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1.
Artículo en Inglés | MEDLINE | ID: mdl-36640215

RESUMEN

PURPOSE: The aim of this study was to evaluate the safety and efficacy of the Fantom BRS 6 months after implantation using the optical coherence tomography (OCT) imaging. METHODS: Twenty STEMI patients treated with a sirolimus-eluting Fantom BRS were enrolled into a prospective, single-arm, serial observational study. The scaffold sizing, positioning and optimisation were guided by OCT imaging. The primary endpoint was device-orientated composite endpoints (DOCE), comprised of cardiac death, target-vessel-related myocardial infarction and target lesion failure. To evaluate the device performance at the scaffold level, we performed a quantitative coronary angiography (QCA) and OCT imaging at 6 months. RESULTS: The primary endpoint did not occur in any patient within the 6-month follow-up. There were no major adverse cardiac events (MACEs) or DOCEs, no cases of scaffold thrombosis, target lesion revascularization and no deaths. In QCA, we observed a decrease in the minimum and mean lumen diameter in the in-scaffold region and in the proximal and distal peri-scaffold region. Similarly, the minimum lumen area and reference vessel diameter had decreased in both QCA and OCT. The OCT imaging showed improvement in the expansion index and malposition rate. CONCLUSION: A serial 6-month OCT imaging after implantation of a third-generation Tyrocore-based bioresorbable coronary scaffold indicated good coverage of the struts with excellent healing of the scaffold, low neointima growth and no signs of neoatherosclerosis.

2.
J Korean Med Sci ; 38(5): e34, 2023 Feb 06.
Artículo en Inglés | MEDLINE | ID: mdl-36747363

RESUMEN

BACKGROUND: The risk of device thrombosis and device-oriented clinical outcomes with bioresorbable vascular scaffold (BVS) was reported to be significantly higher than with contemporary drug-eluting stents (DESs). However, optimal device implantation may improve clinical outcomes in patients receiving BVS. The current study evaluated mid-term safety and efficacy of Absorb BVS with meticulous device optimization under intravascular imaging guidance. METHODS: The SMART-REWARD and PERSPECTIVE-PCI registries in Korea prospectively enrolled 390 patients with BVS and 675 patients with DES, respectively. The primary endpoint was target vessel failure (TVF) at 2 years and the secondary major endpoint was patient-oriented composite outcome (POCO) at 2 years. RESULTS: Patient-level pooled analysis evaluated 1,003 patients (377 patients with BVS and 626 patients with DES). Mean scaffold diameter per lesion was 3.24 ± 0.30 mm in BVS group. Most BVSs were implanted with pre-dilatation (90.9%), intravascular imaging guidance (74.9%), and post-dilatation (73.1%) at proximal to mid segment (81.9%) in target vessel. Patients treated with BVS showed comparable risks of 2-year TVF (2.9% vs. 3.7%, adjusted hazard ratio [HR], 1.283, 95% confidence interval [CI], 0.487-3.378, P = 0.615) and 2-year POCO (4.5% vs. 5.9%, adjusted HR, 1.413, 95% CI, 0.663-3.012, P = 0.370) than those with DES. The rate of 2-year definite or probable device thrombosis (0.3% vs. 0.5%, P = 0.424) was also similar. The sensitivity analyses consistently showed comparable risk of TVF and POCO between the 2 groups. CONCLUSION: With meticulous device optimization under imaging guidance and avoidance of implantation in small vessels, BVS showed comparable risks of 2-year TVF and device thrombosis with DES. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02601404, NCT04265443.


Asunto(s)
Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Trombosis , Humanos , Everolimus/uso terapéutico , Implantes Absorbibles , Intervención Coronaria Percutánea/efectos adversos , Resultado del Tratamiento , Trombosis/etiología , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia
3.
Catheter Cardiovasc Interv ; 99(3): 523-532, 2022 02.
Artículo en Inglés | MEDLINE | ID: mdl-34173699

