OBG Management

“DOES PREOPERATIVE URODYNAMICS IMPROVE OUTCOMES FOR WOMEN UNDERGOING SURGERY FOR STRESS URINARY INCONTINENCE?” CHARLES W. NAGER, MD 
(EXAMINING THE EVIDENCE; AUGUST 2015)

Priorities for determining the etiology of incontinence
While I believe Dr. Nager’s approach accurately interprets current clinical evidence, it also reflects an inadequate paradigm. Whether or not incontinence surgery should be preceded by formal invasive urodynamic evaluation is not the question. As director of urodynamics at UConn, I understand that even the most advanced clinical urodynamics evaluation is limited in what it can measure. Nowhere in that data set is “determine the etiology of incontinence.” Therefore, the more appropriate question is: When should one consider 
urodynamic evaluation before making a diagnosis requiring therapy? The answer: By prioritizing aspects of lower urinary tract function.

As recommended by the International Continence Society, the diagnosing physician actually must conduct the urodynamic testing. This physician’s first priority is to determine if the bladder can maintain low storage pressures. History and physical examination must include an acknowledgment of potential causes, including chronic urethral obstruction or failure of autonomic/sympathetic regulation. Yes, in an otherwise healthy 45-year-old vaginally parous woman with stress urinary incontinence (SUI) symptoms, it is unlikely that storage pressures aren’t normally regulated. It takes little office visit time to reach that conclusion.

The diagnosing physician’s second priority is to determine the actual functional size of the urinary reservoir. Only the bladder can expel urine actively. Is there a bladder diverticulum or reflux into the upper tracts augmenting the reservoir? Bladder/urethral function is about volume management, yet the sphincteric mechanism is not tolerant of very high volumes, even in “normal” patients. Knowing reservoir volumes when leakage occurs and the relationship of these volumes to perceptions of “empty” and “full” is critical to determining how to respond to sphincteric insufficiency that produces SUI symptoms. I agree that an otherwise healthy 45-year-old vaginally parous woman with SUI symptoms will have a problem here. However, if the diagnosing physician has any reason to doubt that the urinary reservoir has the same functionality as the bladder and that operational 
volumes are “normal,” then 
video­urodynamic investigation is the most direct approach. 

The third priority during evaluation is to determine how the reservoir empties. What is the source of the expulsive pressure of voiding? What is the interaction of the expulsive pressure and the urethral opening? How effectively does the bladder empty? In an otherwise healthy 45-year-old vaginally parous woman with SUI symptoms, it is unlikely that there is a problem, but if the physician doesn’t consider how this patient’s bladder empties, determining how the sphincter is stressed during storage and how the patient might respond to intervention is impossible. If normal efficient voiding by detrusor pressurization cannot be assured by office evaluation, then urodynamic examination, including a pressure/flow study, is necessary. 

The last priority is to determine how the urine storage/emptying system is controlled. This is most important to the patient but least important for diagnosis. Often this can be deduced from a simple office evaluation that includes urinalysis, a voiding diary, standing stress test, possibly simple “office cystometry” (with a large Toomey syringe, a straight catheter, and saline solution), and the patient’s history. No aspect of this last priority requires invasive computerized urodynamics—unless the physician just cannot figure it out even after considering results of the first 3 steps. 

Once these evaluative priorities have been completed, a diagnosis can be considered and treatment options determined. But only then.
Phillip P. Smith, MD
Farmington, Connecticut

Dr. Nager responds:
Dr. Smith provides a very nice review of what the bladder and urethra need to do. As he points out, the most appropriate question is: When should one consider urodynamic evaluation before making a diagnosis requiring therapy? Well, when a reliable diagnosis cannot be made by history, physical examination, and simple office tests.

The literature suggests that a neurologically normal woman without prolapse and without previous incontinence surgeries can receive a reliable diagnosis without urodynamic testing. If she demonstrates SUI on office stress testing, she is not storing urine normally and urodynamics will confirm urodynamic stress incontinence 97% of the time.¹ If she voluntarily voids with a normal postvoid residual, her emptying function has been assessed and is normal.

I think Dr. Smith and I both agree that, “In an otherwise healthy 45-year-old vaginally parous woman with SUI symptoms, it is unlikely that there is a problem.” We also both agree that whenever the diagnosis is unclear, or the situation is complicated, urodynamic testing is a helpful tool to assess the bladder’s storage and emptying function. I perform urodynamics regularly in my practice; it just is not necessary before surgery in a woman without prolapse and without previous incontinence surgeries who demonstrates her SUI and has a normal urinalysis and normal postvoid residual. We seem to agree on that point also.

Reference

1. Nager C, Brubaker L, Litman H, et al; Urinary Incontinence Treatment Network. A randomized trial of urodynamic testing before stress-incontinence surgery. N Engl J Med. 2012;366(21):1987–1997.
    

Share your thoughts on this or other articles! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

“DOES PREOPERATIVE URODYNAMICS IMPROVE OUTCOMES FOR WOMEN UNDERGOING SURGERY FOR STRESS URINARY INCONTINENCE?” CHARLES W. NAGER, MD 
(EXAMINING THE EVIDENCE; AUGUST 2015)

Priorities for determining the etiology of incontinence
While I believe Dr. Nager’s approach accurately interprets current clinical evidence, it also reflects an inadequate paradigm. Whether or not incontinence surgery should be preceded by formal invasive urodynamic evaluation is not the question. As director of urodynamics at UConn, I understand that even the most advanced clinical urodynamics evaluation is limited in what it can measure. Nowhere in that data set is “determine the etiology of incontinence.” Therefore, the more appropriate question is: When should one consider 
urodynamic evaluation before making a diagnosis requiring therapy? The answer: By prioritizing aspects of lower urinary tract function.

As recommended by the International Continence Society, the diagnosing physician actually must conduct the urodynamic testing. This physician’s first priority is to determine if the bladder can maintain low storage pressures. History and physical examination must include an acknowledgment of potential causes, including chronic urethral obstruction or failure of autonomic/sympathetic regulation. Yes, in an otherwise healthy 45-year-old vaginally parous woman with stress urinary incontinence (SUI) symptoms, it is unlikely that storage pressures aren’t normally regulated. It takes little office visit time to reach that conclusion.

The diagnosing physician’s second priority is to determine the actual functional size of the urinary reservoir. Only the bladder can expel urine actively. Is there a bladder diverticulum or reflux into the upper tracts augmenting the reservoir? Bladder/urethral function is about volume management, yet the sphincteric mechanism is not tolerant of very high volumes, even in “normal” patients. Knowing reservoir volumes when leakage occurs and the relationship of these volumes to perceptions of “empty” and “full” is critical to determining how to respond to sphincteric insufficiency that produces SUI symptoms. I agree that an otherwise healthy 45-year-old vaginally parous woman with SUI symptoms will have a problem here. However, if the diagnosing physician has any reason to doubt that the urinary reservoir has the same functionality as the bladder and that operational 
volumes are “normal,” then 
video­urodynamic investigation is the most direct approach. 

The third priority during evaluation is to determine how the reservoir empties. What is the source of the expulsive pressure of voiding? What is the interaction of the expulsive pressure and the urethral opening? How effectively does the bladder empty? In an otherwise healthy 45-year-old vaginally parous woman with SUI symptoms, it is unlikely that there is a problem, but if the physician doesn’t consider how this patient’s bladder empties, determining how the sphincter is stressed during storage and how the patient might respond to intervention is impossible. If normal efficient voiding by detrusor pressurization cannot be assured by office evaluation, then urodynamic examination, including a pressure/flow study, is necessary. 

The last priority is to determine how the urine storage/emptying system is controlled. This is most important to the patient but least important for diagnosis. Often this can be deduced from a simple office evaluation that includes urinalysis, a voiding diary, standing stress test, possibly simple “office cystometry” (with a large Toomey syringe, a straight catheter, and saline solution), and the patient’s history. No aspect of this last priority requires invasive computerized urodynamics—unless the physician just cannot figure it out even after considering results of the first 3 steps. 

Once these evaluative priorities have been completed, a diagnosis can be considered and treatment options determined. But only then.
Phillip P. Smith, MD
Farmington, Connecticut

Dr. Nager responds:
Dr. Smith provides a very nice review of what the bladder and urethra need to do. As he points out, the most appropriate question is: When should one consider urodynamic evaluation before making a diagnosis requiring therapy? Well, when a reliable diagnosis cannot be made by history, physical examination, and simple office tests.

The literature suggests that a neurologically normal woman without prolapse and without previous incontinence surgeries can receive a reliable diagnosis without urodynamic testing. If she demonstrates SUI on office stress testing, she is not storing urine normally and urodynamics will confirm urodynamic stress incontinence 97% of the time.¹ If she voluntarily voids with a normal postvoid residual, her emptying function has been assessed and is normal.

