Surgery

From the Department of Cardiothoracic Surgery, Stanford University, Stanford, CA.

Abstract

Complex cardiac patients are often referred for surgery or palliative care based on the risk of perioperative mortality. This decision ignores factors such as quality of life or duration of life in either surgery or the palliative path. Here, we propose a model to numerically assess and compare the value of surgery vs palliation. This model includes quality and duration of life, as well as risk of perioperative mortality, and involves a patient’s preferences in the decision-making process.

For each pathway, surgery or palliative care, a value is calculated and compared to a normal life value (no disease symptoms and normal life expectancy). The formula is adjusted for the risk of operative mortality. The model produces a ratio of the value of surgery to the value of palliative care that signifies the superiority of one or another. This model calculation presents an objective estimated numerical value to compare the value of surgery and palliative care. It can be applied to every decision-making process before surgery. In general, if a procedure has the potential to significantly extend life in a patient who otherwise has a very short life expectancy with palliation only, performing high-risk surgery would be a reasonable option. A model that provides a numerical value for surgery vs palliative care and includes quality and duration of life in each pathway could be a useful tool for cardiac surgeons in decision making regarding high-risk surgery.

Keywords: high-risk surgery, palliative care, quality of life, life expectancy.

Patients with complex cardiovascular disease are occasionally considered inoperable due to the high risk of surgical mortality. When the risk of perioperative mortality (POM) is predicted to be too high, surgical intervention is denied, and patients are often referred to palliative care. The risk of POM in cardiac surgery is often calculated using large-scale databases, such as the Society of Thoracic Surgeons (STS) records. The STS risk models, which are regularly updated, are based on large data sets and incorporate precise statistical methods for risk adjustment.¹ In general, these calculators provide a percentage value that defines the magnitude of the risk of death, and then an arbitrary range is selected to categorize the procedure as low, medium, or high risk or inoperable status. The STS database does not set a cutoff point or range to define “operability.” Assigning inoperable status to a certain risk rate is problematic, with many ethical, legal, and moral implications, and for this reason, it has mostly remained undefined. In contrast, the low- and medium-risk ranges are easier to define. Another limitation encountered in the STS database is the lack of risk data for less common but very high-risk procedures, such as a triple valve replacement.

A common example where risk classification has been defined is in patients who are candidates for surgical vs transcatheter aortic valve replacement. Some groups have described a risk of <4% as low risk, 4% to 8% as intermediate risk, >8% as high risk, and >15% as inoperable²; for some other groups, a risk of POM >50% is considered extreme risk or inoperable.^3,4 This procedure-specific classification is a useful decision-making tool and helps the surgeon perform an initial risk assessment to allocate a specific patient to a group—operable or nonoperable—only by calculating the risk of surgical death. However, this allocation method does not provide any information on how and when death occurs in either group. These 2 parameters of how and when death occurs define the quality of life (QOL) and the duration of life (DOL), respectively, and together could be considered as the value of life in each pathway. A survivor of a high-risk surgery may benefit from good quality and extended life (a high value), or, on the other end of the spectrum, a high-risk patient who does not undergo surgery is spared the mortality risk of the surgery but dies sooner (low value) with symptoms due to the natural course of the untreated disease.

The central question is, if a surgery is high risk but has the potential of providing a good value (for those who survive it), what QOL and DOL values are acceptable to risk or to justify accepting and proceeding with a risky surgery? Or how high a POM risk is justified to proceed with surgery rather than the alternative palliative care with a certain quality and duration? It is obvious that a decision-making process that is based on POM cannot compare the value of surgery (Vs) and the value of palliation (Vp). Furthermore, it ignores patient preferences and their input, as these are excluded from this decision-making process.

To be able to include QOL and DOL in any decision making, one must precisely describe these parameters. Both QOL and DOL are used for estimation of disease burden by health care administrators, public health experts, insurance agencies, and others. Multiple models have been proposed and used to estimate the overall burden of the disease. Most of the models for this purpose are created for large-scale economic purposes and not for decision making in individual cases.

An important measure is the quality-adjusted life year (QALY). This is an important parameter since it includes both measures of quality and quantity of life.^5,6 QALY is a simplified measure to assess the value of health outcomes, and it has been used in economic calculations to assess mainly the cost-effectiveness of various interventions. We sought to evaluate the utility of a similar method in adding further insight into the surgical decision-making process. In this article, we propose a simple model to compare the value of surgery vs palliative care, similar to QALY. This model includes and adjusts for the quality and the quantity of life, in addition to the risk of POM, in the decision-making process for high-risk patients.

The Model

The 2 decision pathways, surgery and palliative care, are compared for their value. We define the value as the product of QOL and DOL in each pathway and use the severity of the symptoms as a surrogate for QOL. If duration and quality were depicted on the x and y axes of a graph (Figure 1), then the area under the curve would represent the collective value in each situation. Figure 2 shows the timeline and the different pathways with each decision. The value in each situation is calculated in relation to the full value, which is represented as the value of normal life (Vn), that is, life without disease and with normal life expectancy. The values of each decision pathway, the value of surgery (Vs) and the value of palliation (Vp), are then compared to define the benefit for each decision as follows:

If Vs/Vp > 1, the benefit is toward surgery;

If Vs/Vp < 1, the benefit is for palliative care.

Definitions

Both quality and duration of life are presented on a 1-10 scale, 1 being the lowest and 10 the highest value, to yield a product with a value of 100 in normal, disease-free life. Any lower value is presented as a percentage to represent the comparison to the full value. QOL is determined by degradation of full quality with the average level of symptoms. DOL is calculated as a lost time (period of time from death after a specific intervention [surgery or palliation] until death at normal life expectancy) in fraction of full life (death at life expectancy). The Vs is adjusted to exclude the nonsurvivors using the chance of survival (100 – POM risk).

For the DOL under any condition, a 10-year survival rate could be used as a surrogate in this formula. Compared to life expectancy value, using the 10-year survival rate simplifies the calculation since cardiac diseases are more prevalent in older age, close to or beyond the average life expectancy value.

Using the time intervals from the timeline in Figure 2:

dh = time interval from diagnosis to death at life expectancy

dg = time interval from diagnosis to death after successful surgery

df = time interval from diagnosis to death after palliative care

Duration for palliative care:

Duration for surgery:

Adjustment: This value is calculated for those who survive the surgery. To adjust for the POM, it is multiplied by the 100 − POM risk.

Since value is the base for comparison in this model, and it is the product of 2 equally important factors in the formula (severity and duration of symptoms), a factor of 10 was chosen to yield a value of 100, which represents 100% health or absence of symptoms for any duration.

After elimination of normal life expectancy, form the numerator and denominator:

To adjust for surgical outcomes in special circumstances where less than optimal or standard surgical results are expected (eg, in very rare surgeries, limited resource institutions, or suboptimal postoperative surgical care), an optional coefficient R can be added to the numerator (surgical value). This optional coefficient, with values such as 0.8, 0.9 (to degrade the value of surgery) or 1 (standard surgical outcome), adjusts for variability in interinstitutional surgical results or surgeon variability. No coefficient is added to the denominator since palliative care provides minimal differences between clinicians and hospitals. Thus, the final adjusted formula would be as follows:

Example

A 60-year-old patient with a 10% POM risk needs to be allocated to surgical or palliative care. With palliative care, if this patient lived 6 years with average symptoms grade 4, the Vp would be 20; that is, 20% of the normal life value (if he lived 18 years instead without the disease).

Using the formula for calculation of value in each pathway:

With adjustment of 90% survival chance in surgery, 53 × 90% = 48%. In this example, Vs/Vp = 48/20 = 2.4, showing a significant benefit for surgical care. Notably, the unknown value of normal life expectancy is not needed for the calculation of Vs/Vp, since it is the same in both pathways and it is eliminated by calculation in fraction.

Based on this formula, since the duration of surgical symptoms is short, no matter how severe these are, if the potential duration of life after surgery is high (represented by smaller area under the curve in Figure 1), the numerator becomes larger and the value of the surgery grows. For example, if a patient with a 15% risk of POM, which is generally considered inoperable, lives 5 years, as opposed to 2 years with palliative care with mild symptoms (eg 3/10), Vs/Vp would be 2.7, still showing a significant benefit for surgical care.

Discussion

Any surgical intervention is offered with 2 goals in mind, improving QOL and extending DOL. In a high-risk patient, surgery might be declined due to a high risk of POM, and the patient is offered palliative care, which other than providing symptom relief does not change the course of disease and eventually the patient will die due to the untreated disease. In this decision-making method, mostly completed by a care team only, a potential risk of death due to surgery which possibly could cure the patient is traded for immediate survival; however, the symptomatic course ensues until death. This mostly unilateral decision-making process by a care team, which incorporates minimal input from the patient or ignores patient preferences altogether, is based only on POM risk, and roughly includes a single parameter: years of potential life lost (YPLL). YPLL is a measure of premature mortality, and in the setting of surgical intervention, YPLL is the number of years a patient would lose unless a successful surgery were undertaken. Obviously, patients would live longer if a surgery that was intended to save them failed.

In this article, we proposed a simple method to quantify each decision to decide whether to operate or choose surgical care vs palliative care. Since quality and duration of life are both end factors clinicians and patients aspire to in each decision, they can be considered together as the value of each decision. We believe a numerical framework would provide an objective way to assist both the patient at high risk and the care team in the decision-making process.

The 2 parameters we consider are DOL and QOL. DOL, or survival, can be extracted from large-scale data using statistical methods that have been developed to predict survival under various conditions, such as Kaplan-Meier curves. These methods present the chance of survival in percentages in a defined time frame, such as a 5- or 10-year period.

While the DOL is a numerical parameter and quantifiable, the QOL is a more complex entity. This subjective parameter bears multiple definitions, aspects, and categories, and therefore multiple scales for quantification of QOL have been proposed. These scales have been used extensively for the purpose of health determination in health care policy and economic planning. Most scales acknowledge that QOL is multifactorial and includes interrelated aspects such as mental and socioeconomic factors. We have also noticed that QOL is better determined by the palliative care team than surgeons, so including these care providers in the decision-making process might reduce surgeon bias.

Since our purpose here is only to assist with the decision on medical intervention, we focus on physical QOL. Multiple scales are used to assess health-related QOL, such as the Assessment of Quality of Life (AQoL)-8D,⁷ EuroQol-5 Dimension (EQ-5D),⁸ 15D,⁹ and the 36-Item Short Form Survey (SF-36).¹⁰ These complex scales are built for systematic reviews, and they are not practical for a clinical user. To simplify and keep this practical, we define QOL by using the severity or grade of symptoms related to the disease the patient has on a scale of 0 to 10. The severity of symptoms can be easily determined using available scales. An applicable scale for this purpose is the Edmonton Symptom Assessment Scale (ESAS), which has been in use for years and has evolved as a useful tool in the medical field.¹¹

Once DOL and QOL are determined on a 1-10 scale, the multiplied value then provides a product that we consider a value. The highest value hoped for in each decision is the achievement of the best QOL and DOL, a value of 100. In Figure 1, a graphic presentation of value in each decision is best seen as the area under the curve. As shown, a successful surgery, even when accompanied by significant symptoms during initial recovery, has a chance (100 – risk of POM%) to gain a larger area under curve (value) by achieving a longer life with no or fewer symptoms. However, in palliative care, progressing disease and even palliated symptoms with a shorter life expectancy impose a large burden on the patient and a much lower value. Note that in this calculation, life expectancy, which is an important but unpredictable factor, is initially included; however, by ratio comparison, it is eliminated, simplifying the calculation further.

Using this formula in different settings reveals that high-risk surgery has a greater potential to reduce YPLL in the general population. Based on this formula, compared to a surgery with potential to significantly extend DOL, a definite shorter and symptomatic life course with palliative care makes it a significantly less favorable option. In fact, in the cardiovascular field, palliative care has minimal or no effect on natural history, as the mechanism of illness is mechanical, such as occlusion of coronary arteries or valve dysfunction, leading eventually to heart failure and death. In a study by Xu et al, although palliative care reduced readmission rates and improved symptoms on a variety of scales, there was no effect on mortality and QOL in patients with heart failure.¹²

No model in this field has proven to be ideal, and this model bears multiple limitations as well. We have used severity of symptoms as a surrogate for QOL based on the fact that cardiac patients with different pathologies who are untreated will have a common final pathway with development of heart failure symptoms that dictate their QOL. Also, grading QOL is a difficult task at times. Even a model such as QALY, which is one of the most used, is not a perfect model and is not free of problems.⁶ The difference in surgical results and life expectancy between sexes and ethnic groups might be a source of bias in this formula. Also, multiple factors directly and indirectly affect QOL and DOL and create inaccuracies; therefore, making an exact science from an inexact one naturally relies on multiple assumptions. Although it has previously been shown that most POM occurs in a short period of time after cardiac surgery,¹³ long-term complications that potentially degrade QOL are not included in this model. By applying this model, one must assume indefinite economic resources. Moreover, applying a single mathematical model in a biologic system and in the general population has intrinsic shortcomings, and it must overlook many other factors (eg, ethical, legal). For example, it will be hard to justify a failed surgery with 15% risk of POM undertaken to eliminate the severe long-lasting symptoms of a disease, while the outcome of a successful surgery with a 20% risk of POM that adds life and quality would be ignored in the current health care system. Thus, regardless of the significant potential, most surgeons would waive a surgery based solely on the percentage rate of POM, perhaps using other terms such as ”peri-nonoperative mortality.”

Conclusion

We have proposed a simple and practical formula for decision making regarding surgical vs palliative care in high-risk patients. By assigning a value that is composed of QOL and DOL in each pathway and including the risk of POM, a ratio of values provides a numerical estimation that can be used to show preference over a specific decision. An advantage of this formula, in addition to presenting an arithmetic value that is easier to understand, is that it can be used in shared decision making with patients. We emphasize that this model is only a preliminary concept at this time and has not been tested or validated for clinical use. Validation of such a model will require extensive work and testing within a large-scale population. We hope that this article will serve as a starting point for the development of other models, and that this formula will become more sophisticated with fewer limitations through larger multidisciplinary efforts in the future.

Corresponding author: Rabin Gerrah, MD, Good Samaritan Regional Medical Center, 3640 NW Samaritan Drive, Suite 100B, Corvallis, OR 97330; [email protected].

Disclosures: None reported.

From the Department of Cardiothoracic Surgery, Stanford University, Stanford, CA.

Abstract

Complex cardiac patients are often referred for surgery or palliative care based on the risk of perioperative mortality. This decision ignores factors such as quality of life or duration of life in either surgery or the palliative path. Here, we propose a model to numerically assess and compare the value of surgery vs palliation. This model includes quality and duration of life, as well as risk of perioperative mortality, and involves a patient’s preferences in the decision-making process.

For each pathway, surgery or palliative care, a value is calculated and compared to a normal life value (no disease symptoms and normal life expectancy). The formula is adjusted for the risk of operative mortality. The model produces a ratio of the value of surgery to the value of palliative care that signifies the superiority of one or another. This model calculation presents an objective estimated numerical value to compare the value of surgery and palliative care. It can be applied to every decision-making process before surgery. In general, if a procedure has the potential to significantly extend life in a patient who otherwise has a very short life expectancy with palliation only, performing high-risk surgery would be a reasonable option. A model that provides a numerical value for surgery vs palliative care and includes quality and duration of life in each pathway could be a useful tool for cardiac surgeons in decision making regarding high-risk surgery.

Keywords: high-risk surgery, palliative care, quality of life, life expectancy.

Patients with complex cardiovascular disease are occasionally considered inoperable due to the high risk of surgical mortality. When the risk of perioperative mortality (POM) is predicted to be too high, surgical intervention is denied, and patients are often referred to palliative care. The risk of POM in cardiac surgery is often calculated using large-scale databases, such as the Society of Thoracic Surgeons (STS) records. The STS risk models, which are regularly updated, are based on large data sets and incorporate precise statistical methods for risk adjustment.¹ In general, these calculators provide a percentage value that defines the magnitude of the risk of death, and then an arbitrary range is selected to categorize the procedure as low, medium, or high risk or inoperable status. The STS database does not set a cutoff point or range to define “operability.” Assigning inoperable status to a certain risk rate is problematic, with many ethical, legal, and moral implications, and for this reason, it has mostly remained undefined. In contrast, the low- and medium-risk ranges are easier to define. Another limitation encountered in the STS database is the lack of risk data for less common but very high-risk procedures, such as a triple valve replacement.

A common example where risk classification has been defined is in patients who are candidates for surgical vs transcatheter aortic valve replacement. Some groups have described a risk of <4% as low risk, 4% to 8% as intermediate risk, >8% as high risk, and >15% as inoperable²; for some other groups, a risk of POM >50% is considered extreme risk or inoperable.^3,4 This procedure-specific classification is a useful decision-making tool and helps the surgeon perform an initial risk assessment to allocate a specific patient to a group—operable or nonoperable—only by calculating the risk of surgical death. However, this allocation method does not provide any information on how and when death occurs in either group. These 2 parameters of how and when death occurs define the quality of life (QOL) and the duration of life (DOL), respectively, and together could be considered as the value of life in each pathway. A survivor of a high-risk surgery may benefit from good quality and extended life (a high value), or, on the other end of the spectrum, a high-risk patient who does not undergo surgery is spared the mortality risk of the surgery but dies sooner (low value) with symptoms due to the natural course of the untreated disease.

The central question is, if a surgery is high risk but has the potential of providing a good value (for those who survive it), what QOL and DOL values are acceptable to risk or to justify accepting and proceeding with a risky surgery? Or how high a POM risk is justified to proceed with surgery rather than the alternative palliative care with a certain quality and duration? It is obvious that a decision-making process that is based on POM cannot compare the value of surgery (Vs) and the value of palliation (Vp). Furthermore, it ignores patient preferences and their input, as these are excluded from this decision-making process.

To be able to include QOL and DOL in any decision making, one must precisely describe these parameters. Both QOL and DOL are used for estimation of disease burden by health care administrators, public health experts, insurance agencies, and others. Multiple models have been proposed and used to estimate the overall burden of the disease. Most of the models for this purpose are created for large-scale economic purposes and not for decision making in individual cases.

An important measure is the quality-adjusted life year (QALY). This is an important parameter since it includes both measures of quality and quantity of life.^5,6 QALY is a simplified measure to assess the value of health outcomes, and it has been used in economic calculations to assess mainly the cost-effectiveness of various interventions. We sought to evaluate the utility of a similar method in adding further insight into the surgical decision-making process. In this article, we propose a simple model to compare the value of surgery vs palliative care, similar to QALY. This model includes and adjusts for the quality and the quantity of life, in addition to the risk of POM, in the decision-making process for high-risk patients.

The Model

The 2 decision pathways, surgery and palliative care, are compared for their value. We define the value as the product of QOL and DOL in each pathway and use the severity of the symptoms as a surrogate for QOL. If duration and quality were depicted on the x and y axes of a graph (Figure 1), then the area under the curve would represent the collective value in each situation. Figure 2 shows the timeline and the different pathways with each decision. The value in each situation is calculated in relation to the full value, which is represented as the value of normal life (Vn), that is, life without disease and with normal life expectancy. The values of each decision pathway, the value of surgery (Vs) and the value of palliation (Vp), are then compared to define the benefit for each decision as follows:

If Vs/Vp > 1, the benefit is toward surgery;

If Vs/Vp < 1, the benefit is for palliative care.

Definitions

Both quality and duration of life are presented on a 1-10 scale, 1 being the lowest and 10 the highest value, to yield a product with a value of 100 in normal, disease-free life. Any lower value is presented as a percentage to represent the comparison to the full value. QOL is determined by degradation of full quality with the average level of symptoms. DOL is calculated as a lost time (period of time from death after a specific intervention [surgery or palliation] until death at normal life expectancy) in fraction of full life (death at life expectancy). The Vs is adjusted to exclude the nonsurvivors using the chance of survival (100 – POM risk).

For the DOL under any condition, a 10-year survival rate could be used as a surrogate in this formula. Compared to life expectancy value, using the 10-year survival rate simplifies the calculation since cardiac diseases are more prevalent in older age, close to or beyond the average life expectancy value.

Using the time intervals from the timeline in Figure 2:

dh = time interval from diagnosis to death at life expectancy

dg = time interval from diagnosis to death after successful surgery

df = time interval from diagnosis to death after palliative care

Duration for palliative care:

Duration for surgery:

Adjustment: This value is calculated for those who survive the surgery. To adjust for the POM, it is multiplied by the 100 − POM risk.

Since value is the base for comparison in this model, and it is the product of 2 equally important factors in the formula (severity and duration of symptoms), a factor of 10 was chosen to yield a value of 100, which represents 100% health or absence of symptoms for any duration.

After elimination of normal life expectancy, form the numerator and denominator:

To adjust for surgical outcomes in special circumstances where less than optimal or standard surgical results are expected (eg, in very rare surgeries, limited resource institutions, or suboptimal postoperative surgical care), an optional coefficient R can be added to the numerator (surgical value). This optional coefficient, with values such as 0.8, 0.9 (to degrade the value of surgery) or 1 (standard surgical outcome), adjusts for variability in interinstitutional surgical results or surgeon variability. No coefficient is added to the denominator since palliative care provides minimal differences between clinicians and hospitals. Thus, the final adjusted formula would be as follows:

Example

A 60-year-old patient with a 10% POM risk needs to be allocated to surgical or palliative care. With palliative care, if this patient lived 6 years with average symptoms grade 4, the Vp would be 20; that is, 20% of the normal life value (if he lived 18 years instead without the disease).

