P3599Novel, preclinical model of aortic banding for evaluation of implantation feasibility and long term durability of transcatheter aortic valves

Buszman, Piotr P.; Milewski, Krzysztof; Fernández, Carlos; Michalak, Magdalena; Kachel, Mateusz; Domaradzki, Wojciech; Czerwińska, Karolina; Świątkiewicz, Małgorzata; Cisowski, Marek; Gerber, Witold; Bochenek, Andrzej

doi:10.1093/eurheartj/ehy563.p3599

Cited by 1 publication

(3 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…At long-term follow-up in the current preclinical study of the InFlow ATHV, there were two of 15 (13,3%) degenerated valves, but in pathology, the calcifications originated from the banding and were qualified as model-related. In a study in which no THV was implanted, the banding site itself created calcification and ossification originating from the graft ( Supplementary Figure 1 ) ( 6 ). Therefore, to the best of our knowledge, no device-related SVDs were identified in this study.…”

Section: Discussionmentioning

confidence: 99%

“…Most recently, we introduced a novel ovine model of aortic banding and TAVI, which allows for stable valve anchoring and long-term evaluation, including mechanical performance and biological response (6). Bearing in mind the above-mentioned limitations, an innovative polymeric ATHV would outrun the biological counterpart in terms of durability and become more affordable and thus attainable.…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Temporal, biomechanical evaluation of a novel, transcatheter polymeric aortic valve in ovine aortic banding model

Kachel

Buszman

Milewski

et al. 2022

Front. Cardiovasc. Med.

View full text Add to dashboard Cite

ObjectivesThe aim of the study is to evaluate the functionality, durability, and temporal biocompatibility of a novel, balloon-expandable polymeric transcatheter heart valve (ATHV) system (InFlow, CardValve Consortium, Poland). Along with expanding TAVI indications, the demand for new transcatheter valves is increasing.MethodsA surgical ascending aortic banding model was created in 20 sheep. Two weeks later, 16 sheep were implanted with ATHV systems (15–16F). Three animals were euthanized after a 30-day follow-up, four animals after a 90-day follow-up, and six animals after a 180-day follow-up. A follow-up transthoracic echocardiography (TTE) was performed.ResultsThere was one procedure-related (6,25%) and two model-related deaths (12,5%; banding site calcification with subsequent infection originating externally from banding). TTE revealed the flow gradients (max/average) of 30,75/17,91; 32,57/19,21; and 21,34/10,63 mmHg at 30, 90, and 180 days, respectively. There were two cases of low-degree regurgitation after 180 days with no perivalvular leak observed. Histopathological analysis showed no valve degeneration at terminal follow-up with optimal healing. Small thrombi were present at the aortic wall adjacent to the base of the leaflets, and between the aortic wall and the stent in most of the valves; however, leaflets remained free from thrombi in all cases. Scanty calcifications of leaflets were reported in three animals evaluated 180 days after implantation.ConclusionThis preclinical study in the aortic banding model showed good hemodynamic performance, durability, and biocompatibility of the novel ATHV. Furthermore, regulatory studies with longer follow-ups are warranted.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%