Experimental evaluation of the JenaClip transcatheter aortic valve

Lauten, Alexander; Ferrari, Markus; Petri, Alexander; Ensminger, Stephan; Gummert, Jan; Boudjemline, Younès; Schubert, Harald; Schumm, Julia; Hekmat, Khosro; Schlosser, Markus; Figulla, Hans R.

doi:10.1002/ccd.22093

Cited by 25 publications

(12 citation statements)

References 12 publications

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“…Specifically, the acute rise in liberation in ARR and LG3 observed during mild hypothermic I/R attests cleavage of collagen IV and Hspg2 in this group and confirms increased proteolytic activity at this early stage. Together with previous data this supports that ECM cleavage is an early and generalized process during myocardial I/R, affecting several collagen subtypes and non-collagenous proteins of the ECM directly adjacent to the endothelial cells and cardiomoycytes [11]. The data also demonstrate time-dependent differences of release of ARR and LG3 in different temperature conditions.…”

Section: Discussionsupporting

confidence: 88%

“…Due to their modulating function, the dynamic changes of release of these fragments are of particular interest during early reperfusion after myocardial ischemia, as this period may offer opportunities for additional therapy in the clinical setting. We recently characterized the in vivo post-ischemic release of endostatin by collagen XVIII degradation during early ischemia-reperfusion and demonstrated the highly dynamic changes of release of matrix cleavage in this time period [11]. Endostatin is currently undergoing preclinical trials to investigate its therapeutic potential in tumor therapy [1], [18].…”

Section: Discussionmentioning

confidence: 99%

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Impact of Ischemia-Reperfusion on Extracellular Matrix Processing and Structure of the Basement Membrane of the Heart

et al. 2014

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PurposeAcute ischemic injury is a strong inductor of cardiac remodelling, resulting in structural changes of the extracellular matrix (ECM) and basement membrane (BM). In a large animal model of ischemia-reperfusion (I/R) we investigated the post-ischemic liberation of the collagen-IV-fragments Tumstatin (TUM; 28 kDa-fragment of collagen-IV-alpha-3), Arresten (ARR; 26 kDa-fragment of collagen-IV-alpha-1) and Endorepellin (LG3, 85 kDa-fragment of perlecan) which are biologically active in angiogenesis and vascularization in the post-ischemic myocardium.Methods and ResultsIn this blinded study, 30 pigs were randomized to 60 min of global I/R at either 4°C or 32°C or served as control. Three transmyocardial tissue samples were collected prior to ischemia and within 30 min and 150 min of reperfusion. Tissue content of TUM, ARR and LG3 was analyzed by western blotting and immunostaining.Within 150 min of mild hypothermic I/R a significantly increased tissue content of ARR (0.17±0.14 vs. 0.56±0.56; p = 0.001) and LG3 (1.13±0.34 vs. 2.51±1.71, p<0.001) was observed. In contrast, deep hypothermic I/R was not associated with a significant release of cleavage products. Cleavage of TUM remained unchanged irrespective of temperature. Increased matrix processing following mild hypothermia I/R is further supported by a >11fold elevation of creatine kinase (2075±2595 U/l vs. 23248±6551 U/l; p<0.001) in the coronary sinus plasma samples. Immunostaining demonstrated no changes for ARR and LG3 presentation irrespective of temperature. In contrast, TUM significantly decreased in the BM surrounding cardiomyocytes and capillaries after mild and deep hypothermic I/R, thus representing structural alterations of the BM in these groups.ConclusionThe study demonstrates an early temperature-dependent processing of Col-IV as major component of the BM of cardiomyocytes and vascular endothelium. These observations support the protective effects of deep hypothermia during I/R. Furthermore, the results suggest an increased structural remodelling of the myocardial basement membrane with potential functional impairment during mild hypothermic I/R which may contribute to the progression to post-ischemic heart failure.

