Contemporary trends of leadless pacemaker implantation in the United States.

INTRODUCTION: Leadless pacemakers (LPM) have established themselves as the important therapeutic modality in management of selected patients with symptomatic bradycardia. To determine real-world utilization and in-hospital outcomes of LPM implantation since its approval by the Food and Drug Administration in 2016. METHODS: For this retrospective cohort study, data were extracted from the National Inpatient Sample database from the years 2016-2020. The outcomes analyzed in our study included implantation trends of LPM over study years, mortality, major complications (defined as pericardial effusion requiring intervention, any vascular complication, or acute kidney injury), length of stay, and cost of hospitalization. Implantation trends of LPM were assessed using linear regression. Using years 2016-2017 as a reference, adjusted outcomes of mortality, major complications, prolonged length of stay (defined as >6 days), and increased hospitalization cost (defined as median cost >34 098$) were analyzed for subsequent years using a multivariable logistic regression model. RESULTS: There was a gradual increased trend of LPM implantation over our study years (3230 devices in years 2016-2017 to 11 815 devices in year 2020, p for trend <.01). The adjusted mortality improved significantly after LPM implantation in subsequent years compared to the reference years 2016-2017 (aOR for the year 2018: 0.61, 95% CI: 0.51-0.73; aOR for the year 2019: 0.49, 95% CI: 0.41-0.59; and aOR for the year 2020: 0.52, 95% CI: 0.44-0.62). No differences in adjusted rates of major complications were demonstrated over the subsequent years. The adjusted cost of hospitalization was higher for the years 2019 (aOR: 1.33, 95% CI: 1.22-1.46) and 2020 (aOR: 1.69, 95% CI: 1.55-1.84). CONCLUSION: The contemporary US practice has shown significantly increased implantation rates of LPM since its approval with reduced rates of inpatient mortality.

Trends and disparities in cardiac implantable electronic device infection-related mortality in the United States.

INTRODUCTION: We performed a cross-sectional study using the Centers for Disease Control and Prevention's (CDC's) Wide-Ranging Online Data for Epidemiologic Research (WONDER) database to analyze the trends in cardiac implantable electronic device (CIED) infection-related mortality from 1999 to 2020. METHODS: We analyzed the death certificate data from the CDC WONDER database from 1999 to 2020 for CIED infections in the US population aged ≥25 years using International Classification of Diseases, Tenth Revision (ICD-10) codes, listed as the underlying or contributing cause of death. Age-adjusted mortality rates (AAMR) and 95% confidence intervals (CIs) were computed per 1 million population by standardizing crude mortality rates to the 2000 US census population. To assess annual mortality trends, we employed the Joinpoint regression model, calculating the annual percent change (APC) in AAMR and corresponding 95% CIs. RESULTS: Overall, there was an observed declining trend in AAMRs related to CIED infection-related mortality. Males accounted for 55% of the total deaths, with persistently higher AAMRs compared to females over the study duration. Both males and females had an overall decreasing trend in AAMRs throughout the study duration. On race/ethnicity stratified analysis, non-Hispanic (NH) Blacks exhibited the highest overall AAMR, followed by NH American Indians or Alaska Natives, NH Whites, Hispanic or Latinos, and NH Asian or Pacific Islanders. On a stratified analysis based on region, the South region had the highest overall AAMR, followed by the Midwest, West, and Northeast regions. CONCLUSION: Our study demonstrates a significant decline in CIED infection-related mortality in patients over the last two decades. Notable gender, racial/ethnic, and regional differences exist in the rates of mortality related to CIED infections.

Leadless pacemakers: A review of current data and future directions.

Leadless pacemakers (LPs) have revolutionized the field of pacing by miniaturizing pacemakers and rendering them completelty intracardiac, hence reducing complications related to pacemaker pockets and transvenous leads. However, first generation LPs appear to be associated with a higher rate of myocardial perforation as compared to transvenous pacemakers (TV-PPM). Currently, LPs are predominantly designed to pace the right ventricle with no LPs that provide atrial or biventricular pacing. In this article, we review the available data on LPs while advocating for the need for a randomized controlled trial comparing LPs to TV-PPMs. In addition, we review the future directions of leadless devices.

Reduction in new cardiac electronic device implantations in Catalonia during COVID-19.

