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1.
Interact Cardiovasc Thorac Surg ; 33(2): 173-180, 2021 07 26.
Artigo em Inglês | MEDLINE | ID: mdl-33782703

RESUMO

OBJECTIVES: This study aims to analyse the risks associated with valve-in-valve procedures for treating structural valve deterioration in Mitroflow bioprostheses, as well as to determine the impact of the original Mitroflow size on the patients' long-term outcomes. METHODS: Between January 2012 and September 2019, 21 patients (61.9% males; mean age 82.4 ± 5.4 years) were treated for Mitroflow deterioration with valve-in-valve procedures (12 transapical and 9 transfemoral). RESULTS: Mean EuroSCORE I and EuroSCORE II were 28.2% ± 13.6% and 10.5% ± 6.1%, respectively. Six patients presented an indexed aortic root diameter <14 mm/m2 and 7 patients a diameter of sinus of Valsalva <30 mm. Implanted transcatheter valve sizes were 20 mm in 6 cases, 23 mm in 14 cases and 26 mm in 1 patient. A Valve Academic Research Consortium-2 complication occurred in 23.8% of cases, including 3 coronary occlusions. In-hospital mortality was 9.5%. The 20 mm transcatheter valves presented significantly higher postoperative peak and mean aortic gradients than other sizes (54.1 ± 11.3 mmHg vs 29.9 ± 9.6 mmHg, P = 0.003; and 29.3 ± 7.7 mmHg vs 17.4 ± 5.9 mmHg, P = 0.015, respectively). There were 12 cases of patient-prosthesis mismatch (57.1%) and 3 cases (14.3%) of severe patient-prosthesis mismatch. Cumulative survival was 85.7% ± 7.6% at 1 year, 74.3% ± 10% at 2 years and 37.1% ± 14.1% at 5 years. CONCLUSIONS: Valve-in-valve procedures with balloon-expandable transcatheter valves associate a high risk of coronary occlusion in patients with indexed aortic root diameter <14 mm/m2 and low coronary ostia <12 mm. Valve-in valve procedures with 20 mm balloon-expandable transcatheter valves in ≤21 mm Mitroflow bioprosthesis leave significant residual transvalvular gradients that might obscure patients' long-term outcomes.


Assuntos
Estenose da Valva Aórtica , Bioprótese , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Ecocardiografia , Feminino , Fluoroscopia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Masculino , Desenho de Prótese , Falha de Prótese , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
2.
Rev Esp Cardiol (Engl Ed) ; 74(12): 1054-1061, 2021 Dec.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-33257214

RESUMO

INTRODUCTION AND OBJECTIVES: Economic studies may help decision making in the management of multivessel disease in the setting of myocardial infarction. We sought to perform an economic evaluation of CROSS-AMI (Complete Revascularization or Stress Echocardiography in Patients With Multivessel Disease and ST-Segment Elevation Acute Myocardial Infarction) randomized clinical trial. METHODS: We performed a cost minimization analysis for the strategies (complete angiographic revascularization [ComR] and selective stress echocardiography-guided revascularization [SelR]) compared in the CROSS-AMI clinical trial (N=306), attributable the initial hospitalization and readmissions during the first year of follow-up, using current rates for health services provided by our health system. RESULTS: The index hospitalization costs were higher in the ComR group than in SelR arm (19 657.9±6236.8 € vs 14 038.7±4958.5 €; P <.001). There were no differences in the costs of the first year of follow-up rehospitalizations between both groups for (ComR 2423.5±4568.0 vs SelR 2653.9±5709.1; P=.697). Total cost was 22 081.3±7505.6 for the ComR arm and 16 692.6±7669.9 for the SelR group (P <.001). CONCLUSIONS: In the CROSS-AMI trial, the initial extra economic costs of the ComR versus SelR were not offset by significant savings during follow-up. SelR seems to be more efficient than ComR in patients with ST-segment elevation acute coronary syndrome and multivessel disease treated by emergent angioplasty. Study registred at ClinicalTrial.gov (Identifier: NCT01179126).