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Section: Discussionsupporting

confidence: 88%

Section: Discussionmentioning

confidence: 99%

Impact of Ischemia-Reperfusion on Extracellular Matrix Processing and Structure of the Basement Membrane of the Heart

et al. 2014

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“…After feasibility has been demonstrated in animal trials [5], first-in-man implantation of the JenaValve TM transapically has been successfully performed and the design of the device has demonstrated proof of concept.…”

Section: Discussionmentioning

confidence: 97%

A new self-expanding transcatheter aortic valve for transapical implantation — first in man implantation of the JenaValve™

Kempfert¹,

Rastan²,

Mohr³

et al. 2011

European Journal of Cardio-Thoracic Surgery

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Transapical aortic valve implantation (TA-AVI) has evolved as a routine procedure to treat selected high-risk elderly patients. In the vast majority, the balloon-expandable SAPIEN™ prosthesis has been used for TA-AVI. The new JenaValve™ prosthesis is designed for antegrade transapical implantation and consists of a self-expandable Nitinol™ stent with a porcine tissue-prosthesis mounted on a sheath-less delivery catheter. Key features of the device are three 'positioning feelers' facilitating intuitive 'self-positioning' valve implantation. The JenaValve™ concept results in a subcoronary valve position with an anatomically correct valve rotation relying on axial in addition to radial fixation by the three Nitinol™ 'feelers' embracing the native valve leaflets. Here, we report the successful first-in-man implantation in an elderly high-risk patient using a transapical off-pump approach. The JenaValve™ demonstrated proof of concept and a good functional result immediately after deployment and at 12-months' follow-up.

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“…Several THVs are currently available with a different anchoring mechanism that does not need valvular calcification, such as the JenaValve, Engager valve, and J-Valve. The JenaValve has a feeler-guided positioning and a clip fixation mechanism of the native aortic valve leaflets, which ensure anatomically correct and secure implantation even in the absence of valvular cal- cification [23]. Moreover, it does not need oversizing to reduce the risk of annular dilation or rupture during TAVR.…”

Section: Discussionmentioning

confidence: 99%

Transcatheter Aortic Valve Replacement for Pure Native Aortic Valve Regurgitation: A Systematic Review

Jiang

Liu

et al. 2018

Cardiology

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Background: Transcatheter aortic valve replacement (TAVR) is a recent and an effective treatment option for high- or extreme-surgical-risk patients with symptomatic severe aortic stenosis. However, pure severe native aortic valve regurgitation (NAVR) without aortic stenosis remains a contraindication to TAVR. The aim of our systemic review analysis was to evaluate TAVR in patients with pure NAVR. Methods: We searched the published articles in the PubMed and Web of Science databases (2002–2017) using the Boolean operators for studies of NAVR patients undergoing TAVR. Reference lists of all returned articles were searched recursively for other relevant citations. Pooled estimates were calculated using a random-effects meta-analysis. Results: Finally, a total of 10 studies were included in this analysis. The CoreValve was more frequently used with a lower rate of device success and a higher rate of residual aortic regurgitation. The new-generation transcatheter heart valves (THVs) performed a significantly higher rate with less residual aortic regurgitation and a success rate close to 100%. The 30-day all-cause mortality rates ranged from 0 to 30% with an estimate summary rate of 9% (95% CI: 5–15%; I² = 33%). Cerebrovascular events, major or life-threatening bleeding, major vascular complications, acute kidney disease, and new permanent pacemaker implantation occurred similarly in both the new- and old-generation THV devices. Conclusions: Aortic regurgitation remains a challenging pathology for TAVR. TAVR is a feasible and reasonable option for carefully selected patients with pure aortic regurgitation.

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Experimental evaluation of the JenaClip transcatheter aortic valve

Cited by 25 publications

References 12 publications

Impact of Ischemia-Reperfusion on Extracellular Matrix Processing and Structure of the Basement Membrane of the Heart

Impact of Ischemia-Reperfusion on Extracellular Matrix Processing and Structure of the Basement Membrane of the Heart

A new self-expanding transcatheter aortic valve for transapical implantation — first in man implantation of the JenaValve™

Transcatheter Aortic Valve Replacement for Pure Native Aortic Valve Regurgitation: A Systematic Review

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