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BACKGROUND: Stent underexpansion, typically related to lesion calcification, is the strongest predictor of adverse events after percutaneous coronary intervention (PCI). Although uncommon, underexpansion may also occur in non-severely calcified lesions. AIM: We sought to identify the prevalence and anatomical characteristics of underexpansion in non-severely calcified lesions. METHODS: We included 993 patients who underwent optical coherence tomography-guided PCI of 1051 de novo lesions with maximum calcium arc <180°. Negative remodeling (NR) was the smallest lesion site external elastic lamina diameter that was also smaller than the distal reference. Stent expansion was evaluated using a linear regression model accounting for vessel tapering; underexpansion required both stent expansion <70% and stent area <4.5mm2. RESULTS: Underexpansion was observed in 3.6% of non-heavily calcified lesions (38/1051). Pre-stent maximum calcium arc and thickness were greater in lesions with versus without underexpansion (median 119° vs. 85°, p = 0.002; median 0.95 mm vs. 0.78 mm, p = 0.008). NR was also more common in lesions with underexpansion (44.7% vs. 24.5%, p = 0.007). In the multivariable logistic regression model, larger and thicker eccentric calcium, mid left anterior descending artery (LAD) location, and NR were associated with underexpansion in non-severely calcified lesions. The rate of underexpansion was especially high (30.7%) in lesions exhibiting all three morphologies. Two-year TLF tended to be higher in underexpanded versus non-underexpanded stents (9.7% vs. 3.7%, unadjusted hazard ratio [95% confidence interval] = 3.02 [0.92, 9.58], p = 0.06). CONCLUSION: Although underexpansion in the absence of severe calcium (<180°) is uncommon, mid-LAD lesions with NR and large and thick eccentric calcium were associated with underexpansion.
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Enfermedad de la Arteria Coronaria , Vasos Coronarios , Intervención Coronaria Percutánea , Stents , Tomografía de Coherencia Óptica , Calcificación Vascular , Humanos , Masculino , Femenino , Calcificación Vascular/diagnóstico por imagen , Calcificación Vascular/terapia , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/efectos adversos , Anciano , Persona de Mediana Edad , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Prevalencia , Factores de Riesgo , Vasos Coronarios/diagnóstico por imagen , Resultado del Tratamiento , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Diseño de Prótesis , Valor Predictivo de las Pruebas , Factores de Tiempo , Angiografía Coronaria , Remodelación VascularRESUMEN
BACKGROUND: Although use of sirolimus-based analogs has shown superiority over paclitaxel in drug-eluting stents, the relative efficacy of these two agents released from drug-coated balloons (DCB) is unclear. The present meta-analysis is aimed to compare outcomes after percutaneous coronary intervention (PCI) with paclitaxel-coated balloons (PCB) versus sirolimus-coated balloons (SCB) for either in-stent restenosis or native de novo lesions. METHODS: The study outcomes were 1) target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or target lesion revascularization, and 2) follow-up angiographic parameters including late lumen loss (LLL), diameter stenosis, and minimal lumen diameter (MLD). Pooled odds ratios (OR) and weighted mean differences (WMD) with 95% confidence intervals (CI) were calculated by using random-effects models. RESULTS: A search of PubMed, EMBASE, and Cochrane Library from their inception to January 2024 identified five randomized clinical trials and three observational studies with a total of 1861 patients (889 in PCB and 972 in SCB groups). During 9-12 months of follow-up, there was no significant difference in TLF (OR 1.01, 95% CI 0.75-1.35) between the two groups. On follow-up angiography at 6-9 months, MLD (WMD 0.10, 95% CI 0.02-0.17) was larger in PCB but there was no statistically significant difference in LLL (WMD -0.11, 95% CI -0.23-0.02) and diameter stenosis (WMD -3.33, 95% CI -8.11-1.45). CONCLUSIONS: Among patients undergoing DCB-only PCI, the risk of TLF was similar during 9-12 months of follow-up after PCB and SCB treatment. However, the MLD was larger favoring PCB over SCB on follow-up angiography.
