Army Pvt. Shamika Burrage almost died in 2016. The 19-year-old was returning back to base after visiting her family when her tire blew out, causing her to lose control of the car, which flipped and skidded for 700 feet before ejecting her. Thanks to prompt medical care, she only lost an ear instead of her life. But now, thanks to military plastic surgeons, she’s even got that back.
In a first for United States Army doctors, Burrage received an ear transplant that was grown from her own tissue inside her own body. A team, led by Lieutenant Colonel Owen Johnson III, the chief of plastic and reconstructive surgery at William Beaumont Army Medical Center in El Paso, Texas, harvested cartilage from Burrage’s ribs, carved it into the shape of an ear, and implanted it under the skin in her arm. There, it developed blood vessels, which Johnson says will allow Burrage to regain feeling in the ear once it’s healed. In an announcement released on Monday, Johnson called the operation a success.
“The whole goal is by the time she’s done with all this, it looks good, it’s sensate, and in five years if somebody doesn’t know her they won’t notice,” said Johnson in the statement. “As a young active-duty Soldier, they deserve the best reconstruction they can get.” Johnson also used skin from Burrage’s arm to help conceal the borders of the transplant and make the reconstruction more seamless. Soon Burrage, who is now 21 years old, will bear few marks of her fateful crash.
This procedure may be the U.S. Army’s first such transplant, but it’s definitely not the first time doctors have grown ears for patients. In 2012, doctors at Johns Hopkins University grew an ear under the forearm skin of a cancer survivor. In January, doctors in China successfully grew and transplanted ears onto children born with a birth defect that affects natural ear growth. In 2015, a child who had suffered burn injuries received the first 3D-printed nose.
Recent history suggests that procedures like Burrage’s will likely become more and more commonplace. Some doctors have even predicted that 2019 will be the year we’ll regularly print new noses and ears with human cells. In the meantime, Burrage has a couple more surgeries before her procedure can be considered complete. She’s feeling good about the surgery, though.
The ear had closed up because of the trauma from the accident, but Burrage says she can hear just as well as she could before. “I didn’t lose any hearing and [Johnson] opened the canal back up.”
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The U.S. Food and Drug Administration today permitted marketing of the first blood test to evaluate mild traumatic brain injury (mTBI), commonly referred to as concussion, in adults. The FDA reviewed and authorized for marketing the Banyan Brain Trauma Indicator in fewer than 6 months as part of its Breakthrough Devices Program.
Most patients with a suspected head injury are examined using a neurological scale, called the 15-point Glasgow Coma Scale, followed by a computed tomography or CT scan of the head to detect brain tissue damage, or intracranial lesions, that may require treatment; however, a majority of patients evaluated for mTBI/concussion do not have detectable intracranial lesions after having a CT scan. Availability of a blood test for concussion will help health care professionals determine the need for a CT scan in patients suspected of having mTBI and help prevent unnecessary neuroimaging and associated radiation exposure to patients.
“Helping to deliver innovative testing technologies that minimize health impacts to patients while still providing accurate and reliable results to inform appropriate evaluation and treatment is an FDA priority. Today’s action supports the FDA’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging—an effort to ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose,” said FDA Commissioner Scott Gottlieb, M.D. “A blood-testing option for the evaluation of mTBI/concussion not only provides health care professionals with a new tool, but also sets the stage for a more modernized standard of care for testing of suspected cases. In addition, availability of a blood test for mTBI/concussion will likely reduce the CT scans performed on patients with concussion each year, potentially saving our health care system the cost of often unnecessary neuroimaging tests.”
According to the U.S. Centers for Disease Control and Prevention, in 2013 there were approximately 2.8 million TBI-related emergency department visits, hospitalizations and deaths in the U.S. Of these cases, TBI contributed to the deaths of nearly 50,000 people. TBI is caused by a bump, blow or jolt to the head or a penetrating head injury that disrupts the brain’s normal functioning. Its severity may range from mild to severe, with 75 percent of TBIs that occur each year being assessed as mTBIs or concussions. A majority of patients with concussion symptoms have a negative CT scan. Potential effects of TBI can include impaired thinking or memory, movement, sensation or emotional functioning.
