Proactive Protocols to Reduce Complications After Cardiac Surgery

Improving outcomes and reducing costs is a continual effort in modern healthcare. For heart surgery patients, a good place to start is by focusing on something that is common to nearly all patients recovering. All cardiac surgery patients have some degree of bleeding postoperatively, and chest tubes are used to evacuate this blood from the pleural and/or pericardial spaces. Studies have shown that higher chest tube output is statistically associated with longer ICU stays, more complications, higher costs, and a greater risk of mortality. (1, 2)

The tipping point in terms of patient outcomes occurs early in the recovery period, within the first six hours postoperatively, and when total chest tube output exceeds 200mL in any one-hour period.(1) A part of the problem may not be what is evacuated, but what is not evacuated.(2) Chest tube clogging, which has been found to occur in 36% of heart surgery patients, can cause blood to be retained around the heart and lungs, which can lead to Retained Blood Complex  (RBC).(3) Chest tube clogging is also statistically associated with more complications, including atrial fibrillation.(3)

The link between outcomes and postoperative bleeding has led many hospitals to look at their postoperative evacuation management protocols. Nurses in the postoperative ICU, among many other things, monitor chest tube output, check for indications that the tubes are obstructed, and notify the physicians if chest tube output suddenly ceases or reaches an alarming level. In the absence of defined tube management protocols to address chest tube clogging, however, clinicians use makeshift methods  like milking, tapping, stripping, and open suction. These approaches are all reactive, and none have been shown to have clinical benefit. (4-6) By the time clot is visualized in the chest tubes, the evacuation has often been impaired for some time, allowing blood and clot  to accumulate in the pleural and/or pericardial spaces. 

Proactive clearance with PleuraFlow ACT, however, has been shown to be clinically efficient (Perrault), to improve the evacuation of post-surgical blood, and to reduce the volume of blood retained in the surgical spaces.(7, 8) With PleuraFlow ACT, the only FDA cleared chest tube clearance system, hospitals are now developing chest tube clearance protocols to proactively prevent chest tube clogging. By actively and systematically maintaining chest tube patency, top hospitals are working to improve the efficiency of chest tube management, and potentially decrease incidence of RBC complications by reducing the volume of retained post-surgical blood.  

For more information about how the PROACT program and PleuraFlow ACT can help your facility address this common and costly problem, contact us.

1. Dixon, B., Santamaria, J.D., Reid, D., Collins, M., Rechnitzer, T., Newcomb, A.E., Nixon, I., Yii, M., Rosalion, A., and Campbell, D.J. 2012. The association of blood transfusion with mortality after cardiac surgery: cause or confounding? Transfusion.
2. Christensen, M.C., Dziewior, F., Kempel, A., and von Heymann, C. 2012. Increased chest tube drainage is independently associated with adverse outcome after cardiac surgery. J Cardiothorac Vasc Anesth 26:46-51.
3.  Karimov JH, Gillinov A M, Schenck L, Cook M, Kosty Sweeney D, Boyle EM, Fukamachi K. Incidence of chest tube clogging after cardiac surgery: a single-centre prospective observational study. Eur J Cardiothorac Surj 2013; 1-8.
4. Wallen M, Morrison A, Gillies D, O’Riordan E, Bridge C, Stoddart F. Mediastinal chest drain clearance for cardiac surgery. Cochrane Data- base of Systematic Reviews 2002.
5. Pierce JD, Piazza D, Naftel DC. Effect of two chest tube clearance protocols on drainage in patients after myocardial revascularisation surgery. Heart and Lung 1991;20:125–130.
6. Isaacson JJ, Brewer MJ. The effect of chest tube manipulation on mediastinal drainage. Heart and Lung 1986;15:601–605
7. Shiose, A.; Takaseya, T.; Fumoto, H.; Arakawa, Y.; Horai, T.; Boyle, E. M.; Gillinov, A. M.; Fukamachi, K. “Improved drainage with active chest tube clearance.” Interactive CardioVascular and Thoracic Surgery 10 (5): 685–688.
8. Arakawa, Yoko; Shiose, Akira; Takaseya, Tohru; Fumoto, Hideyuki; Kim, Hyun-Il; Boyle, Edward M.; Gillinov, A. Marc; Fukamachi, Kiyotaka. “Superior Chest Drainage With an Active Tube Clearance System: Evaluation of a Downsized Chest Tube.” The Annals of Thoracic Surgery 91 (2): 580–583.

