Original Title: Implante de marcapasos de estimulación del sistema de conducción mediante navegador intracardiaco frente a fluoroscopia

Authors' objectives: The main objective of this Health Technology Assessment report is to evaluate the safety, clinical effectiveness, cost-effectiveness, and costs, as well as the ethical, legal, organizational, social, patient-related, and environmental aspects of using the EAM compared to fluoroscopy to guide the implantation of CSP in the treatment of bradyarrhythmias (sinus node dysfunction and advanced atrioventricular block).

Authors' results and conclusions: RESULTS: SYSTEMATIC REVIEW OF EFFECTIVENESS AND SAFETY: 895 unique references associated with the electronic database search were retrieved. The evaluation of effectiveness and safety relied on data from 7 comparative observational studies (N=259), published between 2019 and 2023, analyzing the use of the EAM versus fluoroscopy in patients with bradyarrhythmias requiring CSP. The evidence was of very low quality. No studies evaluating key outcomes such as mortality and quality of life were identified. Results for procedure success (RR=0.98, 95% CI: 0.92 to 1.05, p=0.59; k=5; n=194; I2=0%), total fluoroscopy dose (MD=-55.28 mGy; 95% CI: -118.67 to 8.12; p=0.09; k=3; n=80; I2=97%), immediate procedure-related complications (RR=not estimable, 0/91 EAM vs. 0/93 fluoroscopy; k=5; n=184), electrode revision (RR=0.33, 95% CI: 0.01 to 7.86, p=0.50; I2=Not applicable; k=4; n=174), or device infection (RR=not estimable, 0/10 EAM vs. 0/20 fluoroscopy; k=1; n=30) were similar. Publication bias could not be assessed due to the number of included studies. The overall quality of evidence was considered very low. COST ANALYSIS: The SR did not identify any economic evaluations meeting the established criteria. Cost analysis showed that CSP implantation using an EAM incurred a cost of €4248.86 per patient, while implantation using fluoroscopy cost €2851.06, resulting in an incremental cost of €1397.81 per patient. If acquiring an EAM system were necessary, the incremental cost would rise to €1738.74 per patient. Implementing this technology nationwide in the target population would represent an additional €1.63 million over 5 years (or €9.68 million if new EAM systems were required), compared to the current scenario (implantation using fluoroscopy). ORGANIZATIONAL, ETHICAL, SOCIAL, LEGAL AND PATIENT-RELATED ASPECTS: No studies considering ethical, legal, organizational, social, and environmental aspects related to the evaluated technology or the comparison were identified. As no studies were found in the literature review, an expert consultation with a cardiologist experienced in intracardiac navigation was conducted. CONCLUSIONS: • The available evidence on the clinical effectiveness and safety of the technology comes from 7 observational studies (N=259) evaluating the use of the EAM versus fluoroscopy in patients requiring CSP. • This evidence led to the following conclusions regarding the use of the EAM versus fluoroscopy for CSP implantation in a population with bradyarrhythmias (symptomatic sinus node dysfunction or advanced atrioventricular block) especially vulnerable to fluoroscopy: - No studies evaluating key outcomes such as mortality and quality of life were identified. - The EAM has no effect on procedure success rates compared to fluoroscopy (RR=0.98; 95% CI: 0.92 to 1.05; p=0.59, k=5; n=194; I2=0%) (evidence quality: very low ⊕⊖⊖⊖). - The EAM has no effect on total fluoroscopy dose levels compared to fluoroscopy (MD=-55.28 mGy; 95% CI: -118.67 to 8.12; p=0.09; k=3; n=80; I2=97%) (evidence quality: very low ⊕⊖⊖⊖). - The EAM has no effect on rates of immediate procedure-related complications compared to fluoroscopy (RR=not estimable 0/91 vs. 0/93; k=5; n=184) (evidence quality: very low ⊕⊖⊖⊖). - The EAM has no effect on rates of electrode displacement compared to fluoroscopy (RR=0.33; 95% CI: 0.01 to 7.86; k=4; n=174) (evidence quality: very low ⊕⊖⊖⊖). - The EAM has no effect on rates of electrode revision compared to fluoroscopy (RR=not estimable 0/22 vs. 0/24; k=1; n=46) (evidence quality: very low ⊕⊖⊖⊖). - The EAM has no effect on rates of device infection compared to fluoroscopy (RR=not estimable 0/10 vs. 0/20; k=1; n=30) (evidence quality: very low ⊕⊖⊖⊖). • No published economic evaluations evaluating CSP implantation using an EAM met the selection criteria in the SR. • CSP implantation using an EAM would incur an incremental cost of €1397.81 per patient (or €1738.74 if acquiring the intracardiac navigation system) from the perspective of the NHS. • Implementing this technology in routine clinical practice would result in a net budgetary impact of €1.63 million over 5 years (or €9.68 million if new intracardiac navigation systems were required) for the NHS. • No studies were identified analyzing ethical, legal, organizational, and social aspects related to the evaluated technology. • From the expert consultation on ethical, legal, organizational, and social aspects, the following conclusions were drawn: - Some electrophysiology team professionals may highly accept this technology due to the potential reduction in radiation exposure and associated fatigue. - Any person could be a candidate, but it's essential to highlight that higher-risk groups, such as pregnant women or pediatric patients, would benefit more. Equity in the availability and acceptance of this technology varies based on the presence of specialized units. - Additional training is required to operate the navigation system. The lack of availability of these units may impact the acceptance and implementation of this technology.

