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1.
Lancet ; 383(9915): 413-23, 2014 Feb 01.
Artículo en Inglés | MEDLINE | ID: mdl-24183564

RESUMEN

BACKGROUND: Third-generation, permanent-polymer-based drug-eluting stents with novel, flexible designs might be more easily delivered than previous generations of stents in complex coronary lesions, but might be less longitudinally stable. We aimed to assess the safety and efficacy in all-comer patients of two third-generation stents that are often used clinically, but that have not yet been compared, and one of which has not previously been assessed in a randomised trial. METHODS: In this investigator-initiated, single-blind, multicentre, randomised, two-arm, non-inferiority trial, patients aged 18 years and older who required a percutaneous coronary intervention with implantation of a drug-eluting stent were recruited from four study sites in the Netherlands. We randomly assigned patients by independently managed computer-generated allocation sequences in a 1:1 ratio to receive either cobalt-chromium-based zotarolimus-eluting stents (Resolute Integrity, Medtronic, Santa Rosa, CA, USA) or platinum-chromium-based everolimus-eluting stents (Promus Element, Boston Scientific, Natick, MA, USA). Patients and analysts were masked to the allocated stent, but treating clinicians were not. The primary endpoint of target-vessel failure was a composite of safety (cardiac death or target-vessel-related myocardial infarction) and efficacy (target-vessel revascularisation) at 12 months, analysed by intention to treat (with a non-inferiority margin of 3·6%). This trial is registered with ClinicalTrials.gov, number NCT01331707. FINDINGS: Between Nov 25, 2010, and May 24, 2012, 1811 eligible all-comer patients, with 2371 target lesions, were enrolled in the study. 370 (20%) patients presented with ST-elevation myocardial infarction and 447 (25%) with non-ST-elevation myocardial infarction. 906 patients were assigned to receive zotarolimus-eluting stents and 905 to receive everolimus-eluting stents. Ease of stent delivery was shown by very low numbers of patients requiring treatment other than their assigned study treatment (six [1%] in the zotarolimus-eluting stent group vs five [1%] in the everolimus-eluting stent group; p=0·22). 12-month follow-up results were available for 1810 patients (one patient in the zotarolimus-eluting stent group withdrew consent). The primary endpoint was met by 55 (6%) of 905 patients in the zotarolimus-eluting stent group and 47 (5%) of 905 in the everolimus-eluting stent group. The zotarolimus-eluting stent was non-inferior to the everolimus-eluting stent (absolute risk difference 0·88%, 95% CI -1·24% to 3·01%; upper limit of one-sided 95% CI 2·69%; non-inferiority p=0·006). We noted no significant between-group differences in individual components of the primary endpoint. Definite stent thrombosis occurred in three (0·3%) patients in the zotarolimus-eluting stent group and six (0·7%) patients in the everolimus-eluting stent group (p=0·34). Longitudinal stent deformation was seen only in the everolimus-eluting stent group (nine [1·0%] of 905 vs 0 of 906, p=0·002; nine of 1591 [0·6%] everolimus-eluting stents implanted became deformed), but was not associated with any adverse events. INTERPRETATION: Both stents were similarly efficacious and safe, and provided excellent clinical outcomes, especially in view of the large number of patients who presented with acute myocardial infarctions. FUNDING: Boston Scientific, Medtronic.


Asunto(s)
Inmunosupresores/administración & dosificación , Infarto del Miocardio/tratamiento farmacológico , Intervención Coronaria Percutánea/métodos , Sirolimus/análogos & derivados , Adulto , Anciano , Anciano de 80 o más Años , Oclusión Coronaria/tratamiento farmacológico , Muerte Súbita Cardíaca/etiología , Stents Liberadores de Fármacos , Everolimus , Femenino , Humanos , Inmunosupresores/efectos adversos , Masculino , Persona de Mediana Edad , Método Simple Ciego , Sirolimus/administración & dosificación , Sirolimus/efectos adversos , Resultado del Tratamiento , Adulto Joven
2.
Catheter Cardiovasc Interv ; 82(3): 396-405, 2013 Sep 01.
Artículo en Inglés | MEDLINE | ID: mdl-23359390