Click to Download Study

Louis P. Perraut, Michel Pellerin, Michel Carrier, Raymond Cartier, Denis Bouchard, Philippe Demers, Edward M. Boyle. Innovations 2012; 7(5):354-358

This initial clincial experience found found that the PleuraFlow system was easily incorporated into the postoperative workflow of managing the drainage of patients after heart surgery. The PleuraFlow system was easily understood by the nurses in the ICU and the use of the device was obvious to learn, efficient, and effective.

“PleuraFlow may be useful to allow caregivers to be certain that chest tubes are functioning in the early hours after surgery, when active bleeding is resolving and when complications from undrained blood can ensue.”

Click to Download Study

Yoko Arakawa, Akira Shiose, Tohru Takaseya, Hideyuki Fumoto, Hyun-Il Kim, Edward M. Boyle, A. Marc Gillinov and Kiyotaka Fukamachi. Ann Thorac Surg 2011; 91:580-583

As a followup to the previous study, this preclinical study performed in the laboratories of the Cleveland Clinic compared 20 Fr PleuraFlow® ACT Systems to 32 Fr conventional chest tubes. In another head to head comparison in the setting of heavy bleeding, downsized PleuraFlow systems evacuated significantly more blood from the chest, resulting in significantly less retained blood in the chest cavicty. This is the first time a small diameter tube has not only been found to be equivalent to a larger tube, but in fact superior.

Click to Download Study

Akira Shiose, Tohru Takaseya, Hideyuki Fumoto, Yoko Arakawa, Tetsuya Horai, Edward M. Boyle, A. Marc
Gillinov and Kiyotaka Fukamachi. Interactive CardioVascular and Thoracic Surgery 2010; 10:685–688

A preclinical study performed in the laboratories of the Cleveland Clinic compared 32 Fr PleuraFlow® ACT
Systems to 32 Fr conventional chest tubes. In a head to head comparison with a same sized conventional chest
tube in the setting of heavy bleeding, the PleuraFlow evacuated significantly more blood from the chest, resulting in significantly less retained blood in the chest cavicty.

Click to Download Study

Shanaz Shalli, Diyar Saeed, Kiyotaka Fukamachi, A. Marc Gillinov, William E. Cohn, Louis Perrault, Edward M. Boyle. J CARD SURG 2009;24:503-509

A survey of North American cardiothoracic surgeons and specialty cardiac surgery nurses performed to better define problems with current
paradigms for chest drainage.

• 100% of surgeons had observed chest tube clogging
• 87% of surgeons reported adverse patient outcomes from a clogged chest tube
• 87% of surgeons reported that they use larger diameter chest tubes due to the concern for the potential for chest tube clogging
• 51% of surgeons stated that they are not satisfied with currently available tubes and procedures to avoid tube occlusion
• 74% of surgeons believe that patient discomfort is impacted by the diameter of chest tubes used
• 72% of nurses reported that their institution does not allow nurses to strip chest tubes
• 75% of nurses report that managing chest tube clogging takes them away from other important tasks.

At the end of every open-heart surgery, surgeons place chest tubes in the surgical spaces to evacuate any post-surgical blood and/or fluid until normal coagulation is restored and hemostasis is achieved. The goal is to evacuate as much of the blood from these spaces as possible before the chemically thinned blood undergoes the phase change from liquid to solid as the coagulation system is restored. Any blood that is not effectively evacuated will naturally turn to clot, which the body then has to break down in a process called lysis. Depending on the volume of blood clot retained, this process can cause additional clinical complications that can last for weeks or months, and is a leading cause of hospital readmission.

Therefore, the challenge for post-op care staff is to get the blood out before the phase change to solid clot occurs. When clots are observed in the chest tubes where they exit the skin, the obvious response is to try to get them out to keep the tubes open and flowing. For decades, nurses have used three main makeshift bedside manipulations termed tapping, milking, and stripping to try to accomplish this. Tapping and milking, generally less aggressive techniques, involve either tapping the outside of the tube or progressively squeezing the clots down the tubing. Stripping, which is done by hand or with special rollers, is done by squeezing, then pulling the length of tube through the fingers or rollers. Despite these and other techniques, a recent prospective study found that 36% of patients had chest tubes clog after heart surgery.(2)

In published studies these techniques have never been shown to have any clinical benefit.(3-7) And worse, stripping has been shown to cause negative pressure bursts up to -400 cm H₂O (20 times the suction pressure that is routinely applied to chest tubes after surgery) giving it the potential of causing tissue injury, and potentially re-initiating bleeding.(7) This may be why 71% of nurses surveyed report that their institutions do not allow nurses to strip chest tubes.(1) 

