Transcatheter implantation of a self-expanding pulmonary valve in animal experiment
Abstract
Background. Obstruction of the outlet of the right ventricle
occurs in such congenital heart defects as tetrad of Fallot, atresia or
stenosis of the pulmonary artery and other anomalies of the conotruncus. As the
child grows, several repeated open interventions are required due to the
discrepancy in the size of the “prosthesis–patient”. However, repeated
prosthetics in conditions of artificial circulation is associated with a high
risk of complications. An alternative to this approach has become transcatheter
technologies for implantation of the PA valve. Currently, there are 2 types of
balloon expansion valves Melody (Medtronic) and SAPIEN (Edwards LifeSciences).
These bioprostheses are intended for implantation into the trunk/“neotrunk” of
the PA, what makes them practically useless when combined with dysfunction of
the trunk and distal/proximal parts.
Aim. To determine possible intra- and postoperative
complications associated with valve implantation and to evaluate the safety and
effectiveness of transcatheter implantation of a self-opening pulmonary artery
valve.
Material and methods.
In total, 5 male pigs
of the breed “mini pig” were operated. For transcatheter implantation, a
self-opening valve developed in the Meshalkin National Medical Research Center,
Ministry of Health of Russian Federation was used, the frame of which is made
of nitinol with a “memory effect”. The flap apparatus is made of pork
pericardium. The path of the guide during the valve implantation procedure is
described as follows: the right femoral vein in the first, third, fourth and
fifth experiments, the right jugular vein in the second experiment – the
inferior vena cava – the right atrium – the right ventricle – the pulmonary
artery – the distal part of the left pulmonary artery.
Results. In 3 of 5 cases valve implantation was successful. In
the first case, the animal had a
dislocation of the valve into the trunk of the pulmonary artery during its
implantation. In the second case, when trying to carry out the delivery system
with access through the right jugular vein, the trunk of the pulmonary artery
ruptured, which led to the development of tamponade and the death of the animal
on the operating table. Transesophageal echocardiography performed immediately
after valve implantation showed the absence of regurgitation on the
transcatheter valve in 3 animals and 1 animal with dislocation of the
transcatheter valve had a 2 mm paroprosthetic fistula. The average pressure
gradient on the transcatheter valve was 8 (6; 10) mm Hg. In 6 months of follow
up, according to the ECG data, no negative dynamics was detected in 3 animals.
In an animal with a dislocation of the transcatheter valve, paraprosthetic
regurgitation increased to 2 art., the gradient on the transcatheter valve was
32 (average – 18) mm Hg, while the contractility of the right and left
ventricles was preserved. When examined after 12 months, according to
angiography data, the correct position of the transcatheter valve was noted in
3 animals, the peak pressure in the right ventricle was 35 (32; 38) mm Hg, the
gradient on the transcatheter valve was 7 (5; 9) mm Hg. Deformations of the
pulmonary arteries were not revealed. In an animal with a dislocation of the
transcatheter valve, the peak pressure in the right ventricle was 49 mm Hg, the
gradient on the valve was 29 mm Hg. Microscopic assessment showed no cellular
infiltration or structural damage to the valves. No signs of calcification of
the leaf apparatus after staining by the von Koss method were found.
Conclusion. Transcatheter implanted valves proved successful in 3
out of 5 laboratory animals. Short-term follow-up after surgery showed the
safety and effectiveness of the implanted device.
Keywords:right ventricular outlet; self-opening valve; transcatheter implantation
Funding. This work was supported by a grant from the Russian
Science Foundation, project No. 21-75-10041.
Conflict of interest. The authors declare no conflict of interest.
For citation: Rzaeva K.A., Timchenko T.P., Zhuravleva I.Yu.,
Arkhipov A.N., Gorbatykh A.V., Voitov A.V., Bogachev-Prokophiev A.V., Soynov
I.A. Transcatheter implantation of a self-expanding pulmonary valve in animal
experiment. Clinical and Experimental Surgery. Petrovsky Journal. 2023; 11 (1):
47–53. DOI: https://doi.org/10.33029/2308-1198-2023-11-1-47-53
(in Russian)
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