Assuntos
Doença da Artéria Coronariana , Infarto do Miocárdio , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/cirurgia , Análise Custo-Benefício , Ecocardiografia sob Estresse , Humanos , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Resultado do Tratamento
4.
Circ Cardiovasc Interv ; 12(10): e007924, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31554422

RESUMO

BACKGROUND: Recent trials suggest that complete revascularization in patients with acute ST-segment-elevation myocardial infarction and multivessel disease is associated with better outcomes than infarct-related artery (IRA)-only revascularization. There are different methods to select non-IRA lesions for revascularization procedures. We assessed the clinical outcomes of complete angiographically guided revascularization versus stress echocardiography-guided revascularization in patients with ST-segment-elevation myocardial infarction. METHODS: We performed a randomized clinical trial in patients with multivessel disease who underwent a successful percutaneous coronary intervention of the IRA to test differences in prognosis (composite end point included cardiovascular mortality, nonfatal reinfarction, coronary revascularization, and readmission for heart failure after 12 months of follow-up) between complete angiographically guided revascularization (n=154) or stress echocardiography-guided revascularization (n=152) of the non-IRA lesions in an elective procedure before hospital discharge. RESULTS: The trial was prematurely stopped after the inclusion of 77% of the planned study population. As many as 152 (99%) patients in the complete revascularization group and 44 (29%) patients in the selective revascularization group required a percutaneous coronary intervention procedure of a non-IRA lesion before discharge. The primary end point occurred in 21 (14%) patients of the stress echocardiography-guided revascularization group and 22 (14%) patients of the complete angiographically guided revascularization group (hazard ratio, 0.95; 95% CI, 0.52-1.72; P=0.85). CONCLUSIONS: In patients with ST-segment-elevation myocardial infarction and multivessel disease, stress echocardiography-guided revascularization may not be significantly different to complete angiographically guided revascularization, thereby reducing the need for elective revascularization before hospital discharge. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01179126.


Assuntos
Angiografia Coronária , Doença da Artéria Coronariana/terapia , Vasos Coronários/diagnóstico por imagem , Ecocardiografia sob Estresse , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Idoso , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/fisiopatologia , Vasos Coronários/fisiopatologia , Término Precoce de Ensaios Clínicos , Teste de Esforço , Feminino , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Readmissão do Paciente , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Valor Preditivo dos Testes , Recidiva , Fatores de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Infarto do Miocárdio com Supradesnível do Segmento ST/fisiopatologia , Espanha , Fatores de Tempo , Resultado do Tratamento
5.
EuroIntervention ; 14(18): e1836-e1842, 2019 Apr 05.
Artigo em Inglês | MEDLINE | ID: mdl-29957593

RESUMO

AIMS: The MASTER study was designed to compare the performance of a new biodegradable polymer sirolimus-eluting stent (BP-SES) with a bare metal stent (BMS) in patients with ST-segment elevation myocardial infarction (STEMI). METHODS AND RESULTS: The study was a prospective, randomised (3:1), controlled, single-blind multicentre trial that enrolled 500 STEMI patients within 24 hours of symptom onset during 2013-2015. Three hundred and seventy-five patients were treated with BP-SES and 125 with BMS. One hundred and four (104) randomised patients underwent angiographic follow-up at six months. The primary clinical endpoint was target vessel failure (TVF), defined as cardiac death, MI not clearly attributable to a non-target vessel, or clinically driven target vessel revascularisation (TVR) at 12 months. The primary angiographic endpoint was in-stent late lumen loss (LLL) at six months in the angiographic cohort. The major secondary endpoint for safety was a composite of all-cause death, recurrent MI, unplanned infarct-related artery revascularisation, stroke, definite stent thrombosis (ST) or major bleeding at one month. At 12 months, TVF had occurred in 6.1% of BP-SES and 14.4% of BMS patients (pnon-inferiority=0.0004), mainly driven by a higher rate of repeat revascularisation in BMS patients. The safety endpoint occurred in 3.5% of BP-SES and 7.2% of BMS patients (p=0.127). In-stent LLL demonstrated the superiority (p=0.0125) of BP-SES (0.09±0.43 mm) over BMS (0.79±0.67 mm). CONCLUSIONS: The study showed clinical non-inferiority and angiographic superiority of BP-SES versus a comparator BMS, suggesting that this novel DES may be a potential treatment option in STEMI.


