How to evaluate the azoospermic male? ASRM committee recommendations

The Practice Committee of the American Society for Reproductive Medicine (ASRM) in collaboration with the Society for Male Reproduction and Urology recently issued guidelines about the diagnosis and evaluation of the azoospermic male partner. The committee opinion was published recently in journal Fertility and Sterility.

Of all the infertility cases about 30% is because of ‘male-factor’ of whom about 10-15% of men will receive the diagnosis of azoospermia. Recent studies have documented a decline in sperm count globally with a concurrent increase in male factor infertility.

Azoospermia is classified into 3 categories-pre-testicular, testicular, and post-testicular according to the etiology but in clinical practice, azoospermia is commonly classified as obstructive azoospermia (OA) and nonobstructive azoospermia (NOA) which can be of central or testicular origin. 

 

Azoospermic men with normal size testes with normal serum follicle-stimulating hormone (FSH) levels are more likely to have obstructive azoospermia, while men with a significant elevation in FSH have a testicular failure, and thus testicular NOA.

On the other hand, low gonadotropins levels with low to low-normal T points towards a diagnosis of central NOA.

According to the American Society for Reproductive Medicine (ASRM) Practice Committee, the evaluation begins with a standard reproductive history and physical examination, followed by measurement of serum FSH and testosterone(T), luteinizing hormone (LH), free T, estradiol, and prolactin. Most experts state that an FSH >7.6 mIU/mL would be considered abnormal.

Semen volume and FSH levels play an essential part in determining the etiology of azoospermia. If men have low semen volume and normal FSH the lab test should be repeated after 2-3 days of abstinence, with attention to proper collection technique. A post-ejaculate urinalysis is advised to rule out retrograde ejaculation. If there is no retrograde ejaculation and semen pH is < 7.2, a transrectal ultrasound (TRUS) is the next step to identify a possible ejaculatory duct obstruction (EDO).

In men with normal semen volume, determining serum FSH and testicular volume is critical to decide in favor of testicular biopsy for the prognostic purpose. Elevation of serum FSH along with low testicular volume strongly suggests NOA. In case sperm retrieval is planned for ICSI, the testicular biopsy is deferred till the sperm retrieval when a biopsy sample is concurrently sent to the lab.

A normal testicular biopsy indicates an obstruction at some level in the reproductive tract. If the cause of OA is not iatrogenic, then the cause is a bilateral epididymal obstruction. It should be confirmed by surgical exploration. Vasography is only indicated if reconstructive surgery is planned simultaneously.

In men with the congenital bilateral absence of the vasa deferentia (CBAVD or vasal agenesis), unilateral renal agenesis should be ruled out. Most men with vasal agenesis will also have seminal vesicle hypoplasia or agenesis which manifests as low semen volume and pH.

CBAVD is also strongly associated with mutations of the CFTR gene. Hence, before planning a sperm retrieval for ICSI in men with CBAVD or congenital unilateral absence of the vas deferens (CUAVD), genetic testing should be offered to female partner to rule out her carrier status (∼4%) for CFTR gene.

Men with suspected NOA due to an elevated FSH and a normal ejaculate volume have bilateral testicular atrophy.  They should be offered genetic testing to exclude chromosomal abnormalities and Y-chromosome microdeletions (YCMD). A diagnostic testicular biopsy is not usually indicated in such cases. 

Low gonadotropins levels may be because of feedback inhibition secondary to exogenous T or illicit anabolic-androgenic steroid use, a high T level with suppressed gonadotropins will be confirmatory in such instances.

In men with markedly elevated serum FSH levels, the diagnostic testicular biopsy is only indicated when there is uncertainty about the etiology of the azoospermia- obstructive or nonobstructive. In all other cases, a testicular biopsy is done when sperm retrieval is planned for ICSI.

A diagnostic biopsy is also not necessary in patients with expected obstruction and normal FSH levels.

Full-text Practice Committee of the American Society for Reproductive Medicine in collaboration with the Society for Male Reproduction and Urology

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Reinventing clinical grade Blood Pressure Monitoring by optical sensors

Image source: aktiia

aktiia, a Swiss company based at Neuchatel and Zürich in Switzerland has achieved a breakthrough in the way the blood pressure is monitored. Backed by nearly 15 years of research, this medical startup company has patented the technology for continuous blood pressure monitor, 24/7, without interrupting the daily routine.

