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Favilavir : First Antiviral Drug Showing Promising Results In Treatment Of COVID-19
GI Bleeding on Oral Anticoagulants in Atrial Fib Foremost a Colon Cancer Red Flag
Bleeding from the lower gastrointestinal (GI) tract shouldn’t be seen as simply a manageable adverse effect of oral anticoagulation (OAC) for atrial fibrillation (AF). Rather, it’s a red flag that the patient may be facing a much bigger threat, say researchers based on their observational study.
The absolute risk for lower-GI bleeding in a large national cohort of patients with AF who started on OAC was less than 1% over 6 months, regardless of age, and substantially less than 1% in patients 65 years and younger.
But those few with such bleeding showed a 10- to 15-fold increased 1-year risk for a diagnosis of colorectal cancer if they were older than 65, and 24 times that risk if they were 65 or younger, compared with those without lower-GI bleeding on OAC.
“Patients should be informed when initiating treatment with anticoagulants that blood in the stool should always lead to consulting their treating physician, and not be ignored as merely a benign consequence of treatment,” Peter Vibe Rasmussen, MD, University of Copenhagen, Hellerup, Denmark, told theheart.org | Medscape Cardiology.
“Our study included patients with bleeding severe enough for hospital contact. However, we think our data support that all eligible patients presenting with a sign or symptom of lower GI bleeding should be offered examinations to rule out cancer,” he said.
Only 61% of the youngest and less than 40% of the oldest patients with lower GI bleeds underwent endoscopy to investigate the cause, which points to “a potential underutilization of diagnostic procedures” in the cohort, said Rasmussen, who is lead author on the analysis, published February 7 in the European Heart Journal.
“I think we’re learning that we cannot just let those bleeds go without further investigation,” agreed Renato D. Lopes, MD, PhD, Duke Clinical Research Institute, Durham, North Carolina, speaking with theheart.org | Medscape Cardiology.
“Anticoagulants don’t make people bleed. What they do is magnify small bleeds or increase the likelihood of people bleeding because of underlying disease, in this case, GI cancer.”
So the current analysis, which supports and strengthens cautions from previous research, “is a wake-up call for us to not let any kind of bleed in the GI tract go without a more detailed investigation for potential cancer,” said Lopes, who isn’t connected with the current study.
That’s especially so as the newer generation of direct oral anticoagulants (DOAC) largely replaces warfarin and other vitamin K antagonists (VKA) in patients with AF.
“DOACs are much better than warfarin across the board, but they have one pitfall,” Lopes said. “It’s not true for all DOACs, but in general as a class, they cause more GI bleeding than warfarin.”
And that means “maybe we need to switch our mindset to be a bit more aggressive in the investigation of GI bleeds than we were in the warfarin era.”
Rasmussen said the study wasn’t sufficiently powered to compare DOACs and VKA for their effects on GI bleeding. The analysis is based on 125,418 patients in Danish administrative registries who initiated OAC for AF from 1996 through 2014, a time when such patients overwhelmingly received VKA. However, results were similar in a secondary analysis limited to only VKA recipients.
In the main analysis, the absolute risk for colorectal cancer in patients with vs without lower GI bleeding more than doubled from the 65-and-younger group to its peak in the 76-to-80-year age group. Meanwhile, the relative risk was highest in the youngest patients, who are likely to have fewer noncancer competing causes of GI bleeding than older groups.
It’s unknown whether a colorectal cancer diagnosis after investigation of an OAC-related bleed might often catch a malignancy at an earlier stage than otherwise would have occurred, “potentially increasing the likelihood of successful treatment,” Rasmussen said.
That’s possible, but “it should be seen in the perspective that any major bleeding is potentially harmful and could pose an immediate serious risk to the patient.”
Lower GI bleeding could indeed “trigger investigation of a more severe clinical disease, such as a cancer, and help save lives,” Lopes agreed. “Is that really impacting with lower mortality or less cancer related death? We don’t have that data yet.”