RESUMEN

AIMS: To compare 5-year angiographic, optical coherence tomography (OCT), and clinical outcomes between patients treated with bioresorbable vascular scaffolds (BVS) and drug-eluting stents (DES). METHODS: The EverBio-2 trial (Comparison of Everolimus- and Biolimus-Eluting Coronary Stents with Everolimus-Eluting Bioresorbable Vascular Scaffold) was a single-center, assessor-blinded, randomized controlled trial in which 240 patients were randomly allocated (1:1:1) to BVS, everolimus-eluting (EES) or biolimus-eluting (BES) DES. Clinical follow-up was scheduled up to 5 years. All patients, alive and who did not have repeat revascularization of the target lesion during follow-up were asked to return for angiographic follow-up at 5 years. RESULTS: Five-year angiographic follow-up was completed in 122 patients (51%) and OCT analysis was performed in 86 (36%) patients. In-stent late lumen loss was similar in both groups with 0.50 ± 0.38 mm in BVS versus 0.58 ± 0.36 mm in EES/BES, p = 0.20. Clinical follow-up was complete in 232 patients (97%) at 5 years. The rate of the device-oriented endpoint was 22% in the BVS and 18% in the EES/BES group (p = 0.49). The patient-oriented composite endpoint occurred in 40% of BVS- and 43% of EES/BES-treated patients (p = 0.72) at 5 years. No acute coronary syndrome due to stent thrombosis was detected after 2 years. Complete BVS strut resorption was observed at 5 years in the OCT subgroup. CONCLUSION: Five-year clinical outcomes were similar between BVS and DES patients as well as angiographic outcomes in a selected subgroup. However, a definitive conclusion cannot be drawn because the EverBio-2 trial was not powered for clinical and angiographic endpoints at 5 years of follow-up.


Asunto(s)
Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Implantes Absorbibles , Stents Liberadores de Fármacos/efectos adversos , Everolimus/efectos adversos , Humanos , Intervención Coronaria Percutánea/efectos adversos , Diseño de Prótesis , Sirolimus/efectos adversos , Stents , Factores de Tiempo , Tomografía de Coherencia Óptica , Resultado del Tratamiento
4.
Heart Vessels ; 37(12): 2137-2149, 2022 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-35857064

RESUMEN

Endothelial and smooth muscle cell dysfunction is an early event at the onset of atherosclerosis, a heterogeneous and multifactorial pathology of the vascular wall. Bone morphogenetic protein (BMP)-4, a mechanosensitive autocrine cytokine, and BMPR-1a, BMPR-1b, BMPR-2 specific receptors play a key role in atherosclerotic plaque formation and vascular calcification and BMP4 is regarded as a biomarker of endothelial cell activation. The study aimed to examine the BMP4 system expression by Real-Time PCR in Human Coronary Artery Endothelial (HCAECs) and Smooth Muscle Cells (HCASMCs) under different flow rates determining low or physiological shear stress in the presence/absence of medicated Bioresorbable Vascular Scaffold (BVS). The HCAEC and HCASMC were subjected to 1-10-20 dyne/cm2 shear stress in a laminar flow bioreactor system, with/without BVS+ Everolimus (600 nM). In HCAECs without BVS the BMP4 expression was similar at 1, 20 dyne/cm2 decreasing at 10 dyne/cm2, while adding BVS+ Everolimus, it decreased both at 1, 10 compared to 20 dyne/cm2. In HCASMCs without BVS + Everolimus, the BMP4 system mRNA expression was significantly reduced at 1, 10 dyne/cm2 compared to 20 dyne/cm2, while in the presence of BVS+ Everolimus, higher BMP4 mRNA levels were observed at 10 compared to 1, 20 dyne/cm2. In HCAECs and HCASMCs BMPRs were expressed in all experimental conditions except for BMPR-1a at 1 dyne/cm2 in HCAEC. Significant correlations were found between BMP4 and BMPRs. The more negligible on BMP4 expression due to low shear stress in HCAEC compared to HCASMC and its reduction in the presence of BVS+ Everolimus at low shear stress highlighted the protection of BMP4-mediated against endothelial dysfunction and neoatherogenesis.


