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BACKGROUND: Abdominal aortic aneurysm (AAA) is a potentially life-threatening vascular condition, but approved medical therapies to prevent AAA progression and rupture are currently lacking. Sphingolipid metabolism disorders are associated with the occurrence and development of AAA. It has been discovered that ganglioside GM3, a sialic acid-containing type of glycosphingolipid, plays a protective role in atherosclerosis, which is an important risk factor for AAA; however, the potential contribution of GM3 to AAA development has not been investigated. METHODS: We performed a metabolomics study to evaluated GM3 level in plasma of human patients with AAA. We profiled GM3 synthase (ST3GAL5) expression in the mouse model of aneurysm and human AAA tissues through Western blotting and immunofluorescence staining. RNA sequencing, affinity purification and mass spectrometry, proteomic analysis, surface plasmon resonance analysis, and functional studies were used to dissect the molecular mechanism of GM3-regulating ferroptosis. We conditionally deleted and overexpressed St3gal5 in smooth muscle cells (SMCs) in vivo to investigate its role in AAA. RESULTS: We found significantly reduced plasma levels of GM3 in human patients with AAA. GM3 content and ST3GAL5 expression were decreased in abdominal aortic vascular SMCs in patients with AAA and an AAA mouse model. RNA sequencing analysis showed that ST3GAL5 silencing in human aortic SMCs induced ferroptosis. We showed that GM3 interacted directly with the extracellular domain of TFR1 (transferrin receptor 1), a cell membrane protein critical for cellular iron uptake, and disrupted its interaction with holo-transferrin. SMC-specific St3gal5 knockout exacerbated iron accumulation at lesion sites and significantly promoted AAA development in mice, whereas GM3 supplementation suppressed lipid peroxidation, reduced iron deposition in aortic vascular SMCs, and markedly decreased AAA incidence. CONCLUSIONS: Together, these results suggest that GM3 dysregulation promotes ferroptosis of vascular SMCs in AAA. Furthermore, GM3 may constitute a new therapeutic target for AAA.
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Aneurisma de la Aorta Abdominal , Ferroptosis , Humanos , Ratones , Animales , Gangliósido G(M3)/metabolismo , Proteómica , Músculo Liso Vascular/metabolismo , Aneurisma de la Aorta Abdominal/genética , Aneurisma de la Aorta Abdominal/prevención & control , Aneurisma de la Aorta Abdominal/metabolismo , Hierro , Miocitos del Músculo Liso/metabolismo , Modelos Animales de EnfermedadRESUMEN
PURPOSE: The aim of this study was to evaluate the midterm efficacy and safety of a single-branch Castor stent graft in the treatment of thoracic aortic disease. MATERIALS AND METHODS: Clinical data of 106 patients with thoracic aortic disease treated with Castor single-branch stent graft at 3 centers were collected between May 2018 and June 2023. The indicators included technical success, stent-related complication, reintervention, retrograde dissection, endoleak, distal stent graft-induced entry (dSINE), branch patency, and mortality. The outcomes of the Castor stent graft for multibranch reconstruction above the arch was also analyzed. RESULTS: The technical success was 98.1% (104/106), while the surgical success was 93.4% (99/106). The reintervention was 2.8% (3/106), consisting of a case of retrograde type A dissection, an endoleak, and a dSINE. The retrograde dissection was 1.9% (2/106), while type I endoleak was 1.9% (2/106). The new dSINE was 2.8% (3/106), and the branch patency rate was 100%. The mortality was 1.9% (2/106). The mean follow-up time was 29.1±17.7 months. The 2-year post-surgery cumulative survival rate was 91.0%±3.1%, while the cumulative branch patency rate was 96.2%±2.2%. In addition, the cumulative freedom from stent-related reintervention rate was 93.2%±2.8%. A comparison showed no significant difference in the stent-related complication, branch patency, endoleak, reintervention, and mortality when the proximal end of the Castor stent graft was anchored to zones 1 or 2 of the aorta. CONCLUSION: Castor single-branch stent graft showed favorable early and midterm outcomes in the treatment of thoracic aortic disease. In addition, it was feasible to combine Castor stent graft with other advanced techniques for multibranch aortic arch reconstruction. CLINICAL IMPACT: The Castor single-branch stent graft was approval by the Chinese Food and Drug Administration in 2017. However, there were few studies on the mid-term outcomes for thoracic aortic disease after launching, which mainly focused on small single-center retrospective study. In the study, we assessed the mid-term outcomes of Castor stent graft through multi-center cases, Castor stent graft combined with other advanced techniques (such as fenestration and hybrid) for multi-branch reconstruction of aortic arch were also conducted. We found Castor single-branch stent graft showed favorable early and mid-term outcomes in the treatment of thoracic aortic disease. Additionally, it was feasible to combine Castor stent graft with other advanced technique for multi-branch aortic arch reconstruction. As an off-the-shelf branched stent graft with a wide range of models, it could be also used in most emergent situation. The Castor stent graft was expected to become more widely used in the future.
