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Temporary Pacing with Active-Fixation Leads: Clinical and Economic Impact Versus Conventional Temporary Transvenous Pacing
Background/Objectives: The use of temporary pacemakers is increasing every year. Conventional temporary pacemakers are connected to the myocardium via a passive-fixation lead (temporary pacing with passive fixation leads; TPPF), which compromises their effectiveness and safety. Off-label active-fixation systems (temporary pacing with active fixation leads; TPAF) are a safer alternative. The main objective of this study was to assess the clinical and economic impact of TPAF versus TPPF. Methods: We conducted a literature search based on the clinical outcomes of both pacing techniques. We then carried out a descriptive comparative analysis and extrapolated the results to the Spanish, European, and global populations. Results: Of the 1015 articles located, the analysis included five articles from ECTSF and eight from ECTEFA, prospective and focused on the recording of complications. It is estimated that the implementation of ECTEFA as the first option for ECT would lead to a 94.7% reduction in complications. In economic terms, it would mean a 55.72% reduction in the cost of the procedure. Conclusions: TPAF leads to considerable clinical improvement compared with TPPF. Furthermore, while the price of TPAF doubles the procedural cost, the reduced cost of hospital stays and treating complications means the active-fixation systems could substantially reduce the overall cost of temporary pacing for healthcare systems.
Journal Article
A Leadless Intracardiac Transcatheter Pacing System
A series of 725 patients underwent attempted implantation of a leadless transcatheter pacemaker. At 6 months, 96.0% of patients had no major device-related complications, and 98.3% had a low and stable pacing capture threshold.
For more than half a century, permanent cardiac pacing for symptomatic bradycardia has been achieved with systems that consist of a surgically implanted subcutaneous electrical generator connected to one or more transvenous leads that deliver the pacing therapy to the heart. Although these devices are effective, approximately one in eight patients has an early complication, frequently related to the lead or leads or to the subcutaneous “pocket.”
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Complications include problems with the subcutaneous pocket, such as hematomas and infections; lead-insertion problems, such as pneumothoraxes and hemothoraxes; lead dislodgements and integrity problems; infections, including septicemia and endocarditis; vascular obstructions; and reduced . . .
Journal Article
Fully implantable and bioresorbable cardiac pacemakers without leads or batteries
Temporary cardiac pacemakers used in periods of need during surgical recovery involve percutaneous leads and externalized hardware that carry risks of infection, constrain patient mobility and may damage the heart during lead removal. Here we report a leadless, battery-free, fully implantable cardiac pacemaker for postoperative control of cardiac rate and rhythm that undergoes complete dissolution and clearance by natural biological processes after a defined operating timeframe. We show that these devices provide effective pacing of hearts of various sizes in mouse, rat, rabbit, canine and human cardiac models, with tailored geometries and operation timescales, powered by wireless energy transfer. This approach overcomes key disadvantages of traditional temporary pacing devices and may serve as the basis for the next generation of postoperative temporary pacing technology.
A biodegradable pacemaker without external leads improves the safety of temporary cardiac pacing.
Journal Article
Cost–utility analysis of telemonitoring versus conventional hospital-based follow-up of patients with pacemakers. The NORDLAND randomized clinical trial
The aim of our study was to perform an economic assessment in order to check whether or not telemonitoring of users with pacemakers offers a cost-effective alternative to traditional follow-up in outpatient clinics.
We used effectiveness and cost data from the NORDLAND trial, which is a controlled, randomized, non-masked clinical trial. Fifty patients were assigned to receive either telemonitoring (TM; n = 25) or conventional monitoring (CM; n = 25) and were followed up for 12 months after the implantation. A cost-utility analysis was performed in terms of additional costs per additional Quality-Adjusted Life Year (QALY) attained from the perspectives of the Norwegian National Healthcare System and patients and their caregivers.
