related aortic injury is a major complication after thoracic endovascular aortic repair (TEVAR) and seriously affects patient prognosis. However, the distribution characteristics of aortic wall stress under the action of stent grafts and the mechanism of abnormal wall stress leading to aortic wall injury and adverse remodeling were unclear. The aim of this study was to explore the potential mechanisms of high wall stress on the structural and functional alterations of the aortic wall by combining animal experiments, numerical simulations, and bioinformatics. METHODS: We observed stent graft-induced aortic injury by performing fenestrated TEVAR in 6 pigs, and quantitatively analyzed and visualized the stress distribution of the aortic wall under the stent graft through numerical simulation. Hematoxylin and eosin (HE) staining, Masson's trichrome staining, Verhoeff's Van Gieson (EVG) staining, and immunostaining were used to evaluate pathological changes in the aorta. Based on the numerical simulation results, the corresponding high-stress and low-stress regions of the aortic wall were subjected to bulk-RNA sequencing, and hub genes were identified by bioinformatics analysis. RESULTS: Stent grafts were successfully implanted in 5 pigs. In all computational models, we found that obvious deformation and characteristic maximum stress concentration occurred on the side of the greater curve of the aortic arch in contact with the stent graft tip, and the high wall stress concentration areas were highly consistent with the obvious pathological injury area. Subsequent pathological analysis revealed that high wall stress-induced confusion and fragmentation of elastic fibers, collagen deposition, loss and phenotypic switching of vascular smooth muscle cells, and increased inflammatory responses. Gene expression profiles of the aortic wall under different wall stress conditions were described for the first time, and the hub genes (TGFB1, CDH5, DCN, ITGA5, ITGB3, and WT1) that may be involved in regulating the aortic injury and remodeling process in response to high wall stress stimulation were identified. CONCLUSIONS: This study revealed a panoramic view of stent graft-associated high wall stress-induced aortic wall injury through technical approaches of multiple dimensions. Understanding these biomechanical features and hub genes is pivotal for advancing our comprehension of the complications associated with aortic injury after TEVAR and facilitating the development of future therapeutic interventions. CLINICAL IMPACT: This study revealed a panoramic view of stent graft-associated high wall stress-induced aortic wall injury through technical approaches of multiple dimensions. The biomechanical distribution characteristics of the aortic wall, the secondary pathological injury and the alteration of gene expression profile under the action of stent graft were comprehensively revealed by animal experiments for the first time. This will advance clinicians' comprehension of complications associated with aortic injury after TEVAR, provide a new biomechanical perspective for the rational preoperative planning of TEVAR and the management of postoperative complications, and facilitate the development of future therapeutic interventions and stent graft device designs.

6.
J Endovasc Ther ; : 15266028241245907, 2024 Apr 09.
Artigo em Inglês | MEDLINE | ID: mdl-38590278

RESUMO

BACKGROUND: Blunt traumatic aortic injury (BTAI) is a rare occurrence in adolescents, yet it is associated with a high mortality rate necessitating immediate treatment. Although endovascular repair has become the preferred treatment for such injuries in adults, its effectiveness in adolescents remains uncertain. CASE SUMMARY: Blunt traumatic aortic injury typically presents with concomitant injuries to other organs and carries a high perioperative mortality rate with operative repair (OR). In this report, we describe the treatment of 3 clinical cases of BTAI in adolescents using thoracic endovascular aortic repair (TEVAR). These cases contribute pertinent evidence supporting the efficacy of intravascular repair for BTAI. CONCLUSION: Operative repair (OR) remains the gold standard for treating BTAI in adolescents. Nevertheless, TEVAR therapy presents a viable alternative for patients with multiple injuries in whom anticoagulation is contraindicated. Further long-term observation is necessary to assess the lasting effects of TEVAR therapy. CLINICAL IMPACT: This study has provided insights into endovascular repair for adolescent BTAT, offering clinicians significant reference material for choosing treatment strategies for adolescent BTAT. The study aims to demonstrate the safety and effectiveness of endovascular repair treatments in a series of clinical cases involving adolescent BTAI.

