Medical Research: What is the background for this study?
Dr. Mahler: Care patterns for patients with acute chest pain are inefficient. Most patients presenting to US Emergency Departments (ED) with chest pain, including those at low-risk for acute coronary syndrome (ACS), are hospitalized for comprehensive cardiac testing. These evaluations cost the US health system $10-13 billion annually, but have a diagnostic yield for ACS of <10%. American College of Cardiology/ American Heart Association (ACC/AHA) guidelines recommend that low-risk patients with acute chest pain should receive serial cardiac markers followed by objective cardiac testing (stress testing or cardiac imaging). However, guideline adherent care among low-risk patients fails to accurately focus health system resources on those likely to benefit. Among low-risk patients, who have acute coronary syndrome rates less than 2%, objective cardiac testing is associated with a substantial number of false positive and non-diagnostic tests, which often lead to invasive testing. Consensus is building within the US health care system regarding the need to more efficiently evaluate patients with acute chest pain.
Medical Research: What are the main findings?
Dr. Mahler: Patients randomized to the HEART Pathway were less likely to receive stress testing or angiography within 30 days than patients in the usual care arm (an absolute reduction of 12%. P=0.048). Early discharge (discharges from the ED without stress testing or angiography) occurred in 39.7% of patients in the HEART Pathway arm compared to 18.4%: an absolute increase of 21.3% (p<0.001). Patients in the HEART Pathway group had a median LOS of 9.9 hours compared to 21.9 hours in the usual care group: a median reduction in LOS of 12 hours (p=0.013). These reductions in utilization outcomes were accomplished without missing adverse cardiac events or increasing cardiac-related ED visits or non-index hospitalizations.
The HEART Pathway, which combines the HEART score, with 0- and 3-hour cardiac troponin tests, is an accelerated diagnostic protocol (ADP), which may improve the value of chest pain care by identify patients who can safely be discharged from the ED without stress testing or angiography. Observational studies have demonstrated that the HEART Pathway can classify >20% of patients with acute chest pain for early discharge while maintaining a negative predictive value (NPV) for major adverse cardiac event (MACE) rate of greater than 99% at 30 days. However, prior to this study the real-time use of the HEART Pathway had never been compared with usual care. Therefore, we designed a randomized controlled trial to evaluate the efficacy of the HEART Pathway to guide providers’ testing and disposition decisions for patients with acute chest pain. The hypothesis was that the HEART Pathway would meaningfully reduce objective cardiac testing, increase early discharges, and reduce index hospital length of stay compared to usual care while maintaining high sensitivity and NPV (>99%) for MACE.
Medical Research: What should clinicians and patients take away from your report?
Dr. Mahler: When the results of this trial are considered in the context of prior HEART Pathway, HEART score, and other chest pain risk stratification decision aid studies, there is now strong evidence to support structured implementation of the HEART Pathway. The HEART score has now been examined in more than 6,000 patients and has demonstrated a high negative predictive value for MACE exceeding 98%. The HEART Pathway (which adds serial troponin measurements at 0 and 3 hours to the HEART score) has a higher sensitivity and negative predictive value for MACE than the HEART score alone. Prior studies of the HEART Pathway among patients identified for chest pain observation unit care demonstrated 100% sensitivity and negative predictive value for MACE at 30 days and an early discharge rate of 82% in a low risk cohort. Among 1005 patients in a multicenter cohort of patients with suspected ACS and planned objective cardiac testing, the HEART Pathway was 99% sensitive for ACS (cardiac death, MI, or UA) within 30 days with a negative predictive value >99% and an early discharge rate of 20%. This first prospective randomized study of the HEART Pathway adds to this growing body of literature, by demonstrating the HEART Pathway’s ability, to reduce healthcare utilization outcomes (hospitalizations, LOS, etc) compared to usual care, without compromising patient safety.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Mahler: What is needed next is a rigorous evaluation of the implementation of the HEART Pathway within health systems to determine its effectiveness. We are currently conducting an implementation trial within the Wake Forest Baptist Health System and we plan to conduct a larger multicenter effectiveness study in the near future. Other opportunities for future research include an economic analysis, use of the HEART Pathway with hs-cTn, and comparisons between the HEART Pathway and alternative chest pain risk stratification strategies.
Circ Cardiovasc Qual Outcomes. 2015;CIRCOUTCOMES.114.001384published online before print March 3 2015, doi:10.1161/CIRCOUTCOMES.114.001384
MedicalResearch.com Interview with:, Simon A. Mahler MD, MS, FACEP (2015). HEART Pathway Improves Efficiency Of Chest Pain Evaluation In ER