The N-LVA Study: effectiveness and cost-effectiveness of lymphaticovenous anastomosis (LVA) for patients with cancer who suffer from chronic peripheral lymphoedema - study protocol of a multicentre, randomised sham-controlled trial.

INTRODUCTION: Cancer-related lymphoedema is one of the most debilitating side-effects of cancer treatment with an overall incidence of 15.5%. Patients may suffer from a variety of symptoms, possibly resulting in a diminished health-related quality of life (HRQoL). A microsurgical technique known as lymphaticovenous anastomosis (LVA) might be a promising treatment option. The objective of this study is to evaluate whether LVA is effective and cost-effective compared with sham surgery in improving the HRQoL. METHODS AND ANALYSIS: A multicentre, double-blind, randomised sham-controlled trial conducted in three university hospitals in the Netherlands. The study population comprises 110 patients over the age of 18 years with unilateral, peripheral cancer-related lymphoedema, including 70 patients with upper limb lymphoedema and 40 patients with lower limb lymphoedema. A total of 55 patients will undergo the LVA operation, while the remaining 55 will undergo sham surgery. The follow-up will be at least 24 months. Patients are encouraged to complete the follow-up by explaining the importance of the study. Furthermore, patients may benefit from regular monitoring moments for their lymphoedema. The primary outcome is the HRQoL. The secondary outcomes are the limb circumference, excess limb volume, changes in conservative therapy, postoperative complications, patency of the LVA and incremental cost-effectiveness. ETHICS AND DISSEMINATION: The study was approved by the Medical Ethical Committee of Maastricht University Medical Center on 20 September 2023 (NL84169.068.23). The results will be presented at scientific conferences and published in peer-reviewed medical journals. TRIAL REGISTRATION NUMBER: NCT06082349.

Evaluating the accuracy of three-dimensional surface-imaging for circumference analysis of the thigh.

BACKGROUND: Three-dimensional (3D) surface-imaging is an increasingly popular and useful tool in surgical planning and evaluation. These systems are used for anthropometric measurements of the face, breast and upper extremity. Its accuracy has, however, not yet been evaluated for the thigh. This could prove useful in the evaluation of autologous breast reconstructions using fasciocutaneous tissue of the thigh, such as the profunda artery perforator (PAP) flap. METHODS: Thirty-five patients who underwent PAP flap surgery and 35 healthy controls were included. Thigh circumferences were measured using a flexible measuring tape at pre-defined levels. 3D images of the thigh were taken with the Canfield Vectra XT and fused to create 3D reconstructions. 3D circumferences were measured using the Vectra Analysis Module. Measuring tape and 3D circumferences were compared for mutual agreement. RESULTS: Thigh circumference measurements by measuring tape correlated excellently with 3D measurements (r = 0.999). Bland-Altman plots demonstrated good agreement with a mean difference of -1.2 mm between the measuring tape and 3D measurements. The mean relative difference of both methods was -0.24%. Paired t-tests showed no significant statistical differences between the measuring tape and 3D circumference measurements in legs that underwent PAP flap surgery and without. CONCLUSIONS: Flexible measuring tape and 3D circumference measurements of the thigh show excellent correlation. Three-dimensional surface imaging can thus be used to measure thigh circumferences in both patients with and without prior surgery of the thigh.

A systematic review and meta-analysis of vascularized lymph node transfer for breast cancer-related lymphedema.

BACKGROUND: Vascularized lymph node transfer (VLNT) has become an increasingly popular technique for treating lymphedema. However, although many studies have been performed, its efficacy in increasing patients' quality of life (QoL) and reducing lymphedema in the affected body part has remained controversial. In the present systematic review, we summarized the evidence for VLNT for treating breast cancer-related lymphedema. METHODS: The MEDLINE, Embase, and Cochrane Central databases were searched for studies of patients with breast cancer-related lymphedema who had received VLNT. The study methods were assessed using the MINORS (methodologic index for nonrandomized studies) tool. The primary outcomes were the change in volume difference between the arms and QoL. The secondary outcomes were skin infection, complications, and discontinuation of compression garment use. RESULTS: A total of 17 studies were included for qualitative synthesis and 8 for meta-analysis. The average reduction rate between the healthy and affected arms in the studies included in the meta-analysis was 40.31%. Five studies had evaluated QoL, and all five studies had reported that QoL was significantly increased. Eight studies had evaluated skin infections, of which three had reported the annual infection rates before and after surgery. In these studies, infection rate had decreased significantly. Three studies had described usage of compression garments. When the patients were pooled, 27 of 60 were able to discontinue use of the compression garment. The donor and recipient complication rates were 12.1% and 7.3%, respectively. CONCLUSIONS: The current evidence indicates that VLNT can improve the volume differences between the arms in patients with unilateral lymphedema by ∼40%. In addition, although determined from a few studies, it is likely that VLNT has a positive effect on patients' QoL, the number of skin infections, and compression garment usage and coincided with a low complication rate.

