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Journal of Clinical Medicine Aug 2023Level 2.
LEVEL OF EVIDENCE
Level 2.
PURPOSE
To compare the safety and efficacy of vascular plug (VP) and vascular plug and polidocanol foam (VPPF) treatments for embolization in pelvic congestion syndrome (PCS).
MATERIALS AND METHODS
A comparative, prospective, two-center study enrolled 50 women with PCS from January 2019 to January 2020. The patients were divided into two groups, and embolization was performed with VP (n = 25) and VPPF (n = 25) treatments. The mean age of the patients was 45.6 years ± 6.9. Three clinical parameters were assessed: abdominal pain, dyspareunia, and lower limb pain. The primary outcome (clinical success at 1 yr using a VAS), number of devices, procedure and fluoroscopy times, radiation doses, costs, and complications were compared. The participants were followed-up at 1, 3, 6, and 12 months.
RESULTS
At the 1-year follow-up, clinical success did not significantly differ between the two groups (VP vs. VPPF) regarding the improvement of the symptoms analyzed (pelvic pain, dyspareunia, lower extremity pain, and other symptoms ( < 0.05)). The mean number of devices per case was 4 ± 1.1 for the VP group and 2 ± 0.31 for the VPPF group ( < 0.001). No major complications were recorded in either group. The VPPF group had a significantly longer fluoroscopy time (42.8 min ± 14.2 vs. 25.4 min ± 7) and longer radiation dose (VPPF air kerma 839.4 ± 513 vs. VP air kerma 658.4 mGy ± 355 (all < 0.001)).
CONCLUSIONS
Embolization for PCS resulted in pain relief in 90% of patients; the use of polidocanol did not demonstrate changes in the clinical outcome. The use of a VP alone was associated with decreased fluoroscopy time and radiation dose.
PubMed: 37629450
DOI: 10.3390/jcm12165408 -
Journal of Vascular Surgery. Venous and... Apr 2024Polidocanol endovenous microfoam (PEM) has been used to treat lower extremity venous reflux for almost one decade with specific advantages for below knee (BK) truncal...
BACKGROUND
Polidocanol endovenous microfoam (PEM) has been used to treat lower extremity venous reflux for almost one decade with specific advantages for below knee (BK) truncal veins where thermal ablation poses a risk of injury to adjacent nerves. The current literature of the BK segment often examines short-term outcomes with modest sample sizes. We aim to identify factors associated with recanalization and reintervention in this subset of patients.
METHODS
We performed a retrospective study of a prospectively maintained database of patients from a single institution who underwent 1% PEM ablation for BK great saphenous vein (GSV) and small saphenous vein (SSV) reflux. Patients underwent duplex ultrasound (DU) within 7 days after injection, every 3 to 6 months for 1 year, and every 6 to 12 months thereafter. Patients with symptomatic recanalization underwent reintervention. The 26 patients lost to follow-up without DU after ablation were excluded. The factors associated with recanalization and reintervention were examined by multivariate and nonparametric analyses.
RESULTS
Between March 2018 and July 2023, 411 patients (166 male, 245 female) with 573 treated limbs (284 right, 289 left) met the study criteria. Of the 573 included limbs, 457 (79.8%) had undergone prior above knee saphenous ablations. A total of 554 BK GSV and 42 SSV ablations were performed. The most recent DU was performed at a mean of 231 ± 329 days. The overall recanalization rate was 10.6% (55 GSVs and 8 SSVs) at a mean follow-up of 104 ± 180 days. Comparing the closed and recanalized veins, we found no significant difference in age (P = .90), treated laterality (P = .14), patient body mass index (P = .59), preprocedural CEAP (clinical-etiology-anatomy-pathophysiology) score (P = .79), recanalization rate in GSVs vs SSVs (P = .06), or administered PEM volume (P = .24). The recanalized veins had significantly larger preprocedural diameters than the veins that remained closed (recanalized, 4.9 mm; closed, 4.3 mm; P = .001). Men had higher incidence of recanalization than women (men, 14.2%; women, 8%; P = .015). Anticoagulation use was associated with recanalization (odds ratio, 1.96; 95% confidence interval, 1.1-3.6; P = .03). Early recanalization at the first DU accounted for 31 failures (49.2%) and had a significantly lower administered PEM volume compared with later recanalization (early, 4 mL; late, 5 mL; P = .025). There were no significant differences between the 33 recanalized patients requiring reintervention (52.4%) and the 30 who did not. Twenty-four reinterventions were performed with PEM, 100% of which remained closed at a median of 160 days (interquartile range, 257 days).
