The Numbers Game: Door-to-Balloon or First Medical Contact? STEMI Care Still Needs Work Nationwide

For more than a decade, efforts to improve door-to-balloon (D2B) times for STEMI patients have led to new support systems and guideline recommendations that have, in turn, expedited care from the moment patients arrive at the hospital. But as those practices have become more routine and nuanced, experts are taking a good hard look at what happens to patients before they get to the hospital and in particular at whether a shift in focus to “first medical contact”-to-balloon times has made any meaningful gains.

“We’re clearly a lot better than we were 10 years ago, but the reality is we’re probably not as good as we think,” Timothy Henry, MD (Cedars-Sinai Heart Institute, Los Angeles, CA), told TCTMD. “Everybody thinks that this issue is solved, but it’s not.”

In 2004, American College of Cardiology (ACC) guidelines stated that primary PCI should be performed within 90 minutes. At the time, a goal of less than 90 minutes was thought by many to be impossible for the nation, even as both the ACC and the American Heart Association launched national campaigns (D2B Alliance and Mission: Lifeline) to promote improvement in door-to-balloon times nationwide. 

Those initiatives are paying off. As reported in a national assessment of D2B times, the intensive efforts coupled with the Centers for Medicare & Medicaid Services’ Hospital Compare program were credited with contributing to a marked increase—from 44.2% to 91.4%—in the proportion of patients with D2B times below 90 minutes over the 6-year period beginning in 2005.

Then in 2013, a full-scale revision of the guidelines for STEMI management proposed that the D2B benchmark be changed to first medical contact (FMC)-to-device time, which would include any prehospital location and virtually any type of device (balloons, coronary stents, wires, aspiration catheters, etc). This shift put the emphasis on early assessment, care, and transport, and recommended a time of 90 minutes or less.

“As we’ve gotten our house in order with regard to door-to-balloon time, it’s allowed us to think a bit more preemptively about how we can better coordinate with prehospital systems,” noted Brahmajee Nallamothu, MD (University of Michigan, Ann Arbor).

Moving Technology Into the Field

Wireless prehospital transmission of the ECG is one of the key means that may help, with data showing it can effectively shave minutes off FMC-to-device times. One barrier to this approach, according to Christopher Granger, MD (Duke University, Durham, NC), is that each vendor of wireless ECG systems has its own proprietary system, and they don’t all interface with each other.

A second challenge is HIPAA regulations, because while it might be most efficient to just take a picture of the ECG with a smartphone and transmit it to the on-call cardiologist, doing so would infringe on electronic rights to privacy and security of health information.

“Counterintuitively, it’s not necessarily helpful to transmit the EKG when it’s a clear-cut STEMI, because you’re forcing there to be somebody who gets it and interprets it and gets back into the system to address it,” Granger said. “The faster way may just be for EMS to diagnose it and activate the lab, which we know can lead to false activations sometimes.”

While some worry that false activation wastes time and resources, Granger sees it as a teaching opportunity if the lab is falsely activated because EMS is wrong. “If they’re wrong, we go out and teach them more,” he said. “We track it. They’re wrong about 20% of the time, but that’s a pretty small price to pay for lifesaving care. That being said, there’s a certain proportion of EKGs where the diagnosis is uncertain. And, there are times when EKG transmission is helpful and should be part of the ideal system.”

Nallamothu agreed: “I think what we’re starting to see now is more efforts to bring technology out into the field . . . and trying to make sure that the EKG and some important basic patient characteristics are being sent to the correct hospital and providers sooner to help them in their decisions.”

He added that emerging data on field ECGs appear to indicate that in-hospital D2B times are improved because of it, particularly when bypass of the emergency department (ED) occurs. Even if the ED is not bypassed, Nallamothu said, prehospital ECG can at least allow for streamlining some of the decision-making there if you already know that a STEMI is coming in.

Who Is Counted?

Another challenge in assessing national quality for STEMI treatment is how times are calculated and who is included in those averages. Henry points out that “gaming of the system” can occur if certain STEMI patients aren’t counted, such as those who, for whatever reason, don’t go on to get a PCI. There’s also the fact that as many as 50% of STEMI patients don’t call EMS but get themselves to the hospital.

“The concept of FMC-to-balloon is a great idea and based on sound principles,” Henry said. But, he continued, “When you ask me how we’re doing [with FMC-to-device times] I think it’s difficult to know, honestly, how we’re doing, because the number of people excluded from the measure has gone up. It’s now 20%.”

Henry, who was recently appointed chairman of the ACS committee of Mission: Lifeline, said what is badly needed now is a system that keeps track of all STEMIs and outcomes. “It’s okay to have exclusions, but we should put everybody in and count everybody,” he stressed. “If you excluded everybody with door-to-balloon times greater than 90 minutes, 100% would have less and that’s not reality.”

There’s also the issue that many hospitals have been slow to adopt FMC-to-device time and actively strive to achieve the guideline-recommend metric. “I would guess that a third of the country is doing a pretty good job [of using FMC-to-device times] and two-thirds really haven’t done that much with it,” Granger said.

