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1.
Catheter Cardiovasc Interv ; 99(5): 1619-1625, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-35043543

RESUMO

BACKGROUND AND OBJECTIVES: Evidence regarding redo percutaneous interventions for recurrent mitral regurgitation is scarce. We ought to evaluate procedural and clinical outcomes of repeated edge-to-edge transcatheter mitral valve repair (TMVR) interventions. METHODS: This multicenter study collected individual data from eight high-volume TMVR Centers in Spain. Between 2012 and 2020, all patients undergoing a second edge-to-edge TMVR intervention (Redo) were included in the study. RESULTS: Among a total of 1028 procedures, 31 patients (3%) with residual MR ≥ 3 at follow-up underwent a second procedure (Redo). Redo intervention was mainly conducted between the first and second year after the first procedure. The most common cause of MR progression was partial detachment (46.7%) followed by LV remodeling (35.5%). Procedural success was achieved in 87% of cases. After a mean follow-up of 1.75 ± 1.54 years, all-cause and cardiovascular mortality were 48.1% and 25%, respectively. Nearly half of the patients (48.1%) required at least one hospital admission for CHF within the follow-up period. However, most of the patients presented symptomatic improvement as depicted by an NYHA class ≤2. Elective mitral surgery was conducted in only one patient at follow-up due to insufficient MR reduction. CONCLUSIONS: According to our findings, redo edge-to-edge TMVR interventions were feasible and safe with a high procedural success rate. Clinical and echocardiographic follow-up showed however modest long-term results in this specific setting.


Assuntos
Procedimentos Cirúrgicos Cardíacos , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Cateterismo Cardíaco/métodos , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Resultado do Tratamento
2.
Eur Heart J ; 35(38): 2685-96, 2014 Oct 07.
Artigo em Inglês | MEDLINE | ID: mdl-24796337

RESUMO

AIM: The aim of this study was to determine the effects of advanced chronic kidney disease (CKD) on early and late outcomes after transcatheter aortic valve implantation (TAVI), and to evaluate the predictive factors of poorer outcomes in such patients. METHODS AND RESULTS: This was a multicentre study including a total of 2075 consecutive patients who had undergone TAVI. Patients were grouped according the estimated glomerular filtration rate as follows: CKD stage 1-2 (≥60 mL/min/1.73 m(2); n = 950), stage 3 (30-59 mL/min/1.73 m(2); n = 924), stage 4 (15-29 mL/min/1.73 m(2); n = 134) and stage 5 (<15 mL/min/1.73 m² or dialysis; n = 67). Clinical outcomes were evaluated at 30-days and at follow-up (median of 15 [6-29] months) and defined according to the VARC criteria. Advanced CKD (stage 4-5) was an independent predictor of 30-day major/life-threatening bleeding (P = 0.001) and mortality (P = 0.027), and late overall, cardiovascular and non-cardiovascular mortality (P < 0.01 for all). Pre-existing atrial fibrillation (HR: 2.29, 95% CI: 1.47-3.58, P = 0.001) and dialysis therapy (HR: 1.86, 95% CI: 1.17-2.97, P = 0.009) were the predictors of mortality in advanced CKD patients, with a mortality rate as high as 71% at 1-year follow-up in those patients with these 2 factors. Advanced CKD patients who had survived at 1-year follow-up exhibited both a significant improvement in NYHA class (P < 0.001) and no deterioration in valve hemodynamics (P = NS for changes in mean gradient and valve area over time). CONCLUSIONS: Advanced CKD was associated with a higher rate of early and late mortality and bleeding events following TAVI, with AF and dialysis therapy determining a higher risk in these patients. The mortality rate of patients with both factors was unacceptably high and this should be taken into account in the clinical decision-making process in this challenging group of patients.


Assuntos
Estenose da Valva Aórtica/cirurgia , Insuficiência Renal Crônica/complicações , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/mortalidade , Feminino , Hemodinâmica/fisiologia , Humanos , Estimativa de Kaplan-Meier , Tempo de Internação , Masculino , Hemorragia Pós-Operatória/etiologia , Hemorragia Pós-Operatória/mortalidade , Prognóstico , Insuficiência Renal Crônica/mortalidade , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/mortalidade , Substituição da Valva Aórtica Transcateter/instrumentação , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento
3.
Am Heart J ; 163(2): 288-94, 2012 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-22305849

RESUMO

BACKGROUND: Few data exist on the clinical impact of transcatheter aortic valve implantation (TAVI) in patients with symptomatic aortic stenosis and a high surgical risk. The aim of this study was to determine the survival and the factors predicting mortality after 30 days post-TAVI with the CoreValve prosthesis (Medtronic, Minneapolis, MN). METHODS: From April 2008 to October 2010, the CoreValve prosthesis (Medtronic) was implanted in 133 consecutive high-risk surgical patients with symptomatic severe aortic stenosis. RESULTS: The mean age was 79.5 ± 6.7 years. The logistic European System for Cardiac Operative Risk Evaluation was 21.5% ± 14%. The implantation success rate was 97.7%. In-hospital mortality was 4.5%, and the combined end point of death, vascular complications, myocardial infarction, or stroke had a rate of 9%. Survival at 12 and 24 months was 84.5% and 79%, respectively, after a mean follow-up of 11.3 ± 8 months. The New York Heart Association functional class improved from 3.3 ± 0.5 to 1.18 ± 0.4 and remained stable at 1 year. A high Charlson index (hazard ratio [HR] 1.44, 95% CI 1.09-1.89, P < .01) and a worse Karnofsky score before the procedure (HR 0.95, 95% CI 0.92-0.99, P = .021) were predictors of mortality after 30 days. CONCLUSIONS: Transcatheter aortic valve implantation with the CoreValve prosthesis for patients with aortic stenosis and a high surgical risk is a safe, efficient option resulting in a medium-term clinical improvement. Survival during follow-up depends on the associated comorbidities. Early mortality beyond 30 days is predicted by preoperative comorbidity scores and the functional status of the patient.