CONCLUSIONS
PEM is successful for the treatment of BK GSV and SSV reflux with a closure rate of 89% at a mean of 231 days and shows promise as salvage therapy. Most cases of recanalization were noted in the early postprocedure period and were associated with a lower PEM volume. A larger vein diameter, male sex, and anticoagulation use are associated with higher rates of recanalization.
PubMed: 38580208
DOI: 10.1016/j.jvsv.2024.101886 -
Journal of Vascular Surgery. Venous and... Mar 2024This study aims to investigate the difference in safety and efficacy between two treatments for venous malformations (VMs), electrochemotherapy combined with polidocanol...
OBJECTIVE
This study aims to investigate the difference in safety and efficacy between two treatments for venous malformations (VMs), electrochemotherapy combined with polidocanol foam (ECP) and bleomycin polidocanol foam (BPF), providing alternative therapies for VMs.
METHODS
We conducted a retrospective review of 152 patients with VMs treated with ECP and BPF. Pre- and post-treatment magnetic resonance images (MRIs) were collected, and clinical follow-up assessments were performed. Imaging results were used to calculate lesion volume changes. Clinical outcomes included changes in pain and improvements in perceived swelling. Patients were followed up at 1 week and 6 months after surgery. All emerging complications were documented in detail.
RESULTS
Of the 152 patients, 87 (57.2%) received BPF treatment, and 65 (42.8%) received ECP treatment. The most common location of VMs was the lower extremities (92/152; 60.2%), and the most common symptom was pain (108/152; 71.1%). Forty-three patients had previously undergone therapy in the BPF group (43/87; 49.4%), whereas 30 patients had received prior treatment in the ECP group (30/65; 46.2%). The study found that the percentage of lesion volume reduction in the BPF group was not significantly different from that in the ECP group (75.00% ± 17.85% vs 74.69% ± 8.48%; P = .899). ECP was more effective when the initial lesion volume was greater than 30 mL (67.66% ± 12.34% vs 73.47% ± 8.00%; P = .048). Patients treated with BPF had significantly less posttreatment pain than those treated with ECP, in different baseline lesion size. In the overall sample, pain relief was significantly higher in the BPF group than in the ECP group (4.21 ± 1.19 vs 3.57 ± 0.76; P = .002). However, there was no difference in pain relief between the two groups for the treatment of initially large VMs (4.20 ± 0.94 vs 3.70 ± 0.87; P = .113). The ECP group was significantly more likely to develop hyperpigmentation (5/87; 5.75% vs 11/65; 16.92%; P = .026) and swelling (9/87; 10.34% vs 16/65; 24.62%; P = .019) 1 week after surgery than the BPF group.
CONCLUSIONS
Our study demonstrates that both BPF and ECP are effective treatments for VMs, with BPF being a safer option. ECP is a better choice for patients with the initial lesion volume greater than 30 mL, but it is more likely to lead to early swelling and hyperpigmentation.
Topics: Humans; Polidocanol; Sclerosing Solutions; Bleomycin; Sclerotherapy; Electrochemotherapy; Vascular Malformations; Treatment Outcome; Pain; Retrospective Studies; Hyperpigmentation; Polyethylene Glycols
PubMed: 37890588
DOI: 10.1016/j.jvsv.2023.101697 -
Frontiers in Surgery 2023Around 20% of population in western countries is under anticoagulant treatment. However, there is paucity of evidence about the treatment of HD in patients under...
Sclerobanding in the treatment of second and third degree hemorrhoidal disease in high risk patients on antiplatelet/anticoagulant therapy without suspension: a pilot study.
INTRODUCTION
Around 20% of population in western countries is under anticoagulant treatment. However, there is paucity of evidence about the treatment of HD in patients under anticoagulant/antiplatelet therapy, although both suspension and continuation in the perioperative period may increase the risk of severe complications. The aim of this pilot study was to confirm the feasibility and safety of sclerobanding (Combined Rubber Band Ligation with 3% Polidocanol Foam Sclerotherapy), an office-based procedure, for the treatment of second-and third-degree HD in patients under anticoagulant/antiplatelet therapy without suspension.