Asunto(s)
Aterosclerosis , Vasos Coronarios , Humanos , Vasos Coronarios/metabolismo , Everolimus/farmacología , Implantes Absorbibles , Miocitos del Músculo Liso/metabolismo , Aterosclerosis/genética , ARN Mensajero/metabolismo , Biomarcadores/metabolismo , Citocinas/metabolismo
5.
Proc Natl Acad Sci U S A ; 115(41): 10239-10244, 2018 10 09.
Artículo en Inglés | MEDLINE | ID: mdl-30224483

RESUMEN

Biodegradable polymers open the way to treatment of heart disease using transient implants (bioresorbable vascular scaffolds, BVSs) that overcome the most serious complication associated with permanent metal stents-late stent thrombosis. Here, we address the long-standing paradox that the clinically approved BVS maintains its radial strength even after 9 mo of hydrolysis, which induces a ∼40% decrease in the poly l-lactide molecular weight (Mn). X-ray microdiffraction evidence of nonuniform hydrolysis in the scaffold reveals that regions subjected to tensile stress during crimping develop a microstructure that provides strength and resists hydrolysis. These beneficial morphological changes occur where they are needed most-where stress is localized when a radial load is placed on the scaffold. We hypothesize that the observed decrease in Mn reflects the majority of the material, which is undeformed during crimping. Thus, the global measures of degradation may be decoupled from the localized, degradation-resistant regions that confer the ability to support the artery for the first several months after implantation.


Asunto(s)
Implantes Absorbibles , Poliésteres/química , Andamios del Tejido/química , Hidrólisis , Ensayo de Materiales , Microscopía Electrónica de Rastreo , Microtomía , Peso Molecular , Difracción de Rayos X
6.
Neurosurg Focus ; 48(2): E13, 2020 02 01.
Artículo en Inglés | MEDLINE | ID: mdl-32006951

RESUMEN

OBJECTIVE: By looking at how the accuracy of preoperative brain mapping methods vary according to differences in the distance from the activation clusters used for the analysis, the present study aimed to elucidate how preoperative functional neuroimaging may be used in such a way that maximizes the mapping accuracy. METHODS: The eloquent function of 19 patients with a brain tumor or cavernoma was mapped prior to resection with both functional MRI (fMRI) and magnetoencephalography (MEG). The mapping results were then validated using direct cortical stimulation mapping performed immediately after craniotomy and prior to resection. The subset of patients with equivalent MEG and fMRI tasks performed for motor (n = 14) and language (n = 12) were evaluated as both individual and combined predictions. Furthermore, the distance resulting in the maximum accuracy, as evaluated by the J statistic, was determined by plotting the sensitivities and specificities against a linearly increasing distance threshold. RESULTS: fMRI showed a maximum mapping accuracy at 5 mm for both motor and language mapping. MEG showed a maximum mapping accuracy at 40 mm for motor and 15 mm for language mapping. At the standard 10-mm distance used in the literature, MEG showed a greater specificity than fMRI for both motor and language mapping but a lower sensitivity for motor mapping. Combining MEG and fMRI showed a maximum accuracy at 15 mm and 5 mm-MEG and fMRI distances, respectively-for motor mapping and at a 10-mm distance for both MEG and fMRI for language mapping. For motor mapping, combining MEG and fMRI at the optimal distances resulted in a greater accuracy than the maximum accuracy of the individual predictions. CONCLUSIONS: This study demonstrates that the accuracy of language and motor mapping for both fMRI and MEG is heavily dependent on the distance threshold used in the analysis. Furthermore, combining MEG and fMRI showed the potential for increased motor mapping accuracy compared to when using the modalities separately.Clinical trial registration no.: NCT01535430 (clinicaltrials.gov).


Asunto(s)
Mapeo Encefálico/normas , Neoplasias Encefálicas/diagnóstico por imagen , Neoplasias Encefálicas/fisiopatología , Monitorización Neurofisiológica Intraoperatoria/normas , Imagen por Resonancia Magnética/normas , Magnetoencefalografía/normas , Mapeo Encefálico/métodos , Neoplasias Encefálicas/cirugía , Humanos , Monitorización Neurofisiológica Intraoperatoria/métodos , Lenguaje , Imagen por Resonancia Magnética/métodos , Magnetoencefalografía/métodos , Corteza Motora/diagnóstico por imagen , Corteza Motora/fisiopatología , Corteza Motora/cirugía
7.
Microcirculation ; 26(3): e12521, 2019 04.
Artículo en Inglés | MEDLINE | ID: mdl-30561875