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PURPOSE OF REVIEW: To provide a summary of prevalence, pathogenesis, and treatment of coronary calcified nodules (CNs). RECENT FINDINGS: CNs are most frequently detected at the sites of hinge motion of severely calcified lesions such as in the middle segment of right coronary artery and left main coronary bifurcation. On histopathology, CNs exhibit two distinctive morphologies: eruptive and non-eruptive. Eruptive CNs, which have a disrupted fibrous cap with adherent thrombi, are biologically active. Non-eruptive CNs, which have an intact fibrous cap without thrombi, are biologically inactive, representing either healed eruptive CNs or protrusion of calcium due to plaque progression. Recent studies using optical coherence tomography (OCT) have shown a difference in the mechanism of stent failure in the two subtypes, demonstrating early reappearance of eruptive CNs in the stent (at ~ 6 months) as a unique mechanism of stent failure that does not seem to be preventable by simply achieving adequate stent expansion. The cause of CN reappearance in stent is not known and could be due to acute or subacute intrusion or continued growth of the CN. Whether modification of CN is needed, the most effective calcium modification modality and effectiveness of stent implantation in eruptive CNs has not been elucidated. In this review, we discuss pathogenesis of CNs and how intravascular imaging can help diagnose and manage patients with CNs. We also discuss medical and transcatheter therapies beyond conventional stent implantation for effective treatment of eruptive CNs that warrant testing in prospective studies.
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Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Stents , Tomografía de Coherencia Óptica , Calcificación Vascular , Humanos , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/cirugía , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Calcificación Vascular/diagnóstico por imagen , Calcificación Vascular/terapia , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/patología , Placa Aterosclerótica/diagnóstico por imagenRESUMEN
Studies utilizing intravascular imaging have replicated the findings of histopathological studies, identifying the most common substrates for acute coronary syndromes (ACS) as plaque rupture, erosion, and calcified nodule, with spontaneous coronary artery dissection, coronary artery spasm, and coronary embolism constituting the less common etiologies. The purpose of this review is to summarize the data from clinical studies that have used high-resolution intravascular optical coherence tomography (OCT) to assess culprit plaque morphology in ACS. In addition, we discuss the utility of intravascular OCT for effective treatment of patients presenting with ACS, including the possibility of culprit lesion-based treatment by percutaneous coronary intervention.
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Síndrome Coronario Agudo , Enfermedad de la Arteria Coronaria , Placa Aterosclerótica , Humanos , Síndrome Coronario Agudo/diagnóstico por imagen , Síndrome Coronario Agudo/terapia , Síndrome Coronario Agudo/etiología , Resultado del Tratamiento , Tomografía de Coherencia Óptica/métodos , Rotura Espontánea/complicaciones , Rotura Espontánea/patología , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/complicaciones , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/patología , Angiografía Coronaria/efectos adversosRESUMEN
Although extensive clinical data support the utility of intravascular imaging to guide and optimize outcomes following percutaneous coronary interventions (PCI), clinical adoption remains limited. One of the primary reasons for limited utilization may be a lack of standardization on how to best integrate the data provided by intravascular imaging practically. Optical coherence tomography (OCT) offers a high-resolution intravascular imaging modality with integrated software automation that allows for incorporation of OCT into the routine workflow of PCIs. We suggest use of an algorithm called MLD MAX to incorporate OCT for imaging-guided interventions: the baseline OCT imaging run is intended to facilitate procedural planning and strategizing, consisting of assessment for predominant lesion morphology (M), measurement for stent length (L) and determination of stent diameter (D); the post-PCI OCT imaging run is designated for assessment of need for further optimization of stent result, and consists of analysis for medial dissections (M), adequate stent apposition (A) and stent expansion (X). Incorporation of the MLD MAX algorithm into daily practice guides an efficient and easily-memorable workflow for optimized PCI procedures.
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Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Humanos , Tomografía de Coherencia Óptica/métodos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Angiografía Coronaria/métodos , Flujo de Trabajo , Resultado del Tratamiento , Stents , Algoritmos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/patología , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/patología , Ultrasonografía Intervencional/métodosRESUMEN
OBJECTIVES: Assess the impact on fluoroscopy time and contrast use in patients with tortuous brachiocephalic/thoracic aortas undergoing right transradial coronary angiography (RTCA) and provide strategies to manage. BACKGROUND: Unfavorable anatomy with severe brachiocephalic/thoracic tortuosity, referred to as an "elephant head," remains a significant obstacle for RTCA. METHODS: We reviewed the coronary angiograms of patients who underwent RTCA and had tortuous aortas. Angiography was attempted first using a universal catheter (Tiger) and switched to a left coronary specific catheter (Judkins Left [JL]) if challenging. Fluoroscopy time, contrast volume, and greatest distance from the patient's midline to the catheter in the aorta were recorded. RESULTS: Forty-nine patients (62.6 ± 12.0 years, 69.4% male) were included. Fifteen (30.6%) patients underwent successful angiography with a Tiger catheter; 34 (69.4%) patients required switching to JL catheter. The average distance of Tiger catheters to the midline of the spine was 0.78 ± 0.41 cm versus 1.28 ± 0.44 cm (p = .001) in JL catheters. Tiger catheter use resulted in less fluoroscopy time (6.48 ± 4.73 min) and contrast use (58.87 ± 43.53 ml) than in cases switched to JL (13.26 ± 10.76 min [p = .026]; 86.5 ± 69.95 ml [(p = .017]). CONCLUSIONS: For patients undergoing RTCA with significant brachiocephalic/thoracic aorta tortuosity, "elephant head," a Tiger catheter can be used efficiently for curvatures <1 cm from the middle of the spine. We propose that for curvatures >1 cm, operators should consider immediately switching to a JL catheter.
