Revisiting INR Targets Prior to TKA
An elevated International Normalized Ratio (INR)—a standardized gauge for how long it takes blood to clot—is rarely a good sign when someone is about to undergo an elective orthopaedic procedure. This is especially true for larger surgeries such as total hip or knee arthroplasty, in which there are already concerns about perioperative bleeding. Excessive surgery-related blood loss can lead to wound complications, increased length of hospital stay, and higher mortality rates. But what precisely constitutes an “elevated” INR? While some recommendations suggest that elective procedures be performed only when a patient’s INR is ≤1.5, the evidence supporting this recommendation, especially in the setting of total knee arthroplasty (TKA), is sparse at best.
In the March 20, 2019 issue of The Journal, Rudasill et al. use the National Surgical Quality Improvement Program (NSQIP) database to help define what “elevated” should mean in the context of TKA. They evaluated data from >21,000 patients who underwent a TKA between 2010 and 2016 and who also had an INR level reported within one day before their joint replacement. They stratified these patients based on their INR levels (≤1, >1 to 1.25, >1.25 to 1.5, and >1.5). Using multivariate regression analysis to adjust for patient demographics and comorbidities, the authors found a progressively increasing risk of bleeding requiring transfusion for each group with an INR >1 (odds ratios of 1.19, 1.29 and 2.02, respectively). Relative to patients with an INR of ≤1, Rudasill et al. also found a significantly increased risk of infection in TKA patients with an INR >1.5 (odds ratio 5.34), and an increased risk of mortality within 30 days of surgery among patients with an INR >1.25 to 1.5 (odds ratio 3.37). Lastly, rates of readmission and the length of stay were significantly increased in patients with an INR >1.25.
While there are certainly weaknesses inherent in using the NSQIP dataset, this study is the first to carefully evaluate the impact of slight INR elevations on post-TKA morbidity and mortality. While I was not surprised that increasing INR levels were associated with increased bleeding events, I was impressed by the profound differences in length of stay, infection, and mortality between patients with an INR ≤1 and those with an INR >1.25. I agree with the authors’ conclusion that “current guidelines for a target INR of <1.5 should be reconsidered for patients undergoing TKA.” Further, based on the risks highlighted in this study, prospective or propensity matched cohort studies should be performed to help determine whether anyone with an INR >1 should undergo a TKA.
Chad A. Krueger, MD
JBJS Deputy Editor for Social Media
Will New Payment Models Adversely Affect Medicaid Patient Access to THA?
Concerns have arisen that the implementation of value-based, alternative payment models pegged to “bundled” episodes of care and/or patient outcomes may make it harder for a subset of patients to access the care they need. Specifically, some surgeons may be apprehensive to treat patients who have substantial medical comorbidities or socioeconomic situations that increase their risk of postsurgical complications and poor outcomes, because these alternative payment models often financially penalize physicians and hospitals for the cost of suboptimal results. The study by Shau et al. in the December 5, 2018 issue of The Journal provides data that sharpens the horns of this dilemma.
The authors used the National Readmissions Database to perform a propensity-score-matched comparison between >5,300 patients with Medicaid payer status who underwent a primary total hip arthroplasty (THA) and an equal number of patients with other types of insurance who also underwent primary THA. Shau et al. found that Medicaid-covered THA patients had significantly increased overall readmission rates (28.8% vs 21%, p <0.001, relative risk=1.37), mean length of stay (4.5 vs 3.3 days, p <0.0001), and mean total cost of care ($71,110 vs $65,309, p <0.0001), relative to the other group. These results strongly suggest that Medicaid payer status is an independent factor associated with increased resource utilization after total hip arthroplasty.
These findings can be viewed from a couple of different perspectives. First, from a preventive standpoint, surgeons and healthcare systems providing THA for Medicaid patients may need to spend more time preoperatively optimizing these patients (both physically and psychosocially) to decrease their postoperative resource burden and increase the likelihood of a good clinical outcome. Second, these results are further proof that any fair and effective alternative payment model needs to take into consideration factors such as Medicaid payer status and patient comorbidities. If they do not, such models will actually throw access barriers in front of patients in this demographic because providers may feel that caring for them increases the likelihood of being penalized financially.
