Investigators from the Cleveland Clinic have developed a four-step protocol that not only improves outcomes for patients with ST elevation myocardial infarction (STEMI), but also reduces gender disparities that have been observed in both the care and outcomes of patients who present with the condition.1
Researchers note that although the protocol is different than common practices in most U.S. hospitals, the results show that further improvements are possible in the care of STEMI patients. Further, the data underscore the benefits of tightly standardizing the steps that providers follow when patients present with the most severe type of heart attack.
Although there was a general approach in place for managing STEMI heart attacks at the Cleveland Clinic before the new four-step protocol was implemented in 2014, investigators believed they could refine the process.
“We wanted to come up with a way to standardize the care and make sure that every step of the process was structured so that during an emergency, people didn’t have to come up with the way they were going to do things on the fly,” explains Umesh Khot, MD, the vice chairman of cardiovascular medicine at the Cleveland Clinic and the senior author of the study. “We spent about a year of preparation work with our emergency doctors, our cardiologists, and our nursing team to lay out the structure for every step of the process.”
Establish Criteria for Activation
The first step in the new protocol establishes clear criteria for the ED to use when activating the catheterization lab. This is designed to clear up any confusion about who makes this decision and under what specific circumstances. Before the new protocol was implemented, when a STEMI patient arrived in the ED, providers there could activate the catheterization lab, but there often would be some consultation with cardiology and a bit of uncertainty surrounding the decision-making process, Khot explains. “We really strengthened that to make sure the ED was completely authorized to activate the cath lab, and we provided written guidelines on what criteria they would use to [take that step],” he explains. “We transferred [that decision] very strongly to the ED, and then the cardiology response is to accept the patient and move forward on getting [him or her] to the cath lab. We made the decision-making very clear.”
Khot notes that the specific criteria for activating the catheterization lab are relatively straightforward.
“There are a few contraindications we want [emergency providers] to check for, but the criteria are pretty simple from that standpoint,” he says.
Create a Checklist
The second step in the protocol is a checklist of items that clinicians must go through for every STEMI patient to ensure that nothing is missed and safety is prioritized. The checklist includes what specific medicines to administer and labs to send out. It also specifies what risk factors must be considered so that cardiologists can assess the safety of the catheterization procedure in terms of recognized risks such as bleeding. Further, the checklist directs providers to make sure the connection with the cath lab has occurred.
“Before [the new protocol], people would often decide on the fly what they were going to do, so this specifies every [item] in terms of what nurses, cardiologists, and the emergency providers need to initiate,” Khot says.
The third step involves the immediate transfer of the patient to the cath lab. This sounds entirely logical, but Khot notes that this action isn’t standard practice at most hospitals. While it is common for hospitals to activate their cath labs when a STEMI patient presents to the ED, they do not generally transfer the patient until the cath lab team comes in, he explains.
“The patient actually waits in the ED until the cath lab is ready. That is the standard practice at most hospitals nationwide,” Khot observes. “Our new policy is that once the cath lab is activated and the checklist is completed, then the patient is moved to the lab, and the lab is assumed to be ready at all times, so there isn’t any waiting or checking to see if the lab is ready or not.”
The only exception to this step is if the cath lab is currently involved with another case.
“Then, there will be communication about that, but otherwise it is assumed that the lab is ready and the patient is moved,” Khot adds.
Finally, the fourth step calls for using the radial artery in the wrist as the first option for percutaneous coronary intervention. Khot explains that the reason for this approach stems from studies showing that it reduces the risk of bleeding complications and may reduce mortality in STEMI patients. However, Khot notes that fewer than 25% of STEMI patients nationwide are treated in this way. Indeed, prior to implementation of the new protocol, that was the case at Cleveland Clinic, too.
However, now 75% of STEMI cases are treated via radial access. What accounts for the hesitancy to prioritize the wrist radial artery, given the benefits? Khot explains that some experts are concerned that emergency providers are not accustomed to using this approach, and that procedure could be delayed.
“There is also some concern about the procedure being completed successfully,” he says, noting that has not been the experience at Cleveland Clinic. “We have been able to do the procedure successfully, improve outcomes, and do it within the appropriate time. People are used to doing this procedure electively, meaning that radial access is not uncommon in non-emergency settings, but people are concerned about doing it under time pressure. So, what we did is create a system where [providers] could do the procedure successfully, even under the time pressure they are under to get this done rapidly.”
Implementation of the new protocol not only has improved outcomes and reduced mortality, it also has reduced the gender disparities commonly observed in the treatment and outcomes of STEMI patients.
“What is known and well-described across multiple studies is that women with STEMI [heart attacks] tend to be older and have a higher-risk presentation than men,” Khot explains. “They have more complex disease, and they have more shock.”
On top of these factors, women tend to receive less ideal treatment in terms of fewer medications and slower time to treatment, Khot adds. “Women have more complications, and have a significantly higher death rate than men,” he says.
However, the new four-step protocol has made a sizable dent in these disparities. “What we think happens is that the system — because it is now so tight in terms of making sure that everything happens accurately, properly, and rapidly — it doesn’t matter as much that women present with a higher-risk presentation,” Khot observes. “Patients are treated in a very standard, rapid fashion, and then they receive the benefit of that treatment, so the system really locks down and makes sure patients are treated in a very structured way.”
The four-step protocol has been fully implemented at Cleveland Clinic for more than two years, and data show it has produced substantial improvements in medication administration, time-to-treatment rates, and complication rates.
“Mortality among women is still higher than men, but the gap between men and women has decreased by more than 50%,” Khot explains.
While the four-step protocol is now firmly in place, Khot acknowledges that implementing the new approach came with a set of challenges.
“It took us about a year to put together all of the steps and to gain consensus between the ED, cardiology, and nursing [on what to do],” he explains.
Also, since the goal was to deploy the protocol throughout the entire health system, including 10 hospitals and three freestanding EDs, the task required multiple channels of communication and a sustained effort, which encompassed on-site visits, regular email communication, and group meetings. “The big picture is that we have shown that there is value to the patient to standardize and structure the care across the entire health system,” Khot says. “Even though it takes an enormous amount of work to put together and coordinate, you can deliver real benefits for patients.”
Khot adds that while investigators knew from the start that they wanted to standardize care for STEMI patients, they did not know what the outcome would be, but that verdict is in.
“We have more than two and a half years of follow-up, and we have been able to see a dramatic and sustained improvement in care, so we really believe this process is beneficial to patients,” he says.
- Huded C, Johnson M, Kravitz K, et al. Four-step protocol for disparities in STEMI care and outcomes in women. J Am Coll Cardiol 2018 Mar 7. pii: S0735-1097(18)33370-9. doi: 10.1016/j.jacc.2018.02.039. [Epub ahead of print].
- Umesh Khot, MD, Vice Chairman, Cardiovascular Medicine, Cleveland Clinic, Ohio. Email: email@example.com.