JenaValve

Novel dedicated devices allow transcatheter treatment of pure aortic regurgitation (AR). The JenaValve Trilogy Heart Valve System was introduced as the first dedicated and on-label AR transcatheter aortic valve replacement system, implementing a locator-based and calcium-independent anchoring mechanism. Here, we present the first-in-human transcatheter aortic valve replacement for pure AR via a transcaval access in a patient with prohibitive alternative arterial accesses.

BACKGROUND: Surgery remains the only recommended intervention for patients with native aortic regurgitation. A transcatheter therapy to treat patients at high risk for mortality and complications with surgical aortic valve replacement represents an unmet need. Commercial transcatheter heart valves in pure aortic regurgitation are hampered by unacceptable rates of embolisation and paravalvular regurgitation. The Trilogy transcatheter heart valve (JenaValve Technology, Irvine, CA, USA) provides a treatment option for these patients...

OBJECTIVES: Aortic valve regurgitation (AR) frequently complicates the clinical course after left-ventricular assist device (LVAD) implantation. Transcatheter aortic valve implantation (TAVI) has emerged as an alternative to surgical aortic valve replacement (SAVR) in this cohort with a mostly high surgical risk profile. The unique challenges in LVAD patients, such as presence of non-calcified aortic valves and annular dilatation, raise concerns about device migration and paravalvular leakage (PVL) leading to missing device success...

Recently, a novel transfemoral self-expandable valve (JenaValve Trilogy) was granted a CE mark as a dedicated device for transfemoral treatment of both aortic valve stenosis and regurgitation. Here, we highlight the importance of 3-dimensional preprocedural planning for the optimal choice of a prosthesis in challenging anatomies by reporting an unusual case of a heavily calcified aortic sinus.

A 54-year-old woman who had recently undergone surgical mitral and tricuspid valve repair was diagnosed with severe aortic regurgitation. She was scheduled for percutaneous treatment and underwent successful transcatheter aortic valve implantation with a 27-mm Trilogy valve (JenaValve Technology). The case documents feasibility of percutaneous treatment in the presence of a mitral ring.

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No abstract text is available yet for this article.

BACKGROUND: Patients with severe aortic regurgitation (AR) are often not considered for surgery because of increased surgical risk. Because of unique anatomical characteristics among patients with AR, interventional treatment options are limited, and implantation results are inconsistent compared with those among patients with aortic stenosis. OBJECTIVES: The authors describe the initial commercial experience of the first Conformité Européenne-marked transfemoral transcatheter aortic valve replacement system (JenaValve Trilogy [JV]) for the treatment of patients with AR...

Aortic regurgitation (AR) is associated with morbidity and premature mortality. Surgical aortic valve replacement is not an option for many patients due to an adverse surgical risk profile, whilst transcatheter aortic valve implantation with most available prostheses has demonstrated suboptimal implantation success and outcomes. The JenaValve Trilogy™ system provides an attractive solution for such patients as it utilizes clips that directly attach onto the native valve leaflets to anchor. Initially designed for transapical delivery, the current transfemoral delivery system is under investigation in the United States and approved for aortic stenosis and regurgitation in Europe...

BACKGROUND: Up to 30% of patients with the left ventricular assist device (LVAD) develop moderate to severe aortic regurgitation (AR) within the first year. Surgical aortic valve replacement (SAVR) is the treatment of choice in patients with native AR. However, the high perioperative risk in patients with LVAD might prohibit surgery and choice of therapy is challenging. CASE SUMMARY: We report on a 55-year-old female patient with a severe AR 15 months after implantation of LVAD due to advanced heart failure (HF) as a consequence of ischaemic cardiomyopathy...

BACKGROUND: Cardiac computed tomography angiography was used to identify anatomical characteristics of the aortic root in patients with severe aortic regurgitation (AR) as compared to those with aortic stenosis (AS) to judge feasibility of transcatheter aortic valve replacement (TAVR) with the JenaValve Trilogy system. METHODS: Cardiac computed tomography angiography was performed prior to planned TAVR for 107 patients with severe AR and 92 patients with severe AS...

Aortic regurgitation (AR) is not the most common valvular disease; however, its prevalence increases with age, with more than 2% of those aged >70 years having at least moderate AR. Once symptoms related to AR develop, the prognosis becomes poor. Transcatheter aortic valve implantation for patients with pure severe AR and at prohibitive surgical risk is occasionally performed, but remains a clinical challenge due to absence of valvular calcium, large aortic root and increased stroke volume. These issues make the positioning and deployment of transcatheter aortic valve implantation devices unpredictable, with a tendency to prosthesis embolisation or malposition...

