News for Your Practice

In order to identify the prevalence of concerns among postpartum women and the factors associated with them, the University of California–San Francisco (UCSF) began calling all of its obstetric patients through an automated phone call within 72 hours after hospital discharge.

Study details

All postpartum women from March to June 2017 were contacted after discharge via an automated call. Calls were considered successful if the woman engaged with the automated system; those who reported concerns were contacted by a nurse. UCSF researchers compared call success and presence of concerns by mode of delivery, insurance type (public or private), parity, pregnancy complication (diabetes, hypertension, hemorrhage), and neonatal intensive care (ICN) admission using univariate analyses and multivariable logistic regression.

A total of 881 women were called, and 730 (83%) were successfully contacted (meaning they engaged with the automated system through to the end of the call). About one-third of women (224 / 29%) reported a concern. Women with operative vaginal delivery were more likely to report an issue than spontaneous vaginal and cesarean delivery (42% vs 28%; P = .04). Nulliparous women also were more likely to report an issue (32% vs 25%; P = .05). They also were more likely to answer the call (86% vs 79%; P = .004). Women with public insurance were less likely to be successfully contacted (68% vs 84%; P = .003), but the frequency of concerns were equivalent (28% vs 29%). Women with neonates in the ICN were less likely to be successfully contacted. When controlling for confounders, nulliparity (odds ratio [OR], 1.5; 95% confidence interval [CI], 1.1–2.2) and private insurance (OR, 1.9; 95% CI, 1.1–3.8) both were independently associated with successful contact.

What do the results mean for practice?

Nulliparous women and women with operative vaginal deliveries may benefit from additional discharge support, concluded the researchers. “For most patients we can’t predict in advance if they will have an operative vaginal delivery but I do think that we could do more counseling in the antepartum period about different options or mode of delivery and include operative vaginal deliveries in that bucket, especially as we are doing more of them,” said Dr. Molly Siegel, Resident at UCSF. “In the postpartum period we probably should be thinking more about our instructions to those patients because we have cesarean delivery and vaginal delivery discharge instructions, and I think there needs to be something specific for operative vaginal delivery. Ultimately the goal is to improve our counseling of patients so that they don’t have as many questions after they leave the hospital.”

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

In order to identify the prevalence of concerns among postpartum women and the factors associated with them, the University of California–San Francisco (UCSF) began calling all of its obstetric patients through an automated phone call within 72 hours after hospital discharge.

Study details

All postpartum women from March to June 2017 were contacted after discharge via an automated call. Calls were considered successful if the woman engaged with the automated system; those who reported concerns were contacted by a nurse. UCSF researchers compared call success and presence of concerns by mode of delivery, insurance type (public or private), parity, pregnancy complication (diabetes, hypertension, hemorrhage), and neonatal intensive care (ICN) admission using univariate analyses and multivariable logistic regression.

A total of 881 women were called, and 730 (83%) were successfully contacted (meaning they engaged with the automated system through to the end of the call). About one-third of women (224 / 29%) reported a concern. Women with operative vaginal delivery were more likely to report an issue than spontaneous vaginal and cesarean delivery (42% vs 28%; P = .04). Nulliparous women also were more likely to report an issue (32% vs 25%; P = .05). They also were more likely to answer the call (86% vs 79%; P = .004). Women with public insurance were less likely to be successfully contacted (68% vs 84%; P = .003), but the frequency of concerns were equivalent (28% vs 29%). Women with neonates in the ICN were less likely to be successfully contacted. When controlling for confounders, nulliparity (odds ratio [OR], 1.5; 95% confidence interval [CI], 1.1–2.2) and private insurance (OR, 1.9; 95% CI, 1.1–3.8) both were independently associated with successful contact.

What do the results mean for practice?

Nulliparous women and women with operative vaginal deliveries may benefit from additional discharge support, concluded the researchers. “For most patients we can’t predict in advance if they will have an operative vaginal delivery but I do think that we could do more counseling in the antepartum period about different options or mode of delivery and include operative vaginal deliveries in that bucket, especially as we are doing more of them,” said Dr. Molly Siegel, Resident at UCSF. “In the postpartum period we probably should be thinking more about our instructions to those patients because we have cesarean delivery and vaginal delivery discharge instructions, and I think there needs to be something specific for operative vaginal delivery. Ultimately the goal is to improve our counseling of patients so that they don’t have as many questions after they leave the hospital.”

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

In order to identify the prevalence of concerns among postpartum women and the factors associated with them, the University of California–San Francisco (UCSF) began calling all of its obstetric patients through an automated phone call within 72 hours after hospital discharge.

Study details

All postpartum women from March to June 2017 were contacted after discharge via an automated call. Calls were considered successful if the woman engaged with the automated system; those who reported concerns were contacted by a nurse. UCSF researchers compared call success and presence of concerns by mode of delivery, insurance type (public or private), parity, pregnancy complication (diabetes, hypertension, hemorrhage), and neonatal intensive care (ICN) admission using univariate analyses and multivariable logistic regression.

A total of 881 women were called, and 730 (83%) were successfully contacted (meaning they engaged with the automated system through to the end of the call). About one-third of women (224 / 29%) reported a concern. Women with operative vaginal delivery were more likely to report an issue than spontaneous vaginal and cesarean delivery (42% vs 28%; P = .04). Nulliparous women also were more likely to report an issue (32% vs 25%; P = .05). They also were more likely to answer the call (86% vs 79%; P = .004). Women with public insurance were less likely to be successfully contacted (68% vs 84%; P = .003), but the frequency of concerns were equivalent (28% vs 29%). Women with neonates in the ICN were less likely to be successfully contacted. When controlling for confounders, nulliparity (odds ratio [OR], 1.5; 95% confidence interval [CI], 1.1–2.2) and private insurance (OR, 1.9; 95% CI, 1.1–3.8) both were independently associated with successful contact.

What do the results mean for practice?

Nulliparous women and women with operative vaginal deliveries may benefit from additional discharge support, concluded the researchers. “For most patients we can’t predict in advance if they will have an operative vaginal delivery but I do think that we could do more counseling in the antepartum period about different options or mode of delivery and include operative vaginal deliveries in that bucket, especially as we are doing more of them,” said Dr. Molly Siegel, Resident at UCSF. “In the postpartum period we probably should be thinking more about our instructions to those patients because we have cesarean delivery and vaginal delivery discharge instructions, and I think there needs to be something specific for operative vaginal delivery. Ultimately the goal is to improve our counseling of patients so that they don’t have as many questions after they leave the hospital.”