Using the formula for calculation of value in each pathway:

With adjustment of 90% survival chance in surgery, 53 × 90% = 48%. In this example, Vs/Vp = 48/20 = 2.4, showing a significant benefit for surgical care. Notably, the unknown value of normal life expectancy is not needed for the calculation of Vs/Vp, since it is the same in both pathways and it is eliminated by calculation in fraction.

Based on this formula, since the duration of surgical symptoms is short, no matter how severe these are, if the potential duration of life after surgery is high (represented by smaller area under the curve in Figure 1), the numerator becomes larger and the value of the surgery grows. For example, if a patient with a 15% risk of POM, which is generally considered inoperable, lives 5 years, as opposed to 2 years with palliative care with mild symptoms (eg 3/10), Vs/Vp would be 2.7, still showing a significant benefit for surgical care.

Discussion

Any surgical intervention is offered with 2 goals in mind, improving QOL and extending DOL. In a high-risk patient, surgery might be declined due to a high risk of POM, and the patient is offered palliative care, which other than providing symptom relief does not change the course of disease and eventually the patient will die due to the untreated disease. In this decision-making method, mostly completed by a care team only, a potential risk of death due to surgery which possibly could cure the patient is traded for immediate survival; however, the symptomatic course ensues until death. This mostly unilateral decision-making process by a care team, which incorporates minimal input from the patient or ignores patient preferences altogether, is based only on POM risk, and roughly includes a single parameter: years of potential life lost (YPLL). YPLL is a measure of premature mortality, and in the setting of surgical intervention, YPLL is the number of years a patient would lose unless a successful surgery were undertaken. Obviously, patients would live longer if a surgery that was intended to save them failed.

In this article, we proposed a simple method to quantify each decision to decide whether to operate or choose surgical care vs palliative care. Since quality and duration of life are both end factors clinicians and patients aspire to in each decision, they can be considered together as the value of each decision. We believe a numerical framework would provide an objective way to assist both the patient at high risk and the care team in the decision-making process.

The 2 parameters we consider are DOL and QOL. DOL, or survival, can be extracted from large-scale data using statistical methods that have been developed to predict survival under various conditions, such as Kaplan-Meier curves. These methods present the chance of survival in percentages in a defined time frame, such as a 5- or 10-year period.

While the DOL is a numerical parameter and quantifiable, the QOL is a more complex entity. This subjective parameter bears multiple definitions, aspects, and categories, and therefore multiple scales for quantification of QOL have been proposed. These scales have been used extensively for the purpose of health determination in health care policy and economic planning. Most scales acknowledge that QOL is multifactorial and includes interrelated aspects such as mental and socioeconomic factors. We have also noticed that QOL is better determined by the palliative care team than surgeons, so including these care providers in the decision-making process might reduce surgeon bias.

Since our purpose here is only to assist with the decision on medical intervention, we focus on physical QOL. Multiple scales are used to assess health-related QOL, such as the Assessment of Quality of Life (AQoL)-8D,⁷ EuroQol-5 Dimension (EQ-5D),⁸ 15D,⁹ and the 36-Item Short Form Survey (SF-36).¹⁰ These complex scales are built for systematic reviews, and they are not practical for a clinical user. To simplify and keep this practical, we define QOL by using the severity or grade of symptoms related to the disease the patient has on a scale of 0 to 10. The severity of symptoms can be easily determined using available scales. An applicable scale for this purpose is the Edmonton Symptom Assessment Scale (ESAS), which has been in use for years and has evolved as a useful tool in the medical field.¹¹

Once DOL and QOL are determined on a 1-10 scale, the multiplied value then provides a product that we consider a value. The highest value hoped for in each decision is the achievement of the best QOL and DOL, a value of 100. In Figure 1, a graphic presentation of value in each decision is best seen as the area under the curve. As shown, a successful surgery, even when accompanied by significant symptoms during initial recovery, has a chance (100 – risk of POM%) to gain a larger area under curve (value) by achieving a longer life with no or fewer symptoms. However, in palliative care, progressing disease and even palliated symptoms with a shorter life expectancy impose a large burden on the patient and a much lower value. Note that in this calculation, life expectancy, which is an important but unpredictable factor, is initially included; however, by ratio comparison, it is eliminated, simplifying the calculation further.

Using this formula in different settings reveals that high-risk surgery has a greater potential to reduce YPLL in the general population. Based on this formula, compared to a surgery with potential to significantly extend DOL, a definite shorter and symptomatic life course with palliative care makes it a significantly less favorable option. In fact, in the cardiovascular field, palliative care has minimal or no effect on natural history, as the mechanism of illness is mechanical, such as occlusion of coronary arteries or valve dysfunction, leading eventually to heart failure and death. In a study by Xu et al, although palliative care reduced readmission rates and improved symptoms on a variety of scales, there was no effect on mortality and QOL in patients with heart failure.¹²

No model in this field has proven to be ideal, and this model bears multiple limitations as well. We have used severity of symptoms as a surrogate for QOL based on the fact that cardiac patients with different pathologies who are untreated will have a common final pathway with development of heart failure symptoms that dictate their QOL. Also, grading QOL is a difficult task at times. Even a model such as QALY, which is one of the most used, is not a perfect model and is not free of problems.⁶ The difference in surgical results and life expectancy between sexes and ethnic groups might be a source of bias in this formula. Also, multiple factors directly and indirectly affect QOL and DOL and create inaccuracies; therefore, making an exact science from an inexact one naturally relies on multiple assumptions. Although it has previously been shown that most POM occurs in a short period of time after cardiac surgery,¹³ long-term complications that potentially degrade QOL are not included in this model. By applying this model, one must assume indefinite economic resources. Moreover, applying a single mathematical model in a biologic system and in the general population has intrinsic shortcomings, and it must overlook many other factors (eg, ethical, legal). For example, it will be hard to justify a failed surgery with 15% risk of POM undertaken to eliminate the severe long-lasting symptoms of a disease, while the outcome of a successful surgery with a 20% risk of POM that adds life and quality would be ignored in the current health care system. Thus, regardless of the significant potential, most surgeons would waive a surgery based solely on the percentage rate of POM, perhaps using other terms such as ”peri-nonoperative mortality.”

Conclusion

We have proposed a simple and practical formula for decision making regarding surgical vs palliative care in high-risk patients. By assigning a value that is composed of QOL and DOL in each pathway and including the risk of POM, a ratio of values provides a numerical estimation that can be used to show preference over a specific decision. An advantage of this formula, in addition to presenting an arithmetic value that is easier to understand, is that it can be used in shared decision making with patients. We emphasize that this model is only a preliminary concept at this time and has not been tested or validated for clinical use. Validation of such a model will require extensive work and testing within a large-scale population. We hope that this article will serve as a starting point for the development of other models, and that this formula will become more sophisticated with fewer limitations through larger multidisciplinary efforts in the future.

Corresponding author: Rabin Gerrah, MD, Good Samaritan Regional Medical Center, 3640 NW Samaritan Drive, Suite 100B, Corvallis, OR 97330; [email protected].

Disclosures: None reported.

From the Department of Cardiothoracic Surgery, Stanford University, Stanford, CA.

Abstract

Complex cardiac patients are often referred for surgery or palliative care based on the risk of perioperative mortality. This decision ignores factors such as quality of life or duration of life in either surgery or the palliative path. Here, we propose a model to numerically assess and compare the value of surgery vs palliation. This model includes quality and duration of life, as well as risk of perioperative mortality, and involves a patient’s preferences in the decision-making process.

For each pathway, surgery or palliative care, a value is calculated and compared to a normal life value (no disease symptoms and normal life expectancy). The formula is adjusted for the risk of operative mortality. The model produces a ratio of the value of surgery to the value of palliative care that signifies the superiority of one or another. This model calculation presents an objective estimated numerical value to compare the value of surgery and palliative care. It can be applied to every decision-making process before surgery. In general, if a procedure has the potential to significantly extend life in a patient who otherwise has a very short life expectancy with palliation only, performing high-risk surgery would be a reasonable option. A model that provides a numerical value for surgery vs palliative care and includes quality and duration of life in each pathway could be a useful tool for cardiac surgeons in decision making regarding high-risk surgery.

Keywords: high-risk surgery, palliative care, quality of life, life expectancy.

Patients with complex cardiovascular disease are occasionally considered inoperable due to the high risk of surgical mortality. When the risk of perioperative mortality (POM) is predicted to be too high, surgical intervention is denied, and patients are often referred to palliative care. The risk of POM in cardiac surgery is often calculated using large-scale databases, such as the Society of Thoracic Surgeons (STS) records. The STS risk models, which are regularly updated, are based on large data sets and incorporate precise statistical methods for risk adjustment.¹ In general, these calculators provide a percentage value that defines the magnitude of the risk of death, and then an arbitrary range is selected to categorize the procedure as low, medium, or high risk or inoperable status. The STS database does not set a cutoff point or range to define “operability.” Assigning inoperable status to a certain risk rate is problematic, with many ethical, legal, and moral implications, and for this reason, it has mostly remained undefined. In contrast, the low- and medium-risk ranges are easier to define. Another limitation encountered in the STS database is the lack of risk data for less common but very high-risk procedures, such as a triple valve replacement.

A common example where risk classification has been defined is in patients who are candidates for surgical vs transcatheter aortic valve replacement. Some groups have described a risk of <4% as low risk, 4% to 8% as intermediate risk, >8% as high risk, and >15% as inoperable²; for some other groups, a risk of POM >50% is considered extreme risk or inoperable.^3,4 This procedure-specific classification is a useful decision-making tool and helps the surgeon perform an initial risk assessment to allocate a specific patient to a group—operable or nonoperable—only by calculating the risk of surgical death. However, this allocation method does not provide any information on how and when death occurs in either group. These 2 parameters of how and when death occurs define the quality of life (QOL) and the duration of life (DOL), respectively, and together could be considered as the value of life in each pathway. A survivor of a high-risk surgery may benefit from good quality and extended life (a high value), or, on the other end of the spectrum, a high-risk patient who does not undergo surgery is spared the mortality risk of the surgery but dies sooner (low value) with symptoms due to the natural course of the untreated disease.

The central question is, if a surgery is high risk but has the potential of providing a good value (for those who survive it), what QOL and DOL values are acceptable to risk or to justify accepting and proceeding with a risky surgery? Or how high a POM risk is justified to proceed with surgery rather than the alternative palliative care with a certain quality and duration? It is obvious that a decision-making process that is based on POM cannot compare the value of surgery (Vs) and the value of palliation (Vp). Furthermore, it ignores patient preferences and their input, as these are excluded from this decision-making process.

To be able to include QOL and DOL in any decision making, one must precisely describe these parameters. Both QOL and DOL are used for estimation of disease burden by health care administrators, public health experts, insurance agencies, and others. Multiple models have been proposed and used to estimate the overall burden of the disease. Most of the models for this purpose are created for large-scale economic purposes and not for decision making in individual cases.

An important measure is the quality-adjusted life year (QALY). This is an important parameter since it includes both measures of quality and quantity of life.^5,6 QALY is a simplified measure to assess the value of health outcomes, and it has been used in economic calculations to assess mainly the cost-effectiveness of various interventions. We sought to evaluate the utility of a similar method in adding further insight into the surgical decision-making process. In this article, we propose a simple model to compare the value of surgery vs palliative care, similar to QALY. This model includes and adjusts for the quality and the quantity of life, in addition to the risk of POM, in the decision-making process for high-risk patients.

The Model

The 2 decision pathways, surgery and palliative care, are compared for their value. We define the value as the product of QOL and DOL in each pathway and use the severity of the symptoms as a surrogate for QOL. If duration and quality were depicted on the x and y axes of a graph (Figure 1), then the area under the curve would represent the collective value in each situation. Figure 2 shows the timeline and the different pathways with each decision. The value in each situation is calculated in relation to the full value, which is represented as the value of normal life (Vn), that is, life without disease and with normal life expectancy. The values of each decision pathway, the value of surgery (Vs) and the value of palliation (Vp), are then compared to define the benefit for each decision as follows:

If Vs/Vp > 1, the benefit is toward surgery;

If Vs/Vp < 1, the benefit is for palliative care.

Definitions

Both quality and duration of life are presented on a 1-10 scale, 1 being the lowest and 10 the highest value, to yield a product with a value of 100 in normal, disease-free life. Any lower value is presented as a percentage to represent the comparison to the full value. QOL is determined by degradation of full quality with the average level of symptoms. DOL is calculated as a lost time (period of time from death after a specific intervention [surgery or palliation] until death at normal life expectancy) in fraction of full life (death at life expectancy). The Vs is adjusted to exclude the nonsurvivors using the chance of survival (100 – POM risk).

For the DOL under any condition, a 10-year survival rate could be used as a surrogate in this formula. Compared to life expectancy value, using the 10-year survival rate simplifies the calculation since cardiac diseases are more prevalent in older age, close to or beyond the average life expectancy value.

Using the time intervals from the timeline in Figure 2:

dh = time interval from diagnosis to death at life expectancy

dg = time interval from diagnosis to death after successful surgery

df = time interval from diagnosis to death after palliative care

Duration for palliative care:

Duration for surgery:

Adjustment: This value is calculated for those who survive the surgery. To adjust for the POM, it is multiplied by the 100 − POM risk.

Since value is the base for comparison in this model, and it is the product of 2 equally important factors in the formula (severity and duration of symptoms), a factor of 10 was chosen to yield a value of 100, which represents 100% health or absence of symptoms for any duration.

After elimination of normal life expectancy, form the numerator and denominator:

To adjust for surgical outcomes in special circumstances where less than optimal or standard surgical results are expected (eg, in very rare surgeries, limited resource institutions, or suboptimal postoperative surgical care), an optional coefficient R can be added to the numerator (surgical value). This optional coefficient, with values such as 0.8, 0.9 (to degrade the value of surgery) or 1 (standard surgical outcome), adjusts for variability in interinstitutional surgical results or surgeon variability. No coefficient is added to the denominator since palliative care provides minimal differences between clinicians and hospitals. Thus, the final adjusted formula would be as follows:

Example

A 60-year-old patient with a 10% POM risk needs to be allocated to surgical or palliative care. With palliative care, if this patient lived 6 years with average symptoms grade 4, the Vp would be 20; that is, 20% of the normal life value (if he lived 18 years instead without the disease).

Using the formula for calculation of value in each pathway:

With adjustment of 90% survival chance in surgery, 53 × 90% = 48%. In this example, Vs/Vp = 48/20 = 2.4, showing a significant benefit for surgical care. Notably, the unknown value of normal life expectancy is not needed for the calculation of Vs/Vp, since it is the same in both pathways and it is eliminated by calculation in fraction.

Based on this formula, since the duration of surgical symptoms is short, no matter how severe these are, if the potential duration of life after surgery is high (represented by smaller area under the curve in Figure 1), the numerator becomes larger and the value of the surgery grows. For example, if a patient with a 15% risk of POM, which is generally considered inoperable, lives 5 years, as opposed to 2 years with palliative care with mild symptoms (eg 3/10), Vs/Vp would be 2.7, still showing a significant benefit for surgical care.

Discussion

Any surgical intervention is offered with 2 goals in mind, improving QOL and extending DOL. In a high-risk patient, surgery might be declined due to a high risk of POM, and the patient is offered palliative care, which other than providing symptom relief does not change the course of disease and eventually the patient will die due to the untreated disease. In this decision-making method, mostly completed by a care team only, a potential risk of death due to surgery which possibly could cure the patient is traded for immediate survival; however, the symptomatic course ensues until death. This mostly unilateral decision-making process by a care team, which incorporates minimal input from the patient or ignores patient preferences altogether, is based only on POM risk, and roughly includes a single parameter: years of potential life lost (YPLL). YPLL is a measure of premature mortality, and in the setting of surgical intervention, YPLL is the number of years a patient would lose unless a successful surgery were undertaken. Obviously, patients would live longer if a surgery that was intended to save them failed.

In this article, we proposed a simple method to quantify each decision to decide whether to operate or choose surgical care vs palliative care. Since quality and duration of life are both end factors clinicians and patients aspire to in each decision, they can be considered together as the value of each decision. We believe a numerical framework would provide an objective way to assist both the patient at high risk and the care team in the decision-making process.

The 2 parameters we consider are DOL and QOL. DOL, or survival, can be extracted from large-scale data using statistical methods that have been developed to predict survival under various conditions, such as Kaplan-Meier curves. These methods present the chance of survival in percentages in a defined time frame, such as a 5- or 10-year period.

While the DOL is a numerical parameter and quantifiable, the QOL is a more complex entity. This subjective parameter bears multiple definitions, aspects, and categories, and therefore multiple scales for quantification of QOL have been proposed. These scales have been used extensively for the purpose of health determination in health care policy and economic planning. Most scales acknowledge that QOL is multifactorial and includes interrelated aspects such as mental and socioeconomic factors. We have also noticed that QOL is better determined by the palliative care team than surgeons, so including these care providers in the decision-making process might reduce surgeon bias.

Since our purpose here is only to assist with the decision on medical intervention, we focus on physical QOL. Multiple scales are used to assess health-related QOL, such as the Assessment of Quality of Life (AQoL)-8D,⁷ EuroQol-5 Dimension (EQ-5D),⁸ 15D,⁹ and the 36-Item Short Form Survey (SF-36).¹⁰ These complex scales are built for systematic reviews, and they are not practical for a clinical user. To simplify and keep this practical, we define QOL by using the severity or grade of symptoms related to the disease the patient has on a scale of 0 to 10. The severity of symptoms can be easily determined using available scales. An applicable scale for this purpose is the Edmonton Symptom Assessment Scale (ESAS), which has been in use for years and has evolved as a useful tool in the medical field.¹¹

Once DOL and QOL are determined on a 1-10 scale, the multiplied value then provides a product that we consider a value. The highest value hoped for in each decision is the achievement of the best QOL and DOL, a value of 100. In Figure 1, a graphic presentation of value in each decision is best seen as the area under the curve. As shown, a successful surgery, even when accompanied by significant symptoms during initial recovery, has a chance (100 – risk of POM%) to gain a larger area under curve (value) by achieving a longer life with no or fewer symptoms. However, in palliative care, progressing disease and even palliated symptoms with a shorter life expectancy impose a large burden on the patient and a much lower value. Note that in this calculation, life expectancy, which is an important but unpredictable factor, is initially included; however, by ratio comparison, it is eliminated, simplifying the calculation further.

Using this formula in different settings reveals that high-risk surgery has a greater potential to reduce YPLL in the general population. Based on this formula, compared to a surgery with potential to significantly extend DOL, a definite shorter and symptomatic life course with palliative care makes it a significantly less favorable option. In fact, in the cardiovascular field, palliative care has minimal or no effect on natural history, as the mechanism of illness is mechanical, such as occlusion of coronary arteries or valve dysfunction, leading eventually to heart failure and death. In a study by Xu et al, although palliative care reduced readmission rates and improved symptoms on a variety of scales, there was no effect on mortality and QOL in patients with heart failure.¹²

No model in this field has proven to be ideal, and this model bears multiple limitations as well. We have used severity of symptoms as a surrogate for QOL based on the fact that cardiac patients with different pathologies who are untreated will have a common final pathway with development of heart failure symptoms that dictate their QOL. Also, grading QOL is a difficult task at times. Even a model such as QALY, which is one of the most used, is not a perfect model and is not free of problems.⁶ The difference in surgical results and life expectancy between sexes and ethnic groups might be a source of bias in this formula. Also, multiple factors directly and indirectly affect QOL and DOL and create inaccuracies; therefore, making an exact science from an inexact one naturally relies on multiple assumptions. Although it has previously been shown that most POM occurs in a short period of time after cardiac surgery,¹³ long-term complications that potentially degrade QOL are not included in this model. By applying this model, one must assume indefinite economic resources. Moreover, applying a single mathematical model in a biologic system and in the general population has intrinsic shortcomings, and it must overlook many other factors (eg, ethical, legal). For example, it will be hard to justify a failed surgery with 15% risk of POM undertaken to eliminate the severe long-lasting symptoms of a disease, while the outcome of a successful surgery with a 20% risk of POM that adds life and quality would be ignored in the current health care system. Thus, regardless of the significant potential, most surgeons would waive a surgery based solely on the percentage rate of POM, perhaps using other terms such as ”peri-nonoperative mortality.”

Conclusion

We have proposed a simple and practical formula for decision making regarding surgical vs palliative care in high-risk patients. By assigning a value that is composed of QOL and DOL in each pathway and including the risk of POM, a ratio of values provides a numerical estimation that can be used to show preference over a specific decision. An advantage of this formula, in addition to presenting an arithmetic value that is easier to understand, is that it can be used in shared decision making with patients. We emphasize that this model is only a preliminary concept at this time and has not been tested or validated for clinical use. Validation of such a model will require extensive work and testing within a large-scale population. We hope that this article will serve as a starting point for the development of other models, and that this formula will become more sophisticated with fewer limitations through larger multidisciplinary efforts in the future.

Corresponding author: Rabin Gerrah, MD, Good Samaritan Regional Medical Center, 3640 NW Samaritan Drive, Suite 100B, Corvallis, OR 97330; [email protected].

Disclosures: None reported.

