Eligibility Criteria for Renal Denervation
Eligibility Criteria for Renal Denervation
Source: Secemsky EA, et al. JACC: Cardiovascular Interventions, June 4, 2025
1. FDA-Approved Device Criteria
Used to identify eligible patients for the two recently approved RDN systems:
• Adults (≥18 years old)
• Diagnosed with uncontrolled hypertension
• Taking three or more antihypertensive medications, including a diuretic
• Blood pressure remains elevated despite adherence to therapy
• No significant renal artery stenosis or secondary causes of hypertension
→ Estimated eligible population: Up to 35 million U.S. adults
2. Randomized Sham-Controlled Trial Criteria
These criteria are highly selective and reflect the inclusion used in pivotal RDN trials:
• On stable antihypertensive regimen
• Office systolic BP ≥140 mmHg despite treatment
• Adherence strictly confirmed
• Exclusion of complex comorbidities or severe CKD
→ Estimated eligible population: Only ~2% of hypertensive U.S. adults
3. SCAI 2023 Clinical Consensus Statement Criteria
Broader, more inclusive, and designed for real-world application:
• Patients with resistant or uncontrolled hypertension
• Includes those intolerant to medications
• Focus on a comprehensive clinical assessment beyond BP numbers alone
• Recommends shared decision-making and individualized consideration
→ Estimated eligible population: ~25 million U.S. adults
Key Insight from the Study
• While many patients meet eligibility, up to 30% of them may not benefit from RDN
• No currently available tool reliably predicts RDN responders
• Overuse may result in significant economic burden without outcome benefit
