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European Journal of Vascular and... Mar 2023To compare the outcomes of ultrasound guided foam sclerotherapy (UGFS) and endovenous laser ablation (EVLA) to treat isolated small saphenous vein (SSV) incompetence in... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To compare the outcomes of ultrasound guided foam sclerotherapy (UGFS) and endovenous laser ablation (EVLA) to treat isolated small saphenous vein (SSV) incompetence in a multicentre randomised controlled study (RCT; ClinicalTrials.gov identifier: NCT05468450).
METHODS
Patients aged ≥ 18 years undergoing isolated SSV treatment (reflux > 0.5 seconds) were randomised to UGFS or EVLA. Patients treated with UGFS were allowed one additional truncal treatment at six weeks. Tributary treatments (phlebectomy or sclerotherapy) were permitted after six months. Participants were assessed at eight days, six months, and one, two, and three years. The primary endpoint was the absence of SSV reflux (> 0.5 seconds). Secondary outcomes included clinical scores and quality of life (QoL) scores. All analyses were done by intention to treat.
RESULTS
Of 1 522 screened patients, 161 were randomised to UGFS (n = 82) and EVLA (n = 79). Only 3% of patients who received UGFS had the second (allowed) treatment and 86% of patients completed the three year study. Forty-one and 19 tributary treatments (by sclerotherapy) were performed in 27 UGFS patients (33%) and 15 EVLA patients (19%), respectively. The complete absence of reflux at three years was significantly better after EVLA (86%) than after UGFS (56%) (odds ratio [OR] 5.36, 95% confidence interval [CI] 2.31 - 12.44; risk ratio 1.59, 95% CI 1.26 - 2.01). Two deep vein thromboses (DVTs; one femoropopliteal and one gastrocnemius) and one endovenous heat induced thrombosis occurred in the EVLA group. Seven DVTs were seen in the UGFS group, including two partial popliteal DVTs and five gastrocnemius vein thromboses (four asymptomatic and incidental on day 8 screening). At three years, there was no difference between groups for the following: rate of visible varices (p = .87), revised Venous Clinical Severity Score (p = .28), and QoL (p = .59). Patient satisfaction scores were high in both groups (median score: EVLA 97/100 and UGFS 93/100; p = .080). Symptoms were significantly improved in both groups. (p < .001) CONCLUSION: Technical success was better for EVLA than for UGFS three years after SSV treatment. This agrees with studies that have reported on these treatments in the great saphenous vein. However, improvements in clinical outcome were similar for both groups.
Topics: Humans; Polidocanol; Quality of Life; Saphenous Vein; Varicose Veins; Sclerotherapy; Laser Therapy; Treatment Outcome; Venous Insufficiency
PubMed: 36470312
DOI: 10.1016/j.ejvs.2022.11.021 -
JVS-vascular Science 2022Fatal allergic responses and cardiac arrhythmias have been reported with the intravenous (IV) administration of polidocanol. We sought to identify the physiologic...
OBJECTIVE
Fatal allergic responses and cardiac arrhythmias have been reported with the intravenous (IV) administration of polidocanol. We sought to identify the physiologic mechanism of systemic cardiovascular response after transcervical (TC) and IV administration of polidocanol.
METHODS
We continuously monitored blood pressure (BP) and heart rate using an arterial line during IV and intraperitoneal (IP) administration of polidocanol solution (PS) and polidocanol doxycycline solution in female rats and TC and IP administration of polidocanol foam (PF) and PDF (TC only) in female baboons. We performed TC procedures using a catheter with (pressurized) and without (nonpressurized) balloon inflation. Baboons also underwent monitoring during IV PS administration with and without pretreatment with antihistamines. We performed cardiac echo and electrocardiograms during selected experiments. We defined a refractory hypotension as a sustained decrease of more than 30% from baseline that prevented delivery of the target dose.
RESULTS
We found a dose-related increase in the proportion of baboons that developed refractory hypotension during TC administration of 5% PDF and PF, an effect confined to pressurized administration. The infusion of 0.5% PS in rats induced a rapid and dramatic refractory hypotension. The inclusion of doxycycline did not improve or deteriorate these outcomes, and doxycycline solution or saline (control) alone did not affect BP. All five female baboons that received up to 20 mL of 1% PS (200 mg) developed refractory hypotension. Pretreatment with diphenhydramine, ranitidine, or both did not block the refractory hypotension induced by IV administration of 1% PS (100 mg). In contrast, only one of the six female baboons treated with IP PF 400 mg developed a decrease of more than 30% in BP, and this response was not sustained. Cardiac echocardiography done in four baboons during TC treatment demonstrated a decrease in cardiac output as the physiologic mechanism of hypotension. We did not observe important changes on the electrocardiograms.
