RESUMEN
BACKGROUND AND AIMS: Endothelial-to-mesenchymal transition (EndMT) is an important reason for restenosis but the underlying mechanisms need to be further explored. Therefore, the purpose of this study is to screen significantly different microRNAs (miRNAs) and assess their functions and downstream pathways. METHODS: This study screened several miRNAs with significant differences between human arterial segments from restenosis patients and healthy volunteers using whole transcriptome resequencing and real-time quantitative reverse transcription PCR (qRT-PCR). We explored the correlation between miR-1290 and EndMT using Western blot, qRT-PCR, Pearson correlation analysis and further functional gain and loss experiments. Subsequently, we identified the direct downstream target of miR-1290 by bioinformatics analysis, RNA pull-down, double Luciferase reporter gene and other functional experiments. Finally, rat carotid artery balloon injury model demonstrated the therapeutic potential of miR-1290 regulator. RESULTS: We screened 129 differentially expressed miRNAs. Among them, miR-1290 levels were significantly higher in restenosis arteries than in healthy arteries, and as expected, EndMT was functionally enhanced with miR-1290 overexpression and comparatively weakened when miR-1290 was knocked down. In addition, fibroblast growth factor-2 (FGF2) was established as the downstream target of miR-1290. Finally, we utilized an animal model and found that low miR-1290 levels could alleviate EndMT and the progression of restenosis. CONCLUSIONS: Our study demonstrated the strong regulatory effects of miR-1290 on EndMT, endometrial hyperplasia and restenosis, which could be useful as biomarker and therapeutic target for stent implantation in patients with arterial occlusive disease of the lower extremities.
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Factor 2 de Crecimiento de Fibroblastos , MicroARNs , Animales , Femenino , Humanos , Masculino , Ratas , Angioplastia de Balón/efectos adversos , Traumatismos de las Arterias Carótidas/genética , Traumatismos de las Arterias Carótidas/patología , Traumatismos de las Arterias Carótidas/metabolismo , Traumatismos de las Arterias Carótidas/terapia , Estudios de Casos y Controles , Proliferación Celular , Modelos Animales de Enfermedad , Células Endoteliales/metabolismo , Células Endoteliales/patología , Transición Epitelial-Mesenquimal , Factor 2 de Crecimiento de Fibroblastos/metabolismo , Factor 2 de Crecimiento de Fibroblastos/genética , Regulación de la Expresión Génica , Células Endoteliales de la Vena Umbilical Humana/metabolismo , MicroARNs/metabolismo , MicroARNs/genética , Ratas Sprague-Dawley , Transducción de SeñalRESUMEN
BACKGROUND: After drug-coated balloon (DCB) treatment of the femoropopliteal artery in-stent restenosis (ISR), a certain proportion of patients also experience target lesion restenosis. The purpose of this study was to explore the efficacy and safety of rivaroxaban combined with aspirin in the treatment of ISR after DCB intervention. METHODS: Patients who underwent DCB treatment for ISR after femoropopliteal artery intervention at our center from March 2017 to February 2022 were included consecutively. According to the drug treatment after DCB intervention of ISR, the patients were divided into rivaroxaban and aspirin group (RA Group) and dual antiplatelet therapy (DAPT) group. The outcomes of 2 groups during the 12-month follow-up after DCB intervention were compared. RESULTS: A total of 92 patients were included in final analysis, with 43 in RA group and 49 in DAPT group. During 12-month follow-up, a total of 15 cases of recurrent ISR were detected, and the recurrence rate of ISR and clinically driven target lesion revascularization in the RA group were lower than those in the DAPT group (P < 0.05). The vascular patency rate in the RA group was higher than that in the DAPT group at 6 and 12 months of follow-up (P < 0.05). During the follow-up, there were no adverse events such as death, myocardial infarction, stroke, amputation, or major bleeding, and only a total of 5 cases of minor bleeding occurred. CONCLUSIONS: Compared with the standard DAPT regimen, rivaroxaban combined with aspirin can safely improve the follow-up outcome after DCB for femoropopliteal ISR.
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Angioplastia de Balón , Aspirina , Materiales Biocompatibles Revestidos , Inhibidores del Factor Xa , Arteria Femoral , Enfermedad Arterial Periférica , Inhibidores de Agregación Plaquetaria , Arteria Poplítea , Recurrencia , Rivaroxabán , Grado de Desobstrucción Vascular , Humanos , Masculino , Femenino , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/fisiopatología , Rivaroxabán/administración & dosificación , Rivaroxabán/efectos adversos , Estudios Retrospectivos , Anciano , Aspirina/administración & dosificación , Aspirina/efectos adversos , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/fisiopatología , Enfermedad Arterial Periférica/diagnóstico por imagen , Angioplastia de Balón/instrumentación , Angioplastia de Balón/efectos adversos , Arteria Poplítea/fisiopatología , Arteria Poplítea/diagnóstico por imagen , Inhibidores de Agregación Plaquetaria/administración & dosificación , Inhibidores de Agregación Plaquetaria/efectos adversos , Persona de Mediana Edad , Resultado del Tratamiento , Factores de Tiempo , Inhibidores del Factor Xa/administración & dosificación , Inhibidores del Factor Xa/efectos adversos , Stents , Dispositivos de Acceso Vascular , Factores de Riesgo , Anciano de 80 o más Años , Terapia Antiplaquetaria DobleRESUMEN
BACKGROUND: Vessel injury is a common complication during balloon pulmonary angioplasty (BPA). For persistent hemoptysis, gelatin sponge embolization (GSE) is considered, but its impact on subsequent perfusion in embolized vessels remains unknown. This study explores the feasibility of revascularization in vessels post-GSE. METHODS: We included 64 vessels from 50 patients with chronic thromboembolic pulmonary hypertension who experienced hemoptysis during BPA in 2012-2023. Twenty-four vessels were treated conservatively (conservative group), while 40 were treated with GSE for persistent hemoptysis or desaturation despite conservative treatment (GSE group). We assessed hemoptysis-related parameters, perfusion of injured vessels pre- and post-treatment, and hemodynamic parameters through multiple BPA sessions. RESULTS: Hemoptysis resolved immediately after the procedure in 67% of patients, including 70% of those in the GSE group, and all cases resolved by the next day. Of 37 embolized vessels, 41% showed spontaneous perfusion improvement in subsequent sessions. BPA was reperformed in 22 embolized vessels, with 86% showing further improvement, resulting in 70% of all embolized vessels finally showing improvement in perfusion. In both groups, clinical and hemodynamic parameters significantly improved after BPA. CONCLUSIONS: Perfusion of embolized vessels improved after GSE, suggesting that GSE is safe for the treatment of severe persistent hemoptysis after conservative treatment.
