Immune to education

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Let’s be honest. Although pediatricians invest most of their days, some of their nights, and untold cockles of heartfelt concern trying to keep their patients well, there is very little evidence that what we do actually makes a difference. The one shining exception comes when we administer immunizations. This humbling fact makes the problem of vaccine refusal so frustrating and depressing.

I have always considered the increasing number of parents who refuse or who are hesitant about immunization just another example of decay in our nation’s educational system. How could anyone who was even half awake in American History class not be aware of the toll that infectious diseases took on the children born before 1900? Diseases that are now preventable. Do introductory science courses even touch on the basic mechanisms that underlie immunizations? High school students may not be expected to know that John Enders was the lead investigator in the development of the measles vaccine, but someone should have told them the story of Jonas Salk and polio.

Like many of you, I assumed that if I could just do a better job of filling in the gaps in our educational system that vaccine-hesitant parents would see the light. If I could share with parents even a small fraction of what I know about the efficacy of vaccines they couldn’t possibly refuse to immunize their children. However, after 40 years of failed attempts and frustration, I have begun to doubt my communication skills.

Some work by Brendan Nyhan, Ph.D., a government professor at Dartmouth College, and his colleagues suggests that my attempts at education were destined to fail. ("Effective Messages in Vaccine Promotion: A Randomized Trial," [Pediatrics 2014;133:1-8]). Aware that people frequently resist information that contradicts their views, these investigators began a small study. Nearly 1,800 parents were randomized to receive one of four messages supporting the value of MMR vaccine from textual excerpts to pictures of children with the diseases prevented by the vaccine.

What they discovered was that parents who had "mixed or negative feelings" about the vaccine were actually less likely to say that they would choose to vaccinate a future child after they had been presented with literature refuting the MMR-autism link. While these families were less likely to accept the vaccine-autism link, the informational materials had prompted them to consider other reasons that supported their negative views about vaccines.

Although other studies have found that parents still consider their children’s doctor to be the most trusted source of vaccine information, it appears that education as we understand it may not be our best tool. In fact, it may even be counterproductive. Attempts to engender fear may seem logical to us, but in reality they may be backfiring.

Dr. Nyhan and his colleagues didn’t bore down to discover what factors made a particular view so resistant to education. But, in my experience inheritance doesn’t seem to play a role. I hear from many fearful and frustrated grandparents who can’t understand why their grandchildren aren’t being immunized.

There is the hermit mentality that says by keeping apart from "all those other people" in society and by living a better life, we can protect ourselves from their diseases and don’t need immunizations. And, of course, there is the notion that even though we understand the rationale for immunization, God will protect us.

This important study suggests that we must be very thoughtful about our attempts at education in all public health issues. Our intuition has failed us here. As unfair as it may be to the child victims of this parental foolishness, we may need to fall back on strict exclusion and quarantine to protect the rest us until we learn how to convince families that they are making a serious mistake.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including "How to Say No to Your Toddler." E-mail him at [email protected].

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Let’s be honest. Although pediatricians invest most of their days, some of their nights, and untold cockles of heartfelt concern trying to keep their patients well, there is very little evidence that what we do actually makes a difference. The one shining exception comes when we administer immunizations. This humbling fact makes the problem of vaccine refusal so frustrating and depressing.

I have always considered the increasing number of parents who refuse or who are hesitant about immunization just another example of decay in our nation’s educational system. How could anyone who was even half awake in American History class not be aware of the toll that infectious diseases took on the children born before 1900? Diseases that are now preventable. Do introductory science courses even touch on the basic mechanisms that underlie immunizations? High school students may not be expected to know that John Enders was the lead investigator in the development of the measles vaccine, but someone should have told them the story of Jonas Salk and polio.

Like many of you, I assumed that if I could just do a better job of filling in the gaps in our educational system that vaccine-hesitant parents would see the light. If I could share with parents even a small fraction of what I know about the efficacy of vaccines they couldn’t possibly refuse to immunize their children. However, after 40 years of failed attempts and frustration, I have begun to doubt my communication skills.

Some work by Brendan Nyhan, Ph.D., a government professor at Dartmouth College, and his colleagues suggests that my attempts at education were destined to fail. ("Effective Messages in Vaccine Promotion: A Randomized Trial," [Pediatrics 2014;133:1-8]). Aware that people frequently resist information that contradicts their views, these investigators began a small study. Nearly 1,800 parents were randomized to receive one of four messages supporting the value of MMR vaccine from textual excerpts to pictures of children with the diseases prevented by the vaccine.

What they discovered was that parents who had "mixed or negative feelings" about the vaccine were actually less likely to say that they would choose to vaccinate a future child after they had been presented with literature refuting the MMR-autism link. While these families were less likely to accept the vaccine-autism link, the informational materials had prompted them to consider other reasons that supported their negative views about vaccines.

Although other studies have found that parents still consider their children’s doctor to be the most trusted source of vaccine information, it appears that education as we understand it may not be our best tool. In fact, it may even be counterproductive. Attempts to engender fear may seem logical to us, but in reality they may be backfiring.

Dr. Nyhan and his colleagues didn’t bore down to discover what factors made a particular view so resistant to education. But, in my experience inheritance doesn’t seem to play a role. I hear from many fearful and frustrated grandparents who can’t understand why their grandchildren aren’t being immunized.

There is the hermit mentality that says by keeping apart from "all those other people" in society and by living a better life, we can protect ourselves from their diseases and don’t need immunizations. And, of course, there is the notion that even though we understand the rationale for immunization, God will protect us.

This important study suggests that we must be very thoughtful about our attempts at education in all public health issues. Our intuition has failed us here. As unfair as it may be to the child victims of this parental foolishness, we may need to fall back on strict exclusion and quarantine to protect the rest us until we learn how to convince families that they are making a serious mistake.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including "How to Say No to Your Toddler." E-mail him at [email protected].

Let’s be honest. Although pediatricians invest most of their days, some of their nights, and untold cockles of heartfelt concern trying to keep their patients well, there is very little evidence that what we do actually makes a difference. The one shining exception comes when we administer immunizations. This humbling fact makes the problem of vaccine refusal so frustrating and depressing.

I have always considered the increasing number of parents who refuse or who are hesitant about immunization just another example of decay in our nation’s educational system. How could anyone who was even half awake in American History class not be aware of the toll that infectious diseases took on the children born before 1900? Diseases that are now preventable. Do introductory science courses even touch on the basic mechanisms that underlie immunizations? High school students may not be expected to know that John Enders was the lead investigator in the development of the measles vaccine, but someone should have told them the story of Jonas Salk and polio.

Like many of you, I assumed that if I could just do a better job of filling in the gaps in our educational system that vaccine-hesitant parents would see the light. If I could share with parents even a small fraction of what I know about the efficacy of vaccines they couldn’t possibly refuse to immunize their children. However, after 40 years of failed attempts and frustration, I have begun to doubt my communication skills.

Some work by Brendan Nyhan, Ph.D., a government professor at Dartmouth College, and his colleagues suggests that my attempts at education were destined to fail. ("Effective Messages in Vaccine Promotion: A Randomized Trial," [Pediatrics 2014;133:1-8]). Aware that people frequently resist information that contradicts their views, these investigators began a small study. Nearly 1,800 parents were randomized to receive one of four messages supporting the value of MMR vaccine from textual excerpts to pictures of children with the diseases prevented by the vaccine.

What they discovered was that parents who had "mixed or negative feelings" about the vaccine were actually less likely to say that they would choose to vaccinate a future child after they had been presented with literature refuting the MMR-autism link. While these families were less likely to accept the vaccine-autism link, the informational materials had prompted them to consider other reasons that supported their negative views about vaccines.

Although other studies have found that parents still consider their children’s doctor to be the most trusted source of vaccine information, it appears that education as we understand it may not be our best tool. In fact, it may even be counterproductive. Attempts to engender fear may seem logical to us, but in reality they may be backfiring.

Dr. Nyhan and his colleagues didn’t bore down to discover what factors made a particular view so resistant to education. But, in my experience inheritance doesn’t seem to play a role. I hear from many fearful and frustrated grandparents who can’t understand why their grandchildren aren’t being immunized.

There is the hermit mentality that says by keeping apart from "all those other people" in society and by living a better life, we can protect ourselves from their diseases and don’t need immunizations. And, of course, there is the notion that even though we understand the rationale for immunization, God will protect us.

This important study suggests that we must be very thoughtful about our attempts at education in all public health issues. Our intuition has failed us here. As unfair as it may be to the child victims of this parental foolishness, we may need to fall back on strict exclusion and quarantine to protect the rest us until we learn how to convince families that they are making a serious mistake.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including "How to Say No to Your Toddler." E-mail him at [email protected].

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Electromechanical power morcellation confined to a bag

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Electromechanical power morcellation confined to a bag

In the previous edition of Master Class in Gynecologic Surgery, I described the controversy concerning electromechanical power morcellation freely in the abdominopelvic cavity. I also discussed the risks, as noted in the literature, of spreading an unsuspected leiomyosarcoma, and thus, up-staging the disease and lowering both the length of the disease-free state and the overall survival. I also talked about the lack of an adequate diagnostic study to definitively separate a leiomyoma from a leiomyosarcoma, discussed the at-risk population group, and also noted the benefits of minimally invasive gynecologic surgery. At that time, I stated I was against a ban on the morcellator, and that I recommended that physicians provide proper informed consent and, when possible, consider other treatment options, especially in the at-risk population. These included continued use of minimally invasive gynecologic surgery utilizing a specimen bag for electromechanical power morcellation.

Following that publication, the Food and Drug Administration released a statement regarding electromechanical power morcellation on April 17, 2014. While "discouraging" the use of electromechanical power morcellation, they wisely did not call for a moratorium. Again, the FDA recommended that patients be properly informed as to risk and that alternative therapies be discussed, which included the use of power morcellation in a bag.

Dr. Charles E. Miller

While the FDA did not ban electromechanical power morcellation, the phrase "discourages the use" sent widespread ripples throughout our specialty. Within a week, Ethicon Endo-Surgery pulled its morcellator off the market worldwide. My hospital system – Advocate Health Care – as well as virtually every hospital in Boston placed a moratorium on electromechanical power morcellation. Dr. Jim Tsaltas, president of the Australian Gynecological Endoscopy & Surgery Society (AGES), was contacted by his country’s FDA equivalent to discuss the use of power morcellation freely in the abdominopelvic cavity.

Since the letter from the FDA, position papers have come from both the world’s largest society focused on minimally invasive surgery, the AAGL, and the American College of Obstetricians and Gynecologists (ACOG). Both of the society’s statements agree that proper informed consent is imperative and that alternate treatment be considered, especially in the at-risk population. Although both papers discuss the use of electromechanical power morcellation in the confines of a bag, the ACOG statement accurately notes that there is very little data regarding morcellation in a bag placed in the abdominopelvic cavity.

Experience with electromechanical power morcellation in a bag placed in the abdominopelvic cavity is now quickly developing. To quote my coauthor, Dr. Ceana Nezhat, "My goal with this Master Class is to provide a forum for discussion and encourage gynecologic surgeons to continue to practice minimally invasive surgery for the benefit of their patients. Despite the current limitation on unprotected, intraperitoneal electromechanical morcellation, the hope is that surgeons will not revert back to laparotomy, but will continue to learn and find innovative ways to provide the least invasive surgical techniques or refer to centers that can provide these services to women."

In this edition of Master Class in Gynecologic Surgery, I am featuring techniques of electromechanical power morcellation in a specimen bag by early adapters and innovators, and other techniques by Dr. Tony Shibley, Dr. Bernard Taylor, and Dr. Ceana H. Nezhat.

Dr. Shibley has been in full-time practice with Ob.Gyn. Specialists, Fairview Health Services in the Minneapolis area (Edina), for the past 20 years. He has a focus on single-site surgery and has been involved in minimally invasive surgical education both nationally and internationally, as well as in medical device development.

Dr. Taylor is a urogynecologist who is a female pelvic medicine and reconstructive surgeon practicing at the Carolinas Medical Center–Advanced Surgical Specialties for Women in Charlotte, N.C. He lectures nationally and internationally on minimally invasive gynecologic surgery.

