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AIMS: This ANSWER (EvaluAtioN of the SafeR mode in patients With a dual chambER pacemaker indication) sub-study assesses safety and effectiveness of SafeR™ and the impact of ventricular pacing (VP) prevention on anticipated device longevity and replacement rate. METHODS AND RESULTS: Patients implanted for atrioventricular block (AVB, n = 310) or sinus node dysfunction (SND, n = 336) were randomly assigned to SafeR (n = 314) or DDD (n = 318) and followed for 36 months. Safety, median VP, estimated device longevity (mean difference, 95% confidence interval [CI]), and anticipated replacement rates were analysed by pacing mode and implant indication. No difference in mortality, syncope, or mode intolerance was observed between randomization groups regardless of the indication. Ventricular pacing on SafeR vs. DDD was 11.5 vs. 93.6% in the overall population (P < 0.001), 89.2 vs. 83.8% in permanent AVB (P = 0.944), 53.5 vs. 98.2% in intermittent AVB (P < 0.001), and 2.2 vs. 84.7% in SND (P < 0.001). Anticipated median device longevity increased on SafeR by 14 [Q1 10; Q3 17] months [10; 17] (P < 0.001) in the overall population, 9 months [-5; 22] (P = 0.193) in permanent AVB, 14 months [8; 19] (P < 0.001) in intermittent AVB, and 14 months [9; 19] (P < 0.001) in SND. In intermittent AVB and SND, prolonged estimated battery longevity translated into the prevention of one anticipated replacement in at least 23% of patients. CONCLUSION: SafeR was effective in reducing VP in intermittent AVB and in SND. No effect was observed in permanent AVB. No safety issue was observed. Ventricular pacing reduction by SafeR translated into relevant estimated prolongation of device longevity and anticipated reduction of required replacements.
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Bloqueo Atrioventricular/terapia , Estimulación Cardíaca Artificial/métodos , Diseño de Equipo/métodos , Marcapaso Artificial/efectos adversos , Síndrome del Seno Enfermo/terapia , Anciano , Anciano de 80 o más Años , Estimulación Cardíaca Artificial/efectos adversos , Suministros de Energía Eléctrica , Europa (Continente) , Femenino , Ventrículos Cardíacos/fisiopatología , Humanos , Masculino , Persona de Mediana Edad , Marcapaso Artificial/clasificación , Estudios Prospectivos , Método Simple Ciego , Resultado del TratamientoRESUMEN
BACKGROUND: Patient self reported measures for Health Related Quality of Life (HRQOL) and mental distress are frequently used to evaluate outcome of therapeutic strategies in cardiac patients.Our study aims to describe changes in HRQOL and mental distress after percutaneous coronary intervention (PCI) focusing on temporal pattern of change and interdependences between both outcome measures. METHOD: 163 PCI patients recruited at 7 cardiovascular care units in Austria answered MacNew Health Related Quality of Life and Hospital Anxiety and Depression Scale (HADS) questionnaires during hospital stay after intervention and at 1, 6, 12 and 24 months. RESULTS: Improvement of MacNew HRQOL was found up to 6 month after PCI. Mental distress declined during the first month of the follow-up period. MacNew HRQOL is negatively correlated to mental distress. The relationship could be well described by a linear regression with MacNew HRQOL as dependent and HADS Total score as independent variable. The explained variance (R2) of the regression equation increases drastically from 45% at the baseline to a level between 67% and 77% in the follow up. CONCLUSION: Our data suggest that the regression equation describing the relation between MacNew HRQOL and HADS-Total score six month after PCI defines a state of equilibrium: In absence of actual symptoms of coronary artery disease (CAD) both measures reflect the general health status and the general attitude underlying the self-assessment of health. At the baseline this equilibrium is imbalanced because the symptoms of CAD have a more pronounced impact on the disease specific MacNew HRQOL measure than on the non-disease specific HADS measure for mental distress. In order to use the MacNew questionnaire as a monitoring and/or prognostic tool it seems promising to refer to the state of equilibrium to define expectancy values for successful treatment.
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Enfermedad de la Arteria Coronaria/cirugía , Stents Liberadores de Fármacos/psicología , Estado de Salud , Calidad de Vida , Estrés Psicológico , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Austria , Enfermedad de la Arteria Coronaria/psicología , Femenino , Humanos , Modelos Lineales , Masculino , Persona de Mediana Edad , Evaluación de Resultado en la Atención de Salud/métodos , Encuestas y Cuestionarios , Adulto JovenRESUMEN
OBJECTIVE: To examine patient-reported causal attributions in patients with coronary artery disease and classify them according to attribution theory. DESIGN: Patients with angiographically verified coronary artery disease (n = 459) were asked to report causal attributions by answering the respective open-ended item of the Brief Illness Perception Questionnaire. MAIN OUTCOME MEASURES: Groups resulting from classifications were characterised with regard to sociodemographic and clinical variables, Quality of Life (SF-12), depression (PHQ-9), anxiety (GAD-7), and illness perception (BIPQ). RESULTS: Stress emerged as the single most important attribution followed by various behavioural factors and genetic predisposition. There was a remarkable mismatch between the presence of modifiable risk factors (smoking, obesity) and patient-reported illness attributions. Based on the results of the descriptive categorisation of illness attributions we developed a transparent, easily reproducible scheme for dimensional classification of the fifteen most common responses according to attribution theory. The classification resulted in four groups: Behaviour/Emotional State, Past Behaviour/Emotional State, Physical/Psychological Trait and External. CONCLUSION: We found a pattern of illness attributions largely in line with previous trials. The dimensional classification resulted in four groups and highlighted potential entry points for physician-patient communication aimed at establishing beneficial disease self-management.
