Cadherin-5 facilitated the differentiation of human induced pluripotent stem cells into sinoatrial node-like pacemaker cells by regulating ß-catenin.

Our study was conducted to investigate whether cadherin-5 (CDH5), a vascular endothelial cell adhesion glycoprotein, could facilitate the differentiation of human induced pluripotent stem cells (hiPSCs) into sinoatrial node-like pacemaker cells (SANLPCs), following previous findings of silk-fibroin hydrogel-induced direct conversion of quiescent cardiomyocytes into pacemaker cells in rats through the activation of CDH5. In this study, the differentiating hiPSCs were treated with CDH5 (40 ng/mL) between Day 5 and 7 during cardiomyocytes differentiation. The findings in the present study demonstrated that CDH5 stimulated the expression of pacemaker-specific markers while suppressing markers associated with working cardiomyocytes, resulting in an increased proportion of SANLPCs among hiPSCs-derived cardiomyocytes (hiPSC-CMs) population. Moreover, CDH5 induced typical electrophysiological characteristics resembling cardiac pacemaker cells in hiPSC-CMs. Further mechanistic investigations revealed that the enriched differentiation of hiPSCs into SANLPCs induced by CDH5 was partially reversed by iCRT14, an inhibitor of ß-catenin. Therefore, based on the aforementioned findings, it could be inferred that the regulation of ß-catenin by CDH5 played a crucial role in promoting the enriched differentiation of hiPSCs into SANLPCs, which presents a novel avenue for the construction of biological pacemakers in forthcoming research.

Transitioning from 0.5 to 0.9 mT: Protecting against inadvertent activation of magnet mode in active implants.

The "5 gauss line" is a phrase that is likely to be familiar to everyone working with MRI, but what is its significance, how was it defined, and what changes are currently in progress? This review explores the history of 5 gauss (0.5 mT) as a threshold for protecting against inadvertently putting cardiac pacemakers, implantable cardioverter defibrillators, and other active implantable medical devices into a "magnet mode." Additionally, it describes the background to the recent change of this threshold to 9 gauss (0.9 mT) in the International Standard IEC 60601-2-33 edition 4.0 that defines basic safety requirements for MRI. Practical implications of this change and some ongoing and emerging issues are also discussed.

Informational Postcards Increase Engagement with Remote Monitoring Among Veterans with Pacemakers and Implantable Cardioverter-Defibrillators: a Stepped-Wedge Randomized Controlled Trial.

BACKGROUND: Remote monitoring (RM) of pacemakers and implantable cardioverter-defibrillators (ICDs) reduces morbidity and mortality. However, many patients are not adherent to RM. OBJECTIVE: To test the effect of informational postcards on RM adherence. DESIGN/PATIENTS: Stepped-wedge randomized controlled trial among Veterans with pacemakers and ICDs. INTERVENTION: In wave 1, Veterans who had sent at least 1 transmission within the past 2 years but had become non-adherent were randomly assigned to receive a postcard or no postcard. Those receiving postcards were randomized to 1 of 2 messages: (1) a"warning" postcard describing risks of non-adherence or (2) an "encouraging" postcard describing benefits of adherence. In wave 2, Veterans who had either not received a postcard in wave 1 or had since become non-adherent were mailed a postcard (again, randomized to 1 of 2 messages). Patients who did not send an RM transmission within 1 month were mailed a second, identical postcard. MAIN MEASURES: Transmission within 70 days. KEY RESULTS: Overall, 6351 Veterans were included. In waves 1 and 2, postcards were mailed to 5657 Veterans (2821 "warning" messages and 2836 "encouraging" messages). Wave 1 included 2178 Veterans as controls (i.e., not mailed a postcard), some of whom received a postcard in wave 2 if they remained non-adherent. In wave 2, 3473 postcards were sent. Of the 5657 patients mailed a postcard, 2756 (48.7%) sent an RM transmission within 70 days, compared to 530 (24.3%) of 2178 controls (absolute difference 24.4%, 95% confidence interval [CI] 22.2%, 26.6%). Of those who sent a transmission, 71.8% did so after the first postcard. Transmission rates at 70 days did not significantly differ between "warning" and "encouraging" messages (odds ratio 1.04, 95% CI 0.92, 1.18). CONCLUSIONS: Informational postcards led to a 24.4% absolute increase in adherence at 70 days among Veterans with pacemakers and ICDs who were non-adherent to RM.

