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BACKGROUND: The 1-year clinical outcomes of the Absorb GT1 Japan post-market surveillance (PMS) suggested that an appropriate intracoronary imaging-guided bioresorbable vascular scaffold (BVS) implantation technique may reduce the risk of target lesion failure (TLF) and scaffold thrombosis (ST) associated with the Absorb GT1 BVS. The long-term outcomes through 5 years are now available. METHODSâANDâRESULTS: This study enrolled 135 consecutive patients (n=139 lesions) with ischemic heart disease in whom percutaneous coronary intervention (PCI) with the Absorb GT1 BVS was attempted. Adequate lesion preparation, imaging-guided appropriate sizing, and high-pressure post-dilatation using a non-compliant balloon were strongly encouraged. All patients had at least 1 Absorb GT1 successfully implanted at the index procedure. Intracoronary imaging was performed in all patients (optical coherence tomography: 127/139 [91.4%] lesions) and adherence to the implantation technique recommendations was excellent: predilatation, 100% (139/139) lesions; post-dilatation, 98.6% (137/139) lesions; mean (±SD) post-dilatation pressure, 18.8±3.5 atm. At 5 years, the follow-up rate was 87.4% (118/135). No definite/probable ST was reported through 5 years. The cumulative TLF rate was 5.1% (6/118), including 2 cardiac deaths, 1 target vessel-attributable myocardial infarction, and 3 ischemia-driven target lesion revascularizations. CONCLUSIONS: Appropriate intracoronary imaging-guided BVS implantation, including the proactive use of pre- and post-balloon dilatation during implantation may be beneficial, reducing the risk of TLF and ST through 5 years.
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Implantes Absorbibles , Vigilancia de Productos Comercializados , Humanos , Japón , Masculino , Femenino , Persona de Mediana Edad , Anciano , Intervención Coronaria Percutánea/efectos adversos , Tomografía de Coherencia Óptica , Estudios de Seguimiento , Andamios del Tejido , Isquemia Miocárdica , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/diagnóstico por imagenRESUMEN
The coexistence of heart failure is frequent and associated with higher mortality in patients with type 2 diabetes (T2DM), and its management is a critical issue. The WATCH-DM risk score is a tool to predict heart failure in patients with type 2 diabetes mellitus (T2DM). We investigated whether it could estimate outcomes in T2DM patients with heart failure with preserved ejection fraction (HFpEF). The WATCH-DM risk score was calculated in 418 patients with T2DM hospitalized for HFpEF (male 49.5%, age 80 ± 9 years, HbA1c 6.8 ± 1.0%), and they were divided into the "average or lower" (≤ 10 points), "high" (11-13 points) and "very high" (≥ 14 points) risk groups. We followed patients to observe all-cause death for 386 days (median). We compared the area under the curve (AUC) of the WATCH-DM score for predicting 1-year mortality with that of the Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) score and of the Barcelona Bio-Heart Failure Risk (BCN Bio-HF). Among the study patients, 108 patients (25.8%) had average or lower risk scores, 147 patients (35.2%) had high risk scores, and 163 patients (39.0%) had very high risk scores. The Cox proportional hazard model selected the WATCH-DM score as an independent predictor of all-cause death (HR per unit 1.10, 95% CI 1.03 to 1.19), and the "average or lower" risk group had lower mortality than the other groups (p = 0.047 by log-rank test). The AUC of the WATCH-DM for 1-year mortality was 0.64 (95% CI 0.45 to 0.74), which was not different from that of the MAGGIC score (0.72, 95% CI 0.63 to 0.80, p = 0.08) or that of BCN Bio-HF (0.70, 0.61 to 0.80, p = 0.25). The WATCH-DM risk score can estimate prognosis in T2DM patients with HFpEF and can identify patients at higher risk of mortality.