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Angioplastia de Balón , Embolización Terapéutica , Estudios de Factibilidad , Hemoptisis , Humanos , Hemoptisis/terapia , Hemoptisis/etiología , Masculino , Femenino , Persona de Mediana Edad , Angioplastia de Balón/métodos , Angioplastia de Balón/efectos adversos , Embolización Terapéutica/métodos , Anciano , Esponja de Gelatina Absorbible , Estudios Retrospectivos , Hipertensión Pulmonar/etiología , Hipertensión Pulmonar/terapia , Resultado del Tratamiento , Adulto , Embolia Pulmonar/terapia , Embolia Pulmonar/etiología , Arteria PulmonarRESUMEN
Background: Controversy persists concerning the endovascular treatment of the post-thrombotic syndrome (PTS), particularly if femoropopliteal veins are involved. Methods: We screened consecutive patients with PTS who underwent percutaneous transluminal angioplasty (PTA) of femoropopliteal veins using posterior tibial or popliteal vein access who had at least 3-month follow-up. Our assessment included the evaluation of primary and secondary patency of the treated segments by Doppler ultrasound (DUS) and clinical outcomes measured by the change in Villalta score as well as ulcer healing. Results: Among 29 patients, 8 (27.7%) were women and the mean (SD) age was 53.3 (13.6) years. Posterior tibial vein and popliteal access were used in 26 (89.7%) and 3 patients (10.3%), respectively. 13 (44.8%) patients had prior (n = 11, 37.9%) or concomitant (n = 9, 31.0%) endovascular treatment of the iliac or common femoral veins. At a median follow-up of 395 days (Q1: 205-Q3: 756 days), primary patency of femoropopliteal veins was 79.3% (95% CI 64.6-94.1%) and secondary patency was 82.8% (95% CI, 69.0-96.5%). The percentage of patients with moderate or severe PTS according to the Villalta score decreased from baseline to last follow-up from 34.5% to 18.5% and from 31% to 14.8%, respectively (p<0.003). Overall, the mean (SD) Villalta score decreased from 11.5 (1.7) to 8.0 (1.7) (p<0.0001). Postprocedural complete ulcer healing occurred in 4 out of 5 (80%) patients. Two (6.9%) patients developed new ulcers. No major bleeding, pulmonary embolism, stroke, or death occurred. Conclusion: PTA of femoropopliteal veins via posterior tibial or popliteal vein access appears to improve the severity of PTS with acceptable patency rates.
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Vena Femoral , Vena Poplítea , Síndrome Postrombótico , Grado de Desobstrucción Vascular , Humanos , Femenino , Síndrome Postrombótico/terapia , Síndrome Postrombótico/fisiopatología , Síndrome Postrombótico/diagnóstico por imagen , Masculino , Persona de Mediana Edad , Resultado del Tratamiento , Vena Poplítea/diagnóstico por imagen , Vena Poplítea/fisiopatología , Vena Femoral/diagnóstico por imagen , Vena Femoral/fisiopatología , Factores de Tiempo , Adulto , Anciano , Angioplastia de Balón/efectos adversos , Cicatrización de Heridas , Estudios Retrospectivos , Ultrasonografía Doppler , Úlcera Varicosa/terapia , Úlcera Varicosa/fisiopatología , Úlcera Varicosa/diagnóstico por imagenRESUMEN
BACKGROUND: The study aims to evaluate the association of proximal flow-inversion cerebral protection and MicroNet-covered CGuard stents in reducing early and late embolic events in carotid artery stenting procedures. METHODS: From 2018 to 2023, we performed 204 procedures in 180 patients with flow inversion cerebral protection and CGuard stents at the Vascular Surgery Unit of Sant'Eugenio Hospital in Rome. Cerebral protection was achieved with a Flow-Gate2 catheter connected to a peripheral vein. The tip balloon is inflated in the CCA to obtain an effective endoclamping, the pressure difference between the carotid bifurcation and the venous compartment ensures a constant back flow with wash-out in the venous compartment. Inclusion criteria were: life expectancy of >12 months, target lesions indicating treatment according to ESVS Guidelines, increased surgical risk due to comorbidities or anatomic issues. ECD follow-up was performed immediately postoperatively, at 30 days, 6 and 12 months, and subsequently annually. RESULTS: The treatment protocol was successfully implemented in 99% of cases. No major strokes occurred, while one minor stroke (0.5%) occurred within 8 hours of the procedure, regressing in the following months. One perioperative death (0.5%) due to cerebral hemorrhage occurred three hours after the procedure. All patients remained asymptomatic, with no short or medium-term neurological score deterioration. One hemodynamically significant restenosis (0.5%) was detected at the 6-month follow-up. All patients completed the 6 months follow-up, though 6 (3%) were lost at the 12-month appointment. CONCLUSIONS: Our prospective monocentric study has demonstrated the effectiveness and safety of the FlowGate2 flow inversion cerebral protection system in association with MicroNet covered CGuard stent.
