Toward International Harmonization of Breast Implant Registries: International Collaboration of Breast Registry Activities Global Common Data Set.

BACKGROUND: The Poly Implant Prothèse incident and breast implant-associated anaplastic large cell lymphoma have pointed to the need for uniform registries for breast implants as key features to monitoring the outcomes of breast implant surgeries internationally. The purpose of this study was to identify and harmonize common data elements collected by breast implant registries across the International Collaboration of Breast Registry Activities (ICOBRA) global consortium. METHODS: The authors convened an international group of surgeons, consumers, nurses, registry experts, and regulators to review the data points. A modified Delphi approach was applied, to rate the importance of each point on a six-point Likert scale. RESULTS: Data points from six national breast implant registries were divided into categories: clinical, implant-related, patient-reported findings; operation details and implanting technique details; patient characteristics; unique device identifiers; unique patient identifiers; and clinical demographics. A total of 52 data points collected by over 33 percent of national registries were identified. After five rounds, 34 data points formed the final set with agreed definitions. The group recognized the critical importance of additional elements that are currently not uniformly collected (e.g., patient-reported outcomes and long-term data) and set out the process for the dynamic global set updates driven by evidence gaps. CONCLUSIONS: The authors defined internationally agreed on common data elements and definitions used in breast implant registries. This collaboration will allow data sets to be combined, enabling an effective global early warning system of implant-related problems and further work on data sets.

Establishing Priorities for the International Confederation of Plastic Surgery Societies.

BACKGROUND: The mission of the International Confederation of Plastic Surgery Societies (ICOPLAST) is to improve patient outcomes through collaboratively structured processes in education, advocacy and communication. This article explains how we approached the task of establishing priorities for this nascent confederation in an equitable and achievable manner. METHODS: In late 2016, an online survey was sent to the inaugural 62 ICOPLAST member national societies for dissemination to their respective plastic surgeon members. Functional domains and proposed initiatives were ranked according to their level of importance by individual plastic surgeons. RESULTS: The survey was completed by 572 plastic surgeons. As a functional domain, education was highly ranked by 75.3% of respondents, followed by patient safety (67.4%), communication (59.3%), humanitarian (46.6%), regulation (41.2%), and advocacy (41.1%). Respondents also ranked individual initiatives within each domain to produce a compilation list of the top 13 initiatives of importance. CONCLUSION: This study has identified priorities of importance to ICOPLAST members, which will aid in building a strategic framework and enhancing outcomes for patients, plastic surgeons, and the field of plastic surgery more broadly.

Introducing the International Confederation of Plastic Surgery Societies: ICOPLAST.

This article describes the formation of the International Confederation of Plastic Surgery Societies (ICOPLAST) as a novel, transparent, dynamic, and proactive confederation of national plastic surgery societies. ICOPLAST aspires to provide a voice for the entire international community of plastic surgeons. ICOPLAST has been designed to benefit the patient, plastic surgery as a profession, and each individual plastic surgeon. Its principal objective is to enhance international communication, education, and advocacy processes to ultimately improve patient outcomes for plastic surgery patients globally. The new ICOPLAST's focus is to add true value for patients. ICOPLAST's evolution, philosophy, governance, and bylaws are explained and all societies worldwide are encouraged and cordially invited to join. An open and warm invitation is provided. Additional information is found at www.ICOPLAST.org.

International importance of robust breast device registries.

BACKGROUND: Breast implants are high-risk devices that have been at the epicenter of much debate and controversy. In light of the Poly Implant Prothèse crisis, data registries among 11 national societies around the world are cooperatively calling for the urgent need to establish robust national clinical quality registries based on international best practice within a framework of international collaboration. METHODS: A survey was conducted on the historic and current status of national breast device registries. Eleven countries participated in the study, illustrating different data collection systems and registries around the world. Data collection was designed to illustrate the capabilities of current national registries, with particular focus on capture rate and outcome reporting mechanisms. RESULTS: A study of national breast implant registries revealed that less than half of the participating countries had operational registries and that none of these had adequately high data capture to enable reliable outcome analysis. The study revealed that the two most common problems that discouraged participation are the complexity of data sets and the opt-in consent model. CONCLUSIONS: Recent implant crises have highlighted the need for robust registries. This article argues the importance of securing at least 90 percent data capture, which is achievable through the opt-out consent model. Since adopting this model, the Australian Breast Device Registry has increased data capture from 4 percent to over 97 percent. Simultaneously, it is important to foster international collaboration from the outset to avoid duplication of efforts and enable the development of effective international early warning systems.

Mohs micrographic surgery for dermatofibrosarcoma protuberans (DFSP): a single-centre series of 76 patients treated by frozen-section Mohs micrographic surgery with a review of the literature.

Dermatofibrosarcoma protuberans (DFSP) is a rare low-grade sarcoma that typically presents with local invasion but rarely metastasises. Surgical excision remains the first-line treatment for DFSP. There are no randomised controlled or prospective studies comparing wide local excision (WLE) with Mohs micrographic surgery (MMS), but available evidence from the retrospective studies and case series available has consistently shown higher recurrence rates for standard surgery and WLE than for MMS. Combined recurrence rates of data within the last 20 years for WLE have been reported at 7.3% compared with 1.1% for MMS. Our aim was to review the clinical details and recurrence rates of DFSP cases treated with frozen-section MMS in our centre between 1996 and February 2013. The relevant data were collected from the case notes. It involved 76 patients with nine of these patients lost to follow-up. In the remaining 67 (67/76) cases, the recurrence rate was 1.5% during the mean follow-up period of 50 months (2-132). This is comparable to recurrence rates for the MMS in the literature [20,21]. Our series is the largest series for frozen-section MMS reported to date. Based on these findings and the current literature evidence, we advocate MMS as the treatment of choice for DFSP in all locations.