Assuntos
Stents Farmacológicos , Infarto do Miocárdio com Supradesnível do Segmento ST , Humanos , Polímeros , Estudos Prospectivos , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Método Simples-Cego , Sirolimo , Resultado do Tratamento
7.
J Card Surg ; 33(7): 356-362, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-29790206

RESUMO

OBJECTIVES: Bioprostheses with pericardial leaflets mounted externally on the stent pose a high risk for valve-in-valve (ViV) procedures. This study analyzed the efficacy and safety of ViV procedures for treating structural valve deterioration (SVD) in Mitroflow bioprostheses. METHODS: Between January 2012 and August 2017, 11 patients (mean age 80.3 ± 5.6 years) were treated for SVD of Mitroflow bioprostheses with transcatheter ViV procedures (six transapical [TA] and five transfemoral [TF]) using balloon expandable bioprostheses. RESULTS: All patients but one were in NYHA class III-IV. Mean STS PROM, euroSCORE I, and euroSCORE II were 8 ± 6.5%, 27.8 ± 11.5%, and 12 ± 5.9%, respectively. Two patients had a "porcelain aorta." The size of implanted valves were 23 mm in 10 cases and 26 mm in one case. One patient suffered a coronary occlusion during a TF approach. The mean volume of contrast used in TF implants was 163 ± 69.8 mL. No contrast media were used in TA procedures. There was one in-hospital death (10%). At 1 year of follow-up, peak and mean aortic gradients were 25.5 ± 5.8 mmHg and 15.5 ± 5.7 mmHg, respectively. One patient had mild paravalvular regurgitation. Cumulative survival was 90.9% at 1 year, 70.7% at 2 years, and 53% at 3 years. CONCLUSIONS: ViV procedures with balloon-expandable aortic valves provide good hemodynamic and clinical mid-term results for treating patients with a degenerated Mitroflow aortic bioprosthesis. Special care must be taken in small aortic roots, when the stented valve is in the supra-annular position to avoid coronary ostial obstruction.


Assuntos
Valva Aórtica/cirurgia , Bioprótese/efeitos adversos , Doenças das Valvas Cardíacas/cirurgia , Próteses Valvulares Cardíacas/efeitos adversos , Falha de Prótese/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Doenças das Valvas Cardíacas/fisiopatologia , Hemodinâmica , Humanos , Masculino , Segurança , Stents , Resultado do Tratamento
9.
Am J Cardiol ; 118(4): 578-84, 2016 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-27378142

RESUMO

Vascular complications in transcatheter aortic valve implantation using transfemoral approach are related to higher mortality. Complete percutaneous approach is currently the preferred technique for vascular access. However, some centers still perform surgical cutdown. Our purpose was to determine complications related to vascular access technique in the population of the Spanish TAVI National Registry. From January 2010 to July 2015, 3,046 patients were included in this Registry. Of them, 2,465 underwent transfemoral approach and were treated with either surgical cutdown and closure (cutdown group, n = 632) or percutaneous approach (puncture group, n = 1,833). Valve Academic Research Consortium-2 definitions were used to assess vascular and bleeding complications. Propensity matching resulted in 615 matched pairs. Overall, 30-day vascular complications were significantly higher in the puncture group (109 [18%] vs 42 [6.9%]; relative risk [RR] 2.60; 95% confidence interval [CI] 1.85 to 3.64, p <0.001) due mostly by minor vascular events (89 [15%] vs 25 [4.1%], RR 3.56, 95% CI 2.32 to 5.47, p <0.001). Bleeding rates were lower in the puncture group (18 [3%] vs 40 [6.6%], RR 0.45, 95% CI 0.26 to 0.78, p = 0.003) mainly driven by major bleeding (9 [1.5%] vs 21 [3.4%], RR 0.43, 95% CI 0.20 to 0.93, p = 0.03). At a mean follow-up of 323 days, complication rates remained significantly different between groups (minor vascular complications 90 [15%] vs 31 [5.1%], hazard ratio 2.99, 95% CI 1.99 to 4.50, p <0.001 and major bleeding 10 [1.6%] vs 21 [3.4%], hazard ratio 0.47, 95% CI 0.22 to 1.0, p = 0.04, puncture versus cutdown group, respectively). In conclusion, percutaneous approach yielded higher rates of minor vascular complications but lower rates of major bleeding compared with the surgical cutdown, both at 30-day and at mid-term follow-up in our population.


