Autologous Fat Grafting Is Not Superior to Placebo as Treatment of Postherpetic Neuralgia: A Double-Blind Randomized Clinical Trial.

BACKGROUND: Postherpetic neuralgia (PHN) is a chronic pain syndrome occurring after a herpes zoster outbreak. While there is no effective treatment available today, autologous fat grafting has shown promise. This randomized controlled trial investigated the effectiveness of fat grafting as treatment for PHN compared with a sham treatment. METHODS: A total of 46 participants with PHN were included. After liposuction under general anesthesia, participants were randomly assigned to receive either autologous fat grafting or saline injection to the area of pain. The primary outcomes were the average and maximum degree of pain measured on an 11-point numeric rating scale. Secondary outcomes were quality and degree of neuropathic pain (Neuropathic Pain Symptom Inventory) and quality of life (36-Item Short-Form Health Survey). RESULTS: Forty-two participants completed follow-up of 6 months. For maximal degree of pain, a reduction of -1.1 ± 0.6 and -1.0 ± 0.5 mean change (±SE) on the numeric rating scale was observed in the intervention and control groups, respectively. For average degree of pain, the reduction was -1.2 ± 0.5 and -1.3 ± 0.4 in the intervention and control groups, respectively. The authors did not observe any significant changes in the neuropathic pain and quality-of-life parameters. For all measured outcomes, the differences between the groups were not statistically significant. CONCLUSIONS: The authors did not find autologous fat grafting superior to a placebo when treating PHN of the skin. Given their results, they cannot recommend the routine use of this method to treat these pains. CLINICAL RELEVANCE STATEMENT: Since autologous fat grafting was not proven to be more effective than a placebo in treating PHN, alternative treatment options should be explored. It is also essential to emphasize the importance of prophylactic vaccination against herpes zoster. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

Evaluation of Breast Animation Deformity following Pre- and Subpectoral Direct-to-Implant Breast Reconstruction: A Randomized Controlled Trial.

Background The incidence of breast animation deformity (BAD) is reported to be substantial after direct-to-implant breast reconstruction with subpectoral implant placement. It has, however, never been examined if BAD can occur following prepectoral implant placement. Our primary aim was to compare the incidence and degree of BAD after direct-to-implant breast reconstruction using either subpectoral or prepectoral implant placement. Secondary aim of this study was to assess and compare the level of pain between sub- and prepectoral reconstructed women. Methods In this randomized controlled trial, patients were allocated to reconstruction by either subpectoral or prepectoral implant placement in accordance with the CONSORT guidelines. The degree of BAD was assessed by the "Nipple, Surrounding skin, Entire breast (NSE)" grading scale 12 months after surgery. The level of postoperative pain was assessed on a numerical pain rating scale. Results We found a significant difference in the degree of BAD favoring patients in the prepectoral group (23.8 vs. 100%, p < 0.0001; mean NSE grading scale score: 0.4 vs. 3.6, p < 0.0001). The subpectoral reconstructed group reported higher levels of pain on the three subsequent days after surgery. No significant difference in pain levels could be found at 3 months postoperatively. Conclusion The incidence and degree of BAD was significantly lower in women reconstructed by prepectoral direct-to-implant breast reconstruction. Unexpectedly, we found mild degrees of BAD in the prepectoral group. When assessing BAD, distortion can be challenging to discern from rippling.

A cost-effectiveness analysis of delayed breast reconstruction with pedicled flaps from the back.

BACKGROUND: Variability in breast reconstruction methods provides an opportunity to investigate whether a method is superior to another with regard to cost, quality, or both. We performed a cost-effectiveness analysis (CEA) study based on tertiary endpoint data from a randomized clinical trial to compare the cost-effectiveness of delayed breast reconstruction by either a latissimus dorsi flap (LD) or a thoracodorsal artery perforator flap (TAP). MATERIAL & METHODS: A total of 50 women were included for unilateral delayed breast reconstruction and were randomized to reconstruction by either the LD flap (n = 18) or the TAP flap (n = 22). The CEA was based on differences in shoulder function after the reconstruction. Direct and indirect costs relating to the two procedures were assessed by the Danish Diagnosis-Related Groups tariffs. RESULTS: Our analysis showed a significant positive effect of introducing the TAP flap on the total shoulder score with an additional cost of $2779. The incremental cost-effectiveness ratio was $4481 and based on a willingness to pay (WTP) $500, we found an estimated net benefit of $519, which was statistically significant (p = 0.0375). The cost-effectiveness acceptability curve indicated that there is a 96.3% probability for the TAP flap being cost-effective to the LD flap at a WTP threshold of $500. CONCLUSION: From a societal perspective, our cost-effective analysis demonstrated that the TAP flap is the more cost-effective method of breast reconstruction compared to the LD flap with respect to patient-reported shoulder-related disability.