Dr. Nezhat is the current president of the AAGL, adjunct professor of obstetrics and gynecology at Emory University and program director of minimally invasive surgery at Northside Hospital, both in Atlanta, and adjunct clinical professor of obstetrics and gynecology at Stanford (Calif.) University.

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. Dr. Miller disclosed that he is a consultant to Ethicon Endo-Surgery.

Videos of our experts’ individual techniques of electromechanical power morcellation within the confines of a bag, as well as that of Dr. Douglas Brown, director of the Center for Minimally Invasive Gynecologic Surgery at Massachusetts General Hospital, Boston, can be viewed at the SurgeryU website. Also at SurgeryU is a video of the electromechanical power morcellation technique in a bag that my partner, Dr. Aarathi Cholkeri-Singh, and I utilize. We use a 3,100-cc ripstop nylon specimen bag from Espiner Medical and the 5 x 150 mm, extra-long, shielded-bladed balloon-tipped trocar from Applied Medical. Go to SurgeryU to view videos of the procedures.

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In the previous edition of Master Class in Gynecologic Surgery, I described the controversy concerning electromechanical power morcellation freely in the abdominopelvic cavity. I also discussed the risks, as noted in the literature, of spreading an unsuspected leiomyosarcoma, and thus, up-staging the disease and lowering both the length of the disease-free state and the overall survival. I also talked about the lack of an adequate diagnostic study to definitively separate a leiomyoma from a leiomyosarcoma, discussed the at-risk population group, and also noted the benefits of minimally invasive gynecologic surgery. At that time, I stated I was against a ban on the morcellator, and that I recommended that physicians provide proper informed consent and, when possible, consider other treatment options, especially in the at-risk population. These included continued use of minimally invasive gynecologic surgery utilizing a specimen bag for electromechanical power morcellation.

Following that publication, the Food and Drug Administration released a statement regarding electromechanical power morcellation on April 17, 2014. While "discouraging" the use of electromechanical power morcellation, they wisely did not call for a moratorium. Again, the FDA recommended that patients be properly informed as to risk and that alternative therapies be discussed, which included the use of power morcellation in a bag.

Dr. Charles E. Miller

While the FDA did not ban electromechanical power morcellation, the phrase "discourages the use" sent widespread ripples throughout our specialty. Within a week, Ethicon Endo-Surgery pulled its morcellator off the market worldwide. My hospital system – Advocate Health Care – as well as virtually every hospital in Boston placed a moratorium on electromechanical power morcellation. Dr. Jim Tsaltas, president of the Australian Gynecological Endoscopy & Surgery Society (AGES), was contacted by his country’s FDA equivalent to discuss the use of power morcellation freely in the abdominopelvic cavity.

Since the letter from the FDA, position papers have come from both the world’s largest society focused on minimally invasive surgery, the AAGL, and the American College of Obstetricians and Gynecologists (ACOG). Both of the society’s statements agree that proper informed consent is imperative and that alternate treatment be considered, especially in the at-risk population. Although both papers discuss the use of electromechanical power morcellation in the confines of a bag, the ACOG statement accurately notes that there is very little data regarding morcellation in a bag placed in the abdominopelvic cavity.

Experience with electromechanical power morcellation in a bag placed in the abdominopelvic cavity is now quickly developing. To quote my coauthor, Dr. Ceana Nezhat, "My goal with this Master Class is to provide a forum for discussion and encourage gynecologic surgeons to continue to practice minimally invasive surgery for the benefit of their patients. Despite the current limitation on unprotected, intraperitoneal electromechanical morcellation, the hope is that surgeons will not revert back to laparotomy, but will continue to learn and find innovative ways to provide the least invasive surgical techniques or refer to centers that can provide these services to women."

In this edition of Master Class in Gynecologic Surgery, I am featuring techniques of electromechanical power morcellation in a specimen bag by early adapters and innovators, and other techniques by Dr. Tony Shibley, Dr. Bernard Taylor, and Dr. Ceana H. Nezhat.

Dr. Shibley has been in full-time practice with Ob.Gyn. Specialists, Fairview Health Services in the Minneapolis area (Edina), for the past 20 years. He has a focus on single-site surgery and has been involved in minimally invasive surgical education both nationally and internationally, as well as in medical device development.

Dr. Taylor is a urogynecologist who is a female pelvic medicine and reconstructive surgeon practicing at the Carolinas Medical Center–Advanced Surgical Specialties for Women in Charlotte, N.C. He lectures nationally and internationally on minimally invasive gynecologic surgery.

Dr. Nezhat is the current president of the AAGL, adjunct professor of obstetrics and gynecology at Emory University and program director of minimally invasive surgery at Northside Hospital, both in Atlanta, and adjunct clinical professor of obstetrics and gynecology at Stanford (Calif.) University.

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. Dr. Miller disclosed that he is a consultant to Ethicon Endo-Surgery.

Videos of our experts’ individual techniques of electromechanical power morcellation within the confines of a bag, as well as that of Dr. Douglas Brown, director of the Center for Minimally Invasive Gynecologic Surgery at Massachusetts General Hospital, Boston, can be viewed at the SurgeryU website. Also at SurgeryU is a video of the electromechanical power morcellation technique in a bag that my partner, Dr. Aarathi Cholkeri-Singh, and I utilize. We use a 3,100-cc ripstop nylon specimen bag from Espiner Medical and the 5 x 150 mm, extra-long, shielded-bladed balloon-tipped trocar from Applied Medical. Go to SurgeryU to view videos of the procedures.

In the previous edition of Master Class in Gynecologic Surgery, I described the controversy concerning electromechanical power morcellation freely in the abdominopelvic cavity. I also discussed the risks, as noted in the literature, of spreading an unsuspected leiomyosarcoma, and thus, up-staging the disease and lowering both the length of the disease-free state and the overall survival. I also talked about the lack of an adequate diagnostic study to definitively separate a leiomyoma from a leiomyosarcoma, discussed the at-risk population group, and also noted the benefits of minimally invasive gynecologic surgery. At that time, I stated I was against a ban on the morcellator, and that I recommended that physicians provide proper informed consent and, when possible, consider other treatment options, especially in the at-risk population. These included continued use of minimally invasive gynecologic surgery utilizing a specimen bag for electromechanical power morcellation.

Following that publication, the Food and Drug Administration released a statement regarding electromechanical power morcellation on April 17, 2014. While "discouraging" the use of electromechanical power morcellation, they wisely did not call for a moratorium. Again, the FDA recommended that patients be properly informed as to risk and that alternative therapies be discussed, which included the use of power morcellation in a bag.

Dr. Charles E. Miller

While the FDA did not ban electromechanical power morcellation, the phrase "discourages the use" sent widespread ripples throughout our specialty. Within a week, Ethicon Endo-Surgery pulled its morcellator off the market worldwide. My hospital system – Advocate Health Care – as well as virtually every hospital in Boston placed a moratorium on electromechanical power morcellation. Dr. Jim Tsaltas, president of the Australian Gynecological Endoscopy & Surgery Society (AGES), was contacted by his country’s FDA equivalent to discuss the use of power morcellation freely in the abdominopelvic cavity.

Since the letter from the FDA, position papers have come from both the world’s largest society focused on minimally invasive surgery, the AAGL, and the American College of Obstetricians and Gynecologists (ACOG). Both of the society’s statements agree that proper informed consent is imperative and that alternate treatment be considered, especially in the at-risk population. Although both papers discuss the use of electromechanical power morcellation in the confines of a bag, the ACOG statement accurately notes that there is very little data regarding morcellation in a bag placed in the abdominopelvic cavity.

Experience with electromechanical power morcellation in a bag placed in the abdominopelvic cavity is now quickly developing. To quote my coauthor, Dr. Ceana Nezhat, "My goal with this Master Class is to provide a forum for discussion and encourage gynecologic surgeons to continue to practice minimally invasive surgery for the benefit of their patients. Despite the current limitation on unprotected, intraperitoneal electromechanical morcellation, the hope is that surgeons will not revert back to laparotomy, but will continue to learn and find innovative ways to provide the least invasive surgical techniques or refer to centers that can provide these services to women."

In this edition of Master Class in Gynecologic Surgery, I am featuring techniques of electromechanical power morcellation in a specimen bag by early adapters and innovators, and other techniques by Dr. Tony Shibley, Dr. Bernard Taylor, and Dr. Ceana H. Nezhat.

Dr. Shibley has been in full-time practice with Ob.Gyn. Specialists, Fairview Health Services in the Minneapolis area (Edina), for the past 20 years. He has a focus on single-site surgery and has been involved in minimally invasive surgical education both nationally and internationally, as well as in medical device development.

Dr. Taylor is a urogynecologist who is a female pelvic medicine and reconstructive surgeon practicing at the Carolinas Medical Center–Advanced Surgical Specialties for Women in Charlotte, N.C. He lectures nationally and internationally on minimally invasive gynecologic surgery.

Dr. Nezhat is the current president of the AAGL, adjunct professor of obstetrics and gynecology at Emory University and program director of minimally invasive surgery at Northside Hospital, both in Atlanta, and adjunct clinical professor of obstetrics and gynecology at Stanford (Calif.) University.

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. Dr. Miller disclosed that he is a consultant to Ethicon Endo-Surgery.

Videos of our experts’ individual techniques of electromechanical power morcellation within the confines of a bag, as well as that of Dr. Douglas Brown, director of the Center for Minimally Invasive Gynecologic Surgery at Massachusetts General Hospital, Boston, can be viewed at the SurgeryU website. Also at SurgeryU is a video of the electromechanical power morcellation technique in a bag that my partner, Dr. Aarathi Cholkeri-Singh, and I utilize. We use a 3,100-cc ripstop nylon specimen bag from Espiner Medical and the 5 x 150 mm, extra-long, shielded-bladed balloon-tipped trocar from Applied Medical. Go to SurgeryU to view videos of the procedures.

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Point/Counterpoint: Is accreditation necessary to maintain quality in bariatric surgery?

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Point/Counterpoint: Is accreditation necessary to maintain quality in bariatric surgery?

Yes: Accreditation is why bariatric surgery outcomes are so good.

In the early days of bariatric surgery, there were very high mortality rates, up to 21% at 1 year in some studies. Because of that level of risk to patients, accreditation was implemented. Currently, mortality rates for bariatric surgery are at 0.15%, an extraordinary achievement in less than a decade. There are now 729 accredited hospitals in the United States, and that number says much about the level of access for patients. It is not unfettered access to bariatric surgery that is important, but rather access by patients to quality care. That’s what matters at the end of the day.

Dr. John M. Morton

Accreditation isn’t keeping patients from gaining access to bariatric surgery. The bigger problem in access is making sure the federal and state health exchanges provide coverage for bariatric surgery among the essential health benefits. Fewer than half the states have this coverage.

Since accreditation started, there have been six studies with findings supporting it and three with findings that did not. Among the papers supporting it, Flum et al. is most persuasive because it looks at the Medicare population before and after the implementation of accreditation. It shows a big improvement in deaths, complications, and readmissions after the accreditation mandate despite an increase in the number of patients undergoing bariatric surgery (Ann. Surg. 2011;254:860-5).

The question that always comes up is whether it is volume (the number of cases you’re doing) or accreditation that matters for outcomes. A 2013 study found that accreditation status rendered a benefit independent of volume (Surg. Endosc. 2013;27:4539-46).

If we look at the three papers that found against accreditation, I would dismiss one study because it preceded the accreditation movement (Arch. Surg. 2009;144:319-25).

A study of Michigan patients reported similar complication rates at Centers of Excellence (COEs) and non-COEs (JAMA 2010;304:435-42). The problem with that study is that all of the hospitals in the study essentially are COEs, with the same components that come out of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). They have a registry. They have volume requirements. They have quality improvement. So, essentially, they’re all COEs, and I’m glad that they embrace the same concepts that we espouse.

The final paper, by Dr. Dimick, takes an econometric approach using differences within differences analysis, which means you look at the differential rate of change to see if the experimental group (in this case, the Medicare population) is different in some way from the control group (non-Medicare). Here’s the problem: That is not a true control. Non-Medicare patients were exposed to accreditation. All of the major insurers embraced accreditation then and continue to do so.