Assuntos
Estenose da Valva Aórtica/cirurgia , Dissecação/métodos , Artéria Femoral , Infarto do Miocárdio/epidemiologia , Hemorragia Pós-Operatória/epidemiologia , Punções/métodos , Sistema de Registros , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Idoso de 80 Anos ou mais , Meios de Contraste , Feminino , Fluoroscopia , Humanos , Estimativa de Kaplan-Meier , Tempo de Internação , Masculino , Duração da Cirurgia , Complicações Pós-Operatórias/epidemiologia , Modelos de Riscos Proporcionais , Espanha
10.
EuroIntervention ; 12(2): e167-74, 2016 Jun 12.
Artigo em Inglês | MEDLINE | ID: mdl-27290676

RESUMO

AIMS: CENTURY II is a prospective, multicentre, randomised, single-blind trial comparing the bioresorbable polymer sirolimus-eluting Ultimaster® stent (BP-SES) with the permanent polymer everolimus-eluting XIENCE stent (PP-EES). Here we present a pre-specified analysis of safety and efficacy outcomes in a subgroup of patients with small vessel coronary artery disease. METHODS AND RESULTS: CENTURY II included 525 patients with lesions of reference diameter ≤2.5 mm. Treatment was randomly assigned: 277 patients received BP-SES (399 lesions) and 248 patients received PP-EES (377 lesions). The primary outcome was target lesion failure (TLF), which is a composite of cardiac death, target vessel-related myocardial infarction (MI) and target lesion revascularisation (TLR). There was no significant difference between treatment groups in baseline or procedural data. Mean pre-procedural reference diameter was similar (BP-SES 2.30±0.40 mm, PP-EES 2.31±0.42 mm, p=0.59). Stented length was 24.0±11.7 mm for BP-SES and 23.5±11.5 mm for PP-EES (p=0.45). At 12 months, there was no significant difference between the BP-SES and PP-EES groups in TLF (6.9% vs. 7.7%; p=0.72), cardiac death (1.1% vs. 1.2%; p=0.90), target vessel MI (1.8% vs. 3.2%; p=0.30), TLR (4.0% vs. 5.7%; p=0.37), or definite or probable stent thrombosis (0.7% vs. 1.2%; p=0.57). CONCLUSIONS: In the large-scale, randomised CENTURY II trial, use of BP-SES and PP-EES for the treatment of small vessel coronary artery disease resulted in similar outcomes at 12 months.


Assuntos
Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Everolimo/uso terapêutico , Intervenção Coronária Percutânea , Sirolimo/uso terapêutico , Implantes Absorvíveis/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Fármacos Cardiovasculares/uso terapêutico , Trombose Coronária/etiologia , Stents Farmacológicos/efeitos adversos , Feminino , Humanos , Imunossupressores/uso terapêutico , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/métodos , Polímeros
11.
Rev. esp. cardiol. (Ed. impr.) ; 68(2): 107-114, feb. 2015. ilus, tab
Artigo em Espanhol | IBECS | ID: ibc-132553

RESUMO

Introducción y objetivos El propósito de este estudio es evaluar el valor pronóstico de la disfunción sistólica ventricular izquierda inducida por el ejercicio en pacientes hipertensos con ecocardiograma en reposo normal y sin enfermedad arterial coronaria. Métodos De nuestra base de datos de pacientes referidos a ecocardiografía de ejercicio, se identificó a 93 pacientes hipertensos, con fracción de eyección del ventrículo izquierdo en reposo normal (≥ 50%), sin cardiopatía estructural ni evidencia de enfermedad arterial coronaria en la angiografía. Del total, 39 pacientes desarrollaron disfunción sistólica ventricular izquierda inducida por el ejercicio (definida como caída de la fracción de eyección del ventrículo izquierdo por debajo de 50% en el máximo ejercicio) y 54 mostraron una respuesta normal de la fracción de eyección del ventrículo izquierdo al ejercicio. El seguimiento medio fue 6,1 ± 3,7 años. Los objetivos primarios fueron muerte por cualquier causa, muerte cardiaca, aparición de insuficiencia cardiaca y el evento combinado de muerte cardiaca o insuficiencia cardiaca. Resultados La aparición de disfunción sistólica ventricular izquierda inducida por el ejercicio se asoció con mayor riesgo de muerte por cualquier causa (hazard ratio = 3,4; intervalo de confianza del 95%, 1,1-10,3), muerte cardiaca (hazard ratio = 5,6; intervalo de confianza del 95%, 1,1-29,4), insuficiencia cardiaca (hazard ratio=8,9; intervalo de confianza del 95%, 1,8-44,2) y del evento combinado (hazard ratio=5,7; intervalo de confianza del 95%, 1,7-19,0). En un análisis multivariable, la disfunción sistólica ventricular izquierda inducida por el ejercicio continuó asociándose de manera independiente con mayor riesgo de insuficiencia cardiaca (hazard ratio = 6,9; intervalo de confianza del 95%, 1,3-37,4) y del evento combinado de muerte cardiaca o insuficiencia cardiaca (hazard ratio = 4,5; intervalo de confianza del 95%, 1,2-16,0). Conclusiones: La aparición de disfunción sistólica ventricular izquierda inducida por el ejercicio en pacientes hipertensos con fracción de eyección del ventrículo izquierdo normal en reposo y ausencia de enfermedad arterial coronaria es un potente predictor de eventos cardiacos y podría ser un marcador precoz de cardiopatía hipertensiva


