Thursday, November 30, 2017

In case you missed it: Here are the top 5 posts this month


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.

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.  
In 2012, WHO recommended Use of TXA  for the treatment of PPH if oxytocin and other uterotonics fail to stop the bleeding or if it is thought that the bleeding may be partly due to trauma.

ACOG recommends against vaginal seeding in Cesarean births
ACOG today issued a policy statement against the practice of vaginal seeding in cesarean deliveries, in absence of sufficient data on potential benefits associated with the procedure.

Just wait a minute, and you save thousands of preterm babies a year
November 17 is celebrated as World Prematurity Day and theme for this year is ‘let them thrive.’
According to WHO An estimated 15 million babies are born preterm every year – more than 1 in 10 babies around the world and this number is rising. Preterm birth complications are the leading cause of death for children under 5.

ACOG updates the practice advisory for influenza vaccination during pregnancy
The American congress of obstetrics and gynecologists(ACOG) has issued a recent practice advisory for influenza vaccination during pregnancy.

A recent case -control study published in September issue of journal Vaccines linked spontaneous abortion and receipt of influenza vaccine in first trimester of pregnancy. In this case control study women had nearly twice the odds of experiencing a miscarriage if they were vaccinated in the preceding 28 days period. (OR 2.0; 95% CI 1.1–3.6)


CDC links overweight and obesity to increased risk of 13 different cancers


CDC recently released ‘vital signs’ have reported that being obese or overweight puts you at increased risk of 13 different cancers. These cancers constitute about 40% of all burden of cancer incidence in US. In 2014, approximately 631,000 persons in the United States received a diagnosis of a cancer associated with overweight and obesity.

Endometrial, ovarian, and postmenopausal female breast cancers accounted for 42% of new cases of overweight-and obesity-related cancers in 2014.

A review of data from 2005-2014 revealed that incidence of many of these cancers have increased by 7% in last 10 years, except colorectal cancers. Nearly 30% of US adult weigh more than what’s recommended and 50% do not have any idea that being overweight puts them at risk for these cancers.

CDC fact sheet
The obesity related cancers are adenocarcinoma of the esophagus, cancers of the breast [in postmenopausal women], colon and rectum, endometrium, gallbladder, gastric cardia, kidney, liver, ovary, pancreas, and thyroid; meningioma; and multiple myeloma.

On the other hand, non-obesity related cancers are down by 13%.

These obesity related cancers constitute nearly half of all the cancers in women and quarter of all cancers in men.

This finding has important public health implications as the burden can be considerably reduced by making a change in lifestyle and behaviors.

Multiple level interventions into policy, systems, and environmental changes that promote physical activity and healthy food options in communities

The CDC’s National Comprehensive Cancer Control Program supports comprehensive cancer control efforts, including environmental approaches that promote physical activity and healthy food options in communities.

To start with everyone can:
Eat a healthy diet by following the 2015-2020 Dietary Guidelines for Americans.
Do at least 150 minutes of moderate intensity physical activity, such as brisk walking, every week.
Talk to your primary healthcare provider about losing weight.


Wednesday, November 29, 2017

FDA clears Hologic’s Quantra 2.2 Breast Density Assessment Software during routine screening mammography


Hologic Inc. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Quantra 2.2 Breast Density Assessment Software. The software helps radiologists and clinicians to provide information about breast density to women during routine breast cancer screenings.

Quantra standardizes breast density reporting and helps eliminates the visual subjectivity by radiologists, through a proprietary algorithm powered by machine learning. The software classifies the breast tissue into four density categories based on  ACR Breast Imaging Reporting and Data System( ACRBI-RADS®) Atlas 5th Edition, based on the distribution of fibroglandular tissue  and texture of breast tissue.

The BI-RADS® Atlas provides standardized breast imaging findings terminology, report organization, assessment structure and a classification system for mammography, ultrasound and MRI of the breast.

The Quantra software is compatible with Hologic's 3D Mammography systems, including the new 3Dimensions mammography system, which is designed to be the fastest, highest resolution breast tomosynthesis system ever, with the 'Intelligent 2D imaging technology'.

