Wieneke Vlastra

Anxiety levels of patients undergoing coronary procedures in the catheterization laboratory

BACKGROUND High levels of anxiety are associated with worse outcomes in coronary artery disease patients. Little is known about anxiety levels in patients undergoing coronary procedures. Our objective is to examine the levels of anxiety in patients undergoing coronary angiography (CAG) or percutaneous coronary intervention (PCI) during the different phases of hospital stay and to evaluate which patient characteristics are associated with increased anxiety. METHODS Patients undergoing CAG or PCI between April 2009 and April 2010 were included in this prospective cohort study. Anxiety levels were measured using the self reported Visual Analogue Scale (VAS) of Anxiety, ranging from 0 to 100. VAS anxiety scores were obtained at hospital intake, pre- and post-procedure, and at hospital discharge. Multivariate linear regression analyses were performed to assess correlations between baseline characteristics and anxiety levels at the different time points. RESULTS In total 2604 patients were included, with 70.4% male participants with a mean age of 65±12years. VAS anxiety scores were highest pre-procedure (44.2±27.0mm). Female patients reported a significantly higher pre procedure VAS anxiety score (50.4±26.5) compared to males (41.5±26.8, p=0.02). Other factors associated with higher levels of anxiety at different time points were age<65years, low level of education and an acute primary PCI. CONCLUSION In the largest cohort to date, we examined anxiety among patients undergoing PCI or CAG was highest immediately around the procedure, particularly in patients aged <65years, of female gender, undergoing primary PCI, or with a lower level of education. Better pre-procedural information or pharmacological strategies may reduce anxiety in these patients.

Efficacy of the RADPAD Protection Drape in Reducing Operators' Radiation Exposure in the Catheterization Laboratory: A Sham-Controlled Randomized Trial

Background— Interventional cardiologists are increasingly exposed to radiation-induced diseases like cataract and the stochastic risk of left-sided brain tumors. The RADPAD is a sterile, disposable, lead-free shield placed on the patient with the aim to minimize operator-received scatter radiation. The objective of the trial was to examine the RADPAD’s efficacy in a real-world situation. Methods and Results— In the current, double-blind, sham-controlled, all-comer trial, patients undergoing diagnostic catheterization or percutaneous coronary interventions were randomized in a 1:1:1 ratio to a radiation absorbing shield (RADPAD), standard treatment (NOPAD), or a sham shield (SHAMPAD). The sham shield allowed testing for shield-induced radiation behavior. The primary outcome was the difference in relative exposure of the primary operator between the RADPAD and NOPAD arms and was defined as the ratio between operator’s exposure (E in µSv) and patient exposure (dose area product in mGy·cm2), measured per procedure. A total of 766 consecutive coronary procedures were randomized to the use of RADPAD (N=255), NOPAD (N=255), or SHAMPAD (N=256). The use of RADPAD was associated with a 20% reduction in relative operator exposure compared with that of NOPAD (P=0.01) and a 44% relative exposure reduction compared with the use of a SHAMPAD (P<0.001). Use of the SHAMPAD was associated with a 43% higher relative radiation exposure than procedures with NOPAD (P=0.009). Conclusions— In clinical daily practice, the standard use of the RADPAD radiation shield reduced operator radiation exposure compared with procedures with NOPAD or SHAMPAD. This study supports the routine use of RADPAD in the catheterization laboratory. Clinical Trial Registration— URL: https://www.clinicaltrials.gov. Unique identifier: NCT03139968.

Long-term left ventricular remodelling after revascularisation for ST-segment elevation myocardial infarction as assessed by cardiac magnetic resonance imaging

