JenaValve for Aortic Regurgitation
The JenaValve Trilogy system is indicated for high-risk or inoperable patients with severe symptomatic aortic regurgitation who are not suitable candidates for surgical aortic valve replacement, based on landmark evidence from the ALIGN-AR trial demonstrating 95% technical success and only 7.8% one-year mortality. 1
Current Guideline Framework
Traditional guidelines have historically contraindicated TAVI for isolated severe AR. The 2020 ACC/AHA guidelines explicitly state that "in patients with isolated severe AR who have indications for SAVR and are candidates for surgery, TAVI should not be performed" 2, and the 2017 ESC/EACTS guidelines similarly recommend surgery as the primary intervention for severe AR 3. However, these recommendations were written before dedicated AR devices became available and reflect the poor outcomes with conventional TAVI systems in pure AR.
The landscape has fundamentally changed with dedicated devices. Recent 2025 ESC/EACTS guidelines now provide the first conditional recommendation for TAVI in selected AR patients, and NICE recommends TAVI for native AR when surgical AVR is unavailable or high-risk 4.
Patient Selection Criteria
Anatomic Requirements
- Severe symptomatic AR (moderate-to-severe or severe by echocardiography)
- Adequate aortic root anatomy for device anchoring
- Absence of contraindications to transfemoral access
Clinical Risk Profile
The ALIGN-AR trial enrolled patients with:
- High surgical risk as determined by heart team assessment
- Mean age 75.5 years
- Symptomatic presentation (NYHA class II-IV)
- Median EuroSCORE II of 3.0% (IQR 2.0-6.7%) 5
Critical distinction: Unlike conventional TAVI for stenosis, the JenaValve's leaflet-grasping mechanism enables secure anchoring independent of annular calcification 4, addressing the primary limitation that made conventional TAVI unsuitable for AR.
Specific Populations
LVAD patients with AR: The JenaValve has demonstrated feasibility in LVAD-associated AR under compassionate use, with 93.3% device success in a multicenter registry 6. This represents an important option for a population with prohibitive surgical risk.
Procedural Outcomes
The ALIGN-AR trial (n=180) demonstrated:
- Technical success: 95% 1
- 30-day composite safety endpoint: 27% (significantly better than the 40.5% performance goal, p<0.0001)
- One-year mortality: 7.8% (significantly better than the 25% performance goal, p<0.0001)
- Pacemaker requirement: 24% 1
Hemodynamic efficacy: Quantitative aortography shows median regurgitant fraction reduction from 31.0% pre-implant to 5.0% post-implant, with 72.3% achieving none/trace AR and 27.7% mild AR—no cases of moderate/severe residual AR 7.
Post-Implantation Management
Immediate Post-Procedure
- Standard TAVI monitoring protocols
- Echocardiographic assessment of valve function and residual AR
- Evaluation for conduction abnormalities (given 24% pacemaker rate)
Functional Recovery
Patients demonstrate:
- Significant NYHA class improvement (p<0.001) 5
- Left ventricular ejection fraction improvement (p=0.009)
- Left ventricular end-diastolic diameter reduction (p<0.001) 5
- Meaningful ventricular remodeling 1
Long-Term Follow-Up
- Serial echocardiography to assess valve durability
- Anticoagulation per standard TAVI protocols (typically dual antiplatelet therapy transitioning to single agent)
- Monitoring for late complications including paravalvular leak and structural valve deterioration
Critical Caveats
Autoimmune disease screening: One case of valve migration occurred in a patient with Behçet's disease, highlighting the need for careful preoperative screening for inflammatory/autoimmune conditions that may affect tissue integrity 5.
Anatomic heterogeneity: AR patients have more variable aortic root anatomy compared to stenosis patients. Careful CT planning is essential to ensure appropriate sizing and landing zone 8.
Stroke risk: While overall stroke rates are acceptable (2% at 30 days in ALIGN-AR), one fatal hemorrhagic stroke occurred in the LVAD cohort 6, emphasizing the need for meticulous technique.
Contraindications
- Low surgical risk patients suitable for SAVR (surgery remains standard of care per guidelines) 2
- Unfavorable anatomy for transfemoral JenaValve deployment
- Active endocarditis
- Severe aortic root pathology requiring surgical correction
The JenaValve represents a paradigm shift for inoperable/high-risk AR patients who previously had no transcatheter option, but surgical AVR remains the gold standard for suitable candidates.