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Investigators at Thomas Jefferson University found that low-dose aspirin therapy in pregnant women with chronic hypertension—as recommended by the American College of Obstetricians and Gynecologists (ACOG) in 2016¹—was associated with a 57% decrease in superimposed preeclampsia. Chaitra Banala, BS, presented the study’s results in a poster presentation at the ACOG 2018 annual meeting (April 27–30, 2018, Austin, Texas).²

The study’s goal was to evaluate the incidence of superimposed preeclampsia in women with chronic hypertension in the periods before and after the ACOG recommendation was published.

Study participants. Pregnant women with chronic hypertension who delivered at Thomas Jefferson University Hospital from January 2008 to July 2017 were included in this retrospective cohort study. Women with multiple gestations were excluded.

The cohort included 715 pregnant patients with chronic hypertension divided into 2 groups: 635 pre-ACOG patients and 80 post-ACOG patients (that is, patients who delivered before and after the ACOG recommendation). The investigators offered daily low-dose (81 mg) aspirin.

The cohort was further stratified by additional risk factors for superimposed preeclampsia, including a history of preeclampsia and pregestational diabetes.

Outcomes. The primary outcome was the incidence of superimposed preeclampsia. Secondary outcomes included the incidence of superimposed preeclampsia with severe features (SIPSF), small for gestational age, and preterm birth.

Findings. The incidence of superimposed preeclampsia in women with chronic hypertension was 20 (25%) in the post-ACOG group versus 232 (37%) in the pre-ACOG group (odds ratio [OR], 0.43; 95% confidence interval [CI], 0.26–0.73).

In the subgroup of women with chronic hypertension who did not have other risk factors, superimposed preeclampsia and SIPSF were significantly decreased: 4/41 (10%) versus 106/355 (30%) (OR, 0.25 [95% CI, 0.08–0.73]) and 2/41 (5%) versus 65/355 (18%) (OR, 0.22 [95% CI, 0.54–0.97]), respectively. The maternal demographics and secondary outcomes did not differ significantly.

After the ACOG guidance was released, low-dose aspirin decreased superimposed preeclampsia by 57% in all women with chronic hypertension. Of those with chronic hypertension without other risk factors, there were decreases of 75% in superimposed preeclampsia and 78% in SIPSF.

Final thoughts. Ms. Banala said in an interview with OBG Management following her presentation, “When we stratified the cohort based on their risk factors, we found that aspirin had the highest benefit in patients with only chronic hypertension, so without other risk factors. And we found that there was a benefit in patients with chronic hypertension who were not on antihypertensive medication. So overall our study concluded that this guideline has made a significant impact in decreasing the frequency of superimposed preeclampsia.”

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Investigators at Thomas Jefferson University found that low-dose aspirin therapy in pregnant women with chronic hypertension—as recommended by the American College of Obstetricians and Gynecologists (ACOG) in 2016¹—was associated with a 57% decrease in superimposed preeclampsia. Chaitra Banala, BS, presented the study’s results in a poster presentation at the ACOG 2018 annual meeting (April 27–30, 2018, Austin, Texas).²

The study’s goal was to evaluate the incidence of superimposed preeclampsia in women with chronic hypertension in the periods before and after the ACOG recommendation was published.

Study participants. Pregnant women with chronic hypertension who delivered at Thomas Jefferson University Hospital from January 2008 to July 2017 were included in this retrospective cohort study. Women with multiple gestations were excluded.

The cohort included 715 pregnant patients with chronic hypertension divided into 2 groups: 635 pre-ACOG patients and 80 post-ACOG patients (that is, patients who delivered before and after the ACOG recommendation). The investigators offered daily low-dose (81 mg) aspirin.

The cohort was further stratified by additional risk factors for superimposed preeclampsia, including a history of preeclampsia and pregestational diabetes.

Outcomes. The primary outcome was the incidence of superimposed preeclampsia. Secondary outcomes included the incidence of superimposed preeclampsia with severe features (SIPSF), small for gestational age, and preterm birth.

Findings. The incidence of superimposed preeclampsia in women with chronic hypertension was 20 (25%) in the post-ACOG group versus 232 (37%) in the pre-ACOG group (odds ratio [OR], 0.43; 95% confidence interval [CI], 0.26–0.73).

In the subgroup of women with chronic hypertension who did not have other risk factors, superimposed preeclampsia and SIPSF were significantly decreased: 4/41 (10%) versus 106/355 (30%) (OR, 0.25 [95% CI, 0.08–0.73]) and 2/41 (5%) versus 65/355 (18%) (OR, 0.22 [95% CI, 0.54–0.97]), respectively. The maternal demographics and secondary outcomes did not differ significantly.

After the ACOG guidance was released, low-dose aspirin decreased superimposed preeclampsia by 57% in all women with chronic hypertension. Of those with chronic hypertension without other risk factors, there were decreases of 75% in superimposed preeclampsia and 78% in SIPSF.

Final thoughts. Ms. Banala said in an interview with OBG Management following her presentation, “When we stratified the cohort based on their risk factors, we found that aspirin had the highest benefit in patients with only chronic hypertension, so without other risk factors. And we found that there was a benefit in patients with chronic hypertension who were not on antihypertensive medication. So overall our study concluded that this guideline has made a significant impact in decreasing the frequency of superimposed preeclampsia.”

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Investigators at Thomas Jefferson University found that low-dose aspirin therapy in pregnant women with chronic hypertension—as recommended by the American College of Obstetricians and Gynecologists (ACOG) in 2016¹—was associated with a 57% decrease in superimposed preeclampsia. Chaitra Banala, BS, presented the study’s results in a poster presentation at the ACOG 2018 annual meeting (April 27–30, 2018, Austin, Texas).²

The study’s goal was to evaluate the incidence of superimposed preeclampsia in women with chronic hypertension in the periods before and after the ACOG recommendation was published.

Study participants. Pregnant women with chronic hypertension who delivered at Thomas Jefferson University Hospital from January 2008 to July 2017 were included in this retrospective cohort study. Women with multiple gestations were excluded.

The cohort included 715 pregnant patients with chronic hypertension divided into 2 groups: 635 pre-ACOG patients and 80 post-ACOG patients (that is, patients who delivered before and after the ACOG recommendation). The investigators offered daily low-dose (81 mg) aspirin.

The cohort was further stratified by additional risk factors for superimposed preeclampsia, including a history of preeclampsia and pregestational diabetes.

