Nation-wide validation of a multicenter risk model for implant loss following implant-based breast reconstruction.

INTRODUCTION: Implant loss following breast reconstruction is a devastating complication, which should be prevented as much as possible. This study aimed to validate a previously developed multicenter risk model for implant loss after implant-based breast reconstructions, using national data from the Dutch Breast Implant Registry (DBIR). METHODS: The validation cohort consisted of patients who underwent a mastectomy followed by either a direct-to-implant (DTI) or two-stage breast reconstruction between September 2017 and January 2021 registered in the DBIR. Reconstructions with an autologous adjunctive and patients with missing data on the risk factors extracted from the multicenter risk model (obesity, smoking, nipple preserving procedure, DTI reconstruction) were excluded. The primary outcome was implant loss. The predicted probability of implant loss was calculated using beta regression coefficients extracted from the multicenter risk model and compared to the observed probability. RESULTS: The validation cohort consisted of 3769 reconstructions and implant loss occurred after 307 reconstructions (8.1%). Although the observed implant loss rate increased when the risk factors accumulated, the predicted and observed probabilities of implant loss did not match. Of the four risk factors in the multicenter risk model, only obesity and smoking were significantly associated to implant loss. CONCLUSION: The multicenter risk model could not be validated using nationwide data of the DBIR and is therefore not accurate in Dutch practice. In the future, the risk model should be improved by including other factors to provide a validated tool for the preoperative risk assessment of implant loss.

An analysis of complication rates and the influence on patient satisfaction and cosmetic outcomes following oncoplastic breast surgery.

INTRODUCTION: This study aimed to evaluate complication rates, patient satisfaction, and cosmetic outcomes after oncoplastic breast-conserving surgery (OPS). Furthermore, outcome differences between volume displacement and volume replacement techniques and the effect of postoperative complications on outcomes were evaluated. METHODS: This was a prospective single-center study addressing patients who underwent OPS from 2017 to 2020. The BREAST-Q was used to measure patient satisfaction, and cosmetic outcomes were assessed by patient self-evaluation and panel evaluation based on medical photographs. RESULTS: A total of 75 patients were included. The overall complication rate was 18.7%, of which 4% required invasive interventions. Median BREAST-Q scores ranged from 56 to 100 and cosmetic outcomes were scored good to excellent in 60-86%. No differences in complications were observed between volume replacement and volume displacement techniques. Following volume displacement techniques, patients-reported higher BREAST-Q scores for the domain "physical well-being of the chest" and lower cosmetic outcomes scores for "mammary symmetry." Patients with complications scored significantly lower on several domains of the BREAST-Q and in various cosmetic outcome categories. CONCLUSION: In this cohort, an overall complication rate of 18.7% was observed. Patients were generally satisfied, and most cosmetic outcomes were good to excellent. Volume displacement or replacement techniques were performed for different indications and generally showed comparable results. Expected differences in physical discomfort and symmetry between both techniques were observed. In addition, the occurrence of complications resulted in lower patient satisfaction and cosmetic outcomes. These findings emphasize the importance of thorough preoperative counselling.

[Ultrasound-guided surgery for breast cancer]. / Echogeleid opereren bij mammacarcinoom.

Recent literature shows that perioperative ultrasound guidance of surgery for palpable and nonpalpable breast carcinoma results in improved surgical effectiveness. Ultrasound-guided surgery can easily lead to significant improvement of the number of radical resections and can decrease the need for additional surgery or extra radiotherapy. Ultrasound-guided surgery also contributes to a reduction in the amount of excessive breast tissue removal, which means the final cosmetic result is better. Ultrasound-guided surgery is cost-effective and easy to learn. Implementation of ultrasound-guided surgery has increased in recent years, albeit slowly. Surgeons as well as radiologists should become more aware of the improvement of primary and secondary outcome measures that can be achieved with ultrasound-guided surgery of breast cancer. In addition to radicality, the quantity of excised tissue - tumour tissue and healthy tissue - can be used as a quality indicator, given the impact on cosmetic outcome and quality of life for patients with breast cancer.

