Incidence, risk factors, and long-term outcomes associated with permanent pacemaker implantation after aortic root replacement.

OBJECTIVE: Permanent pacemaker implantation (PPI) after AVR is associated with long-term mortality. However, data regarding PPI after aortic root replacement (ARR) is lacking. Herein we describe the incidence, risk factors, and long-term outcomes of PPI after ARR. METHODS: Consecutive patients undergoing ARR from 2005-2020 were selected after excluding those with endocarditis, Type A dissection, or preoperative PPI. Patients requiring PPI after ARR were identified, along with the indication and timing. Independent factors associated with PPI after ARR were identified and long-term survival was assessed. RESULTS: The incidence of PPI was 3.8% (n=85) among 2240 patients undergoing ARR. PPI was performed a median of 7 days (IQR 5-12) after ARR most commonly for complete heart block (73%). Bicuspid aortic valve (OR 1.89, p=0.02), female gender (OR 1.74, p=0.04), preoperative heart block (OR 2.70, p=0.02), and prior AVR (OR 2.18, p=0.01) were independently associated with PPI while preoperative aortic insufficiency (OR 0.52, p=0.01) and VSRR procedure compared to bio-Bentall (OR 0.40, p=0.01) were protective. Patients requiring PPI after ARR were not at increased risk of operative or long-term mortality compared to patients not requiring PPI (p=0.26), however those undergoing PPI suffered from significantly longer hospital length of stay (13 vs 7 days, p<0.001). CONCLUSIONS: The incidence of PPI after ARR remains low, particularly after VSRR. Preoperative conduction disturbance, prior AVR, and bicuspid AV are all associated with increased risk of PPI. While PPI is associated with longer length of stay, it is not associated with early or late mortality.

Chronic clinical performance of a novel subxiphoidal pacemaker system: Early feasibility study design.

BACKGROUND: Extravascular and leadless pacemakers are a new class of cardiac devices that may reduce the rate of complications common to traditional cardiac pacemakers with intracardiac leads. These devices also have the potential of expanding access to cardiac pacing therapy by simplifying the complexity and cost of implantation. The objective of this study is to evaluate the implantation, chronic safety, and performance of a novel subxiphoidal pacemaker. METHODS: This study is an open-label, non-randomized, early feasibility study. Ten patients indicated for implantation of a single-chamber ventricular pacemaker will be enrolled and implanted with the investigational device. The pacemaker will be inserted underneath the ribcage and clipped to the xiphoid process, with stimulation electrodes positioned on the cardiac pericardium. Patients will be programmed to chronic pacing; pacing capture threshold, sensing amplitude, and lead impedance will be measured at implant and regularly scheduled follow-up visits. 24-h Holter ECG and cardiac troponin will also be periodically measured. Adverse events will be recorded throughout the study period. CONCLUSION: This study is designed to assess the feasibility, safety, and chronic performance of a novel extravascular pacemaker, and will provide valuable data on whether this device has the potential to be a viable alternative to conventional pacemakers.

Comparison of Patient Outcomes Between Leadless vs Transvenous Pacemakers Following Transcatheter Aortic Valve Replacement.

