RESUMO
BACKGROUND: A stent with characteristics of a hybrid design may have advantages in improving the patency of symptomatic iliofemoral vein obstruction. This study assessed the safety and effectiveness of the V-Mixtent Venous Stent in treating symptomatic iliofemoral outflow obstruction. METHODS: Eligible patients had a Clinical-Etiologic-Anatomic-Physiologic (CEAP) C classification of ≥ 3 or a Venous Clinical Severity Score (VCSS) pain score of ≥ 2. The primary safety endpoint was the rate of major adverse events within 30 days. The primary effectiveness endpoint was the 12-month primary patency rate. Secondary endpoints included changes in VCSS from baseline to 6 and 12 months, alterations in CEAP C classification, Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-14) scores at 12 months, and stent durability measures. RESULTS: Between December 2020 and November 2021, 171 patients were enrolled across 15 institutions. A total of 185 endovenous stents were placed, with 91.81% of subjects receiving one stent and 8.19% receiving 2 stents. Within 30 days, only two major adverse events occurred (1.17%; 95% confidence interval [CI], 0.14-4.16%), below the literature-defined performance goal of 11% (P < .001). The 12-month primary patency rate (91.36%; 95% CI, 85.93-95.19%; P < .001) exceeded the literature-defined performance goal. VCSS changes from baseline demonstrated clinical improvement at 6 months (- 4.30 ± 3.66) and 12 months (- 4.98 ± 3.67) (P < .001). Significant reduction in symptoms, as measured by CEAP C classification and CIVIQ-14, was observed from pre-procedure to 12 months (P < .001). CONCLUSIONS: The 12-month outcomes confirm the safety and effectiveness of the V-Mixtent Venous Stent in managing symptomatic iliofemoral venous outflow obstruction, including clinical symptom improvement compared to before treatment.
Assuntos
Veia Femoral , Veia Ilíaca , Stents , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Estudos Prospectivos , Veia Femoral/cirurgia , Veia Ilíaca/cirurgia , Resultado do Tratamento , Adulto , Idoso , Qualidade de VidaRESUMO
BACKGROUND: Heart disease and chronic kidney disease are often comorbid conditions owing to shared risk factors, including diabetes and hypertension. However, the effect of congestive heart failure (CHF) on arteriovenous fistula (AVF) and AV graft (AVG) patency rates is poorly understood. We hypothesize preexisting HF may diminish blood flow to the developing AVF and worsen patency. METHODS: We conducted a single-institution retrospective review of 412 patients with end-stage renal disease who underwent hemodialysis access creation from 2015 to 2021. Patients were stratified based on presence of preexisting CHF, defined as clinical symptoms plus evidence of reduced left ventricular ejection fraction (EF) (<50%) or diastolic dysfunction on preoperative echocardiography. Baseline demographics, preoperative measures of cardiac function, and dialysis access-related surgical history were collected. Kaplan-Meier time-to-event analyses were performed for primary patency, primary-assisted patency, and secondary patency using standard definitions for patency from the literature. We assessed differences in patency for patients with CHF vs patients without CHF, patients with a reduced vs a normal EF, and AVG vs AVF in patients with CHF. RESULTS: We included 204 patients (50%) with preexisting CHF with confirmatory echocardiography. Patients with CHF were more likely to be male and have comorbidities including, diabetes, chronic obstructive pulmonary disease, hypertension, and a history of cerebrovascular accident. The groups were not significantly different in terms of prior fistula history (P = .99), body mass index (P = .74), or type of hemodialysis access created (P = .54). There was no statistically significant difference in primary patency, primary-assisted patency, or secondary patency over time in the CHF vs non-CHF group (log-rank P > .05 for all three patency measures). When stratified by preoperative left ventricular EF, patients with an EF of <50% had lower primary (38% vs 51% at 1 year), primary-assisted (76% vs 82% at 1 year), and secondary patency (86% vs 93% at 1 year) rates than those with a normal EF. Difference reached significance for secondary patency only (log-rank P = .029). AVG patency was compared against AVF patency within the CHF subgroup, with significantly lower primary-assisted (39% vs 87% at 1 year) and secondary (62% vs 95%) patency rates for AVG (P < .0001 for both). CONCLUSIONS: In this 7-year experience of hemodialysis access creation, reduced EF is associated with lower secondary patency. Preoperative CHF (including HF with reduced EF and HF with preserved EF together) is not associated with significant differences in overall hemodialysis access patency rates over time, but patients with CHF who receive AVG have markedly worse patency than those who receive AVF. For patients with end-stage renal disease and CHF, the risks and benefits must be carefully weighed, particularly for those with low EF or lack of a suitable vein for fistula creation.
Assuntos
Derivação Arteriovenosa Cirúrgica , Diabetes Mellitus , Fístula , Insuficiência Cardíaca , Hipertensão , Falência Renal Crônica , Humanos , Masculino , Feminino , Derivação Arteriovenosa Cirúrgica/efeitos adversos , Volume Sistólico , Oclusão de Enxerto Vascular/diagnóstico por imagem , Oclusão de Enxerto Vascular/etiologia , Oclusão de Enxerto Vascular/terapia , Grau de Desobstrução Vascular , Função Ventricular Esquerda , Falência Renal Crônica/complicações , Falência Renal Crônica/diagnóstico , Falência Renal Crônica/terapia , Diálise Renal/efeitos adversos , Insuficiência Cardíaca/etiologia , Fístula/complicações , Hipertensão/etiologia , Estudos Retrospectivos , Resultado do TratamentoRESUMO
OBJECTIVE: Primary arteriovenous access such as radiocephalic and brachiocephalic fistulas are initial choices for creating vascular access in dialysis patients. When neither of these choices is an option, upper arm arteriovenous graft or brachiobasilic transposition is recommended. Although primary fistula is better than prosthetic graft for suitable patients, there is little data to guide the best treatment strategy in the absence of suitable vein for primary access creation. This study identifies factors that influence patency rates and compares outcomes of patients treated with brachiobasilic fistula vs upper arm graft in patients who have failed forearm access or are not candidates for primary access. METHODS: A prospectively maintained database of patients with dialysis-dependent renal failure from 2010 to 2022 was analyzed. Primary, primary assisted, and secondary patency rates were calculated. Incidence rates of complications and reinterventions were compared. RESULTS: There were 148 patients with brachiobasilic fistulas and 157 patients with upper arm grafts. The graft group was older (70.1 ± 14.7 vs 62.5 ± 14.6 years; P = .003) and had a higher incidence of pacemakers (11.9% vs 4.1%; P = .005). Brachiobasilic fistulas had higher 6-month (77.0% vs 64.3%; P = .02) and 1-year (68.2% vs 55.4%; P = .03) primary-assisted patency. Secondary patency rates were better for upper arm grafts at 1-year (82.2% vs 72.3%; P = .05). Access complications of non-maturation and aneurysm were higher in basilic vein transposition (21.6% vs 1.3%; P < .0001; 15.5% vs 6.4%; P = .017). Grafts had higher rates of occlusion (58.0% vs 25.7%; P < .0001). In terms of interventions, upper arm grafts had higher rates of thrombectomy (50.3% vs 18.9%; P < .0001), but there was no difference seen in angioplasty, stent, surgical revision, or steal procedures. Basilic vein transpositions had longer time to cannulation (104.6 ± 81.1 vs 32.5 ± 22.4 days; P < .0001), longer total catheter days (251.1 ± 181.7 vs 72.9 ± 56.3 days; P < .0001), and higher number of procedures to aid maturity (0.7 ± 0.7 vs 0.1 ± 0.3; P < .0001). CONCLUSIONS: In this retrospective analysis, when forearm access or primary arteriovenous access is not an option, basilic vein transposition and upper arm grafts have fairly equivalent primary patency. Primary assisted patency is slightly better in basilic vein fistulas, but secondary patency is better in upper arm grafts at 1 year. Basilic fistulas also had longer time to cannulation, longer total catheter days, and more procedures to aid maturity.