I think Dr. Smith and I both agree that, “In an otherwise healthy 45-year-old vaginally parous woman with SUI symptoms, it is unlikely that there is a problem.” We also both agree that whenever the diagnosis is unclear, or the situation is complicated, urodynamic testing is a helpful tool to assess the bladder’s storage and emptying function. I perform urodynamics regularly in my practice; it just is not necessary before surgery in a woman without prolapse and without previous incontinence surgeries who demonstrates her SUI and has a normal urinalysis and normal postvoid residual. We seem to agree on that point also.

Reference

1. Nager C, Brubaker L, Litman H, et al; Urinary Incontinence Treatment Network. A randomized trial of urodynamic testing before stress-incontinence surgery. N Engl J Med. 2012;366(21):1987–1997.
    

Share your thoughts on this or other articles! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

“DOES PREOPERATIVE URODYNAMICS IMPROVE OUTCOMES FOR WOMEN UNDERGOING SURGERY FOR STRESS URINARY INCONTINENCE?” CHARLES W. NAGER, MD 
(EXAMINING THE EVIDENCE; AUGUST 2015)

Priorities for determining the etiology of incontinence
While I believe Dr. Nager’s approach accurately interprets current clinical evidence, it also reflects an inadequate paradigm. Whether or not incontinence surgery should be preceded by formal invasive urodynamic evaluation is not the question. As director of urodynamics at UConn, I understand that even the most advanced clinical urodynamics evaluation is limited in what it can measure. Nowhere in that data set is “determine the etiology of incontinence.” Therefore, the more appropriate question is: When should one consider 
urodynamic evaluation before making a diagnosis requiring therapy? The answer: By prioritizing aspects of lower urinary tract function.

As recommended by the International Continence Society, the diagnosing physician actually must conduct the urodynamic testing. This physician’s first priority is to determine if the bladder can maintain low storage pressures. History and physical examination must include an acknowledgment of potential causes, including chronic urethral obstruction or failure of autonomic/sympathetic regulation. Yes, in an otherwise healthy 45-year-old vaginally parous woman with stress urinary incontinence (SUI) symptoms, it is unlikely that storage pressures aren’t normally regulated. It takes little office visit time to reach that conclusion.

The diagnosing physician’s second priority is to determine the actual functional size of the urinary reservoir. Only the bladder can expel urine actively. Is there a bladder diverticulum or reflux into the upper tracts augmenting the reservoir? Bladder/urethral function is about volume management, yet the sphincteric mechanism is not tolerant of very high volumes, even in “normal” patients. Knowing reservoir volumes when leakage occurs and the relationship of these volumes to perceptions of “empty” and “full” is critical to determining how to respond to sphincteric insufficiency that produces SUI symptoms. I agree that an otherwise healthy 45-year-old vaginally parous woman with SUI symptoms will have a problem here. However, if the diagnosing physician has any reason to doubt that the urinary reservoir has the same functionality as the bladder and that operational 
volumes are “normal,” then 
video­urodynamic investigation is the most direct approach. 

The third priority during evaluation is to determine how the reservoir empties. What is the source of the expulsive pressure of voiding? What is the interaction of the expulsive pressure and the urethral opening? How effectively does the bladder empty? In an otherwise healthy 45-year-old vaginally parous woman with SUI symptoms, it is unlikely that there is a problem, but if the physician doesn’t consider how this patient’s bladder empties, determining how the sphincter is stressed during storage and how the patient might respond to intervention is impossible. If normal efficient voiding by detrusor pressurization cannot be assured by office evaluation, then urodynamic examination, including a pressure/flow study, is necessary. 

The last priority is to determine how the urine storage/emptying system is controlled. This is most important to the patient but least important for diagnosis. Often this can be deduced from a simple office evaluation that includes urinalysis, a voiding diary, standing stress test, possibly simple “office cystometry” (with a large Toomey syringe, a straight catheter, and saline solution), and the patient’s history. No aspect of this last priority requires invasive computerized urodynamics—unless the physician just cannot figure it out even after considering results of the first 3 steps. 

Once these evaluative priorities have been completed, a diagnosis can be considered and treatment options determined. But only then.
Phillip P. Smith, MD
Farmington, Connecticut

Dr. Nager responds:
Dr. Smith provides a very nice review of what the bladder and urethra need to do. As he points out, the most appropriate question is: When should one consider urodynamic evaluation before making a diagnosis requiring therapy? Well, when a reliable diagnosis cannot be made by history, physical examination, and simple office tests.

The literature suggests that a neurologically normal woman without prolapse and without previous incontinence surgeries can receive a reliable diagnosis without urodynamic testing. If she demonstrates SUI on office stress testing, she is not storing urine normally and urodynamics will confirm urodynamic stress incontinence 97% of the time.¹ If she voluntarily voids with a normal postvoid residual, her emptying function has been assessed and is normal.

I think Dr. Smith and I both agree that, “In an otherwise healthy 45-year-old vaginally parous woman with SUI symptoms, it is unlikely that there is a problem.” We also both agree that whenever the diagnosis is unclear, or the situation is complicated, urodynamic testing is a helpful tool to assess the bladder’s storage and emptying function. I perform urodynamics regularly in my practice; it just is not necessary before surgery in a woman without prolapse and without previous incontinence surgeries who demonstrates her SUI and has a normal urinalysis and normal postvoid residual. We seem to agree on that point also.

Reference

1. Nager C, Brubaker L, Litman H, et al; Urinary Incontinence Treatment Network. A randomized trial of urodynamic testing before stress-incontinence surgery. N Engl J Med. 2012;366(21):1987–1997.
    

Share your thoughts on this or other articles! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Case Miscarriage in a 29-year-old woman
A woman (G0P0) presents to her gynecologist with amenorrhea for 3 months and a positive home urine pregnancy test. She is 29 years of age. She denies any bleeding or pain and intends to continue the pregnancy, though it was unplanned. Results of office ultrasonography to assess fetal viability reveal an intrauterine gestation with an 8-mm fetal pole but no heartbeat. The diagnosis is miscarriage.

This case illustrates a typical miscarriage diagnosis; most women with miscarriage are asymptomatic and without serious bleeding requiring emergency 
intervention. The management options include surgical, medical, and expectant. Women should be offered all 3 of these, and clinicians should explain the risks and benefits of each approach. But while each strategy can be safe, effective, and acceptable, many women, as well as their health care providers, will benefit from office-based uterine aspiration. In this article, we present the data available on office-based manual vacuum aspiration (MVA) as well as procedure pointers and urge you to consider MVA in your practice for your patients.

Surgical management
Surgical management of miscarriage offers several clear advantages over medical and expectant management. Perhaps the most important advantage to patients is that surgery offers rapid resolution of miscarriage with the shortest duration of bleeding.^1,2 When skilled providers perform electric vacuum aspiration (EVA) or MVA in outpatient or emergency department settings, successful uterine evacuation is completed in a single medical encounter 99% of the time.¹ By comparison, several follow-up visits and additional ultrasounds may be required during medical or expectant management. Uterine aspiration rarely requires an operating room (OR). Such a setting should be limited to cases in which the clinical picture reflects:

Office-based MVA
Office-based MVA is well tolerated when performed using a combination of verbal distraction and reassurance, oral nonsteroidal anti-inflammatory drugs (NSAIDs), and a paracervical block with or without intravenous sedation.

Evidence on managing pain at MVA. Multiple studies have assessed preprocedure and postprocedure pain using NSAIDs, oral anxiolytics, and local anesthesia at the time of EVA or MVA.^3,4 Renner and colleagues found that women who received a paracervical block prior to MVA or EVA reported moderate levels of pain, according to a 100-point visual analogue scale (VAS), at the time of cervical dilation (mean, 42) and uterine aspiration (mean, 63).⁴ In this same study, patients’ willingness to treat a future pregnancy with EVA or MVA using local anesthesia and their overall satisfaction with the procedure was high (mean, 90 on 100-point VAS).

In-office advantages over the OR. Women and clinicians can avoid the extensive scheduling delays associated with ORs, as well as the complications associated with medical and expectant management, if office-based EVA and MVA services are readily available. Compared with surgical management of miscarriage in an OR, office-based EVA and MVA are faster to complete. For example, Dalton and colleagues compared patients undergoing first-trimester procedures in an office setting with those undergoing a procedure in an OR. The mean procedure time for women treated in an office was 10 minutes, compared with 19 minutes for women treated in the OR. In addition, women 
treated in an office setting spent a mean total of 97 minutes at the office; women treated in an OR spent a mean total of 290 minutes at the hospital.⁵

Patients’ satisfaction with care provided in the OR was comparable to patients’ satisfaction with care provided in a medical office. In fact, the median total satisfaction score was high among women who had a procedure in either setting (office score, 19 of 20; OR score, 20 of 20).

Cost and equipment for in-office MVA
Office-based surgical management of miscarriage is more cost-effective than OR-based management. In 2006, Dalton and colleagues conducted a cost analysis and found that average charges for office-based MVA were less than half the cost of charges for a dilation and curettage (D&C) in the OR ($968 vs $1,965, respectively).⁵

More recently, these researchers found that usual care (expectant or OR management) was more costly than a model that also included medical and office-based surgical options. They found that the expanded care model—with use of the OR only when needed—cost $1,033.29 per case. This was compared with $1,247.58 per case when management options did not include medical and office-based surgical treatments.⁶

The cost of supplies needed to initiate MVA services within an established outpatient gynecologist’s office is modest. Equipment includes manual vacuum aspirators; disposable cannulae of various sizes; reusable plastic or metal dilators; supplies for disinfection, allowing reuse of MVA aspirators; and supplies for examination of products of conception (POC; FIGURE 1).

