Sepsis — one of the most deadly and costly conditions at hospitals — remains a widespread problem, but hospitals and health systems across the nation are improving sepsis management through earlier detection and more rapid treatment.
This content is sponsored by T2 Biosystems
Sepsis is the body's extreme response to an infection characterized by systemic inflammatory response. It is a life-threatening condition that affects more than 1 million U.S. patients each year. The incidence of sepsis is high because almost any infection can lead to sepsis, and anyone can get an infection. Sepsis was present in 6 percent of hospitalizations from 2009 to 2014, according to a study published in JAMA in 2017.
Although common, the fast-moving illness is extremely difficult to diagnose. Infections in the respiratory, genitourinary and gastrointestinal systems, as well as the skin and soft tissue, are often linked with sepsis, and the clinical presentation of sepsis varies depending on the site of the infection. It can cause a variety of symptoms, including high heart rate, clammy or sweaty skin, confusion, shortness of breath, and fever or shivering.
Without timely treatment, sepsis can cause tissue damage, organ failure and death. About 250,000 Americans die from sepsis each year, and it is the leading cause of death in hospitals annually. According to the JAMA study, roughly 15 percent of in-hospital deaths are attributable to sepsis.
Sepsis is a major threat to patients' health, but it can also take a toll on a hospital or health system's finances. Sepsis accounts for $23.6 billion in combined costs each year for hospitals across the nation, making it the most expensive condition treated in hospitals, according to a 2016 report from the Healthcare Cost and Utilization Project and the Agency for Healthcare Research and Quality.
Challenges in the management of sepsis
To understand how to improve sepsis management, it is important to first understand how sepsis is traditionally diagnosed and treated.
Most sepsis cases are due to bacterial infections, but some are due to fungal infections. There are more than 100 drugs available to treat sepsis, but effective treatment requires first knowing if the patient has a bacterial or fungal infection and then pinpointing the species of bacteria or fungus.
For the last 90 years, a blood culture was the only means available to detect the presence of bacteria or fungi in the blood. It can take several days to receive results from a blood culture, as the bacteria or fungi must grow to sufficient numbers before they can be detected or identified.
"The reason why blood culture has been the only way to identify species [of bacteria or fungi] is that when patients are sick they typically have somewhere between one and 25 cells of the pathogen per milliliter of blood in their blood stream, and there has been no diagnostic that can detect at that low concentration," said John McDonough, president and CEO of T2 Biosystems, an emerging leader in the field of in vitro diagnostics.
While hospitals wait for blood culture results, physicians examine a patient's symptoms to make an educated guess as to what drugs to give the patient. "They'll give a drug to a patient, and 12 to 24 hours later if the patient is not responding they switch, and then they sometimes switch again," said Mr. McDonough.
Clinicians play this guessing game because they know every minute counts when treating serious blood infections. In patients with sepsis, each hour of delayed targeted treatment increases the risk of mortality by 8 percent. However, treating patients with the wrong drugs can lead to a new problem: antimicrobial resistance. When microorganisms, such as bacteria or fungi, develop antimicrobial resistance, medicines become ineffective, increasing the risk of spreading infections to others.
Blood cultures can also fail to detect infections because theyare dependent upon cell growth, which only occurs 50 to 60 percent of the time, according to Mr. McDonough.
How hospitals and health systems can improve sepsis management
To avoid relying on guesswork in the identification and treatment of sepsis, hospitals and health systems across the nation are using the T2Candida Panel, an FDA-cleared test for the detection of Candida, one of the deadliest sepsis-causing pathogens. T2Candida is the only FDA-cleared product that can identify sepsis-causing pathogens directly from blood without the need for blood culture. T2Candida can detect these pathogens at concentration levels as low as one cell of the pathogen per milliliter of blood, and test results are available in three to five hours.
Because the test is not dependent on growing cells through a culturing process, it can detect infections completely missed by a blood culture. This allows provider organizations to begin targeted treatment sooner.
