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BACKGROUND: Cardiovascular events frequently recur after acute myocardial infarction, and low cholesterol efflux - a process mediated by apolipoprotein A1, which is the main protein in high-density lipoprotein - has been associated with an increased risk of cardiovascular events. CSL112 is human apolipoprotein A1 derived from plasma that increases cholesterol efflux capacity. Whether infusions of CSL112 can reduce the risk of recurrent cardiovascular events after acute myocardial infarction is unclear. METHODS: We conducted an international, double-blind, placebo-controlled trial involving patients with acute myocardial infarction, multivessel coronary artery disease, and additional cardiovascular risk factors. Patients were randomly assigned to receive either four weekly infusions of 6 g of CSL112 or matching placebo, with the first infusion administered within 5 days after the first medical contact for the acute myocardial infarction. The primary end point was a composite of myocardial infarction, stroke, or death from cardiovascular causes from randomization through 90 days of follow-up. RESULTS: A total of 18,219 patients were included in the trial (9112 in the CSL112 group and 9107 in the placebo group). There was no significant difference between the groups in the risk of a primary end-point event at 90 days of follow-up (439 patients [4.8%] in the CSL112 group vs. 472 patients [5.2%] in the placebo group; hazard ratio, 0.93; 95% confidence interval [CI], 0.81 to 1.05; P = 0.24), at 180 days of follow-up (622 patients [6.9%] vs. 683 patients [7.6%]; hazard ratio, 0.91; 95% CI, 0.81 to 1.01), or at 365 days of follow-up (885 patients [9.8%] vs. 944 patients [10.5%]; hazard ratio, 0.93; 95% CI, 0.85 to 1.02). The percentage of patients with adverse events was similar in the two groups; a higher number of hypersensitivity events was reported in the CSL112 group. CONCLUSIONS: Among patients with acute myocardial infarction, multivessel coronary artery disease, and additional cardiovascular risk factors, four weekly infusions of CSL112 did not result in a lower risk of myocardial infarction, stroke, or death from cardiovascular causes than placebo through 90 days. (Funded by CSL Behring; AEGIS-II ClinicalTrials.gov number, NCT03473223.).
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Apolipoproteína A-I , Lipoproteínas HDL , Infarto del Miocardio , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Apolipoproteína A-I/administración & dosificación , Apolipoproteína A-I/sangre , Enfermedades Cardiovasculares/etiología , Enfermedades Cardiovasculares/metabolismo , Enfermedades Cardiovasculares/mortalidad , Enfermedades Cardiovasculares/prevención & control , Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Enfermedad de la Arteria Coronaria/complicaciones , Método Doble Ciego , Infusiones Intravenosas , Estimación de Kaplan-Meier , Lipoproteínas HDL/sangre , Lipoproteínas HDL/metabolismo , Infarto del Miocardio/complicaciones , Infarto del Miocardio/tratamiento farmacológico , Infarto del Miocardio/metabolismo , Infarto del Miocardio/mortalidad , Recurrencia , Prevención Secundaria , Accidente Cerebrovascular/prevención & control , Factores de RiesgoRESUMEN
BACKGROUND: Patients with diabetes mellitus (DM) are at high risk for recurrent ischemic events after coronary stenting. We assessed the effects of continued thienopyridine among patients with DM participating in the Dual Antiplatelet Therapy (DAPT) Study as a prespecified analysis. METHODS AND RESULTS: After coronary stent placement and 12 months treatment with open-label thienopyridine plus aspirin, 11 648 patients free of ischemic or bleeding events and who were medication compliant were randomly assigned to continued thienopyridine or placebo, in addition to aspirin, for 18 more months. After randomization, patients with DM (n=3391), in comparison with patients without DM (n=8257), had increased composite outcome of death, myocardial infarction (MI), or stroke (6.8% versus 4.3%, P<0.001), increased death (2.5% versus 1.4%, P<0.001), and MI (4.2% versus 2.6%, P<0.001). Among patients with DM, in a comparison of continued thienopyridine versus placebo, rates of stent thrombosis were 0.5% versus 1.1%, P=0.06, and rates of MI were 3.5% versus 4.8%, P=0.058; and among patients without DM the rates were 0.4% versus 1.4%, P<0.001 (stent thrombosis, P interaction=0.21) and 1.6% versus 3.6%, P<0.001 (MI, P interaction=0.02). Bleeding risk with continued thienopyridine was similar among patients with or without DM (interaction P=0.61). CONCLUSIONS: In patients with DM, continued thienopyridine beyond 1 year after coronary stenting is associated with reduced risk of MI, although this benefit is attenuated in comparison with patients without DM. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00977938.
