RESUMEN
Intravascular ultrasound and optical coherence tomography are used with increasing frequency for the care of coronary patients and in research studies. These imaging tools can identify culprit lesions in acute coronary syndromes, assess coronary stenosis severity, guide percutaneous coronary intervention (PCI), and detect vulnerable plaques and patients. However, they have significant limitations that have stimulated the development of multimodality intracoronary imaging catheters, which provide improvements in assessing vessel wall pathology and guiding PCI. Prototypes combining 2 or even 3 imaging probes with complementary attributes have been developed, and several multimodality systems have already been used in patients, with near-infrared spectroscopy intravascular ultrasound-based studies showing promising results for the identification of high-risk plaques. Moreover, postmortem histology studies have documented that hybrid imaging catheters can enable more accurate characterization of plaque morphology than standalone imaging. This review describes the evolution in the field of hybrid intracoronary imaging; presents the available multimodality catheters; and discusses their potential role in PCI guidance, vulnerable plaque detection, and the assessment of endovascular devices and emerging pharmacotherapies targeting atherosclerosis.
Asunto(s)
Enfermedad de la Arteria Coronaria , Vasos Coronarios , Imagen Multimodal , Intervención Coronaria Percutánea , Placa Aterosclerótica , Valor Predictivo de las Pruebas , Tomografía de Coherencia Óptica , Ultrasonografía Intervencional , Humanos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/patología , Intervención Coronaria Percutánea/instrumentación , Diseño de Equipo , Catéteres Cardíacos , Difusión de Innovaciones , Cateterismo Cardíaco/instrumentación , Espectroscopía Infrarroja Corta , AnimalesRESUMEN
AIMS: Pulsed-field ablation (PFA) is a novel, myocardial-selective, non-thermal ablation modality used to target cardiac arrhythmias. Although prompt electrogram (EGM) signal disappearance is observed immediately after PFA application in the pulmonary veins, whether this finding results in adequate transmural lesions is unknown. The aim of this study is to check whether application repetition and catheter-tissue contact impact lesion formation during PFA. METHODS AND RESULTS: A circular loop PFA catheter was used to deliver repeated energy applications with various levels of contact force. A benchtop vegetal potato model and a beating heart ventricular myocardial model were utilized to evaluate the impact of application repetition, contact force, and catheter repositioning on contiguity and lesion depth. Lesion development occurred over 18â h in the vegetal model and over 6â h in the porcine model. Lesion formation was found to be dependent on application repetition and contact. In porcine ventricles, single and multiple stacked applications led to a lesion depth of 3.5 ± 0.7 and 4.4 ± 1.3â mm, respectively (P = 0.002). Furthermore, the greater the catheter-tissue contact, the more contiguous and deeper the lesions in the vegetal model (1.0 ± 0.9â mm with no contact vs. 5.4 ± 1.4â mm with 30â g of force; P = 0.0001). CONCLUSION: Pulsed-field ablation delivered via a circular catheter showed that both repetition and catheter contact led independently to deeper lesion formation. These findings indicate that endpoints for effective PFA are related more to PFA biophysics than to mere EGM attenuation.
Asunto(s)
Catéteres Cardíacos , Ablación por Catéter , Diseño de Equipo , Ablación por Catéter/métodos , Ablación por Catéter/instrumentación , Animales , Porcinos , Ventrículos Cardíacos/fisiopatología , Ventrículos Cardíacos/cirugía , Modelos Animales , Sus scrofa , Factores de TiempoRESUMEN
Coronary intervention involving the region of bifurcation remains a challenging issue for the cardiologist as well as a complication. A number of factors including the angulation of side branch with the main branch determines the success. Though provisional strategy remains the best option in bifurcation intervention, at times a two-stent strategy cannot be avoided. We report a case in which percutaneous coronary intervention was performed on the left anterior descending artery (LAD) at its bifurcation with a major diagonal branch (> 2.5 mm). The ostium of the diagonal was diseased, and the branch took off from the LAD at an unfavorable angle (> 120°). We describe the use of the "shepherd's crook wire curve" approach, a modification of the reverse wire technique, which allowed us to successfully wire, dilate, and protect the diagonal and so named to reflect its resemblance to the shape of a shepherd's crook.