Source : Medscape
First Robotic Supermicrosurgery For Lymphedema
The first trial of robot-assisted, high-precision supermicrosurgery in humans has shown that the technique is safe for treating breast cancer–related lymphedema.
Although results are preliminary — only 20 patients participated, and a single highly skilled surgeon performed the supermicrosurgery — additional trials are underway to test the new robotic technique at other centers.
The pilot study was published online February 11 in Nature Communications.
The new device, known as MUSA, was supplied by MicroSure.
MUSA allows surgeons to connect tiny vessels, as small as 0.3–0.8 mm across, a technique referred to as supermicrosurgery. This technique can be used to connect blocked lymph vessels to veins, which can reestablish flow of lymphatic fluid and decrease arm swelling in women with breast cancer–related lymphedema, the researchers explain.
Only a few highly skilled surgeons worldwide can conduct supermicrosurgery using current surgical techniques, the authors comment.
“The success of supermicrosurgery is limited by the precision and stability of the surgeon’s hands. Robot-assisted supermicrosurgery has the potential to overcome this obstacle because more refined and subtle movements can be performed. Before now, no robots were able to perform this type of surgery,” coauthor Rutger M. Schols, MD, PhD, from the Maastricht University Medical Center in the Netherlands, told Medscape Medical News in an email.
Robot-assisted surgery is not new — the Da Vinci system was the first robotic surgery device to be approved by the US Food and Drug Administration. It was approved in 2000. However, Da Vinci was developed for minimally invasive surgery and is not precise enough for supermicrosurgery. And despite its $2 million price tag, Da Vinci has yet to show that it performs better than traditional surgery.
Designed Specifically for Supermicrosurgery
The MUSA robot was designed in the Netherlands by surgeons at Maastricht University Medical Center, engineers at the Eindhoven University of Technology, and the medical technology company Microsure specifically for reconstructive supermicrosurgery. Two of the authors of the article hold positions and are shareholders in the company.
Surgeons activate MUSA using foot pedals and operate forceps-like joysticks to control high-precision surgical instruments that filter out hand tremors and scale down motions. For example, moving the joystick 1 cm causes the robot to move 0.10 mm. MUSA also works with standard microscopes found in most operating rooms.
To test MUSA, Schols and colleagues at Maastricht University conducted a prospective, randomized trial that included 20 women with breast cancer–related lymphedema. The team randomly assigned eight women to undergo supermicrosurgery with MUSA and 12 women to undergo manual supermicrosurgery performed by a single surgeon. Two microsurgeons who were blinded to treatment groups evaluated the quality of the surgery using standardized scoring methods.
The results, which were adjusted for baseline factors, showed no significant differences in upper limb lymphedema between the two groups 1 and 3 months after surgery, nor were there significant differences between the two groups in quality of life.
A slightly higher percentage of women in the MUSA group were able to discontinue daily use of a compressive garment to treat arm swelling at 3 months, compared to the group that underwent manual supermicrosurgery (87.5% vs 83.3%).
Participants reported no serious adverse events.
For the group that underwent manual surgery, the quality of anastomosis was significantly better, compared to the MUSA group. Surgical competency was also significantly higher in the group that underwent manual surgery.
The MUSA group experienced a longer total surgery time (mean, 115 min) compared to the group that underwent manual surgery (mean, 81 min). But the authors note that duration of surgery declined steeply over time for the MUSA group, suggesting a learning curve in using the robot.
The researchers caution that the study may have been too small to detect significant differences between groups. Larger studies are needed to test MUSA with other surgeons operating in other centers, the authors note.
“With respect to treatment of breast cancer–related lymphedema, we are continuing trials with more patients, more surgeons, and more centers,” Schols told Medscape Medical News.
“We expect that other centers — both national and international — are willing to test the MUSA,” he added
Source : Medscape
Virtual Crossmatching For Faster Kidney Transplantation
Kidney transplantation can be safely performed with virtual crossmatching of donor and recipient without the need for a prospective physical crossmatch, according to a retrospective review.
