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1.
Rev. esp. cardiol. (Ed. impr.) ; 76(11): 922-935, Nov. 2023. tab, graf, mapas
Artículo en Español | IBECS | ID: ibc-226976

RESUMEN

Introducción y objetivos: Se presentan los datos de implantes de desfibrilador automático implantable en España en el año 2022.Métodos: Los datos provienen de los centros implantadores, que cumplimentaron voluntariamente una hoja de recogida de datos durante el implante, a mano o a través de una página web.Resultados: Durante 2022, han participado en el registro 170 hospitales. Se han recibido 7.693 formularios, frente a los 7.970 comunicados por la European Confederation of Medical Suppliers Associations (Eucomed), lo que representa un 96,5% de los dispositivos. La tasa total de implantes registrados fue 162/millón de habitantes (168 según Eucomed), un ligero incremento respecto a años anteriores. Las diferencias entre las comunidades autónomas persisten, así como nuestra última posición respecto a los países europeos que participan en la Eucomed.Conclusiones: Los datos del registro de 2022 reflejan la recuperación completa de la actividad tras el impacto de la pandemia de la COVID-19 en 2020. Pese a la leve mejora, se mantiene nuestra posición en Europa y también las grandes diferencias entre nuestras comunidades autónomas.(AU)


Introduction and objectives: This article presents data on implantable cardioverter-defibrillator implants in Spain in 2022.Methods: The data were collected from implantation centers, which voluntarily completed a data collection sheet during the implantation process, either manually or through a web page.Results: In 2022, 170 hospitals participated in the registry. A total of 7693 forms were received compared with the 7970 reported by Eucomed (European Confederation of Medical Suppliers Associations), representing 96.5% of the devices. The total rate of registered implants was 162/million inhabitants (168 according to Eucomed), showing a slight increase compared with previous years. Disparities persisted among autonomous communities and Spain continued to have the lowest implantation rate among countries participating in Eucomed.Conclusions: The data from the registry for 2022 reflect the complete recovery of activity after the impact of the COVID-19 pandemic in 2020. Despite a slight improvement, there was no significant change in our position in Europe or in the substantial differences among autonomous communities.(AU)


Asunto(s)
Humanos , Masculino , Femenino , Desfibriladores Implantables/estadística & datos numéricos , Muerte Súbita Cardíaca , Sistema de Registros/estadística & datos numéricos , Arritmias Cardíacas , Cardiología , España , Desfibriladores Implantables/tendencias
2.
Rev Esp Cardiol (Engl Ed) ; 76(11): 922-935, 2023 Nov.
Artículo en Inglés, Español | MEDLINE | ID: mdl-37774946

RESUMEN

INTRODUCTION AND OBJECTIVES: This article presents data on implantable cardioverter-defibrillator implants in Spain in 2022. METHODS: The data were collected from implantation centers, which voluntarily completed a data collection sheet during the implantation process, either manually or through a web page. RESULTS: In 2022, 170 hospitals participated in the registry. A total of 7693 forms were received compared with the 7970 reported by Eucomed (European Confederation of Medical Suppliers Associations), representing 96.5% of the devices. The total rate of registered implants was 162/million inhabitants (168 according to Eucomed), showing a slight increase compared with previous years. Disparities persisted among autonomous communities and Spain continued to have the lowest implantation rate among countries participating in Eucomed. CONCLUSIONS: The data from the registry for 2022 reflect the complete recovery of activity after the impact of the COVID-19 pandemic in 2020. Despite a slight improvement, there was no significant change in our position in Europe or in the substantial differences among autonomous communities.


