A detached helix of pacemaker pacing lead.

Permanent pacemaker implantation is the main treatment of symptomatic bradyarrhythmia, which has been widely used. Lead implantation is a critical step. When the lead malfunctions and needs to be replaced, extraction or abandonment of the primary lead (in whole or in part) should be determined according to the situation.

Periprocedural Management and Multidisciplinary Care Pathways for Patients With Cardiac Implantable Electronic Devices: A Scientific Statement From the American Heart Association.

The rapid technological advancements in cardiac implantable electronic devices such as pacemakers, implantable cardioverter defibrillators, and loop recorders, coupled with a rise in the number of patients with these devices, necessitate an updated clinical framework for periprocedural management. The introduction of leadless pacemakers, subcutaneous and extravascular defibrillators, and novel device communication protocols underscores the imperative for clinical updates. This scientific statement provides an inclusive framework for the periprocedural management of patients with these devices, encompassing the planning phase, procedure, and subsequent care coordinated with the primary device managing clinic. Expert contributions from anesthesiologists, cardiac electrophysiologists, and cardiac nurses are consolidated to appraise current evidence, offer patient and health system management strategies, and highlight key areas for future research. The statement, pertinent to a wide range of health care professionals, underscores the importance of quality care pathways for patient safety, optimal device function, and minimization of hemodynamic disturbances or arrhythmias during procedures. Our primary objective is to deliver quality care to the expanding patient cohort with cardiac implanted electronic devices, offering direction in the era of evolving technologies and laying a foundation for sustained education and practice enhancement.

Atrioventricular Synchrony Delivered by a Dual-Chamber Leadless Pacemaker System.

BACKGROUND: A dual-chamber leadless pacemaker system has been designed for AV synchronous pacing using wireless, beat-to-beat, implant-to-implant (i2i) communication between distinct atrial and ventricular leadless pacemakers. The AV synchrony achieved across various ambulatory scenarios has yet to be systematically evaluated. METHODS: A prospective, single-arm, unblinded, multicenter, international clinical trial of the leadless pacemaker system was conducted in patients with a conventional dual-chamber pacing indication enrolled from February 2022 to March 2023. Leadless pacemaker systems were implanted, and 12-lead Holter electrocardiographic recordings were collected 3 months after implantation over various postures/activities: sitting, supine, left lateral recumbent, right lateral recumbent, standing, normal walk, and fast walk. An independent Holter core laboratory performed a manual adjudication of the percent of AV synchronous beats using the standard 300-millisecond PR interval limit. Atrium-to-ventricle and ventricle-to-atrium i2i communication success rates were also assessed. Post hoc summary statistics describing the relationships between AV synchrony and i2i success, posture/activity, implantation indication, AV event, and heart rate were calculated. RESULTS: In the evaluable population (n=384 of 464 enrolled [83%]; 61% male; age, 70 years; weight, 82 kg; 60% ejection fraction; 95% of beats evaluable), the mean AV synchrony of 98% of beats observed across all postures using the standard 300-millisecond limit was greater than both atrium-to-ventricle i2i (94%) and ventricle-to-atrium i2i (94%; P<0.001), exceeding both i2i values in 95% of patients. AV synchrony was achieved in >95% of evaluable beats across all postures/activities, implantation indications, AV paced/sensed event combinations, and heart rate ranges (including >100 bpm). CONCLUSIONS: This dual-chamber leadless pacemaker system demonstrated AV synchrony in 98% of evaluable beats at 3 months after implantation. AV synchrony was maintained across postures/activities and remained robust for heart rates >100 bpm.

Incidence of Coronary Artery Disease After Permanent Pacemaker Implantation: A Hospital-based Study from East India.

