Mohsen, T.A., Zeid, A.A., Meshref, M., Tawfeek, N., Redmond, K., Ananiadou, O.G., & Haj-Yahia, S. (2011). Local iodine pleurodesis versus thoracoscopic talc insufflation in recurrent malignant pleural effusion: A prospective randomized control trial. European Journal of Cardio-Thoracic Surgery: Official Journal of the European Association for Cardio-Thoracic Surgery, 40(2), 282-286.doi: 10.1016/j.ejcts.2010.09.005
The objective of the study was to compare the efficacy and safety of 10% povidone-iodine and thoracoscopic talc insufflation for pleurodesis of recurrent malignant pleural effusions due to metastatic breast cancer.
Forty-two participants were randomized into two groups. Patients assigned to Group A received video-assisted thoracoscopic (VATS) drainage, mechanical adhesiolysis, and 4 g of talc poudrage, while the 20 patients assigned to Group B received VATS drainage, mechanical adhesiolysis, bedside pleurodesis with 20 mL of 10% povidone-iodine diluted in 30 mL of normal saline. Therapeutic thoracentesis was performed in all participants, and pleural fluid volume was recorded and sent for biochemical (pH, LDH, glucose), bacteriologic, and cytologic evaluation. All patients were scheduled for a follow-up every three months at which symptoms and chest x-rays were evaluated, and efficacy of pleurodesis was gauged on three levels: complete (absence of pleural fluid reaccumulation), partial (residual pleural fluid or reaccumulation that remained asymptomatic and not requiring thoracentesis), or failed (necessitating pleural procedures). Success was defined as a normal chest x-ray or radiologic reaccumulation of pleural fluid without recurrence of dyspnea or need for thoracentesis. Repeated ultrasound-guided thoracentesis was provided for patients with failed pleurodesis and reaccumulation of effusion at weekly intervals, and a PleurX® catheter was offered for home management of effusions when required.
This single-site study was conducted in an outpatient setting in the Department of Chest Medicine and Cardiothoracic Surgery in Cairo University Hospitals.
The study was a prospective, randomized controlled trial.
Dyspnea and cough symptoms were improved in all patients after drainage and pleurodesis, and no mortality related to the procedure or perioperative mortality were observed. Survival rates between the two groups and totally at follow-up were 32 patients (76%) at eight months, 22 patients (52%) at two years, and 10 patients (23%) at four years. All had good outcomes with no bleeding complications and were discharged when both radiologic and clinical evidence confirmed complete resolution of pleural effusion. Group B experienced a significantly lesser post-procedural hospital stay (mean 5.7 days [SD = 2 days]) than Group A (mean 4.5 days [SD = 1.1 days]) (p = 0.009). During early follow-up in Group A, successful/complete response was achieved in 19 patients (87%), failure in 2 patients (9%), and partial response with radiologic reaccumulation at two months post-procedure but remaining asymptomatic during the 14 months’ follow-up. Early follow-up in Group B resulted in 17 (85%) complete response, no partial response, and three failures (15%) with recurrence of dyspnea at 33, 41, and 49 days respectively. No loculations were observed in Group B, thus a small-bore chest tube was placed and iodine was used again. In Group A, observed loculations were repeatedly aspirated with an ultrasound guide, and when repeated reaccumulation was experienced, an ultrasound-guided PleurX® catheter was offered. No recurrence was detected at more than six months during follow-up, and no statistical difference between long-term success (four years) rates in Groups A (91%) and B (85%) were observed. Complications of pleuritic pain were observed in four participants of Group A (18%) but none in Group B, and fever was observed in four participants (18%) in Group A, and one participant (5%) in Group B.
Authors concluded that povidone-iodine pleurodesis is a safe and effective alternative to talc pleurodesis in the prevention of recurrent malignant pleural effusion at 30 days post-procedure. Additionally, while chest pain and fever are the most common adverse effects of pleurodesis, those in the iodine-povidone population (Group B) experienced less analgesic requirements and reports of fever, albeit at no statistical significance. Authors also emphasized that the dose of 10% povidone-iodine was administered in dilute form, thereby significantly increasing povidone safety with decreased toxicity when compared to other studies.
Given its good success rate and fewer complications, povidone-iodine appears to be a successful, safe, and cost-effective alternative to talc pleurodesis for palliative management of malignant pleural effusion stemming from metastatic breast cancer.