A case of endocardial dissection caused by Micra implantation.

BACKGROUND: Leadless pacemakers are a recent technological advancement. It has many advantages, but there are still a few serious complications. CASE PRESENTATION: This article reports the case of a patient with an endocardial tear and dissection caused by contact with the tip of the Micra cup during surgery and summarises the relevant data. CONCLUSIONS: This case report details the occurrence and management of the incident and provides some guidance for future clinical management.

Electromagnetic Exposure Levels of Electric Vehicle Drive Motors to Passenger Wearing Cardiac Pacemakers.

The number of individuals wearing cardiac pacemakers is gradually increasing as the population ages and cardiovascular disease becomes highly prevalent. The safety of pacemaker wearers is of significant concern because they must ensure that the device properly functions in various life scenarios. Electric vehicles have become one of the most frequently used travel tools due to the gradual promotion of low-carbon travel policies in various countries. The electromagnetic environment inside the vehicle is highly complex during driving due to the integration of numerous high-power electrical devices inside the vehicle. In order to ensure the safety of this group, the paper takes passengers wearing cardiac pacemakers as the object and the electric vehicle drive motors as the exposure source. Calculation models, with the vehicle body, human body, heart, and cardiac pacemaker, are built. The induced electric field, specific absorption rate, and temperature changes in the passenger's body and heart are calculated by using the finite element method. Results show that the maximum value of the induced electric field of the passenger occurs at the ankle of the body, which is 60.3 mV/m. The value of the induced electric field of the heart is greater than that of the human trunk, and the maximum value (283 mV/m) is around the pacemaker electrode. The maximum specific absorption rate of the human body is 1.08 × 10-6 W/kg, and that of heart positioned near the electrode is 2.76 × 10-5 W/kg. In addition, the maximum temperature increases of the human torso, heart, and pacemaker are 0.16 × 10-5 °C, 0.4 × 10-6 °C, and 0.44 × 10-6 °C within 30 min, respectively. Accordingly, the induced electric field, specific absorption rate, and temperature rise in the human body and heart are less than the safety limits specified in the ICNIRP. The electric field intensity at the pacemaker electrode and the temperature rise of the pacemaker meet the requirements of the medical device standards of ICNIRP and ISO 14708-2. Consequently, the electromagnetic radiation from the motor operation in the electric vehicle does not pose a safety risk to the health of passengers wearing cardiac pacemakers in this paper. This study also contributes to advancing research on the electromagnetic environment of electric vehicles and provides guidance for ensuring the safe travel of individuals wearing cardiac pacemakers.

An evolutionarily conserved pacemaker role for HCN ion channels in smooth muscle.

