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.

[How to: Basics of programming cardiac pacemakers]. / How to: Basics der Schrittmacherprogrammierung.

Programming of implantable cardiac devices, especially dual-chamber pacemakers, can be challenging in daily clinical practice. Precise knowledge of programmable parameters is important; furthermore, one should also be familiar with the specific algorithms of each manufacturer. During programming, the patient's individual requirements should be taken into account, but out-of-the-box programming should be avoided. Another important goal of programming should be to stimulate as much as needed but as little as possible to provide the patient good exercise capacity while not being aware of the pacing. Manufacturers' algorithms can help reach these aims but need to be understood and-in case of inappropriate behavior-to be deactivated.

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.

Pacing devices to treat bradycardia: current status and future perspectives.

Introduction: Cardiac stimulation evolved from life-saving devices to prevent asystole to the treatment of heart rhythm disorders and heart failure, capable of remote patient and disease-progression monitoring. Cardiac stimulation nowadays aims to correct the electrophysiologic roots of mechanical inefficiency in different structural heart diseases.Areas covered: Clinical experience, as per available literature, has led to awareness of the concealed risks of customary cardiac pacing, that can inadvertently cause atrio-ventricular and inter/intra-ventricular dyssynchrony. New pacing modalities have emerged, leading to a new concept of what truly represents 'physiologic pacing' beyond maintenance of atrio-ventricular coupling. In this article we will analyze the emerging evidence in favor of the available strategies to achieve an individualized physiologic setting in bradycardia pacing, and the hints of future developments.Expert opinion: 'physiologic stimulation' technologies should evolve to enable an effective and widespread adoption. In one way new guiding catheters and the adoption of electrophysiologic guidance and non-fluoroscopic lead implantation are needed to make His-Purkinje pacing successful and effective at long term in a shorter procedure time; in the other way leadless stimulation needs to upgrade to a superior physiologic setting to mimic customary DDD pacing and possibly His-Purkinje pacing.

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.

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.

Permanent His bundle pacing: shaping the future of physiological ventricular pacing.

Conventional right ventricular (RV) pacing, particularly RV apical pacing, can have deleterious effects on cardiac function. Long-term RV apical pacing has been associated with increased risk of atrial fibrillation, hospitalization for heart failure, pacing-induced cardiomyopathy and associated death. His bundle pacing (HBP) results in physiological ventricular activation and has generated tremendous research interest and enthusiasm. By stimulating the His-Purkinje network directly, HBP results in synchronized ventricular activation, which might translate into improved clinical outcomes compared with dyssynchronous ventricular activation with RV apical pacing. HBP can also overcome bundle branch block patterns, and data are accumulating on the benefit of HBP for cardiac resynchronization therapy. In this Review, we summarize the anatomy of the His bundle and early clinical observations, implantation techniques and available outcome data associated with permanent HBP. We also highlight the challenges with HBP and the need for additional tools and more randomized data before widespread application of permanent HBP.

Leadless cardiac pacing systems: current status and future prospects.

Introduction: Permanent transvenous pacemaker therapy is an essential management option in patients with symptomatic bradyarrhythmias, but harbors a concomitant risk of serious complications. As most complications are lead- or pocket-related, intracardiac leadless pacemaker therapy has the potential to positively impact patient outcome. Since the first leadless pacemaker implant in 2012, many studies have been conducted to evaluate the effectiveness, safety, and applicability of this novel pacing approach.Areas covered: This review will cover the current status of leadless pacemaker technology. Available safety and efficacy outcomes, current area of indication, and end-of-life management will be evaluated. Furthermore, future perspectives for clinical practice and new pacing modalities are discussed.Expert opinion: The first-generation leadless pacemakers are a promising innovation that provide safe and efficient single-chamber pacing therapy without the use of transvenous pacemaker leads. Yet, broad implementation of this technology is hampered by limitations of the current leadless devices, such as end-of-life management and its single-chamber pacing indication. Further innovations such as leadless dual-chamber pacing therapy, leadless cardiac synchronization therapy, energy-harvesting leadless pacemakers, communicating leadless pacemakers with subcutaneous implantable cardiac defibrillators, and minimally invasive completely extracardiac pacemakers are currently being developed that have the potential to become major game changers in pacing therapy.

