Tag Archive | complication

Residents in the OR—What’s the Risk?

Orthopaedic educators have long confronted the subtle implication that resident participation in surgical care can contribute to patient harm or even death. While there have been numerous changes in residency education to improve the  supervision and training of residents, the reality is that surgical trainees have to learn how to operate. This fact can leave surgical patients understandably nervous, and many of them heave heard rumors of a “July effect”—a hypothetical increase in surgery-related complications attributed to resident education at the beginning of an academic year. To provide further clarity on this quandary, in the November 21, 2018 issue of The Journal, Casp et alexamine the relationship between complication rates after lower-extremity trauma surgery (for hip fractures, predominantly), the participation and seniority of residents, and when during the academic year the surgery occurred.

The authors used the NSQIP surgical database to examine >1,800 patient outcomes after lower-extremity surgery according to academic-year quarter and the postgraduate year of the most senior resident involved in the case. The analysis revealed two major findings:

  1. Overall, there was no “July effect” at the beginning of the academic year in terms of composite complication rates.
  2. Cases involving more senior residents were associated with an increased risk of superficial surgical site infection during the first academic quarter.

While the authors were unable to provide a precise reason for the second finding, they hypothesized that it could have been related to more stringent data collection early in the academic year, senior-resident inexperience with newly increased responsibilities, or the warm-temperature time of year in which the infections occurred. Casp et al. emphasize that the database used in the study was not robust in terms of documenting case details such as complexity and the degree of resident autonomy, which makes cause-and-effect conclusions impossible to pinpoint.

Although this large database study does not answer granular questions regarding the appropriate role of residents in orthopaedic surgery, it should stimulate further research in this area. Gradually increasing responsibility is necessary within residency programs so that residents develop the skills and decision-making prowess necessary for them to succeed as attending surgeons. Studies like this help guide future research into the important topic of graduate medical education, and they provide patients with some reassurance that the surgical care they receive is not affected by the time during the academic-calendar year in which they receive it.

Marc Swiontkowski, MD
JBJS Editor-in-Chief

Outpatient Knee Replacement Complications: How Important Are They?

Outpatient TKA for OBuzzIn the December 6, 2017 issue of The Journal, Arshi et al. report on a detailed analysis of a large administrative database, looking specifically at one-year complications associated with outpatient versus standard inpatient knee replacement. This type of analysis is crucial because of the rapidly growing interest in outpatient joint replacement among patients, payers, and the orthopaedic community.

The data convince me that these outpatient procedures should proceed, but with a little more caution. Although the absolute complication rates in both surgical settings were very low, after adjusting for age, sex, and comorbidities, the authors found a higher relative risk of several surgical and medical complications among outpatients—including component failure, infection, knee stiffness requiring manipulation under anesthesia, and deep vein thrombosis.

One important element that is lacking in this analysis is adjustment for surgeon/hospital volume. We know from important work by Katz and others that patients managed at centers and by surgeons with greater volumes of total knee replacement have lower risks of perioperative adverse events.

These results from Arshi et al. are definitely not a call to stop the expansion of outpatient joint replacement protocols. Instead, I think this study should prompt every joint-replacement center to analyze its risk-adjusted inpatient and outpatient outcomes—and to ensure, as these authors emphasize, that outpatients receive the same level of attention to rehabilitation, antibiotic administration, and thromboprophylaxis as inpatients.

Enhancing outpatient knee-replacement protocols will serve local communities well, and the nationwide orthopaedic community will receive further confirmation that outpatient joint replacement is a move in the right direction.

Marc Swiontkowski, MD
JBJS Editor-in-Chief

Fructosamine Bests HbA1c for Preop Glycemic Screening

Fructosamine for OBuzzPatients with diabetes have an increased risk of postoperative complications following total joint arthroplasty (TJA). Additionally, perioperative hyperglycemia has been identified as a common and independent risk factor for periprosthetic joint infection, even among patients without diabetes. Therefore, knowing a patient’s glycemic status prior to surgery is very helpful.

In the November 15, 2017 edition of The Journal of Bone & Joint Surgery, Shohat et al. demonstrate that serum fructosamine, a measure of glycemic control obtainable via a simple and inexpensive blood test, is a good predictor of adverse outcomes among TJA patients—whether or not they have diabetes.

Researchers screened 829 patients undergoing TJA for serum fructosamine and HbA1c—a common measure, levels of which <7% are typically considered good glycemic control. Patients with fructosamine levels ≥292 µmol/L had a significantly higher risk of postoperative deep infection, readmission, and reoperation, while HbA1c levels ≥7% showed no significant correlations with any of those three adverse outcomes. Among the 51 patients who had fructosamine levels ≥292 µmol/L, 39% did not have HbA1c levels ≥7%, and 35% did not have diabetes.

