3D models, simulations, holograms: quasi-futuristic elements that seem very far from the everyday clinical practice. Only when these transform into an extraordinary intervention, we finally understand the true importance of research: saving a life. It has been achieved at Policlinico San Donato, regarding a 73-year-old patient, who would not have been able to undergo an open-heart intervention. Thanks to the synergy between cardiologists and bio-engineers, a device has been designed and constructed based on the patient’s anatomy, to be then implanted in a minimally invasive way. An intervention without precedent within continental Europe: only in Great Britain and in the United States have similar procedures been carried out, up to only four cases within the medical literature.
The story: Mrs Giacoma is a 73 year-old patient from Puglia, full of life, who chose to be treated at Policlinico San Donato. She was feeling tired and fatigued for some time, lacking the energy that usually characterised her: she even came to be exhausted by a simple walk. This was caused by congenital cardiopathy, a cardiac birth defect, which she discovered only ten years ago. Between the two atria of the heart, a “hole” allows the anomalous passage of blood from left to right (inter-atrial defect of venous sinus type); the pulmonary veins being also positioned in an anomalous manner. At the time of diagnosis, however, Mrs. Giacoma needed treatment for a tumour, and as the years passed, her heart became even more fatigued.
Intervention: The specific nature of the congenital cardiopathy affecting Mrs. Giacoma only allowed for surgical treatment, that is “open heart”. Her health conditions made such an intervention extremely risky: age, the restrictive pulmonary syndrome, and other pathologies further complicated the situation. It was necessary to go down a path never taken before: correcting the defect with an interventional cardiology procedure, then inserting a device through a catheter that flowed along a vein, arriving at the heart. A quite common procedure for other cardiopathies, but which had only been applied in a case like this in four instances in the world. Given its extraordinary nature, the decision required everybody’s consent: the directors’ of the Cardio-surgery and Paediatric Cardiology operating units at Policlinico San Donato, Doctors’ Alessandro Frigiola, Alessandro Giamberti and Mario Carminati, the cardiologist’s, Doctor’s Gianfranco Butera and Mrs. Giacoma’s. The doctors who had already trialled this in Great Britain and the United States were also contacted. Once the route to take was decided upon, a clinical report needed to be presented to the Ethics Committee and once this was approved, a request was made towards the Ministry of Health. This is all because it was an extraordinary procedure, not codified, but studied ad-hoc for the specific case. In addition, the device to be placed in the patient’s heart was custom-made: a covered stent, slightly longer than those available commercially, specially manufactured by an American company. With the entire process of authorisations and studies completed, Mrs. Giacoma was finally able to undergo the procedure, carried out by Doctor Butera. During three hours in the haemodynamics theatre, the device was implanted within the superior vena cava via a trans-catheter route, to exclude the blood flow from the inter-atrial defect and correctly direct that coming from the pulmonary veins. Thanks to the procedure carried out, the cardiac chambers were restored to “normality”, and consequently the functionality of the muscle and the circulatory system.
Synergy between medicine and engineering: But how is it possible to forecast with pinpoint accuracy how a procedure never carried out before will go? This is where the crucial role of bio-engineers comes into play: at Policlinico San Donato, they engage in important and wide-ranging research activities within the Computational Simulation and 3D Laboratory, established at the start of 2017 from a collaboration with Politecnico di Milano and Università degli Studi di Pavia. In order to be able to proceed in complete safety, planning every step of the intervention was required: firstly, a 3D model of Mrs. Giacoma’s heart was created, based on several CAT images and using a 3D printer. Then a computational model was developed, i.e. the result of a mathematical simulation able to reproduce the procedure exactly, and to provide an understanding of the stress that the intervention might generate on the patient’s tissues. Last but not least, the creation of a hologram of the heart made it possible to “navigate” inside it, examine specific sections, and simulate all of the phases “quasi-live”, from the introduction of the catheter to the positioning of the device. Each of these applications, inches away from being considered science fiction, contributed in a concrete and decisive way to the success of the procedure. They enabled an accurate clinical report to be drawn up, which in turn enabled the necessary authorisations to be obtained, a customised medical device to be designed, and everything that took place in theatre to be planned as thoroughly as possible.
Special thanks to the Scientific Management and to the team that carried out the procedure, including: the Paediatric and Adult Congenital Cardiology doctors (Gianfranco Butera, Francesca Pluchinotta, Angelo Micheletti, Luca Giugno, Domenica Basile and Diana Negura), the bio-engineers from the Computational Simulation and 3D Laboratory, Politecnico di Milano, the start-up Artiness (Francesco Sturla, Alessandro Caimi, Omar Pappalardo, Filippo Piatti, Giovanni Rossini and Emiliano Votta), the medical, technical and nursing personnel within the haemodynamics theatre (Chiara Gallazzi, Chiara Stamigna, Miriam Deamici, Davide Abbiati, Claudio Mele and Giovanna Dibattista), the post-operative intensive care ward, and the recovery ward.