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Elefantes , Animales , Aorta Torácica/diagnóstico por imagen , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/métodos , Angiografía Coronaria/efectos adversos , Angiografía Coronaria/métodos , Femenino , Fluoroscopía , Humanos , Masculino , Arteria Radial/diagnóstico por imagen , Resultado del TratamientoRESUMEN
BACKGROUND: Optical coherence tomography (OCT) is an adjunct to angiography-guided coronary stent placement. However, in the absence of dedicated, appropriately powered randomized controlled trials, the impact of OCT on clinical outcomes is unclear. OBJECTIVE: To conduct a systematic review and meta-analysis of all available studies comparing OCT-guided versus angiography-guided and intravascular ultrasound (IVUS)-guided coronary stent implantation. METHODS: MEDLINE and Cochrane Central were queried from their inception through July 2022 for all studies that sought to compare OCT-guided percutaneous coronary intervention (PCI) to angiography-guided and IVUS-guided PCI. The primary endpoint was minimal stent area (MSA) compared between modalities. Clinical endpoints of interest were all-cause and cardiovascular mortality, major adverse cardiovascular events (MACE), myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis (ST). Risk ratios (RRs) and mean differences (MDs) with their corresponding 95% confidence intervals (CIs) were pooled using a random-effects model. RESULTS: Thirteen studies (8 randomized control trials and 5 observational studies) enrolling 6312 participants were included. OCT was associated with a strong trend toward increased MSA compared to angiography (MD = 0.36, p = 0.06). OCT-guided PCI was also associated with a reduction in the incidence of all-cause mortality [RR = 0.59, 95% CI (0.35, 0.97), p = 0.04] and cardiovascular mortality [RR = 0.41, 95% CI (0.21, 0.80), p = 0.009] compared with angiography-guided PCI. Point estimates favored OCT relative to angiography in MACE [RR = 0.75, 95% CI (0.47, 1.20), p = 0.22] and MI [RR = 0.75, 95% CI (0.53, 1.07), p = 0.12]. No differences were detected in ST [RR = 0.71, 95% CI (0.21, 2.44), p = 0.58], TLR [RR = 0.71, 95% CI (0.17, 3.05), p = 0.65], or TVR rates [RR = 0.89, 95% CI (0.46, 1.73), p = 0.73]. Compared with IVUS guidance, OCT guidance was associated with a nonsignificant reduction in the MSA (MD = -0.16, p = 0.27). The rates of all-cause and cardiovascular mortality, MACE, MI, TLR, TVR, or ST were similar between OCT-guided and IVUS-guided PCI. CONCLUSIONS: OCT-guided PCI was associated with reduced all-cause and cardiovascular mortality compared to angiography-guided PCI. These results should be considered hypothesis generating as the mechanisms for the improved outcomes were unclear as no differences were detected in the rates of TLR, TVR, or ST. OCT- and IVUS-guided PCI resulted in similar post-PCI outcomes.