Breast reconstruction with the extended profunda artery perforator flap.

BACKGROUND: The profunda artery perforator (PAP) flap is a reliable flap for breast reconstruction. By extending the traditional flap, it is possible to include more tissue and thereby enhance flap volume. The aim of this study is to demonstrate the technique for extended profundal artery perforator flap harvest and to demonstrate results in a population otherwise not suited for autologous breast reconstruction. METHODS: Retrospective chart review of all patients who received extended PAP flap breast reconstruction between 2016 and 2018 was performed. Patient demographics, perioperative data, and postoperative complications were recorded in a pre-defined form and analyzed. A fully illustrated and step-by-step description of the procedure was created and included. RESULTS: A total of 46 extended PAP flaps for breast reconstruction were performed on 28 patients. Forty-three were 'regular' extended PAP flaps, one was a stacked flap, and two were transverse myocutaneous gracilis flaps with extended PAP flap skin design. Mean pre-operative breast volume was 330 cc, and mean flap weight was 400 g. The success rate was high (97.8%), and complications included one partial flap loss (2.2%), one wound dehiscence of the breast (2.2%), and wound dehiscence of the donor site (11 patients, 23.9%). CONCLUSIONS: The modified and extended profunda artery perforator flap is an excellent autologous tissue option for breast reconstruction even in large-breasted patients or patients with a relatively low body mass index. Advantages include higher flap volume, reliable blood supply, higher skin volume, and the possibility of choosing from several perforators, making dissection more convenient.

Alternative Perforator Options for Insufficient Profunda Artery Perforators: A Case and Anatomical Study.

INTRODUCTION: The profunda artery perforator (PAP) flap can be an alternative to the deep inferior epigastric artery flap. However, in some cases, the PAP may not be adequate to perfuse the whole flap. In this study, we describe 3 cases in which an alternative perforator was used for PAP flap perfusion. In addition, we describe an anatomical study to explore the perforasome of the PAP and alternative perforators. MATERIALS AND METHODS: Three cases are described in which an alternative perforator was used to successfully perfuse the pap flap. For the anatomical study, 7 PAP flaps were raised from cadavers. Ink was injected in the PAP, the gracilis perforator (GP) and the descending branch of the inferior gluteal artery perforator (DBIGA). Then, perfused area of the flap by each perforator was calculated. RESULTS: The 3 patients with alternative perforators recovered without complications, in addition, no signs of fat necrosis were observed. Concerning the anatomical study, mean perfusion area of the PAP pedicle was 204 ± 90 cm (range, 141-364 cm). The GP and the DBIGA had a perfusion area of 182 ± 42 cm (range, 123-235 cm) and 157 ± 22 cm (range, 136-192), respectively. CONCLUSION: Although the PAP flap has considerable benefits over the more traditional inferior gluteal artery perforator and transverse upper gracilis flaps, a plastic surgeon might encounter a PAP flap perforator that is not deemed viable for flap perfusion. In these cases, the GP and DBIGA may be suitable "escape" alternatives to complete the reconstruction.

"Three-dimensional evaluation of breast volume changes following autologous free flap breast reconstruction over six months".

OBJECTIVES: To date, little is known about postoperative changes in breast volume after autologous breast reconstruction. The purpose of this retrospective study was to investigate breast volume changes following autologous free flap reconstruction and the factors affecting flap volume. MATERIALS AND METHODS: Patients who underwent deep inferior epigastric perforator, superficial inferior epigastric artery and profunda artery perforator flaps between December 2016 and January 2019 were included. Exclusion criteria were breast complications requiring surgical debridement, and the absence of at least two suitable three-dimensional images postoperatively. Three-dimensional stereophotogrammetry volume measurements were performed at the time of standard surgical check-ups. Changes in breast volume were modeled using a quartic polynomial curve function in a nested mixed effects model. RESULTS: 136 breasts in 101 patients were included. An average decrease of predicted breast volume was found from 637.8 cc (95%-CI [624.4, 651.1]) at two weeks to 566.6 cc (95%-CI [535.1, 598.0]) after three and 567.6 cc (95%-CI [515.9, 617.6]) after six months postoperatively. Reconstruction timing and first postoperatively measured breast volume showed a statistically significant difference in initial reconstructed breast volume and in the shape of the relationship between time and breast volume, whereas autologous technique and BMI only showed a statistically significant difference in initial reconstructed volume and mastectomy indication in the shape of the relationship. CONCLUSION: The final overall flap volume decreased to 88.9% of its original volume after six months. Gaining more insight into the factors influencing flap volume is of crucial importance to facilitate predictable surgical outcomes.