“A blood test to aid in concussion evaluation is an important tool for the American public and for our Service Members abroad who need access to quick and accurate tests,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA’s review team worked closely with the test developer and the U.S. Department of Defense to expedite a blood test for the evaluation of mTBI that can be used both in the continental U.S. as well as foreign U.S. laboratories that service the American military.”
The Brain Trauma Indicator works by measuring levels of proteins, known as UCH-L1 and GFAP, that are released from the brain into blood and measured within 12 hours of head injury. Levels of these blood proteins after mTBI/concussion can help predict which patients may have intracranial lesions visible by CT scan and which won’t. Being able to predict if patients have a low probability of intracranial lesions can help health care professionals in their management of patients and the decision to perform a CT scan. Test results can be available within 3 to 4 hours.
The FDA evaluated data from a multi-center, prospective clinical study of 1,947 individual blood samples from adults with suspected mTBI/concussion and reviewed the product’s performance by comparing mTBI/concussion blood tests results with CT scan results. The Brain Trauma Indicator was able to predict the presence of intracranial lesions on a CT scan 97.5 percent of the time and those who did not have intracranial lesions on a CT scan 99.6 percent of the time. These findings indicate that the test can reliably predict the absence of intracranial lesions and that health care professionals can incorporate this tool into the standard of care for patients to rule out the need for a CT scan in at least one-third of patients who are suspected of having mTBI.
The Brain Trauma Indicator was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device.
The FDA is permitting marketing of the Brain Trauma Indicator to Banyan Biomarkers, Inc.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
A randomized controlled trial has shown that patients are less likely to develop an incisional hernia in the 2.5 years after a laparoscopic colectomy when they have a transverse instead of a midline specimen extraction site.
The findings confirm results from smaller retrospective studies, but offer the strongest evidence demonstrating that extraction site location significantly affects incisional hernia risk.
The study also highlights the need for careful selection of patients who undergo transverse incisions.
In an intent-to-treat analysis, investigators found no significant difference in incisional hernias between midline and transverse incisions one year after surgery. This may be explained by the high number of patients randomly assigned to a transverse incision who were switched to a midline, open or Pfannenstiel incision, indicating the transverse incision is best reserved for selected patients.
“These results suggest that while a transverse incision results in less internal hernias compared to midline, it is less versatile and may only be feasible in select patients,” wrote Lawrence Lee, MD, PhD, and his colleagues from the Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, McGill University Health Centre, in Montreal.
The study is published online in the Annals of Surgery (2017 Nov 21. [Epub ahead of print]).
Dr. Lee and his colleagues randomly assigned 165 adult patients to a transverse (n=79) or midline (n=86) specimen extraction site, of which 141 completed one-year follow-up. Eligible patients underwent an elective laparoscopic right hemicolectomy, left hemicolectomy or rectosigmoid resection for malignant or benign disease, and did not have inflammatory bowel disease, emergency surgery, mid to low-rectal resection, transverse colectomy, single-incision laparoscopic surgery, planned stoma, ASA class IV to V status or morbid obesity. They could not participate in another trial that would have influenced the results.
Twenty-three of the 79 patients allocated to transverse were converted to open (n=15), or received a midline (n=10) or Pfannenstiel (n=8) incision.
With one year of follow-up after surgery, 141 patients were included in the intent-to-treat analysis, including 68 in the transverse group and 73 in the midline group. The incidence of incisional hernias was similar between the transverse group at 2% and the midline group at 8% (P=0.065). With a mean follow-up of 29.9 months in the transverse group and 30.6 months in the midline group, the incidence of incisional hernias was 14% in the midline group and 6% in the transverse group. Of the four patients who developed incisional hernias in the transverse group, only one underwent a transverse incision and three were converted to midline laparotomy during the initial surgery.