Nearly 40% of women between the age of 40 and 74 have dense breasts, which can make it difficult to detect breast cancer during annual screenings and necessitates additional imaging, resulting in increased patient anxiety and unnecessary facility costs. Perhaps most importantly, women with very dense breasts are four to five times more likely to develop breast cancer than women with less dense breasts.

The software is one of several groundbreaking products that is available for demonstration in Hologic's booth (#4705) at the ongoing 103rd ScientificAssembly and Annual Meeting of the Radiological Society of North America (RSNA) at McCormick Place in Chicago from Nov. 26 to 30.

Pete Valenti, Hologic's Division President, Breast and Skeletal Health Solutions said, "As the global leader in breast cancer screening technology, we relentlessly pursue the development of clinically superior products that address the unmet and changing needs of our customers and their patients, especially when it comes to breast density. Quantra software is yet another example of our dedication and we are proud to feature it – along with a number of other new, breakthrough products – for the world's leading radiologists at RSNA this week."

Earlier this year, FDA approved its Genius 3D Tomosynthesis Mammography as the only test superior to 2D mammography for routine breast cancer screening for women with dense breasts. 

Hologic also commercially launched its SmartcCurve breast stabilization system at the same time, that makes mammography experience less painful for women without compromising on image quality and diagnostic accuracy.

Hologic Worldwide Quantra Volumetric Breast Density Assessment


Monday, November 27, 2017

Video: From Population Based screening to Personalized Breast Care by Nancy Cappello

https://www.womenshealthmag.com

Nancy Cappello, Ph.D., executive director and founder of Are You Dense Inc. and Are You Dense Advocacy, explains how a personalized breast screening program can improve cancer detection for women with dense breasts at the 2017 AHRA annual meeting in Anaheim.

Quick facts about breast cancer in dense breast and the screening dilemma associated with it.

What is meant by “being dense”? Breast density does not correlate with physically palpated firmness of breast, it is a radiologic finding and cannot be predicted without obtaining a mammogram. 

Nearly 40% of women have dense breast. In fact, Simple screening mammography will only detect 30% cancer in dense breasts and 80% in non-dense breasts. According to the American Cancer Society, having heterogeneously or extremely dense breast tissue puts you at risk of breast cancer that is equivalent having one first-degree relative with breast cancer. (2.1 to 4 times the normal risk)

The current options available in addition to screening mammography are Tomosynthesis or 3D mammography, Ultrasound, Magnetic Resonance Imaging (MRI), Molecular Breast Imaging (MBI) or Breast Specific Gamma Imaging (BSGI) and Contrast Enhanced Spectral Mammography (CESM)

Nancy M. Cappello, Ph.D. has founded Are You Dense, Inc., and Are You Dense Advocacy, Inc., to educate women and general public about the challenges women with dense breast face regarding the screening tools for detecting early breast cancer.




Sunday, November 26, 2017

ACOG updates the practice advisory for influenza vaccination during pregnancy



The American congress of obstetrics and gynecologists(ACOG) has issued a recent practice advisory for influenza vaccination during pregnancy.

A recent case -control study published in September issue of journal Vaccines linked spontaneous abortion and receipt of influenza vaccine in first trimester of pregnancy. In this case control study women had nearly twice the odds of experiencing a miscarriage if they were vaccinated in the preceding 28 days period. (OR 2.0; 95% CI 1.1–3.6)

The odds of spontaneous miscarriage were further increased 7 times if the women also received the pH1N1-containing vaccine in the previous influenza season. (OR 7.7; 95% CI 2.2–27.3)
Once the 28 days window is passed, not increased chances of spontaneous pregnancy loss was observed.

The same study also observed no adverse effects or pregnancy loss when vaccination was given either later in the first trimester or in the second or third trimester.

Hence, ACOG reviewed the evidence by evaluating all the scientific information available and concluded that this study had some limitations and does not establishes causality. It also calls for additional studies and clinical trials before the concern is fully addressed.

ACOG still affirms it stand of vaccinating every pregnant woman with a flu shot, irrespective of the trimester she is in.

For many years, ACOG and the CDC have recommended that every pregnant woman receive a flu shot during any trimester.






