Surgery

Keeping current with causes of and treatments for abnormal uterine bleeding (AUB) is important. AUB can have a major impact on women’s lives in terms of health care expenses, productivity, and quality of life. The focus of this Update is on information that has been published over the past year that is helpful for clinicians who counsel and treat women with AUB. First, we focus on new data on endometrial polyps, which are a common cause of AUB. For the first time, a meta-analysis has examined polyp-associated cancer risk. In addition, does a causal relationship exist between endometrial polyps and chronic endometritis? We also address the first published report of successful treatment of endometrial intraepithelial neoplasia (EIN, formerly complex endometrial hyperplasia with atypia) using the etonogestrel subdermal implant. Last, we discuss efficacy data for a new device for endometrial ablation, which has new features to consider.

What is the risk of malignancy with endometrial polyps? 

Sasaki LM, Andrade KR, Figeuiredo AC, et al. Factors associated with malignancy in hysteroscopically resected endometrial polyps: a systematic review and meta-analysis. J Minim Invasive Gynecol. 2018;25:777-785. 

What can information from more than 21,000 patients with polyps teach us about the risk factors associated with endometrial malignancy? For instance, with concern over balancing health care costs with potential surgical risks, should all patients with endometrial polyps undergo routine surgical removal, or should we stratify risks and offer surgery to only selected patients? This is the first meta-analysis to evaluate the risk factors for endometrial cancer (such as obesity, parity, tamoxifen use, and hormonal therapy use) in patients with endometrial polyps.

Risk factors for and prevalence of malignancy

Sasaki and colleagues found that about 3 of every 100 patients with recognized polyps will harbor a premalignant or malignant lesion (3.4%; 716 of 21,057 patients). The identified risk factors for a cancerous polyp included: menopausal status, age greater than 60 years, presence of AUB, diabetes mellitus, hypertension, obesity, and tamoxifen use. The risk for cancer was 2-fold greater in women older than 60 years compared with those younger than age 60 (prevalence ratio, 2.41). The authors found no risk association with use of combination hormone therapy, parity, breast cancer, or polyp size.

The investigators advised caution with using their conclusions, as there was high heterogeneity for some of the factors studied (including age, AUB, parity, and hypertension).

New evidence associates endometrial polyps with chronic endometritis 

The second important study published this year on polyps was conducted by Cicinelli and colleagues and suggests that inflammation may be part of the pathophysiology behind the common problem of polyps. The authors cite a recent study that showed that abnormal expression of "local" paracrine inflammatory mediators, such as interferon-gamma, may enhance the proliferation of endometrial mucosa.¹ Building on this possibility further, they hypothesized that chronic endometrial inflammation may affect the pathogenesis of endometrial polyps.  

Details of the study 

To investigate the possible correlation between polyps and chronic endometritis, Cicinelli and colleagues compared the endometrial biopsies of 240 women with AUB and hysteroscopically and histologically diagnosed endometrial polyps with 240 women with AUB and no polyp seen on hysteroscopy. The tissue samples were evaluated with immunohistochemistry for CD-138 for plasma cell identification.  

The study authors found a significantly higher prevalence of chronic endometritis in the group with endometrial polyps than in the group without polyps (61.7% vs 24.2%, respectively; P <.0001). They suggest that this evidence supports the hypothesis that endometrial polyps may be a result of endometrial proliferation and vasculopathy triggered by chronic endometritis. 

Continue to: Can endometrial intraepithelial neoplasia be treated with the etonogestrel subdermal implant? 

Can endometrial intraepithelial neoplasia be treated with the etonogestrel subdermal implant? 

Wong S, Naresh A. Etonogestrel subdermal implant-associated regression of endometrial intraepithelial neoplasia. Obstet Gynecol. 2019;133:780-782. 

Recently, Wong and Naresh gave us the first case report of successful treatment of EIN using the etonogestrel subdermal implant. With so many other options available to treat EIN, some of which have been studied extensively, why should we take note of this study? First, the authors point out the risk of endometrial cancer development among patients with EIN, and they acknowledge the standard recommendation of hysterectomy in women with EIN who have finished childbearing and are appropriate candidates for a surgical approach. There is also concern about lower serum etonogestrel levels in obese patients. In this case, the patient (aged 36 with obesity) had been nonadherent with oral progestin therapy and stated that she would not adhere to daily oral therapy. She also declined hysterectomy, levonorgestrel-releasing intrauterine device therapy, and injectable progestin therapy after being counseled about the risk of malignancy development. She consented to subdermal etonogestrel as an alternative to no therapy.  

EIN regressed. Endometrial biopsies at 4 and 8 months showed regression of EIN, and at 16 months after implantation (as well as a dilation and curettage at 9 months) demonstrated an inactive endometrium with no sign of hyperplasia. 

New endometrial ablation technology shows promising benefits  

Do we need another endometrial ablation device? Are there improvements that can be made to our existing technology? There already are several endometrial ablation devices, using varying technology, that currently are approved by the US Food and Drug Administration (FDA) for treatment of AUB. The devices use bipolar radiofrequency, cryotherapy, circulating hot fluid, and combined thermal and radiofrequency modalities. Additional devices, employing heated balloon and microwaves, are no longer used. Data on a new device, approved by the FDA in 2017 (the AEGEA Vapor System, called Mara), were recently published.  

Details of the study 

Levie and colleagues conducted a prospective pivotal trial on Mara's safety and effectiveness. The benefits presented by the authors include that the device 1) does not require that an intrauterine array be deployed up to and abutting the fundus and cornu, 2) does not necessitate cervical dilatation, 3) is a free-flowing vapor system that can navigate differences in uterine contour and sizes (up to 12 cm in length), and 4) accomplishes ablation in 2 minutes. So there are indeed some novel features of this device.  

This pivotal study was a multicenter trial using objective performance criterion (OPC), which is based on using the average success rates across the 5 FDA-approved ablation devices as historic controls. In the study an OPC of 66% correlated to the lower bound of the 95% confidence intervals. The primary outcome of the study was effectiveness in the reduction of blood loss using a pictorial blood loss assessment score (PBLAS) of less than 75. Of note, a PBLAS of 150 was a study entry criterion. FIGO types 2 through 6 fibroids were included in the trial. Secondary endpoints were quality of life and patient satisfaction as assessed by the Menorrhagia Impact Questionnaire and the Aberdeen Menorrhagia Severity Score, as well as the need to intervene medically or surgically to treat AUB in the first 12 months after ablation.  

Efficacy, satisfaction, and quality of life results 

At 12 months, the primary effectiveness end point was achieved in 78.7% of study participants. The satisfaction rate was 90.8% (satisfied or very satisfied), and 99% of participants showed improvement in quality of life scores. There were no reported serious adverse events.  
 

Keeping current with causes of and treatments for abnormal uterine bleeding (AUB) is important. AUB can have a major impact on women’s lives in terms of health care expenses, productivity, and quality of life. The focus of this Update is on information that has been published over the past year that is helpful for clinicians who counsel and treat women with AUB. First, we focus on new data on endometrial polyps, which are a common cause of AUB. For the first time, a meta-analysis has examined polyp-associated cancer risk. In addition, does a causal relationship exist between endometrial polyps and chronic endometritis? We also address the first published report of successful treatment of endometrial intraepithelial neoplasia (EIN, formerly complex endometrial hyperplasia with atypia) using the etonogestrel subdermal implant. Last, we discuss efficacy data for a new device for endometrial ablation, which has new features to consider.

What is the risk of malignancy with endometrial polyps? 

Sasaki LM, Andrade KR, Figeuiredo AC, et al. Factors associated with malignancy in hysteroscopically resected endometrial polyps: a systematic review and meta-analysis. J Minim Invasive Gynecol. 2018;25:777-785. 

What can information from more than 21,000 patients with polyps teach us about the risk factors associated with endometrial malignancy? For instance, with concern over balancing health care costs with potential surgical risks, should all patients with endometrial polyps undergo routine surgical removal, or should we stratify risks and offer surgery to only selected patients? This is the first meta-analysis to evaluate the risk factors for endometrial cancer (such as obesity, parity, tamoxifen use, and hormonal therapy use) in patients with endometrial polyps.

Risk factors for and prevalence of malignancy

Sasaki and colleagues found that about 3 of every 100 patients with recognized polyps will harbor a premalignant or malignant lesion (3.4%; 716 of 21,057 patients). The identified risk factors for a cancerous polyp included: menopausal status, age greater than 60 years, presence of AUB, diabetes mellitus, hypertension, obesity, and tamoxifen use. The risk for cancer was 2-fold greater in women older than 60 years compared with those younger than age 60 (prevalence ratio, 2.41). The authors found no risk association with use of combination hormone therapy, parity, breast cancer, or polyp size.

The investigators advised caution with using their conclusions, as there was high heterogeneity for some of the factors studied (including age, AUB, parity, and hypertension).

New evidence associates endometrial polyps with chronic endometritis 

The second important study published this year on polyps was conducted by Cicinelli and colleagues and suggests that inflammation may be part of the pathophysiology behind the common problem of polyps. The authors cite a recent study that showed that abnormal expression of "local" paracrine inflammatory mediators, such as interferon-gamma, may enhance the proliferation of endometrial mucosa.¹ Building on this possibility further, they hypothesized that chronic endometrial inflammation may affect the pathogenesis of endometrial polyps.  

Details of the study 

To investigate the possible correlation between polyps and chronic endometritis, Cicinelli and colleagues compared the endometrial biopsies of 240 women with AUB and hysteroscopically and histologically diagnosed endometrial polyps with 240 women with AUB and no polyp seen on hysteroscopy. The tissue samples were evaluated with immunohistochemistry for CD-138 for plasma cell identification.  

The study authors found a significantly higher prevalence of chronic endometritis in the group with endometrial polyps than in the group without polyps (61.7% vs 24.2%, respectively; P <.0001). They suggest that this evidence supports the hypothesis that endometrial polyps may be a result of endometrial proliferation and vasculopathy triggered by chronic endometritis. 

Continue to: Can endometrial intraepithelial neoplasia be treated with the etonogestrel subdermal implant? 

Can endometrial intraepithelial neoplasia be treated with the etonogestrel subdermal implant? 

Wong S, Naresh A. Etonogestrel subdermal implant-associated regression of endometrial intraepithelial neoplasia. Obstet Gynecol. 2019;133:780-782. 

Recently, Wong and Naresh gave us the first case report of successful treatment of EIN using the etonogestrel subdermal implant. With so many other options available to treat EIN, some of which have been studied extensively, why should we take note of this study? First, the authors point out the risk of endometrial cancer development among patients with EIN, and they acknowledge the standard recommendation of hysterectomy in women with EIN who have finished childbearing and are appropriate candidates for a surgical approach. There is also concern about lower serum etonogestrel levels in obese patients. In this case, the patient (aged 36 with obesity) had been nonadherent with oral progestin therapy and stated that she would not adhere to daily oral therapy. She also declined hysterectomy, levonorgestrel-releasing intrauterine device therapy, and injectable progestin therapy after being counseled about the risk of malignancy development. She consented to subdermal etonogestrel as an alternative to no therapy.  

EIN regressed. Endometrial biopsies at 4 and 8 months showed regression of EIN, and at 16 months after implantation (as well as a dilation and curettage at 9 months) demonstrated an inactive endometrium with no sign of hyperplasia. 

New endometrial ablation technology shows promising benefits  

Do we need another endometrial ablation device? Are there improvements that can be made to our existing technology? There already are several endometrial ablation devices, using varying technology, that currently are approved by the US Food and Drug Administration (FDA) for treatment of AUB. The devices use bipolar radiofrequency, cryotherapy, circulating hot fluid, and combined thermal and radiofrequency modalities. Additional devices, employing heated balloon and microwaves, are no longer used. Data on a new device, approved by the FDA in 2017 (the AEGEA Vapor System, called Mara), were recently published.  

Details of the study 

Levie and colleagues conducted a prospective pivotal trial on Mara's safety and effectiveness. The benefits presented by the authors include that the device 1) does not require that an intrauterine array be deployed up to and abutting the fundus and cornu, 2) does not necessitate cervical dilatation, 3) is a free-flowing vapor system that can navigate differences in uterine contour and sizes (up to 12 cm in length), and 4) accomplishes ablation in 2 minutes. So there are indeed some novel features of this device.  

This pivotal study was a multicenter trial using objective performance criterion (OPC), which is based on using the average success rates across the 5 FDA-approved ablation devices as historic controls. In the study an OPC of 66% correlated to the lower bound of the 95% confidence intervals. The primary outcome of the study was effectiveness in the reduction of blood loss using a pictorial blood loss assessment score (PBLAS) of less than 75. Of note, a PBLAS of 150 was a study entry criterion. FIGO types 2 through 6 fibroids were included in the trial. Secondary endpoints were quality of life and patient satisfaction as assessed by the Menorrhagia Impact Questionnaire and the Aberdeen Menorrhagia Severity Score, as well as the need to intervene medically or surgically to treat AUB in the first 12 months after ablation.  

Efficacy, satisfaction, and quality of life results 

At 12 months, the primary effectiveness end point was achieved in 78.7% of study participants. The satisfaction rate was 90.8% (satisfied or very satisfied), and 99% of participants showed improvement in quality of life scores. There were no reported serious adverse events.  
 

Keeping current with causes of and treatments for abnormal uterine bleeding (AUB) is important. AUB can have a major impact on women’s lives in terms of health care expenses, productivity, and quality of life. The focus of this Update is on information that has been published over the past year that is helpful for clinicians who counsel and treat women with AUB. First, we focus on new data on endometrial polyps, which are a common cause of AUB. For the first time, a meta-analysis has examined polyp-associated cancer risk. In addition, does a causal relationship exist between endometrial polyps and chronic endometritis? We also address the first published report of successful treatment of endometrial intraepithelial neoplasia (EIN, formerly complex endometrial hyperplasia with atypia) using the etonogestrel subdermal implant. Last, we discuss efficacy data for a new device for endometrial ablation, which has new features to consider.

What is the risk of malignancy with endometrial polyps? 

Sasaki LM, Andrade KR, Figeuiredo AC, et al. Factors associated with malignancy in hysteroscopically resected endometrial polyps: a systematic review and meta-analysis. J Minim Invasive Gynecol. 2018;25:777-785. 

What can information from more than 21,000 patients with polyps teach us about the risk factors associated with endometrial malignancy? For instance, with concern over balancing health care costs with potential surgical risks, should all patients with endometrial polyps undergo routine surgical removal, or should we stratify risks and offer surgery to only selected patients? This is the first meta-analysis to evaluate the risk factors for endometrial cancer (such as obesity, parity, tamoxifen use, and hormonal therapy use) in patients with endometrial polyps.

Risk factors for and prevalence of malignancy

Sasaki and colleagues found that about 3 of every 100 patients with recognized polyps will harbor a premalignant or malignant lesion (3.4%; 716 of 21,057 patients). The identified risk factors for a cancerous polyp included: menopausal status, age greater than 60 years, presence of AUB, diabetes mellitus, hypertension, obesity, and tamoxifen use. The risk for cancer was 2-fold greater in women older than 60 years compared with those younger than age 60 (prevalence ratio, 2.41). The authors found no risk association with use of combination hormone therapy, parity, breast cancer, or polyp size.

The investigators advised caution with using their conclusions, as there was high heterogeneity for some of the factors studied (including age, AUB, parity, and hypertension).

New evidence associates endometrial polyps with chronic endometritis 

The second important study published this year on polyps was conducted by Cicinelli and colleagues and suggests that inflammation may be part of the pathophysiology behind the common problem of polyps. The authors cite a recent study that showed that abnormal expression of "local" paracrine inflammatory mediators, such as interferon-gamma, may enhance the proliferation of endometrial mucosa.¹ Building on this possibility further, they hypothesized that chronic endometrial inflammation may affect the pathogenesis of endometrial polyps.  

Details of the study 

To investigate the possible correlation between polyps and chronic endometritis, Cicinelli and colleagues compared the endometrial biopsies of 240 women with AUB and hysteroscopically and histologically diagnosed endometrial polyps with 240 women with AUB and no polyp seen on hysteroscopy. The tissue samples were evaluated with immunohistochemistry for CD-138 for plasma cell identification.  

The study authors found a significantly higher prevalence of chronic endometritis in the group with endometrial polyps than in the group without polyps (61.7% vs 24.2%, respectively; P <.0001). They suggest that this evidence supports the hypothesis that endometrial polyps may be a result of endometrial proliferation and vasculopathy triggered by chronic endometritis. 

Continue to: Can endometrial intraepithelial neoplasia be treated with the etonogestrel subdermal implant? 

Can endometrial intraepithelial neoplasia be treated with the etonogestrel subdermal implant? 

Wong S, Naresh A. Etonogestrel subdermal implant-associated regression of endometrial intraepithelial neoplasia. Obstet Gynecol. 2019;133:780-782. 

Recently, Wong and Naresh gave us the first case report of successful treatment of EIN using the etonogestrel subdermal implant. With so many other options available to treat EIN, some of which have been studied extensively, why should we take note of this study? First, the authors point out the risk of endometrial cancer development among patients with EIN, and they acknowledge the standard recommendation of hysterectomy in women with EIN who have finished childbearing and are appropriate candidates for a surgical approach. There is also concern about lower serum etonogestrel levels in obese patients. In this case, the patient (aged 36 with obesity) had been nonadherent with oral progestin therapy and stated that she would not adhere to daily oral therapy. She also declined hysterectomy, levonorgestrel-releasing intrauterine device therapy, and injectable progestin therapy after being counseled about the risk of malignancy development. She consented to subdermal etonogestrel as an alternative to no therapy.  

EIN regressed. Endometrial biopsies at 4 and 8 months showed regression of EIN, and at 16 months after implantation (as well as a dilation and curettage at 9 months) demonstrated an inactive endometrium with no sign of hyperplasia. 

New endometrial ablation technology shows promising benefits  

Do we need another endometrial ablation device? Are there improvements that can be made to our existing technology? There already are several endometrial ablation devices, using varying technology, that currently are approved by the US Food and Drug Administration (FDA) for treatment of AUB. The devices use bipolar radiofrequency, cryotherapy, circulating hot fluid, and combined thermal and radiofrequency modalities. Additional devices, employing heated balloon and microwaves, are no longer used. Data on a new device, approved by the FDA in 2017 (the AEGEA Vapor System, called Mara), were recently published.  

Details of the study 

Levie and colleagues conducted a prospective pivotal trial on Mara's safety and effectiveness. The benefits presented by the authors include that the device 1) does not require that an intrauterine array be deployed up to and abutting the fundus and cornu, 2) does not necessitate cervical dilatation, 3) is a free-flowing vapor system that can navigate differences in uterine contour and sizes (up to 12 cm in length), and 4) accomplishes ablation in 2 minutes. So there are indeed some novel features of this device.  

This pivotal study was a multicenter trial using objective performance criterion (OPC), which is based on using the average success rates across the 5 FDA-approved ablation devices as historic controls. In the study an OPC of 66% correlated to the lower bound of the 95% confidence intervals. The primary outcome of the study was effectiveness in the reduction of blood loss using a pictorial blood loss assessment score (PBLAS) of less than 75. Of note, a PBLAS of 150 was a study entry criterion. FIGO types 2 through 6 fibroids were included in the trial. Secondary endpoints were quality of life and patient satisfaction as assessed by the Menorrhagia Impact Questionnaire and the Aberdeen Menorrhagia Severity Score, as well as the need to intervene medically or surgically to treat AUB in the first 12 months after ablation.  

Efficacy, satisfaction, and quality of life results 

At 12 months, the primary effectiveness end point was achieved in 78.7% of study participants. The satisfaction rate was 90.8% (satisfied or very satisfied), and 99% of participants showed improvement in quality of life scores. There were no reported serious adverse events.  
 