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Aspirina/administración & dosificación , Diabetes Mellitus/tratamiento farmacológico , Stents Liberadores de Fármacos , Infarto del Miocardio/prevención & control , Inhibidores de Agregación Plaquetaria/administración & dosificación , Piridinas/administración & dosificación , Anciano , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/epidemiología , Quimioterapia Combinada , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/epidemiologíaRESUMEN
BACKGROUND: We sought to investigate the relation between frailty indices and 12-month mortality after transcatheter aortic valve implantation (TAVI). METHODS: We included 101 consecutive patients with severe aortic stenosis who have undergone TAVI. Frailty indices according to Valve Academic Research Consortium-2 recommendations (5-m walk test [5MWT] and hand grip strength) as well as other available scales of frailty (Katz index, Elderly Mobility Scale [EMS], Canadian Study of Health and Aging [CSHA] scale, Identification of Seniors at Risk [ISAR] scale) were assessed at baseline. The primary endpoint was 12-month all-cause mortality. RESULTS: Twelve-month all-cause mortality was 17.8%. According to 5MWT, 17.8% were frail; hand grip test: 6.9%; Katz index: 17.8%; EMS: 7.9%; CSHA scale: 16.9%; and ISAR scale: 52.5%. Associations between frailty indices and 12-month all-cause mortality after TAVI were significant in Cox regression analysis (frail vs not frail, presented as hazard ratio[95%CI] adjusted for logistic EuroSCORE): for 5MWT, 72.38 (15.95-328.44); for EMS, 23.39 (6.89-79.34); for CSHA scale, 53.97 (14.67-198.53); for Katz index, 21.69 (6.89-68.25); for hand grip strength, 51.54 (12.98-204.74); and for ISAR scale, 15.94 (2.10-120.74). Similarly, such relationship was confirmed when 5MWT, EMS, and CSHA were used as continuous variables (hazard ratio [95%CI] adjusted for logistic EuroSCORE: for 5MWT per 1-second increase, 2.55 [1.94-3.37]; for EMS per 1-point decrease, 2.90 (1.99-4.21); and for CSHA per 1-point increase, 3.13 [2.17-4.53]). CONCLUSIONS: Our study confirmed a strong predictive ability of most of the proposed frailty indices for 12-month mortality after TAVI. For patients scheduled for TAVI, the use of frailty indices, which are easy and quick to assess on clinical basis but with strong performance, for example, 5MWT, EMS, or hand grip test, may be advocated.
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Estenosis de la Válvula Aórtica/cirugía , Fuerza de la Mano , Mortalidad , Reemplazo de la Válvula Aórtica Transcatéter , Prueba de Paso , Anciano , Anciano de 80 o más Años , Causas de Muerte , Femenino , Anciano Frágil , Humanos , Masculino , Modelos de Riesgos Proporcionales , Medición de RiesgoRESUMEN
OBJECTIVES: This study aimed to evaluate the indications, short- and long-term outcomes of balloon aortic valvuloplasty (BAV) in patients with severe aortic stenosis (AS). METHODS: A cohort of 112 patients with AS underwent 114 BAV procedures between October 2012 and July 2015 in two Polish interventional cardiology centers. Clinical and echocardiographic data were prospectively collected within 1, 6, and 12 months follow-up. RESULTS: BAV was performed as a bridge to TAVI (51.8%), surgical aortic valve replacement (AVR, 5.4%), before urgent noncardiac surgery (8.0%), for symptom relief (33.0%) and cardiogenic shock (1.8%). Periprocedural, in-hospital, 1-, 6-, 12-month mortality were 2.7%; 8.9%; 8.9%; 16.9%; 22.3%, respectively. Serious periprocedural adverse events occurred in 18.8% of patients. After the procedure, mean aortic valve area (AVA) increased from 0.59 ± 0.18 to 0.82 ± 0.24 cm2 , mean peak aortic valve gradient (pAVG) decreased from 94.0 ± 27.6 to 65.4 ± 20.0 mm Hg, mean aortic gradient decreased from 58.0 ± 17.8 to 40.5 ± 14.6 mm Hg, P < 0.05 for all. Left ventricular ejection fraction (LVEF) increased from median (interquartile range) of 53.5 (30 - 64) to 60 (45 - 65)% after 1 month (P < 0.05). In patients with impaired left ventricle function (LVEF <40%), LVEF significantly improved (median increase of 16%) after 1 and 6 months (P < 0.05). At 12 months patients had higher AVA, pAVG, and LVEF as compared to baseline (P < 0.05). CONCLUSIONS: BAV is a useful procedure in high-risk AS patients, where achieved effects can be sufficient in bridging patients for TAVI/AVR. © 2016 Wiley Periodicals, Inc.