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Estenosis Carotídea , Dispositivos de Protección Embólica , Diseño de Prótesis , Stents , Humanos , Femenino , Masculino , Anciano , Estenosis Carotídea/complicaciones , Estenosis Carotídea/fisiopatología , Estenosis Carotídea/cirugía , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/terapia , Resultado del Tratamiento , Factores de Tiempo , Circulación Cerebrovascular , Persona de Mediana Edad , Anciano de 80 o más Años , Factores de Riesgo , Ciudad de Roma , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/instrumentación , Embolia Intracraneal/prevención & control , Embolia Intracraneal/etiología , Estudios ProspectivosRESUMEN
BACKGROUND: Sirolimus-coated balloons (SCB) for the treatment of femoropopliteal (FP) lesions have not been systematically studied, but initial outcomes from early studies are promising. OBJECTIVES: The authors sought to evaluate the safety and efficacy of the SELUTION SLR SCB, composed of proprietary microreservoir technology combining sirolimus and biodegradable polymer, when used to treat mild-to-moderate FP disease in a Japanese population. METHODS: This multicenter, prospective, single-arm study (SELUTION SFA JAPAN) enrolled 134 patients with FP disease. It was independently adjudicated by an imaging core laboratory and clinical events committee. The primary endpoint was 12-month primary patency, defined as peak systolic velocity ratio ≥2.5 by duplex ultrasound and compared against a prespecified performance goal of 60% based on established angioplasty data. RESULTS: The mean age was 73.8 ± 6.9 years, and 60.3% of patients had diabetes mellitus. The mean lesion length was 127.4 ± 59.7 mm, 17.2% were chronic total occlusions, and 47.8% involved the popliteal artery. Data on 12-month restenosis were available in 127 patients (94.8%). The 12-month primary patency rate was 87.9%, and the freedom from clinically driven target lesion revascularization (CD-TLR) was 97.0% per Kaplan-Meier estimate. The major adverse event rate was 6.7%, driven by 4 CD-TLRs and 5 deaths, none of which were related to the device or procedure. Ankle-brachial index data improved significantly from 0.73 ± 0.16 at baseline to 0.96 ± 0.14 at 30 days postprocedure and was sustained through 12 months (0.94 ± 0.13). CONCLUSIONS: The SELUTION SFA JAPAN trial demonstrated that a novel SELUTION SCB is a safe and effective treatment option for FP disease in symptomatic patients.
Asunto(s)
Angioplastia de Balón , Fármacos Cardiovasculares , Materiales Biocompatibles Revestidos , Arteria Femoral , Enfermedad Arterial Periférica , Arteria Poplítea , Sirolimus , Dispositivos de Acceso Vascular , Grado de Desobstrucción Vascular , Humanos , Arteria Poplítea/fisiopatología , Arteria Poplítea/diagnóstico por imagen , Anciano , Masculino , Femenino , Arteria Femoral/fisiopatología , Arteria Femoral/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/fisiopatología , Enfermedad Arterial Periférica/diagnóstico por imagen , Estudios Prospectivos , Japón , Fármacos Cardiovasculares/administración & dosificación , Fármacos Cardiovasculares/efectos adversos , Angioplastia de Balón/instrumentación , Angioplastia de Balón/efectos adversos , Factores de Tiempo , Sirolimus/administración & dosificación , Sirolimus/efectos adversos , Anciano de 80 o más Años , Recurrencia , Resultado del Tratamiento , Diseño de Equipo , Factores de Riesgo , Persona de Mediana EdadRESUMEN
BACKGROUND: Endovascular therapy has become established as a first-line therapy in most arterial regions. However, open vascular surgery (endarterectomy) remains the treatment of choice for common femoral artery (CFA) lesions. The aim of this study is to investigate the acute and mid-term results of directional atherectomy plus drug-coated balloon (DCB) in comparison to endarterectomy in treatment of de novo arteriosclerotic CFA lesions. METHODS: This prospective, randomized, multicenter non-inferiority study will enroll 306 participants with symptomatic (Rutherford category 1 to 5) de novo stenosis of the CFA including the bifurcation. Patients eligible for both treatment groups could be included in this 1:1 randomized trial. Primary efficacy endpoint is patency of the target lesion at 12 months defined as restenosis < 50% without the need of clinically driven target lesion revascularization (cdTLR). Primary safety endpoint is a combined endpoint including death, myocardial infarction, major or minor amputation of the target limb, and peri-procedural complications at 30 days. Secondary endpoints include primary patency of the target lesion at 6 and 24 months, secondary patency, cdTLR 6, 12, and 24 months, change in ankle-brachial index, and Rutherford-Becker class at 6, 12, and 24 months. Limb salvage, change in quality of life measured by Walking Impairment Questionnaire, and major adverse events including death, myocardial infarction, and minor or major amputation of the target limb will be determined at 6, 12, 24, and 36 months. DISCUSSION: Endovascular treatment of CFA lesions is still a matter of debate. Few studies compared modern endovascular therapy methods against the so-called gold standard surgical endarterectomy so far. Based on recent positive results, this study aims to confirm non-inferiority of a "leaving nothing behind" endovascular approach combining directional atherectomy and DCB compared to surgical therapy. TRIAL REGISTRATION: ClinicalTrials.gov NCT02517827.