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Diabetes Mellitus Tipo 2 , Insuficiencia Cardíaca , Humanos , Masculino , Anciano , Anciano de 80 o más Años , Diabetes Mellitus Tipo 2/complicaciones , Volumen Sistólico , Factores de Riesgo , PronósticoRESUMEN
The Agent device consists of a semi-compliant balloon catheter, which is coated with a therapeutic low-dose formulation of paclitaxel (2 µg/mm2) blended with an inactive excipient acetyl-tri-n-butyl citrate (ATBC). AGENT Japan SV is a randomized controlled study that enrolled 150 patients from 14 Japanese sites treated with Agent or SeQuent Please paclitaxel-coated balloon. This study also includes a single-arm substudy evaluating the safety and effectiveness of Agent in patients with in-stent restenosis (ISR). Patients with a single de novo native lesion (lesion length ≤ 28 mm and reference diameter ≥ 2.00 to < 3.00 mm) were randomized 2:1 to receive either Agent (n = 101) or SeQuent Please (n = 49). The ISR substudy enrolled 30 patients with lesion length ≤ 28 mm and reference diameter ≥ 2.00 to ≤ 4.00 mm. In the SV RCT, target lesion failure (TLF) at 1 year occurred in four patients treated with Agent (4.0%) versus one patient with SeQuent Please (2.0%; P = 1.00). None of the patients in either treatment arm died. There were no significant differences in the rates of myocardial infarction, target lesion revascularization and target lesion thrombosis through 1 year. In the ISR substudy, the 1-year rates of TLF and target lesion thrombosis were 6.7% and 0.0%, respectively. These data support the safety and effectiveness of the Agent paclitaxel-coated balloon in patients with small vessels and ISR.
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Angioplastia Coronaria con Balón , Reestenosis Coronaria , Trombosis , Humanos , Paclitaxel/farmacología , Reestenosis Coronaria/etiología , Reestenosis Coronaria/terapia , Resultado del Tratamiento , Factores de Riesgo , Trombosis/etiología , Materiales Biocompatibles RevestidosRESUMEN
Background: Sleep apnea (SA) is highly prevalent and should be treated in patients referred for catheter ablation (CA) of atrial fibrillation (AF). Watch-type peripheral arterial tonometry (WP) for home SA testing has demonstrated a high correlation of the apnea-hypopnea index (AHI) with Polysomnography (PSG), but the evidence of its accuracy in AF patients is not adequate. Methods: This study was conducted under a retrospective, single-center, observational design. We included 464 consecutive AF patients (age 65 ± 11 years, 76.5% male, 45.0% paroxysmal-AF) who received both WP and PSG during the periprocedural period of the CA. We compared the AHI using the WP (WP-AHI) to that using PSG (PSG-AHI). Results: The WP-AHI was 25.9 ± 12.7 and PSG-AHI 31.4 ± 18.9 (r = .48). Among 325 patients with a WP-AHI < 30, 116 (35.7%) exhibited a PSG-AHI ≥ 30. Only 12.5% of the patients were indicated for continuous positive airway pressure (CPAP) treatment only by the WP-AHI, while 70.9% were indicated for CPAP by the PSG-AHI according to the Japanese health insurance system. The best cut-off value of the WP-AHI was 18.1 to predict a PSG-AHI ≥ 20 with an area under the curve of 0.72 (95% confidence interval, 0.67-0.76). Conclusions: The WP-AHI and PSG-AHI were weakly correlated in AF patients receiving CA. About one-third of the patients with moderate SA using the WP was diagnosed with severe SA evaluated by PSG. The majority required PSG for the CPAP indication.
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Functional mitral regurgitation (FMR) negatively impacts the prognosis in patients with atrial fibrillation (AF) and reduced left ventricular (LV) ejection fraction (LVEF). Although structural reverse remodeling after AF ablation can reduce FMR severity, the prognostic impact of FMR and its evolution remain unclear. Of 491 patients with baseline LVEF <50% who underwent first-time AF ablation, 134 patients (27%) had grade 2 to 4 FMR at baseline. Among them, 88 patients (66%) exhibited FMR improvement to grade 0 to 1 FMR 6 months after AF ablation. Conversely, among 357 with baseline grade 0 to 1 FMR, 13 patients (3.6%) exhibited FMR worsening to grade 2 to 4 FMR despite AF ablation. Assessment with multidetector computed tomography revealed that an increase in the left atrial emptying fraction (odds ratio 3.55 per 10% increase; 95% confidence interval 2.12 to 5.95) and a reduction in the LV end-diastolic volume index (1.35 per 10-ml/m2 decrease; 1.04 to 1.76) were identified as contributors to the FMR improvement. During a follow-up of 43 months, patients with postprocedural grade 2 to 4 FMR more frequently experienced hospitalizations for heart failure or cardiovascular death than those with grade 0 to 1 FMR (30.5% vs 4.6%, log-rank p <0.001). An age-adjusted multivariate Cox regression analysis including baseline and postprocedural FMR revealed that postprocedural grade 2 to 4 FMR (hazard ratio, 3.24; 95% confidence interval 1.43 to 7.35) was significantly associated with unfavorable events. In conclusion, AF ablation modified and often improved FMR severity in patients with reduced LVEF. Residual grade 2 to 4 FMR 6 months after AF ablation was associated with a poor prognosis.
