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Adaptive Extracorporeal Circulation Circuit:Reducing the risk of complications in cardiac surgery.
Naresuan University Hospital

A. Problem Analysis

 1. What was the problem before the implementation of the initiative?
The World Health Organization (WHO) reported that cardiovascular disease (CVD) is a disease with a high mortality rate. Is the number one cause of death of the world's population. It was found that the population totaling 17.3 million premature deaths, and forecasts for 2030 this will increase to 23 million people. Incidents of heart disease in Thailand are likely to increase in 2013 that killed 54,530 people, an average of 150 people per day, or an average of 6 people per hour. The rate of patients per one hundred thousand in 2012 was 427, up from the year 2004 at a rate equal to 185 sick people. Statistics in 2013 showed that Thailand has a cardiovascular number of 6,623,636 cases. However, patients were given the opportunity to undergo surgery to correct the condition of just 13,968 cases per year, representing only 0.21 percent, of which open heart surgery represented 11,248 cases, whom has a risk of mortality in open heart surgery about 0.5-2.5% and 2.5-5% chance of severe complications. The Heart Center of Naresuan University is located in northern Thailand, is an institute that serves the diagnosis and treatment of cardiovascular disease, including cardiovascular and thoracic surgery. Most of the patients are poor, who lack the opportunity to be treated with surgery. Because the numbers of patients are increasing while the surgery route was limited. Many patients died while waiting for surgery. From the statistics above, leading to the thought process on a patient survival, at least complications to make it worth of opportunity to get surgery. The Cardiac Surgery followed Extracorporeal Circulation as a result, patients will suffer excess water in the body that required water withdrawal by used of ultrafiltration. Ultrafiltration is divided into two types: Conventional Ultrafiltration (CUF) is performed during Extracorporeal Circulation and Modified Ultrafiltration (MUF) is performed after Extracorporeal Circulation. Both procedures can be done by use of a Hemoconcentrator combined with Extracorporeal Circulation by Extracorporeal Circulation Circuit. Usually surgeons are often the only alternative methods, but sometimes the surgeon needs to do two simultaneous methods. We have to use of two different types of Ultrafiltration Circuit, other methods require long periods of time and the need for cutting and replacing the Ultrafiltration Circuit, which took more than five minutes for expelling air bubbles from the Ultrafiltration Circuit has been replaced prior to connect with the patient’s Extracorporeal Circulation Circuit. This process has the risk of infection, the blood or secretions spilled on the floor, the air bubbles in the Extracorporeal Circulation Circuit, which may result in patient death and the worker have injuries from the operation.