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Enfermedad de la Arteria Coronaria , Infarto del Miocardio , Intervención Coronaria Percutánea , Trombosis , Humanos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/complicaciones , Angiografía Coronaria/efectos adversos , Tomografía de Coherencia Óptica/efectos adversos , Ultrasonografía Intervencional/efectos adversos , Ultrasonografía Intervencional/métodos , Resultado del Tratamiento , Stents/efectos adversos , Infarto del Miocardio/etiología , Trombosis/etiología , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
OBJECTIVES: We analyzed post-marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for suture-based vascular closure devices (VCDs) - Perclose ProGlide (Abbott, Chicago, Illinois) and Prostar XL (Abbott). BACKGROUND: Suture-based VCDs are mostly used for large-bore femoral arterial access-site closure. Real-world, contemporary experience on the most commonly reported complications and modes of failure associated with these devices is limited. METHODS: Post-marketing surveillance data from the FDA MAUDE database, for the ProGlide system and for the Prostar XL system, were analyzed, yielding 827 Perclose ProGlide reports and 175 Prostar XL reports. RESULTS: Of the 827 reports of major complications involving the Perclose ProGlide devices, 404 reports involved injury, and one involved death related to the device. In the Prostar XL analysis, 94 reports involved injury, and one involved death. Bleeding from vessel injury was the most common adverse outcome described with both devices, followed by hematoma and thrombus. Surgical repair was the most commonly used treatment strategy. In terms of device malfunction, suture-related malfunction (212 reports) was most commonly seen in the Perclose ProGlide group, while failed deployment was most commonly seen in the Prostar XL group. CONCLUSIONS: Our analysis of the MAUDE database demonstrates that in real-world practice, suture-based VCDs were found to be associated with complications, including vascular injury, difficulties with the device itself, and even death. Ongoing user education and pre-procedural patient selection are important to minimize risks associated with suture-based vascular closure devices.
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Dispositivos de Cierre Vascular , Arteria Femoral/cirugía , Humanos , Suturas , Resultado del Tratamiento , Estados Unidos , United States Food and Drug AdministrationRESUMEN
OBJECTIVES: We sought to evaluate the severity and patterns of calcifications in the left main coronary artery (LMCA) and proximal segments of left anterior descending coronary artery (LAD) and left circumflex artery (LCX) using optical coherence tomography (OCT) in patients with and without prior coronary artery bypass grafting (CABG). BACKGROUND: CABG may accelerate upstream calcium development. METHODS: OCT images (n = 76) of the LMCA bifurcation from either the LAD or LCX in 76 patients with at least one patent left coronary graft, on average 7.0 ± 5.6 years post-CABG, were compared with 148 OCT images in propensity-score-matched non-CABG controls. RESULTS: Minimum lumen areas in the LMCA, LAD, and LCX in post-CABG patients were smaller than non-CABG controls. Maximum calcium arc and thickness as well as calcium length were greater in the LMCA and LCX, but not in the LAD in post-CABG patients versus non-CABG controls. Calcium located at the carina of a bifurcation, calcified nodules (CN), thin intimal calcium, and lobulated calcium were more prevalent in post-CABG patients. After adjusting for multiple covariates, prior CABG was an independent predictor of calcification at the carina of a bifurcation (odds ratio [OR] 5.77 [95% confidence interval, CI: 1.5-21.6]), thin intimal calcium (4.7 [1.5-14.4]), and the presence of a CN (15.60 [3.2-76.2]). CONCLUSIONS: Prior CABG is associated with greater amount of calcium in the LMCA and the proximal LCX, as well as higher prevalence of atypical calcium patterns, including CN, thin or lobulated calcium, and calcifications located at the carina of a bifurcation, compared with non-CABG controls.
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Enfermedad de la Arteria Coronaria , Estenosis Coronaria , Angiografía Coronaria , Puente de Arteria Coronaria/efectos adversos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/cirugía , Humanos , Tomografía de Coherencia Óptica , Resultado del TratamientoRESUMEN
OBJECTIVE: Coronary artery calcification (CAC) is one of the paramount hurdles for percutaneous coronary intervention (PCI) since it impedes stent delivery and complete expansion. This study intended to evaluate the short-term clinical and procedural outcomes comparing rotational atherectomy (RA) and orbital atherectomy (OA) in patients with heavily calcified coronary lesions undergoing PCI. Design: This systematic review and meta-analysis included all head-to-head published comparisons of coronary RA versus OA. Procedural endpoints and post-procedural clinical outcomes (30 days/in-hospital), were compared. RevMan 5.3 software was used for data analysis. Results: Seven retrospective observational investigations with a total of 4623 patients, including 3203 patients in the RA group and 1420 patients in the OA group, were incorporated. Compared with OA, the RA group was associated with a higher incidence of myocardial infarction at short-term follow-up (OR: 1.56, 95% CI: 1.07-2.29, p = .02, I2 = 0%). No difference was noted among other short-term post-procedural clinical outcomes including all-cause mortality, target vessel revascularization, or major adverse cardiac events. Among procedural complications, RA was associated with reduced coronary artery dissection and arterial perforation. Increased fluoroscopy time was observed in the RA cohort as compared with OA (MD: 4.78, 95% CI: 2.25-7.30, p = .0002, I2 = 80%). Conclusion: RA was associated with fewer vascular complications, but at a cost of higher incidence of myocardial infarction and higher fluoroscopy time compared with OA, at short term follow-up. OA is a safe and effective alternative for the management of CAC.
