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.

Patient with sick sinus syndrome and implanted dual-chamber pacemaker with reduced P-wave duration following low interatrial septal pacing: Case report.

INTRODUCTION: A dual-chamber pacemaker (DDD/R) for a sinus node disease is sometimes referred to as a physiological pacemaker as it maintains atrioventricular synchrony, however several clinical trials have proved its inferiority to a nonphysiological single-chamber ventricular back-up pacing. PATIENT CONCERNS: A subject of the study is a 74-year-old woman with a sick sinus syndrome (SSS) and a previously implanted physiological DDD/R pacemaker. The SSS was diagnosed because of patient's very slow sinus rhythm of about 36 bpm, and due to several episodes of dizziness. After the DDD/R implantation the percentage of atrial pacing approached 100%, with almost none ventricular pacing. DIAGNOSES: Sick sinus syndrome, complete Bachmann's bundle block, atrial fibrillation, atrial flutter. INTERVENTIONS: The patient was previously implanted with a physiological DDD/R pacemaker. Several years after the implantation, the atrial fibrillation was diagnosed and the pulmonary vein isolation was then performed by cryoablation. During the follow-up after pulmonary vein isolation, the improvement of mitral filling parameters was assessed using echocardiography. Shortly thereafter the patient developed the persistent paroxysm of a typical atrial flutter which was successfully terminated using a radiofrequency ablation. No recurrence thereof has been observed ever since (24 months). OUTCOMES: The atrial electrode of the pacing system was implanted within the low interatrial septal region that resulted in a reduced P-wave duration compared to native sinus rhythm P-waves. The said morphology was deformed because of the complete Bachmann bundle block. That approach, despite a nonphysiological direction of an atrial activation, yielded relatively short P-waves (paced P-wave: 179 ms vs intrinsic sinus P-wave: 237 ms). It also contributed to a significantly shorter PR interval (paced PR: 204 ms vs sinus rhythm PR: 254 ms). CONCLUSIONS: The authors took into consideration different aspects of alternative right atrial pacing sites. This report has shown that in some patients with a sinus node disease, low interatrial septal pacing can reduce the P-wave duration but does not prevent from the development of atrial arrhythmias.

Lower rate limit for pacing by cardiac resynchronization defibrillators: Should lower rate programming be reconsidered?

BACKGROUND: No real-world large database associates lower rate limit (LRL) programming and survival of subjects with cardiac resynchronization therapy-defibrillators (CRT-Ds). OBJECTIVE: The purpose of this study was to test the hypothesis that lower LRL programming is independently associated with survival, and that LRL and heart rate score (HrSc) are associated. METHODS: All dual-chamber CRT-D devices in the Remote Patient Monitoring (RPM) ALTITUDE database (2006-2011) were queried. Baseline HrSc was defined as the percentage of all atrial sensed and paced beats in the tallest 10-beat histogram bin postimplant. LRL was assessed during repeated RPM uploads. Using a Cox model multivariable analysis, relationships between LRL, survival, HrSc, and other variables were evaluated. Survival was determined by query of death indices. RESULTS: Data analyzed included 61,881 subjects (mean follow-up 2.9 years). LRL ranged from 40 to 85 bpm. Baseline lower LRL was associated with younger age, less atrial fibrillation, female sex, and lower HrSc (P <.001 for all covariates). Lower LRL was associated with improved survival, with LRL 40 associated with the largest survival benefit. This was significant for all 3 HrSc subgroups (P <.001). An interaction between HrSc and LRL was observed, with the largest survival difference between HrSc groups observed at LRL-40 (P <.001). CONCLUSION: LRL programming and HrSc were associated, and lower values of both were associated with improved survival in a large database of CRT-D subjects. Relationships between survival, LRL programming, and HrSc merit further study.

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.

Safety and Long-term Outcomes of Defibrillator Therapy in Patients With Right-Sided Implantable Cardiac Devices in Adults With Congenital Heart Disease.