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.

Clinical and organizational management of cardiac implantable electronic device replacements: an Italian Survey promoted by AIAC (Italian Association of Arrhythmology and Cardiac Pacing).

AIMS: The aim of this survey was to assess the management and organization of cardiac implantable electronic device (CIED) replacement in Italy. METHODS: A questionnaire consisting of 24 questions on organizational aspects and on the peri-procedural management of anticoagulant therapies and antibiotic prophylaxis was sent via the Internet to 154 Italian arrhythmia centers. RESULTS: A total of 103 out of 154 centers completed the questionnaire (67% response rate). In 43% of the centers, the procedures were performed under day-case admission, in 40% under ordinary admission, and in 17% under either day-case or ordinary admission. The most frequent reason (66%) for choosing ordinary admission rather than day-case admission was to obtain full reimbursement. Although warfarin therapy was continued in 73% of the centers, nonvitamin K oral anticoagulants were discontinued, without bridging, 24 h or less prior to replacement procedures in 88%. Prophylactic antibiotic therapy was systematically administered in all centers; in 97%, the first antibiotic dose was administered 1-2 h prior to procedures. Local antibacterial envelopes were also used in 43% of the centers in patients with a higher risk of device infection. CONCLUSION: This survey provides a representative picture of how CIED replacements are organized and managed in current Italian clinical practice. The choice of the type of hospitalization (short versus ordinary) was more often motivated by economic reasons (reimbursement of the procedure) than by clinical and organizational factors. Peri-procedural management of anticoagulation and prophylactic antibiotic therapy was consistent with current scientific evidence.

Trends in complete heart block after transcatheter aortic valve replacement: A population based analysis.

OBJECTIVES: To define the national rate of complete heart block (CHB) after transcatheter aortic valve replacement (TAVR) and its impact on procedural mortality, overall cost, and length of hospital stay. BACKGROUND: CHB leading to permanent pacemaker (PPM) implantation is one of the most common complications post TAVR. National data on the temporal trend of CHB post TAVR are lacking. METHODS: We queried the 2012-2014 National Inpatient Sample databases to identify all patients who underwent TAVR. Patients with preoperative pacemakers or implantable cardioverter-defibrillators were excluded. Association between CHB and outcomes, and overall trends in rate of CHB, PPM implantation, and inpatient mortality were examined. RESULTS: Of 35,500 TAVR procedures, 3,675 (10.4%) had CHB. Overall, occurrence of CHB significantly increased from 8.4% in 2012 to 11.8% in 2014 (adjusted OR per year: 1.23; 95% confidence interval [CI]: 1.17-1.29, P trend <0.001). During the same period, PPM implantation increased from 9.5 to 13.7% (adjusted OR per year: 1.22; 95% CI: 1.16-1.28, P trend <0.001). Patients with CHB had higher odds of in-hospital mortality when compared to patients without CHB (5.9% vs. 4.2%, adjusted OR: 1.32; 95% CI: 1.12-1.56; p = 0.001). Moreover, CHB was also associated with longer length of stay (LOS) and higher hospitalization cost. CONCLUSIONS: There was a significant increase in rates of CHB and PPM implantation over the study period. Development of CHB was associated with increased in-hospital mortality, LOS, and hospitalization cost.

Carotid baroreceptor stimulation improves cardiac performance and reverses ventricular remodelling in canines with pacing-induced heart failure.