Intraoperative ultrasound guidance in breast-conserving surgery shows superiority in oncological outcome, long-term cosmetic and patient-reported outcomes: Final outcomes of a randomized controlled trial (COBALT).

BACKGROUND: The multicenter randomized controlled COBALT trial demonstrated that ultrasound-guided breast-conserving surgery (USS) results in a significant reduction of margin involvement (3.1% vs. 13%) and excision volumes compared to palpation-guided surgery (PGS). The aim of the present study was to determine long term oncological and patient-reported outcomes including quality of life (QoL), together with their progress over time. METHODS: 134 patients with T1-T2 breast cancer were randomized to USS (N = 65) or PGS (N = 69). Cosmetic outcomes were assessed with the Breast Cancer Conservative Treatment cosmetic results (BCCT.core) software, panel-evaluation and patient self-evaluation on a 4-point Likert-scale. QoL was measured using the EORTC QLQ-C30/-BR23 questionnaire. RESULTS: No locoregional recurrences were reported after mean follow-up of 41 months. Seven patients (5%) developed distant metastatic disease (USS 6.3%, PGS 4.4%, p = 0.466), of whom six died of disease (95.5% overall survival). USS achieved better cosmetic outcomes compared to PGS, with poor outcomes of 11% and 21% respectively, a result mainly attributable to mastectomies due to involved margins following PGS. There was no difference after 1 and 3 years in cosmetic outcome. Dissatisfied patients included those with larger excision volumes, additional local therapies and worse QoL. Patients with poor/fair cosmetic outcomes scored significantly lower on aspects of QoL, including breast-symptoms, body image and sexual enjoyment. CONCLUSION: By significantly reducing positive margin status and lowering resection volumes, USS improves the rate of good cosmetic outcomes and increases patient-satisfaction. Considering the large impact of cosmetic outcome on QoL, USS has great potential to improve QoL following breast-conserving therapy.

Neoadjuvant chemotherapy in breast-conserving surgery - Consequences on margin status and excision volumes: A nationwide pathology study.

BACKGROUND: Neoadjuvant chemotherapy (NACT) is increasingly used in patients with operable disease due to the potential of converting patients requiring mastectomy to breast conserving surgery (BCS) or lowering resection volumes to improve cosmetic outcome. This nationwide retrospective study aims to determine margin status and specimen volume in patients with invasive breast cancer who underwent BCS after NACT. METHODS: All patients who underwent BCS in 2012-2013 for invasive breast cancer were selected from a nationwide network and registry of histology and cytopathology in the Netherlands (PALGA). RESULTS: Of the 9901 patients, 626 (6.3%) received NACT. After primary surgery 949 (10.2%) patients had tumour-involved margins compared to 152 (24.3%) after NACT. Close margins (≤1 mm) were seen in another 111 (17.7%) patients after NACT. The adjusted odds ratio for involved margins after NACT was 2.94, meaning a three times higher risk of involved margins compared with primary surgery. In patients with lobular carcinoma (54.9%) and no response to NACT (42.1%) higher tumour-involved margins were seen. High resection volumes >60 cc were observed in 224 (36%) patients after NACT of which 37 (16.5%) had tumour involved margins and 32 (14.3%) close margins ≤1 mm. CONCLUSION: The primary goal of the surgeon performing BCS after NACT, to reach tumour-free margins, is not accomplished in one out of four patients. Patients especially at risk are patients with ILC and no pathological tumour response. Excessive resection volumes after NACT do not guarantee tumour-free margins. Further research is necessary to analyze whether we are counterproductive when NACT is given in order to lower resection volumes.

A nationwide pathology study on surgical margins and excision volumes after breast-conserving surgery: There is still much to be gained.

