Estudio de la transferencia directa para angioplastia primaria en pacientes con infarto de miocardio con elevación del segmento ST : efecto en los retrasos temporales y en el pronóstico

[Resumo] Este tese doctoral recolle o análisis de 1.194 pacientes con infarto de miocardio con elevación do segmento ST (IAMEST) tratados mediante anxioplastia primaria (AP) dentro do programa galego de atención ó infarto de miocardio (PROGALIAM), dos cales 255 foron trasladados directamente ó laboratorio de hemodinámica tras establecer o diagnóstico de sospeita. O resto dos pacientes foron levados en primeira estancia a calquera dos departamentos de emerxencias dos hospitais que compoñen a nosa rede de infarto. A transferencia directa asociouse cunha redución significativa dos atrasos temporais implicados na AP, tanto no tempo contacto-balón como no tempo total de isquemia, observando una reducción maior naqueles pacientes procedentes de hospitais non intervencionistas. Os pacientes que recibiron a transferencia directa tiveron menor mortalidade que os que foron atendidos nos departamentos de emerxencias dos hospitais máis próximos, tanto a 30 días, como a 6 meses e ó final do seguimento (que foi de 2,6 anos). Nunha análise de subgrupos observamos que houbo un efecto significativo e beneficioso da transferencia directa, en termos de pronóstico, en pacientes con infarto anterior e presentación precoz (<2 horas). Estes resultados levannos a concluír que se trata dunha estratexia segura e eficaz reducindo os atrasos temporais e que se asocia además a un mellor pronóstico.[Resumen] Esta tesis doctoral recoge el análisis de 1194 pacientes con infarto agudo de miocardio con elevación del segmento ST (IAMEST) tratados mediante angioplastia primaria (AP) dentro del programa gallego de atención al infarto de miocardio (PROGALIAM), de los cuales 255 fueron trasladados directamente a la sala de hemodinámica tras establecer el diagnóstico de sospecha. El grupo restante fue derivado en primera estancia a alguno de los departamentos de urgencias de los hospitales que integran nuestra red de infarto. La transferencia directa se asoció con una reducción significativa de los retrasos temporales implicados en la realización de AP, tanto en el tiempo contacto-balón como en el tiempo total de isquemia, y sobre todo en los pacientes que provenían de hospitales no intervencionistas. Los pacientes que recibieron el traslado directo experimentaron una menor mortalidad que aquellos que acudieron o fueron llevados al servicio de urgencias del hospital más cercano tanto a 30 días, como a 6 meses y al final del seguimiento (que fue de 2,6 años). En un análisis de subgrupos observamos que existía un efecto beneficioso y significativo, en cuanto al pronóstico, en aquellos pacientes con infarto anterior y presentación precoz (<2 horas). Estos resultados nos hacen concluir que es una estrategia segura y eficaz disminuyendo los retrasos temporales y que además que se asocia a un mejor pronóstico.[Abstract] This thesis shows the analysis of 1194 patients with ST-segment elevation myocardial infarction (STEMI) treated by means of primary percutaneous coronary intervention (PPCI) within the Galician program of myocardial infarction (PROGALIAM). From that group 255 patients were transferred directly to the catheterization laboratory. The remaining group was derived in first stay at any of the emergency departments of hospitals that make up our STEMI network. Direct transfer was associated with a significant reduction of time delays involved in PPCI (both contact-to-balloon and total ischemic time intervals). The benefit was greater in those patients referred from noninterventional hospitals. Patients receiving direct transfer experienced lower mortality than those who came or were brought to the emergency room of the nearest hospital at 30-day, 6-month and at the end of follow-up (2.6 years). In a subgroup analysis we observe that there was a significant and beneficial effect, in terms of prognosis, in patients with anterior wall myocardial infarction and early presentation (<2 hours). These results allow us to conclude that direct transfer is as safe and effective strategy in reducing time delays associated with PPCI and that improves prognosis of patients with STEMI

Percutaneous Treatment of Mitral and Tricuspid Regurgitation in Heart Failure

Heart failure has become a real epidemic condition related to poor outcomes despite advances in medical therapies. Prevalence of significant mitral and/or tricuspid regurgitation is high in patients with advanced heart failure. Novel transcatheter techniques have recently emerged as a minimally invasive alternative in patients deemed high-risk for surgery or inoperable. Among them, MitraClip® system is thus far the first device that received regulatory approval and gained widespread clinical application, especially in patients with functional mitral regurgitation. Furthermore, first experiences with new devices for percutaneous mitral and tricuspid valves repair, and transcatheter mitral valve prosthesis have been increasingly reported. Percutaneous therapies for valvular heart disease have therefore become one of the most promising fields in the present and future of interventional cardiology and heart failure