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Aterectomía Coronaria , Aterectomía , Intervención Coronaria Percutánea , Aterectomía/efectos adversos , Aterectomía Coronaria/efectos adversos , Humanos , Estudios Observacionales como Asunto , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
PURPOSE OF REVIEW: Moderate or severe calcification is present in approximately one third of coronary lesions in patients with stable ischemic heart disease and acute coronary syndromes and portends unfavorable procedural results and long-term outcomes. In this review, we provide an overview on the state-of-the-art in evaluation and treatment of calcified coronary lesions. RECENT FINDINGS: Intravascular imaging (intravascular ultrasound or optical coherence tomography) can guide percutaneous coronary intervention of severely calcified lesions. New technologies such as orbital atherectomy and intravascular lithotripsy have significantly expanded the range of available techniques to effectively modify coronary calcium and facilitate stent expansion. Calcium fracture improves lesion compliance and is essential to optimize stent implantation. Intravascular imaging allows for detailed assessment of patterns and severity of coronary calcium that are integrated into scoring systems to predict stent expansion, identifying which lesions require atherectomy for lesion modification. Guided by intravascular imaging, older technologies such as rotational atherectomy and excimer laser can be incorporated with newer technologies such as orbital atherectomy and intravascular lithotripsy into an algorithmic approach for the safe and effective treatment of patients with heavily calcified coronary lesions.
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Aterectomía Coronaria , Enfermedad de la Arteria Coronaria , Tecnología Disruptiva , Intervención Coronaria Percutánea , Calcificación Vascular , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugía , Humanos , Resultado del Tratamiento , Calcificación Vascular/diagnóstico por imagen , Calcificación Vascular/terapiaRESUMEN
Following the December 2018 publication of a meta-analysis by Katsanos et al reporting higher rates of long-term mortality with the utilization of paclitaxel-related devices (balloons and stents) when compared to control in femoropopliteal arteries, the US Food and Drug Administration (FDA) issued a safety alert in January 2019 and further detailed the implications for future clinical use of these devices in March 2019. The FDA convened a public meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee in June 2019. This report summarizes the proceedings of this meeting and the panel's response to the 12 questions posed by the FDA related to the potentially increased late mortality of drug-coated balloons and drug-eluting stents with paclitaxel in patients with peripheral arterial disease.
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Angioplastia de Balón/métodos , Materiales Biocompatibles Revestidos , Paclitaxel/farmacología , Enfermedad Arterial Periférica/cirugía , Stents , Antineoplásicos Fitogénicos/farmacología , Congresos como Asunto , Humanos , Diseño de Prótesis , Estados Unidos , United States Food and Drug AdministrationRESUMEN
BACKGROUND: Clinical data support the use of intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) as being associated with improved outcomes. Nonetheless, global utilization of IVUS remains low. We hypothesize that, in the revascularization of complex lesions, IVUS use is associated with improved outcomes. METHODS: All patients with complex lesions treated with PCI at a single center from 2003 to 2016 were stratified by use of IVUS. Complex lesions were defined as follows: American College of Cardiology/American Heart Association type C lesions, in-stent restenosis, long lesions, bifurcations, severe calcification, left main lesions, and chronic total occlusions. The primary end point was the rate of major adverse cardiac events (MACE) at 1-year follow-up, defined as the composite of all-cause mortality, Q-wave myocardial infarction, and target vessel revascularization. Inverse probability weighting was used in the adjusted analysis. RESULTS: A total of 6,855 patients were included in the final analysis, of whom 67.3% had IVUS and 32.7% had angiography alone. The primary end point occurred in 13.4% of patients treated with IVUS and 18.3% of patients treated with angiography alone (Pâ¯<â¯.001). Inverse probability weighting-adjusted 1-year MACE rates demonstrated significant reduction with IVUS for each complex lesion type. CONCLUSIONS: Among patients with complex lesions, the use of IVUS was associated with lower MACE 1â¯year after PCI than angiography alone was. Because of the increased procedural risk in complex lesions, routine utilization of IVUS-guided PCI should be considered in this subset of patients.
