Wednesday, December 27, 2017

Stair-step ovulation induction protocols are not just limited to Clomiphene

Stair-step ovulation induction protocol with Letrozole is also as effective as stair-step method using Clomiphene Citrate, and has a slight edge over CC in obese patients reports the result of study published in March issue of Fertility and Sterility.

Stair-step ovulation induction protocols have shown to achieve ovulation induction in shorter time as compared to traditional protocols in women with PCOS. But, so far studies and clinical trials have mainly focused on Clomiphene Citrate(CC).

Letrozole has shown to have superior ovulation rates over CC in women with PCOS, but no study has so far evaluated the stair-step method for Letrozole in cases of absent follicular recruitment after the initial dose.

This Retrospective cohort study recruited 92 infertile PCOS patients, 49 patients completed a letrozole stair-step from Jan 2015-Oct 2016 while 43 patients received stair-step protocols from July 2013-2014.

Letrozole protocol used in the study

CC protocol used in the study 
The demographics of both the groups were nearly similar, except patients in the Letrozole group were obese with a mean BMI of 30.8 as compared to 26.3 in CC group.

Ovulation rates were comparable in both groups (95.9% vs 88.1%, p=0.09), as also time to attain pregnancy, clinical pregnancy rates and side effects.

Thus, letrozole can also be effectively used in stair-step doses for achieving ovulation and pregnancy in PCOS women resistant to traditional protocols.

Tuesday, December 26, 2017

Stair-step clomiphene protocols shortens time to ovulation in women with PCOS

 Stair-step clomiphene protocol shortens induction time and brings about more ovulation in women with PCOS says the results of a retrospective cohort study published in January issue of Journal Obstetrics and Gynecology.

The researchers looked at traditional and step-up protocol in terms of ovulation rates and time to ovulation in women who have not responded to initial dose of 50mg of clomiphene citrate(CC).

Over a period of 2 years, the study included 109 patients attending a university hospital infertility clinic, with 66 women receiving traditional treatment and 43 were given the stair-step dose of clomiphene.  

The women were monitored for time to ovulation, as well as ovulation rates, clinical pregnancy rates and mild to moderate side effects.

The traditional protocol was used in 2012, in which CC 50mg was given between days 5-9. If no ovulation occurred, the dose was increased by 50mg after a spontaneous menses or a progestin induced bleed.

The stair-step protocol was used in 2013, in which CC 50mg was given between days 5-9. If no developing follicle >10mm was noted between days 11-14, the dose was increased to100mg immediately for 5 days and an ultrasound was repeated 12 days later. The dose was increased in increments of 50mg until a dose of 250mg was achieved.

It was seen that time to ovulation was nearly 50% less with stair-step method as compared with that of traditional method (23±1.8 vs 47.5±12.5 days, p<0.001). With 100 mg of CC, ovulation rates were comparable with both methods but was nearly 3 times with 150 mg CC (37% vs 12%, p=0.004) and 4 times with 200mg CC (21% vs 5%, p=0.01), with stair-step method as compared to traditional one.

Once ovulation was achieved, clinical and overall pregnancy rates did not differ between both the methods (16% vs 17%, p>0.05).

Women with stair-step method did experience mild side effects like headaches, vasomotor flushing, mastalgia and GI more frequently; however, incidence of severe side effects were similar in both the groups.

The authors concluded that stair-step method is an efficient and effective method for ovulation induction with CC at significantly decreased time. Authors of a prospective cohort study even cited the stair-step protocol as an alternative to gonadotrophin therapy with similar efficacy.

The abstract was also presented as 70th Annual Meeting of the American Society for Reproductive Medicine, October 18-22, 2014, Honolulu, Hawaii and could be accessed here.

Monday, December 25, 2017

ACOG updates its guidelines on Nausea and Vomiting in Pregnancy

The American College of Obstetricians and Gynecologists have updated its practice guidelines about managing Nausea and Vomiting in Pregnancy, published in the January issue of Obstetrics & Gynecology.

The guidelines replace the earlier document published in September 2015.

Nausea and vomiting of pregnancy affects nearly 50%-80% of women and ACOG urges obstetrician to start the treatment early before it progresses to hyperemesis gravidarum. "Hyperemesis gravidarum is the most common indication for admission to the hospital during the first part of pregnancy and is second only to preterm labor as the most common reason for hospitalization during pregnancy," they write.