RESUMEN

BACKGROUND: Women are underrepresented in clinical research, and few data are available from randomized head-to-head comparisons of second-generation drug-eluting stents (DES) in female patients. Aim of this study was to assess safety and efficacy of two second-generation DES in women. In TWENTE-a prospective, randomized, comparative DES trial-"real-world" patients were stratified for gender before randomization for Resolute or Xience V stents. METHODS: Target vessel failure (TVF; cardiac death, target vessel-related myocardial infarction, and clinically indicated target vessel revascularization) after 1 year was the predefined endpoint. RESULTS: Among 1,391 patients, 382 (27.5%) women were randomized to Resolute (n = 192) and Xience V (n = 190). Baseline and procedural characteristics were similar for females in both study arms, except for smaller vessel and stent diameters in Resolute-treated lesions. After 1 year, TVF (8.9 vs. 8.4%; adjusted odds ratio [OR]: 0.95, 95% confidence interval [CI]: 0.41-2.20, P = 0.91) and a patient-oriented composite endpoint (13.0 vs. 12.1%, P = 0.79) did not differ significantly between women in both arms. Women were older than men (P < 0.01) and had more often diabetes mellitus (26.4 vs. 19.8%, P = 0.01) and hypertension (63.6 vs. 52.5%, P < 0.01), but there was no significant gender difference in TVF (adjusted OR: 1.18, 95% CI: 0.73-1.92, P = 0.50). CONCLUSIONS: This gender-stratified TWENTE trial analysis resulted in no significant difference in safety and efficacy outcomes between Resolute- and Xience V-treated females.


Asunto(s)
Fármacos Cardiovasculares/administración & dosificación , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea/instrumentación , Sirolimus/análogos & derivados , Factores de Edad , Anciano , Distribución de Chi-Cuadrado , Comorbilidad , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/mortalidad , Everolimus , Femenino , Humanos , Estimación de Kaplan-Meier , Modelos Logísticos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/mortalidad , Países Bajos , Oportunidad Relativa , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Estudios Prospectivos , Diseño de Prótesis , Factores de Riesgo , Factores Sexuales , Sirolimus/administración & dosificación , Factores de Tiempo , Resultado del Tratamiento
3.
Europace ; 12(6): 830-4, 2010 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-20348144

RESUMEN

AIMS: The evoked QT interval can be detected beat by beat through an implanted pacing system. The correlation between the right ventricular paced QT interval and the left ventricular systolic interval is not known. The aim of our study was to collect data on the correlation between QT and systolic and diastolic indexes at different heart rates in patients with dual-chamber rate-responsive pacemakers. METHOD AND RESULTS: The study involved 13 patients [67 +/- 9 years; ejection fraction (EF) 52 +/- 10%] with standard indication for dual-chamber pacing. Patients were evaluated at rest in the supine position. The AV delay was set at 130 ms, and the pacing rate was increased from 90 to 130 bpm (10 bpm steps for 3 min). At the end of each 3 min step, QT intervals were automatically evaluated in real time by means of pacemaker telemetry. We also evaluated heart performance by means of echo-2D (end-diastolic/end-systolic volumes, EF) and echo-Doppler measurements [left ventricular ejection time (LVET) and diastolic filling time (LVDFT), aortic velocity time integral, and systolic volume] and systemic arterial pressure. The QT interval progressively decreased from 330 +/- 20 to 280 +/- 10 ms as the pacing rate was increased from 90 to 130 bpm. The correlation between the QT interval and LVET as a function of the pacing rate was R(2) = 0.966, indicating a good and relatively parallel trend in these two parameters. The correlation between RR-QT (reflecting electrical diastole) and LVDFT (reflecting mechanical diastole) was R(2) = 0.975. The index LVET/QT (ratio between mechanical and electrical systole) was constant in the range 90-120 bpm, but significantly decreased at 130 bpm: the mechanical LVET shortens more than the electrical QT does at the highest heart rates. CONCLUSION: In paced patients at rest and during artificially increased heart rates, QT interval dynamics is closely correlated with changes in ejection time, thus constituting an electrical parameter of systolic time. A similar correlation exists between RR-QT, as a diastolic electrical interval, and the DFT.


