Safety and efficiency of femoral artery access closure with a novel biodegradable closure device: a prospective single-centre pilot study.

OBJECTIVES: Vascular closure devices can accelerate haemostasis after arteriotomy, but induce scarring. The aim of the study was to prospectively analyse the feasibility of a novel biodegradable arterial closure device (CD). METHODS: Two hundred fifty-five patients (183 male; age 36-98 years) with an access vessel diameter >3 mm received the biodegradable CD after endovascular therapy. Technical success rate, time-to-haemostasis (TTH) and time-to-ambulation (TTA) were measured. Puncture site complications were categorized as minor (local hematoma, minor bleeding) or major (pseudoaneurysm, embolization, dissection, thrombotic occlusion, hematoma/major bleeding requiring surgery, access site infection). RESULTS: Technical success was achieved in 98.8 % (252 cases); device failure occurred in three cases (1.2 %). The average TTH and TTA were 11.3 ± 26.9 s and 73.0 ± 126.3 min. The major complication rate was 1.6 %, with three pseudoaneurysms and one retroperitoneal bleeding. The minor complication rate was 2.0 %, with five small hematomas. Neither cardiovascular risk factors nor access vessel characteristics had statistically significant influence on adverse events. Re-puncture was uncomplicated in 32 cases after 155.0 ± 128.8 days. CONCLUSIONS: Handling of the new biodegradable CD is safe. The complication rates are tolerably low and comparable to other CDs. Post-procedural sonography showed no significant palpable subcutaneous changes in the access site. KEY POINTS: • VCDs can increase time efficiency and patient comfort after intervention. • In this prospective single-centre-study, biodegradable CD was safe and easily applicable. • Its major and minor complication rates are comparable to other CDs. • Its mean time-to-haemostasis and time-to-ambulation were 11.3 ± 26.9 s and 73.0 ± 126.3 min. • Post-procedural sonography showed no significant palpable subcutaneous changes at the access site.

Treatment of male varicoceles by transcatheter polidocanol foam sclerotherapy: evaluation of clinical success, complications, and patients' satisfaction with regard to alternative techniques.

OBJECTIVES: We report our experience with polidocanol foam sclerotherapy with no additional coils, evaluating clinical success, patients' satisfaction, and complications. METHODS: We conducted a retrospective study of 141 patients with 146 varicoceles (mean age: 29.3 years; range: 13 - 60 years) who underwent foam sclerotherapy with polidocanol 2% (range: 2 - 12 ml) in an outpatient setting between January 2007 and December 2013. For the follow-up, telephone interviews with the patients were conducted (mean follow-up time: 46.4 months, standard deviation: 20.17 months). RESULTS: The technical success rate was 91.8%. There was a 55.8% response rate to the telephone interviews. Follow-up revealed a clinical success rate of 83.9% and a persistence or relapse rate of 16.1%. Of the patients, 81.9% were absolutely satisfied with the outcome. In 94.9% of cases, pain or discomfort resolution was reported, and in 97% of cases, aesthetic issues were no longer a problem. Of partners, 63.2% achieved pregnancy, and in 50% of patients with preprocedural testicular atrophy, catch-up growth was observed. One patient with pampiniform plexus phlebitis received inpatient treatment with no long-term damage recorded. CONCLUSIONS: Polidocanol foam varicocele sclerotherapy is a safe and effective procedure, with a high rate of patients' satisfaction, clinical and technical success, and considerable catch-up growth and pregnancy achievement. KEY POINTS: • Varicocele treatment using polidocanol foam sclerotherapy is a safe and effective procedure. • It is easily feasible in an outpatient setting. • The clinical and technical success rates are high. • It shows a high rate of patients' satisfaction and symptom resolution. • Postinterventional catch-up growth and pregnancy achievement are considerable.