Decades after undergoing surgery and radiotherapy, survivors of a pediatric CNS tumor may have worse neuropsychologic and socioeconomic outcomes, compared with their unaffected siblings. Children who underwent surgery alone had better neuropsychologic and socioeconomic outcomes than those who also underwent radiotherapy, but their outcomes were worse than those of unaffected siblings. These findings were published online June 24 in Cancer.

“Late effects in adulthood are evident even for children with the least malignant types of brain tumors who were treated with the least toxic therapies available at the time,” said M. Douglas Ris, PhD, professor of pediatrics and psychology at Baylor College of Medicine in Houston, in a press release. “As pediatric brain tumors become more survivable with continued advances in treatments, we need to improve surveillance of these populations so that survivors continue to receive the best interventions during their transition to adulthood and well beyond.”

Clinicians generally have assumed that children with low-grade CNS tumors who receive less toxic treatment will have fewer long-term effects than survivors of more malignant tumors who undergo neurotoxic therapies. Yet research has indicated that the former patients can have lasting neurobehavioral or functional morbidity.

Dr. Ris and colleagues invited survivors of pediatric low-grade gliomas participating in the Childhood Cancer Survivor Study (CCSS) and a sibling comparison group to undergo a direct, comprehensive neurocognitive assessment. Of 495 eligible survivors, 257 participated. Seventy-six patients did not travel to a study site, but completed a questionnaire, and the researchers did not include data for this group in their analysis. Dr. Ris and colleagues obtained information about surgery and radiotherapy from participants’ medical records. Patients underwent standardized, age-normed neuropsychologic tests. The primary neuropsychologic outcomes were the Composite Neuropsychological Index (CNI) and estimated IQ. To evaluate socioeconomic outcomes, Dr. Ris and colleagues measured participants’ educational attainment, income, and occupational prestige.

After the researchers adjusted the data for age and sex, they found that siblings had higher mean scores than survivors treated with surgery plus radiotherapy or surgery alone on all neuropsychologic outcomes, including the CNI (siblings, 106.8; surgery only, 95.6; surgery plus radiotherapy, 88.3) and estimated IQ. Survivors who had been diagnosed at younger ages had low scores for all outcomes except for attention/processing speed.

Furthermore, surgery plus radiotherapy was associated with a 7.7-fold higher risk of having an occupation in the lowest sibling quartile, compared with siblings. Survivors who underwent surgery alone had a 2.8-fold higher risk than siblings of having an occupation in the lowest quartile. Surgery plus radiotherapy was associated with a 2.6-fold increased risk of a low occupation score, compared with survivors who underwent surgery alone.

Compared with siblings, surgery plus radiotherapy was associated with a 4.5-fold risk of an annual income of less than $20,000, while the risk for survivors who underwent surgery alone did not differ significantly from that for siblings. Surgery plus radiotherapy was associated with a 2.6-fold higher risk than surgery alone. Surgery plus radiotherapy was also associated with a significantly increased risk for an education level lower than a bachelor’s degree, compared with siblings, but surgery alone was not.

The National Cancer Institute supported the study. The authors had no disclosures.

egreb@mdedge.com

SOURCE: Ris MD et al. Cancer. 2019 Jun 24. doi: 10.1002/cncr.32186.

Decades after undergoing surgery and radiotherapy, survivors of a pediatric CNS tumor may have worse neuropsychologic and socioeconomic outcomes, compared with their unaffected siblings. Children who underwent surgery alone had better neuropsychologic and socioeconomic outcomes than those who also underwent radiotherapy, but their outcomes were worse than those of unaffected siblings. These findings were published online June 24 in Cancer.

“Late effects in adulthood are evident even for children with the least malignant types of brain tumors who were treated with the least toxic therapies available at the time,” said M. Douglas Ris, PhD, professor of pediatrics and psychology at Baylor College of Medicine in Houston, in a press release. “As pediatric brain tumors become more survivable with continued advances in treatments, we need to improve surveillance of these populations so that survivors continue to receive the best interventions during their transition to adulthood and well beyond.”

Clinicians generally have assumed that children with low-grade CNS tumors who receive less toxic treatment will have fewer long-term effects than survivors of more malignant tumors who undergo neurotoxic therapies. Yet research has indicated that the former patients can have lasting neurobehavioral or functional morbidity.

Dr. Ris and colleagues invited survivors of pediatric low-grade gliomas participating in the Childhood Cancer Survivor Study (CCSS) and a sibling comparison group to undergo a direct, comprehensive neurocognitive assessment. Of 495 eligible survivors, 257 participated. Seventy-six patients did not travel to a study site, but completed a questionnaire, and the researchers did not include data for this group in their analysis. Dr. Ris and colleagues obtained information about surgery and radiotherapy from participants’ medical records. Patients underwent standardized, age-normed neuropsychologic tests. The primary neuropsychologic outcomes were the Composite Neuropsychological Index (CNI) and estimated IQ. To evaluate socioeconomic outcomes, Dr. Ris and colleagues measured participants’ educational attainment, income, and occupational prestige.

After the researchers adjusted the data for age and sex, they found that siblings had higher mean scores than survivors treated with surgery plus radiotherapy or surgery alone on all neuropsychologic outcomes, including the CNI (siblings, 106.8; surgery only, 95.6; surgery plus radiotherapy, 88.3) and estimated IQ. Survivors who had been diagnosed at younger ages had low scores for all outcomes except for attention/processing speed.

Furthermore, surgery plus radiotherapy was associated with a 7.7-fold higher risk of having an occupation in the lowest sibling quartile, compared with siblings. Survivors who underwent surgery alone had a 2.8-fold higher risk than siblings of having an occupation in the lowest quartile. Surgery plus radiotherapy was associated with a 2.6-fold increased risk of a low occupation score, compared with survivors who underwent surgery alone.

Compared with siblings, surgery plus radiotherapy was associated with a 4.5-fold risk of an annual income of less than $20,000, while the risk for survivors who underwent surgery alone did not differ significantly from that for siblings. Surgery plus radiotherapy was associated with a 2.6-fold higher risk than surgery alone. Surgery plus radiotherapy was also associated with a significantly increased risk for an education level lower than a bachelor’s degree, compared with siblings, but surgery alone was not.

The National Cancer Institute supported the study. The authors had no disclosures.

egreb@mdedge.com

SOURCE: Ris MD et al. Cancer. 2019 Jun 24. doi: 10.1002/cncr.32186.

Decades after undergoing surgery and radiotherapy, survivors of a pediatric CNS tumor may have worse neuropsychologic and socioeconomic outcomes, compared with their unaffected siblings. Children who underwent surgery alone had better neuropsychologic and socioeconomic outcomes than those who also underwent radiotherapy, but their outcomes were worse than those of unaffected siblings. These findings were published online June 24 in Cancer.

“Late effects in adulthood are evident even for children with the least malignant types of brain tumors who were treated with the least toxic therapies available at the time,” said M. Douglas Ris, PhD, professor of pediatrics and psychology at Baylor College of Medicine in Houston, in a press release. “As pediatric brain tumors become more survivable with continued advances in treatments, we need to improve surveillance of these populations so that survivors continue to receive the best interventions during their transition to adulthood and well beyond.”

Clinicians generally have assumed that children with low-grade CNS tumors who receive less toxic treatment will have fewer long-term effects than survivors of more malignant tumors who undergo neurotoxic therapies. Yet research has indicated that the former patients can have lasting neurobehavioral or functional morbidity.

Dr. Ris and colleagues invited survivors of pediatric low-grade gliomas participating in the Childhood Cancer Survivor Study (CCSS) and a sibling comparison group to undergo a direct, comprehensive neurocognitive assessment. Of 495 eligible survivors, 257 participated. Seventy-six patients did not travel to a study site, but completed a questionnaire, and the researchers did not include data for this group in their analysis. Dr. Ris and colleagues obtained information about surgery and radiotherapy from participants’ medical records. Patients underwent standardized, age-normed neuropsychologic tests. The primary neuropsychologic outcomes were the Composite Neuropsychological Index (CNI) and estimated IQ. To evaluate socioeconomic outcomes, Dr. Ris and colleagues measured participants’ educational attainment, income, and occupational prestige.

After the researchers adjusted the data for age and sex, they found that siblings had higher mean scores than survivors treated with surgery plus radiotherapy or surgery alone on all neuropsychologic outcomes, including the CNI (siblings, 106.8; surgery only, 95.6; surgery plus radiotherapy, 88.3) and estimated IQ. Survivors who had been diagnosed at younger ages had low scores for all outcomes except for attention/processing speed.

Furthermore, surgery plus radiotherapy was associated with a 7.7-fold higher risk of having an occupation in the lowest sibling quartile, compared with siblings. Survivors who underwent surgery alone had a 2.8-fold higher risk than siblings of having an occupation in the lowest quartile. Surgery plus radiotherapy was associated with a 2.6-fold increased risk of a low occupation score, compared with survivors who underwent surgery alone.

Compared with siblings, surgery plus radiotherapy was associated with a 4.5-fold risk of an annual income of less than $20,000, while the risk for survivors who underwent surgery alone did not differ significantly from that for siblings. Surgery plus radiotherapy was associated with a 2.6-fold higher risk than surgery alone. Surgery plus radiotherapy was also associated with a significantly increased risk for an education level lower than a bachelor’s degree, compared with siblings, but surgery alone was not.

The National Cancer Institute supported the study. The authors had no disclosures.

egreb@mdedge.com

SOURCE: Ris MD et al. Cancer. 2019 Jun 24. doi: 10.1002/cncr.32186.

The new National Coverage Determination by Medicare for transcatheter aortic valve replacement should produce a bump in the number of U.S. programs offering the procedure, especially with the Food and Drug Administration on the cusp of approving the procedure for low-risk patients.

Mitchel L. Zoler/MDedge News

In the revised National Coverage Determination (NCD) by the Centers for Medicare & Medicaid Services that went into effect on June 21, 2019, the agency allowed for Medicare coverage of transcatheter aortic valve (TAVR) procedures at hospitals that perform at least 20 of these procedures annually or at least 40 every 2 years, the same volume minimums that CMS first applied to TAVR in its prior 2012 NCD. Retention of this minimum ran against the 2018 proposal of the American College of Cardiology, the Society of Thoracic Surgeons, and two other collaborating societies that called for an annual TAVR volume minimum at a hospital program of 50 procedures annually or 100 every 2 years (J Am Coll Cardiol. 2019 Jan 29;73[3]:340-74).

That change, coupled with a cut in the minimum number of annual percutaneous coronary interventions a TAVR program needs to perform – newly revised to a minimum of 300 cases/year – will likely mean more U.S. sites performing TAVR, predicted James Vavricek, director of regulatory affairs for the ACC in Washington. TAVR volume is seen as a reasonable, approximate surrogate for a more rigorous, statistically adjusted assessment of program quality. The ACC and representatives from the other societies that collaborated on the 2018 statement used a 50 case/year minimum for a TAVR program because volume at that level generates enough outcomes data to allow for a meaningful, risk-adjusted measure of performance.

The ACC does not consider the minimum of 20 TAVR cases/year the “right decision,” Mr. Vavricek said in an interview, but the ACC sees it as a compromise that accommodated the interests of multiple TAVR stakeholders. “It will be interesting to see where new TAVR programs locate,” whether they will expand access in underserved regions or mostly cluster in regions already fairly replete with TAVR access, he added. Currently, over 600 U.S. TAVR programs are in operation.

In April 2019, the president of the ACC along with the presidents of three other U.S. societies with an interest in TAVR told the CMS in a comment letter that “we are extremely concerned that the proposed volume requirements will translate into a proliferation of low-volume TAVR programs at increased risk for having suboptimal outcomes.”

Another change to procedure volume requirements in the new NCD was setting a minimum of 100 total TAVR plus surgical aortic valve replacements in a 2-year period or 50 total procedures/year for each TAVR program. Setting a minimum that bundles TAVR plus surgical valve replacements is a “forward-looking” approach as wider application of TAVR gradually erodes the volume of surgical procedures, Mr. Vavricek said.

An additional notable change in the revised NCD was elimination of the “two-surgeon” rule, which the CMS had made mandatory for TAVR decisions until now, stipulating that a patient considered for TAVR needed independent assessment by two cardiac surgeons. The final 2019 NCD calls for the TAVR decision to come from one cardiac surgeon and one interventional cardiologist working together on a care team.

“The ACC is pleased to see CMS issue updated TAVR coverage criteria that emphasizes care by an interdisciplinary heart team for these complex patients, as well as continues to mandate the collection of TAVR patient data. With the new lowered minimum yearly volume criteria set by CMS in their efforts to improve patient access, the value of the STS/ACC TVT Registry, along with ACC’s Transcatheter Valve Certification, will be critical in assuring quality of care for our patients particularly in low-volume centers,” commented Richard J. Kovacs, MD, ACC’s president.

mzoler@mdedge.com

The new National Coverage Determination by Medicare for transcatheter aortic valve replacement should produce a bump in the number of U.S. programs offering the procedure, especially with the Food and Drug Administration on the cusp of approving the procedure for low-risk patients.

Mitchel L. Zoler/MDedge News

In the revised National Coverage Determination (NCD) by the Centers for Medicare & Medicaid Services that went into effect on June 21, 2019, the agency allowed for Medicare coverage of transcatheter aortic valve (TAVR) procedures at hospitals that perform at least 20 of these procedures annually or at least 40 every 2 years, the same volume minimums that CMS first applied to TAVR in its prior 2012 NCD. Retention of this minimum ran against the 2018 proposal of the American College of Cardiology, the Society of Thoracic Surgeons, and two other collaborating societies that called for an annual TAVR volume minimum at a hospital program of 50 procedures annually or 100 every 2 years (J Am Coll Cardiol. 2019 Jan 29;73[3]:340-74).

That change, coupled with a cut in the minimum number of annual percutaneous coronary interventions a TAVR program needs to perform – newly revised to a minimum of 300 cases/year – will likely mean more U.S. sites performing TAVR, predicted James Vavricek, director of regulatory affairs for the ACC in Washington. TAVR volume is seen as a reasonable, approximate surrogate for a more rigorous, statistically adjusted assessment of program quality. The ACC and representatives from the other societies that collaborated on the 2018 statement used a 50 case/year minimum for a TAVR program because volume at that level generates enough outcomes data to allow for a meaningful, risk-adjusted measure of performance.

The ACC does not consider the minimum of 20 TAVR cases/year the “right decision,” Mr. Vavricek said in an interview, but the ACC sees it as a compromise that accommodated the interests of multiple TAVR stakeholders. “It will be interesting to see where new TAVR programs locate,” whether they will expand access in underserved regions or mostly cluster in regions already fairly replete with TAVR access, he added. Currently, over 600 U.S. TAVR programs are in operation.

In April 2019, the president of the ACC along with the presidents of three other U.S. societies with an interest in TAVR told the CMS in a comment letter that “we are extremely concerned that the proposed volume requirements will translate into a proliferation of low-volume TAVR programs at increased risk for having suboptimal outcomes.”

Another change to procedure volume requirements in the new NCD was setting a minimum of 100 total TAVR plus surgical aortic valve replacements in a 2-year period or 50 total procedures/year for each TAVR program. Setting a minimum that bundles TAVR plus surgical valve replacements is a “forward-looking” approach as wider application of TAVR gradually erodes the volume of surgical procedures, Mr. Vavricek said.

An additional notable change in the revised NCD was elimination of the “two-surgeon” rule, which the CMS had made mandatory for TAVR decisions until now, stipulating that a patient considered for TAVR needed independent assessment by two cardiac surgeons. The final 2019 NCD calls for the TAVR decision to come from one cardiac surgeon and one interventional cardiologist working together on a care team.

“The ACC is pleased to see CMS issue updated TAVR coverage criteria that emphasizes care by an interdisciplinary heart team for these complex patients, as well as continues to mandate the collection of TAVR patient data. With the new lowered minimum yearly volume criteria set by CMS in their efforts to improve patient access, the value of the STS/ACC TVT Registry, along with ACC’s Transcatheter Valve Certification, will be critical in assuring quality of care for our patients particularly in low-volume centers,” commented Richard J. Kovacs, MD, ACC’s president.

mzoler@mdedge.com

The new National Coverage Determination by Medicare for transcatheter aortic valve replacement should produce a bump in the number of U.S. programs offering the procedure, especially with the Food and Drug Administration on the cusp of approving the procedure for low-risk patients.

Mitchel L. Zoler/MDedge News

In the revised National Coverage Determination (NCD) by the Centers for Medicare & Medicaid Services that went into effect on June 21, 2019, the agency allowed for Medicare coverage of transcatheter aortic valve (TAVR) procedures at hospitals that perform at least 20 of these procedures annually or at least 40 every 2 years, the same volume minimums that CMS first applied to TAVR in its prior 2012 NCD. Retention of this minimum ran against the 2018 proposal of the American College of Cardiology, the Society of Thoracic Surgeons, and two other collaborating societies that called for an annual TAVR volume minimum at a hospital program of 50 procedures annually or 100 every 2 years (J Am Coll Cardiol. 2019 Jan 29;73[3]:340-74).

That change, coupled with a cut in the minimum number of annual percutaneous coronary interventions a TAVR program needs to perform – newly revised to a minimum of 300 cases/year – will likely mean more U.S. sites performing TAVR, predicted James Vavricek, director of regulatory affairs for the ACC in Washington. TAVR volume is seen as a reasonable, approximate surrogate for a more rigorous, statistically adjusted assessment of program quality. The ACC and representatives from the other societies that collaborated on the 2018 statement used a 50 case/year minimum for a TAVR program because volume at that level generates enough outcomes data to allow for a meaningful, risk-adjusted measure of performance.

The ACC does not consider the minimum of 20 TAVR cases/year the “right decision,” Mr. Vavricek said in an interview, but the ACC sees it as a compromise that accommodated the interests of multiple TAVR stakeholders. “It will be interesting to see where new TAVR programs locate,” whether they will expand access in underserved regions or mostly cluster in regions already fairly replete with TAVR access, he added. Currently, over 600 U.S. TAVR programs are in operation.

In April 2019, the president of the ACC along with the presidents of three other U.S. societies with an interest in TAVR told the CMS in a comment letter that “we are extremely concerned that the proposed volume requirements will translate into a proliferation of low-volume TAVR programs at increased risk for having suboptimal outcomes.”

Another change to procedure volume requirements in the new NCD was setting a minimum of 100 total TAVR plus surgical aortic valve replacements in a 2-year period or 50 total procedures/year for each TAVR program. Setting a minimum that bundles TAVR plus surgical valve replacements is a “forward-looking” approach as wider application of TAVR gradually erodes the volume of surgical procedures, Mr. Vavricek said.

An additional notable change in the revised NCD was elimination of the “two-surgeon” rule, which the CMS had made mandatory for TAVR decisions until now, stipulating that a patient considered for TAVR needed independent assessment by two cardiac surgeons. The final 2019 NCD calls for the TAVR decision to come from one cardiac surgeon and one interventional cardiologist working together on a care team.

“The ACC is pleased to see CMS issue updated TAVR coverage criteria that emphasizes care by an interdisciplinary heart team for these complex patients, as well as continues to mandate the collection of TAVR patient data. With the new lowered minimum yearly volume criteria set by CMS in their efforts to improve patient access, the value of the STS/ACC TVT Registry, along with ACC’s Transcatheter Valve Certification, will be critical in assuring quality of care for our patients particularly in low-volume centers,” commented Richard J. Kovacs, MD, ACC’s president.

mzoler@mdedge.com

Acute graft-vs-host disease (GVHD) is a T-cell mediated immunogenic response in which T lymphocytes from a donor regard host tissue as foreign and attack it in the setting of immunosuppression.¹ The most common cause of acute GVHD is allogeneic stem cell transplantation, with solid-organ transplantation being a much less common cause.² The incidence of acute GVHD following orthotopic liver transplantation (OLT) is 0.1%, as reported by the United Network for Organ Sharing, compared to an incidence of 40% to 60% in hematopoietic stem cell transplant recipients.^3,4

Early recognition and treatment of acute GVHD following liver transplantation is imperative, as the mortality rate is 85% to 90%.² We present a case of acute GVHD in a liver transplantation patient, with a focus on diagnostic criteria and comparison to acute GVHD following hematopoietic stem cell transplantation.