Acceso transcava como solución al implante de TAVI en pacientes con acceso vascular complejo

TAVI implantation has become the best treatment option in high-risk patients with severe aortic stenosis. Sometimes the limiting factor is the access route to get the prosthesis into place. With this brief clinical case we show how the transcaval implant is an option that can solve these complex cases.El implante de TAVI se ha convertido en la primera opción de tratamiento en pacientes con estenosis aórtica severa de alto riesgo. Muchas veces el factor limitante es la ruta de acceso para llevar la prótesis a su lugar. Con este caso clínico breve mostramos cómo el implante transcava es una opción que puede resolver estos casos complejos.&nbsp

Percutaneous Treatment of Tricuspid Regurgitation

Tricuspid valve regurgitation is one of the most common valvular disorders and moderate to severe tricuspid regurgitation is consistently associated to an increased morbidity and mortality. From an etiopathological perspective, tricuspid regurgitation can be classified in primary, due to the organic disease of any of the valve components, or secondary, as a result of tricuspid valve annulus dilatation, adverse right ventricular remodeling and tricuspid valve leaflet tethering. Despite its poor prognosis, most patients with tricuspid insufficiency are managed conservatively and only those with concomitant left heart valvular disease do finally go surgery in the real-world setting. In fact, outcomes of conventional surgery in patients with isolated tricuspid regurgitation are poor and this approach has not proven yet any survival benefit over stand-alone medical therapy. Given this unmet need, new transcatheter techniques have been developed in the last years, including leaflet plication, percutaneous annuloplasty and valve implantation in either the tricuspid position (orthotopic implantation) or in a different position such as the vena cava (heterotopic implantation). These techniques, with promising outcomes, are seen as an interesting alternative to open-heart surgery given the much lower periprocedural risk

Development and Evaluation of a Disease Large Animal Model for Preclinical Assessment of Renal Denervation Therapies

[EN] New-generation catheters-based renal denervation (RDN) is under investigation for the treatment of uncontrolled hypertension (HTN). We assessed the feasibility of a large animal model of HTN to accommodate the human RDN devices. Ten minipigs were instrumented to measure blood pressure (BP) in an awake-state. HTN was induced with subcutaneous 11-deoxycorticosterone (DOCA, 100 mg/kg) implants. Five months after, the surviving animals underwent RDN with the Symplicity® system. Norepinephrine (NE) renal gradients were determined before and 1 month after RDN. Renal arteries were processed for histological (hematoxylin-eosin, Movat pentachrome) and immunohistochemical (S100, tyrosine-hydroxylase) analyses. BP significantly rose after DOCA implants. Six animals died prematurely, mainly from infectious causes. The surviving animals showed stable BP levels after 5 months. One month after RDN, nerve damage was showed in three animals, with impedance drop >10%, NE gradient drop and reduction in BP. The fourth animal showed no nerve damage, impedance drop <10%, NE gradient increase and no change in BP. In conclusion, the minipig model of DOCA-induced HTN is feasible, showing durable effects. High mortality should be addressed in next iterations of this model. RDN may partially offset the DOCA-induced HTN. Impedance drop and NE renal gradient could be markers of RDN success.SIThis research was funded by Consejería de Salud, Junta de Castilla and Leon, Spain, the Grant GRS 1001/A/2014.We want to thank Medtronic Iberia for the donation of the Symplicity catheters used in this experiment

Prevalence, etiology, and outcome of catheterization laboratory false alarms in patients with suspected ST-elevation myocardial infarction

