Manufacturing Better Outcomes in Cardiovascular Intervention: 3D Printing in Clinical Practice Today

Describe and evaluate the integration of 3D printing-related innovations into current cardiovascular treatment paradigms and examine the state of regulatory and reimbursement hurdles ahead.

Mounting years of clinical experience have established the utility of printed models of patient anatomy in numerous treatment and teaching scenarios, most notably as pre- and intra-procedural planning tools guiding decision-making for congenital heart disease and catheter-based interventions. In part due to a continued lack of reimbursement and under-defined (and slow to evolve) regulatory status, these use cases remain largely investigational even as they grow increasingly routine. Patients, physicians, and/or imaging centers therefore remain burdened by the associated cost to create such models, and the perceptual and decision-making enhancements, while demonstrable and significant, still may not clearly or independently justify a potentially high cost. Simulation and implantable device applications may represent a deeper well of unrealized value in cardiovascular intervention; however, further development of these applications relies on-and is throttled by-progress in material science and tissue-engineering research. The relevance of simulation applications in recent years is also now in competition with digital analogs including augmented and virtual reality. Innovative incorporation of alternative manufacturing processes such as porous scaffold infusion, injection molding, and vascular mesh forming can provide immediate access to more realistic tissue-mimicking materials and custom implantable devices, while comparable and directly printable materials continue to be developed. Tissue-engineering applications remain years if not decades away from a more substantive role in translatable clinical research. Regulatory challenges associated with in-house manufacture of implantable investigational devices are complex and subject to change, and the success of some in navigating these hurdles in non-cardiovascular applications is instructive and encouraging. Complex geometries characterizing cardiovascular anatomy are an ideal use case for translating the perceptual advantages of printed models of patient anatomy into better decision-making, especially so in the setting of congenital or post-surgical anatomy. Procedural planning applications take further advantage of the demonstrably robust dimensional reproduction of patient anatomy, with notably rapid integration into surgical and catheter-based intervention workflows. Despite a continued lack of codification in the healthcare system, 2018 could be a milestone year for 3D printing services, pending a successful application for a CPT Category III designation.