Purpose
The number of breast cancer survivors continues to grow. Due to refinements in operating techniques, autologous breast reconstruction has become part of standard care. Impaired sensation ...remains a debilitating side effect with a significant impact on the quality of life. Microsurgical nerve coaptation of a sensory nerve has the potential to improve sensation of the reconstructed breast. This study investigates the effect of improved sensation of the reconstructed breast on the quality of life in breast cancer survivors.
Methods
A retrospective cohort study was performed in the Maastricht University Medical Center. Patients undergoing a DIEP flap breast reconstruction between January 2015 and January 2016 were included. The primary outcome was quality of life (BREAST-Q domain ‘physical well-being of the chest’). The Semmes–Weinstein monofilaments were used for objective sensation measurement of the reconstructed breast(s).
Results
Eighteen patients with and 14 patients without nerve coaptation responded. Nipple reconstruction was the only characteristic that differed statistically significant between both groups (
p
= 0.04). The BREAST-Q score for the domain physical well-being of the chest was 77.89 ± 18.89 on average in patients with nerve coaptation and 66.21 ± 18.26 in patients without nerve coaptation (
p
= 0.09). Linear regression showed a statistically significant relation between objectively measured sensation and BREAST-Q score for the domain physical well-being of the chest with a regression coefficient of − 13.17 ± 3.61 (
p
< 0.01).
Conclusions
Improved sensation in the autologous reconstructed breast, with the addition of microsurgical nerve coaptation, has a statistical significant positive impact on the quality of life in breast cancer survivors according to the BREAST-Q.
Valid and reliable outcome measures are needed to determine and compare treatment results of port wine stain (PWS) studies. Besides, uniformity in outcome measures is crucial to enable inter-study ...comparisons and meta-analyses. This study aimed to assess the heterogeneity in reported PWS outcome measures by mapping the (clinical) outcome measures currently used in prospective PWS studies.
OVID MEDLINE, OVID Embase, and CENTRAL were searched for prospective PWS studies published from 2005 to May 2020. Interventional studies with a clinical efficacy assessment were included. Two reviewers independently evaluated methodological quality using a modified Downs and Black checklist.
In total, 85 studies comprising 3,310 patients were included in which 94 clinician/observer-reported clinical efficacy assessments had been performed using 46 different scoring systems. Eighty-one- studies employed a global assessment of PWS appearance/improvement, of which -82% was expressed as percentage improvement and categorized in 26 different scoring systems. A wide variety of other global and multi-item scoring systems was identified. As a result of outcome heterogeneity and insufficient data reporting, only 44% of studies could be directly compared. A minority of studies included patient-reported or objective outcomes. Thirteen studies of good quality were found.
Clinical PWS outcomes are highly heterogeneous, which hampers study comparisons and meta-analyses. Consensus-based development of a core outcome-set would benefit future research and clinical practice, especially considering the lack of high-quality trials.
Purpose
The aim of the study is to evaluate the level of sensible impairment after mastectomy or implant-based breast reconstruction (IBBR). In addition, factors influencing breast sensibility were ...evaluated.
Methods
A cross-sectional study was performed in Maastricht University Medical Center between July 2016 and August 2018. Women with unilateral mastectomy with or without IBBR were included. Objective sensory measurements were performed using Semmes–Weinstein monofilaments. Their healthy breast served as control, using a paired
t
test. Differences between mastectomy with and without IBBR were evaluated using the independent
t
test. Linear regression was performed to evaluate the association between patient characteristics on breast sensibility. The paired
t
test was used to evaluate in which part of the breast the sensibility is best preserved.
Results
Fifty-one patients were eligible for inclusion. Sixteen patients underwent IBBR after mastectomy. Twenty-three patients received radiotherapy and 35 patients received chemotherapy. Monofilament values were significantly higher in the operated group compared to the reference group (
p
< 0.001). Linear regression showed a statistically significant association between IBBR and objectively measured impaired sensation (
p
= 0.008). After mastectomy, the cutaneous protective sensation is only diminished. After IBBR, it is lost in the majority of the breast. The medial part of the breast was significantly more sensitive than the lateral part in all operated breasts (
p
< 0.001).
