A novel route for tubal surgery: Transvaginal natural orifice transluminal endoscopic surgery

Natural orifice transluminal endoscopic surgery (NOTES) is a challenging minimally invasive procedure where ‘scarless’ abdominal surgeries are performed through an endoscope inserted through a natural orifice (mouth, anus, vagina, and urethra) and is considered as a less invasive approach to laparoscopic surgeries.

NOTES is considered a logical next step in the evolution of minimal invasive surgery, and the first NOTES procedure in humans is often considered to be a transgastric appendectomy performed in India in 2006 which was presented but not reported in manuscript form.

vNOTES is a natural orifice surgery performed through the vaginal route. A look into history reveals that gynecologists have been performing colpotomies for years, adding their valuable experience towards NOTES surgeries and subsequent closure.

A recently published paper in July issue of Fertility and Sterility have demonstrated a new technique of performing tubal reanastomosis via the vaginal route. The step-by-step procedure is explained in the accompanying video, using the surgical case of a 42-year-old female G2P2 with a history of tubal ligation 11 years before, who requested a tubal reanastomosis.   

A three-dimensional sonohystogram at 8 weeks postop showed bilateral patency of both the fallopian tubes.

The current method of performing tubal reanastomosis involves a minimal invasive surgery with end-to-end anastomosis with a 60% to 90% success rate of post-operative intrauterine pregnancy.

A recent systematic review comparing laparotomy vs laparoscopy vs robotic mode of surgery showed that laparotomy had the worst outlook.

NOTES have the advantage of a fast recovery, no abdominal incision, and an extremely cosmetic outcome. With prophylactic antibiotic, the current rate of pelvic infection with NOTES is a 0%–3.1%.

In the hands of a skilled minimally invasive surgeon, vNOTES offers an alternate route for tubal surgery.

Here is a video showing the stepwise surgical procedure 

Abstract

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New approach to ovarian cystectomy: Transvaginal natural orifice transluminal endoscopic surgery

New approach to myomectomy: Transvaginal natural orifice transluminal endoscopic surgery

FDA clears the first smartphone camera-based clinical grade at-home urine test

An Israel-based Healthy.io has received FDA 510(k) clearance for Dip.io, a home-based urinalysis kit that transforms the smartphone into a clinical-grade urine diagnostic device. It is the first smartphone-based urine test to secure clearance as a Class 2 device.

Millions of people around the globe such as pregnant women, those suffering from kidney disease, diabetes, high blood pressure and others are required to get their urine tested very frequently- but going to the lab every day is very cumbersome and time-consuming. Dip.io let patient perform urine test in the privacy of their home with results that are equivalent to a hospital-based lab urine test.

The Dip.io kit comes with a cup, dipsticks and patented colorboard. The user simply opens the smartphone apps and is guided step-by-step through the kit by the chatbot nurse named Emily. After peeing in the cup, the user dips the stick and places it on the colorboard. After a lapse of 60 seconds the dipstick and the board are scanned, the image normalized, and data points are sent to the cloud platform to be analyzed and turned into clinical results.

The results are conveyed to the health care provider or directly stored as a part of the patient’s medical record.

The app is straightforward to use as apparent from the tagline “If you can text, you can test,” and has achieved more than 99 percent usability across age groups ranging from 18-80 because of rapid prototyping and repeated user testing. 

The dipstick measures 10 parameters including blood, protein, and glucose in urine and is enormously useful for patients with chronic kidney disease, diabetes, and high-risk pregnancies.

The FDA approval is based on the demonstration of the significant rise in the use of the Dip.io platform by patients of chronic kidney disease as reported by the results of a study initiated by the National Kidney Foundation (NKF) and Geisinger Health.

The Dip.io technology has already been approved by the National Health Trust of UK and is nationally available through the G-Cloud procurement framework. It is also a part of NHS first 'virtual renal clinic' to improve patient convenience and improve cost.