Friday, November 24, 2017

North American Menopause Society (NAMS) video series about important midlife health topics: The Timing Hypothesis of HRT

The North American Menopause Society is proud of its comprehensive video series for clinicians about important midlife health topics. All the interviews in the series are hosted by NAMS 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 latest video, The Timing Hypothesis, Dr. Shapiro interviews Dr. Peter Schnatz, Past President of NAMS and Associate Chairman and Residency Program Director in the Department of Obstetrics and Gynecology at the Reading Hospital in Reading, Pennsylvania. Dr. Schnatz discusses the benefits of starting women on hormone therapy at the beginning of the menopause transition, along with the cardiovascular health advantages.   

The ELITE:Early Versus Late Intervention Trial With Estradiol also affirms the timing hypothesis in relation to timing of estradiol administration, when a beneficial cardiovascular effect is only seen in women with early, but not later menopause.





Tuesday, November 21, 2017

FDA clears world’s first and only, non-radioactive, wire free breast tumor localizer for extended use


Cianna Medical, Inc. has received FDA clearance of the SAVI SCOUT® reflector for long term use.

The SAVI SCOUT reflector is an integral part of the SAVI SCOUT® surgical guidance system, a novel wire free technology that uses real-time audible and visual indicators for precise localization of tumor during lumpectomy and excisional biopsy procedures.

This technology is the first and only non-radioactive implant, that uses electromagnetic wave technology, with no restrictions on the length of time the reflector can remain in the breast. 

This will enable the surgeons to precisely target the affected tissue using the system’s capability of 360˚ detection and ability to pinpoint tumor location down to ±1mm, this conserves breast tissue and is more aesthetic for women at the same time increasing the surgical precision and reducing the need for repeat surgery.  

In addition, a woman with in situ SCOUT reflector can easily undergo MRI, as it does not interfere with the study.

The SCOUT reflector is 4 mm in size, and remains completely passive till it is activated by a handheld radar system. As the radar system is placed against breast, the Scout system starts sending audio-visual cues for the precise position of the reflector.  

It also eliminates the need of same day surgery and can remain in place between the time of biopsy to surgery.

Before the clearance the reflector was only allowed to stay in place for 30 days, now the time limit has been removed.

The device received its initial clearance in 2014, based on a result of small pilot study of 50 patients published later in June 2016 in the Annals of Surgical Oncology.

A larger subsequent study also by Cox et al. was published in Annals of Surgical Oncology involved 154 patients and the researchers concluded that, “SCOUT provides a reliable and effective alternative method for the localization and surgical excision of nonpalpable breast lesions using no wires or radioactive materials, with excellent patient, radiologist, and surgeon acceptance.”

Dr. Alice Police was the first surgeon in the country to adopt SCOUT in late 2015, at UC Irvine Medical Center, in Orange County, CA.   “My focus is always on finding a better breast cancer operation,” Dr. Police said.   “SCOUT is the standard of care for my breast localizations as I utilize this wire-free approach for all scenarios requiring localization.  The distance feature provides more control over the procedure which is important for predictable outcomes.”

Cianna Medical requires that each site and physician using SCOUT Radar Localization successfully complete training prior to initial cases. 

Monday, November 20, 2017

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.  


In 2012, WHO recommended Use of TXA  for the treatment of PPH if oxytocin and other uterotonics fail to stop the bleeding or if it is thought that the bleeding may be partly due to trauma.


Globally, PPH accounts for 25% of all maternal deaths and in most low-income countries it is the leading cause of maternal deaths. And minutes count when treating postpartum hemorrhage with tranexamic acid: for every 15-min delay, there's a 10% reduction in effect.

The key recommendations from WHO are:

  • The World Health Organization (WHO) recommends early use of intravenous tranexamic acid (TXA) within 3 hours of birth in addition to standard care for women with clinically diagnosed postpartum hemorrhage (PPH) following vaginal birth or caesarean section.
  • Administration of TXA should be considered as part of the standard PPH treatment package and be administered as soon as possible after onset of bleeding and within 3 hours of birth. TXA for PPH treatment should not be initiated more than 3 hours after birth.
  • TXA should be used in all cases of PPH, regardless of whether the bleeding is due to genital tract trauma or other causes.
  • TXA should be administered at a fixed dose of 1 g in 10 mL (100 mg/mL) IV at 1 mL per minute (i.e., administered over 10 minutes), with a second dose of 1 g IV if bleeding continues after 30 minutes.
  • TXA should be administered via an IV route only for treatment of PPH. Research on other routes of TXA administration is a priority.


