Increasing opportunities for breast-conserving therapy in multiple ipsilateral breast cancer: Dutch nationwide study.

INTRODUCTION: An increasing number of breast cancer patients undergo breast-conserving surgery (BCS), but multiple ipsilateral breast cancer (MIBC) is still considered a relative contraindication for breast conservation. This study provides an update on trends in the surgical management for MIBC over a 10-year period. METHODS: Nationwide data from the Netherlands Cancer Registration of all patients diagnosed with breast cancer between 2011 and 2021 were analysed. The primary outcomes of this study were the incidence of MIBC and the trend in breast surgery type among patients between 2011 and 2021. Secondary outcomes were the positive resection margin rates in patients treated with BCS, the proportion of patients requiring re-excision and overall survival. RESULTS: In total, 114 433 patients (83%) with unifocal breast cancer and 23 932 patients (17%) with MIBC were identified. The incidence of MIBC was stable (17%) over the years. Overall BCS rates, both primary and after neoadjuvant chemotherapy, increased in MIBC from 29% in 2011 to 41% in 2021. Re-excision was performed in 1348 patients (n = 8455, 16%). The 5-year OS estimate for patients with MIBC treated with BCS was 93%. The pathological complete response (pCR) in MIBC patients treated with neoadjuvant chemotherapy followed by mastectomy was 23%. CONCLUSION: The breast conservation rate in MIBC has increased over the last decade. In addition, 23% of MIBC patients treated with neoadjuvant chemotherapy followed by mastectomy achieved a pCR. This suggests increasing opportunities for even more BCS in MIBC.

Quilting following mastectomy reduces seroma, associated complications and health care consumption without impairing patient comfort.

BACKGROUND: An important complication following mastectomy is seroma formation. Quilting, in which skin flaps are sutured to the underlying muscle, is reported to reduce seroma incidence, but might induce pain and impair shoulder function. Main objective is to compare quilting with conventional wound closure, regarding seroma incidence, health care consumption, and patient discomfort. METHODS: In a combined prospective and retrospective study, 254 patients undergoing mastectomy and/or axillary lymph node dissection (ALND) were included. Patients received quilting sutures or conventional closure. Primary outcome was clinical significant seroma (CSS). In prospectively included patients shoulder function and analgesic use was observed. RESULTS: CSS incidence was 12.9% in the quilted versus 62.3% in the nonquilted cohort (p < 0.001). Surgical site infections were reported significantly less in the quilted cohort. Duration of hospital stay was shorter and outpatient clinic visits were less in the quilted cohort. Surgical procedure required 10 additional minutes for quilting. No significant differences were observed in postoperative shoulder function and analgesic use. CONCLUSION: Quilting following mastectomy reduces CSS incidence. Quilting requires 10 additional minutes during surgery. It facilitates day treatment and results in less additional outpatient clinic visits culminating in reduced health care consumption. Shoulder function and pain are not affected by quilting.

Development and testing of a tailored online fertility preservation decision aid for female cancer patients.

BACKGROUND: Decision making regarding future fertility can be very difficult for female cancer patients. To support patients in decision making, fertility preservation decision aids (DAs) are being developed. However, to make a well-informed decision, patients need personalized information tailored to their cancer type and treatment. Tailored cancer-specific DAs are not available yet. METHODS: Our DA was systematically developed by a multidisciplinary steering group (n = 21) in an iterative process of draft development, three rounds of alpha testing, and revisions. The drafts were based on current guidelines, literature, and patients' and professionals' needs. RESULTS: In total, 24 cancer-specific DAs were developed. In alpha testing, cancer survivors and professionals considered the DA very helpful in decision making, and scored an 8.5 (scale 1-10). In particular, the cancer-specific information and the tool for recognizing personal values were of great value. Revisions were made to increase readability, personalization, usability, and be more careful in giving any false hope. CONCLUSIONS: A fertility preservation DA containing cancer-specific information is important in the daily care of female cancer patients and should be broadly available. Our final Dutch version is highly appraised, valid, and usable in decision making. After evaluating its effectiveness with newly diagnosed patients, the DA can be translated and adjusted according to (inter)national guidelines.

Implementation of robot-assisted total mesorectal excision by multiple surgeons in a large teaching hospital: Morbidity, long-term oncological and functional outcome.