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Fibrilación Atrial , Ablación por Catéter , Insuficiencia de la Válvula Mitral , Disfunción Ventricular Izquierda , Humanos , Fibrilación Atrial/complicaciones , Fibrilación Atrial/cirugía , Insuficiencia de la Válvula Mitral/complicaciones , Insuficiencia de la Válvula Mitral/cirugía , Resultado del Tratamiento , Pronóstico , Volumen SistólicoRESUMEN
The impact of rhythm outcomes on heart failure (HF) hospitalizations remains unknown after radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF). We sought to elucidate whether AF recurrence was associated with HF hospitalizations after AF RFCA. We conducted a large-scale, prospective, multicenter, observational study (Kansai Plus Atrial Fibrillation Registry), enrolling 5,010 consecutive patients (age 64 ± 10 years, 27.3% female, and 35.7% nonparoxysmal AF) who underwent an initial AF RFCA at 26 centers. The median follow-up duration was 2.9 years. The cumulative 3-year incidence of HF hospitalizations after the initial RFCA was 1.84% (0.69%/year). Hospitalized patients with HF were older with a higher prevalence of nonparoxysmal AF, renal dysfunction, diabetes, and underlying heart disease pre-RFCA. HF hospitalizations occurred more often in patients with than without recurrences (3.27 vs 0.84%, log-rank p <0.0001). After adjusting for confounders using a Cox model, AF recurrence remained an independent predictor of HF hospitalizations (hazard ratio [HR] 2.84, 95% confidence interval [CI] 1.80 to 4.47, p <0.0001). AF recurrence was a distinct HF hospitalization risk in patients with a left ventricular ejection fraction ≥50% (HR 4.54, 95% CI 2.38 to 8.65, p <0.0001) but not <50% (HR 1.31, 95% CI 0.65 to 2.62, p = 0.45), with significant interactions. Furthermore, patients with AF recurrences within 1 year had a greater HF hospitalization risk after 1 year (1.61% vs 0.79%, log-rank p = 0.019). In conclusion, AF recurrence after RFCA was independently associated with HF hospitalizations.
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Fibrilación Atrial , Ablación por Catéter , Insuficiencia Cardíaca , Humanos , Femenino , Persona de Mediana Edad , Anciano , Masculino , Fibrilación Atrial/complicaciones , Fibrilación Atrial/epidemiología , Fibrilación Atrial/cirugía , Volumen Sistólico , Estudios Prospectivos , Función Ventricular Izquierda , Resultado del Tratamiento , Sistema de Registros , RecurrenciaRESUMEN
BACKGROUND: Drug-coated balloons (DCB) have shown promising results for the treatment of in-stent restenosis (ISR) and small vessel disease (SVD). However, data comparing the treatment efficacy of different DCBs are limited.MethodsâandâResults: AGENT Japan is a prospective randomized controlled trial that compares the Agent balloon coated with a low-dose formulation of paclitaxel (2 µg/mm2) to the SeQuent Please paclitaxel-coated balloon (3 µg/mm2) for the treatment of SVD. Patients with target lesion length ≤28 mm and reference diameter between ≥2.00 and <3.00 mm were randomized 2 : 1 for treatment with Agent (n=101) or SeQuent Please (n=49). This trial also includes a separate single-arm substudy evaluating the clinical safety and effectiveness of Agent in patients with ISR. The primary endpoint of 6-month target lesion failure (TLF) was observed in 3.0% of Agent and 0.0% of SeQuent Please patients (difference=3.0%; 97.5% upper confidence bound [UCB]=9.57%, which is less than the prespecified margin of 13.2%; Pnon-inferiority=0.0012). There were no deaths or thrombosis, and angiographic and quality-of-life outcomes were comparable between groups. The AGENT Japan ISR substudy (n=30) primary endpoint was met because the one-sided 97.5% UCB for 6-month TLF (3.3%) was significantly less than the study success criterion of 15.1% (97.5% UCB=9.8%; P<0.0001). CONCLUSIONS: Data from this study demonstrate good clinical outcomes with the Agent DCB when used to treat patients with SVD or ISR.