Assuntos
Estenose da Valva Aórtica/mortalidade , Cateterismo Cardíaco/métodos , Próteses Valvulares Cardíacas , Idoso , Estenose da Valva Aórtica/cirurgia , Feminino , Mortalidade Hospitalar/tendências , Humanos , Masculino , Prognóstico , Desenho de Prótese , Fatores de Risco , Índice de Gravidade de Doença , Espanha/epidemiologia , Taxa de Sobrevida/tendências , Fatores de Tempo , Resultado do Tratamento
4.
Rev Esp Cardiol (Engl Ed) ; 75(12): 1001-1010, 2022 Dec.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-35272968

RESUMO

INTRODUCTION AND OBJECTIVES: Transcatheter edge-to-edge repair (TEER) should be considered in patients with heart failure and secondary mitral regurgitation (MR). Angiotensin receptor-neprilysin inhibitors (ARNIs) have been demonstrated to improve prognosis in heart failure. We aimed to evaluate the impact ARNIs on patient selection and outcomes. METHODS: The population of the Spanish TEER prospective registry (March 2012 to January 2021) was divided into 2 groups: a) TEER before the ARNI era (n=450) and b) TEER after the recommendation of ARNIs by European Guidelines (n=639), with further analysis according to intake (n=52) or not (n=587) of ARNIs. RESULTS: A total of 1089 consecutive patients underwent TEER for secondary MR. In the ARNI era, there was a reduction in left ventricle dilation (82mL vs 100mL, P=.025), and better function (35% vs 38%, P=.011). At 2 years of follow-up, mortality (10.6% vs 17.3%, P <.001) and heart failure readmissions (16.6% vs 27.8%, P <.001) were lower in the ARNI era, but not recurrent MR. In the ARNI era, 1- and 2-year mortality were similar irrespective of ARNI intake but patients on ARNIs had a lower risk of readmission+mortality at 2 years (OR, 0.369; 95%CI, 0.137-0.992; P=.048), better NYHA class, and lower recurrence of MR III-IV (1.9% vs 14.3%, P=.011). CONCLUSIONS: Better patient selection for TEER has been achieved in the last few years with a parallel improvement in outcomes. The use of ARNIs was associated with a significant reduction in overall events, better NYHA class, and lower MR recurrence.


Assuntos
Insuficiência Cardíaca , Insuficiência da Valva Mitral , Neprilisina , Humanos , Insuficiência Cardíaca/tratamento farmacológico , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/tratamento farmacológico , Insuficiência da Valva Mitral/cirurgia , Neprilisina/antagonistas & inibidores , Receptores de Angiotensina , Resultado do Tratamento
5.
Clin Lab ; 57(11-12): 901-7, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-22239020

RESUMO

BACKGROUND: Diabetic patients undergoing percutaneous coronary intervention (PCI) have a worse prognosis than non-diabetic patients. The anti-oxidized LDL antibodies (anti-LDLox ab) have recently been suggested to be protective against the development of diabetes. The aim of this study was to compare the levels of IgG and IgM anti-oxidized LDL antibodies with reference to the new diagnostic criteria for carbohydrate metabolism disorders after an oral glucose tolerance test (OGTT) in hospitalized patients scheduled to undergo percutaneous coronary intervention. METHODS: We undertook a cross-sectional study of 110 patients undergoing PCI. The patients were classified as being normal (oral glucose test tolerance normal, OGTT-N), or having impaired glucose tolerance (IGT) or type 2 diabetes mellitus (T2DM) according to their glucose levels at baseline and after an OGTT. RESULTS: An inverse slope was found in the levels of IgG anti-oxidized LDL antibodies between the OGTT-N patients (optical density (OD) = 0.109) and the patients with IGT (OD = 0.099) or T2DM (OD = 0.084) (p = 0.019). An inverse correlation was also detected between the levels of IgG anti-oxidized LDL antibodies and baseline glycemia (r = -0.23, p = 0.018). CONCLUSIONS: Patients with coronary disease and carbohydrate metabolism disorders have much lower levels of IgG anti-oxidized LDL antibodies than normoglycemic patients.