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PURPOSE: The purpose was to evaluate the clinical outcomes of a dedicated venous stent with the tripartite composite segments for the treatment of iliofemoral venous obstruction (IVO) in a mixed cohort of nonthrombotic iliac vein lesion (NIVL) and post-thrombotic syndrome (PTS) over a period of 12 months. METHODS: The Grency Trial is a prospective, multicenter, single-arm, open-label, pivotal study, which was conducted at 18 large tertiary hospitals in China from August 2019 to October 2020. A total of 133 hospitalized patients were screened and 110 patients with clinical, etiology, anatomical, and pathophysiology clinical class (CEAP) clinical grade C>3 and iliac vein stenosis >50% or occlusion, including 72 patients with NIVL and 38 patients with PTS, were implanted with Grency venous stents. Primary endpoint was stent patency at 12 months follow-up, and secondary outcomes were technical success; improvement in venous clinical severity score (VCSS) at 3, 6, and 12 month follow-up; and rates of clinical adverse events. RESULTS: Among 110 patients who were implanted with Grency venous stents, 107 patients completed the 12 month follow-up. All 129 stents were successfully implanted in 110 limbs. Twelve-month primary patency rate was 94.39% [95% confidence interval [CI]=88.19%-97.91%] overall, and 100% [94.94%-100%] and 83.33% [67.19%-93.63%] in the NIVL and PTS subgroups, respectively. Venous clinical severity score after iliac vein stenting improved significantly up to 12 months follow-up. There were 3 early major adverse events (1 intracerebral hemorrhage and 2 stent thrombosis events related to anticoagulation therapy), and 7 late major adverse events (1 cardiovascular death, 1 intracranial hemorrhage with uncontrolled hypertension, and 5 in-stent restenosis cases without stent fractures or migration). CONCLUSIONS: The Grency venous stent system appeared excellent preliminary safe and effective for IVO treatment. Further large-scale studies with longer-term follow-up are needed to evaluate long-term patency and durability of stent. CLINICAL IMPACT: The design of venous stents for iliofemoral venous obstruction (IVO) must address engineering challenges distinct from those encountered in arterial stenting. The Grency venous stent, a nitinol self-expanding stent specifically tailored for IVO, features a composite structure designed to meet the stent requirements of various iliac vein segments. The Grency Trial is a prospective, multicenter, single-arm, open-label pivotal study aimed at evaluating the efficacy and safety of the Grency stent system. Following a 12-month follow-up period, the Grency venous stent system has demonstrated both safety and efficacy in treating iliofemoral venous outflow obstruction.
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PURPOSE: To report the outcomes of the IN-DEPT trial assessing the feasibility, preliminary safety data, and 12-month outcomes of a new drug-coated balloon (DCB) product for peripheral artery disease (PAD) in Chinese patients. MATERIALS AND METHODS: This is a prospective, multicenter, single-arm clinical trial. A total of 160 patients with superficial femoral artery (SFA) and/or proximal popliteal artery lesions were treated with a new paclitaxel-coated DCB. The preliminary effectiveness end point was 12-month primary patency. The primary safety end point was freedom from device- and procedure-related mortality over 30 days and freedom from major target limb amputation and clinically driven target lesion revascularization (CD-TLR) within 12 months after the index procedure. RESULTS: In total, 160 patients presented with 162 target lesions. A total of 139 lesions (85.8%) were treated with 1 DCB, whereas the other 23 lesions (14.2%) were treated with 2 devices. The device success rate was 100%. A total of 135 subjects reached the preliminary effectiveness end point, with a 12-month primary patency rate of 84.4%. There was no 30-day device- or procedure-related death or unplanned major target limb amputation at 12 months. Five CD-TLRs (3.1%) occurred during the 12-month follow-up period. CONCLUSIONS: Results from the IN-DEPT SFA trial showed satisfactory feasibility and safety of the new DCB over 12 months in Chinese patients with PAD and femoropopliteal de novo lesions, including both stenoses and total occlusions.
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Angioplastia de Balón , Fármacos Cardiovasculares , Enfermedad Arterial Periférica , Humanos , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/patología , Estudios Prospectivos , Angioplastia de Balón/efectos adversos , Materiales Biocompatibles Revestidos , Factores de Tiempo , Fármacos Cardiovasculares/efectos adversos , Arteria Poplítea/diagnóstico por imagen , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/patología , Grado de Desobstrucción Vascular , Resultado del TratamientoRESUMEN
BACKGROUND: Risks of recurrence and major bleeding with extended anticoagulation in Asian patients with venous thromboembolism (VTE) are similar to those in non-Asian patients but risks according to baseline risk factor profiles is not well documented. METHODS: Subgroup analysis of two randomized trials, which compared once-daily rivaroxaban (20 mg or 10 mg) with placebo or aspirin (100 mg) for extended treatment in Asian patients with VTE who had completed 6-12 months of anticoagulation. Index events were classified as unprovoked, provoked by major persistent risk factors, minor persistent risk factors, minor transient risk factors, or major transient risk factors. One-year cumulative risks of recurrent VTE were calculated for these risk factor profiles. RESULTS: 367 patients received rivaroxaban, 159 aspirin, and 48 placebo. For patients with unprovoked VTE, one-year cumulative incidences of recurrence in the 202 patients given rivaroxaban, the 89 given aspirin and the 28 given placebo were 1.6%, 5.8%, and 14.8%, respectively. For patients with VTE provoked by minor persistent risk factors, these incidences were 0% in the 74 patients given rivaroxaban, 9.3% in the 36 given aspirin, and 0% in the 12 given placebo. No recurrent VTE occurred in patients with VTE provoked by major persistent or transient risk factors or minor transient risk factors. Rivaroxaban was not associated with a significant increase in major bleeding. CONCLUSIONS: Rivaroxaban seems to be an effective and safe option for extended treatment in Asian patients, especially those presenting with unprovoked VTE. Subgroups of patients with provoked risk factors were too small to draw meaningful conclusions. TRIAL REGISTRATION: NCT00439725 and NCT02064439.