According to WomanCare Global, manufacturer of the IPAS MVA Plus, equipment should be sterilized after each use with soap and water, medical cleaning solution (such as Cidex, SPOROX II, etc.), or autoclaving.⁷ If 2 reusable aspirators are purchased along with dilators, disposable cannulae, and tools for tissue assessment, the price of supplies is estimated at US $500.⁸ WomanCare Global also offers prepackaged, single-use aspirator kits, which may be ideal for the emergency department setting.⁹

The procedure
To view a video on the MVA device and procedure, including step-by-step technique (FIGURE 2), local anesthesia administration, choosing cannula size, and cervical dilation, visit the Managing Early Pregnancy Loss Web site (http://www.earlypregnancylossresources.org) and access “Videos.” The video “Uterine aspiration for EPL” is available under password protection and broken into chapters for viewing ease.

The risk of endometritis after surgical management of miscarriage is low. Antibiotic prophylaxis prior to MVA or EVA should be considered. Experts recommend giving a single dose of doxycycline 200 mg orally at least 1 hour prior to uterine aspiration.^2,10

Use of EVA or MVA for outpatient management of miscarriage yields the opportunity to conduct immediate gross examination of the evacuated tissue and to verify the presence of complete POC. The process is simple: rinse the specimen through a sieve with water or saline, placed in a clear glass container under a small water bath and backlit on a light box. This allows clinicians to separate uterine decidua and pregnancy tissues. “Floating” tissue in this manner is especially useful in patients with pregnancy of unknown location, as immediate confirmation of a gestational sac rules out ectopic pregnancy.

Examine evacuated tissue for macroscopic evidence of pregnancy. Chorionic villi, which arise from syncytiotrophoblasts, can be seen with the naked eye. Immediate evaluation of POC is also useful for patients who desire diagnostic testing to ascertain a cause of their miscarriage because evacuated tissue stored in saline may be sent to a laboratory for cytogenetic analysis.

Medical management
Management of miscarriage with misoprostol is also safe and acceptable to women, though it has a lower success rate than surgical management.

Comparing efficacy: Medical vs surgical management. The Management of Early Pregnancy Failure Trial (MEPF) is the largest randomized controlled trial comparing medical management of miscarriage to surgical management. This multicenter study compared treatment with office-based EVA or MVA to vaginal misoprostol 800 µg. A repeat dose of vaginal misoprostol was offered 48 hours after the initial dose if a gestational sac was present on ultrasound.

Findings from the MEPF trial revealed a 71% complete uterine evacuation rate after 
1 dose of misoprostol and an 84% rate after 
2 doses.¹ The average (SD) reported pain score documented within 48 hours of treatment with misoprostol or MVA/EVA was moderate (5.7 cm [2.4] on 10-cm VAS). The rate of infection or hospitalization was less than 1% in both treatment groups.

These data should provide patients who are clinically stable and who wish to avoid an invasive procedure reassurance that using medication for the management of miscarriage is a reasonable option.

Misoprostol. Use of misoprostol is associated with a longer median duration of bleeding compared with suction aspiration. After misoprostol, bleeding usually begins after several hours and may continue for weeks.¹¹ Based on 2-week prospective bleeding diary entries from the MEPF trial, women who used misoprostol for management of miscarriage were more likely to have any bleeding during the 2 weeks after initiation of treatment, compared with women who had suction aspiration.¹²

Clinically significant changes in hemoglobin levels are more common in women treated with misoprostol than in those who choose EVA or MVA; however, these differences rarely require hospitalization or transfusion.¹ Women who are considering use of misoprostol should be aware of common adverse effects, including nausea, vomiting, diarrhea, and low-grade temperature.

Medical management of miscarriage requires multiple office visits with repeat ultrasounds or serum beta–human chorionic gonadotropin (β-hCG) levels to confirm treatment success. In cases of medication failure (persistent gestational sac with or without bleeding) or suspected retained POC (endometrial stripe greater than 
30 mm measured on ultrasound or persistent vaginal bleeding remote from treatment), women should be prepared for surgical resolution of pregnancy and clinicians should be able to perform an office-based procedure.

Expectant management
Women who choose the “watch and wait” approach should be advised that the process is unpredictable and occasionally requires urgent surgical intervention. Successful resolution of pregnancies that are expectantly managed depends on the type of miscarriage diagnosed at initial presentation. Luise and colleagues conducted a prospective study of 451 women with miscarriage who declined medical and surgical management. They found that the watch-and-wait approach was successful in 91% of women with an incomplete abortion, 76% of women with missed abortion, and 66% of women with anembryonic pregnancies.¹³ Success was defined by the absence of vaginal bleeding and an anterior-posterior endometrial stripe measuring less than 15 mm 4 weeks after initial diagnosis of miscarriage.

Like medical management for miscarriage, expectant management requires multiple office visits plus repeat ultrasounds or β-hCG measurement trends to confirm treatment success. Women who fail expectant management will require medical or surgical intervention to resolve the pregnancy. For those who are seeking pregnancy right away, the unpredictability and longer time to resolution of miscarriage may render expectant management anxiety provoking and unacceptable.

Etiology: Do true and perceived causes match?
Miscarriage during the first 13 weeks of gestation occurs in at least 10% of all clinically diagnosed pregnancies.¹⁰ A recent survey administered by Bardos and colleagues 
assessed perceived prevalence and causes of miscarriage in more than 1,000 US men and women.¹⁴ The majority of respondents believed miscarriage is uncommon, occurring in less than 5% of pregnancies. Respondents also believed stressful events, lifting heavy objects, and prior use of intrauterine or hormonal contraception are often to blame for pregnancy loss.

Despite more than 3 decades of data confirming that more than 60% of early losses are associated with chromosomal abnormalities and that an additional 18% may be associated with fetal anomalies, women often blame themselves.¹⁵ Bardos and colleagues found that 47% of women felt guilty about the experience of miscarriage.

Diagnosis: Updated ultrasonography criteria issued
When miscarriage is suspected based on symptoms of pain and bleeding in preg-
nancy, obtain a thorough history and conduct a limited physical examination. If an intrauterine pregnancy (IUP) was previously identified, a repeat ultrasound can confirm the presence or absence of the gestational sac. If an IUP has not been documented, then additional studies, including serial serum β-hCG examinations and ultrasonography, are essential to rule out ectopic pregnancy. Rh status should be determined and a 50-µg dose of Rh(D)-immune globulin administered to Rh(D)-unsensitized women within 72 hours of documented bleeding.

Ultrasonography is often used to diagnose miscarriage. Many gynecologists use ultrasound criteria based on studies conducted in the early 1990s that define nonviability by an empty gestational sac with mean gestational sac diameter greater than 16 mm or a crown-rump length (CRL) without evidence of fetal cardiac activity greater than 5 mm.¹⁰ In 2012, members of the Society of Radiologists in Ultrasound Multispecialty Panel on Early First Trimester Diagnosis of Miscarriage and Exclusion of a Viable Intrauterine Pregnancy developed more conservative criteria for the diagnosis of miscarriage.¹⁶

Doubilet and colleagues suggested new cutoffs, based on their reanalysis of 2 large prospective studies conducted in the United Kingdom.¹⁷ Calculations for these new cut-offs are based on mathematical adjustments for interobserver variability. Strict adherence to these more conservative criteria is sensible when a pregnancy is desired. For women who do not want to continue the pregnancy there is no medical justification for using this diagnostic process. Indeed, delays can lead to stress and poor outcomes including emergent surgical management for spontaneous and heavy bleeding.

Culture change is needed
Patients’ beliefs and scientific evidence about miscarriage are incongruous. By making simple changes in practice and providing straightforward patient education, ObGyns
can demystify the causes of miscarriage and improve its management. In particular, providing office-based MVA when requested can streamline treatment for many women. For too long, patients have blamed themselves for miscarriage and physicians have relied on D&C in the OR. Changes in culture surrounding miscarriage are 
long overdue.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Case Miscarriage in a 29-year-old woman
A woman (G0P0) presents to her gynecologist with amenorrhea for 3 months and a positive home urine pregnancy test. She is 29 years of age. She denies any bleeding or pain and intends to continue the pregnancy, though it was unplanned. Results of office ultrasonography to assess fetal viability reveal an intrauterine gestation with an 8-mm fetal pole but no heartbeat. The diagnosis is miscarriage.

This case illustrates a typical miscarriage diagnosis; most women with miscarriage are asymptomatic and without serious bleeding requiring emergency 
intervention. The management options include surgical, medical, and expectant. Women should be offered all 3 of these, and clinicians should explain the risks and benefits of each approach. But while each strategy can be safe, effective, and acceptable, many women, as well as their health care providers, will benefit from office-based uterine aspiration. In this article, we present the data available on office-based manual vacuum aspiration (MVA) as well as procedure pointers and urge you to consider MVA in your practice for your patients.