Bradyarrhythmias, characterized by heart rates of <60 bpm due to conduction issues, carry risks of sudden cardiac death and falls. Pacemaker implantation is a standard treatment, but the interplay between bradyarrhythmias, coronary artery disease (CAD), and patient attributes requires further exploration. This study was a retrospective hospital record-based study that analyzed data from 699 patients who underwent pacemaker implantation for symptomatic bradyarrhythmias between February 2019 and February 2022. Clinical parameters, coronary angiography (CAG) findings, ejection fraction, and indications for pacemaker implantation were documented. The relationship between CAD severity, specific bradyarrhythmias, and ejection fraction was explored. Statistical analysis included chi-squared tests and t tests. The mean age of the study population (n = 699) was 66.75 years (male:female ratio, 70:30), with 77.2% having type 2 diabetes and 61.6% being hypertensive. The majority of patients had minor or non-obstructive CAD (61.8%), followed by normal CAG findings (25.75%) and obstructive CAD (12.45%). Complete heart block (CHB) was the primary indication for pacemaker implantation (55.2%), followed by sick sinus syndrome (22.3%). The results did not show any association between ejection fraction and CAG findings. Patients who presented with CHB had a higher incidence of obstructive CAD, indicating greater severity. This study sheds light on the intricate interplay between severe bradyarrhythmias, CAD, and patient characteristics. Our analysis revealed no statistical significance between obstructive CAD and the need for a permanent pacemaker. This makes us question our practice of maintaining a low threshold for coronary angiography during pacemaker implantation. The observed low yield and anticoagulation protocol reassure us of the choice to delay this diagnostic intervention. These insights can guide tailored management strategies, enhancing clinical care approaches for patients with severe bradyarrhythmias necessitating pacemaker implantation.

Wireless Device Therapy in Hypertrophic Cardiomyopathy Using the Combination of a Leadless Pacemaker and a Subcutaneous Defibrillator: A Report with 2-year Follow-up of Two Patients.

Cardiac implantable electronic devices (CIEDs) are essential tools in cardiology for tackling rhythm disturbances and have come a long way over the last decades. Technology is shifting toward leadless devices that spare the complications and limitations of traditional intravascular CIEDs. Herein, we report the simultaneous implantation of a leadless pacemaker (LP) and a subcutaneous implantable cardioverter-defibrillator (S-ICD) in two patients with hypertrophic cardiomyopathy, as well as their 2-year follow-up results, while explaining the preventive measures taken to steer around unwanted device interaction. Implantation of an S-ICD with an LP is reserved for unique cases but is a feasible approach when there is a contraindication for intravascular CIED implantation. Furthermore, this technique may be used in younger patients with cardiomyopathies in whom multiple generator replacements are expected, along with their known adverse effects.

Pacemaker-induced atrial fibrillation reconsidered-associations with different pacing sites and prevention approaches.

The incidence of atrial fibrillation (AF) is significantly higher in patients with pacemakers than in the general population, which could be due to patient characteristics and the diagnostic tool of the pacemaker in detecting atrial high-rate episodes and subclinical AF, but also to the pacemaker itself providing AF-promoting conditions. It is well known that high ventricular pacemaker burden increases the likelihood of AF occurrence. However, the sites of atrial and ventricular pacing may also influence the risk for AF. The conventional sites for atrial and ventricular pacing are in the right atrial appendage and in the right ventricular apex. However, growing evidence suggests that alternative pacing sites may be superior for the prevention of AF. Bachmann bundle pacing, for example, promotes interatrial excitation conduction, resulting in atrial synchronicity and a shorter total atrial activation time, which may be preventive for the occurrence of AF. Moreover, in recent years, new ventricular pacing sites have come into focus with His bundle and left bundle branch pacing. In addition to the hemodynamic and electrophysiological cardiac benefits, these new options may also offer benefits in the prevention of AF. This review provides an overview of pacing-induced AF mechanisms and the association with different pacing sites, as well as approaches for prevention of pacing-induced AF, highlighting different sites and modes of atrial pacing and the newer sites of ventricular pacing.

Managing SVC Syndrome in Patients with Cardiac Implantable Electronic Device Leads: Strategies and Considerations.

BACKGROUND: Data on Transvenous (TV) lead-associated superior vena cava (SVC) syndrome are limited. The management of this problem might require a multidisciplinary approach, often involving TV lead extraction (TLE) followed by angioplasty and stenting. OBJECTIVE: To describe the management and outcome of TV lead-associated SVC syndrome METHODS: We retrospectively identified patients with a diagnosis of SVC syndrome and TV leads at Emory Healthcare between 2015 and 2023. RESULTS: 15 patients with lead-related SVC syndrome were identified. The cohort average age was 50 years. Symptoms included swelling in the face, neck, and upper extremity (67%), shortness of breath (53%) and lightheadedness (40%). Patients had on average 2 ± 0.7 leads crossing the SVC with a lead dwell time of 9.8 ± 7.5 years. Thirteen patients were managed with transvenous lead extraction (TLE), followed by SVC stenting and angioplasty (10), angioplasty alone (2), while one patient had no intervention after TLE. One patient was managed with anticoagulation, and another had angioplasty and stenting with lead jailing. One patient experienced SVC perforation and cardiac tamponade during SVC stenting managed successfully with a covered stent and pericardiocentesis. Among the 12 patients with TLE and angioplasty ± stenting, 7 patients underwent reimplantation of a transvenous lead. Two of those patients had symptoms recurrence and none of the 5 patients without lead reimplantation had recurrence of symptoms. CONCLUSION: Lead-related SVC syndrome management requires a multidisciplinary approach often including TLE followed by angioplasty and stenting. Avoiding TV lead reimplantation might help reduce symptoms recurrence.

