Recent meta-analysis that suggests aspirin might be as effective as some commonly used anticoagulants in preventing VTE following hip and knee replacement surgeries makes a case for further study, says a veteran hospitalist.

"Whereas we currently have a number of alternatives [at variable cost and efficacy] for preoperative prophylaxis against DVT and ensuing complications, we may be able to ultimately standardize a prophylactic regimen," Jairy C. Hunter, MD, MBA, SFHM, associate executive medical director for case management and care transitions at the Medical University of South Carolina in Charleston told The Hospitalist in an email. "If aspirin is found to be effective and safe as part of that regimen, then we can improve outcomes, as well as cost, while reducing the risk of complications from the prophylactic regimen itself."

Recently published in the Journal of Hospital Medicine, the paper reviewed eight randomized clinical trials comparing aspirin to anticoagulants for prevention of VTE following major lower extremity surgery (hip or knee replacement). Researchers' analysis included 1,408 participants and compared data on VTE, bleeding, and mortality risk with the type of medication involved.

The authors found aspirin to be as effective as anticoagulants for preventing VTE after lower extremity arthroplasty and linked it with lower bleeding risk after these surgeries. Aspirin also carried a lower risk of bleeding in patients following hip fracture repair, but researchers noted it might be linked with a higher risk of DVT in these patients, making anticoagulants a better choice for VTE prophylaxis post-hip fracture repair.

Frank Drescher, MD, assistant professor of medicine at the Geisel School of Medicine at Dartmouth in Hanover, N.H., and lead author of the research, says he was surprised to see anticoagulants—often considered the stronger medication—made no difference compared with aspirin in lowering DVT risk with hip and knee replacement surgeries. He contends that patients' behavior post-surgery may make a difference.

Check out SHM's VTE prevention toolkit

"Early mobilization and pneumatic compression devices can help to prevent [VTE]," Dr. Dresher told The Hospitalist in an email. "It's possible that increasing use of non-pharmacological measures helps to mitigate differences between different pharmacological agents."

Hospitalists routinely see hip fracture repair patients and become involved in the orthopedic management of DVT prophylaxis, according to Anand Kartha, MD, MS, an academic hospitalist in the Veterans Affairs Boston Healthcare System and a member of Team Hospitalist. He says the research strengthens the idea "that physicians should not use aspirin on hip fracture patients for DVT prophylaxis or prevention" after surgery.

Dr. Drescher acknowledges some limitations of his meta-analysis, including the fact that researchers found few randomized trials with direct comparisons between aspirin and anticoagulants, and some trials were more than 10 years old. In the future, Dr. Drescher says he hopes to see more research on this topic.

Dr. Kartha agrees but says the first step is ensuring consistent use of the existing research. "Rather than debating the validity of one therapy versus the other…what is needed is consistent application of what is already known," he explains. "That is, there needs to be a standardized, institutional approach to this issue."TH

Visit our website for more information on VTE prophylaxis.

Recent meta-analysis that suggests aspirin might be as effective as some commonly used anticoagulants in preventing VTE following hip and knee replacement surgeries makes a case for further study, says a veteran hospitalist.

"Whereas we currently have a number of alternatives [at variable cost and efficacy] for preoperative prophylaxis against DVT and ensuing complications, we may be able to ultimately standardize a prophylactic regimen," Jairy C. Hunter, MD, MBA, SFHM, associate executive medical director for case management and care transitions at the Medical University of South Carolina in Charleston told The Hospitalist in an email. "If aspirin is found to be effective and safe as part of that regimen, then we can improve outcomes, as well as cost, while reducing the risk of complications from the prophylactic regimen itself."

Recently published in the Journal of Hospital Medicine, the paper reviewed eight randomized clinical trials comparing aspirin to anticoagulants for prevention of VTE following major lower extremity surgery (hip or knee replacement). Researchers' analysis included 1,408 participants and compared data on VTE, bleeding, and mortality risk with the type of medication involved.

The authors found aspirin to be as effective as anticoagulants for preventing VTE after lower extremity arthroplasty and linked it with lower bleeding risk after these surgeries. Aspirin also carried a lower risk of bleeding in patients following hip fracture repair, but researchers noted it might be linked with a higher risk of DVT in these patients, making anticoagulants a better choice for VTE prophylaxis post-hip fracture repair.

Frank Drescher, MD, assistant professor of medicine at the Geisel School of Medicine at Dartmouth in Hanover, N.H., and lead author of the research, says he was surprised to see anticoagulants—often considered the stronger medication—made no difference compared with aspirin in lowering DVT risk with hip and knee replacement surgeries. He contends that patients' behavior post-surgery may make a difference.

Check out SHM's VTE prevention toolkit

"Early mobilization and pneumatic compression devices can help to prevent [VTE]," Dr. Dresher told The Hospitalist in an email. "It's possible that increasing use of non-pharmacological measures helps to mitigate differences between different pharmacological agents."

Hospitalists routinely see hip fracture repair patients and become involved in the orthopedic management of DVT prophylaxis, according to Anand Kartha, MD, MS, an academic hospitalist in the Veterans Affairs Boston Healthcare System and a member of Team Hospitalist. He says the research strengthens the idea "that physicians should not use aspirin on hip fracture patients for DVT prophylaxis or prevention" after surgery.

Dr. Drescher acknowledges some limitations of his meta-analysis, including the fact that researchers found few randomized trials with direct comparisons between aspirin and anticoagulants, and some trials were more than 10 years old. In the future, Dr. Drescher says he hopes to see more research on this topic.

Dr. Kartha agrees but says the first step is ensuring consistent use of the existing research. "Rather than debating the validity of one therapy versus the other…what is needed is consistent application of what is already known," he explains. "That is, there needs to be a standardized, institutional approach to this issue."TH

Visit our website for more information on VTE prophylaxis.

Recent meta-analysis that suggests aspirin might be as effective as some commonly used anticoagulants in preventing VTE following hip and knee replacement surgeries makes a case for further study, says a veteran hospitalist.

"Whereas we currently have a number of alternatives [at variable cost and efficacy] for preoperative prophylaxis against DVT and ensuing complications, we may be able to ultimately standardize a prophylactic regimen," Jairy C. Hunter, MD, MBA, SFHM, associate executive medical director for case management and care transitions at the Medical University of South Carolina in Charleston told The Hospitalist in an email. "If aspirin is found to be effective and safe as part of that regimen, then we can improve outcomes, as well as cost, while reducing the risk of complications from the prophylactic regimen itself."

Recently published in the Journal of Hospital Medicine, the paper reviewed eight randomized clinical trials comparing aspirin to anticoagulants for prevention of VTE following major lower extremity surgery (hip or knee replacement). Researchers' analysis included 1,408 participants and compared data on VTE, bleeding, and mortality risk with the type of medication involved.

The authors found aspirin to be as effective as anticoagulants for preventing VTE after lower extremity arthroplasty and linked it with lower bleeding risk after these surgeries. Aspirin also carried a lower risk of bleeding in patients following hip fracture repair, but researchers noted it might be linked with a higher risk of DVT in these patients, making anticoagulants a better choice for VTE prophylaxis post-hip fracture repair.

Frank Drescher, MD, assistant professor of medicine at the Geisel School of Medicine at Dartmouth in Hanover, N.H., and lead author of the research, says he was surprised to see anticoagulants—often considered the stronger medication—made no difference compared with aspirin in lowering DVT risk with hip and knee replacement surgeries. He contends that patients' behavior post-surgery may make a difference.

Check out SHM's VTE prevention toolkit

"Early mobilization and pneumatic compression devices can help to prevent [VTE]," Dr. Dresher told The Hospitalist in an email. "It's possible that increasing use of non-pharmacological measures helps to mitigate differences between different pharmacological agents."

Hospitalists routinely see hip fracture repair patients and become involved in the orthopedic management of DVT prophylaxis, according to Anand Kartha, MD, MS, an academic hospitalist in the Veterans Affairs Boston Healthcare System and a member of Team Hospitalist. He says the research strengthens the idea "that physicians should not use aspirin on hip fracture patients for DVT prophylaxis or prevention" after surgery.

Dr. Drescher acknowledges some limitations of his meta-analysis, including the fact that researchers found few randomized trials with direct comparisons between aspirin and anticoagulants, and some trials were more than 10 years old. In the future, Dr. Drescher says he hopes to see more research on this topic.

Dr. Kartha agrees but says the first step is ensuring consistent use of the existing research. "Rather than debating the validity of one therapy versus the other…what is needed is consistent application of what is already known," he explains. "That is, there needs to be a standardized, institutional approach to this issue."TH

Visit our website for more information on VTE prophylaxis.

In March 2012, physicians and staff of the hospital medicine division at the University of California San Francisco (UCSF) kicked off a high-value care (HVC) program to more efficiently tie quality care delivery to healthcare costs. Early results suggest the plan is working, and the lead author of a recent paper believes other HM groups could use the program as a guide to implement similar plans in their own practices.

"There are a lot of idiosyncrasies between different programs and different medical centers, particularly when it comes to cost," says Christopher Moriates, MD, co-chair of the UCSF division's high-value care committee. "Many of the things we're identifying are indeed transplantable…but not all of them."

Published online this month in the Journal of Hospital Medicine, authors identify six ongoing HVC projects that have shown encouraging data in promoting improved healthcare value and clinician engagement. The projects are designed to:

• Reduce unnecessary nebulizer use;
• Curb overuse and inappropriate use of gastric stress ulcer prophylaxis;
• Encourage better blood utilization stewardship;
• Improve the use of telemetry;
• Scale back on inappropriate, repeat inpatient echocardiograms; and
• Reduce the number of ionized calcium labs.

To date, the nebulizer program has dropped usage rates by more than 50% on a high-acuity medical floor. Along with merely identifying waste-reduction and cost-savings plans, the program spells out goals for each initiative, strategies for reaching those goals, and next steps.

"We're not just creating these pilot programs and asking people to do more," Dr. Moriates says. "We're really thinking through these interventions as complete packages. We're really baking it into our culture. As we address what people actually do and change the systems around and change the way we think about things, it becomes standard practice and thus more likely to be sustainable." TH

Visit our website for more information on cost-effective, value-based patient care.

In March 2012, physicians and staff of the hospital medicine division at the University of California San Francisco (UCSF) kicked off a high-value care (HVC) program to more efficiently tie quality care delivery to healthcare costs. Early results suggest the plan is working, and the lead author of a recent paper believes other HM groups could use the program as a guide to implement similar plans in their own practices.

"There are a lot of idiosyncrasies between different programs and different medical centers, particularly when it comes to cost," says Christopher Moriates, MD, co-chair of the UCSF division's high-value care committee. "Many of the things we're identifying are indeed transplantable…but not all of them."

Published online this month in the Journal of Hospital Medicine, authors identify six ongoing HVC projects that have shown encouraging data in promoting improved healthcare value and clinician engagement. The projects are designed to:

• Reduce unnecessary nebulizer use;
• Curb overuse and inappropriate use of gastric stress ulcer prophylaxis;
• Encourage better blood utilization stewardship;
• Improve the use of telemetry;
• Scale back on inappropriate, repeat inpatient echocardiograms; and
• Reduce the number of ionized calcium labs.

To date, the nebulizer program has dropped usage rates by more than 50% on a high-acuity medical floor. Along with merely identifying waste-reduction and cost-savings plans, the program spells out goals for each initiative, strategies for reaching those goals, and next steps.

"We're not just creating these pilot programs and asking people to do more," Dr. Moriates says. "We're really thinking through these interventions as complete packages. We're really baking it into our culture. As we address what people actually do and change the systems around and change the way we think about things, it becomes standard practice and thus more likely to be sustainable." TH

Visit our website for more information on cost-effective, value-based patient care.

In March 2012, physicians and staff of the hospital medicine division at the University of California San Francisco (UCSF) kicked off a high-value care (HVC) program to more efficiently tie quality care delivery to healthcare costs. Early results suggest the plan is working, and the lead author of a recent paper believes other HM groups could use the program as a guide to implement similar plans in their own practices.

"There are a lot of idiosyncrasies between different programs and different medical centers, particularly when it comes to cost," says Christopher Moriates, MD, co-chair of the UCSF division's high-value care committee. "Many of the things we're identifying are indeed transplantable…but not all of them."

Published online this month in the Journal of Hospital Medicine, authors identify six ongoing HVC projects that have shown encouraging data in promoting improved healthcare value and clinician engagement. The projects are designed to:

• Reduce unnecessary nebulizer use;
• Curb overuse and inappropriate use of gastric stress ulcer prophylaxis;
• Encourage better blood utilization stewardship;
• Improve the use of telemetry;
• Scale back on inappropriate, repeat inpatient echocardiograms; and
• Reduce the number of ionized calcium labs.

To date, the nebulizer program has dropped usage rates by more than 50% on a high-acuity medical floor. Along with merely identifying waste-reduction and cost-savings plans, the program spells out goals for each initiative, strategies for reaching those goals, and next steps.

"We're not just creating these pilot programs and asking people to do more," Dr. Moriates says. "We're really thinking through these interventions as complete packages. We're really baking it into our culture. As we address what people actually do and change the systems around and change the way we think about things, it becomes standard practice and thus more likely to be sustainable." TH

Visit our website for more information on cost-effective, value-based patient care.

Presenter

Vincent Chiang, MD, Harvard Medical School and Boston Children's Hospital

Summary

Physicians suffer from “arrested development,” said Dr. Chiang, a hospitalist and chief of inpatient services at Boston Children’s Hospital, during a PHM2014 workshop on the basics of negotiation. Dr. Chiang was referring to the fact that in several professional realms, including negotiation, most physicians have not had the traditional experience of interviewing for and negotiating for jobs after high school or college.

An understanding of several negotiation concepts can help the negotiator achieve an agreeable solution. Awareness of values and limits prior to the actual discussion or negotiation will increase the chance of a successful negotiation. Examples of some of these concepts are:

1. Best alternative to a negotiation agreement (BATNA). This is the course of action if negotiations fail. The negotiator should not accept a worse resolution than the BATNA.
2. Reservation value (RV). This is the lowest value a negotiator will accept in a deal.
3. Zone of possible agreement (ZOPA). This is the intellectual zone between two parties in a negotiation where an agreement can be reached.

The twin tasks of negotiation are a) the need to learn about the true ZOPA in advance; and b) how to influence the other person’s perception of this zone.

There are several negotiation methods and strategies of influence that can be used to support your position or goals. For example, status quo bias is very common. By addressing the specific reason a person is not willing to change from the status quo, progress can be made.

While it is important to advocate for one’s position, fairness is an important variable in reaching an agreement. Fairness often is not universally defined. Communication is essential in understanding each group’s position.

Key Takeaways

1. Before entering a negotiation, understand your best alternative to a negotiation agreement and reservation value.
2. Understand your zone of possible agreement and then be aware of the zone of possible agreement of the person you are working with.
3. Learn strategies of influence to assist negotiations.
4. Fairness will assist in reaching agreement. TH

Dr. Hale is a member of Team Hospitalist and is a pediatric hospitalist at the Floating Hospital for Children at Tufts Medical Center in Boston.