Introduction and objectives We sought to assess the prognostic value of exercise-induced left ventricular systolic dysfunction in hypertensive patients with normal resting echocardiography and absence of coronary artery disease. Methods From our database of patients referred for treadmill exercise echocardiography, we identified 93 hypertensive patients with preserved resting left ventricular ejection fraction (≥ 50%), no evidence of structural heart disease, and absence of coronary artery disease on angiography. Overall, 39 patients developed exercise-induced left ventricular systolic dysfunction (defined as a decrease in left ventricular ejection fraction below 50% at peak exercise) and 54 exhibited a normal left ventricular ejection fraction response to exercise. The mean follow-up was 6.1 (3.7) years. End points were all-cause mortality, cardiac death, heart failure, and the composite event of cardiac death or heart failure. Results Patients who developed exercise-induced left ventricular systolic dysfunction were at higher risk of death from any cause (hazard ratio = 3.4; 95% confidence interval, 1.1-10.3), cardiac death (hazard ratio = 5.6; 95%CI, 1.1-29.4), heart failure (hazard ratio = 8.9; 95% confidence interval, 1.8-44.2), and the composite end point (hazard ratio = 5.7; 95% confidence interval, 1.7-19.0). In the multivariate analysis, exercise-induced left ventricular systolic dysfunction remained an independent predictor of both heart failure (hazard ratio = 6.9; 95% CI, 1.3-37.4) and the composite event of cardiac death or heart failure (hazard ratio = 4.5; 95% confidence interval, 1.2-16.0).Conclusions In hypertensive patients with preserved resting left ventricular ejection fraction and absence of coronary artery disease, exercise-induced left ventricular systolic dysfunction is a strong predictor of cardiac events and may represent early hypertensive heart disease (AU)


Assuntos
Humanos , /fisiopatologia , Hipertensão/complicações , Ecocardiografia sob Estresse/métodos , Exercício Físico/fisiologia , Insuficiência Cardíaca/fisiopatologia , Fatores de Risco
12.
Rev Esp Cardiol (Engl Ed) ; 68(2): 107-14, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25499955

RESUMO

INTRODUCTION AND OBJECTIVES: We sought to assess the prognostic value of exercise-induced left ventricular systolic dysfunction in hypertensive patients with normal resting echocardiography and absence of coronary artery disease. METHODS: From our database of patients referred for treadmill exercise echocardiography, we identified 93 hypertensive patients with preserved resting left ventricular ejection fraction (≥ 50%), no evidence of structural heart disease, and absence of coronary artery disease on angiography. Overall, 39 patients developed exercise-induced left ventricular systolic dysfunction (defined as a decrease in left ventricular ejection fraction below 50% at peak exercise) and 54 exhibited a normal left ventricular ejection fraction response to exercise. The mean follow-up was 6.1 (3.7) years. End points were all-cause mortality, cardiac death, heart failure, and the composite event of cardiac death or heart failure. RESULTS: Patients who developed exercise-induced left ventricular systolic dysfunction were at higher risk of death from any cause (hazard ratio=3.4; 95% confidence interval, 1.1-10.3), cardiac death (hazard ratio=5.6; 95%CI, 1.1-29.4), heart failure (hazard ratio=8.9; 95% confidence interval, 1.8-44.2), and the composite end point (hazard ratio=5.7; 95% confidence interval, 1.7-19.0). In the multivariate analysis, exercise-induced left ventricular systolic dysfunction remained an independent predictor of both heart failure (hazard ratio=6.9; 95% CI, 1.3-37.4) and the composite event of cardiac death or heart failure (hazard ratio=4.5; 95% confidence interval, 1.2-16.0). CONCLUSIONS: In hypertensive patients with preserved resting left ventricular ejection fraction and absence of coronary artery disease, exercise-induced left ventricular systolic dysfunction is a strong predictor of cardiac events and may represent early hypertensive heart disease.