[Abstract] Introduction and objectives. To investigate the prevalence, causes and outcome of catheterization laboratory false alarms (CLFAs) in a regional primary angioplasty network. Methods. A prospective registry of 1,662 patients referred for primary angioplasty between January 2003 and August 2008 was reviewed to identify CLFAs (i.e. when no culprit coronary lesion could be found). Results. No culprit coronary lesion could be identified in 120 patients (7.2%; 95% confidence interval [CI], 5.9- 8.5%). Of these, 104 (6.3%, 95% CI, 5.1-7.4%) had a discharge diagnosis other than ST-elevation myocardial infarction, 91 (5.5%; 95% CI, 4.3-6.6%) had no significant coronary disease, and 64 (3.8%; 95% CI, 2.9-4.8%) tested negative for cardiac biomarkers. The most frequent alternative diagnoses were: previous Q-wave myocardial infarction (18 cases), nonspecific ST-segment abnormalities (11), pericarditis (10) and transient apical dyskinesia (10). The 30-day mortality rate was similar in patients with and without culprit lesions (5.8% vs. 5.8%; P=.99). The prevalence of CLFAs was slightly higher in patients not previously evaluated by a cardiologist and referred from emergency departments in hospitals without catheterization laboratories than in those referred by cardiologists from emergency departments at hospitals with such facilities (9.5% vs. 6.1%; P=.02; odds ratio=1.64; 95% CI, 1.08-2.5). The prevalence of CLFAs was not significantly higher in patients referred by physicians with out-of-hospital emergency medical services (7.2%; P=.51; odds ratio=1.37; 95% CI, 0.79-2.37). Conclusions. The prevalence of CLFAs was 7.2%, with the criterion of no culprit coronary lesion. Our findings suggest that different patterns of referral to catheterization laboratories could account for small variations in the prevalence of CLFAs.[Resumen] Introducción y objetivos. Determinar prevalencia, causas y pronóstico de las «falsas alarmas» al laboratorio de hemodinámica (FALH) en una red regional de angioplastia primaria. Métodos. Registro prospectivo de 1.662 pacientes remitidos para angioplastia primaria entre enero de 2003 y agosto de 2008. Se definió FALH como ausencia de lesión coronaria causal. Resultados. En 120 pacientes (7,2%; intervalo de confianza [IC] del 95%, 5,9-8,5) no se identificó ninguna lesión coronaria causal. De ellos, 104 (6,3%; IC del 95%, 5,1-7,4) recibieron un diagnóstico alternativo a IAMCEST, 91 (5,5%; IC del 95%, 4,3-6,6) no presentaron enfermedad coronaria significativa y 64 (3,8%; IC del 95%, 2,9-4,8) presentaron marcadores de daño miocárdico negativos. Los diagnósticos alternativos más frecuentes fueron: infarto con onda Q previo (18 casos), alteraciones inespecíficas del segmento ST (11), pericarditis (10) y discinesia apical transitoria (10). La mortalidad a 30 días fue similar en los pacientes con y sin lesión causal (el 5,8 frente al 5,8%; p = 0,99). La prevalencia de FALH fue discretamente superior entre los pacientes remitidos desde los servicios de urgencias de hospitales no intervencionistas sin evaluación previa por un cardiólogo que entre los remitidos por cardiólogos desde el servicio de urgencias del hospital intervencionista (el 9,5 frente al 6,1%; p = 0,02; odds ratio [OR] = 1,64; IC del 95%, 1,08-2,5). No observamos un exceso de FALH entre los pacientes remitidos por médicos de UVI Móviles-061 (7,2%; p = 0,51; OR = 1,37; IC del 95%, 0,79-2,37). Conclusiones. Hemos observado una prevalencia de FALH del 7,2% de acuerdo con el criterio de ausencia de lesión coronaria causal. Nuestros resultados indican que diferentes modelos de activación del laboratorio de hemodinámica podrían justificar discretas variaciones en la prevalencia de FALH

Safety and Feasibility of MitraClip Implantation in Patients with Acute Mitral Regurgitation after Recent Myocardial Infarction and Severe Left Ventricle Dysfunction