Presenter

Vincent Chiang, MD, Harvard Medical School and Boston Children's Hospital

Summary

Physicians suffer from “arrested development,” said Dr. Chiang, a hospitalist and chief of inpatient services at Boston Children’s Hospital, during a PHM2014 workshop on the basics of negotiation. Dr. Chiang was referring to the fact that in several professional realms, including negotiation, most physicians have not had the traditional experience of interviewing for and negotiating for jobs after high school or college.

An understanding of several negotiation concepts can help the negotiator achieve an agreeable solution. Awareness of values and limits prior to the actual discussion or negotiation will increase the chance of a successful negotiation. Examples of some of these concepts are:

1. Best alternative to a negotiation agreement (BATNA). This is the course of action if negotiations fail. The negotiator should not accept a worse resolution than the BATNA.
2. Reservation value (RV). This is the lowest value a negotiator will accept in a deal.
3. Zone of possible agreement (ZOPA). This is the intellectual zone between two parties in a negotiation where an agreement can be reached.

The twin tasks of negotiation are a) the need to learn about the true ZOPA in advance; and b) how to influence the other person’s perception of this zone.

There are several negotiation methods and strategies of influence that can be used to support your position or goals. For example, status quo bias is very common. By addressing the specific reason a person is not willing to change from the status quo, progress can be made.

While it is important to advocate for one’s position, fairness is an important variable in reaching an agreement. Fairness often is not universally defined. Communication is essential in understanding each group’s position.

Key Takeaways

1. Before entering a negotiation, understand your best alternative to a negotiation agreement and reservation value.
2. Understand your zone of possible agreement and then be aware of the zone of possible agreement of the person you are working with.
3. Learn strategies of influence to assist negotiations.
4. Fairness will assist in reaching agreement. TH

Dr. Hale is a member of Team Hospitalist and is a pediatric hospitalist at the Floating Hospital for Children at Tufts Medical Center in Boston.

Presenter

Vincent Chiang, MD, Harvard Medical School and Boston Children's Hospital

Summary

Physicians suffer from “arrested development,” said Dr. Chiang, a hospitalist and chief of inpatient services at Boston Children’s Hospital, during a PHM2014 workshop on the basics of negotiation. Dr. Chiang was referring to the fact that in several professional realms, including negotiation, most physicians have not had the traditional experience of interviewing for and negotiating for jobs after high school or college.

An understanding of several negotiation concepts can help the negotiator achieve an agreeable solution. Awareness of values and limits prior to the actual discussion or negotiation will increase the chance of a successful negotiation. Examples of some of these concepts are:

1. Best alternative to a negotiation agreement (BATNA). This is the course of action if negotiations fail. The negotiator should not accept a worse resolution than the BATNA.
2. Reservation value (RV). This is the lowest value a negotiator will accept in a deal.
3. Zone of possible agreement (ZOPA). This is the intellectual zone between two parties in a negotiation where an agreement can be reached.

The twin tasks of negotiation are a) the need to learn about the true ZOPA in advance; and b) how to influence the other person’s perception of this zone.

There are several negotiation methods and strategies of influence that can be used to support your position or goals. For example, status quo bias is very common. By addressing the specific reason a person is not willing to change from the status quo, progress can be made.

While it is important to advocate for one’s position, fairness is an important variable in reaching an agreement. Fairness often is not universally defined. Communication is essential in understanding each group’s position.

Key Takeaways

1. Before entering a negotiation, understand your best alternative to a negotiation agreement and reservation value.
2. Understand your zone of possible agreement and then be aware of the zone of possible agreement of the person you are working with.
3. Learn strategies of influence to assist negotiations.
4. Fairness will assist in reaching agreement. TH

Dr. Hale is a member of Team Hospitalist and is a pediatric hospitalist at the Floating Hospital for Children at Tufts Medical Center in Boston.

Presenters

--- Welcome Remarks: Doug Carlson, MD, FAAP, chief of pediatric hospital medicine programs, St. Louis Children’s Hospital

--- The Next Phase of Delivery System Reform: Patrick Conway, MD, MSc, FAAP, MHM, deputy administrator for innovation and quality, CMO for the Centers for Medicare & Medicaid Services (CMS)

--- Hospitals and Health Systems: What’s on the Mind of Your CEO?: David J. Bailey, MD, MBA, president and CEO, the Nemours Foundation; Steve Narang, MD, MHCM, CEO, Banner Good Samaritan Medical Center, Phoenix, Ariz.; Jeff Sperring, MD, FAAP, president and CEO, Riley Hospital for Children at Indiana University Health, Indianapolis.

Summary

PHM 2014 began to heat up in steamy Orlando, as Dr. Carlson, chair of the PHM 2014 Organizing Committee, welcomed more than 800 pediatric hospitalists at the four-day annual meeting dedicated to pediatric hospital medicine.

Dr. Conway, a pediatric hospitalist prior to joining CMS, updated the crowd of ongoing reforms in the U.S. healthcare delivery system, with a focus on pediatrics. Healthcare delivery, Dr. Conway asserted, needs to move from an unsustainable, volume-driven, fee-for-service system to a people-centered, sustainable system where payment can be shaped by value-based purchasing, ACO-shared savings, and episode-based payments.

“Pediatrics,” Dr. Conway said, “is a leader in patient and family engagement, and population health.”

As such, the six goals of the CMS Quality Strategy align well with ongoing PHM efforts:

• Make care safer by reducing harm caused in care delivery;
•  Strengthen patient and family engagement as partners in their care;
•  Promote effective communication and coordination of care;
•  Promote effective prevention and treatment of chronic disease;
•  Work with communities to promote healthy living; and
•  Make care affordable.

Citing Maryland as an example, where a plan is being considered to shift 80% of hospital revenues to global models by 2018, Dr. Conway painted a picture of a rapidly-shifting reimbursement landscape that will soon be dominated by value-based purchasing, penalties for readmissions and healthcare-acquired conditions, and increasing emphasis on bundled payments, ACOs, and primary care medical homes.

“Hospitals are getting paid to keep people out of the hospital,” he said, and concurrently per capita spending on healthcare is now at historic lows. While pediatric quality measures are not as mature as those for adult patients, many opportunities for increasing value in pediatric care have been developed, such as the Choosing Wisely campaign and the Value in Inpatient Pediatrics (VIP) network.

Although not restricted to pediatrics, the CMS Partnership for Patients also aims to have a major impact on child health. Goals of a 40% reduction in HACs and 20% reduction in preventable 30-day readmissions have been set by the Partnership, with specific focus on 10 core patient-safety areas. Preliminary data have been promising, with a 9% reduction in HACs between 2010 and 2012 across all measures.

“This is a historical reduction,” said Dr. Conway, representing more than 500,000 patient harm events avoided, over 15,000 lives saved, and more than $4 billion in cost savings.

Within pediatrics, a number of research efforts have added to this reduction, including the Pediatric Research in Inpatient Settings (PRIS) Network, PHIS+, I-PASS, as well as several collaborative improvement networks.

Looking to the future, Medicaid and Children’s Health Insurance Program will continue to focus on quality initiatives and system transformation. These will include developing more pediatric-focused quality measures, improving health information technology, and continuing to award innovation in pediatrics. Pediatrics will continue to be a leader in these efforts, Dr. Conway said, because “we should care about longer time horizons.”

Four healthcare system CEOs also took the stage to answer questions from the audience, with Mark Shen, MD, president of Dell Children’s Medical Center, posing questions like a seasoned talk-show host. Panel members fielded a wide range of questions, including:

— How did you become a CEO?

“All I had to do was keep on saying ‘yes,’” Dr. Bailey said.

— What are you doing as a CEO to move from a fee-for-service system to a population-based system?

“We are still living in two different worlds…It depends on ACO penetration whether quality or volume will be the driver over the next 3-5 years,” Dr. Narang said.

“We have to create an accountable health community,” Dr. Shen said.

“The question is, how can you build a model that will allow you to flip the switch when this change occurs?” Dr. Sperring said.

— What is the role of hospitalists as care progresses from the most intensive but sometimes least appropriate site?

“I think the environment will drastically change, but there will be an ever enlarging role for hospitalists. … Hospitalists will likely be moving to LTACs, SNFs, even outpatient work.” Dr. Bailey said.

— If PHM fellowship becomes a requirement, will your hospital fund them?

“It’s hard to define what we do, but we know there are core competencies. … I don’t think we’re going to be at a point where certification will limit being a hospitalist any time soon,” Dr. Shen said.

— How can we make health care pricing more transparent?

“Why is it that in other industries, things are getting cheaper and higher quality, but in healthcare we seem to be going in the opposite direction?” Dr. Bailey said. “There has to be transparency for the patient. How about transparency for the provider? Every EMR should have a price for everything your order.”

— What do you think we can do to get more women into executive roles?

“Based on the percentages of women in medical school, residencies, and fellowships, I think it is inevitable that women will be the future leaders for our system,” Dr. Sperring said.

— What are the three most important things from a CEO perspective that a hospitalist should know?

“You have to have self-awareness…as a leader, are you a listener, are you a delegator?” Dr. Bailey said.

“Know where your organization wants to go,” Dr. Sperring said.

Dr. Chang is associate clinical professor of medicine and pediatrics at the University of California at San Diego School of Medicine, and a hospitalist at both UCSD Medical Center and Rady Children’s Hospital. He is pediatric editor of The Hospitalist.

Presenters

--- Welcome Remarks: Doug Carlson, MD, FAAP, chief of pediatric hospital medicine programs, St. Louis Children’s Hospital

--- The Next Phase of Delivery System Reform: Patrick Conway, MD, MSc, FAAP, MHM, deputy administrator for innovation and quality, CMO for the Centers for Medicare & Medicaid Services (CMS)

--- Hospitals and Health Systems: What’s on the Mind of Your CEO?: David J. Bailey, MD, MBA, president and CEO, the Nemours Foundation; Steve Narang, MD, MHCM, CEO, Banner Good Samaritan Medical Center, Phoenix, Ariz.; Jeff Sperring, MD, FAAP, president and CEO, Riley Hospital for Children at Indiana University Health, Indianapolis.

Summary

PHM 2014 began to heat up in steamy Orlando, as Dr. Carlson, chair of the PHM 2014 Organizing Committee, welcomed more than 800 pediatric hospitalists at the four-day annual meeting dedicated to pediatric hospital medicine.

Dr. Conway, a pediatric hospitalist prior to joining CMS, updated the crowd of ongoing reforms in the U.S. healthcare delivery system, with a focus on pediatrics. Healthcare delivery, Dr. Conway asserted, needs to move from an unsustainable, volume-driven, fee-for-service system to a people-centered, sustainable system where payment can be shaped by value-based purchasing, ACO-shared savings, and episode-based payments.

“Pediatrics,” Dr. Conway said, “is a leader in patient and family engagement, and population health.”

As such, the six goals of the CMS Quality Strategy align well with ongoing PHM efforts:

• Make care safer by reducing harm caused in care delivery;
•  Strengthen patient and family engagement as partners in their care;
•  Promote effective communication and coordination of care;
•  Promote effective prevention and treatment of chronic disease;
•  Work with communities to promote healthy living; and
•  Make care affordable.

Citing Maryland as an example, where a plan is being considered to shift 80% of hospital revenues to global models by 2018, Dr. Conway painted a picture of a rapidly-shifting reimbursement landscape that will soon be dominated by value-based purchasing, penalties for readmissions and healthcare-acquired conditions, and increasing emphasis on bundled payments, ACOs, and primary care medical homes.

“Hospitals are getting paid to keep people out of the hospital,” he said, and concurrently per capita spending on healthcare is now at historic lows. While pediatric quality measures are not as mature as those for adult patients, many opportunities for increasing value in pediatric care have been developed, such as the Choosing Wisely campaign and the Value in Inpatient Pediatrics (VIP) network.

Although not restricted to pediatrics, the CMS Partnership for Patients also aims to have a major impact on child health. Goals of a 40% reduction in HACs and 20% reduction in preventable 30-day readmissions have been set by the Partnership, with specific focus on 10 core patient-safety areas. Preliminary data have been promising, with a 9% reduction in HACs between 2010 and 2012 across all measures.

“This is a historical reduction,” said Dr. Conway, representing more than 500,000 patient harm events avoided, over 15,000 lives saved, and more than $4 billion in cost savings.

Within pediatrics, a number of research efforts have added to this reduction, including the Pediatric Research in Inpatient Settings (PRIS) Network, PHIS+, I-PASS, as well as several collaborative improvement networks.

Looking to the future, Medicaid and Children’s Health Insurance Program will continue to focus on quality initiatives and system transformation. These will include developing more pediatric-focused quality measures, improving health information technology, and continuing to award innovation in pediatrics. Pediatrics will continue to be a leader in these efforts, Dr. Conway said, because “we should care about longer time horizons.”

Four healthcare system CEOs also took the stage to answer questions from the audience, with Mark Shen, MD, president of Dell Children’s Medical Center, posing questions like a seasoned talk-show host. Panel members fielded a wide range of questions, including:

— How did you become a CEO?

“All I had to do was keep on saying ‘yes,’” Dr. Bailey said.

— What are you doing as a CEO to move from a fee-for-service system to a population-based system?

“We are still living in two different worlds…It depends on ACO penetration whether quality or volume will be the driver over the next 3-5 years,” Dr. Narang said.

“We have to create an accountable health community,” Dr. Shen said.

“The question is, how can you build a model that will allow you to flip the switch when this change occurs?” Dr. Sperring said.

— What is the role of hospitalists as care progresses from the most intensive but sometimes least appropriate site?

“I think the environment will drastically change, but there will be an ever enlarging role for hospitalists. … Hospitalists will likely be moving to LTACs, SNFs, even outpatient work.” Dr. Bailey said.

— If PHM fellowship becomes a requirement, will your hospital fund them?

“It’s hard to define what we do, but we know there are core competencies. … I don’t think we’re going to be at a point where certification will limit being a hospitalist any time soon,” Dr. Shen said.

— How can we make health care pricing more transparent?

“Why is it that in other industries, things are getting cheaper and higher quality, but in healthcare we seem to be going in the opposite direction?” Dr. Bailey said. “There has to be transparency for the patient. How about transparency for the provider? Every EMR should have a price for everything your order.”

— What do you think we can do to get more women into executive roles?

“Based on the percentages of women in medical school, residencies, and fellowships, I think it is inevitable that women will be the future leaders for our system,” Dr. Sperring said.

— What are the three most important things from a CEO perspective that a hospitalist should know?

“You have to have self-awareness…as a leader, are you a listener, are you a delegator?” Dr. Bailey said.

“Know where your organization wants to go,” Dr. Sperring said.