Although hyperpolarization-activated cation (HCN) ion channels are well established to underlie cardiac pacemaker activity, their role in smooth muscle organs remains controversial. HCN-expressing cells are localized to renal pelvic smooth muscle (RPSM) pacemaker tissues of the murine upper urinary tract and HCN channel conductance is required for peristalsis. To date, however, the Ih pacemaker current conducted by HCN channels has never been detected in these cells, raising questions on the identity of RPSM pacemakers. Indeed, the RPSM pacemaker mechanisms of the unique multicalyceal upper urinary tract exhibited by humans remains unknown. Here, we developed immunopanning purification protocols and demonstrate that 96% of isolated HCN+ cells exhibit Ih . Single-molecule STORM to whole-tissue imaging showed HCN+ cells express single HCN channels on their plasma membrane and integrate into the muscular syncytium. By contrast, PDGFR-α+ cells exhibiting the morphology of ICC gut pacemakers were shown to be vascular mural cells. Translational studies in the homologous human and porcine multicalyceal upper urinary tracts showed that contractions and pacemaker depolarizations originate in proximal calyceal RPSM. Critically, HCN+ cells were shown to integrate into calyceal RPSM pacemaker tissues, and HCN channel block abolished electrical pacemaker activity and peristalsis of the multicalyceal upper urinary tract. Cumulatively, these studies demonstrate that HCN ion channels play a broad, evolutionarily conserved pacemaker role in both cardiac and smooth muscle organs and have implications for channelopathies as putative aetiologies of smooth muscle disorders. KEY POINTS: Pacemakers trigger contractions of involuntary muscles. Hyperpolarization-activated cation (HCN) ion channels underpin cardiac pacemaker activity, but their role in smooth muscle organs remains controversial. Renal pelvic smooth muscle (RPSM) pacemakers trigger contractions that propel waste away from the kidney. HCN+ cells localize to murine RPSM pacemaker tissue and HCN channel conductance is required for peristalsis. The HCN (Ih ) current has never been detected in RPSM cells, raising doubt whether HCN+ cells are bona fide pacemakers. Moreover, the pacemaker mechanisms of the unique multicalyceal RPSM of higher order mammals remains unknown. In total, 97% of purified HCN+ RPSM cells exhibit Ih . HCN+ cells integrate into the RPSM musculature, and pacemaker tissue peristalsis is dependent on HCN channels. Translational studies in human and swine demonstrate HCN channels are conserved in the multicalyceal RPSM and that HCN channels underlie pacemaker activity that drives peristalsis. These studies provide insight into putative channelopathies that can underlie smooth muscle dysfunction.

Leadless versus transvenous single-chamber ventricular pacemakers: 3 year follow-up of the Micra CED study.

INTRODUCTION: The Micra Coverage with Evidence Development (CED) Study is a novel comparative analysis of Micra (leadless VVI) and transvenous single-chamber ventricular pacemakers (transvenous VVI) using administrative claims data. To compare chronic complications, device reinterventions, heart failure hospitalizations, and all-cause mortality after 3 years of follow-up. METHODS: US Medicare claims data linked to manufacturer device registration information were used to identify Medicare beneficiaries with a de novo implant of either a Micra VR leadless VVI or transvenous VVI pacemaker from March 9, 2017 to December 31, 2018. Unadjusted and propensity score overlap-weight adjusted Fine-Gray competing risk models were used to compare outcomes at 3 years. RESULTS: Leadless VVI patients (N = 6219) had a 32% lower rate of chronic complications and a 41% lower rate of reintervention compared with transvenous VVI patients (N = 10 212) (chronic complication hazard ratio [HR] 0.68; 95% confidence interval [CI], 0.59-0.78; reintervention HR 0.59; 95% CI 0.44-0.78). Infections rates were significantly lower among patients with a leadless VVI (<0.2% vs. 0.7%, p < .0001). Patients with a leadless VVI also had slightly lower rates of heart failure hospitalization (HR 0.90; 95% CI 0.84-0.97). There was no difference in the adjusted 3-year all-cause mortality rate (HR 0.97; 95% CI, 0.92-1.03). CONCLUSION: This nationwide comparative evaluation of leadless VVI versus transvenous VVI de novo pacemaker implants demonstrated that the leadless group had significantly fewer complications, reinterventions, heart failure hospitalizations, and infections than the transvenous group at 3 years, confirming that the previously reported shorter-term advantages associated with leadless pacing persist and continue to accrue in the medium-to-long-term.

A survival analysis of bipolar steroid-eluting and unipolar nonsteroid-eluting epicardial leads.