Assuntos
Derivação Arteriovenosa Cirúrgica , Implante de Prótese Vascular , Prótese Vascular , Artéria Braquial , Bases de Dados Factuais , Oclusão de Enxerto Vascular , Diálise Renal , Extremidade Superior , Grau de Desobstrução Vascular , Humanos , Derivação Arteriovenosa Cirúrgica/efeitos adversos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Fatores de Tempo , Extremidade Superior/irrigação sanguínea , Estudos Retrospectivos , Resultado do Tratamento , Oclusão de Enxerto Vascular/etiologia , Oclusão de Enxerto Vascular/fisiopatologia , Oclusão de Enxerto Vascular/cirurgia , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/instrumentação , Artéria Braquial/cirurgia , Artéria Braquial/fisiopatologia , Fatores de Risco , Idoso de 80 Anos ou maisRESUMO
OBJECTIVE: Vascular access is difficult in patients without suitable arm veins and prior graft infections. The use of femoral vein translocation (FVT) to the upper extremity or contralateral lower extremity for hemodialysis access may be associated with low infection rates and high patency rates. FVT is used for patients without central venous occlusion who have failed prior access either owing to graft infection or repetitive graft thrombosis. The largest case series consists of 30 cases. The objective of this study is to determine the infection incidence, primary patency, primary-assisted patency, and secondary patency rates among FVTs. METHODS: A retrospective chart review was performed on all patients who underwent FVT by a single vascular practice over a 10-year period (2013-2023). Study variables included length to last follow-up (months), prior access, prior graft infection, comorbid conditions, primary patency, primary-assisted patency, secondary patency, postoperative steal syndrome, postoperative graft infection, postoperative harvest site complication, and postoperative lower extremity compartment syndrome. RESULTS: A total of 131 FVTs were performed from 2013 to 2023; 126 patients (47% male, 53% female; 76% Black, 24% White) with a mean age of 52 ± 14 years and a mean body mass index of 29 ± 8 had at least 1 month of follow-up and were included for analysis. The median follow-up was 46 months (interqurtile range, 19-72 months). The mean number of prior permanent accesses was 2.5 ± 1.4. Forty-eight percent of patients had prior graft infections. The primary, primary-assisted, and secondary patency rates were 66%, 93%, and 98%, respectively, at 6 months; 43%, 85%, and 96% at 12 months; 25%, 70%, and 92% at 24 months; 16%, 61%, and 88% at 36 months; and 14%, 56%, and 82% at 48 months. Postoperative steal syndrome and postoperative access infection requiring excision was observed 16% and 5% of patients, respectively. Harvest site complications requiring an additional procedure occurred in 19% of cases. Three patients developed lower extremity compartment syndrome postoperatively, requiring fasciotomy. Six patients developed chronic lower extremity edema after femoral vein harvest. The mean procedure time and hospital length of stay were 197 ± 40 minutes and 3.5 ± 2.8 days, respectively. CONCLUSIONS: FVT is associated with low infection rates and high long-term patency rates. Significant postoperative complications include steal syndrome and harvest site complications. FVT remains a viable option for patients who have failed prior access owing to graft infection or repetitive graft thrombosis.
Assuntos
Derivação Arteriovenosa Cirúrgica , Implante de Prótese Vascular , Veia Femoral , Diálise Renal , Grau de Desobstrução Vascular , Humanos , Masculino , Feminino , Estudos Retrospectivos , Pessoa de Meia-Idade , Veia Femoral/cirurgia , Derivação Arteriovenosa Cirúrgica/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Adulto , Idoso , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/instrumentação , Fatores de Risco , Infecções Relacionadas à Prótese/cirurgia , Infecções Relacionadas à Prótese/microbiologia , Infecções Relacionadas à Prótese/etiologia , Extremidade Superior/irrigação sanguínea , Oclusão de Enxerto Vascular/etiologia , Oclusão de Enxerto Vascular/fisiopatologia , Oclusão de Enxerto Vascular/epidemiologiaRESUMO
OBJECTIVE: Complex endovascular procedures are now recognized as the gold standard treatments for extensive aortic diseases. Bridging stents (covered stents used to couple the aortic graft to the visceral vessels) play a pivotal role, yet there is currently no dedicated device available on the market. The aim of the study was to evaluate the midterm performance of the Gore Viabahn balloon-expandable (VBX) stent graft as a bridging stent for target visceral vessels (TVVs). METHODS: Data from all consecutive patients who underwent a fenestrated and branched endovascular aortic repair and received the VBX stent graft as a bridging stent between July 2018 and September 2022 were prospectively collected and subsequently analyzed retrospectively. Primary end points included freedom from TVV instability and freedom from TVV-related reinterventions, both overall and in comparison between branched and fenestrated graft configurations. Secondary end points were overall survival, procedure and TVV-related (in an intent-to-treat basis) technical success, freedom from type IC/IIIC endoleak, and freedom from TVV patency loss. RESULTS: Sixty-three patients were treated with a fenestrated and branched endovascular aortic repair using the VBX stent graft as a bridging stent, of whom 47 (74.6%) presented an atherosclerotic aneurysm, 7 (11.1%) a post-dissecative aneurysm, and 9 (14.3%) an anastomotic pseudoaneursym or a type IA endoleak in a previous endovascular aortic repair. Included in the aortic repair were 231 of 243 (95.1%) total visceral vessels. The intraoperative requirement of 13 additional VBX stent grafts determined a TVV-related technical success of 94.4%. The mean follow-up was 26.1 ± 16.4 months. The estimated overall survival at 36 months was 73% ± 7.5%. The estimated rates at 36 months for freedom from type IC/IIIC endoleaks and TVV primary patency were 90.6% ± 3.9% and 99% ± 0.7%, respectively. The estimated rate at 36 months for freedom from TVV instability was 92.1% ± 3% and did not differ between branched and fenestrated configurations, whereas freedom from TVV-related reinterventions was 90.6% ± 3.1% and significantly in favor of fenestrations (69.4% vs 96.8%, P < .001). Multivariate analyses confirmed fenestrated configuration as a protective factor against TVV-related reinterventions (hazard ratio: 0.079; 95% confidence interval: 0.016-0.403). CONCLUSIONS: The VBX stent graft proves to be a reliable bridging stent for complex aortic procedures involving both fenestrated and branched endografts. Although immediate results are deemed satisfactory, they favor fenestrations regarding the need of reinterventions through 3 years. The success of the procedure heavily relies on a thorough understanding of the unique characteristics of this stent.