CONCLUSIONS
Adverse cardiovascular effects of polidocanol treatment occur owing to a direct myocardial effect of polidocanol and not as a result of a hypersensitivity reaction. Pressurized TC administration of PF results in refractory hypotension owing to endometrial vascular uptake of polidocanol and not as a result of uptake from peritoneal surfaces.
PubMed: 36439699
DOI: 10.1016/j.jvssci.2022.08.002 -
Current Opinion in Pediatrics Feb 2023Aneurysmal bone cysts are rare, locally aggressive bone tumors. Optimal treatment of ABCs is still matter of debate as therapies including sclerotherapy, selective... (Review)
Review
PURPOSE OF REVIEW
Aneurysmal bone cysts are rare, locally aggressive bone tumors. Optimal treatment of ABCs is still matter of debate as therapies including sclerotherapy, selective arterial embolization and systemic treatment with denosumab are increasingly utilized, in addition to or instead of traditional curettage. The purpose of this review is to discuss current concepts and difficulties in diagnosing and treating primary ABCs, based on latest available literature.
RECENT FINDINGS
In diagnostics, multiple new fusion partners of USP-6 have been described on next-generation sequencing specifically for primary ABCs. In a recent systematic review, failure rates of percutaneous injections and surgery were comparable. In a literature review, the use of denosumab seemed effective but resulted in multiple cases of severe hypercalcemia in children.
SUMMARY
Accurately diagnosing primary ABC is crucial for treatment decisions. Curettage remains a valid treatment option, especially with adjuvant burring, autogenous bone grafting and phenolization. Percutaneous sclerotherapy represents a solid alternative to surgery, with polidocanol showing good results in larger studies. Systematic therapy with denosumab exhibits favorable results but should be reserved in the pediatric population for unresectable lesions, as it may result in severe hypercalcemia in children. When selecting a treatment option, localization, stability and safety should be considered.
Topics: Humans; Child; Denosumab; Bone Cysts, Aneurysmal; Hypercalcemia; Neoplasm Recurrence, Local; Polidocanol; Treatment Outcome
PubMed: 36409159
DOI: 10.1097/MOP.0000000000001205 -
European Journal of Medical Research Oct 2022In this manuscript, we purposed to identify the prognostic factors for treatment of lymphatic malformations in children using polidocanol foam combined with...
PURPOSE
In this manuscript, we purposed to identify the prognostic factors for treatment of lymphatic malformations in children using polidocanol foam combined with pingyangmycin and to construct nomogram for predicting sclerotherapy response.
METHODS
A retrospective analysis of 77 children having LMs who underwent sclerotherapy using polidocanol foam combined with pingyangmycin under ultrasound display from January 2017 to April 2020 was done. The clinical response was graded as excellent (≥ 90%), good (≥ 50%, < 90%), and poor (< 50%). More than 50% was considered as acceptable response. Prognostic factors were identified by Pearson's Chi-square or Fisher's exact test and multivariable logistic regression model was used to construct a nomogram to predict sclerotherapy response. The discrimination and calibration of nomogram were verified through the receiver operating characteristic cure and calibration plots.
RESULTS
The mean number of treatment sessions was 3.1 (range, 1-6). Among 77 patients, 58 patients (75.3%) had excellent response to treatment (≥ 90%) and 68 patients (88.3%) had an acceptable response (≥ 50%, < 90%). Clinical disfigurement (P = 0.014), skin discoloration (P = 0.040), morphological subtype (P < 0.001) and extent of the lesion (P < 0.001) correlated with clinical response to sclerotherapy in LMs. Sclerotherapy response was predicted through nomogram constructed in this study, which shows good calibration and discrimination. Also, focal lesion and macrocystic or mixed morphological subtype lesion were seen more often in lower number of treatment sessions among the patients with excellent response.
CONCLUSIONS
An acceptable response to sclerotherapy using polidocanol foam combined with pingyangmycin was achieved in majority of LMs in children with extremely low complication rates. Nomogram based on the prognostic factors of sclerotherapy response for LMs in children was shown to possess an excellent performance to predict the probability of LMs sclerotherapy response.