Why don’t milking and stripping work? Probably because 86% of clogged chest tubes are clogged inside the patient and aren’t visible to clinicians.(2) By the time a nurse observes clots in the external portion of the chest tube, the portion inside the patient is most likely already obstructed, and clot is forming or has formed inside the patient. Breaking up the clots in the visible portion of the chest tube by milking and stripping won’t clear the clog inside the patient. And opening the tube and using a suction catheter to clear the clog may evacuate any leftover non-clotted blood, but the solids that have formed inside the chest are, for the most part, there to stay without significant intervention.

Why not be more proactive  in preventing these problems? PleuraFlow ACTenables clinicians to actively clear chest tube obstructions, even those not visible externally. Combined with a systematic blood evacuation strategy, clinicians can proactively prevent chest tube clogging and maximize the evacuation of post-surgical blood.

1. Shalli S, Saeed D, Fukamachi K, Gillinov AM, Cohn WE, Perrault LP et al. Chest tube selection in cardiac and thoracic surgery: a survey of chest tube-related complications and their management. J Card Surg 2009;24: 503–9.
2. Karimov JH, Gillinov A M, Schenck L, Cook M, Kosty Sweeney D, Boyle EM, Fukamachi K. Incidence of chest tube clogging after cardiac surgery: a single-centre prospective observational study. Eur J Cardiothorac Surj 2013; 1-8.
3.  Isaacson JJ, Brewer MJ. The effect of chest tube manipulation on mediastinal drainage. Heart and Lung 1986;15:601–605.
4.  Lim-Levy F, Babler SA, De Groot-Kosolcharoen J, Kosolcharoen P, Kroncke GM. Is milking and stripping chest tubes really necessary? Ann Thorac Surg 1986;42:77–80.
5.  Pierce JD, Piazza D, Naftel DC. Effect of two chest tube clearance protocols on drainage in patients after myocardial revascularisation surgery. Heart and Lung 1991;20:125–130.
6. Wallen M, Morrison A, Gillies D, O’Riordan E, Bridge C, Stoddart F. Mediastinal chest drain clearance for cardiac surgery. Cochrane Data- base of Systematic Reviews 2002.
7. Duncan C, Erickson R. Pressures associated with chest tube stripping. Heart and Lung 1982;11:166–171.

In a recently published prospective, single center study from the Cleveland Clinic, investigators inspected the chest tubes of 100 cardiac surgery patients and found that 36% of these patients had clogged chest tubes.(2) Clogging was significantly more common after urgent procedures, reoperative procedures, and those with intraoperative blood use. Patients with clogged chest tubes tended to have longer hospital stays, more renal failure, and a trend toward higher rates of stroke and cardiac arrest.  One notable finding was that patients with chest tube clogging had a statistically significant increase in post-operative atrial fibrillation, a common complication after cardiac surgery that increases length of stay and readmissions.

Perhaps most surprising is that of the chest tubes that were clogged, 86% were not visibly recognizable by clinicians because the obstructions formed in the portion of the chest tube inside the patient (see illustration above). Though chest tube clogging is associated with serious complications, most of the time it goes unobserved and unaddressed.

One way to prevent chest tube clogging is to actively clear the chest tubes during the early recovery period. PleuraFlow ACT enables clinicians to actively prevent chest tube clogging, which studies have shown can improve the evacuation of post-surgical blood.(3, 4) PleuraFlow also provides clinicians with real-time feedback about obstructions that form in the portion of the chest tube inside the patient. This addresses the problem identified in this study where clogs go unnoticed and unaddressed.

Chest tube clogging occurs in more than one in three cardiac surgery patients, is statistically significantly associated with serious postoperative complications, and mostly goes unobserved. Doesn’t it seem like the right time to be PROACTive with this problem?

1)    Shalli S, Saeed D, Fukamachi K, Gillinov AM, Cohn WE, Perrault LP et al. Chest tube selection in cardiac and thoracic surgery: a survey of chest tube-related complications and their management. J Card Surg 2009;24: 503–9.

2)    Karimov JH, Gillinov A M, Schenck L, Cook M, Kosty Sweeney D, Boyle EM, Fukamachi K. Incidence of chest tube clogging after cardiac surgery: a single-centre prospective observational study. Eur J Cardiothorac Surj 2013; 1-8.

