Impacto de la pandemia por COVID-19 en el implante de dispositivos cardiacos implantables y las activaciones de la monitorización a distancia / Impact of the COVID-19 pandemic on implantation of cardiac implantable electronic devices and remote monitoring activations

Introducción y objetivos La monitorización a distancia (MD) de los dispositivos cardiacos implantables (DCI) se considera más fiable, eficiente y segura que los convencionales seguimientos presenciales, aunque su implantación es aún subóptima. Este estudio pretende analizar el impacto de la pandemia de COVID-19 en las tasas de implantes y activaciones de MD de DCI en España. Métodos Se utilizó el Registro COVID-19 de MD en España para analizar el número mensual de todos los implantes de DCI y activaciones de MD desde enero de 2018 hasta diciembre de 2021 en España. Se sumaron los datos de los 5 principales fabricantes de DCI y se analizaron de manera descriptiva. Resultados Se registró un total de 205.345 DCI. El número de implantes disminuyó bruscamente (48,2%) con el confinamiento (marzo a junio de 2020) y aumentó progresivamente después hasta compensar la reducción previa, excepto en marcapasos y desfibriladores automáticos implantables (DAI), con una pérdida agregada (2020-2021) del 7 y el 3%, respectivamente, respecto a la media anual. Aumentaron la terapia de resincronización cardiaca con desfibrilador (TRC-D, 17%) y con marcapasos (TRC-P, 4,5%) a los 2 años. El porcentaje de activaciones de MD aumentó del 24,5% en 2018 al 49,0% en 2021, con un fuerte aumento durante el confinamiento. Las tasas de activación de MD aumentaron invariablemente durante el confinamiento con todos los dispositivos: marcapasos (el 14,4 frente al 37,2%; p<0,001); DAI (el 75,6 frente al 94,2%; p<0,001); TRC-D/TRC-P (del 68,6/44,2% al 81,6/61%; p<0,001), y Holters implantables (el 50,2 frente al 68,7%; p<0,001). Conclusiones La significativa reducción de los implantes que se produjo durante el confinamiento se recuperó gradualmente después, excepto los de marcapasos y DAI. La pandemia de COVID-19 impulsó la MD de todos los DCI en España. (AU)

Introduction and objectives Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) is considered more reliable, efficient, and safer than conventional in-person follow-up. However, the implementation of RM is still suboptimal. This study aimed to analyze the impact of the COVID-19 pandemic on the rates of CIED implants and RM activations in Spain. Methods The COVID-19 RM Spain Registry was used to analyze the monthly number of all CIED implantations and RM activations from January 2018 to December 2021. A descriptive analysis was performed using aggregated data from the five major CIED manufacturers. Results A total of 205 345 CIEDs were recorded. The number of implants decreased sharply (48.2%) during the pandemic lockdown (March-June 2020) but gradually increased thereafter, compensating for the previous reduction. However, pacemakers and implantable cardiac defibrillators (ICD) showed an aggregate loss of 7% and 3%, respectively, from the annual average during 2020-2021. In contrast, cardiac resynchronization therapy defibrillators (CRT-D) increased by 17%, and pacemakers (CRT-P) by 4.5% over the 2-year period. The percentage of RM activations increased from 24.5% in 2018 to 49.0% in 2021, with a sharp increase during the lockdown. The RM activation rates consistently increased during the lockdown for all devices: pacemakers (14.4% vs 37.2%; P<.001); ICD (75.6% vs 94.2%; P<.001); CRT-D/CRT-P (68.6-44.2% vs 81.6-61%; P<.001), and implantable loop recorders (50.2% vs 68.7%; P<.001). Conclusions The significant decline in implants during the lockdown gradually recovered, except for pacemakers and ICD. However, the COVID-19 pandemic boosted RM for all CIEDs in Spain. (AU)

Seasonal influence on sleep apnoea recorded daily by pacemakers.