The authors draw attention to the importance of timing of the onset. They explain "The timing of the onset of nausea and vomiting is important — symptoms of nausea and vomiting of pregnancy manifest before 9 weeks of gestation in virtually all affected women. When a patient experiences nausea and vomiting for the first time after 9 weeks of gestation, other conditions should be carefully considered in the differential diagnosis. A history of a chronic condition associated with nausea and vomiting that predates pregnancy should be sought (eg, cholelithiasis or diabetic gastroparesis)."

Level A recommendations (good and consistent scientific evidence):
Treatment should always be started with Vitamin B6 (pyridoxine) alone or in combination with doxylamine as the first line therapy, as it is safe and effective.

Women should be encouraged to start the pregnancy multivitamin 1 month before conception as it is known to decrease the incidence and severity of nausea and vomiting of pregnancy.

ACOG recommends avoiding antithyroid therapy for the transient gestational thyrotoxicosis or hyperemesis gravidarum and urges physicians to only use supportive therapy.

Level B recommendations (limited or inconsistent scientific evidence, include):
Ginger has been found to be effective in some cases of nausea and vomiting and it is recommended as non-pharmacologic therapy.

Methylprednisolone is found effective in some refractory cases of nausea and vomiting of pregnancy, but it should only be used as a last resort, when other treatments have been ineffective.   

Level C recommendations (based on consensus and expert opinion):
Intravenous fluid support should be offered to patients who exhibit sign of dehydration and are unable to tolerate oral fluids.

Dextrose and vitamins should be included in the therapy for prolonged vomiting to correct ketosis and vitamin deficiency, but always administer thiamine before dextrose infusion to prevent Wernicke encephalopathy.

Enteral tube feeding (nasogastric or nasoduodenal) should be started as first line therapy in women with hyperemesis gravidarum who fail to respond to oral medication. Peripheral parenteral nutrition should be used as last resort as it is associated with significant maternal morbidity.

Treating the nausea and vomiting of pregnancy at the very start may prevent it from progressing to hyperemesis gravidarum.

The bulletin also recommends that after the initial workup and hospitalization rules out other comorbidities as cause of vomiting, patient can have the rest of treatment at home too.

Finally, the authors concluded, “Nevertheless, the option of hospitalization for observation and further assessment should be preserved for patients who experience a change in vital signs or a change in mental status, continue to lose weight, and are refractory to treatment."

Media: Courtesy Dreamstime and Readers Digest.

Friday, December 22, 2017

A year in review: Best of 2017

We are already round the corner to 2018, here are the top 10 most read articles from 2017.

News from ACOG 2017: Changing gloves before abdominal closure brings down the rate of wound infection by almost 50% in Cesarean Section

Results of a randomized controlled trial presented at the ACOG 2017 showed that changing the outer gloves before closing the abdomen decreases the wound complication of infection, cellulitis and dehiscence.

Clinical review: Updates on Cesarean Section
Here is a roundup of the latest research on Cesarean Section.

The American Heart Association updates BP guidelines in 14 years: now 130 is the new 140
The American Heart Association (AHA)  and The American College of Cardiology (ACC) has changed the definition of hypertension for the first time in 14 years, moving the number from the old standard of 140/90 to the newly revised 130/80.

According to the new definition, 130 to 139 mm Hg systolic and or 80 to 89 mm Hg will be labelled as stage 1 hypertension.

First US baby born after uterine transplant delivered in Texas
The first birth as a result of a uterine transplant in the United States took place on Friday in Texas at the Baylor University Medical Center in Dallas. The women had undergone a live donor transplant and have received her uterus from Taylor Siler, 36, a registered nurse in the Dallas area.

New use of old drug: Sildenafil Citrate (Viagra) improves amniotic fluid index in oligohydramnios.
Sildenafil Citrate (Viagra) improves amniotic fluid index in pregnancies complicated by oligohydramnios according to a new study published ahead of print on March 6,2017 in Journal of Obstetrics and Gynecology.

WHO updates its guidance on Tranexamic Acid for the Treatment of Postpartum Hemorrhage

WHO has recently updated their guidelines for use of Tranexamic acid for treatment of Postpartum Hemorrhage: TXA should now be included in the treatment regimen for PPH along with other drugs, irrespective of the cause of hemorrhage.  