Asunto(s)
Arritmias Cardíacas/terapia , Estimulación Cardíaca Artificial/métodos , Diástole/fisiología , Electrocardiografía , Frecuencia Cardíaca/fisiología , Sístole/fisiología , Potenciales de Acción/fisiología , Anciano , Algoritmos , Aorta/fisiología , Arritmias Cardíacas/fisiopatología , Velocidad del Flujo Sanguíneo/fisiología , Ecocardiografía , Humanos , Persona de Mediana Edad , Volumen Sistólico/fisiología
4.
World J Cardiol ; 8(8): 488-95, 2016 Aug 26.
Artículo en Inglés | MEDLINE | ID: mdl-27621777

RESUMEN

AIM: To delineate the features and current therapeutic option of congenital and acquired aortocameral fistulas (ACF) secondary to iatrogenic or infectious disorders. METHODS: From a PubMed search using the term "aortocameral fistula", 30 suitable papers for the current review were retrieved. Reviews, case series and case reports published in English were considered. Abstracts and reports from scientific meetings were not included. A total of 38 reviewed subjects were collected and analyzed. In addition, another case - an adult male who presented with ACF between commissures of the right and non-coronary sinuses and right atrium as a late complication of Staphylococcus aureus infective endocarditis of the AV - is added, the world literature is briefly reviewed. RESULTS: A total of thirty-eight subjects producing 39 fistulas were reviewed, analyzed and stratified into either congenital (47%) or acquired (53%) according to their etiology. Of all subjects, 11% were asymptomatic and 89% were symptomatic with dyspnea (21 ×) as the most common presentation. Diagnosis was established by a multidiagnostic approach in 23 (60%), single method in 14 (37%) (echocardiography in 12 and catheterization in 2), and at autopsy in 2 (3%) of the subjects. Treatment options included percutaneous transcatheter closure in 12 (30%) with the deployment of the Amplatzer duct or septal occluder and Gianturco coil and surgical correction in 24 (63%). CONCLUSION: Acquired ACF is an infrequent entity which may occur late after an episode of endocarditis of the native AV. The management of ACF is generally by surgical correction but non-surgical device intervention has recently been introduced as a safe alternative.

5.
Am J Case Rep ; 17: 507-11, 2016 Jul 20.
Artículo en Inglés | MEDLINE | ID: mdl-27435910

RESUMEN

BACKGROUND Cardiac resynchronization therapy (CRT) has been demonstrated to reduce morbidity and mortality in patients with advanced, drug-refractory heart failure. Procedure-related mortality is less than 1% in larger studies. Approximately10% of CRT patients have to undergo surgical revision because of infections, dislocations, or unacceptable electrical behavior manifested as high threshold, unstable sensing, or unwanted phrenic nerve stimulation. CASE REPORT A 70-year-old man with symptomatic congestive heart failure underwent implantation of a biventricular pacemaker on the left anterior chest wall in 2003 and pulse generator exchange in August 2009. The patient responded well to CRT. At follow-up, the pacing system functioned normally. In September 2009, in the context of a predialysis program, an abdominal computed tomography (CT) scan was performed in another hospital for assessment and evaluation of chronic kidney disease. This procedure was complicated with peripheral thrombophlebitis that was managed appropriately with complete recovery. Eight months later (May 2010), the patient was admitted to our hospital with fever, anemia, and elevated infection parameters. During admission, blood cultures grew Staphylococcus epidermidis. The chest X-ray, lung perfusion scintigraphy, and CT scan depicted pulmonary embolism and infarction. The right ventricular lead threshold was found to be increased to 7 volts with unsuccessful capture. Echocardiography demonstrated vegetations on leads. The entire pacing system was explanted, but the patient expired few days later following percutaneous removal due to multiorgan failure. CONCLUSIONS In heart failure, replacement of the CRT device may be complicated by bacterial endocarditis. As noted from this case report, sudden elevation of the pacing lead threshold should prompt thorough and immediate investigation to unravel its causes, not only the electrical characteristics but also the anatomical features.


Asunto(s)
Contaminación de Equipos , Insuficiencia Cardíaca/terapia , Marcapaso Artificial/efectos adversos , Embolia Pulmonar/etiología , Sepsis/complicaciones , Anciano , Ecocardiografía , Resultado Fatal , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/fisiopatología , Ventrículos Cardíacos/fisiopatología , Humanos , Masculino , Tomografía de Emisión de Positrones , Embolia Pulmonar/diagnóstico , Radiografía Torácica , Sepsis/diagnóstico , Tomografía Computarizada por Rayos X
6.
JACC Clin Electrophysiol ; 1(4): 326-334, 2015 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-29759321