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Enfermedad de la Arteria Coronaria , Ansiedad , Enfermedad de la Arteria Coronaria/psicología , Humanos , Calidad de Vida/psicología , Percepción Social , Encuestas y CuestionariosRESUMEN
BACKGROUND: Randomised controlled trials have shown diverse results for radial access in patients undergoing primary percutaneous coronary intervention (PPCI). Moreover, it is questionable whether radial access improves outcome in patients with cardiogenic shock undergoing PPCI. We aimed to investigate the outcome according to access site in patients with or without cardiogenic shock, in daily clinical practice. METHODS: For the present analysis we included 9,980 patients undergoing PPCI between 2012 and 2018, registered in the multi-centre, nationwide registry on PCI for myocardial infarction (MI). In-hospital mortality, major adverse cardiovascular events (MACE), and net adverse clinical events (NACE) until discharge were compared between 4,498 patients with radial (45%) and 5,482 patients with femoral (55%) access. RESULTS: Radial compared to femoral access was associated with lower in-hospital mortality (3.5% vs. 7.7%; P<0.01). Multivariable logistic regression analysis confirmed reduced in-hospital mortality [odds ratio (OR) 0.57, 95% confidence interval (CI): 0.43 to 0.75]. Furthermore, MACE (OR 0.60, 95% CI: 0.47 to 0.78) as well as NACE (OR 0.59, 95% CI: 0.46 to 0.75) occurred less frequently in patients with radial access. Interaction analysis with cardiogenic shock showed an effect modification, resulting in lower mortality in PCI via radial access in patients without, but no difference in those with cardiogenic shock (OR 1.78, 95% CI: 1.07 to 2.96). CONCLUSIONS: Radial access for patients with acute MI undergoing PPCI is associated with improved survival in a large contemporary cohort of daily practice. However, this beneficial effect is restricted to hemodynamically stable patients.
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We report on a 29-year-old man who underwent an ablation procedure for a focal atrial tachycardia. Three-dimensional mapping located the site of origin to the ostium of the right inferior pulmonary vein. By using a novel multi-electrode duty cycled ablation catheter, pulmonary vein isolation and elimination of tachycardia was achieved.
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Ablación por Catéter/instrumentación , Ablación por Catéter/métodos , Atrios Cardíacos/fisiopatología , Venas Pulmonares/cirugía , Taquicardia/cirugía , Adulto , Electrocardiografía Ambulatoria , Electrodos , Fluoroscopía , Atrios Cardíacos/cirugía , Humanos , Masculino , Prevención Secundaria , Taquicardia/prevención & control , Resultado del TratamientoRESUMEN
BACKGROUND In recent years, a series of studies have investigated long-term outcome of rotational atherectomy (RA). However, only little attention was given to the procedural details of RA technique, especially with regard to platform speed. AIMS The aim of the study was to evaluate the impact of low-speed RA with substantial debulking before stenting on long-term mortality. METHODS A group of 356 patients with a high plaque burden underwent substantial debulking with RA with low platform speed of 135 000 rpm and was compared with a group of 553 patients treated without RA in the same time period. In both cohorts lesion preparation was followed by stent implantation. The endpoint was all-cause mortality up to 80 months with a mean (SD) follow-up of 49 (24) months. RESULTS Despite the fact that patients treated with RA were significantly older and presented more unfavorable lesion characteristics than non-RA patients, there was no significant difference in long-term survival between groups. A propensity analysis with 279 matched pairs showed that long-time survival in RA patients was better than in non-RA patients (hazard ratio, 0.52; CI, 0.32-0.85; P <0.01). CONCLUSIONS Substantial debulking with RA continues to play a role in the treatment of calcified coronary arteries. We hypothesize that RA with low platform speed and substantial debulking with a burr-to-artery ratio of up to 0.64 results in favorable long-time survival in patients with high plaque burden. However, this can only be proved in a prospective randomized trial.