BACKGROUND: Robot-assisted total mesorectal excision (TME) might offer benefits in less morbidity, better functional and long-term outcome over laparoscopic TME. METHODS: All consecutive patients undergoing robot-assisted TME for rectal cancer during implementation between May 2015 and December 2019 performed by five surgeons in a single centre were included. Outcomes included local recurrence rate at 3 years, conversion rate, circumferential resection margin (CRM) positivity rate, 30-day postoperative morbidity and outcomes of low anterior resection syndrome (LARS) questionnaires. RESULTS: In 105 robot-assisted TME, local recurrence rate at 3 years was 7.4%, conversion to open surgery rate was 8.6%, CRM positivity rate was 5.7%, 73.3% had good quality specimen, postoperative morbidity rate was 47.6% and anastomotic leakage rate was 9.0%. Incidence of major LARS was 55.3%. CONCLUSIONS: results of this study described acceptable morbidity, functional and long-term outcome during implementation of robotic TME for rectal cancer by multiple surgeons in a single centre.

Outcomes of Stenting as a Bridge to Surgery in Malignant Colonic Obstruction, With Emphasis on Perforation Rate and Clinical Success.

BACKGROUND: Colonic stent placement in acute malignant obstruction has proven to be an alternative for emergency surgery. It has been associated with reduced stoma creation and postoperative morbidity. Concerns have risen that manipulation of the tumor and risk of perforation might result in lower disease-free survival. Therefore, we investigated the long-term outcomes of stenting as a bridge to surgery in these patients, with emphasis on clinical success of the stenting procedure. METHODS: We performed a comparative study in the Rijnstate Hospital in Arnhem, The Netherlands. Data were collected from patients who underwent colonic stenting procedures or acute surgical resection due to malignant obstruction performed between 2007 and 2015. Patients treated with palliative intent were excluded. RESULTS: We included 92 patients, 66 underwent stent placement and 26 had an acute surgical resection. Technical and clinical success rates of the stenting procedures were 94% and 82%, respectively. No significant differences in demographic, tumor or stenting characteristics were found for patients with clinically (un)successful stent placement or stent-related perforations. Patients with unsuccessful stent procedures or perforation had higher rates of open procedures and rescue colostomy. Survival rates were similar for patients who underwent stent placements compared with acute resection. We found no significant differences in survival between patients with successful compared with unsuccessful procedures or perforation. CONCLUSIONS: Survival rates of patients who underwent colonic stenting are similar to those of patients who had an acute resection. No negative effects on survival were observed for clinically failed stenting procedures or stent-related perforations.

Two-year results of a multicenter randomized controlled trial comparing Mechanochemical endovenous Ablation to RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA trial).

OBJECTIVE: Endothermal techniques have proved to be effective for treatment of incompetent truncal veins. The tumescentless mechanochemical ablation (MOCA) technique has become an alternative treatment modality, but its outcome with regard to endothermal techniques is still unclear. METHODS: A multicenter prospective randomized controlled trial was designed comparing MOCA with radiofrequency ablation (RFA) to treat great saphenous vein incompetence with the hypothesis that MOCA is associated with less postprocedural pain and a comparable anatomic and clinical success rate at 1-year follow-up. Disease-specific quality of life and general health-related quality of life (HRQoL) were measured using questionnaires. Inclusion was terminated prematurely because reimbursement was suspended. RESULTS: A total of 213 patients (46.3% of intended number of patients) were randomized, of whom 209 were treated (105 in the MOCA group and 104 in the RFA group). Overall median pain scores during the first 14 days were lower after MOCA (0.2 vs 0.5 after RFA; P = .010), although the absolute difference was small. At 30 days, similar complication numbers (MOCA, n = 62; RFA, n = 63) and HRQoL scores (Aberdeen Varicose Vein Questionnaire: MOCA, 8.9; RFA, 7.6; P = .233) were observed. Hyperpigmentation was reported in seven patients in the MOCA group and two patients in the RFA group (P = .038). In the MOCA group, there were four complete failures (3.8%) compared with none in the RFA group (P = .045), although in one patient at 1 year, the vein showed occlusion. Median 30-day Venous Clinical Severity Score (VCSS) was significantly lower at 30 days after MOCA (1.0 vs 2.0 in the RFA group; P = .001), whereas VCSS was comparable at baseline (MOCA, 4.0; RFA, 5.0; P = .155). The 1- and 2-year anatomic success rate was lower after MOCA (83.5% and 80.0%) compared with RFA (94.2% and 88.3%; P = .025 and .066), mainly driven by partial recanalizations. After 2 years of follow-up, no differences were observed in the number of complete failures. Similar clinical success rates at 1 year (MOCA, 88.7%; RFA, 93.2%; P = .315) and 2 years (MOCA, 93.0%; RFA, 90.4%; P = .699) and no differences in HRQoL scores on the Aberdeen Varicose Vein Questionnaire at 1 year (MOCA, 7.5; RFA, 7.0; P = .753) and 2 years (MOCA, 5.0%; RFA, 4.8%; P = .573) were observed. There were two cardiac serious adverse events, a ventricular fibrillation in the MOCA group (1 year) and an unstable angina in the RFA group (2 years). One deep venous thrombosis occurred in the RFA group on 1-year duplex ultrasound, without clinical sequelae. CONCLUSIONS: Unilateral treatment with MOCA in the short term resulted in less postoperative pain but more hyperpigmentation compared with RFA and a faster improvement in VCSS. More anatomic failures were reported after MOCA, mostly driven by partial recanalizations, but both techniques were associated with similar clinical outcomes at 1 year and 2 years.