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Estenosis de la Válvula Aórtica/terapia , Válvula Aórtica/fisiopatología , Valvuloplastia con Balón , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/fisiopatología , Valvuloplastia con Balón/efectos adversos , Valvuloplastia con Balón/mortalidad , Ecocardiografía , Femenino , Hemodinámica , Mortalidad Hospitalaria , Humanos , Masculino , Polonia , Estudios Prospectivos , Recuperación de la Función , Sistema de Registros , Índice de Severidad de la Enfermedad , Volumen Sistólico , Factores de Tiempo , Resultado del Tratamiento , Función Ventricular IzquierdaRESUMEN
Blood transfusions are considered as an important predictor of adverse outcome in patients with severe aortic (AS) undergoing transcatheter aortic valve implantation (TAVI). We sought to investigate the association between blood transfusions and mortality after TAVI. We enrolled 101 consecutive patients with severe AS undergoing TAVI. Patients who required transfusion were defined as patients in whom at least one unit of packed red blood cells (PRBCs) was transfused in the perioperative period. Twelve-month outcomes were assessed based on Valve Academic Research Consortium definitions. A total of 28 (27.7%) patients required blood transfusion after TAVI. Baseline characteristics of the patients with and without a transfusion were similar. Median amount of PRBCs was 2 (interquartile range, 2-4). Twelvemonth all-cause mortality was higher in patients with than without a blood transfusion (39.3% versus 9.6%; P = 0.001). Importantly, the need for a blood transfusion after TAVI was an independent predictor of higher mortality rates after 12 months (hazard ratio (HR) 2.84 95%CI (1.06-7.63); P = 0.039; (HR for incomplete coronary revascularization 10.86, 95%CI 3.72-31.73; P < 0.001; HR for a history of stroke/TIA 3.93, 95%CI 1.39-11.07; P < 0.001). The duration of inhospital stay was longer in patients requiring transfusion (16.0 (14.0-22.0) versus 7.0 (7.0-11.5) days; P = 0.014). In conclusion, blood transfusions after TAVI were associated with higher mortality rates after 12 months, longer in-hospital stay, and were identified as an independent predictor of impaired clinical outcome.
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Transfusión Sanguínea/estadística & datos numéricos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Polonia/epidemiología , Estudios ProspectivosRESUMEN
OBJECTIVES: The aim of the study was to compare 12-month mortality rate of patients with and without complete coronary revascularization before transcatheter aortic valve implantation (TAVI). BACKGROUND: There are limited data on the impact of coronary artery disease burden in patients with severe aortic stenosis undergoing TAVI. METHODS: One hundred and one consecutive patients undergoing TAVI were enrolled. Of them 16 (15.8%) had an incomplete coronary revascularization. The primary endpoint was 12-month all-cause mortality. RESULTS: Twelve-month all-cause mortality was higher in patients with incomplete coronary revascularization than in patients with complete coronary revascularization or without significant lesions (75.0% vs 7.1%; P < 0.001). Importantly, incomplete coronary revascularization was an independent predictor of higher mortality rate after 12 months (hazard ratio (HR) for incomplete coronary revascularization 10.86, 95% CI 3.72-31.73; P < 0.001; HR for a history of stroke/TIA 3.93, 95% confidence interval (CI) 1.39-11.07; P < 0.001; HR for blood transfusion 2.84 95% CI (1.06-7.63); P = 0.039). In 9 of 16 (56.3%) patients, incomplete revascularization was related to the presence of chronic total occlusions (CTO). Patients with CTO had an increased mortality rate after 12 months (55.6% vs 14.1%; P = 0.008) as compared to patients without the CTO. CONCLUSIONS: Incomplete coronary revascularization and a history of stroke or TIA may be independent predictors of all-cause mortality in patients undergoing TAVI. However, further studies are recommended to confirm the results, especially in terms of the impact of CTO presence on long-term mortality after TAVI.