Surgical management
Surgical management of miscarriage offers several clear advantages over medical and expectant management. Perhaps the most important advantage to patients is that surgery offers rapid resolution of miscarriage with the shortest duration of bleeding.^1,2 When skilled providers perform electric vacuum aspiration (EVA) or MVA in outpatient or emergency department settings, successful uterine evacuation is completed in a single medical encounter 99% of the time.¹ By comparison, several follow-up visits and additional ultrasounds may be required during medical or expectant management. Uterine aspiration rarely requires an operating room (OR). Such a setting should be limited to cases in which the clinical picture reflects:

Office-based MVA
Office-based MVA is well tolerated when performed using a combination of verbal distraction and reassurance, oral nonsteroidal anti-inflammatory drugs (NSAIDs), and a paracervical block with or without intravenous sedation.

Evidence on managing pain at MVA. Multiple studies have assessed preprocedure and postprocedure pain using NSAIDs, oral anxiolytics, and local anesthesia at the time of EVA or MVA.^3,4 Renner and colleagues found that women who received a paracervical block prior to MVA or EVA reported moderate levels of pain, according to a 100-point visual analogue scale (VAS), at the time of cervical dilation (mean, 42) and uterine aspiration (mean, 63).⁴ In this same study, patients’ willingness to treat a future pregnancy with EVA or MVA using local anesthesia and their overall satisfaction with the procedure was high (mean, 90 on 100-point VAS).

In-office advantages over the OR. Women and clinicians can avoid the extensive scheduling delays associated with ORs, as well as the complications associated with medical and expectant management, if office-based EVA and MVA services are readily available. Compared with surgical management of miscarriage in an OR, office-based EVA and MVA are faster to complete. For example, Dalton and colleagues compared patients undergoing first-trimester procedures in an office setting with those undergoing a procedure in an OR. The mean procedure time for women treated in an office was 10 minutes, compared with 19 minutes for women treated in the OR. In addition, women 
treated in an office setting spent a mean total of 97 minutes at the office; women treated in an OR spent a mean total of 290 minutes at the hospital.⁵

Patients’ satisfaction with care provided in the OR was comparable to patients’ satisfaction with care provided in a medical office. In fact, the median total satisfaction score was high among women who had a procedure in either setting (office score, 19 of 20; OR score, 20 of 20).

Cost and equipment for in-office MVA
Office-based surgical management of miscarriage is more cost-effective than OR-based management. In 2006, Dalton and colleagues conducted a cost analysis and found that average charges for office-based MVA were less than half the cost of charges for a dilation and curettage (D&C) in the OR ($968 vs $1,965, respectively).⁵

More recently, these researchers found that usual care (expectant or OR management) was more costly than a model that also included medical and office-based surgical options. They found that the expanded care model—with use of the OR only when needed—cost $1,033.29 per case. This was compared with $1,247.58 per case when management options did not include medical and office-based surgical treatments.⁶

The cost of supplies needed to initiate MVA services within an established outpatient gynecologist’s office is modest. Equipment includes manual vacuum aspirators; disposable cannulae of various sizes; reusable plastic or metal dilators; supplies for disinfection, allowing reuse of MVA aspirators; and supplies for examination of products of conception (POC; FIGURE 1).

According to WomanCare Global, manufacturer of the IPAS MVA Plus, equipment should be sterilized after each use with soap and water, medical cleaning solution (such as Cidex, SPOROX II, etc.), or autoclaving.⁷ If 2 reusable aspirators are purchased along with dilators, disposable cannulae, and tools for tissue assessment, the price of supplies is estimated at US $500.⁸ WomanCare Global also offers prepackaged, single-use aspirator kits, which may be ideal for the emergency department setting.⁹

The procedure
To view a video on the MVA device and procedure, including step-by-step technique (FIGURE 2), local anesthesia administration, choosing cannula size, and cervical dilation, visit the Managing Early Pregnancy Loss Web site (http://www.earlypregnancylossresources.org) and access “Videos.” The video “Uterine aspiration for EPL” is available under password protection and broken into chapters for viewing ease.

The risk of endometritis after surgical management of miscarriage is low. Antibiotic prophylaxis prior to MVA or EVA should be considered. Experts recommend giving a single dose of doxycycline 200 mg orally at least 1 hour prior to uterine aspiration.^2,10

Use of EVA or MVA for outpatient management of miscarriage yields the opportunity to conduct immediate gross examination of the evacuated tissue and to verify the presence of complete POC. The process is simple: rinse the specimen through a sieve with water or saline, placed in a clear glass container under a small water bath and backlit on a light box. This allows clinicians to separate uterine decidua and pregnancy tissues. “Floating” tissue in this manner is especially useful in patients with pregnancy of unknown location, as immediate confirmation of a gestational sac rules out ectopic pregnancy.

Examine evacuated tissue for macroscopic evidence of pregnancy. Chorionic villi, which arise from syncytiotrophoblasts, can be seen with the naked eye. Immediate evaluation of POC is also useful for patients who desire diagnostic testing to ascertain a cause of their miscarriage because evacuated tissue stored in saline may be sent to a laboratory for cytogenetic analysis.

Medical management
Management of miscarriage with misoprostol is also safe and acceptable to women, though it has a lower success rate than surgical management.

Comparing efficacy: Medical vs surgical management. The Management of Early Pregnancy Failure Trial (MEPF) is the largest randomized controlled trial comparing medical management of miscarriage to surgical management. This multicenter study compared treatment with office-based EVA or MVA to vaginal misoprostol 800 µg. A repeat dose of vaginal misoprostol was offered 48 hours after the initial dose if a gestational sac was present on ultrasound.

Findings from the MEPF trial revealed a 71% complete uterine evacuation rate after 
1 dose of misoprostol and an 84% rate after 
2 doses.¹ The average (SD) reported pain score documented within 48 hours of treatment with misoprostol or MVA/EVA was moderate (5.7 cm [2.4] on 10-cm VAS). The rate of infection or hospitalization was less than 1% in both treatment groups.

These data should provide patients who are clinically stable and who wish to avoid an invasive procedure reassurance that using medication for the management of miscarriage is a reasonable option.

Misoprostol. Use of misoprostol is associated with a longer median duration of bleeding compared with suction aspiration. After misoprostol, bleeding usually begins after several hours and may continue for weeks.¹¹ Based on 2-week prospective bleeding diary entries from the MEPF trial, women who used misoprostol for management of miscarriage were more likely to have any bleeding during the 2 weeks after initiation of treatment, compared with women who had suction aspiration.¹²

Clinically significant changes in hemoglobin levels are more common in women treated with misoprostol than in those who choose EVA or MVA; however, these differences rarely require hospitalization or transfusion.¹ Women who are considering use of misoprostol should be aware of common adverse effects, including nausea, vomiting, diarrhea, and low-grade temperature.

Medical management of miscarriage requires multiple office visits with repeat ultrasounds or serum beta–human chorionic gonadotropin (β-hCG) levels to confirm treatment success. In cases of medication failure (persistent gestational sac with or without bleeding) or suspected retained POC (endometrial stripe greater than 
30 mm measured on ultrasound or persistent vaginal bleeding remote from treatment), women should be prepared for surgical resolution of pregnancy and clinicians should be able to perform an office-based procedure.

Expectant management
Women who choose the “watch and wait” approach should be advised that the process is unpredictable and occasionally requires urgent surgical intervention. Successful resolution of pregnancies that are expectantly managed depends on the type of miscarriage diagnosed at initial presentation. Luise and colleagues conducted a prospective study of 451 women with miscarriage who declined medical and surgical management. They found that the watch-and-wait approach was successful in 91% of women with an incomplete abortion, 76% of women with missed abortion, and 66% of women with anembryonic pregnancies.¹³ Success was defined by the absence of vaginal bleeding and an anterior-posterior endometrial stripe measuring less than 15 mm 4 weeks after initial diagnosis of miscarriage.

Like medical management for miscarriage, expectant management requires multiple office visits plus repeat ultrasounds or β-hCG measurement trends to confirm treatment success. Women who fail expectant management will require medical or surgical intervention to resolve the pregnancy. For those who are seeking pregnancy right away, the unpredictability and longer time to resolution of miscarriage may render expectant management anxiety provoking and unacceptable.

Etiology: Do true and perceived causes match?
Miscarriage during the first 13 weeks of gestation occurs in at least 10% of all clinically diagnosed pregnancies.¹⁰ A recent survey administered by Bardos and colleagues 
assessed perceived prevalence and causes of miscarriage in more than 1,000 US men and women.¹⁴ The majority of respondents believed miscarriage is uncommon, occurring in less than 5% of pregnancies. Respondents also believed stressful events, lifting heavy objects, and prior use of intrauterine or hormonal contraception are often to blame for pregnancy loss.