Treatment Modalities for Small Saphenous Vein Insufficiency: Systematic Review and Meta-analysis.

PURPOSE: To investigate and compare the anatomical success rates and complications of the treatment modalities for small saphenous vein (SSV) incompetence. METHODS: A systematic literature search was performed in PubMed, EMBASE, and the Cochrane Library on the following therapies for incompetence of SSVs: surgery, endovenous laser ablation (EVLA), radiofrequency ablation (RFA), ultrasound-guided foam sclerotherapy (UGFS), steam ablation, and mechanochemical endovenous ablation (MOCA). The search found 49 articles (5 randomized controlled trials, 44 cohort studies) reporting on the different treatment modalities: surgery (n=9), EVLA (n=28), RFA (n=9), UGFS (n=6), and MOCA (n=1). A random-effects model was used to estimate the primary outcome of anatomical success, which was defined as closure of the treated vein on follow-up duplex ultrasound imaging. The estimate is reported with the 95% confidence interval (CI). Secondary outcomes were technical success and major complications [paresthesia and deep vein thrombosis (DVT)], given as the weighted means. RESULTS: The pooled anatomical success rate was 58.0% (95% CI 40.9% to 75.0%) for surgery in 798 SSVs, 98.5% (95% CI 97.7% to 99.2%) for EVLA in 2950 SSVs, 97.1% (95% CI 94.3% to 99.9%) for RFA in 386 SSVs, and 63.6% (95% CI 47.1% to 80.1%) for UGFS in 494 SSVs. One study reported results of MOCA, with an anatomical success rate of 94%. Neurologic complications were most frequently reported after surgery (mean 19.6%) and thermal ablation (EVLA: mean 4.8%; RFA: mean 9.7%). Deep venous thrombosis was a rare complication (0% to 1.2%). CONCLUSION: Endovenous thermal ablation (EVLA/RFA) should be preferred to surgery and foam sclerotherapy in the treatment of SSV incompetence. Although data on nonthermal techniques in SSV are still sparse, the potential benefits, especially the reduced risk of nerve injury, might be of considerable clinical importance.

Mechanochemical endovenous ablation versus radiofrequency ablation in the treatment of primary small saphenous vein insufficiency (MESSI trial): study protocol for a randomized controlled trial.

BACKGROUND: Minimally invasive endothermal techniques, for example, radiofrequency ablation (RFA), have revolutionized the treatment of insufficient truncal veins and are associated with an excellent outcome. The use of thermal energy requires the instillation of tumescent anesthesia around the vein. Mechanochemical endovenous ablation (MOCA™) combines mechanical endothelial damage, using a rotating wire, with simultaneous infusion of a liquid sclerosans. Tumescent anesthesia is not required as no heat is used. Prospective studies using MOCA™ in both great and small saphenous veins showed good anatomical and clinical results with fast postoperative recovery. METHODS/DESIGN: The MESSI trial (Mechanochemical Endovenous ablation versus radiofrequency ablation in the treatment of primary Small Saphenous vein Insufficiency) is a multicenter randomized controlled trial in which a total of 160 patients will be randomized (1:1) to MOCA™ or RFA. Consecutive patients with primary small saphenous vein incompetence, who meet the eligibility criteria, will be invited to participate in this trial. The primary endpoint is anatomic success, defined as occlusion of the treated veins objectified with duplex ultrasonography at 1 year follow-up. Secondary endpoints are post-procedural pain, initial technical success, clinical success, complications and the duration of the procedure. Initial technical success is defined as the ability to position the device adequately, treat the veins as planned and occlude the treated vein directly after the procedure has been proven by duplex ultrasonography. Clinical success is defined as an objective improvement of clinical outcome after treatment, measured with the Venous Clinical Severity Score (VCSS). Power analyses are conducted for anatomical success and post-procedural pain.Both groups will be evaluated on an intention-to-treat principle. DISCUSSION: The hypothesis of the MESSI trial is that the anatomic success rate of MOCA™ is not inferior to RFA. The second hypothesis is that post-procedural pain is significantly less after MOCA compared to RFA. TRIAL REGISTRATION: NTR4613 Date of trial registration: 28 May 2014.