The paper didn’t look at mortality and failure to rescue patients from complications (JAMA 2013;309:792-9). Even though mortality may be low, it still matters. It’s what I would call a sentinel event. It’s become so rare that when it happens, it’s a signal of an issue around quality. We see improvements in both the Medicare and non-Medicare populations. Do two rights make a wrong? Does that mean that accreditation doesn’t work? I think it points out that we’re seeing important changes for the better for all groups.

We presented findings at the American Surgical Association this year showing that accredited hospitals had lower total charges with lower rates of complications, mortality, and failure to rescue. What accreditation provides is a safety net. If something goes wrong, the difference is the ability to recover from complications. There was not a big difference between accredited and non-accredited hospitals in complications in general, but a bigger difference in mortality. Mortality still counts. Failure to rescue is a very important metric that we all need to pay attention to.

Some of our other data show a halo effect from accreditation. In the accredited centers, outcomes were better for non-bariatric procedures. Why? Because they had more experience with obese patients. It’s a collateral benefit.

Without accreditation, I wonder what will happen at hospitals that aren’t required to be accredited. Will they still have the registry? Will they still have the resources they need? Not everybody has the advantages that Michigan has with major insurer support to pay for accreditation efforts. And it’s critical that we have those data. You can’t manage what you don’t measure. Accreditation is vital for bariatric surgery.

Dr. Morton is director of both bariatric surgery and surgical quality at Stanford (Calif.) University Medical Center. He disclosed financial associations with Vivus, Covidien, and Ethicon.

 

 

No: The data do not show that outcomes are better in COEs.

The Centers of Excellence has evolved into the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP), which is an outcomes benchmarking and quality improvement program. So we are, in many ways, looking in the rear-view mirror when we talk about whether or not the historical accreditation process improved outcomes.

I’m going to make two arguments against the historical way it was done. The first argument is that limiting care to Centers of Excellence (COEs) as they were defined had very little benefit on outcomes and may have caused some harm.

Dr. Justin B. Dimick

A lot of the data out there to evaluate the COE program are a little misleading. They looked at Medicare data for outcomes before and after the Medicare COE mandate was put in place requiring that bariatric surgery be performed in a COE to qualify for coverage. The problem with that is the outcomes are improving so quickly that you can’t just do a before and after study. You need to adjust for that time frame to make sure you’re not getting a spurious finding.

We did a study comparing improvement trends for any complications, serious complications, and reoperations before and after Medicare implemented its coverage decision. Surgeons were already getting better before that. There was no change in the trajectory of improvements when the policy was implemented. We concluded that the policy that selectively referred patients to Centers of Excellence didn’t have any benefit (JAMA 2013;309:792-9). We originally included mortality in our analysis but deaths were so rare that it didn’t meet power specifications set by the journal.

In that paper, we did a head-to-head comparison of COEs vs. non-COEs in 12 large states. It’s hard to do a randomized controlled trial for this, so we did an instrumental variable analysis, a sophisticated analysis that takes out a lot of the unmeasured confounding in selection bias. We found that there was no benefit to having bariatric surgery in a COE.

We noticed that many hospitals that traditionally served minorities did not achieve accreditation. One can assume that’s because they probably didn’t have the resources to participate in the program. After the policy was implemented, the rate of bariatric surgery in minorities dropped substantially, whereas it went up in non-minority patients (JAMA 2013;310:1399-1400). So, there’s potential evidence of harm with these policies.

Medicare eliminated their facility accreditation requirement for bariatric surgery last September.

My second argument is that we could be doing something so much better than accreditation to improve bariatric surgery outcomes. Michigan’s approach is a large quality improvement collaborative funded by Blue Cross Blue Shield. We’re using lessons learned in Michigan to implement change on a broader scale without the involvement of payers. We have 70 surgeons and 32 bariatric surgery programs benchmarking outcomes and using those in strategic ways to learn from each other, hopefully improving everybody’s outcomes.

We standardized venous thromboembolism (VTE) prophylaxis across the state and implemented decision support. VTE rates fell by half. We saw a 90% improvement in mortality and a 24% drop in overall complications. Yes, bariatric surgery centers everywhere were improving at that same time, but when we compared Michigan hospitals participating in our collaborative to non-Michigan hospitals, we saw steeper declines in adverse outcomes in Michigan. That’s very robust evidence that this approach is effective for improving perioperative care.

We have launched a technical skill initiative in which surgeons participating in the collaborative give us a video of a typical procedure that gets rated in a blinded fashion by their peers. We just got funded to use these videos in a coaching program to help surgeons in Michigan improve our technique.

Doing this kind of collaborative work doesn’t take a ton of money. It does take time, strategy, and social capital – developing networks of surgeons that work together and learn together. The historical Centers of Excellence program wasn’t a bad idea, but it wasn’t correlated with perioperative outcomes, and it did have harms.

Dr. Dimick is chief of minimally invasive surgery at the University of Michigan Health System, Ann Arbor. He disclosed being a stockholder in ArborMetrix.

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Yes: Accreditation is why bariatric surgery outcomes are so good.

In the early days of bariatric surgery, there were very high mortality rates, up to 21% at 1 year in some studies. Because of that level of risk to patients, accreditation was implemented. Currently, mortality rates for bariatric surgery are at 0.15%, an extraordinary achievement in less than a decade. There are now 729 accredited hospitals in the United States, and that number says much about the level of access for patients. It is not unfettered access to bariatric surgery that is important, but rather access by patients to quality care. That’s what matters at the end of the day.

Dr. John M. Morton

Accreditation isn’t keeping patients from gaining access to bariatric surgery. The bigger problem in access is making sure the federal and state health exchanges provide coverage for bariatric surgery among the essential health benefits. Fewer than half the states have this coverage.

Since accreditation started, there have been six studies with findings supporting it and three with findings that did not. Among the papers supporting it, Flum et al. is most persuasive because it looks at the Medicare population before and after the implementation of accreditation. It shows a big improvement in deaths, complications, and readmissions after the accreditation mandate despite an increase in the number of patients undergoing bariatric surgery (Ann. Surg. 2011;254:860-5).

The question that always comes up is whether it is volume (the number of cases you’re doing) or accreditation that matters for outcomes. A 2013 study found that accreditation status rendered a benefit independent of volume (Surg. Endosc. 2013;27:4539-46).

If we look at the three papers that found against accreditation, I would dismiss one study because it preceded the accreditation movement (Arch. Surg. 2009;144:319-25).

A study of Michigan patients reported similar complication rates at Centers of Excellence (COEs) and non-COEs (JAMA 2010;304:435-42). The problem with that study is that all of the hospitals in the study essentially are COEs, with the same components that come out of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). They have a registry. They have volume requirements. They have quality improvement. So, essentially, they’re all COEs, and I’m glad that they embrace the same concepts that we espouse.

The final paper, by Dr. Dimick, takes an econometric approach using differences within differences analysis, which means you look at the differential rate of change to see if the experimental group (in this case, the Medicare population) is different in some way from the control group (non-Medicare). Here’s the problem: That is not a true control. Non-Medicare patients were exposed to accreditation. All of the major insurers embraced accreditation then and continue to do so.

The paper didn’t look at mortality and failure to rescue patients from complications (JAMA 2013;309:792-9). Even though mortality may be low, it still matters. It’s what I would call a sentinel event. It’s become so rare that when it happens, it’s a signal of an issue around quality. We see improvements in both the Medicare and non-Medicare populations. Do two rights make a wrong? Does that mean that accreditation doesn’t work? I think it points out that we’re seeing important changes for the better for all groups.

We presented findings at the American Surgical Association this year showing that accredited hospitals had lower total charges with lower rates of complications, mortality, and failure to rescue. What accreditation provides is a safety net. If something goes wrong, the difference is the ability to recover from complications. There was not a big difference between accredited and non-accredited hospitals in complications in general, but a bigger difference in mortality. Mortality still counts. Failure to rescue is a very important metric that we all need to pay attention to.

Some of our other data show a halo effect from accreditation. In the accredited centers, outcomes were better for non-bariatric procedures. Why? Because they had more experience with obese patients. It’s a collateral benefit.

Without accreditation, I wonder what will happen at hospitals that aren’t required to be accredited. Will they still have the registry? Will they still have the resources they need? Not everybody has the advantages that Michigan has with major insurer support to pay for accreditation efforts. And it’s critical that we have those data. You can’t manage what you don’t measure. Accreditation is vital for bariatric surgery.

Dr. Morton is director of both bariatric surgery and surgical quality at Stanford (Calif.) University Medical Center. He disclosed financial associations with Vivus, Covidien, and Ethicon.

 

 

No: The data do not show that outcomes are better in COEs.

The Centers of Excellence has evolved into the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP), which is an outcomes benchmarking and quality improvement program. So we are, in many ways, looking in the rear-view mirror when we talk about whether or not the historical accreditation process improved outcomes.

I’m going to make two arguments against the historical way it was done. The first argument is that limiting care to Centers of Excellence (COEs) as they were defined had very little benefit on outcomes and may have caused some harm.

Dr. Justin B. Dimick

A lot of the data out there to evaluate the COE program are a little misleading. They looked at Medicare data for outcomes before and after the Medicare COE mandate was put in place requiring that bariatric surgery be performed in a COE to qualify for coverage. The problem with that is the outcomes are improving so quickly that you can’t just do a before and after study. You need to adjust for that time frame to make sure you’re not getting a spurious finding.

We did a study comparing improvement trends for any complications, serious complications, and reoperations before and after Medicare implemented its coverage decision. Surgeons were already getting better before that. There was no change in the trajectory of improvements when the policy was implemented. We concluded that the policy that selectively referred patients to Centers of Excellence didn’t have any benefit (JAMA 2013;309:792-9). We originally included mortality in our analysis but deaths were so rare that it didn’t meet power specifications set by the journal.

In that paper, we did a head-to-head comparison of COEs vs. non-COEs in 12 large states. It’s hard to do a randomized controlled trial for this, so we did an instrumental variable analysis, a sophisticated analysis that takes out a lot of the unmeasured confounding in selection bias. We found that there was no benefit to having bariatric surgery in a COE.

We noticed that many hospitals that traditionally served minorities did not achieve accreditation. One can assume that’s because they probably didn’t have the resources to participate in the program. After the policy was implemented, the rate of bariatric surgery in minorities dropped substantially, whereas it went up in non-minority patients (JAMA 2013;310:1399-1400). So, there’s potential evidence of harm with these policies.

Medicare eliminated their facility accreditation requirement for bariatric surgery last September.

My second argument is that we could be doing something so much better than accreditation to improve bariatric surgery outcomes. Michigan’s approach is a large quality improvement collaborative funded by Blue Cross Blue Shield. We’re using lessons learned in Michigan to implement change on a broader scale without the involvement of payers. We have 70 surgeons and 32 bariatric surgery programs benchmarking outcomes and using those in strategic ways to learn from each other, hopefully improving everybody’s outcomes.

We standardized venous thromboembolism (VTE) prophylaxis across the state and implemented decision support. VTE rates fell by half. We saw a 90% improvement in mortality and a 24% drop in overall complications. Yes, bariatric surgery centers everywhere were improving at that same time, but when we compared Michigan hospitals participating in our collaborative to non-Michigan hospitals, we saw steeper declines in adverse outcomes in Michigan. That’s very robust evidence that this approach is effective for improving perioperative care.

We have launched a technical skill initiative in which surgeons participating in the collaborative give us a video of a typical procedure that gets rated in a blinded fashion by their peers. We just got funded to use these videos in a coaching program to help surgeons in Michigan improve our technique.

Doing this kind of collaborative work doesn’t take a ton of money. It does take time, strategy, and social capital – developing networks of surgeons that work together and learn together. The historical Centers of Excellence program wasn’t a bad idea, but it wasn’t correlated with perioperative outcomes, and it did have harms.

Dr. Dimick is chief of minimally invasive surgery at the University of Michigan Health System, Ann Arbor. He disclosed being a stockholder in ArborMetrix.

Yes: Accreditation is why bariatric surgery outcomes are so good.

In the early days of bariatric surgery, there were very high mortality rates, up to 21% at 1 year in some studies. Because of that level of risk to patients, accreditation was implemented. Currently, mortality rates for bariatric surgery are at 0.15%, an extraordinary achievement in less than a decade. There are now 729 accredited hospitals in the United States, and that number says much about the level of access for patients. It is not unfettered access to bariatric surgery that is important, but rather access by patients to quality care. That’s what matters at the end of the day.