Conclusion
IBBR has a significantly negative impact on the breast sensibility compared to mastectomy alone. This study shows that the protective sensation of the skin in the breast is lost after IBBR. To our knowledge, this is the first study to evaluate the level of sensible impairment after mastectomy or IBBR. More research is necessary to confirm these results.
Advancements in reconstructive microsurgery have evolved into supermicrosurgery; connecting vessels with diameter between 0.3 and 0.8 mm for reconstruction of lymphatic flow and vascularized tissue ...transplantation. Supermicrosurgery is limited by the precision and dexterity of the surgeon's hands. Robot assistance can help overcome these human limitations, thereby enabling a breakthrough in supermicrosurgery. We report the first-in-human study of robot-assisted supermicrosurgery using a dedicated microsurgical robotic platform. A prospective randomized pilot study is conducted comparing robot-assisted and manual supermicrosurgical lymphatico-venous anastomosis (LVA) in treating breast cancer-related lymphedema. We evaluate patient outcome at 1 and 3 months post surgery, duration of the surgery, and quality of the anastomosis. At 3 months, patient outcome improves. Furthermore, a steep decline in duration of time required to complete the anastomosis is observed in the robot-assisted group (33-16 min). Here, we report the feasibility of robot-assisted supermicrosurgical anastomosis in LVA, indicating promising results for the future of reconstructive supermicrosurgery.
The sensory recovery of the breast remains an undervalued aspect of autologous breast reconstruction. The aim of this study was to evaluate the effect of nerve coaptation on the sensory recovery of ...the breast following DIEP flap breast reconstruction and to assess the associations of length of follow-up and timing of the reconstruction.
A prospective comparative study was conducted of all patients who underwent either innervated or noninnervated DIEP flap breast reconstruction and returned for follow-up between September of 2015 and July of 2017. Nerve coaptation was performed to the anterior cutaneous branch of the third intercostal nerve. Semmes-Weinstein monofilaments were used for sensory testing of the native skin and flap skin.
A total of 48 innervated DIEP flaps in 36 patients and 61 noninnervated DIEP flaps in 45 patients were tested at different follow-up time points. Nerve coaptation was significantly associated with lower monofilament values in all areas of the reconstructed breast (adjusted difference, -1.2; p < 0.001), which indicated that sensory recovery of the breast was significantly better in innervated compared with noninnervated DIEP flaps. For every month of follow-up, the mean monofilament value decreased by 0.083 in innervated flaps (p < 0.001) and 0.012 in noninnervated flaps (p < 0.001). Nerve coaptation significantly improved sensation in both immediate and delayed reconstructions.
This study demonstrated that nerve coaptation in DIEP flap breast reconstruction is associated with a significantly better sensory recovery in all areas of the reconstructed breast compared with noninnervated flaps. The length of follow-up was significantly associated with the sensory recovery.
Worldwide, many newborns who are preterm, small or large for gestational age, or born to mothers with diabetes are screened for hypoglycemia, with a goal of preventing brain injury. However, there is ...no consensus on a treatment threshold that is safe but also avoids overtreatment.
In a multicenter, randomized, noninferiority trial involving 689 otherwise healthy newborns born at 35 weeks of gestation or later and identified as being at risk for hypoglycemia, we compared two threshold values for treatment of asymptomatic moderate hypoglycemia. We sought to determine whether a management strategy that used a lower threshold (treatment administered at a glucose concentration of <36 mg per deciliter 2.0 mmol per liter) would be noninferior to a traditional threshold (treatment at a glucose concentration of <47 mg per deciliter 2.6 mmol per liter) with respect to psychomotor development at 18 months, assessed with the Bayley Scales of Infant and Toddler Development, third edition, Dutch version (Bayley-III-NL; scores range from 50 to 150 mean {±SD}, 100±15), with higher scores indicating more advanced development and 7.5 points (one half the SD) representing a clinically important difference). The lower threshold would be considered noninferior if scores were less than 7.5 points lower than scores in the traditional-threshold group.
