Registro español de marcapasos. XX informe oficial de la Asociación del Ritmo Cardiaco de la Sociedad Española de Cardiología (2022) / Spanish pacemaker registry. 20th official report of the Heart Rhythm Association of the Spanish Society of Cardiology (2022)

Introducción y objetivos: En este informe se comunica la actividad de estimulación cardiaca en 2022: número total de implantes, adherencia a la monitorización a distancia, factores demográficos y clínicos y características del material implantado. Métodos: Las fuentes de información son la plataforma CardioDispositivos, la tarjeta europea del paciente portador de marcapasos y los datos facilitados por los fabricantes. Resultados: Las tasas de marcapasos convencionales y resincronizadores de baja energía fueron de 866 y 34 unidades/millón respectivamente. Se implantaron 815 marcapasos sin cables. Se registraron 16.426 procedimientos de 82 hospitales (9.407 a través de CardioDispositivos), lo que supone un 40% de la actividad. La media de edad fue 78,6 años, con predominio de varones (60,3%). El bloqueo auriculoventricular fue el trastorno más frecuente y el 14,5% de los pacientes estaban en fibrilación auricular. Predomina el modo de estimulación DDD/R (55,6%) y la edad influye en el modo de estimulación, de forma que más de un tercio de los pacientes mayores de 80 años en ritmo sinusal recibieron estimulación monocameral en ventrículo. Se incluyeron en monitorización a distancia el 35% de los marcapasos y el 55% de los resincronizadores de baja energía. Conclusiones: Aumentan en un 5,6% el número de marcapasos convencionales, un 16% los resincronizadores de baja energía y un 25% los marcapasos sin cables. Se estabiliza la adherencia a la monitorización a distancia. Aumenta en un 11% el número de procedimientos incluidos en CardioDispositivos, aunque disminuye el volumen de muestra. El uso extensivo de la plataforma es lo que permitirá en años venideros contar con un registro de calidad.(AU)

Introduction and objectives: This article reports the cardiac pacing activity performed in 2022, including the total number of implants, adherence to remote monitoring, demographic and clinical factors, and the characteristics of the implanted devices. Methods: The information sources were the CardioDispositivos online platform, the European pacemaker patient identification card, and data provided by the manufacturers. Results: The rates of conventional pacemakers and low-energy resynchronizers were 866 and 34 units per million population, respectively. A total of 815 leadless pacemakers were implanted. In all, 16426 procedures performed in 82 hospitals were reported (9407 through CardioDispositivos), representing 40% of the activity. The mean age was 78.6 years, with a predominance of men (60.3%). The most frequent disorder was atrioventricular block, and 14.5% of the patients had atrial fibrillation. There was a predominance of the DDD/R pacing mode (55.6%), and pacing mode was influenced by age, such that more than one-third of patients older than 80 years in sinus rhythm received single-chamber ventricular pacing. The remote monitoring program included 35% of conventional pacemakers and 55% of low-energy resynchronization pacemakers. Conclusions: The number of conventional pacemakers increased by 5.6%, low-energy resynchronizers by 16%, and leadless pacemakers by 25%. Adherence to remote monitoring was stable. The number of procedures included in CardioDispositivos increased by 11%, although the sample volume decreased. In the coming years, the widespread use of the platform will likely lead to a high-quality registry.(AU)

Site-Level Variation and Predictors of Permanent Pacemaker Implantation Following TAVR in the Evolut Low-Risk Trial.

We evaluated predictors of permanent pacemaker implantation (PPI) following self-expanding transcatheter aortic valve replacement (TAVR), examined site-to-site variability of PPI rates, and explored the relationship of implantation methods on the need for PPI. Despite the benefits of TAVR compared to surgical aortic valve replacement, increased PPI remains a limitation. A total of 699 patients without baseline PPI were included in the study. Clinical, echocardiographic, and procedural characteristics were compared in patient with and without new PPI. Clinical outcomes were assessed at 30 days and 1 year. Funnel plots were constructed to display site-to- site variability and identify outliers in PPI. Clinical outcomes were similar in patients with and without PPI. Predictors of a new PPI within 7 days included a baseline right bundle branch block (p < 0.001) and not using general anesthesia (p = 0.003). There was substantial site to site variability in the rate of PPI. Patients at sites with a lower PPI rate had shallower implantation depth at the non-coronary (p < 0.001) and the left coronary sinus (p < 0.001), and fewer patients with an implantation depth > 5 mm below the annulus (p = 0.004). In low-risk patients undergoing TAVR with Evolut valves, baseline conduction disorders and implant depth were important predictors of PPI. Implantation method may have contributed to this variability in PPI rates across clinical sites.