RESUMEN

OBJECTIVES: This study sought to compare age-related differences in presentation, treatment, and outcome of atrial fibrillation (AF) in a wide cohort of European subjects. BACKGROUND: AF is the most common sustained arrhythmia in the elderly. METHODS: We evaluated all patients enrolled in the EORP-AF (EURObservational Research Programme-Atrial Fibrillation) General Pilot Registry in 70 centers of 9 European countries. RESULTS: Among 3,119 subjects, 1,051 (33.7%) were age ≥75 years. Permanent AF was significantly more common in the elderly, who had a higher prevalence of hypertension, valvular diseases, chronic heart failure, coronary artery disease, renal failure, chronic obstructive pulmonary disease, and prior hemorrhagic event or a transient ischemic attack. Common diagnostic tests were underused in older subjects. Despite their higher stroke risk, the use of oral anticoagulants was significantly lower in the elderly (76.7% vs. 82.8%; p = 0.0012), whereas aspirin and clopidogrel alone or in combination were more often prescribed. Rate control was the management of choice in the older group, with electrical cardioversion and catheter ablation performed less frequently than in the younger age group. Antiarrhythmic drugs were significantly less prescribed in the elderly (29.8% vs. 41.7%; p < 0.0001). At the 1-year follow-up, mortality (11.5% vs. 3.7%; p < 0.0001) and the composite of stroke/transient ischemic attack, systemic thromboembolism, and/or death (13.6% vs. 4.9%; p < 0.0001) were significantly higher in the ≥75 years of age cohort. CONCLUSIONS: In older patients, AF is more often associated with comorbidities. Rate control is the preferred therapeutic approach. Despite a higher CHA2DS2-VASc score, the use of oral anticoagulation is suboptimal. In elderly subjects, the rate of adverse events is higher at follow-up.

7.
EuroIntervention ; 11(2): 180-7, 2015 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-24602919

RESUMEN

AIMS: To investigate the prognostic value of coronary dominance for various adverse clinical events following the implantation of drug-eluting stents. METHODS AND RESULTS: We assessed two-year follow-up data of 1,387 patients from the randomised TWENTE trial. Based on the origin of the posterior descending coronary artery, coronary circulation was categorised into left and non-left dominance (i.e., right and balanced). Target vessel-related myocardial infarction (MI) was defined according to the updated Academic Research Consortium (ARC) definition (2x upper reference limit of creatine kinase [CK], confirmed by CK-MB elevation), and periprocedural MI (PMI) as MI ≤48 hours following PCI. One hundred and thirty-six patients (9.8%) had left and 1,251 (90.2%) non-left dominance. Target lesions were more frequently located in dominant arteries (p<0.005). Left dominance was associated with more severe calcifications (p=0.006) and more bifurcation lesions (p=0.031). Non-left dominance tended to be less frequent in men (p=0.09). Left coronary dominance was associated with more target vessel-related MI (14 [10.3%] vs. 62 [5.0%], p=0.009). Left dominance independently predicted PMI (adjusted HR 2.19, 95% CI: 1.15-4.15, p=0.017), while no difference in other clinical endpoints was observed between dominance groups. CONCLUSIONS: In the population of the TWENTE trial, we observed a higher incidence of periprocedural myocardial infarction in patients who had left coronary dominance.


Asunto(s)
Enfermedad de la Arteria Coronaria/epidemiología , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos , Infarto del Miocardio/epidemiología , Intervención Coronaria Percutánea , Adulto , Anciano , Enfermedad de la Arteria Coronaria/complicaciones , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Infarto del Miocardio/complicaciones , Infarto del Miocardio/terapia , Intervención Coronaria Percutánea/efectos adversos , Estudios Prospectivos , Factores de Riesgo , Resultado del Tratamiento
9.
Clin Cardiol ; 37(9): 536-45, 2014 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-25196980

RESUMEN

BACKGROUND: Congenital coronary-pulmonary fistulas (CPFs) are commonly unilateral, but bilateral and multilateral fistulas may occur. In multilateral CPFs, the value of a multidetector computed tomography (MDCT) imaging technique as an adjuvant to coronary angiography (CAG) is eminent. The purpose of this study was to describe the clinical presentation, diagnostic modalities, and management of coincidentally detected congenital CPFs. HYPOTHESIS: Unilateral and multilateral coronary-pulmonary fistulas are increasingly detected due to the wide speard application of multidetector computed tomography which might be a supplementary or replacing to conventional coronary angiography. METHODS: We evaluated 14 adult patients with congenital coronary artery fistulas (CAFs) who were identified from several Dutch cardiology departments. RESULTS: Fourteen adult patients (5 female and 9 male), with a mean age of 57.5 years (range, 24-80 years) had the following abnormal findings: audible systolic cardiac murmur (n = 4), chronic atrial fibrillation (n = 2), nonsustained ventricular tachycardia (n = 1), and cardiomegaly on chest x-ray (n = 2). Echocardiography revealed normal findings with trivial valvular abnormalities (n = 9), depressed left ventricle systolic function (n = 3), and severe mitral regurgitation and atrial dilatation (n = 2). The findings in the rest of the patients were unremarkable. CAG and MDCT were used as a diagnostic imaging techniques either alone (CAG, n = 6; MDCT, n = 1) or in combination (n = 7). Single modality and multimodality diagnostic methods revealed 22 fistulas including CPFs (n = 15), coronary cameral fistulas terminating into the right (n = 2) and the left atrium (n = 1), and systemic-pulmonary fistulas (n = 4). Of all of the fistulas, 10 were unilateral, 6 were bilateral, and 6 was hexalateral. (13) N-ammonia positron emission tomography-computed tomography was performed in 3 patients revealing decreased myocardial perfusion reserve. CONCLUSIONS: CAG remains the gold standard for detection of CPFs. An adjuvant technique using MDCT provides full anatomical details of the fistulas.