CDC releases ‘long awaited’ guidelines for preventing surgical site infections.
The Center for Disease Control released its much-awaited update to its 1999 guidelines for the prevention of surgical site infections (SSIs). The guidelines were published online May 3, 2017 in JAMA.

Finally, an oral drug found effective in treatment of Uterine Fibroids following successful phase-3 trial

Relugolix successfully reduced heavy menstrual blood loss among Japanese women in a Multicenter, Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of Oral relugolix 40 mg as compared with injectable leuprolide in the Treatment of Uterine Fibroids.

Now ‘Switch’ the way you suture: Reinventing suturing technique with the new device
Mellon Medical, a Dutch MedTech developer has reinvented suturing by developing a device which enables the surgeon to suture with only one hand, the other hand remaining free to use as needed. The product is named Switch®, a single use precision instrument that allows the surgeon to suture tubular structures or skin with twice the speed of conventional suturing.

A simple, novel solution to identify and protect ureter during surgery

AllotropeMedical, a Houston based medical startup has devised StimSite, a novel, hand-held, single use device that precisely identifies ureter during surgery; thus, eliminating the need for ureteral stenting.

Misoprostol in combination with transcervical Foley catheter shortens the induction-delivery interval

Medical study notes

Cervical ripening using misoprostol in combination with Foley catheter accelerates the induction as compared to misoprostol alone reports the results of a randomized control trial published in forthcoming issue of Journal of Obstetrics and Gynecology.

The duration of labor was shortened on an average by 3 hours in the combined misoprostol-catheter group.

A total of 200 women from Roosevelt Hospital, New York, New York were recruited over a period of 10 months and randomized to receive either misoprostol plus Foley catheter or misoprostol alone for induction of labor (100 in each arm). Women were matched for gestational age, parity, BMI, Bishop score and reason for induction of labor.

The women in the misoprostol only group received 25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. Once the cervix becomes favorable or if the patient is in active labor, or if there is no progress for 24 hours, misoprostol administration was discontinued.

Women in the combination group received vaginal misoprostol per standard protocol. In addition, a Foley bulb was inserted digitally or by direct visualization with the use of a sterile speculum. The Foley was inserted through the internal os and filled with 60cc of normal saline. The catheter was taped to the patient's inner thigh under gentle traction.

Inclusion criteria were singleton fetus, intact membranes, cephalic presentation, Bishop score 6 or less and gestational age 37 weeks or more.

Patients with previous history of uterine surgery, non-assuring fetal heart tracing, multiple fetuses, contraindication to vaginal delivery or ruptured membranes were excluded from study.

All patients were closely followed up for total time to delivery as well as time to active phase, time from active phase to delivery, cesarean delivery rate, uterine tachysystole, estimated blood loss, chorioamnionitis, cord pH, 5-minute Apgar score, and neonatal intensive care unit admission.

The combined group average induction-delivery interval was 15.00 (11.0–21.8) hours as compared to 19.00 (14.0–27.3) hours in misoprostol only group (P= .001).

There were no significant differences in both the groups in terms of rate of cesarean delivery, PPH, infection or neonatal outcome.

The authors concluded that misoprostol in combination with Foley catheter effectively shortens induction to delivery process. Identifier: NCT02566005

Wednesday, December 20, 2017

Novel CleanCision™ Wound Retraction system won FDA clearance for its abdominal wound Retraction and Protection System

Prescient Surgical, Inc., a medical device innovator based in San Carlos, California  just won FDA clearance for commercializing its novel CleanCision wound retraction and protection system.

This system is one of its kind, advanced surgical protection system designed by surgeons and infection control specialists. It is used by surgeons during abdominal surgery to retract the surgical incision, providing easy access to the surgical site while protecting the edges with an impermeable barrier thereby reducing the chances of wound infection. 

The device is placed in the wound and pulled apart, to open the radial fan like expanding system that is suitable for incisions ranging from 7-16 cm. The wound edges are continuously irrigated by an irrigant fluid of surgeon’s choice with the help of gravitational force from an external fluid bag and the excess is drained via a suction connected to the device. The impermeable inner layer of retractor prevents the wound contamination by fluids in the operative field.

Studies have shown a 61% reduction in rates of SSI using this device. The product is initially promoted for abdominal surgery and particularly colorectal surgery, where the risk, frequency and severity of surgical site infection is high, and the need is acute. But, it is useful in other specialties like Oncology and Ob/Gyn also.