Registro español de marcapasos. XIX informe oficial de la Asociación del Ritmo Cardiaco de la Sociedad Española de Cardiología (2021) / Spanish pacemaker registry. 19th official report of the Heart Rhythm Association of the Spanish Society of Cardiology (2021)

Introducción y objetivos En el presente documento se recoge la actividad de estimulación cardiaca realizada en España en 2021: cifras de dispositivos, factores demográficos y clínicos, características del material implantado y datos de monitorización a distancia. Métodos Los datos se obtienen a través de la Tarjeta Europea del Paciente Portador de Marcapasos, la plataforma online CardioDispositivos.es, las bases de datos propias de los centros y los datos facilitados por los fabricantes. Resultados Se registraron 17.360 procedimientos de 95 hospitales, lo que supone el 43% de la actividad realizada. Crecieron en un 40,5% los procedimientos incluidos en CardiodioDispositivos.es. La tasa de marcapasos convencionales y resincronizadores de baja energía fue de 822 y 31 unidades/millón respectivamente y se implantaron 652 marcapasos sin cables. La media de edad al implante es avanzada (78,9 años) y el bloqueo auriculoventricular, la alteración electrocardiográfica más frecuente. Predomina el modo de estimulación bicameral, aunque para el 18,5% de los pacientes en ritmo sinusal es monocameral, fundamentalmente pacientes de más edad. Se incluyeron en programa de monitorización a distancia el 28,5% de los marcapasos y el 56,2% de los resincronizadores de baja energía. Conclusiones En 2021 aumentó el número de marcapasos convencionales en un 8,3% y el de resincronizadores, un 8,9%, a pesar del descenso de la resincronización de baja energía, probablemente atribuible al desarrollo de la estimulación del sistema de conducción. Aumentaron los marcapasos sin cables en un 25%. Continúa la expansión de la monitorización a distancia como modo fundamental de seguimiento (AU)

Introduction and objectives This document includes cardiac pacing activity performed in Spain in 2021: figures for implanted devices, demographic and clinical factors, characteristics of the implanted material, and remote monitoring data. Methods The European Pacemaker Patient Card, the CardioDispositivos.es online platform, the centers’ own databases and the data provided by the supplier companies are used as sources of information. Results 17.360 procedures were registered from 95 hospitals, which represents 43% of the activity. The implantation rates of conventional and resynchronization pacemakers were 822 and 31 units per million population, respectively. 652 leadless pacemakers were implanted. The mean age of implantation is high (78.8 years), and atrioventricular block is the most frequent electrocardiographic abnormality. Dual-chamber pacing mode predominated, nonetheless single-chamber pacing was performed in 19% of patients in sinus rhythm, mainly in the elderly. 28.5% of implanted conventional pacemakers and 56,2% of low-energy resynchronization pacemakers were included in the remote monitoring program. Conclusions In 2021 the number of conventional pacemakers increased by 8.3% and resynchronizers by 18.9%, despite the decrease in low-energy resynchronization, probably attributable to the development of physiological pacing. Leadless pacemakers increased by 25%. The expansion of remote monitoring continued, consolidating as a fundamental follow-up method (AU)

Recent improvement in operative techniques lead to lower pacemaker rate after Perceval implant.

OBJECTIVES: Our goal was to compare pacemaker rate usage following two different operating techniques for implanting the Perceval aortic valve replacement. METHODS: In this retrospective, single-centre study, we studied patients with isolated or concomitant Perceval aortic valve replacement operated on first between April 2013 and January 2016, following traditional operating techniques, with patients operated on between January 2016 and December 2020, after the adoption of a modified protocol based on different annulus sizing, higher positioning of the valve and no ballooning after valve deployment was adopted. The operations were performed by 2 surgeons, and patients were followed-up for a period of 30 days. RESULTS: A total of 286 patients, with a mean age of 77 (4.9) years, had Perceval valves implanted during the study period, of which 79% were isolated aortic valve procedures. Most patients (66.8%) underwent minimally invasive procedures. Cross-clamp time was 55.1 (17.6) min. The overall postoperative pacemaker insertion rate was 8.4%, which decreased decisively after the 2016 change in the implant protocol (16% vs 5.6%; P = 0.005), adjusted odds ratio of 0.31 (95% confidence interval: 0.13-0.74, P = 0.012). Univariable and multivariable analysis showed that larger valve size (P = 0.01) and ballooning (P = 0.002) were associated with higher risk of implanting a pacemaker. Postoperative 30-day mortality was of 4.5%. CONCLUSIONS: Improvement in the operating techniques for implanting the Perceval valve may decrease the rate of pacemakers implanted postoperatively. Although further studies are needed to confirm these results, such a risk reduction may lead to wider use of Perceval valves in the future, potentially benefiting patients who are suitable candidates for minimally invasive surgery.