7.
J Endovasc Ther ; : 15266028241271732, 2024 Aug 26.
Artigo em Inglês | MEDLINE | ID: mdl-39183688

RESUMO

PURPOSE: Thoracic endovascular aortic repair (TEVAR) is a treatment for traumatic blunt thoracic aortic injury (BTAI) with good survival rates and safety. However, there is limited study on the risk factors for in-hospital mortality and complications. This study aimed to identify risk factors associated with poor in-hospital outcomes after TEVAR. MATERIALS AND METHODS: This is a population-based, retrospective observational study. Data of adults ≥20 years admitted for BTAI who received TEVAR were extracted from the Nationwide Inpatient Sample (NIS) database 2005 to 2018. The primary outcome was in-hospital mortality, and the secondary outcomes were length of stay (LOS) and unfavorable discharge (ie, non-routine discharge, including nursing homes or long-term care facilities). Associations between study variables and in-hospital outcomes were determined using univariate and multivariable logistic and linear regression analyses. RESULTS: Data of 1095 participants (representing 5360 hospitalized patients in the United States) were analyzed. Multivariable analysis revealed that older age (adjusted odds ratio [aOR]=1.02) and having at least 1 perioperative complication (aOR=4.01) were significantly associated with increased risk for in-hospital mortality. Patients with at least 1 perioperative complication (aOR=11.19) had significantly increased odds for prolonged LOS. Risk for unfavorable discharge was significantly increased by older age (aOR=1.02), household income at quartile 2 (aOR=1.58), Charlson Comorbidity Index (CCI) 2 to 3 (aOR=1.66), and having at least 1 complication (aOR=3.94). Complications including perioperative cerebrovascular accident (CVA) (aOR=2.75), venous thromboembolism (VTE) (aOR=2.87), pneumonia (aOR=3.93), sepsis (aOR=4.69), infection (aOR=4.49), respiratory failure (aOR=4.55), mechanical ventilation (aOR=3.27), and acute kidney injury (AKI) (aOR=3.09) significantly predicted prolonged LOS. CONCLUSIONS: In adults with traumatic BTAI undergoing TEVAR, advanced age and perioperative complications are risk factors for poor in-hospital outcomes. Acute kidney injury, CVA, respiratory failure, and sepsis are strong predictors of prolonged LOS, unfavorable discharge, and in-hospital mortality. CLINICAL IMPACT: The study identifies advanced age and perioperative complications as key risk factors for poor in-hospital outcomes in patients undergoing TEVAR for BTAI. Clinicians should be vigilant in managing these patients, particularly those with comorbidities, to mitigate risks. The findings suggest a need for tailored perioperative care strategies to improve survival rates and reduce complications. This research highlights the critical importance of early identification and intervention in high-risk patients, offering an innovative approach to refining TEVAR protocols and enhancing patient outcomes in trauma care.

8.
Vascular ; : 17085381241254427, 2024 May 13.
Artigo em Inglês | MEDLINE | ID: mdl-38739928

RESUMO

OBJECTIVES: Blunt thoracic aortic injuries (BTAIs) involving the aortic arch are a challenging condition. Thoracic endovascular aortic repair (TEVAR) with fenestration, which expands the proximal landing zone, is able to exclude the injury while preserving blood flow in supra-aortic branches. METHODS: Here we report a case of TEVAR with fenestrations of all supra-aortic branches for traumatic aortic pseudoaneurysm and perform a systematic review. RESULTS: A 24-year-old man suffering a blunt thoracic injury and a left femoral fracture was sent to our hospital. A pseudoaneurysm was found in the aortic arch between the brachiocephalic artery and the left common carotid artery. The patient underwent emergent TEVAR with fenestrations of all supra-aortic branches, which excluded the pseudoaneurysm and preserved the patency of all branches. The orthopedic team then treated the femoral fracture. The patient's recovery was unremarkable. We performed a systematic review on TEVAR with fenestrations for BTAI. Six patients (75%) received TEVAR with single fenestration, 1 patient (12.5%) received TEVAR with two fenestrations, and 1 patient (12.5%) had fenestrations of all supra-aortic branches. Except one patient died in the perioperative, other patients survived without stent-related complications in the short-term follow-up. CONCLUSIONS: TEVAR with fenestration is feasible for treating BTAI involving the aortic arch in selected patients.