ACOG also has recently updated its practice bulletin on Postpartum Hemorrhage, based on the results of The WOMAN (World Maternal Antifibrinolytic) trial published in May 2017, in The Lancet.

The researchers concluded that “Tranexamic acid reduces death due to bleeding in women with post-partum hemorrhage with no adverse effects. When used as a treatment for postpartum hemorrhage, tranexamic acid should be given as soon as possible after bleeding onset.”

ACOG says, “Although the generalizability of the WOMAN trial and the degree of effect in the United States is uncertain, given the mortality reduction findings, tranexamic acid should be considered in the setting of obstetric hemorrhage when initial medical therapy fails.” (Level B evidence)


AWHONN video on Quantification of Blood Loss



Sunday, November 19, 2017

Adequate vitamin D levels result in higher live birth rate in women undergoing ART

www.hlbenefits.com


Women undergoing ART with adequate levels of Vitamin D have a 30% increase chances of live birth as compared to women who were found deficient in Vitamin D says the results of a systematic review and meta-analysis published November 15, 2017 in Journal Human Reproduction.

The lead researcher was  Dr Justin Chu, an Academic Clinical Lecturer and Specialist Registrar in Obstetrics and Gynaecology for Tommy's National Centre for Miscarriage Research at the University of Birmingham and Birmingham Women's and Children's NHS Foundation Trust.

It is known that every nearly 20%-50% of women of reproductive age are deficient in Vitamin D and many mechanisms are suggested. This meta-analysis found a higher prevalence of women with Vit D deficiency (34.6%) and insufficiency (34.6%). 

A total of 11 studies conducted over a period of 5 years (2010-2015) were included in the review, amounting to 2700 women receiving ART. Vitamin D levels were labelled as adequate or deficient according to Endocrine Society classification (<50 nmol/l deficient, 50–75 nmol/l insufficient and greater than 75nmol/l replete).

Pooled data from all the study for clinical pregnancy showed that women with more than 75nmol/l of vitamin D levels have 46% higher chances of clinical pregnancy (OR 1.46; CI 1.05–2.02; P = 0.02).
Similarly, these women with replete Vitamin D levels had a 33% increase chance of live birth rate (OR 1.33; CI 1.08–1.65; P = 0.39) and 34% increased chances of biochemical pregnancy (OR 1.34; CI 1.04–1.73; P = 0.28).

No correlation was found between Vitamin D levels and risk of miscarriages.

The main source of vitamin D for people is sunlight. Foods rich in Vitamin D are oily fish, red meat, liver and egg yolks also provide vitamin D, as well as vitamin D supplements

The researchers say the improved ART success in women replete in vitamin D "could be via the actions of vitamin D on the endometrium promoting embryo implantation or as a surrogate marker for general well-being."

Dr Chu, from the University of Birmingham’s Institute of Metabolism and Systems Research, cautioned that the findings do not mean that vitamin D supplementation necessarily improves women’s chances of having a baby following ART as the research can only show an association.

Dr Chu said: “Although an association has been identified, the beneficial effect of correction of vitamin D deficiency or insufficiency needs to be tested by performing a clinical trial.

“In the meantime, women who want to achieve a successful pregnancy should not rush off to their local pharmacy to buy vitamin D supplements until we know more about its effects. It is possible to overdose on vitamin D and this can lead to too much calcium building up in the body, which can weaken bones and damage the heart and kidneys.”

The researchers are calling for large randomizes studies to confirm the findings of other studies and prove causation.

“Testing for vitamin D concentrations is relatively cheap and widely available and its treatment is not costly,” said Dr Chu. “It could be that correcting vitamin D deficiency could benefit women undergoing assisted reproduction treatment, but further research is needed to test this.”

News Release by the University of Birmingham

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Friday, November 17, 2017

Just wait a minute, and you save thousands of preterm babies a year

babycenter.com
   
November 17 is celebrated as World Prematurity Day and theme for this year is ‘let them thrive.’

According to WHO An estimated 15 million babies are born preterm every year – more than 1 in 10 babies around the world and this number is rising. Preterm birth complications are the leading cause of death for children under 5.

