**3.7 JenaValve system**

The JenaValve system by JenaValve technology is designed for patients with severe AS, AR, and both [42]. The valve comprises porcine leaflets with a self-expanding framework for transfemoral delivery. Sizes in development include 65–92 mm (**Figure 8**). It provides the advantage of calcium-independent anchorage by grasping

*Transcatheter Therapies for Aortic Regurgitation: Where Are We in 2023? DOI: http://dx.doi.org/10.5772/intechopen.112679*

**Figure 5.** *ACURATE TA valve with self-expanding nitinol frame (credit: Symetis).*

**Figure 6.** *Portico valve with self-expandable nitinol frame (credit: Abbot).*

**Figure 7.** *J-valve Ausper with nitinol stent frame (credit: Jiecheng medical technology).*

**Figure 8.** *Jena valve with self-expanding calcium-independent anchorage frame.*

*Transcatheter Therapies for Aortic Regurgitation: Where Are We in 2023? DOI: http://dx.doi.org/10.5772/intechopen.112679*

#### **Figure 9.**

*Direct flow medical valve with two rings and polyester fabric skirt (credit: Direct flow medical).*

the native leaflets and moving them towards the periphery, forming a natural seal (paper clip-like anchorage) [43]. The prosthetic leaflets are supra-annular. Large cells provide easy access for coronary engagement post-procedure. JenaValve is currently explored in ALIGN-AR pivotal, multicenter trial (NCT04415047) for severe AR in the USA. Key inclusion criteria include severe AR, high surgical risk, and NYHA class ≥ II. Exclusion factors are previous prosthetic valves, hemodynamic instability, endocarditis, unicuspid or bicuspid valve, and severe mitral regurgitation.

#### **3.8 Direct flow medical**

Direct Flow Medical (DFM) valve by Direct Flow Medical, California, comprises three bovine pericardial leaflets attached to a frame covered with polyester fabric (**Figure 9**). The frame comprises aortic (upper) and ventricular (lower) rings [44]. The size chart includes 25 mm, 27 mm, and 29 mm valves. It is delivered via an 18 F transfemoral approach and is commercially available in Europe. A small multicenter retrospective European study of 11 patients showed the feasibility of DFM valve for severe non-calcific native AR [45]. The device success rate was 100%, with one patient requiring SAVR after the downward dislocation of the prosthesis by TAVR. All patients had a reduction in NYHA class, and 30-day all-cause mortality was 9% (n = 1 due to pneumonia).

#### **4. Procedural technique**

Appropriate valve sizing is crucial in TAVR for pure AR to allow optimal valve anchorage and prevent complications such as annular rupture from oversizing or prosthetic valve embolization from under-sizing. Pre-procedural multimodality imaging (i.e., TTE, transesophageal echocardiogram (TEE), CT, and CMR) can help understand the size of the aortic annulus and aortic root [46, 47]. Fluoroscopy and TEE are important intra-operative tools for deploying the prosthetic valve at the appropriate position. Valve oversizing is frequently required for optimal apposition of the valve to dilated annulus and prevent PVL. Oversizing by 10–15% is recommended


*outflow tract, MR = mitral regurgitation, NYHA = New York Heart Association, STS = Society of Thoracic Surgeons, TAVR = transcatheter aortic valve replacement.*

**Table2.**  *Comparison of ongoing TAVR clinical trials.* with caution not to oversize beyond 20% [23–25]. The newer generation valve, JenaValve, is designed for pure AR grasps onto native leaflets and can be beneficial in the absence of leaflet calcium [43].