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Enfermedad de la Arteria Coronaria/cirugía , Intervención Coronaria Percutánea/métodos , Ultrasonografía Intervencional/métodos , Anciano , Aterectomía Coronaria , Angiografía Coronaria , Stents Liberadores de Fármacos , Femenino , Mortalidad Hospitalaria , Humanos , Masculino , Persona de Mediana Edad , Mortalidad , Infarto del Miocardio/epidemiología , Revascularización Miocárdica/estadística & datos numéricos , Stents , Cirugía Asistida por Computador/métodosRESUMEN
Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent major adverse cardiovascular events after PCI. However, IVUS utilization remains low. An increasing number of high-risk or complex coronary artery lesions are treated with PCI, and we hypothesize that the impact of IVUS in guiding treatment of these complex lesions will be of increased importance in reducing major adverse cardiovascular events while remaining cost-effective. The "IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact" trial (registered on clinicaltrials.gov: NCT04221815) is a multicenter, international, clinical trial randomizing subjects to IVUS-guided versus angiography-guided PCI in a 1:1 ratio. Patients undergoing PCI involving a complex lesion are eligible for enrollment. Complex lesion is defined as involving at least 1 of the following characteristics: chronic total occlusion, in-stent restenosis, severe coronary artery calcification, long lesion (≥28â¯mm), or bifurcation lesion. The clinical investigation will be conducted at approximately 120 centers in North America and Europe, enrolling approximately 2,500 to 3,100 randomized subjects with an adaptive design. The primary clinical end point is the rate of target vessel failure at 12â¯months, defined as the composite of cardiac death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization. The co-primary imaging end point is the final post-PCI minimum stent area assessed by IVUS. The primary objective of this study is to assess the impact of IVUS guidance on the PCI treatment of complex lesions.
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Enfermedad de la Arteria Coronaria , Vasos Coronarios/diagnóstico por imagen , Intervención Coronaria Percutánea , Complicaciones Posoperatorias , Ajuste de Riesgo/métodos , Ultrasonografía Intervencional , Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/cirugía , Stents Liberadores de Fármacos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/métodos , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/prevención & control , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Riesgo , Cirugía Asistida por Computador/métodos , Ultrasonografía Intervencional/economía , Ultrasonografía Intervencional/métodosRESUMEN
BACKGROUND: Drug-eluting stents (DESs) have improved clinical outcomes of patients undergoing percutaneous coronary intervention (PCI). Nevertheless, adverse events related to previously treated lesion still occur. We sought to evaluate the incidence and predictors of target lesion failure (TLF) in patients undergoing contemporary DES implantation. METHODS: Patient-level data from 6 prospective, randomized trials were pooled, and DES treatment outcomes were analyzed at up to 5â¯years. Primary outcome was TLF (cardiac death, target lesion revascularization, or target vessel myocardial infarction). Cox proportional-hazards model was used to identify predictors of TLF. RESULTS: Overall, 10,072 patients were included in the analysis. TLF rate was 1.7%, 4.3%, and 11.9% at 30â¯days, 1â¯year, and 5â¯years, respectively. The only independent predictor of TLF at 30â¯days was stent length (hazard ratio [HR] 1.017, 95% CI 1.011-1.024, Pâ¯<â¯.0001). Moderate/severe calcification, stent length and post procedural diameter sthenosis were predictors between 30â¯days to 1â¯year but not at 1 to 5â¯years. Reference vessel diameter was the only lesion-related predictor at 5â¯years (Pâ¯=â¯.003). Clinical predictors of TLF between 30â¯days and 1â¯year were diabetes and hypertension (Pâ¯<â¯.01 for both), and between 1 and 5â¯years, diabetes (HR 1.40, 95% CI 1.13-1.73, Pâ¯=â¯.002), prior coronary artery bypass grafting (HR 2.52, 95% CI 1.92-3.30, Pâ¯<â¯.0001), and prior PCI (HR 1.29, 95% CI 1.02-1.64, Pâ¯=â¯.04) predicted TLF. CONCLUSIONS: Predictors of TLF vary in the early, late, and very late postprocedural periods. Reference vessel diameter was the only lesion-related predictor of long-term TLF; clinical predictors were diabetes, prior coronary artery bypass grafting, and prior PCI.
