Transcatheter Aortic Valve Implantation in Centers Without Cardiac Surgery: A Preliminary Medico-Legal Discussion in Italy

Background/Objectives: The expansion of minimally invasive and transcatheter approaches has progressively blurred boundaries between medical and surgical disciplines. Valvular heart diseases, especially aortic ones, exemplify this translational shift, with transcatheter aortic valve implantation (TAVI) increasingly replacing conventional cardiac surgery. Current guidelines recommend the performance of these procedures in centers equipped with on-site cardiac surgery, ensuring management of time-dependent complications. In fact, even if the incidence of major complications is low, the absence of immediate surgical bailout may translate into a concrete loss of therapeutic opportunity. Methods: The authors discuss the forensic implications of performing TAVI in centers without on-site cardiac surgery. Results: Patient safety is an integral component of the right to health, emphasizing risks minimization. Structural or logistical inability to manage foreseeable complications, or safety mechanisms constraint in elective treatments may therefore constitute a harm of this right. In this context, several aspects must be considered in light of guideline evidence and available data, including the training and competencies of medical and surgical specialties in Italy; the lack of data on the timing of complication management and related mortality, with the consequent hypothesis of therapeutic delay; and the liability of Heart Team members in cases of deviation from the guidelines. Moreover, the issue of proximity of care and the Heart Valve Center model and the adequacy of patient information must be considered. Conclusion: Overall, while TAVI represents a major advance, it must be supported by organizational models proportionate to its complexity, integrating patient safety, healthcare accountability, and patient’s right to health.