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Angioplastia Coronaria con Balón , Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Paclitaxel , Humanos , Angioplastia Coronaria con Balón/efectos adversos , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos/efectos adversos , Paclitaxel/efectos adversos , Estudios Prospectivos , Resultado del TratamientoRESUMEN
Background: Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the urinary albumin-to-creatinine ratio (UACR) in patients with elevated levels of albuminuria in the presence or absence of heart failure (HF) or type 2 diabetes mellitus (T2D). However, these effects have not yet been reported in the presence of both HF and T2D. This lack of evidence prompted us to conduct a clinical trial on the effects of dapagliflozin on UACR in patients with HF and T2D. Methods: DAPPER is a multicentre, randomised, open-labeled, parallel-group, standard treatment-controlled trial that enrolled patients at 18 medical facilities in Japan. Eligible participants with both HF and T2D and aged between 20 and 85 years were randomly assigned to a dapagliflozin or control (anti-diabetic drugs other than SGLT 2 inhibitors) group with a 1:1 allocation. The primary outcome was changes in UACR from baseline after a two-year observation, and secondary endpoints were cardiovascular (CV) events and parameters related to HF. This trial was registered with the UMIN-CTR registry, UMIN000025102 and the Japan Registry of Clinical Trials, jRCTs051180135. Findings: Between 12 May 2017 and 31 March 2020, 294 patients were randomly assigned to the dapagliflozin group (n = 146) or control group (n = 148). The mean age of patients was 72.1 years and 29% were female. The mean glycated hemoglobin value was 6.9%, mean NT-proBNP was 429.1 pg/mL, mean estimated GFR was 65.7 mL/min/1.73 m2, and median UACR was 25.0 (8.8-74.6) mg/g Cr in the dapagliflozin group and 25.6 (8.2-95.0) mg/g Cr in the control group. Of the 146 patients in the dapagliflozin group, 122 completed the study, and 107 (87.7%) were taking 5 mg of dapagliflozin daily at the end of the observation period. The primary outcome did not significantly differ between the dapagliflozin and control groups. Among the secondary endpoints, the mean decrease in left ventricular end-diastolic dimensions as one of the echocardiographic parameters was larger in the dapagliflozin group than in the control group. The composite endpoint, defined as CV death or hospitalisation for CV events, hospitalisation for HF events, hospitalisation for all causes, and an additional change in prescriptions for heart failure in a two-year observation, was less frequent in the dapagliflozin group than in the control group. Interpretation: Although dapagliflozin at a dose of 5 mg daily did not reduce urinary albumin excretion in patients with HF and T2D from that in the controls, our findings suggest that dapagliflozin decreased CV events and suppressed left ventricular remodeling. Funding: AstraZeneca KK, Ono Pharmaceutical Co., Ltd.
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BACKGROUND: Statins have been shown to prevent microvascular dysfunction that may cause periprocedural myocardial infarction after percutaneous coronary intervention (PCI). Evolocumab has more potent lipid-lowering properties than statins. Aims: The aims of this study were to investigate whether evolocumab pretreatment on top of statin therapy could prevent periprocedural microvascular dysfunction. Methods: This study included 100 patients with stable coronary artery disease who were scheduled to undergo PCI and had high low-density lipoprotein cholesterol (LDL-C) under statin therapy. Patients were randomised to receive evolocumab 140 mg every 2 weeks for 2 to 6 weeks before PCI (evolocumab group: N=54) or not (control group: N=46). The primary endpoint was the index of microvascular resistance (IMR) after PCI. Troponin T was measured before and 24 hours after PCI. Results: Geometric mean LDL-C was 94.1 (95% confidence interval [CI]: 86.8-102.1) mg/dl and 89.4 (95% CI: 83.5-95.7) mg/dl at baseline, and 25.6 (95% CI: 21.9-30.0) mg/dl and 79.8 (95% CI: 73.9-86.3) mg/dl before PCI, in the evolocumab group and in the control group, respectively. PCI was performed 22.1±8.5 days after allocation. Geometric mean IMR was 20.6 (95% CI: 17.2-24.6) in the evolocumab group and 20.6 (95% CI: 17.0-25.0) in the control group (p=0.98). There was no significant difference in the geometric mean of post-PCI troponin T (0.054, 95% CI: 0.041-0.071 ng/ml vs 0.054, 95% CI: 0.038-0.077 ng/ml; p=0.99) and in the incidence of major periprocedural myocardial infarction between the 2 groups (44.4% vs 44.2%; p=1.00). Conclusions: Evolocumab pretreatment did not prevent periprocedural microvascular dysfunction in patients on modern medical management with statins.
