On-site reporting from the Society of Gynecologic Surgeons 2016 annual meeting

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On-site reporting from the Society of Gynecologic Surgeons 2016 annual meeting

4/13/16. DAY 4 AT SGS

 

A jam-packed day of sessions, posters, awards, and clinical updates

Our last educational day was kicked off by a fascinating lecture by Dr. Amy Park on the “Genetic Determinants of Pelvic Organ Prolapse in Women of European American Descent: The Women’s Health Initiative.” Dr. Park and her colleagues found that there is evidence of phenotypic and genotypic heterogeneity in patients with pelvic organ prolapse, and there were 4 genetic loci identified that correlated with prolapse. Any uterine prolapse was associated with a genome-wide significant intergenic variant on chromosome 13, cystocele was associated with LOXL2, and all prolapse was associated with BMP.

Surmounting surgical site infection

Dr. Sarah Andiman then gave a lecture on the effects of a perioperative bundle and offered timely feedback for surgical site infection (SSI) prevention in hysterectomy. We all know that wound infections are a major morbidity associated with surgery, and Dr. Andiman’s group at Yale found that, by implementing this prevention program, the surgical site infection decreased 52.8%. Another suggestion from the audience was to have all patients use chlorhexidine wipes the night before and morning of a surgery to decrease wound infection. Similarly, Dr. Ali Bazzi gave a lecture on “Chlorhexidine-Alcohol Compared with Povidone-Iodine for Surgical-Site Antisepsis after Abdominal Hysterectomy.” The chlorhexidine was associated with 30% lower odds of SSI compared with povidone-iodine, even though this group had several medical comorbidities and risk factors known for SSIs.

Oral poster presenters make several interesting points

Dr. Christopher Ripperda from UT Southwestern Medical Center in Dallas, Texas, found that medical comorbidities and the presence of detrusor overactivity and PVR are predictors of early postoperative voiding dysfunction following a midurethral sling placement. Dr. Nabila Noor then described a fabulous surgical alternative to the use of morcellation to remove the uterus after a supracervical hysterectomy. She described the technique for performing a posterior colpotomy and stated that patients who had a surgery performed at her institution using this technique did not experience increased postoperative pain or longer postoperative stay.

Dr. Jennifer Thompson then shed some light on a very important question related to the Sunshine Act: Are physicians including all of their disclosures when they submit articles to a conference? When the physicians who submitted an abstract to the Society of Gynecologic Surgeons (SGS) in 2015 were searched on the Centers for Medicare and Medicaid Services (CMS) website, 62% of them had incomplete disclosures, with a total of nondisclosed CMS transactions equaling $1.3 million. We can do better!

Status update: The FPRN and passing of the torch

Congratulations to Dr. Kristin Jacobs, the new Fellows’ Pelvic Research Network (FPRN) Chair! The morning session ended with an innovative video from Dr. Janet Li and colleagues on the “Use of Suprapubic Carter-Thomason Needle to Assist in Cystoscopic Excision of Intravesical Foreign Object.”

The winner of the Distinguished Surgeon Award was given to Dr. Javier Magrina, and the SGS gavel was passed on to Dr. Vivian Sung! Congratulations!

Dr. Stephanie Pickett kicked off the eighth scientific session with a study entitled, “Comparing Methods of NSAID Delivery for Postoperative Pain.” When she and her colleagues compared IV toradol to IV ibuprofen for postoperative pain control after urogynecologic surgery, they found that patients experienced similar rates of pain control and satisfaction regardless of the type of analgesia.

Why are patients being readmitted after gynecologic oncology surgery?

The answer to this question is important as readmission rates are being considered for physician and hospital reimbursement. Dr. MaryAnn Wilbur and colleagues looked at the rates of unplanned 30-day readmission in gyn oncology patients. The patients who were readmitted had the following characteristics: ovarian cancer, creation of ostomy, Charleston score >5, language barrier, and positive discharge screen. Gastrointestinal disturbance and SSI were the most common reasons for readmission, and the total readmission-related costs for these patients was about $4.5 million.

Considering tissue extraction, surgical complications, and cognitive impairment

We then had 3 fabulous oral poster presentations. Dr. Emily Von Bargen and colleagues presented a study entitled, “Prevalence of Occult Pre-malignant or Malignant Pathology at the time of Uterine Morcellation for Benign Disease.” They performed a multicenter retrospective cohort study and found that 1.2% of women had a premalignant or malignant uterine pathology after surgery, with a prevalence of 0.66% of occult malignancy. She was unable to identify risk factors for those patients who had a premalignant or malignant pathology. Overall she found a low prevalence of premalignant or malignant uterine pathology when uterine morcellation was performed for benign disease.

 

 

Dr. Alix Leader-Cramer from Northwestern University pointed out “risk factors for a 30-day perioperative complications for total vaginal hysterectomy,” including chronic steroid use, higher ASA classification, current smoking status, diabetes, and lower preoperative serum albumin and sodium levels. Adnexectomy and resident participation were also associated with increased perioperative complications. About 9.5% of patients had a perioperative complication in the study population studied.

Finally, Dr. Elisa Trowbridge pointed out in her talk, on “Cognitive Impairment among Elderly Urogynecologic Patients,” that cognitive impairment is very prevalent among such women aged older than 75 years, and the Mini-Cog is a feasible screening tool.

What a way to end an AMAZING conference!

The conference ended with a fabulous video presentation by Dr. Andrea Benton, entitled “Surgical Approaches to the Management of Bladder and Ureteral Endometriosis.” Overall, the themes of this year’s SGS conference were to:

 

  • emphasize the importance of performing a vaginal hysterectomy when feasible
  • continue to strive to balance innovation with experimentation
  • ensure that patients are being operated on by surgeons who are competent and frequently performing the indicated procedure.

Thank you to everyone who shared their research to educate the attendees at the conference! I can’t wait until next year!

 

 

4/12/16. DAY 3 AT SGS

Vaginal hysterectomy, fecal incontinence, transgender surgery amid tackled topics in Palm Springs

I could get used to sipping my coffee with the sunny background here in Palm Springs! It was a beautiful morning to learn.

We started the day with breakfast and a fabulous lecture on the inferior gluteal neurovascular anatomy in female cadavers, and an insightful lecture by Dr. Bhumy Dave, who brought up concerns about tracking for obstetrics and gynecology residency programs. She specifically highlighted the need for more experience with vaginal hysterectomies for residents who are going to be in a subspecialty that performs vaginal surgery. As the number of hysterectomies, specifically vaginal hysterectomies, declines every year, we need to make sure we are adequately training the physicians who will be performing this procedure in the future. One solution is to have residents join a track their 4th year of residency, after their future career path has been established. Another possible solution would be to increase use of a simulation model for vaginal hysterectomy, as described by Dr. Douglas Miyazaki.

Indigo carmine replacement? A recent issue in gynecologic surgery resulted when there was a national shortage of indigo carmine, which is commonly used to identify UO efflux at the time of cystoscopy. Dr. Katie Propst provided a solution: In the setting of planned cystoscopy, she found that preoperative phenazopyridine is an acceptable alternative and its use led to similar UO identification as with indigo carmine without an increase in complications.

Who should have a vaginal hysterectomy? Dr. Jennifer Schmitt from the Mayo Clinic gave another wonderful lecture describing a decision-tree algorithm for determining the ideal route of hysterectomy. According to a retrospective review of patients at their institution, vaginal hysterectomy was associated with lower infection rates, operative times, and costs.

The highlight of the morning was a very insightful Presidential Address by Dr. Andrew Walter! Not only is a he a very entertaining speaker but he also shed some light on 2 challenges that we currently face in the field. He eloquently stated that, “every woman who is a candidate for a vaginal hysterectomy should be able to get one and have it performed competently, and every woman who needs surgery should have one performed by someone who performs enough surgeries every year to competently perform the surgery.” He frequently alluded to the wise Dr. Mayo, who stated, “The best interest of the patient is the only interest to be considered…” Let’s never forget this as physicians!

Do you find removing the adnexa challenging when performing vaginal surgery? Check out the amazing idea from the Cleveland Clinic shown in video presentation 05! They clearly demonstrate using a single-site gel port or surgical glove placed in the vaginal incision to perform laparoscopy through the vagina. What a novel idea to avoid any abdominal incisions when there is a difficult vaginal adnexal surgery!

After the morning break, we watched a master vaginal surgeon perform a sacral colpopexy through the vaginal route. For details on this method, please reference video presentation 06.

An increase in health care costs is a huge problem in this country. Dr. Mary Van Meter suggested that one area in which we can improve is in the operating room (OR), specifically through decreasing the number of instruments sterilized. She found that only approximately 20% of the instruments on the operating field were actually used by the OR physician. It costs about $3 per instrument on the tray at Vanderbilt University, she said. When you think of the few number of instruments actually used, if we work to limit the number of instruments on the trays, we could cut significant costs. As reimbursement is getting increasingly linked to cost reduction, we all should be thinking about innovative ways to cut costs.

 

 

The oral posters were all excellent!

Dr. Ann Peters showed that, at a high-volume tertiary-care center, multimodal preoperative testing failed to definitively identify leiomyosarcoma (LMS), and the factors associated with increased LMS risk included older age, menopause, and presence of fibroids with concurrent pelvic, uterine, or adnexal mass.

Dr. Kevin Kremer found that preoperative antibiotics were used in 23% of cases in which they were not indicated, and the increased use rate was associated with entrance into the abdomen during surgery, the individual surgeon, and time under anesthesia.

Dr. Jessica Heft then stated that the incontinence rate after midurethral sling revision for vaginal exposure or pain was significantly higher with a partial as opposed to complete mesh excision.

Fecal incontinence treatment options

Dr. Peter Rosenblatt tackled the issue of “Innovation or experimentation: Where do we draw the line?” in the TeLinde lecture. He started by describing a condition for which he feels we do not have an acceptable amount of treatment options for patients: fecal incontinence. He described how he observed that the puborectalis muscle, not the external anal sphincter, was critical for fecal continence. He then devised a surgery that created a sling that would act as a synthetic puborectalis muscle. He had amazing success until one patient had a serious complication. Should you abandon a successful, innovative surgery due to one very severe complication, was the question. Where do we draw the line? I don’t have an answer…but I do know that we all need to thank our puborectalis muscle for our daily fecal continence!

This is not a new issue in medicine, explained Dr. Rosenblatt. From the beginning of medicine, there has been a balance between innovation and experimentation. So, what is innovation? It is when someone improves upon a device or process. In medicine, is it innovation or just variation? We frequently use medications and devices “off label,” and these techniques often improve our surgeries and outcomes for our patients. Innovation comes about through careful planning, a necessity created by an emergency, advances in technology, and through evolution of a procedure. Who are the innovators? YOU are! We are the ones who understand the unmet needs and the potential opportunities for improving medicine. Let’s all work together to innovate NOT experiment and make medicine better so our patients have the best care possible!

“New Frontiers in Gynecologic Surgery: Transgender Surgery and Functional Clitoroplasty after Female Genital Mutilation”

The final talk for the day was by the groundbreaking Dr. Marci Bowers, whose lecture started by reminding everyone that there is a difference between gender identity and gender expression. Once a person knows his or her gender identity they use gender expression to express this to the world, she pointed out. Dr. Bowers is a true innovator and is performing gender reassignment surgeries as well as female genital mutilation corrective surgeries. She has perfected a one-stage vaginoplasty, and she showed a video of the procedure, which results in a 90% chance of orgasm. She also noted that she is able to restore clitoral function in 100% of the cases of genital mutilation, and she performs these procedures free of charge.

She reminded us that all ObGyns need to be trained in treating transgender patients, and given the high rate of suicide among adolescent transgender individuals, we all need to work together to provide a supportive medical environment to help these patients. What a fascinating end to the day!

Some relaxation, and entertainment, amid the sun and outdoors

We then had the afternoon to compete in a golf tournament, explore the area on mountain bikes, or lounge by the pool. Regardless of the daytime activities, we all came back together for the great lip-synch competition! All 4 teams gave an impressive performance, but the team from Brown University went home with the win! Such an entertaining event! (Thanks to incoming SGS President Vivian Sung @wih_sung for the pic!)

 

 

4/11/16. DAY 2 AT SGS

Experts talk surgical innovations, complementary therapies, value-based payment, and much more at SGS day 2

Wake up and learn! The second day of the 42nd Annual Scientific Meeting of the Society of Gynecologic Surgeons began with a review of research posters at the Poster Session as the sun rose over the Palm Springs mountains. We then moved indoors for the scientific sessions.

In the first lecture, "Reasons for Unplanned 30-Day Readmission After Hysterectomy for Benign Disease," Dr. Courtney Penn and colleagues reiterated that the postsurgical readmission rate is higher for patients undergoing abdominal hysterectomy compared with those who have a laparoscopic or vaginal hysterectomy. Similarly, Dr. Jennifer Schmitt and colleagues suggested that in a patient with a relative contraindication for vaginal hysterectomy, when this procedure is performed by an experienced surgeon there may not be increased complications. However, keep in mind that the study described—"A Comparison of Vaginal and Robotic Hysterectomy for Commonly Cited Relative Contraindications to Vaginal Hysterectomy"—was performed at the Mayo Clinic by expert, highly trained surgeons, and this fact may limit the generalizability of the study. As one audience member eloquently stated, it is important to remember that: "Just because it is feasible does not mean it is the correct procedure."

 

 

That yoga or barre class may be doing more good than you think! Lunge, bridge, and cat-into-cow movements may provide a greater degree of pelvic floor muscle unit recruitment than traditional Kegel exercises, according to a presentation by Dr. Bruce Crawford on Kegels versus specialized movement.

Perhaps those exercises should be recommended for surgeons as well. As Dr. Ruchira Singh pointed out, surgeons experience a high amount of musculoskeletal strain when performing vaginal procedures while sitting, regardless of the type of chair used during surgery. Dr. Singh and colleagues’ study, "Effect of Different Chairs on Work-Related Musculoskeletal Discomfort During Vaginal Surgery," found that while the round stool with a backrest and the Capisco chair were more comfortable, they did not eliminate the high risk for musculoskeletal strain, particularly in the head and neck.

Dr. Ann Peters and colleagues, from Magee-Womens Hospital of the University of Pittsburgh Medical Center, gave a fabulous video presentation on "Anatomic and Vascular Considerations in Laparoscopic Uterine Artery Ligation During Hysterectomy."

Need a novel treatment for interstitial cystitis/bladder pain syndrome? Consider mindfulness-based stress reduction. A randomized controlled study performed by Dr. Gregg Kanter and colleagues describes how this technique may help patients and could be considered a first-line therapy.

What is value-based payment and this new trend in reimbursement? And how does it apply to vaginal hysterectomy? Dr. Tina Groat addressed these issues in her keynote lecture. According to the American Congress of Obstetricians and Gynecologists, “Evidence demonstrates that, in general, vaginal hysterectomy is associated with better outcomes and fewer complications than laparoscopic or abdominal hysterectomy.” This is in opposition to what is actually being performed clinically. Dr. Groat explained that United Healthcare decided to incentivize physicians by requiring a prior authorization for all hysterectomies for benign disease. There is both a quality and cost benefit to performing a vaginal hysterectomy. Most insurance companies are moving away from a “fee for service” structure to performance-based payment. Change is always scary and, while I think the overall goal of moving toward the best care for our patients is a positive, this approach may create new challenges for the medical field. What do you think? Is performance-based payment beneficial? Or does it limit physicians and potentially force them to perform a procedure they do not feel as comfortable performing? Will this result in physicians rejecting certain patient populations? [Note from OBG MANAGEMENT: Let Dr. Collins know your thoughts through social media, or email OBG MANAGEMENT with a Letter to the Editor ([email protected]).]

The debate on the best route for hysterectomy continues: According to Dr. Carolyn Swenson and colleagues in their presentation, "Comparison of Robotic and Other Minimally Invasive Routes of Hysterectomy for Benign Indications," while there may be lower complications associated with robotic hysterectomy, the cost of performing a robotic hysterectomy is significantly higher than the cost of laparoscopic or vaginal hysterectomy, thus limiting its utility.

How can we teach a rare surgical procedure to learners? We channel our inner Martha Stewart and make a model out of a beef tongue and chicken. For about $8 a challenging and rare surgery can be taught to residents and medical students, according to the video presentation by Dr. Jana Illston and colleagues, titled "Modified Beef Tongue Model for Fourth-Degree Laceration Repair Simulation."

