Continuous Quality Improvement of Door-to-Balloon Time at a PCI-Capable Hospital

Abstract

A patient’s treatment and survival of an ST-elevation myocardial infarction (STEMI) is dependent upon the healthcare team’s proficiency in emergent delivery of percutaneous coronary intervention (PCI). Early reperfusion therapy is optimal for salvaging cardiac muscle and improves survival of the patient.¹ Door-to-balloon time is a measurement monitored by hospitals in the treatment of a STEMI. The time begins at the patient’s presentation to the emergency room and ends when the compromised vessel is reperfused via coronary intervention. Improved door-to-balloon time is a measure of quality that requires the teamwork of several disciplines. Continuous quality improvement ensures the growth and consistent evolution of a process that works, and is refined and redefined as the standard of care. Herein, we focus on quality improvement procedures initiated at a medical center to decrease door-to-balloon times.

Prevalence

According to the American Heart Association, each year an estimated 785,000 Americans will have a new myocardial infarction (MI), and an estimated 470,000 will have a recurrent MI. Every 25 seconds an American will have a coronary event, and approximately every minute someone will die of one. Coronary artery disease is the leading cause of death for men and women in the United States.²

Many people don’t recognize the warning signs of an MI and delay prompt treatment. According to one study by the CDC conducted in 2005³, only 31% of the respondents in the survey knew the five major signs of a heart attack, which include: pain in the neck, jaw, or back; feeling weak or lightheaded; chest pain or discomfort; pain in the arms or shoulders; and shortness of breath.³ In the same study, 86% of the respondents stated they would call 9-1-1 if they thought someone was having a heart attack or stroke. Timely access to emergency care is critical to surviving a heart attack. Half of all cardiac deaths occur within the first hour of symptoms.³ Because early recognition of signs of an MI are critical, the American Heart Association and the National Heart, Lung, and Blood Institute launched the “Act in Time” campaign in 1991 to increase the public’s awareness of heart attack warning signs and symptoms, along with the importance of immediately calling 9-1-1 to strengthen the chain of survival, including advanced life support.³

Physiology

MIs can occur at any age, but the predisposition to atherosclerosis increases in the presence of hypertension, diabetes, cigarette smoking, and hypercholesterolemia, as well as certain genetic variants.⁴ The microvascular chain of events can unfold into a cardiac emergency. Typically, there is a sudden disruption in the structure of the arterial plaque that may have been building for a period of time. This disruption may be an intra-lumen hemorrhage, erosion, rupture, or fissure. The exposed endothelial cells experience platelet activation and adhesion. Vasospasms are stimulated, leading to pathways of coagulation resulting in thrombus. Within minutes, the thrombus can evolve into a complete occlusion of the lumen of the coronary vessel. The immediate chemical consequence of ischemia is the change from aerobic glycolysis to anaerobic glycolysis, leading to inadequately produced, high-energy phosphates. The interference with energy metabolism decreases cardiac contractility and leads to the buildup of noxious breakdown products (i.e., lactic acid). Inadequate muscle contraction can lead to heart failure long before cell death occurs. The symptoms may be evidenced by shortness of breath, rapid heartbeat, or chest pain. In spite of these early changes, cell death is not immediate and may be reversible if treated in time.⁴

Time

“Time is muscle” is a familiar adage for hospitals promoting their cardiac care, but what does that mean? The groundwork for today’s knowledge of emergency cardiac revascularization can be credited to Dr. Eugene Braunwald, an Austrian cardiologist. Through his experimentation with MIs in dogs, Dr. Braunwald realized that an MI could be altered as it is progressing. This was revolutionary at the time and led to current treatment, which is based on the knowledge that aggressive intervention before, during, and after an MI can decrease myocardial damage and save lives. By the 1970’s, Dr. Braunwald’s team proved that injecting thrombolytic agents into blocked arteries could salvage the threatened myocardial tissue by restoring the supply of oxygen to the tissue.⁵ How much “time” does a patient have before irreversible damage occurs? Fifteen minutes to three hours have been documented in experimental models. Reperfusion therapy can save lives up to 12 hours after onset of symptoms, but this is relative to the extent of the ischemia, the intermittence of the ischemia, or the no-reflow to myocardial tissue post PCI.⁶ We do know that the best chances of survival are directly related to the time it takes for reperfusion and restoration of oxygen to vital tissue.