AIMS: Carotid baroreceptor stimulation (CBS) has potential protective effects on chronic heart failure (CHF). The aim of our study was to investigate the effects of CBS on more detailed aspects of ventricular remodelling and the underlying mechanisms in a CHF canine model. MAIN METHODS: Twenty-four beagles were randomised into Con (n = 8), CHF (n = 8), and CHF-CBS (n = 8) groups. The CHF and CHF-CBS groups underwent 6 weeks of rapid ventricular pacing (RVP) at 250 beats per minute to establish a CHF model. Concomitant CBS was delivered together with RVP in the CHF-CBS group. KEY FINDINGS: RVP for 6 weeks caused typical heart failure in the CHF group. CBS significantly reversed the decrease in the high-frequency heart rate variability component and increase in low-frequency/high-frequency ratio induced by RVP. CBS significantly reduced cardiac dilation, improved left ventricle ejection fraction, and inhibited the increase in natriuretic peptide mRNA expression of LV tissue. CBS alleviated collagen volume fraction and reduced protein expression of transforming growth factor ß1, matrix metallopeptidase 2, and matrix metallopeptidase 9, as well as decreased the percentage of TUNEL-positive nuclei and protein expression of Caspase-3 in LV tissue. The intracellular PKA signalling pathway and cardiac inflammation of LV tissue were upregulated in the CHF group, and markedly inhibited by CBS. SIGNIFICANCE: Our study found that CBS improved cardiac performance and reversed ventricular remodelling in CHF canines by rebalancing the autonomic nervous system; the suppression of the intracellular PKA signalling pathway and cardiac inflammation might underly the mechanisms.

Rationale, design, and endpoints of the 'DEvice-Detected CArdiac Tachyarrhythmic Events and Sleep-disordered Breathing (DEDiCATES)' study: Prospective multicenter observational study of device-detected tachyarrhythmia and sleep-disordered breathing.

BACKGROUND: Few studies have investigated the prognostic value of cardiac implantable electronic device (CIED)-detection of sleep-disordered breathing (SDB) for risk stratification of cardiovascular events. In the Device-Detected CArdiac Tachyarrhythmic events and Sleep-disordered breathing (DEDiCATES) study, we aim to determine whether device-detected SDB events are associated with increased risk of cardiac arrhythmias or other cardiovascular outcomes. METHODS AND DESIGN: Six-hundred patients (300 patients with low-voltage pacing devices and 300 with high-voltage defibrillator devices) who have dual chamber CIEDs with AP Scan™ function (Boston Scientific Inc., Marlborough, MA, USA) are planned to be enrolled in this study. AP Scan reports the average number of sleep disturbance events per hour per night in the form of a Respiratory Disturbance Index (RDI). The daily RDI values are to be used for quantitative measurement of the severity and burden of SDB. CIED-detected atrial high rate episodes (AHREs) and clinical atrial tachyarrhythmia will be assessed as the primary outcomes over a follow-up period of 2 years. Correlations between CIED-detected SDB and AHRE burdens will be analyzed. The secondary outcomes are CIED-detected or clinical ventricular arrhythmic events, stroke, heart failure hospitalization, mortality, and quality of life. CONCLUSION: This study will determine the prognostic value of automated diagnostic function of CIED for SDB, which will help to improve the cardiovascular prognoses of CIED patients by enabling convenient and accurate assessments of SDB events.

Putting down the phone: the obsolescence of transtelephonic monitoring for pacemaker follow-up.

PURPOSE: The evolution of heart rhythm monitoring technology over the past few decades has seen a decline in the use and need of transtelephonic monitoring (TTM). We sought to establish a predicted date for the sun setting of TTM at our institution, as well as establish the current demographics of the patients still using this technology. METHODS: We retrospectively reviewed all patients with permanent pacemakers receiving routine device follow-up at our institution (Mayo Clinic-Rochester) between 2015 and 2018. From this cohort, we reviewed and analyzed patients using TTM for device follow-up and utilized projected battery longevity to determine cessation date. Pacemaker implantation date, underlying arrhythmia, and most recent device interrogation reports were also collected. RESULTS: As of March 2018, a total of 3543 patients with permanent pacemakers were being followed at our institution and 289 (8.2%) are using TTM for monitoring device function (147 male, mean age 79.9 ± 12.0 years). Of those currently using TTM, by January of 2020, only 122 (42.2%) are predicted to be using this technology for device follow-up, 40 (13.8%) by January 2022, with zero patients by November of 2024. CONCLUSIONS: The use of TTM will continue to significantly diminish over the next few years. Based on battery longevity estimates, we predict that by the end of 2024 TTM will no longer be used for device follow-up at our institution.