After the Day 2 lunch break, there was a rousing debate surrounding "Surgeons as Innovators—What Is the Patient Expecting?" Where do we draw the line between using an older more proven therapy as opposed to trying an innovative technology that may actually offer a potential benefit? Dr. Dennis Miller made a good point regarding innovation and pharmaceutical and device companies: If we ignore industry, we lose the ability to help with innovation and shape the future of medical treatments. Perhaps we should use the golden rule: If we would perform the surgery or use the device on ourselves, then we should perform it on our patient. Patients have a greater burden now, because there are more treatment options that they must choose among. Our job as physicians is to educate our patients and to guide them to innovative and evidence-based treatments.

Highlights from the afternoon oral poster session included a presentation by Dr. Caryn Russman that noted the high risk for recurrent urinary tract infection (UTI) after a mid-urethral sling procedure, which seems to be related to specific preoperative risk factors (such as a history of recurrent UTI). Dr. Tanya Hoke suggested that residents and attending physicians have inaccurate estimates of uterine weight, and an educational program may be necessary to improve these estimates. Finally, a study from Massachusetts General Hospital showed that a shorter stay in the hospital, ideally same-day surgery, resulted in a lower complication risk, lower number of emergency department visits, and a decreased readmission rate for patients undergoing urogynecology procedures.

 

 

The following recommendations were then suggested regarding vaginal hysterectomy:

 

  • Preoperative prep with 4% chlorhexidine or povidine iodine
  • Intracervical vasopressin injection to decrease blood loss
  • Use of a pedicle-sealing device for pedicle ligation
  • Vertical cuff closure is preferred to maximize vaginal length

Another important point made was that a prior cesarean delivery is not a contraindication to performing a vaginal hysterectomy.

Recommendations regarding recurrent UTI were also made, which include the recommendation for preoperative use of antibiotics to decrease the rate of UTI, with no benefit for a longer course of antibiotics.

News from the Fellows’ Pelvic Research Network

So much exciting research currently is ongoing with the FPRN! New project ideas include comparison of trimethoprim with methenamie for treatment of recurrent UTI; comparison of laparoscopic/robotic sacrocolpopexy with vaginal USLS for management of apical prolapse; a survey study examining surgeon preferences for timing of midurethral sling placement when performed at the time of pelvic organ prolapse (POP) repair; an assessment of the effect of a midurethal sling on overactive bladder in surgical repair in POP; and a study evaluating female pelvic reconstructive surgery in the setting of human immunodeficiency virus infection. It is so great to see the fellows working together to provide groundbreaking research!

Fun with stats

Learning statistics at the end of the day is never easy, but Dr. Matthew Barber did a fabulous job explaining this often-confusing topic. He reminded attendees that the key to learning statistics is repetition. One new recommendation he offered to enhance understanding is to use common language instead of numbers for P values. For example, instead of saying P <.001, use “is superior,” and instead of saying P = .3, use “seems not superior” or “inconclusive.”

A night to remember

The night ended with a wonderful awards ceremony and the president’s reception. Overall, day 2 was a very educational—and fun—day!

 

 

4/10/16. DAY 1 AT SGS

Postgrad courses address pain management and social media education

Mastering pelvic pain

With the beautiful Palm Springs, California, backdrop of mountains and palm trees, the 2016 meeting of the Society of Gynecologic Surgeons kicked off with 4 postgraduate courses. At the “Mastering Pelvic Pain: Strategies and Techniques for a Multimodal Approach” course, directed by Dr. Cara King, Dr. Matt Siedhoff explained the key components of the history and physical examination: Keep in mind that this generally is a multifactorial issue and may require a multidisciplinary approach, he told attendees. It is also important to make sure that the patient is fully prepared to combat the chronic pelvic pain (CPP) symptoms by focusing on the fundamentals, he said, including smoking, diet, exercise, weight loss, sleep, and relationship stress.

How is your posture? It turns out that something as simple as altering your posture can significantly affect pelvic floor control. Carol Sobeck, PT, demonstrated this importance with a simple group exercise that proved how the ability to contract the pelvic floor changes significantly with posture. Get to know your pelvic floor physical therapist—they are critical in helping with the treatment of CPP.

But what to do when physical therapy fails? Dr. Jennifer Gunter shed some light on this very difficult medical situation. One suggestion, she said, is to consider the possibility of a local presentation of a systemic issue and screen for the following: fibromyalgia, Ehlers-Danlos syndrome, statin use, and diabetes mellitus. Other treatment ideas include trigger point injections and onabotulinumtoxin A (Botox) therapy. A trigger point is a hypercontracted focus of muscle. To treat a trigger point, a needle must mechanically disrupt the trigger point to reduce the pelvic pain, and injection of local anesthetic is only used to help with postprocedure discomfort. Botox in my pelvis, you ask? Yes! The goal is to block presynaptic release of acetylcholine, which is very effective at reducing muscle spasm. 

Tackling endometriosis. Dr. King then described surgical techniques for endometriosis. She recommended that, for mild disease not in close proximity to vital structures, ablation is likely equivalent to excision. For deeply infiltrating endometriosis, or lesions in close proximity to vital structures, excision is more beneficial. Excision is always beneficial for pathologic diagnosis, she said. And she offered this tip for bladder endometriosis: place a stitch in the nodule to allow for counter traction. Here is another tip, for ovarian cystectomy: inject vasopressin (20 U in 60 mL) to help dissect the plane between the ovary and cyst wall, and consider presacral neurectomy for midline pain.

Dr. Frank Tu then explained that we should not think of it as the “terrible triad: endometriosis, irritable bowel syndrome, and interstitial cystsis,” but rather as a system out of balance. Both peripheral and central mechanisms are involved in the generation and maintenance of cross-organ sensitization, he pointed out, which may explain why patients receive multiple diagnoses that describe a myriad of complaints due to a lack of overall homeostasis.

 

 

While Dr. Alaa Abd-Elsayed described innovative nerve blocks for CPP, he emphasized that no one specific treatment will result in a complete resolution of symptoms.

Vaginal mesh placement and pain. Dr. Mario Castellanos gave a fabulous lecture describing the pain issues that surround vaginal mesh placement. Interestingly, he noted that many patients had pelvic pain prior to placement of vaginal mesh, and that pain likely only will worsen with mesh placement. Mesh may cause pain by causing inflammation, visceral injury, muscle injury, and nerve injury. While there are guidelines for where mesh should be placed for bladder slings (TVT and TOT) and for prolapse repair, studies show, he pointed out, that the mesh placement often disrupts several muscle groups and may directly injure a nerve.

Alternatives to the typical diagnoses for CPP. The morning ended with a lecture by Dr. Suzie As-Sanie, in which she reminded everyone to start with “gold standard” therapy but, if those fail, consider alternative diagnoses or a central pain disorder. She also suggested cognitive behavioral therapy for treatment of CPP. For patients who cannot afford cognitive behavioral therapy, there is a free online source at fibroguide.med.umich.edu. Other alternative treatment options include exercise, patient education, instruction on sleep hygiene, and neurostimulatory therapies.

Overall, all the speakers this morning agreed that CPP is rarely treated with one modality, and it is best treated with a multidisciplinary approach.

 

Let’s get social!

The afternoon was spent learning about ways to use social networking sites to educate our patients, in another postgraduate course on “Making Media Social,” presented by the SGS Social Media Committee. Given that a recent survey demonstrated that 74.1% of women have some type of social networking account, it can be a very useful source for medical information for patients. If you have any questions about what is appropriate on social media, check out ACOG committee opinion 622.

Here are some tips that I learned:

Facebook:

 

  • Keep your private Facebook page private and create a separate professional Facebook page
  • Adjust your login setting so only administrators can post on your professional page
  • Adjust settings so your professional profile cannot be “tagged”
  • If a patient contacts your personal page, direct them to your professional page
  • Do not give medical advice since Facebook is not digitally encrypted

Twitter:

 

  • “Short bursts of inconsequential information”
  • Follow societies, medical centers, and medical journals

LinkedIn:

 

  • It provides a great way to find jobs, people, and business opportunities that are recommended by someone in your contact group
  • It is specifically there to help you grow your business and show people who you are and where you have come from

Doximity:
Before we get to tips, first, what is it? Well, Doximity is basically a “LinkedIn” for physicians. It is “a way to find relevant specialists for patients; a rolodex; an email and text service; and a virtual lounge.” It is currently transforming from social network into a ‘platform.’ Now more than 1,000 hospitals and health systems are part of Doximity. Tips:

 

  • There is a secure message option, which is HIPAA compliant
  • Provides a way for residents and fellows to understand possible future places of employment
  • It is a great way to find someone to refer patients to in an unfamiliar location

Vimeo:

 

  • A benefit over YouTube is the lack of advertisements
  • Check out the SGS video archives!
  • You also can set privacy settings and embedding stats

Fifty-nine percent of US adults have looked online for health information in the past year. Therefore, it is important for physicians to get good information out for people to see!

A relaxing day’s end

The night ended with a beautiful poolside reception! I can’t wait to see what day 2 will bring!

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Gretchen Collins, MD
Fellow, Reproductive Endocrinology
Departments of Obstetrics and Gynecology and REI
University Hospitals Case Medical Center
Cleveland, Ohio

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4/13/16. DAY 4 AT SGS

 

A jam-packed day of sessions, posters, awards, and clinical updates

Our last educational day was kicked off by a fascinating lecture by Dr. Amy Park on the “Genetic Determinants of Pelvic Organ Prolapse in Women of European American Descent: The Women’s Health Initiative.” Dr. Park and her colleagues found that there is evidence of phenotypic and genotypic heterogeneity in patients with pelvic organ prolapse, and there were 4 genetic loci identified that correlated with prolapse. Any uterine prolapse was associated with a genome-wide significant intergenic variant on chromosome 13, cystocele was associated with LOXL2, and all prolapse was associated with BMP.

Surmounting surgical site infection

Dr. Sarah Andiman then gave a lecture on the effects of a perioperative bundle and offered timely feedback for surgical site infection (SSI) prevention in hysterectomy. We all know that wound infections are a major morbidity associated with surgery, and Dr. Andiman’s group at Yale found that, by implementing this prevention program, the surgical site infection decreased 52.8%. Another suggestion from the audience was to have all patients use chlorhexidine wipes the night before and morning of a surgery to decrease wound infection. Similarly, Dr. Ali Bazzi gave a lecture on “Chlorhexidine-Alcohol Compared with Povidone-Iodine for Surgical-Site Antisepsis after Abdominal Hysterectomy.” The chlorhexidine was associated with 30% lower odds of SSI compared with povidone-iodine, even though this group had several medical comorbidities and risk factors known for SSIs.

Oral poster presenters make several interesting points

Dr. Christopher Ripperda from UT Southwestern Medical Center in Dallas, Texas, found that medical comorbidities and the presence of detrusor overactivity and PVR are predictors of early postoperative voiding dysfunction following a midurethral sling placement. Dr. Nabila Noor then described a fabulous surgical alternative to the use of morcellation to remove the uterus after a supracervical hysterectomy. She described the technique for performing a posterior colpotomy and stated that patients who had a surgery performed at her institution using this technique did not experience increased postoperative pain or longer postoperative stay.

Dr. Jennifer Thompson then shed some light on a very important question related to the Sunshine Act: Are physicians including all of their disclosures when they submit articles to a conference? When the physicians who submitted an abstract to the Society of Gynecologic Surgeons (SGS) in 2015 were searched on the Centers for Medicare and Medicaid Services (CMS) website, 62% of them had incomplete disclosures, with a total of nondisclosed CMS transactions equaling $1.3 million. We can do better!

Status update: The FPRN and passing of the torch

Congratulations to Dr. Kristin Jacobs, the new Fellows’ Pelvic Research Network (FPRN) Chair! The morning session ended with an innovative video from Dr. Janet Li and colleagues on the “Use of Suprapubic Carter-Thomason Needle to Assist in Cystoscopic Excision of Intravesical Foreign Object.”

The winner of the Distinguished Surgeon Award was given to Dr. Javier Magrina, and the SGS gavel was passed on to Dr. Vivian Sung! Congratulations!

Dr. Stephanie Pickett kicked off the eighth scientific session with a study entitled, “Comparing Methods of NSAID Delivery for Postoperative Pain.” When she and her colleagues compared IV toradol to IV ibuprofen for postoperative pain control after urogynecologic surgery, they found that patients experienced similar rates of pain control and satisfaction regardless of the type of analgesia.

Why are patients being readmitted after gynecologic oncology surgery?

The answer to this question is important as readmission rates are being considered for physician and hospital reimbursement. Dr. MaryAnn Wilbur and colleagues looked at the rates of unplanned 30-day readmission in gyn oncology patients. The patients who were readmitted had the following characteristics: ovarian cancer, creation of ostomy, Charleston score >5, language barrier, and positive discharge screen. Gastrointestinal disturbance and SSI were the most common reasons for readmission, and the total readmission-related costs for these patients was about $4.5 million.

Considering tissue extraction, surgical complications, and cognitive impairment

We then had 3 fabulous oral poster presentations. Dr. Emily Von Bargen and colleagues presented a study entitled, “Prevalence of Occult Pre-malignant or Malignant Pathology at the time of Uterine Morcellation for Benign Disease.” They performed a multicenter retrospective cohort study and found that 1.2% of women had a premalignant or malignant uterine pathology after surgery, with a prevalence of 0.66% of occult malignancy. She was unable to identify risk factors for those patients who had a premalignant or malignant pathology. Overall she found a low prevalence of premalignant or malignant uterine pathology when uterine morcellation was performed for benign disease.

 

 

Dr. Alix Leader-Cramer from Northwestern University pointed out “risk factors for a 30-day perioperative complications for total vaginal hysterectomy,” including chronic steroid use, higher ASA classification, current smoking status, diabetes, and lower preoperative serum albumin and sodium levels. Adnexectomy and resident participation were also associated with increased perioperative complications. About 9.5% of patients had a perioperative complication in the study population studied.

Finally, Dr. Elisa Trowbridge pointed out in her talk, on “Cognitive Impairment among Elderly Urogynecologic Patients,” that cognitive impairment is very prevalent among such women aged older than 75 years, and the Mini-Cog is a feasible screening tool.

What a way to end an AMAZING conference!

The conference ended with a fabulous video presentation by Dr. Andrea Benton, entitled “Surgical Approaches to the Management of Bladder and Ureteral Endometriosis.” Overall, the themes of this year’s SGS conference were to:

 

  • emphasize the importance of performing a vaginal hysterectomy when feasible
  • continue to strive to balance innovation with experimentation
  • ensure that patients are being operated on by surgeons who are competent and frequently performing the indicated procedure.

Thank you to everyone who shared their research to educate the attendees at the conference! I can’t wait until next year!

 

 

4/12/16. DAY 3 AT SGS

Vaginal hysterectomy, fecal incontinence, transgender surgery amid tackled topics in Palm Springs

I could get used to sipping my coffee with the sunny background here in Palm Springs! It was a beautiful morning to learn.

We started the day with breakfast and a fabulous lecture on the inferior gluteal neurovascular anatomy in female cadavers, and an insightful lecture by Dr. Bhumy Dave, who brought up concerns about tracking for obstetrics and gynecology residency programs. She specifically highlighted the need for more experience with vaginal hysterectomies for residents who are going to be in a subspecialty that performs vaginal surgery. As the number of hysterectomies, specifically vaginal hysterectomies, declines every year, we need to make sure we are adequately training the physicians who will be performing this procedure in the future. One solution is to have residents join a track their 4th year of residency, after their future career path has been established. Another possible solution would be to increase use of a simulation model for vaginal hysterectomy, as described by Dr. Douglas Miyazaki.

Indigo carmine replacement? A recent issue in gynecologic surgery resulted when there was a national shortage of indigo carmine, which is commonly used to identify UO efflux at the time of cystoscopy. Dr. Katie Propst provided a solution: In the setting of planned cystoscopy, she found that preoperative phenazopyridine is an acceptable alternative and its use led to similar UO identification as with indigo carmine without an increase in complications.

Who should have a vaginal hysterectomy? Dr. Jennifer Schmitt from the Mayo Clinic gave another wonderful lecture describing a decision-tree algorithm for determining the ideal route of hysterectomy. According to a retrospective review of patients at their institution, vaginal hysterectomy was associated with lower infection rates, operative times, and costs.

The highlight of the morning was a very insightful Presidential Address by Dr. Andrew Walter! Not only is a he a very entertaining speaker but he also shed some light on 2 challenges that we currently face in the field. He eloquently stated that, “every woman who is a candidate for a vaginal hysterectomy should be able to get one and have it performed competently, and every woman who needs surgery should have one performed by someone who performs enough surgeries every year to competently perform the surgery.” He frequently alluded to the wise Dr. Mayo, who stated, “The best interest of the patient is the only interest to be considered…” Let’s never forget this as physicians!