AIMS: During the COVID-19 pandemic, concern regarding its effect on the management of non-communicable diseases has been raised. However, there are no data on the impact on cardiac implantable electronic devices (CIED) implantation rates. We aimed to determine the impact of SARS-CoV2 on the monthly incidence rates and type of pacemaker (PM) and implantable cardiac defibrillator (ICD) implantations in Catalonia before and after the declaration of the state of alarm in Spain on 14 March 2020. METHODS AND RESULTS: Data on new CIED implantations for 2017-20 were prospectively collected by nine hospitals in Catalonia. A mixed model with random intercepts corrected for time was used to estimate the change in monthly CIED implantations. Compared to the pre-COVID-19 period, an absolute decrease of 56.5% was observed (54.7% in PM and 63.7% in ICD) in CIED implantation rates. Total CIED implantations for 2017-19 and January and February 2020 was 250/month (>195 PM and >55 ICD), decreasing to 207 (161 PM and 46 ICD) in March and 131 (108 PM and 23 ICD) in April 2020. In April 2020, there was a significant fall of 185.25 CIED implantations compared to 2018 [95% confidence interval (CI) 129.6-240.9; P < 0.001] and of 188 CIED compared to 2019 (95% CI 132.3-243.7; P < 0.001). No significant differences in the type of PM or ICD were observed, nor in the indication for primary or secondary prevention. CONCLUSIONS: During the first wave of the COVID-19 pandemic, a substantial decrease in CIED implantations was observed in Catalonia. Our findings call for measures to avoid long-term social impact.

Trends in the use, complications, and costs of permanent pacemakers in Australia: A nationwide study from 2008 to 2017.

OBJECTIVE: To characterize contemporary pacemaker procedure trends. METHODS: Nationwide analysis of pacemaker procedures and costs between 2008 and 2017 in Australia. The main outcome measures were total, age- and gender-specific implant, replacement, and complication rates, and costs. RESULTS: Pacemaker implants increased from 12,153 to 17,862. Implantation rates rose from 55.3 to 72.6 per 100,000, a 2.8% annual increase (incidence rate ratio [IRR] 1.028; 95% CI, 1.02-1.04; p < .001). Pacemaker implants in the 80+ age group were 17.37-times higher than the < 50 group (95% CI 16.24-18.59; p < .001), and in males were 1.48-times higher than in females (95% CI 1.42-1.55; p < .001). However, there were similar increases according to age (p = .10) and gender (p = .68) over the study period. Left ventricular lead rates were stable (IRR 0.995; 95% CI 0.98-1.01; p = .53). Generator replacements decreased from 20.5 to 18.3 per 100,000 (IRR 0.975; 95% CI 0.97-0.98; p < .001). Although procedures for generator-related complications were stable (IRR 0.995; 95% CI 0.98-1.01; p = .54), those for lead-related complications decreased (IRR 0.985; 95% CI 0.98-0.99; p < .001). Rates for all pacemaker procedures were consistently greater in males (p < .001). Although annual costs of all pacemaker procedures increased from $178 million to $329 million, inflation-adjusted costs were more stable, rising from $294 million to $329 million. CONCLUSIONS: Increasing demand for pacemaker implants is driven by the ageing population and rising rates across all ages, while replacement and complication procedure rates appeared more stable. Males have consistently greater pacemaker procedure rates than females. Our findings have significant clinical and public health implications for healthcare resource planning.

Sport activity in patients with cardiac implantable electronic devices: evidence and perspectives.

Demographic characteristics of patients with cardiac implantable electronic devices have significantly changed during the last few years, according to the ageing of the population and the consequent increase in the number of elderly individuals with indication for pacemaker implant and, on the other hand, to the increased number of young individuals implanted with an implantable cardioverter defibrillator for the primary prevention of sudden death. More and more often, both elderly and young patients ask the physician to deal with the device in their daily activities, which often include sport practice. This latter is advisable because of its recognized benefits on cardiovascular prevention, although there are many limitations for patients with a cardiac implantable electronic device. Hence, the need to balance the patient's request with the appropriate precautions emerging from existing evidence. The current article aims to provide an overview of the most recent data on this topic, derived from registries and observational studies. Over the years an attempt to standardize recommendations has been made, but robust evidence is still lacking. Substantial differences exist between countries based on their sports regulations. Official recommendations of European and American Scientific Societies are resumed. The future perspective is to obtain data to allow these patients a safer practice of sport activity also through technological advances in terms of device materials and programming improvement and the possibility of remote monitoring.

New frontiers in cardiac devices.