The per-protocol analysis at one year included 117 patients—52 in the transverse group and 65 in the midline group—with incisional hernia rates of 2% and 9%, respectively. Mean follow-up time in the per-protocol analysis was 29.1 months in the transverse group and 29.9 months in the midline group. At that time, incisional hernia incidence was 2% after transverse and 15% after midline incisions (P=0.013).
Conor P. Delaney, MD, professor of surgery and chair of the Digestive Disease and Surgery Institute of the Cleveland Clinic, in Ohio, said the study brings a new level of evidence to an idea that surgeons believe intuitively.
In 2013, he and his colleagues published a retrospective review of 280 laparoscopic colorectal procedures over a six-year period (Am J Surg 2013;205:264-267). They reported that midline hernia rates, although lower than with traditional open surgery, were higher than non-midline rates.
Non-midline incisions are a “very simple way to help patients’ long-term outcomes become improved,” he said, adding that non-midline incisions also tend to cause less pain.
“This study is a really good reminder of the high level of evidence that, wherever possible, we’ve got to get incisions away from the midline.”
The investigators said the number of incisional hernias throughout the study period was lower than in previous studies, and may reflect the low rates of surgical site infections (SSIs), a known risk factor for the development of incisional hernias. During the five years when patients were being enrolled in this study, SSIs were the target for multiple quality improvement initiatives at the study institution.
The investigators noted that they did not use the small bites technique, which has been shown to result in fewer incisional hernias after primary midline fascial closure. “It is unknown whether application of the small bites technique would have altered the result,” they wrote.
Patients in the transverse group reported higher scores in body pain (denoting less pain) and social function domains on the Medical Outcomes Study 36-Item Short Form Health Survey. Patients with midline incisions reported better cosmesis scores, although body image scores did not differ.
“There is a trade-off between cosmesis and risk of incisional hernia that should be important elements of the informed consent process for patients undergoing laparoscopic colectomy,” they wrote.
In the midline group, the umbilical port site was sharply extended using electrosurgery through the linea alba to create a periumbilical midline extraction incision. In the transverse group, an incision was created lateral to the linea semilunaris and rectus sheath. The external oblique aponeurosis was divided parallel to its fibers, and the internal oblique and transversus abdominis split in the direction of their fibers.
An independent surgeon who was not involved in the clinical care of the patient performed the hernia assessment by physical examination, as neither patient nor health care providers could be blinded to group assignment.
Reduced rates of incisional hernia was a hoped-for benefit of the smaller incisions enabled by laparoscopic surgery. However, laparoscopic versus open colectomy randomized trials have not demonstrated a difference in the incidence of incisional hernias with long-term follow-up.
A Cochrane Review of randomized trials comparing midline with transverse incisions concluded that transverse incisions were less painful, had less effect on pulmonary function, and were associated with a decreased incidence of incisional hernia compared with midline incisions, but these data involved open surgery only (Cochrane Database Syst Rev 2005;:CD005199).
Currently in the United States, about twice as many adults with appendicitis are treated without an operation as 20 years ago, but nonoperative management of an infected appendix is linked to a higher death rate in the hospital, according to the first large U.S. study to look at long-term trends in appendicitis.
Studies in Europe over the past two decades have shown that some patients with uncomplicated appendicitis can be treated successfully with antibiotics alone. These results appear to be driving the change in surgical practice for appendicitis in the United States.
But this new study raises questions about whether a nonoperative approach is a safe option for older or medically complex patients.
After matching the cases in both treatment groups on age, sex and comorbidity index, the investigators reported a nearly sixfold increased death rate in the nonoperative care group. Compared with 0.08% of surgically treated patients with appendicitis, 0.47% of the nonoperatively managed patients died in the hospital.
“I am concerned that surgeons may be overextrapolating the European data and applying nonoperative management of appendicitis to patients for whom it is inappropriate,” said the study’s principal investigator Isaiah R. Turnbull, MD, PhD, assistant professor of acute and critical care surgery, Washington University School of Medicine, in St. Louis. “We as a community of surgeons need to consider whether nonoperative management of uncomplicated appendicitis, such as an antibiotics-first approach, is appropriate for these high-risk patients.”