The clearance could not have come at better time because "Hospitals are increasingly focusing on infection control to improve patient care as a primary goal. Prescient's success with the CleanCision device bodes well for providers driven towards the 'triple aim' of quality of care, patient satisfaction, and reduced costs," says Brant Heise, Managing Director at Summation Health Ventures.

The 2016 Surgical Site Infection updated guidelines, published by the American College of Surgeons and Surgical Infection Society, report that the risk of SSI is generally 2 to 5 percent with an estimated 160,000 to 300,000 SSIs occurring annually in the U.S.2 The rate of SSI can be as high as 15 to 30 percent in certain high-risk, clean-contaminated, and contaminated procedures such as colorectal surgery.3 National focus on SSI is increasing due to public reporting of surgical site infection rates and significant financial penalties imposed on hospitals, brought about by the Centers for Medicare and Medicaid Service's (CMS) Hospital-Acquired Condition Reduction Program.

Sunday, December 17, 2017

Risk of fetal deaths in absent or reversed end-diastolic velocities in the umbilical artery quantified

Radiology Key

Growth restricted fetuses with a absent or reversed end-diastolic velocities in the umbilical artery or ductus venosus before 34 weeks of gestation are at considerable increases risk of intrauterine demise (IUD) reports the result of a systematic review and meta-analysis published electronically ahead of print in American Journal of Obstetrics and Gynecology.

A total of 31 observational and randomized controlled trials met the inclusion criteria of early-onset growth-restricted fetuses (diagnosed before 34 weeks of gestation), absent or reversed end-diastolic velocities in the umbilical artery or ductus venosus and the pregnancy outcomes in these pregnancies.

It was seen that fetus with absent umbilical artery end-diastolic velocity were nearly 3.5 times more at risk of fetal death as compared to fetuses with normal velocities (OR 3.59; 95% CI 2.3–5.6).

The risk was nearly 7 times in fetuses with umbilical artery reversed end-diastolic velocity (OR 7.27; 95% CI 4.6–11.4) and 11 times for ductus venosus absent or reversed end-diastolic velocity (OR 11.6; 95% CI 6.3–19.7).

Abnormal umbilical artery flow with absent or reversed end-diastolic velocity is a strong indication of placental insufficiency and these pregnancies should be subjected to close follow-up and early delivery.

The authors concluded that, “Early-onset growth-restricted fetuses with either umbilical artery or ductus venosus absent or reserved end-diastolic velocities are at a substantially increased risk for fetal death.”

Friday, December 15, 2017

A simple, novel solution to identify and protect ureter during surgery

AllotropeMedical, a Houston based medical startup has devised StimSite, a novel, hand-held, single use device that precisely identifies ureter during surgery; thus, eliminating the need for ureteral stenting.

It is specifically useful in all gynecological, colorectal and oncosurgeries. Gynecological surgery accounts for 50% of all iatrogenic ureteric injuries.

It is estimated that around 3 million surgeries performed in US annually, require an identification of ureter. The rate of ureteric injuries is around 2% with disastrous consequences and the total healthcare burden of this complication is about $3.2B every year.

It is also estimated that about 30% surgical time is spent on identifying the ureter.

The surgeon can simply place the tip of the device in the vicinity of the ureter and with a push of a button, the ureter goes into contraction and the full length of ureter towards kidney and bladder can be identified.

There is no other smooth muscle structure in that anatomical region, so the device specifically identifies ureter only.

The device is single use, battery operated and avoids additional procedures like cystoscopy on the operation table.

Allotrope aims to initially market the device for two high volume procedures, Hyterectomy (750,000 in US) and colon resection (300,000 cases). The current alpha prototype is a hand held, stand alone device that can be used in both open and minimal invasive surgeries. The company plans to enter the Robotic market in future by designing device for their platforms.  

Currently, StemSite is at pre-FDA state, but plans to get FDA clearance through the 510(k) pathway, and entering the marketplace by first quarter of 2019.

Allotrope has recently won second place in MedTech Innovator’s 2017 competition, among 600 startups.

Here is a video by Allotrope showing the functioning of the device. 

Thursday, December 14, 2017

Do not use HRT solely for primary prevention of chronic diseases: USPSTF final recommendation

The US Preventive Services Task Force (USPSTF) recommends against the use of HRT in asymptomatic post-menopausal women solely for preventing chronic diseases in its final statement published yesterday in JAMA.

