Tunneled Pleural Catheters for Refractory Effusions Attributed to Congestive Heart Failure (TREAT-CHF) Trial

• All cause mortality[ Time Frame: 1 year post-enrollment ]
  All cause mortality
• New York Heath Association (NYHA) functional class[ Time Frame: Change from baseline at 3 time points over the year of follow up (3, 6, and 12 months) ]
  NYHA functional class: I, III, III, or IV
• Incidence of pleural procedures[ Time Frame: 1 year post-enrollment ]
  By convention, the intervention group will have one pleural procedure (TPC placement). Any additional thoracenteses, video-assisted thoracoscopic surgery, or chest tubes on either side of the chest will be documented for both groups. Removal of or manipulation of TPC will not be recorded as an additional pleural procedure.
• Incidence of pleural space or chest wall infection[ Time Frame: 1 year post-enrollment ]
  Pleural space infection is defined as a positive pleural fluid culture. Chest wall infection will be defined clinically, based on the presence of cellulitis surrounding the catheter or catheter tract, or pus draining from the catheter insertion site.
• Incidence of hemothorax[ Time Frame: 1 year post-enrollment ]
  Hemothorax is defined as a pleural hematocrit or red blood cell count (RBC) exceeding 50% that of the serum hematocrit or RBC count.
• Incidence of trapped lung, loculated pleural effusion, and pneumothorax[ Time Frame: 1 year post-enrollment ]
  Trapped lung is defined as a lung that does not expand after pleural fluid drainage leaving a pneumothorax ex-vacuo or hydropneumothorax. Pneumothorax and loculated pleural effusion will be determined based on classic imaging characteristics.
• Incidence of pleurodesis[ Time Frame: 1 year post-enrollment ]
  Incidence of pleurodesis over the one year after enrollement will be measured. Pleurodesis is defined as apposition of the parietal and visceral pleural such: (i) that the subject drains less than 10cc on three serial drainages, (ii) there is resolution of the pleural effusion on both chest x-ray (CXR) and chest ultrasound, (iii) the TPC is removed, and (iv) the pleural effusion does not accumulate after TPC removal as evidence by CXR and chest ultrasound.
• Time to pleurodesis among those who achieved pleurodesis[ Time Frame: 1 year post-enrollment ]
  The number of days from enrollment (control group) or TPC placement (intervention group) to pleurodesis among those who achieved pleurodesis will be recorded. Pleurodesis is defined as apposition of the parietal and visceral pleural such: (i) that the subject drains less than 10cc on three serial drainages, (ii) there is resolution of the pleural effusion on both chest x-ray (CXR) and chest ultrasound, (iii) the TPC is removed, and (iv) the pleural effusion does not accumulate after TPC removal as evidence by CXR and chest ultrasound.
• Change from baseline serum albumin[ Time Frame: Change from baseline at 3 time points over the year of follow up (3, 6, and 12 months) ]
  serum albumin levels
• Change from baseline serum creatinine[ Time Frame: Change from baseline at 3 time points over the year of follow up (3, 6, and 12 months) ]
  serum creatinine levels
• Rate of hemodialysis initiation[ Time Frame: 1 year post-enrollment ]
  We will record patients who develop worsening renal failure, necessitating initiation of hemodialysis

Congestive heart disease (CHF) can frequently cause transudative pleural effusions, some of which do not completely resolve with diuretics alone. These effusions can cause significant morbidity, leading to ongoing dyspnea and hypoxia, resulting in additional office and hospital visits. TREAT-CHF is a randomized trial studying tunneled pleural catheter (TPC) versus standard medical management for the treatment recurrent symptomatic pleural effusions secondary to CHF that are refractory to maximal medical therapy. TREAT-CHF will study whether the addition of a TPC can improve quality of life and minimize health care utilization over the one year following insertion.

• Device: tunneled pleural catheter
  Placement of a tunneled pleural catheter through the chest wall into the pleural space to drain the patient's chronic pleural effusion. The catheter is an indwelling device that will be drained from home three times per week by nursing care, the patient, or patient's family.

• Experimental: Intervention Group
  This group will receive placement of a tunneled pleural catheter to drain their recurrent, chronic, and symptomatic pleural effusion in addition to their usual medication therapy.
• No Intervention: Usual Care
  The control group will continue with medical therapy by their referring physician and serial thoracenteses when clinically appropriate.