Outcomes. The primary outcome was the incidence of superimposed preeclampsia. Secondary outcomes included the incidence of superimposed preeclampsia with severe features (SIPSF), small for gestational age, and preterm birth.

Findings. The incidence of superimposed preeclampsia in women with chronic hypertension was 20 (25%) in the post-ACOG group versus 232 (37%) in the pre-ACOG group (odds ratio [OR], 0.43; 95% confidence interval [CI], 0.26–0.73).

In the subgroup of women with chronic hypertension who did not have other risk factors, superimposed preeclampsia and SIPSF were significantly decreased: 4/41 (10%) versus 106/355 (30%) (OR, 0.25 [95% CI, 0.08–0.73]) and 2/41 (5%) versus 65/355 (18%) (OR, 0.22 [95% CI, 0.54–0.97]), respectively. The maternal demographics and secondary outcomes did not differ significantly.

After the ACOG guidance was released, low-dose aspirin decreased superimposed preeclampsia by 57% in all women with chronic hypertension. Of those with chronic hypertension without other risk factors, there were decreases of 75% in superimposed preeclampsia and 78% in SIPSF.

Final thoughts. Ms. Banala said in an interview with OBG Management following her presentation, “When we stratified the cohort based on their risk factors, we found that aspirin had the highest benefit in patients with only chronic hypertension, so without other risk factors. And we found that there was a benefit in patients with chronic hypertension who were not on antihypertensive medication. So overall our study concluded that this guideline has made a significant impact in decreasing the frequency of superimposed preeclampsia.”

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Liletta, a levonorgestrel 52 mg contraceptive intrauterine system (IUS) (Allergan), is currently approved by the US Food and Drug Administration for up to 4 years of use. A multicenter trial is continuing to measure Liletta’s efficacy and safety for a total of 8 years of use.¹

Meanwhile, investigators led by Stephanie B. Teal, MD, from the University of Colorado, Aurora, have evaluated the 5-year data for Liletta. Researchers included David K. Turok, MD, from the University of Utah, Salt Lake City; Jeffrey T. Jensen, MD, from the Oregon Health & Science University, Portland; Beatrice A. Chen, MD, from the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Thomas D. Kimble, MD, from Eastern Virginia Medical School, Norfolk; and Mitchell D. Creinin, MD, from the University of California-Davis, Sacramento. Results were reported in a poster presentation at the Annual Clinical Meeting of the American College of Obstetricians and Gynecologists held in Austin, Texas, from April 27–30, 2018.¹

Study details

A total of 1,714 women aged 16−45 years were enrolled in the multicenter study for 5 years after successful IUS placement. This included 146 women aged 36−45 years who received the IUS for safety evaluation only, and 1,568 women aged 16−35 years who were evaluated for both safety and efficacy.¹

Results of the study

The 16−35-year-old participants included 1,011 (57.7%) nulliparous and 438 (25.1%) obese women. Among these participants, 9 pregnancies occurred, including 4 in nulliparous women and 1 in an obese woman. In this age group, 1 pregnancy occurred after perforation and 1 following expulsion. Six (67%) of the pregnancies were ectopic.¹

The Pearl Index in the first year was .15 (95% confidence interval [CI], .02−.55). Cumulative life-table pregnancy rates at the end of years 3 and 5 were .59 (95% CI, .28−1.25) and .92 (95% CI, .46–1.82), respectively.¹

Of the total participants, perforation occurred in 2 (0.1%) women, both within the first year. Expulsion occurred in 63 participants (3.7%), most (50 [80.6%]) during the first year. Eleven patients (0.6%) were found to have a pelvic infection. Thirty-nine women (2.3%) discontinued use of Liletta due to bleeding complaints, primarily (n = 29 [74.3%]) in the first year.¹

Conclusion

The researchers concluded that Liletta is highly effective and has an excellent safety profile over 5 years of use. Most adverse effects, including expulsion and discontinuation for bleeding, occurred during the first year.¹

Liletta, a levonorgestrel 52 mg contraceptive intrauterine system (IUS) (Allergan), is currently approved by the US Food and Drug Administration for up to 4 years of use. A multicenter trial is continuing to measure Liletta’s efficacy and safety for a total of 8 years of use.¹

Meanwhile, investigators led by Stephanie B. Teal, MD, from the University of Colorado, Aurora, have evaluated the 5-year data for Liletta. Researchers included David K. Turok, MD, from the University of Utah, Salt Lake City; Jeffrey T. Jensen, MD, from the Oregon Health & Science University, Portland; Beatrice A. Chen, MD, from the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Thomas D. Kimble, MD, from Eastern Virginia Medical School, Norfolk; and Mitchell D. Creinin, MD, from the University of California-Davis, Sacramento. Results were reported in a poster presentation at the Annual Clinical Meeting of the American College of Obstetricians and Gynecologists held in Austin, Texas, from April 27–30, 2018.¹

Study details

A total of 1,714 women aged 16−45 years were enrolled in the multicenter study for 5 years after successful IUS placement. This included 146 women aged 36−45 years who received the IUS for safety evaluation only, and 1,568 women aged 16−35 years who were evaluated for both safety and efficacy.¹

Results of the study

The 16−35-year-old participants included 1,011 (57.7%) nulliparous and 438 (25.1%) obese women. Among these participants, 9 pregnancies occurred, including 4 in nulliparous women and 1 in an obese woman. In this age group, 1 pregnancy occurred after perforation and 1 following expulsion. Six (67%) of the pregnancies were ectopic.¹

The Pearl Index in the first year was .15 (95% confidence interval [CI], .02−.55). Cumulative life-table pregnancy rates at the end of years 3 and 5 were .59 (95% CI, .28−1.25) and .92 (95% CI, .46–1.82), respectively.¹

Of the total participants, perforation occurred in 2 (0.1%) women, both within the first year. Expulsion occurred in 63 participants (3.7%), most (50 [80.6%]) during the first year. Eleven patients (0.6%) were found to have a pelvic infection. Thirty-nine women (2.3%) discontinued use of Liletta due to bleeding complaints, primarily (n = 29 [74.3%]) in the first year.¹

Conclusion

The researchers concluded that Liletta is highly effective and has an excellent safety profile over 5 years of use. Most adverse effects, including expulsion and discontinuation for bleeding, occurred during the first year.¹

Liletta, a levonorgestrel 52 mg contraceptive intrauterine system (IUS) (Allergan), is currently approved by the US Food and Drug Administration for up to 4 years of use. A multicenter trial is continuing to measure Liletta’s efficacy and safety for a total of 8 years of use.¹

