Renal artery denervation (RDN) has experienced a remarkable trajectory over the past two decades, transitioning from an experimental concept to a guideline-supported treatment option for patients with hypertension. Initially hailed as a breakthrough for resistant hypertension, RDN encountered significant skepticism following early randomized trials [1]. However, improvements in trial design and technology have led to renewed interest, culminating in recent endorsements by both European and American hypertension guidelines [2, 3]. In Western Europe, RDN is increasingly implemented in clinical practice; however, in countries like Poland, the uptake remains limited – primarily due to the lack of reimbursement and procedural standardization.
Clinical background and rationale
Despite the availability of effective antihypertensive drugs, global blood pressure (BP) control remains unsatisfactory. A significant proportion of patients fail to reach target values due to a combination of poor adherence, side effects, and complex drug regimens. According to estimates, up to 30% of treated hypertensive patients are either uncontrolled or partially adherent, even in developed health systems [4].
RDN offers a non-pharmacological adjunctive therapy to solve this challenge. The procedure involves the percutaneous catheter-based disruption of renal sympathetic nerve fibers – typically using radiofrequency or ultrasound energy – to reduce sympathetic outflow and lower blood pressure. The technique is minimally invasive, does not require implantable hardware, and can be performed in an outpatient setting. The rationale for RDN is grounded in the role of sympathetic nervous system overactivity in hypertension. The renal sympathetic nerves, which course along the renal artery adventitia, play a central role in sodium retention, renin release, and vasoconstriction. Targeting these nerves via catheter-based ablation offered a novel approach to blood pressure control, particularly in patients with resistant hypertension [5].
The first-in-human experience with catheter-based RDN was reported in 2009 using a single-electrode radiofrequency catheter. The enthusiasm for RDN peaked with the initiation of the Symplicity HTN-3 trial, a randomized, sham-controlled study in the United States. Disappointingly, HTN-3 failed to meet its primary efficacy endpoint in 2014, causing a significant setback in the field. Criticisms of HTN-3 included procedural variability, incomplete denervation, and inclusion of patients with medication nonadherence. Despite the setback, interest in RDN persisted, prompting technological refinements and more rigorous trial designs [6].
The development of second-generation RDN systems was accompanied by a series of sham-controlled trials that revived clinical interest: SPYRAL HTN-ON MED, SPYRAL HTN-OFF MED, and RADIANCE-HTN TRIO or RADIANCE II [7–10]. These studies consistently showed significant and sustained reductions in office and 24-hour ambulatory systolic blood pressure, even in patients with confirmed drug resistance or intolerance. Moreover, data from long-term registries, including the Global SYMPLICITY Registry, demonstrate durable BP reductions and renal safety for up to 10 years after the procedure. The post-RDN incidence of renal artery injury, renal function decline, or major cardiovascular events remains low and within expected background rates. Importantly, patients undergoing RDN frequently report a reduction in medication burden, which contributes to better quality of life and improves long-term adherence – even when drug therapy is reintroduced at lower doses. The results were confirmed in a meta-analysis as well [11].
Current guideline recommendations
The 2024 European Society of Cardiology (ESC) Guidelines for the management of elevated blood pressure and hypertension represent a clear step forward in integrating RDN into clinical practice. For the first time, ESC provides a formal Class IIb, Level B recommendation for RDN in patients with true resistant hypertension, defined as uncontrolled blood pressure despite treatment with three or more antihypertensive drugs (including a diuretic). RDN may also be considered in patients at high cardiovascular risk with uncontrolled hypertension on fewer drugs, provided that shared decision-making and multidisciplinary evaluation are undertaken. However, the ESC clearly states that RDN should not be used as first-line therapy, nor in patients with significant renal impairment (eGFR < 40 ml/min/1.73 m2) or secondary forms of hypertension. These changes mark a significant shift from earlier editions, which were skeptical or noncommittal about device-based interventions [12].
The 2023 European Society of Hypertension (ESH) Guidelines similarly reflect growing confidence in RDN. The ESH also acknowledges that recent randomized trials have demonstrated consistent blood pressure reductions, though long-term outcome data (e.g., major cardiovascular events) are still lacking [2]. Detailed recommendations are provided in Table I.
Table I
From an American perspective, the 2024 American Heart Association (AHA) Scientific Statement does not offer formal graded recommendations but instead outlines a structured framework for considering RDN in clinical practice. The statement supports RDN as an adjunctive option for patients with confirmed resistant hypertension, especially in cases of medication intolerance or poor adherence. The AHA stresses the importance of multidisciplinary decision-making, comprehensive pre-procedural evaluation (including ambulatory or home BP monitoring), and anatomical assessment of the renal arteries. While acknowledging that the therapy is not yet standard of care, the AHA highlights its recent U.S. Food and Drug Administration (FDA) approval and the expanding clinical trial evidence as reasons for cautious optimism [3].