Assuntos
Pressão Sanguínea , Teste de Esforço/efeitos adversos , Hipertensão/complicações , Disfunção Ventricular Esquerda/etiologia , Idoso , Angiografia Coronária , Doença da Artéria Coronariana , Ecocardiografia , Feminino , Seguimentos , Humanos , Hipertensão/diagnóstico , Hipertensão/fisiopatologia , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Retrospectivos , Volume Sistólico , Disfunção Ventricular Esquerda/diagnóstico , Disfunção Ventricular Esquerda/fisiopatologia
13.
J Eval Clin Pract ; 21(1): 34-42, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25040767

RESUMO

RATIONALE, AIMS AND OBJECTIVES: Transcatheter aortic valve implantation constitutes an example of a technology introduced into the Galician Health Care System basket and subjected to a post-introduction observational study after coverage. This paper aims to describe the process and results of this experience, illustrating the main challenges and opportunities in using these studies for supporting decision making. METHODS: The study protocol was developed by a multidisciplinary team consisting of experts from the Galician HTA Agency (avalia-t), interventional cardiologists and cardiac surgeons. Together they agreed on the information that was relevant and feasible for collection, and planned the study design, data collection and analysis of results. RESULTS: During the 1-year recruitment period, 94 patients underwent percutaneous aortic valve replacement in the three authorized centres. Implantation rate and prosthesis models differed substantially across the centres. Overall, procedural success rate was 96.8% and hospital mortality was 7.4%. Complications during post-surgical admission were recorded in 40.4% of patients. Moderate residual aortic regurgitation was observed in 10% of patients, and the procedure was associated with a stroke rate of 3.3% at 30 days and 5.3% at 1 year. CONCLUSIONS: Post-introduction observation has made it feasible to determine the use of this procedure within the SERGAS context and has enabled the assessment of performance in real-life conditions. The proposed strategic actions and interventions have been drawn up based upon the collective judgement of a group of experienced professionals, and have served to establish recommendations on further research that would be required to optimize health benefits.


Assuntos
Estenose da Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter/métodos , Substituição da Valva Aórtica Transcateter/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Eletrocardiografia , Feminino , Mortalidade Hospitalar , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias , Espanha , Fatores de Tempo
14.
Am J Cardiol ; 113(6): 907-12, 2014 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-24461770

RESUMO

The presence of mitral regurgitation (MR) is associated with an impaired prognosis in patients with ischemic heart disease. However, data with regard to the impact of this condition in patients with ST-segment elevation myocardial infarction (STEMI) treated by means of primary percutaneous coronary intervention (PPCI) are lacking. Our aim was to assess the effect of MR in the long-term prognosis of patients with STEMI after PPCI. We analyzed a prospective registry of 1,868 patients (mean age 62 ± 13 years, 79.9% men) with STEMI treated by PPCI in our center from January 2006 to December 2010. Our primary outcome was the composite end point of all-cause mortality or admission due to heart failure during follow-up. After exclusions, 1,036 patients remained for the final analysis. Moderate or severe MR was detected in 119 patients (11.5%). Those with more severe MR were more frequently women (p <0.001), older (p <0.001), and with lower ejection fraction (p <0.001). After a median follow-up of 2.8 years (1.7 to 4.3), a total of 139 patients (13.4%) experienced our primary end point. There was an association between the unfavorable combined event and the degree of MR (p <0.001). After adjustment for relevant confounders, moderate or severe MR remained as an independent predictor of the combined primary end point (adjusted hazard ratio [HR] 3.14, 95% confidence interval [CI] 1.57 to 6.27) and each event separately (adjusted HR death 3.1, 95% CI 1.34 to 7.2; adjusted HR heart failure 3.3, 95% CI 1.16 to 9.4). In conclusion, moderate or severe MR detected early with echocardiography was independently associated with a worse long-term prognosis in patients with STEMI treated with PPCI.