Asunto(s)
Fístula Arterio-Arterial/diagnóstico por imagen , Fístula Arterio-Arterial/terapia , Angiografía Coronaria/métodos , Anomalías de los Vasos Coronarios/diagnóstico por imagen , Anomalías de los Vasos Coronarios/terapia , Tomografía Computarizada Multidetector , Arteria Pulmonar , Adulto , Anciano , Anciano de 80 o más Años , Fístula Arterio-Arterial/fisiopatología , Anomalías de los Vasos Coronarios/fisiopatología , Ecocardiografía , Electrocardiografía Ambulatoria , Embolización Terapéutica , Femenino , Humanos , Hallazgos Incidentales , Ligadura , Masculino , Persona de Mediana Edad , Imagen Multimodal , Imagen de Perfusión Miocárdica/métodos , Países Bajos , Valor Predictivo de las Pruebas , Arteria Pulmonar/diagnóstico por imagen , Arteria Pulmonar/fisiopatología , Tomografía Computarizada de Emisión de Fotón Único , Resultado del Tratamiento , Procedimientos Quirúrgicos Vasculares , Espera Vigilante , Adulto Joven
10.
EuroIntervention ; 10(6): 664-71, 2014 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-25330500

RESUMEN

AIMS: Drug-eluting stents (DES) were first used on-label - in simple patients with low clinical risk and easily accessible lesions. Currently, DES are increasingly used off-label - in complex patients undergoing percutaneous coronary interventions (PCI) with historically higher event risk. Therefore, our aim was to investigate whether patients with off-label indications for DES use had similar outcomes compared to patients who were treated for on-label indications only. We analysed two-year follow-up data of 1,387 TWENTE trial patients, treated with second-generation everolimus-eluting XIENCE V or zotarolimus-eluting Resolute stents, and compared off-label vs. on-label DES use with regard to the following clinical endpoints: cardiac death, myocardial infarction (MI), periprocedural MI (≤48 hrs), and target vessel revascularisation (TVR). Patients with off-label DES use (n=1,033; 74.5%) had more diabetes (22.9% vs. 17.5%; p=0.032), previous MI (35.9% vs. 22.3%; p<0.001), type B2/C lesions (84.7% vs. 62.7%; p<0.001), and acute coronary syndromes (57.8% vs. 33.3%; p<0.001). Nevertheless, cardiac death and TVR rates were similar to those of patients with on-label DES use (p>0.8). Following off-label DES use, there was a higher incidence of PMI (5.0% vs. 1.4%; p=0.003), of which only 1.1% reached creatine kinase levels >5x the upper limit of normal (ULN). Despite differences in risk profile, patients with off-label DES use did not differ from patients with on-label DES use in clinical endpoints other than periprocedural MI. These largely positive findings underline the favourable safety profile of second-generation DES.


Asunto(s)
Stents Liberadores de Fármacos , Uso Fuera de lo Indicado , Evaluación del Resultado de la Atención al Paciente , Intervención Coronaria Percutánea , Síndrome Coronario Agudo/epidemiología , Calcinosis/epidemiología , Creatina Quinasa/análisis , Diabetes Mellitus/epidemiología , Everolimus , Femenino , Humanos , Fallo Renal Crónico/epidemiología , Masculino , Persona de Mediana Edad , Infarto del Miocardio/epidemiología , Índice de Severidad de la Enfermedad , Sirolimus/administración & dosificación , Sirolimus/análogos & derivados
11.
J Am Coll Cardiol ; 61(24): 2406-2416, 2013 Jun 18.
Artículo en Inglés | MEDLINE | ID: mdl-23602769