Characteristics of and current practice patterns of pacing for high-degree atrioventricular block after transcatheter aortic valve implantation in comparison to surgical aortic valve replacement.

OBJECTIVE: We aimed to investigate the current practice patterns of permanent pacing, especially the timing of implantation, for high-degree AV block (HDAVB) following transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR). BACKGROUND: Comparative data regarding current practice patterns of permanent pacing for HDAVB between TAVI and SAVR is limited. METHODS: Using the National Inpatient Sample database, we identified patients who underwent TAVI or SAVR between 2012 and 2014. The incidence of HDAVB, the rate of permanent pacemaker implantation, and the timing of implantations were compared between TAVI and SAVR groups. RESULTS: We identified 33 690 and 202 110 patients who underwent TAVI and SAVR, respectively. HDAVB occurred in 3480 patients (10.3%) in the TAVI group and 11 405 patients (5.6%) in the SAVR group (P < 0.001). Among the patients who developed HDAVB, patients in the TAVI group were more likely to undergo permanent pacemaker implantation than those in the SAVR group (74.1% vs 64.7%; P < 0.001). The median interval from TAVI to pacemaker implantation was 2 days (interquartile range 1-3 days) vs 5 days (interquartile range 3-7 days) from SAVR to pacemaker implantation (P < 0.001). Among the patients who developed HDAVB, TAVI was associated with higher rates of permanent pacemaker implantation after adjusting for other comorbidities (odds ratio 1.41:95% confidence interval 1.13-1.77; P = 0.003). CONCLUSIONS: HDAVB occurred more commonly after TAVI compared to SAVR. HDAVB after TAVI compared to SAVR was associated with a higher rate of permanent pacemaker implantation at an earlier timing from the index procedure.

Health-related quality of life impact of a transcatheter pacing system.

BACKGROUND: Transcatheter pacing systems (TPS) provide a novel, minimally invasive approach in which a miniaturized, leadless pacemaker (PM) is transfemorally implanted in the right ventricle. We evaluated the health-related quality of life (HRQoL) impact, patient satisfaction, and activity restrictions following TPS in a large prospective multicenter clinical trial. METHODS AND RESULTS: Patients who underwent a Micra TPS implantation between December 2013 and May 2015 were included. HRQoL impact was evaluated using the Short-Form-36 (SF-36) questionnaire at baseline, 3, and 12 months. Patient satisfaction was assessed using a three-item questionnaire determining recovery, activity level, and esthetic appearance at 3 months. Implanting physicians compared the patient activity restrictions for TPS to traditional PM therapy. A total of 720 patients were implanted with a TPS (76 ± 11 years; 59% male). Of these patients, 702 (98%), 681 (95%), and 635 (88%) completed the SF-36 at baseline, 3 and 12 months, respectively. Improvements were observed at 3 and 12 months in all SF-36 domains and all attained statistical significance. Of 693 patients who completed the patient satisfaction questionnaire, 96%, 91%, 74% were (very) satisfied with their esthetic appearance, recovery, and level of activity, respectively. TPS discharge instructions were rated less restrictive in 49%, equally restrictive in 47%, and more restrictive in 4% of cases compared with traditional PM systems. CONCLUSIONS: TPS resulted in postimplant HRQoL improvements at 3 and 12 months, and high levels of patient satisfaction at 3 months. Further, TPS was associated with less activity restrictions compared with traditional PM systems.

Future Developments in His Bundle Pacing.

Because there has been a significant push toward His bundle pacing (HBP), multiple studies and advancements are underway to provide new and improved delivery tools and lead designs, allowing one to apply this technology in daily practice. A better understanding of the pacing configurations and ultimately development of dedicated algorithms will alleviate some of these aforementioned challenges. Ultimately, with such technological advances and mounting clinical evidence, one can surely anticipate HBP to revolutionize the field of cardiac pacing.