Patients with severe mitral regurgitation (MR) after myocardial infarction (MI) have an increased risk of mortality. Transcatheter mitral valve repair may therefore be a suitable therapy. However, data on clinical outcomes of patients in an acute setting are scarce, especially those with reduced left ventricle (LV) dysfunction. We conducted a multinational, collaborative data analysis from 21 centers for patients who were, within 90 days of acute MI, treated with MitraClip due to severe MR. The cohort was divided according to median left ventricle ejection fraction (LVEF)-35%. Included in the study were 105 patients. The mean age was 71 ± 10 years. Patients in the LVEF \u3c 35% group were younger but with comparable Euroscore II, multivessel coronary artery disease, prior MI and coronary artery bypass graft surgery. Procedure time was comparable and acute success rate was high in both groups (94% vs. 90%, p = 0.728). MR grade was significantly reduced in both groups along with an immediate reduction in left atrial V-wave, pulmonary artery pressure and improvement in New York Heart Association (NYHA) class. In-hospital and 1-year mortality rates were not significantly different between the two groups (11% vs. 7%, p = 0.51 and 19% vs. 12%, p = 0.49) and neither was the 3-month re-hospitalization rate. In conclusion, MitraClip intervention in patients with acute severe functional mitral regurgitation (FMR) due to a recent MI in an acute setting is safe and feasible. Even patients with severe LV dysfunction may benefit from transcatheter mitral valve intervention and should not be excluded

Economic evaluation of complete revascularization versus stress echocardiography-guided revascularization in the STEACS with multivessel disease

[Resumen] Introducción y objetivos. Los estudios económicos pueden ayudar a tomar decisiones en el tratamiento de la enfermedad multivaso en el infarto. Se planteó realizar una evaluación económica del ensayo clínico CROSS-AMI (Complete Revascularization or Stress Echocardiography in Patients With Multivessel Disease and ST-Segment Elevation Acute Myocardial Infarction). Métodos. Se realizó un análisis de comparación de costes económicos de las estrategias (revascularización angiográfica completa [RCom] y revascularización selectiva guiada por isquemia en ecocardiograma de estrés [RSel]) comparadas en el ensayo clínico CROSS-AMI (N = 306), derivados de la hospitalización inicial y del primer año de seguimiento, según las tarifas oficiales vigentes en nuestro sistema de salud. Resultados. El coste de la hospitalización inicial resultó superior en el grupo de RCom que en la rama de RSel (19.657,9 ± 6.236,8 frente a 14.038,7 ± 4.958,5 euros; p < 0,001). No hubo diferencias entre ambos grupos en el coste del primer año de seguimiento (RCom, 2.423,5 ± 4.568,0 euros; Rsel, 2.653,9 ± 5.709,1 euros; p = 0,697). El coste total fue 22.081,3 ± 7.505,6 euros en la rama de RCom y 16.692,6 ± 7.669,9 euros en la rama de RSel (p < 0,001). Conclusiones. En el ensayo clínico CROSS-AMI, el sobrecoste inicial de la RCom frente a la RSel no se vio compensado por un ahorro significativo en el seguimiento. La RSel parece ser una estrategia más eficiente que la RCom para los pacientes con síndrome coronario agudo con elevación del segmento ST y enfermedad multivaso tratados mediante angioplastia emergente.[Abstract] 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

Impact of operatoŕs experience on peri-procedural outcomes with Watchman FLX: Insights from the FLX-SPA registry

Background: The Watchman FLX is a device upgrade of the Watchman 2.5 that incorporates several design enhancements intended to simplify left atrial appendage occlusion (LAAO) and improve procedural outcomes. This study compares peri-procedural results of LAAO with Watchman FLX (Boston Scientific, Marlborough, Massachusetts) in centers with varying degrees of experience with the Watchman 2.5 and Watchman FLX. Methods: Prospective, multicenter, 'real-world' registry including consecutive patients undergoing LAAO with the Watchman FLX at 26 Spanish sites (FLX-SPA registry). Implanting centers were classified according to the center's prior experience with the Watchman 2.5. A further division of centers according to whether or not they had performed ≤ 10 or > 10Watchman FLX implants was prespecified at the beginning of the study. Procedural outcomes of institutions stratified according to their experience with the Watchman 2.5 and FLX devices were compared. Results: 359 patients [mean age 75.5 (SD8.1), CHA2DS2-VASc 4.4 (SD1.4), HAS-BLED 3.8(SD0.9)] were included. Global success rate was 98.6%, successful LAAO with the first selected device size was achieved in 95.5% patients and the device was implanted at first attempt in 78.6% cases. There were only 9(2.5%) major peri-procedural complications. No differences in efficacy or safety results according to the centeŕs previous experience with Watchman 2.5 and procedural volume with Watchman FLX existed. Conclusions: The Watchman FLX attains high procedural success rates with complete LAA sealing in unselected, real-world patients, along with a low incidence of peri-procedural complications, regardless of operatoŕs experience with its previous device iteration or the number of Watchman FLX devices implanted