Already commercialized in Europe and Israel since 2016, it is estimated that it will be utilized by 100,000 users by the end of 2018 through different patient pathways, shifting more and more urine testing from labs to homes.

Healthy.io is currently working on expanding the technology for at home assessment of chronic wound through ‘medical-selfies.’

Arming patients with the capability to conduct the critical tests at home with the same accuracy as the lab will curb the tide of many chronic diseases, simplify their daily routine and bring down the healthcare cost significantly.

Press Release

Healthy.io homepage

National Kidney Foundation study

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Here is a short video about how the product works

Here is an animation describing the company’s intention behind developing the product

Healthy IO (Full Version) from Peepshow on Vimeo.

Room air is as good as oxygen for fetal resuscitation during labor

In an intention to treat analyses, as compared to room air use of oxygen for intrauterine resuscitation of patients with category II fetal heart tracings does not result in a better fetal outcome or improve fetal metabolic status. The findings were published online July 23, 2018, in JAMA Pediatrics.

Two-thirds of women in labor are given oxygen in an attempt to reverse perceived fetal hypoxemia and prevent acidemia. It is also routinely administered to all laboring mother with intermediate risk for acidemia as evident by the category II fetal heart tracings.

American Academy of Pediatrics recommends against initial neonatal resuscitation with oxygen, as hyperoxygenation results in significant morbidity.

A 2012 review also states, “There is not enough evidence to support the use of prophylactic oxygen therapy for women in labor, nor to evaluate its effectiveness for fetal distress.”

Dr. Raghuraman from the Department of Obstetrics and Gynecology, Washington University School of Medicine in St Louis, St Louis, Missouri designed this randomized, noninferiority trial to test the hypothesis that room air is as good as oxygen in improving fetal metabolic status as represented by umbilical artery lactate. (ClinicalTrials.gov Identifier: NCT02741284)

Umbilical artery lactate is a marker of metabolic acidosis and neonatal morbidity.

Women in labor with singleton pregnancies at 37 weeks’ gestational age, admitted to a single tertiary center were eligible to be included in the study (705). Of these, 114 patients developed a category II tracing and were randomized to receive either room air without a face mask or 10 L of oxygen per minute by nonrebreather facemask until delivery.

There was no significant difference in the levels of umbilical artery lactate between the oxygen group (30.6 mg/dL) and the room air group (31.5 mg/dL). The two groups were also similar regarding pH, base deficit, the partial pressure of oxygen, and partial pressure of carbon dioxide.

The rates of operative vaginal delivery or cesarean section for non-reassuring fetal heart rate were also similar in both the groups.

Three other previous studies have also shown similar results, prompting Dr. Christopher P. Bonafide from Children's Hospital of Philadelphia and the University of Pennsylvania Perelman School of Medicine, who co-authored an editorial related to this report to urge the medical societies responsible for issuing evidence-based guidelines for obstetrics such as the American College of Obstetricians and Gynecologists to re-examine the most current research and consider issuing new recommendations against maternal supplemental oxygen administration when fetal tracings are intermediate risk.

Dr. Nandini Raghuraman quotes to Reuters Health by email, "I found it very interesting that substituting room air for oxygen did not impact umbilical cord gases, we typically administer maternal oxygen supplementation in hopes of improving fetal status as interpreted by electronic fetal monitoring. Our results suggest that this may not be the case."

She further added, "Another important point this study raises is that we lack high-quality data for many of our commonly used intrauterine resuscitation techniques. The results call for a closer look and thorough understanding of how these techniques affect fetal and maternal physiology."

Three other previous studies have also shown similar results, prompting Dr. Christopher P. Bonafide from Children's Hospital of Philadelphia and the University of Pennsylvania Perelman School of Medicine, who co-authored an editorial related to this report to urge the medical societies responsible for issuing evidence-based guidelines for obstetrics such as the American College of Obstetricians and Gynecologists to re-examine the most current research and consider issuing new recommendations against maternal supplemental oxygen administration when fetal tracings are intermediate risk.