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Estenosis de la Válvula Aórtica , Enfermedad de la Arteria Coronaria , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/cirugía , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/mortalidad , Enfermedad de la Arteria Coronaria/cirugía , Costo de Enfermedad , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Mortalidad , Polonia/epidemiología , Modelos de Riesgos Proporcionales , Factores de Riesgo , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/mortalidad , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Resultado del TratamientoRESUMEN
IMPORTANCE: Despite antirestenotic efficacy of coronary drug-eluting stents (DES) compared with bare metal stents (BMS), the relative risk of stent thrombosis and adverse cardiovascular events is unclear. Although dual antiplatelet therapy (DAPT) beyond 1 year provides ischemic event protection after DES, ischemic event risk is perceived to be less after BMS, and the appropriate duration of DAPT after BMS is unknown. OBJECTIVE: To compare (1) rates of stent thrombosis and major adverse cardiac and cerebrovascular events (MACCE; composite of death, myocardial infarction, or stroke) after 30 vs 12 months of thienopyridine in patients treated with BMS taking aspirin and (2) treatment duration effect within the combined cohorts of randomized patients treated with DES or BMS as prespecified secondary analyses. DESIGN, SETTING, AND PARTICIPANTS: International, multicenter, randomized, double-blinded, placebo-controlled trial comparing extended (30-months) thienopyridine vs placebo in patients taking aspirin who completed 12 months of DAPT without bleeding or ischemic events after receiving stents. The study was initiated in August 2009 with the last follow-up visit in May 2014. INTERVENTIONS: Continued thienopyridine or placebo at months 12 through 30 after stent placement, in 11,648 randomized patients treated with aspirin, of whom 1687 received BMS and 9961 DES. MAIN OUTCOMES AND MEASURES: Stent thrombosis, MACCE, and moderate or severe bleeding. RESULTS: Among 1687 patients treated with BMS who were randomized to continued thienopyridine vs placebo, rates of stent thrombosis were 0.5% vs 1.11% (n = 4 vs 9; hazard ratio [HR], 0.49; 95% CI, 0.15-1.64; P = .24), rates of MACCE were 4.04% vs 4.69% (n = 33 vs 38; HR, 0.92; 95% CI, 0.57-1.47; P = .72), and rates of moderate/severe bleeding were 2.03% vs 0.90% (n = 16 vs 7; P = .07), respectively. Among all 11,648 randomized patients (both BMS and DES), stent thrombosis rates were 0.41% vs 1.32% (n = 23 vs 74; HR, 0.31; 95% CI, 0.19-0.50; P < .001), rates of MACCE were 4.29% vs 5.74% (n = 244 vs 323; HR, 0.73; 95% CI, 0.62-0.87; P < .001), and rates of moderate/severe bleeding were 2.45% vs 1.47% (n = 135 vs 80; P < .001). CONCLUSIONS AND RELEVANCE: Among patients undergoing coronary stent placement with BMS and who tolerated 12 months of thienopyridine, continuing thienopyridine for an additional 18 months compared with placebo did not result in statistically significant differences in rates of stent thrombosis, MACCE, or moderate or severe bleeding. However, the BMS subset may have been underpowered to identify such differences, and further trials are suggested. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00977938.
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Aspirina/administración & dosificación , Stents Liberadores de Fármacos , Inhibidores de Agregación Plaquetaria/administración & dosificación , Piridinas/administración & dosificación , Stents , Anciano , Aspirina/efectos adversos , Enfermedades Cardiovasculares/epidemiología , Reestenosis Coronaria/epidemiología , Reestenosis Coronaria/prevención & control , Método Doble Ciego , Quimioterapia Combinada , Femenino , Hemorragia/inducido químicamente , Humanos , Análisis de Intención de Tratar , Masculino , Persona de Mediana Edad , Inhibidores de Agregación Plaquetaria/efectos adversos , Piridinas/efectos adversos , RiesgoRESUMEN
BACKGROUND: The coexistence of mitral regurgitation (MR) and severe aortic stenosis (AS) has been associated with worse outcomes in patients undergoing transcatheter aortic valve implantation (TAVI). Herein, the aim was to assess the etiology and degree of MR in an unselected TAVI population and investigate the impact of MR reduction at mid-term follow-up. METHODS: Patients subjected to TAVI as a treatment for severe AS in a single center were retrospectively analyzed. The primary endpoint was the MR reduction after TAVI. The secondary endpoint was all-cause mortality and heart failure hospitalization at a 3-year follow-up. RESULTS: Patients undergoing TAVI (n = 283) in the years 2017-2019 were screened for the presence of hemodynamically significant MR. Sixty-nine subjects (24.4%) with severe (16, 23.2%) and moderate (53, 76.8%) MR were included. The primary MR was predominant (39 subjects, 56.5%). The median age of the patients was 82 years. MR improved in 25 patients (36.2%, p < 0.001). Baseline severe MR was more prone to reduce (8 subjects, 50%) than moderate (17 subjects, 32.1%, p = 0.04). The primary MR improved in 14 patients (35.9%), while secondary in 11 patients (36.7%, p = 1). Patients showing MR reduction had lower mortality (8 vs. 29.55%, p = 0.047) and were less frequently hospitalized (20 vs. 45.45%, p = 0.03) at 3-year follow-up. CONCLUSIONS: Hemodynamically significant MR improves after TAVI regardless of its etiology. Moreover, MR reduction after TAVI is associated with better clinical outcomes.