RESUMO
OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) has been used extensively in the management of thoracic aortic diseases. Numerous efforts have been made to enhance clinical outcomes through the use of stent grafts. This study aimed to investigate the effectiveness and safety of physician-manufactured partial micropore stent grafts (PSMGs) in TEVAR. METHODS: Between December 2017 and June 2022, data were collected from 56 patients who underwent TEVAR using physician-manufactured PSMGs. The evaluation encompassed technical success, perioperative and follow-up morbidity and mortality, stroke incidence, and branch artery patency. RESULTS: In this investigation, 56 patients received treatment with physician-manufactured PSMGs. Of these patients, 46 were male, with a mean age of 62.1 ± 11.2 years. Aortic pathologies comprised aortic dissection (n = 31 [55.4%]), aortic aneurysms (n = 10 [17.9%]), penetrating aortic ulcer (n = 8 [14.3%]), and intramural hematoma (n = 7 [12.5%]). During a median follow-up of 18 months (interquartile range, 13-25 months), the stroke rate, supra-aortic branch patency rate, and endoleak rate were 0%, 100%, and 7.1%, respectively. There were no occurrences of all-cause mortality, stroke, or the necessity for open conversion. CONCLUSIONS: TEVAR with physician-manufactured PSMGs is a viable alternative for addressing aortic arch pathologies in proficient medical centers. The approach demonstrates favorable branch patency, a low complication rate, and minimal postoperative mortality.
Assuntos
Aneurisma da Aorta Torácica , Implante de Prótese Vascular , Procedimentos Endovasculares , Acidente Vascular Cerebral , Humanos , Masculino , Pessoa de Meia-Idade , Idoso , Feminino , Aorta Torácica/diagnóstico por imagem , Aorta Torácica/cirurgia , Prótese Vascular , Correção Endovascular de Aneurisma , Implante de Prótese Vascular/efeitos adversos , Stents/efeitos adversos , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/cirurgia , Aneurisma da Aorta Torácica/etiologia , Resultado do Tratamento , Procedimentos Endovasculares/efeitos adversos , Desenho de Prótese , Fatores de Tempo , Estudos Retrospectivos , Acidente Vascular Cerebral/etiologiaRESUMO
OBJECTIVE: Some studies suggest that regional anesthesia provides better patency for arteriovenous fistula (AVF) for hemodialysis access as compared to local and general anesthesia. This study evaluates the impact of anesthetic modality on long term fistula function at 12 months. METHODS: A retrospective review of patients undergoing cephalic vein-based hemodialysis access in consecutive cases between 2014 and 2019 was conducted from five safety net hospitals. The primary endpoint was functional patency at 12 months. Subset analysis individually evaluated cephalic-based lower forearm and wrist vs upper arm AVFs. Bivariate and multivariate logistic regression models evaluated the relationship between anesthetic modality and fistula function at 12 months. RESULTS: There were 818 cephalic-based fistulas created during the study period. The overall 12-month functional patency rate was 78.7%, including an 81.3% patency for upper arm AVF and 73.3% for wrist AVF (P = .009). There was no statistically significant difference among patients with functional and nonfunctional AVFs at 12 months with respect to anesthetic modality when comparing regional, local, and general anesthesia (P = .343). Multivariate regression analysis identified that history of AVF/arteriovenous graft (odds ratio [OR], 0.24; P = .007), receiving intraoperative systemic anticoagulation (OR, 2.49; P < .001), and vein diameter (OR, 1.85; P = .039) as independently associated with AVF functional patency at 12 months. CONCLUSIONS: There was no association between anesthetic modality and functional patency of cephalic-based AVFs at 12 months. Further studies are needed to better define which patients may benefit from regional anesthesia.
Assuntos
Anestesia Geral , Derivação Arteriovenosa Cirúrgica , Diálise Renal , Grau de Desobstrução Vascular , Humanos , Derivação Arteriovenosa Cirúrgica/efeitos adversos , Estudos Retrospectivos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Fatores de Tempo , Resultado do Tratamento , Fatores de Risco , Anestesia Geral/efeitos adversos , Anestesia por Condução , Anestesia Local , Extremidade Superior/irrigação sanguínea , Oclusão de Enxerto Vascular/fisiopatologia , Oclusão de Enxerto Vascular/etiologia , Oclusão de Enxerto Vascular/terapia , Medição de Risco , Veias/fisiopatologia , Veias/cirurgia , Veias/diagnóstico por imagemRESUMO
BACKGROUND: Covered endovascular reconstruction of aortic bifurcation (CERAB) is increasingly used as a first line-treatment in patients with aortoiliac occlusive disease (AIOD). We sought to compare the outcomes of patients who underwent CERAB compared with the gold standard of aortobifemoral bypass (ABF). METHODS: The Vascular Quality Initiative was queried for patients who underwent ABF or CERAB from 2009 to 2021. Propensity scores were generated using demographics, comorbidities, Rutherford class, and urgency. The two groups were matched using 5-to-1 nearest-neighbor match. Our primary outcomes were 1-year estimates of primary patency, major adverse limb events (MALEs), MALE-free survival, reintervention-free survival, and amputation-free survival. Standard statistical methods were used. RESULTS: A total of 3944 ABF and 281 CERAB cases were identified. Of all patients with AIOD, the proportion of CERAB increased from 0% to 17.9% between 2009 and 2021. Compared with ABF, patients who underwent CERAB were more likely to be older (64.7 vs 60.2; P < .001) and more often had diabetes (40.9% vs 24.1%; P < .001) and end-stage renal disease (1.1% vs 0.3%; P = .03). In the matched analysis (229 CERAB vs 929 ABF), ABF patients had improved MALE-free survival (93.2% [±0.9%] vs 83.2% [±3%]; P < .001) and lower rates of MALE (5.2% [±0.9%] vs 14.1% [±3%]; P < .001), with comparable primary patency rates (98.3% [±0.3%] vs 96.6% [±1%]; P = .6) and amputation-free survival (99.3% [±0.3%] vs 99.4% [±0.6%]; P = .9). Patients in the CERAB group had significantly lower reintervention-free survival (62.5% [±6%] vs 92.9% [±0.9%]; P < .001). Matched analysis also revealed shorter length of stay (1 vs 7 days; P < .001), as well as lower pulmonary (1.2% vs 6.6%; P = .01), renal (1.8% vs 10%; P < .001), and cardiac (1.8% vs 12.8%; P < .001) complications among CERAB patients. CONCLUSIONS: CERAB had lower perioperative morbidity compared with ABF with a similar primary patency 1-year estimates. However, patients who underwent CERAB experienced more major adverse limb events and reinterventions. Although CERAB is an effective treatment for patients with AIOD, further studies are needed to determine the long-term outcomes of CERAB compared with the established durability of ABF and further define the role of CEARB in the treatment of AIOD.