“We think virtual crossmatching should become the standard of care for the majority of patients,” Dr. Vinayak S. Rohan of the Medical University of South Carolina, in Charleston, told Reuters Health by email.
Prior to kidney transplant, donor-recipient compatibility is assessed by physical crossmatching, usually by flow cytometry, at most programs. Virtual crossmatching (VXM) relies on complete HLA typing of the donor and current antibody assessment of the recipient, which can be performed quickly and allows for timelier organ allocation decisions.
Dr. Rohan and colleagues compared kidney transplant outcomes, principally the mean cold ischemic times (CIT), between 505 patients transplanted before their 2017 implementation of VXM and 227 patients transplanted using VXM.
After implementation, the mean CIT decreased from 16.67 hours to 14.5 hours (P=0.002), the researchers report in Journal of the American College of Surgeons.
Delayed graft-failure rates did not differ significantly between the pre-implementation (19%) and post-implementation (17%) eras, even though there were more donation after cardiac death (DCD) and higher (less favorable) Kidney Donor Profile Index (KDPI) donors in the post-implementation era.
The rates of one-year graft loss, patient death and biopsy-proven acute rejection rates did not differ between the two eras.
In multivariable modeling that adjusted for baseline characteristics, patients transplanted in the post-implementation era had an estimated 2.35-hour reduction in CIT (P<0.001) and 26% lower odds of developing delayed graft failure (P=0.17).
“We have known for years that VXM is a safe technology,” Dr. Rohan said. “This article not only reaffirms the safety of VXM, but also the outcomes, in terms of cold ischemia times and delayed graft function.”
“The ability to predict the crossmatch and schedule the operation in advance leads to less potential ‘middle of the night’ transplants, improving quality of life not only of patients but surgeons as well,” he said.
Dr. Raja Rajalingam of the University of California, San Francisco, who recently showed that a VXM-based strategy facilitates sharing of DCD kidneys for highly sensitized recipients, told Reuters Health by email, “Virtual crossmatching should become the standard of care at the national level.”
“It is considered to be challenging to perform virtual crossmatch for broadly sensitized patients (due to previous transplantation, pregnancies, and blood transfusions),” said Dr. Rajalingam, who was not involved in the new research. “However, it is not clear how many of the 29 (broadly sensitized) patients (in this study) received a kidney transplantation based on virtual crossmatch.”
He expressed surprise that the decrease in CIT was only about two hours with VXM. Based on the four to five hours required to perform pretransplant flow cytometry physical crossmatch, he would have expected a greater reduction.
Source : Medscape
‘No FGM’ Campaign Started by Egypt Doctors
Doctors in Egypt have taken time out of their surgeries for a campaign to raise awareness of the dangers of female genital mutilation (FGM) after the death of a 12-year-old girl, saying they do not want their white coats “stained with blood.”
Genital cutting of girls was banned in Egypt in 2008, but it remains persistent – a 2016 survey by the U.N. Children’s Fund showed 87% of women and girls aged 15-49 had undergone the procedure.
The campaign, entitled “White Coats,” saw posters with the slogans “No to FGM” and “FGM is a Crime” put up at a Cairo metro station, where doctors in white coats gave out leaflets about the dangers of the practice.
Organizer Randa Fakhr El Deen, head of the NGOs’ Union Against Harmful Practices on Women and Children, said the doctors had faced challenges from proponents of FGM at the station, but the campaign was important.
“We want to send a message to other doctors that we do not want our white coats to be stained with blood as well as to citizens that medicine refuses this practice,” she told the Thomson Reuters Foundation.
“Some ultraconservatives were not convinced of what we were saying, but we opened a discussion with them, responded to their arguments and answered all their questions.”
World leaders have pledged to eradicate FGM by 2030, but campaigners say the ancient ritual, which typically involves the partial or total removal of the external genitalia, remains deeply entrenched in many places.
It can cause long-lasting mental and physical health problems including chronic infections, menstrual problems, infertility, pregnancy and childbirth complications.