The technology combines information from embedded sensors in commonly worn wearables for heart rate monitoring with clinically validated software algorithms to monitor individual blood pressure. The optical sensor in the wearable picks up the signals from the pulse waveform, analyze and modulate it to be displayed as blood pressure reading.

The Optical Heart Rate Monitoring technology (OHRM), so commonly used in smartphones and bracelets was pioneered by the Swiss Research and Technology Organization (CSEM) way back in 2004. The OHRM relied on the so-called Photo-Plethysmography principle (PPG). 

Image source: aktiia

The aktiia team released that the PPG technology applied at the wrist holds much more information than just measuring the heart rate. Under the able guidance of the co-founder and CTO, Josep Sola, the team identified and extracted the additional information from the pulse waveform at the wrist, resulting in the birth of the Optical Blood Pressure Monitoring (OBPM) technology.

The technology is backed by over 30 peer-reviewed publication and numerous clinical trials in acute and low-acute settings.

aktiia has recently raised CHF 4 million in seed round to commercialize its groundbreaking, cuffless, blood pressure monitoring technology. The partners include Silicon Valley-based TransLink Capital, Swiss-based Redalpine, and other international angel investors.

aktiia plans to embed the algorithms in non-medical third-party wearables for daily tracking the blood pressure trends for preventive purposes, as well as in aktiia’s medical grade wearable for the continuous monitoring of blood pressure in patients with hypertension.

Image source: aktiia

“This technology is a quantum leap in the fight against hypertension and will revolutionize the way we look at blood pressure,” stated Michael Sidler, Co-Founder, and Partner of Redalpine.

“TransLink has always been on the forefront of wearable technologies, and we are constantly on the lookout for pioneers. We are very excited to be a part of what will be a healthcare game changer,” said Eric Hsia, Managing Director of TransLink Capital.

aktiia homepage

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ERAS releases its guidelines for Antenatal and Peri-operative care in Cesarean Delivery

The Enhanced Recovery After Surgery (ERAS®) Society recently released its evidence-based, based practice recommendations to accelerate recovery after cesarean delivery (CD).

The recommendations published online ahead of print in the American Journal of Obstetrics and Gynecology involve interventions that start 30-60 minutes before skin incision and extends till the patient is discharged from hospital spanning the pre-operative, intra-operative, and post-operative phases of the CD.

The ERAS protocols were first introduced 15 years ago by Wilmore and Kehlet for colorectal surgery and are now successfully applied in other surgical disciplines like breast, urological, pancreatectomy, liver resection, and gynecologic surgery.

The ERAS team used Embase and PubMed to look at studies spanning 51 years (1966-2017) to gather evidence for developing the protocols and recommendations. The team created maternal FOCUSED pathways that involve protocols for the preoperative, intraoperative, and postoperative phase of the CD. GRADE system was used to assess the quality of studies.

The preoperative recommendations start 30-60 minutes before the skin incision for both elective and emergency cesarean sections and include a one on one communication with the patient about oral intake before surgery, what to expect during the surgery, postoperative pain, initiation of lactation, and recovery.  The Antenatal recommendations mainly focus on patient education about nutrition, supplements, delivery, what to expect during a CD and breastfeeding. 

Antenatal and Preoperative recommendations include:

Patient education

Six- to eight-hour fasting for solids and clear oral fluid intake up to two hours before the induction of anesthesia

Use of antacids and histamine H2 receptor antagonists

Hemoglobin optimization

Contact with patient 24 hours before elective CD

Intraoperative recommendations include:

A single dose of broad-spectrum antibiotics before the skin incision

skin preparation with chlorhexidine-alcohol

Fluid balance with 2L crystalloid and prophylactic phenylephrine infusion initiated at 50 mcg/minute

Maintaining perioperative normothermia (forced warm air, warmed IV fluids, room temperature),

Use of neuraxial anesthesia with neuraxial opioids

Prophylaxis against postoperative nausea and vomiting (PONV)

Delayed cord clamping for 30-60 sec

Initializing early skin to skin contact

Preventing PPH by low dose oxytocin infusion

Postoperative recommendations include :

Encouraging early oral intake within 2 hours

Early mobilization

Early removal of urinary catheter

Regular use of multimodal pain reliever

No VTE prophylaxis with heparin

Pneumatic compression stocking for VTE prophylaxis

Consultation with a lactational expert

Complete neonatal evaluation by the neonatal team

Abstract

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North American Menopause Society (NAMS) video series about important midlife health topics: What women need to know about stress?