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BACKGROUND: To assess the safety and efficacy of ultrasound-assisted sagittal view for retrograde puncture of the P2 segment of popliteal artery (PA) for treating femoropopliteal lesions. METHODS: A retrospective study was conducted on consecutive patients who underwent retrograde puncture of the PA for the recanalization of femoropopliteal lesions. A retrograde access was made to either the P2 or P3 segment of the PA in 23 cases. In 10 cases (8 men; mean age 68 ± 9 years), ultrasound-guided retrograde PA (P2 segment) puncture using the long-axis in-the-plane approach was performed, and in 13 cases (11 men; mean age 69 ± 5 years), angiography-guided retrograde PA (P3 segment) puncture was performed. Clinical data was compared preintraoperatively and postoperatively in the 2 groups. RESULTS: All occluded lesions were successfully recanalized via dual channel intervention. Puncture success were 100% (10/10) in the P2 group compared with 92.3% (12/13) in the P3 group (P > 0.05). The mean puncture time in the P2 group was significantly shorter when compared to the P3 group (4.70 ± 0.95 mins vs 11.33 ± 6.37 mins; P < 0.05). There was no difference in mean hemostasis time between the 2 groups (6.11 ± 2.20 mins vs 8.46 ± 3.76 mins; P > 0.05). There were no in-hospital deaths in all patients. The occurrence of puncture-related complications in the P2 group was 10% compared with 15% in the P3 group (P > 0.05). A low-flow arteriovenous fistula was observed in one case in the P3 group. None of the patients reported any access-related complication at a mean follow-up of 11.3 ± 5.5 months. CONCLUSIONS: Ultrasound-assisted sagittal view for retrograde puncture of the P2 segment of PA is at least as safe as angiography-guided retrograde puncture of the P3 segment for femoropopliteal lesions. Furthermore, this technique appears to be more suitable for patients with tandem iliofemoral artery occlusion, as it allows for the creation of a retrograde access.
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BACKGROUND: To evaluate the short-term and mid-term safety and efficacy of stent-graft compared with bare stents for treatment of aortoiliac occlusive disease (AIOD). METHODS: One hundred eighty three patients diagnosed with AIOD who received stent implantation at 3 vascular centers in north China between January 2019 and December 2021 were enrolled. Patients were divided into those undergoing stent-graft (Group A; n = 67) or bare stent (Group B; n = 116) implantation for retrospective cohort analysis. Efficacy was assessed as surgical success rate and rate of freedom from clinically driven target lesion reintervention at each follow-up time point. Safety was assessed by the rate of perioperative complication, major limb amputation, and aortoiliac artery-related mortality. RESULTS: There were no preoperative baseline differences between the 2 groups (P > 0.05). The surgical success was 91.04% for Group A, significantly higher than that for Group B (79.31%; P < 0.05). Incidence of perioperative complications was 2.98% for Group A, significantly lower than that for Group B (9.48%, P < 0.05), as was the rate of major limb amputation (A: 1.49% vs. B: 5.17%) and aortoiliac artery-related mortality (A: 1.49% vs. B: 4.31%), although these 2 indicators were not significantly different (P > 0.05). Follow-up rates were 91.8% for the total follow-up time of 3 years. Kaplan-Meier survival curve analysis gave significantly higher 1-year and 2-year freedom from clinically driven target lesion reintervention for Group A (98.51% and 95.52%) than for Group B (95.69% and 89.66%, P < 0.05). CONCLUSIONS: Stent-graft is more effective and safer than bare stent in the treatment of AIOD.
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Amputación Quirúrgica , Enfermedades de la Aorta , Arteriopatías Oclusivas , Implantación de Prótesis Vascular , Prótesis Vascular , Procedimientos Endovasculares , Arteria Ilíaca , Stents , Grado de Desobstrucción Vascular , Humanos , Masculino , Femenino , Arteria Ilíaca/cirugía , Arteria Ilíaca/diagnóstico por imagen , Estudios Retrospectivos , Persona de Mediana Edad , Factores de Tiempo , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/mortalidad , Anciano , Enfermedades de la Aorta/cirugía , Enfermedades de la Aorta/diagnóstico por imagen , Enfermedades de la Aorta/mortalidad , Arteriopatías Oclusivas/cirugía , Arteriopatías Oclusivas/diagnóstico por imagen , Arteriopatías Oclusivas/mortalidad , China , Resultado del Tratamiento , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Implantación de Prótesis Vascular/mortalidad , Factores de Riesgo , Recuperación del Miembro , Diseño de Prótesis , Complicaciones Posoperatorias/etiología , Medición de RiesgoRESUMEN
BACKGROUND: The Talos stent-graft has extended length to improve aortic remodeling, and distal porous design to decrease the rate of spinal cord ischemia (SCI). This study retrospectively analyzed its mid-term outcomes for uncomplicated type B aortic dissection in a multicenter study. METHODS: The primary safety end point was 30-day major adverse events, including all-cause mortality, dissection-related mortality, conversion to open surgery, and device-related adverse events. The primary efficacy end point was treatment success at 12 months postoperation, defined as no technical failure or secondary dissection-related reintervention. The survival status of the patients was visualized using the Kaplan-Meier curve. Aortic growth was assessed at 4 levels, and SCI was evaluated at 12 months. RESULTS: 113 patients participated with a mean age of 54.4 (11.1) years and 71.7% (81/113) were male. The 30-day mortality was 0.9% (1/113), no conversions to open surgery or device-related adverse events were recorded. The 12-month treatment success rate was 99.1% (112/113), with no dissection-related reinterventions. There was no spinal cord or visceral ischemia at 12 months. At a median of 34 months follow-up, 9 further deaths were recorded and the 3-year survival rate was 91.7%. The percentage of aortic growth was 1.8% (2/111) at the tracheal bifurcation, 3.6% (4/111) below the left atrium, 6.0% (5/83) above the celiac artery, and 12.1% (9/74) below the lower renal artery. The total thrombosis rate of the false lumen at the stented segment was 80.5% (91/113). CONCLUSIONS: The results showed satisfactory results of Talos stent-graft in terms of safety and efficacy. More data are needed to confirm the long-term performance.