RESUMEN

OBJECTIVES: The aim of this study was to assess the safety and efficacy of the implantation of Resolute zotarolimus-eluting stents (ZES) (Medtronic Inc., Santa Rosa, California) and Xience V everolimus-eluting stents (EES) (Abbott Vascular, Santa Clara, California) following strict discontinuation of dual antiplatelet therapy (DAPT) after 12 months. BACKGROUND: Only limited long-term follow-up data are available from head-to-head comparisons of second-generation drug-eluting stents. METHODS: The randomized TWENTE (The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente) trial is an investigator-initiated study performed in a population with many complex patients and lesions and only limited exclusion criteria. Patients were randomly assigned 1:1 to ZES (n = 697) or EES (n = 694). RESULTS: Two-year follow-up information was available on all patients. The rate of continuation of DAPT beyond 12 months was very low (5.4%). The primary endpoint of target vessel failure, a composite of cardiac death, target vessel-related myocardial infarction, and target vessel revascularization, did not differ between ZES and EES (10.8% vs. 11.6, p = 0.65), despite fewer target lesion revascularizations in patients with EES (2.6% vs. 4.9%, p = 0.03). The patient-oriented composite endpoint was similar (16.4% vs. 17.1%, p = 0.75). Two-year rates of definite or probable stent thrombosis were 1.2% and 1.4%, respectively (p = 0.63). Very late definite or probable stent thrombosis occurred only in 2 patients in each study arm (0.3% vs. 0.3%, p = 1.00). CONCLUSIONS: After 2 years of follow-up and stringent discontinuation of DAPT beyond 12 months, Resolute ZES and Xience V EES showed similar results in terms of safety and efficacy for treating patients with a majority of complex lesions and off-label indications for drug-eluting stents. (The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente [TWENTE]; NCT01066650).


Asunto(s)
Stents Liberadores de Fármacos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Sirolimus/análogos & derivados , Anciano , Everolimus , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea , Estudios Prospectivos , Sirolimus/administración & dosificación , Trombosis/patología , Factores de Tiempo , Resultado del Tratamiento
12.
J Am Coll Cardiol ; 59(15): 1350-61, 2012 Apr 10.
Artículo en Inglés | MEDLINE | ID: mdl-22341737

RESUMEN

OBJECTIVES: The aim of this study was to compare the safety and efficacy of Resolute zotarolimus-eluting stents (ZES) (Medtronic Cardiovascular, Santa Rosa, California) with Xience V everolimus-eluting stents (EES) (Abbott Vascular Devices, Santa Clara, California) at 1-year follow-up. BACKGROUND: Only 1 randomized trial previously compared these stents. METHODS: This investigator-initiated, patient-blinded, randomized noninferiority study had limited exclusion criteria (acute ST-segment elevation myocardial infarctions not eligible). Patients (n = 1,391; 81.4% of eligible population) were randomly assigned to ZES (n = 697) or EES (n = 694). Liberal use of stent post-dilation was encouraged. Cardiac biomarkers were systematically assessed. The primary endpoint was target vessel failure (TVF), a composite of cardiac death, myocardial infarction not clearly attributable to non-target vessels, and clinically indicated target-vessel revascularization. An external independent research organization performed clinical event adjudication (100% follow-up data available). Analysis was by intention-to-treat. RESULTS: Acute coronary syndromes were present in 52% and "off-label" feature in 77% of patients. Of the lesions, 70% were type B2/C; the post-dilation rate was very high (82%). In ZES and EES, TVF occurred in 8.2% and 8.1%, respectively (absolute risk-difference 0.1%; 95% confidence interval: -2.8% to 3.0%, p(noninferiority) = 0.001). There was no significant between-group difference in TVF components. The definite-or-probable stent thrombosis rates were relatively low and similar for ZES and EES (0.9% and 1.2%, respectively, p = 0.59). Definite stent thrombosis rates were also low (0.58% and 0%, respectively, p = 0.12). In EES, probable stent thrombosis beyond day 8 was observed only in patients not adhering to dual antiplatelet therapy. CONCLUSIONS: Resolute ZES were noninferior to Xience V EES in treating "real-world" patients with a vast majority of complex lesions and "off-label" indications for drug-eluting stents, which were implanted with liberal use of post-dilation. (The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting SteNt Study: Head-to-head Comparison of Clinical Outcome After Implantation of Second Generation Drug-eluting Stents in a Real World Scenario; NCT01066650).