Asunto(s)
Cardiología , Desfibriladores Implantables , Humanos , Arritmias Cardíacas/epidemiología , Arritmias Cardíacas/terapia , Pandemias , Sistema de Registros , España/epidemiología
3.
J Interv Card Electrophysiol ; 66(8): 1889-1899, 2023 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-36807734

RESUMEN

BACKGROUND: Electrical isolation of pulmonary veins (PV) with high-power short-duration (HPSD) radiofrequency application (RFa) may reduce the duration of atrial fibrillation (AF) ablation, without compromising the procedural efficacy and safety in comparison with the conventional approach. This hypothesis has been generated in several observational studies; the POWER FAST III will test it in a randomized multicenter clinical trial. METHODS: It is a multicenter randomized, open-label and non-inferiority clinical trial with two parallel groups. AF ablation using 70 W and 9-10 s RFa is compared with the conventional technique using 25-40 W RFa guided by numerical lesion indexes. The main efficacy objective is the incidence of atrial arrhythmia recurrences electrocardiographically documented during 1-year follow-up. The main safety objective is the incidence of endoscopically detected esophageal thermal lesions (EDEL). This trial includes a substudy of incidence of asymptomatic cerebral lesions detected by magnetic resonance imaging (MRI) after ablation. RESULTS: A randomized clinical trial compares for the first time high-power short-duration and conventional ablation in order to obtain data about the efficacy and safety of the high-power technique in an adequate methodological context. CONCLUSIONS: The results of the POWER FAST III could support the use of the high-power short-duration ablation in clinical practice. REGISTRATION: ClinicalTrials.gov: NTC04153747.

4.
Artículo en Inglés, Español | MEDLINE | ID: mdl-36155845

RESUMEN

INTRODUCTION AND OBJECTIVES: This article presents the data corresponding to implantable cardioverter-defibrillator (ICD) implantations in Spain in 2021. METHODS: The data were drawn from implanting centers, which voluntarily completed a data collection sheet during the procedure. RESULTS: In 2021, 7496 implant data sheets were received, compared with 7743 reported by Eucomed (European Confederation of Medical Suppliers Associations), indicating that data were collected from 96.8% of the devices implanted in Spain. Data completion ranged from 99.9% for "name of implanting hospital" to 8.9% for "implanting hospital". In 2021, 199 hospitals participated in the registry, exceeding the figures of previous years, with around 170 participating hospitals. The total rate of registered implants was 158/million inhabitants (163 according to Eucomed), making 2021 the year with the highest activity. However, the registry continues to show significant differences among the various autonomous communities and the lowest implantation rate of all the European countries participating in Eucomed. CONCLUSIONS: The Spanish implantable cardioverter-defibrillator registry for 2021 recorded an increase in the number of ICD implantations, reflecting the recovery of hospital activity after the initial impact of the COVID-19 pandemic in 2020. Although the total number of implants has increased in Spain, figures are still much lower than the European Union average, with differences persisting among Spanish autonomous communities.

5.
Front Cardiovasc Med ; 9: 901267, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35647062

RESUMEN

The aim of the SYNSEQ (Left Ventricular Synchronous vs. Sequential MultiSpot Pacing for CRT) study was to evaluate the acute hemodynamic response (AHR) of simultaneous (3P-MPP syn) or sequential (3P-MPP seq) multi-3-point-left-ventricular (LV) pacing vs. single point pacing (SPP) in a group of patients at risk of a suboptimal response to cardiac resynchronization therapy (CRT). Twenty five patients with myocardial scar or QRS ≤ 150 or the absence of LBBB (age: 66 ± 12 years, QRS: 159 ± 12 ms, NYHA class II/III, LVEF ≤ 35%) underwent acute hemodynamic assessment by LV + dP/dtmax with a variety of LV pacing configurations at an optimized AV delay. The change in LV + dP/dt max (%ΔLV + dP/dt max) with 3P-MPP syn (15.6%, 95% CI: 8.8%-22.5%) was neither statistically significantly different to 3P-MPP seq (11.8%, 95% CI: 7.6-16.0%) nor to SPP basal (11.5%, 95% CI:7.1-15.9%) or SPP mid (12.2%, 95% CI:7.9-16.5%), but higher than SPP apical (10.6%, 95% CI:5.3-15.9%, p = 0.03). AHR (defined as a %ΔLV + dP/dt max ≥ 10%) varied between pacing configurations: 36% (9/25) for SPP apical, 44% (11/25) for SPP basal, 54% (13/24) for SPP mid, 56% (14/25) for 3P-MPP syn and 48% (11/23) for 3P-MPP seq.Fifteen patients (15/25, 60%) had an AHR in at least one pacing configuration. AHR was observed in 10/13 (77%) patients with a LBBB but only in 5/12 (42%) patients with a non-LBBB (p = 0.11). To conclude, simultaneous or sequential multipoint pacing compared to single point pacing did not improve the acute hemodynamic effect in a suboptimal CRT response population. Clinical Trial Registration: ClinicalTrials.gov, identifier: NCT02914457.