The North American Menopause Society (NAMS) provides practical information on important midlife health topics for women. All the interviews in the series are hosted by NAM Board of Trustees Member and Immediate Past-President Dr. Marla Shapiro, a Canadian physician who led this exciting initiative. Dr. Shapiro is also the medical consultant for CTV News.

In this informative video, Dr. Thurston discusses current research regarding the effects of stress on health.

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Suprapannicular Incision Technique for Cesarean Delivery in obese patients

A case series published in September issue of the Journal of Obstetrics and Gynecology describes an alternative suprapannicular skin incision technique for cesarean delivery in obese patients. Lakhi et al. used this technique on 17 obese patients and observed no intraoperative complications or wound complications. The incision permitted easy access to the lower uterine segment thereby eliminating the need for a vertical hysterotomy.

In this technique, an assistant exerts caudal traction on the overhanging panniculus with Allis clamps, and a transverse skin incision was made below the umbilicus, at a point 3 cm below the line joining the anterosuperior iliac crests. Once opening the abdomen, retractors were used for easy access to the lower uterine segment and delivery of the baby.

courtesy:https://journals.lww.com 

With the rising global obesity rates, the obstetrician is increasingly faced with a decision to perform cesarean in obese and morbidly obese patients with large pannus.  However, the use of Pfannenstiel incision in obese patients with a moist region below the panniculus results in increased rate of surgical site infection, and it has been long debated.

Cases of fat necrosis of the abdominal pannus following cesarean section has been reported which may be secondary to pressure applied to the retracted pannus during surgery. Furthermore, this incision also limits access to the lower uterine segment due to overhanging pannus.

Obesity significantly increases the rate of cesarean section, and Weiss et al. report a cesarean section rate of 20.7% in a normal weight control group as compared to 33.8% in obese women, and 47.4% in morbidly obese women (BMI>35kg/m2).

A review of the literature showed that Tixier et al. have reported a case series of 18 patients using the suprapannicular infraumbilical transverse incision with no intraoperative or postoperative complications.

So far there are only case series and case reports about the alternative choice of the incision in obese patients. Currently, a randomized clinical trial comparing Wound Complication Rates Between Low Transverse, Midline Vertical, and High Transverse Skin Incisions in Women with a BMI of 40 or Above Undergoing a Cesarean Section for Delivery is underway at Albany Medical College, New York.

Prospective trials with enough power are needed before a recommendation is made regarding the choice of skin incision in obese and morbidly obese patients.

Abstract

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Video presentation of diagnosis and management of Robert’s uterus

Robert’s uterus is an extremely rare Mullerian duct malformation which is characterized by a septate uterus with obstruction of one of the cavities. The three triads of Robert’s uterus include Blind hemicavity/uterine horn with hematometra, Contralateral Unicornuate uterine cavity and normal uterine fundus with a small indentation.  Only a few cases are reported in the literature since it’s first diagnosis by Robert’s in 1970.

Patients usually present with severe dysmenorrhea at the time of menstruation because of accumulation of menstrual blood in the non-communicating horn, reproductive failure, and dyspareunia. Three different type of Robert’s Uteri have been described: Type 1 is with large hematometra, Type 2 is with no hematometra while Type 3 is with small hematometra.

Classification of this anomaly is debatable, the European Society of Human Reproduction and Embryology–European Society for Gynaecological Endoscopy (ESHRE‐ESGE) classification describes this anomaly as a complete septate uterus with partial cervical aplasia; however, no explanation is given for diagnosing ‘unilateral cervical aplasia.’ The American Society of Reproductive Medicine classification system classifies it as a rare obstructive form of class VB anomalies.

Diagnosis is made based on history, physical examination and a combination of modern imaging techniques like 3D sonography, MRI, three‐dimensional sonohysterography with volume‐contrast imaging, HDLive rendering mode and automatic volume calculation (SonoHysteroAVC). HSG is often misleading and only depicts the Unicornuate horn.

Previous treatments include invasive horn resection surgery or endometrectomy via laparoscopy or laparotomy, which resulted in a loss of normalization of uterine volume and shape, abdominal metroplasty or by combining hysteroscopy/laparoscopy.

This video demonstrates successful management of all three types of Robert’s uterus using:

• Three-dimensional (3D) ultrasound in diagnosing and surgical management
• Hysteroscopic metroplasty transrectal ultrasound guidance
• Sequential balloon therapy to prevent adhesions
• Three-dimensional ultrasound for postoperative assessment of the cavity

In the end, a successful unification of non-communicating and communicating uterine cavity parts during surgery, better shape and several times higher volume of the uterine cavity, and total elimination of pain associated with obstruction after healing period were recorded.