In addition to being more predictive of postsurgical complications than HbA1c, fructosamine is also a more practical measurement. A high HbA1c level during preop screening could mean postponing surgery for 2 to 3 months, while the patient waits to see whether HbA1c levels come down. Fructosamine levels, on the other hand, change within 14 to 21 days, so patients could be reassessed for glycemic control after only 2 or 3 weeks.

While conceding that the ≥292 µmol/L threshold for fructosamine suggested in this study should not be etched in stone, the authors conclude that “fructosamine could serve as the screening marker of choice” for presurgical glycemic assessment. However, because the study did not examine whether correcting fructosamine levels leads to reduced postoperative complications, a prospective clinical trial to answer that question is needed.

High Value Joint Replacements at Physician-Owned Hospitals

H image for OBuzzIn the November 15, 2017 issue of The Journal, Courtney et al. carefully evaluate CMS data to compare TKA and THA costs, complications, and patient satisfaction between physician-owned and non-physician-owned hospitals. The authors used risk-adjusted data when comparing complication scores between the two hospital types, in an attempt to address the oft-rendered claim that surgeons at physician-owned facilities “cherry pick” the healthiest patients and operate on the highest-risk patients in non-physician-owned facilities.

In general, the findings suggest that, for TKA and THA, physician-owned hospitals are associated with lower costs to Medicare, fewer complications and readmissions, and superior patient-satisfaction scores compared with non-physician-owned hospitals. These findings should come as no surprise to readers of The Journal. One fundamental principle of health care finance is that physicians control 70% to 80% of the total cost of care with their direct decisions. When physician incentives are aligned with those related to the facility, the result is better care at lower cost.

Nevertheless, many policymakers remain convinced that physician-owners are completely mercenary and base every decision on maximizing profit margins—even if that includes ordering unnecessary tests, performing unnecessary procedures, or using inferior implants. We need more transparency among physician-owners at local and national levels to address these usually-erroneous assumptions, which are frequently repeated by local non-physician-owned health systems. For example, we should be transparent with the percentage of the margin that ends up in the physician-owner’s pocket. Whatever the “right” percentage is, I believe it should not be the dominant factor in a physician’s total income..

The findings from Courtney et al. should spur further debate on this issue. I am confident that the best outcomes for individual patients and the public result when physicians (and their patients) stay in direct control of decision making regarding care, when surgeons are appropriately motivated to be cost- and outcome-effective, and when we all do our part to care for the under- and uninsured.

Marc Swiontkowski, MD
JBJS Editor-in-Chief

In Spinal-Metastasis Surgery, High-Volume Yields Better Outcomes

Spinal Metastasis for OBuzzIn 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.”

TEA Proves Durable in Elderly Patients with Distal Humeral Fractures

TEA for OBuzzSeveral studies have demonstrated good short- and intermediate-term outcomes with total elbow arthroplasty (TEA) to treat acute distal humeral fractures. Now, in the September 20, 2017 issue of The Journal of Bone & Joint Surgery, Barco et al. provide data confirming that TEA provides durable pain relief and motion improvements over a minimum of 10 years, albeit with a number of major complications.

Among 44 TEAs performed in elderly patients with and without inflammatory arthritis whom the authors followed for ≥10 years, the mean Mayo Elbow Performance Score was 90.5 points. Five elbows (11%) developed deep infection that required surgical treatment. The revision-free survival rates for elbows with rheumatoid arthritis were 85% at 5 years and 76% at 10 years, while survival rates for elbows without rheumatoid arthritis were 92% at both time points. That difference was not statistically significant, although men in the study were much more likely to experience a revision than women. Twenty-five of the 44 patients died during the long-term follow-up, but the majority of those had their implant in place.

While reporting on these promising long-term revision-free survival rates, Barco et al. emphasize that complications were “frequent and diverse in nature…and have required a reoperation, including implant revision, in 12 of 44 patients.” So, while the good news is that a majority of patients in this situation will die with a useful joint and sound implant, the authors conclude that “surgeons treating this kind of injury should follow their patients over time and should be prepared to manage a wide array of complications using complex techniques.”

Fewer In-Hospital Complications with TAA vs Ankle Fusion

TAA for OBuzzAnkle Fusion for OBuzzAmong the many variables discussed when patients and surgeons make a decision between ankle arthrodesis (fusion) and total ankle replacement (TAA) for end-stage ankle arthritis, in-hospital complication rate is an often-overlooked point of comparison, partly due to a dearth of good data.

In the September 6, 2017 edition of The Journal of Bone & Joint Surgery, Odum et al. report findings from a matched cohort study that compared these two ankle procedures in terms of minor and major perioperative complications. To make more of an apples-to-apples comparison, the authors statistically matched 1,574 patients who underwent a TAA with an equal number of those who underwent fusion.