The effect of right ventricle septal pacing versus apical pacing in dual-chamber pacemakers on patients' anxiety and depression: a one-year follow-up study.

BACKGROUND: Anxiety and depression are potentially harmful outcomes of permanent cardiac pacemakers. Dual-chamber P.P.M. is frequently used to treat life threatening bradycardia. The study aims to estimate the effect of the right ventricular PM lead position on recipients' anxiety and depression before, 6 months, and 1 year after implantation. RESULTS: A statistically significant correlation was discovered between the studied groups regarding HADS depression score after 6 months (p 0.013) and 1 year (p 0.013). A statistically non-significant difference was found among the studied groups at any point of time regarding baseline (p 0.063), after 6 months (p 0.054), or after 1 year (p 0.099). Significance was found between HADS anxiety score (p 0.015) or depression score after 1 year and the incidence of complications (p 0.001). CONCLUSIONS: A strong relationship was found between the level of depression and the R.V. site of implantation, as patients with the apical group had higher levels of depression post-implantation. The septal position has less stress and depression on the patient's well-being than the apical one.

Endless loop tachycardia among patients with devices having advanced preventive algorithms: A case series and brief review.

BACKGROUND: Endless loop tachycardia (ELT) is the commonest pacemaker mediated tachycardia (PMT) encountered among patients with cardiac implantable electronic devices (CIEDs). Despite being enabled with various preventive algorithms, we encountered several cases having recurrent, long, and symptomatic ELT. MATERIALS AND METHODS: We retrospectively analyzed consecutive device checkups at device clinic at a single center of eastern India between January 2019 to March 2023. RESULTS: There were 20 cases of confirmed and sustained ELT among 4520 device checks. Although mostly benign, in two cases ELT led to clinical worsening in patients having left ventricular (LV) systolic dysfunction. Even with good ventricular function, ELT resulted in improper atrioventricular (AV) synchrony leading to disabling symptom in one case. The differentiation of ELT from sinus tachycardia and atrial tachycardia (AT) was not always easy. Magnet application is certainly useful to differentiate. The situations that provoked ELT in this study were-long AV delays, VIP (ventricular intrinsic preferences)/MVP (managed ventricular pacing), atrial non-capture, atrial under/over sensing, premature ventricular contractions (PVCs)/couplets, premature atrial contractions (PAC) and slower ventriculo-atrial (VA) conduction. Rate responsive shortening of post-ventricular atrial refractory period (PVARP) also promoted its occurrence and hindered troubleshooting. When ELT occurred despite post-PVC extension of PVARP, lowering the atrial sensitivity, switching to bipolar sensing and manual setting of longer PVARP after measuring VA conduction time were useful. "Rate responsive PVARP" had to be turned off in a few cases to prevent ELT. On the contrary, an over aggressive prolongation of PVARP led to repetitive non-reentrant ventriculo-atrial synchrony (RNRVAS) in two cases. Checking VA conduction during implantation and noninvasive program stimulation (NIPS) during follow up were useful to check the tendency for ELT. CONCLUSION: Clinically significant ELT is rare but not uncommon among devices having in-built preventive algorithms. Manual adjustments are often useful to troubleshoot the same.

A novel balloon-expandable transcatheter aortic valve bioprosthesis: myval and myval Octacor.