Asunto(s)
Angioplastia Coronaria con Balón/métodos , Enfermedad de la Arteria Coronaria/cirugía , Stents Liberadores de Fármacos , Sirolimus/análogos & derivados , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico , Electrocardiografía , Everolimus , Femenino , Estudios de Seguimiento , Humanos , Inmunosupresores/farmacología , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Estudios Retrospectivos , Método Simple Ciego , Sirolimus/farmacología , Factores de Tiempo , Resultado del Tratamiento
13.
Congenit Heart Dis ; 5(6): 599-606, 2010.
Artículo en Inglés | MEDLINE | ID: mdl-21106021

RESUMEN

BACKGROUND: Coronary artery fistulas are uncommon anomalies. They occur in 0.1-0.2% of patients undergoing coronary arteriography. The origin of the fistulas is the right coronary artery followed by the left anterior descending and lastly by the circumflex artery (17%). Termination into the right heart side occurs in 90% of cases. Termination into the coronary sinus is rare in 3% of cases. Circumflex artery-coronary sinus fistulas are even rarer. DESIGN: A single case report and literature review between 1993 and 2007. RESULTS: We describe a 76-year-old female, who was analyzed for dyspnea on exertion (DOE) and chronic fatigue, with known myelodysplastic syndrome and an aneurysmal circumflex coronary artery-coronary sinus fistulous connection associated with severe mitral regurgitation. Mitral valve replacement using a bioprosthesis was performed as well as ligation of the fistula. The postoperative course was complicated with cardiac tamponade, which was successfully drained. CONCLUSION: Our patient presented with chronic fatigue and DOE and was found to have a coronary artery fistula and severe mitral regurgitation associated with known myelodysplasia. Conventional coronary angiography failed to demonstrate the entire fistula characteristics (origin, pathway, and outflow). Multidetector computed tomography was complementary to demonstrate the complex anatomy of the fistula. The fistula was surgically ligated in combination with mitral valve replacement. She remains well.


Asunto(s)
Fístula Arteriovenosa/complicaciones , Seno Coronario/anomalías , Anomalías de los Vasos Coronarios/complicaciones , Insuficiencia de la Válvula Mitral/complicaciones , Síndromes Mielodisplásicos/complicaciones , Anciano , Fístula Arteriovenosa/diagnóstico por imagen , Fístula Arteriovenosa/cirugía , Bioprótesis , Taponamiento Cardíaco/etiología , Angiografía Coronaria/métodos , Seno Coronario/diagnóstico por imagen , Seno Coronario/cirugía , Anomalías de los Vasos Coronarios/diagnóstico por imagen , Anomalías de los Vasos Coronarios/cirugía , Disnea/etiología , Fatiga/etiología , Femenino , Prótesis Valvulares Cardíacas , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Humanos , Ligadura , Insuficiencia de la Válvula Mitral/cirugía , Diseño de Prótesis , Índice de Severidad de la Enfermedad , Tomografía Computarizada por Rayos X , Resultado del Tratamiento
14.
Congenit Heart Dis ; 3(1): 63-8, 2008.
Artículo en Inglés | MEDLINE | ID: mdl-18373752

RESUMEN

AIMS: To delineate the risk factors for rupture of congenital aneurysmal fistulas in adult patients. METHODS: We conducted a literature search of the Medline database using Pubmed search interface to identify reports dealing with rupture of congenital aneurysmal fistulas in an adult population. The search included the English and non-English languages between 1963 and 2005. RESULTS: Fourteen adult patients (12 females) with serious and life-threatening complications secondary to aneurysmal fistulas were reported. Mean age was 62.9 years. The ethnic origins of these 14 patients were 9 Asian and 5 Caucasian. Most patients have had no other cardiac malformations. Five patients had a history of hypertension. One patient was asymptomatic. In 13 symptomatic patients, the clinical presentation was cardiac tamponade, pericardial effusion, syncope, heart failure, chest pain, dyspnea, fatigue, distal thromboembolic events with infarction, shock, and/or sudden death. Aneurysmal fistulas were identified in 10 patients; of these 6 were of the saccular type. Rupture occurred in 9 patients (8 females and 1 male). Eleven patients were treated surgically with 1 late death. Two male subjects experienced sudden unexpected cardiac death. CONCLUSION: Rupture of congenital aneurysmal fistulas occurred more often in females. Identified risk factors for rupture, hemopericardium, tamponade, and death were among others saccular aneurysm, Asian ethnic race, origin of the aneurysmal fistulas from the left coronary artery and a history of hypertension may play a role. In this article, we present a literature review of congenital aneurysmal fistulas associated with or without rupture and a case report of a woman with unruptured aneurysmal fistula.