PURPOSE: Failure of transcatheter heart valves (THV) may potentially be treated with repeat transcatheter aortic valve implantation (redo TAVI). We assessed hydrodynamic performance, stability and pinwheeling utilizing the ALLEGRA (New Valve Technology, Hechingen, Germany) THV, a CE approved and marketed THV in Europe, inside different THVs. METHODS: Redo TAVI was simulated with the 27 mm ALLEGRA THV at three implantation depths (-4 mm, 0 mm and +4 mm) in seven different 'failed' THVs: 26 mm Evolut Pro, 25 mm Lotus, 25 mm JenaValve, 25 mm Portico, 23 mm Sapien 3, 27 mm ALLEGRA and M ACURATE neo...

Transcatheter aortic valve replacement is a valuable alternative technique to surgery and the spectrum of therapy continues to evolve. The JenaValve Pericaridal transcatheter aortic valve replacement System allows prosthesis fixation in a native, noncalcified aortic annulus with a unique paper clip-like anchorage mechanism. The low rate of paravalvular leakage and permanent pacemaker implantation emphasizes the further widespread use of the JenaValve - despite the limited data available. In May 2021, a CE mark for the transfemoral implantation in both aortic regurgitation and aortic stenosis was granted...

PURPOSE OF REVIEW: Accurate imaging of the aortic root during valve implantation is crucial for proper prosthesis positioning during TAVR. The purpose of this review was to determine if routine use of the cusp-overlap view should be adopted for self-expanding valves. RECENT FINDINGS: The use of the cusp-overlap view with the Evolut, Portico, ACURATE neo/neo2, and JenaValve systems is associated with lower post-procedural new permanent pacemaker implantation rates when compared with the standard 3-cusp view, presumably due to more precise valve implantation relative to the conduction system by the non-coronary cusp...

A 66-year-old man with refractory multiple myeloma presented with acute severe aortic insufficiency leading to cardiogenic shock and multiorgan failure. After comprehensive heart team evaluation, he underwent successful JenaValve transcatheter aortic valve (JenaValve Technology, Inc., Irvine, California) implantation resulting in resolution of his aortic insufficiency and improvement in his clinical status. ( Level of Difficulty: Advanced. ).

Transcatheter aortic valve implantation (TAVI) for isolated aortic regurgitation (AR) comprises <1.0% of all TAVI procedures performed in the USA. In this manuscript, we review the challenges, evidence and future directions of TAVI for isolated AR. There are no randomised clinical trials or mid-term data evaluating TAVI for isolated AR, and no commercially available devices are approved for this indication. Challenges in performing TAVI for isolated AR as opposed to aortic stenosis (AS) include: lack of a calcified anchoring zone for valve deployment, large and dynamic size of the aortic annulus and high stroke volume (during systole) and regurgitant volume (during diastole) across the aortic annulus during each cardiac cycle...

OBJECTIVES: The aim of this study was to examine the effect of different transcatheter heart valves (THVs) on valve leaflet displacement when deployed within bioprosthetic surgical valves and, thereby, risk for coronary obstruction. BACKGROUND: Coronary obstruction is a potentially devastating complication during valve-in-valve (ViV) transcatheter aortic valve replacement. Strategies such as provisional stenting and intentional bioprosthetic valve leaflet laceration have been developed to mitigate this risk...

BACKGROUND: Incidence of coronary access (CA) after transcatheter aortic valve replacement (TAVR) at long-term follow-up remains unknown. CA and percutaneous coronary intervention (PCI) after TAVR might present technical challenges, particularly with supra-annular devices. METHODS: Patients undergoing CA after being treated with TAVR at our institution were included in the study. Coronary interventions for coronary obstruction during TAVR procedure were excluded...

In the early 1990s, the idea of Transcatheter Aortic Valve Implantation (TAVI) emerged from clinicians by the insight that the long-term hemodynamic and clinical results of aortic balloon valvuloplasty to treat aortic stenonosis were not satisfying. Thus, Anderson and Cribier developed the balloon-expandable and Figulla and Laborde the self-expendable TAVI systems. Sceptical views by the surgical colleagues and the industry delayed the rapid development of this disruptive new therapy until 2002, when Alain Cribier demonstrated for the first time the proof of his concept...