Abstract

Here is the video presentation of Pre-, Intra- and Postoperative Management of Robert's Uterus

First blood pressure monitor with cellular connectivity launched in the USA

Livongo Health, the leading consumer digital healthcare company today announced its launch of first blood pressure monitor with cellular connectivity in the U.S. at Health 2.0. It provides the simplest way to acquire, monitor and transfer the blood pressure reading to the cloud for Remote Patient Monitoring (RPM). This seamless “cuff to cloud” transfer enables the consumer to remain in the relaxed atmosphere of their home, thereby eliminating the “white coat syndrome.”

The patients also receive useful and timely insight into BP and Health Nudges TM from certified professional specially trained in the management of chronic diseases.

Just as we did with diabetes, Livongo wants to make it easier for people to stay healthy by checking their blood pressure, receiving real-time personalized feedback, sharing the information with their physician and other members of their connected care community from home, thereby avoiding a rise in blood pressure that can come with visiting a doctor," said Amar Kendale, Chief Product Officer, 

Livongo. 

"We are proud to introduce the first cellular-enabled blood pressure monitoring system to market in the U.S. and to add this capability to our comprehensive platform for people with all kinds of chronic conditions. This allows us to treat the whole person and the challenges they face seamlessly."

Livongo’s signature offerings include Livongo for Diabetes, Livongo for Hypertension, and Livongo Diabetes Prevention (DPP) powered by Retrofit.

Diabetes and Hypertension are the fastest growing chronic diseases in the United States and account for 458 billion dollars in healthcare costs. Improving the blood pressure control through lifestyle change and adherence to medication can bring down the chance of cardiovascular event by 50%.

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Use of alternative antibiotics during C-section increase the odds of wound infection

Use of alternative antibiotics other than the standard recommendation of the first-generation cephalosporin is associated with increased risk of infection and other adverse events, according to a new analysis of more than 6500 cesarean section deliveries. Cephazolin in the drug of choice for surgical prophylaxis in C-section deliveries.

"Use of both standard alternative and inappropriate alternative antibiotics was associated with higher odds of surgical site infections compared with the use of cefazolin for prophylaxis at the time of cesarean delivery," conclude the authors in the study published September 7 in Journal Obstetrics & Gynecology.

The American College of Obstetricians and Gynecologists (ACOG) recommend an infusion of intravenous 1 g cefazolin within 60 min before skin incision. For women with (BMI >30 kg/m 2 or weight > 100 kg, a dose of 2 g cefazolin intravenous infusion is recommended.

In women who are allergic to cephalosporin ACOG recommends alternative antibiotics, such as clindamycin combined with an aminoglycoside.

In this retrospective cohort study conducted over a period of 5 years (2012 – 2017), Tetsuya Kawakita, MD, Department of Obstetrics and Gynecology, MedStar Washington Hospital Center, Washington, DC, and colleagues analyzed data from 6584 women who had cesarean delivery in their center.

Majority of women, 6163(93.6%) received standard cefazolin, 274 (4.2%) received the standard alternative, while 147 (2.2%) received inappropriate alternatives— mostly clindamycin or gentamycin.

Propensity score adjusted logistic regression showed that use of alternative antibiotic was not associated with increased risk of the composite primary outcome namely endometritis, cellulitis, deep-wound infection, abdominopelvic abscess, and sepsis. But a subgroup analysis revealed that use of alternative antibiotic increased chances of cellulitis by 93% as compared to use of cephalosporins (adjusted odds ratio [OR], 1.93; 95% CI, 1.03 - 3.31).

Patient receiving alternative antibiotic faced nearly twice the risk of visiting the ER for wound complication (adjusted OR, 2.34; 95% CI, 1.19 - 4.18) compared with cefazolin.

Similarly, use of inappropriate antibiotics increased the odds of primary outcome nearly 4 times as compared to cephazolin (adjusted OR, 4.13; 95% CI, 2.59 - 6.36), while odds of endometritis (adjusted OR, 6.68; 95% CI, 3.69 - 11.44) and cellulitis (adjusted OR, 3.23; 95% CI, 1.63 - 5.81) also increased drastically.