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Endarterectomía , Arteria Femoral , Enfermedad Arterial Periférica , Grado de Desobstrucción Vascular , Humanos , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/métodos , Angioplastia de Balón/instrumentación , Aterectomía/efectos adversos , Aterectomía/métodos , Materiales Biocompatibles Revestidos , Endarterectomía/efectos adversos , Endarterectomía/métodos , Estudios de Equivalencia como Asunto , Arteria Femoral/cirugía , Recuperación del Miembro , Estudios Multicéntricos como Asunto , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/cirugía , Enfermedad Arterial Periférica/fisiopatología , Estudios Prospectivos , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Tiempo , Resultado del Tratamiento , Dispositivos de Acceso VascularRESUMEN
To investigate the effect and safety of percutaneous endovascular angioplasty (PEA) with optional stenting for the treatment of severe stenosis or occlusion of subclavian artery, patients with severe stenosis ≥ 70% or occlusion of subclavian artery treated with PEA were retrospectively enrolled. The clinical data were analyzed. A total of 222 patients were retrospectively enrolled, including 151 males (68.0%) and 71 females (32.0%) aged 48-86 (mean 63.9 ± 9.0) years. Forty-seven (21.2%) patients had comorbidities. Subclavian artery stenosis ≥ 70% was present in 201 (90.5%) patients and complete subclavian occlusion in 21 (9.5%) cases. Angioplasty was successfully performed in all (100%) patients. Balloon-expandable stents were used in 190 (85.6%) cases, and self-expandable stents in 20 (9.0%) cases. Only 12 (5.4%) cases were treated with balloon dilation only. Among 210 patients treated with stent angioplasty, 71 (33.8% or 71/210) cases underwent balloon pre-dilation, 139 (66.2% or 139/210) had direct deployment of balloon-expandable stents, and 2 (1.0% or 2/210) experienced balloon post-dilation. Distal embolization protection devices were used in 5 (2.3% or 5/222) cases. Periprocedural complications occurred in 3 (1.4%) patients, including aortic dissection in 2 (0.9%) cases and right middle cerebral artery embolism in 1 (0.5%). No hemorrhage occurred. Among 182 (82.0%) patients with 6-month follow-up, restenosis > 70% occurred in 1 (0.5%) patient, and among 68 (30.6%) patients with 12-month follow-up, restenosis > 70% took place in 11 (16.2%) patients. Percutaneous endovascular angioplasty can be safely and efficiently performed for the treatment of severe stenosis ≥ 70% or occlusion of subclavian artery.
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Stents , Arteria Subclavia , Humanos , Masculino , Femenino , Anciano , Persona de Mediana Edad , Anciano de 80 o más Años , Arteria Subclavia/cirugía , Estudios Retrospectivos , Stents/efectos adversos , Resultado del Tratamiento , Síndrome del Robo de la Subclavia/terapia , Síndrome del Robo de la Subclavia/cirugía , Procedimientos Endovasculares/métodos , Procedimientos Endovasculares/efectos adversos , Angioplastia/métodos , Angioplastia/efectos adversos , Constricción Patológica/terapia , Angioplastia de Balón/métodos , Angioplastia de Balón/efectos adversos , Arteriopatías Oclusivas/terapia , Arteriopatías Oclusivas/cirugíaRESUMEN
BACKGROUND: Drug-eluting devices improved outcomes of endovascular therapy (EVT) for femoropopliteal lesions, but mainly for de novo lesions. Endovascular therapy for in-stent restenosis/occlusion (ISR/O) is challenging, and large trials and long-term data are not well reported. MATERIALS AND METHODS: This study is a physician initiated, multicenter, and retrospective design. From 7 Japanese institutes, 3635 femoropopliteal cases were enrolled in the study. Among these, 346 cases of first ISR/O were studied. We defined drug-coated-balloon, drug-eluting stent, and covered stent as New devices. Balloon angioplasty and bare nitinol stent were included in the control group. RESULTS: The propensity score matching extracted 112 pairs. At 12 months, the primary patency rate was 80.3% in the new device group and 52.7% in the control group, and there was a significant intergroup difference (P = .004). However, at 36 months, the rate was 43.3% vs 39.2%, with no significant difference (P = .090). No baseline characteristics had any significant interaction effect (all P > .05). CONCLUSIONS: The New devices were more effective than the control group for ISR/O at 1 year, but caught up at 3 years.
Asunto(s)
Angioplastia de Balón , Materiales Biocompatibles Revestidos , Stents Liberadores de Fármacos , Arteria Femoral , Enfermedad Arterial Periférica , Arteria Poplítea , Diseño de Prótesis , Recurrencia , Stents , Grado de Desobstrucción Vascular , Humanos , Arteria Femoral/fisiopatología , Arteria Femoral/diagnóstico por imagen , Arteria Poplítea/fisiopatología , Arteria Poplítea/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/fisiopatología , Enfermedad Arterial Periférica/diagnóstico por imagen , Masculino , Estudios Retrospectivos , Femenino , Anciano , Factores de Tiempo , Resultado del Tratamiento , Angioplastia de Balón/instrumentación , Angioplastia de Balón/efectos adversos , Japón , Factores de Riesgo , Persona de Mediana Edad , Anciano de 80 o más Años , Aleaciones , Dispositivos de Acceso Vascular , Constricción Patológica , Estudios de SeguimientoRESUMEN
Background: The purpose was to analyze the use of classical music to reduce procedure-related anxiety while conducting percutaneous transluminal angioplasty in patients with peripheral artery disease. Patients and methods: A total of 155 patients were analyzed in this single center randomized controlled trial. Procedure-related anxiety was assessed by a numerical rating scale (NRS, 0-10) and by recording of physiological parameters at three different points in time. A survey was conducted after the intervention. Results: This study showed that the patients listened to music overcame their procedure-related anxiety more quickly than the patients in the control group. The NRS at second timepoint was significantly reduced in intervention group compared to control group (p<0.01; r=0.2). Most participants stated that they would like to listen to music during possible future interventions. Conclusions: Classical music during endovascular interventions reduced procedure-related anxiety measured as greater reduction in NRS values in intervention group as well as in results of questionnaire performed post procedurally in PAD patients.