Dr. John M. Morton

Accreditation isn’t keeping patients from gaining access to bariatric surgery. The bigger problem in access is making sure the federal and state health exchanges provide coverage for bariatric surgery among the essential health benefits. Fewer than half the states have this coverage.

Since accreditation started, there have been six studies with findings supporting it and three with findings that did not. Among the papers supporting it, Flum et al. is most persuasive because it looks at the Medicare population before and after the implementation of accreditation. It shows a big improvement in deaths, complications, and readmissions after the accreditation mandate despite an increase in the number of patients undergoing bariatric surgery (Ann. Surg. 2011;254:860-5).

The question that always comes up is whether it is volume (the number of cases you’re doing) or accreditation that matters for outcomes. A 2013 study found that accreditation status rendered a benefit independent of volume (Surg. Endosc. 2013;27:4539-46).

If we look at the three papers that found against accreditation, I would dismiss one study because it preceded the accreditation movement (Arch. Surg. 2009;144:319-25).

A study of Michigan patients reported similar complication rates at Centers of Excellence (COEs) and non-COEs (JAMA 2010;304:435-42). The problem with that study is that all of the hospitals in the study essentially are COEs, with the same components that come out of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). They have a registry. They have volume requirements. They have quality improvement. So, essentially, they’re all COEs, and I’m glad that they embrace the same concepts that we espouse.

The final paper, by Dr. Dimick, takes an econometric approach using differences within differences analysis, which means you look at the differential rate of change to see if the experimental group (in this case, the Medicare population) is different in some way from the control group (non-Medicare). Here’s the problem: That is not a true control. Non-Medicare patients were exposed to accreditation. All of the major insurers embraced accreditation then and continue to do so.

The paper didn’t look at mortality and failure to rescue patients from complications (JAMA 2013;309:792-9). Even though mortality may be low, it still matters. It’s what I would call a sentinel event. It’s become so rare that when it happens, it’s a signal of an issue around quality. We see improvements in both the Medicare and non-Medicare populations. Do two rights make a wrong? Does that mean that accreditation doesn’t work? I think it points out that we’re seeing important changes for the better for all groups.

We presented findings at the American Surgical Association this year showing that accredited hospitals had lower total charges with lower rates of complications, mortality, and failure to rescue. What accreditation provides is a safety net. If something goes wrong, the difference is the ability to recover from complications. There was not a big difference between accredited and non-accredited hospitals in complications in general, but a bigger difference in mortality. Mortality still counts. Failure to rescue is a very important metric that we all need to pay attention to.

Some of our other data show a halo effect from accreditation. In the accredited centers, outcomes were better for non-bariatric procedures. Why? Because they had more experience with obese patients. It’s a collateral benefit.

Without accreditation, I wonder what will happen at hospitals that aren’t required to be accredited. Will they still have the registry? Will they still have the resources they need? Not everybody has the advantages that Michigan has with major insurer support to pay for accreditation efforts. And it’s critical that we have those data. You can’t manage what you don’t measure. Accreditation is vital for bariatric surgery.

Dr. Morton is director of both bariatric surgery and surgical quality at Stanford (Calif.) University Medical Center. He disclosed financial associations with Vivus, Covidien, and Ethicon.

 

 

No: The data do not show that outcomes are better in COEs.

The Centers of Excellence has evolved into the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP), which is an outcomes benchmarking and quality improvement program. So we are, in many ways, looking in the rear-view mirror when we talk about whether or not the historical accreditation process improved outcomes.

I’m going to make two arguments against the historical way it was done. The first argument is that limiting care to Centers of Excellence (COEs) as they were defined had very little benefit on outcomes and may have caused some harm.

Dr. Justin B. Dimick

A lot of the data out there to evaluate the COE program are a little misleading. They looked at Medicare data for outcomes before and after the Medicare COE mandate was put in place requiring that bariatric surgery be performed in a COE to qualify for coverage. The problem with that is the outcomes are improving so quickly that you can’t just do a before and after study. You need to adjust for that time frame to make sure you’re not getting a spurious finding.

We did a study comparing improvement trends for any complications, serious complications, and reoperations before and after Medicare implemented its coverage decision. Surgeons were already getting better before that. There was no change in the trajectory of improvements when the policy was implemented. We concluded that the policy that selectively referred patients to Centers of Excellence didn’t have any benefit (JAMA 2013;309:792-9). We originally included mortality in our analysis but deaths were so rare that it didn’t meet power specifications set by the journal.

In that paper, we did a head-to-head comparison of COEs vs. non-COEs in 12 large states. It’s hard to do a randomized controlled trial for this, so we did an instrumental variable analysis, a sophisticated analysis that takes out a lot of the unmeasured confounding in selection bias. We found that there was no benefit to having bariatric surgery in a COE.

We noticed that many hospitals that traditionally served minorities did not achieve accreditation. One can assume that’s because they probably didn’t have the resources to participate in the program. After the policy was implemented, the rate of bariatric surgery in minorities dropped substantially, whereas it went up in non-minority patients (JAMA 2013;310:1399-1400). So, there’s potential evidence of harm with these policies.

Medicare eliminated their facility accreditation requirement for bariatric surgery last September.

My second argument is that we could be doing something so much better than accreditation to improve bariatric surgery outcomes. Michigan’s approach is a large quality improvement collaborative funded by Blue Cross Blue Shield. We’re using lessons learned in Michigan to implement change on a broader scale without the involvement of payers. We have 70 surgeons and 32 bariatric surgery programs benchmarking outcomes and using those in strategic ways to learn from each other, hopefully improving everybody’s outcomes.

We standardized venous thromboembolism (VTE) prophylaxis across the state and implemented decision support. VTE rates fell by half. We saw a 90% improvement in mortality and a 24% drop in overall complications. Yes, bariatric surgery centers everywhere were improving at that same time, but when we compared Michigan hospitals participating in our collaborative to non-Michigan hospitals, we saw steeper declines in adverse outcomes in Michigan. That’s very robust evidence that this approach is effective for improving perioperative care.

We have launched a technical skill initiative in which surgeons participating in the collaborative give us a video of a typical procedure that gets rated in a blinded fashion by their peers. We just got funded to use these videos in a coaching program to help surgeons in Michigan improve our technique.

Doing this kind of collaborative work doesn’t take a ton of money. It does take time, strategy, and social capital – developing networks of surgeons that work together and learn together. The historical Centers of Excellence program wasn’t a bad idea, but it wasn’t correlated with perioperative outcomes, and it did have harms.

Dr. Dimick is chief of minimally invasive surgery at the University of Michigan Health System, Ann Arbor. He disclosed being a stockholder in ArborMetrix.

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Morcellation may be impractical

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Over one-half million hysterectomies are performed annually in the United States. Approximately one-third of them are done using minimally invasive techniques. Electromechanical morcellation was introduced to gynecologic surgery in the 1990s. This allowed for women with larger uteri to be able to undergo minimally invasive surgery (MIS). Over time, there was a shift from laparoscopic-assisted vaginal hysterectomy to laparoscopic-assisted supracervical hysterectomy using the morcellator. This is done even in cases when the uterus is small enough to be easily delivered transvaginally.

Uncontained intraperitoneal morcellation, especially with the rotating blade morcellator, carries the risk of peritoneal spread of an unsuspected malignancy. This not only upstages the cancer and impacts the need for or type of adjuvant therapy, but also worsens the prognosis.

No one argues that intraperitoneal morcellation of a known malignancy should be avoided. At present, there is no accurate way of diagnosing a uterine leiomyosarcoma in a woman thought to have leiomyoma before the specimen is evaluated in the pathology laboratory. Endometrial sampling and imaging studies have poor sensitivity for detecting this pathology prior to surgery. The symptoms associated with uterine leiomyosarcoma can be similar to those experienced by women with leiomyomas. Several studies have shown that the median age of women who undergo surgery for removal of leiomyomas but are found to have a leiomyosarcoma is 50 years. The incidence of unsuspected leiomyosarcoma in women having uterine leiomyomas surgically removed increases with age. However, the age of these women with unsuspected uterine leiomyosarcoma ranges from 18 to 95 years. Therefore, it should be noted that uterine leiomyosarcoma can occur at almost any age in a woman’s lifetime.

A Food and Drug Administration analysis released in April 2014 suggests that a uterine leiomyosarcoma can be found in 1 out of 350 women undergoing surgery for presumed leiomyomas. Leibsohn et al. (Am. J. Obstet. Gynecol. 1990;162:968-76) reviewed 1,432 cases of hysterectomy performed in women with symptoms thought to be due to uterine leiomyomas. A leiomyosarcoma was found in seven cases (0.49%). One of 511 (0.2%) women between the ages of 31 and 40 years had an unsuspected leiomyosarcoma.

We could ask, at what level of risk is peritoneal dissemination by uncontained morcellation of an unsuspected malignancy justified? Is the harm to one patient justified by the possible benefit to thousands of other patients? I will argue that any level of risk is too high if there is a way to achieve the same results without worsening the prognosis of women who harbor unsuspected leiomyosarcoma. The safe use of morcellation will not impede MIS. Women with smaller uteri can undergo transvaginal hysterectomy or laparoscopic-assisted vaginal hysterectomy. Leiomyomas could be removed intact through a colpotomy or through a small abdominal incision. Larger specimens could be morcellated within an isolation bag. In some situations the specimen may be too large or the surgeon lacks the necessary skills for MIS to be safely performed. In those cases a laparotomy is the safest approach. It is ingenuous to suggest that these cases should be referred to a gynecologist with the skill to perform these challenging procedures minimally invasively. This may be possible in some geographic locations and acceptable to some patients, but frequently it is impractical.

Dr. Enrique Hernandez is the Abraham Roth Professor and Chair of Obstetrics, Gynecology and Reproductive Sciences at Temple University, Philadelphia. Dr. Hernandez said he had no relevant financial disclosures.

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Over one-half million hysterectomies are performed annually in the United States. Approximately one-third of them are done using minimally invasive techniques. Electromechanical morcellation was introduced to gynecologic surgery in the 1990s. This allowed for women with larger uteri to be able to undergo minimally invasive surgery (MIS). Over time, there was a shift from laparoscopic-assisted vaginal hysterectomy to laparoscopic-assisted supracervical hysterectomy using the morcellator. This is done even in cases when the uterus is small enough to be easily delivered transvaginally.

Uncontained intraperitoneal morcellation, especially with the rotating blade morcellator, carries the risk of peritoneal spread of an unsuspected malignancy. This not only upstages the cancer and impacts the need for or type of adjuvant therapy, but also worsens the prognosis.

No one argues that intraperitoneal morcellation of a known malignancy should be avoided. At present, there is no accurate way of diagnosing a uterine leiomyosarcoma in a woman thought to have leiomyoma before the specimen is evaluated in the pathology laboratory. Endometrial sampling and imaging studies have poor sensitivity for detecting this pathology prior to surgery. The symptoms associated with uterine leiomyosarcoma can be similar to those experienced by women with leiomyomas. Several studies have shown that the median age of women who undergo surgery for removal of leiomyomas but are found to have a leiomyosarcoma is 50 years. The incidence of unsuspected leiomyosarcoma in women having uterine leiomyomas surgically removed increases with age. However, the age of these women with unsuspected uterine leiomyosarcoma ranges from 18 to 95 years. Therefore, it should be noted that uterine leiomyosarcoma can occur at almost any age in a woman’s lifetime.

A Food and Drug Administration analysis released in April 2014 suggests that a uterine leiomyosarcoma can be found in 1 out of 350 women undergoing surgery for presumed leiomyomas. Leibsohn et al. (Am. J. Obstet. Gynecol. 1990;162:968-76) reviewed 1,432 cases of hysterectomy performed in women with symptoms thought to be due to uterine leiomyomas. A leiomyosarcoma was found in seven cases (0.49%). One of 511 (0.2%) women between the ages of 31 and 40 years had an unsuspected leiomyosarcoma.