Dr. Chang is associate clinical professor of medicine and pediatrics at the University of California at San Diego School of Medicine, and a hospitalist at both UCSD Medical Center and Rady Children’s Hospital. He is pediatric editor of The Hospitalist.

Presenters

--- Welcome Remarks: Doug Carlson, MD, FAAP, chief of pediatric hospital medicine programs, St. Louis Children’s Hospital

--- The Next Phase of Delivery System Reform: Patrick Conway, MD, MSc, FAAP, MHM, deputy administrator for innovation and quality, CMO for the Centers for Medicare & Medicaid Services (CMS)

--- Hospitals and Health Systems: What’s on the Mind of Your CEO?: David J. Bailey, MD, MBA, president and CEO, the Nemours Foundation; Steve Narang, MD, MHCM, CEO, Banner Good Samaritan Medical Center, Phoenix, Ariz.; Jeff Sperring, MD, FAAP, president and CEO, Riley Hospital for Children at Indiana University Health, Indianapolis.

Summary

PHM 2014 began to heat up in steamy Orlando, as Dr. Carlson, chair of the PHM 2014 Organizing Committee, welcomed more than 800 pediatric hospitalists at the four-day annual meeting dedicated to pediatric hospital medicine.

Dr. Conway, a pediatric hospitalist prior to joining CMS, updated the crowd of ongoing reforms in the U.S. healthcare delivery system, with a focus on pediatrics. Healthcare delivery, Dr. Conway asserted, needs to move from an unsustainable, volume-driven, fee-for-service system to a people-centered, sustainable system where payment can be shaped by value-based purchasing, ACO-shared savings, and episode-based payments.

“Pediatrics,” Dr. Conway said, “is a leader in patient and family engagement, and population health.”

As such, the six goals of the CMS Quality Strategy align well with ongoing PHM efforts:

• Make care safer by reducing harm caused in care delivery;
•  Strengthen patient and family engagement as partners in their care;
•  Promote effective communication and coordination of care;
•  Promote effective prevention and treatment of chronic disease;
•  Work with communities to promote healthy living; and
•  Make care affordable.

Citing Maryland as an example, where a plan is being considered to shift 80% of hospital revenues to global models by 2018, Dr. Conway painted a picture of a rapidly-shifting reimbursement landscape that will soon be dominated by value-based purchasing, penalties for readmissions and healthcare-acquired conditions, and increasing emphasis on bundled payments, ACOs, and primary care medical homes.

“Hospitals are getting paid to keep people out of the hospital,” he said, and concurrently per capita spending on healthcare is now at historic lows. While pediatric quality measures are not as mature as those for adult patients, many opportunities for increasing value in pediatric care have been developed, such as the Choosing Wisely campaign and the Value in Inpatient Pediatrics (VIP) network.

Although not restricted to pediatrics, the CMS Partnership for Patients also aims to have a major impact on child health. Goals of a 40% reduction in HACs and 20% reduction in preventable 30-day readmissions have been set by the Partnership, with specific focus on 10 core patient-safety areas. Preliminary data have been promising, with a 9% reduction in HACs between 2010 and 2012 across all measures.

“This is a historical reduction,” said Dr. Conway, representing more than 500,000 patient harm events avoided, over 15,000 lives saved, and more than $4 billion in cost savings.

Within pediatrics, a number of research efforts have added to this reduction, including the Pediatric Research in Inpatient Settings (PRIS) Network, PHIS+, I-PASS, as well as several collaborative improvement networks.

Looking to the future, Medicaid and Children’s Health Insurance Program will continue to focus on quality initiatives and system transformation. These will include developing more pediatric-focused quality measures, improving health information technology, and continuing to award innovation in pediatrics. Pediatrics will continue to be a leader in these efforts, Dr. Conway said, because “we should care about longer time horizons.”

Four healthcare system CEOs also took the stage to answer questions from the audience, with Mark Shen, MD, president of Dell Children’s Medical Center, posing questions like a seasoned talk-show host. Panel members fielded a wide range of questions, including:

— How did you become a CEO?

“All I had to do was keep on saying ‘yes,’” Dr. Bailey said.

— What are you doing as a CEO to move from a fee-for-service system to a population-based system?

“We are still living in two different worlds…It depends on ACO penetration whether quality or volume will be the driver over the next 3-5 years,” Dr. Narang said.

“We have to create an accountable health community,” Dr. Shen said.

“The question is, how can you build a model that will allow you to flip the switch when this change occurs?” Dr. Sperring said.

— What is the role of hospitalists as care progresses from the most intensive but sometimes least appropriate site?

“I think the environment will drastically change, but there will be an ever enlarging role for hospitalists. … Hospitalists will likely be moving to LTACs, SNFs, even outpatient work.” Dr. Bailey said.

— If PHM fellowship becomes a requirement, will your hospital fund them?

“It’s hard to define what we do, but we know there are core competencies. … I don’t think we’re going to be at a point where certification will limit being a hospitalist any time soon,” Dr. Shen said.

— How can we make health care pricing more transparent?

“Why is it that in other industries, things are getting cheaper and higher quality, but in healthcare we seem to be going in the opposite direction?” Dr. Bailey said. “There has to be transparency for the patient. How about transparency for the provider? Every EMR should have a price for everything your order.”

— What do you think we can do to get more women into executive roles?

“Based on the percentages of women in medical school, residencies, and fellowships, I think it is inevitable that women will be the future leaders for our system,” Dr. Sperring said.

— What are the three most important things from a CEO perspective that a hospitalist should know?

“You have to have self-awareness…as a leader, are you a listener, are you a delegator?” Dr. Bailey said.

“Know where your organization wants to go,” Dr. Sperring said.

Dr. Chang is associate clinical professor of medicine and pediatrics at the University of California at San Diego School of Medicine, and a hospitalist at both UCSD Medical Center and Rady Children’s Hospital. He is pediatric editor of The Hospitalist.

Although an ultrasound is not required after uncomplicated placement of an intrauterine device (IUD) or during routine management of women who are doing well with an IUD, it is invaluable in the evaluation of patients who present with pain or other symptoms suggestive of IUD malpositioning.

In this article, we outline the sonographic features of the IUDs available today in the United States and describe the basics of localization by ultrasound.

Related articles: STOP relying on 2D ultrasound for IUD localization. Steven R. Goldstein, MD, and Chrystie Fujimoto, MD (August 2014)
Update on Contraception. Melissa J. Chen, MD, MPH, and Mitchell D. Creinin, MD (August 2014)

Ultrasound features of IUDsWhen positioned normally, an IUD is centrally located within the endometrial cavity, with the crossbar positioned in the fundal area.¹ Copper and progestin-releasing IUDs can be identified easily on ultrasound if one is familiar with their basic sonographic features:

• Copper IUD: The central stem is uniformly echogenic due to its copper coils (FIGURE 1)
• Levonorgestrel-releasing intrauterine system (LNG-IUS): The LNG-IUS consists of a plastic sleeve that contains the progestin and surrounds a central stem. This configuration causes acoustic shadowing and has a characteristic “laminated” sonographic appearance with parallel lines (FIGURE 2). The Mirena IUD has echogenic arms due to barium sulfate, as well as an echogenic distal tip, with acoustic shadowing from the stem. Skyla is similar except for a highly echogenic silver ring on the stem approximately 3 to 4 mm inferior to the crossbar. On occasion, the echogenic strings of Mirena and Skyla can be mistaken for the device.

Three-dimensional ultrasound is useful in imaging of an IUD. If a patient’s IUD cannot be visualized by ultrasound, plain radiography of the kidney, ureter, and bladder may be helpful. If an IUD is not apparent on plain film, consider that it may have been expelled.

Potential malpositioningA malpositioned IUD may be partially expelled, rotated, embedded in the myometrium, or perforating the uterine serosa.

Related article: Malpositioned IUDs: When you should intervene (and when you should not). Kari Braaten, MD, MPH, and Alisa B. Goldberg, MD, MPH (August 2012)

In a retrospective case-control study that compared 182 women with sonographicallyidentified malpositioned IUDs with 182 women with properly positioned IUDs, Braaten and colleagues found that suspected adenomyosis was associated with malpositioning (odds ratio [OR], 3.04; 95% confidence interval [CI], 1.08–8.52), but a history of vaginal delivery was protective (OR, 0.53; 95% CI, 0.32–0.87).² A distorted uterine cavity also increases the risk of malpositioning.³

Although no uterine perforations were reported in a review of the LNG-IUS, expulsions were reported and may be more common among women who use the IUD for heavy menstrual bleeding.⁴

Additional images

WE WANT TO HEAR FROM YOU! Share your thoughts on this article. Send your Letter to the Editor to: [email protected] 

Although an ultrasound is not required after uncomplicated placement of an intrauterine device (IUD) or during routine management of women who are doing well with an IUD, it is invaluable in the evaluation of patients who present with pain or other symptoms suggestive of IUD malpositioning.

In this article, we outline the sonographic features of the IUDs available today in the United States and describe the basics of localization by ultrasound.

Related articles: STOP relying on 2D ultrasound for IUD localization. Steven R. Goldstein, MD, and Chrystie Fujimoto, MD (August 2014)
Update on Contraception. Melissa J. Chen, MD, MPH, and Mitchell D. Creinin, MD (August 2014)

Ultrasound features of IUDsWhen positioned normally, an IUD is centrally located within the endometrial cavity, with the crossbar positioned in the fundal area.¹ Copper and progestin-releasing IUDs can be identified easily on ultrasound if one is familiar with their basic sonographic features:

• Copper IUD: The central stem is uniformly echogenic due to its copper coils (FIGURE 1)
• Levonorgestrel-releasing intrauterine system (LNG-IUS): The LNG-IUS consists of a plastic sleeve that contains the progestin and surrounds a central stem. This configuration causes acoustic shadowing and has a characteristic “laminated” sonographic appearance with parallel lines (FIGURE 2). The Mirena IUD has echogenic arms due to barium sulfate, as well as an echogenic distal tip, with acoustic shadowing from the stem. Skyla is similar except for a highly echogenic silver ring on the stem approximately 3 to 4 mm inferior to the crossbar. On occasion, the echogenic strings of Mirena and Skyla can be mistaken for the device.

Three-dimensional ultrasound is useful in imaging of an IUD. If a patient’s IUD cannot be visualized by ultrasound, plain radiography of the kidney, ureter, and bladder may be helpful. If an IUD is not apparent on plain film, consider that it may have been expelled.

Potential malpositioningA malpositioned IUD may be partially expelled, rotated, embedded in the myometrium, or perforating the uterine serosa.

Related article: Malpositioned IUDs: When you should intervene (and when you should not). Kari Braaten, MD, MPH, and Alisa B. Goldberg, MD, MPH (August 2012)

In a retrospective case-control study that compared 182 women with sonographicallyidentified malpositioned IUDs with 182 women with properly positioned IUDs, Braaten and colleagues found that suspected adenomyosis was associated with malpositioning (odds ratio [OR], 3.04; 95% confidence interval [CI], 1.08–8.52), but a history of vaginal delivery was protective (OR, 0.53; 95% CI, 0.32–0.87).² A distorted uterine cavity also increases the risk of malpositioning.³

Although no uterine perforations were reported in a review of the LNG-IUS, expulsions were reported and may be more common among women who use the IUD for heavy menstrual bleeding.⁴

Additional images

WE WANT TO HEAR FROM YOU! Share your thoughts on this article. Send your Letter to the Editor to: [email protected] 

Although an ultrasound is not required after uncomplicated placement of an intrauterine device (IUD) or during routine management of women who are doing well with an IUD, it is invaluable in the evaluation of patients who present with pain or other symptoms suggestive of IUD malpositioning.

In this article, we outline the sonographic features of the IUDs available today in the United States and describe the basics of localization by ultrasound.

Related articles: STOP relying on 2D ultrasound for IUD localization. Steven R. Goldstein, MD, and Chrystie Fujimoto, MD (August 2014)
Update on Contraception. Melissa J. Chen, MD, MPH, and Mitchell D. Creinin, MD (August 2014)

Ultrasound features of IUDsWhen positioned normally, an IUD is centrally located within the endometrial cavity, with the crossbar positioned in the fundal area.¹ Copper and progestin-releasing IUDs can be identified easily on ultrasound if one is familiar with their basic sonographic features:

• Copper IUD: The central stem is uniformly echogenic due to its copper coils (FIGURE 1)
• Levonorgestrel-releasing intrauterine system (LNG-IUS): The LNG-IUS consists of a plastic sleeve that contains the progestin and surrounds a central stem. This configuration causes acoustic shadowing and has a characteristic “laminated” sonographic appearance with parallel lines (FIGURE 2). The Mirena IUD has echogenic arms due to barium sulfate, as well as an echogenic distal tip, with acoustic shadowing from the stem. Skyla is similar except for a highly echogenic silver ring on the stem approximately 3 to 4 mm inferior to the crossbar. On occasion, the echogenic strings of Mirena and Skyla can be mistaken for the device.

Three-dimensional ultrasound is useful in imaging of an IUD. If a patient’s IUD cannot be visualized by ultrasound, plain radiography of the kidney, ureter, and bladder may be helpful. If an IUD is not apparent on plain film, consider that it may have been expelled.

Potential malpositioningA malpositioned IUD may be partially expelled, rotated, embedded in the myometrium, or perforating the uterine serosa.

Related article: Malpositioned IUDs: When you should intervene (and when you should not). Kari Braaten, MD, MPH, and Alisa B. Goldberg, MD, MPH (August 2012)

In a retrospective case-control study that compared 182 women with sonographicallyidentified malpositioned IUDs with 182 women with properly positioned IUDs, Braaten and colleagues found that suspected adenomyosis was associated with malpositioning (odds ratio [OR], 3.04; 95% confidence interval [CI], 1.08–8.52), but a history of vaginal delivery was protective (OR, 0.53; 95% CI, 0.32–0.87).² A distorted uterine cavity also increases the risk of malpositioning.³

Although no uterine perforations were reported in a review of the LNG-IUS, expulsions were reported and may be more common among women who use the IUD for heavy menstrual bleeding.⁴

Additional images

WE WANT TO HEAR FROM YOU! Share your thoughts on this article. Send your Letter to the Editor to: [email protected] 

One of the hottest and most controversial topics in gynecologic surgery, at present, is laparoscopic electromechanical power morcellation.

In April of this year, the Food and Drug Administration sent out a news release regarding the potential risk of spread of sarcomatous tissue at the time of this procedure. In that release, the agency "discouraged" use of laparoscopic electromechanical power morcellation. Responses came from many societies, including the American College of Obstetricians and Gynecologists and the AAGL, which indicated that laparoscopic electromechanical power morcellation could be used if proper care was taken.

I am personally proud that the Master Class in Gynecologic Surgery has been very proactive and diligent in its discussion of laparoscopic electromechanical power morcellation. This is the third in our series regarding this topic.