Both perspectives are valid, so Medicaid payer status is a crucial factor to consider as alternative payment programs move forward. Nowadays, controlling costs is an important goal of any healthcare delivery system, but it must not lead to unintended discrimination in patient access to care. As we create further alternative payment models and refine existing ones, we must be careful not to prioritize cost cutting ahead of equitable patient access.
Chad A. Krueger, MD
JBJS Deputy Editor for Social Media
Prescribing Opioids: Smallest Dose for Shortest Time
Some people are tired of reading and hearing about the opioid crisis in America. When this topic comes up at meetings, there are rumblings in the crowd. When it’s brought up during hospital safety briefings, there are not-so-subtle eye-rolls, and occasionally I hear frank assertions of “enough already” when new information on the topic appears in the literature. Yet, as two studies in the July 18, 2018 edition of JBJS highlight, this topic is not going away any time soon. And for good reason. We are only starting to scratch the surface of the serious unintended consequences—beyond the risk of addiction—from overly aggressive prescribing and consumption of narcotics.
The first article, by Zhu et al., directly addresses the topic of overprescribing by doctors in China. The authors evaluated how many opioid pills were given to patients who sustained fractures that were treated nonoperatively. The mean number of opioid pills patients reported consuming (7.2) was less than half the mean number prescribed (14.7). More than 70% of patients did not consume all the opioid pills they were prescribed, and 10% of patients consumed no opioids at all. Zhu et al. conclude that “if opioids are used [in this setting], surgeons should prescribe the smallest dose for the shortest time after considering the injury location and type of fracture or dislocation.”
The second article, by Weick et al., underscores the patient-outcome and societal impact of opioid use prior to total hip and knee arthroplasty. Patients from North America who consumed opioids for 60+ days prior to their joint replacement had a significantly increased risk of revision at both the 1-year and 3-year postoperative follow-ups, compared to similar patients who were opioid-naïve before surgery. Similarly, patients who used opioids for 60+ days prior to undergoing a total hip or knee arthroplasty had a significantly increased risk of 30-day readmission, compared to patients who were opioid-naïve. All these differences held when the authors made adjustments for patient age, sex, and comorbidities—meaning that tens of thousands of patients each year can expect to have worse outcomes (and add a large cost burden to the health care system) simply by being on opioid medications for two months preoperatively.
These articles address two very different research questions in two very different regions of the world, but they help expose the chasm in our knowledge surrounding opioid use and misuse. We have been prescribing patients more narcotics than they need while just starting to recognize the importance of minimizing opioid use preoperatively in an effort to maximize surgical outcomes. These two competing impulses emphasize why further opioid-related studies are important. While continuing to look at the negative effects these medications can have on patients, we have to take a hard look at our contribution to the problem.
Chad A. Krueger, MD
JBJS Deputy Editor for Social Media
More Data on Outpatient vs Inpatient Joint Replacement
In addition to the Pearl Diver-based retrospective study by Arshi et al. on one-year complications after outpatient knee replacement, the December 6, 2017 issue of JBJS contains a NSQIP-based retrospective study by Basques et al. that compares 30-day adverse events and readmissions among 1,236 patients who underwent same-day-discharge hip or knee (total or unicompartmental) arthroplasty with an equal number of propensity score-matched patients who were discharged at least 1 calendar day after the procedure.
When analyzing all three procedures together, the authors found no overall between-group differences in the rates of any adverse event (severe or minor) or readmission. However, when authors analyzed individual adverse events, the same-day group had decreased thromboembolic events and increased 30-day reoperations compared to inpatients. Analysis of individual procedures revealed an increased 30-day reoperation rate for same-day total knee arthroplasty (TKA), compared with inpatient TKA. Overall, infection was the most common reason for reoperation and readmission following same-day procedures.
As with the Arshi et al. study, the limitations of the database prevented these authors from accounting for physician or hospital volume. However, they did identify several preoperative patient characteristics that increased the risk of 30-day readmission among same-day patients, and from those findings Basques et al. concluded that “obese patients, older patients [≥85 years of age], and those with diabetes mellitus may not be appropriate candidates for same-day procedures.”
In Spinal-Metastasis Surgery, High-Volume Yields Better Outcomes
In orthopaedics, the connection between a hospital/surgeon performing a surgical procedure many times and improved outcomes has been demonstrated compellingly with total joint replacement. In the October 18, 2017 edition of JBJS, Schoenfeld et al. show that this same volume-outcome relationship holds true in the surgical treatment of spinal metastases.