INTRODUCTION: Over the past two decades, transcatheter aortic valve replacement (TAVR) has expanded its application across all surgical risk levels, including low-risk patients, where, due to longer life expectancy, reducing common pitfalls of TAVR is essential. To address these needs, many technological advancements have been developed. Myval and the new generation Myval Octacor (Meril Life Sciences Pvt. Ltd) are novel balloon-expandable (BE) transcatheter heart valve (THV) systems designed for the treatment of severe aortic stenosis. AREAS COVERED: This review aims to illustrate the design features of these novel THVs and the main evidence from available studies. Furthermore, we provide evidence of these THVs' performance in challenging scenarios such as extra-large aortic annuli, bicuspid aortic valves, and valve-in-valve/valve-in-ring procedures. EXPERT OPINION: Myval and Myval Octacor have demonstrated comparable early safety and clinical efficacy to the leading contemporary THVs, exhibiting remarkably low rates of moderate to severe paravalvular leak (PVL) and permanent pacemaker implantation (PPI). The wide range of sizes offered by the Myval family may minimize the risk of under-/oversizing, potentially explaining the lower rates of the aforementioned phenomena. Moreover, the presence of both, internal skirt and external reinforced cuff, may also explain the low rate of moderate to severe PVL.

Closed loop stimulation reduces the incidence of atrial high-rate episodes compared with conventional rate-adaptive pacing in patients with sinus node dysfunctions.

AIMS: Subclinical atrial fibrillation (AF) is associated with increased risk of progression to clinical AF, stroke, and cardiovascular death. We hypothesized that in pacemaker patients requiring dual-chamber rate-adaptive (DDDR) pacing, closed loop stimulation (CLS) integrated into the circulatory control system through intra-cardiac impedance monitoring would reduce the occurrence of atrial high-rate episodes (AHREs) compared with conventional DDDR pacing. METHODS AND RESULTS: Patients with sinus node dysfunctions (SNDs) and an implanted pacemaker or defibrillator were randomly allocated to dual-chamber CLS (n = 612) or accelerometer-based DDDR pacing (n = 598) and followed for 3 years. The primary endpoint was time to the composite endpoint of the first AHRE lasting ≥6 min, stroke, or transient ischaemic attack (TIA). All AHREs were independently adjudicated using intra-cardiac electrograms. The incidence of the primary endpoint was lower in the CLS arm (50.6%) than in the DDDR arm (55.7%), primarily due to the reduction in AHREs lasting between 6 h and 7 days. Unadjusted site-stratified hazard ratio (HR) for CLS vs. DDDR was 0.84 [95% confidence interval (CI), 0.72-0.99; P = 0.035]. After adjusting for CHA2DS2-VASc score, the HR remained 0.84 (95% CI, 0.71-0.99; P = 0.033). In subgroup analyses of AHRE incidence, the incremental benefit of CLS was greatest in patients without atrioventricular block (HR, 0.77; P = 0.008) and in patients without AF history (HR, 0.73; P = 0.009). The contribution of stroke/TIA to the primary endpoint (1.3%) was low and not statistically different between study arms. CONCLUSION: Dual-chamber CLS in patients with SND is associated with a significantly lower AHRE incidence than conventional DDDR pacing.

Decreasing pacemaker implantation rates with Evolut supra-annular transcatheter aortic valves in a large real-world registry.

BACKGROUND: Permanent pacemaker implantation (PPI) rates following transcatheter aortic valve replacement (TAVR) remain a concern. We assessed the PPI rates over time in patients implanted with an Evolut supra-annular, self-expanding transcatheter valve from the US STS/ACC TVT Registry. METHODS: Patients who underwent TAVR with an Evolut R, Evolut PRO or Evolut PRO+ valve between July 2018 (Q3) and June 2021 (Q2) were included. PPI rates were reported by calendar quarter. In-hospital PPI rates were reported as proportions and 30-day rates as Kaplan-Meier estimates. A Cox regression model was used to determine potential predictors of a new PPI within 30 days of the TAVR procedure. RESULTS: From July 2018 to June 2021, 54,014 TAVR procedures were performed using Evolut valves. Mean age was 79.3 ± 8.8 years and 49.2 % were male. The 30-day PPI rate was 16.6 % in 2018 (Q3) and 10.8 % in 2021 (Q2, 34.9 % decrease, p < 0.001 for trend across all quarters). The in-hospital PPI rate decreased by 40.1 %; from 14.7 % in 2018 (Q3) to 8.8 % in 2021 (Q2) (p < 0.001 for trend across all quarters). Significant predictors of a new PPI within 30 days included a baseline conduction defect, history of atrial fibrillation, home oxygen, and diabetes mellitus. CONCLUSION: From 2018 to 2021, TAVR with an Evolut transcatheter heart valve in over 50,000 patients showed a significant decreasing trend in the rates of in-hospital and 30-day PPI, representing the lowest rate of PPI in any large real-world registry of Evolut. During the same evaluated period, high device success and shorter length of stay was also observed.