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INTRODUCTION: Intricate management of heart failure (HF), especially in the context of reduced ejection fraction, is further complicated by an elevated risk of thromboembolic events. Studies published so far offer inconclusive insight into the interplay between mitral regurgitation (MR) and the coagulation system. OBJECTIVES: This study aimed to investigate the impact of transcatheter edgetoedge repair (TEER) on specific coagulation parameters in HF patients. PATIENTS AND METHODS: A cohort of 31 HF patients with severe MR treated with TEER underwent a systematic evaluation at 3 visits (V1, V2, and V3). Coagulation parameters, including fibrinogen concentration, thrombin generation, fibrin clot permeability, and clot lysis time (CLT) were assessed (n = 27 at V2; n = 25 at V3). RESULTS: TEER induced changes in fibrinogen levels (P = 0.01; V3 vs V2) and improved fibrin clot properties over 50day followup (P = 0.01; V3 vs V2). No significant differences were observed between time points in the analyzed blood clot parameters. Correlation analysis showed that baseline CLT was associated with ΔNterminal pro-Btype natriuretic peptide (NTproBNP) level (P = 0.049; r = 0.4). Multivariable analysis identified baseline CLT as an independent predictor of early postTEER NTproBNP change (R2 = 0.55; P = 0.02). CONCLUSIONS: We found decreased level of fibrinogen and increased permeation coefficient over a median 50 (interquartile range, 32.5-75.5)-day postTEER followup, as compared with early postprocedural assessments. Other blood coagulation parameters remained unchanged from baseline at both followup time points after TEER. Finally, CLT was an independent predictor of early NTproBNP increase, emphasizing its role as an indicator of hemodynamic response to TEER.
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Fibrina , Insuficiencia de la Válvula Mitral , Trombina , Humanos , Insuficiencia de la Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/sangre , Femenino , Masculino , Anciano , Trombina/metabolismo , Fibrina/metabolismo , Persona de Mediana Edad , Válvula Mitral/cirugía , Fibrinógeno/análisis , Fibrinógeno/metabolismo , Tiempo de Lisis del Coágulo de Fibrina , Coagulación SanguíneaRESUMEN
BACKGROUND: The AEGIS-II trial hypothesized that CSL112, an intravenous formulation of human apoA-I, would lower the risk of plaque disruption, decreasing the risk of recurrent events such as myocardial infarction (MI) among high-risk patients with MI. OBJECTIVES: This exploratory analysis evaluates the effect of CSL112 therapy on the incidence of cardiovascular (CV) death and recurrent MI. METHODS: The AEGIS-II trial was an international, multicenter, randomized, double-blind, placebo-controlled trial that randomized 18,219 high-risk acute MI patients to 4 weekly infusions of apoA-I (6 g CSL112) or placebo. RESULTS: The incidence of the composite of CV death and type 1 MI was 11% to 16% lower in the CSL112 group over the study period (HR: 0.84; 95% CI: 0.7-1.0; P = 0.056 at day 90; HR: 0.86; 95% CI: 0.74-0.99; P = 0.048 at day 180; and HR: 0.89; 95% CI: 0.79-1.01; P = 0.07 at day 365). Similarly, the incidence of CV death or any MI was numerically lower in CSL112-treated patients throughout the follow-up period (HR: 0.92; 95% CI: 0.80-1.05 at day 90, HR: 0.89; 95% CI: 0.79-0.996 at day 180, HR: 0.91; 95% CI: 0.83-1.01 at day 365). The effect of CSL112 treatment on MI was predominantly observed for type 1 MI and type 4b (MI due to stent thrombosis). CONCLUSIONS: Although CSL112 did not significantly reduce the occurrence of the primary study endpoints, patients treated with CSL112 infusions had numerically lower rates of CV death and MI, type-1 MI, and stent thrombosis-related MI compared with placebo. These findings could suggest a role of apoA-I in reducing subsequent plaque disruption events via enhanced cholesterol efflux. Further prospective data would be needed to confirm these observations.