Case Report

A 68-year-old woman with a history of hepatitis C virus infection, hepatocellular carcinoma, and OLT 1 month prior presented to the hospital with fever and abdominal cellulitis in close proximity to the surgical site of 1 week’s duration. The patient was started on vancomycin and cefepime; pan cultures were performed.

At 10 days of hospitalization, the patient developed a pruritic, nontender, erythematous rash on the abdomen, with extension onto the chest and legs. The rash was associated with low-grade fever but not with diarrhea. Physical examination was notable for a few erythematous macules and scattered papules over the neck and chest and a large erythematous plaque with multiple ecchymoses over the lower abdomen (Figure 1A). Erythematous macules and papules coalescing into plaques were present on the lower back (Figure 1B) and proximal thighs. Oral, ocular, and genital lesions were absent.

Over a 2-day period, the rash progressed to diffuse erythematous papules over the chest (Figure 2A) and bilateral arms (Figure 2B) including the palms. The patient also developed erythematous papules over the jawline and forehead as well as confluent erythematous plaques over the back with extension of the rash to involve the legs. She also had erythema and swelling bilaterally over the ears. She reported diarrhea. The low-grade fever resolved.

Comment

GVHD Subtypes
The 2 types of GVHD are humoral and cellular.⁵ The humoral type results from ABO blood type incompatibility between donor and recipient and causes mild hemolytic anemia and fever. The cellular type is directed against major histocompatibility complexes and is associated with high morbidity and mortality.

Presentation of GVHD
Acute GVHD following OLT usually occurs 3 to 5 weeks after transplantation,⁶ as in our patient. Symptoms include rash, fever, pancytopenia, and diarrhea.² Skin is the most commonly involved organ in acute GVHD; rash is the earliest manifestation.¹ The rash can be asymptomatic or associated with pain and pruritus. Initial cutaneous manifestations include palmar erythema and erythematous to violaceous discoloration of the face and ears. A diffuse maculopapular rash can develop, involving the face, abdomen, and trunk. The rash may progress to formation of bullae or skin sloughing, resembling Stevens-Johnson syndrome or toxic epidermal necrolysis.¹ The skin manifestation of acute GVHD following OLT is similar to hematopoietic stem cell transplantation (Table).^7,8

Prevention
Acute GVHD following OLT can be prevented by eliminating donor T lymphocytes from the liver before transplantation. However, because the incidence of acute GVHD following OLT is very low, this approach is not routinely taken.²

Conclusion

Acute GVHD following liver transplantation is a rare complication; however, it has high mortality, necessitating further research regarding treatment and prevention. Early recognition and treatment of this condition can improve outcomes. Dermatologists should be familiar with the skin manifestations of acute GVHD following liver transplantation due to the rising number of cases of solid-organ transplantation.

Acute graft-vs-host disease (GVHD) is a T-cell mediated immunogenic response in which T lymphocytes from a donor regard host tissue as foreign and attack it in the setting of immunosuppression.¹ The most common cause of acute GVHD is allogeneic stem cell transplantation, with solid-organ transplantation being a much less common cause.² The incidence of acute GVHD following orthotopic liver transplantation (OLT) is 0.1%, as reported by the United Network for Organ Sharing, compared to an incidence of 40% to 60% in hematopoietic stem cell transplant recipients.^3,4

Early recognition and treatment of acute GVHD following liver transplantation is imperative, as the mortality rate is 85% to 90%.² We present a case of acute GVHD in a liver transplantation patient, with a focus on diagnostic criteria and comparison to acute GVHD following hematopoietic stem cell transplantation.

Case Report

A 68-year-old woman with a history of hepatitis C virus infection, hepatocellular carcinoma, and OLT 1 month prior presented to the hospital with fever and abdominal cellulitis in close proximity to the surgical site of 1 week’s duration. The patient was started on vancomycin and cefepime; pan cultures were performed.

At 10 days of hospitalization, the patient developed a pruritic, nontender, erythematous rash on the abdomen, with extension onto the chest and legs. The rash was associated with low-grade fever but not with diarrhea. Physical examination was notable for a few erythematous macules and scattered papules over the neck and chest and a large erythematous plaque with multiple ecchymoses over the lower abdomen (Figure 1A). Erythematous macules and papules coalescing into plaques were present on the lower back (Figure 1B) and proximal thighs. Oral, ocular, and genital lesions were absent.

Over a 2-day period, the rash progressed to diffuse erythematous papules over the chest (Figure 2A) and bilateral arms (Figure 2B) including the palms. The patient also developed erythematous papules over the jawline and forehead as well as confluent erythematous plaques over the back with extension of the rash to involve the legs. She also had erythema and swelling bilaterally over the ears. She reported diarrhea. The low-grade fever resolved.

Comment

GVHD Subtypes
The 2 types of GVHD are humoral and cellular.⁵ The humoral type results from ABO blood type incompatibility between donor and recipient and causes mild hemolytic anemia and fever. The cellular type is directed against major histocompatibility complexes and is associated with high morbidity and mortality.

Presentation of GVHD
Acute GVHD following OLT usually occurs 3 to 5 weeks after transplantation,⁶ as in our patient. Symptoms include rash, fever, pancytopenia, and diarrhea.² Skin is the most commonly involved organ in acute GVHD; rash is the earliest manifestation.¹ The rash can be asymptomatic or associated with pain and pruritus. Initial cutaneous manifestations include palmar erythema and erythematous to violaceous discoloration of the face and ears. A diffuse maculopapular rash can develop, involving the face, abdomen, and trunk. The rash may progress to formation of bullae or skin sloughing, resembling Stevens-Johnson syndrome or toxic epidermal necrolysis.¹ The skin manifestation of acute GVHD following OLT is similar to hematopoietic stem cell transplantation (Table).^7,8

Prevention
Acute GVHD following OLT can be prevented by eliminating donor T lymphocytes from the liver before transplantation. However, because the incidence of acute GVHD following OLT is very low, this approach is not routinely taken.²

Conclusion

Acute GVHD following liver transplantation is a rare complication; however, it has high mortality, necessitating further research regarding treatment and prevention. Early recognition and treatment of this condition can improve outcomes. Dermatologists should be familiar with the skin manifestations of acute GVHD following liver transplantation due to the rising number of cases of solid-organ transplantation.

Acute graft-vs-host disease (GVHD) is a T-cell mediated immunogenic response in which T lymphocytes from a donor regard host tissue as foreign and attack it in the setting of immunosuppression.¹ The most common cause of acute GVHD is allogeneic stem cell transplantation, with solid-organ transplantation being a much less common cause.² The incidence of acute GVHD following orthotopic liver transplantation (OLT) is 0.1%, as reported by the United Network for Organ Sharing, compared to an incidence of 40% to 60% in hematopoietic stem cell transplant recipients.^3,4

Early recognition and treatment of acute GVHD following liver transplantation is imperative, as the mortality rate is 85% to 90%.² We present a case of acute GVHD in a liver transplantation patient, with a focus on diagnostic criteria and comparison to acute GVHD following hematopoietic stem cell transplantation.

Case Report

A 68-year-old woman with a history of hepatitis C virus infection, hepatocellular carcinoma, and OLT 1 month prior presented to the hospital with fever and abdominal cellulitis in close proximity to the surgical site of 1 week’s duration. The patient was started on vancomycin and cefepime; pan cultures were performed.

At 10 days of hospitalization, the patient developed a pruritic, nontender, erythematous rash on the abdomen, with extension onto the chest and legs. The rash was associated with low-grade fever but not with diarrhea. Physical examination was notable for a few erythematous macules and scattered papules over the neck and chest and a large erythematous plaque with multiple ecchymoses over the lower abdomen (Figure 1A). Erythematous macules and papules coalescing into plaques were present on the lower back (Figure 1B) and proximal thighs. Oral, ocular, and genital lesions were absent.

Over a 2-day period, the rash progressed to diffuse erythematous papules over the chest (Figure 2A) and bilateral arms (Figure 2B) including the palms. The patient also developed erythematous papules over the jawline and forehead as well as confluent erythematous plaques over the back with extension of the rash to involve the legs. She also had erythema and swelling bilaterally over the ears. She reported diarrhea. The low-grade fever resolved.

Comment

GVHD Subtypes
The 2 types of GVHD are humoral and cellular.⁵ The humoral type results from ABO blood type incompatibility between donor and recipient and causes mild hemolytic anemia and fever. The cellular type is directed against major histocompatibility complexes and is associated with high morbidity and mortality.

Presentation of GVHD
Acute GVHD following OLT usually occurs 3 to 5 weeks after transplantation,⁶ as in our patient. Symptoms include rash, fever, pancytopenia, and diarrhea.² Skin is the most commonly involved organ in acute GVHD; rash is the earliest manifestation.¹ The rash can be asymptomatic or associated with pain and pruritus. Initial cutaneous manifestations include palmar erythema and erythematous to violaceous discoloration of the face and ears. A diffuse maculopapular rash can develop, involving the face, abdomen, and trunk. The rash may progress to formation of bullae or skin sloughing, resembling Stevens-Johnson syndrome or toxic epidermal necrolysis.¹ The skin manifestation of acute GVHD following OLT is similar to hematopoietic stem cell transplantation (Table).^7,8

Prevention
Acute GVHD following OLT can be prevented by eliminating donor T lymphocytes from the liver before transplantation. However, because the incidence of acute GVHD following OLT is very low, this approach is not routinely taken.²

Conclusion

Acute GVHD following liver transplantation is a rare complication; however, it has high mortality, necessitating further research regarding treatment and prevention. Early recognition and treatment of this condition can improve outcomes. Dermatologists should be familiar with the skin manifestations of acute GVHD following liver transplantation due to the rising number of cases of solid-organ transplantation.

CHICAGO – Nearly two-thirds of more than 400 U.S.-based physician members of the Society of Gynecologic Oncology who participated in a recent survey reported experiencing sexual harassment in training or practice.

Notably, of the 255 women and 147 men who responded, 71% and 51%, respectively, reported such sexual harassment – and only 15% overall reported it to officials, Marina Stasenko, MD, reported at the annual meeting of the American Society of Clinical Oncology.

The survey also addressed gender-based discrimination and disparities, including respondents’ views on pay disparities. In this video interview, Dr. Stasenko, a gynecologic oncology fellow at Memorial Sloan Kettering Cancer Center, New York, discusses the findings, their implications and context in this age of #MeToo and #TimesUp, and potential approaches to addressing the ongoing problem and the concerns victims have about reporting harassment.

“We need to start by setting an example, saying these things are not tolerated [and] put that into policy – really show folks how it can be reported and what is being done once that report is filed,” she said.

Dr. Stasenko reported having no disclosures.

sworcester@mdedge.com

SOURCE: Stasenko M et al. ASCO 2019, Abstract LBA10502.

CHICAGO – Nearly two-thirds of more than 400 U.S.-based physician members of the Society of Gynecologic Oncology who participated in a recent survey reported experiencing sexual harassment in training or practice.

Notably, of the 255 women and 147 men who responded, 71% and 51%, respectively, reported such sexual harassment – and only 15% overall reported it to officials, Marina Stasenko, MD, reported at the annual meeting of the American Society of Clinical Oncology.

The survey also addressed gender-based discrimination and disparities, including respondents’ views on pay disparities. In this video interview, Dr. Stasenko, a gynecologic oncology fellow at Memorial Sloan Kettering Cancer Center, New York, discusses the findings, their implications and context in this age of #MeToo and #TimesUp, and potential approaches to addressing the ongoing problem and the concerns victims have about reporting harassment.

“We need to start by setting an example, saying these things are not tolerated [and] put that into policy – really show folks how it can be reported and what is being done once that report is filed,” she said.

Dr. Stasenko reported having no disclosures.

sworcester@mdedge.com

SOURCE: Stasenko M et al. ASCO 2019, Abstract LBA10502.

CHICAGO – Nearly two-thirds of more than 400 U.S.-based physician members of the Society of Gynecologic Oncology who participated in a recent survey reported experiencing sexual harassment in training or practice.

Notably, of the 255 women and 147 men who responded, 71% and 51%, respectively, reported such sexual harassment – and only 15% overall reported it to officials, Marina Stasenko, MD, reported at the annual meeting of the American Society of Clinical Oncology.

The survey also addressed gender-based discrimination and disparities, including respondents’ views on pay disparities. In this video interview, Dr. Stasenko, a gynecologic oncology fellow at Memorial Sloan Kettering Cancer Center, New York, discusses the findings, their implications and context in this age of #MeToo and #TimesUp, and potential approaches to addressing the ongoing problem and the concerns victims have about reporting harassment.

“We need to start by setting an example, saying these things are not tolerated [and] put that into policy – really show folks how it can be reported and what is being done once that report is filed,” she said.

Dr. Stasenko reported having no disclosures.

sworcester@mdedge.com

SOURCE: Stasenko M et al. ASCO 2019, Abstract LBA10502.

TORONTO – A high level of pain catastrophizing prior to scheduled knee arthroplasty is not, as previously thought, a harbinger of poor outcomes, and affected patients don’t benefit from cognitive-behavioral therapy–based training in pain coping skills, Daniel L. Riddle, PhD, reported at the OARSI 2019 World Congress.

Bruce Jancin/MDedge News

“The take-home message for us is knee arthroplasty is incredibly effective and there really is no reason to do pain coping skills training in these high–pain catastrophizing patients because the great majority of them have such good outcomes,” said Dr. Riddle, professor of physical therapy at Virginia Commonwealth University, Richmond.

“The other clear message from our trial is that, when you have pain-catastrophizing patients and you lower their pain, their catastrophizing is also lowered. So pain catastrophizing is clearly a response to pain and not a personality trait per se,” he said at the meeting sponsored by the Osteoarthritis Research Society International.

He presented the results of a 402-patient, randomized, three-arm, single-blind trial conducted at five U.S. medical centers. All participants were scheduled for knee arthroplasty for osteoarthritis, and all had moderate- to high-level pain catastrophizing as reflected in the group’s average Pain Catastrophizing Score of 30. They were assigned to an arthritis education active control group, usual care, or an intervention developed specifically for this study: a cognitive-behavioral therapy–based training program for pain coping skills. Similar pain coping skills training interventions have been shown to be beneficial in patients with medically treated knee OA but hadn’t previously been evaluated in surgically treated patients. The primary study endpoint was change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale at 2, 6, and 12 months after surgery.

The improvement in WOMAC pain in the three study arms was virtually superimposable, going from an average pain score of about 12 preoperatively to 2 postoperatively.

“This was a clear no-effect trial,” Dr. Riddle observed. “These are patients we thought to be at increased risk for poor outcome, but indeed they’re not.”

Pain Catastrophizing Scores improved from 30 preoperatively to roughly 7 at 1 year. “We’ve never seen pain catastrophizing improvements of this magnitude,” the researcher commented.

The study participants typically had a large number of chronically painful areas, but only minimal change in pain scores occurred except in the surgically treated knee.

Of note, even with the impressively large improvements in knee pain, function, and other secondary endpoints in the study group as a whole, roughly 20% of study participants experienced essentially no improvement in their function-limiting knee pain during the first year after arthroplasty. These nonresponders were spread equally across all three study arms. Further research will be needed to develop interventions to help this challenging patient subgroup.

The pain coping skills training consisted of 8 weekly sessions, each an hour long, which began prior to surgery and continued afterward. The intervention was delivered by physical therapists who had been trained by pain psychologists with expertise in cognitive-behavioral therapy. The intervention was delivered by telephone and in face-to-face sessions. The trainers were tracked over the course of the study to make sure that the structured intervention was delivered as planned.

Dr. Riddle reported having no financial conflicts regarding the National Institutes of Health-funded study, the full details of which have been published (J Bone Joint Surg Am. 2019 Feb 6;101[3]:218-227).

bjancin@mdedge.com

TORONTO – A high level of pain catastrophizing prior to scheduled knee arthroplasty is not, as previously thought, a harbinger of poor outcomes, and affected patients don’t benefit from cognitive-behavioral therapy–based training in pain coping skills, Daniel L. Riddle, PhD, reported at the OARSI 2019 World Congress.

Bruce Jancin/MDedge News

“The take-home message for us is knee arthroplasty is incredibly effective and there really is no reason to do pain coping skills training in these high–pain catastrophizing patients because the great majority of them have such good outcomes,” said Dr. Riddle, professor of physical therapy at Virginia Commonwealth University, Richmond.

“The other clear message from our trial is that, when you have pain-catastrophizing patients and you lower their pain, their catastrophizing is also lowered. So pain catastrophizing is clearly a response to pain and not a personality trait per se,” he said at the meeting sponsored by the Osteoarthritis Research Society International.

He presented the results of a 402-patient, randomized, three-arm, single-blind trial conducted at five U.S. medical centers. All participants were scheduled for knee arthroplasty for osteoarthritis, and all had moderate- to high-level pain catastrophizing as reflected in the group’s average Pain Catastrophizing Score of 30. They were assigned to an arthritis education active control group, usual care, or an intervention developed specifically for this study: a cognitive-behavioral therapy–based training program for pain coping skills. Similar pain coping skills training interventions have been shown to be beneficial in patients with medically treated knee OA but hadn’t previously been evaluated in surgically treated patients. The primary study endpoint was change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale at 2, 6, and 12 months after surgery.

The improvement in WOMAC pain in the three study arms was virtually superimposable, going from an average pain score of about 12 preoperatively to 2 postoperatively.

“This was a clear no-effect trial,” Dr. Riddle observed. “These are patients we thought to be at increased risk for poor outcome, but indeed they’re not.”

Pain Catastrophizing Scores improved from 30 preoperatively to roughly 7 at 1 year. “We’ve never seen pain catastrophizing improvements of this magnitude,” the researcher commented.

The study participants typically had a large number of chronically painful areas, but only minimal change in pain scores occurred except in the surgically treated knee.

Of note, even with the impressively large improvements in knee pain, function, and other secondary endpoints in the study group as a whole, roughly 20% of study participants experienced essentially no improvement in their function-limiting knee pain during the first year after arthroplasty. These nonresponders were spread equally across all three study arms. Further research will be needed to develop interventions to help this challenging patient subgroup.

The pain coping skills training consisted of 8 weekly sessions, each an hour long, which began prior to surgery and continued afterward. The intervention was delivered by physical therapists who had been trained by pain psychologists with expertise in cognitive-behavioral therapy. The intervention was delivered by telephone and in face-to-face sessions. The trainers were tracked over the course of the study to make sure that the structured intervention was delivered as planned.

Dr. Riddle reported having no financial conflicts regarding the National Institutes of Health-funded study, the full details of which have been published (J Bone Joint Surg Am. 2019 Feb 6;101[3]:218-227).

bjancin@mdedge.com

TORONTO – A high level of pain catastrophizing prior to scheduled knee arthroplasty is not, as previously thought, a harbinger of poor outcomes, and affected patients don’t benefit from cognitive-behavioral therapy–based training in pain coping skills, Daniel L. Riddle, PhD, reported at the OARSI 2019 World Congress.

Bruce Jancin/MDedge News

“The take-home message for us is knee arthroplasty is incredibly effective and there really is no reason to do pain coping skills training in these high–pain catastrophizing patients because the great majority of them have such good outcomes,” said Dr. Riddle, professor of physical therapy at Virginia Commonwealth University, Richmond.

“The other clear message from our trial is that, when you have pain-catastrophizing patients and you lower their pain, their catastrophizing is also lowered. So pain catastrophizing is clearly a response to pain and not a personality trait per se,” he said at the meeting sponsored by the Osteoarthritis Research Society International.

