The JenaValve pericardial transcatheter aortic valve replacement system to treat aortic valve disease

2021 ◽  
Author(s):  
Thomas Poschner ◽  
Paul Werner ◽  
Alfred Kocher ◽  
Guenther Laufer ◽  
Francesco Musumeci ◽  
...  

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. However, no data have been published so far. The ongoing ALIGN trials are expected to provide the pending long-term data.

2020 ◽  
Vol 58 (1) ◽  
pp. 130-137 ◽  
Author(s):  
Josephina Haunschild ◽  
Martin Misfeld ◽  
Thomas Schroeter ◽  
Frank Lindemann ◽  
Piroze Davierwala ◽  
...  

Abstract OBJECTIVES Elective treatment of aortic valve disease by transcatheter aortic valve replacement (TAVR) is becoming increasingly popular, even in patients with low risk and intermediate risk. Even patients with a bicuspid aortic valve (BAV) are increasingly considered eligible for TAVR. Permanent pacemaker implantation (PMI) is a known—frequently understated—complication of TAVR affecting 9–15% of TAVR patients with a potentially significant impact on longevity and quality of life. BAV patients are affected by the highest PMI rates, although they are frequently younger compared to their tricuspid peers. The aim of the study is to report benchmark data—from a high-volume centre (with a competitive TAVR programme) on PMI after isolated surgical aortic valve replacement (SAVR) in patients with BAV and tricuspid aortic valve (TAV). METHODS We performed a retrospective single-centre analysis on 4154 patients receiving isolated SAVRs (w/o concomitant procedures), between 2000 and 2019, of whom 1108 had BAV (27%). PMI rate and early- and long-term outcomes were analysed. For better comparability of these demographically unequal cohorts, 1:1 nearest neighbour matching was performed. RESULTS At the time of SAVR, BAV patients were on average 10 years younger than their TAV peers (59.7 ± 12 vs 69.3 ± 9; P < 0.001) and had less comorbidities; all relevant characteristics were equally balanced after statistical matching. Overall PMI rate was significantly higher in BAV patients (5.4% vs 3.8%; P = 0.03). BAV required PMI exclusively (100%) and TAV required predominately (96%) for persistent postoperative high-degree atrioventricular block. After matching, the PMI rate was similar (5.1% vs 4.4%, P = 0.5). In-hospital mortality in the matched cohort was 1% in both groups. Long-term survival was more favourable in BAV patients (94% vs 90% in TAV at 5 years; 89% vs 82% in TAV at 9 years; P = 0.013). CONCLUSIONS With SAVR, the overall incidence of PMI among BAV patients seems significantly higher; however, after propensity matching, no difference in PMI rates between BAV and TAV is evident. The PMI rate was remarkably lower among BAV patients after SAVR compared to the reported incidence after TAVR.


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