INTRODUCTION: Epicardial pacemakers are known as an alternative for endocardial pacemakers in some cases such as heart block, and complex congenital heart diseases. Considering recent advances and improvement of epicardial lead subtypes, it is essential to investigate the long-term function of them. In this study, we aimed to assess the sensing and pacing characteristics, and survival of bipolar steroid-eluting and unipolar nonsteroid-eluting epicardial pacemakers. METHODS: We conducted an entirely concentrated search on the documents of all patients who had undergone epicardial lead implantation in the Shaheed Rajaie Cardiovascular, Medical & Research Center during 2015-2018. Implant, and follow-up data were extracted. Kaplan-Meier analysis and Weibull regression hazards model were applied for the survival analysis. RESULTS: Eighty-nine leads were implanted for 77 patients. Of the total leads, 52.81%, 53.93%, and 47.19% were implanted in children (under 18-year-old), females, and patients with congenital heart diseases, respectively. Bipolar steroid-eluting leads comprised 33.71% of 89 leads. The pacing threshold of unipolar nonsteroid-eluting leads that were implanted on the left ventricle and right atrium increased significantly during the follow-up to greater records than bipolar steroid-eluting leads. Survival analysis also revealed that bipolar steroid-eluting leads are significantly better in 48-month survival (Weibull hazard ratio [HR]: 0.13 (95% confidence interval [CI]: 0.02-0.99), p = .049). Age, ventricular location of the lead, and acute pacing characteristics were not associated with survival. CONCLUSIONS: Bipolar steroid-eluting epicardial leads have an acceptable survival compared with unipolar nonsteroid-eluting, without a significant difference regarding patients age. Therefore, they could be an excellent alternative for endocardial ones.

Development of a carpark cardiac implantable electronic device clinic to improve time efficiency and patient satisfaction in the context of restrictions imposed by the COVID-19 pandemic.

INTRODUCTION: We evaluated time efficiency and patient satisfaction of a "car park clinic" (CPC) compared to traditional face-to-face (F2F) during the COVID-19 pandemic. METHODS: Consecutive patients attending CPC between September 2020 and November 2021 were surveyed. CPC time was recorded by staff. F2F time was reported by patients and administrative data. RESULTS: A total of 591 patients attended the CPC. A total of 176 responses were collected for F2F clinic. Regarding satisfaction, 90% of CPC patients responded "happy" or "very happy." 96% reported feeling "safe" or "very safe." Patients spent significantly less time in CPC compared to F2F (17 ± 8 vs. 50 ± 24 min, p < .001). CONCLUSION: CPC had excellent patient satisfaction and superior time efficiency compared to F2F.

Two-year outcomes of leadless vs. transvenous single-chamber ventricular pacemaker in high-risk subgroups.

AIMS: This study compares clinical outcomes between leadless pacemakers (leadless-VVI) and transvenous ventricular pacemakers (transvenous ventricular permanent-VVI) in subgroups of patients at higher risk of pacemaker complications. METHODS AND RESULTS: This study is based on the Micra Coverage with Evidence Development (CED) study. Patients from the Micra CED study were considered in a high-risk subgroup if they had a diagnosis of chronic kidney disease Stages 4-5 (CKD45), end-stage renal disease, malignancy, diabetes, tricuspid valve disease (TVD), or chronic obstructive pulmonary disease (COPD) 12 months prior to pacemaker implant. A pre-specified set of complications and reinterventions were identified using diagnosis and procedure codes. Competing risks models were used to compare reinterventions and complications between leadless-VVI and transvenous-VVI patients within each subgroup; results were adjusted for multiple comparisons. A post hoc comparison of a composite outcome of reinterventions and device complications was conducted. Out of 27 991 patients, 9858 leadless-VVI and 12 157 transvenous-VVI patients have at least one high-risk comorbidity. Compared to transvenous-VVI patients, leadless-VVI patients in four subgroups [malignancy, HR 0.68 (0.48-0.95); diabetes, HR 0.69 (0.53-0.89); TVD, HR 0.60 (0.44-0.82); COPD, HR 0.73 (0.55-0.98)] had fewer complications, in three subgroups [diabetes, HR 0.58 (0.37-0.89); TVD, HR 0.46 (0.28-0.76); COPD, HR 0.51 (0.29-0.90)) had fewer reinterventions, and in four subgroups (malignancy, HR 0.52 (0.32-0.83); diabetes, HR 0.52 (0.35-0.77); TVD, HR 0.44 (0.28-0.70); COPD, HR 0.55 (0.34-0.89)] had lower rates of the combined outcome. CONCLUSION: In a real-world study, leadless pacemaker patients had lower 2-year complications and reinterventions rates compared with transvenous-VVI pacing in several high-risk subgroups. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT03039712.