Despite more than 3 decades of data confirming that more than 60% of early losses are associated with chromosomal abnormalities and that an additional 18% may be associated with fetal anomalies, women often blame themselves.¹⁵ Bardos and colleagues found that 47% of women felt guilty about the experience of miscarriage.

Diagnosis: Updated ultrasonography criteria issued
When miscarriage is suspected based on symptoms of pain and bleeding in preg-
nancy, obtain a thorough history and conduct a limited physical examination. If an intrauterine pregnancy (IUP) was previously identified, a repeat ultrasound can confirm the presence or absence of the gestational sac. If an IUP has not been documented, then additional studies, including serial serum β-hCG examinations and ultrasonography, are essential to rule out ectopic pregnancy. Rh status should be determined and a 50-µg dose of Rh(D)-immune globulin administered to Rh(D)-unsensitized women within 72 hours of documented bleeding.

Ultrasonography is often used to diagnose miscarriage. Many gynecologists use ultrasound criteria based on studies conducted in the early 1990s that define nonviability by an empty gestational sac with mean gestational sac diameter greater than 16 mm or a crown-rump length (CRL) without evidence of fetal cardiac activity greater than 5 mm.¹⁰ In 2012, members of the Society of Radiologists in Ultrasound Multispecialty Panel on Early First Trimester Diagnosis of Miscarriage and Exclusion of a Viable Intrauterine Pregnancy developed more conservative criteria for the diagnosis of miscarriage.¹⁶

Doubilet and colleagues suggested new cutoffs, based on their reanalysis of 2 large prospective studies conducted in the United Kingdom.¹⁷ Calculations for these new cut-offs are based on mathematical adjustments for interobserver variability. Strict adherence to these more conservative criteria is sensible when a pregnancy is desired. For women who do not want to continue the pregnancy there is no medical justification for using this diagnostic process. Indeed, delays can lead to stress and poor outcomes including emergent surgical management for spontaneous and heavy bleeding.

Culture change is needed
Patients’ beliefs and scientific evidence about miscarriage are incongruous. By making simple changes in practice and providing straightforward patient education, ObGyns
can demystify the causes of miscarriage and improve its management. In particular, providing office-based MVA when requested can streamline treatment for many women. For too long, patients have blamed themselves for miscarriage and physicians have relied on D&C in the OR. Changes in culture surrounding miscarriage are 
long overdue.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Case Miscarriage in a 29-year-old woman
A woman (G0P0) presents to her gynecologist with amenorrhea for 3 months and a positive home urine pregnancy test. She is 29 years of age. She denies any bleeding or pain and intends to continue the pregnancy, though it was unplanned. Results of office ultrasonography to assess fetal viability reveal an intrauterine gestation with an 8-mm fetal pole but no heartbeat. The diagnosis is miscarriage.

This case illustrates a typical miscarriage diagnosis; most women with miscarriage are asymptomatic and without serious bleeding requiring emergency 
intervention. The management options include surgical, medical, and expectant. Women should be offered all 3 of these, and clinicians should explain the risks and benefits of each approach. But while each strategy can be safe, effective, and acceptable, many women, as well as their health care providers, will benefit from office-based uterine aspiration. In this article, we present the data available on office-based manual vacuum aspiration (MVA) as well as procedure pointers and urge you to consider MVA in your practice for your patients.

Surgical management
Surgical management of miscarriage offers several clear advantages over medical and expectant management. Perhaps the most important advantage to patients is that surgery offers rapid resolution of miscarriage with the shortest duration of bleeding.^1,2 When skilled providers perform electric vacuum aspiration (EVA) or MVA in outpatient or emergency department settings, successful uterine evacuation is completed in a single medical encounter 99% of the time.¹ By comparison, several follow-up visits and additional ultrasounds may be required during medical or expectant management. Uterine aspiration rarely requires an operating room (OR). Such a setting should be limited to cases in which the clinical picture reflects:

Office-based MVA
Office-based MVA is well tolerated when performed using a combination of verbal distraction and reassurance, oral nonsteroidal anti-inflammatory drugs (NSAIDs), and a paracervical block with or without intravenous sedation.

Evidence on managing pain at MVA. Multiple studies have assessed preprocedure and postprocedure pain using NSAIDs, oral anxiolytics, and local anesthesia at the time of EVA or MVA.^3,4 Renner and colleagues found that women who received a paracervical block prior to MVA or EVA reported moderate levels of pain, according to a 100-point visual analogue scale (VAS), at the time of cervical dilation (mean, 42) and uterine aspiration (mean, 63).⁴ In this same study, patients’ willingness to treat a future pregnancy with EVA or MVA using local anesthesia and their overall satisfaction with the procedure was high (mean, 90 on 100-point VAS).

In-office advantages over the OR. Women and clinicians can avoid the extensive scheduling delays associated with ORs, as well as the complications associated with medical and expectant management, if office-based EVA and MVA services are readily available. Compared with surgical management of miscarriage in an OR, office-based EVA and MVA are faster to complete. For example, Dalton and colleagues compared patients undergoing first-trimester procedures in an office setting with those undergoing a procedure in an OR. The mean procedure time for women treated in an office was 10 minutes, compared with 19 minutes for women treated in the OR. In addition, women 
treated in an office setting spent a mean total of 97 minutes at the office; women treated in an OR spent a mean total of 290 minutes at the hospital.⁵

Patients’ satisfaction with care provided in the OR was comparable to patients’ satisfaction with care provided in a medical office. In fact, the median total satisfaction score was high among women who had a procedure in either setting (office score, 19 of 20; OR score, 20 of 20).

Cost and equipment for in-office MVA
Office-based surgical management of miscarriage is more cost-effective than OR-based management. In 2006, Dalton and colleagues conducted a cost analysis and found that average charges for office-based MVA were less than half the cost of charges for a dilation and curettage (D&C) in the OR ($968 vs $1,965, respectively).⁵

More recently, these researchers found that usual care (expectant or OR management) was more costly than a model that also included medical and office-based surgical options. They found that the expanded care model—with use of the OR only when needed—cost $1,033.29 per case. This was compared with $1,247.58 per case when management options did not include medical and office-based surgical treatments.⁶

The cost of supplies needed to initiate MVA services within an established outpatient gynecologist’s office is modest. Equipment includes manual vacuum aspirators; disposable cannulae of various sizes; reusable plastic or metal dilators; supplies for disinfection, allowing reuse of MVA aspirators; and supplies for examination of products of conception (POC; FIGURE 1).

According to WomanCare Global, manufacturer of the IPAS MVA Plus, equipment should be sterilized after each use with soap and water, medical cleaning solution (such as Cidex, SPOROX II, etc.), or autoclaving.⁷ If 2 reusable aspirators are purchased along with dilators, disposable cannulae, and tools for tissue assessment, the price of supplies is estimated at US $500.⁸ WomanCare Global also offers prepackaged, single-use aspirator kits, which may be ideal for the emergency department setting.⁹

The procedure
To view a video on the MVA device and procedure, including step-by-step technique (FIGURE 2), local anesthesia administration, choosing cannula size, and cervical dilation, visit the Managing Early Pregnancy Loss Web site (http://www.earlypregnancylossresources.org) and access “Videos.” The video “Uterine aspiration for EPL” is available under password protection and broken into chapters for viewing ease.

The risk of endometritis after surgical management of miscarriage is low. Antibiotic prophylaxis prior to MVA or EVA should be considered. Experts recommend giving a single dose of doxycycline 200 mg orally at least 1 hour prior to uterine aspiration.^2,10

Use of EVA or MVA for outpatient management of miscarriage yields the opportunity to conduct immediate gross examination of the evacuated tissue and to verify the presence of complete POC. The process is simple: rinse the specimen through a sieve with water or saline, placed in a clear glass container under a small water bath and backlit on a light box. This allows clinicians to separate uterine decidua and pregnancy tissues. “Floating” tissue in this manner is especially useful in patients with pregnancy of unknown location, as immediate confirmation of a gestational sac rules out ectopic pregnancy.

Examine evacuated tissue for macroscopic evidence of pregnancy. Chorionic villi, which arise from syncytiotrophoblasts, can be seen with the naked eye. Immediate evaluation of POC is also useful for patients who desire diagnostic testing to ascertain a cause of their miscarriage because evacuated tissue stored in saline may be sent to a laboratory for cytogenetic analysis.

Medical management
Management of miscarriage with misoprostol is also safe and acceptable to women, though it has a lower success rate than surgical management.

Comparing efficacy: Medical vs surgical management. The Management of Early Pregnancy Failure Trial (MEPF) is the largest randomized controlled trial comparing medical management of miscarriage to surgical management. This multicenter study compared treatment with office-based EVA or MVA to vaginal misoprostol 800 µg. A repeat dose of vaginal misoprostol was offered 48 hours after the initial dose if a gestational sac was present on ultrasound.

Findings from the MEPF trial revealed a 71% complete uterine evacuation rate after 
1 dose of misoprostol and an 84% rate after 
2 doses.¹ The average (SD) reported pain score documented within 48 hours of treatment with misoprostol or MVA/EVA was moderate (5.7 cm [2.4] on 10-cm VAS). The rate of infection or hospitalization was less than 1% in both treatment groups.

