A novel ventricular septal reconstruction device for post-myocardial infarction ventricular septal rupture: preclinical and first-in-human study results.

BACKGROUND: Post-myocardial infarction ventricular septal rupture (PIVSR) is a severe mechanical complication of acute myocardial infarction (AMI) with a poor prognosis. Current therapeutic strategies-including pharmacotherapy, surgery, and off-label use of congenital occluders-are associated with inherent limitations. OBJECTIVES: The primary objective of this study was to evaluate the procedural feasibility, preliminary safety, and short-term performance of a novel dedicated Ventricular Septal Reconstruction Device (VSRD) for the treatment of PIVSR. METHODS: This study employed preclinical animal studies and a prospective first-in-human (FIM) clinical study. For the animal experiments, VSD-like defect creation was attempted in 14 Labrador retrievers; 11 underwent device-placement attempts, and 10 completed implantation and detachment with the VSRS 3226 device. Five animals were assessed at day 1 and five at day 60. The canine model was used to evaluate device deliverability, deployment, anchoring, shunt reduction, and short-term local tissue response in a VSD-like defect model rather than to reproduce infarct-related PIVSR pathology. For the first-in-human study, 4 PIVSR patients were enrolled; the transjugular approach was adopted, guidance was provided by transthoracic echocardiography (TTE) combined with left ventricular angiography, and follow-up duration exceeded 6 months. RESULTS: In animal experiments, 11 of 14 animals proceeded to device-placement attempts, and 10 completed implantation and detachment; no device structural malfunction or delivery-system failure was recorded. Minor residual leakage was qualitatively observed in 4/5 animals at day 1, whereas no leakage was detected in the separate five-animal day-60 group; tissue coverage consistent with endothelialization was observed at day 60, and no adverse events occurred among implanted animals during follow-up. In the first-in-human study, implantation was completed in all four patients; residual shunts were ≤2 mm during follow-up, and no high-grade atrioventricular block or permanent pacemaker implantation occurred. CONCLUSIONS: The VSRD demonstrated procedural feasibility and acceptable short-term safety and performance in this preclinical and first-in-human experience, in selected patients and a VSD-like animal model. Larger-scale clinical studies with longer follow-up are needed to evaluate its long-term safety, effectiveness, durability, and comparative performance. These findings should be interpreted cautiously because the clinical cohort was small, highly selected, and non-comparative.