In our first segment, I discussed the issue of electromechanical power morcellation relative to the inadvertent spread of sarcomatous tissue. In our second in the series, Dr. Ceana Nezhat, Dr. Bernard Taylor, and Dr. Tony Shibley discussed ways to minimize this risk – including morcellation in a bag. Videos of their individual techniques of electromechanical power morcellation, as well as that of Dr. Douglas Brown, can be viewed on SurgeryU. In addition, my partner, Dr. Aarathi Cholkeri-Singh, and I have a video on SurgeryU illustrating our technique of morcellation in a bag.

This current Master Class in Gynecologic Surgery is now devoted to hysteroscopic electromechanical power morcellation. In my discussions with physicians throughout the country relative to this technique, it has become evident that some institutions have not only banned the use of electromechanical power morcellation at time of laparoscopy, but have also stopped usage of hysteroscopic electromechanical power morcellation. While neither the FDA nor the lay press has ever questioned the use of hysteroscopic morcellators, I believe it is imperative that this topic be reviewed. I am sure that it will be obvious that hysteroscopic electromechanical power morcellation has thus far proved to be a safe and effective treatment option for various pathologic entities, including submucosal uterine fibroids.

To review hysteroscopic electromechanical power morcellation, I have invited Dr. Joseph S. Sanfilippo, professor of obstetrics, gynecology, and reproductive sciences at the University of Pittsburgh and director of the division of reproductive endocrinology and infertility at Magee-Womens Hospital in Pittsburgh.

Dr. Sanfilippo is a lecturer and educator. He has written an extensive number of peer-reviewed articles, and has been a contributor to several textbooks. In addition, Dr. Sanfilippo has been and remains a very active member of the AAGL.

It is a pleasure and honor to welcome Dr. Sanfilippo to this edition of the Master Class in Gynecologic Surgery, the third installment on morcellation.

Dr. Miller is clinical associate professor at the University of Illinois at Chicago, immediate past president of the International Society for Gynecologic Endoscopy, and a past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville, Ill., and Schaumburg, Ill.; the director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill. and the medical editor of this column, Master Class. Dr. Miller disclosed that he is a consultant to Hologic and is on the speakers bureau for Smith & Nephew. Videos for this and past Master Class in Gynecology Surgery articles can be viewed on SurgeryU.

One of the hottest and most controversial topics in gynecologic surgery, at present, is laparoscopic electromechanical power morcellation.

In April of this year, the Food and Drug Administration sent out a news release regarding the potential risk of spread of sarcomatous tissue at the time of this procedure. In that release, the agency "discouraged" use of laparoscopic electromechanical power morcellation. Responses came from many societies, including the American College of Obstetricians and Gynecologists and the AAGL, which indicated that laparoscopic electromechanical power morcellation could be used if proper care was taken.

I am personally proud that the Master Class in Gynecologic Surgery has been very proactive and diligent in its discussion of laparoscopic electromechanical power morcellation. This is the third in our series regarding this topic.

In our first segment, I discussed the issue of electromechanical power morcellation relative to the inadvertent spread of sarcomatous tissue. In our second in the series, Dr. Ceana Nezhat, Dr. Bernard Taylor, and Dr. Tony Shibley discussed ways to minimize this risk – including morcellation in a bag. Videos of their individual techniques of electromechanical power morcellation, as well as that of Dr. Douglas Brown, can be viewed on SurgeryU. In addition, my partner, Dr. Aarathi Cholkeri-Singh, and I have a video on SurgeryU illustrating our technique of morcellation in a bag.

This current Master Class in Gynecologic Surgery is now devoted to hysteroscopic electromechanical power morcellation. In my discussions with physicians throughout the country relative to this technique, it has become evident that some institutions have not only banned the use of electromechanical power morcellation at time of laparoscopy, but have also stopped usage of hysteroscopic electromechanical power morcellation. While neither the FDA nor the lay press has ever questioned the use of hysteroscopic morcellators, I believe it is imperative that this topic be reviewed. I am sure that it will be obvious that hysteroscopic electromechanical power morcellation has thus far proved to be a safe and effective treatment option for various pathologic entities, including submucosal uterine fibroids.

To review hysteroscopic electromechanical power morcellation, I have invited Dr. Joseph S. Sanfilippo, professor of obstetrics, gynecology, and reproductive sciences at the University of Pittsburgh and director of the division of reproductive endocrinology and infertility at Magee-Womens Hospital in Pittsburgh.

Dr. Sanfilippo is a lecturer and educator. He has written an extensive number of peer-reviewed articles, and has been a contributor to several textbooks. In addition, Dr. Sanfilippo has been and remains a very active member of the AAGL.

It is a pleasure and honor to welcome Dr. Sanfilippo to this edition of the Master Class in Gynecologic Surgery, the third installment on morcellation.

Dr. Miller is clinical associate professor at the University of Illinois at Chicago, immediate past president of the International Society for Gynecologic Endoscopy, and a past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville, Ill., and Schaumburg, Ill.; the director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill. and the medical editor of this column, Master Class. Dr. Miller disclosed that he is a consultant to Hologic and is on the speakers bureau for Smith & Nephew. Videos for this and past Master Class in Gynecology Surgery articles can be viewed on SurgeryU.

One of the hottest and most controversial topics in gynecologic surgery, at present, is laparoscopic electromechanical power morcellation.

In April of this year, the Food and Drug Administration sent out a news release regarding the potential risk of spread of sarcomatous tissue at the time of this procedure. In that release, the agency "discouraged" use of laparoscopic electromechanical power morcellation. Responses came from many societies, including the American College of Obstetricians and Gynecologists and the AAGL, which indicated that laparoscopic electromechanical power morcellation could be used if proper care was taken.

I am personally proud that the Master Class in Gynecologic Surgery has been very proactive and diligent in its discussion of laparoscopic electromechanical power morcellation. This is the third in our series regarding this topic.

In our first segment, I discussed the issue of electromechanical power morcellation relative to the inadvertent spread of sarcomatous tissue. In our second in the series, Dr. Ceana Nezhat, Dr. Bernard Taylor, and Dr. Tony Shibley discussed ways to minimize this risk – including morcellation in a bag. Videos of their individual techniques of electromechanical power morcellation, as well as that of Dr. Douglas Brown, can be viewed on SurgeryU. In addition, my partner, Dr. Aarathi Cholkeri-Singh, and I have a video on SurgeryU illustrating our technique of morcellation in a bag.

This current Master Class in Gynecologic Surgery is now devoted to hysteroscopic electromechanical power morcellation. In my discussions with physicians throughout the country relative to this technique, it has become evident that some institutions have not only banned the use of electromechanical power morcellation at time of laparoscopy, but have also stopped usage of hysteroscopic electromechanical power morcellation. While neither the FDA nor the lay press has ever questioned the use of hysteroscopic morcellators, I believe it is imperative that this topic be reviewed. I am sure that it will be obvious that hysteroscopic electromechanical power morcellation has thus far proved to be a safe and effective treatment option for various pathologic entities, including submucosal uterine fibroids.

To review hysteroscopic electromechanical power morcellation, I have invited Dr. Joseph S. Sanfilippo, professor of obstetrics, gynecology, and reproductive sciences at the University of Pittsburgh and director of the division of reproductive endocrinology and infertility at Magee-Womens Hospital in Pittsburgh.

Dr. Sanfilippo is a lecturer and educator. He has written an extensive number of peer-reviewed articles, and has been a contributor to several textbooks. In addition, Dr. Sanfilippo has been and remains a very active member of the AAGL.

It is a pleasure and honor to welcome Dr. Sanfilippo to this edition of the Master Class in Gynecologic Surgery, the third installment on morcellation.

Dr. Miller is clinical associate professor at the University of Illinois at Chicago, immediate past president of the International Society for Gynecologic Endoscopy, and a past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville, Ill., and Schaumburg, Ill.; the director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill. and the medical editor of this column, Master Class. Dr. Miller disclosed that he is a consultant to Hologic and is on the speakers bureau for Smith & Nephew. Videos for this and past Master Class in Gynecology Surgery articles can be viewed on SurgeryU.

Submucous leiomyomas are the most problematic type of fibroid and have been associated with abnormal uterine bleeding, infertility, and other clinical issues. Treatment has been shown to be effective in improving fertility and success rates with assisted reproduction.

Newer hysteroscopic surgical techniques and morcellation technology allow us to remove not only polyps, but selected submucous myomas, in a fashion that is not only minimally invasive but that also raises few if any concerns about spreading or upstaging an unsuspected leiomyosarcoma. In this respect, the controversy over laparoscopic power morcellation does not extend to hysteroscopic morcellation.

Such a distinction was made during opening remarks at a meeting in June 2014 of the Obstetrics & Gynecology Devices Panel of the Food and Drug Administration’s Medical Devices Advisory Committee, which was charged with addressing such concerns.

Dr. Aron Yustein, deputy director of clinical affairs and chief medical officer of the FDA’s Office of Surveillance and Biometrics, explained that the panel would not address hysteroscopic morcellators "as we do not believe that when used [as intended], they pose the same risk" as that of laparoscopic morcellation in terms of potentially disseminating and upstaging an undetected uterine malignancy.

In hysteroscopic morcellation, tissue is contained and delivered through the morcellation system into a trap, or collecting pouch. This allows for complete capture and histopathologic assessment of all fragments extracted from the uterine cavity.

Numerous equipment options are currently available to gynecologic surgeons for hysteroscopically-guided myomectomy: Newer systems such as the Gynecare VersaPoint (Ethicon Endo-Surgery), and the Symphion system (Boston Scientific) facilitate bipolar electrosurgical resection. MyoSure (Hologic) and TRUCLEAR (Smith & Nephew), on the other hand, are hysteroscopic morcellators; they both use mechanical energy rather than high-frequency electrical energy to simultaneously cut and aspirate tissue.

Common to each of these options are advanced, automated fluid management systems that continuously measure distending media input and output, intrauterine distension pressure, and fluid deficit volume throughout the procedure. Such monitoring is critical to preventing excess fluid absorption and its associated complications. The new fluid management systems allow excellent visualization of the intrauterine cavity.

Benefit of Treatment

Leiomyomas, synonymously known as myomas, are among the uterine bleeding abnormalities included in a new classification system introduced in 2011 by the International Federation of Gynecology and Obstetrics. The system classifies the causes of abnormal uterine bleeding in reproductive-aged women; it is known by the acronym PALM-COEIN, for polyp, adenomyosis, leiomyoma, malignancy and hyperplasia, coagulopathy, ovulatory dysfunction, endometrial, iatrogenic, and not yet classified.

In a practice bulletin published in 2012, the American College of Obstetricians and Gynecologists endorsed the nomenclature system and provided guidelines for evaluating reproductive-aged patients with abnormal uterine bleeding (Obstet. Gynecol. 2012;120:197-206).

The diagnosis and management of submucous leiomyomas is particularly important in cases of infertility, as these types of myomas (compared with intramural or subserosal) appear to have the greatest impact on pregnancy and implantation rates.

In general, uterine myomas are found in 5%-10% of women with infertility. In 1%-3% of infertility patients, myomas are the only abnormal findings. As described in a literature review, it is believed that myomas may interfere with sperm transport or access, and with implantation. Endometrial cavity deformity, cornual ostia obstruction, altered uterine contractility, and altered endometrial development may each play a role (Obstet. Gynecol. Clin. North Am. 2006;33:145-52).

Studies evaluating the impact of myomectomy on fertility outcomes provide evidence that submucous myomas should be removed before assisted reproductive technology/in vitro fertilization. According to the AAGL’s practice guidelines on the diagnosis and management of submucous leiomyomas, it "seems clear from high-quality studies that pregnancy rates are higher after myomectomy than no or ‘placebo’ procedures" (J. Minim. Invasive Gynecol. 2012;19:152-71).

The most widely used system for categorizing submucous myomas, developed by the European Society of Gynecological Endoscopy (ESGE), breaks them into three subtypes according to how much of the lesion’s diameter is contained within the myometrium: Type 0 myomas are entirely within the endometrial cavity, while type I have less than 50% myometrial extension, and type II are 50% or more within the myometrium.

It is the ESGE type 0 submucous myomas that are appropriate for resectoscopic surgery.

(Another system known as the STEPW classification system adds other categories, taking into account factors such as topography, extension of the base, and penetration. This system is becoming more recognized and may be useful in the future for evaluating patients for resectoscopic surgery and predicting outcomes, but it is not being used as often as the ESGE classification system.)

As the AAGL guidelines state, diagnosis is generally achieved with one or a combination of hysteroscopic and radiological techniques that may include transvaginal ultrasonography, saline infusion sonohysterography, and magnetic resonance imaging.

Research on safety

Hysteroscopic morcellation is the most recent operative hysteroscopic technique to be employed for the removal of submucous leiomyomas. In lieu of concerns about laparoscopic power morcellation, the question arises: Should we be concerned about cancer and hysteroscopy?

Numerous studies have looked at the question of whether hysteroscopic procedures produce intraperitoneal spread of endometrial cancer cells and, if so, whether this results in the "upstaging" of unsuspected cancer. Much of the research has involved diagnostic hysteroscopy, which includes the use of intrauterine cavity distension with fluid media, similar to that of operative hysteroscopy.

Investigators at Memorial Sloan-Kettering Cancer Center in New York, for instance, looked retrospectively at whether initial diagnostic procedures were associated with abnormal peritoneal washings (PW) in almost 300 women who were treated for endometrial carcinoma with hysterectomy and intraoperative PW. They found no association between the initial diagnostic procedures, including hysteroscopy, and the results of peritoneal cytology (Cancer 2000;90:143-7).

Similarly, physicians in the Czech Republic compared PW done at the start of surgery in 134 patients whose endometrial carcinoma had been diagnosed by hysteroscopy with 61 patients whose cancer had been diagnosed by dilation and curettage. The results, they said, suggest that hysteroscopy does not increase the risk of penetration of tumor cells into the peritoneal cavity more than does D&C (Eur. J. Gynaecol. Oncol. 2001; 22:342-4).

Another retrospective study of 146 patients with endometrial cancer who underwent either D&C or office hysteroscopy showed that diagnostic hysteroscopy did not increase the risk of adnexal, abdominal, or retroperitoneal lymph node metastases, compared with D&C, although there was an increase in positive peritoneal cytology (Gynecol. Oncol. 2007;107:94-8).

At least two broader reviews/meta-analyses also show no evidence for an upstaging of cancer from hysteroscopic procedures performed in the presence of cancer.

A meta-analysis of 19 studies suggests that preoperative hysteroscopy resulted in a statistically significant higher risk of positive peritoneal cytology compared with no hysteroscopy, but there was no evidence to support avoiding diagnostic hysteroscopy prior to surgical intervention for endometrial cancer (Fertil. Steril. 2011;96:957-61).

A literature review covering studies published between 1980 and 2001 showed that while there might be an increased risk of peritoneal contamination by cancer cells after hysteroscopy, there is no evidence that these patients fare worse compared with patients who have undergone other diagnostic procedures (Obstet. Gynecol. Surv. 2004;59:280-4).