Variation in regional implantation patterns of cardiac implantable electronic device in Switzerland.

INTRODUCTION: There is a substantial geographical variation in the rates of pacemaker (PM), implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) device implantation across European countries. We assessed the extent of regional variation and potential determinants of such variation. METHODS: We conducted a population-based analysis using discharge data for PM/ICD/CRT implantations from all Swiss acute care hospitals during 2013-2016. We derived hospital service areas (HSA) by analyzing patient flows. We calculated age- and sex-standardized rates and quantified variation using the extremal quotient (EQ) and the systemic component of variation (SCV). We estimated the reduction in variance of crude implantation rates across HSAs using multilevel regression models, with incremental adjustment for age and sex, language, socioeconomic factors, population health, diabetes mellitus, and the density of cardiologists on the HSA level. RESULTS: We analyzed implantations of 8129 PM, 1461 ICD, and 1411 CRT from 25 Swiss HSAs. The mean age- and sex-standardized implantation rate was 29 (range 8-57) per 100,000 persons for PM, 5 (1-9) for ICD, and 5 (2-8) for CRT. There was a very high variation in PM (EQ 7.0; SCV 12.6) and ICD (EQ 7.2; SCV 11.3) and a high variation in CRT implantation rates (EQ 3.9; SCV 7.1) across HSAs. Adjustments for age and sex, language, socioeconomic factors, population health, diabetes mellitus, and density of cardiologists explained 94% of the variance in ICD and 87.5% of the variance in CRT implantation rates, but only 36.3% of the variance in PM implantation rates. Women had substantially lower PM/ICD/CRT implantation rates than men. CONCLUSION: Switzerland has a very high regional variation in PM/ICD implantation and a high variation in CRT implantation rates. Women had substantially lower implantation rates than men. A large share of the variation in PM procedure rates remained unexplained which might reflect variations in physicians' preferences and practices.

Implantation of cardiac electronic devices in active COVID-19 patients: Results from an international survey.

BACKGROUND: Cardiac implantable electronic device (CIED) implantation rates as well as the clinical and procedural characteristics and outcomes in patients with known active coronavirus disease 2019 (COVID-19) are unknown. OBJECTIVE: The purpose of this study was to gather information regarding CIED procedures during active COVID-19, performed with personal protective equipment, based on an international survey. METHODS: Fifty-three centers from 13 countries across 4 continents provided information on 166 patients with known active COVID-19 who underwent a CIED procedure. RESULTS: The CIED procedure rate in 133,655 hospitalized COVID-19 patients ranged from 0 to 16.2 per 1000 patients (P <.001). Most devices were implanted due to high-degree/complete atrioventricular block (112 [67.5%]) or sick sinus syndrome (31 [18.7%]). Of the 166 patients in the study survey, the 30-day complication rate was 13.9% and the 180-day mortality rate was 9.6%. One patient had a fatal outcome as a direct result of the procedure. Differences in patient and procedural characteristics and outcomes were found between Europe and North America. An older population (76.6 vs 66 years; P <.001) with a nonsignificant higher complication rate (16.5% vs 7.7%; P = .2) was observed in Europe vs North America, whereas higher rates of critically ill patients (33.3% vs 3.3%; P <.001) and mortality (26.9% vs 5%; P = .002) were observed in North America vs Europe. CONCLUSION: CIED procedure rates during known active COVID-19 disease varied greatly, from 0 to 16.2 per 1000 hospitalized COVID-19 patients worldwide. Patients with active COVID-19 infection who underwent CIED implantation had high complication and mortality rates. Operators should take these risks into consideration before proceeding with CIED implantation in active COVID-19 patients.

Reduction of admissions for urgent and elective pacemaker implant during the COVID-19 outbreak in Northern Italy.