Asunto(s)
Angioplastia Coronaria con Balón , Angiografía Coronaria , Enfermedad de la Arteria Coronaria , Humanos , Resultado del Tratamiento , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/cirugía , Angioplastia Coronaria con Balón/instrumentación , Masculino , Stents Liberadores de Fármacos , Catéteres Cardíacos , AncianoAsunto(s)
Angioplastia Coronaria con Balón , Materiales Biocompatibles Revestidos , Humanos , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/efectos adversos , Resultado del Tratamiento , Catéteres Cardíacos , Diseño de Equipo , Stents Liberadores de Fármacos , Fármacos Cardiovasculares/administración & dosificación , Fármacos Cardiovasculares/uso terapéutico , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/diagnóstico por imagenRESUMEN
BACKGROUND: Debulking devices are often followed by a scoring or cutting balloon in percutaneous coronary intervention (PCI) for severely calcified lesions. However, there are limited data on balloon preparation after orbital atherectomy (OA) assessed using optical coherence tomography (OCT). AIM: We aimed to compare the effects of a novel scoring and cutting balloon on calcified coronary lesions with OCT. METHODS: We retrospectively examined 38 patients (38 lesions) who underwent PCI with a scoring or a cutting balloon after OA. All patients underwent pre-PCI, preballooning, postballooning, and post-PCI OCT imaging. We divided the patients into novel scoring-balloon (group A: n = 22) and cutting-balloon (group B: n = 16) groups and compared the OCT findings, including minimum lumen area (MLA) and expansion ratio (MLA divided by mean reference lumen area). RESULTS: The mean patient age was 76.1 ± 8.7 years; 71.5% were male. There were no significant differences in patient background between both groups. Regarding procedural characteristics, the maximum balloon pressure was significantly higher in group A (median 23 atm, interquartile range [IQR] 18-24 vs. 12 atm [IQR: 10-12], p < 0.01). Although a calcium score of 4 was more frequently observed in group A (86.4% vs. 62.5%, p = 0.12), post-PCI MLA was comparable between both groups (3.95 mm2 [IQR: 3.27-4.41] vs. 3.43 mm2 [IQR: 2.90-4.82], p = 0.63). Furthermore, the expansion ratio was significantly greater in group A (0.83 ± 0.20 vs. 0.68 ± 0.14, p < 0.01). CONCLUSION: Despite a higher calcium score, a larger expansion ratio was achieved in patients with a novel scoring balloon than in those with a cutting balloon after OA.
Asunto(s)
Angioplastia Coronaria con Balón , Aterectomía Coronaria , Enfermedad de la Arteria Coronaria , Vasos Coronarios , Valor Predictivo de las Pruebas , Índice de Severidad de la Enfermedad , Tomografía de Coherencia Óptica , Calcificación Vascular , Humanos , Masculino , Femenino , Estudios Retrospectivos , Calcificación Vascular/diagnóstico por imagen , Calcificación Vascular/terapia , Aterectomía Coronaria/efectos adversos , Anciano , Resultado del Tratamiento , Vasos Coronarios/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Anciano de 80 o más Años , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/efectos adversos , Catéteres Cardíacos , Diseño de Equipo , Angiografía CoronariaRESUMEN
BACKGROUND: During pulsed field ablation (PFA), relationships between ablation parameters (contact force [CF], number of burst pulses, impedance decrease, and electrode temperature) and lesion size in beating hearts have not been well validated. METHODS: A 7.5F-catheter with a 3.5-mm ablation electrode and CF sensor (ThermoCool SmartTouch SF-Dual-Energy, Biosense Webster, Inc, Irwindale, CA) was connected to a PFA system (TRUPULSE2, Biosense Webster, Inc). In 11 closed-chest swine, biphasic PFA current was delivered between the ablation electrode and the skin patch at 219 sites in left ventricle and right ventricle using 12, 18, and 24 burst pulses with 4 different levels of CF: (1) low (n=57; CF, 4-15g; median, 10g); (2) moderate (n=60; CF, 16-30g; median, 22.5g); (3) high (n=68; CF, 32-65g; median, 40g); and (4) no electrode contact (n=34), 2 mm away from the endocardium. Swine were euthanized 2 hours after ablation, and lesion size was measured using triphenyl tetrazolium chloride staining. RESULTS: All PFA lesions with electrode-myocardium contact were well demarcated with triphenyl tetrazolium chloride staining, demonstrating (1) pale central zone (contraction band necrosis with minimal coagulation necrosis), (2) dark brown zone (contraction band necrosis with hemorrhage), and (3) hyperstained red zone by triphenyl tetrazolium chloride (unaffected normal myocardium with preserved mitochondrial activity, consistent with reversible zone). Lesion depth increased significantly with increasing CF and the number of PFA burst pulses. An exponential/logarithmic formula combined with CF and the number of PFA burst pulses correlated lesion depth with high accuracy: R=0.809, P<0.0001, ±1.0-mm accuracy in 128 of 163 (79%) lesions, and ±1.5-mm accuracy in 153 of 163 (94%) lesions. Impedance decrease and electrode temperature were poor predictors of lesion size. There were no detectable lesions resulting from ablation without electrode contact. CONCLUSIONS: Acute PFA ventricular lesions demonstrate irreversible and reversible lesion boundaries. Electrode-tissue contact is required for effective lesion formation. Lesion depth increases significantly with increasing CF and PFA burst pulses. A new exponential/logarithmic formula combined with CF and the number of PFA burst pulses correlates lesion depth with high accuracy.
Asunto(s)
Ablación por Catéter , Animales , Ablación por Catéter/instrumentación , Ablación por Catéter/métodos , Porcinos , Ventrículos Cardíacos/patología , Ventrículos Cardíacos/fisiopatología , Catéteres Cardíacos , Diseño de Equipo , Miocardio/patología , Modelos Animales , Impedancia Eléctrica , Necrosis , Sus scrofa , Temperatura , Factores de Tiempo , Frecuencia CardíacaRESUMEN
BACKGROUND: Evidence suggests that drug-coated balloons may benefit in-stent restenosis (ISR) treatment. However, the efficacy of new-generation sirolimus-coated balloon (SCB) compared with the latest generation drug-eluting stents (DESs) has not been studied in this setting. METHODS: All patients in the EASTBORNE (The All-Comers Sirolimus-Coated Balloon European Registry) and DEB-DRAGON (DEB vs Thin-DES in DES-ISR: Long Term Outcomes) registries undergoing percutaneous coronary intervention for DES-ISR were included in the study. The primary study end point was target lesion revascularization at 24 months. Secondary end points were major adverse cardiovascular events, all-cause death, myocardial infarction, and target vessel revascularization at 24 months. Our goal was to evaluate the efficacy and safety of SCB versus thin-struts DES in ISR at long-term follow-up. RESULTS: A total of 1545 patients with 1679 ISR lesions were included in the pooled analysis, of whom 621 (40.2%) patients with 621 lesions were treated with thin-strut DES and 924 (59.8%) patients with 1045 lesions were treated with SCB. The unmatched cohort showed no differences in the incidence of target lesion revascularization (10.8% versus 11.8%; P=0.568); however, there was a trend toward lower rates of myocardial infarction (7.4% versus 5.0%; P=0.062) and major adverse cardiovascular events (20.8% versus 17.1%; P=0.072) in the SCB group. After propensity score matching (n=335 patients per group), there were no significant differences in the rates of target lesion revascularization (11.6% versus 11.8%; P=0.329), target vessel revascularization (14.0% versus 13.1%; P=0.822), myocardial infarction (7.2% versus 4.5%; P=0.186), all-cause death (5.7% versus 4.2%; P=0.476), and major adverse cardiovascular event (21.5% versus 17.6%; P=0.242) between DES and SCB treatment. CONCLUSIONS: In patients with ISR, angioplasty with SCB compared with thin-struts DES is associated with comparable rates of target lesion revascularization, target vessel revascularization, myocardial infarction, all-cause death, and major adverse cardiovascular events at 2 years.