Assuntos
Doenças da Aorta , Implante de Prótese Vascular , Procedimentos Endovasculares , Artéria Femoral , Salvamento de Membro , Grau de Desobstrução Vascular , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Estudos Retrospectivos , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/mortalidade , Doenças da Aorta/cirurgia , Doenças da Aorta/diagnóstico por imagem , Doenças da Aorta/mortalidade , Doenças da Aorta/fisiopatologia , Artéria Femoral/cirurgia , Artéria Femoral/fisiopatologia , Artéria Femoral/diagnóstico por imagem , Fatores de Tempo , Fatores de Risco , Amputação Cirúrgica , Artéria Ilíaca/cirurgia , Artéria Ilíaca/fisiopatologia , Artéria Ilíaca/diagnóstico por imagem , Medição de Risco , Arteriopatias Oclusivas/cirurgia , Arteriopatias Oclusivas/fisiopatologia , Arteriopatias Oclusivas/diagnóstico por imagem , Arteriopatias Oclusivas/mortalidade , Prótese Vascular , Resultado do Tratamento , Bases de Dados Factuais , Complicações Pós-Operatórias/etiologiaRESUMO
OBJECTIVE: The aim of this study was to evaluate the 5-year outcomes of fenestrated/branched endovascular aortic repair (F/BEVAR) for the treatment of complex aortic aneurysms stratified by the aneurysm extent. METHODS: Patients with the diagnosis of complex aortic aneurysm, who underwent F/BEVAR at a single center were included in this study and retrospectively analyzed. The cohort was divided according to the aneurysm extent, comparing group 1 (types I-III thoracoabdominal aneurysms [TAAAs]), group 2 (type IV TAAAs), and group 3 (juxtarenal [JRAAs], pararenal [PRAAs], or paravisceral [PVAAs] aortic aneurysms). The primary endpoints were 30-day and 5-year survival. The secondary endpoints were technical success, occurrence of spinal cord ischemia, primary patency of the visceral arteries, freedom from target vessel instability, and secondary interventions. RESULTS: Of 436 patients who underwent F/BEVAR between July 2012 and May 2023, 131 presented with types I to III TAAAs, 69 with type IV TAAAs, and 236 with JRAAs, PRAAs, or PVAAs. All cases were treated under a physician-sponsored investigational device exemption protocol with a patient-specific company-manufactured or off-the-shelf device. Group 1 had significantly younger patients than group 2 or 3 respectively (69.6 ± 8.7 vs 72.4 ± 7.1 vs 73.2 ± 7.3 years; P < .001) and had a higher percentage of females (50.4% vs 21.7% vs 17.8%; P < .001). Prior history of aortic dissection was significantly more common among patients in group 1 (26% vs 1.4% vs 0.9%; P < .001), and mean aneurysm diameter was larger in group 1 (64.5 vs 60.7 vs 63.2 mm; P = .033). Comorbidities were similar between groups, except for coronary artery disease (P < .001) and tobacco use (P = .003), which were less prevalent in group 1. Technical success was similar in the three groups (98.5% vs 98.6% vs 98.7%; P > .99). The 30-day mortality was 4.5%, 1.4%, and 0.4%, in groups 1, 2, and 3, respectively, and was significantly higher in group 1 when compared with group 3 (P = .01). The incidence of spinal cord ischemia was significantly higher in group 1 compared with group 3 (5.3% vs 4.3% vs 0.4%; P = .004). The 5-year survival was significantly higher in group 3 when compared with group 1 (P = .01). Freedom from secondary intervention was significantly higher in group 3 when compared with group 1 (P = .003). At 5 years, there was no significant difference in freedom from target vessel instability between groups or primary patency in the 1652 target vessels examined. CONCLUSIONS: Larger aneurysm extent was associated with lower 5-year survival, higher 30-day mortality, incidence of secondary interventions, and spinal cord ischemia. The prevalence of secondary interventions in all groups makes meticulous follow-up paramount in patients with complex aortic aneurysm treated with F/BEVAR.
Assuntos
Aneurisma da Aorta Torácica , Implante de Prótese Vascular , Prótese Vascular , Procedimentos Endovasculares , Complicações Pós-Operatórias , Humanos , Feminino , Estudos Retrospectivos , Masculino , Procedimentos Endovasculares/instrumentação , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Idoso , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/instrumentação , Implante de Prótese Vascular/mortalidade , Fatores de Tempo , Aneurisma da Aorta Torácica/cirurgia , Aneurisma da Aorta Torácica/mortalidade , Aneurisma da Aorta Torácica/diagnóstico por imagem , Fatores de Risco , Idoso de 80 Anos ou mais , Complicações Pós-Operatórias/etiologia , Desenho de Prótese , Pessoa de Meia-Idade , Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/mortalidade , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Resultado do Tratamento , Stents , Medição de RiscoRESUMO
OBJECTIVE: The aim of this study was to evaluate the effect of fenestration configuration and fenestration gap on renal artery outcomes during fenestrated-branched endovascular aortic repair (F/BEVAR). METHODS: A retrospective multicenter analysis was performed, including patients with complex aortic aneurysms treated with F/BEVAR that incorporated at least one small fenestration to a renal artery. The renal fenestrations were divided into groups 1 (8 × 6 mm) and 2 (6 × 6 mm). Primary patency, target vessel instability (TVI), freedom from secondary interventions (SIs), occurrence of type IIIc endoleak, all related to the renal arteries, were analyzed at 30-day, 1-year, and 5-year landmarks. The fenestration gap (FG) distance was analyzed as a modifier, and clustering was addressed at the patient level. RESULTS: A total of 796 patients were included in this study, 71.7% male, with a mean age of 73.3 ± 8.1 years. The mean follow-up was 30.0 ± 20.6 months. Of the 1474 small renal fenestrations analyzed, 47.6% were 8 × 6 mm, and 52.4% were 6 × 6 mm. At the 30-day landmark, primary patency (99.9% vs 98.0%; P value < .001 for groups 1 and 2, respectively), freedom from TVI (99.6% vs 97.1%; P value < .001 for groups 1 and 2, respectively), and freedom from SI (99.8% vs 98.4%; P value = .022 for groups 1 and 2, respectively) were higher in 8 × 6 compared with 6 × 6 fenestrations, and the incidence of acute kidney injury was similar across the groups (92.6% vs 92.7%; P value = .953 for groups 1 and 2 respectively). The primary patency at 1 and 5 years was higher in 8 × 6 fenestrations (1-year: 98.8% vs 96.9%; 5-year: 97.8% vs 95.7%, for groups 1 and 2, respectively, P values = .010 and .021 for 1 and 5 year comparisons, respectively). The freedom from SIs was significantly higher among 6 × 6 fenestrations at 5 years (93.1% vs 96.4%, for groups 1 and 2, respectively, P value = .007). The groups were equally as likely to experience a type Ic endoleak (1.3% and 1.6% for 8 × 6 and 6 × 6mm fenestrations, respectively, P = .689). The 6 × 6 fenestrations were associated with higher risk of kidney function deterioration (17.8%) when compared with 8 × 6 fenestrations (7.6%) at 5 years (P < .001). The risk of type IIIc endoleak was significantly higher among 8 × 6 fenestrations at 5 years (4.9% and 2% for 8 × 6 and 6 × 6 mm fenestrations, respectively; P = .005). A FG ≥5 mm negatively impacted the cumulative 5-year freedom from TVI (group 1: FG ≥5 mm = 0.714, FG <5 mm = 0.857; P < .001; group 2: FG ≥5 mm = 0.761, FG <5 mm = 0.929; P < .001) and the cumulative 5-year freedom from type IIIc endoleak (group 1: FG ≥5 mm = 0.759, FG <5 mm = 0.921; P = .034; group 2: FG ≥5 mm = 0.853, FG <5 mm = 0.979; P < .001) in both groups and the cumulative 5-year patency in group 2 (group 1: FG ≥5 mm = 0.963, FG <5 mm = 0.948; P = .572; group 2: FG ≥5 mm = 0.905, FG <5 mm = 0.938; P = .036). CONCLUSIONS: Fenestration configuration for the renal arteries impacts outcomes. The 8 × 6 small fenestrations have better patency at 30 days, 1 year, and 5 years, whereas 6 × 6 small fenestrations are associated with lower rates of SIs, primarily due to a lower incidence of type IIIc endoleaks. FG ≥5 mm at the level of the renal arteries significantly impacts the freedom from TVI, freedom from type IIIc endoleak, and 5-year patency independently of the fenestration size or vessel diameter.