AIMS: The coronavirus disease-19 (COVID-19) outbreak has been recently associated with lower hospitalization rates for acute coronary syndromes. Aim of the study was to investigate whether a similar behaviour is observed in admissions for urgent pacemaker implant. METHODS: This retrospective study included 1315 patients from 18 hospitals in Northern Italy with a high number of COVID-19 cases. Hospitalization rates for urgent pacemaker implant were compared between the following periods: 20 February to 20 April 2020 (case period); from 1 January to 19 February 2020 (intra-year control period); from 20 February to 20 April 2019 (inter-year control period). RESULTS: The incidence rate of urgent implants was 5.0/day in the case period, 6.0/day in the intra-year control period and 5.8/day in the inter-year control period. Incidence rate in the case period was significantly lower than both the intra-year [incidence rate ratio (IRR): 0.81, 95% CI 0.67-0.99, P = 0.040] and inter-year control periods (IRR: 0.79, 95% CI 0.66-0.95, P = 0.012); this reduction was highest after the national lockdown (IRR 0.68, 95% CI 0.52-0.91, P = 0.009). The prevalence of residents in rural areas undergoing urgent pacemaker implant was lower in the case period (36%) than in both the intra-year (47%, P = 0.03) and inter-year control periods (51%, P = 0.002). Elective pacemaker implants also decreased in the case period, with the incidence rate here being 3.5/day vs. 6.4/day in the intra-year (-45%) and 6.9/day in the inter-year period (-49%). CONCLUSION: Despite severe clinical patterns, the COVID-19 outbreak has negatively affected the population presentation to Emergency Departments for bradyarrhythmias requiring urgent pacemaker implant in Northern Italy. This mainly occurred after the national lockdown and concerned patients living in rural areas.

Periprocedural complications of cardiac implantable electronic device implantation in very elderly patients with cognitive impairment: A prospective study.

ABSTRACT: Very elderly people (over 80 years) with cardiac implantable electronic devices (CIEDs) indications often have a higher prevalence of aging comorbidity, among which cognitive impairment is not uncommon. This study aimed to investigate periprocedural complications of CIED implantation among very elderly patients with and without cognitive impairment. One hundred eighty patients ≥80 years of age indicated for CIED implantation were included in our study. During hospitalization, the cognitive evaluation was performed according to the Diagnostic and Statistical Manual of Mental Disorders (fifth edition). According to the cognitive test results, patients were divided into 2 groups (90 patients with normal cognitive function and 90 patients with cognitive impairment). Meanwhile, their physical parameters and laboratory measurements were completed. The procedural data and periprocedural complications were collected from both groups. The association between cognitive impairment and periprocedural complications was analyzed using univariate and multiple logistic regression analyses. During a one-month follow-up, the most frequent periprocedural complications in very elderly patients were pocket hematoma and thrombosis events. Cognitively impaired patients had a higher incidence of complications than normal cognitive patients. Multivariate regression analysis showed that cognitive impairment was positively correlated with periprocedural complications in very elderly patients. Cognitive impairment is associated with increased periprocedural complications of CIED implantation in very elderly patients.

Tissues attached to retrieved leadless pacemakers: Histopathological evaluation of tissue composition in relation to implantation time and complications.

BACKGROUND: Leadless pacemakers (LPs) have proven safe and effective, but device revisions remain necessary. Either replacing the LP or implanting a new adjacent LP is feasible. Replacement seems more appealing, but encapsulation and tissue adhesions may hamper the safety and efficacy of LP retrieval. OBJECTIVE: We determined the incidence and cellular characteristics of tissue adherent to retrieved LPs and the potential implications for end-of-life strategy. METHODS: All 15 consecutive successful Nanostim LP retrievals in a tertiary center were included. We assessed the histopathology of adherent tissue and obtained clinical characteristics. RESULTS: Adherent tissue was present in 14 of 15 retrievals (93%; median implantation duration 36 months; range 0-96 months). The tissue consisted of fibrosis (n = 2), fibrosis and thrombus (n = 9), or thrombus only (n = 3). In short-term retrievals (<1 year), mostly fresh thrombi without fibrosis were seen. In later retrievals, the tissue consisted of fibrosis often with organizing or lytic thrombi. Fibrosis showed different stages of organization, notably early fibrocellular and later fibrosclerotic tissue. Inflammatory cells were seen (n = 4) without signs of infection. Tricuspid valve material was retrieved in 1 patient after 36 months, resulting in increased tricuspid regurgitation. CONCLUSION: Our results suggest that fibrosis and thrombus adherent to LPs are common and encapsulate the LP as seen in transvenous pacemakers. LPs may adhere to the tricuspid valve or subvalvular apparatus affecting retrieval safety. The end-of-life strategy should be optimized by incorporating risk stratification for excessive fibrotic encapsulation and adhesions.