3 Tesla magnetic resonance imaging in patients with cardiac implantable electronic devices: a single centre experience.

AIMS: Three Tesla (T) magnetic resonance imaging (MRI) provides critical imaging information for many conditions. Owing to potential interactions of the magnetic field, it is largely withheld from patients with cardiac implantable electronic devices (CIEDs). Therefore, we assessed the safety of 3T MRI in patients with '3T MRI-conditional' and 'non-3T MRI-conditional' CIEDs. METHODS AND RESULTS: We performed a retrospective single-centre analysis of clinically indicated 3T MRI examinations in patients with conventional pacemakers, cardiac resynchronization devices, and implanted defibrillators from April 2020 to May 2022. All CIEDs were interrogated and programmed before and after scanning. Adverse events included all-cause death, arrhythmias, loss of capture, inappropriate anti-tachycardia therapies, electrical reset, and lead or generator failure during or shortly after MRI. Changes in signal amplitude and lead impedance were systematically assessed. Statistics included median and interquartile range. A total of 132 MRI examinations were performed on a 3T scanner in 97 patients. Thirty-five examinations were performed in patients with 'non-3T MRI-conditional' CIEDs. Twenty-six scans were performed in pacemaker-dependent patients. No adverse events occurred during or shortly after MRI. P-wave or R-wave reductions ≥ 50 and ≥ 25%, respectively, were noted after three (2.3%) scans, all in patients with '3T MRI-conditional' CIEDs. Pacing and shock impedance changed by ± 30% in one case (0.7%). Battery voltage and stimulation thresholds did not relevantly change after MRI. CONCLUSION: Pending verification in independent series, our data suggest that clinically indicated MRI scans at 3T field strength should not be withheld from patients with cardiac pacemakers or defibrillators.

Anesthetic Considerations in the Electrophysiology Laboratory: A Comprehensive Review.

Catheter ablation procedures for arrhythmias or implantation and/or extraction of cardiac pacemakers can present many clinical challenges. It is imperative that there is clear communication and understanding between the anesthesiologist and electrophysiologist during the perioperative period regarding the mode of ventilation, hemodynamic considerations, and various procedural complications. This article provides a comprehensive narrative review of the anesthetic techniques and considerations for catheter ablation procedures, ventilatory modes using techniques such as high-frequency jet ventilation, and strategies such as esophageal deviation and luminal temperature monitoring to decrease the risk of esophageal injury during catheter ablation. Various hemodynamic considerations, such as the intraprocedural triaging of cardiac tamponade and fluid administration during catheter ablation, also are discussed. Finally, this review briefly highlights the early research findings on pulse-field ablation, a new and evolving ablation modality.

Complementary role of governments, non-governmental organizations, industry, and medical societies in expanding bradycardia therapy access.

As the aging population continues to grow, so has the incidence of cardiovascular diseases, including bradycardia, with much of the burden falling on low- and middle-income countries (LMICs). Pacemaker therapy remains the only guideline-recommended therapy for symptomatic bradycardia, but due to the cost and expertise required for pacemaker implants, patients in LMICs have less access to pacemaker therapies. However, with the concerted effort of organizations (governments, non-governmental organizations, industry, and medical societies) strides can continue to be made in improving access to care. Governments play a role in extending health coverage to its citizens and improving their physical and digital healthcare infrastructure. Non-governmental organizations promote access and awareness through charity and advocacy programs. Industries can continue innovating technology that is both affordable and accessible. Medical societies provide guidelines for treatment and necessary educational and networking opportunities for physicians who serve in LMICs. All of these organizations have individual responsibilities and goals in expanding access to bradycardia therapy, which can be more easily realized by their continued collaboration.

Long-Term Remote vs. Conventional Monitoring of Pacemakers: Systematic Review and Meta-Analysis of Randomized Controlled Trials.