Histological observations one year after mechanochemical endovenous ablation of the great saphenous vein.

PURPOSE: To report histological analysis of a great saphenous vein (GSV) 1 year after undergoing mechanochemical endovenous ablation (MOCA) and compare the findings with those of a healthy vein. CASE REPORT: A 59-year-old patient with bilateral GSV incompetence was treated with MOCA using the ClariVein catheter, which has a dispersion wire that rotates as liquid sclerosant is injected in the vein. After 1 year, the patient had recurrent edema of the right leg; duplex ultrasound was suspicious for recanalization. The patient was reoperated, and the deep femoral vein was explored. The GSV was completely obliterated, and its proximal part was excised and sent for histological processing. Microscopic evaluation of the MOCA-treated vein showed a circumferential disappearance of the endothelial layer and fibrosis of the vein. The media was considerably damaged, with changes in collagen structure, supporting the therapeutic effect of MOCA. CONCLUSION: MOCA is a novel endovenous treatment modality for saphenous vein insufficiency. Results of MOCA on the cellular level are essential to optimize treatment.

Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA): study protocol for a randomized controlled trial.

BACKGROUND: Radiofrequency ablation (RFA) is associated with an excellent outcome in the treatment of great saphenous vein (GSV) incompetence. The use of thermal energy as a treatment source requires the instillation of tumescence anesthesia. Mechanochemical endovenous ablation (MOCA) combines mechanical endothelial damage, using a rotating wire, with the infusion of a liquid sclerosant. Tumescence anesthesia is not required. Preliminary experiences with MOCA showed good results and low post-procedural pain. METHODS/DESIGN: The MARADONA (Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation) trial is a multicenter randomized controlled trial in which 460 patients will be randomly allocated to MOCA or RFA. All patients with primary GSV incompetence who meet the eligibility criteria will be invited to participate in this trial. The primary endpoints are anatomic and clinical success at a one-year follow-up, and post-procedural pain. The secondary endpoints are technical success, complications, operation time, procedural pain, disease-specific quality of life, time taken to return to daily activities and/or work, and cost-efficiency analyses after RFA or MOCA. Both groups will be evaluated on an intention to treat base. DISCUSSION: The MARADONA trial is designed to show equal results in anatomic and clinical success after one year, comparing MOCA with RFA. In our hypothesis MOCA has an equal anatomic and clinical success compared with RFA, with less post-procedural pain. TRIAL REGISTRATION: Clinicaltrials NCT01936168.

Mechanochemical endovenous ablation for the treatment of great saphenous vein insufficiency.

OBJECTIVE: This study evaluated the feasibility, safety, and 1-year results of mechanochemical endovenous ablation (MOCA) of great saphenous vein (GSV) insufficiency. METHODS: A consecutive 106 patients were treated for primary GSV insufficiency with MOCA by the ClariVein device and polidocanol. The primary outcome measures were technical success, clinical success, and anatomic success after 1 year of follow-up. Secondary outcome measures were postprocedural pain, complications, general- and disease-specific quality of life, and time to return to work. Patients were evaluated with clinical examination and duplex ultrasonography at 6 weeks, 6 months, and 1 year after treatment. RESULTS: The technical success was 99%. The mean postprocedural pain during the first 14 days after treatment was 7.5 mm (interquartile range [IQR], 0.0-10.0 mm) per day on a 0- to 100-mm visual analog scale. The time to return to normal activities and work was 1.0 day (IQR, 0-1.0 day) and 1.0 day (IQR, 1.0-4.0 days), respectively. No major complications were recorded. At 1-year follow-up, the clinical success was 93%. The Venous Clinical Severity Score decreased significantly from 4.0 (IQR, 3.0-5.0) before treatment to 1.0 (IQR, 0-1.0) (P < .001) 1 year after MOCA. At 1 year, 88.2% of the treated GSVs remained occluded as measured by duplex ultrasonography. Twelve patients had a recanalization, of which eight were partial. Disease-specific quality of life and the RAND 36-Item Health Survey scores improved significantly at 1-year follow-up. CONCLUSIONS: MOCA is a safe and effective technique in the treatment of GSV insufficiency with good clinical and anatomic success at 1-year follow-up. The technique is related to low postprocedural pain scores, low complication rate, improved quality of life, and rapid resumption of normal activities and work.

Update of endovenous treatment modalities for insufficient saphenous veins--a review of literature.