AIM OF THE STUDY: The current study aims to assess margin status in relation to amount of healthy breast tissue resected in breast-conserving surgery (BCS) on a nationwide scale. METHODS: Using PALGA (a nationwide network and registry of histology and cytopathology in the Netherlands), all patients who underwent BCS for primary invasive carcinoma in 2012-13 were selected (10,058 excerpts). 9276 pathology excerpts were analyzed for a range of criteria including oncological margin status and distance to closest margin, specimen weight/volume, greatest tumor diameter, and with or without localization method. Calculated resection ratios (CRR) were assessed to determine excess healthy breast tissue resection. RESULTS: Margins for invasive carcinoma and in situ carcinoma combined were tumor-involved in 498 (5.4%) and focally involved in 1021 cases (11.0%) of cases. Unsatisfactory resections including (focally) involved margins and margins ≤ 1 mm were reported in 33.8% of patients. The median lumpectomy volume was 46 cc (range 1-807 cc; SD 49.18) and median CRR 2.32 (range 0.10-104.17; SD 3.23), indicating the excision of 2.3 the optimal resection volume. CONCLUSION: The unacceptable rate of tumor-involved margins as well as margins ≤ 1 mm in one third of all patients is also achieved at the expense of healthy breast tissue resection, which may carry the drawback of high rates of cosmetic failure. These data clearly suggest the need for improvement in current breast conserving surgical procedures to decrease tumor-involved margin rates while reducing the amount of healthy breast tissue resected.

Ultrasound-guided surgery for palpable breast cancer is cost-saving: results of a cost-benefit analysis.

Ultrasound-guided surgery (USS) has recently been proven to result in a significant reduction of tumour-involved surgical margins, for patients with palpable invasive breast cancer. The objective of this economic evaluation alongside a randomised trial was to evaluate the costs and benefits of USS compared to palpation-guided surgery (PGS). The hospital perspective was used. On the cost side of the analysis, resource use related to baseline treatment was taken into account and on the benefit side, resource use related to additional treatments was included. On the cost side, the difference in costs per patient was €193 (95% CI €153-€233) with higher costs in the USS group. On the benefit side, the difference in costs per patient was -€349 (95% CI -€591 to -€103) with higher costs in the PGS group. This resulted in a cost decrease of -€154 (95% CI -€388 to €81) in the USS group compared to the PGS group. Intra-operative use of a US system during BCS reduces the rate of tumour-involved margins and thereby the costs of additional treatments.

Optimising surgical accuracy in palpable breast cancer with intra-operative breast ultrasound--feasibility and surgeons' learning curve.

AIMS: To evaluate if intra-operative guidance with ultrasonography (US) could improve surgical accuracy of palpable breast cancer excision, and to evaluate the performance of surgeons during training for US-guided excision. MATERIALS AND METHODS: Thirty female patients undergoing breast-conserving surgery for palpable T1-T2 invasive breast cancer were recruited. Three individual breast surgeons, assisted by US, targeted and excised the tumours. The main objective was to obtain adequate resection margins with optimal resection volumes. The specimen volume, tumour diameter and histological margin status were recorded. The specimen volume was divided by the optimal resection volume, defined as the spherical tumour volume plus a 1.0-cm margin. The resulting calculated resection ratio (CRR) indicated the amount of excess tissue resected. RESULTS: All tumours were correctly identified during surgery, 29 of 30 tumours (96.7%) were removed with adequately negative margins, and one tumour was removed with focally positive margins. The median CRR was 1.0 (range, 0.4-2.8), implying optimal excision volume. For all breast surgeons, CRR improved during the training period. By the 8th procedure, all surgeons showed proficiency in performing intra-operative breast US. CONCLUSION: Surgeons can easily learn the skills needed to perform intra-operative US for palpable breast tumour excision. The technique is non-invasive, simple, safe and effective for obtaining adequate resection margins. Within the first two cases, resections reached optimal volumes, thereby, presumably resulting in improved cosmetic outcomes. In a multicentre, randomised, clinical trial, intra-operative US guidance for palpable breast tumours will be evaluated for oncological and cosmetic outcomes.

A comparison of three methods for nonpalpable breast cancer excision.