The authors speculated that the difference in sensitivity of skin bacterial flora to the alternative antibiotics might be responsible for increased odds of having cellulitis after the C-section. More studies are warranted on alternate antibiotics other than those recommended by ACOG.

Besides, the authors also stressed that physicians should validate the patients claim of allergy to beta-lactam antibiotics and should not only rely on history given by the patients. They found that only 10-20% of patients documented true allergy on skin testing.

If patients gave a history of nonsignificant beta-lactam allergies, use of cefazolin in such patients might lower the risk of adverse event during cesarean delivery.

Abstract

More on prevention of sepsis during cesarean deliveries:

What is best for Cesarean Antisepsis? Chlorhexidine-Alcohol versus Povidone-Iodine

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

Maternal clinical risk factors for the increased rate of post-cesarean infection identified

Use of Monocryl suture minimizes wound complications in cesarean sections - News from SMFM 2017, Las Vegas

Vaginal cleaning before cesarean delivery significantly reduces infection: A Systematic Review and Meta-analysis

Novel microfluidic device quickly corrals vigorous motile sperms for IVF

Courtesy: Pixabay

Cornell University scientist has created an innovative microfluidic device that effectively separates the motile, highly energetic sperms; thereby increasing the chances of fertilization for couples undergoing IVF.

The current method of separating sperms for IVF is highly tedious, manual and can take hours for completion. Doctors and technicians spend hours to separate the motile, good quality sperms making the process expensive and time-consuming.

“With the new method, it’s 5 minutes instead of hours,” said Alireza Abbaspourrad, a researcher involved in the latest study.

The new device takes advantage of sperm’s ability of positive rheotaxis—natural tendency of the sperms to face against fluid flow after reaching a specific velocity. The researchers devised a microfluidic channel through which the semen sample flows to which the researchers added a “C” shaped corral and a retaining wall.

The structure creates interference to flow of sperms, and the highly motile, stronger sperm enter the corral only to be trapped by the retaining wall. “We could separate the good sperm from the not-so-strong in a reasonably elegant way. We are able to fine-tune our selection process,” said Soon Hon Cheong, another researcher involved in the study.

Meisam Zaferani, a doctoral student at the Cornell, said the device might find broader application beyond its uses in Assisted Reproductive Techniques, especially in dairy and livestock industries. “The unprecedented efficiency of our device in comparison to previous studies and its benign, passive nature makes it favorable for sperm separation,” he said.

The study, “Rheotaxis-Based Separation of Sperm with Progressive Motility Using a Microfluidic Corral System,” published in the Proceedings of the National Academy of Sciences July 30.

Cornell newsletter

Here is the short video of how the technique works

What is the best approach for labor induction in a multiparous patient?

Simultaneous administration of oxytocin along with cervical ripening with balloon catheter minimized the time to vaginal delivery and increased the rate of delivery within 24 hours in multiparous patients with an unfavorable cervix. This has significant benefits regarding patient care and satisfaction reports the results of a randomized control trial published in September issue of the American Journal of Obstetrics and Gynecology.

The best method of induction of labor in a multiparous patient is debatable because of a paucity of data. Results available from the only previous RCT comparing the simultaneous vs. sequential use of balloon catheter and oxytocin found no difference in median time to delivery between the two groups (FIAT-M Trial).

In this RCT involving 180 patients, Bauer et al. sought to determine whether the simultaneous vs. sequential use of balloon catheter and oxytocin helps decrease the time to delivery in multiparous patients who present with an unfavorable cervix.

The study recruited multiparous women ≥18 years with prior vaginal delivery who needed induction of labor and presented with a non-anomalous, singleton fetus in cephalic presentation with intact membranes with cervical dilatation ≤2 cm on admission.

Women were randomized to receive either simultaneous (oxytocin with cervical ripening balloon) or sequential (oxytocin following cervical ripening balloon expulsion) regimen.

Investigators looked at the time from induction to delivery as the primary outcome measure while the secondary measures of interest were time to cervical ripening balloon expulsion, induction-to-delivery interval, mode of delivery and adverse maternal or neonatal outcomes.

Women who simultaneously received balloon and oxytocin were more likely to deliver within 24 hours as compared to those in whom oxytocin was started after the balloon expulsion (87.8% vs. 73.3%; P=0.02). The average induction-to-delivery interval in the simultaneous group was 12.5 h vs. 16.3 h with greater cervical dilatation when the balloon was expelled.

Both groups were comparable regarding mode of delivery, chorioamnionitis, or adverse maternal or neonatal outcomes.

