First case of the novel GrOwnValve procedure—a case report

Current pulmonary valve replacement strategies rely on bioprosthetic or mechanical prostheses, which are limited by structural valve degeneration, reduced durability, or the need for lifelong anticoagulation. Tissue-engineered alternatives have been proposed but remain constrained by complex manufacturing processes and limited intraoperative applicability. We report the first clinical application of the GrOwnValve procedure, a novel approach for intraoperative fabrication of a patient-specific pulmonary valve prosthesis using autologous tissue and 3D-printed moulds. A 35-year-old man with severe homograft stenosis following Ross procedure (peak gradient 115 mmHg) underwent implantation of a patient-specific GrOwnValve prosthesis. Patient-specific moulds were generated from preoperative computed tomography data. During the intervention, autologous pericardium was harvested, shaped, and stabilized using a novel alternative to glutaraldehyde before assembly onto a transcatheter stent frame and implantation. The procedure was completed without complications. At follow-up, exercise capacity improved from 180 to 196 W. Cardiac magnetic resonance imaging demonstrated a reduction in peak gradient (115 to 16 mmHg), regurgitant fraction (20% to 10%), and right ventricular end-diastolic volume index (196 to 133 mL/m2). Echocardiography showed decreasing transvalvular velocity (5.08 to 1.89 m/s) and increasing pressure half-time (158 to 350 ms), indicating sustained valve function. This case demonstrates the feasibility of intraoperative manufacturing and transcatheter implantation of a patient-specific autologous pulmonary valve prosthesis. Early follow-up showed favourable hemodynamic performance and signs of right ventricular reverse remodelling. While long-term durability remains to be established, this first-in-human case highlights a novel treatment concept that combines autologous tissue, patient-specific valve design, and transcatheter implantation.