Effectiveness was similar between alternatives (TM: 0.7804 [CI: 0.6864 to 0.8745] vs. CM: 0.7465 [CI: 0.6543 to 0.8387]), while cost per patient was higher in the RM group, both from the Norwegian NHS perspective (TM: €2,079.84 [CI: 0.00 to 4,610.58] vs. €271.97 [CI: 158.18 to 385.76]; p = 0.147) and including the patient/family perspective (TM: €2,295.91 [CI: 0.00 to 4,843.28] vs. CM: €430.39 [CI: 0.00 to 4,841.48]), although these large differences-mainly due to a few patients being hospitalized in the TM group, as opposed to none in the CM group-did not reach statistical significance. The Incremental Cost-Effectiveness Ratio (ICER) from the Norwegian NHS perspective (€53,345.27/QALY) and including the patient/caregiver perspective (€55,046.40/QALY), as well as the Incremental Net Benefit (INB), favors the CM alternative, albeit with very broad 95%CIs. The probabilistic analysis confirmed inconclusive results due to the wide CIs even suggesting that TM was not cost-effective in this study. Supplemental analysis excluding the hospitalization costs shows positive INBs, whereby suggesting a discrete superiority of the RM alternative if hospitalization costs were not considered, albeit also with broad CIs.
Cost-utility analysis of TM vs. CM shows inconclusive results because of broad confidence intervals with ICER and INB figures ranging from potential savings to high costs for an additional QALY, with the majority of ICERs being above the usual NHS thresholds for coverage decisions.
ClinicalTrials.gov NCT02237404.
Journal Article
Relation of Prolonged Pacemaker Dependency After Cardiac Surgery to Mortality
•In a retrospective multicenter study, around 1% of the patients require PPI after cardiac surgery.•More than 30% of these patients recover A/V conduction property within months.•Pacemaker dependency is associated with higher mortality.•SR before surgery seems to have a protective effect on pacemaker dependency.
Permanent pacemaker implantation (PPI) represents a rare complication after cardiac surgery, with no uniform agreement on timing and no information on follow-up. A multicenter retrospective study was designed to assess pacemaker dependency (PMD) and long-term mortality after cardiac surgery procedures. Between 2004 and 2016, PPI-patients from 18 centers were followed. Time-to-event data were evaluated with semiparametric regression Cox models and semiparametric Fine and Gray model for competing risk framework. Of 859 (0.90%) PPI-patients, 30% were pacemaker independent (PMI) at 6 months. PMD showed higher mortality compared with PMI (10-year survival 80.1% ± 2.6% and 92.2% +2.4%, respectively, log-rank p-value < 0.001) with an unadjusted hazard ratio for death of 0.36 (95% CI 0.20 to 0.65, p< 0.001 favoring PMI) and an adjusted hazard ratio of 0.19 (95% CI 0.08 to 0.45, p< 0.001 with PMD as reference). Crude cumulative incidence function of restored PMI rhythm at follow-up at 6 months, 1 year and 12 years were 30.5% (95% CI 27.3% to 33.7%), 33.7% (95% CI 30.4% to 36.9%) and 37.2% (95% CI 33.8% to 40.6%) respectively. PMI was favored by preoperative sinus rhythm with normal conduction (SR) (HR 2.37, 95% CI 1.65 to 3.40, p< 0.001), whereas coronary artery bypass grafting and aortic valve replacement were independently associated with PMD (HR 0.63, 95% CI 0.45 to 0.88, p = 0.006 and HR 0.807, 95% CI 0.65 to 0.99, p = 0.047 respectively). Time-to-implantation was not associated with increased rate of PMI. Although 30% of PPI-patients are PMI after 6 months, PMD is associated with higher mortality at long term.
Journal Article
Comparation of quality of life in Chinese patients undergoing leadless versus conventional pacemaker implantation
Background Leadless pacemakers are widely used, but the quality of life assessment of patients with leadless pacemakers is still unclear. Hypothesis Assume that leadless pacemakers can improve the patients' quality of life. Methods Total of 119 patients who received pacemaker implantation at Beijing Anzhen Hospital from January 2020 to March 2022 were selected, including 35 leadless pacemakers and 84 conventional pacemakers. The SF‐36 questionnaire was used to evaluate quality of life at baseline, 1 month and 3 months after surgery. We also used a questionnaire consisted of 4 specific questions related to the implant procedure to assess the surgery. Results There were no differences in baseline characteristics between the two groups, except for age and oral anticoagulant treatment. There was no difference in baseline SF‐36 scores. At the 3‐month follow‐up, patients in leadless pacemakers group were significantly better at physical function (63.63 vs 47.50, p = .000), role physical (60.20 vs 40.23, p = .000), bodily pain (65.57 vs. 61.69, p = .042), physical component summary (61.25 vs. 50.57, p = .000), vitality (56.26 vs 49.57, p = .001), social function (80.14 vs 74.70, p = .004), role emotional (76.14 vs. 71.42, p = .015), mental health (75.46 vs. 68.18, p = .000), mental component summary (72.00 vs. 65.97, p = .000), even after adjusting for clinical baseline and SF‐36 baseline. Pacemaker‐related discomfort and mobility limitations were significantly reduced in leadless pacemakers group. Conclusions Leadless pacemakers is associated with better quality of life with less activity limitations due to surgical discomfort and less emotional distress. However, current use of leadless pacemakers in China is limited due to the high cost.