Meanwhile, investigators led by Stephanie B. Teal, MD, from the University of Colorado, Aurora, have evaluated the 5-year data for Liletta. Researchers included David K. Turok, MD, from the University of Utah, Salt Lake City; Jeffrey T. Jensen, MD, from the Oregon Health & Science University, Portland; Beatrice A. Chen, MD, from the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Thomas D. Kimble, MD, from Eastern Virginia Medical School, Norfolk; and Mitchell D. Creinin, MD, from the University of California-Davis, Sacramento. Results were reported in a poster presentation at the Annual Clinical Meeting of the American College of Obstetricians and Gynecologists held in Austin, Texas, from April 27–30, 2018.¹

Study details

A total of 1,714 women aged 16−45 years were enrolled in the multicenter study for 5 years after successful IUS placement. This included 146 women aged 36−45 years who received the IUS for safety evaluation only, and 1,568 women aged 16−35 years who were evaluated for both safety and efficacy.¹

Results of the study

The 16−35-year-old participants included 1,011 (57.7%) nulliparous and 438 (25.1%) obese women. Among these participants, 9 pregnancies occurred, including 4 in nulliparous women and 1 in an obese woman. In this age group, 1 pregnancy occurred after perforation and 1 following expulsion. Six (67%) of the pregnancies were ectopic.¹

The Pearl Index in the first year was .15 (95% confidence interval [CI], .02−.55). Cumulative life-table pregnancy rates at the end of years 3 and 5 were .59 (95% CI, .28−1.25) and .92 (95% CI, .46–1.82), respectively.¹

Of the total participants, perforation occurred in 2 (0.1%) women, both within the first year. Expulsion occurred in 63 participants (3.7%), most (50 [80.6%]) during the first year. Eleven patients (0.6%) were found to have a pelvic infection. Thirty-nine women (2.3%) discontinued use of Liletta due to bleeding complaints, primarily (n = 29 [74.3%]) in the first year.¹

Conclusion

The researchers concluded that Liletta is highly effective and has an excellent safety profile over 5 years of use. Most adverse effects, including expulsion and discontinuation for bleeding, occurred during the first year.¹

3/13/18. DAY 3 AT SGS

A busy day gets underway

During a busy morning scientific session, Dr. Amit Sood (@amitsoodMD) delivered the TeLinde lecture, titled "Building resilience," which he defined as doing well when you should not be doing well. He walked meeting attendees through a few exercises, including practicing morning gratitude and finding curious moments. He received a well-deserved standing ovation.

After a quick lunch, the group reconvened for a riveting panel discussion regarding the future of ObGyn in the session, "What is the future of gynecologic surgery and the subspecialties?" Dr. Eric Sokol moderated the discussion, and the panelists included Dr. Carl Zimmerman representing general gynecology, Dr. Dee Fenner from urogynecology, Dr. Arnold Advincula from minimally invasive gynecologic surgery (MIGS), Dr. Javier Magrina from gynecologic oncology, and Dr. Wilma Larsen representing the American Board of Obstetrics and Gynecology (ABOG). Many opinions were shared, including the possibility of allowing residents to choose a track in obstetrics or gynecology. Clearly there is a lot to explore in the future of our field. As a MIGS fellow, it was great to hear Dr. Advincula define our specialty as "non-malignant, advanced pelvic surgery."

The FMIGS Young Alumni Network then met to hear Dr. Samar Nahas give a talk on "Life as you see it, from all the struggles to all the success." She gave an inspiring overview of her life and encouraged those in attendance to keep searching for their next goal in life, whether it be academic, career-related, family, or personal.

Taking in Orlando sun and fun

The afternoon was free for leisure, and many meeting attendees took advantage of the activities offered, including a golf tournament as well as ziplining at nearby Gatorland. Others, like myself, simply took the opportunity to enjoy the sun and warm weather in Orlando, especially while there was a nor'easter occurring back home.

SGS' Got Talent was the festive evening activity on the agenda, during which a competitive talent show occurred. Attendees were able to vote for their favorites while giving donations to the organization Surgeons Helping Advance Research & Education (SHARE). Highlights included a Disney sing-along and a rousing medley of Michael Jackson songs sung on the kazoo.

See you next year!

Tomorrow is the last day of #SGS2018. I look forward to returning to my MIGS fellowship at Bridgeport Hospital in Bridgeport, Connecticut, and sharing all that I have learned. Thank you to Dr. Nancy Frankel, SGS, and OBG Management and all the sponsors supporting the Fellow Scholar program for allowing us trainees to take part in this excellent conference! I am looking forward to #SGS2019 in Tucson, Arizona.

3/12/18. DAY 2 AT SGS

Something for everyone at Day 2 SGS sessions

This morning’s Scientific Sessions began with the Keynote address by Dr. James Merlino, President and Chief Medical Officer, Strategic Consulting, at Press Ganey, who spoke on “Patient Experience: It Is Not About Making People Happy.” Dr. Merlino opened with a personal anecdote about an experience he had with a poor hospital outcome. He reminded us that showing empathy can make a huge difference in patients’ perspectives on their experience and that “an engaged culture is essential to high performance.” He also emphasized that all physicians are leaders and that our involvement in patient safety and decreasing errors is essential.

Surgeons debate best approach for POP

Another highlight of the Scientific Sessions was the debate moderated by Dr. Peter Rosenblatt on “Optimal Surgical Management of Stage 3 and 4 Pelvic Organ Prolapse.” Drs. Rebecca Rogers, Patrick Culligan, and Vincent Lucente participated. The consensus was that Dr. Rogers won over the crowd, convincing us that native tissue repair is the answer. Excellent job by all the panelists for an informative—and entertaining—debate!

Focus on fellows

Immediately following the third Scientific Session, the fellows convened at the Fellows’ Pelvic Research Network (FPRN)^® meeting. After a quick joint session during which Dr. Donna Mazloomdoost gave an informative talk on the grant process at the National Institute of Child Health and Human Development (NICHD), the MIGS fellows broke out to review projects that are currently recruiting new sites and to hear a new proposal for a collaborative multicenter study.