Topics: Child; Humans; Sclerotherapy; Polidocanol; Sclerosing Solutions; Retrospective Studies; Nomograms; Treatment Outcome; Lymphatic Abnormalities
PubMed: 36271467
DOI: 10.1186/s40001-022-00844-3 -
Corrigendum: Effectiveness of polidocanol in the treatment of venous malformations: A meta-analysis.Frontiers in Pediatrics 2022[This corrects the article DOI: 10.3389/fped.2022.925318.].
[This corrects the article DOI: 10.3389/fped.2022.925318.].
PubMed: 36210935
DOI: 10.3389/fped.2022.1011511 -
Journal of the European Academy of... Feb 2023Skin hyperpigmentation after sclerotherapy with polidocanol-containing sclerosants is a common local side effect. Sclerotherapists should be familiar with factors that... (Review)
Review
Skin hyperpigmentation after sclerotherapy with polidocanol-containing sclerosants is a common local side effect. Sclerotherapists should be familiar with factors that trigger hyperpigmentation after sclerotherapy with polidocanol-containing sclerosants. A systematic literature review of works reporting hyperpigmentation after sclerotherapy for telangiectasias, reticular veins, side branches and truncal varices with polidocanol-containing sclerosants was performed. Reported incidence rates, follow-up periods and potentially triggering factors were assessed and analysed. The search yielded 1687 results; of these, 27 reports met the inclusion criteria. The incidence of hyperpigmentation seemed to increase with higher concentrations of polidocanol and was more evident after sclerotherapy for epifascial veins than for intrafascial truncal veins when the polidocanol concentration was more than 0.25%. Regarding sclerotherapy for telangiectasias and reticular veins, the incidence of hyperpigmentation ranged between 2% and 25% for polidocanol 0.25% (liquid and foam), between 12.5% and 67.9% for polidocanol 0.5% (liquid and foam) and between 13% and 73% for polidocanol 1% (liquid and foam). Regarding truncal veins, the incidence ranged from 7% to 45.8% for polidocanol 1% (liquid and foam), from 16% to 17% for polidocanol 2% (foam) and from 7.4% to 32.5% for polidocanol 3% (liquid and foam). Regarding the treatment of side branches, the incidence of hyperpigmentation ranged from 5.6% to 53% for both foam and liquid sclerotherapy. Regarding the duration of hyperpigmentation, there are few data describing reticular veins and telangiectasias. Hyperpigmentation persisting for more than 6 months has been reported to have an incidence of up to 7.5%. Hyperpigmentation persisting for more than 1 year after foam polidocanol 1%-3% treatment for truncal veins has an incidence ranging from 8.1% to 17.5%. Other factors such as higher volumes and compression therapy after treatment seem to have a minor influence. Data regarding hyperpigmentation after polidocanol-related sclerotherapy are poor and should be improved by higher-quality research.
Topics: Humans; Polidocanol; Sclerotherapy; Sclerosing Solutions; Varicose Veins; Polyethylene Glycols; Telangiectasis; Hyperpigmentation; Treatment Outcome
PubMed: 36196455
DOI: 10.1111/jdv.18639 -
Journal of Clinical Medicine Sep 2022Klippel-Trenaunay syndrome (KTS) is characterized by a triad of symptoms; varicose veins and venous malformations (VMs), capillary malformations (port-wine stain), and...
BACKGROUND
Klippel-Trenaunay syndrome (KTS) is characterized by a triad of symptoms; varicose veins and venous malformations (VMs), capillary malformations (port-wine stain), and soft tissue and bone hypertrophy. Herein, we retrospectively studied six patients with KTS who underwent treatment with the Flebogrif system and evaluated their outcomes.
METHODS
Six KTS patients aged 16-22 years who had undergone 18 non-thermal ablations using the Flebogrif system were enrolled. All patients underwent multistage foam sclerotherapy with 3% polidocanol at 3-4-week intervals.
RESULTS
Venous clinical severity score (VCSS) analysis showed improvement in the patients' clinical condition. All patients reported a significant improvement in aesthetic outcomes. One patient presented with recanalization of ablated marginal veins during the 24-month follow-up period. Patients could return to full activity within 7-10 days after the procedure. None of the patients experienced serious systemic complications.