B. Strategic Approach

 2. What was the solution?
The Cardiac Surgery followed Extracorporeal Circulation as a result, patients will suffer excess water in the body that required water withdrawal by used of ultrafiltration (CUF or MUF). For CUF+MUF, We have to use of two different types of Ultrafiltration Circuit and the need for cutting and replacing the Ultrafiltration Circuit, which has the risk of infection, the blood or secretions spilled on the floor, the air bubbles in the Extracorporeal Circulation Circuit which may result in patient death and the worker have injuries from the operation. The Adaptive Extracorporeal Circulation Circuit is used for reducing the risk of complications in cardiac surgery followed by Extracorporeal Circulation. There is no need for cutting or replacing the Ultrafiltration Circuit.
 3. How did the initiative solve the problem and improve people’s lives?
In open heart surgery, the use of hypothermic cardiopulmonary bypass (CPB) in Extracorporeal Circulation may result in an increase in tissue water content leading to an increase in total body water for during and after operation. The effect of CPB periods and hemodilution induced inflammatory response contributes to capillary leaks, which can result in pulmonary and myocardial edemas after cardiac operations leading to increased morbidity and mortality. Ultrafiltration has become an important strategy for mitigating the adverse effects of hemodilution associated with the use of CPB. MUF+CUF can reduce fluid accumulation associated with CPB, congestive heart failure and diuretic resistant heart failure, induces hemoconcentration, decreases inflammatory mediators as well as reduces blood loss and duration of mechanical ventilation. MUF also improves the immediate post-bypass hemodynamic, decreases myocardial edema, reduces pulmonary vascular resistance, induces hemoconcentration, reduces bleeding and thus the need for blood transfusions. So MUF+CUF can reduce the morbidity and mortality rate in cardiac operations, but it is limited by the use of two different types of Ultrafiltration Circuit and the need for cutting and replacing the Ultrafiltration Circuit, which has the risk of infection, blood or secretions spilled on the floor, air bubbles in the Extracorporeal Circulation Circuit, lengthier operations, which may result in patient death and the worker have injuries from operation. To Improve the problem, we developed the Adaptive Extracorporeal Circulation Circuit innovative to use for all methods of Hemodilution and also Hemodialysis (MUF+CUF+Hemodialysis) which reducing the risk of complications, reducing the time to change Ultrafiltration circuit methods in cardiac surgery followed Extracorporeal Circulation by no need for cutting or replacing the Ultrafiltration Circuit. So it can be prevented the occurrence of air bubbles in the Extracorporeal Circulation Circuit, risk of infection, the blood or secretions spilled on the floor, the worker have injuries from the operation and reduce the time to change the Ultrafiltration circuit. We used the Adaptive Extracorporeal Circulation Circuit innovative for all methods of Hemodilution and also Hemodialysis for all of the patient, including with poorest patients (most of patients) to reduce morbidity and mortality in cardiac surgery which are increasing in chance to have a better quality of life for all patients.

C. Execution and Implementation

 4. In which ways is the initiative creative and innovative?
Adaptive Extracorporeal Circulation Circuit innovative is different than other Ultrafiltration methods in that it is lesser in operation time and it used for all of Ultrafiltration procedure additional in Hemodialysis and lesser in chance of occurrence in complication. The first phase of the design is to supply existing equipment within the agency for preparation for the Adaptive Extracorporeal Circulation Circuit is available for all Ultrafiltration procedure. By using the Luer connector attached to the blood inlet and the blood outlet port through a 3 way connector. As a result, it can use both CUF and MUF, but it has a problem and cannot not be used continuously because of the need to stop the MUF procedure to take blood from the Extracorporeal Circulation to replace where patients have low blood pressure. The second phase is redesigned using the heart-lung machine blood pumps. And modified by increasing the length of the blood inlet for the blood pump head. The result is usable as MUF and CUF have continued and can take blood from Extracorporeal Circulation at the same time.
 5. Who implemented the initiative and what is the size of the population affected by this initiative?
Perfusionists of Naresuan University Hospital are using the Adaptive Extracorporeal Circulation Circuit innovative for all methods of Hemodilution and also Hemodialysis for all of the patient to reduce morbidity and mortality in cardiac surgery, which covering patients all of the Lower Northern District about 3 million people as a percentage is 4.6 of the total population. This innovation can be applied to cardiac surgery patients throughout the world.
 6. How was the strategy implemented and what resources were mobilized?
For the strategy using SWOT analysis for design, planning, created innovation of ECC available as MUF+CUF, then record the problems and modify to use it, For the resources to be used for innovation consists of Hemoconcentrator 1 pieces, 1 set of Ultrafiltration collection tubing: PVC ¼ inches in diameter, 24 inches in length, 1 pieces of Ultrafiltration collection container:1,000 ml of empty NSS bottle, 1 set of Blood inlet tubing:PVC ¼ inches in diameter, 50 inches in length, 2 pieces of straight connector: 1/4 inch to male connector, 1 set of Blood outlet port: PVC ¼ inches in diameter, 20 inches in length, 1 pieces of 1/2 straight connector with luer, 1 pieces of 3/8 straight connector with luer, 2 pieces of three way connector. The entire device is a waste material from the Extracorporeal Circulation, except for the Hemoconcentrator can be charged from patients. Almost no cost in invents the Adaptive Extracorporeal Circulation Circuit, just only cost of sterilization.
 7. Who were the stakeholders involved in the design of the initiative and in its implementation?
For this innovation the stakeholders are Open Heart Surgery Team, which consist of Cardiovascular and Thoracic Surgeons, Perfusionists, Scrub nurse, Anesthesiologist, Anesthesiologist nurse and the most important is Cardiac Patients and their family. Adaptive Extracorporeal Circulation Circuit to improve service on open heart surgery following Extracorporeal Circulation Circuit, which has been designed to be able with CUF, MUF and Hemodialysis without cutting or replacing the Ultrafiltration circuit. This innovation makes safety by reducing the risk and complications that will occur with the client. They are also able to filter the water and solution and improve customer satisfaction and safety to both service providers and customers. For the cardiac patients has a safety service, no complication and get a good result from pulling out of the blood while the provider has a facilities service, the surgeon has a continued working and overall operative time is faster.
 8. What were the most successful outputs and why was the initiative effective?
The most successful output of this innovative is to be applied to all Ultrafiltration Procedures (MUF, CUF, Hemodialysis) and to all patients (Infant, Pediatric, Young children, Adolescent, Adult) which are the results of the position of blood inlet and blood outlet we chose, its flexibility for all procedure. It can be used for all patients because of the various sizes of connector with luer for each patient. Reduced time to change Ultrafiltration Circuit, the incidence of infection from blood and secretions spilled, the incidence of injuries from cutting Ultrafiltration Circuit, the incidence of the Air bubbles in Extracorporeal Circulation Circuit, all of the above are the resulting from we don’t need to change the Ultrafiltration Circuit so we can take the operative procedure by continuously. The monitoring indicators we use as a basis for monitoring and evaluation of innovative applications to meet the strategy. In case of problems in each step that does not go according to plan, it will have to improve to the goal.
 9. What were the main obstacles encountered and how were they overcome?
From the use of innovations have not found significant problems and risks, including patients not affected or complications from its use. The problem is only in the second phase showed that the filtration rate of each patient is unstable and cannot be filtered continuously by the need to take blood from Extracorporeal Circulation Circuit to replace it, so it has to use the blood pump to solve the filtration rate.