This article provides an overview of current cardiac device management, complications, and future areas for development. The last 70 years have seen huge advances in the field of implantable cardiac devices, from diagnostic tools to electrical therapies for bradycardia, ventricular arrhythmia and cardiac resynchronisation. While out-of-hours specialist cardiology cover and regional arrhythmia pathways are increasingly established, they are not universal, and the management of arrhythmia remains an important facet of clinical medicine for the general physician. This article discusses core recommendations from international guidelines with respect to heart rhythm diagnostics, pacing for bradycardia, cardiac resynchronisation and implantable cardioverter defibrillators, along with common complications. Finally, future innovations such as the diagnostic potential of portable technologies, antibiotic envelopes for cardiac devices and the increasing use of leadless pacemakers are described.

Seguimiento a muy largo plazo de pacientes sometidos a cierre de defectos septales interauriculares / Long-term outcomes after percutaneous atrial septal deffects closure

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Temporary transvenous cardiac pacing: a survey on current practice.

BACKGROUND: Temporary transvenous cardiac pacing (TTCP) is a standard procedure in current practice, despite limited coverage in consensus guidelines. However, many authors reported several complications associated with TTCP, especially development of infections of cardiac implantable electronic devices (CIED). The aim of this survey was to provide a country-wide picture of current practice regarding TTCP. METHODS: Data were collected using an online survey that was administered to members of the Italian Association of Arrhythmology and Cardiac Pacing. RESULTS: We collected data from 102 physicians, working in 81 Italian hospitals from 17/21 regions. Our data evidenced that different strategies are adopted in case of acute bradycardia with a tendency to limit TTCP mainly to advanced atrioventricular block. However, some centers reported a greater use in elective procedures. TTCP is usually performed by electrophysiologists or interventional cardiologists and, differently from previous reports, mainly by a femoral approach and with nonfloating catheters. We found high inhomogeneity regarding prevention of infections and thromboembolic complications and in post-TTCP management, associated with different TTCP volumes and a strategy for management of acute bradyarrhythmias. CONCLUSION: This survey evidenced a high inhomogeneity in the approaches adopted by Italian cardiologists for TTCP. Further studies are needed to explore if these divergences are associated with different long-term outcomes, especially incidence of CIED-related infections.

Change in the use of remote monitoring of cardiac implantable electronic devices in Italian clinical practice over a 5-year period: results of two surveys promoted by the AIAC (Italian Association of Arrhythmology and Cardiac Pacing).

AIMS: The aim of this study was to evaluate the use of remote monitoring in Italian clinical practice and its trend over the last 5 years. METHODS: In 2012 and 2017, two surveys were conducted. Both were open to all Italian implanting centres and consisted of 25 questions on the characteristics of the centre, their actual use of remote monitoring, applied organizational models and administrative and legal aspects. RESULTS: The questionnaires were completed by 132 and 108 centres in 2012 and 2017, respectively (30.6 and 24.7% of all Italian implanting centres). In 2017, significantly fewer centres followed up fewer than 200 patients by remote monitoring than in 2012, while more followed up more than 500 patients (all P < 0.005). In most of the centres (77.6%) that responded to both surveys, the number of patients remotely monitored significantly increased from 2012 to 2017.In both surveys, remote monitoring was usually managed by physicians and nurses. Over the period, primary review of transmissions by physicians declined, while it was increasingly performed by nurses; the involvement of technicians rose, while that of manufacturers' technical personnel decreased. The percentage of centres in which transmissions were submitted to the physician only in critical cases rose (from 28.3 to 64.3%; P < 0.001). In 86.7% of centres, the lack of a reimbursement system was deemed the main barrier to implementing remote monitoring. CONCLUSION: In the last 5 years, the number of patients followed up by remote monitoring has increased markedly. In most Italian centres, remote monitoring has increasingly been managed through a primary nursing model. The lack of a specific reimbursement system is perceived as the main barrier to implementing remote monitoring .

Cardiac implantable electrical devices in patients with hypertrophic cardiomyopathy: single center implant data extracted from the Swedish pacemaker and ICD registry.