9.
Vascular ; : 17085381241254629, 2024 May 13.
Artigo em Inglês | MEDLINE | ID: mdl-38741044

RESUMO

INTRODUCTION: Blunt thoracic aortic injury (BTAI) represents one of the most devastating scenarios of vascular trauma which warrants prompt recognition with expedited management. Clinical manifestations of BTAI may not be straightforward to detect and may be misdiagnosed. Therefore, diagnosis of BTAI requires a high index of suspicion based on the mechanism of injury along with urgent transfer to centers with appropriate expertise and facilities. METHODS: We provide an expert-based narrative review on endovascular treatment of BTAI highlighting indications, techniques, results, and challenges. RESULTS: Multiple imaging modalities can be used including computed tomography angiography, transesophageal echocardiography, magnetic resonance imaging, and intravascular ultrasound. Whilst conservative pharmacological management can be a safe option in low-grade BTAI, thoracic endovascular aortic repair has become the gold-standard strategy in most cases, replacing open surgical repair. Nevertheless, it is important to account for patient demographics particularly age, severity of injury, choice of endograft including its type and size, and endovascular technique including landing zone and left subclavian artery revascularization. CONCLUSIONS: Overall, TEVAR in BTAI has been shown to be an efficacious strategy with favorable early outcomes. In contrast, less is known on the long-term clinical outcomes of TEVAR in BTAI. Hence, despite the optimal early technical and clinical success rates, concerns remain about the need for long-term surveillance. The exact timing of follow-up and the integration of different modalities that can also investigate potential downstream cardiovascular effects remain hot topics for future research. Finally, industry should focus on developing more compliant endografts to improve the stiffness mismatch between the endograft and the aorta to optimize results.

10.
Chin J Traumatol ; 2024 Aug 05.
Artigo em Inglês | MEDLINE | ID: mdl-39147675

RESUMO

Traumatic aortic injury (TAI) is an acute, critical, and severe disease, and then combined with multiple organ damage, it is even more dangerous. TAI progresses very rapidly, with a pre-hospital mortality rate of 57% - 80%, and even when arriving at the hospital, more than one-third of the patients die within 4 h, and it is the 2nd leading cause of death in individuals aged 4 - 34 years. In addition, the incidence of TAI combined with injury was 81.4%. Therefore, early diagnosis, expeditious surgery, and timely and effective multidisciplinary cooperation are essential for successful rescue. The authors report 2 patients with acute traumatic aortic dissection combined with multiple organ injuries and treated with emergency endovascular surgery to discuss their clinical characteristics and treatment experience, and to provide experience in the diagnosis and treatment of such patients.

11.
Chin J Traumatol ; 2024 Aug 05.
Artigo em Inglês | MEDLINE | ID: mdl-39179447

RESUMO

PURPOSE: To evaluate the relationship between the timing of thoracic endovascular aortic repair (TEVAR) for blunt thoracic aortic injury (BTAI) and prognosis. METHODS: This is a single-center retrospective cohort study. Patients who received TEVAR for BTAI at our institution from October 2016 to September 2023 were divided into 2 categories depending on the injury severity score (ISS) (≤ 25 vs. > 25) and when the TEVAR was performed for BTAI (within 24 h vs. after 24 h), respectively. The analysis included all patients who received TEVAR treatment after being diagnosed with BTAI through whole-body CT angiography. Patients treated with open repair and non-operative management were excluded. After propensity-score matching for various factors, outcomes during hospitalization and follow-up were compared. These factors included demographics, comorbidities, concomitant injuries, cause and location of aortic injury, Glasgow coma scale score, society for vascular surgery grading, hemoglobin concentration, creatinine concentration, shock, systolic blood pressure, and heart rate at admission. The comparison was conducted using SPSS 26 software. Continuous variables were presented as either the mean ± standard deviation or median (Q1, Q3), and were compared using either the t-test or the Mann-Whitney U test. Categorical variables were expressed as n (%), and comparisons were made between the 2 groups using the χ2 test or Fisher's exact test. Statistical significance was defined as a 2-sided p < 0.05. RESULTS: In total, 110 patients were involved in the study, with 65 (59.1%) patients having ISS scores > 25 and 32 (29.1%) receiving immediate TEVAR. The perioperative overall mortality rate in the group with ISS > 25 was significantly higher than that in the group with ISS ≤ 25 (11 (16.9%) vs. 2 (4.4%), p < 0.001). Upon admission, the elective group exhibited a notably higher Glasgow coma scale score (median (Q1, Q3)) compared to the immediate group (15 (12, 15) vs. 13.5 (9, 15), p = 0.039), while the creatinine concentration (median (Q1, Q3)) at admission was significantly higher in the immediate group (90.5 (63.8, 144.0) vs. 71.5 (58.3, 80.8), p = 0.012). The final sample included 52 matched patients. Complications occurred significantly less frequently in the elective group compared to the immediate group (16 (50.0%) vs. 3 (10.0%), p < 0.001). Single-factor analysis of variance showed that complications in hospitalized patients were significantly associated with immediate TEVAR as the sole independent risk factor (odds ratio: 9.000, 95% confidence interval: 2.266 - 35.752, p = 0.002). CONCLUSION: In this propensity-score matched analysis of patients undergoing TEVAR for BTAI, elective TEVAR was significantly associated with a lower risk of complication rates. In this study using propensity-score matching, patients who underwent elective TEVAR for BTAI had lower complication rates than immediate TEVAR.