By providing test results more quickly, sick patients can get treated sooner and the use of unnecessary antifungals can be substantially reduced by ensuring that negative patients are not treated with drugs they do not need. "The value of the negative test result, where the negative predictive value is over 99 percent, is that you know not to put a patient on the drug because you know they are not likely to need it," said Mr. McDonough. This can prevent the rise of superbugs and help hospitals achieve cost savings.
T2 Biosystems also offers the T2Bacteria Panel, which is currently CE marked and available in Europe and has been submitted for FDA clearance for clinical use in the U.S.
T2Bacteria is currently available for research use only in the U.S. The test identifies six of the most deadly and prevalent bacteria species, and will provide species-specific information within hours from a blood sample.
"In our FDA clinical trial for the T2Bacteria Panel there were 102 patients with known bacterial infections, of which blood culture detected 39 and T2 detected 98. Additionally, the average time to species identification with blood culture was over 70 hours where the average time to result for T2 was just over five hours," said Mr. McDonough.
T2Bacteria has the potential to reduce patient mortality rates while also saving hospitals about $25,000 per patient due to spending less time in the hospital and the intensive care unit.
Sepsis management improvement success stories
Today, hospitals and health systems across the country are focused on sepsis management to improve patients' health and saves lives while reducing the use of unnecessary drugs, thereby relieving cost pressure. Many provider organizations who are using T2 Biosystems' tests are realizing the clinical and financial benefits of treating this patient population more effectively.
Henry Ford Health System
Detroit-based Henry Ford Health System implemented T2MR, a diagnostic detection method utilizing miniaturized magnetic resonance technology, and the T2Candida Panel as part of its sepsis protocol and management of Candida.
Within six months after implementation, the seven-hospital health system significantly reduced patient length of stay and saved millions of dollars. A statistically powered, independent study of over 150 patients who had Candida infections revealed patients were spending an average of four fewer days in the hospital, and an average of seven fewer days in the intensive care unit.
Henry Ford Health System also experienced cost savings after it began using the test. The health system is realizing more than $2.3 million in annual savings by reducing patient length of stay and using fewer drugs to treat infections.
Lee Health
Like Henry Ford Health System, Lee Health, a four-hospital system based in Fort Myers, Fla., is using the T2Candida Panel to identify patients with Candida infections. The test is allowing the health system to detect the sepsis-causing pathogen sooner, which benefits patients and the organization's finances.
After implementing the panel, Lee Health physicians are receiving diagnostic test results much sooner than with a traditional blood culture, which has allowed them to begin targeted treatment in a timelier manner. The implementation of T2Candida is enabling patients to spend an average of seven fewer days in the hospital. Additionally, knowing that patients do not have a Candida infection results in a significant reduction in the use of antifungal drugs, which saves about $200 per patient tested with T2Candida.
Huntsville Hospital
Huntsville (Ala.) Hospital, a 941-bed hospital that serves as a regional referral center, saw a significant increase in the number of patients who tested positive for Candida after it began using the T2Candida Panel.
Since the test has higher sensitivity than a traditional blood culture, the T2Candida Panel identifies infections that can be missed by a blood culture. After implementing the panel, the hospital detected 56 percent more positive Candida patients than with blood cultures, enabling caregivers to provide better patient care and potentially saving lives.
Huntsville Hospital also reduced the use of unnecessary medication after it began using the T2Candida Panel. The hospital saved roughly $500 per patient in medication costs due to the reduction in drug therapy.
The future of sepsis management
Sepsis is a life-threatening condition that kills hundreds of thousands of patients each year in the U.S. However, it can be manageable with early diagnosis and treatment. There are many drugs available to effectively treat sepsis, but physicians must identify the sepsis-causing pathogen in order to know which drug to use. By providing rapid and accurate test results, T2 Biosystems' sepsis solution not only allows physicians to begin effective treatment as early as possible, but it also helps hospitals and health systems reduce costs associated with treatment delay and the use of ineffective drugs.