Well, the obstetricians and health care personal assisting in child birth could save thousands of lives by waiting 60 seconds before clamping the umbilical cord after birth instead of clamping it immediately reports the results of a systematic review and meta-analysis led by the University of Sydney's National Health and Medical Research Council Clinical Trials Centre.

The review will be published in forthcoming issue of American Journal of Obstetrics and Gynecology.

The researchers  looked into data from 18 randomized controlled trials that compared delayed vs early clamping amounting to total of 2834 infants born before 37 weeks' gestation. The cord was clamped after 60 seconds in infants allocated to delayed cord clamping group.

Infants who had their cord clamped after 1 minute faced a 32% reduced risk of mortality and 33 infants need to have delayed cord clamping to save one infant (number need to treat = 33).

Out of 18 trials, 3 trials consisted of about 1000 infants born before ≤28 weeks’ gestation. They had a 30% reduction in mortality and the number need to treat was 20.

The two groups were comparable for Apgar scores, intubation for resuscitation, admission temperature, mechanical ventilation, intraventricular hemorrhage, brain injury, chronic lung disease, patent ductus arteriosus, necrotizing enterocolitis, late-onset sepsis, or retinopathy of prematurity.

combatbootmama.com
Delay in cord clamping improved the hematocrit by 3% and 10% fewer babies required blood transfusion.

The side effects of delayed clamping were polycythemia and hyperbilirubinemia.

"The review shows for the first time that simply clamping the cord 60 seconds after birth improves survival," said the University of Sydney's Professor William Tarnow-Mordi, senior author.
"It confirms international guidelines recommending delayed clamping in all preterm babies who do not need immediate resuscitation."

"We estimate that for every thousand very preterm babies born more than ten weeks early, delayed clamping will save up to 100 additional lives compared with immediate clamping," said the University of Sydney's Associate Professor David Osborn, the review's lead author and a neonatal specialist at Royal Prince Alfred Hospital.

"This means that, worldwide, using delayed clamping instead of immediate clamping can be expected to save between 11,000 and 100,000 additional lives every year."

The study findings are in accordance with a second Australian study published in The New England Journal of Medicine. The Australian study enrolled about 1500 babies, from25 centers in 7 countries. The babies were born on an average 10 weeks early. Delayed cord clamping saved 3% more babies, as compared to immediate cord clamping (mortality was  6% vs 9%)(p=0.03).

Currently, WHO recommends waiting at least 60 seconds before cord clamping in premature and term babies.

ACOG also recommends, “a delay in umbilical cord clamping for all healthy infants for at least 30-60 seconds after birth given the numerous benefits to most newborns.” 




Thursday, November 16, 2017

FDA approves the first digital pill, that tracks its own course after ingestion



The U.S. Food and Drug Administration today approved the first drug in the U.S. with a digital ingestion tracking system, to track whether you have ingested it or not. The drug-device combination is Abilify MyCite, it  comes with an embedded Ingestible Event Marker (IEM) sensor, and is manufactured by Japan-based Otsuka Pharmaceutical.

The ABILIFY MYCITE System includes: ABILIFY MYCITE, the MYCITE® Patch (wearable sensor); the MYCITE APP (a smartphone application); and web-based portals for healthcare providers and caregivers.

Abilify is the brand name for Aripiprazole, an antipsychotic used to treat schizophrenia, bipolar disorder and as an add-on treatment for depression in adults.

The sensor is the size of grain of sand and is made from ingredients found in food. As soon as the tablet is ingested,the sensor is activated by coming in contact with stomach acid. It communicates with the wearable sensor, called the MYCITE Patch which detects and records the date and time the pill is ingested.

The Mycite Patch in turn communicates the data with the MYCITE APP on a compatible mobile device.

The patient’s healthcare providers and caregivers also can view the data and record the patterns of drug ingestion by the patient via Web-based dashboards. With patient consent, selected members of the family and care team can also access this information. 

The system targets the major problem of ‘nonadherence’ to medications in US, common with people suffering from hypertension and diabetes.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research in a press release. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”

The prize of the medication will be finalized in 2018, when the initial rollout of drugs begins.