Long-term Outcomes Associated With Permanent Pacemaker Implantation After Surgical Aortic Valve Replacement.

Importance: Prior studies investigating the long-term clinical outcomes of patients who have undergone permanent pacemaker implantation after aortic valve replacement reported conflicting results. Objective: To investigate long-term outcomes after primary surgical aortic valve replacement among patients who underwent postoperative permanent pacemaker implantation. Design, Setting, and Participants: This cohort study included all patients who underwent surgical aortic valve replacement in Sweden from 1997 to 2018. All patients who underwent primary surgical aortic valve replacement in Sweden and survived the first 30 days after surgical treatment were included. Patients who underwent preoperative permanent pacemaker implantation, concomitant surgical treatment for another valve, or emergency surgical treatment were excluded. Patients who underwent concomitant coronary artery bypass grafting or surgical treatment of the ascending aorta were included. Follow-up data were complete for all patients. Data were analyzed from October through December 2020. Exposures: Patients underwent implantation of a permanent pacemaker or implantable cardioverter defibrillator within 30 days after aortic valve replacement. Main Outcomes and Measures: The primary outcome was all-cause mortality. Results: Among 24 983 patients who underwent surgical aortic valve replacement, 849 patients (3.4%) underwent permanent pacemaker implantation within 30 days after surgical treatment and 24 134 patients (96.6%) did not receive pacemakers in that time. The mean (SD) age of the total study population was 69.7 (10.8) years, and 9209 patients were women (36.9%). The mean (SD) and maximum follow-up periods were 7.3 (5.0) years and 22.0 years, respectively. At 10 years and 20 years after surgical treatment, the Kaplan-Meier estimated survival rates were 52.8% and 18.0% in the pacemaker group, respectively, and 57.5% and 19.6% in the nonpacemaker group, respectively. All-cause mortality was statistically significantly increased in the pacemaker group compared with the nonpacemaker group (hazard ratio [HR], 1.14; 95% CI, 1.01-1.29; P = .03), and so was risk of heart failure hospitalization (HR, 1.58; 95% CI, 1.31-1.89; P < .001). No statistically significant increase was found in the risk of endocarditis in the pacemaker group. Conclusions and Relevance: This study found that there were increased risks of all-cause mortality and heart failure hospitalization among patients who underwent permanent pacemaker implantation after surgical aortic valve replacement, suggesting that these risks are important considerations, especially in an era when transcatheter aortic valve replacement is used in younger patients at lower risk of adverse surgical outcomes. These findings further suggest that future research should investigate how to avoid permanent pacemaker dependency after surgical and transcatheter aortic valve replacement.

Pacemaker dependency after transcatheter aortic valve replacement compared to surgical aortic valve replacement.

ABSTRACT: Transcatheter aortic valve replacement (TAVR) is a standard treatment indicated for severe aortic stenosis in high-risk patients. The objective of this study was to evaluate the incidence of pacemaker dependency after permanent pacemaker implantation (PPI) following TAVR or surgical aortic valve replacement (SAVR) and the risk of mortality at a tertiary center in Korea.In this retrospective study conducted at a single tertiary center, clinical outcomes related to pacemaker dependency were evaluated for patients implanted with pacemakers after TAVR from January 2012 to November 2018 and post-SAVR from January 2005 to May 2015. Investigators reviewed patients' electrocardiograms and baseline rhythms as well as conduction abnormalities. Pacemaker dependency was defined as a ventricular pacing rate > 90% with an intrinsic rate of <40 bpm during interrogation.Of 511 patients who underwent TAVR for severe AS, 37(7.3%) underwent PPI after a median duration of 6 (3-7) days, whereas pacemakers were implanted after a median interval of 13 (8-28) days post-SAVR in 10 of 663 patients (P < .001). Pacemaker dependency was observed in 36 (97.3%) patients during 7 days immediately post-TAVR and in 25 (64.9%) patients between 8 and 180 days post-TAVR. Pacemaker dependency occurred after 180 days in 17 (50%) patients with TAVR and in 4 (44.4%) patients with SAVR. Twelve (41.4%) patients were pacemaker-dependent after 365 days post-TAVR.Pacemaker dependency did not differ at 6 months after TAVR vs SAVR. In patients undergoing post-TAVR PPI, 58.6% were not pacemaker-dependent at 1 year after the TAVR procedure.