Surgical rather than diagnostic hysterectomy was the focus of one recent case report from Italy. The patient was a 52-year-old nulliparous woman with a leiomyosarcoma detected 2 months after a hysteroscopic resection of a presumed myoma. After resection, the myoma was determined to be an atypical "mitotically active" leiomyoma (Eur. J. Gynaecol. Oncol. 2012;33:656-7).

The authors emphasize the "rarity" of this particular finding, and the available data overall offer no evidence for an upstaging of unsuspected endometrial cancer with hysteroscopic procedures. While hysteroscopy should not be used in cases of known cancer, as it does not facilitate treatment, there are no data that should lead us to be concerned about adverse effects in the presence of cancer.

Current systems

Traditionally, resectoscopy has posed numerous challenges for the removal of intracavitary lesions: Tissue removal has been difficult and time consuming. Visibility has been disrupted by gas bubbles, tissue fragments, blood clots, and cervical mucus. Multiple insertions have been required, raising the risk of embolism (a "piston effect"). There also have been concerns about the risk of perforation and about the learning curve.

Older resectoscopes – loop-electrode resectoscopes – were designed for monopolar electrosurgery, which requires the use of nonconductive, electrolyte-free solutions for uterine distension. This limited the amount of fluid absorption that could occur before procedures needed to be stopped.

The incorporation of bipolar instrumentation – and more recently, the development of hysteroscopic morcellation systems that use reciprocating blades driven by mechanical energy rather radiofrequency electrical energy – have enabled the use of electrolyte-containing distending media (saline or Ringer’s Lactate) and, consequently, a higher allowable amount of fluid absorption.

Saline is an ideal medium: It is isotonic, nonhemolytic, nonconductive, nontoxic, and rapidly cleared. The AAGL’s Practice Guidelines for the Management of Hysteroscopic Distending Media lists an intravasation safety limit of 2,500 cc for isotonic solution, compared with a maximum limit of 1,000 cc when using hypotonic solutions (J. Minim. Invasive Gynecol. 2013;20:137-48). This higher cut-off means we can achieve the vast majority of myoma resections in one sitting.

Hysteroscopic morcellators have additional advantages, in my experience. They allow for the use of smaller-diameter hysteroscopes, which in turn requires less cervical dilation. They also have improved reciprocating blades that enable the resection of myomas in addition to endometrial polyps. Previously, the focus was primarily on hysteroscopic polypectomy.

As technology has advanced with tissue removal being instantaneous, there is simultaneous cutting and extraction, and resections are therefore quicker. Overall, there is better visualization and a lower risk of perforation. The learning curve is quicker.

In a randomized trial focused on polypectomy, hysteroscopic mechanical morcellation was superior to electrosurgical resection. The multicenter trial from the United Kingdom compared the two modalities for removal of endometrial polyps in 121 women, and found that hysteroscopic morcellation with a mechanical-based morcellator was significantly quicker for polyp removal (a median time of 5½ minutes, versus 10 minutes, approximately), less painful and more acceptable to women, and more likely to completely remove the polyps (98% compared with 83%), the investigators reported (Obstet. Gynecol. 2014;123:745-51).

The only surgical complications in either group were vasovagal reactions, which occurred in 2% (1 out of 62) and 10% (6 out of 59) of the hysteroscopic morcellation and electrosurgical resection procedures, respectively. There was one serious adverse event, with a woman treated 2 weeks after morcellation for endomyometritis.

Indeed, infection, perforation and cervical trauma, mechanical complications, and media-related complications (intravasation and gas embolism) are risks with all modalities of operative hysteroscopy and all indications. Bleeding appears rarely to be a problem with mechanical morcellation, however, as does perforation. Certainly, perforation that occurs with a nonelectrical morcellator will be significantly less complicating than when energy is engaged.

Our experience overall with resections of intracavitary polyps and small myomas via hysteroscopic morcellation in 50 cases indicates a mean operating time of 9.4 min, a mean fluid deficit of 329 milliliters, and a mean surgeon rating of 9, with 10 representing an excellent rating. We have had no intra-or postoperative hemorrhage, no obvious electrolyte changes, and uneventful recoveries.

The majority of our hysteroscopic morcellations are done under conscious sedation with the addition of a local anesthetic in the form of a paracervical block. A 200-mcg vaginal tablet of misoprostol (Cytotec) off label the night before surgery is the pretreatment strategy I most often employ for cervical preparation. To prevent infection, I prescribe one dose of a broad-spectrum antibiotic, such as a cephalosporin, to my patients receiving myomectomies.

To learn hysteroscopic morcellation, one should begin with polypectomy and move to myomectomy once comfortable. With the TRUCLEAR system, the system I use most frequently, the hysteroscopic sheath should be inserted with the obturator in place to lessen cervical trauma.

The early flow of saline will not only aid the insertion process, it will assist in achieving good visualization quickly, as will increasing the uterine pressure setting at the start of the process. After the beginning of the procedure, however, pressure is maintained at the lowest setting capable of achieving adequate distension and providing good visualization.

When morcellating pathology, one should work from the periphery to the base. The pathology is kept between the morcellator blade opening and the optics of the camera. Large myomas can be split in half, with each half approached from distal to proximal.

Running the morcellator in the open cavity for a short time will aid in clearing the visual field of debris. Overall, however, visualization with today’s hysteroscopic morcellators and advancements in fluid management is excellent. In our experience, hysteroscopic morcellation is proving to be a safe and effective tool for performing myomectomy and addressing problems of infertility and abnormal uterine bleeding.

Dr. Sanfilippo is professor of obstetrics, gynecology, and reproductive sciences at the University of Pittsburgh and director of the division of reproductive endocrinology and infertility at Magee-Womens Hospital in Pittsburgh. He is on the advisory board for Bayer Healthcare and Smith &Nephew. A lecturer and educator, Dr. Sanfilippo has written peer-reviewed articles and has been a contributor to several textbooks. He is a member of the AAGL.

Submucous leiomyomas are the most problematic type of fibroid and have been associated with abnormal uterine bleeding, infertility, and other clinical issues. Treatment has been shown to be effective in improving fertility and success rates with assisted reproduction.

Newer hysteroscopic surgical techniques and morcellation technology allow us to remove not only polyps, but selected submucous myomas, in a fashion that is not only minimally invasive but that also raises few if any concerns about spreading or upstaging an unsuspected leiomyosarcoma. In this respect, the controversy over laparoscopic power morcellation does not extend to hysteroscopic morcellation.

Such a distinction was made during opening remarks at a meeting in June 2014 of the Obstetrics & Gynecology Devices Panel of the Food and Drug Administration’s Medical Devices Advisory Committee, which was charged with addressing such concerns.

Dr. Aron Yustein, deputy director of clinical affairs and chief medical officer of the FDA’s Office of Surveillance and Biometrics, explained that the panel would not address hysteroscopic morcellators "as we do not believe that when used [as intended], they pose the same risk" as that of laparoscopic morcellation in terms of potentially disseminating and upstaging an undetected uterine malignancy.

In hysteroscopic morcellation, tissue is contained and delivered through the morcellation system into a trap, or collecting pouch. This allows for complete capture and histopathologic assessment of all fragments extracted from the uterine cavity.

Numerous equipment options are currently available to gynecologic surgeons for hysteroscopically-guided myomectomy: Newer systems such as the Gynecare VersaPoint (Ethicon Endo-Surgery), and the Symphion system (Boston Scientific) facilitate bipolar electrosurgical resection. MyoSure (Hologic) and TRUCLEAR (Smith & Nephew), on the other hand, are hysteroscopic morcellators; they both use mechanical energy rather than high-frequency electrical energy to simultaneously cut and aspirate tissue.

Common to each of these options are advanced, automated fluid management systems that continuously measure distending media input and output, intrauterine distension pressure, and fluid deficit volume throughout the procedure. Such monitoring is critical to preventing excess fluid absorption and its associated complications. The new fluid management systems allow excellent visualization of the intrauterine cavity.

Benefit of Treatment

Leiomyomas, synonymously known as myomas, are among the uterine bleeding abnormalities included in a new classification system introduced in 2011 by the International Federation of Gynecology and Obstetrics. The system classifies the causes of abnormal uterine bleeding in reproductive-aged women; it is known by the acronym PALM-COEIN, for polyp, adenomyosis, leiomyoma, malignancy and hyperplasia, coagulopathy, ovulatory dysfunction, endometrial, iatrogenic, and not yet classified.

In a practice bulletin published in 2012, the American College of Obstetricians and Gynecologists endorsed the nomenclature system and provided guidelines for evaluating reproductive-aged patients with abnormal uterine bleeding (Obstet. Gynecol. 2012;120:197-206).

The diagnosis and management of submucous leiomyomas is particularly important in cases of infertility, as these types of myomas (compared with intramural or subserosal) appear to have the greatest impact on pregnancy and implantation rates.

In general, uterine myomas are found in 5%-10% of women with infertility. In 1%-3% of infertility patients, myomas are the only abnormal findings. As described in a literature review, it is believed that myomas may interfere with sperm transport or access, and with implantation. Endometrial cavity deformity, cornual ostia obstruction, altered uterine contractility, and altered endometrial development may each play a role (Obstet. Gynecol. Clin. North Am. 2006;33:145-52).

Studies evaluating the impact of myomectomy on fertility outcomes provide evidence that submucous myomas should be removed before assisted reproductive technology/in vitro fertilization. According to the AAGL’s practice guidelines on the diagnosis and management of submucous leiomyomas, it "seems clear from high-quality studies that pregnancy rates are higher after myomectomy than no or ‘placebo’ procedures" (J. Minim. Invasive Gynecol. 2012;19:152-71).

The most widely used system for categorizing submucous myomas, developed by the European Society of Gynecological Endoscopy (ESGE), breaks them into three subtypes according to how much of the lesion’s diameter is contained within the myometrium: Type 0 myomas are entirely within the endometrial cavity, while type I have less than 50% myometrial extension, and type II are 50% or more within the myometrium.

It is the ESGE type 0 submucous myomas that are appropriate for resectoscopic surgery.

(Another system known as the STEPW classification system adds other categories, taking into account factors such as topography, extension of the base, and penetration. This system is becoming more recognized and may be useful in the future for evaluating patients for resectoscopic surgery and predicting outcomes, but it is not being used as often as the ESGE classification system.)

As the AAGL guidelines state, diagnosis is generally achieved with one or a combination of hysteroscopic and radiological techniques that may include transvaginal ultrasonography, saline infusion sonohysterography, and magnetic resonance imaging.

Research on safety

Hysteroscopic morcellation is the most recent operative hysteroscopic technique to be employed for the removal of submucous leiomyomas. In lieu of concerns about laparoscopic power morcellation, the question arises: Should we be concerned about cancer and hysteroscopy?

Numerous studies have looked at the question of whether hysteroscopic procedures produce intraperitoneal spread of endometrial cancer cells and, if so, whether this results in the "upstaging" of unsuspected cancer. Much of the research has involved diagnostic hysteroscopy, which includes the use of intrauterine cavity distension with fluid media, similar to that of operative hysteroscopy.

Investigators at Memorial Sloan-Kettering Cancer Center in New York, for instance, looked retrospectively at whether initial diagnostic procedures were associated with abnormal peritoneal washings (PW) in almost 300 women who were treated for endometrial carcinoma with hysterectomy and intraoperative PW. They found no association between the initial diagnostic procedures, including hysteroscopy, and the results of peritoneal cytology (Cancer 2000;90:143-7).

Similarly, physicians in the Czech Republic compared PW done at the start of surgery in 134 patients whose endometrial carcinoma had been diagnosed by hysteroscopy with 61 patients whose cancer had been diagnosed by dilation and curettage. The results, they said, suggest that hysteroscopy does not increase the risk of penetration of tumor cells into the peritoneal cavity more than does D&C (Eur. J. Gynaecol. Oncol. 2001; 22:342-4).

Another retrospective study of 146 patients with endometrial cancer who underwent either D&C or office hysteroscopy showed that diagnostic hysteroscopy did not increase the risk of adnexal, abdominal, or retroperitoneal lymph node metastases, compared with D&C, although there was an increase in positive peritoneal cytology (Gynecol. Oncol. 2007;107:94-8).

At least two broader reviews/meta-analyses also show no evidence for an upstaging of cancer from hysteroscopic procedures performed in the presence of cancer.

A meta-analysis of 19 studies suggests that preoperative hysteroscopy resulted in a statistically significant higher risk of positive peritoneal cytology compared with no hysteroscopy, but there was no evidence to support avoiding diagnostic hysteroscopy prior to surgical intervention for endometrial cancer (Fertil. Steril. 2011;96:957-61).

A literature review covering studies published between 1980 and 2001 showed that while there might be an increased risk of peritoneal contamination by cancer cells after hysteroscopy, there is no evidence that these patients fare worse compared with patients who have undergone other diagnostic procedures (Obstet. Gynecol. Surv. 2004;59:280-4).

Surgical rather than diagnostic hysterectomy was the focus of one recent case report from Italy. The patient was a 52-year-old nulliparous woman with a leiomyosarcoma detected 2 months after a hysteroscopic resection of a presumed myoma. After resection, the myoma was determined to be an atypical "mitotically active" leiomyoma (Eur. J. Gynaecol. Oncol. 2012;33:656-7).

The authors emphasize the "rarity" of this particular finding, and the available data overall offer no evidence for an upstaging of unsuspected endometrial cancer with hysteroscopic procedures. While hysteroscopy should not be used in cases of known cancer, as it does not facilitate treatment, there are no data that should lead us to be concerned about adverse effects in the presence of cancer.

Current systems

Traditionally, resectoscopy has posed numerous challenges for the removal of intracavitary lesions: Tissue removal has been difficult and time consuming. Visibility has been disrupted by gas bubbles, tissue fragments, blood clots, and cervical mucus. Multiple insertions have been required, raising the risk of embolism (a "piston effect"). There also have been concerns about the risk of perforation and about the learning curve.

Older resectoscopes – loop-electrode resectoscopes – were designed for monopolar electrosurgery, which requires the use of nonconductive, electrolyte-free solutions for uterine distension. This limited the amount of fluid absorption that could occur before procedures needed to be stopped.

The incorporation of bipolar instrumentation – and more recently, the development of hysteroscopic morcellation systems that use reciprocating blades driven by mechanical energy rather radiofrequency electrical energy – have enabled the use of electrolyte-containing distending media (saline or Ringer’s Lactate) and, consequently, a higher allowable amount of fluid absorption.

Saline is an ideal medium: It is isotonic, nonhemolytic, nonconductive, nontoxic, and rapidly cleared. The AAGL’s Practice Guidelines for the Management of Hysteroscopic Distending Media lists an intravasation safety limit of 2,500 cc for isotonic solution, compared with a maximum limit of 1,000 cc when using hypotonic solutions (J. Minim. Invasive Gynecol. 2013;20:137-48). This higher cut-off means we can achieve the vast majority of myoma resections in one sitting.