Decisions for development of other digital medication is under consideration, especially for diabetes and hypertension.



Wednesday, November 15, 2017

Biop launches accurate, on the spot, 3 minutes screening and detection system for cervical cancer


Biop Medical announced the launch of its high tech, point of care cervical cancer screening and detection device at MEDICA 2017 in DĂĽsseldorf, Germany, Nov. 13-16. This "sample free biopsy" device helps gynecologist in screening and diagnosis of pre-cancerous and cancerous lesions in real time without the painful wait for the biopsy results.

Biop system is a digital colposcope that make use of advanced and high-resolution optics to obtain a magnified view of vagina, cervix and external genitalia, allowing doctors to identify abnormalities such as lesions or cancer and selecting areas for biopsy.

The innovative system consists of a main control unit, that can be connected to the Digital Colposcope unit or the Micro-Colposcope Probe unit.

A fully digital and high-resolution imaging of the cervix can be performed by connecting the Digital Colposcope unit to the control unit. Panoramic color images, using LED lights are acquired by the camera.

On the other hand, the Micro- Colposcope Probe unit captures a macro-image of the cervix, using its macro-camera. Using a sterile and disposable cover, the probe is advanced in the vagina, upon coming in contact with the cervix, the unit captures high-resolution, high-magnification images within a radius of 11mm around the external os, which serves as the center of the scan.

The physician does not need to constantly adjust the magnification, to focus on the specific areas, as with the current colposcopy units.  

The images are enhanced and processed by the software of the system. The high resolution, macro images are than combined with the panoramic images to obtain a full a color map of cervix, that is analyzed by Biop’s proprietary algorithm.



Two pictures are displayed on the physician's screen; a high-resolution photograph of the patient's cervix, immediately next to a hot/cold map indicating a precise classification and location of any diseased lesions.

If needed, the physician can take biopsies from a precise location, and reducing the need for unnecessary biopsies.

The data obtained is uploaded and secured on Bluemix virtual servers in the IBM Cloud and can be used for consultation with any specialist around the world. These new data sets can be used to improve the accuracy of Biop’s diagnostic and create predictive data, which will determine which cells are likely to convert to cancer and which will regress to healthy cells.

With Biop, a woman can be screened in 3 minutes and if precancerous or cancerous lesions are detected, the women can be referred for immediate treatment.

The device is particularly useful in developing countries, and remote access areas where the physician can carry the device to the patients.

Operating the device requires minimum screening, so that healthcare professional can be quickly trained to do the scanning, as compared to years of training required for routine colposcopy.

“With this new precision, physicians can see where to target biopsies and only perform the procedure when necessary,” said Biop Medical CEO Ilan Landesman in a news release. “Patients gain a more accurate and faster diagnosis while avoiding the painful procedure as well as reduced costs for hospitals and healthcare providers.”

Cervical cancer is the number one cause of cancer-related death for women in the developed world. Out of BRICS (Brazil, Russia, India and China and South Africa) countries, India is the leader in overall deaths, with nearly 73,000 annual deaths. China and Brazil follow closely.

Biop Medical is based in Ramat Gan, Israel.




Media courtesy: Biop 

Monday, November 13, 2017

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.

The guidelines were released here at the American Heart Association(AHA) 2017 Scientific Sessions : November 11–15, 2017, Anaheim, California and published simultaneously in the Journal of the American College of Cardiology,and in the AHA journal Hypertension.

The definition of the normal blood pressure has not changed in the new classification , but the new guidelines eliminate the class of ‘ pre-hypertension’.

Previously a systolic pressure between 120 and 129 and diastolic pressure less than 80 mm Hg was classified as pre-hypertension, now it is defined as elevated BP and a systolic pressure 130 to 139 or a diastolic pressure of 80 to 89 mm Hg is labelled as stage 1 hypertension.



This new classification raises the prevalence of hypertension from 31.9% to 45.6% and number of Americans with hypertension from 72.2 to 103.3 million.

In patients who are labelled as stage 1 hypertension, the treatment will be guided by underlying cardiovascular risk: only those with clinical cardiovascular disease or an estimated risk of 10% or more of atherosclerotic cardiovascular disease (ASCVD) would be offered treatment, and the remainder should be given advice on lifestyle modification.