Registro Costarricense de Resincronizadores, Desfibriladores Automáticos y Marcapasos Endovasculares (RECORDAME). I Informe oficial de la Comisión de Electrofisiología de la Asociación Costarricense de Cardiología (2019-2020) / Costa Rican Registry of Resynchronizers, Automatic Defibrillators and Endovascular Pacemakers (RECORDAME). I Official Report of the Electrophysiology Commission of the Costa Rican Cardiology Association (2019-2020)

Resumen Introducción y objetivo: Comunicar el primer informe del del registro nacional de dispositivos de estimulación cardíaca de agosto 2019 a agosto 2020, registro prospectivo de participación voluntaria. Métodos: Se analiza la información registrada, en forma voluntaria, por los centros implantadores con respecto a la población de pacientes a quienes se implantó un marcapaso, un desfibrilador o un resincronizador entre el 22 de agosto de 2019 hasta setiembre de 2020. Resultados: Se registraron un total de 317 procedimientos de marcapasos, por 10 centros implantadores, lo que corresponde a una participación en el registro de un 40%. La tasa de uso de marcapasos de 6,27 x 100 mil habitantes. Un 83% de los marcapasos fueron implantados en centros públicos, un 70% correspondió a dispositivos bicamerales. La edad media de la población fue de 73,7 años. La indicación más frecuente fue el trastorno de conducción AV (70,3%). Los electrodos de fijación activa fueron los más utilizados (97,8%). Un 83,3% de los sistemas implantados tuvieron compatibilidad con resonancia magnética. El uso de marcapasos unicamerales fue más frecuente en pacientes con 80 o más años. Con respecto a la terapia DAI se registraron un total de 63 procedimientos, por 5 centros implantadores, con una participación del 41%. La tasa total de implantes durante el período fue de 1,25 x 100 mil habitantes. La cardiomiopatía dilatada no isquémica fue la cardiopatía más frecuente en la población registrada. Conclusiones: El registro permite conocer la dinámica de procedimientos e indicaciones más usuales para el uso de dispositivos electrónicos cardíacos así como establecer la tasa de uso de las terapias en nuestro país. El porcentaje de participación en el registro puede mejorar. La implantación de dispositivos de estimulación cardíaca es financiada predominantemente por el sistema de seguridad social. La tasa de implantación es baja con respecto a otras regiones.

Abstract Costa Rican Registry of Resynchronizers, Automatic Defibrillators and Endovascular Pacemakers (RECORDAME). I Official Report of the Electrophysiology Commission of the Costa Rican Cardiology Association (2019-2020) Introduction and objective: To communicate the results of the first national registry of cardiac stimulation devices from August 2019 to August 2020. Methods: We analyze the information recorded prospectively, on a voluntary basis, by the implant centers with respect to the population of patients who were implanted with a pacemaker, a defibrillator or a resynchronizer between August 22, 2019 and September 2020. Results: A total of 317 pacemaker procedures were registered from 10 centers participated. Participation was 40% of total procedures reported by companies. The pacemaker implantation rate was 6.27 per hundred thousand. A 83% of pacemakers were implanted in public centers, 70% corresponded to dual chamber devices. Mean age of the population was 73.7 years. Most frequent indication was AV conduction disorder (70.3%). Active fixation electrodes were the most used (97.8%). A 83.3% were MRI conditional. Use of single chamber pacemakers was more frequent in patients aged 80 years or older. Regarding ICD therapy, a total of 63 procedures were registered. from 5 centers, with a participation of 41%. Rate of ICD use was 1.25 per hundred thousand. Non-ischemic dilated cardiomyopathy was the most common heart disease in the recorded population. Conclusions: The registry allowed to know the frequency of procedures and more usual indications as well as to establish the rate of use of therapies in our country. The percentage of participation in the registration can be improved. The implementation of cardiac stimulation devices is predominantly financed by the social security system. The implantation rate is low compared to other regions.

Impact of Cusp-Overlap View for TAVR with Self-Expandable Valves on 30-Day Conduction Disturbances.

METHODS AND RESULTS: We retrospectively compared 257 consecutive patients undergoing TAVR with self-expandable valves using either CON (n = 101) or COVL (n = 156) in four intermediate/low volume centers. There were no significant differences in baseline characteristics between the groups. The 30-day incidence of new-onset LBBB (12.9% vs. 5.8%; p=0.05) and PPMI rate (17.8% vs. 6.4%; p=0.004) was significantly lower when using the COVL implantation view. There was no difference between the CON and COVL groups in 30-day incidence of death (4.9% vs. 2.6%), any stroke (0% vs. 0.6%), and the need for surgical aortic valve replacement (0% for both groups). CONCLUSION: Using the COVL view for implantation, we achieved a significant reduction of the LBBB and PPMI rate after TAVR in comparison with the traditional CON view, without compromising the TAVR outcomes when using self-expandable prostheses.