RESUMEN

INTRODUCTION: Stenting with metal stents can affect microcirculatory function. The impact of BVS on the microvascular network has not been studied. METHODS: A total of 30 patients with bifurcation disease of Medina (X,X,0) scheduled for elective PCI with the ABSORB BVS were studied. Pressure wire studies were performed before and after scaffold implantation and at a mean follow-up of 9 months. At each time point, FFR, IMR, and CFR were calculated using the thermodilution method. RESULTS: Following scaffold implantation, FFR change from pre-PCI, post-PCI and follow-up was 0.76, 0.92 and 0.91, respectively (P < 0.001 from pre to post-PCI and P = 0.91 from post-PCI to follow-up). There was a statistically significant improvement between pre- and post-procedural IMR (median 27.7 to 17.9, P = 0.02) and CFR (median 2.2 to 2.9, P = 0.02). Median IMR at follow-up (23.6) remained numerically lower than pre-procedure but this was not statistically significant (P = 0.05). Similarly, while median CFR at follow-up remained at post-procedural level (2.9), this effect did not reach statistical significance (P = 0.06). CONCLUSION: There is an immediate reduction in microvascular resistance after elective BVS implantation but this effect is not sustained long term.


Asunto(s)
Implantes Absorbibles , Implantación de Prótesis Vascular , Prótesis Vascular , Circulación Coronaria , Enfermedad Coronaria , Microcirculación , Intervención Coronaria Percutánea , Resistencia Vascular , Anciano , Enfermedad Coronaria/fisiopatología , Enfermedad Coronaria/cirugía , Procedimientos Quirúrgicos Electivos , Femenino , Humanos , Masculino , Microvasos , Persona de Mediana Edad
8.
Acta Cardiol ; 73(3): 276-281, 2018 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-28954592

RESUMEN

BACKGROUND: Bioresorbable vascular scaffolds (BVS) implantation in selected patients with stable angina has been demonstrated feasible and safe. However, limited data are currently available on long-term outcomes after BVS implantation for ST-elevation myocardial infarction (STEMI). Therefore, we sought to assess the safety, efficacy and long-term results of BVS implantation in STEMI patients. METHODS: Retrospective review of all STEMI patients treated with the Absorb® BVS (Abbott Vascular, Santa Clara, CA) or conventional drug eluting stent (DES) between 1 April 2013 and 30 March 2014. Primary outcomes were procedural success, device thrombosis and device-oriented composite endpoint (DOCE) including cardiac death, target vessel myocardial infarction and target lesion revascularization. The study included 54 BVS patients and 121 DES patients. RESULTS: Patients were slightly younger in the BVS group (60 vs. 63 years old, p = .03). Other baseline characteristics were comparable between the two groups. Procedural success was achieved in all patients. Median follow-up was 901 days and 849 days for BVS and DES patients, respectively (p = .01). The cumulative incidence of DOCE was not significantly different between the BVS and DES groups (7.5% vs. 9.1%, hazard ratio [HR]: 0.74 [95% confidence interval (CI): 0.26-2.2], p = NS). Rate of probable/definite device thrombosis were not statistically different between both groups (3.7% vs. 3.3%, p = NS). CONCLUSIONS: The results of this single-centre retrospective study, one of the first assessing long-term safety and efficacy of BVS in STEMI, seems reassuring with similar long-term results as compared with patients treated with conventional DES.


Asunto(s)
Implantes Absorbibles , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea/métodos , Infarto del Miocardio con Elevación del ST/cirugía , Andamios del Tejido , Anciano , Angiografía Coronaria , Electrocardiografía , Femenino , Estudios de Seguimiento , Oclusión de Injerto Vascular/epidemiología , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Quebec/epidemiología , Estudios Retrospectivos , Infarto del Miocardio con Elevación del ST/diagnóstico , Factores de Tiempo , Resultado del Tratamiento
9.
Curr Atheroscler Rep ; 19(3): 14, 2017 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-28220461