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Disección Aórtica , Implantación de Prótesis Vascular , Prótesis Vascular , Procedimientos Endovasculares , Diseño de Prótesis , Stents , Humanos , Masculino , Persona de Mediana Edad , Femenino , Disección Aórtica/cirugía , Disección Aórtica/diagnóstico por imagen , Disección Aórtica/mortalidad , Estudios Retrospectivos , Implantación de Prótesis Vascular/instrumentación , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Resultado del Tratamiento , Factores de Tiempo , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Adulto , Anciano , Factores de Riesgo , Porosidad , Aneurisma de la Aorta/cirugía , Aneurisma de la Aorta/diagnóstico por imagen , Aneurisma de la Aorta/mortalidad , Complicaciones Posoperatorias/etiología , JapónRESUMEN
OBJECTIVE: To identify independent predictors of thoracic aortic growth in patients with type B aortic dissection (TBAD) undergoing thoracic endovascular aortic repair (TEVAR). METHODS: A retrospective analysis of the patients undergoing TEVAR for TBAD or intramural hematoma (IMH) from April 2014 to April 2023 was performed. The baseline morphological data of TBAD was established through computed tomography angiography (CTA) before discharge. Patients were divided into two groups based on aortic growth: growth and no growth. Aortic growth defined as an increase ≥5 mm in thoracic maximal aortic diameter during any serial follow-up CTA measurement. Logistic regression following propensity score matching (PSM) was used to identify independent predictors for aortic growth. Receiver operating characteristic curve and cutoff value of independent predictors were calculated. Linear regression was used to establish a correlation between anatomical variables and follow-up aortic diameter. RESULTS: A total of 145 patients with TBAD (n = 122) or IMH (n = 23) undergoing TEVAR were included, with a male of 83.4% and a mean age of 56 ± 14.1 years. Patients in growth group and no growth group was 26 (17.9%) and 119 (80.1%), respectively. After using PSM method, matched regression analysis showed residual maximal tear diameter (OR = 0.889, 95% CI 0.830-0.952, p = 0.001) and follow-up aortic diameter (OR = 0.977, 95% CI 0.965-0.989, p < 0.001) were independent predictors for aortic growth. The cutoff value was 8.55 mm for residual tear diameter and 40.65 mm for follow-up maximal aortic diameter. The residual maximal tear diameter showed a linear correlation with follow-up aortic diameter (DW = 1.74, R2 = 6.2%, p = 0.033). CONCLUSIONS: This study suggested that residual maximal tear diameter >8.55 mm and follow-up aortic diameter >40.65 mm could predict aortic growth in patients with TBAD undergoing TEVAR.
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PURPOSE: This study aimed to compare midterm efficacy between drug-coated balloon (DCB) and bare metal stent (BMS) in the treatment of TASCII C/D femoropopliteal artery lesions. METHODS: The clinical data of patients with TASCII C/D femoropopliteal artery disease admitted to 3 vascular surgery centers from January 2018 to January 2021 were retrospectively analyzed. Patients were divided into DCB group and BMS group. The DCB group was further subdivided into DCB alone subgroup and DCB+BMS subgroup. Study primary outcomes were freedom from clinical-driven target lesion reintervention (FCD-TLR) at 24 months postprocedure. Secondary outcomes included ankle brachial index (ABI), Rutherford classification, major amputation rate, and mortality. RESULTS: A total of 410 consecutive patients were enrolled. At 24 months follow-up, in DCB group (114 patients) relative to BMS group (296 patients), FCD-TLR (86.00% vs 71.91%, p=0.039), and ABI (0.53±0.11 vs 0.47±0.19, p=0.007) were higher; mean Rutherford class was lower (1.57±0.68 vs 3.31±1.39, p=0.000); and major amputation rate (0.87% vs 4.05%, p>0.05) and all-cause mortality (8.92% vs 6.41%, p>0.05) were statistically similar. In DCB alone, subgroup relative to DCB+BMS subgroup, FCD-TLR (90.00% vs 85.00%, p>0.05), major amputation rate (0 vs 1.08%, p>0.05), and all-cause mortality rate (9.09% vs 8.69%, p>0.05) were statistically similar, while FCD-TLR was higher in the DCB+BMS subgroup (90.00% vs 71.91%, p=0.045). CONCLUSION: At midterm follow-up of patients treated for TASCII C/D femoropopliteal artery disease, use of DCB or of DCB combined with rescue BMS appeared similarly efficacious, and yielded more favorable outcomes than use of BMS. CLINICAL IMPACT: The efficacy of drug-coated balloons relative to that of bare metal stents for the treatment of complex femoropopliteal artery lesions, particularly TASCII grade D lesions, remains uncertain. There is a scarcity of multicenter comparative studies, and in this multicenter retrospective study with up to 24-month follow-up, use of drug-coated balloon alone or combined with rescue bare metal stent appeared similarly efficacious while yielding more favorable outcomes than use of bare metal stent alone in the treatment of TASCII grade C/D femoropopliteal artery lesions. Randomized studies are warranted.