Lower-limb venous insufficiency resulting from saphenous vein incompetence is a common disorder, increasing with age. For decades, surgical stripping of the great saphenous vein has been the gold standard in varicose vein treatment. The desire to optimize outcomes of treatment and reduce surgical trauma has led to the development of endovenous techniques. Today, several endovenous techniques are available to ablate the saphenous vein segments with abnormal vein valve function. In this review, we discuss the techniques, mechanisms of action, outcomes, and complications of all endovenous treatment modalities for the treatment of symptomatic lower-limb varicose veins.

Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical endovenous ablation of incompetent great saphenous veins.

OBJECTIVE: Thermal ablative techniques of varicose veins carry a risk of heat-related complications, including postoperative pain. Mechanochemical endovenous ablation (MOCA) might avoid these complications and reduce postoperative pain because of the absence of thermal energy. This study evaluated postoperative pain and quality of life after radiofrequency ablation (RFA) and MOCA for great saphenous vein (GSV) incompetence. METHODS: Sixty-eight patients with unilateral GSV incompetence were treated with either RFA or MOCA in this prospective observational study. Patients monitored their pain for the first 14 postoperative days on a 100-mm visual analog scale (VAS). They also completed the general (RAND 36-Item Short-Form Health Survey) and disease-specific (Aberdeen Varicose Vein Questionnaire) quality of life questionnaires before and 6 weeks after treatment. RESULTS: Patients treated with MOCA reported significantly less postoperative pain than patients treated with RFA during the first 14 days after treatment (4.8 ± 9.7 mm vs 18.6 ± 17.0 mm; P < .001) (mean VAS over 14 days). The lower postoperative pain score was associated with a significantly earlier return to normal activities (1.2 ± 1.8 vs 2.4 ± 2.8 days; P = .02) and work resumption (3.3 ± 4.7 vs 5.6 ± 5.8 days, respectively; P = .02). At 6 weeks, patients in both groups perceived an improved change in health status and an improved disease-specific quality of life. CONCLUSIONS: MOCA is associated with significantly less postoperative pain, faster recovery, and earlier work resumption compared with RFA in the treatment of GSV incompetence. MOCA and RFA are both related to a rapid improvement in quality of life.

[Endovenous mechanochemical ablation for varicose veins--a new endovenous technique without tumescent anaesthesia]. / Mechano-chemische endoveneuze ablatie bij varicositas. Een nieuwe endoveneuze techniek zonder tumescentie-anesthesie.

In the past decades, endovenous techniques have played an increasingly important role in the treatment of varicose veins. The method of action of these techniques is based on heat, making tumescent anesthesia necessary. Despite this anesthesia, heat-induced complications such as skin burns, nerve damage and prolonged pain may occur. Endovenous mechanochemical ablation, in contrast, utilises an infusion catheter with a rotating tip. Obliteration of the insufficient vein is achieved both by mechanical destruction to the endothelium and by the fibrosing effect of a sclerosant. Tumescent anaesthesia can be omitted during this ablation technique, which makes it quicker and less painful than other endovenous treatments. This new technique is safe and has shown to be effective in the short term, with high satisfaction rates in treated patients.

Endovenous mechanochemical ablation of great saphenous vein incompetence using the ClariVein device: a safety study.

PURPOSE: To evaluate the feasibility and safety of endovenous mechanochemical ablation (MOCA) for the treatment of great saphenous vein (GSV) incompetence. METHODS: The newly developed ClariVein device uses a technique that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. Heating of the vein and tumescent anesthesia are not required; only local anesthesia is utilized at the insertion site. In a pilot study, 30 limbs in 25 patients (18 women; mean age 52 years) with GSV incompetence were treated with MOCA using polidocanol at 2 centers. Initial technical success, complications, patient satisfaction, and classification by venous clinical severity score (VCSS) were assessed 6 weeks after the treatment. RESULTS: Initial technical success of MOCA was 100%. There were no major adverse events. Minor complications consisted of 9 local ecchymoses at the puncture site and superficial phlebitis that resolved within a week in 4 limbs. Duplex ultrasonography at 6 weeks showed 26 (87%) of 30 veins were completely occluded; 3 veins showed partial recanalization in the proximal (n = 2) and distal GSV. One patient had full segment recanalization and was successfully retreated. The VCSS significantly improved at 6 weeks (p < 0.001). Patient satisfaction was high, with a median satisfaction of 8.8 on a 0-10 scale. CONCLUSION: This study showed that endovenous MOCA, using polidocanol, is feasible and safe in the treatment of GSV incompetence. Larger studies with a prolonged follow-up are indicated to prove the efficacy of this technique in terms of obliteration rates.