He presented the results of a 402-patient, randomized, three-arm, single-blind trial conducted at five U.S. medical centers. All participants were scheduled for knee arthroplasty for osteoarthritis, and all had moderate- to high-level pain catastrophizing as reflected in the group’s average Pain Catastrophizing Score of 30. They were assigned to an arthritis education active control group, usual care, or an intervention developed specifically for this study: a cognitive-behavioral therapy–based training program for pain coping skills. Similar pain coping skills training interventions have been shown to be beneficial in patients with medically treated knee OA but hadn’t previously been evaluated in surgically treated patients. The primary study endpoint was change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale at 2, 6, and 12 months after surgery.

The improvement in WOMAC pain in the three study arms was virtually superimposable, going from an average pain score of about 12 preoperatively to 2 postoperatively.

“This was a clear no-effect trial,” Dr. Riddle observed. “These are patients we thought to be at increased risk for poor outcome, but indeed they’re not.”

Pain Catastrophizing Scores improved from 30 preoperatively to roughly 7 at 1 year. “We’ve never seen pain catastrophizing improvements of this magnitude,” the researcher commented.

The study participants typically had a large number of chronically painful areas, but only minimal change in pain scores occurred except in the surgically treated knee.

Of note, even with the impressively large improvements in knee pain, function, and other secondary endpoints in the study group as a whole, roughly 20% of study participants experienced essentially no improvement in their function-limiting knee pain during the first year after arthroplasty. These nonresponders were spread equally across all three study arms. Further research will be needed to develop interventions to help this challenging patient subgroup.

The pain coping skills training consisted of 8 weekly sessions, each an hour long, which began prior to surgery and continued afterward. The intervention was delivered by physical therapists who had been trained by pain psychologists with expertise in cognitive-behavioral therapy. The intervention was delivered by telephone and in face-to-face sessions. The trainers were tracked over the course of the study to make sure that the structured intervention was delivered as planned.

Dr. Riddle reported having no financial conflicts regarding the National Institutes of Health-funded study, the full details of which have been published (J Bone Joint Surg Am. 2019 Feb 6;101[3]:218-227).

bjancin@mdedge.com

About 10% of all reproductive-aged women and 35% to 50% of women with pelvic pain and infertility are affected by endometriosis.^1,2 The disease typically involves the reproductive tract organs, anterior and posterior cul-de-sacs, and uterosacral ligaments. However, disease outside of the reproductive tract occurs frequently and has been found on all organs except the spleen.³

The bowel is the most common site for extragenital endometriosis, affected in an estimated 3.8% to 37% of patients with known endometriosis.^4-7 Implants may be superficial, involving the bowel serosa and subserosa (FIGURE 1), or they can manifest as deeply infiltrating lesions involving the muscularis and mucosa (FIGURE 2). The rectosigmoid colon is the most common location for bowel endometriosis, followed by the rectum, ileum, appendix, and cecum^4,8 (FIGURES 3, 4, and 5). Case reports also have described endometrial implants on the stomach and transverse colon.⁹ Although isolated bowel involvement has been recognized, most patients with bowel endometriosis have concurrent disease elsewhere.^2,4 

Historically, segmental resection was performed regardless of the anatomical location of the lesion.¹⁰ Even today, many surgeons continue to routinely perform segmental bowel resection as a first-line surgical approach.¹¹ Unnecessary segmental resection, however, places patients at risk for short- and long-term postoperative morbidity, including the possibility of permanent ostomy. Modern surgical techniques, such as shaving excision and disc resection, have been performed to successfully treat bowel endometriosis with excellent long-term outcomes and fewer complications when compared with traditional segmental resection.^2,12-16

In this article, we focus on the clinical indications and surgical techniques for video-laparoscopic management, but first we describe the pathophysiology, clinical presentation, and diagnosis of bowel endometriosis.

Pathophysiology of bowel endometriosis

The pathogenesis of endometriosis remains unknown, as no single mechanism explains all clinical cases of the disease. The most popular proposed theory describes retrograde menstruation through the fallopian tubes.¹⁷ Once inside the peritoneal cavity, endometrial cells attach to and invade healthy peritoneum, establishing a blood supply necessary for growth and survival.

In the case of bowel endometriosis, deposition of effluxed endometrial cells may lead to an inflammatory response that increases the risk of adhesion formation, leading to potential cul-de-sac obliteration. Lesions may originate as Allen-Masters peritoneal defects, developing into deeply infiltrative rectovaginal septum lesions. The anatomical shelter theory contributes to lesions within the pelvis, with the rectosigmoid colon blocking the cephalad flow of effluxed menstrual blood from the pelvis, thus leading to a preponderance of lesions in the pelvis and along the rectosigmoid colon.²

Continue to: Clinical presentation and diagnosis...

Clinical presentation and diagnosis

Women presenting with endometriosis of the bowel are typically of reproductive age and commonly report symptoms of dysmenorrhea, chronic pelvic pain, dyspareunia, and dyschezia. Some women also experience catamenial diarrhea, constipation, hematochezia, and bloating.² The differential diagnosis of these symptoms is broad and includes irritable bowel disease, ischemic colitis, inflammatory bowel disease, diverticulitis, pelvic inflammatory disease, and malignancy.

Because of its nonspecific symptoms, bowel endometriosis is often misdiagnosed and the disease goes untreated for years.¹⁸ Therefore, it is imperative that clinicians maintain a high index of suspicion when evaluating reproductive-aged women with gastrointestinal symptoms and pelvic pain.

Physical examination can be helpful in making the diagnosis of endometriosis. During bimanual examination, findings such as a fixed, tender, or retroverted uterus, uterosacral ligament nodularity, or an enlarged adnexal mass representing an ovarian endometrioma may be appreciated. Rectovaginal exam can identify areas of tenderness and nodularity along the rectovaginal septum. Speculum exam may reveal a laterally displaced cervix or blue powder-burn lesions along the cervix or posterior fornix.¹⁹ Rarely, endometriosis is found on the perineum within an episiotomy scar.²⁰

Imaging studies can be used in conjunction with physical examination findings to aid in the diagnosis of endometriosis. Images also guide preoperative planning by characterizing lesions based on their size, location, and depth of invasion. Hudelist and colleagues found transvaginal ultrasound (TVUS) to have an overall sensitivity of 71% to 98% and a specificity of 92% to 100%.²¹ However, it was noted that the accuracy of the diagnosis was directly related to the experience of the sonographer, and lesions above the sigmoid colon were generally unable to be diagnosed. Other imaging modalities that have been reported to have high sensitivity and specificity for diagnosing bowel endometriosis include rectal water contrast TVUS,^22,23 rectal endoscopic sonography,²² magnetic resonance imaging,²² and barium enema.²⁴

Medical management

Medical therapy for patients with endometriosis is utilized with the goal of suppressing ovulation, lowering circulating hormone levels, and inducing endometrial atrophy. Medications commonly employed include gonadotropin-releasing hormone agonists and antagonists, anabolic steriods such as danazol, combined oral contraceptive pills, progestins, and aromatase inhibitors.

Continue to: To date, no optimal hormonal regimen...

To date, no optimal hormonal regimen has been established for the treatment of bowel endometriosis. Vercellini and colleagues demonstrated that progestins with and without low-dose estrogen improved symptoms of dysmenorrhea and dyspareunia.²⁵ Ferrero and colleagues reported that 2.5 mg of norethindrone daily resulted in 53% of women with colorectal endometriosis reporting improved gastrointestinal symptoms.²⁶ However, by 12 months of follow-up, 33% of these patients had elected to undergo surgical management.

Gonadotropin-releasing hormone agonists, such as leuprolide acetate, also can be used to mitigate symptoms of bowel endometriosis or to decrease disease burden at the time of surgery, and they can be used with add-back norethindrone acetate. The use of these medications is limited by adverse effects, such as vasomotor symptoms and decreased bone mineral density when used for longer than 6 months.²

Medical therapy is commonly used for patients with mild to moderate symptoms and in those who are poor surgical candidates or decline surgical intervention. Medical therapy is especially useful when employed postoperatively to suppress the regrowth of microscopic ectopic endometrial tissue.

Patients must be counseled, however, that even with medical management, they may still require surgery in the future to control their symptoms and/or to preserve organ function.²

Surgical management

Surgical treatment for bowel endometriosis depends on the disease location, the size and depth of the lesion, the presence or absence of stricture, and the surgeon’s level of expertise.^2,12,27-30

In our group, we advocate for video-laparoscopy, with or without robotic as sistance. Minimally invasive surgery offers reduced blood loss, shorter recovery time, and fewer postoperative complications compared with laparotomy.^{2,16,27,31-33} The conversion rate to laparotomy has been reported to be about 3% when performed by an experienced surgeon.¹²

Darai and colleagues conducted a randomized trial of 52 patients undergoing surgery for colorectal endometriosis via either laparoscopic or open colon resection.³³ Blood loss was significantly lower in the laparoscopy group (1.6 vs 2.7 mg/L, P <.05). No difference was noted in long-term outcomes. In a retrospective study of 436 cases, Ruffo and colleagues showed that those who underwent laparoscopic colorectal resection had higher postoperative pregnancy rates compared with those who had laparotomy (57.6% vs 23.1%, P <.035).³²

The goal of surgical management of bowel endometriosis is to remove as many of the endometriotic lesions as possible while minimizing short- and long-term complications. Three surgical approaches have been described: shaving excision, disc resection, and segmental resection.²

Some surgeons prefer traditional segmental resection of the bowel regardless of the anatomical site, citing reduced disease recurrence with this approach; however, traditional segmental resection confers increased risk of complications. Increasingly, in an effort to reduce morbidity, more surgeons are advocating for the less aggressive methods of shaving excision and disc resection.

Aggressive resection at the level of the low rectum requires extensive surgical dissection of the retrorectal space, with the potential for inadvertent injury to surrounding neurovascular structures, such as the pelvic splanchnic nerves and superior and inferior hypogastric plexus.²⁹ Injury to these structures can lead to significant complications, including bowel stenosis, fistula formation, constipation, and urinary retention. Complete resection of other areas, such as the small bowel, do not carry the same risks and may have more significant benefit to the patient than less aggressive techniques.

Our group recommends carefully balancing the risks and benefits of aggressive surgical treatment for each individual and treating the patient with the appropriate technique. Regardless of technique, surgical treatment of bowel endometriosis can lead to long-term improvements in pain and infertility.^29,30,34,35

Continue to: Shaving excision...

Shaving excision

The most conservative approach to resection of bowel endometriosis is shaving excision; this involves removing endometriotic tissue layer-by-layer until healthy, underlying tissue is encountered.² With bowel endometriosis, the goal of shaving excision is to remove as much of the diseased tissue as possible while leaving behind the mucosal layer and a portion of the muscularis.^{2,15,16,36-38} This is the most conservative of the 3 surgical techniques and is associated with the lowest complication rate.^{2,14,15,36,37}

Our group reported on 185 women who underwent shaving excision for bowel endometriosis. At the time of surgery, 80 women had complete obliteration of the cul-de-sac (FIGURE 6). Of the study patients, 174 patients were available for follow-up, with 93% reporting moderate to complete pain relief.¹⁵

In a retrospective analysis of 3,298 surgeries for rectovaginal endometriosis in which shaving excision was used on all but 1% of patients, Donnez and colleagues reported a very low complication rate, with 1 case of rectal perforation, 1 case of fecal peritonitis, and 3 cases of ureteral injury.³⁹

Roman and colleagues described the use of shaving excision for rectal endometriosis using plasma energy (n = 54) and laparoscopic scissors (n = 68).⁴⁰ Only 4% of patients reported experiencing symptom recurrence, and the pregnancy rate was 65.4%, with 59% of those patients spontaneously conceiving. Two cases of rectal fistula were noted.

Disc resection

Laparoscopic disc excision has been described in the literature since the 1980s, and the technique involves the full-thickness removal of the diseased portion of the bowel, followed by closure of the remaining defect.^{2,12-14,28,29,31,41-45} To be appropriate for this technique, a lesion should involve only a portion of the bowel wall and, preferably, less than one-half of the bowel circumference.^2,42 Disc excision results in excellent outcomes with fewer postoperative complications than segmental resection, but with more complications when compared to shaving excision.^{2,12,13,29,45,46}

We reported on a series of 141 women with bowel endometriosis who underwent disc excision.² At 1-month follow-up, 87% of patients experienced an improvement in their symptoms. No cases required conversion to laparotomy or were complicated by rectovaginal fistula formation, ureteral injury, bowel perforation, or pelvic abscess.²

Continue to: Segmental resection...

Segmental resection

The most aggressive surgical approach, segmental resection involves complete removal of a diseased portion of bowel, followed by side-to-side or end-to-end reanastomosis of the adjacent segments.² For this procedure, a multidisciplinary approach is recommended, with involvement of a colorectal surgeon or gynecologic oncologist trained in performing bowel resections. Segmental resection is indicated for lesions that are larger than 3 cm, circumferential, obstructive, or multifocal.

Given the higher complication rate associated with this procedure and the good outcomes associated with less invasive techniques, we avoid segmental resection whenever possible, especially for lesions near the anal verge.²

Complications associated with surgical approach

In 2005, our group reported on a cohort of 178 women who underwent laparoscopic treatment of deeply infiltrative bowel endometriosis with shaving excision (n = 93), disc excision (n = 38), and segmental resection (n = 47).³⁴ The major complication rate was significantly higher for those undergoing segmental resection (12.5%, P <.001); only 7.7% of those who underwent disc resection experienced a major complication; and none were observed in the group treated with shaving excision.

In 2011, De Cicco and colleagues conducted a systematic review of 1,889 patients who underwent segmental bowel resection.³⁵ The major complication rate was 11%, with a leakage rate of 2.7%, fistula rate of 1.8%, major obstruction rate of 2.7%, and hemorrhage rate of 2.5%. Many of these complications, however, occurred in patients who had low rectal resections.

Regardless of surgical approach, the complication rate is related to the surgeon’s ability to preserve the superior and inferior hypogastric plexuses and the sympathetic and parasympathetic nerve bundles (FIGURE 7). Nerve-sparing techniques should be used to decrease the incidence of postoperative bowel, bladder, and sexual function complications.² 

Our group’s preferences

In our practice, we emphasize that the choice of surgical technique depends on the location, size, and depth of the lesion, as well as the extent of bowel wall circumferential invasion.²

We categorize lesions by their anatomic location: those above the sigmoid colon, on the sigmoid colon, on the rectosigmoid colon, and on the rectum. For lesions above the sigmoid colon, segmental or disc resection is appropriate.² We recommend segmental resection for multifocal lesions, lesions larger than 3 cm, or for lesions involving more than one-third of the bowel lumen.^37,44,45,47 Disc resection is appropriate for lesions smaller than 3 cm even if the bowel lumen is involved.^44,45,48 If endometriosis is encountered in any location along the bowel, appendectomy can be performed even without visible disease, due to a high incidence of occult disease of the appendix.^49,50

When lesions involve the sigmoid colon, we prefer utilizing shaving excision when possible to limit dissection of the retrorectal space and pelvic sidewall nerves.² Segmental resection at or below the sigmoid colon has been associated with postoperative surgical site leakage⁵¹ and long-term bowel and bladder dysfunction with risk of permanent colostomy.^52,53 For lesions smaller than 3 cm or involving less than one-third of the bowel lumen, disc resection can be performed. Segmental resection is required if multifocal disease or obstruction are present, if lesions are larger than 3 cm, or if more than one-third of the bowel lumen is involved.

For lesions along the rectosigmoid colon, we prefer utilizing shaving excision when possible.² Disc excision can be performed utilizing a transanal approach, being mindful to minimize dissection of the retroperitoneal space and pelvic sidewall nerves.⁴⁸ Segmental resection is avoided even with lesions larger than 3 cm, unless prior surgery has failed. Approaches for segmental resection can utilize laparoscopy or the natural orifices of the rectum or vagina.^31,51

For lesions on the rectum, we strongly advise shaving excision.² Evidence fails to show that the benefits of segmental resection outweigh the risks when compared to conservative techniques at the rectum.^30,39,54 There is evidence indicating that aggressive surgery 5 to 8 cm from the anal verge is predictive of postoperative complications.⁵⁵ In our group, we use shaving excision to remove as much disease as possible without compromising the integrity of the bowel wall or surrounding neurovascular structures. We err on the side of caution, leaving some of the disease on the rectum to avoid rectal perforation, and plan for postoperative hormonal suppression in these patients.

For patients desiring fertility, successful pregnancy is often achieved using the shaving technique.⁴¹

About 10% of all reproductive-aged women and 35% to 50% of women with pelvic pain and infertility are affected by endometriosis.^1,2 The disease typically involves the reproductive tract organs, anterior and posterior cul-de-sacs, and uterosacral ligaments. However, disease outside of the reproductive tract occurs frequently and has been found on all organs except the spleen.³

The bowel is the most common site for extragenital endometriosis, affected in an estimated 3.8% to 37% of patients with known endometriosis.^4-7 Implants may be superficial, involving the bowel serosa and subserosa (FIGURE 1), or they can manifest as deeply infiltrating lesions involving the muscularis and mucosa (FIGURE 2). The rectosigmoid colon is the most common location for bowel endometriosis, followed by the rectum, ileum, appendix, and cecum^4,8 (FIGURES 3, 4, and 5). Case reports also have described endometrial implants on the stomach and transverse colon.⁹ Although isolated bowel involvement has been recognized, most patients with bowel endometriosis have concurrent disease elsewhere.^2,4 

Historically, segmental resection was performed regardless of the anatomical location of the lesion.¹⁰ Even today, many surgeons continue to routinely perform segmental bowel resection as a first-line surgical approach.¹¹ Unnecessary segmental resection, however, places patients at risk for short- and long-term postoperative morbidity, including the possibility of permanent ostomy. Modern surgical techniques, such as shaving excision and disc resection, have been performed to successfully treat bowel endometriosis with excellent long-term outcomes and fewer complications when compared with traditional segmental resection.^2,12-16

In this article, we focus on the clinical indications and surgical techniques for video-laparoscopic management, but first we describe the pathophysiology, clinical presentation, and diagnosis of bowel endometriosis.

Pathophysiology of bowel endometriosis

The pathogenesis of endometriosis remains unknown, as no single mechanism explains all clinical cases of the disease. The most popular proposed theory describes retrograde menstruation through the fallopian tubes.¹⁷ Once inside the peritoneal cavity, endometrial cells attach to and invade healthy peritoneum, establishing a blood supply necessary for growth and survival.

In the case of bowel endometriosis, deposition of effluxed endometrial cells may lead to an inflammatory response that increases the risk of adhesion formation, leading to potential cul-de-sac obliteration. Lesions may originate as Allen-Masters peritoneal defects, developing into deeply infiltrative rectovaginal septum lesions. The anatomical shelter theory contributes to lesions within the pelvis, with the rectosigmoid colon blocking the cephalad flow of effluxed menstrual blood from the pelvis, thus leading to a preponderance of lesions in the pelvis and along the rectosigmoid colon.²

Continue to: Clinical presentation and diagnosis...

Clinical presentation and diagnosis

Women presenting with endometriosis of the bowel are typically of reproductive age and commonly report symptoms of dysmenorrhea, chronic pelvic pain, dyspareunia, and dyschezia. Some women also experience catamenial diarrhea, constipation, hematochezia, and bloating.² The differential diagnosis of these symptoms is broad and includes irritable bowel disease, ischemic colitis, inflammatory bowel disease, diverticulitis, pelvic inflammatory disease, and malignancy.

Because of its nonspecific symptoms, bowel endometriosis is often misdiagnosed and the disease goes untreated for years.¹⁸ Therefore, it is imperative that clinicians maintain a high index of suspicion when evaluating reproductive-aged women with gastrointestinal symptoms and pelvic pain.