The authors concluded that “The simultaneous use of oxytocin with cervical ripening balloon should be incorporated into the management for multiparous women who require cervical ripening while undergoing induction of labor.”

Presented as a poster at the 38th Annual Pregnancy Meeting of the Society for Maternal-Fetal Medicine, Dallas, TX, Jan. 29–Feb. 3, 2018.

Abstract
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CDC encourages healthcare professionals to recognize early signs and symptoms of worsening infection and sepsis

Today is world sepsis day, the Center for Disease Control (CDC) urges healthcare professionals to recognize and educate patients and their families about the early signs and symptoms of worsening infection and sepsis.

Sepsis is a Global health crisis, affecting up to 30 000 000 people a year. Maternal Sepsis is one of the five-leading cause of death during pregnancy. Early recognition and prompt treatment of maternal sepsis is necessary to improve patient outcomes.

ACOG has recently issued guidance on prevention of surgical-site infection in gynecologic surgery. The practice bulletin includes guidelines about pre-operative and intraoperative prophylaxis, procedure-based antibiotic regimen, guidelines for patients with a history of Methicillin-resistant Staphylococcus aureus (MRSA) colonization, and penicillin allergy.

Find the guidelines here. Some other articles about preventing surgical site wound infection in obstetrics and gynecological surgeries are:

What is best for Cesarean Antisepsis? Chlorhexidine-Alcohol versus Povidone-Iodine

Chlorhexidine-Alcohol is not superior to Povidone-Iodine in reducing the rate of surgical site infection in Cesarean section reports the results of Chlorhexidine-Alcohol Versus Povidone-Iodine for Cesarean Antisepsis (CAPICA) Trial published ahead of print in American Journal of Obstetrics and Gynecology.

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.

Maternal clinical risk factors for the increased rate of post-cesarean infection identified

Preincisional extended antibiotic prophylaxis does not prevent the occurrence of maternal infections that significantly contributes to increased maternal morbidity in cesarean sections.

Maternal BMI, rupture of membranes to delivery interval, race and duration of surgery are important contributing factors towards maternal infection even after prophylactic antibiotics were given according to a study published online ahead of print in Journal of obstetrics and gynecology.

FDA clears CleanCision Wound Retractor to reduce surgical site infections

Prescient Surgical got the green signal from FDA’s Center for Devices & Radiological health for de novo clearance of its CleanCision wound retraction and protection system.  The clearance could not have come at a 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.

Use of Monocryl suture minimizes wound complications in cesarean sections - News from SMFM 2017, Las Vegas

Use of poliglecaprone 25 (Monocryl) subcutaneous suture for abdominal wound closure in Cesarean Section reduces the wound complication rate by nearly 50 % as compared to use of polyglactin 910 (coated Vicryl) according to a study that will be presented at the 37th  annual meeting of Society for Maternal-Fetal Medicine , January 23-28 , Las Vegas.

Vaginal cleaning before cesarean delivery significantly reduces infection: A Systematic Review and Meta-analysis

A simple and inexpensive intervention of vaginal cleaning with an antiseptic solution before cesarean delivery brings down the rate of endometritis note the results of a Systematic Review and Meta-analysis published August 4 in Journal of Obstetrics and Gynecology.

VIDEO: “WHAT IS SEPSIS? (SEPSIS EXPLAINED IN 3 MINUTES)”

Apple unveils the new fourth generation Apple Watch with built-in ECG and fall detection

Apple just unveiled its beautifully redesigned new smartwatch – the Apple watch series 4 which has revolutionary health capabilities of capturing an ECG and detect falls.

Along with the redesigning and re-engineering of the watch interface, it also incorporates the capability to take an ECG reading right from the wrist using the new ECG app. With the built-in electrodes in the Digital Crown and new heart rate sensors in the back-sapphire crystal, knowing about heart rate and rhythm is just a touch away.

The user can touch the crown and after 30 seconds, receive a heart rhythm classification. It can classify if the heart is beating in a regular pattern or whether there are signs of Atrial Fibrillation (AFib), a heart condition that could lead to significant health complications. All recordings, their associated classifications and any noted symptoms are stored in the Health app in a PDF that can be shared with physicians.

It also analyzes the heart rhythm continuously in the background and sends notification in case irregular rhythm or AFib is detected. The watch also alerts the user if the heart rate goes up or fall below the desired threshold.