Improving the quality of life of patients with breast cancer-related lymphoedema by lymphaticovenous anastomosis (LVA): study protocol of a multicentre randomised controlled trial.

INTRODUCTION: Early breast cancer detection and advancements in treatment options have resulted in an increase of breast cancer survivors. An increasing number of women are living with the long-term effects of breast cancer treatment, making the quality of survivorship an increasingly important goal. Breast cancer-related lymphoedema (BCRL) is one of the most underestimated complications of breast cancer treatment with a reported incidence of 20%. A microsurgical technique called lymphaticovenous anastomosis (LVA) might be a promising treatment modality for patients with BCRL. The main objective is to assess whether LVA is more effective than the current standard therapy (conservative treatment) in terms of improvement in quality of life and weather it is cost-effective. METHODS AND ANALYSIS: A multicentre, randomised controlled trial, carried out in two academic and two community hospitals in the Netherlands. The study population includes 120 women over the age of 18 who have undergone treatment for breast cancer including axillary treatment (sentinel lymph node biopsy or axillary lymph node dissection) and/or axillary radiotherapy, presenting with an early stage lymphoedema of the arm, viable lymphatic vessels and received at least 3 months conservative treatment. Sixty participants will undergo the LVA operation and the other sixty will continue their regular conservative treatment, both with a follow-up of 24 months. The primary outcome is the health-related quality of life. Secondary outcomes are societal costs, quality adjusted life years, cost-effectiveness ratio, discontinuation rate of conservative treatment and excess limb volume. ETHICS AND DISSEMINATION: The study was approved by the Ethics Committee of Maastricht University Medical Center (METC) on 19 December 2018 (NL67059.068.18). The results of this study will be disseminated in presentations at academic conferences, publications in peer-reviewed journals and other news media. TRIAL REGISTRATION NUMBER: NCT02790021; Pre-results.

The inter-rater and test-retest reliability of skin thickness and skin elasticity measurements by the DermaLab Combo in healthy participants.

BACKGROUND: For several purposes, skin parameters like thickness and elasticity can be measured. However, little is known about the accuracy of those measurements. AIM: The aim of this study was to determine the intrarater and test-retest reliability of skin thickness and elasticity measurements performed with the DermaLab Combo®. METHODS: A total of 49 participants were included in this study. Skin thickness and elasticity were measured at six defined locations on the dominant arm. Measurements were repeated two times by the same observer to determine the test-retest reliability. To determine the inter-rater reliability, a second observer repeated the measurements once. RESULTS: Inter-rater and test-retest reliability for elasticity measurements fluctuates per location and per parameter: Inter-rater intraclass correlation coefficient (ICC) ranged from 0.23 to 0.80, and test-retest ICC ranged from 0.25 to 0.84. Skin thickness was measured reliable by every observer on every location, with a test-retest ICC ranging from 0.71 to 0.83 and an inter-rater ICC ranging from 0.69 to 0.80. CONCLUSION: The DermaLab Combo® showed a good inter-rater reliability when measuring skin thickness and elasticity. Not all locations are suitable for reliable inter-rater or test-retest measurements. The device is difficult to use by inexperienced users, as the echo probe is sensitive to small movements.

The Long-term Patency of Lymphaticovenular Anastomosis in Breast Cancer-Related Lymphedema.

BACKGROUND AND OBJECTIVES: Lymphedema is a condition that can greatly affect patient's quality of life. Promising results have been described with lymphaticovenular anastomosis (LVA) in the treatment of lymphedema. It is currently unknown at what rate anastomoses remain functional after a longer follow-up. The aim of this study was to determine LVA patency at 1-year follow-up. METHODS: Retrospective chart review was performed on patients who underwent LVA surgery. Patients who had indocyanine green lymphography performed at 12 months' follow-up after LVA were included in this study. Volume measurements were performed prior to surgery and at 6 and 12 months' follow-up. Patients quality of life was measured prior to surgery and at 6 months' follow-up. RESULTS: Twelve patients met inclusion criteria. In total, 15 (56.5%) of 23 LVAs were considered patent. In 8 patients (66.7%), at least 1 patent LVA was visible. The volume difference between the healthy and affected arms decreased 32.3% on average. Quality of life increased with 1.4 points on average. CONCLUSIONS: This study is, to our knowledge, the first to evaluate long-term patency of LVA in upper limb lymphedema. Our study demonstrates that at least 56.5% of the anastomoses created are patent after 1-year follow-up.