Good health-related quality-of-life and high patient-reported satisfaction after delayed breast reconstruction with pedicled flaps from the back.

BACKGROUND: This paper presents the results of a randomized controlled trial (RCT) that focus on health-related quality-of-life (QoL) and patient-reported satisfaction following breast reconstruction with pedicled flaps from the back. MATERIALS & METHODS: We included women for unilateral delayed breast reconstruction. Patients were randomized to reconstruction by either a latissimus dorsi (LD) flap or a thoracodorsal artery perforator (TAP) flap. Assessment of QoL and patient satisfaction was made using two different patient-reported outcome measures (PROMs): The EORTC QLQ-30 and the Breast-Q questionnaire for post-mastectomy breast reconstruction. RESULTS: A total of 50 women were enrolled over a two-year period and allocated to reconstruction. Forty patients completed both surgery and follow-up and were included in the analysis - 18 in the LD group and 22 in the TAP group. The EORTC QLQ-30 was administered at the baseline and at one-year follow-up. There was no significant effect of introducing the TAP flap on either the summary score, the global QoL-score or the financial impact-score when compared to the LD flap. The Breast-Q questionnaire was administered only at one-year follow-up. There was no significant difference between the two groups for the scores for satisfaction with the reconstructed breast, the overall outcome and QoL related to psycho-social, sexual and physical well-being. CONCLUSION: Women from both groups report high satisfaction and QoL following the reconstruction. The quality of the dataset and the study design are, however, insufficient to rule out any existing difference. A larger cohort, longer follow-up and different design are warranted to assess the true clinical significance these reconstructions might have on satisfaction and QoL.

Mastopexy with Autologous Augmentation in Women After Massive Weight Loss: A Randomized Clinical Trial.

BACKGROUND: Breast reshaping or mastopexy following massive weight loss can be challenging. The LOPOSAM (lower pole subglandular advancement mastoplasty) technique has shown promising results for correction of ptotic, wide, lateralized and deflated breasts following massive weight loss. MATERIALS AND METHODS: We compared the LOPOSAM technique to the mastopexy technique after massive weight loss described by Rubin JP, in a randomized trial. The main outcome measure was the total operative time. Secondary outcomes measures were socio-economic factors; length of hospital stay, numbers of sutures used, secondary corrective procedures, post-operative sick leave and surgeon- and patient-reported appearance of the breasts. RESULTS: We included 22 women: 11 operated on by the LOPOSAM technique and 11 by the technique described by Rubin JP. The total operative time was 84.8 (SD 12.2) minutes in the LOPOSAM group and 99.1 (SD 23.5) in the Rubin JP group (p = 0.074). There were no differences related to days with drains, length of hospital stay or sick leave between the two groups. The surgeon- and the patient-reported appearance of the breasts changed significantly between the pre-operative and the 12-month post-operative assessments. CONCLUSION: The LOPOSAM technique is a safe and quick surgical procedure for correction of ptotic, wide, lateralized and deflated breasts following massive weight loss and seems to provide results comparable to the better-known Rubin JP's technique. There was a trend that the LOPOSAM technique was faster to perform, however, not significant. The breast appearance improved significantly using both techniques when assessed by both surgeons and patients. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Direct-to-Implant Extracellular Matrix Hammock-based Breast Reconstruction; Prepectoral or Subpectoral?

BACKGROUND: Skin-sparing mastectomy followed by immediate implant-based breast reconstruction is a commonly used treatment for breast cancer. However, when placing the implant in a subpectoral pocket, a high incidence of breast animation deformity (BAD) has been reported. Besides the nuisance that BAD can cause, lifting of the pectoralis major muscle (PMM) can result in a more extended postoperative recovery period. When placing the implant solely prepectorally leaving the PMM undisturbed, the incidence and severity of BAD might be mitigated. However, new challenges may occur because of thinner skin cover. METHODS/DESIGN: A prospective, multi-centre, randomised controlled trial will be carried out with the primary aim of assessing and comparing the incidence and degree of BAD in women having a direct-to-implant breast reconstruction with either a prepectorally or a subpectorally placed implant. The secondary outcomes are shoulder and arm function, quality of life, aesthetic evaluation, length of stay, complications, need for surgical corrections, and development of capsular contracture. A total of 70 included patients will be followed under admittance and at clinical check-ups 3 months and 1 year after surgery. DISCUSSION: To our knowledge, this trial is the first randomised controlled trial evaluating and comparing subpectoral and prepectoral implant placement when performing direct-to-implant breast reconstruction following skin-sparing mastectomy. The results will hopefully provide us with a broader knowledge of the outcomes of immediate breast reconstruction, making better preoperative planning possible in the future by providing our patients with a more objective information. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03143335. Prospectively registered on 8 May 2017.