RESUMEN

PURPOSE OF REVIEW: Drug-eluting stents are the mainstay in the treatment of coronary artery disease using percutaneous coronary intervention. Innovations developed to overcome the limitations of prior generations of stents include biodegradable polymer stents, drug-eluting stents without a polymer, and bioabsorbable scaffolds. Our review briefly discusses the clinical profiles of first- and second-generation coronary stents, and provides an up-to-date overview of design, technology, and clinical safety and efficacy profiles of newer generation coronary stents discussing the relevant clinical trials in this rapidly evolving area of interventional cardiology. RECENT FINDINGS: Drug-eluting stents have previously been shown to be superior to bare metal stents. Second-generation everolimus-eluting stents have proven to have superior outcomes compared with first-generation paclitaxel- and sirolimus-eluting stents, and the second-generation zotarolimus-eluting stents appear to be similar to the everolimus-eluting stents, though with a lesser degree of evidence. Stents with biodegradable polymers have not been shown to be superior to everolimus-eluting stents. Bioabsorbable scaffolds have not demonstrated better outcomes than current standard treatment with second-generation drug-eluting stents but have showed a concerning signal of late and very late stent thrombosis. Everolimus-eluting stents have the most favorable outcomes in terms of safety as well as efficacy in patients undergoing percutaneous coronary intervention. Newer innovations such as biodegradable polymers and bioabsorbable scaffolds lack clinical data to replace second-generation drug-eluting stents as standard of care.


Asunto(s)
Enfermedad de la Arteria Coronaria/terapia , Intervención Coronaria Percutánea/instrumentación , Stents , Implantes Absorbibles/tendencias , Ensayos Clínicos como Asunto , Stents Liberadores de Fármacos/tendencias , Predicción , Humanos , Intervención Coronaria Percutánea/tendencias , Diseño de Prótesis/tendencias , Stents/tendencias , Andamios del Tejido/tendencias
10.
Catheter Cardiovasc Interv ; 89(4): 676-678, 2017 Mar 01.
Artículo en Inglés | MEDLINE | ID: mdl-27649683

RESUMEN

This is the first documented case of a drug-coated balloon strategy for the treatment of bioresorbable in-scaffold restenosis caused by diffuse neointimal proliferation. This case can provide an alternative treatment option in this setting, avoiding potential problems related to further bulky metallic stents in a patient where a different strategy was initially planned. © 2016 Wiley Periodicals, Inc.


Asunto(s)
Implantes Absorbibles , Angioplastia Coronaria con Balón/instrumentación , Reestenosis Coronaria/cirugía , Vasos Coronarios/cirugía , Stents Liberadores de Fármacos , Sirolimus/farmacología , Andamios del Tejido , Anciano , Angiografía Coronaria , Reestenosis Coronaria/diagnóstico , Vasos Coronarios/diagnóstico por imagen , Humanos , Inmunosupresores/farmacología , Masculino , Diseño de Prótesis , Tomografía de Coherencia Óptica , Ultrasonografía Intervencional
11.
J Interv Cardiol ; 30(6): 558-563, 2017 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-28786151

RESUMEN

AIMS: The management of patients with in-stent restenosis (ISR) is still a major clinical challenge even in the era of drug-eluting stents (DES). Recent studies have demonstrated acceptable clinical outcomes for the everolimus-eluting bioresorbable vascular scaffold (BVS) ABSORB™ in patients with stable coronary artery disease but data are scarce on its use in patients with ISR. We report the long-term results of our preliminary experience with this novel approach at our institution. METHODS AND RESULTS: We investigated the safety and efficacy of BVS implantation to treat ISR. 34 consecutive patients (37 lesions) underwent PCI for ISR with BVS implantation between May 2013 and June 2015 at our institution and were included in the current analysis. Follow-up was available in 91.9% of the patients. Mean follow-up period was 801.9 ± 179 days. One patient had definite scaffold thrombosis (ScT) 2 months after stent implantation which was treated with DES. Five patients (six lesions) experienced target lesion revascularization (TLR). The composite endpoint rate of TLR, ScT, myocardial infarction, and death occured in 6/37 lesions at follow-up (16.2%). CONCLUSIONS: These real-world data using BVS in patients with ISR demonstrates that ISR treatment with ABSORB™ BVS is feasible but could have slightly higher target lesion failure rates as compared to DES. This proof of concept could be hypothesis-generating for larger randomized controlled studies.