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Reestenosis Coronaria/terapia , Stents Liberadores de Fármacos/estadística & datos numéricos , Infarto del Miocardio/etiología , Intervención Coronaria Percutánea/estadística & datos numéricos , Falla de Prótesis , Antineoplásicos/uso terapéutico , Everolimus/uso terapéutico , Femenino , Cardiopatías/mortalidad , Humanos , Masculino , Persona de Mediana Edad , Paclitaxel/uso terapéutico , Intervención Coronaria Percutánea/métodos , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto/estadística & datos numéricos , Factores de Tiempo , Insuficiencia del TratamientoRESUMEN
OBJECTIVES: To assess the commonly reported complications and failure modes for FilterWire EZ Embolic Protection Devices (EPD) by analyzing the postmarketing surveillance data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. BACKGROUND: EPDs prevent distal embolization of atheroembolic materials during percutaneous interventions resulting in reduced microvascular obstruction and improved microcirculation while maintaining tissue perfusion. The FilterWire EZ EPD (Boston Scientific, Natick, MA) is approved for use in interventions of de novo saphenous vein grafts (SVG) and carotid artery stenosis. Robust data on the commonly reported complications and failure modes associated with the FilterWire EZ device are limited. METHODS: The MAUDE database was queried from September 1, 2008, through September 30, 2018, for FilterWire EZ system, yielding 474 reports. After exclusion of duplicate and incomplete reports, 464 device reports were included in the final analysis. RESULTS: Device-related adverse events were most commonly reported for carotid (n = 281) and SVG (n = 101) interventions. The most commonly reported major complications were: ischemic stroke (n = 57), vessel perforation or dissection (n = 12), death (n = 8), and myocardial infarction (n = 5). Minor complications included: hypotension (n = 68), bradycardia (n = 41), and vasospasm (n = 27). The most commonly reported failure modes were: detachment and/or damage of the device components (n = 118), device entrapment (n = 90), and stent-related issues (n = 46). CONCLUSIONS: Analysis of the MAUDE dataset is helpful in identifying the commonly reported adverse events and failure modes of FilterWire EZ devices. This platform serves as an important tool for both physicians and manufacturers to optimize device performance and clinical outcomes.
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Estenosis Carotídea/terapia , Trastornos Cerebrovasculares/etiología , Dispositivos de Protección Embólica , Embolia/prevención & control , Procedimientos Endovasculares/instrumentación , Oclusión de Injerto Vascular/terapia , Cardiopatías/etiología , Vigilancia de Productos Comercializados , Falla de Prótesis , Vena Safena/trasplante , United States Food and Drug Administration , Estenosis Carotídea/diagnóstico por imagen , Puente de Arteria Coronaria/efectos adversos , Bases de Datos Factuales , Embolia/etiología , Procedimientos Endovasculares/efectos adversos , Análisis de Falla de Equipo , Oclusión de Injerto Vascular/diagnóstico por imagen , Oclusión de Injerto Vascular/etiología , Humanos , Diseño de Prótesis , Factores de Riesgo , Vena Safena/diagnóstico por imagen , Estados UnidosRESUMEN
Background: Intracoronary imaging is an important tool for guiding decision making in the cardiac catheterization laboratory. Sources of data: We have reviewed the latest available evidence in the field to highlight the various potential benefits of intravascular imaging. Areas of agreement: Coronary angiography has been considered the gold standard test to appropriately diagnose and manage patients with coronary artery disease, but it has the inherent limitation of being a 2-dimensional x-ray lumenogram of a complex 3-dimensional vascular structure. Areas of controversy: There is well-established inter- and intra-observer variability in reporting coronary angiograms leading to potential variability in various management strategies. Intracoronary imaging improves the diagnostic accuracy while optimizing the results of an intervention. Utilization of intracoronary imaging modalities in routine practice however remains low worldwide. Increased costs, resources, time and expertise have been cited as explanations for low incorporation of these techniques. Growing points: Intracoronary imaging supplements and enhances an operator's decision-making ability based on detailed and objective lesion assessment rather than a subjective visual estimation. The benefits of intravascular imaging are becoming more profound as the complexity of cases suitable for revascularization increases. Areas timely for developing research: While the clinical benefits of intravascular ultrasound have been well validated, optical coherence tomography in comparison is a newer technology, with robust clinical trials assessing its clinical benefit are underway.