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Apolipoproteína A-I , Infarto del Miocardio , Humanos , Masculino , Femenino , Método Doble Ciego , Infarto del Miocardio/epidemiología , Persona de Mediana Edad , Anciano , Recurrencia , Infusiones Intravenosas , Lipoproteínas HDLRESUMEN
BACKGROUND: Transfemoral approach (TFA) is the most common access route for transcatheter aortic valve implantation (TAVI). Percutaneous femoral access (PA) is preferred over the surgical approach (SA), however, may be associated with a higher risk of access site complications. Thus, we aimed to assess outcomes of computed tomography-guided tailored approach to percutaneous and surgical TFA in patients undergoing TAVI. METHODS: We evaluated data of 158 patients, who underwent TAVI via femoral route between January 2017 and December 2018. In the PA group, vascular closure was performed with the use of two percutaneous suture devices and an additional mechanical seal device. We compared complications rate and outcomes. RESULTS: Of the 158 patients (92%; mean age 79.6 years, 60.8% female), in 92 (61%) patients PA was performed and in 66 (39%) patients SA was used. Median (interquartile range) radiation exposure as well as contrast volume dose was higher in the PA group compared to the SA group 614.0 (410.0; 1104.0) mGy vs. 405 (240.5; 658.0) mGy (p < 0.001) and 150.0 (120.0; 180.7) mL vs. 130.0 (100.0; 160.0) mL (p = 0.04), respectively. Bleeding complications were similar in the PA group 11 (12.2%) compared to 5 (8.62%) in the SA group (p = 0.48). Median length of hospital stay was also similar in the PA and the SA group 6.00 (5.00; 8.00) days vs. 6.00 (4.00; 8.00) days, respectively (p = 0.31). CONCLUSIONS: Computed tomography-guided PA in TAVI may provide comparable procedural outcomes compared to the SA, despite a higher radiation dose and the use of contrast dye, while being less invasive.
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Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Femenino , Anciano , Masculino , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Resultado del Tratamiento , Tomografía Computarizada por Rayos X , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Arteria Femoral , Estudios RetrospectivosRESUMEN
Introduction: Mitral regurgitation (MR) is a frequent complication in patients with severe aortic stenosis (AS). Material and methods: Echocardiographic assessment of MR was performed at baseline, at 30 days and at 6 months after balloon aortic valvuloplasty (BAV). Results: Data of 271 patients were included in our final analysis, of which 21.2% (n = 85) had at least moderate MR at baseline (in 19 (22.3%) subjects MR was diagnosed as primary). Both groups showed similar severity of AS, but patients in the MR group had a greater left ventricle (LV) size (p = 0.003 for LVESD, p = 0002 for LVEDD) and slightly lower LV ejection fraction (p = 0.04). Mitral regurgitation parameters significantly improved both at 30 days and 6 months after BAV in the MR group (MR jet area: 7.2 (4.5-9.9) vs. 3.6 (2.3-7.2) cm2, and 7.2 (4.5-9.9) vs. 3.2 (2.1-6.7) cm2; %MR/left atrial area 34.5 (23.4-42.7) vs. 17.5 (9.3-29.5) and 34.5 (23.4-42.7) vs. 14.5 (8.3-24.5), p < 0.001 for all). In multivariate logistic regression analysis, the change at 30 days, from baseline, in the LVESD (OR = 1.87; 95% CI: 1.23-2.87; p < 0.001) and LVEF (OR = 0.95; 95% CI: 0.87-1.01; p < 0.001); MR jet area (OR = 2.2, 95% CI: 1.5-4.6; p < 0.001) and the presence of primary MR (OR = 3.2, 95% CI: 1.04-5.98; p < 0.001) were retained as independent predictors of significant persisting MR at 6 months. Conclusions: Balloon aortic valvuloplasty may reduce MR in mid-term follow-up. Predictors of persistent MR at 6 months after BAV included an increase of LVESD and MR jet area and decrease of LVEF at 30 days.
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INTRODUCTION: Transcatheter aortic valvein valve implantation (ViVTAVI) has emerged as an alternative to redo surgery in patients with failed surgical aortic bioprosthesis. OBJECTIVES: We evaluated the safety and efficacy of ViVTAVI in Polish patients after surgical aortic valve replacement. PATIENTS AND METHODS: This was a nationwide multicenter registry of ViVTAVI procedures. Data were collected using an online form, and the clinical follow up lasted 1 year. RESULTS: From 2008 to 2020, 130 ViVTAVI procedures were performed (1.9% of all transcatheter aortic valve implantation [TAVI] cases). A considerable increase in ViVTAVI procedures since 2018 has been observed (n = 59, 45% of ViVTAVI cases). Hancock II, Freestyle, and homograft were the most frequently treated bioprostheses. The self expanding supra annular Corevalve / Evolut valve was used in 76% of cases. In 21% of cases, the mean postprocedural pressure gradient (PG) exceeded 20 mm Hg. Allcause mortality at 1 year was 10.8%. Aortic valve stenosis was associated with a higher mean PG than aortic valve regurgitation or mixed disease (P = 0.004). Supra annular transcatheter aortic valves were associated with lower mean PGs than intra annular valves (P = 0.004). Second generation devices were associated with shorter procedure time (120 min vs 135 min, P = 0.04), less frequent need for additional TAVI (2% vs 10%, P = 0.04), and lower 1year cardiovascular mortality (95% vs 82.8%, P = 0.03) than firstgeneration valves. CONCLUSIONS: Transcatheter treatment of failed bioprostheses is increasingly common, with the best hemodynamic effect shown for supra annular valves. The introduction of secondgeneration valves has improved procedural and clinical outcomes.