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) have been proven to prevent sudden cardiac death in adult congenital heart disease (ACHD) patients. Although the left side is chosen by default, implantation from the right side is often required. However, little is known about the efficacy and safety of right-sided ICDs in ACHD patients. METHODS: In this study we reviewed a total of 191 ACHD patients undergoing ICD/cardioverter resynchronisation therapy-defibrillator (CRT-D) implantation at our hospital between 2001 and 2019 (134 men and 57 women; age [mean ± standard deviation], 41.5 ± 14.8 years). RESULTS: Twenty-seven patients (14.1%) had right-sided devices. The most common causes of right-sided implantation were persistent left superior vena cava and vein occlusion (37.0%). Although procedure time (202.8 ± 60.5 minutes vs 143.8 ± 69.1 minutes, P = 0.008) was longer and the procedural success was lower (92.6% vs 99.4%, P = 0.008) for right-sided devices, no difference in R-wave and pacing threshold were noted. Among the 47 patients (24.6%) who underwent defibrillation threshold testing (DFT), no difference in DFT was observed (25.2 ± 5.3 J vs 23.8 ± 4.1 J, P = 0.460). During the median follow-up of 42.4 months, appropriate ICD therapy was observed in 5 (18.5%) and 30 (18.3%) patients for right- and left-sided ICDs/CRTDs, respectively (P = 0.978). No significant difference was seen in complications between them. CONCLUSIONS: Implantation of an ICD on the right side is technically challenging, but it is feasible as an alternative approach for ACHD patients with contraindications to left-sided device implantation.

Use of Oral Anticoagulation in a Real-World Population With Device Detected Atrial Fibrillation.

Background Guideline recommendations for oral anticoagulation (OAC) in patients with atrial fibrillation (AF) are based on CHA2DS2-VASc score alone. Patients with cardiac implantable electronic devices provide an opportunity to assess how the interaction between AF duration and CHA2DS2-VASc score influences OAC prescription rates. Methods and Results Data from the Optum de-identified Electronic Health Record data set were linked to the Medtronic CareLink database of cardiac implantable electronic devices. An index date was assigned as the later of 6 months after device implant or 1 year after Electronic Health Record data availability. Maximum daily AF duration (no AF, 6 minutes-23.5 hours, and >23.5 hours) was assessed for 6 months before index date. OAC prescription rates were computed as a function of both AF duration and CHA2DS2-VASc score. A total of 35 779 patients with CHA2DS2-VASc scores ≥1 were identified, including 27 198 not prescribed OAC. Overall OAC prescription rate among the 12 938 patients with device-detected AF >6 minutes was 36.7% and significantly higher in those with a maximum daily AF duration >23.5 hours (45.4%) compared with those with 6 minutes to 23.5 hours (28.7%). OAC prescription rates increased monotonically with both increasing AF duration and CHA2DS2-VASc score, reaching a maximum of 67.2% for patients with AF >23.5 hours and a CHA2DS2-VASc score ≥5. Conclusions Real-world prescription of OAC increased with both increasing duration of AF and CHA2DS2-VASc score. This highlights the need for further research into the role of AF duration, stroke risk, and the need for anticoagulation in patients with devices capable of long-term AF monitoring.

Association Between Industry Payments to Physicians and Device Selection in ICD Implantation.

Importance: Little is known about the association between industry payments and medical device selection. Objective: To examine the association between payments from device manufacturers to physicians and device selection for patients undergoing first-time implantation of a cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D). Design, Setting, and Participants: In this cross-sectional study, patients who received a first-time ICD or CRT-D device from any of the 4 major manufacturers (January 1, 2016-December 31, 2018) were identified. The data from the National Cardiovascular Data Registry ICD Registry was linked with the Open Payments Program's payment data. Patients were categorized into 4 groups (A, B, C, and D) corresponding to the manufacturer from which the physician who performed the implantation received the largest payment. For each patient group, the proportion of patients who received a device from the manufacturer that provided the largest payment to the physician who performed implantation was determined. Within each group, the absolute difference in proportional use of devices between the manufacturer that made the highest payment and the proportion of devices from the same manufacturer in the entire study cohort (expected prevalence) was calculated. Exposures: Manufacturers' payments to physicians who performed an ICD or CRT-D implantation. Main Outcomes and Measures: The primary outcome of the study was the manufacturer of the device used for the implantation. Results: Over a 3-year period, 145 900 patients (median age, 65 years; 29.6% women) received ICD or CRT-D devices from the 4 manufacturers implanted by 4435 physicians at 1763 facilities. Among these physicians, 4152 (94%) received payments from device manufacturers ranging from $2 to $323 559 with a median payment of $1211 (interquartile range, $390-$3702). Between 38.5% and 54.7% of patients received devices from the manufacturers that had provided physicians with the largest payments. Patients were substantially more likely to receive devices made by the manufacturer that provided the largest payment to the physician who performed implantation than they were from each other individual manufacturer. The absolute differences in proportional use from the expected prevalence were 22.4% (95% CI, 21.9%-22.9%) for manufacturer A; 14.5% (95% CI, 14.0%-15.0%) for manufacturer B; 18.8% (95% CI, 18.2%-19.4%) for manufacturer C; and 30.6% (95% CI, 30.0%-31.2%) for manufacturer D. Conclusions and Relevance: In this cross-sectional study, a large proportion of ICD or CRT-D implantations were performed by physicians who received payments from device manufacturers. Patients were more likely to receive ICD or CRT-D devices from the manufacturer that provided the highest total payment to the physician who performed an ICD or CRT-D implantation than each other manufacturer individually.