Authors' methods: EFFECTIVENESS AND SAFETY: A systematic review (SR) of published scientific literature was conducted. Searches were performed in the following electronic databases: MEDLINE (OVID), EMBASE (Elsevier), Cochrane Library (Wiley), and CINAHL (EBSCOhost) up to March, with alerts up to September 30, 2023. Randomized controlled trials (RCTs) were selected, and if not available, non-randomized controlled trials (non-RCTs), and if not available, comparative interventional observational studies. The primary outcome measure was procedure success. Other key/important measures included fluoroscopy dose, mortality, immediate procedure-related complications, electrode displacement, electrode revision, device infection, and quality of life. Bias risk was assessed using the ROBINS-I tool from the Cochrane Collaboration. Where possible, a quantitative synthesis of results was performed through meta-analysis using Review Manager version 5.4. The evaluation of the quality of evidence and the grading of the strength of recommendations were conducted following the methodology of the international Grading of Recommendations Assessment, Development, and Evaluation (GRADE) working group. ECONOMIC ANALYSIS / COST-EFFECTIVENESS: The SR for this report included a search for economic evaluations (parallel to primary studies or models) reporting any of the following outcomes: incremental cost-effectiveness ratio (ICER), costs expressed in monetary units, and benefits expressed in quality-adjusted life years (QALYs), life years gained (LYG), monetary units, or any of the outcome measures included in the effectiveness section. The methodological quality was assessed using Drummond et al.'s criteria and/or OSTEBA's Critical Reading Form 3.0, along with data extraction and a narrative synthesis of results. Additionally, a partial economic evaluation was conducted, comparing the costs of two strategies for CSP implantation: one using an EAM and the other using fluoroscopy (standard clinical practice in Spain). The analysis was performed from the perspective of the National Health System (NHS) with a time horizon limited to the intervention duration. Direct healthcare costs were included, expressed in euros from 2023 and without applying a discount rate. Uncertainty around parameters was assessed through deterministic sensitivity analysis of one pathway and scenarios where acquiring the EAM was necessary. Finally, the gross and net budgetary impact of including this technology in the NHS over a 5-year horizon was estimated. ORGANIZATIONAL, ETHICAL, SOCIAL, LEGAL AND PATIENT-RELATED ASPECTS: The evaluation of these aspects started from the same population, intervention, and comparison described above for the effectiveness and cost-effectiveness evaluation. Searches were conducted in the same electronic databases consulted for the effectiveness and safety review. A narrative synthesis of results was carried out, considering criteria of relevance and coherence.

Project Status: Completed

Year Published: 2023

URL for published report: https://sescs.es/implante-marcapasos-navegador-intracardiaco-frente-fluoroscopia/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Canary Health Service

Contact Address: Dirección del Servicio. Servicio Canario de la Salud, Camino Candelaria 44, 1ª planta, 38109 El Rosario, Santa Cruz de Tenerife

Contact Name: sescs@sescs.es

Contact Email: sescs@sescs.es