Abstract

Editorial

ACOG: Management of intrapartum fetal heart rate tracings. ACOG practice bulletin no. 116

Cochrane review: Maternal oxygen administration for fetal distress

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Vaginal dryness— why no one is talking or doing anything about it?

A new study published in the North American Menopause Society's Journal Menopause identifies the factors associated with the taboo of not talking about vaginal dryness. According to the study results, more than 50% of women do not report vaginal dryness and less than 4% of those affected ever use any of the proven therapies.  

It is no secret that as the estradiol level plummets during the transition through menopause, most women experience vaginal dryness and dyspareunia. The Study of Women Across the Nation (SWAN) recruited a multiracial/ethnic cohort of 2,435 women at baseline and followed them over 17 years, with each woman clocking in approximately 13 visits.

This prospective cohort study identifies the incidence of vaginal dryness and its role in the causation of dyspareunia and frequency of sexual intercourse.

When the women were enrolled in the study, 19.4% of women (aged 42-53 years) reported vaginal dryness. At the completion of the study, 34% of women reported dryness (aged 57 to 69 years).

Advancing menopausal stage, anxiety, surgical menopause, and being married all contributed positively towards vaginal dryness.

Higher endogenous estradiol level was inversely associated with vaginal dryness in women not taking hormone replacement therapy. Whereas concurrent testosterone levels, concurrent dehydroepiandrosterone sulfate levels were not associated with developing vaginal dryness.

The study also highlighted the fact that the frequency of sexual intercourse was not related to the degree of vaginal dryness or pain during sexual intimacy. So, women who were thinking that having more or less frequency of sex is a remedy for vaginal dryness have to look for some other proven therapy.

Besides, HRT was more effective in managing vaginal dryness in women who transitioned into menopause naturally as opposed to those who had surgical menopause.

Dr. JoAnn Pinkerton, NAMS executive director, says in a press release, “Studies have confirmed that although more than half of women develop vaginal dryness as they become more postmenopausal, most do not report symptoms. Some will try lubricants as they begin to develop pain with sex. However, if lubricants and vaginal moisturizers are not enough, there are highly effective vaginal therapies such as vaginal estrogen tablets, creams, the low-dose ring, and the new intravaginal dehydroandrosterone. It is shocking that less than 4% of women in the SWAN study were using these effective therapies by the end of the study period.”

She urged women to please report symptoms, and healthcare providers to please offer safe, effective therapies.

Abstract

NAMS press release 

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FDA approves elagolix (Orilissa), the first and only oral treatment for endometriosis pain

The U.S. Food and Drug Administration (FDA) today approved ORILISSA™ (elagolix), the first and only oral gonadotropin-releasing hormone (GnRH) antagonist especially useful in the management of women with moderate to severe endometriosis pain— announced AbbVie and Neurocrine Biosciences.

Orilissa represents the first FDA approved oral treatment for endometriosis in over a decade and is expected to be available in U.S. retail pharmacies in early August 2018.

The drug is available in two oral dosages-150 mg once daily and 200 mg twice daily, taken with or without food roughly at the same time every day.

The FDA approval is supported by the results of 2 of the largest, randomized, double-blind, placebo-controlled phase 3 trials conducted to date, which evaluated nearly 1,700 women with moderate to severe endometriosis pain. Women either received 150 mg, 200 mg (952 women) or a placebo (734 women) and were evaluated at the end of 3 months.

Of the women in the treatment arm, 475 received a 150-mg daily dose, while and 477 received a 200-mg twice-daily dose.

Clinical trial results demonstrate that Orilissa significantly reduced all the 3 types of pain commonly associated with endometriosis— daily menstrual pelvic pain, non-menstrual pelvic pain, and pain with sex (p <0.001). Furthermore, women on 200 mg dose showed a significant reduction in dyspareunia as compared to placebo.

The most significant side effect observed with elagolix is dose-dependent decreases in bone mineral density; limiting the treatment to either 150 mg daily for up to 24 months or 200 mg twice daily for up to 6 months.