Objective Left ventricular remodelling following a ST-segment elevated myocardial infarction (STEMI) is an adaptive response to maintain the cardiac output despite myocardial tissue loss. Limited studies have evaluated long term ventricular function using cardiac magnetic resonance imaging (CMR) after STEMI. Methods Study population consisted of 155 primary percutaneous coronary intervention treated first STEMI patients. CMR was performed at 4±2 days, 4 months and 24 months follow-up. Patients were treated with beta-blockers, ACE-inhibitors or AT-II- inhibitors, statins and dual antiplatelet according to current international guidelines. Results Mean left ventricular ejection fraction (LVEF) at baseline was 44%±8%. Twenty-one per cent of the study population had an increase of more than 5.0% after 4 months of follow-up and 21% of the cohort had a decrease of more than 5.0%. Patients with long-term LVEF deterioration have significantly larger end-systolic volumes than patients with improvement of LVEF (61±23 mL/m2 compared with 52±21 mL/m2, p=0.02) and less wall thickening in the remote zone. Patients with LVEF improvement had significantly greater improvement in wall thickening in the infarct areas and in the non-infarct or remote zone. Conclusion Contrary to previous studies, we demonstrate that myocardial remodelling after STEMI is a long-term process. Long-term LVEF deterioration is characterised by an increase in end-systolic volume and less wall thickening in the remote zones. Patients with LVEF improvement exhibit an increase in left ventricular wall thickening both in the infarct as well as in the remote zones. Trial registration The HEBE study is registered in The Netherlands Trial Register #NTR166 (www.trialregister.nl) and the International Standard Randomised Controlled Trial, #ISRCTN95796863 (https://c-d-qn9pqajji.sec.amc.nl).

Cerebral protection devices during transcatheter aortic valve implantation

Transcatheter aortic valve implantation (TAVI) in patients with aortic valve stenosis is associated with an improvement of clinical outcomes, quality of life, and self-sufficiency. The most feared TAVI-related complication is the occurrence of stroke. In order to reduce peri-procedural cerebral embolizations, diverse cerebral protection devices have been developed. These devices work though deflection or filtering of emboli, and are in different stages of testing. Silent cerebral infarctions identified by diffusion-weighted magnetic resonance imaging (DW-MRI) are used as surrogate primary outcomes, but the clinical significance is still unclear. This review provides a synopsis of the diverse cerebral protection devices and summarizes the current evidence on their efficacy during TAVI.

The current status of antiplatelet therapy in patients undergoing transcatheter aortic valve implantation

Transcatheter aortic valve implantation (TAVI) is a minimally invasive and life-saving treatment in patients with aortic valve stenosis. As a consequence of increased operator experience and the refinement of valve technology, the target population of TAVI has rapidly expanded from inoperable patients to individuals with an intermediate risk score (1-3).

Premedication to reduce anxiety in patients undergoing coronary angiography and percutaneous coronary intervention

Aims In this study, we examined the effects of the routinely administration of benzodiazepines on reducing periprocedural anxiety versus no premedication. Methods In this open label study, we enrolled 1683 patients undergoing diagnostic coronary angiograms (CAG) or percutaneous coronary interventions (PCI). Randomisation was simulated by systematically allocating patients in monthly rotational periods to lorazepam 1  mg/sl, oxazepam 10  mg/po, diazepam 5  mg/po, midazolam 7.5  mg/po or no premedication. Anxiety was measured at four different time points using the one-item Visual Analogue Scale for Anxiety (VAS score) ranging from 0 to 10. The primary outcome was the difference in anxiety reduction (ΔVAS, preprocedure to postprocedure), between the different premedication strategies versus no premedication. Results Anxiety reduction was larger in patients premedicated with lorazepam (ΔVAS=−2.0, SE=1.6, P=0.007) or diazepam (ΔVAS=−2.0, SE=1.5, p=0.003) compared with patients without any premedication (ΔVAS=−1.4, SE=1.2). The use of midazolam or oxazepam did not lead to a significant reduction in anxiety compared with patients who did not receive premedication. Additionally, a high number of patients treated with midazolam (N=39, 19.8%) developed side effects. Conclusions In this study, the use of lorazepam or diazepam was associated with a significant, but modest anxiety reduction in patients undergoing CAG or PCI. This study does not support the standard use of oxazepam or midazolam as premedication to reduce anxiety.

CT determined psoas muscle area predicts mortality in women undergoing transcatheter aortic valve implantation

The aim of this study was to assess the predictive value of PMA measurement for mortality.