Physical examination can be helpful in making the diagnosis of endometriosis. During bimanual examination, findings such as a fixed, tender, or retroverted uterus, uterosacral ligament nodularity, or an enlarged adnexal mass representing an ovarian endometrioma may be appreciated. Rectovaginal exam can identify areas of tenderness and nodularity along the rectovaginal septum. Speculum exam may reveal a laterally displaced cervix or blue powder-burn lesions along the cervix or posterior fornix.¹⁹ Rarely, endometriosis is found on the perineum within an episiotomy scar.²⁰

Imaging studies can be used in conjunction with physical examination findings to aid in the diagnosis of endometriosis. Images also guide preoperative planning by characterizing lesions based on their size, location, and depth of invasion. Hudelist and colleagues found transvaginal ultrasound (TVUS) to have an overall sensitivity of 71% to 98% and a specificity of 92% to 100%.²¹ However, it was noted that the accuracy of the diagnosis was directly related to the experience of the sonographer, and lesions above the sigmoid colon were generally unable to be diagnosed. Other imaging modalities that have been reported to have high sensitivity and specificity for diagnosing bowel endometriosis include rectal water contrast TVUS,^22,23 rectal endoscopic sonography,²² magnetic resonance imaging,²² and barium enema.²⁴

Medical management

Medical therapy for patients with endometriosis is utilized with the goal of suppressing ovulation, lowering circulating hormone levels, and inducing endometrial atrophy. Medications commonly employed include gonadotropin-releasing hormone agonists and antagonists, anabolic steriods such as danazol, combined oral contraceptive pills, progestins, and aromatase inhibitors.

Continue to: To date, no optimal hormonal regimen...

To date, no optimal hormonal regimen has been established for the treatment of bowel endometriosis. Vercellini and colleagues demonstrated that progestins with and without low-dose estrogen improved symptoms of dysmenorrhea and dyspareunia.²⁵ Ferrero and colleagues reported that 2.5 mg of norethindrone daily resulted in 53% of women with colorectal endometriosis reporting improved gastrointestinal symptoms.²⁶ However, by 12 months of follow-up, 33% of these patients had elected to undergo surgical management.

Gonadotropin-releasing hormone agonists, such as leuprolide acetate, also can be used to mitigate symptoms of bowel endometriosis or to decrease disease burden at the time of surgery, and they can be used with add-back norethindrone acetate. The use of these medications is limited by adverse effects, such as vasomotor symptoms and decreased bone mineral density when used for longer than 6 months.²

Medical therapy is commonly used for patients with mild to moderate symptoms and in those who are poor surgical candidates or decline surgical intervention. Medical therapy is especially useful when employed postoperatively to suppress the regrowth of microscopic ectopic endometrial tissue.

Patients must be counseled, however, that even with medical management, they may still require surgery in the future to control their symptoms and/or to preserve organ function.²

Surgical management

Surgical treatment for bowel endometriosis depends on the disease location, the size and depth of the lesion, the presence or absence of stricture, and the surgeon’s level of expertise.^2,12,27-30

In our group, we advocate for video-laparoscopy, with or without robotic as sistance. Minimally invasive surgery offers reduced blood loss, shorter recovery time, and fewer postoperative complications compared with laparotomy.^{2,16,27,31-33} The conversion rate to laparotomy has been reported to be about 3% when performed by an experienced surgeon.¹²

Darai and colleagues conducted a randomized trial of 52 patients undergoing surgery for colorectal endometriosis via either laparoscopic or open colon resection.³³ Blood loss was significantly lower in the laparoscopy group (1.6 vs 2.7 mg/L, P <.05). No difference was noted in long-term outcomes. In a retrospective study of 436 cases, Ruffo and colleagues showed that those who underwent laparoscopic colorectal resection had higher postoperative pregnancy rates compared with those who had laparotomy (57.6% vs 23.1%, P <.035).³²

The goal of surgical management of bowel endometriosis is to remove as many of the endometriotic lesions as possible while minimizing short- and long-term complications. Three surgical approaches have been described: shaving excision, disc resection, and segmental resection.²

Some surgeons prefer traditional segmental resection of the bowel regardless of the anatomical site, citing reduced disease recurrence with this approach; however, traditional segmental resection confers increased risk of complications. Increasingly, in an effort to reduce morbidity, more surgeons are advocating for the less aggressive methods of shaving excision and disc resection.

Aggressive resection at the level of the low rectum requires extensive surgical dissection of the retrorectal space, with the potential for inadvertent injury to surrounding neurovascular structures, such as the pelvic splanchnic nerves and superior and inferior hypogastric plexus.²⁹ Injury to these structures can lead to significant complications, including bowel stenosis, fistula formation, constipation, and urinary retention. Complete resection of other areas, such as the small bowel, do not carry the same risks and may have more significant benefit to the patient than less aggressive techniques.

Our group recommends carefully balancing the risks and benefits of aggressive surgical treatment for each individual and treating the patient with the appropriate technique. Regardless of technique, surgical treatment of bowel endometriosis can lead to long-term improvements in pain and infertility.^29,30,34,35

Continue to: Shaving excision...

Shaving excision

The most conservative approach to resection of bowel endometriosis is shaving excision; this involves removing endometriotic tissue layer-by-layer until healthy, underlying tissue is encountered.² With bowel endometriosis, the goal of shaving excision is to remove as much of the diseased tissue as possible while leaving behind the mucosal layer and a portion of the muscularis.^{2,15,16,36-38} This is the most conservative of the 3 surgical techniques and is associated with the lowest complication rate.^{2,14,15,36,37}

Our group reported on 185 women who underwent shaving excision for bowel endometriosis. At the time of surgery, 80 women had complete obliteration of the cul-de-sac (FIGURE 6). Of the study patients, 174 patients were available for follow-up, with 93% reporting moderate to complete pain relief.¹⁵

In a retrospective analysis of 3,298 surgeries for rectovaginal endometriosis in which shaving excision was used on all but 1% of patients, Donnez and colleagues reported a very low complication rate, with 1 case of rectal perforation, 1 case of fecal peritonitis, and 3 cases of ureteral injury.³⁹

Roman and colleagues described the use of shaving excision for rectal endometriosis using plasma energy (n = 54) and laparoscopic scissors (n = 68).⁴⁰ Only 4% of patients reported experiencing symptom recurrence, and the pregnancy rate was 65.4%, with 59% of those patients spontaneously conceiving. Two cases of rectal fistula were noted.

Disc resection

Laparoscopic disc excision has been described in the literature since the 1980s, and the technique involves the full-thickness removal of the diseased portion of the bowel, followed by closure of the remaining defect.^{2,12-14,28,29,31,41-45} To be appropriate for this technique, a lesion should involve only a portion of the bowel wall and, preferably, less than one-half of the bowel circumference.^2,42 Disc excision results in excellent outcomes with fewer postoperative complications than segmental resection, but with more complications when compared to shaving excision.^{2,12,13,29,45,46}

We reported on a series of 141 women with bowel endometriosis who underwent disc excision.² At 1-month follow-up, 87% of patients experienced an improvement in their symptoms. No cases required conversion to laparotomy or were complicated by rectovaginal fistula formation, ureteral injury, bowel perforation, or pelvic abscess.²

Continue to: Segmental resection...

Segmental resection

The most aggressive surgical approach, segmental resection involves complete removal of a diseased portion of bowel, followed by side-to-side or end-to-end reanastomosis of the adjacent segments.² For this procedure, a multidisciplinary approach is recommended, with involvement of a colorectal surgeon or gynecologic oncologist trained in performing bowel resections. Segmental resection is indicated for lesions that are larger than 3 cm, circumferential, obstructive, or multifocal.

Given the higher complication rate associated with this procedure and the good outcomes associated with less invasive techniques, we avoid segmental resection whenever possible, especially for lesions near the anal verge.²

Complications associated with surgical approach

In 2005, our group reported on a cohort of 178 women who underwent laparoscopic treatment of deeply infiltrative bowel endometriosis with shaving excision (n = 93), disc excision (n = 38), and segmental resection (n = 47).³⁴ The major complication rate was significantly higher for those undergoing segmental resection (12.5%, P <.001); only 7.7% of those who underwent disc resection experienced a major complication; and none were observed in the group treated with shaving excision.

In 2011, De Cicco and colleagues conducted a systematic review of 1,889 patients who underwent segmental bowel resection.³⁵ The major complication rate was 11%, with a leakage rate of 2.7%, fistula rate of 1.8%, major obstruction rate of 2.7%, and hemorrhage rate of 2.5%. Many of these complications, however, occurred in patients who had low rectal resections.

Regardless of surgical approach, the complication rate is related to the surgeon’s ability to preserve the superior and inferior hypogastric plexuses and the sympathetic and parasympathetic nerve bundles (FIGURE 7). Nerve-sparing techniques should be used to decrease the incidence of postoperative bowel, bladder, and sexual function complications.² 

Our group’s preferences

In our practice, we emphasize that the choice of surgical technique depends on the location, size, and depth of the lesion, as well as the extent of bowel wall circumferential invasion.²

We categorize lesions by their anatomic location: those above the sigmoid colon, on the sigmoid colon, on the rectosigmoid colon, and on the rectum. For lesions above the sigmoid colon, segmental or disc resection is appropriate.² We recommend segmental resection for multifocal lesions, lesions larger than 3 cm, or for lesions involving more than one-third of the bowel lumen.^37,44,45,47 Disc resection is appropriate for lesions smaller than 3 cm even if the bowel lumen is involved.^44,45,48 If endometriosis is encountered in any location along the bowel, appendectomy can be performed even without visible disease, due to a high incidence of occult disease of the appendix.^49,50

When lesions involve the sigmoid colon, we prefer utilizing shaving excision when possible to limit dissection of the retrorectal space and pelvic sidewall nerves.² Segmental resection at or below the sigmoid colon has been associated with postoperative surgical site leakage⁵¹ and long-term bowel and bladder dysfunction with risk of permanent colostomy.^52,53 For lesions smaller than 3 cm or involving less than one-third of the bowel lumen, disc resection can be performed. Segmental resection is required if multifocal disease or obstruction are present, if lesions are larger than 3 cm, or if more than one-third of the bowel lumen is involved.

For lesions along the rectosigmoid colon, we prefer utilizing shaving excision when possible.² Disc excision can be performed utilizing a transanal approach, being mindful to minimize dissection of the retroperitoneal space and pelvic sidewall nerves.⁴⁸ Segmental resection is avoided even with lesions larger than 3 cm, unless prior surgery has failed. Approaches for segmental resection can utilize laparoscopy or the natural orifices of the rectum or vagina.^31,51

For lesions on the rectum, we strongly advise shaving excision.² Evidence fails to show that the benefits of segmental resection outweigh the risks when compared to conservative techniques at the rectum.^30,39,54 There is evidence indicating that aggressive surgery 5 to 8 cm from the anal verge is predictive of postoperative complications.⁵⁵ In our group, we use shaving excision to remove as much disease as possible without compromising the integrity of the bowel wall or surrounding neurovascular structures. We err on the side of caution, leaving some of the disease on the rectum to avoid rectal perforation, and plan for postoperative hormonal suppression in these patients.

For patients desiring fertility, successful pregnancy is often achieved using the shaving technique.⁴¹

About 10% of all reproductive-aged women and 35% to 50% of women with pelvic pain and infertility are affected by endometriosis.^1,2 The disease typically involves the reproductive tract organs, anterior and posterior cul-de-sacs, and uterosacral ligaments. However, disease outside of the reproductive tract occurs frequently and has been found on all organs except the spleen.³

The bowel is the most common site for extragenital endometriosis, affected in an estimated 3.8% to 37% of patients with known endometriosis.^4-7 Implants may be superficial, involving the bowel serosa and subserosa (FIGURE 1), or they can manifest as deeply infiltrating lesions involving the muscularis and mucosa (FIGURE 2). The rectosigmoid colon is the most common location for bowel endometriosis, followed by the rectum, ileum, appendix, and cecum^4,8 (FIGURES 3, 4, and 5). Case reports also have described endometrial implants on the stomach and transverse colon.⁹ Although isolated bowel involvement has been recognized, most patients with bowel endometriosis have concurrent disease elsewhere.^2,4 

Historically, segmental resection was performed regardless of the anatomical location of the lesion.¹⁰ Even today, many surgeons continue to routinely perform segmental bowel resection as a first-line surgical approach.¹¹ Unnecessary segmental resection, however, places patients at risk for short- and long-term postoperative morbidity, including the possibility of permanent ostomy. Modern surgical techniques, such as shaving excision and disc resection, have been performed to successfully treat bowel endometriosis with excellent long-term outcomes and fewer complications when compared with traditional segmental resection.^2,12-16

In this article, we focus on the clinical indications and surgical techniques for video-laparoscopic management, but first we describe the pathophysiology, clinical presentation, and diagnosis of bowel endometriosis.

Pathophysiology of bowel endometriosis

The pathogenesis of endometriosis remains unknown, as no single mechanism explains all clinical cases of the disease. The most popular proposed theory describes retrograde menstruation through the fallopian tubes.¹⁷ Once inside the peritoneal cavity, endometrial cells attach to and invade healthy peritoneum, establishing a blood supply necessary for growth and survival.

In the case of bowel endometriosis, deposition of effluxed endometrial cells may lead to an inflammatory response that increases the risk of adhesion formation, leading to potential cul-de-sac obliteration. Lesions may originate as Allen-Masters peritoneal defects, developing into deeply infiltrative rectovaginal septum lesions. The anatomical shelter theory contributes to lesions within the pelvis, with the rectosigmoid colon blocking the cephalad flow of effluxed menstrual blood from the pelvis, thus leading to a preponderance of lesions in the pelvis and along the rectosigmoid colon.²

Continue to: Clinical presentation and diagnosis...

Clinical presentation and diagnosis

Women presenting with endometriosis of the bowel are typically of reproductive age and commonly report symptoms of dysmenorrhea, chronic pelvic pain, dyspareunia, and dyschezia. Some women also experience catamenial diarrhea, constipation, hematochezia, and bloating.² The differential diagnosis of these symptoms is broad and includes irritable bowel disease, ischemic colitis, inflammatory bowel disease, diverticulitis, pelvic inflammatory disease, and malignancy.

Because of its nonspecific symptoms, bowel endometriosis is often misdiagnosed and the disease goes untreated for years.¹⁸ Therefore, it is imperative that clinicians maintain a high index of suspicion when evaluating reproductive-aged women with gastrointestinal symptoms and pelvic pain.

Physical examination can be helpful in making the diagnosis of endometriosis. During bimanual examination, findings such as a fixed, tender, or retroverted uterus, uterosacral ligament nodularity, or an enlarged adnexal mass representing an ovarian endometrioma may be appreciated. Rectovaginal exam can identify areas of tenderness and nodularity along the rectovaginal septum. Speculum exam may reveal a laterally displaced cervix or blue powder-burn lesions along the cervix or posterior fornix.¹⁹ Rarely, endometriosis is found on the perineum within an episiotomy scar.²⁰

Imaging studies can be used in conjunction with physical examination findings to aid in the diagnosis of endometriosis. Images also guide preoperative planning by characterizing lesions based on their size, location, and depth of invasion. Hudelist and colleagues found transvaginal ultrasound (TVUS) to have an overall sensitivity of 71% to 98% and a specificity of 92% to 100%.²¹ However, it was noted that the accuracy of the diagnosis was directly related to the experience of the sonographer, and lesions above the sigmoid colon were generally unable to be diagnosed. Other imaging modalities that have been reported to have high sensitivity and specificity for diagnosing bowel endometriosis include rectal water contrast TVUS,^22,23 rectal endoscopic sonography,²² magnetic resonance imaging,²² and barium enema.²⁴

Medical management

Medical therapy for patients with endometriosis is utilized with the goal of suppressing ovulation, lowering circulating hormone levels, and inducing endometrial atrophy. Medications commonly employed include gonadotropin-releasing hormone agonists and antagonists, anabolic steriods such as danazol, combined oral contraceptive pills, progestins, and aromatase inhibitors.

Continue to: To date, no optimal hormonal regimen...

To date, no optimal hormonal regimen has been established for the treatment of bowel endometriosis. Vercellini and colleagues demonstrated that progestins with and without low-dose estrogen improved symptoms of dysmenorrhea and dyspareunia.²⁵ Ferrero and colleagues reported that 2.5 mg of norethindrone daily resulted in 53% of women with colorectal endometriosis reporting improved gastrointestinal symptoms.²⁶ However, by 12 months of follow-up, 33% of these patients had elected to undergo surgical management.

Gonadotropin-releasing hormone agonists, such as leuprolide acetate, also can be used to mitigate symptoms of bowel endometriosis or to decrease disease burden at the time of surgery, and they can be used with add-back norethindrone acetate. The use of these medications is limited by adverse effects, such as vasomotor symptoms and decreased bone mineral density when used for longer than 6 months.²

Medical therapy is commonly used for patients with mild to moderate symptoms and in those who are poor surgical candidates or decline surgical intervention. Medical therapy is especially useful when employed postoperatively to suppress the regrowth of microscopic ectopic endometrial tissue.

Patients must be counseled, however, that even with medical management, they may still require surgery in the future to control their symptoms and/or to preserve organ function.²

Surgical management

Surgical treatment for bowel endometriosis depends on the disease location, the size and depth of the lesion, the presence or absence of stricture, and the surgeon’s level of expertise.^2,12,27-30

In our group, we advocate for video-laparoscopy, with or without robotic as sistance. Minimally invasive surgery offers reduced blood loss, shorter recovery time, and fewer postoperative complications compared with laparotomy.^{2,16,27,31-33} The conversion rate to laparotomy has been reported to be about 3% when performed by an experienced surgeon.¹²

Darai and colleagues conducted a randomized trial of 52 patients undergoing surgery for colorectal endometriosis via either laparoscopic or open colon resection.³³ Blood loss was significantly lower in the laparoscopy group (1.6 vs 2.7 mg/L, P <.05). No difference was noted in long-term outcomes. In a retrospective study of 436 cases, Ruffo and colleagues showed that those who underwent laparoscopic colorectal resection had higher postoperative pregnancy rates compared with those who had laparotomy (57.6% vs 23.1%, P <.035).³²

The goal of surgical management of bowel endometriosis is to remove as many of the endometriotic lesions as possible while minimizing short- and long-term complications. Three surgical approaches have been described: shaving excision, disc resection, and segmental resection.²

Some surgeons prefer traditional segmental resection of the bowel regardless of the anatomical site, citing reduced disease recurrence with this approach; however, traditional segmental resection confers increased risk of complications. Increasingly, in an effort to reduce morbidity, more surgeons are advocating for the less aggressive methods of shaving excision and disc resection.

Aggressive resection at the level of the low rectum requires extensive surgical dissection of the retrorectal space, with the potential for inadvertent injury to surrounding neurovascular structures, such as the pelvic splanchnic nerves and superior and inferior hypogastric plexus.²⁹ Injury to these structures can lead to significant complications, including bowel stenosis, fistula formation, constipation, and urinary retention. Complete resection of other areas, such as the small bowel, do not carry the same risks and may have more significant benefit to the patient than less aggressive techniques.

Our group recommends carefully balancing the risks and benefits of aggressive surgical treatment for each individual and treating the patient with the appropriate technique. Regardless of technique, surgical treatment of bowel endometriosis can lead to long-term improvements in pain and infertility.^29,30,34,35

Continue to: Shaving excision...

Shaving excision

The most conservative approach to resection of bowel endometriosis is shaving excision; this involves removing endometriotic tissue layer-by-layer until healthy, underlying tissue is encountered.² With bowel endometriosis, the goal of shaving excision is to remove as much of the diseased tissue as possible while leaving behind the mucosal layer and a portion of the muscularis.^{2,15,16,36-38} This is the most conservative of the 3 surgical techniques and is associated with the lowest complication rate.^{2,14,15,36,37}

Our group reported on 185 women who underwent shaving excision for bowel endometriosis. At the time of surgery, 80 women had complete obliteration of the cul-de-sac (FIGURE 6). Of the study patients, 174 patients were available for follow-up, with 93% reporting moderate to complete pain relief.¹⁵

In a retrospective analysis of 3,298 surgeries for rectovaginal endometriosis in which shaving excision was used on all but 1% of patients, Donnez and colleagues reported a very low complication rate, with 1 case of rectal perforation, 1 case of fecal peritonitis, and 3 cases of ureteral injury.³⁹

Roman and colleagues described the use of shaving excision for rectal endometriosis using plasma energy (n = 54) and laparoscopic scissors (n = 68).⁴⁰ Only 4% of patients reported experiencing symptom recurrence, and the pregnancy rate was 65.4%, with 59% of those patients spontaneously conceiving. Two cases of rectal fistula were noted.