6.
J Cardiovasc Electrophysiol ; 33(5): 997-1004, 2022 05.
Artículo en Inglés | MEDLINE | ID: mdl-35322490

RESUMEN

INTRODUCTION: Device infections constitute a major complication of transvenous pacemakers. Mechanical heart valves (MHV) increase the risk of infective endocarditis (IE) and pacemaker infection, requiring lifelong vitamin K-antagonists (VKA), which may affect patient management. Leadless pacemakers (LP) are associated with low infection rates, posing an attractive option in MHV patients requiring permanent pacing. This study describes outcomes following LP implantation in patients with MHV. METHODS: This is a multicenter, observational, retrospective study including consecutive patients implanted with an LP at 5 centers between June 2015 and January 2020. Procedural outcomes, antithrombotic management, complications, performance during follow-up and episodes of bacteremia and IE were compared between patients with and without an MHV (MHV and non-MHV groups). RESULTS: Four hundred fifty-nine patients were included (74 in the MHV group, 16.1%, and 385 in the non-MHV group, 83.9%). Procedural outcomes and acute electrical performance were comparable between groups. Vascular complications and cardiac perforation occurred in 2.7 versus 2.3% (p = 1) and 0% versus 0.8% (p = 1) in the MHV group and non-MHV group. One case of IE occurred in the MHV group and 2 in the non-MHV group. In MHV patients, uninterrupted VKA was used in 83.8%, whereas 16.2% were heparin-bridged. Vascular complication or tamponade occurred in 1 (8.3%) MHV heparin-bridged patient versus 1 (1.6%) MHV uninterrupted VKA patient (p = .3). CONCLUSION: LP implantation outcomes in MHV patients are comparable to the general LP population. Device-related infections are rare following LP implantation, including in patients with MHV. In the MHV group, periprocedural anticoagulation management was not associated with significantly different rates of tamponade or vascular complication.


Asunto(s)
Prótesis Valvulares Cardíacas , Marcapaso Artificial , Válvulas Cardíacas , Heparina , Humanos , Marcapaso Artificial/efectos adversos , Estudios Retrospectivos , Resultado del Tratamiento
7.
Heart Rhythm O2 ; 3(6Part A): 656-664, 2022 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-36589911

RESUMEN

Background: Atrial fibrillation (AF) ablation strategy is associated with a non-negligible risk of complications and often requires repeat procedures (AF ablation track), implying repetitive exposure to procedural risk. Objective: The purpose of this study was to develop and validate a model to estimate individualized cumulative risk of complications in patients undergoing the AF ablation track (Atrial Fibrillation TRAck Complication risK [AF-TRACK] calculator). Methods: The model was derived from a multicenter cohort including 3762 AF ablation procedures in 2943 patients. A first regression model was fitted to predict the propensity for repeat ablation. The AF-TRACK calculator computed the risk of AF ablation track complications, considering the propensity for repeat ablation. Internal (cross-validation) and external (independent cohort) validation were assessed for discrimination capacity (area under the curve [AUC]) and goodness of fit (Hosmer-Lemeshow [HL] test). Results: Complications (N = 111) occurred in 3.7% of patients (2.9% of procedures). Predictors included female sex, heart failure, sleep apnea syndrome, and repeat procedures. The model showed fair discrimination capacity to predict complications (AUC 0.61 [0.55-0.67]) and likelihood of repeat procedure (AUC 0.62 [0.60-0.64]), with good calibration (HL χ2 12.5; P = .13). The model maintained adequate discrimination capacity (AUC 0.67 [0.57-0.77]) and calibration (HL χ2 5.6; P = .23) in the external validation cohort. The validated model was used to create the Web-based AF-TRACK calculator. Conclusion: The proposed risk model provides individualized estimates of the cumulative risk of complications of undergoing the AF ablation track. The AF-TRACK calculator is a validated, easy-to-use, Web-based clinical tool to calibrate the risk-to-benefit ratio of this treatment strategy.