Do you find removing the adnexa challenging when performing vaginal surgery? Check out the amazing idea from the Cleveland Clinic shown in video presentation 05! They clearly demonstrate using a single-site gel port or surgical glove placed in the vaginal incision to perform laparoscopy through the vagina. What a novel idea to avoid any abdominal incisions when there is a difficult vaginal adnexal surgery!

After the morning break, we watched a master vaginal surgeon perform a sacral colpopexy through the vaginal route. For details on this method, please reference video presentation 06.

An increase in health care costs is a huge problem in this country. Dr. Mary Van Meter suggested that one area in which we can improve is in the operating room (OR), specifically through decreasing the number of instruments sterilized. She found that only approximately 20% of the instruments on the operating field were actually used by the OR physician. It costs about $3 per instrument on the tray at Vanderbilt University, she said. When you think of the few number of instruments actually used, if we work to limit the number of instruments on the trays, we could cut significant costs. As reimbursement is getting increasingly linked to cost reduction, we all should be thinking about innovative ways to cut costs.

 

 

The oral posters were all excellent!

Dr. Ann Peters showed that, at a high-volume tertiary-care center, multimodal preoperative testing failed to definitively identify leiomyosarcoma (LMS), and the factors associated with increased LMS risk included older age, menopause, and presence of fibroids with concurrent pelvic, uterine, or adnexal mass.

Dr. Kevin Kremer found that preoperative antibiotics were used in 23% of cases in which they were not indicated, and the increased use rate was associated with entrance into the abdomen during surgery, the individual surgeon, and time under anesthesia.

Dr. Jessica Heft then stated that the incontinence rate after midurethral sling revision for vaginal exposure or pain was significantly higher with a partial as opposed to complete mesh excision.

Fecal incontinence treatment options

Dr. Peter Rosenblatt tackled the issue of “Innovation or experimentation: Where do we draw the line?” in the TeLinde lecture. He started by describing a condition for which he feels we do not have an acceptable amount of treatment options for patients: fecal incontinence. He described how he observed that the puborectalis muscle, not the external anal sphincter, was critical for fecal continence. He then devised a surgery that created a sling that would act as a synthetic puborectalis muscle. He had amazing success until one patient had a serious complication. Should you abandon a successful, innovative surgery due to one very severe complication, was the question. Where do we draw the line? I don’t have an answer…but I do know that we all need to thank our puborectalis muscle for our daily fecal continence!

This is not a new issue in medicine, explained Dr. Rosenblatt. From the beginning of medicine, there has been a balance between innovation and experimentation. So, what is innovation? It is when someone improves upon a device or process. In medicine, is it innovation or just variation? We frequently use medications and devices “off label,” and these techniques often improve our surgeries and outcomes for our patients. Innovation comes about through careful planning, a necessity created by an emergency, advances in technology, and through evolution of a procedure. Who are the innovators? YOU are! We are the ones who understand the unmet needs and the potential opportunities for improving medicine. Let’s all work together to innovate NOT experiment and make medicine better so our patients have the best care possible!

“New Frontiers in Gynecologic Surgery: Transgender Surgery and Functional Clitoroplasty after Female Genital Mutilation”

The final talk for the day was by the groundbreaking Dr. Marci Bowers, whose lecture started by reminding everyone that there is a difference between gender identity and gender expression. Once a person knows his or her gender identity they use gender expression to express this to the world, she pointed out. Dr. Bowers is a true innovator and is performing gender reassignment surgeries as well as female genital mutilation corrective surgeries. She has perfected a one-stage vaginoplasty, and she showed a video of the procedure, which results in a 90% chance of orgasm. She also noted that she is able to restore clitoral function in 100% of the cases of genital mutilation, and she performs these procedures free of charge.

She reminded us that all ObGyns need to be trained in treating transgender patients, and given the high rate of suicide among adolescent transgender individuals, we all need to work together to provide a supportive medical environment to help these patients. What a fascinating end to the day!

Some relaxation, and entertainment, amid the sun and outdoors

We then had the afternoon to compete in a golf tournament, explore the area on mountain bikes, or lounge by the pool. Regardless of the daytime activities, we all came back together for the great lip-synch competition! All 4 teams gave an impressive performance, but the team from Brown University went home with the win! Such an entertaining event! (Thanks to incoming SGS President Vivian Sung @wih_sung for the pic!)

 

 

4/11/16. DAY 2 AT SGS

Experts talk surgical innovations, complementary therapies, value-based payment, and much more at SGS day 2

Wake up and learn! The second day of the 42nd Annual Scientific Meeting of the Society of Gynecologic Surgeons began with a review of research posters at the Poster Session as the sun rose over the Palm Springs mountains. We then moved indoors for the scientific sessions.

In the first lecture, "Reasons for Unplanned 30-Day Readmission After Hysterectomy for Benign Disease," Dr. Courtney Penn and colleagues reiterated that the postsurgical readmission rate is higher for patients undergoing abdominal hysterectomy compared with those who have a laparoscopic or vaginal hysterectomy. Similarly, Dr. Jennifer Schmitt and colleagues suggested that in a patient with a relative contraindication for vaginal hysterectomy, when this procedure is performed by an experienced surgeon there may not be increased complications. However, keep in mind that the study described—"A Comparison of Vaginal and Robotic Hysterectomy for Commonly Cited Relative Contraindications to Vaginal Hysterectomy"—was performed at the Mayo Clinic by expert, highly trained surgeons, and this fact may limit the generalizability of the study. As one audience member eloquently stated, it is important to remember that: "Just because it is feasible does not mean it is the correct procedure."

 

 

That yoga or barre class may be doing more good than you think! Lunge, bridge, and cat-into-cow movements may provide a greater degree of pelvic floor muscle unit recruitment than traditional Kegel exercises, according to a presentation by Dr. Bruce Crawford on Kegels versus specialized movement.

Perhaps those exercises should be recommended for surgeons as well. As Dr. Ruchira Singh pointed out, surgeons experience a high amount of musculoskeletal strain when performing vaginal procedures while sitting, regardless of the type of chair used during surgery. Dr. Singh and colleagues’ study, "Effect of Different Chairs on Work-Related Musculoskeletal Discomfort During Vaginal Surgery," found that while the round stool with a backrest and the Capisco chair were more comfortable, they did not eliminate the high risk for musculoskeletal strain, particularly in the head and neck.

Dr. Ann Peters and colleagues, from Magee-Womens Hospital of the University of Pittsburgh Medical Center, gave a fabulous video presentation on "Anatomic and Vascular Considerations in Laparoscopic Uterine Artery Ligation During Hysterectomy."

Need a novel treatment for interstitial cystitis/bladder pain syndrome? Consider mindfulness-based stress reduction. A randomized controlled study performed by Dr. Gregg Kanter and colleagues describes how this technique may help patients and could be considered a first-line therapy.

What is value-based payment and this new trend in reimbursement? And how does it apply to vaginal hysterectomy? Dr. Tina Groat addressed these issues in her keynote lecture. According to the American Congress of Obstetricians and Gynecologists, “Evidence demonstrates that, in general, vaginal hysterectomy is associated with better outcomes and fewer complications than laparoscopic or abdominal hysterectomy.” This is in opposition to what is actually being performed clinically. Dr. Groat explained that United Healthcare decided to incentivize physicians by requiring a prior authorization for all hysterectomies for benign disease. There is both a quality and cost benefit to performing a vaginal hysterectomy. Most insurance companies are moving away from a “fee for service” structure to performance-based payment. Change is always scary and, while I think the overall goal of moving toward the best care for our patients is a positive, this approach may create new challenges for the medical field. What do you think? Is performance-based payment beneficial? Or does it limit physicians and potentially force them to perform a procedure they do not feel as comfortable performing? Will this result in physicians rejecting certain patient populations? [Note from OBG MANAGEMENT: Let Dr. Collins know your thoughts through social media, or email OBG MANAGEMENT with a Letter to the Editor ([email protected]).]

The debate on the best route for hysterectomy continues: According to Dr. Carolyn Swenson and colleagues in their presentation, "Comparison of Robotic and Other Minimally Invasive Routes of Hysterectomy for Benign Indications," while there may be lower complications associated with robotic hysterectomy, the cost of performing a robotic hysterectomy is significantly higher than the cost of laparoscopic or vaginal hysterectomy, thus limiting its utility.

How can we teach a rare surgical procedure to learners? We channel our inner Martha Stewart and make a model out of a beef tongue and chicken. For about $8 a challenging and rare surgery can be taught to residents and medical students, according to the video presentation by Dr. Jana Illston and colleagues, titled "Modified Beef Tongue Model for Fourth-Degree Laceration Repair Simulation."

After the Day 2 lunch break, there was a rousing debate surrounding "Surgeons as Innovators—What Is the Patient Expecting?" Where do we draw the line between using an older more proven therapy as opposed to trying an innovative technology that may actually offer a potential benefit? Dr. Dennis Miller made a good point regarding innovation and pharmaceutical and device companies: If we ignore industry, we lose the ability to help with innovation and shape the future of medical treatments. Perhaps we should use the golden rule: If we would perform the surgery or use the device on ourselves, then we should perform it on our patient. Patients have a greater burden now, because there are more treatment options that they must choose among. Our job as physicians is to educate our patients and to guide them to innovative and evidence-based treatments.

Highlights from the afternoon oral poster session included a presentation by Dr. Caryn Russman that noted the high risk for recurrent urinary tract infection (UTI) after a mid-urethral sling procedure, which seems to be related to specific preoperative risk factors (such as a history of recurrent UTI). Dr. Tanya Hoke suggested that residents and attending physicians have inaccurate estimates of uterine weight, and an educational program may be necessary to improve these estimates. Finally, a study from Massachusetts General Hospital showed that a shorter stay in the hospital, ideally same-day surgery, resulted in a lower complication risk, lower number of emergency department visits, and a decreased readmission rate for patients undergoing urogynecology procedures.

 

 

The following recommendations were then suggested regarding vaginal hysterectomy:

 

  • Preoperative prep with 4% chlorhexidine or povidine iodine
  • Intracervical vasopressin injection to decrease blood loss
  • Use of a pedicle-sealing device for pedicle ligation
  • Vertical cuff closure is preferred to maximize vaginal length

Another important point made was that a prior cesarean delivery is not a contraindication to performing a vaginal hysterectomy.

Recommendations regarding recurrent UTI were also made, which include the recommendation for preoperative use of antibiotics to decrease the rate of UTI, with no benefit for a longer course of antibiotics.

News from the Fellows’ Pelvic Research Network

So much exciting research currently is ongoing with the FPRN! New project ideas include comparison of trimethoprim with methenamie for treatment of recurrent UTI; comparison of laparoscopic/robotic sacrocolpopexy with vaginal USLS for management of apical prolapse; a survey study examining surgeon preferences for timing of midurethral sling placement when performed at the time of pelvic organ prolapse (POP) repair; an assessment of the effect of a midurethal sling on overactive bladder in surgical repair in POP; and a study evaluating female pelvic reconstructive surgery in the setting of human immunodeficiency virus infection. It is so great to see the fellows working together to provide groundbreaking research!

Fun with stats

Learning statistics at the end of the day is never easy, but Dr. Matthew Barber did a fabulous job explaining this often-confusing topic. He reminded attendees that the key to learning statistics is repetition. One new recommendation he offered to enhance understanding is to use common language instead of numbers for P values. For example, instead of saying P <.001, use “is superior,” and instead of saying P = .3, use “seems not superior” or “inconclusive.”

A night to remember

The night ended with a wonderful awards ceremony and the president’s reception. Overall, day 2 was a very educational—and fun—day!

 

 

4/10/16. DAY 1 AT SGS

Postgrad courses address pain management and social media education

Mastering pelvic pain

With the beautiful Palm Springs, California, backdrop of mountains and palm trees, the 2016 meeting of the Society of Gynecologic Surgeons kicked off with 4 postgraduate courses. At the “Mastering Pelvic Pain: Strategies and Techniques for a Multimodal Approach” course, directed by Dr. Cara King, Dr. Matt Siedhoff explained the key components of the history and physical examination: Keep in mind that this generally is a multifactorial issue and may require a multidisciplinary approach, he told attendees. It is also important to make sure that the patient is fully prepared to combat the chronic pelvic pain (CPP) symptoms by focusing on the fundamentals, he said, including smoking, diet, exercise, weight loss, sleep, and relationship stress.

How is your posture? It turns out that something as simple as altering your posture can significantly affect pelvic floor control. Carol Sobeck, PT, demonstrated this importance with a simple group exercise that proved how the ability to contract the pelvic floor changes significantly with posture. Get to know your pelvic floor physical therapist—they are critical in helping with the treatment of CPP.

But what to do when physical therapy fails? Dr. Jennifer Gunter shed some light on this very difficult medical situation. One suggestion, she said, is to consider the possibility of a local presentation of a systemic issue and screen for the following: fibromyalgia, Ehlers-Danlos syndrome, statin use, and diabetes mellitus. Other treatment ideas include trigger point injections and onabotulinumtoxin A (Botox) therapy. A trigger point is a hypercontracted focus of muscle. To treat a trigger point, a needle must mechanically disrupt the trigger point to reduce the pelvic pain, and injection of local anesthetic is only used to help with postprocedure discomfort. Botox in my pelvis, you ask? Yes! The goal is to block presynaptic release of acetylcholine, which is very effective at reducing muscle spasm. 

Tackling endometriosis. Dr. King then described surgical techniques for endometriosis. She recommended that, for mild disease not in close proximity to vital structures, ablation is likely equivalent to excision. For deeply infiltrating endometriosis, or lesions in close proximity to vital structures, excision is more beneficial. Excision is always beneficial for pathologic diagnosis, she said. And she offered this tip for bladder endometriosis: place a stitch in the nodule to allow for counter traction. Here is another tip, for ovarian cystectomy: inject vasopressin (20 U in 60 mL) to help dissect the plane between the ovary and cyst wall, and consider presacral neurectomy for midline pain.

Dr. Frank Tu then explained that we should not think of it as the “terrible triad: endometriosis, irritable bowel syndrome, and interstitial cystsis,” but rather as a system out of balance. Both peripheral and central mechanisms are involved in the generation and maintenance of cross-organ sensitization, he pointed out, which may explain why patients receive multiple diagnoses that describe a myriad of complaints due to a lack of overall homeostasis.

 

 

While Dr. Alaa Abd-Elsayed described innovative nerve blocks for CPP, he emphasized that no one specific treatment will result in a complete resolution of symptoms.

Vaginal mesh placement and pain. Dr. Mario Castellanos gave a fabulous lecture describing the pain issues that surround vaginal mesh placement. Interestingly, he noted that many patients had pelvic pain prior to placement of vaginal mesh, and that pain likely only will worsen with mesh placement. Mesh may cause pain by causing inflammation, visceral injury, muscle injury, and nerve injury. While there are guidelines for where mesh should be placed for bladder slings (TVT and TOT) and for prolapse repair, studies show, he pointed out, that the mesh placement often disrupts several muscle groups and may directly injure a nerve.

Alternatives to the typical diagnoses for CPP. The morning ended with a lecture by Dr. Suzie As-Sanie, in which she reminded everyone to start with “gold standard” therapy but, if those fail, consider alternative diagnoses or a central pain disorder. She also suggested cognitive behavioral therapy for treatment of CPP. For patients who cannot afford cognitive behavioral therapy, there is a free online source at fibroguide.med.umich.edu. Other alternative treatment options include exercise, patient education, instruction on sleep hygiene, and neurostimulatory therapies.

Overall, all the speakers this morning agreed that CPP is rarely treated with one modality, and it is best treated with a multidisciplinary approach.

 

Let’s get social!

The afternoon was spent learning about ways to use social networking sites to educate our patients, in another postgraduate course on “Making Media Social,” presented by the SGS Social Media Committee. Given that a recent survey demonstrated that 74.1% of women have some type of social networking account, it can be a very useful source for medical information for patients. If you have any questions about what is appropriate on social media, check out ACOG committee opinion 622.