Dr Robert M Carey (University of Virginia School of Medicine), Vice-chair of the writing committee said in a briefing, "Lifestyle modification is the cornerstone of the treatment of hypertension, and we expect that this guideline will cause our society and our physician community to really pay attention much more to lifestyle recommendations."

Specific recommendations include advice to lose weight, follow a DASH-pattern diet, reduce sodium to less than 1500 mg/day and increase potassium intake to 3500 mg/day through dietary intake, increase physical activity to a minimum of 30 minutes of exercise three times per week, and limit alcohol intake to two drinks or less per day for men and one or less for women.

The new goals of treating hypertension has also decreased since the last guideline, lowering it  from 140/90 mm Hg  to a target of 130/80 mm Hg.

The guidelines were developed after a thorough and systematic scientific review of over 900 publications over 3 years and felt that lowering the BP limit will improve the cardiovascular health of all Americans.

The notable studies were  SPRINT and ACCORD trials, in which lowering the blood pressure reduced CVD morbidity and mortality without any increased risk for falls or orthostatic hypotension.

New release by AHA
Full text PDF in Journal Hypertension 

                     Understanding the 2017 Hypertension Guidelines





News from NAMS 2017: Postmenopausal bleeding is always a red flag, unless proven benign


Every postmenopausal bleeding mandates a complete and systematic investigation to rule out endometrial malignancy and blind biopsies are no longer the norm, according to a presentation by Steven R. Goldstein, MD, a professor of obstetrics and gynecology at New York University School of Medicine, New York City here at the North American Menopause Society (NAMS) 2017 Annual Meeting.

“If you’re postmenopausal and not on hormone therapy or tamoxifen, you shouldn’t be bleeding,” he further added.

American Cancer Society estimates that in year 2017, about 61,380 new cases of endometrial cancer and uterine sarcoma will be diagnosed and about 10,920 women will die from these cancers. The average age at diagnosis is 60 and postmenopausal bleeding is the most common presentation in nearly all the cases.

In majority of women who present with postmenopausal bleeding, the cause is atrophic changes of endometrium or vagina, but depending upon other risk factors, 1-14% of these women will harbor a malignancy and it is important not to miss these women.

ACOG advocates endometrial evaluation in any women presenting with abnormal uterine bleeding (AUB), but blind biopsy is no longer sufficient in ruling out uterine malignancy.

Blind biopsy alone could miss the diagnosis of focal lesions in up to 18% of patients
Endosee


Dr Goldstein said, “The standard of care has changed. Now the standard of care corroborates that a negative blind biopsy is not a stopping point. Clinicians can still begin with a blind biopsy, but unless it is malignant or complex atypical hyperplasia, the endometrial evaluation is not complete."

If cancers occupy less than 50% of the surface area of the uterine cavity, it can very much be missed with a blind biopsy.

if cancer occupies less than 50%, of the surface area of the endometrial cavity, the cancer can be missed by a blind biopsy
Endosee

The Evaluation Algorithm


The investigation should ideally begin with transvaginal ultrasonography(TVS), or sonomicroscopy, to determine the thickness of the endometrium. If distinct endometrial echo or lining, less than or equal to 4 mm is visualized, no further endometrial sampling is required. (99.8%- 100% negative predictive value)

But, in many patients it is not possible to see the endometrial lining because of obesity, adenomyosis structural nonalignment or fibroids.  So, if the endometrial thickness is more than 4 mm or the endometrial echo is difficult to visualize, the next logical step is to perform a sonohysterography or hysteroscopy.

By infusing fluid, clinicians can delineate clearly whether the thickening is focal or global throughout the cavity. If the thickness is global, go for a biopsy. If it is focal occupying more than 20-30% of uterine cavity, plan for a biopsy under hysteroscopic guidance.

It’s easy and timesaving to perform office hysteroscopy, with US FDA approved disposable hysteroscope called Endosee (Cooper Surgical). It provides a quick point of care option and does not require sterilization or special storage. Physicians can take a biopsy under direct vision and resolve the dilemma.

If the patient’s first point of contact is not an obgyn but a primary care physician, an internist or physician from some other specialty, they should at least order a TVS, so that by the time the patient is seen by a gynecologist, the initial sonography report is ready.


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