Assuntos
Autoantígenos/imunologia , Diabetes Mellitus Tipo 2/imunologia , Intolerância à Glucose/imunologia , Imunoglobulina G/imunologia , Lipoproteínas LDL/imunologia , Malondialdeído/análogos & derivados , Adulto , Idoso , Angioplastia Coronária com Balão , Especificidade de Anticorpos , Glicemia/análise , Doença das Coronárias/sangue , Doença das Coronárias/complicações , Doença das Coronárias/imunologia , Estudos Transversais , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/diagnóstico , Feminino , Intolerância à Glucose/sangue , Intolerância à Glucose/complicações , Intolerância à Glucose/diagnóstico , Teste de Tolerância a Glucose , Humanos , Hipercolesterolemia/sangue , Hipercolesterolemia/complicações , Hipercolesterolemia/imunologia , Hipertensão/sangue , Hipertensão/complicações , Hipertensão/imunologia , Imunoglobulina G/sangue , Masculino , Malondialdeído/imunologia , Pessoa de Meia-Idade , Oxirredução , Prognóstico , Insuficiência Renal/sangue , Insuficiência Renal/complicações , Insuficiência Renal/imunologia
6.
J Am Coll Cardiol ; 76(21): 2463-2473, 2020 11 24.
Artigo em Inglês | MEDLINE | ID: mdl-33213725

RESUMO

BACKGROUND: In catheter-based procedures, acute kidney injury (AKI) is a frequent, serious complication ranging from 10% to 30%. In MitraClip (Abbott Vascular, Santa Clara, California), a usually contrast-free procedure, there is scarce data about its real incidence and impact. OBJECTIVES: This study aimed to evaluate incidence, predictive factors, and midterm outcomes of AKI in patients with significant mitral regurgitation (MR) undergoing transcatheter valve repair with MitraClip. METHODS: A total of 721 patients undergoing MitraClip were included. AKI was defined as an absolute or a relative increase in serum creatinine of >0.3 mg/dl or ≥50%, respectively, or the need for hemodialysis during index hospitalization. RESULTS: The mean age of the patients was 72 ± 11 years (28.3% women). Median estimated glomerular filtration rate (eGFR) was 43.7 ml/min/1.73 m2 (interquartile range: 30.9 to 60.1 ml/min/1.73 m2), and was <60 ml/min/1.73 m2 in 74.9% of the patients. AKI after MitraClip occurred in 106 patients (14.7%). Baseline hemoglobin (<11 g/dl) (odds ratio [OR]: 1.97; p = 0.003), urgent procedure (OR: 3.44; p = 0.003), and absence of device success (OR: 3.37; p < 0.001) were independent predictors of AKI. Patients with AKI had worse outcomes compared to those without AKI, including a higher proportion of in-hospital bleeding events (3.8% vs. 0.8%; p = 0.011), 2-year all-cause mortality (40.5% vs. 18.7%; p <0.001), and major adverse cardiac events (63.6% vs. 23.5%; p <0.001). Combination of AKI with significant residual MR after the procedure conferred even worst outcomes (2-year all-cause mortality 50.0% vs. 19.6%; p = 0.001, and major adverse cardiac events 70.0% vs. 18.9%; p < 0.001). CONCLUSIONS: Despite being a "zero-contrast" procedure, one-sixth of patients undergoing transcatheter mitral valve repair had AKI, linked to device failure or other severe conditions. The occurrence of AKI was associated with worse outcomes, highlighting the importance to detect and reduce this complication in high-risk population.


Assuntos
Injúria Renal Aguda/mortalidade , Anuloplastia da Valva Mitral/efeitos adversos , Insuficiência da Valva Mitral/cirurgia , Complicações Pós-Operatórias/mortalidade , Injúria Renal Aguda/etiologia , Idoso , Idoso de 80 Anos ou mais , Procedimentos Endovasculares , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Anuloplastia da Valva Mitral/instrumentação , Complicações Pós-Operatórias/etiologia , Estudos Retrospectivos , Espanha/epidemiologia
7.
Rev Esp Cardiol (Engl Ed) ; 73(8): 643-651, 2020 Aug.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-31732437

RESUMO

INTRODUCTION AND OBJECTIVES: Transcatheter mitral valve repair (TMVR) with MitraClip is a therapeutic option for high surgical risk patients with severe mitral regurgitation (MR). The main objective of this study was to analyze differences in outcomes in patients with severe MR according to the cause of MR. METHODS: Observational, multicenter, and prospective study with consecutive patient inclusion. The primary endpoint was the combination of all-cause mortality and new readmissions due to heart failure after 1 year. We compared clinical and procedural characteristics and the event rate for each MR group. We performed a multivariate analysis to identify predictive variables for the primary endpoint. RESULTS: A total of 558 patients were included: 364 (65.2%) with functional etiology, 111 (19.9%) degenerative and 83 (14.9%) mixed. The mean age was 72.8±11.1 years and 70.3% of the sample were men. There were 95 (17%) events in the overall sample. No significant differences were found in the 3 groups in the number of primary outcome events: 11 (11.3%) in degenerative MR, 71 (21.3%) in functional MR, and 13 (18.1%) in mixed MR (P=.101). Independent predictors were functional class (P=.029), previous surgical revascularization (P=.031), EuroSCORE II (P=.003), diabetes mellitus (P=.037), and left ventricular ejection fraction (P=.015). CONCLUSIONS: This study confirms the safety and efficacy of TMVR with MitraClip irrespective of MR etiology in real-life data and shows the main factors related to prognosis during the first year of follow up.


Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Idoso , Idoso de 80 Anos ou mais , Cateterismo Cardíaco , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/epidemiologia , Insuficiência da Valva Mitral/cirurgia , Estudos Prospectivos , Sistema de Registros , Volume Sistólico , Resultado do Tratamento , Função Ventricular Esquerda
8.
J Clin Med ; 9(6)2020 Jun 09.
Artigo em Inglês | MEDLINE | ID: mdl-32526978

RESUMO

BACKGROUND: Transcatheter mitral valve repair (TMVR) could improve survival in functional mitral regurgitation (FMR), but it is necessary to consider the influence of left ventricular ejection fraction (LVEF). Therefore, we compare the outcomes after TMVR with Mitraclip® between two groups according to LVEF. METHODS: In an observational registry study, we compared the outcomes in patients with FMR who underwent TMVR with and without LVEF <30%. The primary endpoint was the combined one-year all-cause mortality and unplanned hospital readmissions due to HF. The secondary end-points were New York Heart Association (NYHA) functional class and mitral regurgitation (MR) severity. Propensity-score matching was used to create two groups with the same baseline characteristics, except for baseline LVEF. RESULTS: Among 535 FMR eligible patients, 144 patients with LVEF <30% (group 1) and 144 with LVEF >30% (group 2) had similar propensity scores and were included in the analyses. The primary study endpoint was significantlly higher in group 1 (33.3% vs. 9.4%, p = 0.002). There was a maintained improvement in secondary endpoints without significant differences among groups. CONCLUSION: FMR patients with LVEF <30% treated with MitraClip® had higher mortality and readmissions than patients with LVEF ≥30% treated with the same device. However, both groups improved the NYHA functional class and MR severity.

9.
Int J Cardiol ; 276: 66-71, 2019 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-30473334

RESUMO

BACKGROUND: Among patients undergoing transcatheter aortic valve replacement (TAVR), prognosis is impacted by nutritional status, but the influence of the nutritional risk index (NRI) is unknown. Here we calculated the NRI to determine the prevalence and prognostic impact in terms of mortality of malnutrition in TAVR patients. METHODS AND RESULTS: This retrospective multicenter study included 941 patients who underwent TAVR between 2008 and 2016 (mean age, 80.7 ±â€¯6.5 years; 57% female). The NRI was calculated as 1.519 × albumin (g/L) + 41.7 × (real weight [kg] / ideal weight [kg]). The mean NRI was 98.1 ±â€¯7.0%. The patients were stratified into the following groups based on malnutrition risk: severe (NRI < 83.5; n = 83; 8.82%), moderate (83.5 ≥ NRI < 97.5; n = 370; 39.32%), mild (97.5 ≥ NRI < 100; n = 102; 10.84%), and no risk (NRI ≥ 100; n = 386; 41.02%). During the follow-up period (2.1 ±â€¯1.1 years), 186 patients died, representing 19.8% of the total cohort. Cox regression models were used to analyze the relationship between NRI and mortality during follow-up. Compared to patients with no or mild nutritional risk, those with moderate or severe nutritional risk had a 45% greater risk of mortality during follow-up (adjusted HR, 1.45; 95% CI, 1.05-1.99; P = 0.021). CONCLUSION: Malnutrition is common among TAVR patients. Our present data indicated that the NRI was independently associated with increased risk of death during long-term follow-up after TAVR. Based on its potential to improve risk prediction, NRI appears to be a promising tool for the clinical assessment of patients who are candidates for TAVR.


Assuntos
Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/cirurgia , Estado Nutricional/fisiologia , Substituição da Valva Aórtica Transcateter/mortalidade , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/fisiopatologia , Estudos de Coortes , Feminino , Seguimentos , Humanos , Masculino , Estudos Retrospectivos , Medição de Risco/tendências , Taxa de Sobrevida/tendências , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/tendências , Resultado do Tratamento
10.
Rev Esp Cardiol (Engl Ed) ; 72(6): 456-465, 2019 Jun.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-29859894

RESUMO

INTRODUCTION AND OBJECTIVES: To analyze the percutaneous revascularization strategy for severe lesions in the secondary branches (SB) (diameter ≥ 2mm) of major epicardial arteries compared with conservative treatment. METHODS: This study analyzed patients with severe SB lesions who underwent percutaneous revascularization treatment compared with patients who received pharmacological treatment. The study examined the percentage of branch-related events (cardiovascular death, myocardial infarction attributable to SB, or the need for revascularization of the SB). RESULTS: We analyzed 679 SB lesions (662 patients). After a mean follow-up of 22.2±10.5 months, there were no significant differences between the 2 treatment groups regarding the percentage of death from cardiovascular causes (1.7% vs 0.4%; P=.14), nonfatal acute myocardial infarction (AMI) (1.7% vs 1.7%; P=.96), the need for SB revascularization (4.1% vs 5.4%; P=.45) or in the total percentage of events (5.1% vs 6.3%; P=.54). The variables showing an association with event occurrence on multivariate analysis were diabetes (SHR, 2.87; 95%CI, 1.37-5.47; P=.004), prior AMI (SHR, 3.54; 95%CI, 1.77-7.30; P<.0001), SB reference diameter (SHR, 0.16; 95%CI, 0.03-0.97; P=.047), and lesion length (SHR, 3.77; 95%CI, 1.03-1.13; P<.0001). These results remained the same after the propensity score analysis. CONCLUSIONS: The percentage of SB-related events during follow-up is low, with no significant differences between the 2 treatment strategies. The variables associated with event occurrence in the multivariate analysis were the presence of diabetes mellitus, prior AMI, and greater lesion length.