Here are some tips that I learned:

Facebook:

 

  • Keep your private Facebook page private and create a separate professional Facebook page
  • Adjust your login setting so only administrators can post on your professional page
  • Adjust settings so your professional profile cannot be “tagged”
  • If a patient contacts your personal page, direct them to your professional page
  • Do not give medical advice since Facebook is not digitally encrypted

Twitter:

 

  • “Short bursts of inconsequential information”
  • Follow societies, medical centers, and medical journals

LinkedIn:

 

  • It provides a great way to find jobs, people, and business opportunities that are recommended by someone in your contact group
  • It is specifically there to help you grow your business and show people who you are and where you have come from

Doximity:
Before we get to tips, first, what is it? Well, Doximity is basically a “LinkedIn” for physicians. It is “a way to find relevant specialists for patients; a rolodex; an email and text service; and a virtual lounge.” It is currently transforming from social network into a ‘platform.’ Now more than 1,000 hospitals and health systems are part of Doximity. Tips:

 

  • There is a secure message option, which is HIPAA compliant
  • Provides a way for residents and fellows to understand possible future places of employment
  • It is a great way to find someone to refer patients to in an unfamiliar location

Vimeo:

 

  • A benefit over YouTube is the lack of advertisements
  • Check out the SGS video archives!
  • You also can set privacy settings and embedding stats

Fifty-nine percent of US adults have looked online for health information in the past year. Therefore, it is important for physicians to get good information out for people to see!

A relaxing day’s end

The night ended with a beautiful poolside reception! I can’t wait to see what day 2 will bring!

4/13/16. DAY 4 AT SGS

 

A jam-packed day of sessions, posters, awards, and clinical updates

Our last educational day was kicked off by a fascinating lecture by Dr. Amy Park on the “Genetic Determinants of Pelvic Organ Prolapse in Women of European American Descent: The Women’s Health Initiative.” Dr. Park and her colleagues found that there is evidence of phenotypic and genotypic heterogeneity in patients with pelvic organ prolapse, and there were 4 genetic loci identified that correlated with prolapse. Any uterine prolapse was associated with a genome-wide significant intergenic variant on chromosome 13, cystocele was associated with LOXL2, and all prolapse was associated with BMP.

Surmounting surgical site infection

Dr. Sarah Andiman then gave a lecture on the effects of a perioperative bundle and offered timely feedback for surgical site infection (SSI) prevention in hysterectomy. We all know that wound infections are a major morbidity associated with surgery, and Dr. Andiman’s group at Yale found that, by implementing this prevention program, the surgical site infection decreased 52.8%. Another suggestion from the audience was to have all patients use chlorhexidine wipes the night before and morning of a surgery to decrease wound infection. Similarly, Dr. Ali Bazzi gave a lecture on “Chlorhexidine-Alcohol Compared with Povidone-Iodine for Surgical-Site Antisepsis after Abdominal Hysterectomy.” The chlorhexidine was associated with 30% lower odds of SSI compared with povidone-iodine, even though this group had several medical comorbidities and risk factors known for SSIs.

Oral poster presenters make several interesting points

Dr. Christopher Ripperda from UT Southwestern Medical Center in Dallas, Texas, found that medical comorbidities and the presence of detrusor overactivity and PVR are predictors of early postoperative voiding dysfunction following a midurethral sling placement. Dr. Nabila Noor then described a fabulous surgical alternative to the use of morcellation to remove the uterus after a supracervical hysterectomy. She described the technique for performing a posterior colpotomy and stated that patients who had a surgery performed at her institution using this technique did not experience increased postoperative pain or longer postoperative stay.

Dr. Jennifer Thompson then shed some light on a very important question related to the Sunshine Act: Are physicians including all of their disclosures when they submit articles to a conference? When the physicians who submitted an abstract to the Society of Gynecologic Surgeons (SGS) in 2015 were searched on the Centers for Medicare and Medicaid Services (CMS) website, 62% of them had incomplete disclosures, with a total of nondisclosed CMS transactions equaling $1.3 million. We can do better!

Status update: The FPRN and passing of the torch

Congratulations to Dr. Kristin Jacobs, the new Fellows’ Pelvic Research Network (FPRN) Chair! The morning session ended with an innovative video from Dr. Janet Li and colleagues on the “Use of Suprapubic Carter-Thomason Needle to Assist in Cystoscopic Excision of Intravesical Foreign Object.”

The winner of the Distinguished Surgeon Award was given to Dr. Javier Magrina, and the SGS gavel was passed on to Dr. Vivian Sung! Congratulations!

Dr. Stephanie Pickett kicked off the eighth scientific session with a study entitled, “Comparing Methods of NSAID Delivery for Postoperative Pain.” When she and her colleagues compared IV toradol to IV ibuprofen for postoperative pain control after urogynecologic surgery, they found that patients experienced similar rates of pain control and satisfaction regardless of the type of analgesia.

Why are patients being readmitted after gynecologic oncology surgery?

The answer to this question is important as readmission rates are being considered for physician and hospital reimbursement. Dr. MaryAnn Wilbur and colleagues looked at the rates of unplanned 30-day readmission in gyn oncology patients. The patients who were readmitted had the following characteristics: ovarian cancer, creation of ostomy, Charleston score >5, language barrier, and positive discharge screen. Gastrointestinal disturbance and SSI were the most common reasons for readmission, and the total readmission-related costs for these patients was about $4.5 million.

Considering tissue extraction, surgical complications, and cognitive impairment

We then had 3 fabulous oral poster presentations. Dr. Emily Von Bargen and colleagues presented a study entitled, “Prevalence of Occult Pre-malignant or Malignant Pathology at the time of Uterine Morcellation for Benign Disease.” They performed a multicenter retrospective cohort study and found that 1.2% of women had a premalignant or malignant uterine pathology after surgery, with a prevalence of 0.66% of occult malignancy. She was unable to identify risk factors for those patients who had a premalignant or malignant pathology. Overall she found a low prevalence of premalignant or malignant uterine pathology when uterine morcellation was performed for benign disease.

 

 

Dr. Alix Leader-Cramer from Northwestern University pointed out “risk factors for a 30-day perioperative complications for total vaginal hysterectomy,” including chronic steroid use, higher ASA classification, current smoking status, diabetes, and lower preoperative serum albumin and sodium levels. Adnexectomy and resident participation were also associated with increased perioperative complications. About 9.5% of patients had a perioperative complication in the study population studied.

Finally, Dr. Elisa Trowbridge pointed out in her talk, on “Cognitive Impairment among Elderly Urogynecologic Patients,” that cognitive impairment is very prevalent among such women aged older than 75 years, and the Mini-Cog is a feasible screening tool.

What a way to end an AMAZING conference!

The conference ended with a fabulous video presentation by Dr. Andrea Benton, entitled “Surgical Approaches to the Management of Bladder and Ureteral Endometriosis.” Overall, the themes of this year’s SGS conference were to:

 

  • emphasize the importance of performing a vaginal hysterectomy when feasible
  • continue to strive to balance innovation with experimentation
  • ensure that patients are being operated on by surgeons who are competent and frequently performing the indicated procedure.

Thank you to everyone who shared their research to educate the attendees at the conference! I can’t wait until next year!

 

 

4/12/16. DAY 3 AT SGS

Vaginal hysterectomy, fecal incontinence, transgender surgery amid tackled topics in Palm Springs

I could get used to sipping my coffee with the sunny background here in Palm Springs! It was a beautiful morning to learn.

We started the day with breakfast and a fabulous lecture on the inferior gluteal neurovascular anatomy in female cadavers, and an insightful lecture by Dr. Bhumy Dave, who brought up concerns about tracking for obstetrics and gynecology residency programs. She specifically highlighted the need for more experience with vaginal hysterectomies for residents who are going to be in a subspecialty that performs vaginal surgery. As the number of hysterectomies, specifically vaginal hysterectomies, declines every year, we need to make sure we are adequately training the physicians who will be performing this procedure in the future. One solution is to have residents join a track their 4th year of residency, after their future career path has been established. Another possible solution would be to increase use of a simulation model for vaginal hysterectomy, as described by Dr. Douglas Miyazaki.

Indigo carmine replacement? A recent issue in gynecologic surgery resulted when there was a national shortage of indigo carmine, which is commonly used to identify UO efflux at the time of cystoscopy. Dr. Katie Propst provided a solution: In the setting of planned cystoscopy, she found that preoperative phenazopyridine is an acceptable alternative and its use led to similar UO identification as with indigo carmine without an increase in complications.

Who should have a vaginal hysterectomy? Dr. Jennifer Schmitt from the Mayo Clinic gave another wonderful lecture describing a decision-tree algorithm for determining the ideal route of hysterectomy. According to a retrospective review of patients at their institution, vaginal hysterectomy was associated with lower infection rates, operative times, and costs.

The highlight of the morning was a very insightful Presidential Address by Dr. Andrew Walter! Not only is a he a very entertaining speaker but he also shed some light on 2 challenges that we currently face in the field. He eloquently stated that, “every woman who is a candidate for a vaginal hysterectomy should be able to get one and have it performed competently, and every woman who needs surgery should have one performed by someone who performs enough surgeries every year to competently perform the surgery.” He frequently alluded to the wise Dr. Mayo, who stated, “The best interest of the patient is the only interest to be considered…” Let’s never forget this as physicians!

Do you find removing the adnexa challenging when performing vaginal surgery? Check out the amazing idea from the Cleveland Clinic shown in video presentation 05! They clearly demonstrate using a single-site gel port or surgical glove placed in the vaginal incision to perform laparoscopy through the vagina. What a novel idea to avoid any abdominal incisions when there is a difficult vaginal adnexal surgery!

After the morning break, we watched a master vaginal surgeon perform a sacral colpopexy through the vaginal route. For details on this method, please reference video presentation 06.

An increase in health care costs is a huge problem in this country. Dr. Mary Van Meter suggested that one area in which we can improve is in the operating room (OR), specifically through decreasing the number of instruments sterilized. She found that only approximately 20% of the instruments on the operating field were actually used by the OR physician. It costs about $3 per instrument on the tray at Vanderbilt University, she said. When you think of the few number of instruments actually used, if we work to limit the number of instruments on the trays, we could cut significant costs. As reimbursement is getting increasingly linked to cost reduction, we all should be thinking about innovative ways to cut costs.

 

 

The oral posters were all excellent!

Dr. Ann Peters showed that, at a high-volume tertiary-care center, multimodal preoperative testing failed to definitively identify leiomyosarcoma (LMS), and the factors associated with increased LMS risk included older age, menopause, and presence of fibroids with concurrent pelvic, uterine, or adnexal mass.

Dr. Kevin Kremer found that preoperative antibiotics were used in 23% of cases in which they were not indicated, and the increased use rate was associated with entrance into the abdomen during surgery, the individual surgeon, and time under anesthesia.

Dr. Jessica Heft then stated that the incontinence rate after midurethral sling revision for vaginal exposure or pain was significantly higher with a partial as opposed to complete mesh excision.

Fecal incontinence treatment options

Dr. Peter Rosenblatt tackled the issue of “Innovation or experimentation: Where do we draw the line?” in the TeLinde lecture. He started by describing a condition for which he feels we do not have an acceptable amount of treatment options for patients: fecal incontinence. He described how he observed that the puborectalis muscle, not the external anal sphincter, was critical for fecal continence. He then devised a surgery that created a sling that would act as a synthetic puborectalis muscle. He had amazing success until one patient had a serious complication. Should you abandon a successful, innovative surgery due to one very severe complication, was the question. Where do we draw the line? I don’t have an answer…but I do know that we all need to thank our puborectalis muscle for our daily fecal continence!

This is not a new issue in medicine, explained Dr. Rosenblatt. From the beginning of medicine, there has been a balance between innovation and experimentation. So, what is innovation? It is when someone improves upon a device or process. In medicine, is it innovation or just variation? We frequently use medications and devices “off label,” and these techniques often improve our surgeries and outcomes for our patients. Innovation comes about through careful planning, a necessity created by an emergency, advances in technology, and through evolution of a procedure. Who are the innovators? YOU are! We are the ones who understand the unmet needs and the potential opportunities for improving medicine. Let’s all work together to innovate NOT experiment and make medicine better so our patients have the best care possible!

“New Frontiers in Gynecologic Surgery: Transgender Surgery and Functional Clitoroplasty after Female Genital Mutilation”

The final talk for the day was by the groundbreaking Dr. Marci Bowers, whose lecture started by reminding everyone that there is a difference between gender identity and gender expression. Once a person knows his or her gender identity they use gender expression to express this to the world, she pointed out. Dr. Bowers is a true innovator and is performing gender reassignment surgeries as well as female genital mutilation corrective surgeries. She has perfected a one-stage vaginoplasty, and she showed a video of the procedure, which results in a 90% chance of orgasm. She also noted that she is able to restore clitoral function in 100% of the cases of genital mutilation, and she performs these procedures free of charge.

She reminded us that all ObGyns need to be trained in treating transgender patients, and given the high rate of suicide among adolescent transgender individuals, we all need to work together to provide a supportive medical environment to help these patients. What a fascinating end to the day!

Some relaxation, and entertainment, amid the sun and outdoors

We then had the afternoon to compete in a golf tournament, explore the area on mountain bikes, or lounge by the pool. Regardless of the daytime activities, we all came back together for the great lip-synch competition! All 4 teams gave an impressive performance, but the team from Brown University went home with the win! Such an entertaining event! (Thanks to incoming SGS President Vivian Sung @wih_sung for the pic!)

 

 

4/11/16. DAY 2 AT SGS

Experts talk surgical innovations, complementary therapies, value-based payment, and much more at SGS day 2

Wake up and learn! The second day of the 42nd Annual Scientific Meeting of the Society of Gynecologic Surgeons began with a review of research posters at the Poster Session as the sun rose over the Palm Springs mountains. We then moved indoors for the scientific sessions.

In the first lecture, "Reasons for Unplanned 30-Day Readmission After Hysterectomy for Benign Disease," Dr. Courtney Penn and colleagues reiterated that the postsurgical readmission rate is higher for patients undergoing abdominal hysterectomy compared with those who have a laparoscopic or vaginal hysterectomy. Similarly, Dr. Jennifer Schmitt and colleagues suggested that in a patient with a relative contraindication for vaginal hysterectomy, when this procedure is performed by an experienced surgeon there may not be increased complications. However, keep in mind that the study described—"A Comparison of Vaginal and Robotic Hysterectomy for Commonly Cited Relative Contraindications to Vaginal Hysterectomy"—was performed at the Mayo Clinic by expert, highly trained surgeons, and this fact may limit the generalizability of the study. As one audience member eloquently stated, it is important to remember that: "Just because it is feasible does not mean it is the correct procedure."

 

 

That yoga or barre class may be doing more good than you think! Lunge, bridge, and cat-into-cow movements may provide a greater degree of pelvic floor muscle unit recruitment than traditional Kegel exercises, according to a presentation by Dr. Bruce Crawford on Kegels versus specialized movement.

Perhaps those exercises should be recommended for surgeons as well. As Dr. Ruchira Singh pointed out, surgeons experience a high amount of musculoskeletal strain when performing vaginal procedures while sitting, regardless of the type of chair used during surgery. Dr. Singh and colleagues’ study, "Effect of Different Chairs on Work-Related Musculoskeletal Discomfort During Vaginal Surgery," found that while the round stool with a backrest and the Capisco chair were more comfortable, they did not eliminate the high risk for musculoskeletal strain, particularly in the head and neck.

Dr. Ann Peters and colleagues, from Magee-Womens Hospital of the University of Pittsburgh Medical Center, gave a fabulous video presentation on "Anatomic and Vascular Considerations in Laparoscopic Uterine Artery Ligation During Hysterectomy."

Need a novel treatment for interstitial cystitis/bladder pain syndrome? Consider mindfulness-based stress reduction. A randomized controlled study performed by Dr. Gregg Kanter and colleagues describes how this technique may help patients and could be considered a first-line therapy.

What is value-based payment and this new trend in reimbursement? And how does it apply to vaginal hysterectomy? Dr. Tina Groat addressed these issues in her keynote lecture. According to the American Congress of Obstetricians and Gynecologists, “Evidence demonstrates that, in general, vaginal hysterectomy is associated with better outcomes and fewer complications than laparoscopic or abdominal hysterectomy.” This is in opposition to what is actually being performed clinically. Dr. Groat explained that United Healthcare decided to incentivize physicians by requiring a prior authorization for all hysterectomies for benign disease. There is both a quality and cost benefit to performing a vaginal hysterectomy. Most insurance companies are moving away from a “fee for service” structure to performance-based payment. Change is always scary and, while I think the overall goal of moving toward the best care for our patients is a positive, this approach may create new challenges for the medical field. What do you think? Is performance-based payment beneficial? Or does it limit physicians and potentially force them to perform a procedure they do not feel as comfortable performing? Will this result in physicians rejecting certain patient populations? [Note from OBG MANAGEMENT: Let Dr. Collins know your thoughts through social media, or email OBG MANAGEMENT with a Letter to the Editor ([email protected]).]