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Implante de Prótese Vascular , Prótese Vascular , Procedimentos Endovasculares , Desenho de Prótese , Artéria Renal , Grau de Desobstrução Vascular , Humanos , Masculino , Estudos Retrospectivos , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Feminino , Idoso , Artéria Renal/cirurgia , Artéria Renal/diagnóstico por imagem , Artéria Renal/fisiopatologia , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/instrumentação , Fatores de Tempo , Idoso de 80 Anos ou mais , Fatores de Risco , Endoleak/etiologia , Endoleak/prevenção & controle , Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/fisiopatologia , Resultado do Tratamento , Stents , Medição de Risco , Correção Endovascular de AneurismaRESUMO
STUDY QUESTION: Does hysterosalpingo-foam sonography (HyFoSy) prior to hysterosalpingography (HSG) or HSG prior to HyFoSy affect visible tubal patency when compared HSG or HyFoSy alone? SUMMARY ANSWER: Undergoing either HyFoSy or HSG prior to tubal patency testing by the alternative method does not demonstrate a significant difference in visible tubal patency when compared to HyFoSy or HSG alone. WHAT IS KNOWN ALREADY: HyFoSy and HSG are two commonly used visual tubal patency tests with a high and comparable diagnostic accuracy for evaluating tubal patency. These tests may also improve fertility, although the underlying mechanism is still not fully understood. One of the hypotheses points to a dislodgment of mucus plugs that may have disrupted the patency of the Fallopian tubes. STUDY DESIGN, SIZE, DURATION: This is a secondary analysis of the randomized controlled FOAM study, in which women underwent tubal patency testing by HyFoSy and HSG, randomized for order of the procedure. Participants either had HyFoSy first and then HSG, or vice versa. Here, we evaluate the relative effectiveness of tubal patency testing by HyFoSy or HSG prior to the alternative tubal patency testing method on visible tubal patency, compared to each method alone. PARTICIPANTS/MATERIALS, SETTING, METHODS: Infertile women aged between 18 and 41 years scheduled for tubal patency testing were eligible for participating in the FOAM study. Women with anovulatory cycles, endometriosis, or with a partner with male infertility were excluded. To evaluate the effect HyFoSy on tubal patency, we relied on HSG results by comparing the proportion of women with bilateral tubal patency visible on HSG in those who underwent and who did not undergo HyFoSy prior to their HSG (HyFoSy prior to HSG versus HSG alone). To evaluate the effect of HSG on tubal patency, we relied on HyFoSy results by comparing the proportion of women with bilateral tubal patency visible on HyFoSy in those who underwent and who did not undergo HSG prior to their HyFoSy (HSG prior to HyFoSy versus HyFoSy alone). MAIN RESULTS AND THE ROLE OF CHANCE: Between May 2015 and January 2019, we randomized 1160 women (576 underwent HyFoSy first followed by HSG, and 584 underwent HSG first followed by HyFoSy). Among the women randomized to HyFoSy prior to HSG, bilateral tubal patency was visible on HSG in 467/537 (87%) women, compared with 472/544 (87%) women who underwent HSG alone (risk difference 0.2%; 95% CI: -3.8% to 4.2%). Among the women randomized to HSG prior to HyFoSy, bilateral tubal patency was visible on HyFoSy in 394/471 (84%) women, compared with 428/486 (88%) women who underwent HyFoSy alone (risk difference -4.4%; 95% CI: -8.8% to 0.0%). LIMITATIONS, REASONS FOR CAUTION: The results of this secondary analysis should be interpreted as exploratory and cannot be regarded as definitive evidence. Furthermore, it has to be noted that pregnancy outcomes were not considered in this analysis. WIDER IMPLICATIONS OF THE FINDINGS: Tubal patency testing by either HyFoSy or HSG, prior to the alternative tubal patency testing method does not significantly affect visible tubal patency, when compared to alternative method alone. This suggests that both methods may have comparable abilities to dislodge mucus plugs in the Fallopian tubes. STUDY FUNDING/COMPETING INTEREST(S): The FOAM study was an investigator-initiated study, funded by ZonMw, a Dutch organization for Health Research and Development (project number 837001504). IQ Medical Ventures provided the ExEm®-FOAM kits free of charge. The funders had no role in study design, collection, analysis, or interpretation of the data. H.R.V. reports consultancy fees from Ferring. M.v.W. received a travel grant from Oxford University Press in the role of Deputy Editor for Human Reproduction and participates in a Data Safety and Monitoring Board as an independent methodologist in obstetrics studies in which she has no other role. M.v.W. is coordinating editor of Cochrane Fertility and Gynaecology. B.W.J.M. received an investigator grant from NHMRC (GNT1176437) and research funding from Merck KGaA. B.W.J.M. reports consultancy for Organon and Merck KGaA, and travel support from Merck KGaA. B.W.J.M. reports holding stocks of ObsEva. V.M. received research grants from Guerbet, Merck and Ferring and travel and speaker fees from Guerbet. The other authors do not report conflicts of interest. TRIAL REGISTRATION NUMBER: International Clinical Trials Registry Platform No. NTR4746.