President’s events

Evening activities included the President’s Awards Ceremony and the President’s Reception. Awards Ceremony notable moments included the “Honor your Mentor” session, during which the honored individuals were each recognized. Dr. Ralph Chesson then received the inaugural “Mentor of the Year” award, to much applause. Fellow/Resident awards were up next. Dr. Christina Jones received the President’s Award–Prize Paper for her oral presentation, “Liposomal bupivacaine efficacy for postoperative pain following posterior vaginal surgery: a randomized, double-blind, placebo-controlled trial.” Congratulations! The day concluded with the President’s Reception, where the food, drink, and conversation were plentiful.

Get appy

Finally, conference attendees were able to plan their meeting on their smartphones using the Event Pilot App, which also had a running Twitter thread under the hashtag #SGS2018. A Twitter scavenger hunt was also underway, with #speculumsunday, #maskmembermonday, and #trocartuesday. During this event attendees are encouraged to find the “object of the day,” Tweet a response to a prompt, and then bring the object to the social media booth to receive a prize.

Stay tuned to @ChrisTierneyMD for more live updates from #SGS2018.

Photo credit: Dr. Mohammad Islam @MoMIGSMD

3/11/18. DAY 1 AT SGS

Good morning from sunny Orlando!

It was a very early morning, due to the conveniently timed daylight savings to start the Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS). First on the agenda was the postgraduate (PG) course, “Endometriosis: Contemporary Approaches to Diagnosis and Treatment” led by Dr. Rosanne Kho. Excellent talks were given and reminded us that, as a specialty, we have made great strides in advancing the diagnosis and treatment of endometriosis. Nevertheless, there is much work to be done in developing a better classification system, including identifying markers that can help stratify the extent of disease.

A highlight was a question from the audience regarding the important facets of a physical exam in diagnosing deep endometriosis. Dr. Mauricio Abrao reviewed his strategy, which included palpating for adnexal masses, pain, or nodules in the cul-de-sac and evaluating trigger points along the psoas muscle. Dr. Scott Young, a radiologist, then provided some key signs to look for in pelvic magnetic resonance imaging and endovaginal ultrasound in diagnosing deep endometriosis. He reminded all of us that a partnership with an excellent radiology department is key in diagnosing and treating deep endometriosis effectively. Dr. Tommaso Falcone then gave an excellent overview of anatomy in relation to deep endometriosis, teaching us all about the different layers of the retroperitoneum.

An afternoon of simulation

After a quick break, it was on to the next course: “Train the Trainer: Comprehensive Hysterectomy Simulation Course for Educators.” Dr. Christine Vaccaro headed this interactive session, and started us off with a reminder that “simulation is the future, and we need to jump on board!” Unfortunately for trainees, the overall number of hysterectomies performed during residency are decreasing secondary to medical management available for abnormal uterine bleeding and the fact that the 4 years of ObGyn residency have a heavy focus on obstetrics. Therefore, it was great to hear Dr. Vaccaro say that the American Board of Obstetrics and Gynecology (ABOG) is requiring Fundamentals of Laparoscopic Surgery (FLSTM) training for those seeking board certification. Attendees of this session included a combination of trainers and trainees, so to speak, and we took turns rotating around models for abdominal, vaginal, laparoscopic, and robotic hysterectomies. I took the opportunity to learn some tips and tricks from experts like Dr. Ernie Lockrow during a simulated laparoscopic myomectomy, in which the struggle felt very real.

Mix and mingle

Other PG courses offered and attended throughout the day included: “Surgical Coding: Working through the Entire Procedure,” “Variations in the Management of the Vaginal Apex during Reconstructive Pelvic Surgery,” Gynecologic Care of Girls and Young Women Born with Urogenital Anomalies,” and “Social Media, Medicine and your Digital Footprint.” SGS Fellow Scholars were then invited to the “Senior Members Engaging Young Learners” event, designed to connect senior SGS members with residents and fellows. Here, residents and fellows mingled with distinguished faculty, many of them with red badges on their nametags, indicating 20 years of membership with SGS. I learned firsthand that connections are very easy to make in this friendly group, where everyone is willing to introduce you to someone who will help advance your career. After this, we moved straight onto the Welcome Reception, where conversations and connections continued.

I look forward to a full day tomorrow! Stay tuned to @ChrisTierneyMD for live updates from #SGS2018.

3/13/18. DAY 3 AT SGS

A busy day gets underway

During a busy morning scientific session, Dr. Amit Sood (@amitsoodMD) delivered the TeLinde lecture, titled "Building resilience," which he defined as doing well when you should not be doing well. He walked meeting attendees through a few exercises, including practicing morning gratitude and finding curious moments. He received a well-deserved standing ovation.

After a quick lunch, the group reconvened for a riveting panel discussion regarding the future of ObGyn in the session, "What is the future of gynecologic surgery and the subspecialties?" Dr. Eric Sokol moderated the discussion, and the panelists included Dr. Carl Zimmerman representing general gynecology, Dr. Dee Fenner from urogynecology, Dr. Arnold Advincula from minimally invasive gynecologic surgery (MIGS), Dr. Javier Magrina from gynecologic oncology, and Dr. Wilma Larsen representing the American Board of Obstetrics and Gynecology (ABOG). Many opinions were shared, including the possibility of allowing residents to choose a track in obstetrics or gynecology. Clearly there is a lot to explore in the future of our field. As a MIGS fellow, it was great to hear Dr. Advincula define our specialty as "non-malignant, advanced pelvic surgery."

The FMIGS Young Alumni Network then met to hear Dr. Samar Nahas give a talk on "Life as you see it, from all the struggles to all the success." She gave an inspiring overview of her life and encouraged those in attendance to keep searching for their next goal in life, whether it be academic, career-related, family, or personal.

Taking in Orlando sun and fun

The afternoon was free for leisure, and many meeting attendees took advantage of the activities offered, including a golf tournament as well as ziplining at nearby Gatorland. Others, like myself, simply took the opportunity to enjoy the sun and warm weather in Orlando, especially while there was a nor'easter occurring back home.

SGS' Got Talent was the festive evening activity on the agenda, during which a competitive talent show occurred. Attendees were able to vote for their favorites while giving donations to the organization Surgeons Helping Advance Research & Education (SHARE). Highlights included a Disney sing-along and a rousing medley of Michael Jackson songs sung on the kazoo.

See you next year!

Tomorrow is the last day of #SGS2018. I look forward to returning to my MIGS fellowship at Bridgeport Hospital in Bridgeport, Connecticut, and sharing all that I have learned. Thank you to Dr. Nancy Frankel, SGS, and OBG Management and all the sponsors supporting the Fellow Scholar program for allowing us trainees to take part in this excellent conference! I am looking forward to #SGS2019 in Tucson, Arizona.

