Total cavopulmonary connection with a new bioabsorbable vascular graft: First clinical experience.
To assess safety and clinical performance of a novel bioabsorbable vascular graft in pediatric patients with univentricular cardiac malformation who received surgical correction via an extracardiac cavopulmonary conduit.



The implanted graft material is designed to attract patient's own cells and proteins, which trigger a cascade of physiological events leading to endogenous tissue restoration. As the graft resorbs progressively after implantation, components of native tissue including collagen, endothelial lining, and capillary blood vessels develop and organize into a natural tissue. Five patients (aged 4-12 years) received this new vascular graft as interposition between the inferior vena cava and the pulmonary artery. They were followed up to 12 months after surgery. The conduit was assessed by echocardiography, computed tomography and magnetic resonance imaging, including 4-dimensional flow.



All patients recovered from the procedure without complications. No device-related adverse events were reported. Two patients required interventional occlusion of aortopulmonary collaterals. At 12 months, there was a significant improvement in the patients' general condition. Imaging studies demonstrated anatomical (conduit diameter, length and wall thickness) and functional (blood flow pattern) stability of the bioabsorbable grafts in all patients with no significant changes at 12 months compared with early postoperative data.



Initial clinical experience with a novel absorbable graft underlines the potential of this new material to improve cardiac and vascular surgical procedures. In addition, better biocompatibility may reduce permanent implant-related complications. A longer follow-up is needed to assess the long-term effectiveness of biodegradable vascular grafts, including their ability to grow.
Department of Cardiovascular Surgery, Bakulev Center, Moscow, Russia. Electronic address: leoan@bakulev.ru.
Leo A
LA
Bockeria
Xeltis BV, Eindhoven, The Netherlands.
Oleg
O
Svanidze
Department of Cardiovascular Surgery, Bakulev Center, Moscow, Russia.
Alex
A
Kim
Department of Cardiovascular Surgery, Bakulev Center, Moscow, Russia.
Konstantin
K
Shatalov
Department of Cardiovascular Surgery, Bakulev Center, Moscow, Russia.
Vladimir
V
Makarenko
Xeltis BV, Eindhoven, The Netherlands.
Martijn
M
Cox
Department of Cardiovascular Surgery, University of Bern, Bern, Switzerland.
Thierry
T
Carrel
D020341:Absorbable Implants; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D002648:Child; D002675:Child, Preschool; D004452:Echocardiography; D005260:Female; D018610:Heart Bypass, Right / Q000009:adverse effects / Q000295:instrumentation*; D006330:Heart Defects, Congenital / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D011651:Pulmonary Artery / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D014682:Vena Cava, Inferior / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*
bioabsorbable polymer; conduit; congenital heart disease; pulmonary artery graft Fontan procedure; tissue engineering