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Veritas® bovine pericardium for immediate breast reconstruction: a xenograft alternative to acellular dermal matrix products.

ABSTRACT: BACKGROUND: The technical advantages in utilizing human acellular dermal matrix (ADM) products as pectoral extenders in immediate breast reconstruction with tissue expanders or implants are well documented in the medical literature. In this study, the authors examine a commonly used biologic xenograft product that has not yet been described in the medical literature for use in immediate breast reconstruction to determine whether a lower overall complication rate is identified compared to published data on ADM products. METHODS: A retrospective multicenter medical record review of data on 54 subjects in 93 tissue expander/implant-based, consecutive, immediate breast reconstructions from three surgeons at different institutions was performed in which Veritas® bovine pericardium was used as the biologic graft material for the pectoral extender. RESULTS: Over a 24-month period with an average of 11-month follow-up, complication rates using Veritas® in breast reconstruction for seroma formation (7.5 %), marginal skin flap necrosis (5.4 %) infection (6.5 %), and capsular contracture (0 %) were found to compare equally or favorably with statistically significant lower overall complications relative to one comparison study and lower rates of marginal skin flap necrosis relative to two comparison studies based upon previously published data from multisurgeon studies using ADM products. CONCLUSIONS: Overall complications were found to be lower with Veritas® than ADM products in comparable multisurgeon studies, though this was found to be statistically significant in only one comparison study. Level of Evidence: Level II, theraputic study.

SUBMITTER: Mofid MM

PROVIDER: S-EPMC3443340 | biostudies-literature | 2012 Oct

REPOSITORIES: biostudies-literature

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Veritas® bovine pericardium for immediate breast reconstruction: a xenograft alternative to acellular dermal matrix products.

Mofid Mehrdad Mark MM Meininger Michael S MS Lacey Martin S MS

European journal of plastic surgery 20120617 10

BACKGROUND: The technical advantages in utilizing human acellular dermal matrix (ADM) products as pectoral extenders in immediate breast reconstruction with tissue expanders or implants are well documented in the medical literature. In this study, the authors examine a commonly used biologic xenograft product that has not yet been described in the medical literature for use in immediate breast reconstruction to determine whether a lower overall complication rate is identified compared to publish ...[more]

PMID: 23002328

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Project description:BackgroundThe use of acellular dermal matrix (ADM) in one-stage immediate implant-based breast reconstruction (BR) may offer advantages over the two-stage expander-to-implant technique, but literature shows conflicting results. The aim of the present study was to compare these two techniques for immediate implant-based BR regarding postoperative complications, aesthetic correction procedures and aesthetic outcome.MethodsThe study was designed as an observational cohort study with 44 participants admitted for immediate implant-based BR at Department of Plastic Surgery, Aarhus University Hospital, Denmark. 21 patients underwent BR with a one-stage direct-to-implant technique using ADM and 23 patients underwent BR with a two-stage expander-to-implant technique. Follow-up time was 2 years.ResultsThe risk of implant loss was equal between groups; one-stage group 16% and two-stage group 17% whereas the risk of implant exchange (but not loss of BR) was 13% in the one-stage group compared to 7% in the two-stage group. The risk of at least one major complication were equal between groups; 28% and 24% but the risk of at least one minor complication was significantly higher in the two-stage group (41%) compared to the one-stage group (3%). Number of aesthetic corrections were equally frequent in the two treatment groups (one-stage group 1.8, two-stage group 1.5). Patient and investigator assessed aesthetic outcome was very high in both groups as well as the degree of symmetry between breasts. No capsular contracture Baker grade 3 or 4 was observed.ConclusionsThe present study design sets limitations for drawing wide conclusions. This study did not reveal any significant differences between the two breast reconstructive techniques besides a higher risk of minor complications in the two-stage group, that did, however, not lead to a higher risk of implant loss. With equally high satisfaction with the aesthetic result and no significant difference in number of aesthetic corrections between the two groups we suggest, that the one-stage approach using ADM may be feasible and allows the patient to achieve an implant-based BR with a minimum of surgeries and outpatient visits. The study was registered in ClinicalTrials.gov (NCT04209010).