Study 1 Overview (SCOT-HEART Investigators)

Objective: To assess cardiovascular mortality and nonfatal myocardial infarction at 5 years in patients with stable chest pain referred to cardiology clinic for management with either standard care plus computed tomography angiography (CTA) or standard care alone.

Design: Multicenter, randomized, open-label prospective study.

Setting and participants: A total of 4146 patients with stable chest pain were randomized to standard care or standard care plus CTA at 12 centers across Scotland and were followed for 5 years.

Main outcome measures: The primary end point was a composite of death from coronary heart disease or nonfatal myocardial infarction. Main secondary end points were nonfatal myocardial infarction, nonfatal stroke, and frequency of invasive coronary angiography (ICA) and coronary revascularization with percutaneous coronary intervention or coronary artery bypass grafting.

Main results: The primary outcome including the composite of cardiovascular death or nonfatal myocardial infarction was lower in the CTA group than in the standard-care group at 2.3% (48 of 2073 patients) vs 3.9% (81 of 2073 patients), respectively (hazard ratio, 0.59; 95% CI, 0.41-0.84; P = .004). Although there was a higher rate of ICA and coronary revascularization in the CTA group than in the standard-care group in the first few months of follow-up, the overall rates were similar at 5 years, with ICA performed in 491 patients and 502 patients in the CTA vs standard-care groups, respectively (hazard ratio, 1.00; 95% CI, 0.88-1.13). Similarly, coronary revascularization was performed in 279 patients in the CTA group and in 267 patients in the standard-care group (hazard ratio, 1.07; 95% CI, 0.91-1.27). There were, however, more preventive therapies initiated in patients in the CTA group than in the standard-care group (odds ratio, 1.40; 95% CI, 1.19-1.65).

Conclusion: In patients with stable chest pain, the use of CTA in addition to standard care resulted in a significantly lower rate of death from coronary heart disease or nonfatal myocardial infarction at 5 years; the main contributor to this outcome was a reduced nonfatal myocardial infarction rate. There was no difference in the rate of coronary angiography or coronary revascularization between the 2 groups at 5 years.

Study 2 Overview (DISCHARGE Trial Group)

Objective: To compare the effectiveness of computed tomography (CT) with ICA as a diagnostic tool in patients with stable chest pain and intermediate pretest probability of coronary artery disease (CAD).

Design: Multicenter, randomized, assessor-blinded pragmatic prospective study.

Setting and participants: A total of 3667 patients with stable chest pain and intermediate pretest probability of CAD were enrolled at 26 centers and randomized into CT or ICA groups. Only 3561 patients were included in the modified intention-to-treat analysis, with 1808 patients and 1753 patients in the CT and ICA groups, respectively.

Main outcome measures: The primary outcome was a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke over 3.5 years. The main secondary outcomes were major procedure-related complications and patient-reported angina pectoris during the last 4 weeks of follow up.

Main results: The primary outcome occurred in 38 of 1808 patients (2.1%) in the CT group and in 52 of 1753 patients (3.0%) in the ICA group (hazard ratio, 0.70; 95% CI, 0.46-1.07; P = .10). The secondary outcomes showed that major procedure-related complications occurred in 9 patients (0.5%) in the CT group and in 33 patients (1.9%) in the ICA group (hazard ratio, 0.26; 95% CI, 0.13-0.55). Rates of patient-reported angina in the final 4 weeks of follow-up were 8.8% in the CT group and 7.5% in the ICA group (odds ratio, 1.17; 95% CI, 0.92-1.48).

Conclusion: Risk of major adverse cardiovascular events from the primary outcome were similar in both the CT and ICA groups among patients with stable chest pain and intermediate pretest probability of CAD. Patients referred for CT had a lower rate of coronary angiography leading to fewer major procedure-related complications in these patients than in those referred for ICA.

Evaluation and treatment of obstructive atherosclerosis is an important part of clinical care in patients presenting with angina symptoms.¹ Thus, the initial investigation for patients with suspected obstructive CAD includes ruling out acute coronary syndrome and assessing quality of life.¹ The diagnostic test should be tailored to the pretest probability for the diagnosis of obstructive CAD.²

In the United States, stress testing traditionally has been used for the initial assessment in patients with suspected CAD,³ but recently CTA has been utilized more frequently for this purpose. Compared to a stress test, which often helps identify and assess ischemia, CTA can provide anatomical assessment, with higher sensitivity to identify CAD.⁴ Furthermore, it can distinguish nonobstructive plaques that can be challenging to identify with stress test alone.

Whether CTA is superior to stress testing as the initial assessment for CAD has been debated. The randomized PROMISE trial compared patients with stable angina who underwent functional stress testing or CTA as an initial strategy.⁵ They reported a similar outcome between the 2 groups at a median follow-up of 2 years. However, in the original SCOT-HEART trial (CT coronary angiography in patients with suspected angina due to coronary heart disease), which was published in the same year as the PROMISE trial, the patients who underwent initial assessment with CTA had a numerically lower composite end point of cardiac death and myocardial infarction at a median follow-up of 1.7 years (1.3% vs 2.0%, P = .053).⁶

Given this result, the SCOT-HEART investigators extended the follow-up to evaluate the composite end point of death from coronary heart disease or nonfatal myocardial infarction at 5 years.⁷ This trial enrolled patients who were initially referred to a cardiology clinic for evaluation of chest pain, and they were randomized to standard care plus CTA or standard care alone. At a median duration of 4.8 years, the primary outcome was lower in the CTA group (2.3%, 48 patients) than in the standard-care group (3.9%, 81 patients) (hazard ratio, 0.58; 95% CI, 0.41-0.84; P = .004). Both groups had similar rates of invasive coronary angiography and had similar coronary revascularization rates.

It is hypothesized that this lower rate of nonfatal myocardial infarction in patients with CTA plus standard care is associated with a higher rate of preventive therapies initiated in patients in the CTA-plus-standard-care group compared to standard care alone. However, the difference in the standard-care group should be noted when compared to the PROMISE trial. In the PROMISE trial, the comparator group had predominantly stress imaging (either nuclear stress test or echocardiography), while in the SCOT-HEART trial, the group had predominantly stress electrocardiogram (ECG), and only 10% of the patients underwent stress imaging. It is possible the difference seen in the rate of nonfatal myocardial infarction was due to suboptimal diagnosis of CAD with stress ECG, which has lower sensitivity compared to stress imaging.

The DISCHARGE trial investigated the effectiveness of CTA vs ICA as the initial diagnostic test in the management of patients with stable chest pain and an intermediate pretest probability of obstructive CAD.⁸ At 3.5 years of follow-up, the primary composite of cardiovascular death, myocardial infarction, or stroke was similar in both groups (2.1% vs 3.0; hazard ratio, 0.70; 95% CI, 0.46-1.07; P = .10). Importantly, as fewer patients underwent ICA, the risk of procedure-related complication was lower in the CTA group than in the ICA group. However, it is important to note that only 25% of the patients diagnosed with obstructive CAD had greater than 50% vessel stenosis, which raises the question of whether an initial invasive strategy is appropriate for this population.

The strengths of these 2 studies include the large number of patients enrolled along with adequate follow-up, 5 years in the SCOT-HEART trial and 3.5 years in the DISCHARGE trial. The 2 studies overall suggest the usefulness of CTA for assessment of CAD. However, the control groups were very different in these 2 trials. In the SCOT-HEART study, the comparator group was primarily assessed by stress ECG, while in the DISCHARGE study, the comparator group was primary assessed by ICA. In the PROMISE trial, the composite end point of death, myocardial infarction, hospitalization for unstable angina, or major procedural complication was similar when the strategy of initial CTA was compared to functional testing with imaging (exercise ECG, nuclear stress testing, or echocardiography).⁵ Thus, clinical assessment is still needed when clinicians are selecting the appropriate diagnostic test for patients with suspected CAD. The most recent guidelines give similar recommendations for CTA compared to stress imaging.⁹ Whether further improvement in CTA acquisition or the addition of CT fractional flow reserve can further improve outcomes requires additional study.

Applications for Clinical Practice and System Implementation

In patients with stable chest pain and intermediate pretest probability of CAD, CTA is useful in diagnosis compared to stress ECG and in reducing utilization of low-yield ICA. Whether CTA is more useful compared to the other noninvasive stress imaging modalities in this population requires further study.

Practice Points

• In patients with stable chest pain and intermediate pretest probability of CAD, CTA is useful compared to stress ECG.
• Use of CTA can potentially reduce the use of low-yield coronary angiography.

–Thai Nguyen, MD, Albert Chan, MD, Taishi Hirai, MD
University of Missouri, Columbia, MO

Study 1 Overview (SCOT-HEART Investigators)

Objective: To assess cardiovascular mortality and nonfatal myocardial infarction at 5 years in patients with stable chest pain referred to cardiology clinic for management with either standard care plus computed tomography angiography (CTA) or standard care alone.

Design: Multicenter, randomized, open-label prospective study.

Setting and participants: A total of 4146 patients with stable chest pain were randomized to standard care or standard care plus CTA at 12 centers across Scotland and were followed for 5 years.

Main outcome measures: The primary end point was a composite of death from coronary heart disease or nonfatal myocardial infarction. Main secondary end points were nonfatal myocardial infarction, nonfatal stroke, and frequency of invasive coronary angiography (ICA) and coronary revascularization with percutaneous coronary intervention or coronary artery bypass grafting.

Main results: The primary outcome including the composite of cardiovascular death or nonfatal myocardial infarction was lower in the CTA group than in the standard-care group at 2.3% (48 of 2073 patients) vs 3.9% (81 of 2073 patients), respectively (hazard ratio, 0.59; 95% CI, 0.41-0.84; P = .004). Although there was a higher rate of ICA and coronary revascularization in the CTA group than in the standard-care group in the first few months of follow-up, the overall rates were similar at 5 years, with ICA performed in 491 patients and 502 patients in the CTA vs standard-care groups, respectively (hazard ratio, 1.00; 95% CI, 0.88-1.13). Similarly, coronary revascularization was performed in 279 patients in the CTA group and in 267 patients in the standard-care group (hazard ratio, 1.07; 95% CI, 0.91-1.27). There were, however, more preventive therapies initiated in patients in the CTA group than in the standard-care group (odds ratio, 1.40; 95% CI, 1.19-1.65).

Conclusion: In patients with stable chest pain, the use of CTA in addition to standard care resulted in a significantly lower rate of death from coronary heart disease or nonfatal myocardial infarction at 5 years; the main contributor to this outcome was a reduced nonfatal myocardial infarction rate. There was no difference in the rate of coronary angiography or coronary revascularization between the 2 groups at 5 years.

Study 2 Overview (DISCHARGE Trial Group)

Objective: To compare the effectiveness of computed tomography (CT) with ICA as a diagnostic tool in patients with stable chest pain and intermediate pretest probability of coronary artery disease (CAD).

Design: Multicenter, randomized, assessor-blinded pragmatic prospective study.

Setting and participants: A total of 3667 patients with stable chest pain and intermediate pretest probability of CAD were enrolled at 26 centers and randomized into CT or ICA groups. Only 3561 patients were included in the modified intention-to-treat analysis, with 1808 patients and 1753 patients in the CT and ICA groups, respectively.

Main outcome measures: The primary outcome was a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke over 3.5 years. The main secondary outcomes were major procedure-related complications and patient-reported angina pectoris during the last 4 weeks of follow up.

Main results: The primary outcome occurred in 38 of 1808 patients (2.1%) in the CT group and in 52 of 1753 patients (3.0%) in the ICA group (hazard ratio, 0.70; 95% CI, 0.46-1.07; P = .10). The secondary outcomes showed that major procedure-related complications occurred in 9 patients (0.5%) in the CT group and in 33 patients (1.9%) in the ICA group (hazard ratio, 0.26; 95% CI, 0.13-0.55). Rates of patient-reported angina in the final 4 weeks of follow-up were 8.8% in the CT group and 7.5% in the ICA group (odds ratio, 1.17; 95% CI, 0.92-1.48).

Conclusion: Risk of major adverse cardiovascular events from the primary outcome were similar in both the CT and ICA groups among patients with stable chest pain and intermediate pretest probability of CAD. Patients referred for CT had a lower rate of coronary angiography leading to fewer major procedure-related complications in these patients than in those referred for ICA.

Evaluation and treatment of obstructive atherosclerosis is an important part of clinical care in patients presenting with angina symptoms.¹ Thus, the initial investigation for patients with suspected obstructive CAD includes ruling out acute coronary syndrome and assessing quality of life.¹ The diagnostic test should be tailored to the pretest probability for the diagnosis of obstructive CAD.²

In the United States, stress testing traditionally has been used for the initial assessment in patients with suspected CAD,³ but recently CTA has been utilized more frequently for this purpose. Compared to a stress test, which often helps identify and assess ischemia, CTA can provide anatomical assessment, with higher sensitivity to identify CAD.⁴ Furthermore, it can distinguish nonobstructive plaques that can be challenging to identify with stress test alone.

Whether CTA is superior to stress testing as the initial assessment for CAD has been debated. The randomized PROMISE trial compared patients with stable angina who underwent functional stress testing or CTA as an initial strategy.⁵ They reported a similar outcome between the 2 groups at a median follow-up of 2 years. However, in the original SCOT-HEART trial (CT coronary angiography in patients with suspected angina due to coronary heart disease), which was published in the same year as the PROMISE trial, the patients who underwent initial assessment with CTA had a numerically lower composite end point of cardiac death and myocardial infarction at a median follow-up of 1.7 years (1.3% vs 2.0%, P = .053).⁶

Given this result, the SCOT-HEART investigators extended the follow-up to evaluate the composite end point of death from coronary heart disease or nonfatal myocardial infarction at 5 years.⁷ This trial enrolled patients who were initially referred to a cardiology clinic for evaluation of chest pain, and they were randomized to standard care plus CTA or standard care alone. At a median duration of 4.8 years, the primary outcome was lower in the CTA group (2.3%, 48 patients) than in the standard-care group (3.9%, 81 patients) (hazard ratio, 0.58; 95% CI, 0.41-0.84; P = .004). Both groups had similar rates of invasive coronary angiography and had similar coronary revascularization rates.

It is hypothesized that this lower rate of nonfatal myocardial infarction in patients with CTA plus standard care is associated with a higher rate of preventive therapies initiated in patients in the CTA-plus-standard-care group compared to standard care alone. However, the difference in the standard-care group should be noted when compared to the PROMISE trial. In the PROMISE trial, the comparator group had predominantly stress imaging (either nuclear stress test or echocardiography), while in the SCOT-HEART trial, the group had predominantly stress electrocardiogram (ECG), and only 10% of the patients underwent stress imaging. It is possible the difference seen in the rate of nonfatal myocardial infarction was due to suboptimal diagnosis of CAD with stress ECG, which has lower sensitivity compared to stress imaging.

The DISCHARGE trial investigated the effectiveness of CTA vs ICA as the initial diagnostic test in the management of patients with stable chest pain and an intermediate pretest probability of obstructive CAD.⁸ At 3.5 years of follow-up, the primary composite of cardiovascular death, myocardial infarction, or stroke was similar in both groups (2.1% vs 3.0; hazard ratio, 0.70; 95% CI, 0.46-1.07; P = .10). Importantly, as fewer patients underwent ICA, the risk of procedure-related complication was lower in the CTA group than in the ICA group. However, it is important to note that only 25% of the patients diagnosed with obstructive CAD had greater than 50% vessel stenosis, which raises the question of whether an initial invasive strategy is appropriate for this population.

The strengths of these 2 studies include the large number of patients enrolled along with adequate follow-up, 5 years in the SCOT-HEART trial and 3.5 years in the DISCHARGE trial. The 2 studies overall suggest the usefulness of CTA for assessment of CAD. However, the control groups were very different in these 2 trials. In the SCOT-HEART study, the comparator group was primarily assessed by stress ECG, while in the DISCHARGE study, the comparator group was primary assessed by ICA. In the PROMISE trial, the composite end point of death, myocardial infarction, hospitalization for unstable angina, or major procedural complication was similar when the strategy of initial CTA was compared to functional testing with imaging (exercise ECG, nuclear stress testing, or echocardiography).⁵ Thus, clinical assessment is still needed when clinicians are selecting the appropriate diagnostic test for patients with suspected CAD. The most recent guidelines give similar recommendations for CTA compared to stress imaging.⁹ Whether further improvement in CTA acquisition or the addition of CT fractional flow reserve can further improve outcomes requires additional study.

Applications for Clinical Practice and System Implementation

In patients with stable chest pain and intermediate pretest probability of CAD, CTA is useful in diagnosis compared to stress ECG and in reducing utilization of low-yield ICA. Whether CTA is more useful compared to the other noninvasive stress imaging modalities in this population requires further study.

Practice Points

• In patients with stable chest pain and intermediate pretest probability of CAD, CTA is useful compared to stress ECG.
• Use of CTA can potentially reduce the use of low-yield coronary angiography.

–Thai Nguyen, MD, Albert Chan, MD, Taishi Hirai, MD
University of Missouri, Columbia, MO

Study 1 Overview (SCOT-HEART Investigators)

Objective: To assess cardiovascular mortality and nonfatal myocardial infarction at 5 years in patients with stable chest pain referred to cardiology clinic for management with either standard care plus computed tomography angiography (CTA) or standard care alone.

Design: Multicenter, randomized, open-label prospective study.

Setting and participants: A total of 4146 patients with stable chest pain were randomized to standard care or standard care plus CTA at 12 centers across Scotland and were followed for 5 years.

Main outcome measures: The primary end point was a composite of death from coronary heart disease or nonfatal myocardial infarction. Main secondary end points were nonfatal myocardial infarction, nonfatal stroke, and frequency of invasive coronary angiography (ICA) and coronary revascularization with percutaneous coronary intervention or coronary artery bypass grafting.

Main results: The primary outcome including the composite of cardiovascular death or nonfatal myocardial infarction was lower in the CTA group than in the standard-care group at 2.3% (48 of 2073 patients) vs 3.9% (81 of 2073 patients), respectively (hazard ratio, 0.59; 95% CI, 0.41-0.84; P = .004). Although there was a higher rate of ICA and coronary revascularization in the CTA group than in the standard-care group in the first few months of follow-up, the overall rates were similar at 5 years, with ICA performed in 491 patients and 502 patients in the CTA vs standard-care groups, respectively (hazard ratio, 1.00; 95% CI, 0.88-1.13). Similarly, coronary revascularization was performed in 279 patients in the CTA group and in 267 patients in the standard-care group (hazard ratio, 1.07; 95% CI, 0.91-1.27). There were, however, more preventive therapies initiated in patients in the CTA group than in the standard-care group (odds ratio, 1.40; 95% CI, 1.19-1.65).

Conclusion: In patients with stable chest pain, the use of CTA in addition to standard care resulted in a significantly lower rate of death from coronary heart disease or nonfatal myocardial infarction at 5 years; the main contributor to this outcome was a reduced nonfatal myocardial infarction rate. There was no difference in the rate of coronary angiography or coronary revascularization between the 2 groups at 5 years.

Study 2 Overview (DISCHARGE Trial Group)

Objective: To compare the effectiveness of computed tomography (CT) with ICA as a diagnostic tool in patients with stable chest pain and intermediate pretest probability of coronary artery disease (CAD).

Design: Multicenter, randomized, assessor-blinded pragmatic prospective study.

Setting and participants: A total of 3667 patients with stable chest pain and intermediate pretest probability of CAD were enrolled at 26 centers and randomized into CT or ICA groups. Only 3561 patients were included in the modified intention-to-treat analysis, with 1808 patients and 1753 patients in the CT and ICA groups, respectively.

Main outcome measures: The primary outcome was a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke over 3.5 years. The main secondary outcomes were major procedure-related complications and patient-reported angina pectoris during the last 4 weeks of follow up.

Main results: The primary outcome occurred in 38 of 1808 patients (2.1%) in the CT group and in 52 of 1753 patients (3.0%) in the ICA group (hazard ratio, 0.70; 95% CI, 0.46-1.07; P = .10). The secondary outcomes showed that major procedure-related complications occurred in 9 patients (0.5%) in the CT group and in 33 patients (1.9%) in the ICA group (hazard ratio, 0.26; 95% CI, 0.13-0.55). Rates of patient-reported angina in the final 4 weeks of follow-up were 8.8% in the CT group and 7.5% in the ICA group (odds ratio, 1.17; 95% CI, 0.92-1.48).

Conclusion: Risk of major adverse cardiovascular events from the primary outcome were similar in both the CT and ICA groups among patients with stable chest pain and intermediate pretest probability of CAD. Patients referred for CT had a lower rate of coronary angiography leading to fewer major procedure-related complications in these patients than in those referred for ICA.

Evaluation and treatment of obstructive atherosclerosis is an important part of clinical care in patients presenting with angina symptoms.¹ Thus, the initial investigation for patients with suspected obstructive CAD includes ruling out acute coronary syndrome and assessing quality of life.¹ The diagnostic test should be tailored to the pretest probability for the diagnosis of obstructive CAD.²

In the United States, stress testing traditionally has been used for the initial assessment in patients with suspected CAD,³ but recently CTA has been utilized more frequently for this purpose. Compared to a stress test, which often helps identify and assess ischemia, CTA can provide anatomical assessment, with higher sensitivity to identify CAD.⁴ Furthermore, it can distinguish nonobstructive plaques that can be challenging to identify with stress test alone.