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Inhibidores de Hidroximetilglutaril-CoA Reductasas , Infarto del Miocardio , Intervención Coronaria Percutánea , Anticuerpos Monoclonales Humanizados , LDL-Colesterol , Humanos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Infarto del Miocardio/etiología , Intervención Coronaria Percutánea/efectos adversos , Resultado del Tratamiento , Troponina TRESUMEN
Left atrial (LA) function can help predict various cardiovascular events. Catheter ablation for atrial fibrillation (AF) modifies baseline LA function through the maintenance of sinus rhythm and myocardial injury. We investigated the impact of post-ablation LA function on recurrence of AF after ablation and identified the predictors of reduced post-ablation LA function. A total of 616 patients who underwent AF ablation (paroxysmal, N = 310; non-paroxysmal, N = 306) were retrospectively examined with cardiac computed tomography at baseline and 3 months after the final ablation procedure. Post-ablation LA emptying fraction (LAEFpost) was calculated. We evaluated the association between LAEFpost and recurrence of AF after the final ablation procedure. Further, we assessed the predictors of reduced LAEFpost. The recurrence rate of AF was 72.7% after the final ablation procedure [median follow-up 48 months (48.0, 48.0), total number of ablation sessions: 1.4 ± 0.7]. Multivariate analysis revealed that LAEFpost was associated with the recurrence of AF (hazard ratio/10% increase: 0.62, 95% confidence interval: 0.51-0.75, P < 0.0001). LAEFpost had a mild predictive power for recurrence of AF (c-statistics: 0.670, optimal cutoff: 26.36%, P < 0.0001). The recurrence-free proportion among patients with reduced LAEFpost (< 26.36%, N = 100) and those with preserved LAEFpost (≥ 26.36%, N = 516) was 40% and 79%, respectively (P < 0.0001). The predictors of reduced LAEFpost were low pre-ablation LAEF, high pre-ablation LA volume, low body mass index (BMI), and female sex. Further, reduced LAEFpost was associated with the total number of ablation sessions and extra-pulmonary vein LA ablation. In conclusion, reduced LAEFpost was associated with recurrence of AF after ablation. Advanced LA remodeling, low BMI, and female sex could predict reduced LAEFpost. Although additional ablation was associated with reduced LAEFpost, it remains unclear whether reduced LAEFpost resulted from the additional ablation. Reduced LAEFpost might help stratify patients with ablation-refractory AF.
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Fibrilación Atrial , Ablación por Catéter , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , Función del Atrio Izquierdo , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodos , Femenino , Atrios Cardíacos , Humanos , Recurrencia , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
Red cell distribution width (RDW) is reportedly associated with cardiovascular events, including atrial fibrillation (AF). We investigated whether the RDW values were associated with the outcomes of catheter ablation for AF. This retrospective multicenter study included 501 patients with AF (239 paroxysmal AF cases, 196 persistent AF cases, and 66 long-standing persistent AF cases) who underwent initial AF ablation between March 2017 and May 2018. The RDW values were evaluated before and at 1-3 months after the procedure. The patients were stratified based on the recurrence of AF within 1 year after the index procedure with a blanking period of 3 months into recurrence group (107 patients, 21.4%) and no-recurrence group (394 patients, 78.6%). There were no significant differences in preoperative RDW values between the groups (p = 0.37). The RDW value did not change significantly after the ablation in the recurrence group (13.55-13.60%, p = 0.37), although it decreased significantly in the no-recurrence group (13.64-13.37%, p < 0.001). Multivariate Cox proportional hazards regression analyses revealed that a postoperative change in RDW (ΔRDW) was independently associated with AF recurrence (hazard ratio 2.00, 95% confidence interval 1.42-2.76, p < 0.001). Receiver operating characteristic curve analysis revealed that a ΔRDW cut-off value of - 0.1% provided a c-statistic of 0.65 for predicting AF recurrence. Decrease in RDW during the blanking period after ablation independently predicted the 1-year success of AF ablation.