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PURPOSE: To compare the mid-term outcomes of endovascular and hybrid procedures in treating aortic arch pathologies with an unfavorable proximal landing zone, and analyze the different indications of the 2 methods. METHODS: We collected the clinical data from 59 patients with complex aortic arch pathologies who underwent endovascular or hybrid surgery from March 2018 to April 2020 at a single center. Among the patients, 45 were treated by branched or fenestrated surgery and 14 by hybrid surgery. The clinical data of preoperative, perioperative, and postoperative results were retrospectively analyzed and compared. The main study indexes were the branch patency rate and endoleakage rate during the follow-up period. The secondary study indexes included the operation success rate, operative time, hospital expenses, complication incidence, freedom from reintervention rate, mortality, etc. RESULTS: The operation success rate of all the groups was 100%. The hospital expenses of the hybrid group were lower than those of the endovascular group (p<0.05). The operative time of the hybrid group was longer than that of the endovascular group (p<0.05). The incidence of anatomic variants in the hybrid group was 28.6%, which was significantly higher than that in the endovascular group (2.2%, p=0.011). However, there were no significant differences in operative bleeding, ventilator use duration, and treatment time in intensive care units between the 2 groups (p>0.05). Follow-up was conducted for a period of 12 to 34 months. Four patients of the hybrid group experienced numbness of the upper limb (28.57%); the proportion was higher than the endovascular group (0%, p=0.002). There were no significant differences in the occurrence of endoleaks, retrograde aortic dissection, target lesion, secondary operation, branch patency rate, paraplegia, cerebral apoplexy, renal failure, or other complications in either group (p>0.05). The mortality of the endovascular group was 6.67% (3/45). Overall cumulative survival at 1 year was 100% in the hybrid group and 93.3% in the endovascular group. There was no statistical difference in the increase of the true lumen between the 2 groups for vascular remodeling (p>0.05). CONCLUSION: The hybrid surgery costs less and proves more suitable for treating variants of the aortic arch. The endovascular treatment still has limitations due to anatomical conditions.
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Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Aorta Torácica/diagnóstico por imagen , Aorta Torácica/cirugía , Stents/efectos adversos , Estudios Retrospectivos , Resultado del Tratamiento , Complicaciones PosoperatoriasRESUMEN
OBJECTIVE: Type II endoleak (T2EL) worsens the long-term results of endovascular aneurysm repair (EVAR). How to prevent T2ELs remains controversial. This study aimed to evaluate the efficacy and safety of fibrin glue sac filling (FGSF) to prevent T2ELs after EVAR. METHODS: A prospective randomized controlled trial was conducted. Patients were randomly divided into group A (standard EVAR + FGSF) and group B (standard EVAR). The follow-up plans included outpatient or telephone consultation at 1 and 3 months and computed tomography (CT) angiography at 6 months, 1 year, and once a year after EVAR. RESULTS: A total of 64 abdominal aortic aneurysm (AAA) patients were randomized to the 2 groups. All patients were followed up for more than 6 months. The 2 groups showed similar baseline characteristics. The rate of T2ELs on immediate angiography in group A (9.6%) was significantly lower than that in group B (33.3%, p=0.033). Moreover, the sac area change was significantly reduced in group A at 6 months after EVAR (p=0.021). However, T2EL incidence was similar at the 6-month (p=0.055) and 1-year (p=0.057) follow-ups, and AAA diameter change was also similar at 1 year. There were similar operation times, radiation doses, severe adverse events (SAEs), and reinterventions between the 2 groups. CONCLUSION: Fibrin glue sac filling could prevent short-term type II endoleaks and promote AAA shrinkage after 6 months. The FGSF procedure is swift and straightforward; however, patients are at risk of bowel ischemia, especially after previous bowel resections or concomitant superior mesenteric artery (SMA) disease. CLINICAL IMPACT: Standard endovascular aneurysm repair (EVAR) couldn't prevent type II endoleak (T2EL). In this study, we found fibrin glue sac filling (FGSF) could prevent T2EL and promote AAA shrinkage in a short term. And the FGSF procedure is easy, it will be a useful supplement to standard EVAR for clinicians. And FGSF might have potential usefulness on ruptured aneurysms, although without direct evidence.Fibrin glue is often used to hemostasis and tissue adhesion in surgical patients and burn patients, we firstly carry out a randomized controlled study and prove that fibrin glue sac filling could prevent T2EL and promote sac remodeling.