We could ask, at what level of risk is peritoneal dissemination by uncontained morcellation of an unsuspected malignancy justified? Is the harm to one patient justified by the possible benefit to thousands of other patients? I will argue that any level of risk is too high if there is a way to achieve the same results without worsening the prognosis of women who harbor unsuspected leiomyosarcoma. The safe use of morcellation will not impede MIS. Women with smaller uteri can undergo transvaginal hysterectomy or laparoscopic-assisted vaginal hysterectomy. Leiomyomas could be removed intact through a colpotomy or through a small abdominal incision. Larger specimens could be morcellated within an isolation bag. In some situations the specimen may be too large or the surgeon lacks the necessary skills for MIS to be safely performed. In those cases a laparotomy is the safest approach. It is ingenuous to suggest that these cases should be referred to a gynecologist with the skill to perform these challenging procedures minimally invasively. This may be possible in some geographic locations and acceptable to some patients, but frequently it is impractical.

Dr. Enrique Hernandez is the Abraham Roth Professor and Chair of Obstetrics, Gynecology and Reproductive Sciences at Temple University, Philadelphia. Dr. Hernandez said he had no relevant financial disclosures.

Over one-half million hysterectomies are performed annually in the United States. Approximately one-third of them are done using minimally invasive techniques. Electromechanical morcellation was introduced to gynecologic surgery in the 1990s. This allowed for women with larger uteri to be able to undergo minimally invasive surgery (MIS). Over time, there was a shift from laparoscopic-assisted vaginal hysterectomy to laparoscopic-assisted supracervical hysterectomy using the morcellator. This is done even in cases when the uterus is small enough to be easily delivered transvaginally.

Uncontained intraperitoneal morcellation, especially with the rotating blade morcellator, carries the risk of peritoneal spread of an unsuspected malignancy. This not only upstages the cancer and impacts the need for or type of adjuvant therapy, but also worsens the prognosis.

No one argues that intraperitoneal morcellation of a known malignancy should be avoided. At present, there is no accurate way of diagnosing a uterine leiomyosarcoma in a woman thought to have leiomyoma before the specimen is evaluated in the pathology laboratory. Endometrial sampling and imaging studies have poor sensitivity for detecting this pathology prior to surgery. The symptoms associated with uterine leiomyosarcoma can be similar to those experienced by women with leiomyomas. Several studies have shown that the median age of women who undergo surgery for removal of leiomyomas but are found to have a leiomyosarcoma is 50 years. The incidence of unsuspected leiomyosarcoma in women having uterine leiomyomas surgically removed increases with age. However, the age of these women with unsuspected uterine leiomyosarcoma ranges from 18 to 95 years. Therefore, it should be noted that uterine leiomyosarcoma can occur at almost any age in a woman’s lifetime.

A Food and Drug Administration analysis released in April 2014 suggests that a uterine leiomyosarcoma can be found in 1 out of 350 women undergoing surgery for presumed leiomyomas. Leibsohn et al. (Am. J. Obstet. Gynecol. 1990;162:968-76) reviewed 1,432 cases of hysterectomy performed in women with symptoms thought to be due to uterine leiomyomas. A leiomyosarcoma was found in seven cases (0.49%). One of 511 (0.2%) women between the ages of 31 and 40 years had an unsuspected leiomyosarcoma.

We could ask, at what level of risk is peritoneal dissemination by uncontained morcellation of an unsuspected malignancy justified? Is the harm to one patient justified by the possible benefit to thousands of other patients? I will argue that any level of risk is too high if there is a way to achieve the same results without worsening the prognosis of women who harbor unsuspected leiomyosarcoma. The safe use of morcellation will not impede MIS. Women with smaller uteri can undergo transvaginal hysterectomy or laparoscopic-assisted vaginal hysterectomy. Leiomyomas could be removed intact through a colpotomy or through a small abdominal incision. Larger specimens could be morcellated within an isolation bag. In some situations the specimen may be too large or the surgeon lacks the necessary skills for MIS to be safely performed. In those cases a laparotomy is the safest approach. It is ingenuous to suggest that these cases should be referred to a gynecologist with the skill to perform these challenging procedures minimally invasively. This may be possible in some geographic locations and acceptable to some patients, but frequently it is impractical.

Dr. Enrique Hernandez is the Abraham Roth Professor and Chair of Obstetrics, Gynecology and Reproductive Sciences at Temple University, Philadelphia. Dr. Hernandez said he had no relevant financial disclosures.

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Safety techniques regarding morcellation

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Power morcellation within an insufflated bag

By Tony Shibley, M.D.

Morcellating safely in laparoscopic hysterectomy or myomectomy involves not only the use of a bag, but also the creation of an artificial pneumoperitoneum inside the bag. Inflation of the bag allows us to create a safe and completely contained working environment in the abdomen, with good visualization and adequate working space.

In the past, specimen containment bags were used for morcellation, but the bags would adhere to tissue and would be easily cut or would tear or rupture. Without proper space and visualization, surgeons could not break tissue into smaller fragments without endangering the bag or the structures behind the bag. We were safely and precisely disconnecting tissue in our surgeries, but falling short with tissue removal. There were calls for more durable bags, but the problems of visualization and safe distance were not addressed. Eventually, the goal of morcellating within a bag was largely abandoned in favor of open power morcellation.

Courtesy Dr. Tony Shibley
Figure 1: The isolation bag is folded.

I stopped performing open power morcellation about 2 years ago and developed a new approach to enclosed morcellation. By creating an artificial pneumoperitoneum in a bag, a good working space is developed within it. This meets the needs of containment while significantly lowering the risk of tissue dissemination and also reducing the risk of bowel injury, vascular injury, and other types of morcellator-related mechanical injuries. This approach to morcellation is safer on all fronts.

My method of enclosed morcellation has been utilized in both single-port and multiport hysterectomy (total and supracervical) and myomectomy performed with either traditional laparoscopy or the robotic platform.

The morcellation process is begun after surgery is complete except for tissue removal, and the patient is hemostatic. The specimen has been placed in a location where it can be easily retrieved; I prefer the right upper quadrant.

In a single-port approach, the bag is inserted into the abdomen through an open single-port cannula at the umbilicus. I use a Steri-Drape Isolation Bag (3M), 50 cm by 50 cm, with drawstrings. (See Figure 1.) Standing across from my assistant, I tightly fan-fold the bag and wring it to purge it of air. Using an atraumatic grasper, I position the bag linearly with the opening up; it is inserted into the pelvis first, with the superior end guided upward into the mid- and then upper-abdomen.

Courtesy Dr. Tony Shibley
Figure 2: The sides of the bag are elevated to ensure that the specimen is well contained.

After the bag is placed, the cannula is recapped with the multiport cap. I use the Olympus TriPort 15 (Advanced Surgical Concepts), and the abdomen is reinsufflated. A camera is inserted into one of the 5-mm ports. I use the Olympus 5-mm articulating laparoscope.

Through the other 5-mm port, I maneuver the bag to form a pocket opening by pushing the upper corners of the bag against the respective abdominal sidewalls, and the body of the bag into the pelvis. I then elevate the specimen and, with a rotational movement, I guide the specimen along the right abdominal sidewall and into the pocket opening. I then elevate the sides of the bag and ensure that the specimen is well contained. (See Figure 2.)

 

 

The drawstrings are then brought up into the port hub. The cap is removed, and the opening of the bag is pulled up through the port and out approximately 15-20 cm, as symmetrically as possible.

The port cap is then replaced within the exteriorized neck of the bag, and the bag is insufflated with traditional laparoscopic pressure of 15-18 mm, creating an artificial pneumoperitoneum. (See Figure 3.) The camera is reinserted, followed by the morcellator, into the 15-mm port of the single-site tri-port. The morcellator must be lubricated so it does not catch the bag on the way in. Morcellation is carried out under direct vision.

Courtesy Dr. Tony Shibley
Figure 3: A close-up of the uterus within the artificial pneumoperitoneum.

After the morcellation process is complete, the morcellator is removed, followed by the camera and the tri-port cap. The bag is desufflated and removed through the open cannula, and the abdomen is closed as usual.

In a multiport approach, the umbilical incision is extended to 15 mm after completion of the hysterectomy or myomectomy. The bag is inserted and placed in a manner similar to the single-port approach, except that the lateral ports may be utilized to further position the bag once it is placed about halfway in. The bag is similarly opened, the specimen contained, and the neck of the bag exteriorized. A 15-mm port is similarly lubricated and placed inside the neck of the bag and through the umbilical incision.

As the bag is insufflated, the lateral ports are backed slightly out so that they're flush with the abdominal wall, and the trocars are opened to allow the release of any residual gas in the abdomen. The laparoscope is then placed into the 15-mm umbilical trocar.

Visualization will ultimately occur from another site, however. One of the lateral 5-mm trocars is advanced at a right angle to the insufflated bag, and an introducer is placed to puncture the bag. I recommend using a blunt plastic trocar; a balloon-tip trocar also can be used. Contrary to what one might think, the bag will not leak any gas. The laparoscope is now transferred to this 5-mm lateral port, and the umbilical port is removed. A lubricated morcellator is inserted directly through the umbilical incision, and morcellation is performed under direct visualization from the side port.

These techniques for single-port or multiport enclosed power morcellation have been shown to be reproducible and successful – with all bags intact and specimens contained – in a multicenter analysis that is being prepared for publication. The largest uterus in the study was 1,481 g.

To make the approach less cumbersome, I have designed a morcellation device consisting of a specialized bag that will open automatically and assist in capturing the specimen. The device, which has closure tabs and a retrieval lanyard, has been developed with the input of other minimally invasive gynecologic surgeons and the design and engineering expertise of Advanced Surgical Concepts. It will be manufactured by the company pending Food and Drug Administration approval.

 

 

Concealed power morcellation: Our take

By Bernard Taylor, M.D.

Courtesy Dr. Ceana H. Nezhat
Figure 4: The LapSac Surgical Tissue Pouch.

The approach to the use of power morcellation within a bag in my practice was not specifically driven by the desire to prevent the dispersion of malignant leiomyosarcoma – an issue that is now front and center and indeed, is important – but by a broader desire to perform as complete an extraction as possible.

For years we have used isolation bags to conceal and contain small uteri, ovaries, and specimens that we debulk using a scalpel and remove through a small umbilical incision. However, this approach is cumbersome for removing larger uteri. Consequently, over the past year we refined our methods for performing power morcellation within a bag.

This procedure can be performed after traditional laparoscopy or robotic-assisted hysterectomy or myomectomy to extract the specimen from the abdomen. A surgical tissue bag is placed into the abdomen and is insufflated within the abdomen. Morcellation is carried out within the concealed "pseudopneumoperitoneum," and the bag is exteriorized from the abdomen, typically through the umbilical incision.

The majority of my procedures utilize a multiport approach due to the nature of my practice as a urogynecologist. After hysterectomy or myomectomy, the specimen is placed in the upper abdomen. The cuff is closed, other procedures are completed in the usual fashion, and hemostasis is reassured. In robotic procedures, we undock the robot prior to morcellation. The umbilical port is removed, and the bag is placed into the abdomen with a ring forceps or atraumatic forceps without teeth. The umbilical port is then replaced to reestablish the pneumoperitoneum for visualization.

 

 

For larger uterine specimens, I use an Isodrape isolation bag (Microtek Medical). This 18 x 18 inch bag with a drawstring opening easily accommodates uteri larger than 1,000 g. The bag is placed into the pelvis with the open end at the pelvic brim and is opened wide. I use the term "open from iliac to iliac and sacrum to bladder." Once the bag is positioned, the specimen is grasped; the patient is slowly taken out of the Trendelenburg position to allow for gravity to assist in the placement of the specimen into the bag.

© 2013 Applied Medical Resources. All rights reserved.
Figure 5: The Alexis Wound Protector/Retractor.

The drawstrings are then grasped and taken out of the umbilical trocar with simultaneous removal of the umbilical port. At this time, the open end of the bag is exteriorized, and the specimen technically is extraperitoneal and "concealed."

To insufflate the bag at this point and create the "pseudopneumoperitoneum," a 15-mm port is lubricated and placed through the opening in the bag. The bag is then insufflated to the usual pressure (15 mm Hg). The accessory ports are opened at this time to allow for the abdominal pressure to fall and for the bag to expand and fill the abdominal cavity.

To enable visualization throughout the morcellation procedure, I use one of the previously placed lower abdomen lateral ports to place a 5-mm camera. The camera is placed after a 5-mm balloon tip trocar is introduced and advanced to perforate the bag. The balloon tip is insufflated in the usual fashion, securing the bag against the abdominal wall and preventing a gas leak.