PURPOSE: Obstructive sleep apnoea (OSA) and cardiac conduction disorders are pathologies with a rising prevalence due to increased life expectancy. Upper airway patency is affected by environmental factors that may be associated with seasonal periods. The ability to record the degree of nocturnal apnoea on a daily basis may provide a more accurate picture of seasonal variability. METHODS: This study used an observational, cross-sectional design recruiting consecutive patients with Sorin/Livanova/Microport® pacemakers. The study assessed the seasonal influence on the daily degree of nocturnal apnoea over a minimum period of 180 days. The respiratory events were recorded using a pacemaker-integrated detection algorithm based on transthoracic impedance variation. A generalised linear repeated measure mixed model was used to study the seasonal effect. RESULTS: A sample of 101 subjects with a mean of 227 valid nights was compiled. Summer was associated with higher RDI (respiratory disturbance index) values and winter with lower values. The mean daily RDI ratio in summer was 1.099 times higher than in winter. CONCLUSIONS: Slight seasonal influences on the degree of nocturnal apnoea were detected through the daily observation of an unselected sample of pacemaker wearers. The degree of apnoea is higher in warmer months and lower in colder months.

Evaluation of thoracic impedance trends for implant-based remote monitoring in heart failure patients - Results from the (J-)HomeCARE-II Study.

AIMS: Remote monitoring by implantable devices substantially improves management of heart failure (HF) patients by providing diagnostic day-to-day data. The use of thoracic impedance (TI) as a surrogate measure of fluid accumulation is still strongly debated. The multicenter HomeCARE-II study evaluated clinically apparent HF events in the context of remote device diagnostics, focusing on the controversial role of TI. METHODS AND RESULTS: We followed 497 patients (66.6 ±â€¯10.1 years, 77% male, QRS 139.8 ±â€¯36.0 ms, ejection fraction 26.8 ±â€¯7.0%) implanted with a CRT-D (67%) or an ICD (33%) for 21.4 ±â€¯8.1 months. An independent event committee confirmed 171 HF events of which 82 were used to develop a TI-based algorithm for the prediction of imminent cardiac decompensation. Highly inter-individual variations in patterns of TI trends were observed. The algorithm resulted in a sensitivity of 41.5% (50.0%) with 0.95 (1.34) false alerts per patient year, and a positive predictive value of 7.9% overall and 27.9% in the HF event group of patients. Averaged ratio statistics showed a significant pre-hospital decrease and a highly significant in-hospital increase in TI after intensified diuresis. Recurrent decompensations turned out to be preceded by a significantly stronger decrease of TI compared to first events with a higher chance for detection (63.6% sensitivity, p < 0.05). CONCLUSIONS: Overall performance in predicting imminent decompensation by monitoring TI alone is limited due to its high inter-patient variability. TI stand-alone applications should be redirected towards a target population with more advanced symptoms where post-hospital observation aimed to maintain the patient's discharge status might be the most valuable approach. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT00711360 (HomeCARE-II) and NCT01221649 (J-HomeCARE-II).

Informe Oficial de la Sección de Electrofisiología y Arritmias de la Sociedad Española de Cardiología (2017) / Spanish Catheter Ablation Registry. 17th Official Report of the Spanish Society of Cardiology Working Group on Electrophysiology and Arrhythmias (2017)

Introducción y objetivos: Se describen los resultados del Registro Español de Ablación con Catéter correspondientes al año 2017. Métodos: La recogida de datos se llevó a cabo de forma retrospectiva con la cumplimentación de un formulario de recogida de datos de cada uno de los centros participantes. Resultados: El número total de procedimientos de ablación fue de 15.284 realizados en 98 centros (mayor número de centros y de procedimientos de ablación comunicados históricamente en este registro) con una media de 156 ± 126 y una mediana de 136 procedimientos. El sustrato abordado con más frecuencia ha sido por primera vez en el registro la fibrilación auricular (n = 3.457; 22,6%), seguida del istmo cavotricuspídeo (n = 3.449; 22,5%) y la taquicardia intranodular (n = 3.429; 22,4%). La tasa total de éxito fue del 87%; la de complicaciones mayores, del 2,6% y la mortalidad, del 0,09%. Se ha producido un aumento de los procedimientos realizados sin apoyo de fluoroscopia hasta suponer un 6% del total de las ablaciones. Un 2,3% de las ablaciones se realizó en pacientes pediátricos. Conclusiones: El Registro Español de Ablación con Catéter recoge sistemática e ininterrumpidamente los procedimientos de ablación realizados en España, y esto nos ha permitido observar un aumento progresivo del número de ablaciones y de centros que las realizan manteniendo una tasa de éxito elevada y unos porcentajes de complicaciones bajos