These data should provide patients who are clinically stable and who wish to avoid an invasive procedure reassurance that using medication for the management of miscarriage is a reasonable option.

Misoprostol. Use of misoprostol is associated with a longer median duration of bleeding compared with suction aspiration. After misoprostol, bleeding usually begins after several hours and may continue for weeks.¹¹ Based on 2-week prospective bleeding diary entries from the MEPF trial, women who used misoprostol for management of miscarriage were more likely to have any bleeding during the 2 weeks after initiation of treatment, compared with women who had suction aspiration.¹²

Clinically significant changes in hemoglobin levels are more common in women treated with misoprostol than in those who choose EVA or MVA; however, these differences rarely require hospitalization or transfusion.¹ Women who are considering use of misoprostol should be aware of common adverse effects, including nausea, vomiting, diarrhea, and low-grade temperature.

Medical management of miscarriage requires multiple office visits with repeat ultrasounds or serum beta–human chorionic gonadotropin (β-hCG) levels to confirm treatment success. In cases of medication failure (persistent gestational sac with or without bleeding) or suspected retained POC (endometrial stripe greater than 
30 mm measured on ultrasound or persistent vaginal bleeding remote from treatment), women should be prepared for surgical resolution of pregnancy and clinicians should be able to perform an office-based procedure.

Expectant management
Women who choose the “watch and wait” approach should be advised that the process is unpredictable and occasionally requires urgent surgical intervention. Successful resolution of pregnancies that are expectantly managed depends on the type of miscarriage diagnosed at initial presentation. Luise and colleagues conducted a prospective study of 451 women with miscarriage who declined medical and surgical management. They found that the watch-and-wait approach was successful in 91% of women with an incomplete abortion, 76% of women with missed abortion, and 66% of women with anembryonic pregnancies.¹³ Success was defined by the absence of vaginal bleeding and an anterior-posterior endometrial stripe measuring less than 15 mm 4 weeks after initial diagnosis of miscarriage.

Like medical management for miscarriage, expectant management requires multiple office visits plus repeat ultrasounds or β-hCG measurement trends to confirm treatment success. Women who fail expectant management will require medical or surgical intervention to resolve the pregnancy. For those who are seeking pregnancy right away, the unpredictability and longer time to resolution of miscarriage may render expectant management anxiety provoking and unacceptable.

Etiology: Do true and perceived causes match?
Miscarriage during the first 13 weeks of gestation occurs in at least 10% of all clinically diagnosed pregnancies.¹⁰ A recent survey administered by Bardos and colleagues 
assessed perceived prevalence and causes of miscarriage in more than 1,000 US men and women.¹⁴ The majority of respondents believed miscarriage is uncommon, occurring in less than 5% of pregnancies. Respondents also believed stressful events, lifting heavy objects, and prior use of intrauterine or hormonal contraception are often to blame for pregnancy loss.

Despite more than 3 decades of data confirming that more than 60% of early losses are associated with chromosomal abnormalities and that an additional 18% may be associated with fetal anomalies, women often blame themselves.¹⁵ Bardos and colleagues found that 47% of women felt guilty about the experience of miscarriage.

Diagnosis: Updated ultrasonography criteria issued
When miscarriage is suspected based on symptoms of pain and bleeding in preg-
nancy, obtain a thorough history and conduct a limited physical examination. If an intrauterine pregnancy (IUP) was previously identified, a repeat ultrasound can confirm the presence or absence of the gestational sac. If an IUP has not been documented, then additional studies, including serial serum β-hCG examinations and ultrasonography, are essential to rule out ectopic pregnancy. Rh status should be determined and a 50-µg dose of Rh(D)-immune globulin administered to Rh(D)-unsensitized women within 72 hours of documented bleeding.

Ultrasonography is often used to diagnose miscarriage. Many gynecologists use ultrasound criteria based on studies conducted in the early 1990s that define nonviability by an empty gestational sac with mean gestational sac diameter greater than 16 mm or a crown-rump length (CRL) without evidence of fetal cardiac activity greater than 5 mm.¹⁰ In 2012, members of the Society of Radiologists in Ultrasound Multispecialty Panel on Early First Trimester Diagnosis of Miscarriage and Exclusion of a Viable Intrauterine Pregnancy developed more conservative criteria for the diagnosis of miscarriage.¹⁶

Doubilet and colleagues suggested new cutoffs, based on their reanalysis of 2 large prospective studies conducted in the United Kingdom.¹⁷ Calculations for these new cut-offs are based on mathematical adjustments for interobserver variability. Strict adherence to these more conservative criteria is sensible when a pregnancy is desired. For women who do not want to continue the pregnancy there is no medical justification for using this diagnostic process. Indeed, delays can lead to stress and poor outcomes including emergent surgical management for spontaneous and heavy bleeding.

Culture change is needed
Patients’ beliefs and scientific evidence about miscarriage are incongruous. By making simple changes in practice and providing straightforward patient education, ObGyns
can demystify the causes of miscarriage and improve its management. In particular, providing office-based MVA when requested can streamline treatment for many women. For too long, patients have blamed themselves for miscarriage and physicians have relied on D&C in the OR. Changes in culture surrounding miscarriage are 
long overdue.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Cell-free DNA screening, or so-called noninvasive prenatal testing (NIPT), has had greatly increased utilization recently as advances in technology have elevated it almost to the level of a diagnostic test for detection of certain aneuploidies. Although it is still considered a screening test, recent interest has arisen regarding population screening and whether or not this test should be universally used as first-line or whether it should still be restricted to specific high-risk populations.

FAST TRACK
Cell-free DNA screening technology is rapidly changing, but ACOG's current guideline is the best approach for screening practices

In the current study, Kaimal and colleagues attempted to determine the best strategy for utilization of NIPT using a decision-analytic model. For their study many assumptions had to be made in order to allow for calculation of detection rates and for determination of cost and quality-adjusted life years. (The model followed a theoretical cohort of women desiring prenatal testing [screening or diagnostic or both] from the time of their initial test through the end of their pregnancy, the birth of their neonate, and the remainder of their own life expectancy.)

The conclusion of the authors is that traditional multiple marker screening remains the optimal choice for most women (those aged 20 to 38 years) but that NIPT becomes the optimal strategy at age 38. The goal of this study was not just to determine cost-effectiveness but also to attempt to devise a strategy that would optimize detection of aneuploidy and minimize the need for the performance of diagnostic procedures.

Data not available in this study included such things as population differences with respect to the acceptance of pregnancy termination as an option, and the potential utility of first-trimester ultrasound screening for structural defects that might not be accounted for with NIPT (such as thickened nuchal translucency, altered cardiac axis, cranial defects, and abdominal wall defects).

What this evidence means for practice

For now, the best approach would be to adhere to current recommendations as outlined in the 2015 American College of Obstetricians and Gynecologists (ACOG) Committee Opinion.¹ Summarized, these are:

• Do not utilize NIPT in low-risk populations (although this opinion also suggests that patients may opt to have this test performed regardless of risk status with the understanding that detection rates are lower in low-risk populations and insurance coverage may be different).
• Offer NIPT to high-risk women as a first-line screen, as is suggested in the current study with respect to maternal age criteria (ACOG uses an age cut-off of 35 years, not 38).
• Utilize NIPT as a follow-up test after conventional testing suggests increased risk status in those patients wishing to avoid invasive diagnostic testing.
• The ACOG position remains that all women, regardless of age, who desire the most comprehensive information available regarding fetal chromosomal abnormalities should be offered diagnostic testing (chorionic villus sampling and amniocentesis).

Also, as mentioned in the committee opinion, this technology is evolving rapidly and all practitioners should closely follow this evolution with respect to changing efficacy and changing cost.
—John T. Repke, MD

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Cell-free DNA screening, or so-called noninvasive prenatal testing (NIPT), has had greatly increased utilization recently as advances in technology have elevated it almost to the level of a diagnostic test for detection of certain aneuploidies. Although it is still considered a screening test, recent interest has arisen regarding population screening and whether or not this test should be universally used as first-line or whether it should still be restricted to specific high-risk populations.

FAST TRACK
Cell-free DNA screening technology is rapidly changing, but ACOG's current guideline is the best approach for screening practices

In the current study, Kaimal and colleagues attempted to determine the best strategy for utilization of NIPT using a decision-analytic model. For their study many assumptions had to be made in order to allow for calculation of detection rates and for determination of cost and quality-adjusted life years. (The model followed a theoretical cohort of women desiring prenatal testing [screening or diagnostic or both] from the time of their initial test through the end of their pregnancy, the birth of their neonate, and the remainder of their own life expectancy.)

The conclusion of the authors is that traditional multiple marker screening remains the optimal choice for most women (those aged 20 to 38 years) but that NIPT becomes the optimal strategy at age 38. The goal of this study was not just to determine cost-effectiveness but also to attempt to devise a strategy that would optimize detection of aneuploidy and minimize the need for the performance of diagnostic procedures.

