What is going through your mind when that vessel perforates, the patient starts crashing, anesthetists are unavailable, and all eyes are on you?
OA: First of all, complications are rare events. There will be low training volumes if you simply rely on real-life complication management training. Due to the lack of training on such events, the behavioral response can often be panic and poor decisions.
TR: Complications go hand in hand with any intervention or surgery. As soon as you puncture the patient's skin with a needle, you will expose the patient to the risk of complications. Within IC today, we are fortunate to have a high standard of care, and complications are very rare. The problem in many centers is that the physicians typically lack a proper structure to manage the situation correctly; therefore, major complications often have unexpected outcomes.
OA: Complication management training within IC can be compared to Cardiopulmonary Resuscitation (CPR) training. Performing CPR is a rare event for the majority, and in such situations, the patient's prognosis is poor. However, proper CPR can increase the patient's chance of survival. In IC complication management, there should be a clear and standardized protocol for how to manage the situation, just like with CPR. If a complication occurs, you should not have to think about what to do or complicate the situation by taking steps in the wrong order. Complication management should be an autonomous technical skill, a simple reflex.
TR: There are no complication management courses in the curriculum that you must pass before becoming a consultant IC. Knowledge is transferred during theoretical and real patient training, and you may get to see a few cases at meetings where procedures have gone wrong. However, to our knowledge, there is no formal step-by-step training on how to handle complications.
TR: Since complications are such rare events, they do not impact the daily clinical practice per se. However, we are all aware that a complication can occur at any given time, which builds up inner fear and stress. The increasing complexity of a procedure increases the risk of complications. The fear of complications could be why a number of operators are not doing their best to achieve optimal results in Percutaneous Coronary Intervention (PCI), e.g., such as using different, more aggressive tools for lesion preparation to achieve optimal stent expansion, etc. Many operators know they lack the knowledge and experience to manage potential complications optimally.
TR: The five-point structure we have in place is based on personal experience. We have been engaged in Chronic Total Occlusion (CTO) and complex PCI for several years. To be successful in complex PCI and CTO, you sometimes have to step outside your comfort zone. After many years of experiencing stress, chaos, and disorganization during complications, we realized there had to be a better way to manage it. Oskar and I started to develop the five-point structure by asking ourselves; what are the key elements of proper complication management? We realized that the single most critical element of complication management is to be in control of the situation. Our algorithm brings structure to a chaotic situation and enables us to gain control.
TR: You learn a lot from an unsuccessful procedure or a poorly managed complication, and these cases trigger many thoughts: What happened and why? What did I do right, and what did I do wrong? The thought process goes on for days and weeks after an event and makes you want to improve. The five-point algorithm has evolved over time and is derived from thoughts and evaluations like these.
OA: Always striving to improve your work and workflow is essential regardless of the procedure. Lengthy and complex procedures or procedures with complications are the cases that affect you the most emotionally, and you remember them for a long time. Could I have done something differently?
OA: The awareness of the need for a complication management structure could be higher among healthcare systems or ICs who turn down complex cases. Since they do not take on complex cases, the risk for complications, hence the number of complications they experience, is very low. Complex PCI is evolving rapidly, and more complicated procedures are performed worldwide.
TR: There are some ICs and large healthcare systems that neglect the need for a complication management algorithm. When I have tried to explain Sahlgrenska's five-point structure, some colleagues cannot relate to what I am talking about. Even though they lack the structure and equipment to manage complications during PCI, these centers still perform complex cases. Unfortunately, from my experience, the cases that have gone wrong tend to be ignored, forgotten, and people move on.
OA: Many colleagues often only recall a perforation, not the actual reason for the negative outcome, i.e., the complication was not properly managed.
TR: The five-point structure is a concept created to help gain control over a perforation that occurs as a complication during a PCI procedure. When you gain control over the situation, you buy yourself time to plan the next steps. When a number of operators see a massive perforation, their first reaction is to seal it, which is logical. The problem is that it takes time to seal the perforation; it can be minutes or 30 seconds. Regardless of how fast you can bring the covered stent or coil down into the coronaries, in that time, the patient will deteriorate and be in a much worse condition than before. The first four steps in the algorithm are all about gaining control over the situation. The very last step is to seal the perforation. The five-step algorithm aims to provide the operators with a simple step-by-step guide that will help them to gain control when a complication occurs. The five steps of the complication management structure should turn into instinctual reflexes.
OA: It provides the means to gain control and manage the situation calmly while also ensuring a good working environment.
TR: The complication management structure enables the whole cath lab team to do what they are good at, their job.
TR: No, not another structure per se. As described earlier, it was more the opposite: the lack of structure inspired this algorithm. The structure has slowly developed in my mind during each complication for the past ten years. Seeing some centers with no complication management structure made me want to create a formal structure to teach and pass on to colleagues. 2017 was the year we first put together the five-step algorithm. Sahlgrenska had a structure before this; however, it was never formally put on paper.
TR: It is essential to make the whole cath lab team aware of the structure and ensure that everyone learns it by heart so that it becomes an automatic skill. You cannot turn the algorithm around since that probably will cause the worst outcome for the patient, death. Therefore, like with CPR, the five-point structure must be an automatic skill for the whole cath lab staff. Training should be implemented regularly to keep the algorithm alive. As demonstrated during EuroPCR 2021 and 2022, scenario training with a simulator is ideal. Simulating the stress during a complication is vital, and using manikins such as Laerdal's SimMan Vascular with Mentice technology inside is perfect for scenario training as it creates an immersive training environment. It enables you to simulate the human dynamics and the actual PCI scenario while providing a ping-pong guide.
OA: It is also essential to get accustomed to the equipment; what is needed, what it looks like, how to handle it etc. The equipment should be in a designated place close to the operating rooms. The ideal scenario training takes place in an ordinary PCI lab environment.
TR: This is a difficult question. In most healthcare systems, it is all about production at the end of the day. Closing a cath lab for scenario training for a whole day is tricky; you lose production. However, we must convince the healthcare system management and make them understand that this is essential for patient outcomes. It will not affect the total mortality in a year, but having a program in place is of the highest importance for the individual patient experience and outcome. Implementing a program will affect what the team can do in the cath lab. If we can make the cath lab staff and the operators confident in proper complication management, they will do a better job. Eventually, this will lead to more patients being treated and positively affect patient outcomes as well.
Interested in implementing the approach developed by Dr. Truls Råmunddal and Dr. Oskar Angerås? Their 5-step complication management structure for PCI is available for download.
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