12.
Circulation ; 146(24): e334-e482, 2022 12 13.
Artigo em Inglês | MEDLINE | ID: mdl-36322642

RESUMO

AIM: The "2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease" provides recommendations to guide clinicians in the diagnosis, genetic evaluation and family screening, medical therapy, endovascular and surgical treatment, and long-term surveillance of patients with aortic disease across its multiple clinical presentation subsets (ie, asymptomatic, stable symptomatic, and acute aortic syndromes). METHODS: A comprehensive literature search was conducted from January 2021 to April 2021, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through June 2022 during the guideline writing process, were also considered by the writing committee, where appropriate. Structure: Recommendations from previously published AHA/ACC guidelines on thoracic aortic disease, peripheral artery disease, and bicuspid aortic valve disease have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with aortic disease have been developed. There is added emphasis on the role of shared decision making, especially in the management of patients with aortic disease both before and during pregnancy. The is also an increased emphasis on the importance of institutional interventional volume and multidisciplinary aortic team expertise in the care of patients with aortic disease.


Assuntos
Doenças da Aorta , Doença da Válvula Aórtica Bicúspide , Cardiologia , Feminino , Humanos , Gravidez , American Heart Association , Doenças da Aorta/diagnóstico , Doenças da Aorta/terapia , Relatório de Pesquisa , Estados Unidos
13.
J Vasc Surg ; 78(1): 38-47.e2, 2023 07.
Artigo em Inglês | MEDLINE | ID: mdl-36931613

RESUMO

OBJECTIVES: Although the Society for Vascular Surgery (SVS) aortic injury grading system is used to depict the severity of injury in patients with blunt thoracic aortic injury, prior literature on its association with outcomes after thoracic endovascular aortic repair (TEVAR) is limited. METHODS: We identified patients undergoing TEVAR for BTAI within the VQI between 2013 and 2022. We stratified patients based on their SVS aortic injury grade (grade 1, intimal tear; grade 2, intramural hematoma; grade 3, pseudoaneurysm; and grade 4, transection or extravasation). We assessed perioperative outcomes and 5-year mortality using multivariable logistic and Cox regression analyses. Secondarily, we assessed the proportional trends in patients undergoing TEVAR based on SVS aortic injury grade over time. RESULTS: Overall, 1311 patients were included (grade1, 8%; grade 2, 19%; grade 3, 57%; grade 4, 17%). Baseline characteristics were similar, except for a higher prevalence of renal dysfunction, severe chest injury (Abbreviated Injury Score >3), and lower Glasgow Coma Scale with increasing aortic injury grade (Ptrend < .05). Rates of perioperative mortality by aortic injury grade were as follows: grade 1, 6.6%; grade 2, 4.9%; grade 3, 7.2%; and grade 4, 14% (Ptrend = .003) and 5-year mortality rates were 11% for grade 1, 10% for grade 2, 11% for grade 3, and 19% for grade 4 (P = .004). Patients with grade 1 injury had a high rate of spinal cord ischemia (2.8% vs grade 2, 0.40% vs grade 3, 0.40% vs grade 4, 2.7%; P = .008). After risk adjustment, there was no association between aortic injury grade and perioperative mortality (grade 4 vs grade 1, odds ratio, 1.3; 95% confidence interval, 0.50-3.5; P = .65), or 5-year mortality (grade 4 vs grade 1, hazard ratio, 1.1; 95% confidence interval, 0.52-2.30; P = .82). Although there was a trend for decrease in the proportion of patients undergoing TEVAR with a grade 2 BTAI (22% to 14%; Ptrend = .084), the proportion for grade 1 injury remained unchanged over time (6.0% to 5.1%; Ptrend = .69). CONCLUSIONS: After TEVAR for BTAI, there was higher perioperative and 5-year mortality in patients with grade 4 BTAI. However, after risk adjustment, there was no association between SVS aortic injury grade and perioperative and 5-year mortality in patients undergoing TEVAR for BTAI. More than 5% of patients with BTAI who underwent TEVAR had a grade 1 injury, with a concerning rate of spinal cord ischemia potentially attributable to TEVAR, and this proportion did not decrease over time. Further efforts should focus on enabling careful selection of patients with BTAI who will experience more benefit than harm from operative repair and preventing the inadvertent use of TEVAR in low-grade injuries.