Peri-operative care for patients undergoing lymphaticovenular anastomosis: A systematic review.

BACKGROUND: Lymphaticovenular anastomosis (LVA) is a supermicrosurgical procedure that involves the anastomosis of a functional lymphatic channel to a venule. Although peri-operative care might be an important contributor to the success of this technique, evidence about optimal peri-operative care seems limited. This review aims to summarize the peri-operative methods used by authors reporting on LVA. METHODS: A systematic search of the literature was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Peri-operative care used by authors was summarized and listed in a pre-defined form. Studies were also graded on quality of evidence by the GRADE system and a lymphedema surgery-specific system. RESULTS: In total, 22 studies were identified describing peri-operative measures. Although most authors were sparse in their description of peri-operative management, most recommended initiation of conventional compression therapy at 1-4 weeks after surgery. Prophylactic antibiotics, elevation of the affected limb, bandaging, low-molecular-weight heparin, prostaglandin E1, and manual pressure therapy were also described. The quality of evidence of the included studies was low on average. CONCLUSION: Although supermicrosurgical LVAs are gaining in popularity, there are no high-quality prospective trials evaluating these new techniques and the description of peri-operative management is scarce. Of the available studies, a peri-operative management consisting of prophylactic antibiotics, elevation of the affected limb during night and hospital stay, and compression therapy 4 weeks post-surgery for 6 months seems to be preferred. Future studies should describe a detailed peri-operative protocol to allow for a better comparison between study results and to determine optimal peri-operative recommendations.

Lymphovenous Anastomosis and Secondary Resection for Noonan Syndrome with Vulvar Lymphangiectasia.

In this case report we describe the use of a 2-stage approach to treat severe recurrent vulvar lymphangiectasia in a patient with Noonan syndrome. First, 3 functional lymphatic vessels were identified and anastomosed to venules in an end-to-end fashion. Then, in a second surgical procedure, the vulvar lesions were resected as much as possible and the vulva was reconstructed. By the 12-month follow-up the patient had recovered well. Although there were still some small vesicles on the left labia there was no more ooze, itch, and pain. Lymphatic mapping using indocyanine green showed improvement of the edema of her vulva region and patent LVA. In addition to the demonstration of this 2-stage approach, this case report also demonstrates the benefits of preemptive LVA before performing surgery that may be at high risk for postoperative lymph edema.

The pythagorean theorem as a tool for preoperative planning of a concealed scar in augmentation mammaplasty with round implants.

SUMMARY: The inframammary incision is the most versatile and popular approach in breast augmentation. For an optimal aesthetic result, the incision site should be chosen in such a way that the scar is carefully hidden in the (new) inframammary fold. Based on an assumption of the senior author (B.v.d.L.) that the Pythagorean theorem (α + ß = γ) is suited to describe the ratios of implant and incision location variables, the authors developed an almost perfect roadmap for accurate determination of the right incision location in augmentation mammaplasty with round implants through the inframammary incision. The authors plenary judged the photographs of 263 augmented breasts whether the scar of the augmentation mammaplasty was located in the neo-inframammary fold. In all cases, the Pythagorean theorem was used to determine the exact location of the site of incision. In only four of the 263 augmented breasts (1.5 percent), the position of the scar was a little below the neo-inframammary fold and thereby visible with the patient in the upright position. A scar correction to reposition the scar into the inframammary fold was performed in one patient on one breast by means of additional skin excision above the scar; in the two other cases, the scar was accepted by the patients as being not too bothersome. The Pythagorean theorem is an effective method for determining the right incision site in augmentation mammaplasty with round implants through an inframammary approach.

Is the treatment of keloid scars still a challenge in 2006?

BACKGROUND: Several options are described to treat keloid scars, none of them being 100% successful. Radiotherapy is suggested to have the most significant effect on recurrence rate. OBJECTIVES: The aim of the study is to confirm the effectiveness of iridium brachytherapy combined with surgery and to evaluate patient satisfaction. PATIENTS AND METHODS: We retrospectively enrolled 24 patients with 30 keloids, treated by surgical excision and iridium 192 high-dose-rate (HDR) brachytherapy. RESULTS: We observed a significant difference in scar thickness before and after the treatment (P < 0.001). With regard to patient satisfaction and complaints, 79.1% of them had no pain and irritation after treatment, 79.2% of patients would recommend this treatment to other patients, and 87.5% would undergo this treatment again if necessary. CONCLUSIONS: Our results confirm the effectiveness of surgical keloid excision followed by HDR brachytherapy in primary treatment or if other alternative methods have failed.