The built-in next generation accelerometer and gyroscope detect movements and based on custom algorithms can catch a fall measuring 32 g-forces. Considering the wrist trajectory and impact acceleration the watch sends an alert to the user after a fall which can be used to call emergency medical services.

If Apple Watch senses immobility for 60 seconds after the notification, it will automatically call emergency services and send a message along with the location to emergency contacts.

“We’re thrilled Apple Watch has become an essential part of people's lives,” said Jeff Williams, Apple’s chief operating officer. “The completely redesigned Apple Watch Series 4 continues to be an indispensable communication and fitness companion, and now with the addition of groundbreaking features, like fall detection and the first-ever ECG app offered directly to consumers, it also becomes an intelligent guardian for your health.”

Beginning Friday, September 14, Apple Watch Series 4 (GPS) will be available to order in 26 countries and territories, and Apple Watch Series 4 (GPS + Cellular) will be available to order in 16 countries and territories. Both models will be available in stores beginning Friday, September 21.

Apple News Release

Apple promo video for the Apple watch series 4

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Who is responsible for sponge and instrument count?

Retained surgical sponges and instruments are a common occurrence in surgical practice despite all the count policies, electronic counting and adjunct methods used in the operation theater. When discovered years later, they raise many medicolegal questions.

Lawsuits are brought forth by patients against the operating surgeons and medical facilities and the question about who is responsible for sponge and instrument count is often debated in the court of law. The captain of the ship or the surgeon is no longer responsible for a correct sponge or instrument count at the end of surgery and members of the entire operating team can be held liable in litigation for retained foreign bodies.

In August 2005, Maurine Villapando went to the emergency room at Raritan Bay Medical Center (Raritan Bay), New Jersey complaining of severe abdominal pain on her right side. Physical examinations and imaging studies revealed an ovarian cyst. The attending obstetrician/gynecologist (OB/GYN) surgeon Dr. Nath, performed a laparotomy, an open incision directly into the abdomen, to remove the cyst.

As per the hospital policies, a laparotomy involved three distinct "counts" of instruments and lap pad sponges performed by the nurses, who, in this case, were defendants Virginia Ko Chua, the circulating nurse, and Liza Abundo, the scrub nurse.

The initial count was done before the start of surgery, the second count occurred during the initial closure of the peritoneal lining, wherein the nurses would count aloud for everyone in the operating room to hear. The third and final count occurred when the surgeon was ready to close the skin.

After the third count, the nurses would verbally inform the surgeon that the count is correct, puts a hash mark against each item on the “count-sheet” to ensure that nothing is missing. At the end of the procedure, the circulating nurse would sign the sheet indicating that the surgeon was verbally notified of the final count status, and the surgeon would acknowledge the count report by signing the count sheet.

In this case, the circulating nurse committed an error while adding the hash marks on the “count-sheet” and reported that all the 13 sponges were accounted for. The hash marks denoting the tally revealed a count of only twelve sponges retrieved, thus one was missing. However, the circulating nurse mistakenly wrote the number “13” next to the hash marks after adding them incorrectly. Neither nurse noticed the counting error and after verbally being advised that the count was correct, the gynecologist acknowledged the count by signing the count sheet.

After surgery, the plaintiff developed a fever and continued to have pain, but a repeat CAT scan did not reveal the forgotten sponge. She was then discharged after her symptoms resolved. 

Approximately after 5 years, the plaintiff had an X-ray done for back pain when the missing sponge was found. The sponge has formed a large mass with a lot of scar tissue that involved the right fallopian tube and ovary. She had to undergo a right-sided salpingo-oophorectomy and was told that if she wishes to have children in the future, she would require some assisted reproductive technique.

On February 20, 2013, the plaintiff sued the hospital, the surgeon who performed the laparotomy, the circulating nurse, and the scrub nurse. She eventually settled with all the other defendants except the OB/GYN surgeon, Dr. Nath who proceeded to trial.

At trial, the gynecologist testified that he relied on the nurses' count and didn’t himself do the math.  The plaintiff expert witness, an OB/GYN himself admitted that at the other two hospitals where he has worked, it was the nurses, not the surgeons, who were responsible for the sponge count, but argued that the doctor’s mistake was in not reading the form in detail before he signed it.

Two expert witnesses from the defending gynecologist side testified that the doctor simply signed the form to acknowledge that the nurse told him the count was correct and the surgeon is not required to double-check the nurses tally.