Assuntos
Doenças da Aorta , Procedimentos Endovasculares , Isquemia do Cordão Espinal , Traumatismos Torácicos , Lesões do Sistema Vascular , Ferimentos não Penetrantes , Humanos , Correção Endovascular de Aneurisma , Aorta Torácica/diagnóstico por imagem , Aorta Torácica/cirurgia , Aorta Torácica/lesões , Resultado do Tratamento , Fatores de Tempo , Ferimentos não Penetrantes/diagnóstico por imagem , Ferimentos não Penetrantes/cirurgia , Traumatismos Torácicos/cirurgia , Lesões do Sistema Vascular/diagnóstico por imagem , Lesões do Sistema Vascular/cirurgia , Doenças da Aorta/cirurgia , Estudos Retrospectivos , Fatores de Risco
14.
J Vasc Surg ; 78(1): 48-52, 2023 07.
Artigo em Inglês | MEDLINE | ID: mdl-37088445

RESUMO

OBJECTIVE: Society for Vascular Surgery (SVS) recommendations for managing intimal (grade 1) blunt thoracic aortic injuries (BTAIs) include observation and medical management. University of Washington (UW) revised criteria suggest that intimal injuries with ≥1 cm flap should be upgraded to a moderate injury and treatment be considered. We sought to evaluate and compare SVS and UW criteria for BTAI and determine how discordance in grading affected treatment and outcome. METHODS: We reviewed all patients admitted with BTAI from January 1, 2011, to March 31, 2022. Data included injury grading, demographics, and concomitant traumatic injuries. Images were reviewed to categorize the injury with both grading systems. Treatment and outcomes were analyzed for concordant and discordant groups. RESULTS: Our cohort comprised 208 patients after excluding four who died upon arrival. The mean age was 45 ± 19 years, 69% were men, and the median injury severity score was 34 (interquartile range, 26-45). Strong agreement was observed between the grading systems (kappa = 0.88). All patients with concordant grade 1 injuries (n = 54) were observed. SVS grade 1/2 BTAIs were reclassified in 12 of 71 patients (16.9%). Two (28.6%) SVS grade 2 injuries were graded lower with the UW criteria; neither patient required immediate or delayed repair. Ten (15.6%) SVS grade 1 BTAIs were graded higher with UW criteria. Of these, six underwent repair (one for preoperative embolization), and four were observed without sequalae. Overall mortality was 7.7% with no difference for concordant or discordant grades (7.7% vs 8.3%; P = .99). No aneurysm-related mortalities were observed. Follow-up imaging was available for 94 survivors (49.0%) at a median of 193 days (interquartile range, 42-522 days). Two patients unrepaired at the index hospitalization (SVS grade 3/UW grade 2) underwent successful delayed repair. No patient observed for a minimal injury had BTAI progression or required treatment. CONCLUSIONS: The UW grading system may upgrade or downgrade SVS grade 1 or 2 BTAI for as many as one in six injuries. Upgraded injuries should prompt consideration of repair if there is evidence of flap progression or thromboembolic complications. Downgraded injuries suggest that treatment may not be necessary; clinical expertise is key to determine optimal management in these patients.


Assuntos
Procedimentos Endovasculares , Traumatismos Torácicos , Lesões do Sistema Vascular , Ferimentos não Penetrantes , Masculino , Humanos , Adulto , Pessoa de Meia-Idade , Feminino , Procedimentos Endovasculares/efeitos adversos , Resultado do Tratamento , Fatores de Risco , Lesões do Sistema Vascular/diagnóstico por imagem , Lesões do Sistema Vascular/cirurgia , Fatores de Tempo , Ferimentos não Penetrantes/diagnóstico por imagem , Ferimentos não Penetrantes/cirurgia , Traumatismos Torácicos/cirurgia , Aorta Torácica/diagnóstico por imagem , Aorta Torácica/cirurgia , Aorta Torácica/lesões , Estudos Retrospectivos
15.
J Vasc Surg ; 77(4): 997-1005, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36565777