Disc resection

Laparoscopic disc excision has been described in the literature since the 1980s, and the technique involves the full-thickness removal of the diseased portion of the bowel, followed by closure of the remaining defect.^{2,12-14,28,29,31,41-45} To be appropriate for this technique, a lesion should involve only a portion of the bowel wall and, preferably, less than one-half of the bowel circumference.^2,42 Disc excision results in excellent outcomes with fewer postoperative complications than segmental resection, but with more complications when compared to shaving excision.^{2,12,13,29,45,46}

We reported on a series of 141 women with bowel endometriosis who underwent disc excision.² At 1-month follow-up, 87% of patients experienced an improvement in their symptoms. No cases required conversion to laparotomy or were complicated by rectovaginal fistula formation, ureteral injury, bowel perforation, or pelvic abscess.²

Continue to: Segmental resection...

Segmental resection

The most aggressive surgical approach, segmental resection involves complete removal of a diseased portion of bowel, followed by side-to-side or end-to-end reanastomosis of the adjacent segments.² For this procedure, a multidisciplinary approach is recommended, with involvement of a colorectal surgeon or gynecologic oncologist trained in performing bowel resections. Segmental resection is indicated for lesions that are larger than 3 cm, circumferential, obstructive, or multifocal.

Given the higher complication rate associated with this procedure and the good outcomes associated with less invasive techniques, we avoid segmental resection whenever possible, especially for lesions near the anal verge.²

Complications associated with surgical approach

In 2005, our group reported on a cohort of 178 women who underwent laparoscopic treatment of deeply infiltrative bowel endometriosis with shaving excision (n = 93), disc excision (n = 38), and segmental resection (n = 47).³⁴ The major complication rate was significantly higher for those undergoing segmental resection (12.5%, P <.001); only 7.7% of those who underwent disc resection experienced a major complication; and none were observed in the group treated with shaving excision.

In 2011, De Cicco and colleagues conducted a systematic review of 1,889 patients who underwent segmental bowel resection.³⁵ The major complication rate was 11%, with a leakage rate of 2.7%, fistula rate of 1.8%, major obstruction rate of 2.7%, and hemorrhage rate of 2.5%. Many of these complications, however, occurred in patients who had low rectal resections.

Regardless of surgical approach, the complication rate is related to the surgeon’s ability to preserve the superior and inferior hypogastric plexuses and the sympathetic and parasympathetic nerve bundles (FIGURE 7). Nerve-sparing techniques should be used to decrease the incidence of postoperative bowel, bladder, and sexual function complications.² 

Our group’s preferences

In our practice, we emphasize that the choice of surgical technique depends on the location, size, and depth of the lesion, as well as the extent of bowel wall circumferential invasion.²

We categorize lesions by their anatomic location: those above the sigmoid colon, on the sigmoid colon, on the rectosigmoid colon, and on the rectum. For lesions above the sigmoid colon, segmental or disc resection is appropriate.² We recommend segmental resection for multifocal lesions, lesions larger than 3 cm, or for lesions involving more than one-third of the bowel lumen.^37,44,45,47 Disc resection is appropriate for lesions smaller than 3 cm even if the bowel lumen is involved.^44,45,48 If endometriosis is encountered in any location along the bowel, appendectomy can be performed even without visible disease, due to a high incidence of occult disease of the appendix.^49,50

When lesions involve the sigmoid colon, we prefer utilizing shaving excision when possible to limit dissection of the retrorectal space and pelvic sidewall nerves.² Segmental resection at or below the sigmoid colon has been associated with postoperative surgical site leakage⁵¹ and long-term bowel and bladder dysfunction with risk of permanent colostomy.^52,53 For lesions smaller than 3 cm or involving less than one-third of the bowel lumen, disc resection can be performed. Segmental resection is required if multifocal disease or obstruction are present, if lesions are larger than 3 cm, or if more than one-third of the bowel lumen is involved.

For lesions along the rectosigmoid colon, we prefer utilizing shaving excision when possible.² Disc excision can be performed utilizing a transanal approach, being mindful to minimize dissection of the retroperitoneal space and pelvic sidewall nerves.⁴⁸ Segmental resection is avoided even with lesions larger than 3 cm, unless prior surgery has failed. Approaches for segmental resection can utilize laparoscopy or the natural orifices of the rectum or vagina.^31,51

For lesions on the rectum, we strongly advise shaving excision.² Evidence fails to show that the benefits of segmental resection outweigh the risks when compared to conservative techniques at the rectum.^30,39,54 There is evidence indicating that aggressive surgery 5 to 8 cm from the anal verge is predictive of postoperative complications.⁵⁵ In our group, we use shaving excision to remove as much disease as possible without compromising the integrity of the bowel wall or surrounding neurovascular structures. We err on the side of caution, leaving some of the disease on the rectum to avoid rectal perforation, and plan for postoperative hormonal suppression in these patients.

For patients desiring fertility, successful pregnancy is often achieved using the shaving technique.⁴¹

In an effort to reduce burden on physicians and qualified health care professionals, the Centers for Medicare and Medicaid Services ( CMS) has made changes to Evaluation and Management (E/M) documentation requirements and payment policies. Get ready for fairly extensive changes planned for CY 2021. Here we outline already-implemented and future changes and describe the commitment of the American College of Obstetricians and Gynecologists (ACOG) to ObGyn payment in its collaborations with CMS and the American Medical Association (AMA).

E/M services: CMS reduced documentation

Effective January 2019, the CMS made changes to the documentation requirements for E/M services to provide some common-sense relief for physicians facing excessive documentation requirements in their practices. Most physicians agree that modern medical practice, with the use of electronic health records (EHRs), is different now than in the mid-1990s, when the current E/M structures were developed and implemented. Streamlining documentation requirements reduces paperwork burden and some of the time-consuming duplicative work involved in medical practice today.

For instance, when relevant information is already contained in the medical record, it is not necessary to re-document a full medical history. Physicians will now be able to focus their documentation on the interval since the previous visit. Physicians should still review prior data, update as necessary, and indicate in the medical record that they have done so.

Also, for E/M office and outpatient visits for both new and established patients, physicians are no longer required to re-document information that has already been entered in the patient’s record by practice staff or by the patient. If the patient’s chief complaint and history already has been entered by ancillary staff or the beneficiary, the physician should simply indicate in the medical record that the information has been reviewed and verified.

For E/M visits furnished by teaching physicians, CMS has removed the requirement for potentially duplicative notations that may have been made previously in the medical records by residents or other members of the medical team.

Finally, CMS eliminated the requirement to document the medical necessity of a home visit in lieu of an office visit.

Continue to: Outpatient coding changes for 2021...

Outpatient coding changes for 2021

Outpatient coding for E/M will continue in its current form for the remainder of 2019 and 2020. However, in 2021, expect substantial changes to take effect. If the CMS rule is instituted, payment for E/M office and outpatient visits will be drastically “simplified.” The current CMS plan for 2021 is to collapse payment for existing E/M Levels 2 through 4 to one payment level for new patients and one payment level for established patients, with optional add-on codes. Level 5 visits will continue at a separate payment level and with continuation of current documentation requirements.

In addition to collapsing the payment in E/M Levels 2, 3, and 4, CMS also will allow flexibility in how those E/M office and outpatient visits are documented. Specifically, documentation may be based on any of the following:

• current framework (1995 or 1997 guidelines)
• medical decision making (MDM)
• time.

When using MDM or the current 1995/1997 framework to document an office visit, Medicare will only require documentation to support a Level 2 E/M outpatient visit code for history, exam, and/or MDM. When time is used as the basis for coding the visit, physicians will document the medical necessity of the visit and that the billing practitioner personally spent the required amount of time face-to-face with the beneficiary.

CMS also has finalized the creation of new add-on codes that describe the additional resources inherent in visits for primary care and particular kinds of nonprocedural specialized medical care (and will not be restricted by physician specialty). These codes would only be reportable with E/M office and outpatient level 2 through 4 visits, and their use generally would not impose new documentation requirements. It is not clear which types of visits would support the use of these add-on codes at this time.

Finally, a new “extended visit” add-on code will be available for use only with E/M Level 2 through 4 visits to account for the additional resources required when spending extended time with a patient.

CMS believes these policies will allow physicians, and all who bill E/M codes, greater flexibility to exercise clinical judgment in their documentation, so that they can focus on what is clinically relevant and medically necessary for the beneficiary.

ACOG’s voice in the process

ACOG strongly opposed several proposals that CMS made during the rule-making process that the agency decided not to finalize. These aspects of the proposal would have:

1. reduced payment by 50% for the least expensive procedure or visit when an E/M office or outpatient visit is furnished on the same day as a procedure by the same physician. These are separately identifiable E/M visits that normally would be reported with a modifier 25.
2. established separate coding and payment for podiatric E/M visits, or
3. standardized the allocation of practice expense relative value units (RVUs) for the codes that describe these services.

CMS has stated that they intend to engage in further discussions with the public and stakeholders to potentially further refine the policies for CY 2021.

Continue to: AMA-CPT and RUC initiative...

AMA-CPT and RUC initiative

Although the AMA, ACOG, and physicians in general applauded the CMS initiative to reduce the administrative and documentation burden on providers, there was concern about the unintended consequences of the payment changes that are currently scheduled to take effect in 2021. To address these concerns, the AMA convened a work group of physician experts who are knowledgeable in the Current Procedural Terminology (CPT) code development and valuation processes. The charge to the E/M work group is to collaborate across the provider, payer, and coding communities to establish or revise the coding structure and guidelines for outpatient E/M services. The members formed a multispecialty work group representing primary care and surgical specialties and have experience in developing, defining, and valuing codes.

Dr. Barbara Levy, ACOG’s Vice President of Health Policy, co-chaired this expert panel with geriatrician Dr. Peter Hollmann to develop comprehensive consensus-led changes to revise and modernize E/M codes. The work group followed 4 guiding principles to inform their E/M work:

1. to decrease the administrative burden of documentation and coding
2. to decrease the need for audits
3. to decrease unnecessary and redundant documentation in the medical record that is not needed for patient care
4. to ensure that payment for E/M services is resource based. There is no direct goal for payment redistribution among specialties.

A primary concern expressed by physicians about the CMS proposal was that the collapse of payment for E/M visit across levels 2–4 might lead to a lack of appropriate care for more complex patients since the CMS rule does not provide payment based on the resources required to perform the work of the visit. No one believes that the work needed to care for someone with a sore throat or pink eye is equivalent to the work involved in diagnosing and managing depression, for example.

Beginning in August 2018, the work group met regularly to build consensus. The work group worked at an accelerated pace to develop and value codes that better fit the current medical workflows and meet patient needs.

The work group submitted a code change proposal for E/M codes to the CPT Editorial Panel for consideration during the February 2019 meeting. The next step was the code valuation process through the AMA/Specialty Society RVS Update Committee (RUC) process.

CMS has stated that the 2-year delay to 2021 in implementation of their original proposed changes is to allow time for the E/M code change proposals to move through the development and valuation process and subsequent review by the agency. To date, commercial payers and coders have been supportive of the AMA E/M work group proposals. Dr. Levy, Dr. Hollmann, and AMA staff are meeting with CMS and Department of Health and Human Services staff to provide clarity as they review the CPT proposals. ACOG supports the changes, which would simplify documentation for outpatient E/M codes while retaining differential payments. CMS is closely following the progress of the code changes through the CPT process and RUC code valuation process. We await further rulemaking by CMS in defining and valuing this important code set.

Continue to: ACOG is at the helm, with a watchful eye...

ACOG is at the helm, with a watchful eye

This is a challenging undertaking because E/M codes are used across specialties for office visits and outpatient care. The potential for unintended consequences for all services that include E/M, such as the global obstetrical services or 90-day global surgical services, is substantial. ACOG is intimately involved in this undertaking, watching the developments carefully to ensure that the interests of ObGyns and their patients are protected.

In an effort to reduce burden on physicians and qualified health care professionals, the Centers for Medicare and Medicaid Services ( CMS) has made changes to Evaluation and Management (E/M) documentation requirements and payment policies. Get ready for fairly extensive changes planned for CY 2021. Here we outline already-implemented and future changes and describe the commitment of the American College of Obstetricians and Gynecologists (ACOG) to ObGyn payment in its collaborations with CMS and the American Medical Association (AMA).

E/M services: CMS reduced documentation

Effective January 2019, the CMS made changes to the documentation requirements for E/M services to provide some common-sense relief for physicians facing excessive documentation requirements in their practices. Most physicians agree that modern medical practice, with the use of electronic health records (EHRs), is different now than in the mid-1990s, when the current E/M structures were developed and implemented. Streamlining documentation requirements reduces paperwork burden and some of the time-consuming duplicative work involved in medical practice today.

For instance, when relevant information is already contained in the medical record, it is not necessary to re-document a full medical history. Physicians will now be able to focus their documentation on the interval since the previous visit. Physicians should still review prior data, update as necessary, and indicate in the medical record that they have done so.

Also, for E/M office and outpatient visits for both new and established patients, physicians are no longer required to re-document information that has already been entered in the patient’s record by practice staff or by the patient. If the patient’s chief complaint and history already has been entered by ancillary staff or the beneficiary, the physician should simply indicate in the medical record that the information has been reviewed and verified.

For E/M visits furnished by teaching physicians, CMS has removed the requirement for potentially duplicative notations that may have been made previously in the medical records by residents or other members of the medical team.

Finally, CMS eliminated the requirement to document the medical necessity of a home visit in lieu of an office visit.

Continue to: Outpatient coding changes for 2021...

Outpatient coding changes for 2021

Outpatient coding for E/M will continue in its current form for the remainder of 2019 and 2020. However, in 2021, expect substantial changes to take effect. If the CMS rule is instituted, payment for E/M office and outpatient visits will be drastically “simplified.” The current CMS plan for 2021 is to collapse payment for existing E/M Levels 2 through 4 to one payment level for new patients and one payment level for established patients, with optional add-on codes. Level 5 visits will continue at a separate payment level and with continuation of current documentation requirements.

In addition to collapsing the payment in E/M Levels 2, 3, and 4, CMS also will allow flexibility in how those E/M office and outpatient visits are documented. Specifically, documentation may be based on any of the following:

• current framework (1995 or 1997 guidelines)
• medical decision making (MDM)
• time.

When using MDM or the current 1995/1997 framework to document an office visit, Medicare will only require documentation to support a Level 2 E/M outpatient visit code for history, exam, and/or MDM. When time is used as the basis for coding the visit, physicians will document the medical necessity of the visit and that the billing practitioner personally spent the required amount of time face-to-face with the beneficiary.

CMS also has finalized the creation of new add-on codes that describe the additional resources inherent in visits for primary care and particular kinds of nonprocedural specialized medical care (and will not be restricted by physician specialty). These codes would only be reportable with E/M office and outpatient level 2 through 4 visits, and their use generally would not impose new documentation requirements. It is not clear which types of visits would support the use of these add-on codes at this time.

Finally, a new “extended visit” add-on code will be available for use only with E/M Level 2 through 4 visits to account for the additional resources required when spending extended time with a patient.

CMS believes these policies will allow physicians, and all who bill E/M codes, greater flexibility to exercise clinical judgment in their documentation, so that they can focus on what is clinically relevant and medically necessary for the beneficiary.

ACOG’s voice in the process

ACOG strongly opposed several proposals that CMS made during the rule-making process that the agency decided not to finalize. These aspects of the proposal would have:

1. reduced payment by 50% for the least expensive procedure or visit when an E/M office or outpatient visit is furnished on the same day as a procedure by the same physician. These are separately identifiable E/M visits that normally would be reported with a modifier 25.
2. established separate coding and payment for podiatric E/M visits, or
3. standardized the allocation of practice expense relative value units (RVUs) for the codes that describe these services.

CMS has stated that they intend to engage in further discussions with the public and stakeholders to potentially further refine the policies for CY 2021.

Continue to: AMA-CPT and RUC initiative...

AMA-CPT and RUC initiative

Although the AMA, ACOG, and physicians in general applauded the CMS initiative to reduce the administrative and documentation burden on providers, there was concern about the unintended consequences of the payment changes that are currently scheduled to take effect in 2021. To address these concerns, the AMA convened a work group of physician experts who are knowledgeable in the Current Procedural Terminology (CPT) code development and valuation processes. The charge to the E/M work group is to collaborate across the provider, payer, and coding communities to establish or revise the coding structure and guidelines for outpatient E/M services. The members formed a multispecialty work group representing primary care and surgical specialties and have experience in developing, defining, and valuing codes.

Dr. Barbara Levy, ACOG’s Vice President of Health Policy, co-chaired this expert panel with geriatrician Dr. Peter Hollmann to develop comprehensive consensus-led changes to revise and modernize E/M codes. The work group followed 4 guiding principles to inform their E/M work:

1. to decrease the administrative burden of documentation and coding
2. to decrease the need for audits
3. to decrease unnecessary and redundant documentation in the medical record that is not needed for patient care
4. to ensure that payment for E/M services is resource based. There is no direct goal for payment redistribution among specialties.

A primary concern expressed by physicians about the CMS proposal was that the collapse of payment for E/M visit across levels 2–4 might lead to a lack of appropriate care for more complex patients since the CMS rule does not provide payment based on the resources required to perform the work of the visit. No one believes that the work needed to care for someone with a sore throat or pink eye is equivalent to the work involved in diagnosing and managing depression, for example.

Beginning in August 2018, the work group met regularly to build consensus. The work group worked at an accelerated pace to develop and value codes that better fit the current medical workflows and meet patient needs.

The work group submitted a code change proposal for E/M codes to the CPT Editorial Panel for consideration during the February 2019 meeting. The next step was the code valuation process through the AMA/Specialty Society RVS Update Committee (RUC) process.

CMS has stated that the 2-year delay to 2021 in implementation of their original proposed changes is to allow time for the E/M code change proposals to move through the development and valuation process and subsequent review by the agency. To date, commercial payers and coders have been supportive of the AMA E/M work group proposals. Dr. Levy, Dr. Hollmann, and AMA staff are meeting with CMS and Department of Health and Human Services staff to provide clarity as they review the CPT proposals. ACOG supports the changes, which would simplify documentation for outpatient E/M codes while retaining differential payments. CMS is closely following the progress of the code changes through the CPT process and RUC code valuation process. We await further rulemaking by CMS in defining and valuing this important code set.

Continue to: ACOG is at the helm, with a watchful eye...

ACOG is at the helm, with a watchful eye

This is a challenging undertaking because E/M codes are used across specialties for office visits and outpatient care. The potential for unintended consequences for all services that include E/M, such as the global obstetrical services or 90-day global surgical services, is substantial. ACOG is intimately involved in this undertaking, watching the developments carefully to ensure that the interests of ObGyns and their patients are protected.

In an effort to reduce burden on physicians and qualified health care professionals, the Centers for Medicare and Medicaid Services ( CMS) has made changes to Evaluation and Management (E/M) documentation requirements and payment policies. Get ready for fairly extensive changes planned for CY 2021. Here we outline already-implemented and future changes and describe the commitment of the American College of Obstetricians and Gynecologists (ACOG) to ObGyn payment in its collaborations with CMS and the American Medical Association (AMA).