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Aterectomía Coronaria , Enfermedad de la Arteria Coronaria/cirugía , Procedimientos Quirúrgicos de Citorreducción , Placa Aterosclerótica/cirugía , Anciano , Anciano de 80 o más Años , Enfermedad de la Arteria Coronaria/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Placa Aterosclerótica/mortalidad , Estudios Retrospectivos , Stents , Resultado del TratamientoAsunto(s)
Angiografía Coronaria/efectos adversos , Estenosis Coronaria/diagnóstico por imagen , Radiodermatitis/diagnóstico , Radiodermatitis/etiología , Acetanilidas/uso terapéutico , Anciano , Relación Dosis-Respuesta a Droga , Inhibidores Enzimáticos/uso terapéutico , Humanos , Masculino , Piperazinas/uso terapéutico , Radiodermatitis/tratamiento farmacológico , Ranolazina , Resultado del TratamientoRESUMEN
OBJECTIVE: The study aimed to assess the subjectively perceived need for additional general disease-oriented and psychotherapeutic care in patients with suspected cardiac disease and to investigate if the request for additional care is consistent with impairment of generic quality of life and the presence of psychosomatic risk factors. MATERIAL AND METHODS: Patients referred for cardiac stress testing because of suspected cardiac disease completed the assessment of the demand for additional psychological treatment (ADAPT) questionnaire, an assessment tool for counselling demand in patients with chronic illness, the SF-36 quality of life and the hospital anxiety and depression scale (HADS) questionnaires. RESULTS: The questionnaires were administered to 233 patients (age: 54.5 ± 13.4, 57.5 % male). Exclusive demand for disease-oriented counselling was indicated by 45.1 %, demand for psychotherapeutic counselling (exclusive or combined with disease-oriented demand) by 33.9 %. Almost all patients with psychotherapeutic demand (96.3 %) expressed also request for disease-oriented counselling. Patients with exclusive demand for disease-oriented counselling showed significantly lower scores in the emotional and physical functioning and role domains of the SF-36 than the norm population. Patients demanding psychotherapeutic counselling reported significantly lower scores in all SF-36 domains than the norm population. Psychotherapeutic demand was strongly associated with positive indicators for mental distress: SF-36 MH (OR: 4.1), SF-36 MCS (OR: 5.9), HADS anxiety (OR: 3.9), and HADS depression (OR: 3.0). CONCLUSIONS: Our study shows that the patients' request for additional care reflects impairment of generic health status and psychological risk load. This indicates that the assessment of subjectively perceived demand allows to screen for patients who are in need of psychosomatic care and motivated to participate in additional counselling and therapy.
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Enfermedad de la Arteria Coronaria/epidemiología , Enfermedad de la Arteria Coronaria/psicología , Evaluación de Necesidades , Trastornos Psicofisiológicos/epidemiología , Trastornos Psicofisiológicos/psicología , Calidad de Vida/psicología , Austria , Causalidad , Comorbilidad , Enfermedad de la Arteria Coronaria/diagnóstico , Consejo Dirigido/estadística & datos numéricos , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Técnicas Proyectivas/estadística & datos numéricos , Trastornos Psicofisiológicos/diagnóstico , Factores de Riesgo , Distribución por Sexo , Encuestas y CuestionariosRESUMEN
The interest in rotational atherectomy (RA) has increased over the past decade as a consequence of more complex and calcified coronary stenoses being attempted with percutaneous coronary interventions. Yet adoption of RA is hampered by several factors: amongst others, by the lack of a standardised protocol. This European expert consensus document stems from the awareness of the large heterogeneity in the protocols adopted to perform rotational atherectomy. The objective of the present document is to provide some points of consensus among highly experienced operators on the most controversial steps of RA in an attempt to build the basis of a standardised and universally accepted protocol.
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Aterectomía Coronaria/normas , Estenosis Coronaria/terapia , Calcificación Vascular/terapia , Aterectomía Coronaria/efectos adversos , Consenso , Estenosis Coronaria/diagnóstico , Humanos , Pautas de la Práctica en Medicina/normas , Resultado del Tratamiento , Calcificación Vascular/diagnósticoRESUMEN
BACKGROUND: Apart from pulmonary vein isolation, catheter ablation of atrial fibrillation (AF) lacks reliable electrophysiological endpoints. The present study investigated the prognostic value of changes in AF inducibility due to ablation. METHODS: Between 10/2006 and 10/2009 121 patients referred for catheter ablation of symptomatic, drug refractory paroxysmal AF were included. Sinus rhythm immediately before ablation was a prerequisite for study entry. Two respective attempts to induce AF (>1min) by decremental coronary sinus stimulation before and after ablation were performed. RESULTS: A total of 121 patients aged 59.5±10.4years undergoing pulmonary vein isolation due to paroxysmal AF were included. The median follow-up duration was 12.1months [quartiles: 6.5-20.3months]. In 36 (30%) patients AF was inducible before, but not after ablation. Forty-nine (41%) patients were neither inducible before nor after the procedure, whereas 25 patients (21%) displayed unchanged inducibility. In 11 patients (9%) AF was inducible only after ablation. Patients with inducibility solely after the ablation had the highest risk of AF recurrence (HR 6.71 [95%-CI 2.76-16.30], p=0.0005) compared to patients without inducibility before and after the procedure. CONCLUSION: The results of attempted AF induction before and after ablation have significance with respect to ablation outcome. Both patient groups with either unchanged inducibility or facilitated induction after ablation had the highest recurrence rates of AF.