Alternatively, I have also used a SILSport (Covidien) at the umbilicus in cases when there is a leak at the umbilical incision and the 15-mm port does not seal properly. While use of a single-port technique has been shown to be feasible for both visualization and morcellation, it can present challenges in complex cases with a larger uterus or multiple fibroids.

 

 

Either way, morcellation can take place within the concealed "pseudo-peritoneal" cavity, with the morcellator lubricated and placed either through the umbilical incision or through the Tri-Port. After morcellation is complete, the bag containing the smaller tissue fragments and blood is simply removed through the umbilicus, and closure of the abdomen is completed in the usual fashion.

Courtesy Dr. Ceana H. Nezhat
Figure 6: The Mobius Elastic Abdominal Retractor.

I also have adopted a simplified approach to remove the smaller uteri with supracervical hysterectomy and sacral colpopexy performed laparoscopically. Despite preoperative screening with endometrial biopsy and pelvic ultrasound, several of my patients in the past have been diagnosed with either early ovarian or endometrial neoplasias on final pathology. After completing the procedure, I place the small menopausal senile uterus and adnexa into a 15-mm endoscopic bag. The bag is brought through the umbilical port, and the specimen is removed via morcellation with a scalpel or scissors.

Surgeons have asked about additional time needed to place the bag and position the specimen. Technically, specimen placement is a learned skill; once one is proficient, the case times are not any different. In fact, cases may be shorter because of the time saved by not having to retrieve uterine fragments from the abdomen and pelvis.

Theoretically, the procedure addresses concerns associated with tissue fragmentation and dissemination within the abdominal cavity. To date, there are no trials showing prevention of cancer upstaging or benign conditions such as leiomyomatosis peritonealis disseminata or endometriosis.

 

 

Enclosed vaginal morcellation for enlarged uteri

By Ceana H. Nezhat, M.D.

Removal of large uteri via minimally invasive surgery poses challenges to gynecologic surgeons. Limitations on the use of intraperitoneal electromechanical morcellation are a step forward in terms of protecting patients from undue harm, but we also must acknowledge that minimally invasive surgery has been shown to be superior to laparotomy in the majority of cases.

While safer ways to extract large specimens without risk of spreading both benign and malignant tissue are being studied and developed, gynecologic surgeons need to find alternative minimally invasive approaches for removing large specimens.

Courtesy Dr. Ceana H. Nezhat
Figure 7: The endoscopic specimen removal bag is rolled and placed through the vaginal cuff. The bag is unfolded intraperitonally.

Minimally invasive approaches to extirpate uteri and myomas have been described prior to the advent of electromechanical morcellation. A natural orifice such as the vagina for gynecologic procedures is a clear choice for removing specimens. Laparoscopic-assisted myomectomy is a combination of laparoscopy and minilaparotomy for tissue extraction (JSLS 2001;5:299-303). Another alternative is extracting myoma and other tissues through a posterior colpotomy. Rates of dyspareunia and adhesions in the cul-de-sac after tissue extraction through a colpotomy are low (J. Reprod. Med. 1993;38:534-6).

Vaginal hysterectomy was chronicled and performed by the Greek physician Soranus of Ephesus in 120 A.D. (Acta Chir. Iugosl. 2011:58:9-14), and it is still the preferred route of hysterectomy when it can be performed. Large uteri can be transvaginally morcellated and vaginally extracted; however, this technique still poses the risk, although low, of spilling fragments of uterine tissue in the abdomen.

By combining total laparoscopic hysterectomy and vaginal morcellation of enlarged uteri within an enclosed specimen bag, the risk of spilling uterine fragments is reduced, in addition to avoiding potential visceral and vascular complications associated with intraperitoneal electromechanical morcellation.

Enclosed vaginal morcellation is the technique of placing the enlarged hysterectomy specimen in an endoscopic specimen retrieval bag and then transvaginally morcellating the tissue.

 

 

In the development of this technique, I have experimented with different endoscopic sacs and retractors. In my experience, the optimal laparoscopic bag is the LapSac Surgical Tissue Pouch (Cook Medical). This endoscopic, one-time use, specimen retrieval bag is flexible, durable nylon with an integral polyurethane inner coating and polypropylene drawstring (Figure 4). The bag comes in four sizes, the largest (size 8 x 10 inch, volume 1,500 mL) of which I used to assist in removing the 18-week size uterus in the accompanying video.

Courtesy Dr. Ceana H. Nezhat
Figure 8: The fundus of the hysterectomy specimen is grasped and placed in the bag. The bag is cinched and opening pulled through the vagina.

The other key piece of equipment for vaginal extraction of large uteri is a transvaginally-placed wound retractor. As I have previously described, the self-retaining retractor provides optimal exposure in a narrow field and minimizes trauma to surrounding tissue (J. Minim. Inv. Gynecol. 2009:16:616-7). Two wound retractors are suitable for this surgical technique: the Alexis Wound Protector/Retractor (Applied Medical) (Figure 5) and the Mobius Elastic Abdominal Retractor (Cooper Surgical) (Figure 6).

After complete laparoscopic detachment of the uterus and cervix (and adnexa), the wound retractor is placed transvaginally. One semirigid ring is pushed superiorly through the vagina and into the peritoneal cavity, where is it placed in the cul-de-sac. In this manner, a uniform, circumferential orifice is created. In narrower vaginal vaults, the ring can be compressed between the thumb and index finger to reduce its diameter and thus be introduced into the peritoneal cavity atraumatically. With the small-size retraction systems, an orifice of 2.5 to 6 cm diameter can be created.

The LapSac is folded and then inserted with ring forceps transvaginally through the wound retractor. (See Figure 7.) The bag is unfolded intraperitoneally using the integral tabs to demarcate the edges of the bag. The bag should be unfolded in the pelvis with the opening of the bag cephalad. The fundus of the hysterectomy specimen is grasped with a tenaculum and placed inside the bag. (See Figure 8.)

 

 

It is an important technical point to grab the fundus or the heaviest point of the specimen to allow weight and gravity to facilitate placing the specimen securely in the bag. If the cervix or a lighter part of the specimen is grasped, placement in the bag is more difficult and the specimen will likely slip out of the bag.

Courtesy Dr. Ceana H. Nezhat
Figure 9: Tenaculum are used to pull the uterus to the vaginal opening where it is hand-morcellated with a scalpel.

Once the entire hysterectomy specimen is in the LapSac, the bag is cinched by grasping the blue drawstrings. The opening of the bag is pulled through the vagina. The opening of the bag is externalized and the edges are attached with Allis clamps to the external edge of the wound retractor. The specimen (typically the cervix first) is grasped with a tenaculum and vaginally morcellated and cored with a scalpel (Figure 9).

Metal vaginal retractors are placed within the bag to protect against sharp injury during morcellation. I prefer to amputate the cervix and adnexa separately and en bloc to preserve as much original architecture as possible so the pathologists can properly orient and examine the tissue. After completion of the morcellation, the wound retractor is removed, the cuff closed, and the procedure completed per surgeon preference.

 

 

Dr. Shibley has been in full-time practice with Ob.Gyn. Specialists, Fairview Health Services in the Minneapolis area (Edina), for 20 years. He reported that he has a financial interest in the artificial pneumoperitoneum device under development, and that he is a consultant for Olympus.

Dr. Taylor is a urogynecologist who is a female pelvic medicine and reconstructive surgeon practicing at the Carolinas Medical Center–Advanced Surgical Specialties for Women in Charlotte, N.C. He reported that he has no disclosures relevant to this Master Class.

Dr. Nezhat is the current president of the AAGL, adjunct professor of obstetrics and gynecology at Emory University and program director of minimally invasive surgery at Northside Hospital, both in Atlanta, and adjunct clinical professor of obstetrics and gynecology at Stanford (Calif.) University. He reported that he is a consultant for Karl Storz Endoscopy.

Videos of these experts' individual techniques of electromechanical power morcellation within the confines of a bag, as well as that of Dr. Douglas Brown, director of the Center for Minimally Invasive Gynecologic Surgery at Massachusetts General Hospital, Boston, can be viewed at the SurgeryU website.

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Power morcellation within an insufflated bag

By Tony Shibley, M.D.

Morcellating safely in laparoscopic hysterectomy or myomectomy involves not only the use of a bag, but also the creation of an artificial pneumoperitoneum inside the bag. Inflation of the bag allows us to create a safe and completely contained working environment in the abdomen, with good visualization and adequate working space.

In the past, specimen containment bags were used for morcellation, but the bags would adhere to tissue and would be easily cut or would tear or rupture. Without proper space and visualization, surgeons could not break tissue into smaller fragments without endangering the bag or the structures behind the bag. We were safely and precisely disconnecting tissue in our surgeries, but falling short with tissue removal. There were calls for more durable bags, but the problems of visualization and safe distance were not addressed. Eventually, the goal of morcellating within a bag was largely abandoned in favor of open power morcellation.

Courtesy Dr. Tony Shibley
Figure 1: The isolation bag is folded.

I stopped performing open power morcellation about 2 years ago and developed a new approach to enclosed morcellation. By creating an artificial pneumoperitoneum in a bag, a good working space is developed within it. This meets the needs of containment while significantly lowering the risk of tissue dissemination and also reducing the risk of bowel injury, vascular injury, and other types of morcellator-related mechanical injuries. This approach to morcellation is safer on all fronts.

My method of enclosed morcellation has been utilized in both single-port and multiport hysterectomy (total and supracervical) and myomectomy performed with either traditional laparoscopy or the robotic platform.

The morcellation process is begun after surgery is complete except for tissue removal, and the patient is hemostatic. The specimen has been placed in a location where it can be easily retrieved; I prefer the right upper quadrant.

In a single-port approach, the bag is inserted into the abdomen through an open single-port cannula at the umbilicus. I use a Steri-Drape Isolation Bag (3M), 50 cm by 50 cm, with drawstrings. (See Figure 1.) Standing across from my assistant, I tightly fan-fold the bag and wring it to purge it of air. Using an atraumatic grasper, I position the bag linearly with the opening up; it is inserted into the pelvis first, with the superior end guided upward into the mid- and then upper-abdomen.

Courtesy Dr. Tony Shibley
Figure 2: The sides of the bag are elevated to ensure that the specimen is well contained.

After the bag is placed, the cannula is recapped with the multiport cap. I use the Olympus TriPort 15 (Advanced Surgical Concepts), and the abdomen is reinsufflated. A camera is inserted into one of the 5-mm ports. I use the Olympus 5-mm articulating laparoscope.

Through the other 5-mm port, I maneuver the bag to form a pocket opening by pushing the upper corners of the bag against the respective abdominal sidewalls, and the body of the bag into the pelvis. I then elevate the specimen and, with a rotational movement, I guide the specimen along the right abdominal sidewall and into the pocket opening. I then elevate the sides of the bag and ensure that the specimen is well contained. (See Figure 2.)

 

 

The drawstrings are then brought up into the port hub. The cap is removed, and the opening of the bag is pulled up through the port and out approximately 15-20 cm, as symmetrically as possible.

The port cap is then replaced within the exteriorized neck of the bag, and the bag is insufflated with traditional laparoscopic pressure of 15-18 mm, creating an artificial pneumoperitoneum. (See Figure 3.) The camera is reinserted, followed by the morcellator, into the 15-mm port of the single-site tri-port. The morcellator must be lubricated so it does not catch the bag on the way in. Morcellation is carried out under direct vision.

Courtesy Dr. Tony Shibley
Figure 3: A close-up of the uterus within the artificial pneumoperitoneum.

After the morcellation process is complete, the morcellator is removed, followed by the camera and the tri-port cap. The bag is desufflated and removed through the open cannula, and the abdomen is closed as usual.

In a multiport approach, the umbilical incision is extended to 15 mm after completion of the hysterectomy or myomectomy. The bag is inserted and placed in a manner similar to the single-port approach, except that the lateral ports may be utilized to further position the bag once it is placed about halfway in. The bag is similarly opened, the specimen contained, and the neck of the bag exteriorized. A 15-mm port is similarly lubricated and placed inside the neck of the bag and through the umbilical incision.