E/M services: CMS reduced documentation

Effective January 2019, the CMS made changes to the documentation requirements for E/M services to provide some common-sense relief for physicians facing excessive documentation requirements in their practices. Most physicians agree that modern medical practice, with the use of electronic health records (EHRs), is different now than in the mid-1990s, when the current E/M structures were developed and implemented. Streamlining documentation requirements reduces paperwork burden and some of the time-consuming duplicative work involved in medical practice today.

For instance, when relevant information is already contained in the medical record, it is not necessary to re-document a full medical history. Physicians will now be able to focus their documentation on the interval since the previous visit. Physicians should still review prior data, update as necessary, and indicate in the medical record that they have done so.

Also, for E/M office and outpatient visits for both new and established patients, physicians are no longer required to re-document information that has already been entered in the patient’s record by practice staff or by the patient. If the patient’s chief complaint and history already has been entered by ancillary staff or the beneficiary, the physician should simply indicate in the medical record that the information has been reviewed and verified.

For E/M visits furnished by teaching physicians, CMS has removed the requirement for potentially duplicative notations that may have been made previously in the medical records by residents or other members of the medical team.

Finally, CMS eliminated the requirement to document the medical necessity of a home visit in lieu of an office visit.

Continue to: Outpatient coding changes for 2021...

Outpatient coding changes for 2021

Outpatient coding for E/M will continue in its current form for the remainder of 2019 and 2020. However, in 2021, expect substantial changes to take effect. If the CMS rule is instituted, payment for E/M office and outpatient visits will be drastically “simplified.” The current CMS plan for 2021 is to collapse payment for existing E/M Levels 2 through 4 to one payment level for new patients and one payment level for established patients, with optional add-on codes. Level 5 visits will continue at a separate payment level and with continuation of current documentation requirements.

In addition to collapsing the payment in E/M Levels 2, 3, and 4, CMS also will allow flexibility in how those E/M office and outpatient visits are documented. Specifically, documentation may be based on any of the following:

• current framework (1995 or 1997 guidelines)
• medical decision making (MDM)
• time.

When using MDM or the current 1995/1997 framework to document an office visit, Medicare will only require documentation to support a Level 2 E/M outpatient visit code for history, exam, and/or MDM. When time is used as the basis for coding the visit, physicians will document the medical necessity of the visit and that the billing practitioner personally spent the required amount of time face-to-face with the beneficiary.

CMS also has finalized the creation of new add-on codes that describe the additional resources inherent in visits for primary care and particular kinds of nonprocedural specialized medical care (and will not be restricted by physician specialty). These codes would only be reportable with E/M office and outpatient level 2 through 4 visits, and their use generally would not impose new documentation requirements. It is not clear which types of visits would support the use of these add-on codes at this time.

Finally, a new “extended visit” add-on code will be available for use only with E/M Level 2 through 4 visits to account for the additional resources required when spending extended time with a patient.

CMS believes these policies will allow physicians, and all who bill E/M codes, greater flexibility to exercise clinical judgment in their documentation, so that they can focus on what is clinically relevant and medically necessary for the beneficiary.

ACOG’s voice in the process

ACOG strongly opposed several proposals that CMS made during the rule-making process that the agency decided not to finalize. These aspects of the proposal would have:

1. reduced payment by 50% for the least expensive procedure or visit when an E/M office or outpatient visit is furnished on the same day as a procedure by the same physician. These are separately identifiable E/M visits that normally would be reported with a modifier 25.
2. established separate coding and payment for podiatric E/M visits, or
3. standardized the allocation of practice expense relative value units (RVUs) for the codes that describe these services.

CMS has stated that they intend to engage in further discussions with the public and stakeholders to potentially further refine the policies for CY 2021.

Continue to: AMA-CPT and RUC initiative...

AMA-CPT and RUC initiative

Although the AMA, ACOG, and physicians in general applauded the CMS initiative to reduce the administrative and documentation burden on providers, there was concern about the unintended consequences of the payment changes that are currently scheduled to take effect in 2021. To address these concerns, the AMA convened a work group of physician experts who are knowledgeable in the Current Procedural Terminology (CPT) code development and valuation processes. The charge to the E/M work group is to collaborate across the provider, payer, and coding communities to establish or revise the coding structure and guidelines for outpatient E/M services. The members formed a multispecialty work group representing primary care and surgical specialties and have experience in developing, defining, and valuing codes.

Dr. Barbara Levy, ACOG’s Vice President of Health Policy, co-chaired this expert panel with geriatrician Dr. Peter Hollmann to develop comprehensive consensus-led changes to revise and modernize E/M codes. The work group followed 4 guiding principles to inform their E/M work:

1. to decrease the administrative burden of documentation and coding
2. to decrease the need for audits
3. to decrease unnecessary and redundant documentation in the medical record that is not needed for patient care
4. to ensure that payment for E/M services is resource based. There is no direct goal for payment redistribution among specialties.

A primary concern expressed by physicians about the CMS proposal was that the collapse of payment for E/M visit across levels 2–4 might lead to a lack of appropriate care for more complex patients since the CMS rule does not provide payment based on the resources required to perform the work of the visit. No one believes that the work needed to care for someone with a sore throat or pink eye is equivalent to the work involved in diagnosing and managing depression, for example.

Beginning in August 2018, the work group met regularly to build consensus. The work group worked at an accelerated pace to develop and value codes that better fit the current medical workflows and meet patient needs.

The work group submitted a code change proposal for E/M codes to the CPT Editorial Panel for consideration during the February 2019 meeting. The next step was the code valuation process through the AMA/Specialty Society RVS Update Committee (RUC) process.

CMS has stated that the 2-year delay to 2021 in implementation of their original proposed changes is to allow time for the E/M code change proposals to move through the development and valuation process and subsequent review by the agency. To date, commercial payers and coders have been supportive of the AMA E/M work group proposals. Dr. Levy, Dr. Hollmann, and AMA staff are meeting with CMS and Department of Health and Human Services staff to provide clarity as they review the CPT proposals. ACOG supports the changes, which would simplify documentation for outpatient E/M codes while retaining differential payments. CMS is closely following the progress of the code changes through the CPT process and RUC code valuation process. We await further rulemaking by CMS in defining and valuing this important code set.

Continue to: ACOG is at the helm, with a watchful eye...

ACOG is at the helm, with a watchful eye

This is a challenging undertaking because E/M codes are used across specialties for office visits and outpatient care. The potential for unintended consequences for all services that include E/M, such as the global obstetrical services or 90-day global surgical services, is substantial. ACOG is intimately involved in this undertaking, watching the developments carefully to ensure that the interests of ObGyns and their patients are protected.

From Saint Luke’s Mid America Heart Institute/University of Missouri–Kansas City, Kansas City, MO.

Abstract

• Objective: To outline the tools available to help understand the risk of transcatheter aortic valve replacement (TAVR) and the gaps in knowledge regarding TAVR risk estimation.
• Methods: Review of the literature.
• Results: Two models developed and validated by the American College of Cardiology can be used to estimate the risk of short-term mortality, a 6-variable in-hospital model designed for clinical use and a 41-variable 30-day model designed primarily for site comparisons and quality improvement. Importantly, neither model should be used to inform the choice of TAVR versus surgical aortic valve replacement. Regarding long-term outcomes, a risk model to estimate risk of dying or having a persistently poor quality of life at 1 year after TAVR has been developed and validated. Factors that most significantly increase a patient’s risk for poor outcomes are very poor functional status prior to TAVR, requiring home oxygen, chronic renal insufficiency, atrial fibrillation, dependencies in activities of daily living, and dementia. If a patient has ≥ 2 or 3 major risk factors for a poor outcome, this risk and the uncertainty about the degree of recovery expected after TAVR should be discussed with the patient (and family).
• Conclusion: It is important to understand the patient factors that most strongly drive risk of poor outcomes after TAVR and use this information to set appropriate expectations for recovery.

Keywords: aortic valve stenosis; risk factors; postoperative complications; TAVR.

Among patients with severe aortic stenosis, trans­catheter aortic valve replacement (TAVR) has emerged as a less invasive option for aortic valve replacement. This procedure offers substantial reductions in mortality and improvement in quality of life compared with medical therapy^1,2 and at least similar long-term outcomes compared to surgical aortic valve replacement (SAVR).^3-9

As with any emerging technology, selecting the appropriate patients for TAVR—a procedure with high initial costs¹⁰—has been an area of active investigation. As TAVR was first introduced in patients who were considered inoperable, initial efforts focused on trying to identify the patients who did not improve functionally or live longer following TAVR. Termed Cohort C patients, these patients were thought to have too many comorbidities, be too sick, and have too little reserve to recover from TAVR, and in the early trials, represented a substantial minority of the patients. For example, in pivotal clinical trials of patients at high or extreme surgical risk, approximately 1 in 4 patients who were treated with TAVR were dead at 1 year.^1,3,11 Furthermore, a number of patients who received TAVR were alive at 1 year but continued to have significant heart failure symptoms and functional limitations.^2,4 Practitioners,^12,13 regulators,¹⁴ and third-party payers¹⁵ have recommended that TAVR should not be offered to patients in whom valve replacement would not be expected to positively impact either their survival or quality of life, but how best to identify these patients has been less clear.

More recently, as the use of TAVR has moved down the risk spectrum, patient selection for TAVR has shifted to understanding which patients should be preferentially treated with TAVR versus SAVR. While patients often prefer a less invasive treatment option with faster recovery—which is what TAVR offers—there are lingering questions about valve longevity, need for a pacemaker (and the associated long-term implications), and the ability to treat other cardiovascular conditions (eg, Maze, mitral valve repair) that potentially make a patient a more appropriate candidate for valve surgery. This review outlines the tools currently available to help understand the risk of TAVR and the gaps in knowledge.

Short-Term Outcomes

When TAVR was initially introduced, the 30-day mortality rate was 5% to 8%.^1,11,16 This high mortality rate was a function of treating very ill patients and more invasive procedures with larger sheath sizes and routine use of general anesthesia, transesophageal echocardiography, pulmonary artery catheterization, and so on. Over time, however, this rate has gone down substantially, with the 30-day mortality rate in intermediate- and low-risk patients now ranging from 0.5% to 1%.^8,17-19 Although this low mortality rate indicates that the vast majority of patients will survive to discharge from the hospital, 2 models can be used to estimate the risk of short-term mortality: an in-hospital²⁰ and a 30-day model,²¹ both developed and validated by the American College of Cardiology. The in-hospital model was developed for clinical use, as it includes only 6 variables (age, renal function, severe lung disease, non-femoral access, New York Heart Association class IV, and acuity of the procedure [elective versus urgent versus shock versus emergent])²⁰ and has an online calculator (http://tools.acc.org/tavrrisk/). The 30-day model was developed for risk adjustment (primarily for site comparisons and quality improvement) and includes 41 variables (including pre-TAVR patient health status and gait speed).²¹

While 30 days is a better time frame for assessment because outcome is less impacted by differences in local post-acute care facilities, we explicitly did not create a parsimonious 30-day mortality model for clinical use due to concern that having such a model would allow for indirect comparisons with estimated risk of SAVR using the Society of Thoracic Surgeons risk model (http://riskcalc.sts.org/stswebriskcalc). It would be tempting to estimate a patient’s risk of mortality with the TAVR calculator and the SAVR calculator and use those risk estimates to inform the choice of treatment; however, these risk estimates should not be directly compared to make treatment selections, as they were built on entirely different patient populations. In real-world practice, there is minimal overlap in the characteristics of patients who are treated with TAVR and SAVR. For example, in an analysis that merged surgical and transcatheter databases, less than 25% of patients treated with TAVR could be matched to a clinically similar patient treated with SAVR.²² As such, these TAVR models should be used to estimate a patient’s risk for short-term mortality, but should not be used to contribute to the decision on TAVR versus SAVR.

The decision of selecting SAVR over TAVR is typically driven by factors other than short- or long-term mortality (eg, whether TAVR will be covered by insurance, very young age and concern about durability, need to treat concomitant mitral regurgitation or aortopathy), as clinical trials have shown that survival and quality of life outcomes are at least as good with TAVR compared with SAVR.^6,7,9,23 In fact, in an analysis that compared similar patients treated with TAVR versus SAVR and specifically looked for patient factors that might make one treatment preferable to the other, patients who had a prior cardiac operation and those on home oxygen were more likely to do better with TAVR, whereas no patient factors that favored SAVR were found.²⁴ The majority of patients, however, were expected to have similar long-term outcomes regardless of treatment choice, and as such, the benefit of TAVR appears mostly to be an earlier and easier recovery.

Long-Term Outcomes: Estimating the Risk for Failure to Recover

While many patients who undergo TAVR are quite ill prior to the procedure, with substantial limitations due to the fatigue and shortness of breath associated with severe aortic stenosis, most patients recover well after the procedure, with marked improvement in symptoms and functional capacity. Approximately 25% to 35% of patients currently treated with TAVR commercially (ie, intermediate- and high-surgical-risk patients) either die or do not recover a reasonable quality of life after the procedure. Identifying those patients prior to the procedure can be challenging. We have previously developed and externally validated a risk model to estimate risk of dying or having a persistently poor quality of life at 1 year after TAVR.^25,26 The factors that most significantly increase a patient’s risk for poor outcomes are very poor functional status prior to TAVR, requiring home oxygen, chronic renal insufficiency, atrial fibrillation, and dementia. For example, a patient who is short of breath at rest, is on home oxygen, has a serum creatinine of 2.5 mg/dL, and has atrial fibrillation has an estimated risk of poor outcome at 1 year of ~70%. However, it should be noted that ~25% of patients with no risk factors for poor outcomes (ie, those considered “low risk”) still have a poor outcome at 1 year after TAVR, as the patients who undergo TAVR are typically at an advanced age with at least some comorbidities. Therefore, a 1-year mortality rate of 10% to 15% would not be unexpected in this population independent of the TAVR, although this will likely change over time as TAVR expands to patients at low surgical risk.

Beyond clinical factors, frailty negatively impacts both survival and quality of life after TAVR. Frailty is a geriatric syndrome of impaired physiologic reserve and decreased resistance to stressors²⁷ that is characterized by weakness, slowness, exhaustion, wasting, and low activity level. Across a wide variety of clinical situations (eg, pneumonia,²⁸ myocardial infarction,²⁹ general^30,31 and cardiac surgery^32,33), frailty increases the risk of morbidity and mortality after nearly any intervention³⁴ or clinical insult, independent of traditional demographic and clinical risk factors. Frail patients often do better with less invasive interventions such as TAVR compared with traditional surgery, but nonetheless remain at increased risk for death^35-37 or failure to recover quality of life and functional status^25,37 after TAVR. However, there are unique challenges in both assessing and managing frailty in patients who are considered potential candidates for TAVR. One challenge is the lack of a laboratory or radiologic test for frailty; instead, the lack of physiologic reserve of frailty is identified through a combination of factors, such as slow gait speed, weak grip strength, and unintentional weight loss. While these factors readily identify frail patients in general elderly populations, in patients with severe symptomatic aortic stenosis, these metrics can be impacted by the disease process itself. This distinction is important as slow gait speed that is due to aortic stenosis will be “fixed” by TAVR, but slow gait speed from frailty would identify a patient who will have a difficult time recovering from the procedure. For example, in the CoreValve High Risk Pivotal Trial, 80% of patients had a slow gait speed and 67% had a weak grip strength,⁵ and yet 58% of patients in this trial were alive and with a reasonable quality of life 1 year after TAVR.⁶ A number of studies have attempted to define true frailty within the pre-TAVR population, that which represents decreased physiologic reserve and an impaired ability to recover from an insult, and the factors that appear to be most prognostically important are malnutrition³⁸ or unintentional weight loss²⁵ and the inability to be independent in activities of daily living (eg, dressing, feeding, transferring).^25,37

Even with frailty assessments, the ability to predict who is or is not going to have a poor outcome after TAVR (ie, to use pre-procedural factors to identify patients who perhaps should not be offered TAVR because he or she will not recover from the procedure) is exceedingly difficult. The Table shows how to grossly estimate risk using the major factors that impact risk based on the more precise estimates from our models.^25,26

The model shown in the Table can be used to estimate a patient’s risk for a poor outcome, but it should be noted that even at the extreme high end of risk, there will be some patients who still do well after TAVR. Furthermore, being high risk for a poor outcome after TAVR does not imply anything about how the patient would do without TAVR, as many of these patients would likely die even sooner or have worse quality of life with medical therapy only. However, if a patient has ≥ 2 or 3 major risk factors for a poor outcome, it may be worthwhile to have a serious conversation with the patient (and family) about this risk and the uncertainty about the degree of recovery expected after TAVR.

Conclusion

Calculating the risk of TAVR can be complicated. In patients who are electively treated using transfemoral access and a less invasive approach, the short-term risk of mortality is very low. Risk calculators can be used to estimate short-term risk, but the patients who are high risk for in-hospital mortality are often fairly easy to recognize, as the factors that drive that risk are not subtle (eg, the patient is in shock at the time of the procedure). The true risk of TAVR lies in the inability to recover from the procedure—being chronically ill, frail, or debilitated to a degree that the patient either dies or fails to recover a reasonable quality of life. Given the overlap of symptomatic aortic stenosis with true frailty, it is often difficult to identify these patients who will not thrive after TAVR. Understanding the patient factors that most strongly drive risk of poor outcomes after TAVR, and allowing this information to guide the conversation prior to TAVR so as to set appropriate expectations for recovery, can be a good place to start.

Corresponding author: Suzanne V. Arnold, MD, MHA, 4401 Wornall Rd., Kansas City, MO 64111.

Financial disclosures: This work was funded in part by grant K23HL116799 from the National Institutes of Health.

From Saint Luke’s Mid America Heart Institute/University of Missouri–Kansas City, Kansas City, MO.

Abstract

• Objective: To outline the tools available to help understand the risk of transcatheter aortic valve replacement (TAVR) and the gaps in knowledge regarding TAVR risk estimation.
• Methods: Review of the literature.
• Results: Two models developed and validated by the American College of Cardiology can be used to estimate the risk of short-term mortality, a 6-variable in-hospital model designed for clinical use and a 41-variable 30-day model designed primarily for site comparisons and quality improvement. Importantly, neither model should be used to inform the choice of TAVR versus surgical aortic valve replacement. Regarding long-term outcomes, a risk model to estimate risk of dying or having a persistently poor quality of life at 1 year after TAVR has been developed and validated. Factors that most significantly increase a patient’s risk for poor outcomes are very poor functional status prior to TAVR, requiring home oxygen, chronic renal insufficiency, atrial fibrillation, dependencies in activities of daily living, and dementia. If a patient has ≥ 2 or 3 major risk factors for a poor outcome, this risk and the uncertainty about the degree of recovery expected after TAVR should be discussed with the patient (and family).
• Conclusion: It is important to understand the patient factors that most strongly drive risk of poor outcomes after TAVR and use this information to set appropriate expectations for recovery.

Keywords: aortic valve stenosis; risk factors; postoperative complications; TAVR.

Among patients with severe aortic stenosis, trans­catheter aortic valve replacement (TAVR) has emerged as a less invasive option for aortic valve replacement. This procedure offers substantial reductions in mortality and improvement in quality of life compared with medical therapy^1,2 and at least similar long-term outcomes compared to surgical aortic valve replacement (SAVR).^3-9

As with any emerging technology, selecting the appropriate patients for TAVR—a procedure with high initial costs¹⁰—has been an area of active investigation. As TAVR was first introduced in patients who were considered inoperable, initial efforts focused on trying to identify the patients who did not improve functionally or live longer following TAVR. Termed Cohort C patients, these patients were thought to have too many comorbidities, be too sick, and have too little reserve to recover from TAVR, and in the early trials, represented a substantial minority of the patients. For example, in pivotal clinical trials of patients at high or extreme surgical risk, approximately 1 in 4 patients who were treated with TAVR were dead at 1 year.^1,3,11 Furthermore, a number of patients who received TAVR were alive at 1 year but continued to have significant heart failure symptoms and functional limitations.^2,4 Practitioners,^12,13 regulators,¹⁴ and third-party payers¹⁵ have recommended that TAVR should not be offered to patients in whom valve replacement would not be expected to positively impact either their survival or quality of life, but how best to identify these patients has been less clear.