Bone mineral density loss is not entirely reversible on stopping the treatment. Other adverse effects are reported in 5% of patients and include hot flashes/night sweats, headache, and nausea, difficulty sleeping, an absence of periods, anxiety, joint pain, depression and mood changes.

"ORILISSA represents a significant advancement for women with endometriosis and physicians who need more options for the medical management of this disease," said Michael Severino, M.D., Executive Vice President, Research and Development and Chief Scientific Officer, AbbVie. "The approval of ORILISSA demonstrates AbbVie's continued commitment to address serious diseases and unmet needs."

"Endometriosis is often characterized by chronic pelvic pain that can impact women's daily activities," Hugh Taylor, MD, study investigator from Yale University School of Medicine in New Haven, Connecticut, said in the release. "Women with endometriosis may undergo multiple medical treatments and surgical procedures seeking pain relief, and this approval gives physicians another option for treatment based on a woman's specific type and severity of endometriosis pain."

AbbVie is going to role in an application for the approval of elagolix in Uterine Fibroids too; the drug has already shown promising results in initial trials conducted by the drug manufacturer.

AbbVie press release

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ACOG releases new all-in-one resource on vaccinations in pregnancy

ACOG recently released the new all-in-one resource to help obstetrics care provider ensure that all pregnant women receive the vaccines they need—not only protect themselves but also their unborn child again preventable diseases.

ACOG recommends that all obstetrician should routinely assess the immunization status of their pregnant patients and address their concerns about vaccine safety during prenatal visits.

"Studies consistently demonstrate that when the recommendation and availability of vaccination during pregnancy comes directly from a woman's obstetrician or other obstetric care providers, the odds of vaccine acceptance and receipt are 5-fold to 50-fold higher," write the authors of ACOG committee opinion on vaccination.

During the first prenatal visit, the provider should assess the woman’s immunity status against rubella and varicella. If the woman is not immunized against measles-mumps-rubella (MMR) or varicella, she needs to get these vaccines in the postpartum period, because both the MMR and varicella vaccines are live attenuated vaccines and are contraindicated in pregnancy.

Women who are pregnant during influenza season should receive the flu vaccine during each pregnancy. Other vaccines that are to be given during each pregnancy are tetanus toxoid, reduced diphtheria toxoid and acellular pertussis given as early as possible in the 27 to 36 weeks of gestation window.

All live attenuated vaccines are contraindicated in pregnancy while inactivated virus, bacterial vaccines, or toxoids are entirely safe in pregnancy as indicated by a growing body of research data.

Vaccines that are given in every pregnancy

Inactivated Influenza

Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap)

Maybe given in pregnancy in particular population

Pneumococcal vaccine

Hepatitis A

Meningococcal disease

Hepatitis B

Contraindicated in pregnancy

Measles-mumps-rubella (MMR)

Varicella

Initiated during the postpartum period or when breastfeeding or both

HPV vaccination series

Inactivated Influenza

Tetanus toxoid reduced diphtheria toxoid and acellular pertussis (Tdap)

Pneumococcal vaccine

Hepatitis A

Meningococcal disease

Hepatitis B

Measles-mumps-rubella (MMR)

Varicella

Vaccines in development

Some vaccines that can significantly reduce infectious disease in neonates are in the process of development and are likely to become part of the maternal/newborn arsenal shortly. It includes:

Streptococcus agalactiae, or group B Streptococcus (GBS)

Respiratory syncytial virus (RSV)

ACOG committee opinion

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Vaginal cleansing with antiseptic solution before cesarean section brings down postoperative infection: Cochrane review

A simple and inexpensive intervention of vaginal cleaning with the chlorhexidine-based or iodine-based solution immediately before cesarean section probably reduces the risk of endometritis after the procedure. The benefit could be more for women who underwent cesarean section while in labor or after rupture of membranes reports the results of a Cochrane review published 17 July 2018.

The current review is the fifth update on vaginal preparation before cesarean section and risk of subsequent infection by Cochrane; the first review was published in 2010 and subsequently updated in 2012, and twice in 2014.