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OBJECTIVE: To conduct a meta-analysis to assess the safety and efficacy of t-Branch off-the-shelf multibranched endograft for the treatment of thoracoabdominal aortic aneurysm (TAAA). DATA SOURCES: PubMed, Embase, and Web of Science. REVIEW METHODS: Online databases were searched from June 2012 to March 2023. The data were pooled together using a random-effects model of proportions. The outcomes overall included technical success, spinal cord ischemia, target vessel occlusion, type I or III endoleak, reintervention, early mortality (30-day), and mid-term outcomes. Subgroup meta-analyses and meta-regression were performed to explore variation among studies. RESULTS: A total of 15 studies containing 1238 patients were included in the meta-analysis. The overall study quality assessment was found to be moderate to good. The pooled technical success was 97.0% (95% confidence interval [CI]=95.5-98.6, I2=53.01%, 1185/1238 cases, 15 studies). Overall, early mortality was 7.3% (95% CI=4.4-10.1, I2=74.48%, 124/1238 cases, 15 studies). Early spinal cord ischemia was 13.4% (95% CI=9.6-17.2, I2=67.24%, 160/1238 cases, 15 studies), and early type I or III endoleak was 6.0% (95% CI=3.4-8.5, I2=53.71%, 68/1032 cases, 9 studies). Mid-term outcomes showed target vessel occlusion was 4% (95% CI=1.4-6.5, I2=65.18%, 28/528 cases, 10 studies, 5-21.2 months), type I or III endoleak was 4.7% (95% CI=2-7.5, I2=49.74%, 38/512 cases, 10 studies, 5-21.2 months), reintervention was 11.2% (95% CI=8.1-14.3, I2=31.06%, 85/650 cases, 10 studies, 5-21.2 months), and pooled mortality was 13.9% (95% CI=7.2-20.7, I2=76.32%, 84/550 cases, 11 studies, 5-21.2 months). Meta-regression found a significant linear association between higher technical success and earlier publication year (p=0.014) and studies with anatomic inclusion criteria (p=0.037). Urgent patients (p=0.021) and later publication year (p=0.048) were significantly associated with higher early mortality. CONCLUSION: The use of the off-the-shelf t-Branch multibranched endograft for elective or urgent endovascular TAAA repair is associated with high technical success rates and proved to be safe and effective at early and mid-term follow-up. However, the heterogeneity between the included studies is high, and prospective, randomized studies along with future larger studies with long-term follow-up are needed. CLINICAL IMPACT: The Zenith t-Branch (Cook Medical, Bloomington, Ind) was approved as a commercially available device in Europe in June 2012. Although a decade has past, the outcomes of t-Branch have rarely been synthesized at the global level. This meta-analysis included 15 studies containing 1238 patients. The meta-analyses included technical success, major adverse events, reintervention, early mortality, and mid-term outcomes. The outcome was very meaningful and representative for the use of t-Branch. It is helpful for endovascular surgeons to make decisions on the treatment of TAAA patients.
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A 67-year-old man with massive hematemesis was transferred to the emergency unit of our hospital. The patient was diagnosed with primary aortoduodenal fistula (PADF) based on the CT findings. Upon emergent exploration, multiple duodenal diverticula were found and in situ abdominal aortic aneurysm (AAA) repair using polytetrafluoroethylene (PTFE) graft was performed. The third and fourth parts of the duodenum with multiple duodenal diverticula and the origin of jejunum were excised, and end-to-side duodenojejunostomy was performed. The patient was discharged on the 38th postoperative day with another 6 month oral antibiotic treatment. The duodenal diverticula may be the cause for PADF.
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Enfermedades de la Aorta/etiología , Divertículo/complicaciones , Enfermedades Duodenales/complicaciones , Fístula Intestinal/etiología , Fístula Vascular/etiología , Anciano , Aneurisma de la Aorta Abdominal/complicaciones , Hemorragia Gastrointestinal/etiología , Hematemesis/etiología , Humanos , MasculinoRESUMEN
BACKGROUND: To evaluate the efficacy and safety of the Rotarex mechanical thrombectomy device in treating acute lower extremity arterial ischemia and to explore the appropriate indication of the Rotarex device. METHODS: A retrospective analysis was performed in 186 patients with acute lower extremity arterial ischemia treated with the Rotarex mechanical thrombectomy device from April 2015 to March 2020 in three vascular surgery centers of Tianjin. As per the comprehensive judgment of the etiology, onset time, imaging of ultrasonography (US) and angiography, and findings during treatment, the patients were divided into the embolization group (69 cases), thrombosis group (primary artery stenosis with thrombosis; 86 cases), and restenosis group (stent restenosis with thrombosis; 31 cases). The primary study outcomes included the success rate of Rotarex mechanical thrombectomy device alone, percutaneous transluminal angioplasty (PTA), stent, catheter-directed thrombolysis (CDT) auxiliary rate, target vessel patency rate, and freedom from clinically driven target lesion revascularization rate (f-CD-TLR). The secondary study outcomes included intraoperative distal arterial embolization, postoperative 30-day bleeding, and deterioration of renal function, amputation, and mortality. RESULTS: The success rate of Rotarex mechanical thrombectomy device alone in the embolization group (44.93%) was significantly higher than that in the thrombosis group (13.95%) and restenosis group (0%) (P < 0.01). The PTA auxiliary rate in the embolization group (26.09%) was significantly lower than that in the thrombosis group (72.09%) and restenosis group (100%) (P < 0.01). The stent implantation rates in the embolization group and restenosis group (11.60% and 33.30%, respectively) were significantly lower than that in the thrombosis group (72.09%) (P < 0.01). There were no significant differences in the CDT auxiliary rate, distal arterial embolization, hemorrhage, renal function deterioration, amputation rate, and mortality among the three groups (P > 0.05). The primary patency at 3 months, 6 months, and 12 months postoperatively was 98.6%, 98.6%, and 84.3% in the embolization group, 96.4%, 89.5%, and 74.9% in the thrombosis group, and 93.2%, 84.7%, and 67.5% in the restenosis group, respectively (P < 0.01). The f-CD-TLR at 12 months postoperatively was 88.9% in the embolization group, which was higher than 77.8% in the thrombosis group and 67.5% in the restenosis group (P < 0.01). CONCLUSIONS: The Rotarex mechanical thrombectomy device is a minimally invasive, safe, and effective treatment option for acute lower extremity arterial ischemia, particularly acute arterial embolization. For acute thrombosis secondary to primary artery stenosis and in-stent restenosis, Rotarex device can effectively reduce the thrombus burden and create favorable conditions for other concurrent interventions.