Bayley-III-NL scores were assessed in 287 of the 348 children (82.5%) in the lower-threshold group and in 295 of the 341 children (86.5%) in the traditional-threshold group. Cognitive and motor outcome scores were similar in the two groups (mean scores ±SE, 102.9±0.7 cognitive and 104.6±0.7 motor in the lower-threshold group and 102.2±0.7 cognitive and 104.9±0.7 motor in the traditional-threshold group). The prespecified inferiority limit was not crossed. The mean glucose concentration was 57±0.4 mg per deciliter (3.2±0.02 mmol per liter) in the lower-threshold group and 61±0.5 mg per deciliter (3.4±0.03 mmol per liter) in the traditional-threshold group. Fewer and less severe hypoglycemic episodes occurred in the traditional-threshold group, but that group had more invasive diagnostic and treatment interventions. Serious adverse events in the lower-threshold group included convulsions (during normoglycemia) in one newborn and one death.
In otherwise healthy newborns with asymptomatic moderate hypoglycemia, a lower glucose treatment threshold (36 mg per deciliter) was noninferior to a traditional threshold (47 mg per deciliter) with regard to psychomotor development at 18 months. (Funded by the Netherlands Organization for Health Research and Development; HypoEXIT Current Controlled Trials number, ISRCTN79705768.).
Background
Patient satisfaction after breast reconstruction is dependent on both esthetics and functional outcomes. In an attempt to improve breast sensibility, a sensory nerve coaptation can be ...performed. The aim of this study was to objectify the sensory recovery in patients who, by chance, underwent bilateral autologous breast reconstruction with one innervated and one non-innervated flap. It must be emphasized that the intention was to coaptate the sensory nerves on both sides.
Methods
The cohort study was carried out in the Maastricht University Medical Center between August 2016 and August 2018. Patients were eligible if they underwent bilateral non-complex, autologous breast reconstruction with unilateral sensory nerve coaptation and underwent sensory measurements using Semmes–Weinstein monofilaments at 12 months of follow-up. Sensory outcomes were compared using
t
tests.
Results
A total of 15 patients were included, all contributing one innervated and one non-innervated flap. All patients had a follow-up of at least 12 months, but were measured at different follow-up points with a mean follow-up of 19 months. Sensory nerve coaptation was significantly associated with better sensation in the innervated breasts and showed better sensory recovery over time, compared to non-innervated breasts. Moreover, the protective sensation of the skin can be restored by sensory nerve coaptation.
Conclusions
The study demonstrated that sensory nerve coaptation leads to better sensation in the autologous reconstructed breast in patients who underwent bilateral breast reconstruction and, by chance, received unilateral sensory nerve coaptation.
Purpose
Lymphedema is a debilitating condition that significantly affects patient’s quality of life (QoL). The aim of this study was to assess the long-term outcomes after lymphaticovenous ...anastomosis (LVA) for extremity lymphedema.
Methods
A single-center prospective study on upper and lower extremity lymphedema patients was performed. All LVA procedures were preceded by outpatient Indocyanine Green (ICG) lymphography. Quality of life measured by the Lymph-ICF was the primary outcome. Limb circumference, use of compression garments, and frequency of cellulitis episodes and manual lymphatic drainage (MLD) sessions were secondary outcomes.
Results
One hundred consecutive patients, predominantly experiencing upper extremity lymphedema following breast cancer (
n
= 85), underwent a total of 132 LVAs. During a mean follow-up of 25 months, mean Lymph-ICF score significantly decreased from 43.9 preoperative to 30.6 postoperative, representing significant QoL improvement. Decrease in upper and lower limb circumference was observed in 52% of patients with a mean decrease of 6%. Overall mean circumference was not significantly different. Percentage of patients that could reduce compression garments in the upper and lower extremity group was 65% and 40%, respectively. Number of cellulitis episodes per year and MLD sessions per week showed a mean decrease of respectively 0.6 and 0.8 in the upper extremity and 0.4 and 1.0 in the lower extremity group.