BACKGROUND: Evidence is limited regarding the effectiveness of leadless pacemaker implantation for conduction disturbance following transcatheter aortic valve replacement (TAVR). OBJECTIVES: This study sought to examine the national trends in the use of leadless pacemaker implantation following TAVR and compare its performance with transvenous pacemakers. METHODS: Medicare fee-for-service beneficiaries aged ≥65 years who underwent leadless or transvenous pacemakers following TAVR between 2017 and 2020 were included. Outcomes included in-hospital overall complications as well as midterm (up to 2 years) all-cause death, heart failure hospitalization, infective endocarditis, and device-related complications. Propensity score overlap weighting analysis was used. RESULTS: A total of 10,338 patients (730 leadless vs 9,608 transvenous) were included. Between 2017 and 2020, there was a 3.5-fold increase in the proportion of leadless pacemakers implanted following TAVR. Leadless pacemaker recipients had more comorbidities, including atrial fibrillation and end-stage renal disease. After adjusting for potential confounders, patients with leadless pacemakers experienced a lower rate of in-hospital overall complications compared with patients who received transvenous pacemakers (7.2% vs 10.1%; P = 0.014). In the midterm, we found no significant differences in all-cause death (adjusted HR: 1.13; 95% CI: 0.96-1.32; P = 0.15), heart failure hospitalization (subdistribution HR: 0.89; 95% CI: 0.74-1.08; P = 0.24), or infective endocarditis (subdistribution HR: 0.98; 95% CI: 0.44-2.17; P = 0.95) between the 2 groups, but leadless pacemakers were associated with a lower risk of device-related complications (subdistribution HR: 0.37; 95% CI: 0.21-0.64; P < 0.001). CONCLUSIONS: Leadless pacemakers are increasingly being used for conduction disturbance following TAVR and were associated with a lower rate of in-hospital complications and midterm device-related complications compared to transvenous pacemakers without a difference in midterm mortality.

Artificial Intelligence-Enabled Electrocardiography Predicts Future Pacemaker Implantation and Adverse Cardiovascular Events.

Medical advances prolonging life have led to more permanent pacemaker implants. When pacemaker implantation (PMI) is commonly caused by sick sinus syndrome or conduction disorders, predicting PMI is challenging, as patients often experience related symptoms. This study was designed to create a deep learning model (DLM) for predicting future PMI from ECG data and assess its ability to predict future cardiovascular events. In this study, a DLM was trained on a dataset of 158,471 ECGs from 42,903 academic medical center patients, with additional validation involving 25,640 medical center patients and 26,538 community hospital patients. Primary analysis focused on predicting PMI within 90 days, while all-cause mortality, cardiovascular disease (CVD) mortality, and the development of various cardiovascular conditions were addressed with secondary analysis. The study's raw ECG DLM achieved area under the curve (AUC) values of 0.870, 0.878, and 0.883 for PMI prediction within 30, 60, and 90 days, respectively, along with sensitivities exceeding 82.0% and specificities over 81.9% in the internal validation. Significant ECG features included the PR interval, corrected QT interval, heart rate, QRS duration, P-wave axis, T-wave axis, and QRS complex axis. The AI-predicted PMI group had higher risks of PMI after 90 days (hazard ratio [HR]: 7.49, 95% CI: 5.40-10.39), all-cause mortality (HR: 1.91, 95% CI: 1.74-2.10), CVD mortality (HR: 3.53, 95% CI: 2.73-4.57), and new-onset adverse cardiovascular events. External validation confirmed the model's accuracy. Through ECG analyses, our AI DLM can alert clinicians and patients to the possibility of future PMI and related mortality and cardiovascular risks, aiding in timely patient intervention.

Combined transcatheter vegetectomy and leadless pacemaker implantation for endocarditis and complete heart block.

We describe a case of culture-negative right-sided endocarditis for which simultaneous transcatheter vegetectomy was performed with leadless pacemaker implantation and removal of a temporary externalized pacing system. The patient did not have a recurrence of endocarditis highlighting the safety and efficacy of same-procedure vegetation removal and pacemaker implantation. This report documents a novel approach for the treatment of cardiac implantable electronic device-associated endocarditis in poor surgical candidates who are pacemaker-dependent.

Our patient had a large blood clot in the heart that might have been infected. We needed to remove the potentially infected blood clot as well as replace the patient's pacemaker as it might have been infected too. This case describes a new technique of removing a blood clot by suction as well as replacing the pacemaker during the same procedure.

Feasibility of epicardial implantation of medtronic 3830 lead in a pediatric patient : case report.