At the end of the trial, the jury did not find Dr. Nath guilty of medical negligence, and according to the established standard of care, the doctor is not required to confirm the nurses’ count. The doctor’s signature only meant that the doctor had received an oral confirmation from the nursing staff that the count was complete was correct.  

While this legal case revolved around the individual responsibility of the operating team, it requires teamwork to prevent such type of complications. Whether cases of retained surgical sponges occur because of negligence, mistake or merely human error is irrelevant in the overall picture. What is relevant is that healthcare providers can now potentially eliminate the risk entirely using new computer-assisted advanced technologies.

SITUATE™ DETECTION SYSTEM X

Medtronic’s Situate™ Detection System utilizes low-frequency radio waves to detect sensors embedded in the sponges. Another method, Stryker’s SurgiCount Safety-Sponge System®, utilizes a technology that tracks each medical sponge used with a unique identifier. In the case of SurgiCount, the manufacturer offers a $5 million indemnification guarantee to hospitals that implement it.

In the end, surgeons being the captain of the ship, face increased liability, ultimately assuming responsibility for any negligence committed by those working under their directions. Hence, it is incumbent upon the surgeon to do everything in his capacity to protect the health of patients and protect himself or herself—as well as his or her support team—from potential medical malpractice claims.

Villapando v. Raritan Bay MedicalCenter, No. A-1483-16T3, Superior Court of New Jersey, Appellate Division

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FDA clears Natural Cycles as the first digital method of contraception in the US

Natural Cycles became the first and only app to receive FDA clearance as a method of birth control. The app contains an algorithm that calculates the ‘fertile window’ based on basal body temperature (BBT) and menstrual cycle information. It makes the women aware of her ‘fertile days’ to avoid sex or use a barrier method if practicing birth control.

Terri Cornelison, M.D., Ph.D., assistant director for the health of women in the FDA’s Center for Devices and Radiological Health said in a press release, "Consumers are increasingly using digital health technologies to inform their everyday health decisions, and this new app can provide an effective method of contraception if it’s used carefully and correctly." 

"But women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device," she added further.

“Natural Cycles can adapt to each woman’s body and, with a high degree of precision and accuracy, determine when she is ovulating,” says Dr. Elina Berglund, a physicist who created the app along with her husband Dr. Raoul Scherwitzl, a postdoctoral researcher.

Natural cycles is just like old times period tracker with some added features. The app requires the women to input her daily basal body temperature recordings and the date of menstruation. LH test result is an optional entry point.

The app’s calendar then labels fertile days as red (when you should abstain or use a condom) and the rest green, when you are “safe.” Using the sensitive thermometer and some mathematics the app claims itself “as good as the pill" at preventing pregnancy.

The app is primarily based on the fact that a woman’s body temperature rises slightly (about 0.4℃) after ovulation and remains slightly elevated throughout the rest of the cycle. The app uses an algorithm that considers body temperature, cycle irregularities, sperm survival, length of menstrual cycle and cycle irregularities. The algorithm learns from previously recorded cycles from the same woman and can provide predictions of her fertility status and upcoming ovulation, LH and menstruation days.

Initially, the app shows a nearly equal number of a green and red day but, as women continue using the app and fed more data, the number of red days is reduced to 8 each month. The app is 99.95% sure before it assigns a day red or green. If in doubt it will go red.

Clinical studies involving 15,570 women found that when used correctly, the failure rate for the app was 1.8%, while with typical use, or women sometimes not using the app correctly, the failure rate was 6.5%. "Based on the strength of our clinical data, we are delighted that the FDA granted De Novo classification for Natural Cycles and look forward to working together with healthcare professionals to offer a digital form of birth control to women in the US," said Elina Berglund.

"Our mission at Natural Cycles is to pioneer women's health with research and passion, and this milestone marks a very important step in that journey."

Natural Cycles received CE mark last year for marketing in Europe and has more than 900,000 registered users worldwide.

Anyone can use it, even women with PCOD or irregular cycles, only these women will have more red days on the calendar than green. Natural Cycles is contraindicated in women in whom pregnancy poses a serious risk to mother or fetus or in those who use other forms of contraception that prevent ovulation.  The method also does not prevent STIs.

The Natural Cycles app can be purchased through the Apple store or Google Play on a yearly subscription basis for $79.99 a year (includes oral basal thermometer) or monthly for $9.99 per month. They also offer a free trial period of 1 month.

Here is a video about Natural Cycles app for healthcare professionals. 

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FDA press release

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