STEMI

A “STEMI” is an ST-elevation myocardial infarction, but what does that look like clinically? The first sign of a possible STEMI is evidenced in patient presentation. Most people believe that the patient typically arrives to the ER with the classic complaints of chest pain, shortness of breath, diaphoresis, and an unexplainable feeling of “doom.” This may be the case, but often the patient may paint a slightly different picture. The patient may “just not feel right,” and the history and physical become central to the diagnosis. The patient may complain of having vague chest pain that was relieved at rest. They may feel a bit fatigued, and now the pain is more visceral and deep, with radiation to the jaw, arm, or back. They may have felt nauseated with indigestion and acquired relief from antacids, but remain apprehensive and restless.  Approximately 25% of MIs are “silent,” with atypical or less-prominent symptoms, especially in diabetics, women, and the elderly. Their skin may be cool or pale and diaphoretic. They may be hypertensive initially, with pain, but progress to hypotension due to poor perfusion. Heart sounds may seem distant, with a 4th heart sound often ascultated.⁷

The second clue to a STEMI is the electrocardiogram (EKG) tracing. An EKG should be ordered as soon as a STEMI is suspected and reviewed immediately. If the initial tracing is normal, it should be repeated, because ST segments can be dynamic. ST segment depression can indicate myocardial ischemia. An elevation of the ST segment that is ≥ 1 mm in two contiguous limb leads indicates current injury. Elevation in leads II, III, and aVF indicate an inferior MI (Figure 1), while ST elevation in leads I, aVL, V5 and V6 indicate anterolateral infarct (Figure 2).⁸

The third biomarker of a STEMI is an elevated troponin level, specifically, the troponin I and troponin T levels. These improved biomarkers are contractile proteins not normally found in the blood, and elevated serum levels indicate myocardial necrosis. The troponin levels are detectable in serum 3-6 hours following an MI, and can remain elevated up to two weeks, unlike the rapid decrease of CK-MB levels previously monitored.⁷

Need for Protocols

The diagnosis of a STEMI and its resulting treatment takes the teamwork of several medical disciplines working in concert to efficiently prepare a patient for a PCI. With door-to-balloon time as an important indication of quality, there must be a “best practice” procedure carried out with each patient. STEMI protocols ensure that involved personnel understand what needs to be done and when to do it. Team members from EMS, laboratory, the ER physician, the cardiologist, radiology, cardiopulmonary, cath lab, and ER nurses are the minimum personnel working together for the PCI. Protocols ensure standards of care for all STEMI patients, regardless of who is working that day.

Door-to-Balloon (D2B) Alliance

In 2006, the American College of Cardiology (ACC) realized there was a need to reduce door-to-balloon time for STEMI patients. At that time, only 40% of PCI-capable hospitals were consistently achieving PCI in ≤ 90 minutes. The D2B Alliance was formed with a goal of having PCI-participating hospitals achieve door-to-balloon times of ≤ 90 minutes for at least 75% of the STEMI cases. Strategies included:

1. ER physician activates the cath lab
2. One call activates the cath lab
3. The cath lab team is ready in 20-30 minutes
4. Prompt data feedback
5. Senior management commitment
6. Team-based approach

The American Heart Association and the National Heart Lung and Blood Institute partnered with the ACC to strengthen this effort. The Alliance consists of a community of hospitals and physicians who can educate and support each other in achieving their goals of improved outcomes in this critical area.⁹ By sharing the protocols and procedures that have worked at each facility, the D2B Alliance helps stimulate other facilities to implement standards that will improve their own door-to-balloon times.

Initial STEMI Protocols

In 2008, the cath lab team at Ochsner Medical Center Baton Rouge (OCMBR) focused their efforts on improving door-to-balloon times to become competitive in cardiac care and remain in compliance with the national standard of door-to-balloon time of ≤ 90 minutes. A letter was sent out by the cath lab supervisor to the system asking for the assistance and support of management and department team members. The letter concluded with a system belief: “No institution can have an excellent reputation for cardiac care without an outstanding STEMI treatment program.” The standards were set. The initial STEMI protocols consisted of standing orders for the ER, a STEMI box housed in the ER that provided the needed supplies and paperwork, and a paging system that began with a call to the cardiologist and continued with consecutively paging each individual cath lab team member. There were no “assigned” duties for ER personnel.

We soon found that this flow of events wasted time and led to confusion and duplication. Consistent stats for door-to-balloon times were not being documented. The need for improvement led to formation of a quality improvement team that consisted of the chief of cardiology, cath lab coordinator, ER nurses, cath lab nurses, hospital QI staff, and telemetry nurses.

Quality Improvement (QI) Goals

It was decided that the QI team would meet monthly to set goals, track progress towards those goals, and make changes where appropriate, with the support of administration. The theory of J. M. Juran, considered a leader in quality control, was the basis for policy and procedures decided upon to improve the door-to-balloon times and ultimately improve patient care. Juran’s Trilogy defines quality by three major principles:¹⁰

1. Quality planning — building quality into the processes;
2. Quality control — evaluating performance, comparing that to predetermined goals, and taking action on the differences;
3. Quality improvement — encouraging attainment of previously unprecedented levels of performance by the organization.

A door-to-balloon time goal of ≤ 90 minutes for 75% of STEMI cases was only the beginning. The QI team also wanted to emphasize ways to improve the efficiency of patient care from time of arrival through intervention. The QI team created a “STEMI Wish List” that detailed the products to be used and the step-by-step actions the team members should take. Specialized instructions included use of radiolucent defibrillator pads and electrodes, numbered assignments for personnel that were programmed into the text page, and a pre-filled pharmacy box, accessed without the need for specific patient data. Juran’s Trilogy was being followed as we attempted to streamline processes, but as yet there was no statistical method of “time-tracking” in use. Through QI meetings and the support and encouragement of administration, a tracking method for door-to-balloon times was implemented to compete with the national standard goals. The ER staff began documenting time from patient presentation and ended the time when the lesion was crossed via PCI. 