Data not available in this study included such things as population differences with respect to the acceptance of pregnancy termination as an option, and the potential utility of first-trimester ultrasound screening for structural defects that might not be accounted for with NIPT (such as thickened nuchal translucency, altered cardiac axis, cranial defects, and abdominal wall defects).

What this evidence means for practice

For now, the best approach would be to adhere to current recommendations as outlined in the 2015 American College of Obstetricians and Gynecologists (ACOG) Committee Opinion.¹ Summarized, these are:

• Do not utilize NIPT in low-risk populations (although this opinion also suggests that patients may opt to have this test performed regardless of risk status with the understanding that detection rates are lower in low-risk populations and insurance coverage may be different).
• Offer NIPT to high-risk women as a first-line screen, as is suggested in the current study with respect to maternal age criteria (ACOG uses an age cut-off of 35 years, not 38).
• Utilize NIPT as a follow-up test after conventional testing suggests increased risk status in those patients wishing to avoid invasive diagnostic testing.
• The ACOG position remains that all women, regardless of age, who desire the most comprehensive information available regarding fetal chromosomal abnormalities should be offered diagnostic testing (chorionic villus sampling and amniocentesis).

Also, as mentioned in the committee opinion, this technology is evolving rapidly and all practitioners should closely follow this evolution with respect to changing efficacy and changing cost.
—John T. Repke, MD

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Cell-free DNA screening, or so-called noninvasive prenatal testing (NIPT), has had greatly increased utilization recently as advances in technology have elevated it almost to the level of a diagnostic test for detection of certain aneuploidies. Although it is still considered a screening test, recent interest has arisen regarding population screening and whether or not this test should be universally used as first-line or whether it should still be restricted to specific high-risk populations.

FAST TRACK
Cell-free DNA screening technology is rapidly changing, but ACOG's current guideline is the best approach for screening practices

In the current study, Kaimal and colleagues attempted to determine the best strategy for utilization of NIPT using a decision-analytic model. For their study many assumptions had to be made in order to allow for calculation of detection rates and for determination of cost and quality-adjusted life years. (The model followed a theoretical cohort of women desiring prenatal testing [screening or diagnostic or both] from the time of their initial test through the end of their pregnancy, the birth of their neonate, and the remainder of their own life expectancy.)

The conclusion of the authors is that traditional multiple marker screening remains the optimal choice for most women (those aged 20 to 38 years) but that NIPT becomes the optimal strategy at age 38. The goal of this study was not just to determine cost-effectiveness but also to attempt to devise a strategy that would optimize detection of aneuploidy and minimize the need for the performance of diagnostic procedures.

Data not available in this study included such things as population differences with respect to the acceptance of pregnancy termination as an option, and the potential utility of first-trimester ultrasound screening for structural defects that might not be accounted for with NIPT (such as thickened nuchal translucency, altered cardiac axis, cranial defects, and abdominal wall defects).

What this evidence means for practice

For now, the best approach would be to adhere to current recommendations as outlined in the 2015 American College of Obstetricians and Gynecologists (ACOG) Committee Opinion.¹ Summarized, these are:

• Do not utilize NIPT in low-risk populations (although this opinion also suggests that patients may opt to have this test performed regardless of risk status with the understanding that detection rates are lower in low-risk populations and insurance coverage may be different).
• Offer NIPT to high-risk women as a first-line screen, as is suggested in the current study with respect to maternal age criteria (ACOG uses an age cut-off of 35 years, not 38).
• Utilize NIPT as a follow-up test after conventional testing suggests increased risk status in those patients wishing to avoid invasive diagnostic testing.
• The ACOG position remains that all women, regardless of age, who desire the most comprehensive information available regarding fetal chromosomal abnormalities should be offered diagnostic testing (chorionic villus sampling and amniocentesis).

Also, as mentioned in the committee opinion, this technology is evolving rapidly and all practitioners should closely follow this evolution with respect to changing efficacy and changing cost.
—John T. Repke, MD

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

A recent study reported in JAMA 
Oncology evaluated 10-year and 20-year breast cancer–specific mortality following diagnosis and treatment of ductal carcinoma in situ (DCIS) using the Surveillance, Epidemiology, and End Results (SEER) registries.¹ The study included cases of pure DCIS (without lobular carcinoma in situ or microinvasion) diagnosed from 1988 to 2011 among women younger than age 70. It evaluated variables including age, race, income, type of surgery, radiation, subsequent diagnoses of invasive primary breast cancer, and, when applicable, cause of death.

Overall mortality rate was 3.3%
Mean follow-up was 7.5 years, with a 20-year breast cancer–specific mortality rate of 3.3% overall. Mortality was higher among young women diagnosed before the age of 35 years (7.8% vs 3.2%), and among black women (7.0% vs 3.0% for white women). The risk of dying from breast cancer was 18 times higher for women who developed subsequent ipsilateral invasive breast cancer. Mortality also was related to adverse DCIS characteristics such as grade, size, comedo-necrosis, and lack of an estrogen receptor.

Among patients who underwent lumpectomy, the addition of radiation reduced the risk of subsequent ipsilateral invasive breast cancer at 10 years (2.5% vs 4.9%; P<.001). However, radiation did not improve the 10-year rate of breast cancer mortality (0.8% for women who had lumpectomy with radiation, 0.9% for women who had lumpectomy alone, and 1.3% for women with unilateral mastectomy).

The prevention of ipsilateral invasive recurrence with radiation did not reduce mortality rates, as more than 50% of the women who died of breast cancer did not have an ipsilateral invasive recurrence prior to their death.

How these findings fit 
into the larger picture
The findings of this landmark study confirm earlier reports, which showed that radiation after lumpectomy can reduce local recurrence but does not improve survival.²

Likewise, mastectomy, when compared with lumpectomy, offers no survival benefit and does not represent appropriate therapy for most women with small, unifocal DCIS.³

DCIS itself is not a life-threatening condition and has been described as a precursor lesion that, over 10 to 40 years, can lead to the development of invasive disease (FIGURE).^4,5 High-grade DCIS tends to lead to high-grade invasive ductal carcinoma, and low-grade DCIS may develop into low-grade invasive disease.⁶

The increasing prevalence of screening mammography means that more small in situ lesions are being identified in US women. Unlike colonoscopy, which can prevent colon cancer by removing colon polyps, mammography with subsequent surgical treatment of DCIS has not reduced the incidence of invasive breast cancer.⁷This 
finding leads us to question whether all DCIS should be considered a precursor lesion. This well publicized study is generating controversy regarding overdiagnosis and overtreatment of DCIS.

Limitations of this study
The majority of patients in the SEER registry underwent surgical treatment of DCIS with or without radiation and had a survival rate of more than 97%. Because there was no untreated control group, this study does not allow us to draw any inferences on the role of expectant management of DCIS.

Although it is often declined by patients, tamoxifen reduces the risk of ipsilateral and contralateral invasive and in situ breast cancer. Regrettably, information on the use of adjuvant hormonal therapy after an initial diagnosis of DCIS was not included in this analysis.

Why did death from invasive 
cancer sometimes follow a 
diagnosis of DCIS?
Several factors could have contributed to the 3% mortality rate from invasive breast cancer among women in this large study of DCIS. For one, it is challenging for pathologists to perform comprehensive tissue sampling of mastectomy specimens—or even large lumpectomy specimens. Accordingly, occult microinvasive disease could be missed.^8,9 As a result, occult invasive disease could go untreated, which could have contributed to the breast cancer mortality observed in this study.

Recommendations for practice
How can we better predict the behavior of DCIS and tailor treatment based on the biological behavior of each patient’s disease?

Individualize therapy. The likelihood of local invasive breast cancer recurrence should be estimated for each patient based on the size and grade of her disease. Furthermore, genetic profiling of DCIS has been developed with the Oncotype DX test (Genomic Health) multigene assay. This test can be performed on pathology specimens and has been shown to estimate the risk of in situ and invasive in-breast recurrence in patients who have undergone margin-negative lumpectomy for DCIS and who prefer to avoid radiation but are willing to take tamoxifen.¹⁰

Counsel precisely and accurately. Beyond such testing, we should focus on what is important to our patients in explaining the diagnosis:

Informed and shared 
decision making is key
DCIS is an increasingly common and usually non–life-threatening condition. Radical surgery such as bilateral mastectomy for small unifocal DCIS is excessive and will not improve a patient’s outcome. As a prominent breast surgeon has written:

We must balance the small risk of breast cancer recurrence after lumpectomy for DCIS with patients’ quality of life concerns. This goal is best accomplished by using an informed and shared decision-making strategy to help our patients make sound decisions regarding DCIS.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

A recent study reported in JAMA 
Oncology evaluated 10-year and 20-year breast cancer–specific mortality following diagnosis and treatment of ductal carcinoma in situ (DCIS) using the Surveillance, Epidemiology, and End Results (SEER) registries.¹ The study included cases of pure DCIS (without lobular carcinoma in situ or microinvasion) diagnosed from 1988 to 2011 among women younger than age 70. It evaluated variables including age, race, income, type of surgery, radiation, subsequent diagnoses of invasive primary breast cancer, and, when applicable, cause of death.