Telephone follow-up of patients with cardiovascular implantable electronic devices during the coronavirus disease 2019 pandemic: early results.

BACKGROUND: In the midst of the SARS­CoV­2 pandemic, basic healthcare challenges arise as lockdowns and social isolation are implemented to prevent the spread of the virus. In order to overcome these challenges, the Polish National Health Fund has facilitated telemedical consultations. AIMS: The aim of this study was to compare teleconsultations with regular visits at ambulatory clinic of implantable devices and to assess whether teleconsultations would be an adequate replacement during times of limited face­to­face contact. METHODS: Teleconsultations in the clinic were introduced for patients without the possibility of remote control of cardiac implantable electronic devices. Prior to planned visits, physicians phoned patients and interviewed them about their health. Further treatment decisions were made based on the interview and available medical records. RESULTS: Teleconsultations were carried out over 3.5 weeks (March 13 to April 1, 2020). Out of 400 patients who had visits planned at the clinic, 349 were consulted by phone. A total of 299 patients confirmed stable health status, 14 reported some symptoms, and 4 were hospitalized; 2 patients changed their primary clinic and were no longer under our care, 1 was undergoing quarantine, 15 required additional intervention, and 15 had died prior to contact. In general, patients gave positive feedback on their teleconsultations. CONCLUSIONS: Teleconsultations are a much­needed option during the SARS­CoV­2 pandemic. They are an effective way to decrease interpersonal contact and to overcome sudden changes to the ambulatory visit plan, which may otherwise put an overwhelming burden on the clinic.

Prospective evaluation of the multisensor HeartLogic algorithm for heart failure monitoring.

BACKGROUND: The HeartLogic algorithm measures data from multiple implantable cardioverter-defibrillator-based sensors and combines them into a single index. The associated alert has proved to be a sensitive and timely predictor of impending heart failure (HF) decompensation. HYPOTHESIS: We describe a multicenter experience of remote HF management by means of HeartLogic and appraise the value of an alert-based follow-up strategy. METHODS: The alert was activated in 104 patients. All patients were followed up according to a standardized protocol that included remote data reviews and patient phone contacts every month and at the time of alerts. In-office examinations were performed every 6 months or when deemed necessary. RESULTS: During a median follow-up of 13 (10-16) months, the overall number of HF hospitalizations was 16 (rate 0.15 hospitalizations/patient-year) and 100 alerts were reported in 53 patients. Sixty alerts were judged clinically meaningful, and were associated with multiple HF-related conditions. In 48 of the 60 alerts, the clinician was not previously aware of the condition. Of these 48 alerts, 43 triggered clinical actions. The rate of alerts judged nonclinically meaningful was 0.37/patient-year, and the rate of hospitalizations not associated with an alert was 0.05/patient-year. Centers performed remote follow-up assessments of 1113 scheduled monthly transmissions (10.3/patient-year) and 100 alerts (0.93/patient-year). Monthly remote data review allowed to detect 11 (1%) HF events requiring clinical actions (vs 43% actionable alerts, P < .001). CONCLUSIONS: HeartLogic allowed relevant HF-related clinical conditions to be identified remotely and enabled effective clinical actions to be taken; the rates of unexplained alerts and undetected HF events were low. An alert-based management strategy seemed more efficient than a scheduled monthly remote follow-up scheme.