Whether CTA is superior to stress testing as the initial assessment for CAD has been debated. The randomized PROMISE trial compared patients with stable angina who underwent functional stress testing or CTA as an initial strategy.⁵ They reported a similar outcome between the 2 groups at a median follow-up of 2 years. However, in the original SCOT-HEART trial (CT coronary angiography in patients with suspected angina due to coronary heart disease), which was published in the same year as the PROMISE trial, the patients who underwent initial assessment with CTA had a numerically lower composite end point of cardiac death and myocardial infarction at a median follow-up of 1.7 years (1.3% vs 2.0%, P = .053).⁶

Given this result, the SCOT-HEART investigators extended the follow-up to evaluate the composite end point of death from coronary heart disease or nonfatal myocardial infarction at 5 years.⁷ This trial enrolled patients who were initially referred to a cardiology clinic for evaluation of chest pain, and they were randomized to standard care plus CTA or standard care alone. At a median duration of 4.8 years, the primary outcome was lower in the CTA group (2.3%, 48 patients) than in the standard-care group (3.9%, 81 patients) (hazard ratio, 0.58; 95% CI, 0.41-0.84; P = .004). Both groups had similar rates of invasive coronary angiography and had similar coronary revascularization rates.

It is hypothesized that this lower rate of nonfatal myocardial infarction in patients with CTA plus standard care is associated with a higher rate of preventive therapies initiated in patients in the CTA-plus-standard-care group compared to standard care alone. However, the difference in the standard-care group should be noted when compared to the PROMISE trial. In the PROMISE trial, the comparator group had predominantly stress imaging (either nuclear stress test or echocardiography), while in the SCOT-HEART trial, the group had predominantly stress electrocardiogram (ECG), and only 10% of the patients underwent stress imaging. It is possible the difference seen in the rate of nonfatal myocardial infarction was due to suboptimal diagnosis of CAD with stress ECG, which has lower sensitivity compared to stress imaging.

The DISCHARGE trial investigated the effectiveness of CTA vs ICA as the initial diagnostic test in the management of patients with stable chest pain and an intermediate pretest probability of obstructive CAD.⁸ At 3.5 years of follow-up, the primary composite of cardiovascular death, myocardial infarction, or stroke was similar in both groups (2.1% vs 3.0; hazard ratio, 0.70; 95% CI, 0.46-1.07; P = .10). Importantly, as fewer patients underwent ICA, the risk of procedure-related complication was lower in the CTA group than in the ICA group. However, it is important to note that only 25% of the patients diagnosed with obstructive CAD had greater than 50% vessel stenosis, which raises the question of whether an initial invasive strategy is appropriate for this population.

The strengths of these 2 studies include the large number of patients enrolled along with adequate follow-up, 5 years in the SCOT-HEART trial and 3.5 years in the DISCHARGE trial. The 2 studies overall suggest the usefulness of CTA for assessment of CAD. However, the control groups were very different in these 2 trials. In the SCOT-HEART study, the comparator group was primarily assessed by stress ECG, while in the DISCHARGE study, the comparator group was primary assessed by ICA. In the PROMISE trial, the composite end point of death, myocardial infarction, hospitalization for unstable angina, or major procedural complication was similar when the strategy of initial CTA was compared to functional testing with imaging (exercise ECG, nuclear stress testing, or echocardiography).⁵ Thus, clinical assessment is still needed when clinicians are selecting the appropriate diagnostic test for patients with suspected CAD. The most recent guidelines give similar recommendations for CTA compared to stress imaging.⁹ Whether further improvement in CTA acquisition or the addition of CT fractional flow reserve can further improve outcomes requires additional study.

Applications for Clinical Practice and System Implementation

In patients with stable chest pain and intermediate pretest probability of CAD, CTA is useful in diagnosis compared to stress ECG and in reducing utilization of low-yield ICA. Whether CTA is more useful compared to the other noninvasive stress imaging modalities in this population requires further study.

Practice Points

• In patients with stable chest pain and intermediate pretest probability of CAD, CTA is useful compared to stress ECG.
• Use of CTA can potentially reduce the use of low-yield coronary angiography.

–Thai Nguyen, MD, Albert Chan, MD, Taishi Hirai, MD
University of Missouri, Columbia, MO

The American Society for Reproductive Medicine’s classification system for müllerian anomalies was the standard until the revision in 2021 by ASRM, which updated and expanded the classification presenting nine classes and imaging criteria: müllerian agenesis, cervical agenesis, unicornuate, uterus didelphys, bicornuate, septate, longitudinal vaginal septum, transverse vaginal septum, and complex anomalies. This month’s article addresses müllerian anomalies from embryology to treatment options.

The early embryo has the capability of developing a wolffian (internal male) or müllerian (internal female) system. Unless anti-müllerian hormone (formerly müllerian-inhibiting substance) is produced, the embryo develops a female reproductive system beginning with two lateral uterine anlagen that fuse in the midline and canalize. Müllerian anomalies occur because of accidents during fusion and canalization (see Table).

The incidence of müllerian anomalies is difficult to discern, given the potential for a normal reproductive outcome precluding an evaluation and based on the population studied. Müllerian anomalies are found in approximately 4.3% of fertile women, 3.5%-8% of infertile patients, 12.3%-13% of those with recurrent pregnancy losses, and 24.5% of patients with miscarriage and infertility. Of the müllerian anomalies, the most common is septate (35%), followed by bicornuate (26%), arcuate (18%), unicornuate (10%), didelphys (8%), and agenesis (3%) (Hum Reprod Update. 2001;7[2]:161; Hum Reprod Update. 2011;17[6]:761-71).

In 20%-30% of patients with müllerian anomalies, particularly in women with a unicornuate uterus, renal anomalies exist that are typically ipsilateral to the absent or rudimentary contralateral uterine horn (J Pediatr Adolesc Gynecol. 2021;34[2]:154-60). As there is no definitive evidence to suggest an association between a septate uterus and renal anomalies, the renal system evaluation can be deferred in this population (Fertil Steril. 2021 Nov;116[5]:1238-52).
 

Diagnosis

2-D ultrasound can be a screen for müllerian anomalies and genitourinary anatomic variants. The diagnostic accuracy of 3-D ultrasound with müllerian anomalies is reported to be 97.6% with sensitivity and specificity of 98.3% and 99.4%, respectively (Hum. Reprod. 2016;31[1]:2-7). As a result, office 3-D has essentially replaced MRI in the diagnosis of müllerian anomalies (Ultrasound Obstet Gynecol. 2015 Nov;46[5]:616-22), with one exception because of the avoidance of a transvaginal probe in the non–sexually active adult and younger adolescent/child. MRI is reserved for diagnosing complex müllerian anomalies or if there is a diagnostic challenge.

Criteria to diagnose müllerian anomalies by radiology begins with the “reference line,” i.e., a line joining both tubal ostia (interostial line). A septate uterus is diagnosed if the distance from the interostial line to the cephalad endometrium is more than 1 cm, otherwise it is considered normal or arcuate based on its appearance. An arcuate uterus has not been associated with impaired reproduction and can be viewed as a normal variant. Alternatively, a bicornuate uterus is diagnosed when the external fundal indentation is more than 1 cm (Fertil Steril. 2021 Nov;116[5]:1238-52).
 

Clinical course

Women with müllerian anomalies may experience pelvic pain and prolonged and/or abnormal bleeding at the time of menarche. While the ability to conceive may not be impaired from müllerian anomalies with the possible exception of the septate uterus, the pregnancy course can be affected, i.e., recurrent pregnancy loss, preterm birth, perinatal mortality, and malpresentation in labor (Reprod Biomed Online. 2014;29[6]:665). In women with septate, bicornuate, and uterine didelphys, fetal growth restriction appears to be increased. Spontaneous abortion rates of 32% and preterm birth rates of 28% have been reported in patients with uterus didelphys (Obstet Gynecol. 1990;75[6]:906).

Special consideration of the unicornuate is given because of the potential for a rudimentary horn that may communicate with the main uterine cavity and/or have functional endometrium which places the woman at risk of an ectopic pregnancy in the smaller horn. Patients with a unicornuate uterus are at higher risk for preterm labor and breech presentation. An obstructed (noncommunicating) functional rudimentary horn is a risk for endometriosis with cyclic pain because of outflow tract obstruction and an ectopic pregnancy prompting consideration for hemihysterectomy based on symptoms.
 

The septate uterus – old dogma revisited

The incidence of uterine septa is approximately 1-15 per 1,000. As the most common müllerian anomaly, the septate uterus has traditionally been associated with an increased risk for spontaneous abortion (21%-44%) and preterm birth (12%-33%). The live birth rate ranges from 50% to 72% (Hum Reprod Update. 2001;7[2]:161-74). A uterine septum is believed to develop as a result of failure of resorption of the tissue connecting the two paramesonephric (müllerian) ducts prior to the 20th embryonic week.

Incising the uterine septum (metroplasty) dates back to 1884 when Ruge described a blind transcervical metroplasty in a woman with two previous miscarriages who, postoperatively, delivered a healthy baby. In the early 1900s, Tompkins reported an abdominal metroplasty (Fertil Stertil. 2021;115:1140-2). The decision to proceed with metroplasty is based on only established observational studies (Fertil Steril. 2016;106:530-40). Until recently, the majority of studies suggested that metroplasty is associated with decreased spontaneous abortion rates and improved obstetrical outcomes. A retrospective case series of 361 patients with a septate uterus who had primary infertility of >2 years’ duration, a history of 1-2 spontaneous abortions, or recurrent pregnancy loss suggested a significant improvement in the live birth rate and reduction in miscarriage (Arch Gynecol Obstet. 2003;268:289-92). A meta-analysis found that the overall pregnancy rate after septum incision was 67.8% and the live-birth rate was 53.5% (J Minim Invas Gynecol. 2013;20:22-42).

Recently, two multinational studies question the prevailing dogma (Fertil Steril. 2021 Sep;116[3]:693-4). Both studies could not demonstrate any increase in live birth rate, reduction in preterm birth, or in pregnancy loss after metroplasty. A significant limitation was the lack of a uniform consensus on the definition of the septate uterus and allowing the discretion of the physician to diagnosis a septum (Hum Reprod. 2020;35:1578-88; Hum Reprod. 2021;36:1260-7).

Hysteroscopic metroplasty is not without complications. Uterine rupture during pregnancy or delivery, while rare, may be linked to significant entry into the myometrium and/or overzealous cauterization and perforation, which emphasizes the importance of appropriate techniques.
 

Conclusion

A diagnosis of müllerian anomalies justifies a comprehensive consultation with the patient given the risk of pregnancy complications. Management of the septate uterus has become controversial. In a patient with infertility, prior pregnancy loss, or poor obstetrical outcome, it is reasonable to consider metroplasty; otherwise, expectant management is an option.

Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando. Email him at [email protected].

The American Society for Reproductive Medicine’s classification system for müllerian anomalies was the standard until the revision in 2021 by ASRM, which updated and expanded the classification presenting nine classes and imaging criteria: müllerian agenesis, cervical agenesis, unicornuate, uterus didelphys, bicornuate, septate, longitudinal vaginal septum, transverse vaginal septum, and complex anomalies. This month’s article addresses müllerian anomalies from embryology to treatment options.

The early embryo has the capability of developing a wolffian (internal male) or müllerian (internal female) system. Unless anti-müllerian hormone (formerly müllerian-inhibiting substance) is produced, the embryo develops a female reproductive system beginning with two lateral uterine anlagen that fuse in the midline and canalize. Müllerian anomalies occur because of accidents during fusion and canalization (see Table).

The incidence of müllerian anomalies is difficult to discern, given the potential for a normal reproductive outcome precluding an evaluation and based on the population studied. Müllerian anomalies are found in approximately 4.3% of fertile women, 3.5%-8% of infertile patients, 12.3%-13% of those with recurrent pregnancy losses, and 24.5% of patients with miscarriage and infertility. Of the müllerian anomalies, the most common is septate (35%), followed by bicornuate (26%), arcuate (18%), unicornuate (10%), didelphys (8%), and agenesis (3%) (Hum Reprod Update. 2001;7[2]:161; Hum Reprod Update. 2011;17[6]:761-71).

In 20%-30% of patients with müllerian anomalies, particularly in women with a unicornuate uterus, renal anomalies exist that are typically ipsilateral to the absent or rudimentary contralateral uterine horn (J Pediatr Adolesc Gynecol. 2021;34[2]:154-60). As there is no definitive evidence to suggest an association between a septate uterus and renal anomalies, the renal system evaluation can be deferred in this population (Fertil Steril. 2021 Nov;116[5]:1238-52).
 

Diagnosis

2-D ultrasound can be a screen for müllerian anomalies and genitourinary anatomic variants. The diagnostic accuracy of 3-D ultrasound with müllerian anomalies is reported to be 97.6% with sensitivity and specificity of 98.3% and 99.4%, respectively (Hum. Reprod. 2016;31[1]:2-7). As a result, office 3-D has essentially replaced MRI in the diagnosis of müllerian anomalies (Ultrasound Obstet Gynecol. 2015 Nov;46[5]:616-22), with one exception because of the avoidance of a transvaginal probe in the non–sexually active adult and younger adolescent/child. MRI is reserved for diagnosing complex müllerian anomalies or if there is a diagnostic challenge.

Criteria to diagnose müllerian anomalies by radiology begins with the “reference line,” i.e., a line joining both tubal ostia (interostial line). A septate uterus is diagnosed if the distance from the interostial line to the cephalad endometrium is more than 1 cm, otherwise it is considered normal or arcuate based on its appearance. An arcuate uterus has not been associated with impaired reproduction and can be viewed as a normal variant. Alternatively, a bicornuate uterus is diagnosed when the external fundal indentation is more than 1 cm (Fertil Steril. 2021 Nov;116[5]:1238-52).
 

Clinical course

Women with müllerian anomalies may experience pelvic pain and prolonged and/or abnormal bleeding at the time of menarche. While the ability to conceive may not be impaired from müllerian anomalies with the possible exception of the septate uterus, the pregnancy course can be affected, i.e., recurrent pregnancy loss, preterm birth, perinatal mortality, and malpresentation in labor (Reprod Biomed Online. 2014;29[6]:665). In women with septate, bicornuate, and uterine didelphys, fetal growth restriction appears to be increased. Spontaneous abortion rates of 32% and preterm birth rates of 28% have been reported in patients with uterus didelphys (Obstet Gynecol. 1990;75[6]:906).

Special consideration of the unicornuate is given because of the potential for a rudimentary horn that may communicate with the main uterine cavity and/or have functional endometrium which places the woman at risk of an ectopic pregnancy in the smaller horn. Patients with a unicornuate uterus are at higher risk for preterm labor and breech presentation. An obstructed (noncommunicating) functional rudimentary horn is a risk for endometriosis with cyclic pain because of outflow tract obstruction and an ectopic pregnancy prompting consideration for hemihysterectomy based on symptoms.
 

The septate uterus – old dogma revisited

The incidence of uterine septa is approximately 1-15 per 1,000. As the most common müllerian anomaly, the septate uterus has traditionally been associated with an increased risk for spontaneous abortion (21%-44%) and preterm birth (12%-33%). The live birth rate ranges from 50% to 72% (Hum Reprod Update. 2001;7[2]:161-74). A uterine septum is believed to develop as a result of failure of resorption of the tissue connecting the two paramesonephric (müllerian) ducts prior to the 20th embryonic week.

Incising the uterine septum (metroplasty) dates back to 1884 when Ruge described a blind transcervical metroplasty in a woman with two previous miscarriages who, postoperatively, delivered a healthy baby. In the early 1900s, Tompkins reported an abdominal metroplasty (Fertil Stertil. 2021;115:1140-2). The decision to proceed with metroplasty is based on only established observational studies (Fertil Steril. 2016;106:530-40). Until recently, the majority of studies suggested that metroplasty is associated with decreased spontaneous abortion rates and improved obstetrical outcomes. A retrospective case series of 361 patients with a septate uterus who had primary infertility of >2 years’ duration, a history of 1-2 spontaneous abortions, or recurrent pregnancy loss suggested a significant improvement in the live birth rate and reduction in miscarriage (Arch Gynecol Obstet. 2003;268:289-92). A meta-analysis found that the overall pregnancy rate after septum incision was 67.8% and the live-birth rate was 53.5% (J Minim Invas Gynecol. 2013;20:22-42).

Recently, two multinational studies question the prevailing dogma (Fertil Steril. 2021 Sep;116[3]:693-4). Both studies could not demonstrate any increase in live birth rate, reduction in preterm birth, or in pregnancy loss after metroplasty. A significant limitation was the lack of a uniform consensus on the definition of the septate uterus and allowing the discretion of the physician to diagnosis a septum (Hum Reprod. 2020;35:1578-88; Hum Reprod. 2021;36:1260-7).

Hysteroscopic metroplasty is not without complications. Uterine rupture during pregnancy or delivery, while rare, may be linked to significant entry into the myometrium and/or overzealous cauterization and perforation, which emphasizes the importance of appropriate techniques.
 

Conclusion

A diagnosis of müllerian anomalies justifies a comprehensive consultation with the patient given the risk of pregnancy complications. Management of the septate uterus has become controversial. In a patient with infertility, prior pregnancy loss, or poor obstetrical outcome, it is reasonable to consider metroplasty; otherwise, expectant management is an option.

Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando. Email him at [email protected].

The American Society for Reproductive Medicine’s classification system for müllerian anomalies was the standard until the revision in 2021 by ASRM, which updated and expanded the classification presenting nine classes and imaging criteria: müllerian agenesis, cervical agenesis, unicornuate, uterus didelphys, bicornuate, septate, longitudinal vaginal septum, transverse vaginal septum, and complex anomalies. This month’s article addresses müllerian anomalies from embryology to treatment options.

The early embryo has the capability of developing a wolffian (internal male) or müllerian (internal female) system. Unless anti-müllerian hormone (formerly müllerian-inhibiting substance) is produced, the embryo develops a female reproductive system beginning with two lateral uterine anlagen that fuse in the midline and canalize. Müllerian anomalies occur because of accidents during fusion and canalization (see Table).

The incidence of müllerian anomalies is difficult to discern, given the potential for a normal reproductive outcome precluding an evaluation and based on the population studied. Müllerian anomalies are found in approximately 4.3% of fertile women, 3.5%-8% of infertile patients, 12.3%-13% of those with recurrent pregnancy losses, and 24.5% of patients with miscarriage and infertility. Of the müllerian anomalies, the most common is septate (35%), followed by bicornuate (26%), arcuate (18%), unicornuate (10%), didelphys (8%), and agenesis (3%) (Hum Reprod Update. 2001;7[2]:161; Hum Reprod Update. 2011;17[6]:761-71).

In 20%-30% of patients with müllerian anomalies, particularly in women with a unicornuate uterus, renal anomalies exist that are typically ipsilateral to the absent or rudimentary contralateral uterine horn (J Pediatr Adolesc Gynecol. 2021;34[2]:154-60). As there is no definitive evidence to suggest an association between a septate uterus and renal anomalies, the renal system evaluation can be deferred in this population (Fertil Steril. 2021 Nov;116[5]:1238-52).
 

Diagnosis

2-D ultrasound can be a screen for müllerian anomalies and genitourinary anatomic variants. The diagnostic accuracy of 3-D ultrasound with müllerian anomalies is reported to be 97.6% with sensitivity and specificity of 98.3% and 99.4%, respectively (Hum. Reprod. 2016;31[1]:2-7). As a result, office 3-D has essentially replaced MRI in the diagnosis of müllerian anomalies (Ultrasound Obstet Gynecol. 2015 Nov;46[5]:616-22), with one exception because of the avoidance of a transvaginal probe in the non–sexually active adult and younger adolescent/child. MRI is reserved for diagnosing complex müllerian anomalies or if there is a diagnostic challenge.

Criteria to diagnose müllerian anomalies by radiology begins with the “reference line,” i.e., a line joining both tubal ostia (interostial line). A septate uterus is diagnosed if the distance from the interostial line to the cephalad endometrium is more than 1 cm, otherwise it is considered normal or arcuate based on its appearance. An arcuate uterus has not been associated with impaired reproduction and can be viewed as a normal variant. Alternatively, a bicornuate uterus is diagnosed when the external fundal indentation is more than 1 cm (Fertil Steril. 2021 Nov;116[5]:1238-52).
 

Clinical course

Women with müllerian anomalies may experience pelvic pain and prolonged and/or abnormal bleeding at the time of menarche. While the ability to conceive may not be impaired from müllerian anomalies with the possible exception of the septate uterus, the pregnancy course can be affected, i.e., recurrent pregnancy loss, preterm birth, perinatal mortality, and malpresentation in labor (Reprod Biomed Online. 2014;29[6]:665). In women with septate, bicornuate, and uterine didelphys, fetal growth restriction appears to be increased. Spontaneous abortion rates of 32% and preterm birth rates of 28% have been reported in patients with uterus didelphys (Obstet Gynecol. 1990;75[6]:906).

Special consideration of the unicornuate is given because of the potential for a rudimentary horn that may communicate with the main uterine cavity and/or have functional endometrium which places the woman at risk of an ectopic pregnancy in the smaller horn. Patients with a unicornuate uterus are at higher risk for preterm labor and breech presentation. An obstructed (noncommunicating) functional rudimentary horn is a risk for endometriosis with cyclic pain because of outflow tract obstruction and an ectopic pregnancy prompting consideration for hemihysterectomy based on symptoms.
 