Hysteroscopic morcellators have additional advantages, in my experience. They allow for the use of smaller-diameter hysteroscopes, which in turn requires less cervical dilation. They also have improved reciprocating blades that enable the resection of myomas in addition to endometrial polyps. Previously, the focus was primarily on hysteroscopic polypectomy.

As technology has advanced with tissue removal being instantaneous, there is simultaneous cutting and extraction, and resections are therefore quicker. Overall, there is better visualization and a lower risk of perforation. The learning curve is quicker.

In a randomized trial focused on polypectomy, hysteroscopic mechanical morcellation was superior to electrosurgical resection. The multicenter trial from the United Kingdom compared the two modalities for removal of endometrial polyps in 121 women, and found that hysteroscopic morcellation with a mechanical-based morcellator was significantly quicker for polyp removal (a median time of 5½ minutes, versus 10 minutes, approximately), less painful and more acceptable to women, and more likely to completely remove the polyps (98% compared with 83%), the investigators reported (Obstet. Gynecol. 2014;123:745-51).

The only surgical complications in either group were vasovagal reactions, which occurred in 2% (1 out of 62) and 10% (6 out of 59) of the hysteroscopic morcellation and electrosurgical resection procedures, respectively. There was one serious adverse event, with a woman treated 2 weeks after morcellation for endomyometritis.

Indeed, infection, perforation and cervical trauma, mechanical complications, and media-related complications (intravasation and gas embolism) are risks with all modalities of operative hysteroscopy and all indications. Bleeding appears rarely to be a problem with mechanical morcellation, however, as does perforation. Certainly, perforation that occurs with a nonelectrical morcellator will be significantly less complicating than when energy is engaged.

Our experience overall with resections of intracavitary polyps and small myomas via hysteroscopic morcellation in 50 cases indicates a mean operating time of 9.4 min, a mean fluid deficit of 329 milliliters, and a mean surgeon rating of 9, with 10 representing an excellent rating. We have had no intra-or postoperative hemorrhage, no obvious electrolyte changes, and uneventful recoveries.

The majority of our hysteroscopic morcellations are done under conscious sedation with the addition of a local anesthetic in the form of a paracervical block. A 200-mcg vaginal tablet of misoprostol (Cytotec) off label the night before surgery is the pretreatment strategy I most often employ for cervical preparation. To prevent infection, I prescribe one dose of a broad-spectrum antibiotic, such as a cephalosporin, to my patients receiving myomectomies.

To learn hysteroscopic morcellation, one should begin with polypectomy and move to myomectomy once comfortable. With the TRUCLEAR system, the system I use most frequently, the hysteroscopic sheath should be inserted with the obturator in place to lessen cervical trauma.

The early flow of saline will not only aid the insertion process, it will assist in achieving good visualization quickly, as will increasing the uterine pressure setting at the start of the process. After the beginning of the procedure, however, pressure is maintained at the lowest setting capable of achieving adequate distension and providing good visualization.

When morcellating pathology, one should work from the periphery to the base. The pathology is kept between the morcellator blade opening and the optics of the camera. Large myomas can be split in half, with each half approached from distal to proximal.

Running the morcellator in the open cavity for a short time will aid in clearing the visual field of debris. Overall, however, visualization with today’s hysteroscopic morcellators and advancements in fluid management is excellent. In our experience, hysteroscopic morcellation is proving to be a safe and effective tool for performing myomectomy and addressing problems of infertility and abnormal uterine bleeding.

Dr. Sanfilippo is professor of obstetrics, gynecology, and reproductive sciences at the University of Pittsburgh and director of the division of reproductive endocrinology and infertility at Magee-Womens Hospital in Pittsburgh. He is on the advisory board for Bayer Healthcare and Smith &Nephew. A lecturer and educator, Dr. Sanfilippo has written peer-reviewed articles and has been a contributor to several textbooks. He is a member of the AAGL.

Submucous leiomyomas are the most problematic type of fibroid and have been associated with abnormal uterine bleeding, infertility, and other clinical issues. Treatment has been shown to be effective in improving fertility and success rates with assisted reproduction.

Newer hysteroscopic surgical techniques and morcellation technology allow us to remove not only polyps, but selected submucous myomas, in a fashion that is not only minimally invasive but that also raises few if any concerns about spreading or upstaging an unsuspected leiomyosarcoma. In this respect, the controversy over laparoscopic power morcellation does not extend to hysteroscopic morcellation.

Such a distinction was made during opening remarks at a meeting in June 2014 of the Obstetrics & Gynecology Devices Panel of the Food and Drug Administration’s Medical Devices Advisory Committee, which was charged with addressing such concerns.

Dr. Aron Yustein, deputy director of clinical affairs and chief medical officer of the FDA’s Office of Surveillance and Biometrics, explained that the panel would not address hysteroscopic morcellators "as we do not believe that when used [as intended], they pose the same risk" as that of laparoscopic morcellation in terms of potentially disseminating and upstaging an undetected uterine malignancy.

In hysteroscopic morcellation, tissue is contained and delivered through the morcellation system into a trap, or collecting pouch. This allows for complete capture and histopathologic assessment of all fragments extracted from the uterine cavity.

Numerous equipment options are currently available to gynecologic surgeons for hysteroscopically-guided myomectomy: Newer systems such as the Gynecare VersaPoint (Ethicon Endo-Surgery), and the Symphion system (Boston Scientific) facilitate bipolar electrosurgical resection. MyoSure (Hologic) and TRUCLEAR (Smith & Nephew), on the other hand, are hysteroscopic morcellators; they both use mechanical energy rather than high-frequency electrical energy to simultaneously cut and aspirate tissue.

Common to each of these options are advanced, automated fluid management systems that continuously measure distending media input and output, intrauterine distension pressure, and fluid deficit volume throughout the procedure. Such monitoring is critical to preventing excess fluid absorption and its associated complications. The new fluid management systems allow excellent visualization of the intrauterine cavity.

Benefit of Treatment

Leiomyomas, synonymously known as myomas, are among the uterine bleeding abnormalities included in a new classification system introduced in 2011 by the International Federation of Gynecology and Obstetrics. The system classifies the causes of abnormal uterine bleeding in reproductive-aged women; it is known by the acronym PALM-COEIN, for polyp, adenomyosis, leiomyoma, malignancy and hyperplasia, coagulopathy, ovulatory dysfunction, endometrial, iatrogenic, and not yet classified.

In a practice bulletin published in 2012, the American College of Obstetricians and Gynecologists endorsed the nomenclature system and provided guidelines for evaluating reproductive-aged patients with abnormal uterine bleeding (Obstet. Gynecol. 2012;120:197-206).

The diagnosis and management of submucous leiomyomas is particularly important in cases of infertility, as these types of myomas (compared with intramural or subserosal) appear to have the greatest impact on pregnancy and implantation rates.

In general, uterine myomas are found in 5%-10% of women with infertility. In 1%-3% of infertility patients, myomas are the only abnormal findings. As described in a literature review, it is believed that myomas may interfere with sperm transport or access, and with implantation. Endometrial cavity deformity, cornual ostia obstruction, altered uterine contractility, and altered endometrial development may each play a role (Obstet. Gynecol. Clin. North Am. 2006;33:145-52).

Studies evaluating the impact of myomectomy on fertility outcomes provide evidence that submucous myomas should be removed before assisted reproductive technology/in vitro fertilization. According to the AAGL’s practice guidelines on the diagnosis and management of submucous leiomyomas, it "seems clear from high-quality studies that pregnancy rates are higher after myomectomy than no or ‘placebo’ procedures" (J. Minim. Invasive Gynecol. 2012;19:152-71).

The most widely used system for categorizing submucous myomas, developed by the European Society of Gynecological Endoscopy (ESGE), breaks them into three subtypes according to how much of the lesion’s diameter is contained within the myometrium: Type 0 myomas are entirely within the endometrial cavity, while type I have less than 50% myometrial extension, and type II are 50% or more within the myometrium.

It is the ESGE type 0 submucous myomas that are appropriate for resectoscopic surgery.

(Another system known as the STEPW classification system adds other categories, taking into account factors such as topography, extension of the base, and penetration. This system is becoming more recognized and may be useful in the future for evaluating patients for resectoscopic surgery and predicting outcomes, but it is not being used as often as the ESGE classification system.)

As the AAGL guidelines state, diagnosis is generally achieved with one or a combination of hysteroscopic and radiological techniques that may include transvaginal ultrasonography, saline infusion sonohysterography, and magnetic resonance imaging.

Research on safety

Hysteroscopic morcellation is the most recent operative hysteroscopic technique to be employed for the removal of submucous leiomyomas. In lieu of concerns about laparoscopic power morcellation, the question arises: Should we be concerned about cancer and hysteroscopy?

Numerous studies have looked at the question of whether hysteroscopic procedures produce intraperitoneal spread of endometrial cancer cells and, if so, whether this results in the "upstaging" of unsuspected cancer. Much of the research has involved diagnostic hysteroscopy, which includes the use of intrauterine cavity distension with fluid media, similar to that of operative hysteroscopy.

Investigators at Memorial Sloan-Kettering Cancer Center in New York, for instance, looked retrospectively at whether initial diagnostic procedures were associated with abnormal peritoneal washings (PW) in almost 300 women who were treated for endometrial carcinoma with hysterectomy and intraoperative PW. They found no association between the initial diagnostic procedures, including hysteroscopy, and the results of peritoneal cytology (Cancer 2000;90:143-7).

Similarly, physicians in the Czech Republic compared PW done at the start of surgery in 134 patients whose endometrial carcinoma had been diagnosed by hysteroscopy with 61 patients whose cancer had been diagnosed by dilation and curettage. The results, they said, suggest that hysteroscopy does not increase the risk of penetration of tumor cells into the peritoneal cavity more than does D&C (Eur. J. Gynaecol. Oncol. 2001; 22:342-4).

Another retrospective study of 146 patients with endometrial cancer who underwent either D&C or office hysteroscopy showed that diagnostic hysteroscopy did not increase the risk of adnexal, abdominal, or retroperitoneal lymph node metastases, compared with D&C, although there was an increase in positive peritoneal cytology (Gynecol. Oncol. 2007;107:94-8).

At least two broader reviews/meta-analyses also show no evidence for an upstaging of cancer from hysteroscopic procedures performed in the presence of cancer.

A meta-analysis of 19 studies suggests that preoperative hysteroscopy resulted in a statistically significant higher risk of positive peritoneal cytology compared with no hysteroscopy, but there was no evidence to support avoiding diagnostic hysteroscopy prior to surgical intervention for endometrial cancer (Fertil. Steril. 2011;96:957-61).

A literature review covering studies published between 1980 and 2001 showed that while there might be an increased risk of peritoneal contamination by cancer cells after hysteroscopy, there is no evidence that these patients fare worse compared with patients who have undergone other diagnostic procedures (Obstet. Gynecol. Surv. 2004;59:280-4).

Surgical rather than diagnostic hysterectomy was the focus of one recent case report from Italy. The patient was a 52-year-old nulliparous woman with a leiomyosarcoma detected 2 months after a hysteroscopic resection of a presumed myoma. After resection, the myoma was determined to be an atypical "mitotically active" leiomyoma (Eur. J. Gynaecol. Oncol. 2012;33:656-7).

The authors emphasize the "rarity" of this particular finding, and the available data overall offer no evidence for an upstaging of unsuspected endometrial cancer with hysteroscopic procedures. While hysteroscopy should not be used in cases of known cancer, as it does not facilitate treatment, there are no data that should lead us to be concerned about adverse effects in the presence of cancer.

Current systems

Traditionally, resectoscopy has posed numerous challenges for the removal of intracavitary lesions: Tissue removal has been difficult and time consuming. Visibility has been disrupted by gas bubbles, tissue fragments, blood clots, and cervical mucus. Multiple insertions have been required, raising the risk of embolism (a "piston effect"). There also have been concerns about the risk of perforation and about the learning curve.

Older resectoscopes – loop-electrode resectoscopes – were designed for monopolar electrosurgery, which requires the use of nonconductive, electrolyte-free solutions for uterine distension. This limited the amount of fluid absorption that could occur before procedures needed to be stopped.

The incorporation of bipolar instrumentation – and more recently, the development of hysteroscopic morcellation systems that use reciprocating blades driven by mechanical energy rather radiofrequency electrical energy – have enabled the use of electrolyte-containing distending media (saline or Ringer’s Lactate) and, consequently, a higher allowable amount of fluid absorption.

Saline is an ideal medium: It is isotonic, nonhemolytic, nonconductive, nontoxic, and rapidly cleared. The AAGL’s Practice Guidelines for the Management of Hysteroscopic Distending Media lists an intravasation safety limit of 2,500 cc for isotonic solution, compared with a maximum limit of 1,000 cc when using hypotonic solutions (J. Minim. Invasive Gynecol. 2013;20:137-48). This higher cut-off means we can achieve the vast majority of myoma resections in one sitting.

Hysteroscopic morcellators have additional advantages, in my experience. They allow for the use of smaller-diameter hysteroscopes, which in turn requires less cervical dilation. They also have improved reciprocating blades that enable the resection of myomas in addition to endometrial polyps. Previously, the focus was primarily on hysteroscopic polypectomy.

As technology has advanced with tissue removal being instantaneous, there is simultaneous cutting and extraction, and resections are therefore quicker. Overall, there is better visualization and a lower risk of perforation. The learning curve is quicker.

In a randomized trial focused on polypectomy, hysteroscopic mechanical morcellation was superior to electrosurgical resection. The multicenter trial from the United Kingdom compared the two modalities for removal of endometrial polyps in 121 women, and found that hysteroscopic morcellation with a mechanical-based morcellator was significantly quicker for polyp removal (a median time of 5½ minutes, versus 10 minutes, approximately), less painful and more acceptable to women, and more likely to completely remove the polyps (98% compared with 83%), the investigators reported (Obstet. Gynecol. 2014;123:745-51).

The only surgical complications in either group were vasovagal reactions, which occurred in 2% (1 out of 62) and 10% (6 out of 59) of the hysteroscopic morcellation and electrosurgical resection procedures, respectively. There was one serious adverse event, with a woman treated 2 weeks after morcellation for endomyometritis.

Indeed, infection, perforation and cervical trauma, mechanical complications, and media-related complications (intravasation and gas embolism) are risks with all modalities of operative hysteroscopy and all indications. Bleeding appears rarely to be a problem with mechanical morcellation, however, as does perforation. Certainly, perforation that occurs with a nonelectrical morcellator will be significantly less complicating than when energy is engaged.

Our experience overall with resections of intracavitary polyps and small myomas via hysteroscopic morcellation in 50 cases indicates a mean operating time of 9.4 min, a mean fluid deficit of 329 milliliters, and a mean surgeon rating of 9, with 10 representing an excellent rating. We have had no intra-or postoperative hemorrhage, no obvious electrolyte changes, and uneventful recoveries.