3)    Shiose, A.; Takaseya, T.; Fumoto, H.; Arakawa, Y.; Horai, T.; Boyle, E. M.; Gillinov, A. M.; Fukamachi, K. “Improved drainage with active chest tube clearance.” Interactive CardioVascular and Thoracic Surgery 10 (5): 685–688.

4)    Arakawa, Yoko; Shiose, Akira; Takaseya, Tohru; Fumoto, Hideyuki; Kim, Hyun-Il; Boyle, Edward M.; Gillinov, A. Marc; Fukamachi, Kiyotaka. “Superior Chest Drainage With an Active Tube Clearance System: Evaluation of a Downsized Chest Tube.” The Annals of Thoracic Surgery 91 (2): 580–583.

Unsatisfied with conventional single lumen drainage tubes that frequently clotted off, cardiac surgeons started to explore different drain geometries with the hope of improving evacuation. Channel, or Blake drains, have multiple open channels inside the patient (AB), transition to a closed off section (BC), and finally to a complete tube (CD). The thought was that by providing multiple channels for the fluid to travel through, the tubes would be less susceptible to clogging.

In the open section of the drain (AB), evacuation is thought to work by “capillary” action. Suction in the closed section of the tube draws liquid into the tube, and the cohesive force between the liquid molecules perpetuates the evacuation. We’ve all observed this by watching water “climb” a paper towel, and this form of evacuation works great when evacuating less viscous fluid, like very thin serosanguinous fluid. However, blood in the post-surgical space undergoes a phase change from liquid to solid when coagulation is restored post operatively and the blood encounters the artificial materials of the chest tube. Now consider draining a jar of peanut butter with a paper towel: the oil will soak into the paper towel, but the cohesive attraction is not strong enough to move the solids, which are left behind. Similarly, when blood begins to coagulate, the channels are able to draw the liquid portion of the blood through the drain, but the solid portion is left behind (Fig 1).   Channel (Blake) Drain Cross-Sections.This solid portion is a strong nidus for subsequent effusion production.

Compounding this problem is that at the transition point (BC), the channels form four small paths through which the blood must pass, each of which make up less than a quarter of the internal tube diameter. These paths can easily become clogged with thrombus (Fig. 2) and shut off the evacuation of blood from the chest. When blood finally reaches the tubular section of the drain (CD), it has the same propensity to clog the tube as it does in conventional tubular chest tubes (Fig 3). Though the exact incidence of channel drain clogging is unknown, life-threatening events have been reported because of channel drain clogging after thoracic surgery.(4) For these reasons, studies have shown that channel drains do not improve the evacuation of post surgical blood compared to conventional chest tubes.(5, 6)

So what does improve postoperative blood evacuation? PleuraFlow ACT has been shown not only to improve postoperative evacuation, but to reduce the volume of blood retained in the thorax, even in downsized chest tube systems.(7, 8) So after all the effort in tube innovation, the solution is really quite simple– proactively clear away the clots that form inside of the tube to improve evacuation, prevent retained blood, and clear the pathway to recovery.

1. P. Kumar, D. McKee, M. Grant, J. Pepper. Phosphatidylcholine coated chest drains: are they better than conventional drains after open heart surgery? European Journal of Cardio-thoracic Surgery 11 (1997) 769–773.
2. Beaudet, RL. New technique for drainage after cardiac surgery. J Thorac Cardiovasc Surg.  78 (1979) 119-22.
3. Duncan C, Erickson R, Weigel R. Effect of chest tube management on drainage after cardiac surgery. Heart Lung. 1987;16(1):1-9.
4. Clark G, Licker M, Bertin D, Spiliopoulos A (March 2007). “Small size new silastic drains: life-threatening hypovolemic shock after thoracic surgery associated with a non-functioning chest tube”. Eur J Cardiothorac Surg 31 (3): 566–8.
5. Staffan Bjessmo, Susanne Hylander, Jenny Vedin, Dag Mohlkertb, Torbjo ̈rn Ivert. Comparison of three different chest drainages after coronary artery bypass surgery — a randomised trial in 150 patients. European Journal of Cardio-thoracic Surgery 31 (2007) 372—375.
6. Timothy L. Frankel; Peter C. Hill; Sotiris C. Stamou; Robert C. Lowery; Albert J. Pfister; Arvind Jain; and Paul J. Corso. Silastic Drains vs Conventional Chest Tubes After Coronary Artery Bypass. CHEST 124(2003) 108-113.
7. Shiose, A.; Takaseya, T.; Fumoto, H.; Arakawa, Y.; Horai, T.; Boyle, E. M.; Gillinov, A. M.; Fukamachi, K. “Improved drainage with active chest tube clearance.” Interactive CardioVascular and Thoracic Surgery 10 (5): 685–688.
8. Arakawa, Yoko; Shiose, Akira; Takaseya, Tohru; Fumoto, Hideyuki; Kim, Hyun-Il; Boyle, Edward M.; Gillinov, A. Marc; Fukamachi, Kiyotaka. “Superior Chest Drainage With an Active Tube Clearance System: Evaluation of a Downsized Chest Tube.” The Annals of Thoracic Surgery 91 (2): 580–583.
9. Noriaki Sakakura, Takayuki Fukui, Shoichi Mori, Shunzo Hatooka, Kohei Yokoi and Tetsuya Mitsudomi. Fluid Drainage and Air Evacuation Characteristics of Blake and Conventional Drains Used After Pulmonary Resection
Ann Thorac Surg 2009;87:1539-1545