More recently, as the use of TAVR has moved down the risk spectrum, patient selection for TAVR has shifted to understanding which patients should be preferentially treated with TAVR versus SAVR. While patients often prefer a less invasive treatment option with faster recovery—which is what TAVR offers—there are lingering questions about valve longevity, need for a pacemaker (and the associated long-term implications), and the ability to treat other cardiovascular conditions (eg, Maze, mitral valve repair) that potentially make a patient a more appropriate candidate for valve surgery. This review outlines the tools currently available to help understand the risk of TAVR and the gaps in knowledge.

Short-Term Outcomes

When TAVR was initially introduced, the 30-day mortality rate was 5% to 8%.^1,11,16 This high mortality rate was a function of treating very ill patients and more invasive procedures with larger sheath sizes and routine use of general anesthesia, transesophageal echocardiography, pulmonary artery catheterization, and so on. Over time, however, this rate has gone down substantially, with the 30-day mortality rate in intermediate- and low-risk patients now ranging from 0.5% to 1%.^8,17-19 Although this low mortality rate indicates that the vast majority of patients will survive to discharge from the hospital, 2 models can be used to estimate the risk of short-term mortality: an in-hospital²⁰ and a 30-day model,²¹ both developed and validated by the American College of Cardiology. The in-hospital model was developed for clinical use, as it includes only 6 variables (age, renal function, severe lung disease, non-femoral access, New York Heart Association class IV, and acuity of the procedure [elective versus urgent versus shock versus emergent])²⁰ and has an online calculator (http://tools.acc.org/tavrrisk/). The 30-day model was developed for risk adjustment (primarily for site comparisons and quality improvement) and includes 41 variables (including pre-TAVR patient health status and gait speed).²¹

While 30 days is a better time frame for assessment because outcome is less impacted by differences in local post-acute care facilities, we explicitly did not create a parsimonious 30-day mortality model for clinical use due to concern that having such a model would allow for indirect comparisons with estimated risk of SAVR using the Society of Thoracic Surgeons risk model (http://riskcalc.sts.org/stswebriskcalc). It would be tempting to estimate a patient’s risk of mortality with the TAVR calculator and the SAVR calculator and use those risk estimates to inform the choice of treatment; however, these risk estimates should not be directly compared to make treatment selections, as they were built on entirely different patient populations. In real-world practice, there is minimal overlap in the characteristics of patients who are treated with TAVR and SAVR. For example, in an analysis that merged surgical and transcatheter databases, less than 25% of patients treated with TAVR could be matched to a clinically similar patient treated with SAVR.²² As such, these TAVR models should be used to estimate a patient’s risk for short-term mortality, but should not be used to contribute to the decision on TAVR versus SAVR.

The decision of selecting SAVR over TAVR is typically driven by factors other than short- or long-term mortality (eg, whether TAVR will be covered by insurance, very young age and concern about durability, need to treat concomitant mitral regurgitation or aortopathy), as clinical trials have shown that survival and quality of life outcomes are at least as good with TAVR compared with SAVR.^6,7,9,23 In fact, in an analysis that compared similar patients treated with TAVR versus SAVR and specifically looked for patient factors that might make one treatment preferable to the other, patients who had a prior cardiac operation and those on home oxygen were more likely to do better with TAVR, whereas no patient factors that favored SAVR were found.²⁴ The majority of patients, however, were expected to have similar long-term outcomes regardless of treatment choice, and as such, the benefit of TAVR appears mostly to be an earlier and easier recovery.

Long-Term Outcomes: Estimating the Risk for Failure to Recover

While many patients who undergo TAVR are quite ill prior to the procedure, with substantial limitations due to the fatigue and shortness of breath associated with severe aortic stenosis, most patients recover well after the procedure, with marked improvement in symptoms and functional capacity. Approximately 25% to 35% of patients currently treated with TAVR commercially (ie, intermediate- and high-surgical-risk patients) either die or do not recover a reasonable quality of life after the procedure. Identifying those patients prior to the procedure can be challenging. We have previously developed and externally validated a risk model to estimate risk of dying or having a persistently poor quality of life at 1 year after TAVR.^25,26 The factors that most significantly increase a patient’s risk for poor outcomes are very poor functional status prior to TAVR, requiring home oxygen, chronic renal insufficiency, atrial fibrillation, and dementia. For example, a patient who is short of breath at rest, is on home oxygen, has a serum creatinine of 2.5 mg/dL, and has atrial fibrillation has an estimated risk of poor outcome at 1 year of ~70%. However, it should be noted that ~25% of patients with no risk factors for poor outcomes (ie, those considered “low risk”) still have a poor outcome at 1 year after TAVR, as the patients who undergo TAVR are typically at an advanced age with at least some comorbidities. Therefore, a 1-year mortality rate of 10% to 15% would not be unexpected in this population independent of the TAVR, although this will likely change over time as TAVR expands to patients at low surgical risk.

Beyond clinical factors, frailty negatively impacts both survival and quality of life after TAVR. Frailty is a geriatric syndrome of impaired physiologic reserve and decreased resistance to stressors²⁷ that is characterized by weakness, slowness, exhaustion, wasting, and low activity level. Across a wide variety of clinical situations (eg, pneumonia,²⁸ myocardial infarction,²⁹ general^30,31 and cardiac surgery^32,33), frailty increases the risk of morbidity and mortality after nearly any intervention³⁴ or clinical insult, independent of traditional demographic and clinical risk factors. Frail patients often do better with less invasive interventions such as TAVR compared with traditional surgery, but nonetheless remain at increased risk for death^35-37 or failure to recover quality of life and functional status^25,37 after TAVR. However, there are unique challenges in both assessing and managing frailty in patients who are considered potential candidates for TAVR. One challenge is the lack of a laboratory or radiologic test for frailty; instead, the lack of physiologic reserve of frailty is identified through a combination of factors, such as slow gait speed, weak grip strength, and unintentional weight loss. While these factors readily identify frail patients in general elderly populations, in patients with severe symptomatic aortic stenosis, these metrics can be impacted by the disease process itself. This distinction is important as slow gait speed that is due to aortic stenosis will be “fixed” by TAVR, but slow gait speed from frailty would identify a patient who will have a difficult time recovering from the procedure. For example, in the CoreValve High Risk Pivotal Trial, 80% of patients had a slow gait speed and 67% had a weak grip strength,⁵ and yet 58% of patients in this trial were alive and with a reasonable quality of life 1 year after TAVR.⁶ A number of studies have attempted to define true frailty within the pre-TAVR population, that which represents decreased physiologic reserve and an impaired ability to recover from an insult, and the factors that appear to be most prognostically important are malnutrition³⁸ or unintentional weight loss²⁵ and the inability to be independent in activities of daily living (eg, dressing, feeding, transferring).^25,37

Even with frailty assessments, the ability to predict who is or is not going to have a poor outcome after TAVR (ie, to use pre-procedural factors to identify patients who perhaps should not be offered TAVR because he or she will not recover from the procedure) is exceedingly difficult. The Table shows how to grossly estimate risk using the major factors that impact risk based on the more precise estimates from our models.^25,26

The model shown in the Table can be used to estimate a patient’s risk for a poor outcome, but it should be noted that even at the extreme high end of risk, there will be some patients who still do well after TAVR. Furthermore, being high risk for a poor outcome after TAVR does not imply anything about how the patient would do without TAVR, as many of these patients would likely die even sooner or have worse quality of life with medical therapy only. However, if a patient has ≥ 2 or 3 major risk factors for a poor outcome, it may be worthwhile to have a serious conversation with the patient (and family) about this risk and the uncertainty about the degree of recovery expected after TAVR.

Conclusion

Calculating the risk of TAVR can be complicated. In patients who are electively treated using transfemoral access and a less invasive approach, the short-term risk of mortality is very low. Risk calculators can be used to estimate short-term risk, but the patients who are high risk for in-hospital mortality are often fairly easy to recognize, as the factors that drive that risk are not subtle (eg, the patient is in shock at the time of the procedure). The true risk of TAVR lies in the inability to recover from the procedure—being chronically ill, frail, or debilitated to a degree that the patient either dies or fails to recover a reasonable quality of life. Given the overlap of symptomatic aortic stenosis with true frailty, it is often difficult to identify these patients who will not thrive after TAVR. Understanding the patient factors that most strongly drive risk of poor outcomes after TAVR, and allowing this information to guide the conversation prior to TAVR so as to set appropriate expectations for recovery, can be a good place to start.

Corresponding author: Suzanne V. Arnold, MD, MHA, 4401 Wornall Rd., Kansas City, MO 64111.

Financial disclosures: This work was funded in part by grant K23HL116799 from the National Institutes of Health.

From Saint Luke’s Mid America Heart Institute/University of Missouri–Kansas City, Kansas City, MO.

Abstract

• Objective: To outline the tools available to help understand the risk of transcatheter aortic valve replacement (TAVR) and the gaps in knowledge regarding TAVR risk estimation.
• Methods: Review of the literature.
• Results: Two models developed and validated by the American College of Cardiology can be used to estimate the risk of short-term mortality, a 6-variable in-hospital model designed for clinical use and a 41-variable 30-day model designed primarily for site comparisons and quality improvement. Importantly, neither model should be used to inform the choice of TAVR versus surgical aortic valve replacement. Regarding long-term outcomes, a risk model to estimate risk of dying or having a persistently poor quality of life at 1 year after TAVR has been developed and validated. Factors that most significantly increase a patient’s risk for poor outcomes are very poor functional status prior to TAVR, requiring home oxygen, chronic renal insufficiency, atrial fibrillation, dependencies in activities of daily living, and dementia. If a patient has ≥ 2 or 3 major risk factors for a poor outcome, this risk and the uncertainty about the degree of recovery expected after TAVR should be discussed with the patient (and family).
• Conclusion: It is important to understand the patient factors that most strongly drive risk of poor outcomes after TAVR and use this information to set appropriate expectations for recovery.

Keywords: aortic valve stenosis; risk factors; postoperative complications; TAVR.

Among patients with severe aortic stenosis, trans­catheter aortic valve replacement (TAVR) has emerged as a less invasive option for aortic valve replacement. This procedure offers substantial reductions in mortality and improvement in quality of life compared with medical therapy^1,2 and at least similar long-term outcomes compared to surgical aortic valve replacement (SAVR).^3-9

As with any emerging technology, selecting the appropriate patients for TAVR—a procedure with high initial costs¹⁰—has been an area of active investigation. As TAVR was first introduced in patients who were considered inoperable, initial efforts focused on trying to identify the patients who did not improve functionally or live longer following TAVR. Termed Cohort C patients, these patients were thought to have too many comorbidities, be too sick, and have too little reserve to recover from TAVR, and in the early trials, represented a substantial minority of the patients. For example, in pivotal clinical trials of patients at high or extreme surgical risk, approximately 1 in 4 patients who were treated with TAVR were dead at 1 year.^1,3,11 Furthermore, a number of patients who received TAVR were alive at 1 year but continued to have significant heart failure symptoms and functional limitations.^2,4 Practitioners,^12,13 regulators,¹⁴ and third-party payers¹⁵ have recommended that TAVR should not be offered to patients in whom valve replacement would not be expected to positively impact either their survival or quality of life, but how best to identify these patients has been less clear.

More recently, as the use of TAVR has moved down the risk spectrum, patient selection for TAVR has shifted to understanding which patients should be preferentially treated with TAVR versus SAVR. While patients often prefer a less invasive treatment option with faster recovery—which is what TAVR offers—there are lingering questions about valve longevity, need for a pacemaker (and the associated long-term implications), and the ability to treat other cardiovascular conditions (eg, Maze, mitral valve repair) that potentially make a patient a more appropriate candidate for valve surgery. This review outlines the tools currently available to help understand the risk of TAVR and the gaps in knowledge.

Short-Term Outcomes

When TAVR was initially introduced, the 30-day mortality rate was 5% to 8%.^1,11,16 This high mortality rate was a function of treating very ill patients and more invasive procedures with larger sheath sizes and routine use of general anesthesia, transesophageal echocardiography, pulmonary artery catheterization, and so on. Over time, however, this rate has gone down substantially, with the 30-day mortality rate in intermediate- and low-risk patients now ranging from 0.5% to 1%.^8,17-19 Although this low mortality rate indicates that the vast majority of patients will survive to discharge from the hospital, 2 models can be used to estimate the risk of short-term mortality: an in-hospital²⁰ and a 30-day model,²¹ both developed and validated by the American College of Cardiology. The in-hospital model was developed for clinical use, as it includes only 6 variables (age, renal function, severe lung disease, non-femoral access, New York Heart Association class IV, and acuity of the procedure [elective versus urgent versus shock versus emergent])²⁰ and has an online calculator (http://tools.acc.org/tavrrisk/). The 30-day model was developed for risk adjustment (primarily for site comparisons and quality improvement) and includes 41 variables (including pre-TAVR patient health status and gait speed).²¹

While 30 days is a better time frame for assessment because outcome is less impacted by differences in local post-acute care facilities, we explicitly did not create a parsimonious 30-day mortality model for clinical use due to concern that having such a model would allow for indirect comparisons with estimated risk of SAVR using the Society of Thoracic Surgeons risk model (http://riskcalc.sts.org/stswebriskcalc). It would be tempting to estimate a patient’s risk of mortality with the TAVR calculator and the SAVR calculator and use those risk estimates to inform the choice of treatment; however, these risk estimates should not be directly compared to make treatment selections, as they were built on entirely different patient populations. In real-world practice, there is minimal overlap in the characteristics of patients who are treated with TAVR and SAVR. For example, in an analysis that merged surgical and transcatheter databases, less than 25% of patients treated with TAVR could be matched to a clinically similar patient treated with SAVR.²² As such, these TAVR models should be used to estimate a patient’s risk for short-term mortality, but should not be used to contribute to the decision on TAVR versus SAVR.

The decision of selecting SAVR over TAVR is typically driven by factors other than short- or long-term mortality (eg, whether TAVR will be covered by insurance, very young age and concern about durability, need to treat concomitant mitral regurgitation or aortopathy), as clinical trials have shown that survival and quality of life outcomes are at least as good with TAVR compared with SAVR.^6,7,9,23 In fact, in an analysis that compared similar patients treated with TAVR versus SAVR and specifically looked for patient factors that might make one treatment preferable to the other, patients who had a prior cardiac operation and those on home oxygen were more likely to do better with TAVR, whereas no patient factors that favored SAVR were found.²⁴ The majority of patients, however, were expected to have similar long-term outcomes regardless of treatment choice, and as such, the benefit of TAVR appears mostly to be an earlier and easier recovery.

Long-Term Outcomes: Estimating the Risk for Failure to Recover

While many patients who undergo TAVR are quite ill prior to the procedure, with substantial limitations due to the fatigue and shortness of breath associated with severe aortic stenosis, most patients recover well after the procedure, with marked improvement in symptoms and functional capacity. Approximately 25% to 35% of patients currently treated with TAVR commercially (ie, intermediate- and high-surgical-risk patients) either die or do not recover a reasonable quality of life after the procedure. Identifying those patients prior to the procedure can be challenging. We have previously developed and externally validated a risk model to estimate risk of dying or having a persistently poor quality of life at 1 year after TAVR.^25,26 The factors that most significantly increase a patient’s risk for poor outcomes are very poor functional status prior to TAVR, requiring home oxygen, chronic renal insufficiency, atrial fibrillation, and dementia. For example, a patient who is short of breath at rest, is on home oxygen, has a serum creatinine of 2.5 mg/dL, and has atrial fibrillation has an estimated risk of poor outcome at 1 year of ~70%. However, it should be noted that ~25% of patients with no risk factors for poor outcomes (ie, those considered “low risk”) still have a poor outcome at 1 year after TAVR, as the patients who undergo TAVR are typically at an advanced age with at least some comorbidities. Therefore, a 1-year mortality rate of 10% to 15% would not be unexpected in this population independent of the TAVR, although this will likely change over time as TAVR expands to patients at low surgical risk.

Beyond clinical factors, frailty negatively impacts both survival and quality of life after TAVR. Frailty is a geriatric syndrome of impaired physiologic reserve and decreased resistance to stressors²⁷ that is characterized by weakness, slowness, exhaustion, wasting, and low activity level. Across a wide variety of clinical situations (eg, pneumonia,²⁸ myocardial infarction,²⁹ general^30,31 and cardiac surgery^32,33), frailty increases the risk of morbidity and mortality after nearly any intervention³⁴ or clinical insult, independent of traditional demographic and clinical risk factors. Frail patients often do better with less invasive interventions such as TAVR compared with traditional surgery, but nonetheless remain at increased risk for death^35-37 or failure to recover quality of life and functional status^25,37 after TAVR. However, there are unique challenges in both assessing and managing frailty in patients who are considered potential candidates for TAVR. One challenge is the lack of a laboratory or radiologic test for frailty; instead, the lack of physiologic reserve of frailty is identified through a combination of factors, such as slow gait speed, weak grip strength, and unintentional weight loss. While these factors readily identify frail patients in general elderly populations, in patients with severe symptomatic aortic stenosis, these metrics can be impacted by the disease process itself. This distinction is important as slow gait speed that is due to aortic stenosis will be “fixed” by TAVR, but slow gait speed from frailty would identify a patient who will have a difficult time recovering from the procedure. For example, in the CoreValve High Risk Pivotal Trial, 80% of patients had a slow gait speed and 67% had a weak grip strength,⁵ and yet 58% of patients in this trial were alive and with a reasonable quality of life 1 year after TAVR.⁶ A number of studies have attempted to define true frailty within the pre-TAVR population, that which represents decreased physiologic reserve and an impaired ability to recover from an insult, and the factors that appear to be most prognostically important are malnutrition³⁸ or unintentional weight loss²⁵ and the inability to be independent in activities of daily living (eg, dressing, feeding, transferring).^25,37

Even with frailty assessments, the ability to predict who is or is not going to have a poor outcome after TAVR (ie, to use pre-procedural factors to identify patients who perhaps should not be offered TAVR because he or she will not recover from the procedure) is exceedingly difficult. The Table shows how to grossly estimate risk using the major factors that impact risk based on the more precise estimates from our models.^25,26

The model shown in the Table can be used to estimate a patient’s risk for a poor outcome, but it should be noted that even at the extreme high end of risk, there will be some patients who still do well after TAVR. Furthermore, being high risk for a poor outcome after TAVR does not imply anything about how the patient would do without TAVR, as many of these patients would likely die even sooner or have worse quality of life with medical therapy only. However, if a patient has ≥ 2 or 3 major risk factors for a poor outcome, it may be worthwhile to have a serious conversation with the patient (and family) about this risk and the uncertainty about the degree of recovery expected after TAVR.

Conclusion

Calculating the risk of TAVR can be complicated. In patients who are electively treated using transfemoral access and a less invasive approach, the short-term risk of mortality is very low. Risk calculators can be used to estimate short-term risk, but the patients who are high risk for in-hospital mortality are often fairly easy to recognize, as the factors that drive that risk are not subtle (eg, the patient is in shock at the time of the procedure). The true risk of TAVR lies in the inability to recover from the procedure—being chronically ill, frail, or debilitated to a degree that the patient either dies or fails to recover a reasonable quality of life. Given the overlap of symptomatic aortic stenosis with true frailty, it is often difficult to identify these patients who will not thrive after TAVR. Understanding the patient factors that most strongly drive risk of poor outcomes after TAVR, and allowing this information to guide the conversation prior to TAVR so as to set appropriate expectations for recovery, can be a good place to start.

Corresponding author: Suzanne V. Arnold, MD, MHA, 4401 Wornall Rd., Kansas City, MO 64111.

Financial disclosures: This work was funded in part by grant K23HL116799 from the National Institutes of Health.