Cesarean section is the most commonly performed operation in obstetrics, with 1 in 3 babies being born by cesarean section. Nearly 25% of women have endometritis and 10% of women develop skin infection after C-section.

Pre-op or intra-op antibiotic prophylaxis has not been able to bring down the rate considerably.

The Cochrane researchers searched the Cochrane Pregnancy and Childbirth’s Trials Register, the WHO International Clinical Trials Registry Platform (ICTRP) (10 July 2017), ClinicalTrials.gov, and reference lists of retrieved studies.

The review included 11 trials with a total of 3403 women in whom vaginal preparation was done immediately before the start of the cesarean section. Most of the trials used Povidone-iodine (n=8), while the rest used chlorhexidine (n=2) and benzalkonium chloride (n=1).

The control group included women with no vaginal antisepsis preparation (eight trials) or those in whom saline vaginal preparation (three trials) was used.

Vaginal preparation with the antiseptic solution immediately before cesarean delivery probably reduced the risk of endometritis by 64% (average risk ratio (RR) 0.36, 95% confidence interval (CI) 0.20 to 0.63).

It was not possible to separately analyze the risk reduction in a subgroup of women who were in labor or in women whose membranes had ruptured when antiseptics were used. 

Risk of postoperative fever or surgical wound complications may also be brought down by the use of vaginal antisepsis, but the confidence interval around the effects for both outcomes was very wide consistent with insufficient data.

Composite outcome of wound complication or endometritis was reduced by 54% in two trials consisting of 499 women (RR 0.46, 95% CI 0.26 to 0.82).

No adverse effects were reported with either the povidone-iodine or chlorhexidine vaginal cleansing.

The quality of evidence using GRADE was moderate for all reported outcomes. The authors downgraded the outcome for post-cesarean endometritis and composite of wound complications or endometritis because of bias in the involved study and broader CI.

The recommend that healthcare providers may continue using vaginal antisepsis preparation by either using povidone-iodine or chlorhexidine before performing a cesarean delivery.

Abstract

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EMA approves Ulipristal for Preop Treatment of Uterine Fibroids

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) grants marketing authorization for Ulipristal Acetate (Gedeon Richter) as pre-operative treatment for uterine fibroids.

Ulipristal is a selective progesterone receptor modulator used for intermittent treatment for moderate to severe symptoms of uterine fibroids in women of reproductive age. It is also used as a pre-operative treatment in women scheduled for a uterine fibroid surgery, where it helps reduce bleeding, anemia and fibroid size. It will be available as 5 mg tablet upon approval.

The application for ulipristal approval was an informed consent application, which means that reference is made to an already authorized medication upon obtaining consent to the use of their dossier in the application procedure. The reference product for Gedeon Richter Ulipristal was Esmya.

The approval further recommends that the drug should only be prescribed by physicians who are experienced in the treatment of fibroids. The common side effects of the drug include endometrial thickening, amenorrhea, and hot flushes.

However, European Union drug regulators have expressed concerns about the side effects on the liver by Esmya in the past. In December 2017, the EMA opened an investigation about liver injury by the drug, followed by a monthly recommendation of liver function test in women taking Esmya by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC).

Meanwhile, the United States FDA announced in February 2018 that it had extended the review of ulipristal new drug application (NDA) to August 2018.

  

Committee Statement

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New study opens the door for delaying egg aging by pharmacological treatment

courtesy: Parkinsonsnewstoday.com

Recently a fascinating paper was published about a novel treatment to increase the fertility lifespan in females. The researchers have achieved a breakthrough in finding a treatment to delay the sharp decrease of fertility in females right before their mid-30s.

Research by Dr. Coleen Murphy, Professor of Molecular Biology and Genomics at Princeton University and her team reported about a protein that can preserve the fertility potential of women in mid-30s and can potentially extend eggs’ life.

The work was recently published in Current Biology, and authors were able to document an extension of eggs’ viability in two separate experiments.