The majority of our hysteroscopic morcellations are done under conscious sedation with the addition of a local anesthetic in the form of a paracervical block. A 200-mcg vaginal tablet of misoprostol (Cytotec) off label the night before surgery is the pretreatment strategy I most often employ for cervical preparation. To prevent infection, I prescribe one dose of a broad-spectrum antibiotic, such as a cephalosporin, to my patients receiving myomectomies.

To learn hysteroscopic morcellation, one should begin with polypectomy and move to myomectomy once comfortable. With the TRUCLEAR system, the system I use most frequently, the hysteroscopic sheath should be inserted with the obturator in place to lessen cervical trauma.

The early flow of saline will not only aid the insertion process, it will assist in achieving good visualization quickly, as will increasing the uterine pressure setting at the start of the process. After the beginning of the procedure, however, pressure is maintained at the lowest setting capable of achieving adequate distension and providing good visualization.

When morcellating pathology, one should work from the periphery to the base. The pathology is kept between the morcellator blade opening and the optics of the camera. Large myomas can be split in half, with each half approached from distal to proximal.

Running the morcellator in the open cavity for a short time will aid in clearing the visual field of debris. Overall, however, visualization with today’s hysteroscopic morcellators and advancements in fluid management is excellent. In our experience, hysteroscopic morcellation is proving to be a safe and effective tool for performing myomectomy and addressing problems of infertility and abnormal uterine bleeding.

Dr. Sanfilippo is professor of obstetrics, gynecology, and reproductive sciences at the University of Pittsburgh and director of the division of reproductive endocrinology and infertility at Magee-Womens Hospital in Pittsburgh. He is on the advisory board for Bayer Healthcare and Smith &Nephew. A lecturer and educator, Dr. Sanfilippo has written peer-reviewed articles and has been a contributor to several textbooks. He is a member of the AAGL.

NEW YORK – Conventional disease-modifying antirheumatic drugs will not be included among acceptable treatments for enthesitis related to psoriatic arthritis, according to a draft of guidelines being prepared for publication.

"The only controlled trial with a DMARD [disease-modifying antirheumatic drug] for enthesitis was conducted with sulfasalazine, and it was negative," said Dr. Evan L. Siegel, who is in group practice in rheumatology in Rockville, Md. Dr. Siegel led a group of experts preparing psoriatic arthritis enthesitis treatment recommendations to be issued by the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

In a preliminary report on the planned treatment recommendations, which were delivered at the joint meetings of GRAPPA and the Spondyloarthritis Research & Treatment Network (SPARTAN), Dr. Siegel reported that the new recommendations will recognize only two gradations of enthesitis: mild or moderate/severe.

"It is difficult to differentiate moderate from severe because these have not been treated as distinct entities in the clinical trials," Dr. Siegel said. Patients experience severity in regard to intensity of pain and limitation of function, either or both of which may represent severe enthesitis in any given individual patient, according to Dr. Siegel, who also noted that the number of sites of activity is also generally unhelpful.

"Significant activity at a single site may be sufficient to produce a major functional deficit in one individual, whereas the activity at multiple sites may not produce much symptomatology or functional loss in another," Dr. Siegel said.

Enthesitis, an inflammation at the site where tendons or ligaments attach to bone, has been reported in up to 70% of patients with psoriatic arthritis. In some patients, it is the dominant symptom. However, the number of treatment trials in which control of enthesitis is the primary outcome continues to be limited, according to Dr. Siegel. He acknowledged that many of the proposed treatment recommendations owed more to expert opinion than to data.

This is true of the proposed first-line recommendation, he said, which is the use of nonsteroidal anti-inflammatory drugs and physical therapy. For NSAIDs, the wording of the recommendation will emphasize the need to monitor side effects.

The expert opinion of the GRAPPA consensus group was nearly unanimous that NSAIDs and physical therapy are effective and should be tried initially in both mild and moderate/severe disease, even though Dr. Siegel said that the supportive data from controlled trials are limited.

For those with moderate/severe enthesitis not sufficiently controlled on NSAIDs, alternatives include tumor necrosis factor inhibitors, ustekinumab, and apremilast. Some supportive data are available for each of these options, even though the consensus group concluded that there is not enough comparative evidence "to recommend one over another," he said.

Rather, the consensus group is recommending that the choice of therapies beyond NSAIDs and physical therapy be individualized in relationship to comorbidities, personal preference, and other considerations.

Special wording is being developed in regard to the use of corticosteroid injections. This wording was partly inspired by a meta-analysis that associated corticosteroid injections with an adverse effect on the integrity of tendons. Although there were many criticisms of this report, there was sufficient concern among the consensus group to urge that this treatment be used with caution.

"We think that these injections should only be provided by experienced physicians," Dr. Siegel reported. The wording in the preliminary draft is that adjunctive corticosteroid injections "may be considered on an individual basis."

When published, the enthesitis guidelines will include grading for the quality of the evidence behind each recommendation as well as the relative strength of the recommendation conferred by the expert panel.

Dr. Siegel reported financial relationships with Amgen and AbbVie.

NEW YORK – Conventional disease-modifying antirheumatic drugs will not be included among acceptable treatments for enthesitis related to psoriatic arthritis, according to a draft of guidelines being prepared for publication.

"The only controlled trial with a DMARD [disease-modifying antirheumatic drug] for enthesitis was conducted with sulfasalazine, and it was negative," said Dr. Evan L. Siegel, who is in group practice in rheumatology in Rockville, Md. Dr. Siegel led a group of experts preparing psoriatic arthritis enthesitis treatment recommendations to be issued by the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

In a preliminary report on the planned treatment recommendations, which were delivered at the joint meetings of GRAPPA and the Spondyloarthritis Research & Treatment Network (SPARTAN), Dr. Siegel reported that the new recommendations will recognize only two gradations of enthesitis: mild or moderate/severe.

"It is difficult to differentiate moderate from severe because these have not been treated as distinct entities in the clinical trials," Dr. Siegel said. Patients experience severity in regard to intensity of pain and limitation of function, either or both of which may represent severe enthesitis in any given individual patient, according to Dr. Siegel, who also noted that the number of sites of activity is also generally unhelpful.

"Significant activity at a single site may be sufficient to produce a major functional deficit in one individual, whereas the activity at multiple sites may not produce much symptomatology or functional loss in another," Dr. Siegel said.

Enthesitis, an inflammation at the site where tendons or ligaments attach to bone, has been reported in up to 70% of patients with psoriatic arthritis. In some patients, it is the dominant symptom. However, the number of treatment trials in which control of enthesitis is the primary outcome continues to be limited, according to Dr. Siegel. He acknowledged that many of the proposed treatment recommendations owed more to expert opinion than to data.

This is true of the proposed first-line recommendation, he said, which is the use of nonsteroidal anti-inflammatory drugs and physical therapy. For NSAIDs, the wording of the recommendation will emphasize the need to monitor side effects.

The expert opinion of the GRAPPA consensus group was nearly unanimous that NSAIDs and physical therapy are effective and should be tried initially in both mild and moderate/severe disease, even though Dr. Siegel said that the supportive data from controlled trials are limited.

For those with moderate/severe enthesitis not sufficiently controlled on NSAIDs, alternatives include tumor necrosis factor inhibitors, ustekinumab, and apremilast. Some supportive data are available for each of these options, even though the consensus group concluded that there is not enough comparative evidence "to recommend one over another," he said.

Rather, the consensus group is recommending that the choice of therapies beyond NSAIDs and physical therapy be individualized in relationship to comorbidities, personal preference, and other considerations.

Special wording is being developed in regard to the use of corticosteroid injections. This wording was partly inspired by a meta-analysis that associated corticosteroid injections with an adverse effect on the integrity of tendons. Although there were many criticisms of this report, there was sufficient concern among the consensus group to urge that this treatment be used with caution.

"We think that these injections should only be provided by experienced physicians," Dr. Siegel reported. The wording in the preliminary draft is that adjunctive corticosteroid injections "may be considered on an individual basis."

When published, the enthesitis guidelines will include grading for the quality of the evidence behind each recommendation as well as the relative strength of the recommendation conferred by the expert panel.

Dr. Siegel reported financial relationships with Amgen and AbbVie.

NEW YORK – Conventional disease-modifying antirheumatic drugs will not be included among acceptable treatments for enthesitis related to psoriatic arthritis, according to a draft of guidelines being prepared for publication.

"The only controlled trial with a DMARD [disease-modifying antirheumatic drug] for enthesitis was conducted with sulfasalazine, and it was negative," said Dr. Evan L. Siegel, who is in group practice in rheumatology in Rockville, Md. Dr. Siegel led a group of experts preparing psoriatic arthritis enthesitis treatment recommendations to be issued by the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

In a preliminary report on the planned treatment recommendations, which were delivered at the joint meetings of GRAPPA and the Spondyloarthritis Research & Treatment Network (SPARTAN), Dr. Siegel reported that the new recommendations will recognize only two gradations of enthesitis: mild or moderate/severe.

"It is difficult to differentiate moderate from severe because these have not been treated as distinct entities in the clinical trials," Dr. Siegel said. Patients experience severity in regard to intensity of pain and limitation of function, either or both of which may represent severe enthesitis in any given individual patient, according to Dr. Siegel, who also noted that the number of sites of activity is also generally unhelpful.

"Significant activity at a single site may be sufficient to produce a major functional deficit in one individual, whereas the activity at multiple sites may not produce much symptomatology or functional loss in another," Dr. Siegel said.

Enthesitis, an inflammation at the site where tendons or ligaments attach to bone, has been reported in up to 70% of patients with psoriatic arthritis. In some patients, it is the dominant symptom. However, the number of treatment trials in which control of enthesitis is the primary outcome continues to be limited, according to Dr. Siegel. He acknowledged that many of the proposed treatment recommendations owed more to expert opinion than to data.

This is true of the proposed first-line recommendation, he said, which is the use of nonsteroidal anti-inflammatory drugs and physical therapy. For NSAIDs, the wording of the recommendation will emphasize the need to monitor side effects.

The expert opinion of the GRAPPA consensus group was nearly unanimous that NSAIDs and physical therapy are effective and should be tried initially in both mild and moderate/severe disease, even though Dr. Siegel said that the supportive data from controlled trials are limited.

For those with moderate/severe enthesitis not sufficiently controlled on NSAIDs, alternatives include tumor necrosis factor inhibitors, ustekinumab, and apremilast. Some supportive data are available for each of these options, even though the consensus group concluded that there is not enough comparative evidence "to recommend one over another," he said.

Rather, the consensus group is recommending that the choice of therapies beyond NSAIDs and physical therapy be individualized in relationship to comorbidities, personal preference, and other considerations.

Special wording is being developed in regard to the use of corticosteroid injections. This wording was partly inspired by a meta-analysis that associated corticosteroid injections with an adverse effect on the integrity of tendons. Although there were many criticisms of this report, there was sufficient concern among the consensus group to urge that this treatment be used with caution.

"We think that these injections should only be provided by experienced physicians," Dr. Siegel reported. The wording in the preliminary draft is that adjunctive corticosteroid injections "may be considered on an individual basis."

When published, the enthesitis guidelines will include grading for the quality of the evidence behind each recommendation as well as the relative strength of the recommendation conferred by the expert panel.

Dr. Siegel reported financial relationships with Amgen and AbbVie.

Human sperm stained

for semen quality testing

New research has shown that lymphoma and its treatment can impact a number of sperm characteristics, thereby reducing fertility in males.

Results also indicated that most patients eventually experience semen recovery, but the degree and timing of that recovery may depend on the patient’s diagnosis and treatment.

In this study, recovery was more likely among patients with Hodgkin lymphoma than those with non-Hodgkin lymphoma.

And recovery was both quicker and more likely among patients who did not receive alkylating chemotherapy.

On the other hand, multivariate analyses suggested that only a patient’s pre-treatment total sperm count was related to recovery.

Louis Bujan, MD, PhD, of Université de Toulouse in France, and colleagues reported these results in Fertility and Sterility.

The study included 75 patients—57 with Hodgkin lymphoma and 18 with non-Hodgkin lymphoma. The researchers collected sperm samples before patients began cancer treatment and again at later intervals: 3 months, 6 months, 12 months, and 24 months post-treatment.

The team compared patients’ sperm characteristics to those of a control group consisting of 257 healthy, fertile men.

Results revealed that lymphoma patients had impaired sperm quality even before they began treatment. Compared to fertile controls, patients had higher levels of sperm chromatin alterations and DNA fragmentation, with the only risk factor being their cancer diagnosis.

However, between 3 months and 6 months post-treatment, patients’ levels of sperm DNA fragmentation and chromatin structure damage improved. The damage level decreased relative to a patient’s own pre-treatment level of damage, while still remaining higher than damage levels in the control group.

After treatment, patients’ sperm density, total count, motility, and vitality decreased, with the lowest values seen at the 3- and 6-month marks.

Alkylating chemotherapy was more detrimental to spermatogenesis than non-alkylating drugs. Patients who received alkylating chemotherapy were more likely to cease sperm production entirely or take longer to resume sperm production than patients receiving non-alkylating chemotherapy.

Twelve months after treatment, mean sperm counts recovered to pre-treatment values for patients who had received doxorubicin, bleomycin, vinblastine, and darcarbacine (ABVD) or ABVD and radiotherapy.

But this was not the case for patients who received doxorubicin, cyclophosphamide, vincristine, and prednisone (CHOP) or mechlorethamine, oncovin, procarbazine, and prednisone (MOPP).

At the 24-month mark, 7% of patients remained azoospermic. Kaplan Meir estimates suggested that, after 24 months, most patients would recover normal sperm counts.

Recovery was projected for 92% of patients who received ABVD and radiotherapy, 90% of patients who received ABVD alone, and 61% of CHOP-treated patients. (There was no estimate for MOPP therapy, perhaps due to a low number of patients.)

A patient’s type of lymphoma appeared to impact sperm count recovery as well. Estimates suggested that, after 24 months, 86% of Hodgkin lymphoma patients would experience recovery, compared to 73% of non-Hodgkin lymphoma patients.

“While many men can look forward to their fertility returning after treatment is over, not all will be so fortunate,” said Rebecca Sokol, MD, MPH, President of the American Society for Reproductive Medicine.

“It is imperative that, prior to the initiation of therapy, counseling and sperm preservation be made available to all lymphoma patients and their partners who may want to have children in the future.”

Human sperm stained

for semen quality testing

New research has shown that lymphoma and its treatment can impact a number of sperm characteristics, thereby reducing fertility in males.

Results also indicated that most patients eventually experience semen recovery, but the degree and timing of that recovery may depend on the patient’s diagnosis and treatment.

In this study, recovery was more likely among patients with Hodgkin lymphoma than those with non-Hodgkin lymphoma.

And recovery was both quicker and more likely among patients who did not receive alkylating chemotherapy.

On the other hand, multivariate analyses suggested that only a patient’s pre-treatment total sperm count was related to recovery.