Complications of the 'Enhanced Recovery after Surgery Programme' following pedicled vertical rectus abdominis myocutaneous flap in perineum reconstruction.

The enhanced recovery programme, pioneered in the colorectal surgical setting, aims to reduce the length of inpatient stay following a procedure and was started in our trust in 2006. We present the case of a patient who underwent perineal reconstruction with a pedicled vertical rectus abdominis myocutaneous (VRAM) who subsequently developed bladder outflow obstruction compromising flap viability. As a result of our experience we are in the process of producing new guidelines that advocate patients undergoing a VRAM flap for perineal reconstruction should be exempt from aspects of the enhanced recovery programme, in particular early removal of the catheter should be avoided.

Contrast-enhanced magnetic resonance angiography for preoperative imaging in DIEP flap breast reconstruction.

BACKGROUND: Contrast-enhanced magnetic resonance angiography has been shown to be very accurate for identifying the perforator size, location, and intramuscular course, and the associated venous system, without exposing the patient to ionizing radiation. This study reports the authors' experience using this imaging modality in a large patient series. METHODS: A retrospective review of patients who had undergone preoperative contrast-enhanced magnetic resonance angiography followed by free abdominal flap breast reconstruction was conducted. The results of imaging were compared with intraoperative findings, and surgical outcomes were compared with scan data. The results were compared with control data in patients who did not undergo presurgical imaging. RESULTS: One hundred thirty-two patients underwent contrast-enhanced magnetic resonance angiography presurgical imaging, and the results were compared with 84 controls. The imaging was found to be accurate for evaluating the perforator anatomy for free abdominal flap planning, with a high concordance between imaging and intraoperative findings. Without presurgical angiography, the ratio of deep inferior epigastric perforator (DIEP) flap-to-free transverse rectus abdominis musculocutaneous flap harvest was 0.9:1; with presurgical imaging, the ratio was 1.6:1 (p < 0.05). With presurgical angiography, there was a mean reduction in operating time of 26 minutes for unilateral DIEP flap harvest and 40 minutes for bilateral harvest, although these values were not significant. There was a significant reduction in the partial flap failure rate with preoperative imaging. CONCLUSIONS: Presurgical imaging using contrast-enhanced magnetic resonance angiography demonstrates a high concordance with intraoperative findings. In this series, the percentage of flaps that were raised as DIEP flaps was significantly increased in patients who underwent preoperative imaging, and the partial flap failure rate was significantly reduced. CLINICAL QUESTION/LEVEL OF EVIDENCE: : Therapeutic, III.(Figure is included in full-text article.).

WHO Surgical Checklist and Its Practical Application in Plastic Surgery.

The WHO surgical checklist was introduced to most UK surgical units following the WHO "Safe Surgery Saves Lives" initiative. The aim of this audit was to review patient's safety in the delivery of surgical care and to evaluate the practical application of the new WHO surgical checklist. We conducted a retrospective audit of patients who received operative treatment under general anaesthesia at our Plastic Surgery Department, involving a total number of 90 patients. The WHO form was compared to its former equivalents. Complications or incidents occurring during or after surgery were recorded. Using the department's previous surgical checklist, "Time out" was only performed in only 30% of cases. One patient arrived at theatre reception without a completed consent form, and two clinical incidents were reported without patients suffering harm. Following introduction of current WHO surgical checklist, "Time out" was recorded in 80% of cases. In all cases, the new WHO surgical checklist was used and no incidents were reported. The WHO surgical checklist provides a structured frame work that standardizes the delivery of care across hospitals and specialized units; however, it will take some time and practice for teams to learn to use the checklist effectively and reliably.

A prospective assessment of shoulder morbidity and recovery time scales following latissimus dorsi breast reconstruction.

BACKGROUND: The impact on shoulder function from removal of the latissimus dorsi muscle in breast reconstruction is important because of the common nature of this operation. Informed consent requires us to discuss the impact of surgery and likely recovery times. The literature already supports the absence of long-term effects from this procedure. However, all studies and subsequent reviews are based on retrospective studies, thus making it impossible to assess recovery time scales compared with preoperative values. In this prospective study, the authors set out to define the impact on shoulder function and, importantly, to assess recovery time scales compared with preoperative values. METHODS: Shoulder range of motion, strength, function, and pain were assessed prospectively in 22 subjects who had latissimus dorsi muscle flap breast reconstruction. Assessments were carried out preoperatively and then at 6 weeks, 6 months, and 1 year postoperatively using standardized objective assessments. RESULTS: The results demonstrate no significant loss of range of motion, strength, function, or pain at 1 year. However, strength, disability scores, neural glide, and discomfort were still abnormal at 6 months and then normalized at 1 year. It was noted that the extended latissimus dorsi flap tended to have poorer scores and recovery compared with a latissimus dorsi flap and implant. CONCLUSION: The authors believe this information to be important to the patient, therapist, and surgeon in the assessment of postoperative recovery from this procedure.

Malignant perivascular epithelioid cell tumour ("PEComa") of soft tissue: a unique case.

Tumours of perivascular epithelioid cells (PEComas) are being increasingly reported at visceral and somatic sites. Both benign and malignant variants have been identified, although clinical follow-up is often limited, which prevents meaningful predictions of behavior. We report the case of a malignant soft tissue PEComa with histologically confirmed regional lymph node metastases and radiologically confirmed pulmonary metastases. The light microscopic appearance and immunohistochemical profile (HMB-45, smooth muscle actin positive) and electron microscopic appearance support perivascular epithelioid cell differentiation.