BACKGROUND: High-grade atrioventricular block is the primary reason for epicardial permanent pacemaker implantation during the perioperative period in patients with congenital heart disease. Due to the smaller diameter of venous vessels in children, epicardial permanent pacemaker implantation is usually a preferred choice, we report one pediatric patient who received epicardial permanent pacemaker implantation using a new approach. CASE PRESENTATION: We present the case of a 2-year-old girl who underwent the modified Konno procedure and Pulmonary valvuloplasty surgery and presented after surgery with a High-grade atrioventricular block. At over 20 days after the patient underwent a redo-sternotomy which epicardial permanent pacemaker implantation. Medtronic Model 4965 Capsure Epi ® steroid-eluting unipolar epicardial pacing lead was immobilized on the surface of the right ear. The Medtronic 3830 pacing lead was screwed obliquely and clockwise under direct view from the surface of the right ventricle to the endocardium near the interventricular septum. The patient's recovery was uneventful. CONCLUSION: In this case report, we demonstrate the feasibility and potential benefits of using the Medtronic 3830 lead for epicardial pacing in a pediatric patient with severe cardiac complications following surgery for congenital heart disease. This approach offers a viable alternative to traditional epicardial pacing methods, particularly in complex cases where conventional leads fail to provide stable pacing thresholds.

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.

Deactivation of cardiac implantable electronic devices in palliative patients: When and how.

Cardiac implantable electronic devices have transformed medicine as they improve quality of life and prevent premature death. In palliative care settings, deactivation of these devices must be discussed, particularly at end-of-life. In terminally ill patients it is consensual to recommend implantable cardioverter defibrillator deactivation once shocks are frequent and painful. Concerning pacemakers, the decision to deactivate is controversial and it usually is not an option at patients' end-of-life, since in pacing-dependent patients, such low heart rates might induce symptoms of bradycardia, with no impact on survival. Regarding cardiac resynchronization therapy, deactivation is not recommended as it can worsen symptoms. Left ventricular assistance device deactivation at end-of-life is a well-accepted practice, since it has the benefit of ending the physical burden associated with the device. Advance care planning should be encouraged and patients should be informed that deactivation is possible.

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.

Leadless pacemaker implantation via the internal jugular vein.

BACKGROUND: Leadless pacemaker therapy was introduced to overcome lead- and pocket-related complications in conventional transvenous pacemaker therapy. Implantation via the femoral vein, however, may not always be feasible. The aim of this study was to evaluate leadless pacemaker implantation using a jugular vein approach and compare it to the standard implantation approach through the femoral vein. METHODS: The records of the first consecutive 100 patients undergoing MicraTM leadless pacemaker implantation via the right internal jugular vein from two centers were included in this study. Periprocedural safety and efficacy of the jugular approach were compared to the first 100 patients having undergone a femoral implantation approach at the University Hospital Zurich. RESULTS: 100 patients underwent successful implantation of a leadless pacemaker via the internal jugular vein (mean age, 81.18 ± 8.29, 60% males). Mean procedure time was 35.63 ± 10.29 min with a mean fluoroscopy time of 4.66 ± 5.16 min. The device was positioned at the inferior septum in 25 patients, at the high septum in 24 and mid-septum in 51 patients. The mean pacing threshold was 0.56 ± 0.35 V at 0.24 ms pulse width with a sensed amplitude of 10.0 ± 4.4 mV. At follow-up, electrical parameters remained stable in all patients. Compared with femoral implantation, patients undergoing jugular transvenous pacemaker implantation were of similar age and had similar comorbidities. Mean procedure- (48.9 ± 21.0 min) and fluoroscopy times (7.7 ± 7.8 minutes, both p <0.01) were shorter compared to the femoral approach. Electrical parameters were similar between the two approaches. There were only two complications during jugular veinous implantations (1 pericardial effusion and 1 dislocation), compared to 16 complications using the femoral approach (1 pericardial effusion, 2 femoral artery injuries and 13 major groin hematomas). CONCLUSION: The jugular approach may represent a safe and efficient alternative to the femoral implantation method for implantation of the Micra leadless pacemaker.