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Arteriopatías Oclusivas , Trombosis , Enfermedad Aguda , Arteriopatías Oclusivas/cirugía , Constricción Patológica/etiología , Humanos , Isquemia/diagnóstico por imagen , Isquemia/etiología , Isquemia/terapia , Extremidad Inferior , Estudios Retrospectivos , Trombectomía , Trombosis/etiología , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
OBJECTIVES: To summarize the experience and midterm outcomes of physician-modified endovascular grafts for zone 2 thoracic endovascular aortic repair. METHODS: A retrospective analysis was conducted of 51 consecutive patients (mean age 57.6 ± 12.5 years, 39 males) treated with thoracic endovascular aortic repair using physician-modified endovascular grafts for reconstructing the left subclavian artery from November 2015 to December 2019. The primary endpoints during follow-up were the overall mortality, aorta-related mortality, and major complications. The secondary endpoints were reintervention and the patency of the target branches, the demographics and technical details were also described and analyzed. RESULTS: Sixty-three thoracic stent-grafts were deployed in 51 patients and emergency surgery was performed in 10 patients (19.6%). Technical success was 94.1% (48/51). The incidence of perioperative complications was 15.7%, and the 30-day mortality was 0%. At a mean follow-up of 42.0 ± 14.4 months (range, 14-63 months), all the left subclavian arteries remained patent. All-cause mortality was 3.9% (2/51) and not aorta-related deaths. Estimated survival at one and three years was 98.0 ± 1.9% and 96.0 ± 2.8%, respectively. CONCLUSIONS: The physician-modified endovascular grafts is feasible and effective to preserve left subclavian artery in thoracic endovascular aortic repair for aortic arch pathologies with unhealthy proximal landing zone.
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Aneurisma de la Aorta Torácica , Disección Aórtica , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Médicos , Anciano , Disección Aórtica/cirugía , Aorta Torácica/diagnóstico por imagen , Aorta Torácica/cirugía , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/cirugía , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Procedimientos Endovasculares/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Estudios Retrospectivos , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVES: Hostile neck abdominal aortic aneurysm (AAA) is challenging for standard endovascular aneurysm repair (EVAR). We sought to compare fenestrated endovascular aneurysm repair (fEVAR) and chimney endovascular aneurysm repair (chEVAR) for hostile neck AAA. METHODS: Patients were identified retrospectively. Hostile neck anatomy was defined as a proximal neck length of <15 mm or angulation >60°. The choice of fEVAR or chEVAR was based on neck anatomy and physician preference. Type I endoleak (T1EL) was the primary outcome. Other outcomes included type III endoleak (T3EL), visceral stent occlusion, renal insufficiency, reintervention, and mortality. RESULTS: A total of 84 patients were included from April 2012 to December 2021. fEVAR and chEVAR patients were 48 and 36 cases, respectively. Both groups showed similar rate of T1EL, T3EL, visceral stent occlusion, renal insufficiency, reintervention, and mortality. However, chEVAR patients had a more tortuous neck (61.1% vs. 16.7%, p < 0.001), while fEVAR patients had a greater neck size (29.5 ± 6.3 mm vs. 24.5 ± 4.8 mm, p < 0.001) and more reconstructing target arteries (2.2 ± 1.1 vs 1.3 ± 0.6, p < 0.001). CONCLUSIONS: fEVAR and chEVAR show similar safe and effective outcomes in well-selected hostile neck. fEVAR might be able to reconstruct multiple visceral arteries, and chEVAR seems justified in patients with poor anatomical suitability for fEVAR.
RESUMEN
PURPOSE: To compare the safety and efficacy of drug-coated balloon (DCB) vs uncoated balloon angioplasty in the treatment of de novo and restenotic infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). MATERIALS AND METHODS: The prospective, multicenter, randomized study AcoArt II-BTK study (ClinicalTrials.gov identifier NCT02137577) enrolled 120 patients who were randomly assigned to angioplasty with either a DCB (n=61; mean age 70.7±7.4 years; 36 men) or a conventional balloon catheter (n=59; mean age 70.8±9.0 years; 36 men). There were no significant differences observed in baseline clinical or target lesion characteristics between the groups. The target lesion length was 169.95±86.35 mm in the DCB group vs 179.93±80.16 mm in the control group, and approximately three-quarters of the lesions were chronic occlusions. Primary patency was assessed by angiography at 6 months, and mortality and clinically-driven target lesion revascularization (CD-TLR) were evaluated at 12 months. RESULTS: Primary patency at 6 months was 75.0% in the DCB group and 28.3% in the control group (p<0.001), while late lumen loss was 0.43±0.62 mm for DCBs vs 0.99±0.55 mm for controls (p<0.001). Freedom from CD-TLR at 12 months was 91.5% in the DCB group vs 76.8% in the controls (p=0.03); there was no significant difference in mortality (1.7% DCB vs 3.6% controls; p=0.53). CONCLUSION: This study demonstrated that the Litos/Tulip DCBs are safe and effective in treating infrapopliteal lesions, with improved angiographic and clinical outcomes vs plain balloon angioplasty. The DCBs demonstrated significantly higher primary patency with fewer CD-TLRs than conventional angioplasty. The safety of the DCBs was noninferior to that of the uncoated balloons after 1 year of follow-up.