The recommendation holds good for estrogen alone or combined with progestin and upholds the previous 2012 statement.

The USPSTF statement does acknowledge few benefits of HRT in postmenopausal women such as reducing the risk of fractures and diabetes, but the potential harms outweigh the moderate benefits cited.

Combined use of estrogen and progestin is associated with increased risk of invasive breast cancer, coronary artery disease, venous thromboembolism, stroke, dementia, gallbladder disease, and urinary incontinence.

Use of estrogen alone predisposes the women to greater risk for thromboembolism, stroke, dementia, gallbladder disease, and urinary incontinence.

The recommendations were based on evidence from  Women's Health Initiative (WHI) trials, which were stopped early because of sufficient evidence of serious adverse effects in postmenopausal women.

The USPSTF statement is accompanied by an editorial by Cora E. Lewis, MD, MSPH, from the Division of Preventive Medicine at University of Alabama at Birmingham School of Medicine, and Melissa F. Wellons, MD, MHS, from the Division of Diabetes, Endocrinology and Metabolism at Vanderbilt University Medical Center in Nashville, Tennessee says that although the WHI trial was a observational study, till date no large sufficiently powered trials exist to recommend against the WHI conclusions.

The authors further asserted that these recommendations do not apply to “women who are considering hormone therapy for the management of menopausal symptoms, such as hot flashes or vaginal dryness. It also does not apply to women who have had premature menopause (primary ovarian insufficiency) or surgical menopause.”  

Also, the route of administration considered in the study is oral or transdermal and not creams and rings because those are not generally used for primary prevention of chronic conditions.

The editorial also mentions about the “timing hypothesis” put forward by the American Association of Clinical Endocrinologists/American College of Endocrinology in its July 2017 updated guidelines on menopause.

USPSTF statement stats that there is not sufficient evidence to support the “timing hypothesis” at present. It requires very large, sufficiently powered studies to evaluate the risk/benefit ratio in this specific age group.

At present, few women are on HRT, and physicians consider HRT only for the treatment of menopausal symptoms. Relatively healthy, younger menopausal women with severe climacteric symptoms may be prescribed HRT for symptoms relief and not for chronic disease prevention.

Wednesday, December 13, 2017

Finally, a ‘Heart Patch’ to mend your broken heart

We are one step closer to the goal of repairing dead heart muscle in human beings, because of a research breakthrough by biomedical engineers at Duke University. The researchers have succeeded in creating a fully functioning artificial human heart muscle large enough to patch the area typically seen in patients who have suffered a heart attack.

The study was published on line in Nature Communications on November 28, 2017.

Ilia Shadrin, a biomedical engineering doctoral student at Duke University and first author on the study said in a newsletter, "Right now, virtually all existing therapies are aimed at reducing the symptoms from the damage that's already been done to the heart, but no approaches have been able to replace the muscle that's lost, because once it's dead, it does not grow back on its own. This is a way that we could replace lost muscle with tissue made outside the body."

It is estimated that around 12 million people worldwide suffer for myocardial infarction and continue living with the damaged tissue that could not contract or send electrical signals, both of which are necessary for proper heart function.

The heart patch is grown from human pluripotent stem cells and contains a myriad of different type of cells like cardiomyocytes, fibroblasts, and endothelial and smooth muscle cells, to create a tissue patch similar to functioning heart muscle. The patch can secrete enzymes and growth hormone that could help in recovering from the ischemic damage.

All these cells are put in specific combination in a jelly-like substance, where they reorganize and grow into functioning tissue. Each individual tissue patch has to be ‘custom made’ in separate container that needs a rocking and swaying motion, instead of being static.

Currently, these patches have been successfully into animal hearts. The researchers have to make many modifications to create the same tissue for human heart like increasing the thickness and vascularization.

Here is the video by Duke University showing the patch contracting on its own, a 3D visualization of the patch’s cells, and the rocking bath that proved critical to the heart patch’s record-breaking size.

Tuesday, December 12, 2017

ACOG updates its guidance on Neural Tube Defects

ACOG has recently released its updated guidance on Neural Tube Defects (NTDs) and includes guidelines about prevention, screening, antenatal management and delivery in pregnancies with  such defects. The practice bulletin No.187 is published in December issue of Journal Obstetrics and Gynecology.

NTDs is the second most common group of congenital malformation after cardiac anomalies. The prevalence differs according to race, region and environmental influences.