D. Impact and Sustainability

 10. What were the key benefits resulting from this initiative?
For this innovation to improve service on open heart surgery following Extracorporeal Circulation Circuit, which has been designed to be compatible with CUF, MUF and Hemodialysis without cutting or replacing the Ultrafiltration circuit. This innovation improves safety by reducing the risk and complications that will occur with the patients. They are also able to filter the water and solution continuously. For the patients has a safer service, fewer complications and get better results from pulling out of the blood while the provider has a facilities service, surgeons have continuous working and overall operating times are faster. All of the above are responding to the need of patients and their families that required a better quality of life after surgery and improve customer satisfaction and safety both service providers and customers by assessment of customer satisfaction and the incidence of complications from cardiac surgery.
 11. Did the initiative improve integrity and/or accountability in public service? (If applicable)
This innovation is the integration of a participant of the surgical team by using a satisfactory evaluation and the incidence of complications. It can be used with all patients of all age as well as whether poorest or richest which are improving the accountability in public service by increase the chances in the quality of life of patients who underwent cardiac surgery.
 12. Were special measures put in place to ensure that the initiative benefits women and girls and improves the situation of the poorest and most vulnerable? (If applicable)
Because of innovation is applied in all patients, it is useful not only for women and girls, but it’s useful for men and boys and everyone of all ages. This innovation improves the chances of having a better quality of life after surgery for all patients, especially the poorest and the vulnerable people, because most of our patients are poor and vulnerable people.

Contact Information

Institution Name:   Naresuan University Hospital
Institution Type:   Government Department  
Contact Person:   Anuchit Man-in
Title:   Mr.  
Telephone/ Fax:   +6655965160
Institution's / Project's Website:  
E-mail:   oyamakero@gmail.com  
Address:   99 Moo 9 Tambon Tha Pho
Postal Code:   65000
City:   Muang Phitsanulok
State/Province:   Phitsanulok
Country:  

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