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Bioprótesis , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/cirugía , Humanos , Polonia , Diseño de Prótesis , Sistema de Registros , Resultado del TratamientoRESUMEN
INTRODUCTION: Few studies assessed the development of transcatheter aortic valve implantation (TAVI) in Poland since its introduction in 2008. Effects of the Valve for Life Initiative in the country have not been reported. OBJECTIVE: The aim of the study was to investigate TAVI adoption and practice in Poland in the years 2008 to 2019. PATIENTS AND METHODS: The Polish Interventional Cardiology TAVI Survey (PICTS) analyzed reports of TAVI activity in all 23 TAVI centers. It consisted of 94 questions and encompassed the following topics: 1) characteristics of centers; 2) the annual number of TAVI procedures in the years 2008 to 2019; 3) pre-, intra-, and postprocedural management of patients; and 4) a list of TAVI team members. It was obligatory to answer all questions. The registry survey was published online. RESULTS: Since 2008, 102 certified operators have performed a total of 6910 procedures. In 2019, the annual number of TAVI reached 1550 (40.38 implants per 1 000 000 inhabitants). Among patients aged 65 years and older, TAVI penetration rate was 18.65% in 2019. Inoperable and high-risk patients were treated in all centers, while 18 also treated medium- and 5 treated low-risk individuals. The rate of transfemoral implantations increased to 93.5% of all procedures. CONCLUSIONS: The survey highlighted a slow increase in the rate of TAVI adoption in Poland. We found a significant treatment gap in patients with severe aortic stenosis. Remarkable regional variations in TAVI experience exist among Polish TAVI centers. Further multinational cooperation is warranted to tackle the identified limitations in access to this life-saving procedure.
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Estenosis de la Válvula Aórtica , Cardiología , Reemplazo de la Válvula Aórtica Transcatéter , Estenosis de la Válvula Aórtica/cirugía , Humanos , Polonia , Resultado del TratamientoRESUMEN
Cardiac rehabilitation (CR) provides multifactorial support and intervention for cardiac patients and improves quality of life (QoL). We aimed to assess clinical performance and QoL changes in patients undergoing transcatheter aortic valve replacement (TAVR) scheduled directly to inpatient CR (CR group) and those who were discharged home (DH group). The following patient-related outcomes were recorded: 5 m walk time (5MWT), 6 min walk test (6MWT), handgrip strength (HGS) with dynamometer, Katz index of Independence of Activities in Daily Living (KI of ADL), Hospital Anxiety and Depression Scores (HADS) Score. Quality of life was evaluated with Kansas City Cardiomyopathy Questionnaire (KCCQ). Baseline data, 30-day and 6- and 12-month data were assessed. The CR group consisted of 52 patients and 53 were in the discharged home (DH group). When we compared outcomes between the groups, the 5MWT, 6MWT, HGS KI of ADL, and KCCQ were significantly better in the CR group at 30 days (p = 0.03, p = 0.01, p = 0.02, p = 0.048, respectively), and no difference was found in HADS scores. At 6 months, the effect of CR was sustained for 6MWT, HGS, KI of ADL, and KCCQ (p = 0.001, p = 0.001, p = 0.03, p = 0.003, respectively) but not for 5MWT. Interestingly, at 12 months, the CR group had better performance only in 6MWT and HGS compared with the DH group (p = 0.04, p = 0.03, respectively). We showed that inpatient CR is strongly associated with better clinical performance and QoL in patients undergoing TAVR. All patients may benefit from CR after TAVR. The most important aspect of inpatient CR after TAVR from the patient's perspective may be better performance in daily activities; however, performance was attenuated after 1 year.
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The study aimed to assess procedural complications, patient flow and clinical outcomes after balloon aortic valvuloplasty (BAV) as rescue or bridge therapy, based on data from our registry. A total of 382 BAVs in 374 patients was performed. The main primary indication for BAV was a bridge for TAVI (n = 185, 49.4%). Other indications included a bridge for AVR (n = 26, 6.9%) and rescue procedure in hemodynamically unstable patients (n = 139, 37.2%). The mortality rate at 30 days, 6 and 12 months was 10.4%, 21.6%, 28.3%, respectively. In rescue patients, the death rate raised to 66.9% at 12 months. A significant improvement in symptoms was confirmed after BAV, after 30 days, 6 months, and in survivors after 1 year (p < 0.05 for all). Independent predictors of 12-month mortality were baseline STS score [HR (95% CI) 1.42 (1.34 to 2.88), p < 0.0001], baseline LVEF <20% [HR (95% CI) 1.89 (1.55-2.83), p < 0.0001] and LVEF <30% at 1 month [HR (95% CI) 1.97 (1.62-3.67), p < 0.0001] adjusted for age/gender. In everyday clinical practice in the TAVI era, there are still clinical indications to BAV a standalone procedure as a bridge to surgery, TAVI or for urgent high risk non-cardiac surgical procedures. Patients may improve clinically after BAV with LV function recovery, allowing to perform final therapy, within limited time window, for severe AS which ameliorates long-term outcomes. On the other hand, in patients for whom an isolated BAV becomes a destination therapy, prognosis is extremely poor.