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Fibrilación Atrial , Ablación por Catéter , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , Índices de Eritrocitos , Humanos , Recurrencia , Estudios Retrospectivos , Factores de Riesgo , Resultado del TratamientoRESUMEN
OBJECTIVE: We compared the safety, need for additional foam sclerotherapy, and 1-year venous clinical severity score (VCSS) improvement in the limbs of patients with chronic venous disease and great saphenous vein (GSV) reflux. These patients had undergone endovenous laser ablation (EVLA) using a 1470-nm diode laser and concurrent foam sclerotherapy (1% polidocanol) through the access sheath (transluminal injection of foam sclerotherapy [TLFS]) or EVLA and concurrent direct-puncture ultrasound-guided foam sclerotherapy (UGFS). METHODS: In the present study, we screened 467 patients (577 legs) with symptomatic primary GSV reflux for randomization to either TLFS with EVLA (n = 103 legs; TLFS group) or UGFS with EVLA (n = 94 legs; UGFS group). The exclusion criteria were (1) recurrent varicose veins after previous intervention; (2) hypersensitivity reaction to sclerotherapy; (3) acute deep vein thrombosis; (4) serious lower limb ischemic disease; (5) a coagulation disorder; and (6) simultaneous EVLA of both GSVs and small saphenous veins. The correlations of the VCSS changes with the clinical features, such as age, sex, CEAP (clinical, etiologic, anatomic, pathophysiologic) classification, total amount of sclerosant used at the original procedure, multiple punctures (more than two) for sclerotherapy at the original procedure, the use of TLFS, and linear endovenous energy density, were estimated using logistic regression. RESULTS: No significant differences in the distribution of the CEAP classification were observed between the two groups. After 12 months of follow-up, all truncal veins were occluded. The VCSS had significantly improved in the TLFS group compared with the UGFS group (UGFS, -7.4 ± 1.8; TLFS, -8.7 ± 1.5; P < .0001). Multivariate analysis revealed that TLFS was the only significant factor for an improved VCSS (hazard ratio, 0.63; 95% confidence interval, 0.32-0.96; P < .0001). The need for additional second-stage sclerotherapy was significantly avoided in the TLFS group (n = 10; 10%) compared with the UGFS group (n = 51; 54%; P < .0001). CONCLUSIONS: TLFS combined with EVLA is a safe and feasible procedure that improves the VCSS and reduces the need for additional second-stage interventions compared with UGFS combined with EVLA.
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Ablación por Catéter/métodos , Procedimientos Endovasculares , Terapia por Láser/métodos , Polidocanol/administración & dosificación , Vena Safena , Soluciones Esclerosantes/administración & dosificación , Escleroterapia/métodos , Várices/terapia , Anciano , Formas de Dosificación , Femenino , Humanos , Inyecciones , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Escleroterapia/efectos adversos , Resultado del Tratamiento , Ultrasonografía , Várices/cirugíaRESUMEN
Percutaneous coronary intervention (PCI) is a standard treatment in patients with stable coronary artery disease (CAD); however, periprocedural myocardial infarction (PMI) remains a common complication of PCI. Aggressive lipid-lowering therapy with statin has shown to reduce the incidence of PMI by preventing coronary microvascular dysfunction. It is unclear whether evolocumab, a potent lipid-lowering agent, could diminish microvascular damage after PCI. The EVOCATION trial (jRCTs051180022) is a multicenter, randomized, open-label, active-controlled, parallel-group, exploratory, investigator-initiated clinical study to evaluate whether pretreatment with evolocumab could decrease the index of microvascular resistance (IMR) after PCI in patients with stable CAD. This study population consists of 100 patients with stable CAD who will undergo PCI and have high low-density lipoprotein cholesterol levels despite administration of maximum tolerated dose of statins for at least 2 weeks. Eligible patients are randomized in a 1:1 ratio to receive either evolocumab 140 mg every 2 weeks in addition to standard of care treatment or standard of care treatment only for 2-6 weeks before PCI. The primary endpoint is IMR after PCI. The EVOCATION trial will evaluate whether pretreatment with evolocumab reduces periprocedural microvascular damage in patients with stable CAD undergoing PCI.