8.
Rev Esp Cardiol (Engl Ed) ; 74(11): 971-982, 2021 Nov.
Artículo en Inglés, Español | MEDLINE | ID: mdl-34583912

RESUMEN

INTRODUCTION AND OBJECTIVES: We present the data corresponding to implantable cardioverter-defibrillator (ICD) implants in Spain in 2020. METHODS: The data in this registry were drawn from implantation centers, which voluntarily completed a data collection sheet. RESULTS: In 2020, 7056 implant sheets were received compared with 7106 reported by Eucomed (European Confederation of Medical Suppliers Associations), indicating that data were collected from 99% of the devices implanted in Spain. Completion of the implant sheet ranged from 99.8% for the field "name of the implanting hospital" to 2.6% for the variable "referral hospital". A total of 173 hospitals performed ICD implants and participated in the registry, which is a similar figure to that in 2019 (n=172). The total rate of registered implants was 149/million inhabitants (150 according to Eucomed), revealing a slight reduction in implants in Spain in 2020 as a result of the impact of the COVID-19 pandemic. This reduction was uneven among the autonomous communities. CONCLUSIONS: The Spanish Implantable Cardioverter Defibrillator Registry for 2020 shows an improvement in the rate of implants reported and a reduction in the number of ICD implants, which likely reflects the decrease in hospital activity not related to the treatment of COVID-19 infection. Similar to previous years, the total number of implants in Spain is still much lower than the average for the European Union, with an increase in the differences between Spanish autonomous communities.


Asunto(s)
COVID-19 , Cardiología , Desfibriladores Implantables , Arritmias Cardíacas/epidemiología , Arritmias Cardíacas/terapia , Humanos , Pandemias , Sistema de Registros , SARS-CoV-2
9.
Rev Esp Cardiol (Engl Ed) ; 74(7): 602-607, 2021 Jul.
Artículo en Inglés, Español | MEDLINE | ID: mdl-32792313

RESUMEN

INTRODUCTION AND OBJECTIVES: Early detection of atrial fibrillation (AF) is a priority to reduce embolic events by initiating oral anticoagulation therapy. The aim of this study was to evaluate the diagnostic ability of a wrist device designed for automatic AF detection. METHODS: RITHMI is a prospective, comparative, observational study that included 167 patients referred to a cardiology outpatient clinic for a general consultation or for electrical cardioversion. The study evaluated the ability of a wrist monitor that uses a photoplethysmography (PPG) signal and an electrocardiographic lead to automatically detect AF compared with diagnosis established by 2 cardiologists using the 12-lead electrocardiogram. RESULTS: The AF detection algorithm based on the PPG signal had a sensitivity of 91% and a specificity of 96% (diagnostic accuracy: 93%). The automatic algorithm based on the electrocardiographic signal had a sensitivity of 94% and a specificity of 96% (diagnostic accuracy: 95%). The 2 algorithms concurred in the diagnosis in 96% of the cases. Overall, the monitor had a sensitivity and specificity of 95% (diagnostic accuracy: 95% and Kappa index: 0.98). CONCLUSIONS: This study shows that automatic AF detection through the use of a heart rhythm monitor incorporating sensors and algorithms that analyze the PPG signal and the electrocardiographic signal corresponding to lead I is feasible and has high diagnostic accuracy.