The debate on the best route for hysterectomy continues: According to Dr. Carolyn Swenson and colleagues in their presentation, "Comparison of Robotic and Other Minimally Invasive Routes of Hysterectomy for Benign Indications," while there may be lower complications associated with robotic hysterectomy, the cost of performing a robotic hysterectomy is significantly higher than the cost of laparoscopic or vaginal hysterectomy, thus limiting its utility.

How can we teach a rare surgical procedure to learners? We channel our inner Martha Stewart and make a model out of a beef tongue and chicken. For about $8 a challenging and rare surgery can be taught to residents and medical students, according to the video presentation by Dr. Jana Illston and colleagues, titled "Modified Beef Tongue Model for Fourth-Degree Laceration Repair Simulation."

After the Day 2 lunch break, there was a rousing debate surrounding "Surgeons as Innovators—What Is the Patient Expecting?" Where do we draw the line between using an older more proven therapy as opposed to trying an innovative technology that may actually offer a potential benefit? Dr. Dennis Miller made a good point regarding innovation and pharmaceutical and device companies: If we ignore industry, we lose the ability to help with innovation and shape the future of medical treatments. Perhaps we should use the golden rule: If we would perform the surgery or use the device on ourselves, then we should perform it on our patient. Patients have a greater burden now, because there are more treatment options that they must choose among. Our job as physicians is to educate our patients and to guide them to innovative and evidence-based treatments.

Highlights from the afternoon oral poster session included a presentation by Dr. Caryn Russman that noted the high risk for recurrent urinary tract infection (UTI) after a mid-urethral sling procedure, which seems to be related to specific preoperative risk factors (such as a history of recurrent UTI). Dr. Tanya Hoke suggested that residents and attending physicians have inaccurate estimates of uterine weight, and an educational program may be necessary to improve these estimates. Finally, a study from Massachusetts General Hospital showed that a shorter stay in the hospital, ideally same-day surgery, resulted in a lower complication risk, lower number of emergency department visits, and a decreased readmission rate for patients undergoing urogynecology procedures.

 

 

The following recommendations were then suggested regarding vaginal hysterectomy:

 

  • Preoperative prep with 4% chlorhexidine or povidine iodine
  • Intracervical vasopressin injection to decrease blood loss
  • Use of a pedicle-sealing device for pedicle ligation
  • Vertical cuff closure is preferred to maximize vaginal length

Another important point made was that a prior cesarean delivery is not a contraindication to performing a vaginal hysterectomy.

Recommendations regarding recurrent UTI were also made, which include the recommendation for preoperative use of antibiotics to decrease the rate of UTI, with no benefit for a longer course of antibiotics.

News from the Fellows’ Pelvic Research Network

So much exciting research currently is ongoing with the FPRN! New project ideas include comparison of trimethoprim with methenamie for treatment of recurrent UTI; comparison of laparoscopic/robotic sacrocolpopexy with vaginal USLS for management of apical prolapse; a survey study examining surgeon preferences for timing of midurethral sling placement when performed at the time of pelvic organ prolapse (POP) repair; an assessment of the effect of a midurethal sling on overactive bladder in surgical repair in POP; and a study evaluating female pelvic reconstructive surgery in the setting of human immunodeficiency virus infection. It is so great to see the fellows working together to provide groundbreaking research!

Fun with stats

Learning statistics at the end of the day is never easy, but Dr. Matthew Barber did a fabulous job explaining this often-confusing topic. He reminded attendees that the key to learning statistics is repetition. One new recommendation he offered to enhance understanding is to use common language instead of numbers for P values. For example, instead of saying P <.001, use “is superior,” and instead of saying P = .3, use “seems not superior” or “inconclusive.”

A night to remember

The night ended with a wonderful awards ceremony and the president’s reception. Overall, day 2 was a very educational—and fun—day!

 

 

4/10/16. DAY 1 AT SGS

Postgrad courses address pain management and social media education

Mastering pelvic pain

With the beautiful Palm Springs, California, backdrop of mountains and palm trees, the 2016 meeting of the Society of Gynecologic Surgeons kicked off with 4 postgraduate courses. At the “Mastering Pelvic Pain: Strategies and Techniques for a Multimodal Approach” course, directed by Dr. Cara King, Dr. Matt Siedhoff explained the key components of the history and physical examination: Keep in mind that this generally is a multifactorial issue and may require a multidisciplinary approach, he told attendees. It is also important to make sure that the patient is fully prepared to combat the chronic pelvic pain (CPP) symptoms by focusing on the fundamentals, he said, including smoking, diet, exercise, weight loss, sleep, and relationship stress.

How is your posture? It turns out that something as simple as altering your posture can significantly affect pelvic floor control. Carol Sobeck, PT, demonstrated this importance with a simple group exercise that proved how the ability to contract the pelvic floor changes significantly with posture. Get to know your pelvic floor physical therapist—they are critical in helping with the treatment of CPP.

But what to do when physical therapy fails? Dr. Jennifer Gunter shed some light on this very difficult medical situation. One suggestion, she said, is to consider the possibility of a local presentation of a systemic issue and screen for the following: fibromyalgia, Ehlers-Danlos syndrome, statin use, and diabetes mellitus. Other treatment ideas include trigger point injections and onabotulinumtoxin A (Botox) therapy. A trigger point is a hypercontracted focus of muscle. To treat a trigger point, a needle must mechanically disrupt the trigger point to reduce the pelvic pain, and injection of local anesthetic is only used to help with postprocedure discomfort. Botox in my pelvis, you ask? Yes! The goal is to block presynaptic release of acetylcholine, which is very effective at reducing muscle spasm. 

Tackling endometriosis. Dr. King then described surgical techniques for endometriosis. She recommended that, for mild disease not in close proximity to vital structures, ablation is likely equivalent to excision. For deeply infiltrating endometriosis, or lesions in close proximity to vital structures, excision is more beneficial. Excision is always beneficial for pathologic diagnosis, she said. And she offered this tip for bladder endometriosis: place a stitch in the nodule to allow for counter traction. Here is another tip, for ovarian cystectomy: inject vasopressin (20 U in 60 mL) to help dissect the plane between the ovary and cyst wall, and consider presacral neurectomy for midline pain.

Dr. Frank Tu then explained that we should not think of it as the “terrible triad: endometriosis, irritable bowel syndrome, and interstitial cystsis,” but rather as a system out of balance. Both peripheral and central mechanisms are involved in the generation and maintenance of cross-organ sensitization, he pointed out, which may explain why patients receive multiple diagnoses that describe a myriad of complaints due to a lack of overall homeostasis.

 

 

While Dr. Alaa Abd-Elsayed described innovative nerve blocks for CPP, he emphasized that no one specific treatment will result in a complete resolution of symptoms.

Vaginal mesh placement and pain. Dr. Mario Castellanos gave a fabulous lecture describing the pain issues that surround vaginal mesh placement. Interestingly, he noted that many patients had pelvic pain prior to placement of vaginal mesh, and that pain likely only will worsen with mesh placement. Mesh may cause pain by causing inflammation, visceral injury, muscle injury, and nerve injury. While there are guidelines for where mesh should be placed for bladder slings (TVT and TOT) and for prolapse repair, studies show, he pointed out, that the mesh placement often disrupts several muscle groups and may directly injure a nerve.

Alternatives to the typical diagnoses for CPP. The morning ended with a lecture by Dr. Suzie As-Sanie, in which she reminded everyone to start with “gold standard” therapy but, if those fail, consider alternative diagnoses or a central pain disorder. She also suggested cognitive behavioral therapy for treatment of CPP. For patients who cannot afford cognitive behavioral therapy, there is a free online source at fibroguide.med.umich.edu. Other alternative treatment options include exercise, patient education, instruction on sleep hygiene, and neurostimulatory therapies.

Overall, all the speakers this morning agreed that CPP is rarely treated with one modality, and it is best treated with a multidisciplinary approach.

 

Let’s get social!

The afternoon was spent learning about ways to use social networking sites to educate our patients, in another postgraduate course on “Making Media Social,” presented by the SGS Social Media Committee. Given that a recent survey demonstrated that 74.1% of women have some type of social networking account, it can be a very useful source for medical information for patients. If you have any questions about what is appropriate on social media, check out ACOG committee opinion 622.

Here are some tips that I learned:

Facebook:

 

  • Keep your private Facebook page private and create a separate professional Facebook page
  • Adjust your login setting so only administrators can post on your professional page
  • Adjust settings so your professional profile cannot be “tagged”
  • If a patient contacts your personal page, direct them to your professional page
  • Do not give medical advice since Facebook is not digitally encrypted

Twitter:

 

  • “Short bursts of inconsequential information”
  • Follow societies, medical centers, and medical journals

LinkedIn:

 

  • It provides a great way to find jobs, people, and business opportunities that are recommended by someone in your contact group
  • It is specifically there to help you grow your business and show people who you are and where you have come from

Doximity:
Before we get to tips, first, what is it? Well, Doximity is basically a “LinkedIn” for physicians. It is “a way to find relevant specialists for patients; a rolodex; an email and text service; and a virtual lounge.” It is currently transforming from social network into a ‘platform.’ Now more than 1,000 hospitals and health systems are part of Doximity. Tips:

 

  • There is a secure message option, which is HIPAA compliant
  • Provides a way for residents and fellows to understand possible future places of employment
  • It is a great way to find someone to refer patients to in an unfamiliar location

Vimeo:

 

  • A benefit over YouTube is the lack of advertisements
  • Check out the SGS video archives!
  • You also can set privacy settings and embedding stats

Fifty-nine percent of US adults have looked online for health information in the past year. Therefore, it is important for physicians to get good information out for people to see!

A relaxing day’s end

The night ended with a beautiful poolside reception! I can’t wait to see what day 2 will bring!

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Don’t assume that psychiatric patients lack capacity to make decisions about care

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Don’t assume that psychiatric patients lack capacity to make decisions about care

Some practitioners of medicine—including psychiatrists—might equate “psychosis” with incapacity, but that isn’t necessarily true. Even patients who, by most measures, are deemed psychotic might be capable of making wise and thoughtful decisions about their life. The case I describe in this article demonstrates that fact.

While rotating on a busy consultation service, I was asked to evaluate the capacity of a woman who had a diagnosis of schizophrenia and was being seen for worsening auditory hallucinations and progressive weight loss. She had a complicated medical course that eventually led to multiple requests to the consult team for a capacity evaluation.

The question of capacity in this patient, and in the psychiatric population generally, motivated me to review the literature, because the assumption by many on the medical teams involved in this patient’s care was that psychiatric patients do not have the capacity to participate in their own care. My goal here is to clarify the misconceptions in regard to this situation.


CASE REPORT
Schizophrenia, weight loss, back pain
Ms. V, age 67, a resident of a group home for the past 6 years, was brought to the emergency department (ED) because of weight loss and auditory hallucinations that had developed during the past few months. She had a history of paranoid schizophrenia that included several psychiatric hospitalizations but no known medical history.

The patient appeared cachectic and dehydrated. When approached, she was pleasant and reported hearing voices of the “devil.”

“They are not scary,” she confided. “They talk to me about art and literature.”

Over the past 6 months, Ms. V had lost 60 lb; she was now bedridden because of back pain. Collateral information obtained from staff members at the group home indicated that she had refused to get out of bed, and only intermittently took her medications or ate meals during the past few months. In general, however, she had been relatively stable over the course of her psychiatric illness, was adherent to psychiatric treatment, and had had no psychiatric hospitalizations in the past 3 decades.

Ominous development. Although the ED staff was convinced that Ms. V needed psychiatric admission, we (the consult team) first requested a detailed medical workup, including imaging studies. A CT scan showed multiple metastatic foci throughout her spine. She was admitted to the medical service.

Respiratory distress developed; her condition deteriorated. Numerous capacity consults were requested because she refused a medical workup or to sign do-not-resuscitate and do-not-intubate orders. Each time an evaluation was performed, Ms. V was deemed by various clinicians on the consult service to have decision-making capacity.

The patient grew unhappy with the staff’s insistence that she undergo more tests regardless of her stated wishes. The palliative care service determined that further workup would not benefit her medically: Ms. V’s condition would be grave and her prognosis poor regardless of what treatment she received.

The medical team continued to believe that, because that this patient had a mental illness and was actively hallucinating, she did not have the capacity to refuse any proposed treatments and tests.


What is capacity?
Capacity is an assessment of a person’s ability to make rational decisions. This includes the ability to understand, appreciate, and manipulate information in reaching such decisions. Determining whether a patient has the capacity to accept or refuse treatment is a medical decision that any physician can make; however, consultation−liaison psychiatrists are the experts who often are involved in this activity, particularly in patients who have a psychiatric comorbidity.

Capacity is evaluated by assessing 4 standards; that is, whether a patient can:

 

  • communicate choice about proposed treatment
  • understand her (his) medical situation
  • appreciate the situation and its consequences
  • manipulate information to reach a rational decision.1-3
  • manipulate information to reach a rational decision.
     

CASE REPORT continued
Although Ms. V’s health was deteriorating and her auditory hallucinations were becoming worse, she appeared insightful about her medical problems, understood her prognosis, and wanted comfort care. She understood that having multiple metastases meant a poor prognosis, and that a biopsy might yield a medical diagnosis. She stated, “If it were caught earlier and I was better able to tolerate treatment, it would make sense to know for sure, but now it doesn’t make sense. I just want to have no pain in my end.”
 

Misconceptions
In a study by Ganzini et al,4,5 395 consultation−liaison psychiatrists, geriatricians, and geriatric psychologists responded to a survey in which they rated types of misunderstandings by clinicians who refer patients for assessment of decision-making capacity. Seventy percent reported that it is common that, when a patient has a mental illness such as schizophrenia, practitioners think that the patient lacks capacity to make medical decisions. However, results of a meta-analysis by Jeste et al,6 in which the magnitude of impairment of decisional capacity in patients with schizophrenia was assessed in comparison to that of normal subjects, suggest that the presence of schizophrenia does not necessarily mean the patient has impaired capacity.

 

 

Voluntary participation in research. Many patients with schizophrenia volunteer to participate in clinical trials even when they are acutely psychotic and admitted to a psychiatric hospital. Given the importance placed on participants’ voluntary informed consent as a prerequisite for ethical conduct of research, the cognitive and emotional impairments associated with schizophrenia raise questions about patients’ capacity to consent.

As is true in other areas of functional capacity, the ability of patients with schizophrenia to make competent decisions relates more to their overall cognitive functioning than to the presence or absence of specific symptoms of the disorder.7 Documentation of longitudinal consent-related abilities among research participants with schizophrenia in the long-term Clinical Antipsychotic Trials of Intervention Effectiveness study indicated that most participants had stable or improved consent-related abilities. Although almost 25% of participants experienced substantial worsening, only 4% fell below the study’s capacity threshold for enrollment.8


What I learned from Ms. V
A diagnosis of schizophrenia does not automatically render a person unable to make decisions about medical care. Even patients who have severe mental illness might have significant intact areas of reality testing. Ethically, it is important to at least consider that the chronically mentally ill can understand treatment options and express consistent choices.

Healthcare providers might tend to exclude psychiatric patients from end-of-life decisions because they (1) are worried about the emotional fragility of such patients and (2) assume that patients lack capacity to participate in making such important decisions. The case presented here is an example of a patient with a severe psychiatric diagnosis being able to participate in her care despite her mental state.

 


Disclosure
The author reports no financial relationships with any company whose products are mentioned in this article or with manufacturers of competing products.
References


1. Appelbaum PS, Grisso T. Assessing patients’ capacities to consent to treatment. N Engl J Med. 1988;319(25):1635-1638.
2. Leo RJ. Competency and the capacity to make treatment decisions: a primer for primary care physicians. Prim Care Companion J Clin Psychiatry. 1999;1(5):131-141.
3. White MM, Lofwall MR. Challenges of the capacity evaluation for the consultation-liaison psychiatrist. J Psychiatr Pract. 2015;21(2):160-170.
4. Ganzini L, Volicer L, Nelson W, et al. Pitfalls in assessment of decision-making capacity. Psychosomatics. 2003;44(3):237-243.
5. Ganzini L, Volicer L, Nelson WA, et al. Ten myths about decision-making capacity. J Am Med Dir Assoc. 2005;6(3):S100-S104.
6. Jeste DV, Depp CA, Palmer BW. Magnitude of impairment in decisional capacity in people with schizophrenia compared to normal subjects: an overview. Schizophr Bull. 2005;32(1):121-128.
7. Appelbaum PS. Decisional capacity of patients with schizophrenia to consent to research: taking stock. Schizophr Bull. 2005;32(1):22-25.
8. Stroup TS, Appelbaum PS, Gu H, et al. Longitudinal consent-related abilities among research participants with schizophrenia: results from the CATIE study. Schizophr Res. 2011;130(1-3):47-52.

