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Less restrictive OPAT criteria for infective endocarditis safe, effective

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January 23, 2019

Outpatient parenteral antibiotic therapy for the treatment of infective endocarditis was found to be safe and effective, despite the use of less restrictive criteria than those recommended by the Infectious Diseases Society of America.

In 2001, IDSA established criteria for selecting patients with infective endocarditis (IE) for outpatient parenteral antibiotic therapy (OPAT). Currently, only patients with uncomplicated left-sided mitral or right-sided native valve IE caused by nonaggressive, easy-to-treat streptococci and without indications for cardiac surgery or clinical, echocardiographic or microbiological complications can be considered to complete antibiotic treatment via OPAT.

“OPAT is a good alternative for shortening the length of hospital admission while preserving patients’ safety and convenience of treatment,” Juan M. Pericàs, MD, PhD, MPH, clinical researcher at Hospital Clínic de Barcelona, and colleagues wrote. “Expanding its use might lead to an improvement in the subjective well-being of patients, a reduction in nosocomial infections, and optimization of budget allocations.”

To compare the outcomes of patients who received OPAT with those who received hospital-based antibiotic treatment (HBAT) — or standard hospitalization until the IV antibiotic therapy course was completed — Pericàs and colleagues retrospectively analyzed data from 25 Spanish centers that were included in the multicenter prospective observational cohort study, GAMES. From 2008 to 2012, the study enrolled 2,000 consecutive patients with IE. Because the IDSA criteria are not clear regarding IV drug users, these individuals were not considered suitable candidates and were excluded from the study. The study outcomes included readmission for any cause at 90 days, cardiac surgery within the first year after discharge, relapses and 1-year mortality.

Infective endocarditis treatment strategies

According to the study, 21.5% of the cohort received OPAT, and only 21.7% of that group met IDSA criteria. The median age of patients was 68 years, and men comprised 70.5% of the cohort. The researchers said 57% of patients had native valve IE, 27% had prosthetic valve IE and 19% had pacemaker/defibrillator IE. Viridans group streptococci was the most frequent casual microorganism — observed in 18.6% of cases — whereas 15.6% were Staphylococcus aureus and 14.5% coagulase-negative staphylococci. Antibiotic treatment lasted a median of 42 days, and cardiac surgery was performed on 44% of patients, according to the study.

Pericàs and colleagues observed a 1-year mortality rate of 8% among patients who received OPAT compared with 42% for those receiving HBAT (P < .001). In the OPAT group, 1.4% of patients relapsed and 10.9% were readmitted during the first 3 months after discharge, and the researchers observed no significant differences compared with HBAT. The researchers discovered that 1-year mortality was associated with Charlson score (OR = 1.21; 95% CI, 1.04-1.42) and cardiac surgery (OR = 0.24; 95% CI, 0.09-0.63). The only predictor of readmission at 1 year was aortic valve involvement (OR = 0.47; 95% CI, 0.22-0.98), the researchers noted. Furthermore, nonadherence to IDSA criteria was not observed to be a risk factor for mortality or readmission.

”As a general rule, it seems reasonable to consider as candidates for OPAT all patients with endocarditis not caused by difficult-to-treat microorganisms requiring complex antibiotic combinations and not presenting clinical, echocardiographic, or post-surgical complications that have not resolved shortly after onset,” Pericàs and colleagues wrote. “Naturally, an individualized assessment of each patient performed by OPAT-skilled physicians might lead to rejection of OPAT for more specific reasons. General recommendations apply only to centers with established OPAT programs meeting all appropriate requirements, including a well-organized multidisciplinary team, excellent communication and monitoring systems, and proper physical and support conditions in the patients’ homes or outpatient clinic.” – by Marley Ghizzone

Disclosures: Pericàs reports no relevant financial disclosures. Please see the study for all other author’s relevant financial disclosures.

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The most important thing my fellow clinicians can take away [from this study] is additional evidence for what, I think, has become a common practice among ID clinicians using OPAT, particularly in the United States.

The study provides additional support and evidence for the current guidelines. Both the IDSA endocarditis guidelines and IDSA OPAT guidelines are not as prescriptive as the 2001 guideline cited in the paper. The decision to use OPAT for a patient really is on a case-by-case basis. The issues that would prevent someone from getting OPAT have much more to do with medical needs, health care needs and hospital-based needs rather than their infectious disease treatment.

The use of OPAT in people using IV drugs is an area of ongoing conversation and challenge. Several groups are publishing good data that help with assessing the risk of OPAT in this population, but are generally observational data like this paper and include small numbers of patients. Our facility here at UW Medicine-Harborview Medical Center has published some of these data as well, particularly in patients who are homeless, and have shown you can have good outcomes in historically “at-risk” populations. The key message there is — and again, I think it is what is being practiced in much of the country — OPAT is an option for all patient groups and really needs to be taken on case-by-case basis. We can provide effective outpatient therapy in people’s homes and in many other settings. This is further evidence that, even in complicated, older adults, you can perform safe therapy at home. As an aside, the evidence and support for using oral antimicrobials for diseases that have historically required IV medications is growing rapidly, which may mean less demand and need for OPAT overall.

The cohort for the patients in the study is from 2008 to 2012, and I think we have done a lot since 2012. In the last 5 or 6 years, the opportunities for conducting OPAT have increased dramatically. We have felt more and more comfortable, as ID doctors, providing OPAT for a wider spectrum of patients with really, really good outcome. I think it is really what patients want. The other thing that is interesting about this is, if you think about the population that was studied in Spain, here in the U.S., many patients of that age group — 65 and older — are on Medicare. Currently, Medicare does not allow for, or pay for, OPAT. Many of the patients described in the paper would be, in a sense, “on Medicare” in a U.S. setting and they would not be able to do this at home as Medicare does not cover home antibiotics. I would hope that data like these and guidelines that will be coming forward in the future would support changes at the Medicare level because this is what patients want. They do not want to go to a health care facility simply to get antibiotics. It is a huge limiting factor. In my state, I can send someone home who has Medicaid, and they can get OPAT, but you take someone who is 1 year older, and they cannot go home.

It is also worth noting that in this particular study, they had a very hands-on OPAT program. Patients had daily nurse visits, and had twice-weekly physicians’ visits, which I think is not common in the U.S. Most OPAT in the U.S. includes physician visits every 2 to 4 weeks. There are no data supporting more frequent physicians’ visits, unless there is medical need. In most cases, patients in the U.S. are self-administering antimicrobials and have a nurse visit once a week for PICC dressing changes and blood draws. The study had a much more intense oversight of the program, which is inconsistent, for the most part, with how we do things in the U.S.

John B. Lynch, MD, MPH

Member, Infectious Diseases Society of America
Associate professor of medicine and allergy and infectious diseases
University of Washington School of Medicine
Medical director, infection prevention & control and employee health programs
Harborview Medical Center

Disclosure: Lynch reports no relevant financial disclosures.