José Miguel Ormaetxe

Comparison of radiofrequency catheter ablation of drivers and circumferential pulmonary vein isolation in atrial fibrillation: a noninferiority randomized multicenter RADAR-AF trial.

BACKGROUND Empiric circumferential pulmonary vein isolation (CPVI) has become the therapy of choice for drug-refractory atrial fibrillation (AF). Although results are suboptimal, it is unknown whether mechanistically-based strategies targeting AF drivers are superior. OBJECTIVES This study sought to determine the efficacy and safety of localized high-frequency source ablation (HFSA) compared with CPVI in patients with drug-refractory AF. METHODS This prospective, multicenter, single-blinded study of 232 patients (age 53 ± 10 years, 186 males) randomized those with paroxysmal AF (n = 115) to CPVI or HFSA-only (noninferiority design) and those with persistent AF (n = 117) to CPVI or a combined ablation approach (CPVI + HFSA, superiority design). The primary endpoint was freedom from AF at 6 months post-first ablation procedure. Secondary endpoints included freedom from atrial tachyarrhythmias (AT) at 6 and 12 months, periprocedural complications, overall adverse events, and quality of life. RESULTS In paroxysmal AF, HFSA failed to achieve noninferiority at 6 months after a single procedure but, after redo procedures, was noninferior to CPVI at 12 months for freedom from AF and AF/AT. Serious adverse events were significantly reduced in the HFSA group versus CPVI patients (p = 0.02). In persistent AF, there were no significant differences between treatment groups for primary and secondary endpoints, but CPVI + HFSA trended toward more serious adverse events. CONCLUSIONS In paroxysmal AF, HFSA failed to achieve noninferiority at 6 months but was noninferior to CPVI at 1 year in achieving freedom of AF/AT and a lower incidence of severe adverse events. In persistent AF, CPVI + HFSA offered no incremental value. (Radiofrequency Ablation of Drivers of Atrial Fibrillation [RADAR-AF]; NCT00674401).

Development of a questionnaire to measure health-related quality of life (HRQoL) in patients with atrial fibrillation (AF-QoL)

BackgroundThe Health-Related Quality of Life (HRQoL) assessment in atrial fibrillation (AF) patients has traditionally been carried out in a poorly standardised fashion, or via the use of non disease-specific HRQoL questionnaires. The development of a HRQoL questionnaire with a good measuring performance will allow for a standardised assessment of the impact of this disease on the patients daily living.MethodsA bibliography review was conducted to identify the most relevant domains of daily living in AF patients. Subsequently, a focus group was created with the aid of cardiologists, and 17 patients were interviewed to identify the most-affected HRQoL domains. A qualitative analysis of the interview answers was performed, which was used to develop a pilot questionnaire administered to a 112-patient sample. Based on patient responses, an analysis was carried out following the statistical procedures defined by the Classical Test Theory (CTT) and the Item Response Theory (IRT). Reliablility was assessed via Cronbachs coefficient alpha and item-total score correlations. A factorial analysis was performed to determine the number of domains. For each domain, a Rasch analysis was carried out, in order to reduce and stand hierarchically the questionnaire items.ResultsBy way of the bibliography review and the expert focus group, 10 domains were identified. The patient interviews allowed for the identification of 286 items that later were downsized to 40 items. The resultant preliminary questionnaire was administered to a 112-patient sample (pilot study). The Rasch analysis led to the definition of two domains, comprising 7 and 11 items respectively, which corresponded to the psychological and physical domains (18 items total), thereby giving rise to the initial AF-QoL-18 questionnaire. Cronbachs coefficient alpha was acceptable (0.91).ConclusionAn initial HRQoL questionnaire, AFQoL-18, has been developed to assess HRQoL in AF patients.

Diferencias en la calidad de vida según el tipo de fibrilación auricular

Introduccion y objetivos La fibrilacion auricular (FA) es una de las arritmias mas frecuentes y se clasifica, segun su forma de presentacion, en paroxistica, persistente o permanente. Esta arritmia se ha relacionado con una disminucion de la calidad de vida relacionada con la salud (CVRS) de los pacientes. Recientemente, se ha disenado y validado el cuestionario Atrial Fibrillation-Quality of Life (AF-QoL), especifico para pacientes con FA. El objetivo de este estudio es analizar las posibles diferencias en la CVRS de los pacientes segun que tipo de FA presenten. Metodos Estudio observacional, prospectivo y multicentrico realizado en condiciones de practica clinica habitual en Espana. A los pacientes incluidos, diagnosticados de FA en cualquiera de sus tres tipos, se les aplico el cuestionario AF-QoL. Resultados Participaron en total 341 pacientes con FA. El 43% sufria FA persistente; el 37%, paroxistica y el 20%, permanente. Las puntuaciones totales del AF-QoL no mostraron diferencias significativas segun el tipo de FA, excepto en la dimension psicologica, en la que los pacientes con FA permanente presentaron una puntuacion mas alta (mejor CVRS). Se encontraron diferencias tambien en la CVRS de los pacientes con FA, asociadas con que tenian mas sintomas y visitas a urgencias y menos capacidad funcional. Conclusiones La CVRS de los pacientes con FA, analizada mediante el cuestionario especifico AF-QoL, no se veria afectada, excepto en su dimension psicologica, por el tipo de FA que presenten, sino por las propias caracteristicas clinicas de la enfermedad.