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STUDY QUESTION: What are the costs and effects of tubal patency testing by hysterosalpingo-foam sonography (HyFoSy) compared to hysterosalpingography (HSG) in infertile women during the fertility work-up? SUMMARY ANSWER: During the fertility work-up, clinical management based on the test results of HyFoSy leads to slightly lower, though not statistically significant, live birth rates, at lower costs, compared to management based on HSG results. WHAT IS KNOWN ALREADY: Traditionally, tubal patency testing during the fertility work-up is performed by HSG. The FOAM trial, formally a non-inferiority study, showed that management decisions based on the results of HyFoSy resulted in a comparable live birth rate at 12 months compared to HSG (46% versus 47%; difference -1.2%, 95% CI: -3.4% to 1.5%; P = 0.27). Compared to HSG, HyFoSy is associated with significantly less pain, it lacks ionizing radiation and exposure to iodinated contrast medium. Moreover, HyFoSy can be performed by a gynaecologist during a one-stop fertility work-up. To our knowledge, the costs of both strategies have never been compared. STUDY DESIGN, SIZE, DURATION: We performed an economic evaluation alongside the FOAM trial, a randomized multicenter study conducted in the Netherlands. Participating infertile women underwent, both HyFoSy and HSG, in a randomized order. The results of both tests were compared and women with discordant test results were randomly allocated to management based on the results of one of the tests. The follow-up period was twelve months. PARTICIPANTS/MATERIALS, SETTING, METHODS: We studied 1160 infertile women (18-41 years) scheduled for tubal patency testing. The primary outcome was ongoing pregnancy leading to live birth. The economic evaluation compared costs and effects of management based on either test within 12 months. We calculated incremental cost-effectiveness ratios (ICERs): the difference in total costs and chance of live birth. Data were analyzed using the intention to treat principle. MAIN RESULTS AND THE ROLE OF CHANCE: Between May 2015 and January 2019, 1026 of the 1160 women underwent both tubal tests and had data available: 747 women with concordant results (48% live births), 136 with inconclusive results (40% live births), and 143 with discordant results (41% had a live birth after management based on HyFoSy results versus 49% with live birth after management based on HSG results). When comparing the two strategies-management based on HyfoSy results versus HSG results-the estimated chance of live birth was 46% after HyFoSy versus 47% after HSG (difference -1.2%; 95% CI: -3.4% to 1.5%). For the procedures itself, HyFoSy cost 136 and HSG 280. When costs of additional fertility treatments were incorporated, the mean total costs per couple were 3307 for the HyFoSy strategy and 3427 for the HSG strategy (mean difference -119; 95% CI: -125 to -114). So, while HyFoSy led to lower costs per couple, live birth rates were also slightly lower. The ICER was 10 042, meaning that by using HyFoSy instead of HSG we would save 10 042 per each additional live birth lost. LIMITATIONS, REASONS FOR CAUTION: When interpreting the results of this study, it needs to be considered that there was a considerable uncertainty around the ICER, and that the direct fertility enhancing effect of both tubal patency tests was not incorporated as women underwent both tubal patency tests in this study. WIDER IMPLICATION OF THE FINDINGS: Compared to clinical management based on HSG results, management guided by HyFoSy leads to slightly lower live birth rates (though not statistically significant) at lower costs, less pain, without ionizing radiation and iodinated contrast exposure. Further research on the comparison of the direct fertility-enhancing effect of both tubal patency tests is needed. STUDY FUNDING/COMPETING INTEREST(S): FOAM trial was an investigator-initiated study, funded by ZonMw, a Dutch organization for Health Research and Development (project number 837001504). IQ Medical Ventures provided the ExEm®-FOAM kits free of charge. The funders had no role in study design, collection, analysis, and interpretation of the data. K.D. reports travel-and speakers fees from Guerbet and her department received research grants from Guerbet outside the submitted work. H.R.V. received consulting-and travel fee from Ferring. A.M.v.P. reports received consulting fee from DEKRA and fee for an expert meeting from Ferring, both outside the submitted work. C.H.d.K. received travel fee from Merck. F.J.M.B. received a grant from Merck and speakers fee from Besins Healthcare. F.J.M.B. is a member of the advisory board of Merck and Ferring. J.v.D. reported speakers fee from Ferring. J.S. reports a research agreement with Takeda and consultancy for Sanofi on MR of motility outside the submitted work. M.v.W. received a travel grant from Oxford Press in the role of deputy editor for Human Reproduction and participates in a DSMB as independent methodologist in obstetrics studies in which she has no other role. B.W.M. received an investigator grant from NHMRC GNT1176437. B.W.M. reports consultancy for ObsEva, Merck, Guerbet, iGenomix, and Merck KGaA and travel support from Merck KGaA. V.M. received research grants from Guerbet, Merck, and Ferring and travel and speakers fees from Guerbet. The other authors do not report conflicts of interest. TRIAL REGISTRATION NUMBER: International Clinical Trials Registry Platform No. NTR4746.
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Testes de Obstrução das Tubas Uterinas , Histerossalpingografia , Infertilidade Feminina , Ultrassonografia , Humanos , Feminino , Histerossalpingografia/métodos , Histerossalpingografia/economia , Infertilidade Feminina/terapia , Infertilidade Feminina/economia , Adulto , Gravidez , Testes de Obstrução das Tubas Uterinas/métodos , Testes de Obstrução das Tubas Uterinas/economia , Ultrassonografia/economia , Ultrassonografia/métodos , Análise Custo-Benefício , Taxa de Gravidez , Nascido Vivo , Coeficiente de NatalidadeRESUMO
This review aimed to explore the therapeutic effect of bioabsorbable stents in the inferior genicular artery, from the emergence of absorbable bare metal stents to the latest technology in polymer and anti-proliferative eluting drugs mixed with coated bioresorbable vascular stents (BVSs). Currently, there are conflicting data regarding the safety and effectiveness of BVSs in infrapopliteal artery interventions, especially compared to the current generation of drug-eluting stents (DESs). This review will cover the existing data on BVSs in reconstructing the infrapopliteal arterial blood flow and active clinical trials for future iterations of BVSs. In terms of primary patency rate and target lesion revascularization rate, the available research on the effectiveness of BVSs in reconstructing the infrapopliteal arterial blood flow suggests that a BVS is compatible with current DESs within 3-12 months; long-term data have not yet been reported. The ABSORB BVS is the most studied BVS in cardiovascular disease (CAD). Initially, the ABSORB BVS showed promising results. Managing intricate regions in peripheral artery disorders, such as branching or lengthy lesions, continues to be a formidable undertaking. In contrast to the advanced narrowing of arteries seen in standard permanent stent procedures, bioabsorbable stents have the potential to promote the expansion and beneficial merging of blood channels in the latter stages. Furthermore, incorporating stents and re-establishing the endothelial function can diminish the probability of restenosis or thrombosis. Nevertheless, the extent to which bioabsorbable stents may simultaneously preserve arterial patency and guarantee their structural integrity remains uncertain. The powerful and intricate mechanical stresses exerted by the blood in the superficial femoral artery and popliteal artery can cause negative consequences on any implant inserted into the vessel, regardless of its composition, even metal. Furthermore, incorporating stents is advantageous for treating persistent occlusive lesions since it does not impact later treatments, including corrective bypass operations. Evidence is scarce about the use of bioabsorbable stents in treating infrapopliteal lesions. Utilizing bioabsorbable stents in minor infrapopliteal lesions can successfully maintain the patency of the blood vessel lumen, whereas balloon angioplasty cannot offer this benefit. The primary focus of testing these materials is determining whether bioabsorbable scaffolds can provide adequate radial force in highly calcified elongated lesions. Indeed, using "-limus" medication elution technology in conjunction with bioabsorbable stents has previously offered clinical benefits in treating the popliteal artery, as evidenced by limited trials.BVSs for peripheral arterial disease (PAD) show promise and have the potential to offer a less inflammatory and more vessel-friendly option compared to permanent metallic stents. However, current evidence does not yet allow for a universal recommendation for their use. Thus, ongoing, and future studies, such as those examining the newer generation of bioresorbable scaffolds (BRSs) with improved mechanical properties and resorption profiles, will be crucial in defining the role of BRSs in managing PAD.
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BACKGROUND: Limited data exists regarding incidence, progression, and predictors of left atrial appendage (LAA) sealing after transcatheter LAA closure. We aimed to evaluate the incidence, progression, and predictive factors associated with LAA sealing after LAA closure. METHODS: This study includes patients who underwent successful LAA closure with Watchman FLX device and had both pre- and postprocedural computed tomography (CT). Postprocedural CT was performed 45 days after LAA closure and used to evaluate residual LAA patency. Patient who had residual LAA patency at 45 days underwent 1-year follow-up CT. RESULTS: A total of 105 patients (mean age: 75.2 ± 9.6 years; 53.3% female) who underwent successful LAA closure with Watchman FLX device and had pre- and postprocedural CT at 45 days were included. Residual patency was observed in 35 (33.3%) patients: 21 (20.0%) patients showed complete contrast opacification in LAA (complete LAA patency) while 14 (13.3%) patients showed contrast opacification only in the distal LAA (distal LAA patency). Among patients with residual LAA patency at 45 days, the rate of LAA sealing at 1 year was significantly higher in the distal LAA patency group than in the complete LAA patency group (75.0% vs. 16.7%; p = 0.019). Increased depth oversizing was associated with both distal LAA patency and complete LAA patency. CONCLUSION: Postprocedural CT at 45 days detected patent LAA in one-third of patients after LAA closure. LAA sealing was more frequently observed at 1 year among the distal LAA patency group than the complete LAA patency group.