PURPOSE OF REVIEW: Remote monitoring (RM) is the standard of care for patients with cardiac implantable electronic devices (CIEDs), particularly pacemakers. However, the long-term outcomes of RM versus conventional monitoring (CM) of pacemakers and its effectiveness in reducing in-office (IO) visits for device reprogramming require elucidation. This systematic review and meta-analysis aimed to compare the RM and CM of pacemakers over a long-term follow-up. RECENT FINDINGS: We systematically searched the PubMed/MEDLINE, Embase, Cochrane, and ClinicalTrials.gov databases for randomized controlled trials (RCTs) comparing RM and CM of pacemakers with at least 12 months of follow-up. Binary endpoints were pooled with risk ratios (RRs), whereas continuous outcomes were computed using mean differences (MDs) or standardized MDs (SMDs). Heterogeneity was assessed using I2 statistics. Among the eight included RCTs, 2159 (48.9%) of 4063 patients underwent RM. Follow-up periods ranged from 12 to 24 months. There were no significant between-group differences in all-cause mortality (RR = 1.19; 95% confidence interval [CI], 0.90-1.57; p = 0.22; I2 = 0%), stroke (RR = 0.90; 95% CI, 0.43-1.91; p = 0.79; I2 = 23%), hospitalizations for cardiovascular and/or device-related adverse events (RR = 0.95; 95% CI, 0.75-1.21; p = 0.70; I2 = 0%), and quality of life (SMD = - 0.06; 95% CI, - 0.22 to 0.10; p = 0.473; I2 = 0%). RM was associated with fewer IO visits/patient/year (MD = 0.98; 95% CI, - 1.64 to - 0.33; p = 0.08; I2 = 98%) and higher rates of atrial tachyarrhythmia (ATA) detection (RR = 1.22; 95% CI, 1.01-1.48; p = 0.04; I2 = 0%) than was CM. This meta-analysis suggests that RM of pacemakers leads to higher rates of ATA detection and fewer IO visits/patient/year, without compromising patient safety.

Electrocardiographic parameters associated with pacemaker induced cardiomyopathy.

BACKGROUND: Chronic right ventricular (RV) pacing can induce left ventricular (LV) dyssynchrony and cause pacemaker induced cardiomyopathy (PiCM). Identifying which patients are at risk for PiCM is limited. METHODS: Patients receiving RV-only permanent pacemakers (PPMs) at Duke University Medical Center between 2011 and 2017 who had normal baseline ejection fractions (EFs) were identified. Patients who developed a subsequent decrease in EF, died, or underwent cardiac resynchronization therapy, left ventricular assist device, or heart transplant without a competing cause were considered as the primary endpoint. Pre-PPM and post-PPM electrocardiograms (ECGs) were analyzed to extract scalar measurements including the lead one ratio (LOR) as well as advanced-ECG (A-ECG) features to identify predictors of PiCM. Traditional and penalized Cox regression were used to identify variables predictive of the primary endpoint. RESULTS: Pre-PPM ECGs were evaluated for 404 patients of whom 140 (35%) experienced the primary endpoint. Predictors included female sex (hazard ratio [HR] 1.14), a T' wave in V6 (HR 1.31), a P' wave in aVL (HR 0.88), and estimated glomerular filtration rate (HR 0.88). Post-PPM ECGs were evaluated for 228 patients for whom 94 (41%) experienced the primary endpoint. Predictors included female sex (HR 0.50), age (HR 1.06), and a history of congestive heart failure (HR 1.63). Neither LOR nor A-ECG parameters were strong predictors of the primary endpoint. CONCLUSIONS: Baseline and paced ECG data provide limited insight into which patients are at high risk for developing PiCM.

Leadless vs. transvenous single-chamber ventricular pacing in the Micra CED study: 2-year follow-up.