Introduction and objectives: This report describes the findings of the 2017 Spanish Catheter Ablation Registry. Methods: Data collection was retrospective. A standardized questionnaire was completed by each of the participating centers. Results: A total of 15 284 ablation procedures were performed by 98 institutions (the highest number of ablations and institutions historically reported in this registry), with a mean of 156 ± 126 and a median of 136 procedures per center. For the first time, the most frequently treated ablation target was atrial fibrillation (n = 3457; 22.6%), followed by cavotricuspid isthmus (n = 3449; 22.5%) and atrioventricular nodal re-entrant tachycardia (n = 3429; 22.4%). The overall success rate was 87%. The rate of major complications was 2.6%, and the mortality rate was 0.09%. The percentage of procedures performed without fluoroscopic support increased to 6% of all ablations, and 2.3% of all ablations were performed in pediatric patients. Conclusions: The Spanish Ablation Catheter Registry systematically and uninterruptedly collects data on the ablation procedures performed in Spain, revealing that both the number of ablations and the number of centers performing them has progressively increased, while maintaining a high success rate and a low percentage of complications

Spanish Catheter Ablation Registry. 17th Official Report of the Spanish Society of Cardiology Working Group on Electrophysiology and Arrhythmias (2017).

INTRODUCTION AND OBJECTIVES: This report describes the findings of the 2017 Spanish Catheter Ablation Registry. METHODS: Data collection was retrospective. A standardized questionnaire was completed by each of the participating centers. RESULTS: A total of 15 284 ablation procedures were performed by 98 institutions (the highest number of ablations and institutions historically reported in this registry), with a mean of 156±126 and a median of 136 procedures per center. For the first time, the most frequently treated ablation target was atrial fibrillation (n=3457; 22.6%), followed by cavotricuspid isthmus (n=3449; 22.5%) and atrioventricular nodal re-entrant tachycardia (n=3429; 22.4%). The overall success rate was 87%. The rate of major complications was 2.6%, and the mortality rate was 0.09%. The percentage of procedures performed without fluoroscopic support increased to 6% of all ablations, and 2.3% of all ablations were performed in pediatric patients. CONCLUSIONS: The Spanish Ablation Catheter Registry systematically and uninterruptedly collects data on the ablation procedures performed in Spain, revealing that both the number of ablations and the number of centers performing them has progressively increased, while maintaining a high success rate and a low percentage of complications.

Polymorphisms in the GNAS Gene as Predictors of Ventricular Tachyarrhythmias and Sudden Cardiac Death: Results From the DISCOVERY Trial and Oregon Sudden Unexpected Death Study.

BACKGROUND: Population-based studies suggest that genetic factors contribute to sudden cardiac death (SCD). METHODS AND RESULTS: In the first part of the present study (Diagnostic Data Influence on Disease Management and Relation of Genetic Polymorphisms to Ventricular Tachy-arrhythmia in ICD Patients [DISCOVERY] trial) Cox regression was done to determine if 7 single-nucleotide polymorphisms (SNPs) in 3 genes coding G-protein subunits (GNB3, GNAQ, GNAS) were associated with ventricular tachyarrhythmia (VT) in 1145 patients receiving an implantable cardioverter-defibrillator (ICD). In the second part of the study, SNPs significantly associated with VT were further investigated in 1335 subjects from the Oregon SUDS, a community-based study analyzing causes of SCD. In the DISCOVERY trial, genotypes of 2 SNPs in the GNAS gene were nominally significant in the prospective screening and significantly associated with VT when viewed as recessive traits in post hoc analyses (TT vs CC/CT in c.393C>T: HR 1.42 [CI 1.11-1.80], P=0.005; TT vs CC/CT in c.2273C>T: HR 1.57 [CI 1.18-2.09], P=0.002). TT genotype in either SNP was associated with a HR of 1.58 (CI 1.26-1.99) (P=0.0001). In the Oregon SUDS cohort significant evidence for association with SCD was observed for GNAS c.393C>T under the additive (P=0.039, OR=1.21 [CI 1.05-1.45]) and recessive (P=0.01, OR=1.52 [CI 1.10-2.13]) genetic models. CONCLUSIONS: GNAS harbors 2 SNPs that were associated with an increased risk for VT in ICD patients, of which 1 was successfully replicated in a community-based population of SCD cases. To the best of our knowledge, this is the first example of a gene variant identified by ICD VT monitoring as a surrogate parameter for SCD and also confirmed in the general population. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00478933.