The study analyzed 3,135 patients treated by 1,488 surgeons at 162 hospitals throughout Florida. Using sophisticated statistics, the authors defined high-volume surgeons as those who had performed ≥49 procedures per year and high-volume hospitals as those at which ≥167 procedures per year had been performed.
Among the entire cohort, the 90-day complication rate was 26% and the readmission rate was 43%. (Rates that high are not unexpected with such risky spinal surgeries.) Here are the findings according to surgeon volume:
- 21% complication rate for patients treated by high-volume surgeons
- 30% complication rate for patients treated by low-volume surgeons
- 37% readmission rate for patients treated by high-volume surgeons
- 47% readmission rate for patients treated by low-volume surgeons
In other words, the relative odds of complications and readmissions following operations performed by low-volume surgeons were approximately 40% higher than those following operations done by high-volume surgeons. A similar percentage difference was found between the odds at low- and high-volume hospitals. In a secondary analysis, the authors found that African Americans and Hispanics were significantly less likely than white patients to receive care from a high-volume surgeon or at a high-volume hospital.
Schoenfeld et al. state that the ideal care for patients facing surgery for spinal metastases comes from a team of experienced surgeons, medical oncologists, radiation oncologists, nurses, and support staff. They conclude that their findings “speak to the need for regionalization of subspecialty spinal oncology care as a means to optimize treatment for this cohort of patients.”
Ambulatory Shoulder Arthroplasty Is Safe
In the April 19, 2017 issue of The Journal, Cancienne et al. compare complication and readmission rates for patients undergoing ambulatory shoulder arthroplasty with those among patients admitted as hospital inpatients postoperatively. Because the analysis was based on data from a large national insurer, we can be quite sure of appropriate coding and accurate data capture.
Similar to our recent report regarding outpatient hand and elbow surgery, in no instance were complications present at a significantly higher rate in the patients who underwent ambulatory shoulder arthroplasty, and the rate of hospital readmission after discharge was not significantly different at 30 or 90 days between the two cohorts.
This definitely is a tip of the hat to orthopaedic surgeons, nurses, and anesthesiologists, who are making sound decisions regarding which patients are appropriate for outpatient arthroplasty. Cancienne et al. found that obesity and morbid obesity were significant demographic risk factors for readmission among the ambulatory cohort, and they also identified the following comorbidities as readmission risk factors in that group:
- Diabetes
- Peripheral vascular disease
- Congestive heart failure
- Chronic lung disease
- Depression
- Chronic anemia
These results offer further documentation regarding the shift away from hospital-based care after orthopaedic surgery. Those of us who perform surgery in dedicated orthopaedic centers as well as general hospital operating rooms understand the concepts of efficiency, focus, maintenance of team skills, and limiting waste. Those objectives in large part drive the move to outpatient surgery. But patients, who almost always prefer to be at home and sleep in their own beds (or recliners in the case of shoulder replacement), may be an even more powerful driver of ambulatory care in the future.
Major advances in postoperative pain management are great enablers in this regard, and I believe the trend will continue. I envision a day when the only patients admitted to hospitals after orthopaedic surgery are those with unstable medical issues who potentially may need ICU care postoperatively.
Marc Swiontkowski, MD
JBJS Editor-in-Chief
Unplanned Readmissions After Outpatient Hand and Elbow Surgery
In the April 5, 2017 issue of The Journal, Noureldin et al. analyzed more than 14,000 procedures from the NSQIP database to determine the rate of unplanned 30-day readmission after outpatient surgical procedures of the hand and elbow. The 1.2% rate seems well within the range of acceptability, particularly because the more than 450 institutions contributing to this database probably serve populations who don’t have the best overall health and comorbidity profiles.
Missing causes for about one-third of the readmissions illustrate one issue with data accuracy in these large administrative datasets. While the authors acknowledged a “lack of granularity” as the greatest limitation in analyzing large databases, they added that the readmissions with no listed cause “were likely unrelated to the principal procedure.”
It was not surprising that infection was the most common cause for readmission. However, it would have been nice to know the rate of confirmed infection via positive cultures, as I suspect many of these patients were readmitted for erythema, swelling, warmth, and discomfort associated with postoperative hematoma rather than infection.