Asunto(s)
Fibrilación Atrial , Algoritmos , Fibrilación Atrial/diagnóstico , Electrocardiografía , Humanos , Fotopletismografía , Estudios Prospectivos , Sensibilidad y Especificidad
10.
Rev. esp. cardiol. (Ed. impr.) ; 73(12): 1026-1037, dic. 2020. tab, mapas, graf
Artículo en Español | IBECS | ID: ibc-201129

RESUMEN

INTRODUCCIÓN Y OBJETIVOS: Se presentan los datos correspondientes a los implantes de desfibrilador automático implantable (DAI) en España en el año 2019. MÉTODOS: Los datos provienen de los centros implantadores, que cumplimentaron voluntariamente una hoja de recogida de datos. RESULTADOS: En 2019 se recibieron 7.003 hojas de implante, frente a las 7.389 comunicadas por Eucomed (European Confederation of Medical Suppliers Associations), lo que implica que se han recogido datos del 94,8% de los dispositivos implantados en España. La cumplimentación de la hoja de implante osciló entre el 99,7% en el campo «nombre del hospital implantador» y el 17,8% en la variable «hospital de referencia». En 2019, los hospitales que realizaron implantes de DAI y participaron en el registro fueron 172, cifras similares a las de 2018 (173). La tasa total de implantes registrados fue 149/millón de habitantes; según los datos de Eucomed, 157. A pesar de que este valor supone el máximo de la serie histórica, sigue siendo muy inferior a la tasa media de implantes de DAI en Europa (303). CONCLUSIONES: El Registro Español de Desfibrilador Automático Implantable de 2019 recoge un crecimiento en el número de implantes de DAI y es el año en el que se han implantado más DAI en España. Sin embargo, y de modo similar que años previos, el número total de implantes en España sigue siendo muy inferior a la media de la Unión Europea, con importantes diferencias entre las comunidades autónomas españolas


INTRODUCTION AND OBJECTIVES: We present the data corresponding to implantable cardioverter-defibrillator (ICD) implants in Spain in 2019. METHODS: The data were drawn from implant centers voluntarily completing a data collection sheet. RESULTS: In 2019, 7003 implant sheets were received compared with the 7389 reported by Eucomed (European Confederation of Medical Suppliers Associations), indicating that data were collected from 94.8% of the devices implanted in Spain. Completion of the implant sheet ranged from 99.7% in the field "name of the implanting hospital" to 17.8% in the variable "reference hospital". In 2019, 172 hospitals performed ICD implants and participated in the registry, a figure similar to that of 2018 (173). The total rate of registered implants was 149/million inhabitants; the rate reported by Eucomed was 157. Although this value represents the highest in the historical series, it is still much lower than the average rate of ICD implants in Europe (303). CONCLUSIONS: The Spanish Implantable Cardioverter-Defibrillator Registry for 2019 reflects a growth in the number of ICD implants and is the year with the highest number of ICD implants in Spain. However, similar to previous years, the total number of implants in Spain is still much lower than the European Union average, with substantial differences between Spanish autonomous communities


Asunto(s)
Humanos , Masculino , Femenino , Adulto , Cardiomiopatía Hipertrófica , Cardiomiopatía Hipertrófica/diagnóstico , Cardiomiopatía Hipertrófica/epidemiología , Muerte Súbita Cardíaca/epidemiología , Desfibriladores Implantables , Cardioversión Eléctrica , Factores de Riesgo
11.
Rev Esp Cardiol (Engl Ed) ; 73(12): 1026-1037, 2020 Dec.
Artículo en Inglés, Español | MEDLINE | ID: mdl-33039380

RESUMEN

INTRODUCTION AND OBJECTIVES: We present the data corresponding to implantable cardioverter-defibrillator (ICD) implants in Spain in 2019. METHODS: The data were drawn from implant centers voluntarily completing a data collection sheet. RESULTS: In 2019, 7003 implant sheets were received compared with the 7389 reported by Eucomed (European Confederation of Medical Suppliers Associations), indicating that data were collected from 94.8% of the devices implanted in Spain. Completion of the implant sheet ranged from 99.7% in the field "name of the implanting hospital" to 17.8% in the variable "reference hospital". In 2019, 172 hospitals performed ICD implants and participated in the registry, a figure similar to that of 2018 (173). The total rate of registered implants was 149/million inhabitants; the rate reported by Eucomed was 157. Although this value represents the highest in the historical series, it is still much lower than the average rate of ICD implants in Europe (303). CONCLUSIONS: The Spanish Implantable Cardioverter-Defibrillator Registry for 2019 reflects a growth in the number of ICD implants and is the year with the highest number of ICD implants in Spain. However, similar to previous years, the total number of implants in Spain is still much lower than the European Union average, with substantial differences between Spanish autonomous communities.


