ABSTRACT
BACKGROUND: Leadless pacemakers (LPs) are promising alternatives to traditional transvenous pacemakers (TVPs), but their comparative effectiveness and safety in clinical outcomes remain uncertain. METHODS: We systematically searched PubMed, Embase, Scopus, Cochrane, and ClinicalTrials.gov for studies comparing LPs and TVPs. A restricted maximum likelihood random-effects model was used for all outcomes. Heterogeneity was assessed using I2 statistics. We performed a subgroup analysis with studies with multivariate-adjusted data. RESULTS: We included 21 studies involving 47,229 patients, of whom 12,199 (25.8%) underwent LP implantation. Compared with TVPs, LPs were associated with a significantly lower risk of overall complications (OR 0.61; 95% CI 0.45-0.81; p < 0.01), dislodgement (OR 0.34; 95% CI 0.20-0.56; p < 0.01), and pneumothorax (OR 0.27; 95% CI 0.16-0.46; p < 0.01). No significant difference in all-cause mortality was observed in the overall analysis (OR 1.43; 95% CI 0.65-3.15; p = 0.35) and in studies with multivariate-adjusted data (OR 1.34; 95% CI 0.65-2.78; p = 0.43). However, LPs were associated with a higher risk of pericardial effusion (OR 2.47; 95% CI 1.39-4.38; p < 0.01) and cardiac tamponade (OR 3.75; 95% CI 2.41-5.83; p < 0.01). LPs also demonstrated a lower pacing capture threshold (MD -0.19 V; 95% CI [-0.23 V]-[-0.16 V]; p < 0.01), but no significant difference in impedance (MD 32.63 ohms; 95% CI [-22.50 ohms]-[87.76 ohms]; p = 0.25). CONCLUSIONS: These findings suggest that LPs were associated with lower overall complication rates and similar effectiveness to TVPs. However, randomized controlled trials are warranted to validate these results.
Subject(s)
Pacemaker, Artificial , Humans , Arrhythmias, Cardiac/therapy , Cardiac Pacing, Artificial/adverse effects , Equipment Design , Postoperative Complications , Treatment OutcomeABSTRACT
Background: Leadless pacing has recently emerged as a promising therapy. The impact of frailty on the prognosis of these patients is currently unknown. Objective: The purpose of this study was to assess the association between frailty and clinical outcomes in patients undergoing leadless pacemaker implantation. Methods: We included adult patients who underwent leadless pacemaker implantation using the National Inpatient Sample from 2017 to 2019. Frailty was evaluated using the Hospital Frailty Risk Score and stratified into low, intermediate, and high risk. Primary outcomes were in-hospital mortality and any complication (vascular, pericardial, pneumothorax, infectious, or device related), and secondary outcomes were the length of hospital stay and total charges. Results: A total of 16,825 patients were included in the final analysis, with 62% at intermediate or high risk of frailty. There was a higher risk of in-hospital mortality in patients at high (adjusted risk ratio [aRR] 6.37, 95% confidence interval [CI] 3.31-12.26) or intermediate (aRR 5.15, 95% CI 3.04-8.72) risk of frailty compared with those at low risk. Similarly, those at high or intermediate risk of frailty had higher total expenses and stayed in the hospital longer. Patients with a high (aRR 1.14, 95% CI 0.71-1.81) or intermediate (aRR 1.19, 95% CI 0.94-1.51) risk of frailty had a similar risk of any complication as patients with a low risk. Conclusion: Frailty was common in patients undergoing leadless pacemaker implantation. Higher levels of frailty were a strong predictor of in-hospital mortality, length of hospital stay, and hospital charges, except for any complication.
ABSTRACT
We report 67-year-old woman with a sinus node dysfunction and diffuse conduction system disease, with a history of recurrent paroxysmal atrial fibrillation. She was admitted to the Hospital due to palpitations, dizziness, and vertigo, attributing the symptoms to the rhythm disorder described, for which the implantation of a pacemaker was indicated. With a history of tracheal cancer treated with radio and chemotherapy, and chronic steroid therapy for rheumatoid arthritis, she had an important limitation in vascular access for a conventional pacemaker, so, added to a high risk of infection, a decision was made to implant a leadless pacemaker. We discuss the electrocardiographic and clinical manifestations of sinus node disease, its relationship with oncological treatment and the indication for a permanent pacemaker, highlighting the characteristics of this new modality of artificial cardiac stimulation, for a special type of patients.