3/12/18. DAY 2 AT SGS

Something for everyone at Day 2 SGS sessions

This morning’s Scientific Sessions began with the Keynote address by Dr. James Merlino, President and Chief Medical Officer, Strategic Consulting, at Press Ganey, who spoke on “Patient Experience: It Is Not About Making People Happy.” Dr. Merlino opened with a personal anecdote about an experience he had with a poor hospital outcome. He reminded us that showing empathy can make a huge difference in patients’ perspectives on their experience and that “an engaged culture is essential to high performance.” He also emphasized that all physicians are leaders and that our involvement in patient safety and decreasing errors is essential.

Surgeons debate best approach for POP

Another highlight of the Scientific Sessions was the debate moderated by Dr. Peter Rosenblatt on “Optimal Surgical Management of Stage 3 and 4 Pelvic Organ Prolapse.” Drs. Rebecca Rogers, Patrick Culligan, and Vincent Lucente participated. The consensus was that Dr. Rogers won over the crowd, convincing us that native tissue repair is the answer. Excellent job by all the panelists for an informative—and entertaining—debate!

Focus on fellows

Immediately following the third Scientific Session, the fellows convened at the Fellows’ Pelvic Research Network (FPRN)^® meeting. After a quick joint session during which Dr. Donna Mazloomdoost gave an informative talk on the grant process at the National Institute of Child Health and Human Development (NICHD), the MIGS fellows broke out to review projects that are currently recruiting new sites and to hear a new proposal for a collaborative multicenter study.

President’s events

Evening activities included the President’s Awards Ceremony and the President’s Reception. Awards Ceremony notable moments included the “Honor your Mentor” session, during which the honored individuals were each recognized. Dr. Ralph Chesson then received the inaugural “Mentor of the Year” award, to much applause. Fellow/Resident awards were up next. Dr. Christina Jones received the President’s Award–Prize Paper for her oral presentation, “Liposomal bupivacaine efficacy for postoperative pain following posterior vaginal surgery: a randomized, double-blind, placebo-controlled trial.” Congratulations! The day concluded with the President’s Reception, where the food, drink, and conversation were plentiful.

Get appy

Finally, conference attendees were able to plan their meeting on their smartphones using the Event Pilot App, which also had a running Twitter thread under the hashtag #SGS2018. A Twitter scavenger hunt was also underway, with #speculumsunday, #maskmembermonday, and #trocartuesday. During this event attendees are encouraged to find the “object of the day,” Tweet a response to a prompt, and then bring the object to the social media booth to receive a prize.

Stay tuned to @ChrisTierneyMD for more live updates from #SGS2018.

Photo credit: Dr. Mohammad Islam @MoMIGSMD

3/11/18. DAY 1 AT SGS

Good morning from sunny Orlando!

It was a very early morning, due to the conveniently timed daylight savings to start the Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS). First on the agenda was the postgraduate (PG) course, “Endometriosis: Contemporary Approaches to Diagnosis and Treatment” led by Dr. Rosanne Kho. Excellent talks were given and reminded us that, as a specialty, we have made great strides in advancing the diagnosis and treatment of endometriosis. Nevertheless, there is much work to be done in developing a better classification system, including identifying markers that can help stratify the extent of disease.

A highlight was a question from the audience regarding the important facets of a physical exam in diagnosing deep endometriosis. Dr. Mauricio Abrao reviewed his strategy, which included palpating for adnexal masses, pain, or nodules in the cul-de-sac and evaluating trigger points along the psoas muscle. Dr. Scott Young, a radiologist, then provided some key signs to look for in pelvic magnetic resonance imaging and endovaginal ultrasound in diagnosing deep endometriosis. He reminded all of us that a partnership with an excellent radiology department is key in diagnosing and treating deep endometriosis effectively. Dr. Tommaso Falcone then gave an excellent overview of anatomy in relation to deep endometriosis, teaching us all about the different layers of the retroperitoneum.

An afternoon of simulation

After a quick break, it was on to the next course: “Train the Trainer: Comprehensive Hysterectomy Simulation Course for Educators.” Dr. Christine Vaccaro headed this interactive session, and started us off with a reminder that “simulation is the future, and we need to jump on board!” Unfortunately for trainees, the overall number of hysterectomies performed during residency are decreasing secondary to medical management available for abnormal uterine bleeding and the fact that the 4 years of ObGyn residency have a heavy focus on obstetrics. Therefore, it was great to hear Dr. Vaccaro say that the American Board of Obstetrics and Gynecology (ABOG) is requiring Fundamentals of Laparoscopic Surgery (FLSTM) training for those seeking board certification. Attendees of this session included a combination of trainers and trainees, so to speak, and we took turns rotating around models for abdominal, vaginal, laparoscopic, and robotic hysterectomies. I took the opportunity to learn some tips and tricks from experts like Dr. Ernie Lockrow during a simulated laparoscopic myomectomy, in which the struggle felt very real.

Mix and mingle

Other PG courses offered and attended throughout the day included: “Surgical Coding: Working through the Entire Procedure,” “Variations in the Management of the Vaginal Apex during Reconstructive Pelvic Surgery,” Gynecologic Care of Girls and Young Women Born with Urogenital Anomalies,” and “Social Media, Medicine and your Digital Footprint.” SGS Fellow Scholars were then invited to the “Senior Members Engaging Young Learners” event, designed to connect senior SGS members with residents and fellows. Here, residents and fellows mingled with distinguished faculty, many of them with red badges on their nametags, indicating 20 years of membership with SGS. I learned firsthand that connections are very easy to make in this friendly group, where everyone is willing to introduce you to someone who will help advance your career. After this, we moved straight onto the Welcome Reception, where conversations and connections continued.

I look forward to a full day tomorrow! Stay tuned to @ChrisTierneyMD for live updates from #SGS2018.

3/13/18. DAY 3 AT SGS

A busy day gets underway

During a busy morning scientific session, Dr. Amit Sood (@amitsoodMD) delivered the TeLinde lecture, titled "Building resilience," which he defined as doing well when you should not be doing well. He walked meeting attendees through a few exercises, including practicing morning gratitude and finding curious moments. He received a well-deserved standing ovation.