Assuntos
Eletrocardiografia , Insuficiência da Valva Mitral/etiologia , Infarto do Miocárdio/cirurgia , Intervenção Coronária Percutânea/métodos , Idoso , Causas de Morte/tendências , Angiografia Coronária , Ecocardiografia Doppler em Cores , Feminino , Seguimentos , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Insuficiência da Valva Mitral/diagnóstico , Insuficiência da Valva Mitral/epidemiologia , Infarto do Miocárdio/complicações , Infarto do Miocárdio/diagnóstico , Prognóstico , Estudos Prospectivos , Espanha/epidemiologia , Taxa de Sobrevida/tendências , Fatores de Tempo
15.
Rev. esp. cardiol. (Ed. impr.) ; 66(11): 871-878, nov. 2013.
Artigo em Espanhol | IBECS | ID: ibc-116095

RESUMO

Introducción y objetivos. Se ha prestado poca atención al efecto en la mortalidad que la vía de acceso vascular produce tras una intervención coronaria percutánea, aun cuando hay cada vez más evidencia de que la vía radial aporta un beneficio mucho mayor que el acceso femoral en los pacientes con infarto agudo de miocardio con elevación del segmento ST. El objetivo de este estudio es evaluar la influencia del lugar de acceso vascular en la mortalidad a 30 días y a 1 año en pacientes con infarto agudo de miocardio con elevación del segmento ST. Métodos. Se incluyó en el estudio a todos los pacientes con infarto agudo de miocardio con elevación del segmento ST a los que se practicó una angioplastia primaria en dos hospitales de Galicia entre 2008 y 2010. Se aplicaron dos modelos de regresión multivariable para cada resultado de mortalidad (a 30 días y a 1 año). La única diferencia entre estos modelos fue la inclusión o exclusión del lugar de acceso vascular (femoral o radial). Para cada uno de los cuatro modelos, se calculó la prueba de Hosmer-Lemeshow y el índice C . También se evaluó la interacción entre la inestabilidad hemodinámica y el acceso vascular para la mortalidad. Resultados. Se incluyó a 1.461 pacientes con una media de edad de 64 años. En el 86% se utilizó un acceso vascular radial y en el 7,4% había inestabilidad hemodinámica. La mortalidad por cualquier causa fue del 6,8% (100/1.461) a los 30 días y del 9,3% (136/1.461) a 1 año. El lugar de acceso vascular sigue a la inestabilidad hemodinámica y a la edad en cuanto al efecto en el riesgo de mortalidad (mortalidad a 30 días, odds ratio = 5,20; intervalo de confianza del 95%, 2,80-9,66). Se produce un efecto similar en la mortalidad a 1 año. El índice C mejora ligeramente con la inclusión del lugar de acceso vascular, aunque sin alcanzar significación estadística. Conclusiones. La vía de acceso vascular debería tenerse en cuenta en la predicción de la mortalidad tras una intervención coronaria percutánea primaria (AU)


Introduction and objectives. Little attention has been given to the effect of vascular access site on mortality, while an increasing body of evidence is showing that radial access has much more benefit than femoral access for ST-segment elevation myocardial infarction patients. We aimed to assess the influence of vascular access site on mortality at 30 days and at 1 year in ST-segment elevation myocardial infarction patients. Methods. We included all patients with ST-segment elevation myocardial infarction who had undergone primary angioplasty at 2 Galician hospitals between 2008 and 2010. We performed 2 multivariate regression models for each endpoint (30-day and 1-year mortality). The only difference between these models was the inclusion or not of the vascular access site (femoral vs radial). For each of the 4 models we calculated the Hosmer-Lemeshow test and the C-index. We also tested the interaction between hemodynamic instability and vascular access. Results. We included 1461 patients with a mean age of 64. Of these patients, 86% had radial access and 7.4% had hemodynamic instability. All-cause mortality was 6.8% (100/1461) at 30 days and 9.3% (136/1461) at 1 year. Vascular access site follows hemodynamic instability and age in terms of effect on mortality risk, with an odds ratio of 5.20 (95% confidence interval, 2.80-9.66) for 30-day mortality. A similar effect occurs for 1-year mortality. The C-index slightly improves (without achieving statistical significance) with the inclusion of the vascular access site. Conclusions. Vascular access site should be taken into account when predicting mortality after a primary percutaneous coronary intervention (AU)


Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/cirurgia , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Intervenção Coronária Percutânea , Angiografia Coronária/normas , Angiografia Coronária , Intervenção Coronária Percutânea/normas , Intervenção Coronária Percutânea/tendências , Estudos de Coortes , Estudos Retrospectivos , Curva ROC
16.
Am J Cardiol ; 111(12): 1721-6, 2013 Jun 15.
Artigo em Inglês | MEDLINE | ID: mdl-23499276