Assuntos
Estenose Coronária/cirurgia , Vasos Coronários/cirurgia , Intervenção Coronária Percutânea/métodos , Idoso , Angiografia Coronária , Estenose Coronária/diagnóstico , Vasos Coronários/diagnóstico por imagem , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Pontuação de Propensão , Estudos Retrospectivos , Índice de Gravidade de Doença , Resultado do Tratamento
11.
J Am Coll Cardiol ; 74(5): 631-641, 2019 08 06.
Artigo em Inglês | MEDLINE | ID: mdl-31370954

RESUMO

BACKGROUND: Several studies have demonstrated the benefits of transcatheter aortic valve replacement (TAVR) in patients with aortic stenosis, but the presence of persistent fibrosis and myocardial hypertrophy has been related to worse prognosis. OBJECTIVES: The aim of this study was to explore the potential benefits of renin-angiotensin system (RAS) inhibitors on left ventricular remodeling and major clinical outcomes following successful transcatheter aortic valve replacement (TAVR). METHODS: Patients from 10 institutions with severe aortic stenosis who underwent TAVR between August 2007 and August 2017 were included. All baseline data were prospectively recorded, and pre-specified follow-up was performed. Doses and types of RAS inhibitors at discharge were recorded, and matched comparison according to their prescription at discharge was performed. RESULTS: A total of 2,785 patients were included. Patients treated with RAS inhibitors (n = 1,622) presented similar surgical risk scores but a higher rate of all cardiovascular risk factors, coronary disease, and myocardial infarction. After adjustment for these baseline differences, reduction of left ventricular volumes and hypertrophy was greater and cardiovascular mortality at 3-year follow-up was lower (odds ratio: 0.59; 95% confidence interval: 0.41 to 0.87; p = 0.007) in patients treated with RAS inhibitors. Moreover, RAS inhibitors demonstrated a global cardiovascular protective effect with significantly lower rates of new-onset atrial fibrillation, cerebrovascular events, and readmissions. CONCLUSIONS: Post-TAVR RAS inhibitors are associated with lower cardiac mortality at 3-year follow-up and offer a global cardiovascular protective effect that might be partially explained by a positive left ventricular remodeling. An ongoing randomized trial will help confirm these hypothesis-generating findings. (Renin-Angiotensin System Blockade Benefits in Clinical Evolution and Ventricular Remodeling After Transcatheter Aortic Valve Implantation [RASTAVI]; NCT03201185).


Assuntos
Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Estenose da Valva Aórtica/terapia , Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Disfunção Ventricular Esquerda/prevenção & controle , Função Ventricular Esquerda/fisiologia , Remodelação Ventricular , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/fisiopatologia , Ecocardiografia , Feminino , Seguimentos , Ventrículos do Coração/diagnóstico por imagem , Ventrículos do Coração/efeitos dos fármacos , Ventrículos do Coração/fisiopatologia , Humanos , Masculino , Complicações Pós-Operatórias , Período Pós-Operatório , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento , Disfunção Ventricular Esquerda/diagnóstico , Disfunção Ventricular Esquerda/etiologia
12.
Clin Cardiol ; 31(4): 165-71, 2008 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-18404726

RESUMO

BACKGROUND: Drug-eluting stents (DES) have been shown in randomized trials to reduce clinical events in diabetic patients. Our aim was to determine whether these clinical results are applicable in an unselected population of patients with non-insulin-dependent diabetes mellitus (NIDDM) and insulin-dependent diabetes mellitus (IDDM). METHODS: We studied 440 consecutive patients (271 NIDDM and 169 IDDM) who underwent percutaneous coronary intervention, divided into 2 cohorts: Group A (1998-2000): 220 patients with bare metal stents, and Group B (2002-2004): 220 patients with drug-eluting stents. We analyzed major coronary adverse events (death, nonfatal acute myocardial infarction, and target lesion revascularization) over a mean follow-up of 18+/-15 months. RESULTS: Group B had more patients who were insulin-dependent (44.5 versus 32.3% p<0.001) or had hypertension (64.5 versus 54.1%; p=0.02), a lower left ventricular ejection fraction (53.89 versus 56.8%; p=0.04), more complex lesions (B2/C) (82.7 versus 62.3%; p<0.001), more treated lesions (1.40 versus 1.26; p<0.001), more stents implanted (1.69 versus 1.15; p<0.0001), and more patients treated with abciximab (76.8 versus 42.7%; p<0.0001). During the follow-up, Group B had fewer major adverse coronary events (11.7 versus 27.9%; p<0.001) and a reduction in target lesion revascularization (3.9 versus 17.2%; p<0.001), with no differences in death or myocardial infarction. Both groups experienced a significant reduction in events (NIDDM: 8.1 versus 26.7%; p<0.001 and IDDM: 16 versus 31.9%; p=0.016). Multivariate regression analysis showed the use of drug-eluting stents to be in direct relation with event-free survival (odds ratio [OR]: 3.37; 95% confidence interval [CI], 1.44-7.90; p=0.005). CONCLUSION: Despite the worse angiographic characteristics, the use of DES reduced clinical events, particularly target lesion revascularization.