Murphy and colleagues observed that a protein called cathepsin B proteases was present in abundance in aging oocytes of Caenorhabditis elegans, a nematode commonly used as an animal model for a wide variety of studies.

They also observed that many of the genes from the worm were also conserved in humans, thereby providing an important resource on understanding the aging in human’s eggs.

The researcher hypothesized that knocking of cathepsin-B genes in adult worms should result in stalling the oocyte aging and improving its quality.

They knocked down individual genes in adult worm by sing iRNA, and surprisingly the reproductive lifespan increased by 10% and morphology of oocyte also showed improvements.

Once the aging effect of cathepsin-B proteases was documented, they proceeded to treat wild-worms with a potent cell-permeable cathepsin B inhibitor (MDL-28170). This pharmacological treatment was able to slow down the decline in the quality of oocyte as the women age.

Most importantly, the drug-induced decline was achieved even when it was applied around mid-life. This has wider implications for those women who want to delay childbearing because of socio-economic commitments, they can easily gain 3 to 6 years extension in terms of fertility.

Although cathepsin B inhibitor is not yet ready for testing in humans, the research has opened new doors regarding pharmacological therapy for delaying reproductive aging. 

Abstract

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Ten simple safety tips to avoid complications during hysteroscopy

Courtesy: Hysteroscopy newsletter

A series of precautions taken during before, during and after the hysteroscopic surgery can considerably reduce the risk of complications — reports Dr. Alice Rhoton-Vlasak, MD, Division of Reproductive Endocrinology & Infertility, from the University of Florida in the recent Hysteroscopy newsletter.

Hysteroscopy has evolved from merely a diagnostic procedure to method of choice for surgical treatment of intrauterine pathologies. Pantoleoni performed the first hysteroscopy using Desormeaux hysteroscope in 1869, and since then the development of hysteroscopy has flourished. 

With the increasing number of endometrial ablations, morcellation, electrosurgical procedures, and hysteroscopic sterilization performed worldwide, hysteroscopy has finally found its well-deserved niche in gynecological armamentarium.

It is generally a low-risk technique that utilizes the body’s natural passage to gain entry inside the uterine cavity. But like every surgical procedures complication are known to happen. These can be further reduced by taking simple precautions and being familiar with equipment and distention media.

Before the start of the procedure, the patient should be positioned appropriately to avoid nerve injury because the actual surgical time may be longer than the estimated time.

To avoid uterine perforation under challenging cases like Asherman’s syndrome or sizeable submucosal myoma, always use synchronous laparoscopic or ultrasound guidance.

The light source, suction and irrigation systems should be checked for smooth working before the start of the procedure. A backup set of instruments should be available in case of any intra-operative emergency.

Cervical dilatation should be cautiously performed, and precaution should be taken to avoid endometrial trauma and perforation. Hysteroscopic dilation of the cervix using the scope and hydrodistension is ideal.

Flushing air from tubes easily avoids air embolism, and it is always advisable to stop the procedure to purge the air out during the change of bags. The patient should not be put in Trendelenburg position during cervical dilatation and the hysteroscopic procedure to avoid a suction that may draw air into the uterine cavity.

Insert the hysteroscope cautiously inside the uterine cavity to avoid the formation of false passage in the cervix.

Hemorrhage during the hysteroscopic surgery is preventable with the use of electrosurgical coagulation, injection of vasopressin into the cervical stroma or the use of a Foley catheter balloon to exert intrauterine tamponade.

Avoid fluid overload by keeping a strict record of ins and out, limiting excess fluid absorption, and use of isotonic solutions in healthy individuals. Special precautions should be taken in older patients and those with heart failure or renal insufficiency.

A preoperative pelvic examination before the start of procedure gives a good idea of the uterine position. If the hysteroscope is in and the uterus fails to distend any time— a possibility of uterine perforation should be kept in mind. Stop the procedure immediately, and laparoscopy may be needed to assess the damage.