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Angioplastia de Balón , Enfermedad Arterial Periférica , Preparaciones Farmacéuticas , Anciano , Angioplastia de Balón/efectos adversos , Materiales Biocompatibles Revestidos , Arteria Femoral , Humanos , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Arteria Poplítea/diagnóstico por imagen , Estudios Prospectivos , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
OBJECTIVE: To evaluate the outcome of thoracic endovascular repair (TEVAR) for aortic arch pathologies with surgeon modified fenestrated stent grafts. METHODS: A multicentre, retrospective study consisting of consecutive patients from seven centres treated with surgeon modified fenestrated stent grafts for aortic arch pathologies was conducted. A technique to align fenestrations and supra-aortic vessels was applied. Rates of technical success, mortality, complications, and re-interventions were evaluated. RESULTS: Between February 2016 and January 2020, 513 consecutive patients with aortic arch pathologies received TEVAR with surgeon modified fenestrated stent grafts. The technical success rate was 98.6% (n = 506). In total, 626 fenestrations were created to revascularise 684 branch arteries of the aortic arch. There were 13 deaths and 15 re-interventions within 30 days of the operation. The estimated clinical success rate at 30 days was 94.4% (95% confidence interval [CI] 92.4 - 96.4), the estimated survival at 30 days was 97.5% (95% CI 96.1 - 98.9), and the estimated freedom from re-intervention at 30 days was 97.1% (95% CI 95.7 - 98.5). The median follow up was 27 (interquartile range 13 - 31) months. During follow up, there were five aortic related deaths, three non-aortic related deaths, and four deaths of unknown cause. Eighteen patients underwent re-intervention. The estimated clinical success rate at 24 months was 88.2% (95% CI 85.5 - 91.0), the estimated survival at 24 months was 94.9% (95% CI 92.7 - 97.1), and the estimated freedom from re-intervention at 24 months was 93.1% (95% CI 91.0 - 95.3). In total, 18 cases of stroke were recorded, including 12 within 30 days and six during follow up; six cases of retrograde type A aortic dissection were recorded, including five within 30 days and one during the follow up. CONCLUSION: TEVAR with surgeon modified fenestrated stent grafts for the treatment of aortic arch pathologies provides acceptable outcomes. Further follow up is required to confirm the benefits of this approach.
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Aorta Torácica , Enfermedades de la Aorta/cirugía , Prótesis Vascular , Procedimientos Endovasculares , Stents , Anciano , Enfermedades de la Aorta/diagnóstico , Enfermedades de la Aorta/mortalidad , China , Femenino , Humanos , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Estudios Retrospectivos , Tasa de Supervivencia , Resultado del TratamientoRESUMEN
OBJECTIVE: To explore whether thoracic endovascular aortic repair (TEVAR) plus distal bare metal stent (BMS) implantation leads to favorable clinical outcomes compared with standard TEVAR in treating acute complicated type B aortic dissection. METHODS: Relevant publications were found through a precise search of PubMed, Cochrane Library, and EMBASE. Count data were calculated as the odd ratio (OR)and 95% confidence interval (CI) using the Mantel-Haenszel statistical method, quantitative data were calculated as mean difference and 95% CI using Inverse Variance statistical method. When the data heterogeneity was large, with an I2 > 50%, a random-effects model and sensitivity analysis were performed. The analysis tool we used was the software Revman 5.3 and G*power 3.1. RESULTS: There were 7 publications involving 958 patients who were enrolled ultimately. The incidence of unplanned secondary intervention and postoperative adverse events in the TEVAR + BMS were lower than standard TEVAR (OR, 0.42, (95% CI, 0.23 to 0.75); OR, 0.57, (95% CI, 0.37 to 0.90)), and the pooled number needed to treat was 15 for unplanned secondary intervention and 15 for postoperative adverse events. There were no significant difference in the aortic-related or all-cause 30-day mortality (OR, 0.81, (95% CI, 0.25 to 2.61); OR, 0.47, (95% CI, 0.18 to 1.22)), aortic-related, all-cause mortality at least 6 months or incidence of the postoperative endoleak (OR, 0.47, (95% CI, 0.17 to 1.32); OR, 0.42, (95% CI, 0.17 to 1.06); OR, 0.81, (95% CI, 0.32 to 2.05)). CONCLUSION: There is no significant outcome difference except for reduced reintervention but this does not seem to adversely affect survival. It is unclear whether this justifies the additional cost of placing it in every complicated type B aortic dissection regardless of anatomy after standard TEVAR alone. Besides, more data are needed to verify the adjunctive distal bare metal stents' performance at different dissection stages.