A major in-hospital complication (such as a pulmonary embolism or mechanical hardware problem) occurred in 8.5% of fusion patients and in 5.3% of TAA patients. After adjusting for case mix, Odum et al. found that ankle arthrodesis was 1.8 times more likely than TAA to be followed by a major complication. Regarding minor in-hospital complications (such as venous thrombosis or hematoma/seroma), the authors found a 29% lower risk of complications among arthrodesis patients compared to TAA patients, although that difference was not statistically significant (p = 0.14). Regardless of surgical procedure, patient age ≤67 years and the presence of multiple comorbidities were independently associated with a higher risk of a major complication.

A possible explanation for the lower in-hospital major-complication rate in TAA patients, say the authors, is that “TAA is more likely to be performed in younger, healthier patients with better bone quality and smaller deformities.”

Calculating Individual Complication Rates Is Complicated

Rating hospitals on the basis of complications is one thing, but when you publish complication-rate scorecards for individual surgeons, as ProPublica did recently with nearly 17,000 surgeons nationwide, things can get personal.

ProPublica, an independent investigative-journalism group, examined five years of Medicare records for eight common elective procedures, three of which—knee and hip replacements and spinal fusions—orthopaedists perform. For each of the eight procedures, a panel of at least five physicians, including relevant specialists, reviewed 30-day readmission data to determine whether the readmission represented a complication; if a majority agreement was not achieved, the case was excluded from analysis. The analysis also excluded trauma and other high-risk cases, along with cases that originated in emergency departments.

Overall, complication rates were 2% to 4%. About 11% of the doctors accounted for about 25% of the complications.

In a ProPublica article about the scorecard, Dr. Charles Mick, former president of the North American Spine Society, is quoted as saying, “Hopefully, [the scorecard] will be a step toward a culture where transparency and open discussion of mistakes, complications, and errors will be the norm and not something that’s hidden.”  For its part, the AAOS responded with a press release that welcomed transparency but cautioned that “the surgical complication issue is much more complex, and cannot be effectively addressed without considering all of the variables that impact surgery, care, and outcomes.”

Pre-emptively, ProPublica clarified its methods in a separate article. Any 30-day readmission that the panel determined to be a complication was assigned to the surgeon who performed the original procedure. After compiling a raw complication rate for each doctor, researchers screened each patient’s health record and assigned a “health score.” That health score was used as part of a mixed-effects statistical model to determine an individual’s adjusted complication rate. No rate is reported if a surgeon performed a procedure fewer than 20 times.

Over the years, physician groups have complained that conclusions derived from Medicare data are inherently flawed, an argument that one orthopaedist made in the ProPublica article, citing the “multitude of inaccurate and confusing information that is provided to state and federal organizations.” Interestingly, two renowned patient-outcome experts cited in the ProPublica article came to separate conclusions. Dr. Thomas Lee, chief medical officer at healthcare-metrics consultancy Press Ganey, was quoted as saying that “the methodology was rigorous and conservative,” while Dr. Peter Pronovost, director of the Armstrong Institute for Patient Safety and Quality at Johns Hopkins, told ProPublica in an email just prior to the scorecard release that “it would be highly irresponsible to present this to the public in its current form, or to make an example of any surgeon based on faulty data analysis.”

In another take on ProPublica’s ratings, radiologist Saurabh Jha spins a yarn on KevinMD  of two fictional orthopaedists, Dr. Cherry Picker and Dr. Morbidity Hunter. The moral of this tale, Dr. Jha says, is that ProPublica’s scorecard is “a reservoir of Sampson’s paradox…when the data says ‘bad surgeon,’ the surgeon might in fact be a Top Gun—a technically gifted Morbidity Hunter—the last hope of the poor and sick.”

Obviously the ProPublica scorecard has touched many a nerve among hip/knee-reconstruction and spine surgeons. Have you looked at your numbers? What do you think? Please join the discussion by clicking on the “Leave a comment” button in the box above, next to the article title.

Stop Smoking Before Joint Replacement—But for How Long?

The July 1, 2015 JBJS contains a database-driven analysis by Duchman et al. of more than 78,000 patients who underwent primary total hip or knee arthroplasty between 2006 and 2012. The authors found that the 10% who were current smokers had a higher rate of wound complications (1.8%), compared with rates in former smokers (1.3%) and nonsmokers (1.1%). Current smokers had approximately twice the rate of deep wound infections compared with former smokers or nonsmokers. The authors note, however, that periprosthetic infections—a specific complication of great interest to orthopaedists and patients—are not captured by the National Surgical Quality Improvement Program (NSQIP) database from which the analyzed data was extracted.

These findings align with several others that associate smoking with short-term postsurgical complications. However, commentators Jeffrey Cherian, DO and Michael Mont, MD note that this study’s definitions of “current” smokers (those who smoked within one year of surgery) and “former” smokers (those who did not smoke in the year prior to surgery but did smoke a pack a day or more for at least a year before that) leave surgeons “unable to adequately define a time point at which smoking should be stopped prior to surgery…to decrease the risk of adverse outcomes.” The commentators call for trials that more strictly stratify patients by tobacco usage so that surgeons can “evaluate the optimal time point for smoking cessation as well as the best programs and options for nicotine replacement.”