Assuntos
Angioplastia Coronária com Balão , Doença das Coronárias/terapia , Angiopatias Diabéticas/terapia , Stents Farmacológicos , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
14.
BMJ Open ; 8(2): e020255, 2018 02 13.
Artigo em Inglês | MEDLINE | ID: mdl-29440218

RESUMO

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) as a treatment in severe aortic stenosis (AS) is an excellent alternative to conventional surgical replacement. However, long-term outcomes are not benign. Renin-angiotensin system (RAS) blockade has shown benefit in terms of adverse remodelling in severe AS and after surgical replacement. METHODS AND ANALYSIS: The RAS blockade after TAVI (RASTAVI) trial aims to detect if there is a benefit in clinical outcomes and ventricular remodelling with this therapeutic strategy following the TAVI procedure. The study has been designed as a randomised 1:1 open-label study that will be undertaken in 8 centres including 336 TAVI recipients. All patients will receive the standard treatment. The active treatment group will receive ramipril as well. Randomisation will be done before discharge, after signing informed consent. All patients will be followed up for 3 years. A cardiac magnetic resonance will be performed initially and at 1 year to assess ventricular remodelling, defined as ventricular dimensions, ejection fraction, ventricular mass and fibrosis. Recorded events will include cardiac death, admission due to heart failure and stroke. The RASTAVI Study will improve the management of patients after TAVI and may help to increase their quality of life, reduce readmissions and improve long-term survival in this scenario. ETHICS AND DISSEMINATION: All authors and local ethics committees have approved the study design. All patients will provide informed consent. Results will be published irrespective of whether the findings are positive or negative. TRIAL REGISTRATION NUMBER: NCT03201185.


Assuntos
Inibidores da Enzima Conversora de Angiotensina/administração & dosagem , Estenose da Valva Aórtica/terapia , Ramipril/administração & dosagem , Substituição da Valva Aórtica Transcateter , Remodelação Ventricular/efeitos dos fármacos , Estenose da Valva Aórtica/diagnóstico por imagem , Ventrículos do Coração/fisiopatologia , Humanos , Imageamento por Ressonância Magnética , Estudos Prospectivos , Qualidade de Vida , Sistema Renina-Angiotensina/efeitos dos fármacos , Projetos de Pesquisa , Fatores de Risco , Resultado do Tratamento , Disfunção Ventricular Esquerda/diagnóstico por imagem
15.
JACC Cardiovasc Interv ; 11(17): 1669-1679, 2018 09 10.
Artigo em Inglês | MEDLINE | ID: mdl-30190058

RESUMO

OBJECTIVES: The authors aimed to determine the procedural learning curve and minimum annual institutional volumes associated with optimum clinical outcomes for transcatheter aortic valve replacement (TAVR). BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a complex procedure requiring significant training and experience for successful outcome. Despite increasing use of TAVR across institutions, limited information is available for its learning curve characteristics and minimum annual volumes required to optimize clinical outcomes. METHODS: The study collected data for patients at 16 centers participating in the international TAVR registry since initiation of the respective TAVR program. All cases were chronologically ordered into initial (1 to 75), early (76 to 150), intermediate (151 to 225), high (226 to 300), and very high (>300) experience operators for TAVR learning curve characterization. In addition, participating institutions were stratified by annual TAVR case volume into low-volume (<50), moderate-volume (50 to 100), and high-volume (>100) groups for comparative analysis. Procedural and 30-day clinical outcomes were collected and multivariate regression analysis performed for 30-day mortality and the early safety endpoint. RESULTS: A total of 3,403 patients comprised the study population. On multivariate analysis, all-cause mortality was significantly higher for initial (odds ratio [OR]: 3.83; 95% confidence interval [CI]: 1.93 to 7.60), early (OR: 2.41; 95% CI: 1.51 to 5.03), and intermediate (OR: 2.53; 95% CI: 1.19 to 5.40) experience groups compared with the very high experience operators. In addition, the early safety endpoint was significantly worse for all experience groups compared with the very high experience operators. Low annual volume (<50) TAVR institutions had significantly higher all-cause 30-day mortality (OR: 2.70; 95% CI: 1.44 to 5.07) and worse early safety endpoint (OR: 1.60; 95% CI: 1.17 to 2.17) compared with the moderate- and high-volume groups. There was no difference in patient outcomes between intermediate and high annual volume groups. CONCLUSIONS: TAVR procedures display important learning curve characteristics with both greater procedural safety and a lower mortality when performed by experienced operators. In addition, TAVR performed at low annual volume (<50 procedures) institutions is associated with decreased procedural safety and higher patient mortality. These findings have important implications for operator training and patient care at centers performing TAVR.


Assuntos
Competência Clínica/normas , Hospitais com Alto Volume de Atendimentos/normas , Hospitais com Baixo Volume de Atendimentos/normas , Curva de Aprendizado , Avaliação de Processos e Resultados em Cuidados de Saúde/normas , Cirurgiões/normas , Substituição da Valva Aórtica Transcateter/normas , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Segurança do Paciente/normas , Complicações Pós-Operatórias/epidemiologia , Sistema de Registros , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento , Carga de Trabalho/normas
16.
Circ Cardiovasc Interv ; 11(11): e006927, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30571207

