L’HTA applicato alla ricostruzione mammaria in interventi chirurgici one-step: dall’utilizzo degli espansori all’impiego di matrici biologiche, l’esperienza dell’Azienda Ospedaliero-Universitaria di Parma
Chiara Linguadoca, Cristina Rosi, Maria Eugenia Sesenna, Alessandra Zanardi, Maria Francesca Arcuri, Dante Palli, Leonardo Cattelani
Introduction In the last few years, therapeutic alternatives for breast cancer treatment increased dramatically, making breast cancer a curable disease. Considering surgery, skin-sparing mastectomy and immediate breast reconstruction represent the most reliable choice. Nevertheless, in case of breast volume larger than 350-400 ml, the preparation of a prosthetic pouch solely made by patient’s muscles is extremely complex. In those cases, a two-stage reconstruction is mandatory: 1. mastectomy and expander/implant reconstruction; 2. expander/implant replacement with permanent silicone hydrogel implants. The recent availability of acellular dermal matrices (ADMs) made one-step breast reconstruction a feasible procedure even in case of very large breasts. In the light of medical literature data and considering the optimal esthetic and functional results, the ethical and logistic advantages and the reduction of postoperative pain, the University Hospital of Parma evaluated these new devices. The aims of this study was: 1. to describe the process for ADMs management and utilization two years after their introduction at the University Hospital of Parma; 2. to evaluate economic impact of the new procedure.
Materials and Methods A multidisciplinary working group was created. Different topics were addressed, such as products selection; definition of treatment eligibility criteria; development of a monitoring sheet (consumption and adherence to indications). To evaluate the financial impacts 2 years after the introduction of the new procedure, the costs related to the new surgical approach have been compared to the two stage standard procedure. Particularly, the total expenditures related to staff and materials, and those related to intermediate services and performances (outpatient visits) have been considered. The type of examination and performance codes have been evaluated as well.
Results The analysis of technical sheets, instructions for use, pivotal trials and economic proposals led to the selection of three different ADMs: two animal cell (biologic) membranes (porcine dermal matrix; bovine pericardium) and one silk derived membrane. All of these matrices shared good resistance and tensile strengths, reasonable handling, user-friendliness, tissue inertia. Major inclusion criteria were the followings: breast volume larger than 350 ml, skin flaps viability. Exclusion criteria were obesity, diabetes, smoking history, immune system deficiency, radiotherapy. Since the introduction of the new devices, 58 patients were treated using the one-step procedure (9 cases of bilateral implants). The results of the costs analysis related to the new surgical approach confirmed that, even considering the ADMs massive costs arising, the one-step procedure could lead to a saving of 15% for NHS.
Conclusions The University Hospital of Parma experience confirmed the published data and constituted a nice example of good clinical practice and evaluation according to HTA methodology.
Key words: one-step breast reconstruction, acellular dermal matrices (ADMs) management, inclusion and exclusion criteria, economical evaluation