After a quick lunch, the group reconvened for a riveting panel discussion regarding the future of ObGyn in the session, "What is the future of gynecologic surgery and the subspecialties?" Dr. Eric Sokol moderated the discussion, and the panelists included Dr. Carl Zimmerman representing general gynecology, Dr. Dee Fenner from urogynecology, Dr. Arnold Advincula from minimally invasive gynecologic surgery (MIGS), Dr. Javier Magrina from gynecologic oncology, and Dr. Wilma Larsen representing the American Board of Obstetrics and Gynecology (ABOG). Many opinions were shared, including the possibility of allowing residents to choose a track in obstetrics or gynecology. Clearly there is a lot to explore in the future of our field. As a MIGS fellow, it was great to hear Dr. Advincula define our specialty as "non-malignant, advanced pelvic surgery."

The FMIGS Young Alumni Network then met to hear Dr. Samar Nahas give a talk on "Life as you see it, from all the struggles to all the success." She gave an inspiring overview of her life and encouraged those in attendance to keep searching for their next goal in life, whether it be academic, career-related, family, or personal.

Taking in Orlando sun and fun

The afternoon was free for leisure, and many meeting attendees took advantage of the activities offered, including a golf tournament as well as ziplining at nearby Gatorland. Others, like myself, simply took the opportunity to enjoy the sun and warm weather in Orlando, especially while there was a nor'easter occurring back home.

SGS' Got Talent was the festive evening activity on the agenda, during which a competitive talent show occurred. Attendees were able to vote for their favorites while giving donations to the organization Surgeons Helping Advance Research & Education (SHARE). Highlights included a Disney sing-along and a rousing medley of Michael Jackson songs sung on the kazoo.

See you next year!

Tomorrow is the last day of #SGS2018. I look forward to returning to my MIGS fellowship at Bridgeport Hospital in Bridgeport, Connecticut, and sharing all that I have learned. Thank you to Dr. Nancy Frankel, SGS, and OBG Management and all the sponsors supporting the Fellow Scholar program for allowing us trainees to take part in this excellent conference! I am looking forward to #SGS2019 in Tucson, Arizona.

3/12/18. DAY 2 AT SGS

Something for everyone at Day 2 SGS sessions

This morning’s Scientific Sessions began with the Keynote address by Dr. James Merlino, President and Chief Medical Officer, Strategic Consulting, at Press Ganey, who spoke on “Patient Experience: It Is Not About Making People Happy.” Dr. Merlino opened with a personal anecdote about an experience he had with a poor hospital outcome. He reminded us that showing empathy can make a huge difference in patients’ perspectives on their experience and that “an engaged culture is essential to high performance.” He also emphasized that all physicians are leaders and that our involvement in patient safety and decreasing errors is essential.

Surgeons debate best approach for POP

Another highlight of the Scientific Sessions was the debate moderated by Dr. Peter Rosenblatt on “Optimal Surgical Management of Stage 3 and 4 Pelvic Organ Prolapse.” Drs. Rebecca Rogers, Patrick Culligan, and Vincent Lucente participated. The consensus was that Dr. Rogers won over the crowd, convincing us that native tissue repair is the answer. Excellent job by all the panelists for an informative—and entertaining—debate!

Focus on fellows

Immediately following the third Scientific Session, the fellows convened at the Fellows’ Pelvic Research Network (FPRN)^® meeting. After a quick joint session during which Dr. Donna Mazloomdoost gave an informative talk on the grant process at the National Institute of Child Health and Human Development (NICHD), the MIGS fellows broke out to review projects that are currently recruiting new sites and to hear a new proposal for a collaborative multicenter study.

President’s events

Evening activities included the President’s Awards Ceremony and the President’s Reception. Awards Ceremony notable moments included the “Honor your Mentor” session, during which the honored individuals were each recognized. Dr. Ralph Chesson then received the inaugural “Mentor of the Year” award, to much applause. Fellow/Resident awards were up next. Dr. Christina Jones received the President’s Award–Prize Paper for her oral presentation, “Liposomal bupivacaine efficacy for postoperative pain following posterior vaginal surgery: a randomized, double-blind, placebo-controlled trial.” Congratulations! The day concluded with the President’s Reception, where the food, drink, and conversation were plentiful.

Get appy

Finally, conference attendees were able to plan their meeting on their smartphones using the Event Pilot App, which also had a running Twitter thread under the hashtag #SGS2018. A Twitter scavenger hunt was also underway, with #speculumsunday, #maskmembermonday, and #trocartuesday. During this event attendees are encouraged to find the “object of the day,” Tweet a response to a prompt, and then bring the object to the social media booth to receive a prize.

Stay tuned to @ChrisTierneyMD for more live updates from #SGS2018.

Photo credit: Dr. Mohammad Islam @MoMIGSMD

3/11/18. DAY 1 AT SGS

Good morning from sunny Orlando!

It was a very early morning, due to the conveniently timed daylight savings to start the Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS). First on the agenda was the postgraduate (PG) course, “Endometriosis: Contemporary Approaches to Diagnosis and Treatment” led by Dr. Rosanne Kho. Excellent talks were given and reminded us that, as a specialty, we have made great strides in advancing the diagnosis and treatment of endometriosis. Nevertheless, there is much work to be done in developing a better classification system, including identifying markers that can help stratify the extent of disease.

A highlight was a question from the audience regarding the important facets of a physical exam in diagnosing deep endometriosis. Dr. Mauricio Abrao reviewed his strategy, which included palpating for adnexal masses, pain, or nodules in the cul-de-sac and evaluating trigger points along the psoas muscle. Dr. Scott Young, a radiologist, then provided some key signs to look for in pelvic magnetic resonance imaging and endovaginal ultrasound in diagnosing deep endometriosis. He reminded all of us that a partnership with an excellent radiology department is key in diagnosing and treating deep endometriosis effectively. Dr. Tommaso Falcone then gave an excellent overview of anatomy in relation to deep endometriosis, teaching us all about the different layers of the retroperitoneum.

An afternoon of simulation

After a quick break, it was on to the next course: “Train the Trainer: Comprehensive Hysterectomy Simulation Course for Educators.” Dr. Christine Vaccaro headed this interactive session, and started us off with a reminder that “simulation is the future, and we need to jump on board!” Unfortunately for trainees, the overall number of hysterectomies performed during residency are decreasing secondary to medical management available for abnormal uterine bleeding and the fact that the 4 years of ObGyn residency have a heavy focus on obstetrics. Therefore, it was great to hear Dr. Vaccaro say that the American Board of Obstetrics and Gynecology (ABOG) is requiring Fundamentals of Laparoscopic Surgery (FLSTM) training for those seeking board certification. Attendees of this session included a combination of trainers and trainees, so to speak, and we took turns rotating around models for abdominal, vaginal, laparoscopic, and robotic hysterectomies. I took the opportunity to learn some tips and tricks from experts like Dr. Ernie Lockrow during a simulated laparoscopic myomectomy, in which the struggle felt very real.