As the bag is insufflated, the lateral ports are backed slightly out so that they're flush with the abdominal wall, and the trocars are opened to allow the release of any residual gas in the abdomen. The laparoscope is then placed into the 15-mm umbilical trocar.

Visualization will ultimately occur from another site, however. One of the lateral 5-mm trocars is advanced at a right angle to the insufflated bag, and an introducer is placed to puncture the bag. I recommend using a blunt plastic trocar; a balloon-tip trocar also can be used. Contrary to what one might think, the bag will not leak any gas. The laparoscope is now transferred to this 5-mm lateral port, and the umbilical port is removed. A lubricated morcellator is inserted directly through the umbilical incision, and morcellation is performed under direct visualization from the side port.

These techniques for single-port or multiport enclosed power morcellation have been shown to be reproducible and successful – with all bags intact and specimens contained – in a multicenter analysis that is being prepared for publication. The largest uterus in the study was 1,481 g.

To make the approach less cumbersome, I have designed a morcellation device consisting of a specialized bag that will open automatically and assist in capturing the specimen. The device, which has closure tabs and a retrieval lanyard, has been developed with the input of other minimally invasive gynecologic surgeons and the design and engineering expertise of Advanced Surgical Concepts. It will be manufactured by the company pending Food and Drug Administration approval.

 

 

Concealed power morcellation: Our take

By Bernard Taylor, M.D.

Courtesy Dr. Ceana H. Nezhat
Figure 4: The LapSac Surgical Tissue Pouch.

The approach to the use of power morcellation within a bag in my practice was not specifically driven by the desire to prevent the dispersion of malignant leiomyosarcoma – an issue that is now front and center and indeed, is important – but by a broader desire to perform as complete an extraction as possible.

For years we have used isolation bags to conceal and contain small uteri, ovaries, and specimens that we debulk using a scalpel and remove through a small umbilical incision. However, this approach is cumbersome for removing larger uteri. Consequently, over the past year we refined our methods for performing power morcellation within a bag.

This procedure can be performed after traditional laparoscopy or robotic-assisted hysterectomy or myomectomy to extract the specimen from the abdomen. A surgical tissue bag is placed into the abdomen and is insufflated within the abdomen. Morcellation is carried out within the concealed "pseudopneumoperitoneum," and the bag is exteriorized from the abdomen, typically through the umbilical incision.

The majority of my procedures utilize a multiport approach due to the nature of my practice as a urogynecologist. After hysterectomy or myomectomy, the specimen is placed in the upper abdomen. The cuff is closed, other procedures are completed in the usual fashion, and hemostasis is reassured. In robotic procedures, we undock the robot prior to morcellation. The umbilical port is removed, and the bag is placed into the abdomen with a ring forceps or atraumatic forceps without teeth. The umbilical port is then replaced to reestablish the pneumoperitoneum for visualization.

 

 

For larger uterine specimens, I use an Isodrape isolation bag (Microtek Medical). This 18 x 18 inch bag with a drawstring opening easily accommodates uteri larger than 1,000 g. The bag is placed into the pelvis with the open end at the pelvic brim and is opened wide. I use the term "open from iliac to iliac and sacrum to bladder." Once the bag is positioned, the specimen is grasped; the patient is slowly taken out of the Trendelenburg position to allow for gravity to assist in the placement of the specimen into the bag.

© 2013 Applied Medical Resources. All rights reserved.
Figure 5: The Alexis Wound Protector/Retractor.

The drawstrings are then grasped and taken out of the umbilical trocar with simultaneous removal of the umbilical port. At this time, the open end of the bag is exteriorized, and the specimen technically is extraperitoneal and "concealed."

To insufflate the bag at this point and create the "pseudopneumoperitoneum," a 15-mm port is lubricated and placed through the opening in the bag. The bag is then insufflated to the usual pressure (15 mm Hg). The accessory ports are opened at this time to allow for the abdominal pressure to fall and for the bag to expand and fill the abdominal cavity.

To enable visualization throughout the morcellation procedure, I use one of the previously placed lower abdomen lateral ports to place a 5-mm camera. The camera is placed after a 5-mm balloon tip trocar is introduced and advanced to perforate the bag. The balloon tip is insufflated in the usual fashion, securing the bag against the abdominal wall and preventing a gas leak.

Alternatively, I have also used a SILSport (Covidien) at the umbilicus in cases when there is a leak at the umbilical incision and the 15-mm port does not seal properly. While use of a single-port technique has been shown to be feasible for both visualization and morcellation, it can present challenges in complex cases with a larger uterus or multiple fibroids.

 

 

Either way, morcellation can take place within the concealed "pseudo-peritoneal" cavity, with the morcellator lubricated and placed either through the umbilical incision or through the Tri-Port. After morcellation is complete, the bag containing the smaller tissue fragments and blood is simply removed through the umbilicus, and closure of the abdomen is completed in the usual fashion.

Courtesy Dr. Ceana H. Nezhat
Figure 6: The Mobius Elastic Abdominal Retractor.

I also have adopted a simplified approach to remove the smaller uteri with supracervical hysterectomy and sacral colpopexy performed laparoscopically. Despite preoperative screening with endometrial biopsy and pelvic ultrasound, several of my patients in the past have been diagnosed with either early ovarian or endometrial neoplasias on final pathology. After completing the procedure, I place the small menopausal senile uterus and adnexa into a 15-mm endoscopic bag. The bag is brought through the umbilical port, and the specimen is removed via morcellation with a scalpel or scissors.

Surgeons have asked about additional time needed to place the bag and position the specimen. Technically, specimen placement is a learned skill; once one is proficient, the case times are not any different. In fact, cases may be shorter because of the time saved by not having to retrieve uterine fragments from the abdomen and pelvis.

Theoretically, the procedure addresses concerns associated with tissue fragmentation and dissemination within the abdominal cavity. To date, there are no trials showing prevention of cancer upstaging or benign conditions such as leiomyomatosis peritonealis disseminata or endometriosis.

 

 

Enclosed vaginal morcellation for enlarged uteri

By Ceana H. Nezhat, M.D.

Removal of large uteri via minimally invasive surgery poses challenges to gynecologic surgeons. Limitations on the use of intraperitoneal electromechanical morcellation are a step forward in terms of protecting patients from undue harm, but we also must acknowledge that minimally invasive surgery has been shown to be superior to laparotomy in the majority of cases.

While safer ways to extract large specimens without risk of spreading both benign and malignant tissue are being studied and developed, gynecologic surgeons need to find alternative minimally invasive approaches for removing large specimens.

Courtesy Dr. Ceana H. Nezhat
Figure 7: The endoscopic specimen removal bag is rolled and placed through the vaginal cuff. The bag is unfolded intraperitonally.

Minimally invasive approaches to extirpate uteri and myomas have been described prior to the advent of electromechanical morcellation. A natural orifice such as the vagina for gynecologic procedures is a clear choice for removing specimens. Laparoscopic-assisted myomectomy is a combination of laparoscopy and minilaparotomy for tissue extraction (JSLS 2001;5:299-303). Another alternative is extracting myoma and other tissues through a posterior colpotomy. Rates of dyspareunia and adhesions in the cul-de-sac after tissue extraction through a colpotomy are low (J. Reprod. Med. 1993;38:534-6).

Vaginal hysterectomy was chronicled and performed by the Greek physician Soranus of Ephesus in 120 A.D. (Acta Chir. Iugosl. 2011:58:9-14), and it is still the preferred route of hysterectomy when it can be performed. Large uteri can be transvaginally morcellated and vaginally extracted; however, this technique still poses the risk, although low, of spilling fragments of uterine tissue in the abdomen.

By combining total laparoscopic hysterectomy and vaginal morcellation of enlarged uteri within an enclosed specimen bag, the risk of spilling uterine fragments is reduced, in addition to avoiding potential visceral and vascular complications associated with intraperitoneal electromechanical morcellation.

Enclosed vaginal morcellation is the technique of placing the enlarged hysterectomy specimen in an endoscopic specimen retrieval bag and then transvaginally morcellating the tissue.

 

 

In the development of this technique, I have experimented with different endoscopic sacs and retractors. In my experience, the optimal laparoscopic bag is the LapSac Surgical Tissue Pouch (Cook Medical). This endoscopic, one-time use, specimen retrieval bag is flexible, durable nylon with an integral polyurethane inner coating and polypropylene drawstring (Figure 4). The bag comes in four sizes, the largest (size 8 x 10 inch, volume 1,500 mL) of which I used to assist in removing the 18-week size uterus in the accompanying video.

Courtesy Dr. Ceana H. Nezhat
Figure 8: The fundus of the hysterectomy specimen is grasped and placed in the bag. The bag is cinched and opening pulled through the vagina.

The other key piece of equipment for vaginal extraction of large uteri is a transvaginally-placed wound retractor. As I have previously described, the self-retaining retractor provides optimal exposure in a narrow field and minimizes trauma to surrounding tissue (J. Minim. Inv. Gynecol. 2009:16:616-7). Two wound retractors are suitable for this surgical technique: the Alexis Wound Protector/Retractor (Applied Medical) (Figure 5) and the Mobius Elastic Abdominal Retractor (Cooper Surgical) (Figure 6).

After complete laparoscopic detachment of the uterus and cervix (and adnexa), the wound retractor is placed transvaginally. One semirigid ring is pushed superiorly through the vagina and into the peritoneal cavity, where is it placed in the cul-de-sac. In this manner, a uniform, circumferential orifice is created. In narrower vaginal vaults, the ring can be compressed between the thumb and index finger to reduce its diameter and thus be introduced into the peritoneal cavity atraumatically. With the small-size retraction systems, an orifice of 2.5 to 6 cm diameter can be created.

The LapSac is folded and then inserted with ring forceps transvaginally through the wound retractor. (See Figure 7.) The bag is unfolded intraperitoneally using the integral tabs to demarcate the edges of the bag. The bag should be unfolded in the pelvis with the opening of the bag cephalad. The fundus of the hysterectomy specimen is grasped with a tenaculum and placed inside the bag. (See Figure 8.)

 

 

It is an important technical point to grab the fundus or the heaviest point of the specimen to allow weight and gravity to facilitate placing the specimen securely in the bag. If the cervix or a lighter part of the specimen is grasped, placement in the bag is more difficult and the specimen will likely slip out of the bag.

Courtesy Dr. Ceana H. Nezhat
Figure 9: Tenaculum are used to pull the uterus to the vaginal opening where it is hand-morcellated with a scalpel.

Once the entire hysterectomy specimen is in the LapSac, the bag is cinched by grasping the blue drawstrings. The opening of the bag is pulled through the vagina. The opening of the bag is externalized and the edges are attached with Allis clamps to the external edge of the wound retractor. The specimen (typically the cervix first) is grasped with a tenaculum and vaginally morcellated and cored with a scalpel (Figure 9).

Metal vaginal retractors are placed within the bag to protect against sharp injury during morcellation. I prefer to amputate the cervix and adnexa separately and en bloc to preserve as much original architecture as possible so the pathologists can properly orient and examine the tissue. After completion of the morcellation, the wound retractor is removed, the cuff closed, and the procedure completed per surgeon preference.

 

 

Dr. Shibley has been in full-time practice with Ob.Gyn. Specialists, Fairview Health Services in the Minneapolis area (Edina), for 20 years. He reported that he has a financial interest in the artificial pneumoperitoneum device under development, and that he is a consultant for Olympus.

Dr. Taylor is a urogynecologist who is a female pelvic medicine and reconstructive surgeon practicing at the Carolinas Medical Center–Advanced Surgical Specialties for Women in Charlotte, N.C. He reported that he has no disclosures relevant to this Master Class.

Dr. Nezhat is the current president of the AAGL, adjunct professor of obstetrics and gynecology at Emory University and program director of minimally invasive surgery at Northside Hospital, both in Atlanta, and adjunct clinical professor of obstetrics and gynecology at Stanford (Calif.) University. He reported that he is a consultant for Karl Storz Endoscopy.

Videos of these experts' individual techniques of electromechanical power morcellation within the confines of a bag, as well as that of Dr. Douglas Brown, director of the Center for Minimally Invasive Gynecologic Surgery at Massachusetts General Hospital, Boston, can be viewed at the SurgeryU website.

Power morcellation within an insufflated bag

By Tony Shibley, M.D.