“It was evident that RBC plays a significant role in cardiac surgery care, as there was considerable interest in the clinical aspects of preventing cardio respiratory compromise, as well as the link between RBC and effusions.,” said Dr. Boyle.    Attendees engaged during a question-answer session about how PROACT and PleuraFlow ACT might reduce the occurrence of these complications, improve patient outcomes, and decrease hospital readmissions and healthcare costs.

Clear Catheter Systems is a Bend, Oregon based medical device company pioneering clearable catheter systems to solve the clinical problems caused by internally obstructed medical tubes. The company’s proprietary Active Clearance Technology™ (ACT) is being developed for a platform of surgical catheter systems. Clear Catheter System’s lead product is the PleuraFlow® ACT system, an award winning technology developed by cardiothoracic surgeons that has been proven to improve thoracic drainage.

Clear Catheter is seeking clinical specialists to provide technical and clinical training and sales support. If you have a passion for patient care, solid clinical competency, are a self-motivator and thrive in a fast-paced environment, this is an ideal position for you. Sound like a good fit? Submit your resume to teambuilding@clearcatheter.com.

Position Title: Clinical Specialist

Description: Provide technical/clinical training and sales support to customers in assigned territory in order to assist in achieving company sales objectives

Reports To: This position reports to the Chief Commercial Officer

Primary Responsibilities and Duties:

• Deliver customer training using demonstrated ability to effectively perform an installation and training session per the installation and training presentation guidelines.  Implement effective follow-up training to coach, confirm, and monitor efficacy, and develop physician(s) and nursing champions within the clinical sites.  Confirm clinical Certification in accounts according to the Certification Guidelines.

• Develop site specific product implementation protocols, follow up schedules  and facilitate compliance audits and reporting

• Promote marketing messaging to support sales to ensure accounts within territory are performing.  This includes patient brochures, patient consultant presentation, updated website, patient seminars, direct mail campaigns, etc.

• Maintain updated knowledge of the industry and competitive products

• Facilitate patient enrollment and data collection in site studies

• Collect site data about product use, clinical impressions and feedback

• Troubleshoot clinical site implementation challenges

Secondary Responsibilities and Duties:

• 60-75% travel required to customer accounts, patient seminars, trade shows, workshops, special events or other field co-travel

• Demonstrate a strong work ethic and represent company with high integrity, ethics, honesty, loyalty and professionalism, to include professional standard of dress and courtesy at all times

• Maintain consistent communication with Regional Sales Manager on all matters related to the territory

Experience, Education, Training, Skills, Traits:

• BA/BS in nursing, PA, NP or other health care field or 4 year degree with health care/clinical experience.

• Minimum of 5 years work experience in a clinical or health care field.  Experience in the cardiac surgery/ICU setting preferred

• Must have previous training experience in cardiac surgery ICU or OR setting

• Excellent communication skills (written/verbal) and interpersonal skills are required

• Must have clear, confident oral presentation skills

• Strong organizational skills including the ability to plan effectively, and manage multiple, complex tasks simultaneously

• Ability to effectively work independently

• Proficiency in MS Office applications, including Outlook, Word, Excel and Powerpoint

Language and Verbal Skills

Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.  Must have clear, confident oral presentation skills.

Physical Requirements

Duties of this job may involve standing and/or walking for extended periods of time.

Submit your resume to teambuilding@clearcatheter.com