AIMS: Clinical trials have demonstrated the safety and efficacy of the Micra leadless VVI pacemaker; however, longer-term outcomes in a large, real-world population with a contemporaneous comparison to transvenous VVI pacemakers have not been examined. We compared reinterventions, chronic complications, and all-cause mortality at 2 years between leadless VVI and transvenous VVI implanted patients. METHODS AND RESULTS: The Micra Coverage with Evidence Development study is a continuously enrolling, observational, cohort study of leadless VVI pacemakers in the US Medicare fee-for-service population. Patients implanted with a leadless VVI pacemaker between March 9, 2017, and December 31, 2018, were identified using Medicare claims data linked to manufacturer device registration data (n = 6219). All transvenous VVI patients from facilities with leadless VVI implants during the study period were obtained directly from Medicare claims (n = 10 212). Cox models were used to compare 2-year outcomes between groups. Compared to transvenous VVI, patients with leadless VVI had more end-stage renal disease (12.0% vs. 2.3%) and a higher Charlson comorbidity index (5.1 vs. 4.6). Leadless VVI patients had significantly fewer reinterventions [adjusted hazard ratio (HR) 0.62, 95% confidence interval (CI) 0.45-0.85, P = 0.003] and chronic complications (adjusted HR 0.69, 95% CI 0.60-0.81, P < 0.0001) compared with transvenous VVI patients. Adjusted all-cause mortality at 2 years was not different between the two groups (adjusted HR 0.97, 95% CI 0.91-1.04, P = 0.37). CONCLUSION: In a real-world study of US Medicare patients, the Micra leadless VVI pacemaker was associated with a 38% lower adjusted rate of reinterventions and a 31% lower adjusted rate of chronic complications compared with transvenous VVI pacing. There was no difference in adjusted all-cause mortality at 2 years.

Rate-Responsive Cardiac Pacing: Technological Solutions and Their Applications.

Modern cardiac pacemakers are equipped with a function that allows the heart rate to adapt to the current needs of the patient in situations of increased demand related to exercise and stress ("rate-response" function). This function may be based on a variety of mechanisms, such as a built-in accelerometer responding to increased chest movement or algorithms sensing metabolic demand for oxygen, analysis of intrathoracic impedance, and analysis of the heart rhythm (Q-T interval). The latest technologies in the field of rate-response functionality relate to the use of an accelerometer in leadless endocavitary pacemakers; in these devices, the accelerometer enables mapping of the mechanical wave of the heart's work cycle, enabling the pacemaker to correctly sense native impulses and stimulate the ventricles in synchrony with the cycles of atria and heart valves. Another modern system for synchronizing pacing rate with the patient's real-time needs requires a closed-loop system that continuously monitors changes in the dynamics of heart contractions. This article discusses the technical details of various solutions for detecting and responding to situations related to increased oxygen demand (e.g., exercise or stress) in implantable pacemakers, and reviews the results of clinical trials regarding the use of these algorithms.

The Burden of Cardiac Implantable Electronic Device Checks in the Peri-MRI Setting: The CHECK-MRI Study.

BACKGROUND: Most modern cardiac implantable electronic device (CIED) systems are now compatible with magnetic resonance imaging (MRI) scans. The requirement for both pre- and post-MRI CIED checks imposes significant workload to the cardiac electrophysiology service. Here, we sought to determine the burden of CIED checks associated with MRI scans. METHODS: We identified all CIED checks performed peri-MRI scans at our institution over a 3-year period between 1 July 2017 to 30 June 2020, comprising three separate financial years (FY). Device check reports, MRI scan reports and clinical summaries were collated. The workload burden was determined by assessing the occasions and duration of service. Analysis was performed to determine cost burden/projections for this service and identify factors contributing to the workload. RESULTS: A total of 739 CIED checks were performed in the peri-MRI scan setting (370 pre- and 369 post-MRI scan), including 5% (n=39) that were performed outside of routine hours (weekday <8 am or >5 pm, and weekends). MRIs were performed for 295 patients (75±13 years old, 64% male) with a CIED (88% permanent pacemaker, and 12% high voltage device), including 49 who had more than one MRI scan. The proportion of total MRI scans for patients with a CIED in-situ increased each FY (from 0.5% of all MRIs in FY1, to 0.9% in FY2, to 1.0% in FY3). The weekly workload increased (R2=0.2, p<0.001), but with week-to-week variability due to ad hoc scheduling (209 days with only one MRI vs 78 days with ≥2 MRIs for CIED patients). The projected annual cost of this service will increase to AUD$161,695 in 10 years for an estimated annual 546 MRI scans for CIED patients. CONCLUSIONS: There is an increasing workload burden and expense associated with CIED checks in the peri-MRI setting. Appropriate budgeting, staff allocation and standardisation of automated CIED pre-programming features among manufacturers are urgently needed.