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Apêndice Atrial , Fibrilação Atrial , Cateterismo Cardíaco , Valor Preditivo dos Testes , Desenho de Prótese , Humanos , Apêndice Atrial/diagnóstico por imagem , Apêndice Atrial/fisiopatologia , Feminino , Masculino , Idoso , Idoso de 80 Anos ou mais , Fatores de Risco , Resultado do Tratamento , Fatores de Tempo , Fibrilação Atrial/fisiopatologia , Fibrilação Atrial/diagnóstico por imagem , Fibrilação Atrial/terapia , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/efeitos adversos , Estudos Retrospectivos , Incidência , Tomografia Computadorizada por Raios X , Tomografia Computadorizada MultidetectoresRESUMO
RESEARCH QUESTION: What is the diagnostic accuracy of hysterosalpingo-foam sonography (HyFoSy), using two-dimensional ultrasound in tubal patency assessment in infertile women compared with laparoscopy with dye chromotubation? DESIGN: This prospective study was conducted at My Duc Hospital, Vietnam. Infertile women aged 18 years or older, who were scheduled for laparoscopy, were included. Visual Analogue Scale (VAS) score for perception of pain during HyFoSy was used. Laparoscopy was carried out on the same day. Clinicians undertaking laparoscopy were blinded to HyFoSy results. Sensitivity, specificity, negative and positive predictive value, and 95% confidence intervals were calculated. A sample size of 455 women (nâ¯=â¯910 fallopian tubes) was needed to demonstrate a fluctuation hypothesis, not exceeding 6%, for sensitivity and specificity (power 0.80, two-sided alpha 5%, loss to follow-up 5%). RESULTS: Between 2019 and 2022, 455 participants were recruited. Hysterosalpingo-foam sonography was unsuccessfully carried out in six participants. Two withdrew their consent. Data analysis was conducted on the remaining 447 participants (nâ¯=â¯868 fallopian tubes). The sensitivity and specificity of hysterosalpingo-foam sonography compared with laparoscopy were 0.75 (95% CI 0.71 to 0.79) and 0.70 (95% CI 0.65 to 0.74), respectively. Hysterosalpingo-foam sonography gave a positive predictive value of 0.76 (95% CI 0.73 to 0.80) and negative predictive value of 0.68 (95% CI 0.64 to 0.73). A total of 42.8% of women reported a VAS score of no pain. No adverse event was reported. CONCLUSION: Compared with laparoscopy with dye chromotubation, two-dimensional HyFoSy is a well-tolerated, reliable technique for assessing tubal patency.
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Testes de Obstrução das Tubas Uterinas , Tubas Uterinas , Infertilidade Feminina , Laparoscopia , Ultrassonografia , Humanos , Feminino , Infertilidade Feminina/diagnóstico por imagem , Adulto , Tubas Uterinas/diagnóstico por imagem , Ultrassonografia/métodos , Testes de Obstrução das Tubas Uterinas/métodos , Estudos Prospectivos , Sensibilidade e Especificidade , Adulto Jovem , Histerossalpingografia/métodosRESUMO
OBJECTIVE: We investigated the efficacy of iliofemoral venous stenting in women of childbearing age treated for post-thrombotic syndrome (PTS) and assessed the influence of pregnancy on stent occlusion. METHODS: A retrospective analysis was conducted on women of childbearing age who underwent endovascular stenting for PTS due to chronic iliocava occlusion across 15 centers from 2009 to 2020. The study assessed pregnancy rates, primary patency rates, secondary patency rates, and clinical efficacy using the Villalta score for PTS severity and the Chronic Venous Disease Quality of Life Questionnaire - version 20 (CIVIQ-20), 6-12 months after the procedure. The impact of pregnancy on stent occlusion was analyzed using classical and multi-state survival analyses. Prophylactic low-molecular-weight heparin or fondaparinux was administered to patients during pregnancy until 6 weeks post-partum. RESULTS: In total, 211 women with PTS underwent endovascular stenting, with a median age of 31 years (range: 16-42). Following recanalization, significant improvements were observed in the Villalta score (p < 0.0001) and the CIVIQ-20 score (p < 0.0001). Thirty-seven (17.6%) women became pregnant and 49 (23.2%) experienced stent occlusions. The 1-year and 5-year occlusion-free survival probabilities were 80.6% (95% confidence interval [CI]: 75.1-86.4%) and 66.6% (95% CI: 57.4-77.4%), respectively. There was no significant association between pregnancy and stent occlusion-free survival (hazard ratio = 1.00 [95% CI: 0.11-8.92], p = 0.9930). CONCLUSION: Iliofemoral venous stenting in women of childbearing age was an effective treatment for post-thrombotic syndrome, and it did not increase the risk for stent occlusion during pregnancy when accompanied by appropriate anticoagulation. CLINICAL RELEVANCE STATEMENT: This study demonstrates that pregnancy following iliofemoral venous stenting for post-thrombotic syndrome does not elevate the risk for stent occlusion. KEY POINTS: ⢠The severity of post-thrombotic syndrome and the quality of life, as measured using the Villalta score and Chronic Venous Disease Quality of Life Questionnaire - version 20, respectively, showed significant improvements 6-12 months after iliofemoral venous stenting. ⢠The occurrence of pregnancy after recanalization in women of childbearing age did not lead to a significant increase in the risk for stent occlusion.
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Procedimentos Endovasculares , Síndrome Pós-Trombótica , Gravidez , Humanos , Feminino , Adolescente , Adulto Jovem , Adulto , Masculino , Estudos Retrospectivos , Qualidade de Vida , Veia Ilíaca/diagnóstico por imagem , Síndrome Pós-Trombótica/diagnóstico por imagem , Síndrome Pós-Trombótica/terapia , Stents , Resultado do Tratamento , Doença Crônica , Grau de Desobstrução VascularRESUMO
OBJECTIVES: To determine the diagnostic accuracy of ultra-high-resolution photon-counting detector CT angiography (UHR PCD-CTA) for evaluating coronary stent patency compared to invasive coronary angiography (ICA). METHODS: Consecutive, clinically referred patients with prior coronary stent implantation were prospectively enrolled between August 2022 and March 2023 and underwent UHR PCD-CTA (collimation, 120 × 0.2 mm). Two radiologists independently analyzed image quality of the in-stent lumen using a 5-point Likert scale, ranging from 1 ("excellent") to 5 ("non-diagnostic"), and assessed all coronary stents for the presence of in-stent stenosis (≥ 50% lumen narrowing). The diagnostic accuracy of UHR PCD-CTA was determined, with ICA serving as the standard of reference. RESULTS: A total of 44 coronary stents in 18 participants (mean age, 83 years ± 6 [standard deviation]; 12 women) were included in the analysis. In 3/44 stents, both readers described image quality as non-diagnostic, whereas reader 2 noted a fourth stent to have non-diagnostic image quality. In comparison to ICA, UHR PCD-CTA demonstrated a sensitivity, specificity, and accuracy of 100% (95% CI [confidence interval] 47.8, 100), 92.3% (95% CI 79.1, 98.4), and 93.2% (95% CI 81.3, 98.6) for reader 1 and 100% (95% CI 47.8, 100), 87.2% (95% CI 72.6, 95.7), and 88.6% (95% CI 75.4, 96.2) for reader 2, respectively. Both readers observed a 100% negative predictive value (36/36 stents and 34/34 stents). Stent patency inter-reader agreement was 90.1%, corresponding to a substantial Cohen's kappa value of 0.72. CONCLUSIONS: UHR PCD-CTA enables non-invasive assessment of coronary stent patency with high image quality and diagnostic accuracy. CLINICAL RELEVANCE STATEMENT: Ultra-high-resolution photon-counting detector CT angiography represents a reliable and non-invasive method for assessing coronary stent patency. Its high negative predictive value makes it a promising alternative over invasive coronary angiography for the rule-out of in-stent stenosis. KEY POINTS: ⢠CT-based evaluation of coronary stent patency is limited by stent-induced artifacts and spatial resolution. ⢠Ultra-high-resolution photon-counting detector CT accurately evaluates coronary stent patency compared to invasive coronary angiography. ⢠Photon-counting detector CT represents a promising method for the non-invasive rule-out of in-stent stenosis.