The septate uterus – old dogma revisited

The incidence of uterine septa is approximately 1-15 per 1,000. As the most common müllerian anomaly, the septate uterus has traditionally been associated with an increased risk for spontaneous abortion (21%-44%) and preterm birth (12%-33%). The live birth rate ranges from 50% to 72% (Hum Reprod Update. 2001;7[2]:161-74). A uterine septum is believed to develop as a result of failure of resorption of the tissue connecting the two paramesonephric (müllerian) ducts prior to the 20th embryonic week.

Incising the uterine septum (metroplasty) dates back to 1884 when Ruge described a blind transcervical metroplasty in a woman with two previous miscarriages who, postoperatively, delivered a healthy baby. In the early 1900s, Tompkins reported an abdominal metroplasty (Fertil Stertil. 2021;115:1140-2). The decision to proceed with metroplasty is based on only established observational studies (Fertil Steril. 2016;106:530-40). Until recently, the majority of studies suggested that metroplasty is associated with decreased spontaneous abortion rates and improved obstetrical outcomes. A retrospective case series of 361 patients with a septate uterus who had primary infertility of >2 years’ duration, a history of 1-2 spontaneous abortions, or recurrent pregnancy loss suggested a significant improvement in the live birth rate and reduction in miscarriage (Arch Gynecol Obstet. 2003;268:289-92). A meta-analysis found that the overall pregnancy rate after septum incision was 67.8% and the live-birth rate was 53.5% (J Minim Invas Gynecol. 2013;20:22-42).

Recently, two multinational studies question the prevailing dogma (Fertil Steril. 2021 Sep;116[3]:693-4). Both studies could not demonstrate any increase in live birth rate, reduction in preterm birth, or in pregnancy loss after metroplasty. A significant limitation was the lack of a uniform consensus on the definition of the septate uterus and allowing the discretion of the physician to diagnosis a septum (Hum Reprod. 2020;35:1578-88; Hum Reprod. 2021;36:1260-7).

Hysteroscopic metroplasty is not without complications. Uterine rupture during pregnancy or delivery, while rare, may be linked to significant entry into the myometrium and/or overzealous cauterization and perforation, which emphasizes the importance of appropriate techniques.
 

Conclusion

A diagnosis of müllerian anomalies justifies a comprehensive consultation with the patient given the risk of pregnancy complications. Management of the septate uterus has become controversial. In a patient with infertility, prior pregnancy loss, or poor obstetrical outcome, it is reasonable to consider metroplasty; otherwise, expectant management is an option.

Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando. Email him at [email protected].

Imiquimod cream is a safe, effective, first-line alternative to surgery for the treatment of vulvar high-grade squamous intraepithelial lesions (vHSILs), suggest the results from the first randomized trial to compare the two approaches directly.

The findings provide women with human papillomavirus (HPV)–related precancerous lesions with a new treatment option that can circumvent drawbacks of surgery, according to first author Gerda Trutnovsky, MD, deputy head of the Division of Gynecology at the Medical University of Graz, Austria.

“Surgical removal of [vulvar intraepithelial neoplasia] can cause wound healing disorders, scarring, and even sexual complaints later on,” she explained in a press statement. Further, recurrences are common, and repeat surgeries are often necessary, she said.

The results from the trial show that “imiquimod cream was effective and well tolerated, and the rate of success of this treatment equaled that of surgery,” Dr. Trutnovsky said.

The study was published online in The Lancet.

The findings are of note because HPV vaccination rates remain low, and the incidence of both cervical and vulvar intraepithelial neoplasia has increased in recent years, particularly among younger women, the authors comment.
 

First head-to-head trial

For the trial, Dr. Trutnovsky and her colleagues randomly assigned 110 women with vHSIL to receive either imiquimod treatment or surgery between June 2013 and January 2020. Of these patients, 78% had unifocal lesions, and 22% had multifocal lesions.

The participants (aged 18-90 years) were recruited from six hospitals in Austria. All had histologically confirmed vHSIL with visible unifocal or multifocal lesions. Those with suspected invasive disease, a history of vulvar cancer or severe inflammatory dermatosis of the vulva, or who had undergone active treatment for vHSIL in the prior 3 months were excluded.

Imiquimod treatment was self-administered. The dose was slowly escalated to no more than three times per week for 4-6 months. Surgery involved either excision or ablation.

The team reports that 98 patients (of the 110 who were randomly assigned) completed the study: 46 in the imiquinod arm and 52 in the surgery arm.

Complete clinical response rates at 6 months were 80% with imiquimod versus 79% with surgery. No significant difference was observed between the groups with respect to HPV clearance, adverse events, and treatment satisfaction, the authors report.

“Long-term follow-up ... is ongoing and will assess the effect of treatment modality on recurrence rates,” the team comments.

Dr. Trutnovsky and colleagues recommend that patients with vHSIL be counseled regarding the potential benefits and risks of treatment options. “On the basis of our results, the oncological safety of imiquimod treatment can be assumed as long as regular clinical check-ups are carried out,” they write.

They also note that good patient compliance is important for treatment with imiquimod to be successful and that surgery might remain the treatment of choice for patients who may not be adherent to treatment.

“In all other women with vHSIL, imiquimod can be considered a first-line treatment option,” the authors conclude.

The study was funded by the Austrian Science Fund and Austrian Gynaecological Oncology group. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Imiquimod cream is a safe, effective, first-line alternative to surgery for the treatment of vulvar high-grade squamous intraepithelial lesions (vHSILs), suggest the results from the first randomized trial to compare the two approaches directly.

The findings provide women with human papillomavirus (HPV)–related precancerous lesions with a new treatment option that can circumvent drawbacks of surgery, according to first author Gerda Trutnovsky, MD, deputy head of the Division of Gynecology at the Medical University of Graz, Austria.

“Surgical removal of [vulvar intraepithelial neoplasia] can cause wound healing disorders, scarring, and even sexual complaints later on,” she explained in a press statement. Further, recurrences are common, and repeat surgeries are often necessary, she said.

The results from the trial show that “imiquimod cream was effective and well tolerated, and the rate of success of this treatment equaled that of surgery,” Dr. Trutnovsky said.

The study was published online in The Lancet.

The findings are of note because HPV vaccination rates remain low, and the incidence of both cervical and vulvar intraepithelial neoplasia has increased in recent years, particularly among younger women, the authors comment.
 

First head-to-head trial

For the trial, Dr. Trutnovsky and her colleagues randomly assigned 110 women with vHSIL to receive either imiquimod treatment or surgery between June 2013 and January 2020. Of these patients, 78% had unifocal lesions, and 22% had multifocal lesions.

The participants (aged 18-90 years) were recruited from six hospitals in Austria. All had histologically confirmed vHSIL with visible unifocal or multifocal lesions. Those with suspected invasive disease, a history of vulvar cancer or severe inflammatory dermatosis of the vulva, or who had undergone active treatment for vHSIL in the prior 3 months were excluded.

Imiquimod treatment was self-administered. The dose was slowly escalated to no more than three times per week for 4-6 months. Surgery involved either excision or ablation.

The team reports that 98 patients (of the 110 who were randomly assigned) completed the study: 46 in the imiquinod arm and 52 in the surgery arm.

Complete clinical response rates at 6 months were 80% with imiquimod versus 79% with surgery. No significant difference was observed between the groups with respect to HPV clearance, adverse events, and treatment satisfaction, the authors report.

“Long-term follow-up ... is ongoing and will assess the effect of treatment modality on recurrence rates,” the team comments.

Dr. Trutnovsky and colleagues recommend that patients with vHSIL be counseled regarding the potential benefits and risks of treatment options. “On the basis of our results, the oncological safety of imiquimod treatment can be assumed as long as regular clinical check-ups are carried out,” they write.

They also note that good patient compliance is important for treatment with imiquimod to be successful and that surgery might remain the treatment of choice for patients who may not be adherent to treatment.

“In all other women with vHSIL, imiquimod can be considered a first-line treatment option,” the authors conclude.

The study was funded by the Austrian Science Fund and Austrian Gynaecological Oncology group. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Imiquimod cream is a safe, effective, first-line alternative to surgery for the treatment of vulvar high-grade squamous intraepithelial lesions (vHSILs), suggest the results from the first randomized trial to compare the two approaches directly.

The findings provide women with human papillomavirus (HPV)–related precancerous lesions with a new treatment option that can circumvent drawbacks of surgery, according to first author Gerda Trutnovsky, MD, deputy head of the Division of Gynecology at the Medical University of Graz, Austria.

“Surgical removal of [vulvar intraepithelial neoplasia] can cause wound healing disorders, scarring, and even sexual complaints later on,” she explained in a press statement. Further, recurrences are common, and repeat surgeries are often necessary, she said.

The results from the trial show that “imiquimod cream was effective and well tolerated, and the rate of success of this treatment equaled that of surgery,” Dr. Trutnovsky said.

The study was published online in The Lancet.

The findings are of note because HPV vaccination rates remain low, and the incidence of both cervical and vulvar intraepithelial neoplasia has increased in recent years, particularly among younger women, the authors comment.
 

First head-to-head trial

For the trial, Dr. Trutnovsky and her colleagues randomly assigned 110 women with vHSIL to receive either imiquimod treatment or surgery between June 2013 and January 2020. Of these patients, 78% had unifocal lesions, and 22% had multifocal lesions.

The participants (aged 18-90 years) were recruited from six hospitals in Austria. All had histologically confirmed vHSIL with visible unifocal or multifocal lesions. Those with suspected invasive disease, a history of vulvar cancer or severe inflammatory dermatosis of the vulva, or who had undergone active treatment for vHSIL in the prior 3 months were excluded.

Imiquimod treatment was self-administered. The dose was slowly escalated to no more than three times per week for 4-6 months. Surgery involved either excision or ablation.

The team reports that 98 patients (of the 110 who were randomly assigned) completed the study: 46 in the imiquinod arm and 52 in the surgery arm.

Complete clinical response rates at 6 months were 80% with imiquimod versus 79% with surgery. No significant difference was observed between the groups with respect to HPV clearance, adverse events, and treatment satisfaction, the authors report.

“Long-term follow-up ... is ongoing and will assess the effect of treatment modality on recurrence rates,” the team comments.

Dr. Trutnovsky and colleagues recommend that patients with vHSIL be counseled regarding the potential benefits and risks of treatment options. “On the basis of our results, the oncological safety of imiquimod treatment can be assumed as long as regular clinical check-ups are carried out,” they write.

They also note that good patient compliance is important for treatment with imiquimod to be successful and that surgery might remain the treatment of choice for patients who may not be adherent to treatment.

“In all other women with vHSIL, imiquimod can be considered a first-line treatment option,” the authors conclude.

The study was funded by the Austrian Science Fund and Austrian Gynaecological Oncology group. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention updated its recommendations for doctors and public health officials regarding the unusual outbreak of acute hepatitis among children.

As of May 5, the CDC and state health departments are investigating 109 children with hepatitis of unknown origin across 25 states and territories.

More than half have tested positive for adenovirus, the CDC said. More than 90% have been hospitalized, and 14% have had liver transplants. Five deaths are under investigation.

This week’s CDC alert provides updated recommendations for testing, given the potential association between adenovirus infection and pediatric hepatitis, or liver inflammation.

“Clinicians are recommended to consider adenovirus testing for patients with hepatitis of unknown etiology and to report such cases to their state or jurisdictional public health authorities,” the CDC said.

Doctors should also consider collecting a blood sample, respiratory sample, and stool sample. They may also collect liver tissue if a biopsy occurred or an autopsy is available.

In November 2021, clinicians at a large children’s hospital in Alabama notified the CDC about five pediatric patients with significant liver injury, including three with acute liver failure, who also tested positive for adenovirus. All children were previously healthy, and none had COVID-19, according to a CDC alert in April.

Four additional pediatric patients with hepatitis and adenovirus infection were identified. After lab testing found adenovirus infection in all nine patients in the initial cluster, public health officials began investigating a possible association between pediatric hepatitis and adenovirus. Among the five specimens that could be sequenced, they were all adenovirus type 41.

Unexplained hepatitis cases have been reported in children worldwide, reaching 450 cases and 11 deaths, according to the latest update from the European Centre for Disease Prevention and Control.

The cases have been reported in more than two dozen countries around the world, with 14 countries reporting more than five cases. The United Kingdom and the United States have reported the largest case counts so far.

In the United Kingdom, officials have identified 163 cases in children under age 16 years, including 11 that required liver transplants.

In the European Union, 14 countries have reported 106 cases collectively, with Italy reporting 35 cases and Spain reporting 22 cases. Outside of the European Union, Brazil has reported 16, Indonesia has reported 15, and Israel has reported 12.

Among the 11 deaths reported globally, the Uniyed States has reported five, Indonesia has reported five, and Palestine has reported one.

The cause of severe hepatitis remains a mystery, according to Ars Technica. Some cases have been identified retrospectively, dating back to the beginning of October 2021.

About 70% of the cases that have been tested for an adenovirus have tested positive, and subtype testing continues to show adenovirus type 41. The cases don’t appear to be linked to common causes, such as hepatitis viruses A, B, C, D, or E, which can cause liver inflammation and injury.

Adenoviruses aren’t known to cause hepatitis in healthy children, though the viruses have been linked to liver damage in children with compromised immune systems, according to Ars Technica. Adenoviruses typically cause respiratory infections in children, although type 41 tends to cause gastrointestinal illness.

“At present, the leading hypotheses remain those which involve adenovirus,” Philippa Easterbrook, a senior scientist at the WHO, said May 10 during a press briefing.

“I think [there’s] also still an important consideration about the role of COVID as well, either as a co-infection or as a past infection,” she said.

WHO officials expect data within a week from U.K. cases, Ms. Easterbrook said, which may indicate whether the adenovirus is an incidental infection or a more direct cause.

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention updated its recommendations for doctors and public health officials regarding the unusual outbreak of acute hepatitis among children.

As of May 5, the CDC and state health departments are investigating 109 children with hepatitis of unknown origin across 25 states and territories.

More than half have tested positive for adenovirus, the CDC said. More than 90% have been hospitalized, and 14% have had liver transplants. Five deaths are under investigation.

This week’s CDC alert provides updated recommendations for testing, given the potential association between adenovirus infection and pediatric hepatitis, or liver inflammation.

“Clinicians are recommended to consider adenovirus testing for patients with hepatitis of unknown etiology and to report such cases to their state or jurisdictional public health authorities,” the CDC said.

Doctors should also consider collecting a blood sample, respiratory sample, and stool sample. They may also collect liver tissue if a biopsy occurred or an autopsy is available.

In November 2021, clinicians at a large children’s hospital in Alabama notified the CDC about five pediatric patients with significant liver injury, including three with acute liver failure, who also tested positive for adenovirus. All children were previously healthy, and none had COVID-19, according to a CDC alert in April.

Four additional pediatric patients with hepatitis and adenovirus infection were identified. After lab testing found adenovirus infection in all nine patients in the initial cluster, public health officials began investigating a possible association between pediatric hepatitis and adenovirus. Among the five specimens that could be sequenced, they were all adenovirus type 41.

Unexplained hepatitis cases have been reported in children worldwide, reaching 450 cases and 11 deaths, according to the latest update from the European Centre for Disease Prevention and Control.

The cases have been reported in more than two dozen countries around the world, with 14 countries reporting more than five cases. The United Kingdom and the United States have reported the largest case counts so far.

In the United Kingdom, officials have identified 163 cases in children under age 16 years, including 11 that required liver transplants.

In the European Union, 14 countries have reported 106 cases collectively, with Italy reporting 35 cases and Spain reporting 22 cases. Outside of the European Union, Brazil has reported 16, Indonesia has reported 15, and Israel has reported 12.

Among the 11 deaths reported globally, the Uniyed States has reported five, Indonesia has reported five, and Palestine has reported one.

The cause of severe hepatitis remains a mystery, according to Ars Technica. Some cases have been identified retrospectively, dating back to the beginning of October 2021.

About 70% of the cases that have been tested for an adenovirus have tested positive, and subtype testing continues to show adenovirus type 41. The cases don’t appear to be linked to common causes, such as hepatitis viruses A, B, C, D, or E, which can cause liver inflammation and injury.

Adenoviruses aren’t known to cause hepatitis in healthy children, though the viruses have been linked to liver damage in children with compromised immune systems, according to Ars Technica. Adenoviruses typically cause respiratory infections in children, although type 41 tends to cause gastrointestinal illness.

“At present, the leading hypotheses remain those which involve adenovirus,” Philippa Easterbrook, a senior scientist at the WHO, said May 10 during a press briefing.

“I think [there’s] also still an important consideration about the role of COVID as well, either as a co-infection or as a past infection,” she said.

WHO officials expect data within a week from U.K. cases, Ms. Easterbrook said, which may indicate whether the adenovirus is an incidental infection or a more direct cause.

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention updated its recommendations for doctors and public health officials regarding the unusual outbreak of acute hepatitis among children.

As of May 5, the CDC and state health departments are investigating 109 children with hepatitis of unknown origin across 25 states and territories.

More than half have tested positive for adenovirus, the CDC said. More than 90% have been hospitalized, and 14% have had liver transplants. Five deaths are under investigation.

This week’s CDC alert provides updated recommendations for testing, given the potential association between adenovirus infection and pediatric hepatitis, or liver inflammation.

“Clinicians are recommended to consider adenovirus testing for patients with hepatitis of unknown etiology and to report such cases to their state or jurisdictional public health authorities,” the CDC said.

Doctors should also consider collecting a blood sample, respiratory sample, and stool sample. They may also collect liver tissue if a biopsy occurred or an autopsy is available.

In November 2021, clinicians at a large children’s hospital in Alabama notified the CDC about five pediatric patients with significant liver injury, including three with acute liver failure, who also tested positive for adenovirus. All children were previously healthy, and none had COVID-19, according to a CDC alert in April.

Four additional pediatric patients with hepatitis and adenovirus infection were identified. After lab testing found adenovirus infection in all nine patients in the initial cluster, public health officials began investigating a possible association between pediatric hepatitis and adenovirus. Among the five specimens that could be sequenced, they were all adenovirus type 41.

Unexplained hepatitis cases have been reported in children worldwide, reaching 450 cases and 11 deaths, according to the latest update from the European Centre for Disease Prevention and Control.

The cases have been reported in more than two dozen countries around the world, with 14 countries reporting more than five cases. The United Kingdom and the United States have reported the largest case counts so far.

In the United Kingdom, officials have identified 163 cases in children under age 16 years, including 11 that required liver transplants.

In the European Union, 14 countries have reported 106 cases collectively, with Italy reporting 35 cases and Spain reporting 22 cases. Outside of the European Union, Brazil has reported 16, Indonesia has reported 15, and Israel has reported 12.

Among the 11 deaths reported globally, the Uniyed States has reported five, Indonesia has reported five, and Palestine has reported one.

The cause of severe hepatitis remains a mystery, according to Ars Technica. Some cases have been identified retrospectively, dating back to the beginning of October 2021.

About 70% of the cases that have been tested for an adenovirus have tested positive, and subtype testing continues to show adenovirus type 41. The cases don’t appear to be linked to common causes, such as hepatitis viruses A, B, C, D, or E, which can cause liver inflammation and injury.

Adenoviruses aren’t known to cause hepatitis in healthy children, though the viruses have been linked to liver damage in children with compromised immune systems, according to Ars Technica. Adenoviruses typically cause respiratory infections in children, although type 41 tends to cause gastrointestinal illness.

“At present, the leading hypotheses remain those which involve adenovirus,” Philippa Easterbrook, a senior scientist at the WHO, said May 10 during a press briefing.

“I think [there’s] also still an important consideration about the role of COVID as well, either as a co-infection or as a past infection,” she said.

WHO officials expect data within a week from U.K. cases, Ms. Easterbrook said, which may indicate whether the adenovirus is an incidental infection or a more direct cause.

A version of this article first appeared on Medscape.com.

It was such a pleasure at the 48th Annual Meeting of the Society of Gynecologic Surgeons (SGS) to witness record meeting attendance and strong enthusiasm after 2 depressing years with the COVID-19 pandemic. Evidently, everyone was tired of virtual gatherings and presentations. As a dedicated surgical educator and a passionate vaginal surgeon, SGS President Carl Zimmerman, MD, chose “Gynecologic surgery training: Lessons from the past, looking to the future” as the theme for this year’s meeting. Our keynote speakers, Patricia Turner, MD, MBA, Executive Director of the American College of Surgeons, and Marta Crispens, MD, MBA, Professor and Division Director of Gynecologic Oncology at Vanderbilt, were spot on. They reviewed the current status of surgical training eloquently with convincing statistics. They mapped out the path forward by stressing collaboration and proposing strategies that might produce competent surgeons in all fields.

The meeting featured 2 panel discussions. The first, titled “Innovations in training gynecologic surgeons,” reviewed tracking in residency, use of simulation for surgical proficiency, and European perspective on training. The panelists emphasized the dwindling numbers of surgical procedures, especially vaginal hysterectomies. Cecile Ferrando, MD, suggested that tracking might be part of the answer, based on their experience, which provided a structure for residents to obtain concentrated training in their areas of interest. Douglas Miyazaki, MD, presented the prospects for his innovative, federally funded vaginal surgery simulation model. Oliver Preyer, MD, presented Austrian trainees’ low case volumes, showing that the grass was not actually greener on the other side. Finally, this panel reinvigorated ongoing debate about separating Obstetrics and Gynecology.