In contrast to other malformations, NTDs are preventable by supplementation of folic acid.  

The recommendations:

ACOG along with other professional organizations like CDC, AAFP, AAP, ACMG and AAN: Women in the reproductive age group, having the capacity to become pregnant should take at least 0.4 mg (400 µg) of folic acid daily.

USPSTF: all women who are planning or capable of pregnancy take a daily supplement containing 0.4 to 0.8 mg (400-800 µg) of folic acid.

ACOG, CDC other organization suggests a higher dose of 4 mg (4000 μg) of folic acid for women who are at high risk of having a baby with NTD. These factors are:

Previous history of pregnancy with NTD
Having a partner with NTDs or a partner who previously has had a child with NTD
Patients with a second or third degree relative with NTD
Patient herself was born with NTD
History of taking anti-epileptic medication Valproic acid
Type 1 Diabetes Mellitus

ACOG has also made additional recommendations in the recent 2017 updates.

With Advancements in Ultrasound techniques, Maternal Serum Alpha Feto Protein (MSAFP) has become less important in diagnosing NTDs, when high quality, second trimester ultrasound is routinely used.

MSAFP is more important for screening for other anomalies and placental complications in such cases.

If MSAFP value is ≥ 2.5 MoMs, the detection rate for anencephaly is 95% and 65-80% for other open NTDs.

2D ultrasound has a detection rate of 96% and if structural abnormalities are seen on Ultrasound, they can be considered diagnostic.

3D ultrasound is not superior to 2D in diagnosing NTDs; however, it may be more helpful in delineating the upper limit of spinal defects.

The rates of diagnosing NTDs in first trimester are lower than that of 2nd trimester sonography.
MRI is not mandatory if NTD has already been identified in sonography.

Pregnancy and delivery management:

After a pregnancy with NTD is diagnosed options should be individualized according to each pregnancy:
Pregnancy termination
In Utero fetal surgery for repair
Expectant management with neonatal surgical repair.
Studies on In-Utero repairs have demonstrated that such neonates have functional level two or more times better than expected, and reduce the neonatal mortality and morbidity.


Regarding the timing of delivery, term delivery is preferred. Elective late preterm or early term cesarean is only considered if fetal repair has been done or other obstetric indication for surgery exists.
Retrospective studies with not very long-term follow-up have demonstrated no increased risk of vaginal delivery, but each case needs to be individualized.

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Monday, December 11, 2017

Preterm births more common after IVF/ICSI: a meta-analysis of cohort studies

Pregnancies conceived after IVF/ICSI face a greater risk of preterm delivery as compared to natural conceived cohorts reports the results of meta-analysis published recently in Journal Ultrasound in Obstetrics and Gynecology.

Earlier studies have also documented an increased risk of having a premature baby in couples who have conceived after IVF/ICSI, but whether this is a spontaneous (SPTB) phenomenon or iatrogenic has not been studied.

A research of literature identified 71 studies out of which 15 met the inclusion criteria, and resulted in total sample size of 61,677births.

Statistical analysis showed that SPTB occurred before 37 weeks in nearly 50% more pregnancies conceived by IVF/ICSI (10.1%) than natural conception (5.5%) (odds ratio 1.75; 95% CI 1.50-2.03). The corresponding rates before 34 weeks were 3.6% and 2.1% respectively.

Dr Paolo Cavoretto of IRCCS San Raffaele Hospital in Milan, Italy, is one of the study authors, and he opined that all pregnancies conceived with IVF/ICSI should undergo a mid-trimester transvaginal cervical length evaluation.

If a short cervix is diagnosed, intravaginal progesterone or cerclage should be considered as per individual patient obstetric history.

The researchers called for bigger studies in future, to explore in-depth the mechanism behind SPTB and also differentiate between iatrogenic or indicated PTB.

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Friday, December 8, 2017

On the go blood glucose monitoring by inbuilt Glucometer in Smartphone Case

With a wide array of features like GPS, depth perception and many health-related features like BP and ECG monitoring, Smartphones have become indispensable part of our daily lives. They are the health gadgets of future. But, so far nothing was much developed for diabetics, other than the use of  phone screen to display results of continuous glucose monitoring on the screen.

Engineers at the University of California San Diego have cleverly integrated a glucose monitor in the smartphone case and app, that will enable diabetic patients to record and track their blood glucose readings, whether they’re at home or on the go.