RESUMO

BACKGROUND: The impact of preexisting left bundle branch block (LBBB) in transcatheter aortic valve replacement (TAVR) recipients is unknown. The aim of this study was to determine the impact of preexisting LBBB on clinical outcomes after TAVR. METHODS AND RESULTS: This multicenter study evaluated 3404 TAVR candidates according to the presence or absence of LBBB on baseline ECG. TAVR complications and causes of death were defined according to Valve Academic Research Consortium-2 definitions. Follow-up outpatient visits or telephone interviews were conducted at 30 days, 12 months, and yearly thereafter. Echocardiography examinations were performed at baseline, at hospital discharge, and at 1-year follow-up. Preexisting LBBB was present in 398 patients (11.7%) and was associated with an increased risk of permanent pacemaker implantation (PPI; 21.1% versus 14.8%; adjusted odds ratio, 1.51; 95% CI, 1.12-2.04) but not death (7.3% versus 5.5%; adjusted odds ratio, 1.33; 95% CI, 0.84-2.12) at 30 days. At a mean follow-up of 22±21 months, there were no differences between patients with and without preexisting LBBB in overall mortality (adjusted hazard ratio, 0.94; 95% CI, 0.75-1.18) and cardiovascular mortality (adjusted hazard ratio, 0.90; 95% CI, 0.68-1.21). In a subanalysis of 2421 patients without PPI at 30 days and with complete follow-up about the PPI, preexisting LBBB was not associated with an increased risk of PPI or sudden cardiac death. Patients with preexisting LBBB had a lower left ventricular ejection fraction (LVEF) at baseline and at 1-year follow-up ( P <0.001 for both), but those with low LVEF exhibited a similar increase in LVEF over time after TAVR compared with patients with no preexisting LBBB ( P=0.327). CONCLUSIONS: Preexisting LBBB significantly increased the risk of early (but not late) PPI after TAVR, without any significant effect on overall mortality or cardiovascular mortality. Preexisting LBBB was associated with lower LVEF pre-TAVR but did not prevent an increase in LVEF post-TAVR similar to patients without LBBB.


Assuntos
Valva Aórtica/cirurgia , Bloqueio de Ramo/terapia , Estimulação Cardíaca Artificial , Doenças das Valvas Cardíacas/cirurgia , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Brasil/epidemiologia , Bloqueio de Ramo/diagnóstico , Bloqueio de Ramo/mortalidade , Bloqueio de Ramo/fisiopatologia , Canadá/epidemiologia , Estimulação Cardíaca Artificial/efeitos adversos , Estimulação Cardíaca Artificial/mortalidade , Ecocardiografia , Eletrocardiografia , Europa (Continente)/epidemiologia , Feminino , Doenças das Valvas Cardíacas/diagnóstico por imagem , Doenças das Valvas Cardíacas/mortalidade , Doenças das Valvas Cardíacas/fisiopatologia , Humanos , Masculino , Marca-Passo Artificial , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/terapia , Medição de Risco , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento
17.
Rev Esp Cardiol (Engl Ed) ; 70(4): 247-253, 2017 Apr.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-28277266

RESUMO

INTRODUCTION AND OBJECTIVES: Transcatheter aortic valve implantation (TAVI) is a safe and effective alternative to surgical treatment in patients with severe aortic stenosis (AS) and those who are inoperable or at high surgical risk. The primary objective of this study was to evaluate the long-term survival of consecutive patients with severe AS treated with TAVI. METHODS: Observational, multicenter, prospective, follow-up study of consecutive patients with severe symptomatic AS treated by TAVI in 3 high-volume hospitals in Spain. RESULTS: We recruited 108 patients, treated with a self-expanding CoreValve prosthesis. The mean age at implantation was 78.6 ± 6.7 years, 49 (45.4%) were male and the mean logistic EuroSCORE was 16% ± 13.9%. The median follow-up was 6.1 years (2232 days). Survival rates at the end of years 1, 2, 3, 4, 5, and 6 were 84.3% (92.6% after hospitalization), 77.8%, 72.2%, 66.7%, 58.3%, and 52.8%. During follow-up, 71 patients (65.7%) died, 18 (25.3%) due to cardiac causes. Most (82.5%) survivors were in New York Heart Association class I or II. Six patients (5.5%) developed prosthetic valve dysfunction. CONCLUSIONS: Long-term survival in AS patients after TAVI is acceptable. The main causes of death are cardiovascular in the first year and noncardiac causes in subsequent years. Valve function is maintained over time.


Assuntos
Estenose da Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Estenose da Valva Aórtica/mortalidade , Intervalo Livre de Doença , Feminino , Seguimentos , Humanos , Masculino , Estudos Prospectivos , Desenho de Prótese , Falha de Prótese , Espanha/epidemiologia , Substituição da Valva Aórtica Transcateter/instrumentação , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento
18.
Int J Cardiol ; 232: 342-347, 2017 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-28089155

RESUMO

OBJECTIVES: We aimed to determine whether body mass index (BMI) is a prognostic indicator for long-term, all-cause mortality in patients undergoing transcatheter aortic valve implantation (TAVI). BACKGROUND: Obesity in patients with established cardiovascular disease has previously been identified as an indicator of good prognosis, a phenomenon known as the "obesity paradox". The prognostic significance of BMI in patients with severe aortic stenosis (AoS) undergoing TAVI is a matter of current debate, as published studies are scarce and their results conflicting. METHODS: This is an observational, retrospective study involving 770 patients who underwent TAVI for AoS. The cohort was divided into three groups based on their BMI: normal weight (≥18.5 to <25kg/m2), overweight (≥25 to <30kg/m2) and obese (≥30kg/m2). The predictive effect of BMI on all-cause mortality 3years following TAVI intervention was analysed using a Cox regression. RESULTS: 155 patients died during follow-up. The overweight group (n=302, 38.97%), experienced a lower mortality rate compared to the normal weight and obese groups (15.9% vs 25.7% and 21.0%, respectively [log-rank p-value=0.036]). After adjustment by logistic EuroSCORE, being overweight was found to be an independent protective factor against mortality (HR: 0.63 [95% CI: 0.42 to 0.94], p=0.024). This was not the case for obesity (HR: 0.92 [95% CI: 0.63 to 1.35], p=0.664). We therefore describe for the first time, a "J-shaped" regression curve describing the relationship between BMI and mortality. CONCLUSIONS: BMI is a predictive factor of all-cause mortality in AoS patients undergoing TAVI. This relationship takes the form of a "J-shaped" curve in which overweight patients are associated with the lowest mortality rate at follow-up.