The second panel, “Operating room safety and efficiency,” shed light on human and nontechnical factors that might be as critical as surgeons’ skills and experience, and it highlighted an innovative technology that monitored and analyzed all operating room parameters to improve operational processes and surgical technique. Points by Jason Wright, MD, on the relationship between surgical volume and outcomes complemented the meeting theme and the first panel discussion. He underlined how much surgical volume of individual surgeons and hospitals mattered, but he also indicated that restrictive credentialing strategies might lead to unintended consequences.

Importantly, the SGS Women’s Council held a panel on the “Impact of Texas legislation on the physician/patient relationship” to provide a platform for members who had mixed feelings about attending this meeting in Texas.

The SGS meeting also included several popular postgraduate courses on multidisciplinary management of Müllerian anomalies, pelvic fistula treatment, surgical simulation, management modalities for uterine fibroids, and medical innovation and entrepreneurship. In this special section and in the next issue of OBG Management, several of these topics are presented.

It was such a pleasure at the 48th Annual Meeting of the Society of Gynecologic Surgeons (SGS) to witness record meeting attendance and strong enthusiasm after 2 depressing years with the COVID-19 pandemic. Evidently, everyone was tired of virtual gatherings and presentations. As a dedicated surgical educator and a passionate vaginal surgeon, SGS President Carl Zimmerman, MD, chose “Gynecologic surgery training: Lessons from the past, looking to the future” as the theme for this year’s meeting. Our keynote speakers, Patricia Turner, MD, MBA, Executive Director of the American College of Surgeons, and Marta Crispens, MD, MBA, Professor and Division Director of Gynecologic Oncology at Vanderbilt, were spot on. They reviewed the current status of surgical training eloquently with convincing statistics. They mapped out the path forward by stressing collaboration and proposing strategies that might produce competent surgeons in all fields.

The meeting featured 2 panel discussions. The first, titled “Innovations in training gynecologic surgeons,” reviewed tracking in residency, use of simulation for surgical proficiency, and European perspective on training. The panelists emphasized the dwindling numbers of surgical procedures, especially vaginal hysterectomies. Cecile Ferrando, MD, suggested that tracking might be part of the answer, based on their experience, which provided a structure for residents to obtain concentrated training in their areas of interest. Douglas Miyazaki, MD, presented the prospects for his innovative, federally funded vaginal surgery simulation model. Oliver Preyer, MD, presented Austrian trainees’ low case volumes, showing that the grass was not actually greener on the other side. Finally, this panel reinvigorated ongoing debate about separating Obstetrics and Gynecology.

The second panel, “Operating room safety and efficiency,” shed light on human and nontechnical factors that might be as critical as surgeons’ skills and experience, and it highlighted an innovative technology that monitored and analyzed all operating room parameters to improve operational processes and surgical technique. Points by Jason Wright, MD, on the relationship between surgical volume and outcomes complemented the meeting theme and the first panel discussion. He underlined how much surgical volume of individual surgeons and hospitals mattered, but he also indicated that restrictive credentialing strategies might lead to unintended consequences.

Importantly, the SGS Women’s Council held a panel on the “Impact of Texas legislation on the physician/patient relationship” to provide a platform for members who had mixed feelings about attending this meeting in Texas.

The SGS meeting also included several popular postgraduate courses on multidisciplinary management of Müllerian anomalies, pelvic fistula treatment, surgical simulation, management modalities for uterine fibroids, and medical innovation and entrepreneurship. In this special section and in the next issue of OBG Management, several of these topics are presented.

It was such a pleasure at the 48th Annual Meeting of the Society of Gynecologic Surgeons (SGS) to witness record meeting attendance and strong enthusiasm after 2 depressing years with the COVID-19 pandemic. Evidently, everyone was tired of virtual gatherings and presentations. As a dedicated surgical educator and a passionate vaginal surgeon, SGS President Carl Zimmerman, MD, chose “Gynecologic surgery training: Lessons from the past, looking to the future” as the theme for this year’s meeting. Our keynote speakers, Patricia Turner, MD, MBA, Executive Director of the American College of Surgeons, and Marta Crispens, MD, MBA, Professor and Division Director of Gynecologic Oncology at Vanderbilt, were spot on. They reviewed the current status of surgical training eloquently with convincing statistics. They mapped out the path forward by stressing collaboration and proposing strategies that might produce competent surgeons in all fields.

The meeting featured 2 panel discussions. The first, titled “Innovations in training gynecologic surgeons,” reviewed tracking in residency, use of simulation for surgical proficiency, and European perspective on training. The panelists emphasized the dwindling numbers of surgical procedures, especially vaginal hysterectomies. Cecile Ferrando, MD, suggested that tracking might be part of the answer, based on their experience, which provided a structure for residents to obtain concentrated training in their areas of interest. Douglas Miyazaki, MD, presented the prospects for his innovative, federally funded vaginal surgery simulation model. Oliver Preyer, MD, presented Austrian trainees’ low case volumes, showing that the grass was not actually greener on the other side. Finally, this panel reinvigorated ongoing debate about separating Obstetrics and Gynecology.

The second panel, “Operating room safety and efficiency,” shed light on human and nontechnical factors that might be as critical as surgeons’ skills and experience, and it highlighted an innovative technology that monitored and analyzed all operating room parameters to improve operational processes and surgical technique. Points by Jason Wright, MD, on the relationship between surgical volume and outcomes complemented the meeting theme and the first panel discussion. He underlined how much surgical volume of individual surgeons and hospitals mattered, but he also indicated that restrictive credentialing strategies might lead to unintended consequences.

Importantly, the SGS Women’s Council held a panel on the “Impact of Texas legislation on the physician/patient relationship” to provide a platform for members who had mixed feelings about attending this meeting in Texas.

The SGS meeting also included several popular postgraduate courses on multidisciplinary management of Müllerian anomalies, pelvic fistula treatment, surgical simulation, management modalities for uterine fibroids, and medical innovation and entrepreneurship. In this special section and in the next issue of OBG Management, several of these topics are presented.

Vaginal surgery, including vaginal hysterectomy, is slowly becoming a dying art. According to the National Inpatient Sample and the Nationwide Ambulatory Surgery Sample from 2018, only 11.8% of all hysterectomies were performed vaginally.¹ The combination of uterine-sparing surgeries, advances in conservative therapies for benign uterine conditions, and the diversification of minimally invasive routes (laparoscopic and robotic) has resulted in a continued downtrend in vaginal surgical volumes. This shift has led to fewer operative learning opportunities and declining graduating resident surgical volume.² According to the Accreditation Council for Graduate Medical Education (ACGME), the minimum number of vaginal hysterectomies is 15, which represents only the minimum accepted exposure and does not imply competency.

In response, surgical simulation has been used for skill acquisition and maintenance outside of the operating room in a learning environment that is safe for the learners and does not expose patients to additional risk. Educators are uniquely poised to use simulation to teach residents and to evaluate their procedural competency. Although vaginal surgery, specifically vaginal hysterectomy, continues to decline, it can be resuscitated with the assistance of surgical simulation.

In this article, we provide a broad overview of vaginal surgical simulation. We discuss the basic tenets of simulation, review how to teach and evaluate vaginal surgical skills, and present some of the commonly available vaginal surgery simulation models and their associated resources, cost, setup time, fidelity, and limitations.

Simulation principles relevant for vaginal hysterectomy simulation

Here, we review simulation-based learning principles that will help place specific simulation models into perspective.

One size does not fit all

Simulation, like many educational interventions, does not work via a “one-size-fits-all” approach. While the American College of Obstetricians and Gynecologists (ACOG) Simulations Working Group (SWG) has created a toolkit (available online at https://www.acog.org/education-and-events/simulations/about/curriculum) with many ready-to-use how-to simulation descriptions and lesson plans that cover common topics, what works in one setting may not work in another. The SWG created those modules to help educators save time and resources and to avoid reinventing the wheel for each simulation session. However, these simulations need to be adapted to the local needs of trainees and resources, such as faculty time, space, models, and funding.

Cost vs fidelity

It is important to distinguish between cost and fidelity. “Low cost” is often incorrectly used interchangeably with “low fidelity” when referring to models and simulations. The most basic principle of fidelity is that it is associated with situational realism that in turn, drives learning.^3,4 For example, the term high fidelity does apply to a virtual reality robotic surgery simulator, which also is high cost. However, a low-cost beef tongue model of fourth-degree laceration⁵ is high fidelity, while more expensive commercial models are less realistic, which makes them high cost and low fidelity.⁶ When selecting simulation models, educators need to consider cost based on their available resources and the level of fidelity needed for their learners.

Continue to: Task breakdown...

Task breakdown

As surgeon-educators, we love to teach! And while educators are passionate about imparting vaginal hysterectomy skills to the next generation of surgeons, it is important to assess where the learners are technically. Vaginal hysterectomy is a high-complexity procedure, with each step involving a unique skill set that is new to residents as learners; this is where the science of learning can help us teach more effectively.⁷ Focusing on doing the entire procedure all at once is more likely to result in cognitive overload, while a better approach is to break the procedure down into several components and practice those parts until goal proficiency is reached.

Deliberate practice

The idea of deliberate practice was popularized by Malcolm Gladwell in his book titled Outliers, in which he gives examples of how 10,000 hours of practice leads to mastery of complex skills. This concept was deepened by the work of cognitive psychologist Anders Ericsson, who emphasized that not only the duration but also the quality of practice—which involves concentration, analysis, and problem-solving—leads to the most effective training.⁸

In surgical education, this concept translates into many domains. For example, an individualized learning plan includes frequent low-stakes assessments, video recording for later viewing and analysis, surgical coaching, and detailed planning of future training sessions to incorporate past performance. “Just doing” surgery on a simulator (or in the operating room) results in missed learning opportunities.

Logistics and implementation: Who, where, when

The simulation “formula” takes into account multiple factors but should start with learning objectives and then an assessment of what resources are available to address them. For example, if one surgeon-educator and one resident-learner are available for 30 minutes in between cases in the operating room, and the goal is to teach the resident clamp-and-tie technique on pedicles, the “milk carton” model⁹ and a few instruments from the vaginal hysterectomy tray are ideal for this training. On the other hand, if it is important to achieve competency for an entire procedure prior to operating room debut and a group of surgeon-educators is available to share the time commitment of 2-hour sessions per each resident, then the PROMPT (PRactical Obstetric Multi-Professional Training) shoulder dystocia model could be used (TABLE).^10-14

Learning curves

Ideally, educators would like to know how many simulated training sessions are needed for a learner to reach a proficiency level and become operating room ready. Such information about learning curves, unfortunately, is not available yet for vaginal hysterectomies. The first step in the process is to establish a baseline for performance to know a starting point, with assessment tools specific to each simulator; the next step is to study how many “takes” are needed for learners to move through their learning curve.¹⁵ The use of assessment tools can help assess each learner’s progression.

Continue to: Evaluation, assessment, and feedback...

With more emphasis being placed on patient safety and transparency in every aspect of health care, including surgical training, graduate medical education leaders increasingly highlight the importance of objective assessment tools and outcome-based standards for certification of competency in surgery.^16,17 Commonly used assessment tools that have reliability and validity evidence include surgical checklists and global rating scales. Checklists for common gynecologic procedures, including vaginal hysterectomy, as well as a global rating scale specifically developed for vaginal surgery (Vaginal Surgical Skills Index, VSSI)¹⁸ are accessible on the ACOG Simulations Working Group Surgical Curriculum in Obstetrics and Gynecology website.¹⁹

While checklists contain the main steps of each procedure, these lists do not assess for how well each step of the procedure is performed. By contrast, global rating scales, such as the VSSI, can discriminate between surgeons with different skill levels both in the simulation and operating room settings; each metric within the global rating scale (for example, time and motion) does not pertain to the performance of a procedure’s specific step but rather to the overall performance of the entire procedure.^18,20 Hence, to provide detailed feedback, especially for formative assessment, both checklists and global rating scales often are used together.

Although standardized, checklists and global rating scales ultimately are still subjective (not objective) assessment tools. Recently, more attention has been to use surgical data science, particularly artificial intelligence methods, to objectively assess surgical performance by analyzing data generated during the performance of surgery, such as instrumental motion and video.²¹ These methods have been applied to a wide range of surgical techniques, including open, laparoscopic, robotic, endoscopic, and microsurgical approaches. Most of these types of studies have used assessment of surgical skill as the main outcome, with fewer studies correlating skill with clinically relevant metrics, such as patient outcomes.^22-25 Although this is an area of active research, these methods are still being developed, and their validity and utility are not well established. For now, educators should continue to use validated checklists and global rating skills to help assess any type of surgical performance, particularly vaginal surgery.

Vaginal surgical simulation models

Vaginal surgery requires a surgeon to operate in a narrow, deep space. This requires ambidexterity, accurate depth perception, understanding of how to handle tissues, and use of movements that are efficient, fluid, and rhythmic. Multiple proposed simulation models are relevant to vaginal surgery, and these vary based on level of fidelity, cost, feasibility, ability to maintain standardization, ease of construction (if required), and generalizability to all of pelvic surgery (that is, procedure specific vs basic skills focused).^{10,11,13,26-31}

Below, we describe various simulation models that are available for teaching vaginal surgical skills.

Vaginal hysterectomy simulation model

One commercially available simulation model for vaginal hysterectomy (as well as other vaginal surgical procedures, such as midurethral sling and anterior and posterior colporrhaphy) is the Miya Model (Miyazaki Enterprises) (FIGURE 1) and its accompanying MiyaMODEL App. In a multi-institutional study funded by the National Institutes of Health (NIH), the Miya Model, when used with the VSSI, was shown to be a valid assessment tool in terms of ability to differentiate a competent from a noncompetent surgeon.²⁰ Currently, an ongoing NIH-sponsored multi-institutional study is assessing the Miya Model as a teaching tool and whether skills acquired on the Miya Model are transferable to the operating room.

Continue to: Low-cost vaginal hysterectomy models...

Multiple low-cost vaginal hysterectomy simulation models are described. Two models developed many years ago include the ACOG SWG flowerpot model¹⁴ and the PROMPT shoulder dystocia pelvic trainer model.^10,11,14 The former model is low cost as it can be constructed from easily obtained household materials, but its downside is that it takes time and effort to obtain the materials and to assemble them. The latter model is faster to assemble but requires one to use a PROMPT pelvis for shoulder dystocia training, which has a considerable upfront cost. However, it is available in most hospitals with considerable obstetrical volume, and it allows for the most realistic perineum, which is helpful in recreating the feel of vaginal surgery, including retraction and exposure.

Many models created and described in the literature are variations of the models mentioned above, and many use commercially available low-cost bony pelvis models and polyvinyl chloride (PVC) pipes as a foundation for the soft tissue inserts to attach.^12,13,31-33 Each model varies on what it “teaches best” regarding realism—for example, teaching anatomy, working in a tight space, dissection, or clamp placement and suture ligature.

Furthermore, since vaginal hysterectomy is a high-complexity procedure in terms of skills (working in confined space, limited view, “upside-down” anatomy, and need to direct assistants for retraction and exposure), task breakdown is important for simulation learning, as it is not efficient to repeat the entire procedure until proficiency is reached. Two trainers have been described to address that need: the milk carton and the vaginal suturing trainer. The latter allows learners to practice clamp placement and pedicle ligation multiple times, including in confined space (FIGURE 2), and the former allows them to do the same in a procedural matter as the clamp placement moves caudad to cephalad during the procedure (FIGURE 3).

Native tissue pelvic floor surgery simulation

While there are few publications regarding surgical simulation models for native tissue pelvic floor surgeries, a low-cost anterior and posterior repair model was developed for the ACOG SWG Simulation Toolkit and published online in 2017, after their peer-review process. The fidelity is moderate for this low-cost model, which costs less than $5 per use. The simulation model requires a new vaginal insert for each learner, which is fast and easy to make and requires only a few components; however, the bony pelvis (for example, the flowerpot model) needs to be purchased or created. The stage of the anterior wall prolapse can be adjusted by the amount of fluid placed in the balloon, which is used to simulate the bladder. The more fluid that is placed in the “bladder,” the more severe the anterior wall prolapse appears. The vaginal caliber can be adjusted, if needed, by increasing or decreasing the size of the components to create the vagina, but the suggested sizes simulate a significantly widened vaginal caliber that would benefit from a posterior repair with perineorrhaphy. Although there is no validity evidence for this model, a skills assessment is available through the ACOG Simulation Surgical Curriculum. Of note, native tissue colpopexy repairs are also possible with this model (or another high-fidelity model, such as the Miya Model), if the sacrospinous ligaments and/or uterosacral ligaments are available on the pelvic model in use. This model’s limitations include the absence of a high-fidelity plane of dissection of the vaginal muscularis, and that no bleeding is encountered, which is the case for many low-cost models.^19,34

Fundamentals of Vaginal Surgery (FVS) basic surgical skills simulation

The FVS simulation system, consisting of a task trainer paired with 6 selected surgical tasks, was developed to teach basic skills used in vaginal surgery.³⁵ The FVS task trainer is 3D printed and has 3 main components: a base piece that allows for different surgical materials to be secured, a depth extender, and a width reducer. In addition, it has a mobile phone mount and a window into the system to enable video capture of skills exercises.

The FVS simulator is designed to enable 6 surgical tasks, including one-handed knot tying, two-handed knot tying, running suturing, plication suturing, Heaney transfixion pedicle ligation, and free pedicle ligation (FIGURE 4). In a pilot study, the FVS simulation system was deemed representative of the intended surgical field, useful for inclusion in a training program, and favored as a tool for both training and testing. Additionally, an initial proficiency score of 400 was set, which discriminated between novice and expert surgeons.³⁵

An advantage of this simulation system is that it allows learners to focus on basic skills, rather than on an entire specific procedure. Further, the system is standardized, as it is commercially manufactured; this also allows for easy assembly. The disadvantage of this model is that it cannot be modified to teach specific vaginal procedures, and it must be purchased, rather than constructed on site. Further studies are needed to create generalizable proficiency scores and to assess its use in training and testing. For more information on the FVS simulation model, visit the Arbor Simulation website (http://arborsim.com).

Surgical simulation’s important role

Surgical skills can be learned and improved in the simulation setting in a low-stakes, low-pressure environment. Simulation can enable basic skills development and then higher-level learning of complex procedures. Skill assessment is important to aid in learning (via formative assessments) and for examination or certification (summative assessments).

With decreasing vaginal surgical volumes occurring nationally, it is becoming even more important to use surgical simulation to teach and maintain vaginal surgical skills. In this article, we reviewed various different simulation models that can be used for developing vaginal surgical skills and presented the advantages, limitations, and resources relevant for each simulation model. ●

Vaginal surgery, including vaginal hysterectomy, is slowly becoming a dying art. According to the National Inpatient Sample and the Nationwide Ambulatory Surgery Sample from 2018, only 11.8% of all hysterectomies were performed vaginally.¹ The combination of uterine-sparing surgeries, advances in conservative therapies for benign uterine conditions, and the diversification of minimally invasive routes (laparoscopic and robotic) has resulted in a continued downtrend in vaginal surgical volumes. This shift has led to fewer operative learning opportunities and declining graduating resident surgical volume.² According to the Accreditation Council for Graduate Medical Education (ACGME), the minimum number of vaginal hysterectomies is 15, which represents only the minimum accepted exposure and does not imply competency.

In response, surgical simulation has been used for skill acquisition and maintenance outside of the operating room in a learning environment that is safe for the learners and does not expose patients to additional risk. Educators are uniquely poised to use simulation to teach residents and to evaluate their procedural competency. Although vaginal surgery, specifically vaginal hysterectomy, continues to decline, it can be resuscitated with the assistance of surgical simulation.

In this article, we provide a broad overview of vaginal surgical simulation. We discuss the basic tenets of simulation, review how to teach and evaluate vaginal surgical skills, and present some of the commonly available vaginal surgery simulation models and their associated resources, cost, setup time, fidelity, and limitations.

Simulation principles relevant for vaginal hysterectomy simulation

Here, we review simulation-based learning principles that will help place specific simulation models into perspective.

One size does not fit all

Simulation, like many educational interventions, does not work via a “one-size-fits-all” approach. While the American College of Obstetricians and Gynecologists (ACOG) Simulations Working Group (SWG) has created a toolkit (available online at https://www.acog.org/education-and-events/simulations/about/curriculum) with many ready-to-use how-to simulation descriptions and lesson plans that cover common topics, what works in one setting may not work in another. The SWG created those modules to help educators save time and resources and to avoid reinventing the wheel for each simulation session. However, these simulations need to be adapted to the local needs of trainees and resources, such as faculty time, space, models, and funding.

Cost vs fidelity

It is important to distinguish between cost and fidelity. “Low cost” is often incorrectly used interchangeably with “low fidelity” when referring to models and simulations. The most basic principle of fidelity is that it is associated with situational realism that in turn, drives learning.^3,4 For example, the term high fidelity does apply to a virtual reality robotic surgery simulator, which also is high cost. However, a low-cost beef tongue model of fourth-degree laceration⁵ is high fidelity, while more expensive commercial models are less realistic, which makes them high cost and low fidelity.⁶ When selecting simulation models, educators need to consider cost based on their available resources and the level of fidelity needed for their learners.