Asunto(s)
Implantes Absorbibles , Reestenosis Coronaria/terapia , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Andamios del Tejido , Anciano , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos
12.
J Interv Cardiol ; 30(5): 433-439, 2017 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-28799238

RESUMEN

AIMS: Recent studies have shown favorable outcomes with everolimus-eluting bioresorbable vascular scaffold (BVS) in patients with stable coronary artery disease. Data on the use of BVS in saphenous vein graft disease (SVG) is currently lacking. METHODS AND RESULTS: A total of 10 consecutive patients (13 lesions, including 6 in-stent restenosis) who underwent BVS for SVG disease between May 2013 and June 2015 at a tertiary care institution were included. Median follow-up period was 874 (720-926) days. One patient had scaffold thrombosis (ScT) 15 months after implantation, which was treated medically. Another patient had target lesion revascularization (TLR) in two different lesions, where BVS was used to treat in-stent restenosis. The composite endpoint of TLR, ScT, target vessel myocardial infarction, and cardiac death, was reached in two patients CONCLUSIONS: This first real-world data on the use of the ABSORB™ BVS in patients with SVG disease shows that its implantation is technically feasible. The observed rate of target lesion revascularization was similar to those observed with drug-eluting stents in similar settings. Larger studies are required to better define the optimal use of BVS to treat SVG disease.


Asunto(s)
Implantes Absorbibles , Puente de Arteria Coronaria/efectos adversos , Everolimus/administración & dosificación , Inmunosupresores/administración & dosificación , Intervención Coronaria Percutánea , Andamios del Tejido , Anciano , Estudios de Cohortes , Enfermedad de la Arteria Coronaria/etiología , Enfermedad de la Arteria Coronaria/cirugía , Femenino , Humanos , Masculino , Persona de Mediana Edad , Vena Safena/trasplante , Resultado del Tratamiento
13.
Biometrics ; 73(2): 603-614, 2017 06.
Artículo en Inglés | MEDLINE | ID: mdl-27858978

RESUMEN

Understanding the complex interplay among protein coding genes and regulatory elements requires rigorous interrogation with analytic tools designed for discerning the relative contributions of overlapping genomic regions. To this aim, we offer a novel application of Bayesian variable selection (BVS) for classifying genomic class level associations using existing large meta-analysis summary level resources. This approach is applied using the expectation maximization variable selection (EMVS) algorithm to typed and imputed SNPs across 502 protein coding genes (PCGs) and 220 long intergenic non-coding RNAs (lncRNAs) that overlap 45 known loci for coronary artery disease (CAD) using publicly available Global Lipids Gentics Consortium (GLGC) (Teslovich et al., 2010; Willer et al., 2013) meta-analysis summary statistics for low-density lipoprotein cholesterol (LDL-C). The analysis reveals 33 PCGs and three lncRNAs across 11 loci with >50% posterior probabilities for inclusion in an additive model of association. The findings are consistent with previous reports, while providing some new insight into the architecture of LDL-cholesterol to be investigated further. As genomic taxonomies continue to evolve, additional classes such as enhancer elements and splicing regions, can easily be layered into the proposed analysis framework. Moreover, application of this approach to alternative publicly available meta-analysis resources, or more generally as a post-analytic strategy to further interrogate regions that are identified through single point analysis, is straightforward. All coding examples are implemented in R version 3.2.1 and provided as supplemental material.


Asunto(s)
Teorema de Bayes , Susceptibilidad a Enfermedades , Sitios Genéticos , Estudio de Asociación del Genoma Completo , Genómica , Humanos , Polimorfismo de Nucleótido Simple
14.
Neurosurg Focus ; 42(4): E11, 2017 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-28366059

RESUMEN

Atherosclerotic disease of the cerebral vasculature is a major cause of stroke worldwide. Atherosclerosis that is refractory to best medical management may require revascularization. In these instances, endovascular treatment provides a popular and safe alternative to open surgical techniques. The authors provide an overview of stent technology in the treatment of ischemic stroke, discussing the major studies evaluating stenting for extracranial carotid artery, vertebral artery, and intracranial atherosclerotic disease. The authors describe the commonly used stents with respect to their individual characteristics and technical limitations. Current and future developments in stent technology are also discussed, with areas for further innovation and clinical research.