Henry added that for many hospitals, it simply isn’t on their radar, especially since the publicly reported performance measure is still D2B. “An FMC-to-device time of 90 minutes or less is feasible for the entire country, but I think most hospitals still focus on door-to-balloon because it’s easy,” he said. “I don’t think we are really seeing a big shift over to a focus on FMC-to-device time.”

A Long Way in a Short Time

Despite the ongoing challenges, Nallamothu believes the field has a lot to be proud of, given how far it has come in such a short time.

“When I was a fellow the delays for an incoming STEMI patient were ridiculous, and you think back to how much time we spent doing things like paging people and waiting for calls back. There are definitely things we can do to streamline care further, but within the hospital systems we’ve done a pretty good job,” he said. “If you take a step back . . . we’ve made remarkable strides over the last 10 to 15 years.”

Likewise, Harlan Krumholz, MD (Yale University, New Haven, CT), told TCTMD that improved coordination among physicians, EMS, and hospital staff “makes times that were once felt to be unachievable, within reach.”

“It is matter of early recognition, screening, communication, and coordination,” he elaborated. “I’ve seen many instances where an AMI has been preempted. Not mitigated, but the damage actually entirely averted. We now fully embrace the culture of needing to deliver care as a team—and put egos aside in the interest of serving the patient best.”

Vigilance and Protocols Crucial to Success

But even in systems that seem to have their “house in order” with regard to STEMI treatment times, such as those that are recognized by Mission: Lifeline, slippage has been or is being seen. Being “Mission: Lifeline recognized” means that the hospital system has proven it can meet FMC-to-device times of < 90 minutes. Granger said in North Carolina, which has been ahead of most of the country for a while in STEMI systems of care, 17 of the 21 PCI centers have the designation, but he added that slippage—wherein FMC-to-device times start to creep higher again—remains an issue. Much of it, he said, may come down to simple issues of personnel turnover, either system coordinators, physician champions, or EMS medical directors.

“It’s not enough to develop a system,” said Granger. “You have to maintain that system, and that takes energy and resources and effort. All too often a hospital decides to cut a physician and the coordinator no longer has the time to work on the system that they have in place.”

Henry agreed. “What we have to do is still be vigilant. The ultimate goal that we should be focused on is for every hospital in America to have a standardized protocol for how they deal with STEMI. We have a long way to go to get to that. If you’re a non-PCI hospital or a PCI hospital, you need a standardized protocol. It’s also very important to have a STEMI committee that keeps track of your hospital’s data.”  

According to Granger, that lack of a protocol “is a huge problem” across the country that needs to be addressed as part of efforts to get everyone involved in STEMI care on the same page. “Without a protocol in place, EMS is going to do what they’ve always done—what the default has always been—which is go to the nearest hospital, but it’s not the best care.”

He gave the real-life example of a patient living in a county of North Carolina, an hour’s drive away from a PCI hospital and with only three ambulances available for the entire county. If the ambulance takes the patient to the PCI hospital it leaves a hole in the county’s emergency care system for upwards of 2 hours. Still, the research supports the idea that this situation is best for everyone and it was written into the protocol for the regional STEMI care system in that area, he said. “The way to look at this is that call is probably going to be the way they can best improve health for their county—by making sure individual patients are getting the best treatment.”

The final hurdle—and one with no easy solutions—is how to get patients to recognize their symptoms and activate the system sooner. Many efforts to increase the level of awareness begin with small, community programs. The Texas-based Don’t Die of Doubt campaign is one example that seeks to educate patients that, among other things, driving themselves to the hospital can actually delay their care by up to an hour or more. Improvements in this aspect of the patients’ interaction with healthcare providers, say some, may be the factor that could make the most difference in cutting ischemic times for STEMI patients.

“The median time now from symptom onset until first medical contact [911 being called] in the US is something like 49 minutes,” Granger noted. “In many countries it’s taking 2 or 3 hours from symptom onset until the patient is engaged with the healthcare system.” While faster times in the US are admirable, he noted that a total time of 2 hours from symptom onset to device deployment is a worthy goal.

“When we can treat everyone that quickly and even faster, you’re in a window where it makes a big difference in terms of outcomes,” he added.

The Mission: Lifeline STEMI Systems Accelerator project, a large national effort to organize regional STEMI care that Granger spearheaded, has published data showing that the percentage of patients treated within FMC-to-device time goals can be boosted regardless of the mode of transport to the PCI hospital, including for transferred patients. In a paper published last year, the group urged the adoption of FMC-to-device time as the new focus of national quality metrics and efforts, noting that “reliance on the door-to-balloon metric rather than FMC-to-device time could explain the relative lack of improvement in outcomes identified by efforts that ignore prehospital care.”

Still, there are skeptics. In an editorial that accompanied the STEMI Systems Accelerator paper, Alice K. Jacobs, MD (Boston Medical Center, Boston, MA), noted that it remains to be seen if organized STEMI systems are cost-effective in terms of their potential to decrease mortality, heart failure, and the need for implantable cardioverter defibrillators.

“When you go around the country and look at this, there are still major challenges with STEMI care in the United States,” Henry concluded. “It’s clearly gotten better, but there still are major gaps and tremendous opportunities for improvement.”