Last month Egyptian authorities arrested a retired doctor on charge of carrying out illegal FGM surgery and causing the death of a 12-year-old girl. The girl’s parents were also arrested.
All have since been released, but investigations are continuing and campaigners against FGM say they expect them to face trial.
The ritual is underpinned by the desire to control female sexuality, but is often justified for cultural or religious reasons in conservative societies.
Women and children’s rights groups in Egypt say the ban has not been well enforced and that much of society is permissive of FGM, which is widely practised by both Christians and Muslims.
The majority of FGM procedures are carried out by doctors and nurses at private clinics, with the rest done at home, according to the Egypt Demographic and Health Survey of 2014.
“It is a religious thing. Do you want to change religion?” said metro user Ibrahim Hassan in response to the “White Coats” campaign. “You only listen to what the West is saying.”
In response, Fakhr El Deen told Hassan that FGM had no basis in religion and was not taught in medical schools in Egypt.
Source : Medscape
No Reduction in SSIs With Strict Surgical Attire Policy
Implementing policies that require surgical staff to wear surgical jackets and bouffants in the operating room (OR) does not decrease the risk for surgical site infections (SSIs), according to a study published online today in JAMA Surgery.
“[T]he results of this study suggest that surgical jackets and bouffants are neither beneficial nor cost-effective in preventing SSIs,” write Bradley W. Wills, MD, University of Alabama at Birmingham, and colleagues.
Approximately 300,000 SSIs occur annually in the United States, accounting for one fifth of all hospital-acquired infections and costing the US healthcare system an estimated $10 billion each year.
Although some evidence supports implementation of certain OR attire policies (such as use of gloves and impermeable surgical gowns) to help prevent SSIs, data are lacking on the association between use of surgical jackets and bouffants and infections.
Wills and colleagues performed a retrospective cohort study to investigate whether mandating use of surgical jackets and bouffants in the OR was linked to a lower incidence of SSIs.
The study included 34,042 inpatient surgical encounters at a large academic tertiary care hospital between January 2017 and October 2018. The researchers compared three periods within this time.
During the first period (8 months), no bouffants or surgical jackets were required. During the second period (6 months), surgical jackets were mandated, and during the third period (8 months), surgical jackets and bouffants were required.
Despite the dress code changes, SSI risk remained relatively constant throughout the time frame, with no significant difference between the three periods (1.01% vs 0.99% vs 0.83%; P = .28).
Similarly, the investigators found no significant difference between the periods in risk for mortality (1.83% vs 2.05% vs 1.92%; P = .54), postoperative sepsis (6.60% vs 6.24% vs 6.54%; P = .54), or wound dehiscence (1.07% vs 0.84% vs 1.06%; P = .20).
The researchers calculated that use of surgical jackets during the 14 months of the second and third study periods cost an additional $264,760.78.
“The results add to the growing body of research that there is no clear benefit to bouffants and surgical jackets in the quest to decrease the incidence of SSIs,” the authors conclude.
“Institutions should evaluate their own data to determine whether recommendations by outside governing organizations are beneficial and cost-effective.”
In an accompanying editorial, Radwan Dipp Ramos, MD, and Kamal M. F. Itani, MD, both from the Veterans Affairs Boston Healthcare System, West Roxbury, Massachusetts, agree that sufficient evidence now exists to show that these policies, although well-intentioned, do not reduce SSI risk and raise hospital expenditure.
Ramos and Itani, who is also with Boston University and Harvard Medical School, also stress the need to remember common-sense recommendations regarding OR attire. These include frequent laundering of cloth caps, they say.
Staff must remove headgear, mask, and shoe covers outside restricted areas and use new ones if they return to the OR. When leaving restricted areas for another case, staff should also change scrubs or cover them with a protective coat. And they should not be allowed to enter the OR wearing scrubs from home.
“Short of having best evidence in any of those areas, myth and reality will continue to coexist, and our common sense augmented by available evidence should prevail over emotions and careless practices,” the editorialists conclude.
Source : Medscape
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