Spanish on Registry Implantable Cardioverter Defibrillator Second Official Report of the Spanish Society of Cardiology Working Group on Implantable Cardioverter Defibrillators (2005)

INTRODUCTION AND OBJECTIVE We report the results for the Spanish Registry on Implantable Cardioverter Defibrillators (ICD) (year 2005), developed by the Working Group on ICD of the Spanish Society of Cardiology. METHODS Data were collected (prospectively in 77% of implants) by single page form questionnaires transmitted after the procedure to the Spanish Society of Cardiology. Participation was voluntary. RESULTS The number of implants sent to the Registry was 2050 and this represents 74.4% of the total ICDs implanted. The implantation rate per million was 46.5 and the estimated total implantation rate per million was 62.5. The proportion of first implants was 70.3%. The majority of patients were males, with a median age of 65 years, severe or moderate to severe left ventricular dysfunction and in functional class II or I. Ischemic heart disease was the more frequent underlying heart disease followed by dilated cardiomyopathy. The main reason for ICD indication was secondary prevention related to sustained monomorphic ventricular tachycardia or aborted sudden cardiac death. A significant number of prophylactic indications were done, specially in non ischemic heart disease. The proportion of ICD implanted at the electrophysiology laboratory by cardiac electrophysiologist continues increasing. There was an increase in the number of ICD plus cardiac resynchronization therapy, that represent a 23.6% of the implants. The incidence of complications during the implant was very low. CONCLUSIONS The National Registry on ICD, with a participation rate greater than in previous years, provides a representative sample of the ICD implants performed at our country.

Enalapril-induced regression of hypertensive left ventricular hypertrophy regional ischemia, and microvascular angina

Abstract Our findings suggest that treatment of arterial hypertension with enalapril not only reduces LV mass, but also corrects microvascular ischemia and subsequent angina pectoris, and improves exercise performance.

Implantable Defibrillator Electrograms and Origin of Left Ventricular Impulses: An Analysis of Regionalization Ability and Visual Spatial Resolution

ICD Electrograms and Origin of Impulses. Introduction: The implantable cardioverter‐defibrillator (ICD) electrogram (EG) is a documentation of ventricular tachycardia. We prospectively analyzed EGs from ICD electrodes located at the right ventricle apex to establish (1) ability to regionalize origin of left ventricle (LV) impulses, and (2) spatial resolution to distinguish between paced sites. Methods and Results: LV electro‐anatomic maps were generated in 15 patients. ICD‐EGs were recorded during pacing from 22 ± 10 LV sites. Voltage of far‐field EG deflections (initial, peak, final) and time intervals between far‐field and bipolar EGs were measured. Blinded visual analysis was used for spatial resolution. Initial deflections were more negative and initial/peak ratios were larger for lateral versus septal and superior versus inferior sites. Time intervals were shorter for apical versus basal and septal versus lateral sites. Best predictive cutoff values were voltage of initial deflection <–1.24 mV, and initial/peak ratio >0.45 for a lateral site, voltage of final deflection <–0.30 for an inferior site, and time interval <80 milliseconds for an apical site. In a subsequent group of 9 patients, these values predicted correctly paced site location in 54–75% and tachycardia exit site in 60–100%. Recognition of paced sites as different by EG inspection was 91% accurate. Sensitivity increased with distance (0.96 if ≥ 2 cm vs 0.84 if < 2 cm, P  <  0.001) and with presence of low‐voltage tissue between sites (0.94 vs 0.88, P  <  0.001). Conclusions: Standard ICD‐EG analysis can help regionalize LV sites of impulse formation. It can accurately distinguish between 2 sites of impulse formation if they are ≥2 cm apart. (J Cardiovasc Electrophysiol, Vol. 23, pp. 506‐514, May 2012)

Transseptal Catheterization Using Electrophysiological Landmarks in Ablation Procedures

Since the development of radiofrequency catheter ablation for the treatment of atrial fibrillation, electrophysiology laboratories have experienced a significant rise in the number of transseptal catheterization procedures. Traditionally, the procedure requires the presence of a interventional cardiologist who carries out transseptal catheterization following arterial puncture and placement of a reference pigtail catheter in the aortic root. Use of His bundle and coronary sinus catheters to provide anatomical and electrophysiological landmarks enables transseptal catheterization to be carried out without the need for arterial puncture or intracavity pressure measurement. We report our experience with transseptal catheterization in an electrophysiology laboratory using only electrophysiological landmarks. The procedure was carried out on 68 occasions and was successful in all patients except one, in whom catheterization could not be performed for anatomical reasons and because the patient had previously received anticoagulation therapy. One other patient developed transient ST elevation, which was probably due to an air embolism.