Project description:PurposeWe systematically reviewed the literature to compare the clinical and radiologic outcomes and retear rates of superior capsular reconstruction (SCR) using fascia lata autograft (FLA) versus human dermal allograft (HDA) in cases of massive irreparable rotator cuff tears.MethodsSearches of Pub Med and Cochrane Library identified clinical studies addressing SCR using FLA and HDA. Two reviewers independently screened the titles, abstracts and full texts to extract data from eligible studies. Reported outcome measures were descriptively analyzed.ResultsA total of 6 studies with 2 study groups satisfied the inclusion criteria. The number of shoulders in the HDA group was 155, and in the FLA group, the number was 140 shoulders. The mean age at time of surgery for the HDA group and the FLA group was 60.49 years and 65.8 years, respectively, and the mean follow-up was 15.2 months and 44.6 months, respectively. Active elevation improved from of 121°-130° to 158°-160° in the HDA group and from 74.8°-133° to 130.4°-146° in the FLA group. Active external rotation improved from 36°-45° in the HDA group and from 13°-28° to 30°-43° in the FLA group. The Visual Analog Scale for pain improved from 4-6.25 to 0.38-1.7 points in the HDA group, whereas in the FLA group, it improved from 6-2.5 points. In the HDA group, American Shoulder and Elbow Surgeons scores improved from 42-52 to 77.5-86.5, whereas in the FLA group scores improved from 35-54.4 to 73.7-94.3. The acromiohumeral distance improved in both groups. The retear rate was 3.4%-55% in the HDA group and 4.5%-29% % in the FLA group.ConclusionsArthroscopic SCR for massive, irreparable rotator cuff tears using both fascia lata allograft and human dermal allograft leads to improvement in clinical outcomes and radiologic outcomes. There is a lower retear rate in fascia lata allografts. The current literature is heterogeneous and has low levels of evidence.Level of evidenceLevel IV, systematic review of level IV studies.

Project description:ImportanceThe use of acellular dermal matrix (ADM) in implant-based breast reconstructions (IBBRs) is established practice. Existing evidence validating ADMs proposed advantages, including improved cosmetics and more single-stage IBBRs, is lacking.ObjectiveTo evaluate whether IBBR with ADM results in fewer reoperations and increased health-related quality of life (HRQoL) compared with conventional IBBR without ADM.Design, setting, and participantsThis was an open-label, multicenter, randomized clinical trial of women with primary breast cancer who planned for mastectomy and immediate IBBR, with a 2-year follow-up for all participants. Participants were enrolled at 5 breast cancer units in Sweden and the United Kingdom between 2014 and May 2017. Exclusion criteria included previous radiotherapy and neo-adjuvant chemotherapy. Data were analyzed until August 2017.InterventionsParticipants were allocated to immediate IBBR with or without ADM.Main outcomes and measuresThe primary trial end point was number of reoperations at 2 years. HRQoL, a secondary end point, was measured as patient-reported outcome measures using 3 instruments from the European Organization for Research and Treatment of Cancer Quality of life Questionnaire.ResultsFrom start of enrollment on April 24, 2014, to close of trial on May 10, 2017, a total of 135 women were enrolled (mean [SD] age, 50.4 [9.5] years); 64 were assigned to have an IBBR procedure with ADM and 65 to the control group who had IBBR without ADM. There was no statistically significant difference between groups for the primary outcome. Of 129 patients analyzed at 2-year follow-up, 44 of 64 (69%) had at least 1 surgical event in the ADM group vs 43 of 65 (66%) in the control group. In the ADM group, 31 patients (48%) had at least 1 reoperation on the ipsilateral side vs 35 (54%) in the control group. The overall number of reoperations on the ipsilateral side were 42 and 43 respectively. Within the follow-up time of 24 months, 9 patients (14%) in the ADM group had the implant removed compared with 7 (11%) in the control group. We found no significant mean differences in postoperative patient-reported HRQoL domains, including perception of body image (mean difference, 3; 99% CI, -11 to 17; P = .57) and satisfaction with cosmetic outcome (mean difference, 8; 99% CI, -6 to 20; P = .11).Conclusions and relevanceImmediate IBBR with ADM did not yield fewer reoperations compared with conventional IBBR without ADM, nor was IBBR with ADM superior in terms of HRQoL or patient-reported cosmetic outcomes. Patients treated for breast cancer contemplating ADM-supported IBBR should be informed about the lack of evidence validating ADM's suggested benefits.Trial registrationClinicalTrials.gov Identifier: NCT02061527.

Dataset Information

Veritas® bovine pericardium for immediate breast reconstruction: a xenograft alternative to acellular dermal matrix products.

Publications

Veritas® bovine pericardium for immediate breast reconstruction: a xenograft alternative to acellular dermal matrix products.

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