Regardless of the need for higher-quality data on complications following outpatient orthopaedic surgical procedures, this analysis gives us more confidence that the move toward outpatient surgical care in our specialty is warranted. I think most patients would rather sleep in their own home as long as preoperative comorbidities and ASA levels are considered and adequate postoperative pain control can be achieved in an outpatient setting. The trend toward outpatient orthopaedic treatment is likely to continue as we gather higher-quality data and better understand the risk-benefit profile.
Marc Swiontkowski, MD
JBJS Editor-in-Chief
Smoking Boosts Rate of Reoperation for Infection after TJA
Here’s one thing about which medical studies have been nearly unanimous: Smoking is a health hazard by any measure. In the February 15, 2017 edition of The Journal of Bone & Joint Surgery, Tischler et al. put some hard numbers on the risk of smoking for those undergoing total joint arthroplasty (TJA).
After controlling for confounding factors, the authors of the Level III prognostic study found that:
- Current smokers have a significantly increased risk of reoperation for infection within 90 days of TJA compared with nonsmokers.
- The amount one has smoked, regardless of current smoking status, significantly contributed to increased risk of unplanned nonoperative readmission.
In a commentary on the Tischler et al. study, William, G. Hamilton, MD says, “…as physicians, we should work cooperatively with our patients to enhance outcomes by attempting to reduce these modifiable risk factors. We can educate patients and can suggest smoking cessation programs and weight loss regimens that may not only improve the risk profile during the surgical episode, but also improve the patients’ overall health.”
Tool for Pre-TJA Risk Stratification Piloted
A case-control study by Boraiah et al. in the December 2, 2015 JBJS describes a risk-stratification tool that helps predict which patients undergoing total joint arthroplasty (TJA) are likely to be readmitted to the hospital after discharge. The authors used the tool—dubbed the Readmission Risk Assessment Tool, or RRAT—preoperatively among 207 patients who were subsequently readmitted after primary TJA and two cohorts of 234 patients each (one random and one age-matched) who were not.
The total RRAT score for each individual is the cumulative sum of all scores for modifiable risk factors such as infection, smoking, obesity, diabetes, and VTE. Non-modifiable risk factors such as age, sex, race, and socioeconomic status are not included in the scoring system.
The median RRAT score for those readmitted was 3; the median RRAT score for those not readmitted was 1. An RRAT score of ≥3 was significantly associated with higher odds of readmission. Surgical site infection was the most common cause of readmission (found in 45% of the 207 readmitted patients).
The authors note that in the current and future climate of value-based health care, “any unplanned readmission will have financial consequences on the provider and health-care institution”—not to mention the burden readmissions place on patients. While admitting that the RRAT needs to be further evaluated and validated in larger cohorts and that it may not be possible to modify individual risk factors into “an acceptable range” prior to TJA, the authors suggest that risk stratification with the RRAT “can present a ‘teachable moment’ and an opportunity for shared decision-making discussions.”
Fracture Liaison Service Addresses Epidemic of Osteoporosis
The statistics about osteoporosis and associated fragility fractures are sobering:
- One-quarter of adults living in the US currently have osteoporosis or low bone density.
- Twenty-four percent of people aged 50 and older who sustain a hip fracture will die within a year after the fracture.
- Patients who have had one fragility fracture have an 86% increased risk for a second fracture.
Amid these troubling data stands hope from an effective, team-based clinical response—the fracture liaison service (FLS). In the April 15, 2015 edition of JBJS, Miller et al . explain how an FLS works and the results it achieves.
The authors define the fracture liaison service as “a coordinated care model of multiple providers who help guide the patient through osteoporosis management after a fragility fracture to help prevent future fractures.” The three key players on the FLS team are a coordinator (usually an advanced-practice provider), a physician champion (whom the authors say should be an orthopaedic surgeon), and a “nurse navigator.” Miller et al. describe the roles these FLS core team members play (including patient care and education and communication with other clinical services and administrators), suggest ways to organizationally justify an FLS, and lay out a stepwise implementation roadmap.
The authors conclude that an FLS “is adaptable to any type of health-care system, improves patient outcomes, and decreases complications and readmissions related to secondary fractures.” And there’s an important fringe benefit: “The FLS can help improve performance on quality measures…and help health-care organizations during this transition from volume payment to quality payment,” they say.
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