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Ansiedad , Musicoterapia , Enfermedad Arterial Periférica , Humanos , Femenino , Masculino , Ansiedad/prevención & control , Ansiedad/psicología , Ansiedad/etiología , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/fisiopatología , Anciano , Resultado del Tratamiento , Persona de Mediana Edad , Factores de Tiempo , Encuestas y Cuestionarios , Angioplastia de Balón/efectos adversosRESUMEN
OBJECTIVE: The aim of this study was to compare the efficacy of different endovascular revascularisation procedures for treating chronic limb threatening ischaemia (CLTI) using network meta-analysis (NMA). DATA SOURCES: The databases PubMed and Cochrane Central Register for Controlled Trials were searched on 14 March 2023. REVIEW METHODS: A NMA of randomised controlled trials (RCTs) reporting the efficacy of different endovascular revascularisation techniques for treating CLTI was performed according to PRISMA guidelines. The primary and secondary outcomes were major amputation and death, respectively. Random effects models were developed and the results were presented using surface under the cumulative ranking curve plots and forest plots. A p value of ≤ .050 was considered statistically significant. The Cochrane collaborative tool was used to assess risk of bias. RESULTS: A total of 2 655 participants of whom 94.8% had CLTI were included. Eleven trials compared plain balloon angioplasty (PBA) vs. drug coated balloon (DCB) angioplasty (n = 1 771), five trials compared bare metal stent (BMS) vs. drug coated stent (DCS) (n = 466), three trials compared atherectomy vs. DCB (n = 194), two trials compared PBA vs. BMS (n = 70), one trial compared PBA vs. atherectomy (n = 50), and one trial compared BMS vs. DCB (n = 104). None of the revascularisation strategies significantly reduced the risk of major amputation or death compared with PBA. Using the network estimates, GRADE certainty of evidence for improvement in major amputation outcomes for DCB was moderate, for atherectomy and BMS was low, and for DCS was very low compared with PBA. Risk of bias was low in 16 trials, of some concerns in six trials, and high in one trial, respectively. CONCLUSION: There is no current evidence from RCTs to reliably conclude that BMS, DCB, DCS, or atherectomy are superior to PBA in preventing major amputation and death in patients with CLTI. Larger comparative RCTs are needed to identify the best endovascular revascularisation strategy.
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Amputación Quirúrgica , Isquemia Crónica que Amenaza las Extremidades , Procedimientos Endovasculares , Recuperación del Miembro , Metaanálisis en Red , Enfermedad Arterial Periférica , Ensayos Clínicos Controlados Aleatorios como Asunto , Humanos , Enfermedad Arterial Periférica/mortalidad , Enfermedad Arterial Periférica/cirugía , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/complicaciones , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Amputación Quirúrgica/estadística & datos numéricos , Resultado del Tratamiento , Isquemia Crónica que Amenaza las Extremidades/cirugía , Stents , Angioplastia de Balón/efectos adversosRESUMEN
BACKGROUND: Stent implantation has become standard of care in older children and adults for treatment of branch pulmonary artery stenosis (BPAS) and coarctation aorta (CoAo). There are no stents approved or available for infants that have the potential to be dilated to adult diameters. The Minima stent was designed to fulfill this unmet need. METHODS: Multicenter, prospective, nonrandomized early feasibility study evaluating safety and effectiveness of the Minima stent for treatment of BPAS and CoAo. Primary endpoints included: (1) successful deployment across lesion, (2) stenosis relief defined by an increase in angiographic diameter of >50% and (3) freedom from stent explant, embolization or migration at 30 days and 6 months. RESULTS: Between 2/2022 and 5/2022, 10 pts underwent Minima stent implantation with a median age and weight of 9 months (4-43 months) and 7.6 kg (5.1-16.9 kg). Procedural success and predefined stenosis relief was achieved in all cases (CoAo [n = 4], BPAS [n = 6]). Adverse events occurred in 3 pts: transient diminished lower extremity pulse (n = 2), distal stent on-balloon displacement successfully managed in the catheterization suite (n = 1). There were no deaths or major adverse events. All patients were free from stent explant and migration at 30 days and 6 months with no evidence for significant restenosis at latest follow-up. CONCLUSIONS: Implantation of the Renata Minima stent was safe and effective for the treatment of BPAS and CoAo in this small cohort of infants and young children during early follow-up. Based on these early results, an expanded study with longer follow-up is warranted.
Asunto(s)
Coartación Aórtica , Estudios de Factibilidad , Diseño de Prótesis , Estenosis de Arteria Pulmonar , Stents , Humanos , Coartación Aórtica/diagnóstico por imagen , Coartación Aórtica/terapia , Coartación Aórtica/fisiopatología , Lactante , Estudios Prospectivos , Masculino , Femenino , Resultado del Tratamiento , Estenosis de Arteria Pulmonar/diagnóstico por imagen , Estenosis de Arteria Pulmonar/fisiopatología , Estenosis de Arteria Pulmonar/terapia , Estenosis de Arteria Pulmonar/etiología , Factores de Tiempo , Preescolar , Arteria Pulmonar/diagnóstico por imagen , Arteria Pulmonar/fisiopatología , Factores de Edad , Angioplastia de Balón/instrumentación , Angioplastia de Balón/efectos adversosRESUMEN
BACKGROUND: Limited comparative data exist on different interventional strategies for endovascular revascularization of complex femoropopliteal interventions. OBJECTIVES: In this study, the authors aimed to compare a stent-avoiding (SA) vs a stent-preferred (SP) strategy, promoting optimal lesion preparation and the use of drug-eluting technologies in both arms. METHODS: Within a prospective, multicenter, pilot study, 120 patients with symptomatic complex femoropopliteal lesions (Rutherford classification 2-4, mean lesion length 187.7 ± 78.3 mm, 79.2% total occlusions) were randomly assigned in a 1:1 fashion to endovascular treatment with either paclitaxel-coated balloons or polymer-coated, paclitaxel-eluting stents. Lesion preparation including the use of devices for plaque modification and/or removal was at the operators' discretion in both treatment arms. RESULTS: In the SA group, lesion preparation was more frequently performed (71.7% SA [43/60] vs 51.7% [31/60] SP; P = 0.038) with a high provisional stenting rate (48.3% [29/60]). At the 12-month follow-up, primary patency was 78.2% (43/55) in the SA group and 78.6% (44/56) in the SP group (P = 1.0; relative risk: 0.995; 95% CI: 0.818-1.210). Freedom from major adverse events was determined in 93.1% (54/58) in the SA group and in 94.9% (56/59) in the SP group (P = 0.717; relative risk: 0.981; 95% CI: 0.895-1.075), with all adverse events attributable to clinically driven target lesion revascularization. CONCLUSIONS: Both endovascular strategies promoting lesion preparation before the use of drug-eluting devices suggest promising efficacy and safety results in complex femoropopliteal procedures with a high proportion of total occlusions through 12 months. Ongoing follow-up will show whether different results emerge over time. (Best Endovascular Strategy for Complex Lesions of the Superficial Femoral Artery [BEST-SFA]; NCT03776799).