Overall mortality rate was 3.3%
Mean follow-up was 7.5 years, with a 20-year breast cancer–specific mortality rate of 3.3% overall. Mortality was higher among young women diagnosed before the age of 35 years (7.8% vs 3.2%), and among black women (7.0% vs 3.0% for white women). The risk of dying from breast cancer was 18 times higher for women who developed subsequent ipsilateral invasive breast cancer. Mortality also was related to adverse DCIS characteristics such as grade, size, comedo-necrosis, and lack of an estrogen receptor.

Among patients who underwent lumpectomy, the addition of radiation reduced the risk of subsequent ipsilateral invasive breast cancer at 10 years (2.5% vs 4.9%; P<.001). However, radiation did not improve the 10-year rate of breast cancer mortality (0.8% for women who had lumpectomy with radiation, 0.9% for women who had lumpectomy alone, and 1.3% for women with unilateral mastectomy).

The prevention of ipsilateral invasive recurrence with radiation did not reduce mortality rates, as more than 50% of the women who died of breast cancer did not have an ipsilateral invasive recurrence prior to their death.

How these findings fit 
into the larger picture
The findings of this landmark study confirm earlier reports, which showed that radiation after lumpectomy can reduce local recurrence but does not improve survival.²

Likewise, mastectomy, when compared with lumpectomy, offers no survival benefit and does not represent appropriate therapy for most women with small, unifocal DCIS.³

DCIS itself is not a life-threatening condition and has been described as a precursor lesion that, over 10 to 40 years, can lead to the development of invasive disease (FIGURE).^4,5 High-grade DCIS tends to lead to high-grade invasive ductal carcinoma, and low-grade DCIS may develop into low-grade invasive disease.⁶

The increasing prevalence of screening mammography means that more small in situ lesions are being identified in US women. Unlike colonoscopy, which can prevent colon cancer by removing colon polyps, mammography with subsequent surgical treatment of DCIS has not reduced the incidence of invasive breast cancer.⁷This 
finding leads us to question whether all DCIS should be considered a precursor lesion. This well publicized study is generating controversy regarding overdiagnosis and overtreatment of DCIS.

Limitations of this study
The majority of patients in the SEER registry underwent surgical treatment of DCIS with or without radiation and had a survival rate of more than 97%. Because there was no untreated control group, this study does not allow us to draw any inferences on the role of expectant management of DCIS.

Although it is often declined by patients, tamoxifen reduces the risk of ipsilateral and contralateral invasive and in situ breast cancer. Regrettably, information on the use of adjuvant hormonal therapy after an initial diagnosis of DCIS was not included in this analysis.

Why did death from invasive 
cancer sometimes follow a 
diagnosis of DCIS?
Several factors could have contributed to the 3% mortality rate from invasive breast cancer among women in this large study of DCIS. For one, it is challenging for pathologists to perform comprehensive tissue sampling of mastectomy specimens—or even large lumpectomy specimens. Accordingly, occult microinvasive disease could be missed.^8,9 As a result, occult invasive disease could go untreated, which could have contributed to the breast cancer mortality observed in this study.

Recommendations for practice
How can we better predict the behavior of DCIS and tailor treatment based on the biological behavior of each patient’s disease?

Individualize therapy. The likelihood of local invasive breast cancer recurrence should be estimated for each patient based on the size and grade of her disease. Furthermore, genetic profiling of DCIS has been developed with the Oncotype DX test (Genomic Health) multigene assay. This test can be performed on pathology specimens and has been shown to estimate the risk of in situ and invasive in-breast recurrence in patients who have undergone margin-negative lumpectomy for DCIS and who prefer to avoid radiation but are willing to take tamoxifen.¹⁰

Counsel precisely and accurately. Beyond such testing, we should focus on what is important to our patients in explaining the diagnosis:

Informed and shared 
decision making is key
DCIS is an increasingly common and usually non–life-threatening condition. Radical surgery such as bilateral mastectomy for small unifocal DCIS is excessive and will not improve a patient’s outcome. As a prominent breast surgeon has written:

We must balance the small risk of breast cancer recurrence after lumpectomy for DCIS with patients’ quality of life concerns. This goal is best accomplished by using an informed and shared decision-making strategy to help our patients make sound decisions regarding DCIS.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

A recent study reported in JAMA 
Oncology evaluated 10-year and 20-year breast cancer–specific mortality following diagnosis and treatment of ductal carcinoma in situ (DCIS) using the Surveillance, Epidemiology, and End Results (SEER) registries.¹ The study included cases of pure DCIS (without lobular carcinoma in situ or microinvasion) diagnosed from 1988 to 2011 among women younger than age 70. It evaluated variables including age, race, income, type of surgery, radiation, subsequent diagnoses of invasive primary breast cancer, and, when applicable, cause of death.

Overall mortality rate was 3.3%
Mean follow-up was 7.5 years, with a 20-year breast cancer–specific mortality rate of 3.3% overall. Mortality was higher among young women diagnosed before the age of 35 years (7.8% vs 3.2%), and among black women (7.0% vs 3.0% for white women). The risk of dying from breast cancer was 18 times higher for women who developed subsequent ipsilateral invasive breast cancer. Mortality also was related to adverse DCIS characteristics such as grade, size, comedo-necrosis, and lack of an estrogen receptor.

Among patients who underwent lumpectomy, the addition of radiation reduced the risk of subsequent ipsilateral invasive breast cancer at 10 years (2.5% vs 4.9%; P<.001). However, radiation did not improve the 10-year rate of breast cancer mortality (0.8% for women who had lumpectomy with radiation, 0.9% for women who had lumpectomy alone, and 1.3% for women with unilateral mastectomy).

The prevention of ipsilateral invasive recurrence with radiation did not reduce mortality rates, as more than 50% of the women who died of breast cancer did not have an ipsilateral invasive recurrence prior to their death.

How these findings fit 
into the larger picture
The findings of this landmark study confirm earlier reports, which showed that radiation after lumpectomy can reduce local recurrence but does not improve survival.²

Likewise, mastectomy, when compared with lumpectomy, offers no survival benefit and does not represent appropriate therapy for most women with small, unifocal DCIS.³

DCIS itself is not a life-threatening condition and has been described as a precursor lesion that, over 10 to 40 years, can lead to the development of invasive disease (FIGURE).^4,5 High-grade DCIS tends to lead to high-grade invasive ductal carcinoma, and low-grade DCIS may develop into low-grade invasive disease.⁶

The increasing prevalence of screening mammography means that more small in situ lesions are being identified in US women. Unlike colonoscopy, which can prevent colon cancer by removing colon polyps, mammography with subsequent surgical treatment of DCIS has not reduced the incidence of invasive breast cancer.⁷This 
finding leads us to question whether all DCIS should be considered a precursor lesion. This well publicized study is generating controversy regarding overdiagnosis and overtreatment of DCIS.

Limitations of this study
The majority of patients in the SEER registry underwent surgical treatment of DCIS with or without radiation and had a survival rate of more than 97%. Because there was no untreated control group, this study does not allow us to draw any inferences on the role of expectant management of DCIS.

Although it is often declined by patients, tamoxifen reduces the risk of ipsilateral and contralateral invasive and in situ breast cancer. Regrettably, information on the use of adjuvant hormonal therapy after an initial diagnosis of DCIS was not included in this analysis.

Why did death from invasive 
cancer sometimes follow a 
diagnosis of DCIS?
Several factors could have contributed to the 3% mortality rate from invasive breast cancer among women in this large study of DCIS. For one, it is challenging for pathologists to perform comprehensive tissue sampling of mastectomy specimens—or even large lumpectomy specimens. Accordingly, occult microinvasive disease could be missed.^8,9 As a result, occult invasive disease could go untreated, which could have contributed to the breast cancer mortality observed in this study.

Recommendations for practice
How can we better predict the behavior of DCIS and tailor treatment based on the biological behavior of each patient’s disease?

Individualize therapy. The likelihood of local invasive breast cancer recurrence should be estimated for each patient based on the size and grade of her disease. Furthermore, genetic profiling of DCIS has been developed with the Oncotype DX test (Genomic Health) multigene assay. This test can be performed on pathology specimens and has been shown to estimate the risk of in situ and invasive in-breast recurrence in patients who have undergone margin-negative lumpectomy for DCIS and who prefer to avoid radiation but are willing to take tamoxifen.¹⁰

Counsel precisely and accurately. Beyond such testing, we should focus on what is important to our patients in explaining the diagnosis:

Informed and shared 
decision making is key
DCIS is an increasingly common and usually non–life-threatening condition. Radical surgery such as bilateral mastectomy for small unifocal DCIS is excessive and will not improve a patient’s outcome. As a prominent breast surgeon has written:

We must balance the small risk of breast cancer recurrence after lumpectomy for DCIS with patients’ quality of life concerns. This goal is best accomplished by using an informed and shared decision-making strategy to help our patients make sound decisions regarding DCIS.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.