Asunto(s)
Cardiología , Desfibriladores Implantables , Arritmias Cardíacas/epidemiología , Arritmias Cardíacas/terapia , Europa (Continente)/epidemiología , Humanos , Sistema de Registros , España/epidemiología
12.
Rev. esp. cardiol. (Ed. impr.) ; 72(12): 1054-1064, dic. 2019. tab, mapas, graf
Artículo en Español | IBECS | ID: ibc-190769

RESUMEN

Introducción y objetivos: Se presentan los datos correspondientes a los implantes de desfibrilador automático implantable (DAI) en España comunicados al Registro Español de Desfibrilador Automático Implantable en el año 2018. Métodos: Los datos de este registro incluyen tanto los primoimplantes como los recambios de generador y se documentan a partir de una hoja de recogida de datos que voluntariamente cumplimentan los centros implantadores. Resultados: En el año 2018 se recibieron 6.421 hojas de implante, frente a las 7.077 comunicadas por Eucomed (European Confederation of Medical Suppliers Associations). Esto representa datos del 90,7% de los dispositivos implantados en España. El grado de cumplimiento osciló entre el 99,6% en el campo «nombre del hospital implantador» y el 12,4% en «población de residencia». Comunicaron sus datos al registro 173 hospitales, lo que supone una ligera disminución con respecto a los que participaron en 2017 (181). Conclusiones: El Registro Español de Desfibrilador Automático Implantable del año 2018 recoge un crecimiento en el número de implantes de DAI después de la reducción observada en 2017 y es el año en que se ha implantado un mayor número de DAI en España. El número total de implantes en España sigue siendo muy inferior a la media de la Unión Europea, con importantes diferencias entre comunidades autónomas


Introduction and objectives: This article presents the data corresponding to automated implantable cardioverter-defibrillator (ICD) implants in Spain reported to the Spanish Registry in 2018. Methods: The data in this registry include both primary implants and generator replacements and were gathered from a data collection sheet voluntarily completed by implantation centers. Results: In 2018, 6421 implant sheets were received compared with 7077 reported by Eucomed (European Confederation of Medical Suppliers Associations). This represents data on 90.7% of the devices implanted in Spain. Compliance ranged between 99.6% for the field "name of the implanting hospital" and 12.4% for "population of residence". A total of 173 hospitals reported their data to the registry, representing a slight decrease compared with hospitals participating in 2017 (n=181). Conclusions: After the reduction in ICD implants in 2017, the number of implants increased in 2018, with the highest number of ICDs implanted in Spain. The total number of implants remains much lower than the European Union average, with substantial differences between autonomous communities


Asunto(s)
Humanos , Cardioversión Eléctrica/métodos , Desfibriladores Implantables/estadística & datos numéricos , Arritmias Cardíacas/cirugía , Electrofisiología Cardíaca/métodos , Registros de Enfermedades/estadística & datos numéricos , Estudios Retrospectivos , Resultado del Tratamiento , Arritmias Cardíacas/epidemiología , España/epidemiología
13.
Rev Esp Cardiol (Engl Ed) ; 72(12): 1054-1064, 2019 Dec.
Artículo en Inglés, Español | MEDLINE | ID: mdl-31727564

RESUMEN

INTRODUCTION AND OBJECTIVES: This article presents the data corresponding to automated implantable cardioverter-defibrillator (ICD) implants in Spain reported to the Spanish Registry in 2018. METHODS: The data in this registry include both primary implants and generator replacements and were gathered from a data collection sheet voluntarily completed by implantation centers. RESULTS: In 2018, 6421 implant sheets were received compared with 7077 reported by Eucomed (European Confederation of Medical Suppliers Associations). This represents data on 90.7% of the devices implanted in Spain. Compliance ranged between 99.6% for the field "name of the implanting hospital" and 12.4% for "population of residence". A total of 173 hospitals reported their data to the registry, representing a slight decrease compared with hospitals participating in 2017 (n=181). CONCLUSIONS: After the reduction in ICD implants in 2017, the number of implants increased in 2018, with the highest number of ICDs implanted in Spain. The total number of implants remains much lower than the European Union average, with substantial differences between autonomous communities.