Asunto(s)
Fármacos Cardiovasculares , Materiales Biocompatibles Revestidos , Stents Liberadores de Fármacos , Arteria Femoral , Enfermedad Arterial Periférica , Arteria Poplítea , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Angioplastia de Balón/instrumentación , Angioplastia de Balón/efectos adversos , Fármacos Cardiovasculares/administración & dosificación , Fármacos Cardiovasculares/efectos adversos , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/fisiopatología , Paclitaxel/administración & dosificación , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/fisiopatología , Proyectos Piloto , Arteria Poplítea/diagnóstico por imagen , Arteria Poplítea/fisiopatología , Estudios Prospectivos , Diseño de Prótesis , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Dispositivos de Acceso Vascular , Grado de Desobstrucción VascularRESUMEN
For patients with Chronic Limb Threatening Ischemia (CLTI), endovascular approaches to revascularization are often employed as a component of multimodality care aimed at limb preservation. However, patients with CLTI are also prone to treatment failure, particularly following balloon angioplasty alone. Drug-coated devices utilizing Paclitaxel were developed to decrease restenosis but have been primarily studied in patients presenting with claudication. In recent years, data have emerged which describe the efficacy of drug-coated devices in the treatment of patients with CLTI. Concurrently, there has been major controversy surrounding the use of drug-coated devices in peripheral arterial disease. A historical narrative of the development and use of drug-coated devices for peripheral arterial disease is presented, along with discussion of major trials. Evidence argues that paclitaxel-based therapies for peripheral arterial disease (PAD) do not increase mortality risk compared to nondrug-coated devices. In CLTI patients, paclitaxel-based balloons and stents provide superior patency and freedom reintervention compared to nondrug-coated devices when treating femoropopliteal disease. However, the use of Paclitaxel-based therapies for below-the-knee (BTK) interventions has not been shown to provide clinically meaningful outcomes compared to nondrug-based therapies. Newer generation antiproliferative agents (Sirolimus, Everolimus) and delivery systems (bioabsorbable scaffolds) hold promise for BTK interventions with early data suggesting decreased rates of major amputation or major adverse limb events.
Asunto(s)
Fármacos Cardiovasculares , Isquemia Crónica que Amenaza las Extremidades , Materiales Biocompatibles Revestidos , Stents Liberadores de Fármacos , Enfermedad Arterial Periférica , Grado de Desobstrucción Vascular , Humanos , Fármacos Cardiovasculares/administración & dosificación , Fármacos Cardiovasculares/efectos adversos , Fármacos Cardiovasculares/uso terapéutico , Resultado del Tratamiento , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/fisiopatología , Factores de Riesgo , Recuperación del Miembro , Angioplastia de Balón/instrumentación , Angioplastia de Balón/efectos adversos , Paclitaxel/administración & dosificación , Paclitaxel/efectos adversos , Dispositivos de Acceso Vascular , Diseño de Prótesis , Difusión de Innovaciones , Isquemia/terapia , Isquemia/fisiopatología , Isquemia/mortalidad , Historia del Siglo XXI , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/efectos adversosRESUMEN
PURPOSE: The aim of this study was to determine if postprocedural peripheral fractional flow reserve (pFFR) is associated with patency one year after drug-coated balloon (DCB) angioplasty for femoropopliteal (FP) lesions. MATERIALS AND METHODS: Forty-five consecutive patients having 49 de novo FP lesions were enrolled in this prospective, observational study conducted from April 2022 to Aug 2023. The pFFR was measured under hyperemic conditions after the administration of 30 mg of papaverine. The relationship between pFFR and restenosis 12 months after the procedure was determined using receiver operating characteristic (ROC) curve analysis. RESULTS: The one-year follow-up was completed for 47 lesions (95.9 %). Restenosis was detected in 7 lesions (14.9 %). Postprocedural pFFR was significantly higher in the nonrestenosis group compared with the pFFR in the stenosis group (0.95 ± 0.054 vs. 0.88 ± 0.090, p = 0.010). The optimal pFFR cutoff value for predicting restenosis was 0.92 (sensitivity, 0.824; specificity, 0.600). The area under the curve for pFFR was numerically higher than the area under the curve for minimum lumen area (0.73 vs. 0.64, p = 0.22). Rates of freedom from restenosis at one year were significantly higher in the pFFR >0.92 group compared with the pFFR ≤0.92 group (p = 0.0042). CONCLUSION: Postprocedural pFFR was associated with patency at one year after DCB angioplasty for FP lesions.
Asunto(s)
Angioplastia de Balón , Materiales Biocompatibles Revestidos , Arteria Femoral , Enfermedad Arterial Periférica , Arteria Poplítea , Recurrencia , Dispositivos de Acceso Vascular , Grado de Desobstrucción Vascular , Humanos , Masculino , Arteria Femoral/fisiopatología , Arteria Femoral/diagnóstico por imagen , Femenino , Angioplastia de Balón/instrumentación , Angioplastia de Balón/efectos adversos , Estudios Prospectivos , Anciano , Enfermedad Arterial Periférica/fisiopatología , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/diagnóstico , Resultado del Tratamiento , Arteria Poplítea/fisiopatología , Arteria Poplítea/diagnóstico por imagen , Persona de Mediana Edad , Factores de Tiempo , Factores de Riesgo , Vasodilatadores/administración & dosificación , Anciano de 80 o más Años , Flujo Sanguíneo Regional , Papaverina/administración & dosificaciónRESUMEN
BACKGROUND: Sirolimus-coated balloon (SCB) is a potential treatment option for peripheral arterial disease (PAD). There are currently no long-term clinical data for this novel treatment for PAD. We present the 3-year results of the first-in-human study of MagicTouch PTA SCB for treatment of PAD for both femoropopliteal and below-the-knee arteries. METHODS: The XTOSI pilot study is a prospective, single-arm, open-label, single-center trial evaluating MagicTouch PTA SCB for symptomatic PAD. Assessments through 3 years included freedom from clinically driven target lesion revascularization (CD-TLR), freedom from major amputation, amputation-free survival (AFS), overall survival, and ulcer-free status. RESULTS: At 3 years, the overall freedom from CD-TLR was 84.4%, freedom from major amputation was 86.1%, AFS was 63.3%, overall survival was 63.3%, and ulcer-free status in remaining survivors with intact limbs was 100%. For femoropopliteal lesions, at 3 years, the freedom from CD-TLR was 92.9%, freedom from major amputation was 93.3%, AFS was 70%, and overall survival was 70%. For below-the-knee lesions, at 3 years, the freedom from CD-TLR was 77.8%, freedom from major amputation was 81.0%, AFS was 58.6%, and overall survival was 58.6%. CONCLUSIONS: SCB in the XTOSI pilot study showed promising clinical results sustained to 3 years, and no long-term safety concerns were raised. Randomized trials are currently ongoing to investigate the safety and efficacy of SCB for treatment of PAD.