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Enfermedad de la Arteria Coronaria/diagnóstico , Vasos Coronarios/diagnóstico por imagen , Tomografía de Coherencia Óptica/métodos , Ultrasonografía Intervencional/métodos , Cateterismo Cardíaco/métodos , Humanos , Utilización de Procedimientos y Técnicas , Resultado del TratamientoRESUMEN
Integration of angiographic co-registration (ACR) with optical coherence tomography (OCT) leads to significant changes in PCI strategy. ACR with OCT allows complete integration of all available data-points to aid decision making. Randomized clinical trials comprehensively evaluating the impact of OCT with ACR to improve clinical outcomes are ongoing.
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Intervención Coronaria Percutánea , Angiografía Coronaria , Tomografía de Coherencia Óptica , Resultado del TratamientoRESUMEN
BACKGROUND: Because of the challenges in treating calcified coronary artery disease (CAD), lesion preparation has become increasingly important prior to percutaneous coronary intervention (PCI). Despite growing data for both rotational atherectomy (RA) and orbital atherectomy (OA), there have been no multicenter studies comparing the safety and efficacy of both. We sought to examine the clinical outcomes of patients with calcified CAD who underwent atherectomy. METHODS: A total of 39 870 patients from five tertiary care hospitals who had PCI from January 2011 to January 2017 were identified. 907 patients who had RA or OA were included. This multicenter, prospectively collected observational analysis compared OA and RA. The primary end-point was myocardial infarction and safety outcomes including significant dissection, perforation, cardiac tamponade, and vascular complications. Propensity score matching (1:1) was performed to reduce selection bias. RESULTS: After matching, 546 patients were included in the final analysis. The primary endpoint, myocardial infarction occurred less frequently with OA compared to RA (6.7% vs 13.8%, P ≤ 0.01) in propensity score matched cohorts. Procedural safety outcomes were comparable between the groups. The secondary outcome of death on discharge occurred less in the OA group as compared with RA (0% vs 2.2%, P = 0.01). Fluoroscopy time was less in patients who were treated with OA (21.9 vs 25.6 min, P ≤ 0.01). Additional secondary outcomes were comparable between groups. CONCLUSION: In this non-randomized, multicenter comparison of contemporary atherectomy devices, OA was associated with significantly decreased in-hospital myocardial infarction and mortality after propensity score matching with decreased fluoroscopy time.
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Aterectomía Coronaria , Aterectomía/efectos adversos , Enfermedad de la Arteria Coronaria , Vasos Coronarios , Calcificación Vascular , Anciano , Aterectomía/métodos , Aterectomía Coronaria/efectos adversos , Aterectomía Coronaria/métodos , Enfermedad de la Arteria Coronaria/patología , Enfermedad de la Arteria Coronaria/cirugía , Vasos Coronarios/patología , Vasos Coronarios/cirugía , Femenino , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Reoperación/métodos , Resultado del Tratamiento , Estados Unidos , Calcificación Vascular/patología , Calcificación Vascular/cirugíaRESUMEN
OBJECTIVES: We assessed the feasibility and safety of orbital atherectomy in patients with severely calcified aorto-ostial coronary artery lesions. BACKGROUND: The treatment of calcified aorta-ostial coronary artery lesions is technically challenging. Orbital atherectomy can potentially damage the guiding catheter if it is not retracted sufficiently during treatment of ostial lesions. Orbital atherectomy can also excessively whip if the guiding catheter is not close enough to the ostium to provide sufficient support. Several techniques can be performed to successfully treat ostial lesions with orbital atherectomy. METHODS: Our retrospective multicenter registry included 548 real-world patients who underwent orbital atherectomy, 59 (10.8%) of whom underwent treatment for aorto-ostial coronary artery lesions (left main artery [n = 35] and right coronary artery [n = 24]). The primary endpoint was the rate of 30-day major adverse cardiac and cerebrovascular events (MACCE), defined as the occurrence of death, myocardial infarction, target vessel revascularization, and stroke. RESULTS: The primary endpoint was similar in patients with and without ostial lesions (3.4% vs 2.2%, P = 0.2), as were the 30-day rates of death (1.7% vs 1.4%, P = 0.7), myocardial infarction (1.7% vs 1.0%, P = 0.3), target vessel revascularization (0% vs 0%, P > 0.91), and stroke (0% vs 0.2%, P > 0.9). Angiographic complications and stent thrombosis did not occur in patients with ostial lesions. CONCLUSIONS: Despite its technical challenges, orbital atherectomy appears to be a feasible and safe treatment option for calcified aorto-ostial coronary lesions.