Evaluation, Management, and Outcomes of Patients Poorly Responsive to Cardiac Resynchronization Device Therapy.

BACKGROUND: "Nonresponse" to cardiac resynchronization therapy (CRT) is recognized, but definition(s) applied in practice, treatment(s), and their consequences are little known. OBJECTIVES: The authors sought to assess nonresponse in the prospective, international, ADVANCE CRT registry (Advance Cardiac Resynchronization Therapy Registry). METHODS: Each subject's response was assessed at 6 months post-implantation using site-specific definitions and compared with the independently derived clinical composite score (CCS). Treatment(s) and hospitalization(s) were tracked during the following 6 months. RESULTS: Of 1,524 subjects enrolled in 69 centers (68 ± 12 years of age, 32% female, ischemic disease 39%), 74.3% received CRT-defibrillator devices, using mainly quadripolar LV leads (75%) deployed laterally (78%). Indications for CRT were wider than past trials. Among 1,327 evaluable subjects, site-defined nonresponse was 20.0% (greater age, comorbidities, ischemic cardiomyopathy, non-left bundle branch block, and lower %CRT pacing vs. responders). Site definitions used mainly clinical criteria (echocardiography infrequently), and underestimated nonresponders by 35% compared with CCS (58% sensitivity vs. CCS). Overall, more site-defined nonresponders received treatment (55.9% vs. 38.3% of responders; p < 0.001) using medication changes and heart failure education, but device programming less frequently. Intensification of in-clinic/remote evaluations and involvement of heart failure specialists remained minimal. Remarkably, 44% of site-defined nonresponders received no additional treatment. Frequency and duration of hospitalizations, and death, among site-defined nonresponders was significantly higher than responders. CONCLUSIONS: A high incidence of CRT nonresponders persists despite good patient selection and LV lead position, but site identification methods have modest sensitivity. Following diagnosis, nonresponders are often passively managed, without specialty care, with poor outcome. ADVANCE CRT exposes a vulnerable group of heart failure patients. (Advance Cardiac Resynchronization Therapy Registry [ADVANCE CRT]; NCT01805154).

Sex-Related Procedural Aspects and Complications in CRT Survey II: A Multicenter European Experience in 11,088 Patients.

OBJECTIVES: This study sought to compare sex difference for procedural aspects and complications in the European Society of Cardiology CRT Survey II, exploring whether adverse events were related to the type of CRT device implanted. BACKGROUND: Sex-related differences in procedural aspects and complications in patients undergoing cardiac resynchronization therapy (CRT) implantation has not been explored in a real-life population. METHODS: A post-hoc analysis of procedural data and complications in different sexes and factors associated with events was performed from data collected in the European Society of Cardiology CRT Survey II. RESULTS: Of all patients (n = 11,088) included, 24.3% were women. The mean age (70 years of age) of male and female recipients was similar. Female patients more frequently had an idiopathic cardiomyopathy (67.4% vs. 44.1%) and fewer comorbidities, including atrial fibrillation (34.8% vs. 42.8%), diabetes (29.1% vs. 32.1%), chronic obstructive lung disease (10.3% vs. 12.6%), and renal failure (28.7% vs. 31.9%), compared with men. More women compared with men had a pacemaker (56.6% vs. 46.3%) and much less often an implantable cardioverter-defibrillator (CRT-D) (19.0% vs. 34.7%) implant. Periprocedural event rate was the highest in women with CRT with defibrillator (7.1% vs. 4.8% in men), followed by women with a CRT with pacing (5.5% vs. 4.4% in men). The higher periprocedural event rate in CRT-D women was attributable primarily to the occurrence of pneumothorax (1.4%), coronary sinus dissection (2.1%), and pericardial tamponade (0.3%). The rate of in-hospital major adverse events (6.0%) and complications necessitating reoperation (4.0%) was not different among sex and device type. CONCLUSIONS: Women are more likely to experience adverse procedure-related events during CRT implantation. Thus, preventive strategies should be employed to minimize complication rate.

