ABSTRACT
BACKGROUND: This study was carried out to assess the effectiveness of alprostadil (prostaglandin E1) when used as an adjuvant therapy with indirect revascularization in patients with critical limb ischemia (CLI) after the failure of direct revascularization (DR). METHODS: At our centers, 120 patients suffering from infrainguinal peripheral arterial disease with CLI underwent a failed trial of DR procedure, all revascularization procedures were endovascular. Median follow-up was 2 years and 2.5 years for patients with and without diabetes mellitus (DM). In the alprostadil group, the mean age was 63.41 ± 12.52; 36 (60%) for males and 24 (40%) for females. Post-endovascular intervention alprostadil was administrated immediately postoperatively by intravenous infusion of 40 µg alprostadil diluted in 100 ml of normal saline, over 2 hr every 12 hr for 6 days. RESULTS: In the alprostadil group, the mean ± standard deviation (SD) of the baseline ankle-brachial index (ABI) was 0.45 ± 0.175, while the mean ± SD of ABI at the end of our study was 0.65 ± 0.216 with a difference from the baseline of 0.2 ± 0.041 (P value = 0.08, <0.05 meaning that it is significant). Our 1-month primary patency rate was 93.3%, while our 3- and 6-month patency rate was 92.9%. In the control group, the mean ± SD of the baseline ABI was 0.68 ± 0.22, while the mean ± SD of ABI at the end of our study was 0.69 ± 0.23 with a difference from the baseline of 0.01 ± 0.01 (P value >0.05 meaning that it is nonsignificant) 1-month patency rate was 89%, while 3- and 6-month patency rate was 75%. When we compared the patient's leg vessels before and after our intervention, we found that the percentage of the no-runoff-vessels group decreased from 10 (16.7%) to 4 (6.67%). One-runoff-vessel group percentage dropped from 40 (66.7%) to 36 (60%), whereas, in the two-runoff-vessel group, the percentage increased from 10 (16.7%) to 20 (33.3%). We evaluate leg arteries; we do no pedal arch intervention in the alpostradil group. Out of the total of 60 patients, limb salvage occurred in 58 (96.7%) patients, and 2 (3.3%) patients underwent below-the-knee amputation before the study ended. CONCLUSIONS: Our results show the efficacy and safety of alprostadil as an adjuvant therapy with indirect angiosomal revascularization in patients with tissue loss due to CLI.
Subject(s)
Alprostadil , Ankle Brachial Index , Critical Illness , Ischemia , Limb Salvage , Peripheral Arterial Disease , Vascular Patency , Humans , Alprostadil/administration & dosage , Alprostadil/adverse effects , Male , Female , Aged , Middle Aged , Time Factors , Peripheral Arterial Disease/physiopathology , Peripheral Arterial Disease/therapy , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/drug therapy , Ischemia/physiopathology , Ischemia/therapy , Ischemia/drug therapy , Ischemia/diagnosis , Treatment Failure , Endovascular Procedures/adverse effects , Infusions, Intravenous , Vasodilator Agents/administration & dosage , Vasodilator Agents/adverse effects , Lower Extremity/blood supply , Amputation, Surgical , Treatment Outcome , Risk Factors , Retrospective StudiesABSTRACT
BACKGROUND: Evaluation of the efficacy and safety of cyanoacrylate closure (CAC) for treating incompetent great saphenous veins (GSVs) compared to radiofrequency ablation (RFA). METHODS: In this prospective, randomized controlled study, 248 symptomatic subjects with incompetent GSVs were assigned to either CAC or RFA. The primary end point, complete closure of the target GSV, was determined using a duplex ultrasound examination. RESULTS: In this study, 248 patients (mean age 33.64 ± 8.06 years including 71% women) were treated with either CAC (n = 128) or RFA (n = 120) between August 2018 to May 2022. As a follow-up, after a 1-month duration, the closure rates were 128/128 at the CAC and 154/158 at the RFA. At month 24, closure rates were 122/128 at CAC and 146/158 at RFA. Apart from phlebitis and pigmentation, the incidences of bruising, skin burn, and paresthesia were lower in the CAC group compared to the RFA group. The mean procedural times were shorter for CAC. The satisfaction level with the treatment was moderately higher among CAC patients than RAF patients. CONCLUSIONS: This study suggests that Cyanoacrylate glue closure of the GSV and RFA are effective techniques for managing primary varicose veins. Cyanoacrylate glue closure of the GSV appears to have a lower rate of complications and higher satisfaction levels, rapid return to normal activities, and improved procedure time without the need for perivenous tumescent anesthesia and postprocedure compression stockings when compared to RFA.