Asunto(s)
Fármacos Cardiovasculares , Materiales Biocompatibles Revestidos , Reestenosis Coronaria , Stents Liberadores de Fármacos , Sistema de Registros , Sirolimus , Humanos , Masculino , Femenino , Sirolimus/administración & dosificación , Sirolimus/efectos adversos , Anciano , Persona de Mediana Edad , Resultado del Tratamiento , Reestenosis Coronaria/etiología , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/mortalidad , Reestenosis Coronaria/terapia , Factores de Tiempo , Fármacos Cardiovasculares/administración & dosificación , Fármacos Cardiovasculares/efectos adversos , Factores de Riesgo , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/mortalidad , Diseño de Prótesis , Europa (Continente) , Infarto del Miocardio/mortalidad , Infarto del Miocardio/etiología , Catéteres Cardíacos , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/mortalidad , Enfermedad de la Arteria Coronaria/diagnóstico por imagenAsunto(s)
Angioplastia Coronaria con Balón , Reestenosis Coronaria , Intervención Coronaria Percutánea , Sirolimus , Humanos , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/etiología , Sirolimus/administración & dosificación , Sirolimus/efectos adversos , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/efectos adversos , Materiales Biocompatibles Revestidos , Stents Liberadores de Fármacos , Resultado del Tratamiento , Fármacos Cardiovasculares/administración & dosificación , Fármacos Cardiovasculares/efectos adversos , Catéteres CardíacosAsunto(s)
Angioplastia Coronaria con Balón , Catéteres Cardíacos , Materiales Biocompatibles Revestidos , Enfermedad de la Arteria Coronaria , Humanos , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/efectos adversos , Resultado del Tratamiento , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Fármacos Cardiovasculares/administración & dosificación , Factores de Riesgo , Diseño de Equipo , Stents Liberadores de FármacosAsunto(s)
Ablación por Catéter , Taquicardia Ventricular , Humanos , Taquicardia Ventricular/cirugía , Taquicardia Ventricular/fisiopatología , Taquicardia Ventricular/terapia , Ablación por Catéter/métodos , Resultado del Tratamiento , Catéteres Cardíacos , Masculino , Diseño de Equipo , Persona de Mediana Edad , FemeninoRESUMEN
BACKGROUND: Randomized controlled trials (RCTs) examining the outcomes with limus drug-coated balloons (DCBs) vs paclitaxel DCBs were small and underpowered for clinical endpoints. OBJECTIVES: This study sought to compare the angiographic and clinical outcomes with limus DCBs vs paclitaxel DCBs for percutaneous coronary intervention (PCI). METHODS: An electronic search of Medline, EMBASE, and Cochrane databases was performed through January 2024 for RCTs comparing limus DCBs vs paclitaxel DCBs for PCI. The primary endpoint was clinically driven target lesion revascularization (TLR). The secondary endpoints were late angiographic findings. Summary estimates were constructed using a random effects model. RESULTS: Six RCTs with 821 patients were included; 446 patients received a limus DCB, and 375 patients received a paclitaxel DCB. There was no difference between limus DCBs and paclitaxel DCBs in the incidence of TLR at a mean of 13.4 months (10.3% vs 7.8%; risk ratio [RR]: 1.32; 95% CI: 0.84-2.08). Subgroup analysis suggested no significant interaction among studies for de novo coronary lesions vs in-stent restenosis (Pinteraction = 0.58). There were no differences in the risk of major adverse cardiovascular events, cardiac mortality, or target vessel myocardial infarction between groups. However, limus DCBs were associated with a higher risk of binary restenosis (RR: 1.89; 95% CI: 1.14-3.12), late lumen loss (mean difference = 0.16; 95% CI: 0.03-0.28), and a smaller minimum lumen diameter (mean difference = -0.12; 95% CI: -0.22 to -0.02) at late follow-up. In addition, late lumen enlargement occurred more frequently (50% vs 27.5%; RR: 0.59; 95% CI: 0.45-0.77) with paclitaxel DCBs. CONCLUSIONS: Among patients undergoing DCB-only PCI, there were no differences in the risk of clinically driven TLR and other clinical outcomes between limus DCBs and paclitaxel DCBs. However, paclitaxel DCBs were associated with better late angiographic outcomes. These findings support the need for future trials to establish the role of new-generation limus DCBs for PCI.