Unscheduled Emergency Visits after Cardiac Devices Implantation: Comparison between Cardioverter Defibrillators and Cardiac Resynchronization Therapy Devices in less than one year of Follow Up / Consultas Não Programadas em Emergência após Implante de Dispositivos Cardíacos: Comparativo entre Cardiodesfibriladores e Ressincronizadores em Seguimento Inferior a 1 Ano

Abstract Background: The use of Cardiovascular Implantable Electronic Devices (CIED), such as the Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT), is increasing. The number of leads may vary according to the device. Lead placement in the left ventricle increases surgical time and may be associated with greater morbidity after hospital discharge, an event that is often confused with the underlying disease severity. Objective: To evaluate the rate of unscheduled emergency hospitalizations and death after implantable device surgery stratified by the type of device. Methods: Prospective cohort study of 199 patients submitted to cardiac device implantation. The groups were stratified according to the type of device: ICD group (n = 124) and CRT group (n = 75). Probability estimates were analyzed by the Kaplan-Meier method according to the outcome. A value of p < 0.05 was considered significant in the statistical analyses. Results: Most of the sample comprised male patients (71.9%), with a mean age of 61.1 ± 14.2. Left ventricular ejection fraction was similar between the groups (CRT 37.4 ± 18.1 vs. ICD 39.1 ± 17.0, p = 0.532). The rate of unscheduled visits to the emergency unit related to the device was 4.8% in the ICD group and 10.6% in the CRT group (p = 0.20). The probability of device-related survival of the variable "death" was different between the groups (p = 0.008). Conclusions: Patients after CRT implantation show a higher probability of mortality after surgery at a follow-up of less than 1 year. The rate of unscheduled hospital visits, related or not to the implant, does not differ between the groups.

Resumo Fundamento: O uso de dispositivos cardíacos eletrônicos implantáveis (DCEI) como o cardiodesfibrilador (CDI) e terapia de ressincronização cardíaca (TRC) - é cada vez maior. O número de eletrodos de estimulação e desfibrilação varia de acordo com o dispositivo. A colocação do eletrodo no ventrículo esquerdo aumenta o tempo cirúrgico podendo associar-se a maior morbidade no acompanhamento após alta hospitalar, evento muitas vezes confundível com a gravidade da patologia base. Objetivo: Avaliar a taxa de internação não programada na emergência e óbito após cirurgia de dispositivos implantáveis estratificados pelo tipo de aparelho. Métodos: Estudo de coorte prospectivo analisando 199 pacientes submetidos à implante de dispositivos cardíacos. Os grupos foram divididos de acordo com o tipo de dispositivo: CDI (n = 124) e TRC (n = 75). Estimativas de probabilidades foram analisadas pelo método de Kaplan-Meier de acordo com o desfecho. Valor de p < 0,05 foi considerado significativo nas análises estatísticas. Resultados: A maioria da amostra era do sexo masculino (71,9%) - idade média de 61,1 ± 14,2. A fração de ejeção do ventrículo esquerdo foi similar entre os grupos (TRC 37,4 ± 18,1 vs. CDI 39,1 ± 17,0; p = 0,532). A taxa de visita não programada na emergência relacionada ao dispositivo foi de 4,8% no grupo CDI e de 10,6% no grupo TRC (p = 0,20). A probabilidade de sobrevida relacionada ao dispositivo da variável "óbito" mostrou-se diferente entre os grupos (p = 0,008). Conclusões: Paciente após o implante de TRC apresenta maior probabilidade de mortalidade após o procedimento cirúrgico no seguimento menor que 1 ano. A taxa de visita hospitalar não programada, relacionadas ou não ao implante, não difere entre os grupos.

Unscheduled Emergency Visits after Cardiac Devices Implantation: Comparison between Cardioverter Defibrillators and Cardiac Resynchronization Therapy Devices in less than one year of Follow Up.