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Sahil Munjal, MD
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New York Medical College at Westchester Medical Center
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New York Medical College at Westchester Medical Center
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Some practitioners of medicine—including psychiatrists—might equate “psychosis” with incapacity, but that isn’t necessarily true. Even patients who, by most measures, are deemed psychotic might be capable of making wise and thoughtful decisions about their life. The case I describe in this article demonstrates that fact.

While rotating on a busy consultation service, I was asked to evaluate the capacity of a woman who had a diagnosis of schizophrenia and was being seen for worsening auditory hallucinations and progressive weight loss. She had a complicated medical course that eventually led to multiple requests to the consult team for a capacity evaluation.

The question of capacity in this patient, and in the psychiatric population generally, motivated me to review the literature, because the assumption by many on the medical teams involved in this patient’s care was that psychiatric patients do not have the capacity to participate in their own care. My goal here is to clarify the misconceptions in regard to this situation.


CASE REPORT
Schizophrenia, weight loss, back pain
Ms. V, age 67, a resident of a group home for the past 6 years, was brought to the emergency department (ED) because of weight loss and auditory hallucinations that had developed during the past few months. She had a history of paranoid schizophrenia that included several psychiatric hospitalizations but no known medical history.

The patient appeared cachectic and dehydrated. When approached, she was pleasant and reported hearing voices of the “devil.”

“They are not scary,” she confided. “They talk to me about art and literature.”

Over the past 6 months, Ms. V had lost 60 lb; she was now bedridden because of back pain. Collateral information obtained from staff members at the group home indicated that she had refused to get out of bed, and only intermittently took her medications or ate meals during the past few months. In general, however, she had been relatively stable over the course of her psychiatric illness, was adherent to psychiatric treatment, and had had no psychiatric hospitalizations in the past 3 decades.

Ominous development. Although the ED staff was convinced that Ms. V needed psychiatric admission, we (the consult team) first requested a detailed medical workup, including imaging studies. A CT scan showed multiple metastatic foci throughout her spine. She was admitted to the medical service.

Respiratory distress developed; her condition deteriorated. Numerous capacity consults were requested because she refused a medical workup or to sign do-not-resuscitate and do-not-intubate orders. Each time an evaluation was performed, Ms. V was deemed by various clinicians on the consult service to have decision-making capacity.

The patient grew unhappy with the staff’s insistence that she undergo more tests regardless of her stated wishes. The palliative care service determined that further workup would not benefit her medically: Ms. V’s condition would be grave and her prognosis poor regardless of what treatment she received.

The medical team continued to believe that, because that this patient had a mental illness and was actively hallucinating, she did not have the capacity to refuse any proposed treatments and tests.


What is capacity?
Capacity is an assessment of a person’s ability to make rational decisions. This includes the ability to understand, appreciate, and manipulate information in reaching such decisions. Determining whether a patient has the capacity to accept or refuse treatment is a medical decision that any physician can make; however, consultation−liaison psychiatrists are the experts who often are involved in this activity, particularly in patients who have a psychiatric comorbidity.

Capacity is evaluated by assessing 4 standards; that is, whether a patient can:

 

  • communicate choice about proposed treatment
  • understand her (his) medical situation
  • appreciate the situation and its consequences
  • manipulate information to reach a rational decision.1-3
  • manipulate information to reach a rational decision.
     

CASE REPORT continued
Although Ms. V’s health was deteriorating and her auditory hallucinations were becoming worse, she appeared insightful about her medical problems, understood her prognosis, and wanted comfort care. She understood that having multiple metastases meant a poor prognosis, and that a biopsy might yield a medical diagnosis. She stated, “If it were caught earlier and I was better able to tolerate treatment, it would make sense to know for sure, but now it doesn’t make sense. I just want to have no pain in my end.”
 

Misconceptions
In a study by Ganzini et al,4,5 395 consultation−liaison psychiatrists, geriatricians, and geriatric psychologists responded to a survey in which they rated types of misunderstandings by clinicians who refer patients for assessment of decision-making capacity. Seventy percent reported that it is common that, when a patient has a mental illness such as schizophrenia, practitioners think that the patient lacks capacity to make medical decisions. However, results of a meta-analysis by Jeste et al,6 in which the magnitude of impairment of decisional capacity in patients with schizophrenia was assessed in comparison to that of normal subjects, suggest that the presence of schizophrenia does not necessarily mean the patient has impaired capacity.

 

 

Voluntary participation in research. Many patients with schizophrenia volunteer to participate in clinical trials even when they are acutely psychotic and admitted to a psychiatric hospital. Given the importance placed on participants’ voluntary informed consent as a prerequisite for ethical conduct of research, the cognitive and emotional impairments associated with schizophrenia raise questions about patients’ capacity to consent.

As is true in other areas of functional capacity, the ability of patients with schizophrenia to make competent decisions relates more to their overall cognitive functioning than to the presence or absence of specific symptoms of the disorder.7 Documentation of longitudinal consent-related abilities among research participants with schizophrenia in the long-term Clinical Antipsychotic Trials of Intervention Effectiveness study indicated that most participants had stable or improved consent-related abilities. Although almost 25% of participants experienced substantial worsening, only 4% fell below the study’s capacity threshold for enrollment.8


What I learned from Ms. V
A diagnosis of schizophrenia does not automatically render a person unable to make decisions about medical care. Even patients who have severe mental illness might have significant intact areas of reality testing. Ethically, it is important to at least consider that the chronically mentally ill can understand treatment options and express consistent choices.

Healthcare providers might tend to exclude psychiatric patients from end-of-life decisions because they (1) are worried about the emotional fragility of such patients and (2) assume that patients lack capacity to participate in making such important decisions. The case presented here is an example of a patient with a severe psychiatric diagnosis being able to participate in her care despite her mental state.

 


Disclosure
The author reports no financial relationships with any company whose products are mentioned in this article or with manufacturers of competing products.

Some practitioners of medicine—including psychiatrists—might equate “psychosis” with incapacity, but that isn’t necessarily true. Even patients who, by most measures, are deemed psychotic might be capable of making wise and thoughtful decisions about their life. The case I describe in this article demonstrates that fact.

While rotating on a busy consultation service, I was asked to evaluate the capacity of a woman who had a diagnosis of schizophrenia and was being seen for worsening auditory hallucinations and progressive weight loss. She had a complicated medical course that eventually led to multiple requests to the consult team for a capacity evaluation.

The question of capacity in this patient, and in the psychiatric population generally, motivated me to review the literature, because the assumption by many on the medical teams involved in this patient’s care was that psychiatric patients do not have the capacity to participate in their own care. My goal here is to clarify the misconceptions in regard to this situation.


CASE REPORT
Schizophrenia, weight loss, back pain
Ms. V, age 67, a resident of a group home for the past 6 years, was brought to the emergency department (ED) because of weight loss and auditory hallucinations that had developed during the past few months. She had a history of paranoid schizophrenia that included several psychiatric hospitalizations but no known medical history.

The patient appeared cachectic and dehydrated. When approached, she was pleasant and reported hearing voices of the “devil.”

“They are not scary,” she confided. “They talk to me about art and literature.”

Over the past 6 months, Ms. V had lost 60 lb; she was now bedridden because of back pain. Collateral information obtained from staff members at the group home indicated that she had refused to get out of bed, and only intermittently took her medications or ate meals during the past few months. In general, however, she had been relatively stable over the course of her psychiatric illness, was adherent to psychiatric treatment, and had had no psychiatric hospitalizations in the past 3 decades.

Ominous development. Although the ED staff was convinced that Ms. V needed psychiatric admission, we (the consult team) first requested a detailed medical workup, including imaging studies. A CT scan showed multiple metastatic foci throughout her spine. She was admitted to the medical service.

Respiratory distress developed; her condition deteriorated. Numerous capacity consults were requested because she refused a medical workup or to sign do-not-resuscitate and do-not-intubate orders. Each time an evaluation was performed, Ms. V was deemed by various clinicians on the consult service to have decision-making capacity.

The patient grew unhappy with the staff’s insistence that she undergo more tests regardless of her stated wishes. The palliative care service determined that further workup would not benefit her medically: Ms. V’s condition would be grave and her prognosis poor regardless of what treatment she received.

The medical team continued to believe that, because that this patient had a mental illness and was actively hallucinating, she did not have the capacity to refuse any proposed treatments and tests.


What is capacity?
Capacity is an assessment of a person’s ability to make rational decisions. This includes the ability to understand, appreciate, and manipulate information in reaching such decisions. Determining whether a patient has the capacity to accept or refuse treatment is a medical decision that any physician can make; however, consultation−liaison psychiatrists are the experts who often are involved in this activity, particularly in patients who have a psychiatric comorbidity.

Capacity is evaluated by assessing 4 standards; that is, whether a patient can:

 

  • communicate choice about proposed treatment
  • understand her (his) medical situation
  • appreciate the situation and its consequences
  • manipulate information to reach a rational decision.1-3
  • manipulate information to reach a rational decision.
     

CASE REPORT continued
Although Ms. V’s health was deteriorating and her auditory hallucinations were becoming worse, she appeared insightful about her medical problems, understood her prognosis, and wanted comfort care. She understood that having multiple metastases meant a poor prognosis, and that a biopsy might yield a medical diagnosis. She stated, “If it were caught earlier and I was better able to tolerate treatment, it would make sense to know for sure, but now it doesn’t make sense. I just want to have no pain in my end.”
 

Misconceptions
In a study by Ganzini et al,4,5 395 consultation−liaison psychiatrists, geriatricians, and geriatric psychologists responded to a survey in which they rated types of misunderstandings by clinicians who refer patients for assessment of decision-making capacity. Seventy percent reported that it is common that, when a patient has a mental illness such as schizophrenia, practitioners think that the patient lacks capacity to make medical decisions. However, results of a meta-analysis by Jeste et al,6 in which the magnitude of impairment of decisional capacity in patients with schizophrenia was assessed in comparison to that of normal subjects, suggest that the presence of schizophrenia does not necessarily mean the patient has impaired capacity.

 

 

Voluntary participation in research. Many patients with schizophrenia volunteer to participate in clinical trials even when they are acutely psychotic and admitted to a psychiatric hospital. Given the importance placed on participants’ voluntary informed consent as a prerequisite for ethical conduct of research, the cognitive and emotional impairments associated with schizophrenia raise questions about patients’ capacity to consent.

As is true in other areas of functional capacity, the ability of patients with schizophrenia to make competent decisions relates more to their overall cognitive functioning than to the presence or absence of specific symptoms of the disorder.7 Documentation of longitudinal consent-related abilities among research participants with schizophrenia in the long-term Clinical Antipsychotic Trials of Intervention Effectiveness study indicated that most participants had stable or improved consent-related abilities. Although almost 25% of participants experienced substantial worsening, only 4% fell below the study’s capacity threshold for enrollment.8


What I learned from Ms. V
A diagnosis of schizophrenia does not automatically render a person unable to make decisions about medical care. Even patients who have severe mental illness might have significant intact areas of reality testing. Ethically, it is important to at least consider that the chronically mentally ill can understand treatment options and express consistent choices.

Healthcare providers might tend to exclude psychiatric patients from end-of-life decisions because they (1) are worried about the emotional fragility of such patients and (2) assume that patients lack capacity to participate in making such important decisions. The case presented here is an example of a patient with a severe psychiatric diagnosis being able to participate in her care despite her mental state.

 


Disclosure
The author reports no financial relationships with any company whose products are mentioned in this article or with manufacturers of competing products.
References


1. Appelbaum PS, Grisso T. Assessing patients’ capacities to consent to treatment. N Engl J Med. 1988;319(25):1635-1638.
2. Leo RJ. Competency and the capacity to make treatment decisions: a primer for primary care physicians. Prim Care Companion J Clin Psychiatry. 1999;1(5):131-141.
3. White MM, Lofwall MR. Challenges of the capacity evaluation for the consultation-liaison psychiatrist. J Psychiatr Pract. 2015;21(2):160-170.
4. Ganzini L, Volicer L, Nelson W, et al. Pitfalls in assessment of decision-making capacity. Psychosomatics. 2003;44(3):237-243.
5. Ganzini L, Volicer L, Nelson WA, et al. Ten myths about decision-making capacity. J Am Med Dir Assoc. 2005;6(3):S100-S104.
6. Jeste DV, Depp CA, Palmer BW. Magnitude of impairment in decisional capacity in people with schizophrenia compared to normal subjects: an overview. Schizophr Bull. 2005;32(1):121-128.
7. Appelbaum PS. Decisional capacity of patients with schizophrenia to consent to research: taking stock. Schizophr Bull. 2005;32(1):22-25.
8. Stroup TS, Appelbaum PS, Gu H, et al. Longitudinal consent-related abilities among research participants with schizophrenia: results from the CATIE study. Schizophr Res. 2011;130(1-3):47-52.

References


1. Appelbaum PS, Grisso T. Assessing patients’ capacities to consent to treatment. N Engl J Med. 1988;319(25):1635-1638.
2. Leo RJ. Competency and the capacity to make treatment decisions: a primer for primary care physicians. Prim Care Companion J Clin Psychiatry. 1999;1(5):131-141.
3. White MM, Lofwall MR. Challenges of the capacity evaluation for the consultation-liaison psychiatrist. J Psychiatr Pract. 2015;21(2):160-170.
4. Ganzini L, Volicer L, Nelson W, et al. Pitfalls in assessment of decision-making capacity. Psychosomatics. 2003;44(3):237-243.
5. Ganzini L, Volicer L, Nelson WA, et al. Ten myths about decision-making capacity. J Am Med Dir Assoc. 2005;6(3):S100-S104.
6. Jeste DV, Depp CA, Palmer BW. Magnitude of impairment in decisional capacity in people with schizophrenia compared to normal subjects: an overview. Schizophr Bull. 2005;32(1):121-128.
7. Appelbaum PS. Decisional capacity of patients with schizophrenia to consent to research: taking stock. Schizophr Bull. 2005;32(1):22-25.
8. Stroup TS, Appelbaum PS, Gu H, et al. Longitudinal consent-related abilities among research participants with schizophrenia: results from the CATIE study. Schizophr Res. 2011;130(1-3):47-52.

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Androgen deprivation therapy linked to depression

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Men on androgen deprivation therapy for prostate cancer are at significantly increased risk for depression, a risk that increases with duration of therapy, investigators report.

A review of Surveillance, Epidemiology, and End Results (SEER) Medicare data on nearly 79,000 men older than 65 years with a diagnosis of prostate cancer showed that those who received androgen deprivation therapy (ADT) had a 23% increased risk for depression, compared with men who were not on ADT, reported Kathryn T. Dinh of Harvard Medical School, Boston, and her colleagues.

“We observed a significantly increased risk of depression and inpatient psychiatric treatment in men treated with ADT for prostate cancer, as well as a duration-response effect such that more ADT was linked to an increasing risk of depression and inpatient and outpatient psychiatric treatment. The possible psychiatric effects of ADT should be recognized by physicians and discussed with patients before initiating treatment,” they wrote (J Clin Oncol. 2016 Apr 11. doi: 10.1200/JCO.2015.64.1969).

 

Although ADT has been identified in some studies as a risk factor for clinical depression, evidence for such a relationship has been spotty, the investigators said, prompting them to conduct a population-based retrospective study to get a better handle on the issue.

They reviewed SEER Medicare data on 78,552 men older than 65 years with a diagnosis of stage I-III prostate cancer treated with ADT from 1992 through 2006, excluding from the sample those patients who had a psychiatric diagnosis within the past 12 months.

Ms. Dinh and her associates found that the 33,882 patients (43%) who received ADT had a significantly higher 3-year cumulative incidence of depression than patients who did not have ADT (7.1% vs. 5.2%, P less than .001), and a significantly higher proportion had either inpatient psychiatric treatment (2.8% vs. 1.9%, P less than .001) or outpatient psychiatric therapy (3.4% vs. 2.5%, P less than .001).

In proportional hazard models controlling for demographic and clinical factors, receipt of ADT was associated with adjusted hazard ratios of 1.23 for depression and 1.29 (P less than .001 for both) for inpatient psychiatric treatment. There was no significant increase in risk for outpatient psychiatric treatment in this analysis, however.