MATERIALS AND METHODS
Patients affected by second-third-degree haemorrhoids unresponsive to conservative treatment and under anticoagulant/antiplatelet were enrolled between November 2019 and October 2021. Postoperative complications, readmission, mortality and reintervention during the follow-up were evaluated.
RESULTS
Fifty-one patients were recruited, 23 female (45.1%) and 28 male (54.9%), with an average age of 65 years ± 11.4 SD (range 42-90). Twenty-seven patients (52.9%) had II-degree haemorrhoidal disease, and 24 (47.1%) had grade III-degree. The most frequently taken medications were dual antiplatelet therapy (51%) and new oral anticoagulants (NOACs) (21.6%). The mean follow-up was 23 months. No intraoperative complications were recorded. The rate of complications in the first postoperative month was 13.7%, represented by mild complications: 6 cases of moderate to severe pain and 1 case (2%) of thrombosis of a residual haemorrhoidal nodule, all regressing after conservative therapy. No severe complications were reported. Postoperative complications were not statistically significantly associated with the number of nodules treated (1, 2, or 3), the disease grade (2nd vs. 3rd) or the specific anticoagulant/antiplatelet regimen. During follow-up, 2 patients (4%) required a new procedure for recurrent bleeding: one an infrared photocoagulation as outpatient, and another a haemorrhoidectomy after 3 months. No cases of intraoperative or postoperative mortality occurred.
CONCLUSIONS
Sclerobanding is a safe and effective technique in treating intermediate-grade haemorrhoidal disease in patients at high risk on anticoagulant/antiplatelet therapy. Sclerobanding is repeatable, usually does not require anaesthesia, and is cost-effective. Observational multicentre studies with a larger number of patients and controlled clinical trials will be needed to confirm these results.
PubMed: 38026482
DOI: 10.3389/fsurg.2023.1290706 -
Journal of Clinical Medicine Aug 2023In the original publication [...].
Correction: Pata et al. Sclerobanding (Combined Rubber Band Ligation with 3% Polidocanol Foam Sclerotherapy) for the Treatment of Second- and Third-Degree Hemorrhoidal Disease: Feasibility and Short-Term Outcomes. 2022, , 218.
In the original publication [...].
PubMed: 37568566
DOI: 10.3390/jcm12155159 -
Journal of Vascular Surgery. Venous and... May 2024Polidocanol endovenous microfoam ablation (MFA) is approved by the US Food and Drug Administration for great saphenous vein (GSV) closure, yet there are few published...
OBJECTIVE
Polidocanol endovenous microfoam ablation (MFA) is approved by the US Food and Drug Administration for great saphenous vein (GSV) closure, yet there are few published data on the subsequent risk of ablation-related thrombus extension (ARTE). Recent societal practice guidelines recommend against routine postprocedure duplex ultrasound (DU) examination after thermal ablation of the GSV in asymptomatic patients. At present, limited data do not allow this recommendation to extend to MFA. Our aim is to identify characteristics and outcomes associated with ARTE following MFA vs radiofrequency ablation (RFA).
METHODS
A retrospective review of a prospectively maintained database was conducted of patients who underwent MFA and RFA closure of incompetent above-knee GSVs. Patients treated for isolated tributary vein treatment or did not have a postprocedure DU examination within 48 to 72 hours were not included. Patients were classified into two groups: ARTE and no ARTE. Demographic data, Clinical, Etiologic, Anatomic and Pathophysiologic class, Venous Clinical Severity Score, operative details, postprocedure (48-72 hours) DU findings, and adverse events were analyzed. Variables that were significant on univariate analysis were evaluated using multivariate logistic regression with the primary outcome being development of ARTE.