BACKGROUND: The use of Cardiovascular Implantable Electronic Devices (CIED), such as the Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT), is increasing. The number of leads may vary according to the device. Lead placement in the left ventricle increases surgical time and may be associated with greater morbidity after hospital discharge, an event that is often confused with the underlying disease severity. OBJECTIVE: To evaluate the rate of unscheduled emergency hospitalizations and death after implantable device surgery stratified by the type of device. METHODS: Prospective cohort study of 199 patients submitted to cardiac device implantation. The groups were stratified according to the type of device: ICD group (n = 124) and CRT group (n = 75). Probability estimates were analyzed by the Kaplan-Meier method according to the outcome. A value of p < 0.05 was considered significant in the statistical analyses. RESULTS: Most of the sample comprised male patients (71.9%), with a mean age of 61.1 ± 14.2. Left ventricular ejection fraction was similar between the groups (CRT 37.4 ± 18.1 vs. ICD 39.1 ± 17.0, p = 0.532). The rate of unscheduled visits to the emergency unit related to the device was 4.8% in the ICD group and 10.6% in the CRT group (p = 0.20). The probability of device-related survival of the variable "death" was different between the groups (p = 0.008). CONCLUSIONS: Patients after CRT implantation show a higher probability of mortality after surgery at a follow-up of less than 1 year. The rate of unscheduled hospital visits, related or not to the implant, does not differ between the groups.

The Australian and New Zealand Cardiac Implantable Electronic Device Survey: Calendar Year 2017.

BACKGROUND: A cardiac implantable electronic device (CIED) survey was undertaken in Australia and New Zealand for calendar year 2017 and involved pacemakers (PMs) and implantable cardioverter-defibrillators (ICDs). RESULTS AND CONCLUSIONS: For 2017, there were 17,971 (15,203 in 2013) new PMs sold in Australia and 1,811 (1,641 in 2013) implanted in New Zealand. The number of new PM implants per million population was 745 for Australia (652 in 2013) and 384 for New Zealand (367 in 2013). In both Australia and New Zealand, the number of PM replacements fell as a result of improved power source service life. Pulse generator types implanted were predominantly dual chamber; Australia 73% (74% in 2013) and New Zealand 68% (59% in 2013). There were 1,247 biventricular PMs implanted in Australia (661 in 2013) and 118 in New Zealand (83 in 2013). Transvenous pacing leads were overwhelmingly active fixation in both the atrium and ventricle. In Australia there was an increase in ICD usage with 4,212 new implants (3,904 in 2013), but a small fall in New Zealand to 396 (423 in 2013). The new ICD implants per million population were 175 for Australia (167 in 2013) and 90 for New Zealand (95 in 2013). There was a small reduction in biventricular ICDs in both Australia (2,195) and New Zealand (111).

Implant Characteristics of Quadripolar and Bipolar Left Ventricular Leads for Cardiac Resynchronization Therapy.

Several studies have reported that the left ventricular (LV) lead implant success rate ranges between 88.0% and 92.4%. Coronary venous anatomy differs among patients thus, necessitating multiple types of leads. To date, the implant success rate among Japanese patients utilizing a pre-specified family LV leads (including bipolar and quadripolar) is not well known. The Attain Success Japan Study enrolled patients indicated for a de novo or an upgrade cardiac resynchronization therapy implant. Patients were followed for 3 months, and the implant success rates with Medtronic Attain family LV leads as well as the incidence of complications related to the LV lead were evaluated.Three hundred 53 patients were enrolled from 29 sites in Japan; 346 patients had LV lead implant attempts. The LV lead was successfully implanted in 336 patients (97.1%). Bipolar and quadripolar LV lead implants were successful in 97.2% and 99.2% of patients, respectively (P = 0.43). Four complications (1.2%) related to the LV leads were reported; all of which occurred in patients receiving bipolar LV leads. The quadripolar LV leads were more frequently implanted in the apical segment compared with bipolar leads (21.6% versus 3.8%, P < 0.01). This study demonstrated a high implant success rate and a low LV lead-related complication rate, regardless of bipolar, or quadripolar in a Japanese cohort of patients.

Canadian Registry of Implantable Electronic Device Outcomes: Surveillance of High-Voltage Leads.