If any of the new morcellators or electrosurgical devices are introduced during a procedure, the entire surgical team should be aware of their functioning.

Following this simple safety tips can reduce the rate of hysteroscopic complications considerably. Besides, the patient should be made aware of all the risks before scheduling the procedure, and informed consent should be obtained.

Hysteroscopy Newsletter

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New 3-D printed, air-powered, biopsy robot that can collect sample inside MRI unveiled

The University of Twente revealed its latest version of world’s most accurate 3D-printed biopsy robot during the Surgical Robot Challenge at the international Hamlyn Symposium in London. The robot is named Sunram 5 and is faster and accurate than its previous self.

Today, most breast biopsies are performed by handheld needles under sonographic guidance, based on previous radiological films. But, many a time the needle placement is not perfect because what was seen on MRI or mammography may look quite different on sonography. Coupled with human error, this may create serious problems such as a malignant lesion may be reported as benign.

MRI scanners are unparalleled in terms of locating lesions, and it would be perfect if a biopsy is taken under their guidance. This would though require a robot small enough to fit beside the patient under MRI robot that could fit. The robot should also be made of a material not influenced by strong magnetic field created by MRI.

Researchers at the Twente University, Netherlands, have tailor-made a robot to above specification. The robot is very small and easily fit under the breast compression device. It is powered by air pressure maintained through external pumps, which also enables it to be under operator control. It is made up of hard plastic except for the MR-conditional needle itself.

The dual speed motors in the updated model have improved the speed so as the robot can reach its target location in about 10 seconds. In case of any technical mishap, a safety mechanism in the device retracts the needle from the breast.

Here is the video showing how the new robot works.

University of Twente press release

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FDA issues stronger warning for mental health and hypoglycemic side effects for Fluoroquinolones

The United States Food and Drug Administration today issued a serious warning against the use of Fluoroquinolones class of antibiotics in minor and uncomplicated infections. It is requiring a safety labeling change, warning the consumers and healthcare providers about the serious mental and blood sugar disturbances caused by these drugs.

Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research said in the press release, “The FDA remains committed to keeping the risk information about these products current and comprehensive to ensure that healthcare providers and patients consider the risks and benefits of fluoroquinolones and make an informed decision about their use.”

A list of FDA approved fluoroquinolones included levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin, gemifloxacin (Factive) and delafloxacin (Baxdela).

There are other 60 generic versions of the approved drugs also in the market. The required safety labeling changes issued today was based on an in-depth view of FDA’s adverse event reports and case reports published in medical literature.

A review of the literature found an increased incidence of hypoglycemic coma in patients who experienced hypoglycemia resulting from the use of fluoroquinolones.

The mental side effects of these drugs include disturbances in attention, disorientation, agitation, nervousness, memory impairment and delirium. The description of these side effects is already there on the labels but is not consistent across all class of the fluoroquinolones and is listed under central nervous system side effects.

The warning requires them to be listed separately and consistent across of class of the fluoroquinolones.

• FDA issued the first boxed warning against fluoroquinolones in July 2008 for increased risk of tendinitis and tendon rupture.
• In February 2011, FDA further added the risk of worsening symptoms for those with myasthenia gravis.
• In August 2013, FDA required that the label should be updated to describe the potential for irreversible peripheral neuropathy (serious nerve damage).
• In 2016, an enhanced warning was issued about the potential permanent side effects on tendons, muscles, joints, nerves and the central nervous system.

The FDA’s press release says, “Because the risk of these serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections, the FDA determined that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options.”

Each patient receiving the fluoroquinolones should receive a medication guide describing all the potential side effects of the drugs. 

FDA Press release

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SONON-The world’s first wireless, app-based ultrasound device that fits in your pocket

Healcerion, a company based in South Korea, has developed a small, pocket-sized ultrasound system that is powerful, portable and does not require electricity for scanning. The SONON series devices weigh just about 360gms and can be used for scanning everywhere you go.