Conclusions
LVA resulted in significant QoL improvement in upper and lower extremity lymphedema patients. Limb circumference did not significantly improve but good results concerning compression garments, cellulitis episodes, and MLD sessions were obtained. Additionally, a simple and patient-friendly method for outpatient ICG lymphography is presented.
Purpose
Lymphedema is a chronic and disabling sequel of breast cancer treatment that can be treated by lymphatico-venous anastomosis (LVA). Artificial connections between the venous and lymphatic ...system are performed supermicrosurgically. This prospective study analyses the effect of LVA on quality of life.
Methods
A prospective study was performed between November 2015 and July 2016 on consecutive patients in the Maastricht University Medical Centre. Quality of life was considered as the primary outcome, and the Lymphedema International Classification of Functioning (Lymph-ICF) questionnaire was used. Discontinuation of compressive stockings and arm volume, using the Upper Extremity Lymphedema index (UEL-index), were the secondary outcomes.
Results
Twenty women with early-stage breast cancer-related lymphedema (BCRL) were included. The mean age was 55.9 ± 4 years and the median BMI was 25.1 21–30 kg/m
2
. The mean follow-up was 7.8 ± 1.5 months. Statistically significant improvement in quality of life was achieved in the total score and for all the quality of life domains after one year of follow-up (
p
< 0.05). The discontinuation rate in compressive stockings use was 85%. The difference in mean relative volume did not show a statistically significant decrease.
Conclusions
LVA for early-stage BCRL resulted in a significant improvement in quality of life and a high rate in stocking discontinuation.
There is a need for a new, less invasive breast reconstruction option for patients who undergo mastectomy in their breast cancer treatment.
To investigate quality of life (QoL) among patients ...undergoing a new breast reconstruction technique, autologous fat transfer (AFT), compared with that among patients undergoing implant-based reconstruction (IBR).
The BREAST trial was a randomized clinical trial conducted between November 2, 2015, and October 31, 2021, performed in 7 hospitals across the Netherlands. Follow-up was 12 months. Referrals could be obtained from general practitioners and all departments from participating or nonparticipating hospitals. The patients with breast cancer who had undergone mastectomy and were seeking breast reconstruction were screened for eligibility (radiotherapy history and physique) by participating plastic surgeons. Patients receiving postmastectomy radiotherapy were excluded.
Breast reconstruction with AFT plus expansion or 2-phased IBR. Randomization was done in a 1:1 ratio.
The statistical analysis was performed per protocol. The predefined primary outcome was QoL at 12 months after final surgery. This was measured by the BREAST-Q questionnaire, a validated breast reconstruction surgery questionnaire. Questions on the BREAST-Q questionnaire are scored from 0 to 100, with a higher score indicating greater satisfaction or better QoL (depending on the scale). Secondary outcomes were breast volume and the safety and efficacy of the techniques.
A total of 193 female patients (mean SD age, 49.2 10.6 years) 18 years or older who desired breast reconstruction were included, of whom 91 patients in the AFT group (mean SD age, 49.3 10.3 years) and 80 in the IBR group (mean age, 49.1 11.0 years) received the allocated intervention. In total, 64 women in the AFT group and 68 women in the IBR group completed follow-up. In the IBR group, 18 patients dropped out mainly due to their aversion to implant use while in the AFT group 6 patients ended their treatment prematurely because of the burden (that is, the treatment being too heavy or tiring). The BREAST-Q scores were higher in the AFT group in all 5 domains and significantly higher in 3: satisfaction with breasts (difference, 9.9; P = .002), physical well-being: chest (difference; 7.6; P = .007), and satisfaction with outcome (difference, 7.6; P = .04). Linear mixed-effects regression analysis showed that QoL change over time was dependent on the treatment group in favor of AFT. The mean (SD) breast volume achieved differed between the groups (AFT: 300.3 111.4 mL; IBR: 384.1 86.6 mL). No differences in oncological serious adverse events were found.
This randomized clinical trial found higher QoL and an increase in QoL scores over time in the AFT group compared with the IBR group. No evidence was found that AFT was unsafe. This is encouraging news since it provides a third, less invasive reconstruction option for patients with breast cancer.
ClinicalTrials.gov Identifier: NCT02339779.
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