Visualized pre- and subpectoral implant placement for immediate breast reconstruction.

The use of mesh for immediate breast reconstruction was introduced almost two decades ago. Lately, the number of prepectoral direct to implant breast reconstructions has increased as this technique seems to leave an unimpaired muscle function and may lead to less or no breast animation deformity (BAD) and quicker recovery. However, challenges still remain as there is a risk of thin tissue coverage, visible implant edges and secondary ptosis. In this visualized surgery paper, we visualize the technical disparities between the sub- and prepectoral direct to implant breast reconstruction.

Shoulder-related donor site morbidity after delayed breast reconstruction with pedicled flaps from the back: An open label randomized controlled clinical trial.

BACKGROUND: This randomized controlled trial (RCT) investigates differences in shoulder-related morbidity after delayed breast reconstruction by either a latissimus dorsi (LD) flap or a thoracodorsal artery perforater (TAP) flap. MATERIAL AND METHODS: In accordance with the CONSORT guidelines, we included women for unilateral delayed breast reconstruction. Patients were randomized to reconstruction by either of the two flaps. Shoulder-function was assessed at baseline and at 3, 6 and 12 months after surgery. The primary endpoint was patient-reported shoulder-related pain. A further objective assessment by the Constant Shoulder Score (CSS) was included as secondary endpoints. RESULTS: A total of 50 women were enrolled over a two-year period and allocated to reconstruction, with 25 patients in each group. Patient-reported shoulder-related pain was significantly lower in the TAP group at 12 months after surgery when adjusting for pain at baseline: OR = 0.05 95%CI(0.005-0.51), p-value = 0.011. The estimated effect on the total CSS at 12 months, when applying the TAP flap instead of the LD flap and adjusting for the baseline score, was 6.2 points with 95%CI(0.5-12.0), p-value 0.033. The TAP flap seems to have a statistically significant positive effect on pain and activity in daily life (ADL), while there were no significant effect on range of motion and strength after one year. CONCLUSION: Patient reconstructed by the TAP flap are less likely to experience shoulder-related pain and have a better shoulder-function one year after the reconstruction. Harvest of the LD flap carries a higher risk of shoulder-function impairment, chronic pain and reduced ADL.

Nipple Reconstruction: A Novel Triple Flap Design.

BACKGROUND: Restoring the nipple-areola complex completes the breast reconstructive process. Local flaps are often used for the nipple reconstruction; however, the number of techniques indicates the lack of a superior design. The aims of this study were to test the feasibility of a new triple flap design for nipple reconstruction and to evaluate complication rate and nipple projection. METHODS: From November 2015 to November 2018, we performed the triple flap nipple reconstruction guided by a template for preoperative mark-up. Patients were followed up postoperatively to evaluate healing and signs of complications including wound dehiscence, infection, and flap necrosis, and nipple projection. The areola was tattooed 3 months postoperatively. RESULTS: Twenty-six nipple reconstructions were successfully performed in 22 women. Four nipple reconstructions (15%) were performed in irradiated tissue. One reconstruction had a superficial infection, while there were no cases of wound dehiscence or flap necrosis. Three nipple reconstructions (12%) experienced prolonged healing that did not require intervention. None of these reconstructions had received radiation therapy. The nipple projection was 7.3 mm (range 6-9 mm) at the time of surgery and 3.1 mm (range 0-6 mm), 2.5 mm (range 2-3 mm), and 1.6 mm (range 0-3 mm) at follow-up of 3, 6, and 12 months, respectively. CONCLUSIONS: We present the new triple flap design for nipple reconstruction guided by a template for mark-up. The preliminary results indicate a low complication rate in both irradiated and nonirradiated patients while sustaining the projection over time remains to be a challenge.