Assuntos
Estenose da Valva Aórtica/cirurgia , Índice de Massa Corporal , Sobrepeso/complicações , Substituição da Valva Aórtica Transcateter/métodos , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/mortalidade , Causas de Morte/tendências , Feminino , Humanos , Incidência , Masculino , Sobrepeso/epidemiologia , Prognóstico , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Espanha/epidemiologia , Taxa de Sobrevida/tendências , Fatores de Tempo
19.
JACC Cardiovasc Interv ; 10(19): 1973-1981, 2017 10 09.
Artigo em Inglês | MEDLINE | ID: mdl-28982562

RESUMO

OBJECTIVES: The aim of this study was to determine the prognosis and specific complications of patients with prosthetic mitral valves (PMVs) undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: TAVR is performed relatively often in patients with PMVs, but specific risks are not well described. METHODS: A multicenter analysis was conducted, including patients with severe symptomatic aortic stenosis who underwent TAVR at 10 centers. Patients' clinical characteristics and outcomes were evaluated according to the presence of a PMV. RESULTS: The mean age of the study population (n = 2,414) was 81 ± 8 years, and 48.8% were men. A total of 91 patients (3.77%) had PMVs. They were more commonly women, younger, and had higher surgical risk. PMVs were implanted a median of 14 years before TAVR, and most patients had mechanical prostheses (73.6%). Eighty-six patients (94.5%) were on long-term vitamin K inhibitor therapy, and bridging antithrombotic therapy was administered in 59 (64.8%). TAVR device embolization occurred in 6.7% (vs. 3.3% in the non-PMV group; p = 0.127), in all instances when distance between the PMV and the aortic annulus was <7 mm. Mortality rates did not show a difference, but the rate of bleeding was higher in patients with PMV (24.2% vs. 16.1%; p = 0.041), even in those treated via the transfemoral approach (22.2% vs. 13.9%; p = 0.048). Indeed, bleeding complications, prior atrial fibrillation, chronic obstructive pulmonary disease, surgical risk, and New York Heart Association functional class were independent predictors of mortality. CONCLUSIONS: TAVR presents similar mortality irrespective of the presence of a PMV. However, patients with PMVs had higher bleeding risk that was independently associated with higher mortality. Risk for valve embolization was relatively high, but it occurred only in patients with PMV-to-aortic annulus distances <7 mm.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Valva Mitral/cirurgia , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Feminino , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/mortalidade , Humanos , Masculino , Valva Mitral/diagnóstico por imagem , Valva Mitral/fisiopatologia , Complicações Pós-Operatórias/etiologia , Desenho de Prótese , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento
20.
Int J Cardiol ; 245: 222-227, 2017 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-28760395

RESUMO

BACKGROUND: Despite rapidly increasing use of TAVR across institutions, limited data is available for the effect of procedural experience on TAVR outcomes. We investigate the relationship between institutional experience and TAVR outcomes. METHODS: 1953 patients undergoing TAVR at 8 international sites were grouped into chronological quantiles (Q) to assess temporal changes on procedural and clinical outcomes and multivariate logistic regression performed to determine predictors of device success, early safety and all-cause mortality. RESULTS: The mean age of patients was 81±7years and 991 (51%) were female. The quantiles comprised of first 62 cases for Q1, 63-133 for Q2, 134 to 242 for Q3 and 243 to 476 for Q4. Device success increased from Q1 to Q4 (78% vs 89%, p<0.001) with significant improvement in the early safety endpoint (19% vs 10%, p<0.001). All cause mortality reduced by half in Q4 compared to Q1 (8% vs 4%, p=0.01) and rates of major vascular complications, major bleeding and valve embolization decreased with increasing experience. The multivariate analysis identified TAVR in Q3 and Q4 to be independently associated with higher device success and lower risk of complications. TAVR in Q4 was independently associated with lower mortality (OR 0.36 95% CI 0.19-0.70, p=0.002). CONCLUSIONS: Greater institutional experience with TAVR procedures improves device success and clinical outcomes. An experience of >242 cases is independently associated with lower mortality. These findings have important implications for defining minimum volume criteria for institutions and training standards for TAVR procedure.


Assuntos
Internacionalidade , Complicações Pós-Operatórias/mortalidade , Sistema de Registros , Substituição da Valva Aórtica Transcateter/mortalidade , Substituição da Valva Aórtica Transcateter/tendências , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Mortalidade/tendências , Complicações Pós-Operatórias/diagnóstico por imagem , Estudos Prospectivos , Resultado do Tratamento
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