Louis Bujan, MD, PhD, of Université de Toulouse in France, and colleagues reported these results in Fertility and Sterility.

The study included 75 patients—57 with Hodgkin lymphoma and 18 with non-Hodgkin lymphoma. The researchers collected sperm samples before patients began cancer treatment and again at later intervals: 3 months, 6 months, 12 months, and 24 months post-treatment.

The team compared patients’ sperm characteristics to those of a control group consisting of 257 healthy, fertile men.

Results revealed that lymphoma patients had impaired sperm quality even before they began treatment. Compared to fertile controls, patients had higher levels of sperm chromatin alterations and DNA fragmentation, with the only risk factor being their cancer diagnosis.

However, between 3 months and 6 months post-treatment, patients’ levels of sperm DNA fragmentation and chromatin structure damage improved. The damage level decreased relative to a patient’s own pre-treatment level of damage, while still remaining higher than damage levels in the control group.

After treatment, patients’ sperm density, total count, motility, and vitality decreased, with the lowest values seen at the 3- and 6-month marks.

Alkylating chemotherapy was more detrimental to spermatogenesis than non-alkylating drugs. Patients who received alkylating chemotherapy were more likely to cease sperm production entirely or take longer to resume sperm production than patients receiving non-alkylating chemotherapy.

Twelve months after treatment, mean sperm counts recovered to pre-treatment values for patients who had received doxorubicin, bleomycin, vinblastine, and darcarbacine (ABVD) or ABVD and radiotherapy.

But this was not the case for patients who received doxorubicin, cyclophosphamide, vincristine, and prednisone (CHOP) or mechlorethamine, oncovin, procarbazine, and prednisone (MOPP).

At the 24-month mark, 7% of patients remained azoospermic. Kaplan Meir estimates suggested that, after 24 months, most patients would recover normal sperm counts.

Recovery was projected for 92% of patients who received ABVD and radiotherapy, 90% of patients who received ABVD alone, and 61% of CHOP-treated patients. (There was no estimate for MOPP therapy, perhaps due to a low number of patients.)

A patient’s type of lymphoma appeared to impact sperm count recovery as well. Estimates suggested that, after 24 months, 86% of Hodgkin lymphoma patients would experience recovery, compared to 73% of non-Hodgkin lymphoma patients.

“While many men can look forward to their fertility returning after treatment is over, not all will be so fortunate,” said Rebecca Sokol, MD, MPH, President of the American Society for Reproductive Medicine.

“It is imperative that, prior to the initiation of therapy, counseling and sperm preservation be made available to all lymphoma patients and their partners who may want to have children in the future.”

Human sperm stained

for semen quality testing

New research has shown that lymphoma and its treatment can impact a number of sperm characteristics, thereby reducing fertility in males.

Results also indicated that most patients eventually experience semen recovery, but the degree and timing of that recovery may depend on the patient’s diagnosis and treatment.

In this study, recovery was more likely among patients with Hodgkin lymphoma than those with non-Hodgkin lymphoma.

And recovery was both quicker and more likely among patients who did not receive alkylating chemotherapy.

On the other hand, multivariate analyses suggested that only a patient’s pre-treatment total sperm count was related to recovery.

Louis Bujan, MD, PhD, of Université de Toulouse in France, and colleagues reported these results in Fertility and Sterility.

The study included 75 patients—57 with Hodgkin lymphoma and 18 with non-Hodgkin lymphoma. The researchers collected sperm samples before patients began cancer treatment and again at later intervals: 3 months, 6 months, 12 months, and 24 months post-treatment.

The team compared patients’ sperm characteristics to those of a control group consisting of 257 healthy, fertile men.

Results revealed that lymphoma patients had impaired sperm quality even before they began treatment. Compared to fertile controls, patients had higher levels of sperm chromatin alterations and DNA fragmentation, with the only risk factor being their cancer diagnosis.

However, between 3 months and 6 months post-treatment, patients’ levels of sperm DNA fragmentation and chromatin structure damage improved. The damage level decreased relative to a patient’s own pre-treatment level of damage, while still remaining higher than damage levels in the control group.

After treatment, patients’ sperm density, total count, motility, and vitality decreased, with the lowest values seen at the 3- and 6-month marks.

Alkylating chemotherapy was more detrimental to spermatogenesis than non-alkylating drugs. Patients who received alkylating chemotherapy were more likely to cease sperm production entirely or take longer to resume sperm production than patients receiving non-alkylating chemotherapy.

Twelve months after treatment, mean sperm counts recovered to pre-treatment values for patients who had received doxorubicin, bleomycin, vinblastine, and darcarbacine (ABVD) or ABVD and radiotherapy.

But this was not the case for patients who received doxorubicin, cyclophosphamide, vincristine, and prednisone (CHOP) or mechlorethamine, oncovin, procarbazine, and prednisone (MOPP).

At the 24-month mark, 7% of patients remained azoospermic. Kaplan Meir estimates suggested that, after 24 months, most patients would recover normal sperm counts.

Recovery was projected for 92% of patients who received ABVD and radiotherapy, 90% of patients who received ABVD alone, and 61% of CHOP-treated patients. (There was no estimate for MOPP therapy, perhaps due to a low number of patients.)

A patient’s type of lymphoma appeared to impact sperm count recovery as well. Estimates suggested that, after 24 months, 86% of Hodgkin lymphoma patients would experience recovery, compared to 73% of non-Hodgkin lymphoma patients.

“While many men can look forward to their fertility returning after treatment is over, not all will be so fortunate,” said Rebecca Sokol, MD, MPH, President of the American Society for Reproductive Medicine.

“It is imperative that, prior to the initiation of therapy, counseling and sperm preservation be made available to all lymphoma patients and their partners who may want to have children in the future.”

Thrombus

Credit: Kevin MacKenzie

The European Commission has approved apixaban (Eliquis) to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE).

The approval applies to all European Union (EU) member states, as well as Iceland and Norway.

Apixaban was already approved in the EU to prevent venous thromboembolism (VTE) in adults who have undergone total hip or knee replacement surgery, and to prevent stroke and systemic embolism in adults with nonvalvular atrial fibrillation.

The new marketing authorization for apixaban follows the positive opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use in June and is supported by results of 2 phase 3 clinical trials, AMPLIFY and AMPLIFY-EXT.

Results of AMPLIFY

The AMPLIFY trial included 5395 patients with confirmed, symptomatic DVT or PE requiring treatment for 6 months. They had a mean age of 56.9 years, and 89.8% of randomized patients had unprovoked VTE.

About half of patients (n=2691) were randomized to receive apixaban at 10 mg twice daily for 7 days, followed by 5 mg twice daily for 6 months.

The other half (n=2704) were randomized to the standard of care, which was enoxaparin at 1 mg/kg twice daily for at least 5 days until INR ≥ 2 and warfarin (target INR range 2.0-3.0) for 6 months.

Apixaban proved noninferior to standard therapy in the combined primary endpoint of adjudicated recurrent symptomatic VTE (nonfatal DVT or PE) or VTE-related death.

This outcome occurred in 2.3% of patients in the apixaban arm and 2.7% of patients in the standard-therapy arm (P<0.0001 for noninferiority).

Apixaban also proved superior to standard therapy with regard to bleeding. The composite endpoint of major bleeding and clinically relevant, nonmajor bleeding occurred in 4.3% of patients in the apixaban arm and 9.7% of patients in the standard-therapy arm (P<0.001).

Results of AMPLIFY-EXT

The AMPLIFY-EXT trial included 2486 patients who had completed 6 to 12 months of anticoagulation treatment for DVT or PE. The mean age was 56.7 years, and 91.7% of randomized patients had unprovoked VTE.

Patients were randomized to receive apixaban at 2.5 mg (n=842), apixaban at 5 mg (n=815), or placebo (n=829).

Both apixaban doses were significantly superior to placebo (P<0.001) with regard to the primary efficacy endpoint, which was recurrent VTE or all-cause death.

During the 12-month active study period, these events occurred in 3.8% of patients in the 2.5-mg arm, 4.2% of patients in the 5-mg arm, and 11.6% of patients in the placebo arm.

The primary safety endpoint was the incidence of major bleeding, and there was no significant difference among the treatment arms. Major bleeding occurred in 0.2% of patients in the 2.5-mg arm, 0.1% of patients in the 5-mg arm, and 0.5% of patients in the placebo arm.

About apixaban

Apixaban is approved to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation in the US, EU, Japan, and a number of other countries around the world.

The drug is approved to prevent VTE in adult patients who have undergone elective hip or knee replacement surgery in the US, EU, and a number of other countries.

And now, apixaban is approved for the treatment of DVT/PE and the prevention of recurrent DVT/PE in the EU. The drug is not approved for this indication in the US.

Apixaban is under joint development by Pfizer and Bristol-Myers Squibb.

Thrombus

Credit: Kevin MacKenzie

The European Commission has approved apixaban (Eliquis) to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE).

The approval applies to all European Union (EU) member states, as well as Iceland and Norway.

Apixaban was already approved in the EU to prevent venous thromboembolism (VTE) in adults who have undergone total hip or knee replacement surgery, and to prevent stroke and systemic embolism in adults with nonvalvular atrial fibrillation.

The new marketing authorization for apixaban follows the positive opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use in June and is supported by results of 2 phase 3 clinical trials, AMPLIFY and AMPLIFY-EXT.

Results of AMPLIFY

The AMPLIFY trial included 5395 patients with confirmed, symptomatic DVT or PE requiring treatment for 6 months. They had a mean age of 56.9 years, and 89.8% of randomized patients had unprovoked VTE.

About half of patients (n=2691) were randomized to receive apixaban at 10 mg twice daily for 7 days, followed by 5 mg twice daily for 6 months.

The other half (n=2704) were randomized to the standard of care, which was enoxaparin at 1 mg/kg twice daily for at least 5 days until INR ≥ 2 and warfarin (target INR range 2.0-3.0) for 6 months.

Apixaban proved noninferior to standard therapy in the combined primary endpoint of adjudicated recurrent symptomatic VTE (nonfatal DVT or PE) or VTE-related death.

This outcome occurred in 2.3% of patients in the apixaban arm and 2.7% of patients in the standard-therapy arm (P<0.0001 for noninferiority).

Apixaban also proved superior to standard therapy with regard to bleeding. The composite endpoint of major bleeding and clinically relevant, nonmajor bleeding occurred in 4.3% of patients in the apixaban arm and 9.7% of patients in the standard-therapy arm (P<0.001).

Results of AMPLIFY-EXT

The AMPLIFY-EXT trial included 2486 patients who had completed 6 to 12 months of anticoagulation treatment for DVT or PE. The mean age was 56.7 years, and 91.7% of randomized patients had unprovoked VTE.

Patients were randomized to receive apixaban at 2.5 mg (n=842), apixaban at 5 mg (n=815), or placebo (n=829).

Both apixaban doses were significantly superior to placebo (P<0.001) with regard to the primary efficacy endpoint, which was recurrent VTE or all-cause death.

During the 12-month active study period, these events occurred in 3.8% of patients in the 2.5-mg arm, 4.2% of patients in the 5-mg arm, and 11.6% of patients in the placebo arm.

The primary safety endpoint was the incidence of major bleeding, and there was no significant difference among the treatment arms. Major bleeding occurred in 0.2% of patients in the 2.5-mg arm, 0.1% of patients in the 5-mg arm, and 0.5% of patients in the placebo arm.

About apixaban

Apixaban is approved to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation in the US, EU, Japan, and a number of other countries around the world.

The drug is approved to prevent VTE in adult patients who have undergone elective hip or knee replacement surgery in the US, EU, and a number of other countries.

And now, apixaban is approved for the treatment of DVT/PE and the prevention of recurrent DVT/PE in the EU. The drug is not approved for this indication in the US.

Apixaban is under joint development by Pfizer and Bristol-Myers Squibb.

Thrombus

Credit: Kevin MacKenzie

The European Commission has approved apixaban (Eliquis) to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE).

The approval applies to all European Union (EU) member states, as well as Iceland and Norway.

Apixaban was already approved in the EU to prevent venous thromboembolism (VTE) in adults who have undergone total hip or knee replacement surgery, and to prevent stroke and systemic embolism in adults with nonvalvular atrial fibrillation.

The new marketing authorization for apixaban follows the positive opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use in June and is supported by results of 2 phase 3 clinical trials, AMPLIFY and AMPLIFY-EXT.

Results of AMPLIFY

The AMPLIFY trial included 5395 patients with confirmed, symptomatic DVT or PE requiring treatment for 6 months. They had a mean age of 56.9 years, and 89.8% of randomized patients had unprovoked VTE.

About half of patients (n=2691) were randomized to receive apixaban at 10 mg twice daily for 7 days, followed by 5 mg twice daily for 6 months.

The other half (n=2704) were randomized to the standard of care, which was enoxaparin at 1 mg/kg twice daily for at least 5 days until INR ≥ 2 and warfarin (target INR range 2.0-3.0) for 6 months.

Apixaban proved noninferior to standard therapy in the combined primary endpoint of adjudicated recurrent symptomatic VTE (nonfatal DVT or PE) or VTE-related death.

This outcome occurred in 2.3% of patients in the apixaban arm and 2.7% of patients in the standard-therapy arm (P<0.0001 for noninferiority).

Apixaban also proved superior to standard therapy with regard to bleeding. The composite endpoint of major bleeding and clinically relevant, nonmajor bleeding occurred in 4.3% of patients in the apixaban arm and 9.7% of patients in the standard-therapy arm (P<0.001).

Results of AMPLIFY-EXT

The AMPLIFY-EXT trial included 2486 patients who had completed 6 to 12 months of anticoagulation treatment for DVT or PE. The mean age was 56.7 years, and 91.7% of randomized patients had unprovoked VTE.

Patients were randomized to receive apixaban at 2.5 mg (n=842), apixaban at 5 mg (n=815), or placebo (n=829).

Both apixaban doses were significantly superior to placebo (P<0.001) with regard to the primary efficacy endpoint, which was recurrent VTE or all-cause death.

During the 12-month active study period, these events occurred in 3.8% of patients in the 2.5-mg arm, 4.2% of patients in the 5-mg arm, and 11.6% of patients in the placebo arm.

The primary safety endpoint was the incidence of major bleeding, and there was no significant difference among the treatment arms. Major bleeding occurred in 0.2% of patients in the 2.5-mg arm, 0.1% of patients in the 5-mg arm, and 0.5% of patients in the placebo arm.

About apixaban

Apixaban is approved to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation in the US, EU, Japan, and a number of other countries around the world.

The drug is approved to prevent VTE in adult patients who have undergone elective hip or knee replacement surgery in the US, EU, and a number of other countries.

And now, apixaban is approved for the treatment of DVT/PE and the prevention of recurrent DVT/PE in the EU. The drug is not approved for this indication in the US.

Apixaban is under joint development by Pfizer and Bristol-Myers Squibb.