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Angiografia por Tomografia Computadorizada , Angiografia Coronária , Sensibilidade e Especificidade , Stents , Humanos , Feminino , Masculino , Angiografia Coronária/métodos , Idoso de 80 Anos ou mais , Estudos Prospectivos , Angiografia por Tomografia Computadorizada/métodos , Idoso , FótonsRESUMO
PURPOSE: The purpose of this study was to identify the independent predictors of higher patency rates and investigate the selection of specifications of stent graft in the treatment of central venous disease. MATERIALS AND METHODS: This retrospective study included 54 patients who underwent stent-grafts' placement for the treatment of central venous disease between March 2017 and September 2022 at a tertiary hospital. The demographic data for the patients and the clinical data of the treated lesions were collected and analyzed. The patency rates of the treated lesions with different oversizing range were calculated via the Kaplan-Meier and log-rank analyses. The multivariate Cox proportional hazard models were constructed to identify the independent predictor of the target site primary patency. RESULTS: The median follow-up period was 21.5 months. The primary patency rates of the target sites were 90.7%, 72.2%, and 55.1% at 6, 12, and 24 months, respectively. The assisted primary patency rates of the lesions were 96.3%, 92.5%, and 80.3% at 6, 12, and 24 months, respectively. The log-rank analysis showed that the stent-grafts' placement with small oversizing had significantly higher primary patency rates than those with large oversizing (p=0.022). The multivariate analysis revealed that concomitant stenosis and large oversizing stent graft were the independent predictors of target site primary patency. CONCLUSIONS: Stent grafts showed reasonable primary patency for the treatment of central venous disease in hemodialysis patients. A stent graft with small oversizing is associated with better target site primary patency rates than those with large oversizing. CLINICAL IMPACT: Stent grafts showed reasonable primary patency for the treatment of central venous disease in hemodialysis patients. Few studies, however, have explored the efficiency of stent grafts to treat CVD by considering different factors such as sizing considerations, the rate of oversizing percentage, etc. A stent graft with small oversizing is associated with better target site primary patency rates than those with large oversizing. Excessive oversizing should be avoided to prevent infolding or stent collapse.
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OBJECTIVE: The objective of this study was to compare in vitro the different biomechanical properties of 2 balloon-expandable covered stents, VBX (Viabahn VBX, W.L. Gore & Associates, Flagstaff, AZ) and iCover (iVascular, Barcelona, Spain), as bridging stents in fenestrated aortic endoprostheses. METHODS: Three biomechanical tests were performed to evaluate a total of 12 stents (6 VBX 6 × 59 mm and 6 iCover 6 × 57m). First, a 3-point bending test was performed with a calibrated dynamometer to evaluate the bending strength of the 40% and 150% deformation of the system in its crimped state and the force necessary to deform the expanded stent by 40% with respect to its initial diameter. Then the stents were expanded to their nominal diameter inside a 6-mm-diameter handmade fenestration and flared up to 8 and 10 mm. The whole set was fixed in the dynamometer to carry out the pullout-force (perpendicular dislocation) and shear-stress-force (axial dislocation) tests. The resulting forces were recorded via the force transducer. Load, deformation, and displacement data were recorded in newtons. The results of each stent test were examined under the microscope, and both stent types were compared. RESULTS: Higher forces were required to bend the crimped VBX (16.24 N [IQR, 13.87-17.47 N] for the iCover and 19.01 N [IQR, 16.01-19.50 N] for VBX; P < 0.001), but lower forces were necessary for the expanded VBX compared with the iCover (0.36 N [IQR, 0.1-0.49 N] and 1.01 N [IQR, 0.97-1.09 N], respectively; p = 0.004). Pullout forces were 3.56 N (IQR, 3-4.1 N) and 7.07 N (IQR, 6.86-7.28 N) for the 8-mm flare and 7.29 N (IQR, 6.13-8.45 N) and 14 N (IQR, 12.05-15.95 N) for the 10-mm flare for the iCover and VBX, respectively (P = 0.333 for both comparisons). The shear-stress forces needed to dislocate the 6-mm iCover and VBX axially with a 10-mm flare to 50%, 100%, and 200% were 0.88, 1.61, and 3.55 N for the iCover and 0.71, 1.43, and 2.51 N for the VBX (P = 0.343, P = 0.486, and P = 0.486, respectively). CONCLUSION: After evaluating the stents under in vitro conditions, the VBX and iCover stents showed similar results in terms of biomechanical properties, which demonstrates their competence in in vitro conditions. Further in vitro comparisons with other stent grafts are required. CLINICAL IMPACT: The BECS used in FEVAR / BEVAR must ensure some properties to avoid the most frequent complications derived from the failure of these bridging stents (stenosis, thrombosis, stent integrity, dislodgement or endoleaks) that represent the most common cause for reintervention. This paper adds to the limited data available, information to the clinician after comparing some properties of two BECS used in these techniques that demonstrate their competence in in-vitro conditions.
RESUMO
PURPOSE: To assess effectiveness of selective lymphatic duct embolization (SLDE) for treatment of thoracic lymphatic flow disorders, performed to maintain patency of the thoracic duct (TD), compared to thoracic duct embolization (TDE). MATERIALS AND METHODS: Records of 39 patients (mean age 7.6±7.1 years) with thoracic lymphatic flow disorders who underwent 43 SLDE procedures were analyzed and compared to a cohort of 104 patients (7.8±7.6 y) who underwent TDE. Relevant clinical and imaging data were collated. All patients presented with chylous effusion and/or plastic bronchitis. For the SLDE cohort, etiology of disorders included single-ventricle heart disease palliation in 28 patients (72%) and vascular malformation/aneuploidy in 8 (21%). For the TDE cohort, 92/104(88%) had single-ventricle heart disease palliation. RESULTS: SLDE was performed with glue via microcatheter in 35 procedures, and dextrose flood technique was used in 26. SLDE via direct needle access was performed in 11. After SLDE, presenting symptoms resolved in 33/39 patients (85%), improved in 5 (13%), and were unchanged in 1 (3%) (mean follow-up 693±523 days). The TD remained patent in all cases. There was a significant difference in outcomes (P=0.001) with the TDE cohort-symptoms resolved or improved in 75/104 patients (72%), were unchanged in 15 (14%); and new leak (e.g., ascites, protein-losing enteropathy) developed in 14 TDE patients (13%) (follow-up 1041±879 d). CONCLUSION: SLDE was effective for treatment of thoracic lymphatic flow disorders, and outcomes were comparable to TDE. Selective techniques preserve the patency of the TD and may have potential benefits that warrant further study.