Asunto(s)
Angioplastia Coronaria con Balón , Catéteres Cardíacos , Fármacos Cardiovasculares , Materiales Biocompatibles Revestidos , Enfermedad de la Arteria Coronaria , Paclitaxel , Intervención Coronaria Percutánea , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Fármacos Cardiovasculares/administración & dosificación , Fármacos Cardiovasculares/efectos adversos , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Reestenosis Coronaria/etiología , Paclitaxel/administración & dosificación , Paclitaxel/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Drug-coated balloon (DCB) angioplasty seems a safe and effective option for specific de novo coronary lesions. However, the beneficial effect of intravascular ultrasound (IVUS)-guided DCB angioplasty in de novo lesions remains uncertain. OBJECTIVES: This study aimed to assess the benefits of IVUS guidance over angiography guidance during DCB angioplasty in de novo coronary lesions. METHODS: A total of 260 patients with high bleeding risk who had a de novo coronary lesion (reference vessel diameter 2.0-4.0 mm, and lesion length ≤15 mm) were randomly assigned to either an IVUS-guided or an angioplasty-guided DCB angioplasty group. The primary endpoint was in-segment late lumen loss (LLL) at 7 months after procedure. The secondary endpoint was target vessel failure at 6 months. RESULTS: A total of 2 patients in the angiography-guided group and 7 patients in the IVUS-guided group underwent bailout stent implantation (P = 0.172). The primary endpoint of 7-month LLL was 0.03 ± 0.52 mm with angiography guidance vs -0.10 ± 0.34 mm with IVUS guidance (mean difference 0.14 mm; 95% CI: 0.02-0.26; P = 0.025). IVUS guidance was also associated with a larger 7-month minimal lumen diameter (2.06 ± 0.62 mm vs 1.75 ± 0.63 mm; P < 0.001) and a smaller diameter stenosis (28.15% ± 13.88% vs 35.83% ± 17.69%; P = 0.001) compared with angiography guidance. Five target vessel failures occurred at 6 months, with 4 (3.1%) in the angiography-guided group and 1 (0.8%) in the IVUS-guided group (P = 0.370). CONCLUSIONS: This study demonstrated that IVUS-guided DCB angioplasty is associated with a lower LLL in patients with a de novo coronary lesion compared with angiography guidance. (Intravascular Ultrasound Versus Angiography Guided Drug-Coated Balloon [ULTIMATE-III]; NCT04255043).
Asunto(s)
Angioplastia Coronaria con Balón , Catéteres Cardíacos , Fármacos Cardiovasculares , Materiales Biocompatibles Revestidos , Angiografía Coronaria , Enfermedad de la Arteria Coronaria , Valor Predictivo de las Pruebas , Ultrasonografía Intervencional , Humanos , Masculino , Femenino , Persona de Mediana Edad , Anciano , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/efectos adversos , Resultado del Tratamiento , Factores de Tiempo , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Fármacos Cardiovasculares/administración & dosificación , Fármacos Cardiovasculares/efectos adversos , Estudios Prospectivos , Factores de Riesgo , ChinaAsunto(s)
Ablación por Catéter , Etanol , Taquicardia Ventricular , Humanos , Etanol/administración & dosificación , Taquicardia Ventricular/cirugía , Taquicardia Ventricular/fisiopatología , Taquicardia Ventricular/diagnóstico , Ablación por Catéter/métodos , Resultado del Tratamiento , Ventrículos Cardíacos/cirugía , Ventrículos Cardíacos/fisiopatología , Masculino , Técnicas Electrofisiológicas Cardíacas , Catéteres CardíacosRESUMEN
As the general population ages, the incidence of degenerative mitral stenosis (MS) among patients has increased. Percutaneous mitral valvuloplasty (PMV) has emerged as a well-established option for mitral rheumatic stenosis with specific characteristics. However, a blank therapeutic space must be filled with the treatment options for degenerative or rheumatic mitral stenosis in patients with many comorbidities and contraindication for valvuloplasty. We here present a comprehensive overview of the current possibilities, despite their scarce success. That is the reason why we propose a case series to facilitate a better understanding of our innovative technique in this challenging clinical context.