Journal Article
Introducing a Novel Pacemaker‐Mediated Arrhythmia: The Pseudo‐RNRVAS Arising From Atrial Capture Challenges
Background This study aimed to define and explain a novel form of pacemaker‐mediated arrhythmia which is initiated and sustained by atrial capture loss coinciding with ventriculoatrial (VA) conduction within the postventricular atrial refractory period (PVARP). Unlike repetitive nonreentrant VA synchrony (RNRVAS), in the pseudo‐RNRVAS, the atrium is not stimulated due to pacing below the threshold level, rather than because of refractory atrial myocardium. Objective The objective was to elucidate the mechanisms of this pseudo‐RNRVAS, identify predisposing factors, and propose preventive strategies. Methods Twenty‐one patients with dual‐chamber cardiac implantable electronic devices (CIEDs) exhibiting stable VA conduction within the PVARP were included. Pseudo‐RNRVAS were induced by altering atrial amplitude and lower rate interval while keeping other CIED parameters constant. Results Pseudo‐RNRVAS developed after atrial capture loss in 20 out of 21 patients. Notably, 11 patients experienced pseudo‐RNRVAS at heart rates ≤ 70 bpm, and 7 patients at AV delay ≤ 150 ms. The condition initiated immediately following the first ventricular pace beat after atrial capture loss in 18 patients. In six cases, pseudo‐RNRVAS terminated intermittently and then restarted; in 14 cases, it did not resolve. Conclusion Pseudo‐RNRVAS can occur even at low heart rates and without specific predisposing factors seen in RNRVAS. Conditions that increase atrial pacing probability and threshold raise the likelihood of pseudo‐RNRVAS. Early postimplantation may pose a heightened risk, correlating with pacemaker syndrome and susceptibility to heart failure. A novel form of pacemaker‐mediated arrhythmia (PMA), termed the Pseudo‐RNRVAS, initiated and sustained by atrial capture loss with ventriculoatrial (VA) conduction within the postventricular atrial refractory period (PVARP).
Journal Article
Comparison between leadless and transvenous single-chamber pacemaker therapy in a referral centre for lead extraction
PurposeThe aim of the study was to compare the long-term clinical and electrical performance of Micra leadless pacemaker with transvenous single-chamber pacemaker (TV-VVI PM) in a high-volume centre for transvenous lead extraction (TLE).MethodsOne-hundred patients (group 1) undergoing Micra implant were matched with 100 patients undergoing TV-VVI PM implant (group 2) by age, sex, left ventricular systolic ejection fraction and previous TLE.ResultsThe implant procedure was successful in all patients. In group 1, the procedure duration was lower than in group 2 (43.86 ± 22.38 vs 58.38 ± 17.85 min, p < 0.001), while the fluoroscopy time was longer (12.25 ± 6.84 vs 5.32 ± 4.42 min, p < 0.001). There was no difference about the rate of septal implant at the right ventricle (76% vs 86%, p = 0.10). Patients were followed-up for a median of 12 months. No acute and chronic procedure-related complication was observed in group 1, while we reported acute complications in seven patients (7%, p = 0.02) and long-term complications in three patients (3%, p = 0.24), needing for a system revision in 6 cases (6%, p = 0.038), in group 2. One systemic infection occurred in TV-VVI PM group. Electrical measurements were stable during follow-up in both groups, with a longer estimated battery life in group 1 (mean delivered energy at threshold at discharge: 0.14 ± 0.21 vs 0.26 ± 0.22 μJ, p < 0.001).ConclusionMicra pacemaker implant is a safe and effective procedure, with a lower rate of acute complications and system revisions compared with TV-VVI PM, even in a real-life setting including patients who underwent TLE.
Journal Article
Cardiac Implantable Electronic Devices
Cardiac Implantable Electronic DevicesThis review highlights new developments in cardiac implantable electronic devices, with an emphasis on pacemakers, newer modes of pacing, and implantable cardioverter–defibrillators.
Journal Article