RESUMO

OBJECTIVE: Prior literature has demonstrated worse outcomes for female patients after abdominal aortic aneurysm repair. Also, prior studies in the context of thoracic endovascular aneurysm repair (TEVAR) for thoracic aortic aneurysms have reported conflicting results regarding sex-related outcomes. Because the influence of sex on the outcomes after TEVAR for blunt thoracic aortic injuries (BTAIs) remains understudied, we evaluated the association between sex and outcomes after TEVAR for BTAI. METHODS: We identified patients who had undergone TEVAR for BTAIs in the Vascular Quality Initiative registry from 2013 to 2022 and included those who had undergone TEVAR within zones 2 to 5 of the thoracic aorta. Patients with missing information regarding the aortic injury grade (Society for Vascular Surgery aortic injury grading system) were excluded. We performed multivariable logistic regression and Cox regression to determine the influence of sex on the perioperative outcomes and long-term mortality, respectively. RESULTS: We identified 1311 patients, of whom 27% were female. The female patients were significantly older (female, 47 years [interquartile range (IQR), 30-63 years]; male, 38 years [IQR, 28-55 years]; P < .001) with higher rates of comorbidities. Although the female patients had had higher Glasgow coma scale scores (median, 15 [IQR, 11-15]; vs 14 [IQR, 8-15]; P = .028), no differences were found in the aortic injury grade or other coexisting traumatic injuries between the sexes. Apart from the longer procedure duration for the female patients (median, 79 minutes [IQR, 52-119 minutes]; vs 69 minutes [IQR, 48-106 minutes]; P = .008), the procedural characteristics were comparable. After adjustment, no significant association was found between female sex and perioperative mortality (7.1% vs 8.1%; odds ratio, 0.76; 95% confidence interval [CI], 0.43-1.3; P = .34). The male and female patients had had comparable rates of postoperative complications (26% vs 29%; odds ratio, 0.89; 95% CI: 0.52-1.5]; P = .26) including access-related complications (0.5% vs 0.8%; P=.83). However, females had a significantly higher risk for reintervention during the index admission (odds ratio, 2.5; 95% CI, 1.1-5.5; P = .024). No significant difference was found between the male and female patients with respect to 5-year mortality (hazard ratio, 0.87; 95% CI, 0.57-1.35; P = .50). CONCLUSIONS: Unlike the sex-based outcome disparities observed after thoracic aortic aneurysm repair, we found no significant association between sex and perioperative outcomes or long-term mortality after TEVAR for BTAIs. This contrast in the sex-related outcomes after other vascular pathologies might be explained by differences in the pathology, demographics, and anatomic factors in these patients.


Assuntos
Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Traumatismos Torácicos , Lesões do Sistema Vascular , Ferimentos não Penetrantes , Humanos , Masculino , Feminino , Correção Endovascular de Aneurisma , Fatores de Risco , Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/efeitos adversos , Resultado do Tratamento , Procedimentos Endovasculares/efeitos adversos , Mortalidade Hospitalar , Aorta Torácica/diagnóstico por imagem , Aorta Torácica/cirurgia , Aorta Torácica/lesões , Traumatismos Torácicos/diagnóstico por imagem , Traumatismos Torácicos/cirurgia , Ferimentos não Penetrantes/diagnóstico por imagem , Ferimentos não Penetrantes/cirurgia , Lesões do Sistema Vascular/diagnóstico por imagem , Lesões do Sistema Vascular/cirurgia , Estudos Retrospectivos
16.
Catheter Cardiovasc Interv ; 101(3): 668-675, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-36701398

RESUMO

OBJECTIVES: We review our experience with 13 periprocedural aortic dissection (AD) cases caused by transcatheter aortic valve replacement (TAVR). BACKGROUND: AD is a potentially lethal complication of TAVR; however, only sporadic case reports have been published to date. METHODS: Among 1335 consecutive patients who underwent TAVR in 2013-2021, we retrospectively extracted 13 patients (1.0%) with TAVR-related AD (Stanford type A in 6 [46%], type B in 7 [54%]). AD was defined as a new-onset dissected layer of the aortic wall and diagnosed by aortography, computed tomography, or transesophageal echocardiography. RESULTS: Five of the six type A AD cases (83%) were detected during TAVR versus only one of the seven type B AD cases (14%). Four of the seven type B AD cases (57%) were asymptomatic and incidentally detected on computed tomography. The presumed causes of AD were injury by the delivery sheath (39%), delivery catheter (23%), valve implantation (15%), stent edge (15%), and pre-dilation balloon (8%). Complicated AD occurred in only one patient (8%). Considering the patient's age and prohibitive surgical risk, all patients were treated conservatively and free of any aortic-related deaths or interventions during a follow-up of 1087 days. CONCLUSIONS: TAVR-related AD is a rare but life-threatening condition that may be underdiagnosed. Its optimal therapy remains unclear, and conservative management might be an option for selected patients. Further studies are needed to elucidate the incidence, risk factors, effective screening, optimal therapy, and outcomes of TAVR-related AD.