Asunto(s)
Valvuloplastia con Balón , Estenosis de la Válvula Mitral , Válvula Mitral , Humanos , Estenosis de la Válvula Mitral/diagnóstico por imagen , Estenosis de la Válvula Mitral/fisiopatología , Estenosis de la Válvula Mitral/terapia , Estenosis de la Válvula Mitral/cirugía , Resultado del Tratamiento , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/fisiopatología , Válvula Mitral/cirugía , Femenino , Masculino , Anciano , Persona de Mediana Edad , Catéteres Cardíacos , Diseño de Equipo , HemodinámicaRESUMEN
BACKGROUND: With advancements in chronic total coronary occlusion (CTO) recanalization techniques and concepts, the success rate of recanalization has been steadily increasing. However, the current data are too limited to draw any reliable conclusions about the efficacy and safety of drug-coated balloons (DCBs) in CTO percutaneous coronary intervention (PCI). Herein, we conducted a meta-analysis to confirm the efficacy of DCB in CTO PCI. METHODS: We systematically searched PubMed, Web of Science and Embase from inception to July 25, 2023. The primary outcome was major advent cardiovascular events (MACE), including cardiac death, nonfatal myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR). The follow-up angiographic endpoints were late lumen enlargement (LLE), reocclusion and restenosis. RESULTS: Five studies with a total of 511 patients were included in the meta-analysis. Across studies, patients were predominantly male (72.9-85.7%) and over fifty years old. The summary estimate rate of MACE was 13.0% (95% CI 10.1%-15.9%, I2 = 0%, p = 0.428). The summary estimate rates of cardiac death and MI were 2.2% (95% CI 0.7%-3.7%, I2 = 0%, p = 0.873) and 1.2% (95% CI -0.2-2.6%, I2 = 13.7%, p = 0.314), respectively. Finally, the pooled incidences of TLR and TVR were 10.1% (95% CI 5.7%-14.5%, I2 = 51.7%, p = 0.082) and 7.1% (95% CI 3.0%-11.2%, I2 = 57.6%, p = 0.070), respectively. Finally, the summary estimate rates of LLE, reocclusion and restenosis were 59.4% (95% CI 53.5-65.3%, I2 = 0%, p = 0.742), 3.3% (95% CI 1.1-5.4%, I2 = 0%, p = 0.865) and 17.5% (95% CI 12.9-22.0%, I2 = 0%, p = 0.623), respectively. CONCLUSION: Accordingly, DCB has the potential to be used as a treatment for CTO in suitable patients.
