Cardiac resynchronization therapy (CRT) remains a cornerstone of heart failure (HF) management, and optimizing implantation strategies is increasingly relevant in the context of rising prevalence and constrained resources. Evidence from observational and comparative studies, together with expert consensus, supports left bundle branch area pacing (LBBAP) as an effective alternative to biventricular pacing (BVP) in appropriately selected CRT candidates.1 Because device-based HF therapies account for a substantial share of HF-related expenditure, largely driven by generator and lead costs, implantation procedures, and follow-up, evaluating the budgetary implications of alternative CRT strategies is essential for long-term sustainability as CRT-pacemaker (CRT-P) and CRT-defibrillator (CRT-D) implantation volumes continue to increase.

In a previous multicenter analysis from our group, LBBAP showed clinical and quality-of-life outcomes comparable to conventional BVP, with lower 12-month direct medical costs.2 Based on these findings, we conducted a budget impact analysis (BIA) to estimate the economic implications of adopting LBBAP as an alternative to BVP in CRT candidates in Spain. We applied the 12-month incremental cost difference (ΔC; LBBAP minus BVP) derived from our multicenter study (mean, –€2391 in 2024 euros; 95% confidence interval [95%CI], –€5112.69 to €330.28), based on per-patient costs including generator and lead acquisition, implantation procedure, complications and reinterventions, and follow-up. The BIA adopted the perspective of the Spanish National Health System (SNS) and followed the Advisory Committee for the Financing of the Pharmaceutical Benefit of the SNS (CAPF) (2024), adapted to nonpharmacological health technologies, together with RedETS principles and ISPOR BIA Good Practice II.3,4 We defined the target population as patients with an indication for CRT in Spain and focused on short-term budget impact, assuming stable clinical practice patterns apart from LBBAP uptake. Uncertainty was addressed using a combined multi-parameter scenario analysis (implementation intensity×ΔC assumptions).

To estimate the budgetary impact for the public payer, we used absolute activity volumes rather than rates per million population. Annual data on CRT-D, CRT-P, and total CRT use were obtained from the official report of the Spanish Pacemaker Registry,5 using 2016 to 2024 as the historical reference. Observed national activity in 2024 (3169 CRT-D and 1715 CRT-P implants) served as the projection baseline, applying the most recent year-on-year growth observed between 2023 and 2024 (+4.6% for CRT-D and+4.0% for CRT-P). The analysis covered 2025 to 2028, with 2025 defined as the baseline year reflecting current practice. In 2025, LBBAP uptake was assumed to represent 25% of CRT implants, anchored to contemporary European practice surveys showing substantial between-center heterogeneity in conduction system pacing among patients with an indication for CRT (mean, 33.0%±30.8%).6

The reference scenario assumed constant 25% LBBAP uptake throughout 2025 to 2028; budget impact was estimated within each year as the incremental difference between each implementation scenario and the reference scenario for that year. To enhance plausibility, we modeled 3 implementation trajectories reflecting slow to fast diffusion depending on center experience and training capacity, targeting 1.5×, 2.0×, and 2.5×the baseline uptake by 2028 (37.5%, 50.0%, and 62.5%), with linear diffusion over 2026 to 2028. Even under accelerated diffusion, a residual proportion of patients is expected to remain on conventional BVP due to anatomical or clinical constraints. Unit cost uncertainty was captured using the empirical mean and 95%CI bounds of ΔC, explicitly allowing for the possibility of no savings (upper bound >0). Crossing the 3 uptake trajectories with the 3 ΔC assumptions yielded 9 combined scenarios. In addition, we quantified the probability of a cost increase using the bootstrap distribution of ΔC from the source study (1000 replications). Because budget impact is proportional to ΔC (with uptake differences and volumes constrained to be ≥ 0), the probability of a cost increase is P(ΔC >0), conditional on the assumed uptake trajectories and projected volumes. Costs beyond the first year after implantation were not modeled. All costs were expressed in 2024 euros without discountIng.

Under the mean ΔC assumption, cumulative savings for the SNS over 2026 to 2028 ranged from €3.37 million (low implementation intensity) to €10.11 million (high implementation intensity) (table 1). Across the 9 combined scenarios, the cumulative 2026 to 2028 budget impact ranged from an additional cost of €0.47 to €1.40 million (upper 95%CI bound) to savings of €7.21 to €21.62 million (lower 95%CI bound). Based on 1000 bootstrap replications of ΔC, the estimated probability of a cost increase (BI >0) was 1.3% (95%CI, 0.6%-2.0%), corresponding to a 98.7% probability of savings. Figure 1 shows the annual and cumulative (2026-2028) incremental budget vs current practice under low, medium, and high implementation intensities, with uncertainty derived from the 95%CI bounds of ΔC.

Figure 1.

Annual and cumulative incremental budget impact (2026-2028) of increased LBBAP uptake vs the reference scenario (constant 25% uptake).

Bars show the incremental budget impact using the mean per-implant incremental cost difference (ΔC, LBBAP–BVP). Error bars indicate the range defined by the 95% confidence interval of ΔC. Negative values indicate savings.

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Beyond the direct financial impact, broader implementation of LBBAP for CRT may offer clinical and procedural advantages relevant to healthcare efficiency, including shorter procedures in many cases, lower complication rates, potentially longer generator longevity due to lower pacing thresholds, and elimination of dependence on the coronary venous system for lead placement. These features could yield additional long-term savings not fully captured within the 12-month horizon. Furthermore, the use of LBBAP beyond the CRT indication, particularly in patients requiring permanent pacing who are at risk of pacing-induced cardiomyopathy, could provide additional economic benefit. The ongoing development of LBBAP defibrillation solutions could further increase the economic advantage of LBBAP in CRT-D candidates by simplifying device configurations and potentially enabling the use of less complex generators in selected patients.

This analysis has limitations. Projections relied on recent registry-based growth trends and assumed diffusion trajectories that may not reflect real-world uptake across centers. However, we addressed key uncertainties through combined scenarios crossing implementation intensity with the mean and 95%CI bounds of ΔC. Cost inputs were derived from a multicenter cohort with a limited sample size and Andalusian public sources; because procurement prices and hospital costs may vary across regions, results should be interpreted as an order-of-magnitude estimate, with budget impact scaling linearly with both volume and ΔC. Uncertainty around ΔC remains substantial and includes the possibility of no savings. The bootstrap-based estimate quantifies the likelihood of cost increase implied by uncertainty in ΔC, but it does not resolve uncertainty in future diffusion patterns or local procurement prices.

In conclusion, a shift toward LBBAP in CRT candidates may represent a plausible strategy to optimize resource use for the SNS. Because adoption trajectories and per-implant cost differences are uncertain, results are presented as scenario-based estimates intended to inform planning and decision-making rather than as point predictions.