Shoulder-related donor site morbidity and patient-reported satisfaction after delayed breast reconstruction with pedicled flaps from the back: A comparative analysis.

BACKGROUND: We report a study evaluating and comparing shoulder-related morbidity associated with delayed breast reconstruction using either the conventional latissimus dorsi (LD) flap or the thoracodorsal artery perforator (TAP) flap. MATERIAL & METHODS: We conducted a retrospective cohort study of women over 18 years of age who had a unilateral, delayed breast reconstruction by either an LD or TAP flap at one center over a 56-month period. Shoulder function was assessed using the Constant Shoulder Score (CSS), which evaluated pain, activity of daily life (ADL), range of motion (ROM), and strength. A number of secondary outcomes were also examined. RESULTS: Forty-nine women were included. Demographic and breast treatment data were comparable between the groups. The mean total CSS score for the reconstructed side of the TAP flap was statistically significantly better than that of the LD flap, with a difference of 10.9 points (95% confidence interval [CI] = 2.6-19.2, p-value 0.01). The mean total CSS score for the nonreconstructed side was not statistically significant between groups, with a difference of 0.1 points (95% CI = -6.1-6.2, p-value 0.98). The subscore analysis revealed that women reconstructed using the TAP flap had a difference of 3.2 points for pain (p-value 0.003) and 5.5 points for ROM (p-value 0.011). The factors ADL and strength were of equal magnitude in both groups. CONCLUSIONS: Patients who undergo delayed breast reconstruction by the TAP flap seem less prone to suffer from postoperative pain and restricted ROM, thereby suggesting that this flap should be considered an advantageous alternative to the conventional LD flap. A randomized clinical trial is warranted to provide sufficient evidence to this statement.

Complications following inguinal and ilioinguinal lymphadenectomies: a meta-analysis.

BACKGROUND: Inguinal lymphadenectomy is essential for regional staging of malignant melanoma in the lower part of the body. The procedure is associated with a wide range of complication rates. The objective of this study was to systematically review the literature for papers describing complication rates following inguinal (ID) and ilioinguinal (I-ID) lymphadenectomies, and estimate the actual complication rates in patients with malignant melanoma. METHODS: The PubMed and EMBASE databases were searched for studies reporting complications following ID and I-ID for malignant melanomas. RESULTS: A total of 416 records were identified, of which 20 were deemed eligible for this study. The complication rates (with 95% confidence intervals) were found to be as follows: overall complications = 52% (44-60%); lymphorrea = 29% (0-71%); seroma = 23% (18-29%); infection = 21% (15-27%); wound breakdown =14% (8-21%); skin edge necrosis = 10% (6-15%); haematoma = 3% (1-5%); and lymphoedema = 33% (25-42%). CONCLUSION: Complication rates following ID and I-ID remain high, despite the many efforts to reduce these, with lymphorrea, seromas, and infections being the most prevalent complications.

Bilateral Breast Reconstruction with Extended Thoracodorsal Artery Perforator Propeller Flaps and Implants.

We present our experience of bilateral total breast reconstruction using a double-sided extended thoracodorsal artery perforator propeller flap in a case series of 10 patients. Reconstruction was successfully achieved in all cases with few complications. The median time for surgery was 275 minutes (200-330), and the average implant size used was 350 cm(3) (195-650). We demonstrate how the extended thoracodorsal artery perforator propeller flap allows for a swift and reliable direct to implant bilateral total breast reconstruction in a simple setting and is a valuable adjunct to our armamentarium of techniques for single-stage bilateral breast reconstruction.

Direct delayed breast reconstruction with TAP flap, implant and acellular dermal matrix (TAPIA).

BACKGROUND: The latissimus dorsi (LD) flap is considered one of the working horses within the field of breast reconstruction and it offers several advantages. However, donor-site morbidity may pose a problem. This article describes a new and modified technique for delayed breast reconstruction combining the use of a propeller thoracodorsal artery perforator (TAP) flap with an acellular dermal matrix (ADM) and an implant. METHODS: The paper presents 43 delayed breast reconstructions in 38 women using a modified technique for harvesting the TAP flap in combination with an ADM and an implant for total breast reconstruction. The focus of this paper is the refinements of our technique and short-term outcome in complication rates. The data presented were collected retrospectively. RESULTS: Three patients experienced major complications including hematoma, partial flap necrosis, and venous congestion. In addition, seven patients experienced minor complications including small partial flap necrosis and epidermolysis. There were no cases of infection and all flaps survived. The reconstructive goal was achieved in a single-stage procedure in all but one, 42/43 cases (98%). CONCLUSIONS: The propeller TAP flap combined with an ADM and an implant can safely be used for delayed breast reconstruction. The technique offers a single-stage reconstruction and the donor-site morbidity is limited. The method is safe and reliable with complication rates comparable to those of similar methods. Although there is a learning curve, this simple modified technique does not demand any perforator or other vessel dissection. Any trained plastic surgeon should be able to adopt the technique into the growing armamentarium of breast reconstruction possibilities.