RESULTS
Between June 2018 and February 2023, 800 limbs were treated with either MFA (n = 224) or RFA (n = 576). Ninety-six GSVs treated with MFA met the study criteria. One hundred fifty successive GSVs treated with RFA during the same period were included as a comparison group. There was no statistically significant difference in baseline demographics between the two groups. Six patients (2.4%) demonstrated ARTE on postoperative DU examination at 48 to 72 hours (MFA, n = 5 [5.2%]; RFA, n = 1 [0.7%]; P = .02). Saphenous vein ablation with MFA (P = .045) and a vein diameter of >10 mm (P = .017) were associated with ARTE on both univariable and multivariable analysis. All patients who developed ARTE were treated with oral anticoagulants (mean, 15.6 days). Body mass index, Clinical, Etiologic, Anatomic and Pathophysiologic class, Venous Clinical Severity Score, microfoam volume, operative time, and prior deep venous thrombosis were not predictive of ARTE.
CONCLUSIONS
ARTE after above-knee GSV closure occurred more frequently after MFA. Our results suggest that a saphenous vein diameter of >10 mm may be associated with ARTE. Despite this finding, all patients with ARTE were treated with short-term anticoagulation with no related complications. Until larger studies with high-risk subgroups have been studied after MFA, DU examination should be performed routinely after this procedure and patients with ARTE anticoagulated until the thrombus retracts caudal to the saphenofemoral junction or is no longer present on DU examination. Current societal guidelines recommending against routine post-thermal ablation DU examination should not be applied to similar patients after saphenous nonthermal MFA ablation.
Topics: Humans; Saphenous Vein; Venous Insufficiency; Treatment Outcome; Catheter Ablation; Retrospective Studies; Thrombosis; Varicose Veins
PubMed: 38215907
DOI: 10.1016/j.jvsv.2024.101815 -
BMC Pregnancy and Childbirth Nov 2023This study aimed to investigate the efficacy of hysteroscopic surgery for endogenous cesarean scar pregnancy (CSP) and the value of prophylactic ultrasound-guided local...
Outcomes of prophylactic lauromacrogol injection versus non-injection in patients with endogenous cesarean scar pregnancy treated by hysteroscopic surgery: a retrospective cohort study.
BACKGROUND
This study aimed to investigate the efficacy of hysteroscopic surgery for endogenous cesarean scar pregnancy (CSP) and the value of prophylactic ultrasound-guided local injection of lauromacrogol.
METHODS
This retrospective study included 131 patients diagnosed with endogenous CSP who underwent hysteroscopic surgery at the Hangzhou Fuyang Women and Children Hospital between January 2018 and May 2022. Lauromacrogol (10-20 mL) was administered within 24 h preoperatively using an ultrasound-guided vaginal injection to 78 patients (L group) versus not administered to 53 patients (non-L group). Their clinical data and outcomes were analyzed.
RESULTS
Mean gestational age, gestational mass size, and uterine scar thickness and median preoperative blood β-human chorionic gonadotropin levels of the non-L versus L groups were 46.26 versus 45.01 days, 2.05 versus 2.39 cm, 0.35 versus 0.32 cm, and 19850.0 versus 26790.0 U/L, respectively (P > 0.05 for each). The non-L and L groups had similar success rates (98.1% vs. 98.7%, P = 1.0). Complications related to lauromacrogol administration, including abdominal pain, massive bleeding, and bradycardia, were experienced by 46.2% (36/78; P < 0.001) of L group patients. The non-L had a significantly shorter mean hospital stay (4.85 ± 1.12 vs 5.44 ± 1.08 days) and lower total cost (6148.75 ± 1028.71 vs 9016.61 ± 1181.19) (P < 0.01).
CONCLUSIONS
Hysteroscopic surgery is effective and safe for patients with endogenous CSP. Prophylactic lauromacrogol injection increases the incidence of complications and costs. Direct hysteroscopic surgery can reduce pain and financial burden in patients with endogenous CSP and save medical resources for other patients.
Topics: Pregnancy; Child; Humans; Female; Infant; Hysteroscopy; Retrospective Studies; Polidocanol; Cicatrix; Cesarean Section; Pregnancy, Ectopic; Treatment Outcome
PubMed: 37925452
DOI: 10.1186/s12884-023-06088-1 -
Cureus Jul 2023A hybrid treatment approach was used to successfully manage bilateral varicose veins in a 50-year-old female patient. The patient had venous insufficiency and presented...