Asunto(s)
Angioplastia Coronaria con Balón , Catéteres Cardíacos , Materiales Biocompatibles Revestidos , Oclusión Coronaria , Humanos , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/mortalidad , Oclusión Coronaria/terapia , Resultado del Tratamiento , Enfermedad Crónica , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Factores de Riesgo , Anciano , Femenino , Persona de Mediana Edad , Masculino , Fármacos Cardiovasculares/administración & dosificación , Fármacos Cardiovasculares/efectos adversos , Anciano de 80 o más Años , Medición de Riesgo , Factores de Tiempo , Diseño de Equipo , Reestenosis Coronaria/etiología , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/mortalidadRESUMEN
BACKGROUND: Percutaneous coronary intervention (PCI) with primary stenting, which stands for stent implantation regardless of obtaining satisfactory results with balloon angioplasty, has superseded conventional plain old balloon angioplasty with provisional stenting. With drug-coated balloon (DCB), primary DCB angioplasty with provisional stenting has shown non-inferiority to primary stenting for de novo coronary small vessel disease. However, the long-term efficacy and safety of such a strategy to the primary stenting on clinical endpoints in de novo lesions without vessel diameter restrictions remain uncertain. STUDY DESIGN: The REC-CAGEFREE I is an investigator-initiated, multicenter, randomized, open-label trial aimed to enroll 2270 patients with acute or chronic coronary syndrome from 43 interventional cardiology centers in China to evaluate the non-inferiority of primary paclitaxel-coated balloons angioplasty to primary stenting for the treatment of de novo, non-complex lesions without vessel diameter restrictions. Patients who fulfill all the inclusion and exclusion criteria and have achieved a successful lesion pre-dilatation will be randomly assigned to the two arms in a 1:1 ratio. Protocol-guided DCB angioplasty and bailout stenting after unsatisfactory angioplasty are mandatory in the primary DCB angioplasty group. The second-generation sirolimus-eluting stent will be used as a bailout stent in the primary DCB angioplasty group and the treatment device in the primary stenting group. The primary endpoint is the incidence of Device-oriented Composite Endpoint (DoCE) within 24 months after randomization, including cardiac death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization. DISCUSSION: The ongoing REC-CAGEFREE I trial is the first randomized trial with a clinical endpoint to assess the efficacy and safety of primary DCB angioplasty for the treatment of de novo, non-complex lesions without vessel diameter restrictions. If non-inferiority is shown, PCI with primary DCB angioplasty could be an alternative treatment option to primary stenting. TRIAL REGISTRATION: Registered on clinicaltrial.gov (NCT04561739).
Asunto(s)
Angioplastia Coronaria con Balón , Catéteres Cardíacos , Fármacos Cardiovasculares , Materiales Biocompatibles Revestidos , Enfermedad de la Arteria Coronaria , Paclitaxel , Humanos , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Resultado del Tratamiento , Fármacos Cardiovasculares/administración & dosificación , Fármacos Cardiovasculares/efectos adversos , China , Paclitaxel/administración & dosificación , Paclitaxel/efectos adversos , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Factores de Tiempo , Femenino , Masculino , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Stents , Anciano , Stents Liberadores de Fármacos , Estudios de Equivalencia como Asunto , Ensayos Clínicos Controlados Aleatorios como AsuntoAsunto(s)
Angioplastia Coronaria con Balón , Materiales Biocompatibles Revestidos , Valor Predictivo de las Pruebas , Humanos , Angioplastia Coronaria con Balón/instrumentación , Resultado del Tratamiento , Tomografía de Coherencia Óptica , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Vasos Coronarios/diagnóstico por imagen , Stents Liberadores de Fármacos , Angiografía Coronaria , Ultrasonografía Intervencional , Catéteres Cardíacos , Fármacos Cardiovasculares/administración & dosificaciónRESUMEN
AIMS: Superior vena cava (SVC) isolation during atrial fibrillation catheter ablation is limited by the risk of collateral damage to the sinus node and/or the phrenic nerve. Due to its tissue-specificity, we hypothesized the feasibility and safety of pulsed-field ablation (PFA)-based SVC isolation. METHODS AND RESULTS: One hundred and five consecutive patients undergoing PFA-based AF catheter ablation were prospectively included. After pulmonary vein isolation (±posterior wall isolation and electrical cardioversion), SVC isolation was performed using a standardized workflow. Acute SVC isolation was achieved in 105/105 (100%) patients after 6 ± 1 applications. Transient phrenic nerve stunning occurred in 67/105 (64%) patients but without phrenic nerve palsy at the end of the procedure and at hospital discharge. Transient high-degree sinus node dysfunction occurred in 5/105 (4.7%) patients, with no recurrence at the end of the procedure and until discharge. At the 3-month follow-up visit, no complication occurred. CONCLUSION: SVC isolation using a pentaspline PFA catheter is feasible and safe.