Currently, there is no way for people with diabetes to check the blood glucose when they are out of the house or travelling. They must pack the whole kit and carry it along with them.

Patrick Mercier, a professor of electrical and computer engineering at UC San Diego is the brain behind this new gadget. “Integrating blood glucose sensing into a smartphone would eliminate the need for patients to carry a separate device,” said Patrick Mercier, he said in a news release. “An added benefit is the ability to autonomously store, process and send blood glucose readings from the phone to a care provider or cloud service.”

The new device is named GPhone, and has two main parts. A slim, aesthetically designed, 3D printed case that fits over the smartphone with a permanent, reusable sensor at the top left corner.
The sensor has to be activated by one-time use enzyme packed pellets that magnetically attach to the sensor.

To run a test, a user has to activate the sensor by dispensing a pellet on it, followed by adding a drop of blood to the now activated sensor. The sensor measures the glucose concentration and wireless send it via a Bluetooth to a custom designed android app, that displays the results on the screen.

The user can communicate the results with his healthcare provider or store it in icloud, to track it over a long period of time.

The pellet is discarded after use and the sensor is deactivated. A 3D printed stylus with capacity of 30 pellets store them, and remains attached to the side of the case.

The pellet contains enzyme called glucose oxidase which reacts with glucose and generates an electrical signal in proportion to glucose levels that is picked by the sensor’s electrode.

The work is currently at proof of concept stage. Joseph Wang, nanoengineering professor and his other colleagues dream of integrating the monitor with the smartphone instead of case. They are also working currently to reduce the amount of blood needed for testing and bringing down the cost of the pellets, which are costlier than usual test strips.

The work was recently published in Biosensors and Bioelectronics.
All Media: Courtesy UC San Diego Newsletter

Thursday, December 7, 2017

Yet another warning from FDA against Removal of Uterine Fibroids with Ultrasonic Aspirators

FDA issued a guidance against use of Ultrasonic Surgical Aspirators for removal of uterine fibroids because of risk of unintended spread of uterine cancer in the process of suction by the aspirators, thereby, worsening the patient’s odds for survival.

Ultrasonic aspirators are multifunctional devices that break up and emulsify both hard and soft tissues with ultrasound energy and then suck them out of the body through a small incision. They're used by a wide variety of surgeons in both open and laparoscopic procedures, including the cytoreduction of advanced malignancies that can't be removed completely.

The FDA said that the device’s oscillating tip can disperse the tissue that it breaks up with ultrasonic waves, despite the fact that it is designed to suck up the tissue, and the risk of disseminating cancer cells is outweighed by the aspirator’s benefits, which include “more extensive tumor debulking, little or no collateral thermal damage, and the ability to avoid organ resection.”

However, when it comes to removing uterine fibroids, the risk of spreading occult cancer is not outweighed by the benefits, "particularly since there are alternative treatment options available," the FDA stated. The agency noted that there is "no reliable preoperative screening procedure to detect uterine sarcoma in women with presumed benign fibroids."

Under this guidance, the FDA also requires the manufacturers to add a contraindication label to labeling of the devices, with or without 510(k) clearances, within 120 days of the Oct. 30 release of the guidance: CONTRAINDICATION: This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.

ACOG has however openly opposed the FDA guidance against use of ultrasonic aspirators for fibroid removal by stating it to be “too rigid and eliminates patient choice.” ACOG also disagrees with FDA regarding existence of other safer alternatives to remove the fibroids and claims that abdominal hysterectomy carries more risk.

The US FDA  has already issued a communication discouraging the use of power morcellator was issued on April 17, 2014 and have resulted in 4% decline in rate of laparoscopic hysterectomies, says the results of cross sectional study published in forthcoming issue of Journal Obstetrics and Gynecology.

FDA issued the statement because of advocacy and anti-morcellator campaign by Amy Reed, MD, PhD, an anesthesiologist who died because of uterine leiomyosarcoma on Wednesday, May 24 at age of 44.

She underwent a laparoscopic hysterectomy in October 2013 for fibroid, but her undiagnosed, occult uterine leiomyosarcoma was upstaged because of dispersion in abdominal cavity by the use of power morcellator. Since then, the power morcellator is the focal point of a four-year debate that has divided the surgical field.

Based on an analysis of currently available data, the FDA has estimated that approximately 1 in 350 women who undergo hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma. 

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