Continue to: Task breakdown...

Task breakdown

As surgeon-educators, we love to teach! And while educators are passionate about imparting vaginal hysterectomy skills to the next generation of surgeons, it is important to assess where the learners are technically. Vaginal hysterectomy is a high-complexity procedure, with each step involving a unique skill set that is new to residents as learners; this is where the science of learning can help us teach more effectively.⁷ Focusing on doing the entire procedure all at once is more likely to result in cognitive overload, while a better approach is to break the procedure down into several components and practice those parts until goal proficiency is reached.

Deliberate practice

The idea of deliberate practice was popularized by Malcolm Gladwell in his book titled Outliers, in which he gives examples of how 10,000 hours of practice leads to mastery of complex skills. This concept was deepened by the work of cognitive psychologist Anders Ericsson, who emphasized that not only the duration but also the quality of practice—which involves concentration, analysis, and problem-solving—leads to the most effective training.⁸

In surgical education, this concept translates into many domains. For example, an individualized learning plan includes frequent low-stakes assessments, video recording for later viewing and analysis, surgical coaching, and detailed planning of future training sessions to incorporate past performance. “Just doing” surgery on a simulator (or in the operating room) results in missed learning opportunities.

Logistics and implementation: Who, where, when

The simulation “formula” takes into account multiple factors but should start with learning objectives and then an assessment of what resources are available to address them. For example, if one surgeon-educator and one resident-learner are available for 30 minutes in between cases in the operating room, and the goal is to teach the resident clamp-and-tie technique on pedicles, the “milk carton” model⁹ and a few instruments from the vaginal hysterectomy tray are ideal for this training. On the other hand, if it is important to achieve competency for an entire procedure prior to operating room debut and a group of surgeon-educators is available to share the time commitment of 2-hour sessions per each resident, then the PROMPT (PRactical Obstetric Multi-Professional Training) shoulder dystocia model could be used (TABLE).^10-14

Learning curves

Ideally, educators would like to know how many simulated training sessions are needed for a learner to reach a proficiency level and become operating room ready. Such information about learning curves, unfortunately, is not available yet for vaginal hysterectomies. The first step in the process is to establish a baseline for performance to know a starting point, with assessment tools specific to each simulator; the next step is to study how many “takes” are needed for learners to move through their learning curve.¹⁵ The use of assessment tools can help assess each learner’s progression.

Continue to: Evaluation, assessment, and feedback...

With more emphasis being placed on patient safety and transparency in every aspect of health care, including surgical training, graduate medical education leaders increasingly highlight the importance of objective assessment tools and outcome-based standards for certification of competency in surgery.^16,17 Commonly used assessment tools that have reliability and validity evidence include surgical checklists and global rating scales. Checklists for common gynecologic procedures, including vaginal hysterectomy, as well as a global rating scale specifically developed for vaginal surgery (Vaginal Surgical Skills Index, VSSI)¹⁸ are accessible on the ACOG Simulations Working Group Surgical Curriculum in Obstetrics and Gynecology website.¹⁹

While checklists contain the main steps of each procedure, these lists do not assess for how well each step of the procedure is performed. By contrast, global rating scales, such as the VSSI, can discriminate between surgeons with different skill levels both in the simulation and operating room settings; each metric within the global rating scale (for example, time and motion) does not pertain to the performance of a procedure’s specific step but rather to the overall performance of the entire procedure.^18,20 Hence, to provide detailed feedback, especially for formative assessment, both checklists and global rating scales often are used together.

Although standardized, checklists and global rating scales ultimately are still subjective (not objective) assessment tools. Recently, more attention has been to use surgical data science, particularly artificial intelligence methods, to objectively assess surgical performance by analyzing data generated during the performance of surgery, such as instrumental motion and video.²¹ These methods have been applied to a wide range of surgical techniques, including open, laparoscopic, robotic, endoscopic, and microsurgical approaches. Most of these types of studies have used assessment of surgical skill as the main outcome, with fewer studies correlating skill with clinically relevant metrics, such as patient outcomes.^22-25 Although this is an area of active research, these methods are still being developed, and their validity and utility are not well established. For now, educators should continue to use validated checklists and global rating skills to help assess any type of surgical performance, particularly vaginal surgery.

Vaginal surgical simulation models

Vaginal surgery requires a surgeon to operate in a narrow, deep space. This requires ambidexterity, accurate depth perception, understanding of how to handle tissues, and use of movements that are efficient, fluid, and rhythmic. Multiple proposed simulation models are relevant to vaginal surgery, and these vary based on level of fidelity, cost, feasibility, ability to maintain standardization, ease of construction (if required), and generalizability to all of pelvic surgery (that is, procedure specific vs basic skills focused).^{10,11,13,26-31}

Below, we describe various simulation models that are available for teaching vaginal surgical skills.

Vaginal hysterectomy simulation model

One commercially available simulation model for vaginal hysterectomy (as well as other vaginal surgical procedures, such as midurethral sling and anterior and posterior colporrhaphy) is the Miya Model (Miyazaki Enterprises) (FIGURE 1) and its accompanying MiyaMODEL App. In a multi-institutional study funded by the National Institutes of Health (NIH), the Miya Model, when used with the VSSI, was shown to be a valid assessment tool in terms of ability to differentiate a competent from a noncompetent surgeon.²⁰ Currently, an ongoing NIH-sponsored multi-institutional study is assessing the Miya Model as a teaching tool and whether skills acquired on the Miya Model are transferable to the operating room.

Continue to: Low-cost vaginal hysterectomy models...

Multiple low-cost vaginal hysterectomy simulation models are described. Two models developed many years ago include the ACOG SWG flowerpot model¹⁴ and the PROMPT shoulder dystocia pelvic trainer model.^10,11,14 The former model is low cost as it can be constructed from easily obtained household materials, but its downside is that it takes time and effort to obtain the materials and to assemble them. The latter model is faster to assemble but requires one to use a PROMPT pelvis for shoulder dystocia training, which has a considerable upfront cost. However, it is available in most hospitals with considerable obstetrical volume, and it allows for the most realistic perineum, which is helpful in recreating the feel of vaginal surgery, including retraction and exposure.

Many models created and described in the literature are variations of the models mentioned above, and many use commercially available low-cost bony pelvis models and polyvinyl chloride (PVC) pipes as a foundation for the soft tissue inserts to attach.^12,13,31-33 Each model varies on what it “teaches best” regarding realism—for example, teaching anatomy, working in a tight space, dissection, or clamp placement and suture ligature.

Furthermore, since vaginal hysterectomy is a high-complexity procedure in terms of skills (working in confined space, limited view, “upside-down” anatomy, and need to direct assistants for retraction and exposure), task breakdown is important for simulation learning, as it is not efficient to repeat the entire procedure until proficiency is reached. Two trainers have been described to address that need: the milk carton and the vaginal suturing trainer. The latter allows learners to practice clamp placement and pedicle ligation multiple times, including in confined space (FIGURE 2), and the former allows them to do the same in a procedural matter as the clamp placement moves caudad to cephalad during the procedure (FIGURE 3).

Native tissue pelvic floor surgery simulation

While there are few publications regarding surgical simulation models for native tissue pelvic floor surgeries, a low-cost anterior and posterior repair model was developed for the ACOG SWG Simulation Toolkit and published online in 2017, after their peer-review process. The fidelity is moderate for this low-cost model, which costs less than $5 per use. The simulation model requires a new vaginal insert for each learner, which is fast and easy to make and requires only a few components; however, the bony pelvis (for example, the flowerpot model) needs to be purchased or created. The stage of the anterior wall prolapse can be adjusted by the amount of fluid placed in the balloon, which is used to simulate the bladder. The more fluid that is placed in the “bladder,” the more severe the anterior wall prolapse appears. The vaginal caliber can be adjusted, if needed, by increasing or decreasing the size of the components to create the vagina, but the suggested sizes simulate a significantly widened vaginal caliber that would benefit from a posterior repair with perineorrhaphy. Although there is no validity evidence for this model, a skills assessment is available through the ACOG Simulation Surgical Curriculum. Of note, native tissue colpopexy repairs are also possible with this model (or another high-fidelity model, such as the Miya Model), if the sacrospinous ligaments and/or uterosacral ligaments are available on the pelvic model in use. This model’s limitations include the absence of a high-fidelity plane of dissection of the vaginal muscularis, and that no bleeding is encountered, which is the case for many low-cost models.^19,34

Fundamentals of Vaginal Surgery (FVS) basic surgical skills simulation

The FVS simulation system, consisting of a task trainer paired with 6 selected surgical tasks, was developed to teach basic skills used in vaginal surgery.³⁵ The FVS task trainer is 3D printed and has 3 main components: a base piece that allows for different surgical materials to be secured, a depth extender, and a width reducer. In addition, it has a mobile phone mount and a window into the system to enable video capture of skills exercises.

The FVS simulator is designed to enable 6 surgical tasks, including one-handed knot tying, two-handed knot tying, running suturing, plication suturing, Heaney transfixion pedicle ligation, and free pedicle ligation (FIGURE 4). In a pilot study, the FVS simulation system was deemed representative of the intended surgical field, useful for inclusion in a training program, and favored as a tool for both training and testing. Additionally, an initial proficiency score of 400 was set, which discriminated between novice and expert surgeons.³⁵

An advantage of this simulation system is that it allows learners to focus on basic skills, rather than on an entire specific procedure. Further, the system is standardized, as it is commercially manufactured; this also allows for easy assembly. The disadvantage of this model is that it cannot be modified to teach specific vaginal procedures, and it must be purchased, rather than constructed on site. Further studies are needed to create generalizable proficiency scores and to assess its use in training and testing. For more information on the FVS simulation model, visit the Arbor Simulation website (http://arborsim.com).

Surgical simulation’s important role

Surgical skills can be learned and improved in the simulation setting in a low-stakes, low-pressure environment. Simulation can enable basic skills development and then higher-level learning of complex procedures. Skill assessment is important to aid in learning (via formative assessments) and for examination or certification (summative assessments).

With decreasing vaginal surgical volumes occurring nationally, it is becoming even more important to use surgical simulation to teach and maintain vaginal surgical skills. In this article, we reviewed various different simulation models that can be used for developing vaginal surgical skills and presented the advantages, limitations, and resources relevant for each simulation model. ●

Vaginal surgery, including vaginal hysterectomy, is slowly becoming a dying art. According to the National Inpatient Sample and the Nationwide Ambulatory Surgery Sample from 2018, only 11.8% of all hysterectomies were performed vaginally.¹ The combination of uterine-sparing surgeries, advances in conservative therapies for benign uterine conditions, and the diversification of minimally invasive routes (laparoscopic and robotic) has resulted in a continued downtrend in vaginal surgical volumes. This shift has led to fewer operative learning opportunities and declining graduating resident surgical volume.² According to the Accreditation Council for Graduate Medical Education (ACGME), the minimum number of vaginal hysterectomies is 15, which represents only the minimum accepted exposure and does not imply competency.

In response, surgical simulation has been used for skill acquisition and maintenance outside of the operating room in a learning environment that is safe for the learners and does not expose patients to additional risk. Educators are uniquely poised to use simulation to teach residents and to evaluate their procedural competency. Although vaginal surgery, specifically vaginal hysterectomy, continues to decline, it can be resuscitated with the assistance of surgical simulation.

In this article, we provide a broad overview of vaginal surgical simulation. We discuss the basic tenets of simulation, review how to teach and evaluate vaginal surgical skills, and present some of the commonly available vaginal surgery simulation models and their associated resources, cost, setup time, fidelity, and limitations.

Simulation principles relevant for vaginal hysterectomy simulation

Here, we review simulation-based learning principles that will help place specific simulation models into perspective.

One size does not fit all

Simulation, like many educational interventions, does not work via a “one-size-fits-all” approach. While the American College of Obstetricians and Gynecologists (ACOG) Simulations Working Group (SWG) has created a toolkit (available online at https://www.acog.org/education-and-events/simulations/about/curriculum) with many ready-to-use how-to simulation descriptions and lesson plans that cover common topics, what works in one setting may not work in another. The SWG created those modules to help educators save time and resources and to avoid reinventing the wheel for each simulation session. However, these simulations need to be adapted to the local needs of trainees and resources, such as faculty time, space, models, and funding.

Cost vs fidelity

It is important to distinguish between cost and fidelity. “Low cost” is often incorrectly used interchangeably with “low fidelity” when referring to models and simulations. The most basic principle of fidelity is that it is associated with situational realism that in turn, drives learning.^3,4 For example, the term high fidelity does apply to a virtual reality robotic surgery simulator, which also is high cost. However, a low-cost beef tongue model of fourth-degree laceration⁵ is high fidelity, while more expensive commercial models are less realistic, which makes them high cost and low fidelity.⁶ When selecting simulation models, educators need to consider cost based on their available resources and the level of fidelity needed for their learners.

Continue to: Task breakdown...

Task breakdown

As surgeon-educators, we love to teach! And while educators are passionate about imparting vaginal hysterectomy skills to the next generation of surgeons, it is important to assess where the learners are technically. Vaginal hysterectomy is a high-complexity procedure, with each step involving a unique skill set that is new to residents as learners; this is where the science of learning can help us teach more effectively.⁷ Focusing on doing the entire procedure all at once is more likely to result in cognitive overload, while a better approach is to break the procedure down into several components and practice those parts until goal proficiency is reached.

Deliberate practice

The idea of deliberate practice was popularized by Malcolm Gladwell in his book titled Outliers, in which he gives examples of how 10,000 hours of practice leads to mastery of complex skills. This concept was deepened by the work of cognitive psychologist Anders Ericsson, who emphasized that not only the duration but also the quality of practice—which involves concentration, analysis, and problem-solving—leads to the most effective training.⁸

In surgical education, this concept translates into many domains. For example, an individualized learning plan includes frequent low-stakes assessments, video recording for later viewing and analysis, surgical coaching, and detailed planning of future training sessions to incorporate past performance. “Just doing” surgery on a simulator (or in the operating room) results in missed learning opportunities.

Logistics and implementation: Who, where, when

The simulation “formula” takes into account multiple factors but should start with learning objectives and then an assessment of what resources are available to address them. For example, if one surgeon-educator and one resident-learner are available for 30 minutes in between cases in the operating room, and the goal is to teach the resident clamp-and-tie technique on pedicles, the “milk carton” model⁹ and a few instruments from the vaginal hysterectomy tray are ideal for this training. On the other hand, if it is important to achieve competency for an entire procedure prior to operating room debut and a group of surgeon-educators is available to share the time commitment of 2-hour sessions per each resident, then the PROMPT (PRactical Obstetric Multi-Professional Training) shoulder dystocia model could be used (TABLE).^10-14

Learning curves

Ideally, educators would like to know how many simulated training sessions are needed for a learner to reach a proficiency level and become operating room ready. Such information about learning curves, unfortunately, is not available yet for vaginal hysterectomies. The first step in the process is to establish a baseline for performance to know a starting point, with assessment tools specific to each simulator; the next step is to study how many “takes” are needed for learners to move through their learning curve.¹⁵ The use of assessment tools can help assess each learner’s progression.

Continue to: Evaluation, assessment, and feedback...

With more emphasis being placed on patient safety and transparency in every aspect of health care, including surgical training, graduate medical education leaders increasingly highlight the importance of objective assessment tools and outcome-based standards for certification of competency in surgery.^16,17 Commonly used assessment tools that have reliability and validity evidence include surgical checklists and global rating scales. Checklists for common gynecologic procedures, including vaginal hysterectomy, as well as a global rating scale specifically developed for vaginal surgery (Vaginal Surgical Skills Index, VSSI)¹⁸ are accessible on the ACOG Simulations Working Group Surgical Curriculum in Obstetrics and Gynecology website.¹⁹

While checklists contain the main steps of each procedure, these lists do not assess for how well each step of the procedure is performed. By contrast, global rating scales, such as the VSSI, can discriminate between surgeons with different skill levels both in the simulation and operating room settings; each metric within the global rating scale (for example, time and motion) does not pertain to the performance of a procedure’s specific step but rather to the overall performance of the entire procedure.^18,20 Hence, to provide detailed feedback, especially for formative assessment, both checklists and global rating scales often are used together.

Although standardized, checklists and global rating scales ultimately are still subjective (not objective) assessment tools. Recently, more attention has been to use surgical data science, particularly artificial intelligence methods, to objectively assess surgical performance by analyzing data generated during the performance of surgery, such as instrumental motion and video.²¹ These methods have been applied to a wide range of surgical techniques, including open, laparoscopic, robotic, endoscopic, and microsurgical approaches. Most of these types of studies have used assessment of surgical skill as the main outcome, with fewer studies correlating skill with clinically relevant metrics, such as patient outcomes.^22-25 Although this is an area of active research, these methods are still being developed, and their validity and utility are not well established. For now, educators should continue to use validated checklists and global rating skills to help assess any type of surgical performance, particularly vaginal surgery.

Vaginal surgical simulation models

Vaginal surgery requires a surgeon to operate in a narrow, deep space. This requires ambidexterity, accurate depth perception, understanding of how to handle tissues, and use of movements that are efficient, fluid, and rhythmic. Multiple proposed simulation models are relevant to vaginal surgery, and these vary based on level of fidelity, cost, feasibility, ability to maintain standardization, ease of construction (if required), and generalizability to all of pelvic surgery (that is, procedure specific vs basic skills focused).^{10,11,13,26-31}

Below, we describe various simulation models that are available for teaching vaginal surgical skills.

Vaginal hysterectomy simulation model

One commercially available simulation model for vaginal hysterectomy (as well as other vaginal surgical procedures, such as midurethral sling and anterior and posterior colporrhaphy) is the Miya Model (Miyazaki Enterprises) (FIGURE 1) and its accompanying MiyaMODEL App. In a multi-institutional study funded by the National Institutes of Health (NIH), the Miya Model, when used with the VSSI, was shown to be a valid assessment tool in terms of ability to differentiate a competent from a noncompetent surgeon.²⁰ Currently, an ongoing NIH-sponsored multi-institutional study is assessing the Miya Model as a teaching tool and whether skills acquired on the Miya Model are transferable to the operating room.

Continue to: Low-cost vaginal hysterectomy models...

Multiple low-cost vaginal hysterectomy simulation models are described. Two models developed many years ago include the ACOG SWG flowerpot model¹⁴ and the PROMPT shoulder dystocia pelvic trainer model.^10,11,14 The former model is low cost as it can be constructed from easily obtained household materials, but its downside is that it takes time and effort to obtain the materials and to assemble them. The latter model is faster to assemble but requires one to use a PROMPT pelvis for shoulder dystocia training, which has a considerable upfront cost. However, it is available in most hospitals with considerable obstetrical volume, and it allows for the most realistic perineum, which is helpful in recreating the feel of vaginal surgery, including retraction and exposure.

Many models created and described in the literature are variations of the models mentioned above, and many use commercially available low-cost bony pelvis models and polyvinyl chloride (PVC) pipes as a foundation for the soft tissue inserts to attach.^12,13,31-33 Each model varies on what it “teaches best” regarding realism—for example, teaching anatomy, working in a tight space, dissection, or clamp placement and suture ligature.

Furthermore, since vaginal hysterectomy is a high-complexity procedure in terms of skills (working in confined space, limited view, “upside-down” anatomy, and need to direct assistants for retraction and exposure), task breakdown is important for simulation learning, as it is not efficient to repeat the entire procedure until proficiency is reached. Two trainers have been described to address that need: the milk carton and the vaginal suturing trainer. The latter allows learners to practice clamp placement and pedicle ligation multiple times, including in confined space (FIGURE 2), and the former allows them to do the same in a procedural matter as the clamp placement moves caudad to cephalad during the procedure (FIGURE 3).

Native tissue pelvic floor surgery simulation

While there are few publications regarding surgical simulation models for native tissue pelvic floor surgeries, a low-cost anterior and posterior repair model was developed for the ACOG SWG Simulation Toolkit and published online in 2017, after their peer-review process. The fidelity is moderate for this low-cost model, which costs less than $5 per use. The simulation model requires a new vaginal insert for each learner, which is fast and easy to make and requires only a few components; however, the bony pelvis (for example, the flowerpot model) needs to be purchased or created. The stage of the anterior wall prolapse can be adjusted by the amount of fluid placed in the balloon, which is used to simulate the bladder. The more fluid that is placed in the “bladder,” the more severe the anterior wall prolapse appears. The vaginal caliber can be adjusted, if needed, by increasing or decreasing the size of the components to create the vagina, but the suggested sizes simulate a significantly widened vaginal caliber that would benefit from a posterior repair with perineorrhaphy. Although there is no validity evidence for this model, a skills assessment is available through the ACOG Simulation Surgical Curriculum. Of note, native tissue colpopexy repairs are also possible with this model (or another high-fidelity model, such as the Miya Model), if the sacrospinous ligaments and/or uterosacral ligaments are available on the pelvic model in use. This model’s limitations include the absence of a high-fidelity plane of dissection of the vaginal muscularis, and that no bleeding is encountered, which is the case for many low-cost models.^19,34

Fundamentals of Vaginal Surgery (FVS) basic surgical skills simulation

The FVS simulation system, consisting of a task trainer paired with 6 selected surgical tasks, was developed to teach basic skills used in vaginal surgery.³⁵ The FVS task trainer is 3D printed and has 3 main components: a base piece that allows for different surgical materials to be secured, a depth extender, and a width reducer. In addition, it has a mobile phone mount and a window into the system to enable video capture of skills exercises.