Assuntos
Dissecção Aórtica , Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Humanos , Dissecção Aórtica/diagnóstico por imagem , Dissecção Aórtica/etiologia , Dissecção Aórtica/cirurgia , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Estudos Retrospectivos , Fatores de Risco , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Resultado do Tratamento
17.
J Surg Res ; 284: 290-295, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36621259

RESUMO

INTRODUCTION: Penetrating thoracic aortic injuries (PTAI) represent a rare form of thoracic trauma. Unlike blunt thoracic aortic injuries (BTAI), only scarce data, included in small case series, are currently available for PTAI. The purpose of this study was to describe injury patterns, surgical management, and outcomes of patients with PTAI and compare to those with BTAI. MATERIALS AND METHODS: A 9-y retrospective cohort study (2007-2015) was conducted using the National Trauma Data Bank. Patient demographics, injury profile, procedures performed, and patient outcomes were compared between the PTAI and BTAI group. RESULTS: A total of 2714 patients with PTAI and 14,037 patients with BTAI were identified. Compared to BTAI, PTAI patients were younger (28 versus 42 y, P < 0.001), more often male (89.1% versus 71.7%, P < 0.001), and more likely to arrive without signs of life (27.6% versus 7.5%, P < 0.001). PTAI patients had less associated injuries, overall, compared to those with BTAI; however, were more likely to have injuries to the esophagus, diaphragm, and heart. Patients with PTAI were less likely to undergo endovascular (5.8% versus 30.5%, P < 0.001) or open surgical repair (3.0% versus 4.2%, P < 0.001) compared to BTAI. While the large majority of PTAI patients expired before their hospital arrival or in the emergency department, the in-hospital mortality rate among those who survivedemergency department stay was 43.1%. CONCLUSIONS: Most patients with PTAI present to the hospital without any signs of life, and their overall mortality rate is extremely high. Only a small portion of PTAI patients who survived the initial resuscitation period underwent surgical interventions for thoracic aortic injuries. Further studies are still warranted to clarify the indications and types of surgical interventions for PTAI.


Assuntos
Procedimentos Endovasculares , Traumatismos Torácicos , Lesões do Sistema Vascular , Ferimentos não Penetrantes , Humanos , Masculino , Procedimentos Endovasculares/métodos , Estudos Retrospectivos , Lesões do Sistema Vascular/epidemiologia , Lesões do Sistema Vascular/cirurgia , Aorta Torácica/cirurgia , Aorta Torácica/lesões , Traumatismos Torácicos/epidemiologia , Traumatismos Torácicos/cirurgia , Ferimentos não Penetrantes/diagnóstico , Ferimentos não Penetrantes/epidemiologia , Ferimentos não Penetrantes/cirurgia , Resultado do Tratamento
18.
J Endovasc Ther ; : 15266028231199036, 2023 Sep 20.
Artigo em Inglês | MEDLINE | ID: mdl-37728012

RESUMO

AIM: Blunt traumatic thoracic aortic injury (BTAI) is a highly fatal surgical emergency and is treated with endovascular procedures. We aimed to analyze and report the early and midterm outcomes of surgeon-modified fenestrated stent-grafts (SMFSG) compared with other conventional endovascular methods in patients with BTAI repaired with zone 2 endovascular surgery. MATERIALS AND METHODS: Before and after the study was performed, from January 2015 to January 2020 for a period in which conventional endovascular treatments were used and from January 2020 to January 2023 for the second period in which the SMFSG technique was used. A total of 25 patients who underwent zone 2 endovascular repair for BTAI were included. The patients treated with conventional endovascular methods in the first period, chimney thoracic endovascular aortic repair (TEVAR) (n=3 patients); Left subclavian artery (LSA)-covered (intentionally total) (n=12 patients) LSA-covered (LSAC) TEVAR; carotid-subclavian bypass TEVAR (n=2 patients) was defined as group 1, and the group of patients treated with SMFSG in the second period was defined as group 2. The primary endpoints of the study were technical success, defined as complete closure of BTAI, and in-hospital mortality. Secondary outcomes were aortic pathology-related morbidity, mortality, and re-interventions during the follow-up period. RESULTS: The mean age was 42.6±14.3 years, and 21 (84%) of the patients were male. The patients were compared with respect to the proximal landing zone, fluoroscopy time, duration of the procedure, length of intensive care unit stay, and hospital stay, no statistically significant difference was found between the 2 groups (p>0.05). The mean follow-up time of patients in group I was 46±9 months, while in group II, it was 14±6 months (p<0.001). While no TEVAR-related complications were detected in group II throughout follow-up, they occurred in 4 patients (28.6%) in group I. CONCLUSION: TEVAR is the most appropriate treatment for BTAI in the modern era, especially for polytrauma patients with successful outcomes. Intentional coverage of the LSA can be performed, but SMFSG is an effective, economical, rapid, and available technique for endovascular revascularization of the LSA. CLINICAL IMPACT: Altough intentional left subclavian artery coverage is preferred routinely in patients with blunt traumatic aortic injury (in Zone 2) which is a highly fatal surgical emergency, surgeon-modified fenestrated stent-grafts is also effective, economical, rapid and available technique.