BACKGROUND: Cardiac implantable electrical devices (CIEDs) are subject to advisories and complications that can result in morbidity and mortality for patients; there is currently no system in Canada to track these. METHODS: This was a multicenter, prospective cohort study conducted at 5 centers to determine feasibility. Patients with a de novo high-voltage (HV) lead implantation were included and followed for a minimum of 1 year. RESULTS: There were 611 leads enrolled into the registry over 18 months. The mean age was 62.4 ± 12.8 years; 144 (23.6%) women were enrolled. The indication for lead implantation was for primary prevention in 65.5%. There were 497 (82.1%) de novo devices (single chamber: 54.5%, dual chamber: 20.5%, cardiac resynchronization therapy [CRT] 25.0%); the remainder of the procedures was a system revision for either upgrade (8.1%) or lead revision (9.8%). The lead revision rate at 1 year was 3.4%, with the primary reason being lead dislodgements. Mortality rate was 3.8% at 1 year. The rate of any device-related complication was 2.0% at 30 days, with the highest rate in CRT implants (4.9%, P = 0.0105). At 1 year, the complication rate was 4.5%, with no significant difference among device types. CONCLUSIONS: This study demonstrates that device surveillance is feasible and highlights (1) the need for CIED surveillance to track device-related complications, (2) the scope of this should be larger, and (3) mandatory participation should be considered. This system could predict CIEDs that may be susceptible to higher than usual rates of failure, mitigating adverse outcomes in patients.

Upgrades from a previous device compared to de novo cardiac resynchronization therapy in the European Society of Cardiology CRT Survey II.

BACKGROUND: To date, there are no data from randomized controlled studies on the benefit of cardiac resynchronization therapy (CRT) when implanted as an upgrade in patients with a previous device as compared to de novo CRT. In the CRT Survey II we compared the baseline data of patients upgraded to CRT (CRT-P/CRT-D) from a previous pacemaker (PM) or implantable cardioverter-defibrillator (ICD) to de novo CRT implantation. METHODS AND RESULTS: In the European CRT Survey II, clinical practice data of patients undergoing CRT and/or ICD implantation across 42 European Society of Cardiology (ESC) countries were collected between October 2015 and December 2016. Out of a total of 11 088 patients, 2396 (23.2%) were upgraded from a previous PM or ICD and 7933 (76.8%) underwent de novo implantation. Compared to de novo implantations, upgraded patients were older, more often male, more frequently had ischaemic heart failure aetiology, atrial fibrillation, reduced renal function, worse heart failure symptoms, and higher N-terminal pro-B-type natriuretic peptide levels. Upgraded patients were more often PM-dependent and less frequently received CRT-D. Total peri-procedural, in-hospital complications and length of hospital stay were similar. Upgraded patients were less frequently treated with heart failure medication at discharge. CONCLUSION: Despite a lack of evidenced-based data, close to one quarter of all CRT implantations across 42 ESC countries were upgrades from a previous PM or ICD. Despite older age and worse symptoms, the CRT implantation procedures in upgraded patients were equally frequently successful and complications similar to de novo implantations. These results call for more studies.

Sleep apnea detection by a cardiac resynchronization device integrated thoracic impedance sensor: A validation study against the gold standard polysomnography.

BACKGROUND: Sleep disordered breathing is a common but often undiagnosed comorbidity in heart failure patients. Cardiac implantable electronic devices used for cardiac resynchronization therapy (CRT) may detect sleep apnea by use of a transthoracic impedance sensor. Validation of the AP scan® algorithm (Boston Scientific®) was performed by using the diagnostic gold standard polysomnography (PSG). METHODS: Forty-one patients with impaired left ventricular ejection fraction, frequent right ventricular pacing due to atrioventricular block and heart failure symptoms despite optimal medical therapy underwent upgrading to biventricular pacing. Within one month after left ventricular lead implantation, sleep apnea was assessed by single-night PSG and AP scan® measurements. RESULTS: AP scan® measurements were valid in only 21 of 41 (51.2%) patients in the index night of the PSG. The PSG determined apnea-hypopnea index did not correlate statistically significant with the AP scan® measurements (r = 0.41, 95% confidence interval -0.05-0.72, p = 0.07). The degree of overestimation is displayed by using the Bland-Altman method: mean difference -12.4, standard deviation ± 15.8, 95% confidence interval -43.3-18.6. CONCLUSIONS: In heart failure patients receiving CRT upgrading, the AP scan® algorithm may need further improvement before it can be recommended for sleep apnea detection.