Asunto(s)
Arritmias Cardíacas/terapia , Cardiología , Desfibriladores Implantables/estadística & datos numéricos , Electrofisiología/estadística & datos numéricos , Sistema de Registros , Sociedades Médicas , Recolección de Datos , Femenino , Humanos , Masculino , Estudios Retrospectivos , España
14.
Eur Heart J ; 40(23): 1837-1846, 2019 06 14.
Artículo en Inglés | MEDLINE | ID: mdl-30793735

RESUMEN

AIMS: This trial aimed to evaluate the safety and efficiency of a common and simplified protocol for the surveillance of cardiac implantable electronic devices based on remote monitoring (RM) in patients with pacemakers (PMs) and implantable cardiac defibrillators (ICDs) for at least 24 months. METHODS AND RESULTS: The RM-ALONE is a multicentre prospective trial that randomly assigned 445 patients in two groups, both followed by RM: the home monitoring-only (HMo) based on RM + remote interrogations (RIs) every 6 months and the HM + IO that adds in-office evaluations every 6 months to RM. Four hundred and forty-five patients were enrolled in the study, 294 PMs and 151 ICDs recipients. In the HMo group, 20% of patients experienced ≥1 major adverse cardiac event (MACE) vs. 19.5% in HM + IO group (P = 0.006 for non-inferiority). The proportion of patients with a PM/ICD who experienced ≥1 MACE was 15.2/29.3% in HMo group and 16.1/26.3% in HM + IO group (hazard ratio 0.95/1.15, 95% confidence interval 0.53-1.70/0.62-2.10). There were 789 in-office evaluations (136 in the HMo and 653 in the HM + IO; P < 0.001). There was a 79.2% reduction of in-office evaluations with no significant differences in unscheduled visits between groups: 122 (54.5%) in HMo and 101 (45.3%) in HM + IO; P = 0.15. The time a physician/nurse spent per patient/follow-up was significantly reduced in the HMo group: 4/5 min (0-30)/(1-30) vs. 10/10 min (0-40)/(1-40) in HM + IO (P < 0.0001). CONCLUSION: The RM-ALONE protocol common for ICD and PM surveillance, consisting of RM + RI every 6 months has proven safe and efficient in reducing hospital visits and staff workload.


Asunto(s)
Desfibriladores Implantables/efectos adversos , Servicios de Atención de Salud a Domicilio , Monitoreo Fisiológico/métodos , Marcapaso Artificial/efectos adversos , Telemedicina/métodos , Adulto , Anciano , Anciano de 80 o más Años , Enfermedades Cardiovasculares/mortalidad , Femenino , Hospitalización/estadística & datos numéricos , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Carga de Trabajo/estadística & datos numéricos , Adulto Joven
15.
Rev. esp. cardiol. (Ed. impr.) ; 71(12): 1047-1058, dic. 2018. tab, mapas, graf
Artículo en Español | IBECS | ID: ibc-179011

RESUMEN

Introducción y objetivos: El Registro Español de Desfibrilador Automático aporta datos de actividad desde el año 2002. Métodos: Los datos de este registro provienen de los centros implantadores, que cumplimentaron voluntariamente una hoja de recogida de datos. Resultados: Durante 2017 se han recibido 6.273 hojas de implante, frente a las 6.429 comunicadas por Eucomed (European Confederation of Medical Suppliers Associations); por lo tanto, se han recogido datos del 97,6% de los dispositivos implantados en España. El cumplimiento osciló entre el 99,7% en el campo «nombre del hospital implantador» y el 46,1% en la variable «clase funcional de la New York Heart Association». Comunicaron sus datos al registro 181 hospitales, lo que supone un aumento respecto a los que participaron en 2016 (177) y años anteriores (169 en 2015, 162 en 2014, 154 en 2013 o 153 en 2012). Conclusiones: Después de varios años de crecimiento en el número de implantes por millón de habitantes, este año se ha reducido. Como en los años previos, el número total de implantes en España sigue siendo muy inferior a la media de la Unión Europea, y la diferencia continúa aumentando, al igual que persisten las importantes diferencias entre comunidades autónomas españolas