Asunto(s)
Amputación Quirúrgica , Angioplastia de Balón , Fármacos Cardiovasculares , Materiales Biocompatibles Revestidos , Arteria Femoral , Recuperación del Miembro , Enfermedad Arterial Periférica , Arteria Poplítea , Supervivencia sin Progresión , Sirolimus , Dispositivos de Acceso Vascular , Grado de Desobstrucción Vascular , Humanos , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/fisiopatología , Enfermedad Arterial Periférica/mortalidad , Enfermedad Arterial Periférica/diagnóstico por imagen , Arteria Poplítea/fisiopatología , Arteria Poplítea/diagnóstico por imagen , Masculino , Arteria Femoral/fisiopatología , Arteria Femoral/diagnóstico por imagen , Angioplastia de Balón/instrumentación , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/mortalidad , Estudios Prospectivos , Anciano , Femenino , Proyectos Piloto , Factores de Tiempo , Fármacos Cardiovasculares/administración & dosificación , Fármacos Cardiovasculares/efectos adversos , Sirolimus/administración & dosificación , Sirolimus/efectos adversos , Persona de Mediana Edad , Factores de Riesgo , Anciano de 80 o más Años , Resultado del TratamientoRESUMEN
BACKGROUND: Endovascular treatment (EVT) for aortoiliac (AI) occlusive lesions is now conducted worldwide, but there are challenges in EVT for complex AI lesions. The VIABAHN VBX (W.L. Gore & Associates, Flagstaff, AZ) is a next-generation balloon-expandable covered stent designed for use with complex AI lesions. The purpose of this study is to evaluate the medium-term outcomes of VIABAHN VBX for such lesions. METHODS: Symptomatic patients who underwent EVT with VIABAHN VBX for an AI lesion from 2018 to 2020 at 7 Japanese centers were reviewed retrospectively. The primary endpoints were primary patency and freedom from target lesion revascularization (TLR). RESULTS: A total of 95 EVT procedures with VIABAHN VBX for AI occlusive lesions were performed in 71 patients. The patients had high rates of dyslipidemia (53%) and chronic kidney disease (61%), and 22% had chronic limb-threatening ischemia (CLTI). The Transatlantic Inter-Society Consensus (TASC â ¡) class was A in 12 patients (17%), B in 12 (17%), C in 10 (14%), and D in 37 (52%). Severe calcification (360°) of the treated lesion was present in 31 patients (33%). The median procedure time was 84 (49-158) min, with a technical success rate of 100%. The median follow-up period was 36 (32-43) months. The 3-year primary and secondary patency of VIABAHN VBX were 91% and 99%, the 3-year freedom from TLR was 92%, and the 3-year freedom from major adverse limb event (MALE) was 98%. No limbs required major amputation. Lesion severity (TASC â ¡ C or D) and severe calcification did not affect the primary patency or freedom from TLR. CONCLUSIONS: Medium-term outcomes after EVT with VIABAHN VBX for AI lesions were acceptable regardless of lesion severity and calcification. These results suggest that VIABAHN VBX may be suitable for AI occlusive lesions with severe anatomical complexity and/or severe calcification.
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Enfermedades de la Aorta , Arteria Ilíaca , Enfermedad Arterial Periférica , Diseño de Prótesis , Stents , Grado de Desobstrucción Vascular , Humanos , Masculino , Femenino , Anciano , Estudios Retrospectivos , Arteria Ilíaca/fisiopatología , Arteria Ilíaca/diagnóstico por imagen , Arteria Ilíaca/cirugía , Factores de Tiempo , Enfermedad Arterial Periférica/fisiopatología , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Persona de Mediana Edad , Enfermedades de la Aorta/diagnóstico por imagen , Enfermedades de la Aorta/fisiopatología , Enfermedades de la Aorta/cirugía , Japón , Resultado del Tratamiento , Anciano de 80 o más Años , Angioplastia de Balón/instrumentación , Angioplastia de Balón/efectos adversos , Factores de Riesgo , Recuperación del MiembroRESUMEN
OBJECTIVE: Most surgeons employ an endovascular-first approach to the treatment of peripheral arterial disease (PAD), but controversy remains regarding the ideal interventions for the management of isolated popliteal artery disease (IPAD). Indeed, there are a paucity of data that compare outcomes of popliteal stents vs other peripheral vascular interventions (PVIs). The goal of this study was to evaluate outcomes of PVIs in IPAD. METHODS: The Vascular Study Group of New England database was queried for all IPAD PVIs performed for atherosclerotic occlusive disease from 2010 to 2021. Those with at least 1 year of follow-up data available were included for analysis. The primary endpoint was 1-year freedom from a composite target lesion (TL) treatment failure that included restenosis >50% on duplex, reintervention, or ipsilateral major amputation. RESULTS: We included 689 procedures performed on 634 patients. Of these, 250 (36.3%) were treated with plain balloons (POBA), 215 (31.2%) had stents, 170 (24.7%) had special balloons (drug-coated, cutting, or lithotripsy), and 54 (7.8%) atherectomies were performed. Stent placement was associated with lower freedom from TL treatment failure (72.6%) than special balloon (81.2%; P = .048) and atherectomy (88.9%; P = .012), but not POBA (76.8%; P = .293). On multivariable logistic regression, stents (odds ratio, 0.637; P = .021) and preoperative P2Y12 inhibitor therapy (odds ratio, 0.683; P = .048) were both associated with lower freedom from intervention failure. CONCLUSIONS: Popliteal stent placement is associated with a higher rate of TL treatment failure at 1 year when compared with other PVIs including special balloon angioplasty and atherectomy, but not POBA, and should therefore be avoided in favor of special balloons or atherectomy whenever feasible.
