Prodotti
Magnetic resonance imaging system for intraoperative margin assessment for DCIS and invasive breast cancer using the ClearSightTM system in breast‐conserving surgery—Results from a postmarketing study
2023 - Marc Thill, Iris Szwarcfiter, Katharina Kelling, Viviane van Haasteren, Eyal Kolka, Josefa Noelke, Zachi Pees, Moshe Papa, Sebastian Aulmann, Tanir Allweis

Background: 

Background and objectives: Breast‐conserving surgery (BCS) is followed by re- operations in approximately 25%. Reoperations lead to an increased risk of infection and wound healing problems as well as a worse cosmetic outcome. Several technical approaches for an intraoperative margin assessment to decrease the reoperation rate are under evaluation, some of them are still experimental.

Study results

The ClearSightTM system was performed for both ductal and lobular breast cancer and DCIS, with a sensitivity of 0.80 (95% confidence interval [CI]: 0.44–0.96) and a specificity of 0.84 (95% CI 0.72–0.92), with an overall diag- nostic accuracy of 80%.

Conclusion: 

Had the ClearSightTM been known to the surgeon intraoperatively, the reoperation rate would have been reduced by 83% for invasive carcinoma, from 10% to 2%, and 50% for DCIS, from 30% to 15% reoperations. A trial designed to examine the impact on reoperation rates is currently ongoing.

“To Pre or Not to Pre”: Introduction of a Prepectoral Breast Reconstruction Assessment Score to Help Surgeons Solving the Decision-Making Dilemma. Retrospective Results of a Multicenter Experience
2021 - Donato Casella, Juste Kaciulyte, Federico Lo Torto, Francesco L. R. Mori, Leonardo Barellini, Alfonso Fausto, Benedetta Fanelli, Manfredi Greco, Diego Ribuffo, Marco Marcasciano

Background: 

Implant-based reconstruction is the most performed breast reconstruction, and both subpectoral and prepectoral approaches can lead to excellent results. Choosing the best procedure requires a thorough understanding of every single technique, and proper patient selection is critical to achieve surgical success, in particular when dealing with prepectoral breast reconstruction

Study results

352 patients were included; 112 of them underwent direct-to-implant immediate reconstruction, and 240 underwent the two-stage procedure with temporary tissue expander. In both cases, the implant was wrapped in a titanium-coated polypropylene TiLoop Bra. According to the Prepectoral Breast Reconstruction Assessment score, direct-to-implant reconstruction should have been performed 6.2 percent times less, leading to an increase of 1.4 percent in two-stage reconstruction and 4.8 percent in submuscular implant placement.

Conclusion: 

To date, there is no validated system to guide surgeons in identifying the ideal patient for subcutaneous or retropectoral breast reconstruction and eventually whether she is a good candidate for direct-to-implant or two-stage reconstruction. The authors processed a simple risk-assessment score to objectively evaluate the patient’s risk factors, to standardize the decision-making process, and to identify the safest and most reliable breast reconstructive procedure

Titanium-coated polypropylene mesh as innovative bioactive material in conservatives mastectomies and pre-pectoral breast reconstruction
2021 - Pietro Gentile, Marco Bernini, Lorenzo Orzalesi, Silvia Sordi, Icro Meattini, Francesca Lessi, Ashutosh Kothari e Claudio Calabrese

Background: 

Breast reconstruction is rapidly evolving, thanks to the growing acceptance of synthetic meshes as innovative biomaterials. 276 patients undergoing mastectomy (total of 328 mastectomies) were analyzed in a retrospective observational study to evaluate the pre-pectoral immediate breast reconstruction (IBR) using an implant wrapped with Titanium-Coated Polypropylene Mesh (TCPM) vs. patients treated with tissue expander (TE), equally placed pre-pectorally (and wrapped with the same TCPM in 74.3% of the control group’ breasts). 

Study results

Histological analysis showed a process of normal tissue repair with a complete mesh integration and normal healing. Conservative mastectomies with pre-pectoral IBR assisted by TCPM proved themselves oncologically safe, biologically integrated into native tissues, and highly accepted in terms of quality of life guaranteeing a more natural and aesthetic breast appearance.

Conclusion: 

This retrospective observational study provided clinical and histological outcomes of the pre-pectoral IBR using an implant wrapped with TCPM vs. patients treated with TE, equally placed pre-pectorally.

All the histological analyses performed confirmed the TCPM mesh complete integration with the physiological aspects of healing: The Collagen 1 and 3 expressions did not differ, between TCPM and NO TCPM samples to confirm a process of healing overlapping to perfect device incorporation and normal healing.

Robot-Assisted Nipple-Sparing Mastectomy and Immediate Reconstruction with Prepectoral Tiloop-Enveloped Implant: A Case Report
2021 - Mariotti Carlo, Raffaeli Eugenia, Liverotti Sara, Lenti Enrico, Braccioni Francesco, Gentili Marco, Carrara Maria Cristina and Cardinali Chiara

Background: 

This paper describes the first experience our centre had with robot-assisted nipple-sparing mastectomy, which was performed for prophylactic purposes using the Da Vinci Si robotic Surgical System. 

Study results

This preliminary experience was very positive as to the accuracy of surgical manoeuvres thanks to the high quality of the 3D image; the demolition and reconstruction operations (carried out using a prepectoral implant covered with a Tiloop Bra synthetic mesh) were performed through a single axillary incision of just a few centimeters.

Conclusion: 

The technical difficulties are undeniable, but the learning curves described in the literature are promising

Prepectoral breast reconstruction with TiLoop® Bra Pocket: a single center prospective study
2020 - F. LO TORTO, M. MARCASCIANO, J. KACIULYTE1, U. REDI, L. BARELLINI, A. DE LUCA, A. PERRA, J.M. FRATTAROLI, E. CAVALIERI, G. DI TARANTO, M. GRECO, D. CASELLA

Background: 

The aim of this paper is to describe our case series in IBR with prepectoral implant placement and complete cover- age of it with the TiLoop® Bra titanium-coated poly- propylene mesh (TCPM), pre-shaped as a pocket. 

Study results

This preliminary study showed meaningful results in prepectoral IBR with TiLoop® Bra Pocket covering the implants, we observed a reduction of implant’s exposure time and risk of bacterial contamination. Of the 18 pa- tients that underwent this procedure, only three presented complications that resolved in a maximum of four weeks.

Conclusion: 

A considering reduction of surgical time in implant positioning was achieved, lowering exposure time and risk of complications as infection.

Veritas in Immediate Implant-based Breast Reconstruction Is Associated with Higher Complications Compared with TiLOOP BRA
2020 - Gaik Si Quah, James R. French, Annelise Cocco, Jeremy Hsu, Farid Meybodi, Elisabeth Elder

Background: Biologic and synthetic meshes are used in immediate implant-based breast reconstruction for coverage of the lower pole of the implant. This study aimed to compare outcomes of Veritas with TiLOOP bra 

Study results

Comparison of the Veritas group with the TiLOOP® Bra Group:
- Overall higher complication rate in the Veritas group: 54% vs. 14% of breasts

- Higher seroma rate/ non-integration in the Veritas group: 51.4% vs. 1.6% of breasts

- More implant rotations in the Veritas group: 16.2% vs. 1.1% of breasts

- Higher infection rate in the Veritas group: 18.9% vs. 2.1% of breasts

- More wound dehiscence in the Veritas group: 10.8% vs. 0.5% of breasts

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