Objectives: To investigate cardiac implantable electrical device (CIED) first implants in patients with hypertrophic cardiomyopathy (HCM) in a Swedish tertiary university hospital. Design: Clinical and technical data on pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) first implants performed in HCM patients at the Karolinska University Hospital from 2005 to 2016 were extracted from the Swedish Pacemaker and ICD Registry. Echocardiographic data were obtained by review of hospital recordings. Results: The number of first pacemaker implants in HCM patients was 70 (1.5% of total pacemaker implants). The mean age of HCM pacemaker patients was 71 ± 10 years. Pacemaker implants were almost uniformly distributed between genders. Dual-chamber pacemakers with or without CRT properties were prevalent (6 and 93%, respectively). The number of first ICD implants in HCM patients was 99 (5.1% of total ICD implants). HCM patients receiving an ICD were 53 ± 15 years and prevalently men (70%). Sixty-five (66%) patients were implanted for primary prevention. Dual-chamber ICDs with or without CRT were 21 and 65%, respectively. Obstructive HCM was present in 47% pacemaker patients and 25% ICD patients with available pre-implant echo. Conclusions: This retrospective registry-based study provides a picture of CIED first implants in HCM patients in a Swedish tertiary university hospital. ICDs were the most commonly implanted devices, covering 59% of CIED implants. HCM patients receiving a pacemaker or an ICD had different epidemiological and clinical profiles.

Outcomes of cardiac implantable electronic device transvenous lead extractions performed in centers without onsite cardiac surgery.

BACKGROUND: While major complications associated with CIED lead extractions are uncommon, they carry a significant risk of morbidity and mortality in the absence of surgical intervention. However, there is limited data on the differences in outcomes of these procedures between centers with and without on-site CS support. The present study examined outcomes of transvenous cardiac implantable electronic device (CIED) lead extractions according to admitting hospitals' cardiac surgery (CS) facilities. METHODS: We analyzed the National Inpatient Sample for CIED lead extraction procedures, stratified by hospitals' CS facilities into two groups; on-site and off-site CS. Logistic regression analyses were performed to estimate the adjusted odds (aOR) of procedure-related complications in off-site CS centers. RESULTS: In 221,606 procedures over an 11-year-period, CIED lead extractions were increasingly undertaken in on-site as opposed to off-site CS centers (Onsite CS 2004 vs. 2014: 78.2% vs. 90.4%, p < 0.001) during the study period. In comparison to on-site CS group, patients admitted to off-site CS group were older, less comorbid, and experienced lower adjusted odds of major adverse cardiovascular events (0.72 [0.67, 0.77]), mortality (0.60 [0.52, 0.69]), procedure-related bleeding (0.48 [0.44, 0.54]) and complications (thoracic: 0.81 [0.75, 0.88]; cardiac: 0.45 [0.38, 0.54]) (p < 0.001 for all). CONCLUSIONS: Our national analysis demonstrates that transvenous CIED lead extractions are being increasingly undertaken in centers with on-site CS surgery, in compliance with international guideline recommendations. Patients managed with lead extractions in on-site CS centers are more comorbid and critically ill compared to those admitted to off-site CS centers, and remain at a higher risk of procedure-related complications.

Subclinical and Device-Detected Atrial Fibrillation: Pondering the Knowledge Gap: A Scientific Statement From the American Heart Association.

The widespread use of cardiac implantable electronic devices and wearable monitors has led to the detection of subclinical atrial fibrillation in a substantial proportion of patients. There is evidence that these asymptomatic arrhythmias are associated with increased risk of stroke. Thus, detection of subclinical atrial fibrillation may offer an opportunity to reduce stroke risk by initiating anticoagulation. However, it is unknown whether long-term anticoagulation is warranted and in what populations. This scientific statement explores the existing data on the prevalence, clinical significance, and management of subclinical atrial fibrillation and identifies current gaps in knowledge and areas of controversy and consensus.

Incidence of heart failure after pacemaker implantation: a nationwide Danish Registry-based follow-up study.

AIMS: The objective of the current study is to investigate the risk of heart failure (HF) after implantation of a pacemaker (PM) with a right ventricular pacing (RVP) lead in comparison to a matched cohort without a PM and factors associated with this risk. METHODS AND RESULTS: All patients without a known history of HF who had a PM implanted with an RVP lead between 2000 and 2014 (n = 27 704) were identified using Danish nationwide registries. An age- and gender-matched control cohort (matched 1:5, n = 138 520) without PM and HF was identified to compare the risk. Outcome was the cumulative incidence of HF including fatal HF within the first 2 years of PM implantation, with all-cause mortality and myocardial infarction (MI) as competing risks. Due to violation of proportional hazards, the follow-up period was divided into three time-intervals: <30 days, 30-180 days, and >180 days-2 years. The cumulative incidence of HF including fatal HF was observed in 2937 (10.6%) PM patients. Risks for the three time-intervals were <30 days [hazard ratio (HR) 5.98, 95% CI 5.19-6.90], 30-180 days (HR 1.84, 95% CI 1.71-1.98), and >180 days (HR 1.11, 95% CI 1.04-1.17). Among patients with a PM device, factors associated with increased risk of HF were male sex (HR 1.33, 95% CI 1.24-1.43), presence of chronic kidney disease (CKD) (HR 1.64, 95% CI 1.29-2.09), and prior MI (1.77, 95% 1.50-2.09). CONCLUSIONS: Pacemaker with an RVP lead is strongly associated with risk of HF specifically within the first 6 months. Patients with antecedent history of MI and CKD had substantially increased risk.