RESUMO

Direct transfer (DT) to the catheterization laboratory has been demonstrated to reduce delays in primary percutaneous coronary intervention (PPCI). However, data with regard to its effect on long-term mortality are sparse. The aim of this study was to investigate the effect of DT on long-term mortality in patients with ST-segment elevation myocardial infarctions treated with PPCI. A cohort study was conducted of 1,859 patients (mean age 63.1 ± 13 years, 80.2% men) who underwent PPCI from May 2005 to December 2010. From the whole series, 425 patients (23%) were admitted by DT and 1,434 (77%) by emergency departments. DT patients were younger (mean age 61 ± 12 vs 64 ± 12 years, p = 0.017), were more frequently men (86% vs 76%, p = 0.001), and had a higher proportion of abciximab use (77% vs 64%, p <0.0001). The DT group had a shorter median contact-to-balloon time (105 vs 122 minutes, p <0.0001) and a shorter time to treatment (185 vs 255 minutes, p <0.0001) compared with the emergency department group. Thirty-day and long-term mortality (median follow-up 2.4 years, interquartile range 1.6 to 3.2) were lower in the DT group (3% vs 6%, p = 0.049, and 9.4% vs 14.4%, p = 0.008, respectively). An adjusted Cox regression analysis proved that the DT group had an improved prognosis during follow-up (hazard ratio 0.71, 95% confidence interval 0.50 to 0.99). In conclusion, DT of patients with ST-segment elevation myocardial infarctions for PPCI was associated with fewer delays and improved survival. This benefit was maintained after long follow-up. This strategy should be emphasized in all networks of ST-segment elevation myocardial infarction care.


Assuntos
Angioplastia Coronária com Balão , Sistema de Condução Cardíaco/fisiopatologia , Infarto do Miocárdio/terapia , Transferência de Pacientes , Triagem , Idoso , Estudos de Coortes , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/fisiopatologia , Transferência de Pacientes/estatística & dados numéricos , Prognóstico , Fatores de Tempo , Resultado do Tratamento , Triagem/estatística & dados numéricos
18.
J Invasive Cardiol ; 25(2): 92-5, 2013 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-23388229

RESUMO

Significant periprosthetic aortic regurgitation after transcatheter aortic valve implantation with Edwards SAPIEN prosthesis has become a major concern of this technique given its association with impaired survival. We report the successful closure of such defects using vascular occlusion devices with significant improvement in clinical status of patients.


Assuntos
Insuficiência da Valva Aórtica/etiologia , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Cateterismo Cardíaco , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/diagnóstico , Insuficiência da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico , Ecocardiografia Transesofagiana , Fluoroscopia , Seguimentos , Humanos , Masculino , Falha de Prótese , Reoperação
19.
Rev Esp Cardiol (Engl Ed) ; 66(11): 871-8, 2013 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-24773994

RESUMO

INTRODUCTION AND OBJECTIVES: Little attention has been given to the effect of vascular access site on mortality, while an increasing body of evidence is showing that radial access has much more benefit than femoral access for ST-segment elevation myocardial infarction patients. We aimed to assess the influence of vascular access site on mortality at 30 days and at 1 year in ST-segment elevation myocardial infarction patients. METHODS: We included all patients with ST-segment elevation myocardial infarction who had undergone primary angioplasty at 2 Galician hospitals between 2008 and 2010. We performed 2 multivariate regression models for each endpoint (30-day and 1-year mortality). The only difference between these models was the inclusion or not of the vascular access site (femoral vs radial). For each of the 4 models we calculated the Hosmer-Lemeshow test and the C-index. We also tested the interaction between hemodynamic instability and vascular access. RESULTS: We included 1461 patients with a mean age of 64. Of these patients, 86% had radial access and 7.4% had hemodynamic instability. All-cause mortality was 6.8% (100/1461) at 30 days and 9.3% (136/1461) at 1 year. Vascular access site follows hemodynamic instability and age in terms of effect on mortality risk, with an odds ratio of 5.20 (95% confidence interval, 2.80-9.66) for 30-day mortality. A similar effect occurs for 1-year mortality. The C-index slightly improves (without achieving statistical significance) with the inclusion of the vascular access site. CONCLUSIONS: Vascular access site should be taken into account when predicting mortality after a primary percutaneous coronary intervention.


Assuntos
Artéria Femoral , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea/métodos , Artéria Radial , Dispositivos de Acesso Vascular , Idoso , Determinação de Ponto Final , Feminino , Seguimentos , Hemodinâmica , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
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