Do Women Require Less Permanent Pacemaker After Transcatheter Aortic Valve Implantation? A Meta-Analysis and Meta-Regression.

Background Limited clinical evidence and literature are available about the potential impact of sex on permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI). The aim of this work was to evaluate the relationship between sexes and atrioventricular conduction disturbances requiring PPI after TAVI. Methods and Results Data were obtained from 46 studies from PubMed reporting information about the impact of patient sex on PPI after TAVI. Total proportions with 95% Cls were reported. Funnel plot and Egger test were used for estimation of publication bias. The primary end point was 30-day or in-hospital PPI after TAVI, with odds ratios and 95% CIs extracted. A total of 70 313 patients were included, with a cumulative proportion of 51.5% of women (35 691 patients; 95% CI, 50.2-52.7). The proportion of women undergoing TAVI dropped significantly over time (P<0.0001). The cumulative PPI rate was 15.6% (95% CI, 13.3-18.3). The cumulative rate of PPI in women was 14.9% (95% CI, 12.6-17.6), lower than in men (16.6%; 95% CI, 14.2-19.4). The risk for post-TAVI PPI was lower in women (odds ratio, 0.90; 95% CI, 0.84-0.96 [P=0.0022]). By meta-regression analysis, age (P=0.874) and ventricular function (P=0.302) were not significantly associated with PPI among the sexes. Balloon-expandable TAVI significantly decrease the advantage of women for PPI, approaching the same rate as in men (P=0.0061). Conclusions Female sex is associated with a reduced rate of PPI after TAVI, without influence of age or ventricular function. Balloon-expandable devices attenuate this advantage in favor of women. Additional investigations are warranted to elucidate sex-based differences in developing conduction disturbances after TAVI.

Early and Two-year Outcomes after Sutureless and Conventional Aortic Valve Replacement: a Nationwide Population-based Study.

BACKGROUND: We compared early and 2-year clinical outcomes of sutureless aortic valve replacement (SAVR) with conventional aortic valve replacement (CAVR) in a nationwide study based on claims data. METHODS: From December 2016 to November 2018, 3,173 patients underwent bioprosthetic aortic valve replacements. SAVR and CAVR were performed in 641 and 2,532 patients, respectively. Propensity score-matched analysis was performed in 640 patient pairs. RESULTS: Operative mortality rate was 2.8% without significant differences between the SAVR (3.4%) and CAVR (2.3%) groups (P = 0.324). There were no significant differences in postoperative morbidities between the groups except for permanent pacemaker (PPM) implantation. PPM implantation rate was significantly higher in the SAVR (3.8%) than in the CAVR group (0.9%) (P < 0.001). One- and two-year overall survival was 89.1% and 87.5%, respectively, without significant differences between the groups (SAVR group vs. CAVR grouP = 89.9% and 90.5% vs. 87.2% and 88.7%, respectively; P = 0.475). There were no significant differences in the cumulative incidence of cardiac death, stroke, aortic valve reoperation and infective endocarditis between the groups. Cumulative PPM implantation incidence at 6 months in the CAVR was 1.1%, and no patient required PPM implantation after 6 months. In the SAVR, the cumulative PPM implantation incidence at 0.5, one, and two years was 3.9%, 5.0% and 5.6%, respectively. The cumulative PPM implantation rate was higher in the SAVR group than in the CAVR group (P < 0.001). CONCLUSION: Early and 2-year clinical outcomes between SAVR and CAVR were not different except for a high rate of permanent pacemaker implantation in the SAVR group.

The usefulness of a delivery catheter system for right ventricular "true" septal pacing.