In addition, the longer patients that were on ADT, the greater the risk for depression. The risk of depression was 12% for patients treated for 6 months or less, 26% for those on ADT for 7-11 months, and 37% for those on ADT for at least 1 year.

“The impact of ADT on depression may plausibly occur via deregulation of neurochemicals, such as serotonin, in addition to the well-described physical effects,” Ms. Dinh and her associates wrote.

Side effects of ADT that can impair quality of life also may contribute to clinical depression, they noted.

The study was supported by charitable grants and internal institutional sources. One investigator reported consulting or advisory roles with Medivation, GenomeDx, and Ferring. Three of the other ten coauthors also reported financial disclosures.

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Men on androgen deprivation therapy for prostate cancer are at significantly increased risk for depression, a risk that increases with duration of therapy, investigators report.

A review of Surveillance, Epidemiology, and End Results (SEER) Medicare data on nearly 79,000 men older than 65 years with a diagnosis of prostate cancer showed that those who received androgen deprivation therapy (ADT) had a 23% increased risk for depression, compared with men who were not on ADT, reported Kathryn T. Dinh of Harvard Medical School, Boston, and her colleagues.

“We observed a significantly increased risk of depression and inpatient psychiatric treatment in men treated with ADT for prostate cancer, as well as a duration-response effect such that more ADT was linked to an increasing risk of depression and inpatient and outpatient psychiatric treatment. The possible psychiatric effects of ADT should be recognized by physicians and discussed with patients before initiating treatment,” they wrote (J Clin Oncol. 2016 Apr 11. doi: 10.1200/JCO.2015.64.1969).

 

Although ADT has been identified in some studies as a risk factor for clinical depression, evidence for such a relationship has been spotty, the investigators said, prompting them to conduct a population-based retrospective study to get a better handle on the issue.

They reviewed SEER Medicare data on 78,552 men older than 65 years with a diagnosis of stage I-III prostate cancer treated with ADT from 1992 through 2006, excluding from the sample those patients who had a psychiatric diagnosis within the past 12 months.

Ms. Dinh and her associates found that the 33,882 patients (43%) who received ADT had a significantly higher 3-year cumulative incidence of depression than patients who did not have ADT (7.1% vs. 5.2%, P less than .001), and a significantly higher proportion had either inpatient psychiatric treatment (2.8% vs. 1.9%, P less than .001) or outpatient psychiatric therapy (3.4% vs. 2.5%, P less than .001).

In proportional hazard models controlling for demographic and clinical factors, receipt of ADT was associated with adjusted hazard ratios of 1.23 for depression and 1.29 (P less than .001 for both) for inpatient psychiatric treatment. There was no significant increase in risk for outpatient psychiatric treatment in this analysis, however.

In addition, the longer patients that were on ADT, the greater the risk for depression. The risk of depression was 12% for patients treated for 6 months or less, 26% for those on ADT for 7-11 months, and 37% for those on ADT for at least 1 year.

“The impact of ADT on depression may plausibly occur via deregulation of neurochemicals, such as serotonin, in addition to the well-described physical effects,” Ms. Dinh and her associates wrote.

Side effects of ADT that can impair quality of life also may contribute to clinical depression, they noted.

The study was supported by charitable grants and internal institutional sources. One investigator reported consulting or advisory roles with Medivation, GenomeDx, and Ferring. Three of the other ten coauthors also reported financial disclosures.

Men on androgen deprivation therapy for prostate cancer are at significantly increased risk for depression, a risk that increases with duration of therapy, investigators report.

A review of Surveillance, Epidemiology, and End Results (SEER) Medicare data on nearly 79,000 men older than 65 years with a diagnosis of prostate cancer showed that those who received androgen deprivation therapy (ADT) had a 23% increased risk for depression, compared with men who were not on ADT, reported Kathryn T. Dinh of Harvard Medical School, Boston, and her colleagues.

“We observed a significantly increased risk of depression and inpatient psychiatric treatment in men treated with ADT for prostate cancer, as well as a duration-response effect such that more ADT was linked to an increasing risk of depression and inpatient and outpatient psychiatric treatment. The possible psychiatric effects of ADT should be recognized by physicians and discussed with patients before initiating treatment,” they wrote (J Clin Oncol. 2016 Apr 11. doi: 10.1200/JCO.2015.64.1969).

 

Although ADT has been identified in some studies as a risk factor for clinical depression, evidence for such a relationship has been spotty, the investigators said, prompting them to conduct a population-based retrospective study to get a better handle on the issue.

They reviewed SEER Medicare data on 78,552 men older than 65 years with a diagnosis of stage I-III prostate cancer treated with ADT from 1992 through 2006, excluding from the sample those patients who had a psychiatric diagnosis within the past 12 months.

Ms. Dinh and her associates found that the 33,882 patients (43%) who received ADT had a significantly higher 3-year cumulative incidence of depression than patients who did not have ADT (7.1% vs. 5.2%, P less than .001), and a significantly higher proportion had either inpatient psychiatric treatment (2.8% vs. 1.9%, P less than .001) or outpatient psychiatric therapy (3.4% vs. 2.5%, P less than .001).

In proportional hazard models controlling for demographic and clinical factors, receipt of ADT was associated with adjusted hazard ratios of 1.23 for depression and 1.29 (P less than .001 for both) for inpatient psychiatric treatment. There was no significant increase in risk for outpatient psychiatric treatment in this analysis, however.

In addition, the longer patients that were on ADT, the greater the risk for depression. The risk of depression was 12% for patients treated for 6 months or less, 26% for those on ADT for 7-11 months, and 37% for those on ADT for at least 1 year.

“The impact of ADT on depression may plausibly occur via deregulation of neurochemicals, such as serotonin, in addition to the well-described physical effects,” Ms. Dinh and her associates wrote.

Side effects of ADT that can impair quality of life also may contribute to clinical depression, they noted.

The study was supported by charitable grants and internal institutional sources. One investigator reported consulting or advisory roles with Medivation, GenomeDx, and Ferring. Three of the other ten coauthors also reported financial disclosures.

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Key clinical point: Androgen deprivation therapy for prostate cancer is associated with increased risk for clinical depression.

Major finding: Men who received androgen deprivation therapy (ADT) had a 23% increased risk for depression compared with men who were not on ADT.

Data source: Review of SEER Medicare data on 78,552 men with stage I-III prostate cancer.

Disclosures: The study was supported by charitable grants and internal institutional sources. One investigator reported consulting or advisory roles with Medivation, GenomeDx, and Ferring. Three of the other ten coauthors also reported financial disclosures.

Fecal transplant cures most with C. difficile, but one dies

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AMSTERDAM – Fecal transplants effected a clinical cure in 97% of patients with recurrent Clostridium difficile infection, a small prospective study has determined.

However, the transplants, which were administered via duodenal intubation, were not without serious adverse events, Dr. Yvette van Beurden said at the European Society of Clinical Microbiology and Infectious Diseases annual congress.

Michele G. Sullivan/Frontline Medical News
Dr. Yvette van Beurden

Five patients regurgitated or vomited fecal material, and one of these patients died, presumably from aspiration pneumonia related to the event, said Dr. van Beurden of the VU University Medical Center, Amsterdam.

The study was relatively small – 39 patients – but provided up to 2 years of follow-up on them. All were treated at Academic Medical Center, Amsterdam, from 2010 to 1016.

They were a mean of 73 years old, but the age range was wide (14-97 years). All had experienced recurrent C. difficile infections. The mean recurrence rate was four, but again this varied widely, from one recurrence to 10.

Thus, they had also experienced a mean of four courses of antibiotic treatment, with a range similar to the recurrence range. At the time of transplant, they were a mean of 6 months past their last recurrence.

The transplant protocol called for a minimum of 4 days of vancomycin treatment before transplant, and a full bowel prep 1 day before. The transplant itself consisted of 500 mL of fresh donor feces in solution; it was obtained from a household contact or healthy volunteer and administered by duodenal tube. Patients were discharged on the same day of infusion.

The mean follow-up was 21 months, also with a wide range (3-68 months).

A clinical cure – not microbiologically confirmed – occurred in 82% of the patients. There were seven recurrences (18%), which all happened within the first 3 months. Of these, two were thought to be related to antibiotic use within the first month of the procedure; the cause of the other recurrences was unknown.

Four of the patients with recurrent infections received antibiotics without a repeat transplant; three received fidaxomicin and one, metronidazole. Two underwent a successful repeat transplant. One patient had multiple treatments, including a course of fidaxomicin. This patient experienced another recurrence that was successfully treated with a second transplant.

Six of these seven patients experienced a clinical cure, bringing the secondary cure rate of the entire cohort to 97%.

There were nine serious adverse events (23%), most of which occurred during or shortly after the transplant procedure. This included the single death; four hospitalizations (one related to the transplant); and four transplant-related events.

The patient who died had an uncomplicated transplant, but within an hour started to feel nauseated and regurgitated the fecal material. “This didn’t appear to be severe,” Dr. van Beurden said. “But within a week, pneumonia developed and the patient died despite antibiotic treatment.”

She added that this patient was “medically fragile,” with a swallowing disorder that required a percutaneous endoscopic gastrostomy feeding tube.

Of the other four patients with transplant complications:

• One, following an uncomplicated transplant, was discharged and ate a large meal, then shortly after vomited food and donor feces.

• One experienced abdominal cramping during the procedure, which was immediately stopped. When the cramping subsided, the procedure was completed. However, within a few hours the cramping recurred, along with diarrhea, nausea, and vomiting of fecal material.

• One patient was “very stressed and anxious” during the procedure and regurgitated a mix of gastric juices and donor feces. The infusion tube was immediately removed. The patient was discharged after being symptom-free for 3 hours, but vomited fecal material on the way home.

• One patient experienced nausea during the transplant, which was immediately stopped with tube removal. Upon removal, the patient regurgitated donor material. Nausea shortly resolved.

During the discussion period, Dr. van Beurden fielded a question about duodenal administration rather than delivering the donor feces colonoscopically. She said that decision was made because the duodenal tube doesn’t require anesthesia, and because many of the patients had severely inflamed colons. However, the hospital’s experience with complications did help refine its transplant protocol, she said.

• Colonoscopic administration is mandatory for any patient with a swallowing disorder.

• A smaller volume of feces is now infused.

• Donor material is infused very slowly and immediately discontinued if there is any nausea, cramping, or regurgitation.

• There is no eating or drinking for at least 1 hour after the transplant.

• To minimize the risk of recurrent C. difficile, patients should have no nonessential antibiotic treatment within the first month after transplant.

 

 

She had no financial disclosures.

[email protected]

On Twitter @Alz_Gal

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AMSTERDAM – Fecal transplants effected a clinical cure in 97% of patients with recurrent Clostridium difficile infection, a small prospective study has determined.

However, the transplants, which were administered via duodenal intubation, were not without serious adverse events, Dr. Yvette van Beurden said at the European Society of Clinical Microbiology and Infectious Diseases annual congress.

Michele G. Sullivan/Frontline Medical News
Dr. Yvette van Beurden

Five patients regurgitated or vomited fecal material, and one of these patients died, presumably from aspiration pneumonia related to the event, said Dr. van Beurden of the VU University Medical Center, Amsterdam.

The study was relatively small – 39 patients – but provided up to 2 years of follow-up on them. All were treated at Academic Medical Center, Amsterdam, from 2010 to 1016.

They were a mean of 73 years old, but the age range was wide (14-97 years). All had experienced recurrent C. difficile infections. The mean recurrence rate was four, but again this varied widely, from one recurrence to 10.

Thus, they had also experienced a mean of four courses of antibiotic treatment, with a range similar to the recurrence range. At the time of transplant, they were a mean of 6 months past their last recurrence.

The transplant protocol called for a minimum of 4 days of vancomycin treatment before transplant, and a full bowel prep 1 day before. The transplant itself consisted of 500 mL of fresh donor feces in solution; it was obtained from a household contact or healthy volunteer and administered by duodenal tube. Patients were discharged on the same day of infusion.

The mean follow-up was 21 months, also with a wide range (3-68 months).

A clinical cure – not microbiologically confirmed – occurred in 82% of the patients. There were seven recurrences (18%), which all happened within the first 3 months. Of these, two were thought to be related to antibiotic use within the first month of the procedure; the cause of the other recurrences was unknown.

Four of the patients with recurrent infections received antibiotics without a repeat transplant; three received fidaxomicin and one, metronidazole. Two underwent a successful repeat transplant. One patient had multiple treatments, including a course of fidaxomicin. This patient experienced another recurrence that was successfully treated with a second transplant.

Six of these seven patients experienced a clinical cure, bringing the secondary cure rate of the entire cohort to 97%.

There were nine serious adverse events (23%), most of which occurred during or shortly after the transplant procedure. This included the single death; four hospitalizations (one related to the transplant); and four transplant-related events.

The patient who died had an uncomplicated transplant, but within an hour started to feel nauseated and regurgitated the fecal material. “This didn’t appear to be severe,” Dr. van Beurden said. “But within a week, pneumonia developed and the patient died despite antibiotic treatment.”

She added that this patient was “medically fragile,” with a swallowing disorder that required a percutaneous endoscopic gastrostomy feeding tube.

Of the other four patients with transplant complications:

• One, following an uncomplicated transplant, was discharged and ate a large meal, then shortly after vomited food and donor feces.

• One experienced abdominal cramping during the procedure, which was immediately stopped. When the cramping subsided, the procedure was completed. However, within a few hours the cramping recurred, along with diarrhea, nausea, and vomiting of fecal material.

• One patient was “very stressed and anxious” during the procedure and regurgitated a mix of gastric juices and donor feces. The infusion tube was immediately removed. The patient was discharged after being symptom-free for 3 hours, but vomited fecal material on the way home.

• One patient experienced nausea during the transplant, which was immediately stopped with tube removal. Upon removal, the patient regurgitated donor material. Nausea shortly resolved.

During the discussion period, Dr. van Beurden fielded a question about duodenal administration rather than delivering the donor feces colonoscopically. She said that decision was made because the duodenal tube doesn’t require anesthesia, and because many of the patients had severely inflamed colons. However, the hospital’s experience with complications did help refine its transplant protocol, she said.

• Colonoscopic administration is mandatory for any patient with a swallowing disorder.

• A smaller volume of feces is now infused.

• Donor material is infused very slowly and immediately discontinued if there is any nausea, cramping, or regurgitation.

• There is no eating or drinking for at least 1 hour after the transplant.

• To minimize the risk of recurrent C. difficile, patients should have no nonessential antibiotic treatment within the first month after transplant.

 

 

She had no financial disclosures.

[email protected]

On Twitter @Alz_Gal

AMSTERDAM – Fecal transplants effected a clinical cure in 97% of patients with recurrent Clostridium difficile infection, a small prospective study has determined.

However, the transplants, which were administered via duodenal intubation, were not without serious adverse events, Dr. Yvette van Beurden said at the European Society of Clinical Microbiology and Infectious Diseases annual congress.

Michele G. Sullivan/Frontline Medical News
Dr. Yvette van Beurden

Five patients regurgitated or vomited fecal material, and one of these patients died, presumably from aspiration pneumonia related to the event, said Dr. van Beurden of the VU University Medical Center, Amsterdam.

The study was relatively small – 39 patients – but provided up to 2 years of follow-up on them. All were treated at Academic Medical Center, Amsterdam, from 2010 to 1016.

They were a mean of 73 years old, but the age range was wide (14-97 years). All had experienced recurrent C. difficile infections. The mean recurrence rate was four, but again this varied widely, from one recurrence to 10.

Thus, they had also experienced a mean of four courses of antibiotic treatment, with a range similar to the recurrence range. At the time of transplant, they were a mean of 6 months past their last recurrence.

The transplant protocol called for a minimum of 4 days of vancomycin treatment before transplant, and a full bowel prep 1 day before. The transplant itself consisted of 500 mL of fresh donor feces in solution; it was obtained from a household contact or healthy volunteer and administered by duodenal tube. Patients were discharged on the same day of infusion.

The mean follow-up was 21 months, also with a wide range (3-68 months).

A clinical cure – not microbiologically confirmed – occurred in 82% of the patients. There were seven recurrences (18%), which all happened within the first 3 months. Of these, two were thought to be related to antibiotic use within the first month of the procedure; the cause of the other recurrences was unknown.

Four of the patients with recurrent infections received antibiotics without a repeat transplant; three received fidaxomicin and one, metronidazole. Two underwent a successful repeat transplant. One patient had multiple treatments, including a course of fidaxomicin. This patient experienced another recurrence that was successfully treated with a second transplant.