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Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Anticuerpos Monoclonales Humanizados , Enfermedad de la Arteria Coronaria/terapia , Humanos , Estudios Prospectivos , Resultado del TratamientoAsunto(s)
Aterectomía Coronaria , Enfermedad de la Arteria Coronaria , Placa Aterosclerótica , Aterectomía Coronaria/métodos , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/cirugía , Humanos , Placa Aterosclerótica/diagnóstico , Placa Aterosclerótica/cirugía , Ultrasonografía IntervencionalRESUMEN
BACKGROUND: Pulmonary vein (PV) reconnection is the main cause of atrial fibrillation (AF) recurrence. This study aimed to examine the effect of first-pass PV isolation (PVI) on PV reconnection frequency during the procedure and on AF ablation outcomes. METHODS: This retrospective study included 446 patients with drug-refractory AF (370 men, aged 64 ± 10 years) who underwent initial PVI using an open-irrigated contact force catheter between January 2015 and October 2016. We investigated the effect of first-pass PVI on PV reconnection during spontaneous PV reconnection and dormant conduction after an adenosine triphosphate challenge. RESULTS: First-pass PVI was achieved in 69% (617/892) of ipsilateral PVs, of which we observed PV reconnection during the procedure in 134 (22%) PVs. This value was significantly lower than that observed in those without first-pass PVI (50%, 138/275) (P < .0001). We divided the subjects into two groups based on the presence or absence of first-pass PVI in at least one of two ipsilateral PVs: first-pass (n = 383, 86%) and non-first-pass groups (n = 63, 14%). The 2-year AF recurrence-free rate was significantly higher in the first-pass group than in the other group (75% vs 59%, log-rank P = .032). In 78 patients with repeat AF ablation, the PV reconnection rate in the second procedure was significantly lower in PVs that had first-pass isolation in the first procedure (34% vs 73%, P < .0001). CONCLUSIONS: Absence of first-pass PVI was associated with a higher frequency of spontaneous PV reconnection and dormant conduction and poor ablation outcomes. First-pass isolation may be a useful marker for better PVI durability.
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During removal of an entrapped guidewire, the core wire can fracture, allowing stretching of the spring wire while the distal guidewire is still entrapped. We resolved this issue with rotational atherectomy, allowing cutting of the spring wire at the intended site, regardless of the proximal spring wire fracture. (Level of Difficulty: Advanced.).
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Background: Global longitudinal strain (GLS) can predict prognosis after myocardial infarction (MI). Tissue mitral annular displacement (TMAD) is another index of longitudinal left ventricular deformity, and is less dependent on image quality than GLS. We investigated the relationship between TMAD and GLS, and their ability to predict outcomes after MI. MethodsâandâResults: GLS and TMAD were measured on echocardiograms 2 weeks after MI in 246 consecutive patients (median age 62 years, 85.7% male). TMAD was measured from apical 4- and 2-chamber views (TMAD4ch and TMAD2ch, respectively), and a mean value (TMADav) was calculated. TMAD4ch, TMAD2ch, and GLS were successfully measured in 240 (97.5%), 210 (85.3%) and 214 patients (87.0%), respectively. All TMAD parameters were significantly correlated with GLS (R=0.71-0.75) and left ventricular ejection fraction (LVEF; R=0.48-0.53). TMAD parameters were weakly correlated with peak creatine kinase (CK; R=0.20) and CK-MB (R=0.21-0.25). GLS and TMADav were significantly associated with LVEF after 6 months (R=0.48-0.53) and all-cause mortality during the follow-up period (median 1,242 days). TMADav discriminated patients with higher all-cause mortality when patients were divided into 3 groups, namely upper 25%, middle range, and lower 25% of TMADav (P=0.041, log-rank test). GLS detected high-risk patients using 15.0% as a cut-off value. Conclusions: TMAD could be a simple and reliable alternative to GLS for predicting outcomes in patients with MI.
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Creation of a distal re-entry site is widely performed to treat subintimal hematoma. However, this method has a risk of further vessel damage. The present aspiration technique after sealing the entry site by stenting is more promising because the hematoma can be reduced without additional vessel damage. (Level of Difficulty: Advanced.).