19.
J Endovasc Ther ; 30(1): 151-155, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-35094606

RESUMO

PURPOSE: The purpose of the study was to demonstrate the feasibility of urgent endovascular treatment of a traumatic aortic isthmus rupture in a patient with an aberrant right subclavian artery. CASE REPORT: A 23-year-old man was admitted to a regional trauma center after a motor vehicle collision and found to have cerebral trauma and a large pseudoaneurysm of the aortic arch. Trauma computed tomography (CT) identified a blunt traumatic thoracic aortic injury with an aortic false aneurysm in the context of an aberrant right subclavian artery. A hybrid repair was performed with bilateral subclavian carotid bypasses and a double fenestrated physician-modified stent graft. The patient had an uneventful postoperative course. Postoperative CT scan showed sealing of the aortic arch rupture and patency of all the supra-aortic trunks. CONCLUSION: Endovascular repair of blunt traumatic thoracic aortic injury is considered first-line therapy. Aortic arch anomalies add complexity to treatment. This report demonstrates that a hybrid strategy with bilateral carotid-axillary bypasses and homemade double fenestrated endograft of the aortic arch is a valuable approach for this challenging emergency in the context of an aberrant right subclavian artery.


Assuntos
Aneurisma da Aorta Torácica , Ruptura Aórtica , Implante de Prótese Vascular , Procedimentos Endovasculares , Masculino , Humanos , Adulto Jovem , Adulto , Prótese Vascular , Implante de Prótese Vascular/métodos , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/cirurgia , Resultado do Tratamento , Desenho de Prótese , Procedimentos Endovasculares/métodos , Stents , Aorta Torácica/diagnóstico por imagem , Aorta Torácica/cirurgia , Ruptura Aórtica/diagnóstico por imagem , Ruptura Aórtica/etiologia , Ruptura Aórtica/cirurgia
20.
J Endovasc Ther ; : 15266028231187741, 2023 Jul 24.
Artigo em Inglês | MEDLINE | ID: mdl-37485662

RESUMO

PURPOSE: This study presents analytic techniques to quantify cardiac pulsatility-induced deformations of thoracic aortic endografts in patients with thoracic aortic aneurysm (TAA), dissection (TAD), and blunt thoracic aortic injury (BTAI) after thoracic endovascular aortic repair (TEVAR). TECHNIQUE: We analyzed 19 image data sets from 14 patients treated for TAA, TAD, and BTAI with cardiac-gated post-TEVAR CTs. Systolic and diastolic geometric models were constructed and diametric, axial, and bending deformations were quantified. For patients with cardiac-gated pre-op scans, the damping of pulsatile diametric distension was computed. Maximum localized diametric distension was 2.4±1.0%, 4.2±1.7%, and 5.5±1.6%, and axial deformation was 0.0±0.1%, -0.1±0.3%, and 1.1±0.6% in the endografts of TAA, TAD, and BTAI cohorts, respectively. Diametric distension damping from pre- to post-TEVAR was ~50%. Diametric and bending deformations were localized at certain axial positions on the endograft, and the inner curve bends more than the centerline, especially adjacent to overlapping regions. CONCLUSION: The presented techniques support investigation of multi-axial endograft deformations between disease causes and geometric locations on the device. Discretized quantification of deformation is needed to define device fatigue testing conditions and predict device durability in patients. CLINICAL IMPACT: This study demonstrates analytic techniques to quantify discretized deformation of thoracic endografts. Cardiac-resolved computed tomography is sometimes acquired for surgical planning and follow-up, however, the dynamic data are not typically used to quantify pulsatile deformations. Our analytic techniques extract the centerline and surface geometry of the stented thoracic aorta during the cardiac cycle, which are used to quantify diametric, axial, and bending deformations to provide better understanding of device durability and impact on the native anatomy.

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