Right ventricular (RV) septum is an alternate site for the placement of RV lead tip instead of RV apex. Recent studies have demonstrated that less than half of the RV leads targeted for septal implantation are placed on the RV septum using a conventional stylet system; new guiding catheter systems have become available for RV lead placement. This study aimed to investigate the usefulness of the delivery catheter system in lead placement on the RV septum when compared with the stylet system. We retrospectively evaluated 198 patients who underwent fluoroscopically guided pacemaker implantation with RV leads targeted to be placed in the RV septum and in whom computed tomography was incidentally and subsequently performed. A delivery catheter was used in 16 patients, and a stylet in 182 patients. The primary endpoint of this study was the success rate of RV lead placement on the RV septum. The proportion of RV lead placement on the RV septum was higher in the delivery catheter group than in the stylet group (100% vs. 44%; p < 0.001). In the stylet group, the lead tips were placed at the hinge in 92 cases (51%) and on the free wall in 9 cases (5%). Paced QRS duration was narrower in the delivery catheter group than in the stylet group (128 ± 16 vs. 150 ± 21 ms, p < 0.01). The delivery catheter system designated for pacing leads may aid in selecting RV septal sites and achieve good physiologic ventricular activation.

Transcatheter Replacement of Transcatheter Versus Surgically Implanted Aortic Valve Bioprostheses.

BACKGROUND: Surgical aortic valve replacement and transcatheter aortic valve replacement (TAVR) are now both used to treat aortic stenosis in patients in whom life expectancy may exceed valve durability. The choice of initial bioprosthesis should therefore consider the relative safety and efficacy of potential subsequent interventions. OBJECTIVES: The aim of this study was to compare TAVR in failed transcatheter aortic valves (TAVs) versus surgical aortic valves (SAVs). METHODS: Data were collected on 434 TAV-in-TAV and 624 TAV-in-SAV consecutive procedures performed at centers participating in the Redo-TAVR international registry. Propensity score matching was applied, and 330 matched (165:165) patients were analyzed. Principal endpoints were procedural success, procedural safety, and mortality at 30 days and 1 year. RESULTS: For TAV-in-TAV versus TAV-in-SAV, procedural success was observed in 120 (72.7%) versus 103 (62.4%) patients (p = 0.045), driven by a numerically lower frequency of residual high valve gradient (p = 0.095), ectopic valve deployment (p = 0.081), coronary obstruction (p = 0.091), and conversion to open heart surgery (p = 0.082). Procedural safety was achieved in 116 (70.3%) versus 119 (72.1%) patients (p = 0.715). Mortality at 30 days was 5 (3%) after TAV-in-TAV and 7 (4.4%) after TAV-in-SAV (p = 0.570). At 1 year, mortality was 12 (11.9%) and 10 (10.2%), respectively (p = 0.633). Aortic valve area was larger (1.55 ± 0.5 cm2 vs. 1.37 ± 0.5 cm2; p = 0.040), and the mean residual gradient was lower (12.6 ± 5.2 mm Hg vs. 14.9 ± 5.2 mm Hg; p = 0.011) after TAV-in-TAV. The rate of moderate or greater residual aortic regurgitation was similar, but mild aortic regurgitation was more frequent after TAV-in-TAV (p = 0.003). CONCLUSIONS: In propensity score-matched cohorts of TAV-in-TAV versus TAV-in-SAV patients, TAV-in-TAV was associated with higher procedural success and similar procedural safety or mortality.

Atrioventricular Block after Tricuspid Valve Surgery.

Tricuspid valve (TV) surgery is associated with a high risk of postoperative pacemaker requirement. We set out to identify the incidence of atrioventricular block (AVB) after TV surgery and determine whether atrioventricular conduction recovers within time.We investigated pre/intra- and postoperative predictors of AVB in patients who underwent tricuspid valve surgery (not only isolated TV surgery) at our institution between 2004 and 2017. Patients who had pacemakers prior to surgery were excluded.One year after surgery, 5.8% of the surviving cohort had received a pacemaker due to AVB. In the complete follow-up time, 33 out of 505 patients required pacemaker implantation because of AVB. Of the 37 patients who presented to the intensive care unit postoperatively with AVB III, 14 (38%) underwent pacemaker implantation for AVB, and 20 (54%) did not require a pacemaker. AVB III at ICU admission was identified as a predictor of pacemaker implantation (OR: 9.7, CI: 3.8-24.5, P < 0.001). TV endocarditis was also identified as a predictor (OR: 12.4, CI: 3.3-46.3, P < 0.001). Eleven out of 32 patients (34%) with tricuspid endocarditis required a pacemaker for AVB. The mean ventricular pacing burden within the first 5 years after pacemaker implantation was 79%.The issue of AVB after TV surgery is significant. Both the initial rhythm after surgery and etiology of the tricuspid disease can help predict pacemaker requirement. Within the first 5 years after surgery, the ventricular pacing burden remains high without relevant rhythm recovery.