The device wirelessly transmits data to a paired tablet or smartphone where the images are viewed, analyzed and can easily be shared with others. In emergency situations, SONON 300C can use any network, WiFi, 3G and LTE to share still images or videos (MPEG4).

The system supports Digital Imaging and Communications in Medicine (DICOM) so that it can effectively store and securely share images through picture archiving and communication systems (PACS) server.

The SONON series is powered by a rechargeable lithium-ion battery that provides up to 3 hours of continuous scanning with up to 12 hours of standby mode. The battery gets fully charged in 3 hours.

SONON is especially useful in Telemedicine for providing services to patients in remote areas, emergency medical or disaster situations, medical education and consultations.

The Healcerion started with SONON 300C convex array transducer and have recently launched the SONON 300L linear transducer. The SONON 300C is used for scanning abdomen, bladder, FAST, Early and late OB, and Gynecology.

The SONON 300L features color Doppler mode for easier musculoskeletal (MSK), lungs, vascular(carotid), superficial, small parts (breast, thyroid), and other types of imaging.

Healcerion was the first company to receive FDA clearance for a wireless, app-based ultrasound system back in 2015 and it’s SONON 300L was recently cleared by FDA in November 2017.

Dr. Benjamin Jeongwon Ryu founded Healcerion 4 years ago with a hope to make ultrasound more ubiquitous and reachable in areas where electricity and internet connectivity is limited. It is invaluable for trauma care and medical emergencies where a hand-held portable device is every radiologist dream.

The company is further looking to make the device compact and easier to use. It is also focusing on cloud-based solutions as advancement towards mobile-healthcare platforms.

Healcerion Press Release

Product Brochure

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Video of Dr. Ryu showing off a Healcerion ultrasound

Video showing how to get started with using the device 

News from ESHRE 2018: Endometrial scratch does not result in more pregnancies

Endometrial scratch is often offered as an adjuvant therapy to improve the IVF success rates, but the results of a large randomized control trial have shown that the “add-on” procedure does not improve the pregnancy or live birth rates. The study results were presented at the European Society of Human Reproduction and Embryology (ESHRE) 34^th annual conference in Barcelona, Spain by Dr. Sarah Lensen, a researcher from the University of Auckland, New Zealand.

The study involved 1300 women who underwent IVF across 13 fertility centers in 5 countries (New Zealand, UK, Belgium, Sweden and Australia).

It is proposed that causing injury to the endometrial lining invokes an inflammatory response that helps create a favorable environment for the implantation of the embryo. A survey conducted in Australia, New Zealand, and the UK by Lensen and colleagues in 2016 revealed that about 83% of physician offer endometrial scratch to patients before IVF cycles, especially those who have recurrent implantation failure.

Lensen said in a statement at the conference, "Results from earlier studies have suggested a benefit from endometrial scratching in IVF, especially in women with previous implantation failure. However, many of these studies had a high risk of bias in their design or conduct and did not provide strong evidence. There was still uncertainty about the validity of a beneficial effect."

The women in the study group (690) received an endometrial scratch performed by Pipelle cannula between day 3 of the preceding cycle and day 3 of the IVF/embryo transfer cycle, while the control group (674) didn’t receive any such treatment.

In this intent to treat analysis, the clinical pregnancy rate in the endometrial scratch group was 31.4% and in the control group 31.2%; live birth rates were 26.1% in the former and 26.1% in the latter. No difference was seen in rates of biochemical pregnancy, ectopic pregnancy, or multiple pregnancies among both the groups.

The researchers also looked at other side effects of endometrial scratch and found that the median pain score for the procedure was 3.5. Women also suffered from vasovagal attack, excessive pain, and excessive bleeding. 

“Our results contradict those of many studies published previously,” said Lensen, “and, although our trial was the largest and most robust study undertaken so far, it can be difficult for one trial to change practice. However, there are other trials underway at the moment, including two large studies from the Netherlands and UK. Nevertheless, even based just on our results, I think clinics should now reconsider offering endometrial scratch as an adjuvant treatment.”

ESHRE Press Release

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