CONCLUSION
The use of the Flebogrif system in treating various forms of chronic venous insufficiency, including in patients with KTS, provides a high success rate with a high closure rate.
PubMed: 36142903
DOI: 10.3390/jcm11185255 -
Frontiers in Surgery 2022In the last 2 years, anorectal surgery has been strongly affected and even surgery for urgent cases cannot be scheduled; also, patients with III- and IV-degree bleeding...
BACKGROUND
In the last 2 years, anorectal surgery has been strongly affected and even surgery for urgent cases cannot be scheduled; also, patients with III- and IV-degree bleeding hemorrhoids should be treated conservatively. The aim was to evaluate the effectiveness of sclerotherapy in patients who had to postpone surgery.
METHODS
We included all patients with III- and IV-degree bleeding hemorrhoids who underwent outpatient sclerotherapy. The visual analog scale and the hemorrhoid severity score were used at the baseline and at 4 weeks after the procedure with a telephone interview, and all patients were outpatient-evaluated 1 week, 1 month, and 1 year after the treatment. All pre- and postoperative data were recorded.
RESULTS
From October 2020 to November 2021, 19 patients with III- (12 patients; 63%) and IV-degree (7 patients; 37%) bleeding hemorrhoids were enrolled. The mean operative time was 4.5 min, and no intraoperative complications occurred. One case of tenesmus and three failures were detected. Six months after the procedure, the overall success rate was 84%, although all of the patients enrolled reported persistent bleeding at the end of the study period. Of these, 5 patients (26%) were scheduled for surgery and 11 patients (58%) refused surgery and asked to undergo a re-do sclerotherapy.
CONCLUSION
Sclerotherapy with 3% polidocanol foam is a safe and effective procedure also in III- and IV-degree bleeding hemorrhoids. The long-term data on the length of the foam remain to be evaluated in additional studies.
PubMed: 36117836
DOI: 10.3389/fsurg.2022.978574 -
Frontiers in Pediatrics 2022The aim of this study was to investigate the efficacy of polidocanol against venous malformations (VMs).
OBJECTIVE
The aim of this study was to investigate the efficacy of polidocanol against venous malformations (VMs).
METHODS
Studies reporting the treatment of VMs using polidocanol (published until February 15, 2020) were reviewed in the Embase and PubMed databases. After excluding the same literature, part of the studies were excluded by reading the title, abstract, full text. Eleven studies (with 287 participants) that fulfilled the inclusion criteria were included. Systematic meta-analysis was performed using Reviews Manager 5.2, and a fixed-effects model was used to calculate the pooled effective rate of polidocanol against VMs and the 95% confidence intervals (CI).
RESULTS
Lesion reduction of more than 50% was considered effective. A total of 287 patients were treated, and treatment in 271 was considered effective. The efficacy of polidocanol was 0.89 (95% CI = 0.83-0.93). Heterogeneity among the studies was small ( = 0%, = 0.47). T The funnel plot was roughly symmetric.
CONCLUSION
Our study suggested that polidocanol is effective in the treatment of VMs. VMs at different sites can be treated without serious complications. Therefore, we have reason to believe that polidocanol is a safe and an effective drug for VMs.
PubMed: 35967557
DOI: 10.3389/fped.2022.925318 -
Interventional Radiology... Jul 2021Herein, we have reported a rare case of intracystic hemorrhage due to rupture of a right hepatic artery pseudoaneurysm in a 76-year-old female patient who underwent...
Herein, we have reported a rare case of intracystic hemorrhage due to rupture of a right hepatic artery pseudoaneurysm in a 76-year-old female patient who underwent drainage and 3% polidocanol sclerotherapy for a symptomatic giant hepatic cyst. One month after sclerotherapy, the patient presented to the emergency room with acute and severe abdominal pain. Non-contrast T1-weighted magnetic resonance imaging findings showed high hepatic cyst fluid signal intensity and abdominal arteriography findings revealed a right hepatic artery pseudoaneurysm surrounding the hepatic cystic wall. Therefore, the patient was diagnosed with intracystic hemorrhage due to a ruptured pseudoaneurysm. Embolization, using a detachable coil, was successful. Interventional radiologists should be aware of potential vascular injuries during drainage and sclerotherapy for giant hepatic cysts.
PubMed: 35909912
DOI: 10.22575/interventionalradiology.2021-0005