Safety and efficacy of the INC bioprosthetic heart valve in humans.

Introduction: Heart valve bioprostheses are the gold standard for aortic valve surgical replacement in selected patients.

Objective: To evaluate the safety and efficacy of the National Institute of Cardiology (INC) bioprosthetic heart valve in humans.

Methods: Single-center study that included 341 patients who underwent single surgical aortic valve replacement with INC heart valve.

Results: 318 implants were performed de novo (93%) and 23 as redo surgery (7%); STS scores were 1.4 and 1.8%, and follow-up was for 42 and 46 months, respectively. There were no differences in clinical complications or pacemaker implantation rate. Both groups maintained a normal LVEF. Overall improvement in functional class was observed, with worsening only in two patients of the de novo group. INC prosthesis dysfunction requiring surgical reintervention was observed in eight patients (4.65%) of the de novo group vs. one patient in the redo group.

Conclusions: The INC heart valve is efficacious and safe, and is associated with a low rate of complications and functional class improvement during long-term follow-up. Prospective, comparative studies of this valve are required.