Promising results after single-stage reconstruction of the nipple and areola complex.

INTRODUCTION: Reconstruction of the nipple-areola complex (NAC) traditionally marks the end of breast reconstruction. Several different surgical techniques have been described, but most are staged procedures. This paper describes a simple single-stage approach. MATERIAL AND METHODS: We used a technique based on a local flap for reconstruction of the nipple in combination with immediate intradermal tattooing for reconstruction of the areola. RESULTS: We reviewed the outcome of 22 cases of women who had simple single-stage reconstruction over a period of one year. We found no major and only two minor complications including one case of partial flap necrosis and one case of infection. Only three patients needed additional tattooing after a three-month period. The cosmetic outcome was satisfactory and none of the patients needed corrective procedures. The mean procedure time for unilateral reconstruction was 43 min. (30-50 min.). CONCLUSION: This simple single-stage NAC reconstruction seems beneficial for both patient and surgeon as it seems to be associated with faster reconstruction and reduced procedure-related time without compromising the aesthetic outcome or the morbidity associated with surgery.

Joint practice guidelines for radionuclide lymphoscintigraphy for sentinel node localization in oral/oropharyngeal squamous cell carcinoma.

Involvement of the cervical lymph nodes is the most important prognostic factor for patients with oral/oropharyngeal squamous cell carcinoma (OSCC), and the decision whether to electively treat patients with clinically negative necks remains a controversial topic. Sentinel node biopsy (SNB) provides a minimally invasive method of determining the disease status of the cervical node basin, without the need for a formal neck dissection. This technique potentially improves the accuracy of histological nodal staging and avoids over-treating three-quarters of this patient population, minimizing associated morbidity. The technique has been validated for patients with OSCC, and larger-scale studies are in progress to determine its exact role in the management of this patient population. This article was designed to outline the current best practice guidelines for the provision of SNB in patients with early-stage OSCC, and to provide a framework for the currently evolving recommendations for its use. These guidelines were prepared by a multidisciplinary surgical/nuclear medicine/pathology expert panel under the joint auspices of the European Association of Nuclear Medicine (EANM) Oncology Committee and the Sentinel European Node Trial Committee.

Parathyroid scintigraphy during hypocalcaemia in primary hyperparathyroidism.

BACKGROUND: Minimally invasive parathyroid surgery in patients with primary hyperparathyroidism (PHPT) demands high imaging accuracy. By increasing blood flow to the parathyroid adenoma before injection of a perfusion marker, we intended to improve the parathyroid scintigraphy. We have named the technique stimulated parathyroid scintigraphy (SPS). METHODS: Twenty minutes after injection of 100 MBq (99m)Tc-pertechnetate a thyroid scintigram was performed in 25 patients with PHPT. During the thyroid scintigraphy sodium citrate was infused which lowered plasma calcium by a mean of 14 +/- 1.3%. Then 700 MBq (99m)Tc-sestamibi was injected and another scintigram of the neck was obtained. Perchlorate was given at the end of the sestamibi scintigram to increase the wash-out of (99m)Tc-pertechnetate from the thyroid gland, and after 2 h a delayed scintigram was obtained. A subtraction of the thyroid scintigram from the initial sestamibi scintigram was performed. The results of SPS and a conventional (99m)Tc-sestamibi dual-phase parathyroid scintigraphy were compared with the operative findings. In nine patients the parathyroid adenoma was also localized with ultrasound and the flow pattern before and after citrate infusion was visualized with Doppler technique. RESULTS: Eighty-eight per cent of the adenomas were localized correctly with the SPS technique compared with 62% at the conventional parathyroid scintigraphy. Tissue perfusion of the nine adenomas increased after citrate infusion. CONCLUSIONS: SPS has a high accuracy and it is easy to perform. If only subtraction SPS is performed the whole examination can be completed within an hour, which is acceptable for same day surgery.