Asunto(s)
Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/métodos , Isquemia Encefálica/complicaciones , Stents , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/terapia , Humanos , Resultado del Tratamiento , Arteria Vertebral
15.
Neth Heart J ; 25(7-8): 419-428, 2017 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-28643297

RESUMEN

BACKGROUND: To eliminate some of the potential late limitations of permanent metallic stents, the bioresorbable coronary stents or 'bioresorbable vascular scaffolds' (BVS) have been developed. METHODS: We reviewed all currently available clinical data on BVS implantation. RESULTS: Since the 2015 position statement on the appropriateness of BVS in percutaneous coronary interventions, several large randomised trials have been presented. These have demonstrated that achieving adequate 1 and 2 year outcomes with these first-generation BVS is not straightforward. These first adequately powered studies in non-complex lesions showed worse results if standard implantation techniques were used for these relatively thick scaffolds. Post-hoc analyses hypothesise that outcomes similar to current drug-eluting stents are still possible if aggressive lesion preparation, adequate sizing and high-pressure postdilatation are implemented rigorously. As long as this has not been confirmed in prospective studies the usage should be restricted to experienced centres with continuous outcome monitoring. For more complex lesions, results are even more disappointing and usage should be discouraged. When developed, newer generation scaffolds with thinner struts or faster resorption rates are expected to improve outcomes. In the meantime prolonged dual antiplatelet therapy (DAPT, beyond one year) is recommended in an individualised approach for patients treated with current generation BVS. CONCLUSION: The new 2017 recommendations downgrade and limit the use of the current BVS to experienced centres within dedicated registries using the updated implantation protocol and advise the prolonged usage of DAPT. In line with these recommendations the manufacturer does not supply devices to the hospitals without such registries in place.

16.
Acta Cardiol Sin ; 33(1): 92-95, 2017 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-28115812

RESUMEN

Bioresorbable vascular scaffold (BVS) implantation has been shown to be safe in patients with stable coronary disease, and effective against the thrombotic lesion and the in-stent restenosis (ISR) of the drug-eluting stent (DES). BVSs have the advantages of a snow racket concept, positive vessel remodeling, and better conformability compared with DES in acute coronary syndrome (ACS). We report on a young patient with ST-elevation myocardial infarction (STEMI) who presented to our emergency department arising from very late stent thrombosis (VLST) of a 2.5 × 28 mm paclitaxel-eluting stent (Coroflex® Please) three years after its implantation. After the patient was treated with balloon dilation, intravascular ultrasound (IVUS) revealed a short segment of a guide wire outside the DES mesh. Two BVSs were implanted to prevent a DES recoil. Post-scaffold-implantation IVUS showed adequately expanded strut of BVSs. Six months later, optical coherence tomography (OCT) revealed that some segments of the scaffold had been absorbed and that there was no in-scaffold restenosis. The patient had not complained about angina during the out-patient clinic follow-up. This is the first report of successful BVS implantation for a STEMI patient attributable to DES VLST.

17.
Catheter Cardiovasc Interv ; 88(3): 380-7, 2016 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-27038332

RESUMEN

OBJECTIVE: In this study, we investigated long-term results following bioresorbable vascular scaffold (BVS) implantation in small coronary arteries. BACKGROUND: Management of small coronary vessel disease with percutaneous coronary interventions (PCI) is often associated with high recurrencies and an increased risk of late or very late adverse events. Currently, little is known about BVS behavior in this setting. METHODS: A retrospective cohort analysis in a consecutive all-comer population was performed in patients that had a BVS implanted for coronary artery disease (CAD) in vessels with reference diameter <2.75 mm. Primary end-point was the occurrence of BVS failure (any event between target lesion revascularization (TLR) and definite/probable thrombosis) at the longest available follow-up. Secondary end-points were device-oriented clinical outcome (DOCE, a composite of cardiac death, target-vessel non-fatal myocardial infarction (MI) and TLR) and its single components at 12-month follow-up. RESULTS: A total of 121 patients (133 lesions) were treated between March 2013 and December 2014 at three high volume Italian centers. From baseline clinical and angiographic characteristics emerges a highly complex patient population. Procedural success was obtained in 120 (99.2%) patients. In-hospital events included one cardiac death. At the longest available clinical follow-up (average 12 ± 6, median 11.4 months, interquartile ranges (IQR) 8, primary end-point occurred in 12 patients (9.0%), including 12 (9.0%) TLR and 2 (1.5%) BVS thrombosis. DOCE occurred in 9.0% of cases. The use of overlapping BVS in this setting did not increase the risk of adverse events. CONCLUSIONS: BVS implantation in a highly complex clinical and angiographic setting of small coronary vessels was technically feasible and effective in maintaining vessel patency after 12 months. © 2016 Wiley Periodicals, Inc.