The FVS simulator is designed to enable 6 surgical tasks, including one-handed knot tying, two-handed knot tying, running suturing, plication suturing, Heaney transfixion pedicle ligation, and free pedicle ligation (FIGURE 4). In a pilot study, the FVS simulation system was deemed representative of the intended surgical field, useful for inclusion in a training program, and favored as a tool for both training and testing. Additionally, an initial proficiency score of 400 was set, which discriminated between novice and expert surgeons.³⁵

An advantage of this simulation system is that it allows learners to focus on basic skills, rather than on an entire specific procedure. Further, the system is standardized, as it is commercially manufactured; this also allows for easy assembly. The disadvantage of this model is that it cannot be modified to teach specific vaginal procedures, and it must be purchased, rather than constructed on site. Further studies are needed to create generalizable proficiency scores and to assess its use in training and testing. For more information on the FVS simulation model, visit the Arbor Simulation website (http://arborsim.com).

Surgical simulation’s important role

Surgical skills can be learned and improved in the simulation setting in a low-stakes, low-pressure environment. Simulation can enable basic skills development and then higher-level learning of complex procedures. Skill assessment is important to aid in learning (via formative assessments) and for examination or certification (summative assessments).

With decreasing vaginal surgical volumes occurring nationally, it is becoming even more important to use surgical simulation to teach and maintain vaginal surgical skills. In this article, we reviewed various different simulation models that can be used for developing vaginal surgical skills and presented the advantages, limitations, and resources relevant for each simulation model. ●

Gupta A, Jha P, Baran TM, et al. Ovarian cancer detection in average-risk women: classic- versus nonclassic-appearing adnexal lesions at US. Radiology. 2022;212338. doi: 10.1148/radiol.212338.

Expert commentary

Gupta and colleagues conducted a multicenter, retrospective review of 970 adnexal lesions among 878 women—75% were premenopausal and 25% were postmenopausal.

Imaging details

The lesions were characterized by pattern recognition as “classic” (simple cysts, endometriomas, hemorrhagic cysts, or dermoids) or “nonclassic.” Out of 673 classic lesions, there were 4 malignancies (0.6%), of which 1 was an endometrioma and 3 were classified as simple cysts. However, out of 297 nonclassic lesions (multilocular, unilocular with solid areas or wall irregularity, or mostly solid), 32% (33/103) were malignant when vascularity was present, while 8% (16/184) were malignant when no intralesional vascularity was appreciated.

The authors pointed out that, especially because their study was retrospective, there was no standardization of scan technique or equipment employed. However, this point adds credibility to the “real world” nature of such imaging.

Other data corroborate findings

Other studies have looked at pattern recognition in efforts to optimize a conservative approach to benign masses and referral to oncology for suspected malignant masses, as described above. This was the main cornerstone of the International Consensus Conference,² which also identified next steps for indeterminate masses, including evidence-based risk assessment algorithms and referral (to an expert imager or gynecologic oncologist). A multicenter trial in Europe³ found that ultrasound experience substantially impacts on diagnostic performance when adnexal masses are classified using pattern recognition. This occurred in a stepwise fashion with increasing accuracy directly related to the level of expertise. Shetty and colleagues⁴ found that pattern recognition performed better than the risk of malignancy index (sensitivities of 95% and 79%, respectively). ●

Gupta A, Jha P, Baran TM, et al. Ovarian cancer detection in average-risk women: classic- versus nonclassic-appearing adnexal lesions at US. Radiology. 2022;212338. doi: 10.1148/radiol.212338.

Expert commentary

Gupta and colleagues conducted a multicenter, retrospective review of 970 adnexal lesions among 878 women—75% were premenopausal and 25% were postmenopausal.

Imaging details

The lesions were characterized by pattern recognition as “classic” (simple cysts, endometriomas, hemorrhagic cysts, or dermoids) or “nonclassic.” Out of 673 classic lesions, there were 4 malignancies (0.6%), of which 1 was an endometrioma and 3 were classified as simple cysts. However, out of 297 nonclassic lesions (multilocular, unilocular with solid areas or wall irregularity, or mostly solid), 32% (33/103) were malignant when vascularity was present, while 8% (16/184) were malignant when no intralesional vascularity was appreciated.

The authors pointed out that, especially because their study was retrospective, there was no standardization of scan technique or equipment employed. However, this point adds credibility to the “real world” nature of such imaging.

Other data corroborate findings

Other studies have looked at pattern recognition in efforts to optimize a conservative approach to benign masses and referral to oncology for suspected malignant masses, as described above. This was the main cornerstone of the International Consensus Conference,² which also identified next steps for indeterminate masses, including evidence-based risk assessment algorithms and referral (to an expert imager or gynecologic oncologist). A multicenter trial in Europe³ found that ultrasound experience substantially impacts on diagnostic performance when adnexal masses are classified using pattern recognition. This occurred in a stepwise fashion with increasing accuracy directly related to the level of expertise. Shetty and colleagues⁴ found that pattern recognition performed better than the risk of malignancy index (sensitivities of 95% and 79%, respectively). ●

Gupta A, Jha P, Baran TM, et al. Ovarian cancer detection in average-risk women: classic- versus nonclassic-appearing adnexal lesions at US. Radiology. 2022;212338. doi: 10.1148/radiol.212338.

Expert commentary

Gupta and colleagues conducted a multicenter, retrospective review of 970 adnexal lesions among 878 women—75% were premenopausal and 25% were postmenopausal.

Imaging details

The lesions were characterized by pattern recognition as “classic” (simple cysts, endometriomas, hemorrhagic cysts, or dermoids) or “nonclassic.” Out of 673 classic lesions, there were 4 malignancies (0.6%), of which 1 was an endometrioma and 3 were classified as simple cysts. However, out of 297 nonclassic lesions (multilocular, unilocular with solid areas or wall irregularity, or mostly solid), 32% (33/103) were malignant when vascularity was present, while 8% (16/184) were malignant when no intralesional vascularity was appreciated.

The authors pointed out that, especially because their study was retrospective, there was no standardization of scan technique or equipment employed. However, this point adds credibility to the “real world” nature of such imaging.

Other data corroborate findings

Other studies have looked at pattern recognition in efforts to optimize a conservative approach to benign masses and referral to oncology for suspected malignant masses, as described above. This was the main cornerstone of the International Consensus Conference,² which also identified next steps for indeterminate masses, including evidence-based risk assessment algorithms and referral (to an expert imager or gynecologic oncologist). A multicenter trial in Europe³ found that ultrasound experience substantially impacts on diagnostic performance when adnexal masses are classified using pattern recognition. This occurred in a stepwise fashion with increasing accuracy directly related to the level of expertise. Shetty and colleagues⁴ found that pattern recognition performed better than the risk of malignancy index (sensitivities of 95% and 79%, respectively). ●

Transvaginal mesh was found to be safe and effective for patients with pelvic organ prolapse (POP) when compared with native tissue repair (NTR) in a 3-year trial.

Researchers, led by Bruce S. Kahn, MD, with the department of obstetrics & gynecology at Scripps Clinic in San Diego evaluated the two surgical treatment methods and published their findings in Obstetrics & Gynecology.

At completion of the 3-year follow-up in 2016, there were 401 participants in the transvaginal mesh group and 171 in the NTR group.

The prospective, nonrandomized, parallel-cohort, 27-site trial used a primary composite endpoint of anatomical success; subjective success (vaginal bulging); retreatment measures; and serious device-related or serious procedure-related adverse events.

The secondary endpoint was a composite outcome similar to the primary composite outcome but with anatomical success more stringently defined as POP quantification (POP-Q) point Ba < 0 and/or C < 0.

The secondary outcome was added to this trial because investigators had criticized the primary endpoint, set by the Food and Drug Administration, because it included anatomic outcome measures that were the same for inclusion criteria (POP-Q point Ba < 0 and/or C < 0.)

The secondary-outcome composite also included quality-of-life measures, mesh exposure, and mesh- and procedure-related complications.
 

Outcomes similar for both groups

The primary outcome demonstrated transvaginal mesh was not superior to native tissue repair (P =.056).

In the secondary outcome, superiority of transvaginal mesh over native tissue repair was shown (P =.009), with a propensity score–adjusted difference of 10.6% (90% confidence interval, 3.3%-17.9%) in favor of transvaginal mesh.

The authors noted that subjective success regarding vaginal bulging, which is important in patient satisfaction, was high and not statistically different between the two groups.

Additionally, transvaginal mesh repair was as safe as NTR regarding serious device-related and/or serious procedure-related side effects.

For the primary safety endpoint, 3.1% in the mesh group and 2.7% in the native tissue repair group experienced serious adverse events, demonstrating that mesh was noninferior to NTR.
 

Research results have been mixed

Unanswered questions surround surgical options for POP, which, the authors wrote, “affects 3%-6% of women based on symptoms and up to 50% of women based on vaginal examination.”

The FDA in 2011 issued 522 postmarket surveillance study orders for companies that market transvaginal mesh for POP.

Research results have varied and contentious debate has continued in the field. Some studies have shown that mesh has better subjective and objective outcomes than NTR in the anterior compartment. Others have found more complications with transvaginal mesh, such as mesh exposure and painful intercourse.

Complicating comparisons, early versions of the mesh used were larger and denser than today’s versions.

In this postmarket study, patients received either the Uphold LITE brand of transvaginal mesh or native tissue repair for surgical treatment of POP.
 

Expert: This study unlikely to change minds

In an accompanying editorial, John O.L. DeLancey, MD, professor of gynecology at the University of Michigan, Ann Arbor, pointed out that so far there’s been a lack of randomized trials that could answer whether mesh surgeries result in fewer symptoms or result in sufficient improvements in anatomy to justify their additional risk.

This study may not help with the decision. Dr. DeLancey wrote: “Will this study change the minds of either side of this debate? Probably not. The two sides are deeply entrenched in their positions.”

Two considerations are important in thinking about the issue, he said. Surgical outcomes for POP are “not as good as we would hope.” Also, many women have had serious complications with mesh operations.

He wrote: “Mesh litigation has resulted in more $8 billion in settlements, which is many times the $1 billion annual national cost of providing care for prolapse. Those of us who practice in referral centers have seen women with devastating problems, even though they probably represent a small fraction of cases.”

Dr. DeLancey highlighted some limitations of the study by Dr. Kahn and colleagues, especially regarding differences in the groups studied and the design of the study.

“For example,” he explained, “65% of individuals in the mesh-repair group had a prior hysterectomy as opposed to 30% in the native tissue repair group. In addition, some of the operations in the native tissue group are not typical choices; for example, hysteropexy was used for some patients and had a 47% failure rate.”

He said the all-or-nothing approach to surgical solutions may be clouding the debate – in other words mesh or no mesh for women as a group.

“Rather than asking whether mesh is better than no mesh, knowing which women (if any) stand to benefit from mesh is the critical question. We need to understand, for each woman, what structural failures exist so that we can target our interventions to correct them,” he wrote.

This study was sponsored by Boston Scientific. Dr. Kahn disclosed research support from Solaire, payments from AbbVie and Douchenay as a speaker, payments from Caldera and Cytuity (Boston Scientific) as a medical consultant, and payment from Johnson & Johnson as an expert witness. One coauthor disclosed that money was paid to her institution from Medtronic and Boston Scientific (both unrestricted educational grants for cadaveric lab). Another is chief medical officer at Axonics. One study coauthor receives research funding from Axonics and is a consultant for Group Dynamics, Medpace, and FirstThought. One coauthor received research support, is a consultant for Boston Scientific, and is an expert witness for Johnson & Johnson. Dr. DeLancey declared no relevant financial relationships.

Transvaginal mesh was found to be safe and effective for patients with pelvic organ prolapse (POP) when compared with native tissue repair (NTR) in a 3-year trial.

Researchers, led by Bruce S. Kahn, MD, with the department of obstetrics & gynecology at Scripps Clinic in San Diego evaluated the two surgical treatment methods and published their findings in Obstetrics & Gynecology.

At completion of the 3-year follow-up in 2016, there were 401 participants in the transvaginal mesh group and 171 in the NTR group.

The prospective, nonrandomized, parallel-cohort, 27-site trial used a primary composite endpoint of anatomical success; subjective success (vaginal bulging); retreatment measures; and serious device-related or serious procedure-related adverse events.

The secondary endpoint was a composite outcome similar to the primary composite outcome but with anatomical success more stringently defined as POP quantification (POP-Q) point Ba < 0 and/or C < 0.

The secondary outcome was added to this trial because investigators had criticized the primary endpoint, set by the Food and Drug Administration, because it included anatomic outcome measures that were the same for inclusion criteria (POP-Q point Ba < 0 and/or C < 0.)

The secondary-outcome composite also included quality-of-life measures, mesh exposure, and mesh- and procedure-related complications.
 

Outcomes similar for both groups

The primary outcome demonstrated transvaginal mesh was not superior to native tissue repair (P =.056).

In the secondary outcome, superiority of transvaginal mesh over native tissue repair was shown (P =.009), with a propensity score–adjusted difference of 10.6% (90% confidence interval, 3.3%-17.9%) in favor of transvaginal mesh.

The authors noted that subjective success regarding vaginal bulging, which is important in patient satisfaction, was high and not statistically different between the two groups.

Additionally, transvaginal mesh repair was as safe as NTR regarding serious device-related and/or serious procedure-related side effects.

For the primary safety endpoint, 3.1% in the mesh group and 2.7% in the native tissue repair group experienced serious adverse events, demonstrating that mesh was noninferior to NTR.
 

Research results have been mixed

Unanswered questions surround surgical options for POP, which, the authors wrote, “affects 3%-6% of women based on symptoms and up to 50% of women based on vaginal examination.”

The FDA in 2011 issued 522 postmarket surveillance study orders for companies that market transvaginal mesh for POP.

Research results have varied and contentious debate has continued in the field. Some studies have shown that mesh has better subjective and objective outcomes than NTR in the anterior compartment. Others have found more complications with transvaginal mesh, such as mesh exposure and painful intercourse.

Complicating comparisons, early versions of the mesh used were larger and denser than today’s versions.

In this postmarket study, patients received either the Uphold LITE brand of transvaginal mesh or native tissue repair for surgical treatment of POP.
 

Expert: This study unlikely to change minds

In an accompanying editorial, John O.L. DeLancey, MD, professor of gynecology at the University of Michigan, Ann Arbor, pointed out that so far there’s been a lack of randomized trials that could answer whether mesh surgeries result in fewer symptoms or result in sufficient improvements in anatomy to justify their additional risk.

This study may not help with the decision. Dr. DeLancey wrote: “Will this study change the minds of either side of this debate? Probably not. The two sides are deeply entrenched in their positions.”

Two considerations are important in thinking about the issue, he said. Surgical outcomes for POP are “not as good as we would hope.” Also, many women have had serious complications with mesh operations.

He wrote: “Mesh litigation has resulted in more $8 billion in settlements, which is many times the $1 billion annual national cost of providing care for prolapse. Those of us who practice in referral centers have seen women with devastating problems, even though they probably represent a small fraction of cases.”

Dr. DeLancey highlighted some limitations of the study by Dr. Kahn and colleagues, especially regarding differences in the groups studied and the design of the study.

“For example,” he explained, “65% of individuals in the mesh-repair group had a prior hysterectomy as opposed to 30% in the native tissue repair group. In addition, some of the operations in the native tissue group are not typical choices; for example, hysteropexy was used for some patients and had a 47% failure rate.”

He said the all-or-nothing approach to surgical solutions may be clouding the debate – in other words mesh or no mesh for women as a group.

“Rather than asking whether mesh is better than no mesh, knowing which women (if any) stand to benefit from mesh is the critical question. We need to understand, for each woman, what structural failures exist so that we can target our interventions to correct them,” he wrote.

This study was sponsored by Boston Scientific. Dr. Kahn disclosed research support from Solaire, payments from AbbVie and Douchenay as a speaker, payments from Caldera and Cytuity (Boston Scientific) as a medical consultant, and payment from Johnson & Johnson as an expert witness. One coauthor disclosed that money was paid to her institution from Medtronic and Boston Scientific (both unrestricted educational grants for cadaveric lab). Another is chief medical officer at Axonics. One study coauthor receives research funding from Axonics and is a consultant for Group Dynamics, Medpace, and FirstThought. One coauthor received research support, is a consultant for Boston Scientific, and is an expert witness for Johnson & Johnson. Dr. DeLancey declared no relevant financial relationships.

Transvaginal mesh was found to be safe and effective for patients with pelvic organ prolapse (POP) when compared with native tissue repair (NTR) in a 3-year trial.

Researchers, led by Bruce S. Kahn, MD, with the department of obstetrics & gynecology at Scripps Clinic in San Diego evaluated the two surgical treatment methods and published their findings in Obstetrics & Gynecology.

At completion of the 3-year follow-up in 2016, there were 401 participants in the transvaginal mesh group and 171 in the NTR group.

The prospective, nonrandomized, parallel-cohort, 27-site trial used a primary composite endpoint of anatomical success; subjective success (vaginal bulging); retreatment measures; and serious device-related or serious procedure-related adverse events.

The secondary endpoint was a composite outcome similar to the primary composite outcome but with anatomical success more stringently defined as POP quantification (POP-Q) point Ba < 0 and/or C < 0.

The secondary outcome was added to this trial because investigators had criticized the primary endpoint, set by the Food and Drug Administration, because it included anatomic outcome measures that were the same for inclusion criteria (POP-Q point Ba < 0 and/or C < 0.)

The secondary-outcome composite also included quality-of-life measures, mesh exposure, and mesh- and procedure-related complications.
 

Outcomes similar for both groups

The primary outcome demonstrated transvaginal mesh was not superior to native tissue repair (P =.056).

In the secondary outcome, superiority of transvaginal mesh over native tissue repair was shown (P =.009), with a propensity score–adjusted difference of 10.6% (90% confidence interval, 3.3%-17.9%) in favor of transvaginal mesh.

The authors noted that subjective success regarding vaginal bulging, which is important in patient satisfaction, was high and not statistically different between the two groups.

Additionally, transvaginal mesh repair was as safe as NTR regarding serious device-related and/or serious procedure-related side effects.

For the primary safety endpoint, 3.1% in the mesh group and 2.7% in the native tissue repair group experienced serious adverse events, demonstrating that mesh was noninferior to NTR.
 

Research results have been mixed

Unanswered questions surround surgical options for POP, which, the authors wrote, “affects 3%-6% of women based on symptoms and up to 50% of women based on vaginal examination.”

The FDA in 2011 issued 522 postmarket surveillance study orders for companies that market transvaginal mesh for POP.

Research results have varied and contentious debate has continued in the field. Some studies have shown that mesh has better subjective and objective outcomes than NTR in the anterior compartment. Others have found more complications with transvaginal mesh, such as mesh exposure and painful intercourse.

Complicating comparisons, early versions of the mesh used were larger and denser than today’s versions.

In this postmarket study, patients received either the Uphold LITE brand of transvaginal mesh or native tissue repair for surgical treatment of POP.
 

Expert: This study unlikely to change minds

In an accompanying editorial, John O.L. DeLancey, MD, professor of gynecology at the University of Michigan, Ann Arbor, pointed out that so far there’s been a lack of randomized trials that could answer whether mesh surgeries result in fewer symptoms or result in sufficient improvements in anatomy to justify their additional risk.

This study may not help with the decision. Dr. DeLancey wrote: “Will this study change the minds of either side of this debate? Probably not. The two sides are deeply entrenched in their positions.”

Two considerations are important in thinking about the issue, he said. Surgical outcomes for POP are “not as good as we would hope.” Also, many women have had serious complications with mesh operations.

He wrote: “Mesh litigation has resulted in more $8 billion in settlements, which is many times the $1 billion annual national cost of providing care for prolapse. Those of us who practice in referral centers have seen women with devastating problems, even though they probably represent a small fraction of cases.”

Dr. DeLancey highlighted some limitations of the study by Dr. Kahn and colleagues, especially regarding differences in the groups studied and the design of the study.

“For example,” he explained, “65% of individuals in the mesh-repair group had a prior hysterectomy as opposed to 30% in the native tissue repair group. In addition, some of the operations in the native tissue group are not typical choices; for example, hysteropexy was used for some patients and had a 47% failure rate.”

He said the all-or-nothing approach to surgical solutions may be clouding the debate – in other words mesh or no mesh for women as a group.

“Rather than asking whether mesh is better than no mesh, knowing which women (if any) stand to benefit from mesh is the critical question. We need to understand, for each woman, what structural failures exist so that we can target our interventions to correct them,” he wrote.

This study was sponsored by Boston Scientific. Dr. Kahn disclosed research support from Solaire, payments from AbbVie and Douchenay as a speaker, payments from Caldera and Cytuity (Boston Scientific) as a medical consultant, and payment from Johnson & Johnson as an expert witness. One coauthor disclosed that money was paid to her institution from Medtronic and Boston Scientific (both unrestricted educational grants for cadaveric lab). Another is chief medical officer at Axonics. One study coauthor receives research funding from Axonics and is a consultant for Group Dynamics, Medpace, and FirstThought. One coauthor received research support, is a consultant for Boston Scientific, and is an expert witness for Johnson & Johnson. Dr. DeLancey declared no relevant financial relationships.