Antiplatelet Strategies in Patients Undergoing Transcatheter Aortic Valve Implantation–Data Sharing Is Caring

Por fortuna, en la medicina cardiovascular occidental moderna, las complicaciones graves tras las intervenciones clı́nicas son relativamente raras. Desde un punto de vista epidemiológico, estas tasas de eventos bajas quizá resulten menos cómodas. Los investigadores necesitan grandes inversiones para llevar a cabo ensayos clı́nicos con la potencia estadı́stica suficiente. Por consiguiente, en la continua búsqueda de datos basados en la evidencia, se han desarrollado estrategias metodológicas alternativas destinadas a abordar estas tasas de eventos bajas y aumentar la potencia estadı́stica. El primer enfoque consiste en cambiar el objetivo clı́nico principal y utilizar un objetivo indirecto que lo sustituya. Los objetivos indirectos se emplean con frecuencia en los estudios exploratorios de generación de hipótesis. Se plantea la hipótesis de que, si una estrategia terapéutica concreta influye favorablemente en un factor de riesgo cardiovascular (por ejemplo, la presión arterial o un determinado biomarcador), esto puede reducir los eventos clı́nicos (muerte, ictus, infarto de miocardio). Una segunda estrategia frecuente es el uso de objetivos combinados como criterio de valoración principal. La principal ventaja de emplear estos objetivos es la eficacia estadı́stica (menor tamaño muestral, resultados del estudio disponibles más pronto); además puede definirse una medida de resumen de la eficacia. Una de las limitaciones de los objetivos combinados es que pueden ocultar otro resultado negativo. Estas primeras 2 opciones hacen posibles las comparaciones estadı́sticas al aumentar la incidencia absoluta de eventos. Una tercera opción que resulta útil es ampliar el tamaño total de la población mediante la combinación de toda la evidencia disponible. El planteamiento de alcanzar un objetivo superior combinando datos se corresponde con la tendencia actual a compartir y analizar colectivamente los resultados de las diversas comunidades investigadoras. Se puede alentar con firmeza la cooperación de distintos centros de estudio, ya que aumenta el tamaño muestral y también la validez de los resultados de los estudios individuales. En este artı́culo editorial se evalúa la evidencia actual sobre las estrategias de tratamiento antiagregante plaquetario tras el implante percutáneo de válvula aórtica (TAVI), combinada de los registros y los datos de ensayos controlados y aleatorizados (ECA). Siguiendo la tendencia de la medicina moderna, el TAVI es actualmente una intervención relativamente segura, con unas tasas bajas de complicaciones graves. Sin embargo, estos resultados graves muy poco frecuentes se asocian con un aumento de morbilidad y mortalidad, y por consiguiente requieren estrategias de tratamiento apropiadas. Dos de las complicaciones más temidas asociadas al TAVI son los eventos tromboembólicos y hemorrágicos. El infarto de miocardio se da en un 1% del total de pacientes en los primeros 30 dı́as siguientes al TAVI. El ictus después de un TAVI, incluido el accidente isquémico transitorio (AIT), se da con una frecuencia superior (5-6%). Estos ictus clı́nicos parecen ser la punta del iceberg de la carga de embolización cerebral real asociada con el TAVI. La resonancia magnética cerebral con ponderación de difusión realizada en la primera semana tras el TAVI muestra nuevas lesiones isquémicas en 3/ 4 pacientes tratados con TAVI, con un promedio de 4 lesiones por paciente, dispersas por todas las regiones cerebrales. No obstante, continúa sin estar clara su trascendencia clı́nica. En esta población anciana y frágil tratada con TAVI, el ictus se asocia a un aumento de 3,5 veces en la mortalidad los primeros 30 dı́as tras la intervención. Para reducir estos eventos trombóticos, las actuales guı́as basadas en la opinión de expertos recomiendan de 3 a 6 meses de tratamiento antiagregante plaquetario doble (TAPD) después del TAVI. El motivo que subyace al TAPD periintervención deriva principalmente de la práctica habitual en las intervenciones coronarias percutáneas. Además, al inicio del empleo del TAVI se temı́a que el apoyo hemodinámico con circulación extracorpórea indujera la activación y el consumo de plaquetas. Sin embargo, hoy el apoyo hemodinámico extracorpóreo apenas se emplea durante el TAVI. Por otro lado, el empleo inicial de sistemas de aplicación y catéteres de gran tamaño para el TAVI en combinación con fármacos antitrombóticos se asociaba con un riesgo de complicaciones hemorrágicas considerable. Se han descrito hemorragias en un 41% de los pacientes después del TAVI, la mayorı́a de ellas definidas como hemorragias mayores (22%) Rev Esp Cardiol. 2018;71(4):240–242