Differential Responses of the Septal Ventricle and the Atrial Signals During Ongoing Entrainment: A Method to Differentiate Orthodromic Reciprocating Tachycardia Using Septal Accessory Pathways From Atypical Atrioventricular Nodal Reentry.

BACKGROUND: Differential diagnosis between tachycardia mediated by septal accessory pathways (AP) and atypical atrioventricular nodal reentry can be challenging. We hypothesized that an immediate versus delayed pace-related advancement of the atrial electrogram, once the local septal parahisian ventricular electrogram (SVE) has been advanced, may help in this diagnosis. METHODS AND RESULTS: We focused on differential timing between SVE and atrial signals at the initiation of continuous right ventricular apical pacing during tachycardia. SVE advancement preceding atrial reset was defined as SVE advanced by the paced wave fronts while atrial signal continued at the tachycardia cycle. We analyzed 51 atypical atrioventricular nodal reentry (45% posterior type) and 80 AP tachycardias (anteroseptal [10], parahisian [18], midseptal [12], and posteroseptal [40]). SVE advancement preceding atrial reset was observed in 98% of atrioventricular nodal reentries during 4±1.1 cycles; this phenomena was observed in 6 (8%) of the atrioventricular reentrant tachycardia mediated by septal AP (P<0.001; sensitivity 98%; specificity 93%; positive predictive value 90%; negative predictive value 99%) and lasted 1 single cycle (P<0.001). Right posteroseptal AP tachycardias were distinctly characterized by atrial reset preceding SVE advancement (with ventricular fusion; specificity 100%; positive predictive value 100%). In 11 cases, it was impossible to achieve sustain entrainment. In all of them, the differential responses at the entrainment attempt allowed for appropriate diagnosis. CONCLUSIONS: The differential response of the SVE and the atrial electrogram at the initiation of continuous right ventricular apical pacing during tachycardia effectively distinguishes between atypical atrioventricular nodal reentry and atrioventricular reentrant tachycardia mediated by septal APs.

Update on arrhythmias and cardiac pacing 2013.

This report discusses a selection of the most relevant articles on cardiac arrhythmias and pacing published in 2013. The first section discusses arrhythmias, classified as regular paroxysmal supraventricular tachyarrhythmias, atrial fibrillation, and ventricular arrhythmias, together with their treatment by means of an implantable cardioverter defibrillator. The next section reviews cardiac pacing, subdivided into resynchronization therapy, remote monitoring of implantable devices, and pacemakers. The final section discusses syncope.

Novedades en arritmias y estimulación cardiaca en 2013 / Update on Arrhythmias and Cardiac Pacing 2013

En este trabajo se comentan críticamente los artículos sobre arritmias y estimulación cardiaca aparecidos en 2013 seleccionados como más relevantes. Se repasan las arritmias, subdivididas en taquiarritmias supraventriculares regulares, fibrilación auricular y arritmias ventriculares, incluido su tratamiento mediante desfibrilador automático implantable. Se revisan las publicaciones referidas a estimulación cardiaca, subdivididas en terapia de resincronización, monitorización a domicilio dispositivos implantables y marcapasos. Finalmente, se trata el síncope (AU)

This report discusses a selection of the most relevant articles on cardiac arrhythmias and pacing published in 2013. The first section discusses arrhythmias, classified as regular paroxysmal supraventricular tachyarrhythmias, atrial fibrillation, and ventricular arrhythmias, together with their treatment by means of an implantable cardioverter defibrillator. The next section reviews cardiac pacing, subdivided into resynchronization therapy, remote monitoring of implantable devices, and pacemakers. The final section discusses syncope (AU)