AIMS: To evaluate the efficacy of three methods of breast-conserving surgery (BCS) for nonpalpable invasive breast cancer in obtaining adequate resection margins and volumes of resection. MATERIALS AND METHODS: A total of 201 consecutive patients undergoing BCS for nonpalpable invasive breast cancer between January 2006 and 2009 in four affiliated institutions was retrospectively analysed. Patients with pre-operatively diagnosed primary or associated ductal carcinoma in situ (DCIS), multifocal disease, or a history of breast surgery or neo-adjuvant treatment were excluded from the study. The resections were guided by wire localisation (WL), ultrasound (US), or radio-guided occult lesion localisation (ROLL). The pathology reports were reviewed to determine oncological margin status, as well as tumour and surgical specimen sizes. The optimal resection volume (ORV), defined as the spherical tumour volume with an added 1.0-cm margin, and the total resection volume (TRV), defined as the corresponding ellipsoid, were calculated. By dividing the TRV by the ORV, a calculated resection ratio (CRR) was determined to indicate the excess tissue resection. RESULTS: Of all 201 excisions, 117 (58%) were guided by WL, 52 (26%) by US, and 32 (16%) by ROLL. The rate of focally positive and positive margins for invasive carcinoma was significantly lower in the US group (N = 2 (3.7%)) compared to the WL (N = 25 (21.3%)) and ROLL (N = 8 (25%)) groups (p = 0.023). The median CRRs were 3.2 (US), 2.8 (WL) and 3.8 (ROLL) (WL versus ROLL, p < 0.05), representing a median excess tissue resection of 3.1 times the optimal resection volume. CONCLUSION: US-guided BCS for nonpalpable invasive breast cancer was more accurate than WL- and ROLL-guided surgery because it optimised the surgeon's ability to obtain adequate margins. The excision volumes were large in all excision groups, especially in the ROLL group.

Influence of the angiotensin converting enzyme inhibitor ramipril on high-sensitivity C-reactive protein (hs-CRP) in patients with documented atherosclerosis.

UNLABELLED: Some medications have been shown to produce reductions in hs-CRP levels after initiating therapy. Whereas the role of the renin-angiotensin system in the inflammatory process has been documented in more detail during the last few years, the impact of an ACE-inhibitor therapy on this process has not been fully understood so far. The aim of this study was to investigate the effect of a therapy with the angiotensin-converting enzyme (ACE) inhibitor ramipril on hs-CRP plasma concentrations in patients with atherosclerosis. METHODS AND RESULTS: A total of 24 patients were enrolled in this prospective, uncontrolled, open-label multicenter study. Inclusion criteria were documented atherosclerosis, baseline high-sensitivity C-reactive protein between 3 and 12 mg/l, LDL-Cholesterol < or =150 mg/dl and no previous treatment with ACE inhibitors or angiotensin receptor blockers. Ten patients, pretreated with statins, and 10 patients not previously treated with statins were eligible for statistical analysis. Baseline high-sensitivity C-reactive protein was significantly decreased from 3.99+/-1.61 mg/l (mean+/-SD) to 2.72+/-1.19 mg/l (-32%) after 3 months treatment with 10 mg ramipril daily (p=0.0002). The decrease was more pronounced in patients who had not been treated with statins previously (-1.50 mg/l+/-1.44 mg/l) compared to those who were pretreated (-0.90 mg/l+/-0.93 mg/l). CONCLUSIONS: The ACE inhibitor ramipril administered in a daily dose of 10 mg to patients with atherosclerosis reduces the high-sensitivity C-reactive protein concentration. This effect may contribute to cardiovascular risk reduction mediated by ramipril aside from the blood pressure lowering effect.

[Psychoses in multiple sclerosis--a reevaluation]. / Psychosen bei multipler Sklerose--eine Neubewertung.

With the aim of reaching a new classification of psychoses with multiple sclerosis we reviewed the twentieth century literature for observations with regard to the subject, as well as 688 medical records of our patients, looking for the occurrence of paranoid and hallucinatory psychoses in the course of multiple sclerosis. Special attention was paid to the occurrence of cycloid psychoses. With multiple sclerosis, psychoses on the whole--but cycloid psychoses in particular--occur more frequently than in the general population. Women are affected just as frequently as men. Cycloid psychoses occur earlier in the course of the multiple sclerosis than the other psychoses; here, hallucinations occur with a higher frequency. Similar as in the case of HIV-infection, multiple sclerosis can act as a trigger of a cycloid psychosis. The results of our study indicate that men and women experience this disease as similarly threatening. A shortcoming of critical faculties based on the organic disease is an additional factor that favours the outbreak of such a psychosis.