Collectively, these documents indicate a growing convergence across European and North American expert groups in cautiously endorsing RDN for selected patients. While it is not yet recommended as a routine intervention, the therapy is no longer confined to clinical trials and is increasingly viewed as a viable option in specialized settings. As real-world evidence and long-term safety data continue to accumulate, further guideline upgrades may follow. However, success in implementation will depend on national-level factors such as local guideline adaptation, procedural capacity, and reimbursement structures.
Regulatory momentum: FDA approvals
In parallel with guideline evolution, regulatory approvals have also signaled growing global confidence in the procedure. In November 2023, the FDA approved two RDN systems: the ultrasound-based system and the radiofrequency-based system. These approvals followed rigorous evidence reviews, including sham-controlled trials and long-term safety registries.
Implementation in Western Europe
While formal procedural counts are rarely published, evidence suggests that the number of RDN procedures in Western Europe is steadily increasing, particularly in Germany, France, the Netherlands, and Sweden, where infrastructure and reimbursement models are more advanced. Numerous health economic models have been published in recent years to assess RDN’s value in different healthcare systems. Findings are largely consistent across geographies:
Canada: incremental cost-effectiveness ratio of $11,809 CAD/QALY, based on improved CV outcomes and reduced medication costs [13].
Sweden: Lifetime incremental cost-effectiveness ratio of ~€12,000/QALY, driven by decreased stroke and heart failure rates [14].
France, Belgium, Netherlands: Ultrasound-based RDN found cost-effective at thresholds between €1,500–€6,000 per QALY [15].
These values fall well below typical reimbursement thresholds, justifying public investment in RDN – especially when considering its ability to prevent strokes, myocardial infarctions, and costly hospitalizations. Unfortunately, no such analyses have yet been conducted in Poland, which remains a barrier to engaging healthcare system policymakers and payers.
Polish context and barriers to uptake
In contrast, RDN remains largely unavailable in Polish hospitals, due to several intersecting factors:
The method is not reimbursed by the National Health Fund (NFZ),
There are no national procedural guidelines or centralized training standards,
Many centers lack infrastructure for standardized follow-up and ambulatory BP monitoring, which are essential for assessing treatment outcomes.
Even though select centers may have the technical capacity to perform RDN, the absence of reimbursement presents a major bottleneck. Currently, the procedure is available only in research settings or on a self-pay basis, which severely limits access for the average Polish hypertensive patient – particularly those with low socioeconomic status, who are paradoxically most in need of intervention. This discrepancy highlights the growing gap between clinical reality in Western Europe and the resource-constrained environment of Central and Eastern Europe.
Future outlook
Looking ahead, the landscape for RDN is expected to evolve rapidly. In the United States, broader FDA approvals and forthcoming reimbursement decisions may serve as important precedents for adoption in other regions. New generations of device platforms, including bipolar and multipolar catheters, are being developed with the aim of improving procedural consistency and reducing operator dependence. Additional technologies, such as alcohol ablation, cryoablation, and extravascular approaches, are under investigation and could expand the therapeutic toolkit. Moreover, the concept of multi-organ denervation is being explored as a strategy to enhance blood pressure reduction and potentially impact other sympathetic-driven conditions [16]. As these innovations mature, registry-based evidence will be essential to build real-world data that can support reimbursement applications and inform clinical guidelines. In Poland, initiating a local cost-effectiveness analysis may be a critical step toward eventual inclusion of RDN in NFZ financing schemes.
Conclusions
Renal denervation has evolved from a once-controversial procedure into a scientifically validated treatment option with demonstrated clinical and economic value. Across Western Europe, hospitals are steadily incorporating RDN into routine hypertension care, driven by supportive clinical guidelines, accumulating real-world evidence, and established reimbursement pathways.
In contrast, Poland has yet to implement this evidence-based therapy at scale, largely due to systemic barriers. Bridging this gap will require the development of local clinical guidelines, cost-effectiveness modeling tailored to the Polish healthcare context, procedural standardization, and structured training for physicians. Ultimately, inclusion of RDN in the NFZ reimbursement system will be essential.
Until these steps are taken, renal denervation will remain an underutilized opportunity in Polish hypertension care – despite its growing acceptance and integration just across the border.