Asunto(s)
Implantes Absorbibles , Enfermedad de la Arteria Coronaria/terapia , Vasos Coronarios , Intervención Coronaria Percutánea/instrumentación , Anciano , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Enfermedad de la Arteria Coronaria/fisiopatología , Trombosis Coronaria/etiología , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/fisiopatología , Femenino , Mortalidad Hospitalaria , Hospitales de Alto Volumen , Humanos , Italia , Masculino , Persona de Mediana Edad , Infarto del Miocardio/etiología , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Diseño de Prótesis , Sistema de Registros , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Tomografía de Coherencia Óptica , Resultado del Tratamiento , Grado de Desobstrucción Vascular
18.
Catheter Cardiovasc Interv ; 88(S1): 31-37, 2016 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-27797461

RESUMEN

Bioresorbable vascular scaffolds (BVS, Absorb, Abbott Vascular, Santa Clara, CA) received the CE mark in October 2011, and were approved by the Food and Drug Administration in July 2016. After their introduction in clinical practice a broad amount of post-marketing clinical experience with BVS has been generated so far in Europe and outside the United States. The available BVS registries differ in many aspects, including their being single-center or multicenter, single-arm or controlled, sponsored or investigator-initiated, published or presented at a large-scale international meeting. This article provides an overview of clinical results of the main post-marketing studies of BVS available. © 2016 Wiley Periodicals, Inc.


Asunto(s)
Implantes Absorbibles , Enfermedad de la Arteria Coronaria/cirugía , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea/instrumentación , Vigilancia de Productos Comercializados/métodos , Sistema de Registros , Humanos , Diseño de Prótesis
19.
Catheter Cardiovasc Interv ; 86(4): 664-77, 2015 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-26386235

RESUMEN

The advent of fully bioresorbable stent technology and specifically the ABSORB™, a bioresorbable vascular scaffold (BVS) stent, is heralded as breakthrough technology in the current era of percutaneous coronary interventions. This article reviews the current understanding of this technology along with the clinical evidence from trials and registries of ABSORB BVS that included patients with both simple as well as more complex "real-world" coronary lesions. In addition, considering the current limitations of this device-mostly associated with the mechanical properties of the polymeric scaffold structure-a review of guidelines on successful implantation of the ABSORB BVS is presented. Although expert feedback suggests extensive use of this device in routine clinical practice outside the United States despite a paucity of data on long-term safety in this setting, attention to procedural details and implantation technique is obligatory to achieve optimal clinical outcomes.


Asunto(s)
Implantes Absorbibles , Angioplastia Coronaria con Balón/métodos , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos , Angioplastia Coronaria con Balón/mortalidad , Angiografía Coronaria/métodos , Puente de Arteria Coronaria/métodos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/cirugía , Everolimus/farmacología , Medicina Basada en la Evidencia , Femenino , Estudios de Seguimiento , Humanos , Masculino , Diseño de Prótesis , Medición de Riesgo , Índice de Severidad de la Enfermedad , Sirolimus/farmacología , Análisis de Supervivencia , Factores de Tiempo , Andamios del Tejido , Resultado del Tratamiento
20.
Catheter Cardiovasc Interv ; 86(4): 682-5, 2015 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-25510349

RESUMEN

We present a case of side-branch restenosis after T-stenting and small protrusion (TAP) technique using a bioresorbable vascular scaffold and a drug-eluting metallic stent. According to intravascular ultrasound imaging findings, the simultaneous balloon deflation after kissing balloon post-dilatation was the likely cause of restenosis. In cases where bifurcation treatment requires the TAP technique, operators should pay particular attention to perform kissing balloon inflation with sequential deflation (main branch first, side branch last).


Asunto(s)
Implantes Absorbibles , Angioplastia Coronaria con Balón/métodos , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos , Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/terapia , Estudios de Seguimiento , Humanos , Masculino , Metales , Persona de Mediana Edad , Diseño de Prótesis , Medición de Riesgo , Andamios del Tejido , Resultado del Tratamiento , Ultrasonografía Intervencional , Grado de Desobstrucción Vascular/fisiología
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