Quality Improvement: 2009

Through several monthly QI meetings involving the search for deficiencies in protocols, two changes were decided upon, to become effective in 2009. The first deficiency addressed was the paging system. Initially, once the ER doctor and cardiologist decided that the patient was indeed presenting with a STEMI, cath lab team members were individually paged, along with the nursing supervisor, lab personnel, pharmacy, etc. This was very time-consuming, led to difficulties with finding numbers and delayed time of arrival for all of the needed team members. It was decided that a global paging system would be one factor necessary to eliminate the unnecessary waste of time on the telephone. The second change involved the EKG technologist. Initially, the protocol involved notifying the EKG tech as soon as a patient arrived to the ER with chest pain. If the tech was busy on another floor, there would be time wasted in completing that order and making his or her way down to the ER. It was decided that the EKG tech is now to be stationed in the ER at all times, readily accessible when a STEMI arrives. These two changes promised improvement in door-to-balloon times. The first two principles of Juran’s Trilogy were in place: quality was being built into protocols and the statistics for 2009 would reveal the improvements. At the end of 2009, door-to-balloon averages were calculated. Overall, the times were good, and many of the door-to-balloon times were far less than 60 minutes. The average door-to-balloon time for the year was 75.8 minutes. This initially seemed to be right in line with the national goal of ≤ 90 minutes 75% of the time. But after a closer review, out of 73 cases, only 45 were actually ≤ 90 minutes (62%). There was a large disparity in door-to-balloon times in 2009. Some times were far lower than 90 minutes and some were far greater. This was far below the standards set, and the QI team knew there were deficiencies that still needed to be addressed.

Quality Improvement: 2010

The QI team continued meeting monthly, and appointed a “task force” to focus on the time required for each step of the STEMI protocol to be carried out. A new tracking system was created to identify any possible delay, and every case was reviewed concurrently. Each step of the STEMI protocol was monitored for “time,” including: triage, EKG, cardiologist notification, cath team arrival, patient arrival to cath lab, start time, crossing of the lesion, and door-to-balloon time. The EKG orders were consistently carried out within five minutes of the patient’s presentation to the ER, the ER doctors were diagnosing STEMIs with less hesitation, and the cardiologist and cath team were paged simultaneously to expedite their arrival. Deficiencies in prepping the patient prior to cath lab were discovered. ER team members were well trained in their emergency skills, and assessment of chest pain and MI patients, and they were ready to deliver quality patient care. The difficulty arose when ER members were on shift without prior experience of the “flow” of procedures to be done. When a STEMI patient presents to the ER, there are multiple simultaneous skills to be carried out in a timely manner to minimize the time to PCI. The old system of numbered tasks was confusing and not working, and a straightforward delegation of procedures was needed. The cath lab team began brainstorming and tried to create a method of assignment to each of the ER team members. The idea was to organize the protocols and procedures in such a way that if today was your first day on the unit, you would have no question as to what your “assignment” would be if a STEMI presented in the ER. The decision was made to assign a Red Nurse, Green Nurse/ Tech, and Blue Nurse. Each color would represent a list of procedures to be carried out, possibly simultaneously, in order to expedite PCI (see Figure 3). The cath lab team would assist the ER upon their arrival.

The statistics for 2010 showed quality improvement. In 2010, the average door-to-balloon time was 69.2 minutes; 6.6 minutes less than in 2009. Additionally, there were 51 STEMI cases and 43 of those were ≤ 90 minutes door-to-balloon times (84%). This was a 22% decrease in the overall door-to-balloon time for OMCBR in one year (Figure 3). This improvement in quality patient care was only achieved through the efforts of all of the departments involved.

Future Plans

In 2011, OMCBR has consistently maintained their lower door-to-balloon times. The averages for the first five months were as follows: January: 79 minutes, February: 57 minutes, March: 71 minutes, April: 47 minutes, and May: 71 minutes. The team at OMCBR continues to strive for improvement in quality patient care. Each case is concurrently reviewed while looking for opportunities for time improvement. The third principle of Juran’s Trilogy involves striving for exceptional levels of performance yet to be attained. Continuous improvement of protocols is always a priority for the cath lab. Consistently achieving the national standard of ≤ 90 minutes door-to-balloon time is an ongoing quality goal. Although it is not a standard at present time, decreasing door-to-balloon times to 60 minutes at OMCBR may be on the horizon.

Conclusion

Continuous quality improvement for any policy or procedure at a medical facility is a continually evolving goal that is, by design, never reached. Each time one goal is attained, there has to be another one set a little higher to ensure the best patient care outcomes. The teamwork and efforts of several disciplines at OMCBR allowed us to achieve the quality improvement goal of improved door-to-balloon time exceeding the national standard. The challenge now is to share our experiences in the hope of helping other facilities reach the same goals of quality patient care through membership in the D2B: An Alliance for Quality (now called “Sustain the Gain”).

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