Short-term cost-effectiveness of one-stage implant-based breast reconstruction with an acellular dermal matrix versus two-stage expander-implant reconstruction from a multicentre randomized clinical trial.

BACKGROUND: Implant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure and its economic impact is significant. This study aimed to analyse whether a direct one-stage IBBR with use of an acellular dermal matrix (ADM) is more cost-effective than two-stage (expander-implant) breast reconstruction. METHODS: The BRIOS (Breast Reconstruction In One Stage) study was an open-label multicentre RCT in which women scheduled for skin-sparing mastectomy and immediate IBBR were randomized between one-stage IBBR with ADM or two-stage IBBR. Duration of surgery and hospital stay, and visits for the primary surgery, unplanned and cosmetic procedures were recorded. Costs were estimated at an institutional level. Health status was assessed by means of the EuroQol Five Dimensions 5L questionnaire. RESULTS: Fifty-nine patients (91 breasts) underwent one-stage IBBR with ADM and 62 patients (92 breasts) two-stage IBBR. The mean(s.d.) duration of surgery in the one-stage group was significantly longer than that for two-stage IBBR for unilateral (2·52(0·55) versus 2·02(0·35) h; P < 0·001) and bilateral (4·03(1·00) versus 3·25(0·58) h; P = 0·017) reconstructions. Costs were higher for one-stage compared with two-stage IBBR for both unilateral (€12 448 (95 per cent c.i. 10 722 to 14 387) versus €9871 (9373 to 10 445) respectively; P = 0·025) and bilateral (€16 939 (14 887 to 19 360) versus €13 383 (12 414 to 14 669); P = 0·002) reconstructions. This was partly related to the use of relatively expensive ADM. There was no difference in postoperative health status between the groups. CONCLUSION: One-stage IBBR with ADM was associated with higher costs, but similar health status, compared with conventional two-stage IBBR. Registration number: NTR5446 ( http://www.trialregister.nl).

Predictors of complications after direct-to-implant breast reconstruction with an acellular dermal matrix from a multicentre randomized clinical trial.

BACKGROUND: In the multicentre randomized trial BRIOS (Breast Reconstruction In One Stage), direct-to-implant (DTI) breast reconstruction with an acellular dermal matrix (ADM) was associated with a markedly higher postoperative complication rate compared with two-stage tissue expander/implant breast reconstruction. This study aimed to identify factors that contribute to the occurrence of complications after DTI ADM-assisted breast reconstruction. METHODS: Data were obtained from the BRIOS study, including all patients treated with DTI ADM-assisted breast reconstruction. Logistic regression analyses were performed to identify factors predictive of postoperative complications. RESULTS: Fifty-nine patients (91 breasts) were included, of whom 27 (35 breasts) developed a surgical complication. Reoperations were performed in 29 breasts (32 per cent), with prosthesis removal in 22 (24 per cent). In multivariable analyses, mastectomy weight was associated with complications (odds ratio (OR) 1·94, 95 per cent c.i. 1·33 to 2·83), reoperations (OR 1·70, 1·12 to 2·59) and removal of the implant (OR 1·55, 1·11 to 2·17). Younger patients (OR 1·07, 1·01 to 1·13) and those who received adjuvant chemotherapy (OR 4·83, 1·15 to 20·24) more frequently required reoperation. In univariable analyses, adjuvant radiotherapy showed a trend towards more complications (OR 7·23, 0·75 to 69·95) and removal of the implant (OR 5·12, 0·76 to 34·44), without reaching statistical significance. CONCLUSION: Breast size appeared to be the most significant predictor of complications in DTI ADM-assisted breast reconstruction. The technique should preferably be performed in patients with small to moderate sized breasts. Registration number: NTR5446 ( http://www.trialregister.nl).

The combined free partial vastus lateralis with anterolateral thigh perforator flap reconstruction of extensive composite defects.

Myocutaneous (MC) free flaps are useful for many reconstructive indications. Perforator flaps have become standard of care. The anterolateral thigh flap (ALT) donor site is popular. With the ALT flap varying sizes of vastus lateralis (VL) muscle can be harvested as a MC flap. The skin islands of these flaps have a great range of freedom when dissected on their perforator. It was hypothesised that the VL-ALT perforator flap would offer adequate tissue volume combining maximal freedom in planning with minimal donor site morbidity. From November 2001 to February 2003 a free partial VL with ALT perforator flap was used in 11 patients to reconstruct large defects. Indications for adding a muscular component were exposed bone, skull base, (artificial) dura, or osteosynthesis material, open sinuses, and lack of muscular bulk. Flaps were planned as standard ALT flaps, after which three types of dissection were performed: I. true MC flap; II. muscle flap with a skin island on one perforator, which could be rotated up to 180 degrees ; III. chimera skin perforator flap with muscle being harvested on a separate branch from the source vessel or on a side branch of the skin perforator. Mean skin size of the MC-ALT flaps was 131 cm2. Mean muscle part size of the MC-ALT flaps was 268 cm3. Muscular parts were custom designed for all defects. No total or partial flap failures were seen. Colour mismatch was seen in 6 of 8 patients, when skin was used in the facial area in this all white population. Excessive flap bulk was found in 8 of 11 patients at 6 weeks, however, only in 2 of 11 patients after 6 months. Patients were satisfied with the functional result (8 of 11 patients) as well as the cosmetic result of their reconstruction (7 of 11 patients). All less satisfied patients had received their flap for external facial skin reconstruction. Donor site morbidity was minimal. The combined free partial VL with ALT perforator flap proved valuable as a (chimera type) MC flap with maximal freedom of planning to meet specific reconstructive demands and minimal donor site morbidity.