By Andrew E. Sama, MD, FACEP
With nearly two-thirds of all admitted septic patients presenting to the ED, and with the clear time sensitivity that exists between recognition, treatment, and outcomes, our members are on the front lines to save lives from this frequently fatal disease. In the CY 2015 IPPS rule, in which CMS cited the fact that “that patients admitted through the ED had a 17% lower likelihood of dying from sepsis than when directly admitted,” CMS finalized NQF #0500: Early Management Bundle for Severe Sepsis and Septic Shock, which mandated the invasive monitoring of CVP and ScVO2 via the placement of a central line in the ED. However, late on Friday, CMS notified hospitals, that it will suspend data collection for the Severe Sepsis and Septic Shock: Management Bundle measure (NQF #0500) until further notice.
Emanuel Rivers, MD, MPH, and his team improved mortality and raised the awareness of the EM community about sepsis through their Early Gold Directed Therapy (EGDT) study in the early 2000s. A few years later, the measure was initially endorsed by the NQF in 2008 without the requirement for a central line for the emergency department. While it is certain that early intervention does reduce mortality, not all elements of the sepsis composite bundle were equally evidence-based. Many studies over the years have demonstrated dramatic improvements in sepsis-related mortality after the implementation of early interventions for septic patients, which included early antibiotic administration, source control, and aggressive fluid resuscitation without invasive monitoring of CVP and ScVO2. One study addressing this, authored by Dr. Alan Jones and colleagues, was conducted at three EDs in the US, and compared two protocols that both included central venous pressure measurement; however, one used lactate clearance and the other used central venous oxygenation monitoring as a way to guide resuscitation. Dr. Jones’ 2010 study found no differences in mortality, suggesting that using central venous oxygenation to guide resuscitation may not be necessary.
In 2012 the measure underwent routine NQF maintenance review for re-endorsement in 2012-2013. During those proceedings, under the leadership of David Seaberg, MD, FACEP and myself ACEP commented that central venous pressure (CVP) was not the only reliable measure of intravascular volume. Several members of ACEP’s Quality and Performance Committee (QPC) including chair Jeremiah D. Schuur, MD, MHS, FACEP, Michael Phelan, MD, RDMS, FACEP, Todd Slessinger, MD, FACEP, FCCM, FCCP, Christopher Fee, MD, FACEP, and others testified on conference calls and at in-person meetings, that there were equally effective and less invasive methods for monitoring septic patients. Nonetheless, the NQF endorsed the requirement for the central line, noting that they would re-consider if additional evidence warranted it.
Within a few months the Protocolized Care for Early Septic Shock (ProCESS) trial was published on March 18, 2014 and under Dr. Alexander Rosenau’s leadership ACEP immediately requested that NQF #0500 undergo an ad hoc review given the impact that this new data would have on this quality measure. After reviewing the data from the ProCESS trial, NQF questioned whether NQF #0500’s item ‘F’, which measures central venous pressure and central venous oxygen saturation, should be retained or removed from the measure. During the review, one of the PIs, Donald Yealy, MD, FACEP engaged in a scientific debate noting that the ProCESS trial enrolled 1,341 patients, with a power to detect a 6-7 percent absolute difference, yet demonstrated no difference in mortality 60-day mortality 90-day mortality, one year mortality, or the need for organ support. The ProCESS also noted no benefit in any outcome when using CVC- guided care and the simpler approaches that stressed early and ongoing care produced the same good outcomes.
CMS, NQF, and others are now also convinced that honing the sepsis bundle is a move forward for our septic patients, with or without invasive monitoring depending on the progression of their disease, their unique circumstances, and the resources available at the ED where they are being treated. As it is ACEP’s mission, we will continue to advocate on behalf of our patients presenting with a diagnosis of sepsis to ensure that they receive the highest quality of emergency care. We look forward to continuing to work with the measure developer to ensure that all septic patients receive the timely, effective care they need, and to continue to save lives from this deadly disease.
Dr. Sama is ACEP’s Immediate Past President and Chair of the Board of Directors