Asunto(s)
Fístula Arterio-Arterial/complicaciones , Aneurisma Coronario/complicaciones , Anomalías de los Vasos Coronarios/complicaciones , Arteria Pulmonar/anomalías , Adulto , Anciano , Anciano de 80 o más Años , Fístula Arterio-Arterial/diagnóstico por imagen , Fístula Arterio-Arterial/etnología , Fístula Arterio-Arterial/terapia , Pueblo Asiatico , Taponamiento Cardíaco/etiología , Aneurisma Coronario/diagnóstico por imagen , Aneurisma Coronario/etnología , Aneurisma Coronario/terapia , Angiografía Coronaria , Anomalías de los Vasos Coronarios/diagnóstico por imagen , Anomalías de los Vasos Coronarios/etnología , Anomalías de los Vasos Coronarios/terapia , Vasos Coronarios/patología , Muerte Súbita Cardíaca/etiología , Femenino , Humanos , Hipertensión/complicaciones , Masculino , Persona de Mediana Edad , Derrame Pericárdico/etiología , Arteria Pulmonar/diagnóstico por imagen , Factores de Riesgo , Rotura , Factores Sexuales
15.
Ann Thorac Surg ; 83(1): 291-3, 2007 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-17184684

RESUMEN

A 39-year-old diabetic patient with an old inferior wall infarction presented with disabling angina pectoris, despite medical treatment. Coronary angiography showed severe triple-vessel coronary artery disease, and bilateral coronary to pulmonary fistulas originating from the right coronary artery and the left anterior descending coronary artery. Both coronary artery saphenous vein bypass grafting and ligation of the fistulas was performed.


Asunto(s)
Fístula Arterio-Arterial/cirugía , Aneurisma Coronario/cirugía , Enfermedad de la Arteria Coronaria/complicaciones , Anomalías de los Vasos Coronarios/cirugía , Arteria Pulmonar/anomalías , Adulto , Enfermedad de la Arteria Coronaria/cirugía , Humanos , Masculino
16.
Congenit Heart Dis ; 1(3): 63-76, 2006 May.
Artículo en Inglés | MEDLINE | ID: mdl-18377549

RESUMEN

Congenital solitary coronary artery fistulas (CAFs) in adults are uncommon anomalies, which by themselves may resemble the whole spectrum of cardiac presentations from asymptomatic behavior to life-threatening and catastrophic events with syncope or shock and even sudden death. It may take decades to collect a reasonable series of patients in adults and children. From the literature between 1993 and 2004, 236 patients with CAFs were considered for evaluation. The present review is intended to assist cardiologists who are unfamiliar with congenital CAFs in adults by suggesting clues for decision making regarding diagnosis and management. Dyspnea and chest pain represented a frequent 91/128 (71%) clinical symptom in CAFs in adults while in the pediatric age group the majority were silent 105/133 (79%) and dyspnea and chest pain accounted for only 8% of the symptoms. The diagnostic modalities were mainly cardiac catheterization and coronary angiography. On the other hand, in the pediatric patients, echocardiography and coronary angiography mainly guided the diagnosis. Regarding treatment strategy in the reviewed subjects, percutaneous transluminal embolization was performed in 18% of the pediatric and in only 5% of the adult subjects. Surgical ligation (46% vs. 38%) and conservative medical strategies (36% vs. 24%) were reported in both pediatric and adult groups. Presentations of CAFs vary considerably in both groups. These differences include the diagnostic modalities, spontaneous closure, spontaneous rupture, and management. From this review, it seemed that--but it may be biased--surgical ligation remains the major mainstay for closure of CAFs in adult and pediatric populations. Recommendations are necessary for antibiotic prophylaxis and antiplatelet and/or anticoagulant therapy for prevention of endocarditis and thrombotic events in patients with CAFs associated with coronary artery dilatation or aneurysmal formation of the fistulous tract.


Asunto(s)
Fístula Arterio-Arterial/diagnóstico , Fístula Arterio-Arterial/terapia , Anomalías de los Vasos Coronarios/diagnóstico , Anomalías de los Vasos Coronarios/terapia , Adulto , Factores de Edad , Fístula Arterio-Arterial/epidemiología , Procedimientos Quirúrgicos Cardíacos , Niño , Anomalías de los Vasos Coronarios/epidemiología , Embolización Terapéutica , Humanos , Ligadura , Resultado del Tratamiento
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