Prostatic Artery Embolization (PAE) Using Polyethylene Glycol Microspheres: Safety and Efficacy in 81 Patients.

PURPOSE: To evaluate the safety and efficacy of prostatic artery embolization (PAE) using polyethylene glycol microspheres (PEGM) in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: This multicentric prospective study enrolled 81 patients who underwent PAE with 400 ± 75 µm PEGM (HydroPearl®, Terumo, Japan). Results from baseline and 1-, 3-, 6-, and 12-month follow-ups were assessed for subjective outcomes including International Prostate Symptoms Score (IPSS), Quality of life (QoL), and International Index of Erectile Function, and objective outcomes such as peak urinary flow (Qmax) and post-void residual volume (PVR). The visual analogue scale, satisfaction questionnaire, prostatic volume, and prostatic specific antigen levels were also evaluated. Complications were documented using the modified Clavien-Dindo classification. RESULTS: Technical success was obtained in all patients. Clinical success was achieved in 78.5% of patients. Before PAE, 54.3% of patients had an indwelling catheter which was removed in 75% of them after procedure. A statistically significant decrease was observed in IPSS and QoL from baseline to 12 months (20.14 vs 5.89; 4.8 vs 0.63, P < .01), respectively. Objective outcomes also showed a statistically significant improvement in Qmax (+ 114.9%; P < .01), achieving a maximum urinary flow of 14.2 mL/sec, and PVR (decrease 58%; P < .05) at 12 months. Minor complications (Clavien-Dindo grades I-II) occurred in 13.6% of patients, without major complications observed. CONCLUSION: PAE with PEGM is safe and effective treatment in patients with symptomatic BPH, with a significant improvement in both subjective and objective outcomes.

Randomized Comparison of Prostatic Artery Embolization versus Transurethral Resection of the Prostate for Treatment of Benign Prostatic Hyperplasia.

PURPOSE: To compare clinical and functional outcomes of prostatic artery embolization (PAE) with those of transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: Noninferiority randomized trial was conducted involving men over 60 years of age with LUTS secondary to BPH. From November 2014 to January 2017, 45 patients were randomized to PAE (n = 23) or to TURP (n = 22). PAE was performed with 300- to 500-µm microspheres with the patient under local anesthesia, whereas bipolar TURP was performed with the patients under spinal or general anesthesia. Primary outcomes were changes in peak urinary flow (Qmax) and international prostate symptoms score (IPSS) from baseline to 12 months. Quality of life (QoL), and prostate volume (PV) changes from baseline to 12 month were secondary outcomes. Adverse events were compared using the Clavien classification. RESULTS: Mean Qmax increased from 6.1 mL/s in the PAE group and from 9.6 mL/s in the TURP patients (P = .862 for noninferiority), and mean IPSS reduction was 21.0 points for PAE and 18.2 points for TURP subjects (P = .080) at 12 months. A greater QoL improvement was reported in the PAE group (3.78 points for PAE and 3.09 points for TURP; P = .002). Mean PV reduction was 20.5 cm³ (34.2%) for PAE subjects and 44.7 cm³ (71.2%) for TURP subjects (P < .001). There were fewer adverse events reported in the PAE group than in the TURP group (n = 15 vs n = 47; P < .001). CONCLUSIONS: Reduction of LUTS in the PAE group was similar to that in the TURP group at 12 months, with fewer complications secondary to PAE. Long-term follow-up is needed to compare the durability of the symptomatic improvement from each procedure.

Cryoplasty versus conventional angioplasty in femoropopliteal arterial recanalization: 3-year analysis of reintervention-free survival by treatment received.

PURPOSE: To compare long-term efficacy of cryoplasty therapy versus conventional angioplasty in the treatment of peripheral arterial atherosclerotic stenosis on the basis of our 3-year clinical experience. MATERIALS AND METHODS: From January 2006 to December 2008, a total of 155 patients with 192 lesions of the femoropopliteal sector were randomized to receive either cryoplasty or conventional balloon angioplasty. The primary study end point was lesion target patency. Follow-up with clinical evaluation of patient's symptoms, ankle-brachial index, and Doppler ultrasound was scheduled at 1, 6, 9, 12, 24, and 36 months. RESULTS: For the cryoplasty group (n = 86), technical immediate success was achieved in 74.4% of lesions. Rate of significant dissection was 13.5% and rate of stent placement of 22%. In the long term, target lesion patency rate at 6 months was 59.4%, with rates of 55.9, 52.6, and 49.1% at 1, 2, and 3 years, respectively. For the conventional angioplasty group (n = 69), the immediate technical success rate was 83.7%. Rate of significant dissection was 19%, and rate of stent placement was 72.9%. Patency rates at 6 months and at 1, 2, and 3 years were 71.5, 61.2, 60, and 56%, respectively. CONCLUSION: Compared with conventional angioplasty, cryoplasty showed good immediate success rates with lower stent placement rates. During the 3-year follow-up, patency rates tended to equalize between the two modalities.