The Australian and New Zealand Cardiac Implantable Electronic Device Survey, Calendar Year 2021: 50-Year Anniversary.

BACKGROUND: A cardiac implantable electronic device (CIED) survey was undertaken in Australia and New Zealand for calendar year 2021. The survey involved pacemakers (PMs) and implantable cardioverter-defibrillators (ICDs). The survey was conducted on the 50th anniversary of the first survey for both Australia and New Zealand in 1972; that initial survey being conducted by two of the current authors. RESULTS AND CONCLUSIONS: For 2021, there were 19,410 PMs (17,971 in 2017) sold in Australia for new implants and 2,282 (1,811 in 2017) sold in New Zealand. The number of new PM implants per million population was 755 for Australia (745 in 2017) and 446 for New Zealand (384 in 2017). Unlike previous recent surveys, the percentage of PM replacements compared to total sales in both Australia and New Zealand rose. Pulse generator types implanted were predominantly dual chamber; Australia 77% (73% in 2017) and New Zealand 70% (68% in 2017). There were 1,509 biventricular PMs implanted in Australia (1,247 in 2017) and 172 in New Zealand (118 in 2017). Transvenous pacing leads were >90% active fixation in the atrium and ventricle. There was an increase in ICD usage with Australia 4,519 new implants (4,212 in 2017) and New Zealand 449 (396 in 2017). New ICD implants per million population were 187 for Australia (175 in 2017) and 88 for New Zealand (90 in 2017). For the first time the survey included implantable event monitors with 6,933 being implanted in Australia. However, for proprietary reasons, survey figures for subcutaneous implantable defibrillators, leadless pacemakers and conduction system pacing have not been included. Both Australia and New Zealand have high PM and ICD implant numbers compared to the rest of the Asia Pacific region.

Persistent Opioid Use After Cardiac Implantable Electronic Device Procedures.

BACKGROUND: Prescription opioids are a major contributor to the ongoing epidemic of persistent opioid use (POU). The incidence of POU among opioid-naïve patients after cardiac implantable electronic device (CIED) procedures is unknown. METHODS: This retrospective cohort study used data from a national administrative claims database from 2004 to 2018 of patients undergoing CIED procedures. Adult patients were included if they were opioid-naïve during the 180-day period before the procedure and did not undergo another procedure with anesthesia in the next 180 days. POU was defined by filling an additional opioid prescription >30 days after the CIED procedure. RESULTS: Of the 143 400 patients who met the inclusion criteria, 15 316 (11%) filled an opioid prescription within 14 days of surgery. Among these patients, POU occurred in 1901 (12.4%) patients 30 to 180 days after surgery. The likelihood of developing POU was increased for patients who had a history of drug abuse (odds ratio, 1.52; P=0.005), preoperative muscle relaxant (odds ratio, 1.52; P<0.001) or benzodiazepine (odds ratio, 1.23; P=0.001) use, or opioid use in the previous 5 years (OR, 1.76; P<0.0001). POU did not differ after subcutaneous implantable cardioverter defibrillator or other CIED procedures (11.1 versus 12.4%; P=0.5). In a sensitivity analysis excluding high-risk patients who were discharged to a facility or who had a history of drug abuse or previous opioid, benzodiazepine, or muscle relaxant use, 8.9% of the remaining cohort had POU. Patients prescribed >135 mg of oral morphine equivalents had a significantly increased risk of POU. CONCLUSIONS: POU is common after CIED procedures, and 12% of patients continued to use opioids >30 days after surgery. Higher initially prescribed oral morphine equivalent doses were associated with developing POU.