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INTRODUCTION: Transapical access (TA) transcatheter aortic valve implantation (TAVI) (TA-TAVI) represents one of the possible routes in patients with severe aortic stenosis (AS) who are not suitable for transfemoral access. AIM: To assess early- and mid-term clinical outcomes after TA-TAVI. MATERIAL AND METHODS: Patients with severe symptomatic AS undergoing TA-TAVI from November 2008 to December 2019 were enrolled. Clinical and procedural characteristics as well as clinical outcomes including all-cause mortality during 12-month follow-up were assessed. RESULTS: Sixty-one consecutive patients underwent TA-TAVI for native AS. Patients were elderly with median age of 80.0 (76.0-84.0) years; 55.7% were males. Median baseline EuroSCORE I and STS scores were 18.2% (11.6-27.7) and 4.8% (3.3-8.2), respectively. The procedural success rate was 96.7%. In-hospital, 30-day and 12-month mortality rates were 9.8%; 18.0% and 24.6%, respectively. The main periprocedural and in-hospital complications were bleeding complications (14.8%). The following factors were associated with 12-month mortality: previous cerebrovascular event (CVE), glomerular filtration rate (GFR), aortic valve area (AVA), right ventricular systolic pressure (RVSP) and serum level of N-terminal prohormone of brain natriuretic peptide (NT-proBNP) (RR for CVE 3.17, 95% confidence interval (CI): 1.15-8.76: p = 0.026; RR for AVA per 0.1 cm2 1.28, 95% CI: 1.03-1.55: p = 0.024; RR for GFR per 1 ml/min 0.96: 95% CI: 0.94-0.99: p = 0.007; RR for NT-proBNP per 1000 pg/ml 1.07: 95% CI: 1.01-1.17: p = 0.033; RR for RVSP per 1 mm Hg 1.07: 95% CI 1.02-1.16: p = 0.011). CONCLUSIONS: Transapical TAVI in high-risk patients provides good hemodynamic results with acceptable outcomes.
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Tricuspid regurgitation (TR) is a common acquired valvular heart disease (VHD). TR has progressive character and is associated with impaired long-term survival in both symptomatic and asymptomatic subjects. Despite this knowledge, the overall number of tricuspid valve surgeries is very low worldwide and many patients with clear indications for intervention are left untreated. The development of less invasive transcatheter techniques may offer new treatment options in this growing population of patients. Out of various percutaneous methods proposed, tricuspid edge-to-edge repair has recently gained considerable attention. The article summarizes available data regarding this new treatment method.
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Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Tricúspide , Cateterismo Cardíaco , Ecocardiografía , Testimonio de Experto , Humanos , Selección de Paciente , Polonia , Factores de Tiempo , Resultado del Tratamiento , Insuficiencia de la Válvula Tricúspide/diagnóstico por imagen , Insuficiencia de la Válvula Tricúspide/cirugíaRESUMEN
A case of a 28-year-old women, with acute aortic dissection type B, ten days after childbirth is described. The pregnancy was ended by cesarean section. The patient underwent successful stent grafting. A subsequent one-month follow-up period was uneventful. Diagnosis and treatment of acute aortic dissection are discussed.
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Aneurisma de la Aorta/diagnóstico , Aneurisma de la Aorta/cirugía , Disección Aórtica/diagnóstico , Disección Aórtica/cirugía , Trastornos Puerperales/diagnóstico , Trastornos Puerperales/cirugía , Adulto , Cesárea , Femenino , Humanos , Embarazo , StentsRESUMEN
We report a case of acute coronary syndrome in a 58 year-old man with a history of double Bentall De Bono procedure (redo due to endocarditis). During the second operation, both main native coronary arteries were anastomosed end-to-end to aortic prosthesis using short vein graft insertions. Four months later the patient presented to the CCU with unstable angina. Computed tomography-scan suggested bilateral ostial stenoses. Percutaneous coronary intervention of the left proximal anastomosis was performed with DES. 14 months later the patient was treated with in-(DES) DES implantation.