Dr. Turnbull presented the findings at the 2017 Clinical Congress of the American College of Surgeons. The study was published last month in the Journal of Surgical Research (pii: S0022-480430661-3).
The researchers analyzed the type of treatment for 477,680 adults with a primary diagnosis of appendicitis between 1998 and 2014 included in the National Inpatient Sample, a database of hospitalized patients representing more than 96% of the U.S. population.
Although the database did not specify whether the appendix had ruptured, investigators excluded patients who had a peritoneal abscess, as well as patients younger than 18 years of age and those who had elective admission.
Over the study period, the proportion of patients treated with an early operation decreased from 94.6% to 92.1%. Use of nonoperative management increased twofold, from 2.3% of patients with appendicitis in 1998 to 4.9% in 2014. Most of the remaining patients had an operation later than the second day in the hospital.
Additionally, in 135,856 patients with appendicitis from 2010 to 2014, the investigators compared patient characteristics and outcomes. A total of 131,162 patients underwent an early operation, primarily an appendectomy on the day of hospital admission or the next day. Another 4,694 patients received nonoperative management, defined as no operation or placement of an abdominal drain. It is not clear from this data set whether these patients received antibiotic therapy.
In this subgroup of patients from the most recent five-year period, those receiving nonoperative management were, on average, eight years older than patients in the early operation group—49 versus 41 years. They also had a significantly higher comorbidity index, with a score of 1.35 compared with 0.78.
The odds of dying of any cause during the hospitalization was 2.4 times higher in patients who had no operation compared with those who underwent an early operation.
“Our findings suggest that U.S. surgeons are selecting elderly, sicker patients for nonoperative management, possibly because they believe these patients are not good candidates for an operation,” Dr. Turnbull said. “However, these patients are at increased risk of a poor outcome if nonoperative management fails because they lack the physiologic reserve or ability to tolerate illness.” Many of the European studies of antibiotic treatment for appendicitis excluded elderly patients and had a patient age that was much younger than in this U.S. database, he said.
This is the first known study to show an association between nonoperative management of appendicitis and death. Mortality is rare in appendicitis, so tracking it requires a large data set.
Dr. Turnbull said he was cautious about making clinical recommendations based on this study alone, saying the primary conclusion from these data is that more information is needed. “That said, for me, I would counsel my colleagues that these data suggest that nonoperative management may not be appropriate for elderly patients or patients with significant medical comorbidities.”
The ongoing CODA trial is expected to provide some answers on how to best treat elderly patients as it is open to adults of all ages. It explicitly excludes several populations of medically complicated patients, such as those who have liver failure, immunologic deficiency, or second infectious conditions such as pneumonia.
Lead investigators in the CODA trial said the study presented at the ACS is interesting, but caution should be applied when interpreting the results. Giana H. Davidson, MD, MPH, assistant professor at the University of Washington, said early results from CODA show that surgeons have significant bias in giving treatment recommendations and patients have preferences that drive treatment decisions, which will not be accounted for using administrative data. “These preferences may also be associated with worse outcomes.”
David R. Flum, MD, MPH, professor of surgery and director of the Surgical Outcomes Research Center at the University of Washington, in Seattle, said the CODA trial was developed to answer some of the questions raised by the new study. “There are real questions about actual rates of adverse outcomes with antibiotic management of appendicitis.” Dr. Flum is a member of the editorial board of General Surgery News.
“While it’s likely that claims-based studies like this may show higher rates of adverse events because of confounding, the finding of increased risk is worrisome. For antibiotics to be offered as an alternative to appendectomy in the United States, we need a rigorous [randomized controlled trial] to establish the comparative rate of adverse events. For this reason, we think antibiotics should remain in the research space until CODA is completed and the results are released in 2020.”
Both Dr. Davidson and Dr. Flum commented based on the study abstract.
Appendicitis is the most common intraabdominal surgical emergency in the United States, with more than 250,000 cases annually.