Punción transeptal mediante referencias electrofisiológicas para procedimientos de ablación

Desde el desarrollo de la ablacion con radiofrecuencia para el tratamiento curativo de la fibrilacion auricular, los laboratorios de electrofisiologia han experimentado un incremento considerable en el numero de cateterismos transeptales. Tradicionalmente, el procedimiento requeria la intervencion de un hemodinamista que procedia a realizar el cateterismo transeptal previa puncion arterial y colocacion de un cateter pigtail de referencia en la raiz aortica. Utilizando el cateter del His y el del seno coronario como referencias anatomo-electrofisiologicas se puede llevar a cabo el cateterismo transeptal sin necesidad de realizar puncion arterial ni medicion de presiones intracavitarias. Presentamos nuestra experiencia en cateterizacion transeptal en el laboratorio de electrofisiologia utilizando referencias puramente electrofisiologicas. Hemos realizado el procedimiento en 68 ocasiones, con resultado exitoso en todos los casos salvo en uno, en el que la puncion no pudo llevarse a cabo por dificultades en el acceso anatomico y porque el paciente se encontraba previamente anticoagulado. Un paciente presento elevacion transitoria del segmento ST, probablemente debida a un embolismo aereo.

Comparison of Radiofrequency Catheter Ablation of Drivers and Circumferential Pulmonary Vein Isolation in Atrial Fibrillation

BACKGROUND Empiric circumferential pulmonary vein isolation (CPVI) has become the therapy of choice for drug-refractory atrial fibrillation (AF). Although results are suboptimal, it is unknown whether mechanistically-based strategies targeting AF drivers are superior. OBJECTIVES This study sought to determine the efficacy and safety of localized high-frequency source ablation (HFSA) compared with CPVI in patients with drug-refractory AF. METHODS This prospective, multicenter, single-blinded study of 232 patients (age 53 ± 10 years, 186 males) randomized those with paroxysmal AF (n = 115) to CPVI or HFSA-only (noninferiority design) and those with persistent AF (n = 117) to CPVI or a combined ablation approach (CPVI + HFSA, superiority design). The primary endpoint was freedom from AF at 6 months post-first ablation procedure. Secondary endpoints included freedom from atrial tachyarrhythmias (AT) at 6 and 12 months, periprocedural complications, overall adverse events, and quality of life. RESULTS In paroxysmal AF, HFSA failed to achieve noninferiority at 6 months after a single procedure but, after redo procedures, was noninferior to CPVI at 12 months for freedom from AF and AF/AT. Serious adverse events were significantly reduced in the HFSA group versus CPVI patients (p = 0.02). In persistent AF, there were no significant differences between treatment groups for primary and secondary endpoints, but CPVI + HFSA trended toward more serious adverse events. CONCLUSIONS In paroxysmal AF, HFSA failed to achieve noninferiority at 6 months but was noninferior to CPVI at 1 year in achieving freedom of AF/AT and a lower incidence of severe adverse events. In persistent AF, CPVI + HFSA offered no incremental value. (Radiofrequency Ablation of Drivers of Atrial Fibrillation [RADAR-AF]; NCT00674401).

Comments on the 2018 ESC Guidelines for the Diagnosis and Management of Syncope

The new syncope guidelines significantly increase the volume of information on how to diagnose and manage this entity, which is of considerable importance not only to cardiologists, but also to all physicians involved. A welcome addition is the incorporation of emergency specialists, neurologists, and geriatricians into the working group. The new document comprises 69 pages and 440 references vs the 41 pages and 213 references of the previous guidelines. The increase is even greater if one considers the new online section of additional material called ‘‘Practical Instructions’’. This material includes an extensive glossary that establishes a general vocabulary, a definition of criteria, and a description of techniques and management instructions. This hugely valuable supplement comprises 38 pages and 192 references. The recommendations continue to operate in an environment of pervasive uncertainty. Quantitatively, the number of recommendations has increased by 7%; however, 40% are level I (49% in 2009) and only 3% are level III (14% in 2009). Neither has the level of evidence changed substantially: only 5% of recommendations are level A (3% in 2009) and most–50%–are level C (52% in 2009). In addition to specific novel aspects, which are addressed in each section, the role of syncope units (SUs) is emphasized in a commitment to improved patient-focused safety and efficiency. This same commitment is reflected in the definition of the initial evaluation and risk stratification in the emergency department. Beyond the specific novelties (Figure 1), we also highlight the conceptual aspects that have been updated and describe them in the same order as the headings of the original document (Figure 2).