Introduction and objectives: The Spanish Automatic Defibrillator Registry has provided activity data since 2002. Methods: The data in this registry are submitted by implantation centers that voluntarily complete a data collection sheet. Results: During 2017, a total of 6273 implant sheets were received, compared with 6429 reported by Eucomed (European Confederation of Medical Suppliers Associations). Therefore, the registry contains data on 97.6% of the devices implanted in Spain. Compliance ranged from 99.7% for the field "name of the implanting hospital " to 46.1% for the variable "New York Heart Association functional class ". A total of 181 hospitals reported data to the registry, representing an increase compared with the number of participating hospitals in 2016 (177) and in previous years (169 in 2015, 162 in 2014, 154 in 2013, and 153 in 2012). Conclusions: The number of implants per million inhabitants in Spain increased for several years but decreased in 2017. As in previous years, the total number of implants in Spain is still much lower than the European Union average, and the gap continues to widen. There are still substantial differences between autonomous communities


Asunto(s)
Humanos , Masculino , Femenino , Niño , Adolescente , Adulto Joven , Adulto , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Desfibriladores Implantables/estadística & datos numéricos , Arritmias Cardíacas/epidemiología , Muerte Súbita Cardíaca/prevención & control , Electrofisiología Cardíaca/estadística & datos numéricos , Registros de Enfermedades/estadística & datos numéricos , Cardioversión Eléctrica/estadística & datos numéricos , Arritmias Cardíacas/terapia , Estudios Retrospectivos , Isquemia Miocárdica/epidemiología
16.
Rev Esp Cardiol (Engl Ed) ; 71(12): 1047-1058, 2018 Dec.
Artículo en Inglés, Español | MEDLINE | ID: mdl-30420318

RESUMEN

INTRODUCTION AND OBJECTIVES: The Spanish Automatic Defibrillator Registry has provided activity data since 2002. METHODS: The data in this registry are submitted by implantation centers that voluntarily complete a data collection sheet. RESULTS: During 2017, a total of 6273 implant sheets were received, compared with 6429 reported by Eucomed (European Confederation of Medical Suppliers Associations). Therefore, the registry contains data on 97.6% of the devices implanted in Spain. Compliance ranged from 99.7% for the field "name of the implanting hospital" to 46.1% for the variable "New York Heart Association functional class". A total of 181 hospitals reported data to the registry, representing an increase compared with the number of participating hospitals in 2016 (177) and in previous years (169 in 2015, 162 in 2014, 154 in 2013, and 153 in 2012). CONCLUSIONS: The number of implants per million inhabitants in Spain increased for several years but decreased in 2017. As in previous years, the total number of implants in Spain is still much lower than the European Union average, and the gap continues to widen. There are still substantial differences between autonomous communities.


Asunto(s)
Arritmias Cardíacas/terapia , Cardiología , Desfibriladores Implantables/estadística & datos numéricos , Técnicas Electrofisiológicas Cardíacas/estadística & datos numéricos , Sistema de Registros , Sociedades Médicas , Arritmias Cardíacas/epidemiología , Femenino , Humanos , Incidencia , Masculino , Estudios Retrospectivos , España/epidemiología
18.
Rev Esp Cardiol (Engl Ed) ; 71(9): 754, 2018 Sep.
Artículo en Inglés, Español | MEDLINE | ID: mdl-30146125
20.
Rev Esp Cardiol (Engl Ed) ; 71(8): 671, 2018 Aug.
Artículo en Inglés, Español | MEDLINE | ID: mdl-30054055
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