Six of these seven patients experienced a clinical cure, bringing the secondary cure rate of the entire cohort to 97%.

There were nine serious adverse events (23%), most of which occurred during or shortly after the transplant procedure. This included the single death; four hospitalizations (one related to the transplant); and four transplant-related events.

The patient who died had an uncomplicated transplant, but within an hour started to feel nauseated and regurgitated the fecal material. “This didn’t appear to be severe,” Dr. van Beurden said. “But within a week, pneumonia developed and the patient died despite antibiotic treatment.”

She added that this patient was “medically fragile,” with a swallowing disorder that required a percutaneous endoscopic gastrostomy feeding tube.

Of the other four patients with transplant complications:

• One, following an uncomplicated transplant, was discharged and ate a large meal, then shortly after vomited food and donor feces.

• One experienced abdominal cramping during the procedure, which was immediately stopped. When the cramping subsided, the procedure was completed. However, within a few hours the cramping recurred, along with diarrhea, nausea, and vomiting of fecal material.

• One patient was “very stressed and anxious” during the procedure and regurgitated a mix of gastric juices and donor feces. The infusion tube was immediately removed. The patient was discharged after being symptom-free for 3 hours, but vomited fecal material on the way home.

• One patient experienced nausea during the transplant, which was immediately stopped with tube removal. Upon removal, the patient regurgitated donor material. Nausea shortly resolved.

During the discussion period, Dr. van Beurden fielded a question about duodenal administration rather than delivering the donor feces colonoscopically. She said that decision was made because the duodenal tube doesn’t require anesthesia, and because many of the patients had severely inflamed colons. However, the hospital’s experience with complications did help refine its transplant protocol, she said.

• Colonoscopic administration is mandatory for any patient with a swallowing disorder.

• A smaller volume of feces is now infused.

• Donor material is infused very slowly and immediately discontinued if there is any nausea, cramping, or regurgitation.

• There is no eating or drinking for at least 1 hour after the transplant.

• To minimize the risk of recurrent C. difficile, patients should have no nonessential antibiotic treatment within the first month after transplant.

 

 

She had no financial disclosures.

[email protected]

On Twitter @Alz_Gal

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Key clinical point: Fecal transplants cured most recurrent C. difficile infections, but could be dangerous as well.

Major finding: A duodenal administered fecal transplant cured 97% of patients with recurrent C. difficile, but one patient died after vomiting the fecal material.

Data source: The prospective study comprised 39 patients.

Disclosures: Dr. van Beurden had no financial disclosures.

FDA approves venetoclax for CLL with 17p deletion

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Venetoclax has been approved for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a 17p deletion and who have been treated with a least one prior therapy, the Food and Drug Administration has announced.

The drug will be marketed as Venclexta, and is indicated for daily use after detection of a 17p deletion is confirmed through the use of the FDA-approved companion diagnostic test, the Vysis CLL FISH probe kit. A 17p deletion occurs in about 10% of patients with untreated CLL and in about 20% of patients with relapsed CLL. Venetoclax targets the B-cell lymphoma 2 (BCL-2) protein, according to the FDA press release.

“Up to half of people whose CLL progressed have 17p deletion,” Dr. Sandra Horning, chief medical officer and head of Global Product Development for Genentech, said in a press release issued by the company. Venclexta will be marketed by AbbVie and Genentech USA. The Vysis CLL FISH probe kit is manufactured by Abbott Molecular.

“For certain patients with CLL who have not had favorable outcomes with other therapies, Venclexta may provide a new option,” Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release issued by the FDA.

The approval was based on a clinical trial of 106 patients who had CLL and 17p deletions and who had received at least one prior therapy. Trial participants took oral venetoclax daily, beginning with a 20 mg dose that was increased over a 5-week period to 400 mg. A complete or partial remission of CLL occurred in 80% of trial participants. Data on venetoclax also was presented at the annual meeting of the American Society of Hematology.

The most common side effects of venetoclax include neutropenia, diarrhea, nausea, anemia, upper respiratory tract infection, thrombocytopenia, and fatigue.

The FDA granted the Venclexta application breakthrough therapy designation, priority review status, and accelerated approval for this indication. Venclexta also received orphan drug designation.

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Venetoclax has been approved for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a 17p deletion and who have been treated with a least one prior therapy, the Food and Drug Administration has announced.

The drug will be marketed as Venclexta, and is indicated for daily use after detection of a 17p deletion is confirmed through the use of the FDA-approved companion diagnostic test, the Vysis CLL FISH probe kit. A 17p deletion occurs in about 10% of patients with untreated CLL and in about 20% of patients with relapsed CLL. Venetoclax targets the B-cell lymphoma 2 (BCL-2) protein, according to the FDA press release.

“Up to half of people whose CLL progressed have 17p deletion,” Dr. Sandra Horning, chief medical officer and head of Global Product Development for Genentech, said in a press release issued by the company. Venclexta will be marketed by AbbVie and Genentech USA. The Vysis CLL FISH probe kit is manufactured by Abbott Molecular.

“For certain patients with CLL who have not had favorable outcomes with other therapies, Venclexta may provide a new option,” Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release issued by the FDA.

The approval was based on a clinical trial of 106 patients who had CLL and 17p deletions and who had received at least one prior therapy. Trial participants took oral venetoclax daily, beginning with a 20 mg dose that was increased over a 5-week period to 400 mg. A complete or partial remission of CLL occurred in 80% of trial participants. Data on venetoclax also was presented at the annual meeting of the American Society of Hematology.

The most common side effects of venetoclax include neutropenia, diarrhea, nausea, anemia, upper respiratory tract infection, thrombocytopenia, and fatigue.

The FDA granted the Venclexta application breakthrough therapy designation, priority review status, and accelerated approval for this indication. Venclexta also received orphan drug designation.

[email protected]

On Twitter @maryjodales

Venetoclax has been approved for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a 17p deletion and who have been treated with a least one prior therapy, the Food and Drug Administration has announced.

The drug will be marketed as Venclexta, and is indicated for daily use after detection of a 17p deletion is confirmed through the use of the FDA-approved companion diagnostic test, the Vysis CLL FISH probe kit. A 17p deletion occurs in about 10% of patients with untreated CLL and in about 20% of patients with relapsed CLL. Venetoclax targets the B-cell lymphoma 2 (BCL-2) protein, according to the FDA press release.

“Up to half of people whose CLL progressed have 17p deletion,” Dr. Sandra Horning, chief medical officer and head of Global Product Development for Genentech, said in a press release issued by the company. Venclexta will be marketed by AbbVie and Genentech USA. The Vysis CLL FISH probe kit is manufactured by Abbott Molecular.

“For certain patients with CLL who have not had favorable outcomes with other therapies, Venclexta may provide a new option,” Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release issued by the FDA.

The approval was based on a clinical trial of 106 patients who had CLL and 17p deletions and who had received at least one prior therapy. Trial participants took oral venetoclax daily, beginning with a 20 mg dose that was increased over a 5-week period to 400 mg. A complete or partial remission of CLL occurred in 80% of trial participants. Data on venetoclax also was presented at the annual meeting of the American Society of Hematology.

The most common side effects of venetoclax include neutropenia, diarrhea, nausea, anemia, upper respiratory tract infection, thrombocytopenia, and fatigue.

The FDA granted the Venclexta application breakthrough therapy designation, priority review status, and accelerated approval for this indication. Venclexta also received orphan drug designation.

[email protected]

On Twitter @maryjodales

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FDA approves first leadless pacemaker

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FDA approves first leadless pacemaker

The Food and Drug Administration has approved the first leadless pacemaker, the Micra transcatheter pacing system, the FDA stated in a release accompanying its approval.

The Micra pacemaker eliminates the need for wired leads and the risk of associated complications. The single-chamber ventricular pacemaker is 93% smaller than traditional pacemakers, according to a summary document submitted to the FDA by Medtronic, which makes the device. Like other ventricular pacemakers, Micra provides rate-adaptive pacing, with automated pacing capture threshold management to maximize battery life, which the company estimates at about 10 years.

Courtesy Medtronic plc
The Micra leadless pacemaker is about 1/10 the size of traditional pacemakers.

The pacemaker is inserted directly into the right ventricle through the femoral vein by means of a steerable catheter. Pressing a button on the distal end of the catheter releases four flexible, electrically inactive nitinol tines that hook into the myocardium to secure the device. Engagement by two tines exerts 15 times the amount of force needed to secure the device in place, according to Medtronic.

The device’s approval was based on a pivotal prospective, nonrandomized uncontrolled study of 719 patients at 56 investigational sites in North America, Europe, Asia, Australia, and Africa. The primary efficacy endpoint, low and stable pacing capture thresholds at 6 months (up to 2.0 V at a pulse width of 0.24 milliseconds and an increase of up to 1.5 V from the time of implantation) was achieved for 98% of patients (95% confidence interval, 96%-99.5%), reported Dr. Dwight Reynolds of the University of Oklahoma Health Sciences Center in Oklahoma City and his associates (N Engl J Med. 2016 Feb. 11. doi: 10.1056/NEJMoa1511643).

The researchers also compared safety outcomes among Micra recipients and 2,667 historical controls from six previously published studies. The Micra pacemaker was associated with significantly lower hospitalization and system revision rates, with “no systemic infections, no pneumothoraxes, and no radiographically visible dislodgements or device emboli,” they said. In all, 4% of Micra recipients had complications leading to death or requiring invasive revision, treatment cessation, or hospitalization, which resembled recent reports of transvenous systems and was significantly lower than the rate for historical controls, according to the investigators. However, the rate of cardiac perforation or effusion was 1.6%, slightly higher than the rate of 1.1% for historical controls. Other major complications included cardiac failure (0.9% of study patients), atrioventricular fistula or pseudoaneurysm at the groin puncture site (0.7%), and deep vein thrombosis or pulmonary thromboembolism (0.3%).

Medtronic funded the pivotal study on which approval of the Micra pacemaker was based. Dr. Reynolds had no relevant financial disclosures. Several coinvestigators reported financial relationships with Medtronic and several other cardiac device manufacturers.

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The Food and Drug Administration has approved the first leadless pacemaker, the Micra transcatheter pacing system, the FDA stated in a release accompanying its approval.

The Micra pacemaker eliminates the need for wired leads and the risk of associated complications. The single-chamber ventricular pacemaker is 93% smaller than traditional pacemakers, according to a summary document submitted to the FDA by Medtronic, which makes the device. Like other ventricular pacemakers, Micra provides rate-adaptive pacing, with automated pacing capture threshold management to maximize battery life, which the company estimates at about 10 years.

Courtesy Medtronic plc
The Micra leadless pacemaker is about 1/10 the size of traditional pacemakers.

The pacemaker is inserted directly into the right ventricle through the femoral vein by means of a steerable catheter. Pressing a button on the distal end of the catheter releases four flexible, electrically inactive nitinol tines that hook into the myocardium to secure the device. Engagement by two tines exerts 15 times the amount of force needed to secure the device in place, according to Medtronic.

The device’s approval was based on a pivotal prospective, nonrandomized uncontrolled study of 719 patients at 56 investigational sites in North America, Europe, Asia, Australia, and Africa. The primary efficacy endpoint, low and stable pacing capture thresholds at 6 months (up to 2.0 V at a pulse width of 0.24 milliseconds and an increase of up to 1.5 V from the time of implantation) was achieved for 98% of patients (95% confidence interval, 96%-99.5%), reported Dr. Dwight Reynolds of the University of Oklahoma Health Sciences Center in Oklahoma City and his associates (N Engl J Med. 2016 Feb. 11. doi: 10.1056/NEJMoa1511643).

The researchers also compared safety outcomes among Micra recipients and 2,667 historical controls from six previously published studies. The Micra pacemaker was associated with significantly lower hospitalization and system revision rates, with “no systemic infections, no pneumothoraxes, and no radiographically visible dislodgements or device emboli,” they said. In all, 4% of Micra recipients had complications leading to death or requiring invasive revision, treatment cessation, or hospitalization, which resembled recent reports of transvenous systems and was significantly lower than the rate for historical controls, according to the investigators. However, the rate of cardiac perforation or effusion was 1.6%, slightly higher than the rate of 1.1% for historical controls. Other major complications included cardiac failure (0.9% of study patients), atrioventricular fistula or pseudoaneurysm at the groin puncture site (0.7%), and deep vein thrombosis or pulmonary thromboembolism (0.3%).

Medtronic funded the pivotal study on which approval of the Micra pacemaker was based. Dr. Reynolds had no relevant financial disclosures. Several coinvestigators reported financial relationships with Medtronic and several other cardiac device manufacturers.

The Food and Drug Administration has approved the first leadless pacemaker, the Micra transcatheter pacing system, the FDA stated in a release accompanying its approval.

The Micra pacemaker eliminates the need for wired leads and the risk of associated complications. The single-chamber ventricular pacemaker is 93% smaller than traditional pacemakers, according to a summary document submitted to the FDA by Medtronic, which makes the device. Like other ventricular pacemakers, Micra provides rate-adaptive pacing, with automated pacing capture threshold management to maximize battery life, which the company estimates at about 10 years.

Courtesy Medtronic plc
The Micra leadless pacemaker is about 1/10 the size of traditional pacemakers.

The pacemaker is inserted directly into the right ventricle through the femoral vein by means of a steerable catheter. Pressing a button on the distal end of the catheter releases four flexible, electrically inactive nitinol tines that hook into the myocardium to secure the device. Engagement by two tines exerts 15 times the amount of force needed to secure the device in place, according to Medtronic.

The device’s approval was based on a pivotal prospective, nonrandomized uncontrolled study of 719 patients at 56 investigational sites in North America, Europe, Asia, Australia, and Africa. The primary efficacy endpoint, low and stable pacing capture thresholds at 6 months (up to 2.0 V at a pulse width of 0.24 milliseconds and an increase of up to 1.5 V from the time of implantation) was achieved for 98% of patients (95% confidence interval, 96%-99.5%), reported Dr. Dwight Reynolds of the University of Oklahoma Health Sciences Center in Oklahoma City and his associates (N Engl J Med. 2016 Feb. 11. doi: 10.1056/NEJMoa1511643).

The researchers also compared safety outcomes among Micra recipients and 2,667 historical controls from six previously published studies. The Micra pacemaker was associated with significantly lower hospitalization and system revision rates, with “no systemic infections, no pneumothoraxes, and no radiographically visible dislodgements or device emboli,” they said. In all, 4% of Micra recipients had complications leading to death or requiring invasive revision, treatment cessation, or hospitalization, which resembled recent reports of transvenous systems and was significantly lower than the rate for historical controls, according to the investigators. However, the rate of cardiac perforation or effusion was 1.6%, slightly higher than the rate of 1.1% for historical controls. Other major complications included cardiac failure (0.9% of study patients), atrioventricular fistula or pseudoaneurysm at the groin puncture site (0.7%), and deep vein thrombosis or pulmonary thromboembolism (0.3%).

Medtronic funded the pivotal study on which approval of the Micra pacemaker was based. Dr. Reynolds had no relevant financial disclosures. Several coinvestigators reported financial relationships with Medtronic and several other cardiac device manufacturers.

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HM16 AUDIO: U.S. Surgeon General Vivek Murthy, MD, MBA, Discusses Hospital Medicine's Role in Public Health

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HM16 AUDIO: Alyssa Stephany, MD, Talks about the HM16 RIV Scientific Abstract Competition

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Jennifer Ladd, MD, won an award for pediatric clinical vignette.

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Jennifer Ladd, MD, won an award for pediatric clinical vignette.

Alyssa Stephany, MD, then assistant professor at Duke and now section chief of pediatric hospital medicine at Children’s Hospital of Wisconsin, talks about the evolution in training stemming from her experience in the HM16 RIV competition. This year, she oversaw a study for which resident

Jennifer Ladd, MD, won an award for pediatric clinical vignette.

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HM16 AUDIO: Vineet Chopra, MD, MSc, Chats up His Research on Costs and Complications with PICC Line Usage

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RIV winner Vineet Chopra, MD, MSc, assistant professor at the University of Michigan in Ann Arbor, talks about his research on the costs and complications associated with PICC line use.

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RIV winner Vineet Chopra, MD, MSc, assistant professor at the University of Michigan in Ann Arbor, talks about his research on the costs and complications associated with PICC line use.

RIV winner Vineet Chopra, MD, MSc, assistant professor at the University of Michigan in Ann Arbor, talks about his research on the costs and complications associated with PICC line use.

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HM16 AUDIO: Jordan Romano Discusses Getting Published, Hospitalist Burnout

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