Asunto(s)
Angioplastia de Balón , Enfermedad Arterial Periférica , Arteria Poplítea , Stents , Humanos , Arteria Poplítea/diagnóstico por imagen , Arteria Poplítea/cirugía , Masculino , Femenino , Anciano , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/cirugía , Persona de Mediana Edad , Estudios Retrospectivos , Angioplastia de Balón/instrumentación , Angioplastia de Balón/efectos adversos , Factores de Tiempo , Aterectomía/efectos adversos , Bases de Datos Factuales , Resultado del Tratamiento , Amputación Quirúrgica , Factores de Riesgo , Recuperación del Miembro , Grado de Desobstrucción Vascular , Anciano de 80 o más Años , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/efectos adversos , New England , Medición de RiesgoRESUMEN
BACKGROUND: Transverse aortic arch obstruction is a challenging lesion for which stent implantation provides a potentially important alternate therapy. The objectives were to evaluate the technical, procedural, and medium-to-long-term clinical outcomes of percutaneous stent implantation of transverse aortic arch obstruction. METHODS: This is a retrospective, multicenter study of transverse aortic arch stent implantation. Univariable and multivariable analyses were performed. RESULTS: Index catheterization included 187 stent implants in 146 patients. The median age is 14.3 years (interquartile range, 9.3-19), weight is 53 kg (30-69), and follow-up is 53 months (12-120). The most common stent design was open cell (n=90, 48%). Stents overlapped 142 arch vessels (37 carotid arteries) in 118 (81%) cases. Technical and procedural success rates were 100% and 88%, respectively. Lower weight (P=0.018), body surface area (P=0.013), and minimum-to-descending aortic diameter ratio (P<0.001) were associated with higher baseline aortic gradient. The residual gradient was inversely associated with implant and final dilation diameters (P<0.001). The combined incidence of aortic injury and stent-related complications was 14%. There were no reports of abnormal brain scans or stroke. Blood pressure cuff gradient, echocardiographic arch velocity, and hypertension rates improved within 1-year follow-up with increased antihypertensive medication use. Reintervention was reported in 60 (41%) patients at a median of 84 (22-148) months to first reintervention. On multivariable logistic regression, residual aortic gradient >10 mmâ Hg was associated with increased odds of reintervention at all time points when controlling for each final dilation diameter, weight, and minimum-to-descending aortic diameter ratio. CONCLUSIONS: Transverse aortic arch stent implantation has high rates of technical, procedural, and medium-to-long-term clinical success. Aortic gradient >10 mmâ Hg is associated with increased odds of reintervention at 1-year and most recent follow-ups. Open cell stent design was frequently used for its advantages in conformability, perfusion of arch vessels, low fracture rate, and the ability to perform effective angioplasty of side cells.
Asunto(s)
Angioplastia de Balón , Aorta Torácica , Diseño de Prótesis , Stents , Humanos , Estudios Retrospectivos , Masculino , Femenino , Aorta Torácica/diagnóstico por imagen , Aorta Torácica/cirugía , Aorta Torácica/fisiopatología , Resultado del Tratamiento , Factores de Tiempo , Factores de Riesgo , Adolescente , Adulto Joven , Angioplastia de Balón/instrumentación , Angioplastia de Balón/efectos adversos , Niño , Enfermedades de la Aorta/diagnóstico por imagen , Enfermedades de la Aorta/terapia , Enfermedades de la Aorta/fisiopatología , Arteriopatías Oclusivas/diagnóstico por imagen , Arteriopatías Oclusivas/fisiopatología , Arteriopatías Oclusivas/terapia , Constricción Patológica , Estados Unidos , AortografíaRESUMEN
PURPOSE: To compare patency and reintervention outcomes after either plain old balloon angioplasty (POBA) or drug-coated balloon angioplasty (DCBA) for venous stenoses after percutaneous arteriovenous fistula (pAVF) creation. MATERIALS AND METHODS: One-hundred ninety-five pAVFs were successfully created during the study period, 141 using Ellipsys and 54 using Wavelinq. After pAVF creation, 95 patients (48.7%) required secondary percutaneous transluminal angioplasty (PTA) with either POBA (n = 55, 58%) or DCBA (n = 40, 42.1%). The most common site for PTA was the juxta-anastomotic segment (75.5%; 74/98). Univariate and multivariate Cox regression analyses were used to compare target lesion primary patency, access circuit primary patency, secondary patency, and reintervention rates in the POBA and DCBA cohorts. RESULTS: Thirty-four of 55 (62%) patients in the POBA cohort and 14 of 40 (35%) patients in the DCBA cohort required reinterventions for pAVF restenosis. Mean number of follow-up days among patients treated with POBA was 1,030.4 (SD ± 342.9) and among those treated with DCBA was 744.4 (SD ± 403.5). The use of POBA compared with DCBA was not associated with target lesion and access circuit primary patency loss in multivariate analysis (hazard ratio [HR], 1.81; 95% CI, 0.93-3.51; P = .080; and HR, 1.77; 95% CI, 0.73-4.28; P = .210, respectively). However, time from fistula creation to the first PTA (days) was statistically significantly associated with both outcomes (HR, 0.997; 95% CI, 0.994-0.999; P = .009; and HR, 0.997; 95% CI, 0.992-0.999; P = .021, respectively). There were no major adverse events. CONCLUSIONS: In this retrospective single-center analysis of pAVFs, considerably more patients who underwent PTA with POBA after pAVF creation required reinterventions compared with PTA using DCBA, although the follow-up time of POBA was longer. In multivariate analysis, no differences were noted in the hazard of patency loss between POBA and DCBA.