Patients undergoing major abdominal procedures have an independent risk for mortality when at least 6 L of IV fluid are administered on the day of surgery.
The retrospective study, which used a large administrative database of roughly 36,000 patient discharges from 393 hospitals across the United States, found that patients receiving at least 6 L of IV fluid on the day of surgery had a 48-hour inpatient mortality rate that was 48% higher than expected (Figure).
Overall, 21% of patients received over 6 L of IV fluid on the day of surgery, with 2% of patients receiving at least 9 L. “To me, this finding is provocative,” said Thomas Hopkins, MD, of Duke University Health System, in Durham, N.C. “After rigorously adjusting for patient characteristics like age, comorbidity, acute organ dysfunction and diagnosis, as well as disease-specific factors like procedure, location, surgical approach and duration of procedure, we found that excessive fluid administration was an independent risk factor for perioperative mortality.” The study was presented at the 2017 annual meeting of the American Society of Anesthesiologists (abstract A4147).
Dr. Hopkins, who is director of quality improvement in the Department of Anesthesiology and associate medical director of care redesign at Duke, was inspired to conduct the study because of his long-standing interest in enhanced recovery after surgery and his work on enhanced recovery programs (ERPs).
“Our multidisciplinary team here at Duke University Health System found that there are aspects of our ERP that have a differential impact on patient outcomes,” he said. “One of these factors appears to be perioperative fluid administration. Our preliminary data suggest that the way we administer fluid in the operating room and the way that we administer fluid on the surgical wards following the operation can have an impact on perioperative morbidity, length of hospital stay and ultimately on patient survival.”
The current study took the hypothesis generated from these preliminary data and tested it on a much larger patient population to determine whether the trends established at Duke would be applicable across an extremely large data set.
The study’s patient mortality risk was based on hospital practice, with 22% of hospitals having only 5.8% of their cases in the high-risk fluid category, whereas 26% of hospitals had 40.5% of patients in that category. “Therefore, there is clearly significant variation in practice, depending on site of care,” Dr. Hopkins said.
Based on the study, Dr. Hopkins and his colleagues are uncertain as to the distinguishing factors that each of the two hospital groups possesses to cause such disparate results. “But our hypothesis is that the hospitals in the best-performance group have some type of algorithm or protocol or standard approach to fluid management on the day of surgery, whereas hospitals in the underperforming group most likely did not,” he said.
The reflex assumption after reading the results of the study is that less fluid should be administered on the day of surgery, according to Dr. Hopkins. “This idea is not new. We have seen a fair amount of academic work attempting to elucidate the answer to this question over the past five years,” he said. However, a number of large retrospective analyses have concluded that “if you simply restrict fluid on the day of surgery, you can do harm. In fact, there is probably a bimodal distribution of patient morbidity and mortality that is associated with either too little or too much fluid on the day of surgery,” he said.
Hence, based on the literature and the present study, “the best solution is to consider a dynamic approach to perioperative volume resuscitation that leverages a patient-specific and a patient-tailored strategy,” Dr. Hopkins said.
Dr. Hopkins emphasized it is extremely important to stress that one-fifth of the surgical patient population for major abdominal surgeries in the United States could be at increased risk for perioperative mortality “because our current approach to fluid resuscitation in this patient population is very unstructured. We know there is a significant amount of variability in our practice.”
Dr. Hopkins is optimistic that the study will spur a reassessment of the need to consider fluid as a primary end point in ERPs and to focus on leveraging a dynamic fluid assessment to guide perioperative fluid administration, not only in the operati ng room but postoperatively on the floor. “Hopefully, this will increase awareness about variability in practice, how that variability can impact perioperative outcomes, and ultimately how it can impact value delivery in the perioperative space,” he said.
Dr. Hopkins said we are living in a time where the definition of value, as it applies to perioperative medicine, is changing very rapidly. “In these times of rapid change, ERPs have surfaced as a way to improve the value of care by improving patient outcomes and reducing the cost required to achieve those outcomes,” he said.