Mix and mingle

Other PG courses offered and attended throughout the day included: “Surgical Coding: Working through the Entire Procedure,” “Variations in the Management of the Vaginal Apex during Reconstructive Pelvic Surgery,” Gynecologic Care of Girls and Young Women Born with Urogenital Anomalies,” and “Social Media, Medicine and your Digital Footprint.” SGS Fellow Scholars were then invited to the “Senior Members Engaging Young Learners” event, designed to connect senior SGS members with residents and fellows. Here, residents and fellows mingled with distinguished faculty, many of them with red badges on their nametags, indicating 20 years of membership with SGS. I learned firsthand that connections are very easy to make in this friendly group, where everyone is willing to introduce you to someone who will help advance your career. After this, we moved straight onto the Welcome Reception, where conversations and connections continued.

I look forward to a full day tomorrow! Stay tuned to @ChrisTierneyMD for live updates from #SGS2018.

A US Food & Drug Administration (FDA) Drug Safety Communication concerning a New Class Warning for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) has been released. Gadolinium has been found to remain in patients’ bodies, including the brain, for months to years.¹

The FDA concluded that the benefit of all approved GBCAs outweighs any potential risks because gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function. To date, the only known adverse health effect related to gadolinium retention is a rare condition called nephrogenic systemic fibrosis that occurs in a small subgroup of patients with preexisting kidney failure. However, the FDA has recently received reports of adverse events involving multiple organ systems in patients with normal kidney function.¹

After a review by the Medical Imaging Drugs Advisory Committee, the FDA is requiring several actions¹:

• the development of a new Patient Medication Guide for GBCAs
• a requirement that every patient must read educational information before receiving a GBCA
• manufacturers of GBCAs must conduct human and animal studies to further assess the safety of these contrast agents.

FDA recommendations for your practice

The FDA advises that health care professionals should consider the retention characteristics of each agent when choosing a GBCA for patients who might be of higher risk for gadolinium retention.^1,2 These patients include¹:

• those requiring multiple lifetime doses
• pregnant women
• children
• patients with inflammatory conditions.

There are 2 types of GBCAs based on chemical structure: linear and macrocyclic. Linear GBCAs result in more retention and retention for a longer time than macrocyclic GBCAs.² A list of FDA-approved GBCAs with their chemical structures is found here: https://www.fda.gov/Drugs/DrugSafety/ucm589213.htm.²

Recommendations also state that repeated GBCA imaging studies be minimized when possible, particularly closely spaced MRI studies. However, necessary GBCA MRI scans should not be avoided or deferred.¹

Report adverse effects

Health care professionals and patients are encouraged to report adverse effects or side effects related to the use of GBCAs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program found here: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home.

A US Food & Drug Administration (FDA) Drug Safety Communication concerning a New Class Warning for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) has been released. Gadolinium has been found to remain in patients’ bodies, including the brain, for months to years.¹

The FDA concluded that the benefit of all approved GBCAs outweighs any potential risks because gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function. To date, the only known adverse health effect related to gadolinium retention is a rare condition called nephrogenic systemic fibrosis that occurs in a small subgroup of patients with preexisting kidney failure. However, the FDA has recently received reports of adverse events involving multiple organ systems in patients with normal kidney function.¹

After a review by the Medical Imaging Drugs Advisory Committee, the FDA is requiring several actions¹:

• the development of a new Patient Medication Guide for GBCAs
• a requirement that every patient must read educational information before receiving a GBCA
• manufacturers of GBCAs must conduct human and animal studies to further assess the safety of these contrast agents.

FDA recommendations for your practice

The FDA advises that health care professionals should consider the retention characteristics of each agent when choosing a GBCA for patients who might be of higher risk for gadolinium retention.^1,2 These patients include¹:

• those requiring multiple lifetime doses
• pregnant women
• children
• patients with inflammatory conditions.

There are 2 types of GBCAs based on chemical structure: linear and macrocyclic. Linear GBCAs result in more retention and retention for a longer time than macrocyclic GBCAs.² A list of FDA-approved GBCAs with their chemical structures is found here: https://www.fda.gov/Drugs/DrugSafety/ucm589213.htm.²

Recommendations also state that repeated GBCA imaging studies be minimized when possible, particularly closely spaced MRI studies. However, necessary GBCA MRI scans should not be avoided or deferred.¹

Report adverse effects

Health care professionals and patients are encouraged to report adverse effects or side effects related to the use of GBCAs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program found here: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home.

A US Food & Drug Administration (FDA) Drug Safety Communication concerning a New Class Warning for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) has been released. Gadolinium has been found to remain in patients’ bodies, including the brain, for months to years.¹

The FDA concluded that the benefit of all approved GBCAs outweighs any potential risks because gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function. To date, the only known adverse health effect related to gadolinium retention is a rare condition called nephrogenic systemic fibrosis that occurs in a small subgroup of patients with preexisting kidney failure. However, the FDA has recently received reports of adverse events involving multiple organ systems in patients with normal kidney function.¹

After a review by the Medical Imaging Drugs Advisory Committee, the FDA is requiring several actions¹:

• the development of a new Patient Medication Guide for GBCAs
• a requirement that every patient must read educational information before receiving a GBCA
• manufacturers of GBCAs must conduct human and animal studies to further assess the safety of these contrast agents.

FDA recommendations for your practice

The FDA advises that health care professionals should consider the retention characteristics of each agent when choosing a GBCA for patients who might be of higher risk for gadolinium retention.^1,2 These patients include¹:

• those requiring multiple lifetime doses
• pregnant women
• children
• patients with inflammatory conditions.

There are 2 types of GBCAs based on chemical structure: linear and macrocyclic. Linear GBCAs result in more retention and retention for a longer time than macrocyclic GBCAs.² A list of FDA-approved GBCAs with their chemical structures is found here: https://www.fda.gov/Drugs/DrugSafety/ucm589213.htm.²

Recommendations also state that repeated GBCA imaging studies be minimized when possible, particularly closely spaced MRI studies. However, necessary GBCA MRI scans should not be avoided or deferred.¹

Report adverse effects

Health care professionals and patients are encouraged to report adverse effects or side effects related to the use of GBCAs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program found here: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home.