A hybrid treatment approach was used to successfully manage bilateral varicose veins in a 50-year-old female patient. The patient had venous insufficiency and presented with pain, swelling, and discoloration in her legs. The treatment plan consisted of two sessions of endovenous laser ablation (EVLA) to treat venous reflux, followed by two phlebectomies for residual bulging varicose veins. After a three-month follow-up, an ultrasound evaluation showed no venous reflux, indicating successful treatment. However, small reticular and spider veins remained, so the patient underwent four sessions of foam sclerotherapy using polidocanol as the sclerosant. On her three-month follow-up post-sclerotherapy, the patient reported significant improvement in symptoms, and ultrasound evaluation showed no venous reflux in major veins. The hybrid approach combining EVLA, sclerotherapy, and phlebectomy provided effective treatment for the patient, resulting in symptom improvement and positive cosmetic outcomes.
PubMed: 37602122
DOI: 10.7759/cureus.42161 -
Canadian Association of Radiologists... Apr 2024While hydrocelectomy is the gold-standard for treating hydroceles, it poses an increased risk to patients and a greater burden to the healthcare system. Sclerotherapy is... (Review)
Review
While hydrocelectomy is the gold-standard for treating hydroceles, it poses an increased risk to patients and a greater burden to the healthcare system. Sclerotherapy is an alternative treatment for hydroceles that involves injecting a sclerosant into the hydrocele under ultrasound guidance. This literature review aimed to assess the types of sclerosants used and how sclerotherapy compares to hydrocelectomy. A literature search was conducted of MEDLINE and EMBASE using the terms "sclerotherapy" and "hydrocelectomy," which yielded 1058 studies, of which 29 met the inclusion criteria. Only studies published after 2000 were included to ensure the most recent information was reviewed. The results showed hydrocele sclerotherapy is done using a variety of sclerosants. The most used agents are polidocanol, phenol, and STS. Of these, phenol had the highest clinical success rate of 96.5%. There was evidence for the use of atypical agents, such as tetracycline antibiotics, which yielded cure rates up to 93%, and alcohol, which was found to be especially useful for treating multiseptated hydroceles. The results comparing sclerotherapy to hydrocelectomy indicated hydrocelectomy to be a more effective method in completely curing hydroceles. However, this came at the cost of more complications. Additionally, sclerotherapy was found to be more advantageous for secondary outcomes, such as healthcare costs and burden to patients. In conclusion, this review shows that while hydrocelectomy is more effective, sclerotherapy is a valuable alternative for treating hydroceles. Due to the lack of standardization among studies, a definitive conclusion cannot be made regarding which sclerosant is best to use.
PubMed: 38581354
DOI: 10.1177/08465371241243271 -
The Journal of International Medical... Jan 2024To evaluate the safety and efficacy of bleomycin polidocanol foam (BPF) sclerotherapy for venous malformations (VMs) and analyze the associated clinical outcomes and...
OBJECTIVE
To evaluate the safety and efficacy of bleomycin polidocanol foam (BPF) sclerotherapy for venous malformations (VMs) and analyze the associated clinical outcomes and predictors.
METHODS
We retrospectively assessed BPF sclerotherapy outcomes in 138 patients with VMs. We analyzed pain levels, lesion volume reduction, and subjective perception of response. Logistic regression analysis was performed to identify potential predictors of treatment outcome. Additionally, we carefully monitored and recorded complications.
RESULTS
There was a notable average reduction in lesion volume by 78.50% ± 15.71%. The pain numerical rating scale (NRS) score decreased from 4.17 ± 2.63 prior to treatment to 1.05 ± 1.54 afterward, and 70.3% of the patients experienced effective relief after a single BPF treatment. Multivariate analysis revealed that a high baseline NRS (odds ratio [OR]: 4.026) and elevated activated partial thromboplastin time (APTT, OR: 1.200) were positive predictors of pain reduction. Additionally, a high baseline NRS score (OR: 1.992) and elevated thrombocytocrit (PCT, OR: 2.543) were positive predictors of incomplete postoperative pain relief. Minor complications occurred in 31 (22.46%) patients.
CONCLUSION
BPF sclerotherapy is safe and effective for VMs, resulting in significant reduction in lesion volume, improved symptoms, and minimal complications. APTT and PCT levels are important predictors of pain outcomes following BPF treatment.
Topics: Humans; Bleomycin; Sclerotherapy; Polidocanol; Retrospective Studies; Pain; Polyethylene Glycols
PubMed: 38258803
DOI: 10.1177/03000605231223441