[Design of Cardiac Pacemaker Based on Low Power MCU].

In order to improve the accuracy of the pacemaker's parameter adjustment and to avoid the surgical replacement of the pacemaker when the battery is exhausted, this paper designs a novel single-chamber pacemaker circuit based on low-power single-chip microcomputer. The circuit uses digital control to accurately control the amplitude, pulse width and frequency of the pacing pulse. The circuit is also designed with wireless charging function, and wireless communication with the programmer can wirelessly charge the pacemaker and know the charging information in real time. Wireless charging function can reduce the number of times the patient replaces the pacemaker or even completely avoid it.

Impact of device programming on the success of the first anti-tachycardia pacing therapy: An anonymized large-scale study.

BACKGROUND: Antitachycardia pacing (ATP) is an effective treatment for ventricular tachycardia (VT). We evaluated the efficacy of different ATP programs based on a large remote monitoring data set from patients with implantable cardioverter-defibrillators (ICDs). METHODS: A dataset from 18,679 ICD patients was used to evaluate the first delivered ATP treatment. We considered all device programs that were used for at least 50 patients, leaving us with 7 different programs and a total of 32,045 episodes. We used the two-proportions z-test (α = 0.01) to compare the probability of success and the probability for acceleration in each group with the corresponding values of the default setting. RESULTS: Overall, the first ATP treatment terminated in 78.4%-97.5% of episodes with slow VT and 81.5%-91.1% of episodes with fast VT. The default setting of the ATP programs with the number of sequences S = 3 was applied to treat 30.1% of the slow and 36.6% of the fast episodes. Reducing the maximum number of sequences to S = 2 decreased the success rate for slow VT (P < 0.0001, h = 0.38), while the setting S = 4 resulted in the highest success rate of 97.5% (P < 0.0001, h = 0.27). CONCLUSION: While the default programs performed well, we found that increasing the number of sequences from 3 to 4 was a promising option to improve the overall ATP performance.

Cardiac pacing challenge in Sub-Saharan Africa environnement: experience of the Cardiology Department of Teaching Hospital Aristide Le Dantec in Dakar.

BACKGROUND: Cardiac pacing is a growing activity in Sub-Saharan Africa. There is little data on the characteristics of this interventional treatment in our regions. The goal was to evaluate the results of cardiac pacing in a referral service in sub-Saharan Africa. METHODS: We carried out a twelve-year retrospective study (from January 1st, 2004 to December 31st, 2015) in the Cardiology Department of Aristide Le Dantec University Hospital. This work included all patients who received definitive cardiac pacing during the study period and followed up in the service. RESULTS: In total we included 606 patients. There was a growing trend in activity with a peak in 2015 (17%). The average age was 70.6 ± 12.03 years. Some patients (15.4%) came from the subregion. The patients were mostly of medium socio-economic level (53%); 14% were of low socio-economic level. Patients were symptomatic in 85% of cases (37.4% syncope). The indications were dominated by complete atrioventricular block (81.5%); sinus dysfunction accounted for 1.9% of them. A temporary pacemaker was used in 60% of cases for an average duration of 5.1 ± 6.3 days. Antibiotics, local anesthesia and analgesics were used in all cases. Implanted pacemakers were single chamber in 56% of cases and double chamber in 44% of cases. In 39 patients (6.4%), the pacemaker was a « re-used ¼ one. The atrial leads were most often placed in a lateral position (94.5%). The ventricular ones were predominantly tined (95.7%) and more often located at the apical level. Complications were noted in 24 patients (3.9%), dominated by devices externalizations and infections, which together accounted for 2.7% of cases. The number of people in the cathlab was significantly higher and the duration of the temporary pacemaker was longer for patients who had a complication. There was no significant difference depending on the type of pacemaker used (new or reused). Seven (7) in hospital death cases were reported. CONCLUSION: Cardiac pacing is a growing activity in Dakar.