Morcellating safely in laparoscopic hysterectomy or myomectomy involves not only the use of a bag, but also the creation of an artificial pneumoperitoneum inside the bag. Inflation of the bag allows us to create a safe and completely contained working environment in the abdomen, with good visualization and adequate working space.

In the past, specimen containment bags were used for morcellation, but the bags would adhere to tissue and would be easily cut or would tear or rupture. Without proper space and visualization, surgeons could not break tissue into smaller fragments without endangering the bag or the structures behind the bag. We were safely and precisely disconnecting tissue in our surgeries, but falling short with tissue removal. There were calls for more durable bags, but the problems of visualization and safe distance were not addressed. Eventually, the goal of morcellating within a bag was largely abandoned in favor of open power morcellation.

Courtesy Dr. Tony Shibley
Figure 1: The isolation bag is folded.

I stopped performing open power morcellation about 2 years ago and developed a new approach to enclosed morcellation. By creating an artificial pneumoperitoneum in a bag, a good working space is developed within it. This meets the needs of containment while significantly lowering the risk of tissue dissemination and also reducing the risk of bowel injury, vascular injury, and other types of morcellator-related mechanical injuries. This approach to morcellation is safer on all fronts.

My method of enclosed morcellation has been utilized in both single-port and multiport hysterectomy (total and supracervical) and myomectomy performed with either traditional laparoscopy or the robotic platform.

The morcellation process is begun after surgery is complete except for tissue removal, and the patient is hemostatic. The specimen has been placed in a location where it can be easily retrieved; I prefer the right upper quadrant.

In a single-port approach, the bag is inserted into the abdomen through an open single-port cannula at the umbilicus. I use a Steri-Drape Isolation Bag (3M), 50 cm by 50 cm, with drawstrings. (See Figure 1.) Standing across from my assistant, I tightly fan-fold the bag and wring it to purge it of air. Using an atraumatic grasper, I position the bag linearly with the opening up; it is inserted into the pelvis first, with the superior end guided upward into the mid- and then upper-abdomen.

Courtesy Dr. Tony Shibley
Figure 2: The sides of the bag are elevated to ensure that the specimen is well contained.

After the bag is placed, the cannula is recapped with the multiport cap. I use the Olympus TriPort 15 (Advanced Surgical Concepts), and the abdomen is reinsufflated. A camera is inserted into one of the 5-mm ports. I use the Olympus 5-mm articulating laparoscope.

Through the other 5-mm port, I maneuver the bag to form a pocket opening by pushing the upper corners of the bag against the respective abdominal sidewalls, and the body of the bag into the pelvis. I then elevate the specimen and, with a rotational movement, I guide the specimen along the right abdominal sidewall and into the pocket opening. I then elevate the sides of the bag and ensure that the specimen is well contained. (See Figure 2.)

 

 

The drawstrings are then brought up into the port hub. The cap is removed, and the opening of the bag is pulled up through the port and out approximately 15-20 cm, as symmetrically as possible.

The port cap is then replaced within the exteriorized neck of the bag, and the bag is insufflated with traditional laparoscopic pressure of 15-18 mm, creating an artificial pneumoperitoneum. (See Figure 3.) The camera is reinserted, followed by the morcellator, into the 15-mm port of the single-site tri-port. The morcellator must be lubricated so it does not catch the bag on the way in. Morcellation is carried out under direct vision.

Courtesy Dr. Tony Shibley
Figure 3: A close-up of the uterus within the artificial pneumoperitoneum.

After the morcellation process is complete, the morcellator is removed, followed by the camera and the tri-port cap. The bag is desufflated and removed through the open cannula, and the abdomen is closed as usual.

In a multiport approach, the umbilical incision is extended to 15 mm after completion of the hysterectomy or myomectomy. The bag is inserted and placed in a manner similar to the single-port approach, except that the lateral ports may be utilized to further position the bag once it is placed about halfway in. The bag is similarly opened, the specimen contained, and the neck of the bag exteriorized. A 15-mm port is similarly lubricated and placed inside the neck of the bag and through the umbilical incision.

As the bag is insufflated, the lateral ports are backed slightly out so that they're flush with the abdominal wall, and the trocars are opened to allow the release of any residual gas in the abdomen. The laparoscope is then placed into the 15-mm umbilical trocar.

Visualization will ultimately occur from another site, however. One of the lateral 5-mm trocars is advanced at a right angle to the insufflated bag, and an introducer is placed to puncture the bag. I recommend using a blunt plastic trocar; a balloon-tip trocar also can be used. Contrary to what one might think, the bag will not leak any gas. The laparoscope is now transferred to this 5-mm lateral port, and the umbilical port is removed. A lubricated morcellator is inserted directly through the umbilical incision, and morcellation is performed under direct visualization from the side port.

These techniques for single-port or multiport enclosed power morcellation have been shown to be reproducible and successful – with all bags intact and specimens contained – in a multicenter analysis that is being prepared for publication. The largest uterus in the study was 1,481 g.

To make the approach less cumbersome, I have designed a morcellation device consisting of a specialized bag that will open automatically and assist in capturing the specimen. The device, which has closure tabs and a retrieval lanyard, has been developed with the input of other minimally invasive gynecologic surgeons and the design and engineering expertise of Advanced Surgical Concepts. It will be manufactured by the company pending Food and Drug Administration approval.

 

 

Concealed power morcellation: Our take

By Bernard Taylor, M.D.

Courtesy Dr. Ceana H. Nezhat
Figure 4: The LapSac Surgical Tissue Pouch.

The approach to the use of power morcellation within a bag in my practice was not specifically driven by the desire to prevent the dispersion of malignant leiomyosarcoma – an issue that is now front and center and indeed, is important – but by a broader desire to perform as complete an extraction as possible.

For years we have used isolation bags to conceal and contain small uteri, ovaries, and specimens that we debulk using a scalpel and remove through a small umbilical incision. However, this approach is cumbersome for removing larger uteri. Consequently, over the past year we refined our methods for performing power morcellation within a bag.

This procedure can be performed after traditional laparoscopy or robotic-assisted hysterectomy or myomectomy to extract the specimen from the abdomen. A surgical tissue bag is placed into the abdomen and is insufflated within the abdomen. Morcellation is carried out within the concealed "pseudopneumoperitoneum," and the bag is exteriorized from the abdomen, typically through the umbilical incision.

The majority of my procedures utilize a multiport approach due to the nature of my practice as a urogynecologist. After hysterectomy or myomectomy, the specimen is placed in the upper abdomen. The cuff is closed, other procedures are completed in the usual fashion, and hemostasis is reassured. In robotic procedures, we undock the robot prior to morcellation. The umbilical port is removed, and the bag is placed into the abdomen with a ring forceps or atraumatic forceps without teeth. The umbilical port is then replaced to reestablish the pneumoperitoneum for visualization.

 

 

For larger uterine specimens, I use an Isodrape isolation bag (Microtek Medical). This 18 x 18 inch bag with a drawstring opening easily accommodates uteri larger than 1,000 g. The bag is placed into the pelvis with the open end at the pelvic brim and is opened wide. I use the term "open from iliac to iliac and sacrum to bladder." Once the bag is positioned, the specimen is grasped; the patient is slowly taken out of the Trendelenburg position to allow for gravity to assist in the placement of the specimen into the bag.

© 2013 Applied Medical Resources. All rights reserved.
Figure 5: The Alexis Wound Protector/Retractor.

The drawstrings are then grasped and taken out of the umbilical trocar with simultaneous removal of the umbilical port. At this time, the open end of the bag is exteriorized, and the specimen technically is extraperitoneal and "concealed."

To insufflate the bag at this point and create the "pseudopneumoperitoneum," a 15-mm port is lubricated and placed through the opening in the bag. The bag is then insufflated to the usual pressure (15 mm Hg). The accessory ports are opened at this time to allow for the abdominal pressure to fall and for the bag to expand and fill the abdominal cavity.

To enable visualization throughout the morcellation procedure, I use one of the previously placed lower abdomen lateral ports to place a 5-mm camera. The camera is placed after a 5-mm balloon tip trocar is introduced and advanced to perforate the bag. The balloon tip is insufflated in the usual fashion, securing the bag against the abdominal wall and preventing a gas leak.

Alternatively, I have also used a SILSport (Covidien) at the umbilicus in cases when there is a leak at the umbilical incision and the 15-mm port does not seal properly. While use of a single-port technique has been shown to be feasible for both visualization and morcellation, it can present challenges in complex cases with a larger uterus or multiple fibroids.

 

 

Either way, morcellation can take place within the concealed "pseudo-peritoneal" cavity, with the morcellator lubricated and placed either through the umbilical incision or through the Tri-Port. After morcellation is complete, the bag containing the smaller tissue fragments and blood is simply removed through the umbilicus, and closure of the abdomen is completed in the usual fashion.

Courtesy Dr. Ceana H. Nezhat
Figure 6: The Mobius Elastic Abdominal Retractor.

I also have adopted a simplified approach to remove the smaller uteri with supracervical hysterectomy and sacral colpopexy performed laparoscopically. Despite preoperative screening with endometrial biopsy and pelvic ultrasound, several of my patients in the past have been diagnosed with either early ovarian or endometrial neoplasias on final pathology. After completing the procedure, I place the small menopausal senile uterus and adnexa into a 15-mm endoscopic bag. The bag is brought through the umbilical port, and the specimen is removed via morcellation with a scalpel or scissors.

Surgeons have asked about additional time needed to place the bag and position the specimen. Technically, specimen placement is a learned skill; once one is proficient, the case times are not any different. In fact, cases may be shorter because of the time saved by not having to retrieve uterine fragments from the abdomen and pelvis.

Theoretically, the procedure addresses concerns associated with tissue fragmentation and dissemination within the abdominal cavity. To date, there are no trials showing prevention of cancer upstaging or benign conditions such as leiomyomatosis peritonealis disseminata or endometriosis.

 

 

Enclosed vaginal morcellation for enlarged uteri

By Ceana H. Nezhat, M.D.

Removal of large uteri via minimally invasive surgery poses challenges to gynecologic surgeons. Limitations on the use of intraperitoneal electromechanical morcellation are a step forward in terms of protecting patients from undue harm, but we also must acknowledge that minimally invasive surgery has been shown to be superior to laparotomy in the majority of cases.

While safer ways to extract large specimens without risk of spreading both benign and malignant tissue are being studied and developed, gynecologic surgeons need to find alternative minimally invasive approaches for removing large specimens.

Courtesy Dr. Ceana H. Nezhat
Figure 7: The endoscopic specimen removal bag is rolled and placed through the vaginal cuff. The bag is unfolded intraperitonally.

Minimally invasive approaches to extirpate uteri and myomas have been described prior to the advent of electromechanical morcellation. A natural orifice such as the vagina for gynecologic procedures is a clear choice for removing specimens. Laparoscopic-assisted myomectomy is a combination of laparoscopy and minilaparotomy for tissue extraction (JSLS 2001;5:299-303). Another alternative is extracting myoma and other tissues through a posterior colpotomy. Rates of dyspareunia and adhesions in the cul-de-sac after tissue extraction through a colpotomy are low (J. Reprod. Med. 1993;38:534-6).

Vaginal hysterectomy was chronicled and performed by the Greek physician Soranus of Ephesus in 120 A.D. (Acta Chir. Iugosl. 2011:58:9-14), and it is still the preferred route of hysterectomy when it can be performed. Large uteri can be transvaginally morcellated and vaginally extracted; however, this technique still poses the risk, although low, of spilling fragments of uterine tissue in the abdomen.

By combining total laparoscopic hysterectomy and vaginal morcellation of enlarged uteri within an enclosed specimen bag, the risk of spilling uterine fragments is reduced, in addition to avoiding potential visceral and vascular complications associated with intraperitoneal electromechanical morcellation.

Enclosed vaginal morcellation is the technique of placing the enlarged hysterectomy specimen in an endoscopic specimen retrieval bag and then transvaginally morcellating the tissue.

 

 

In the development of this technique, I have experimented with different endoscopic sacs and retractors. In my experience, the optimal laparoscopic bag is the LapSac Surgical Tissue Pouch (Cook Medical). This endoscopic, one-time use, specimen retrieval bag is flexible, durable nylon with an integral polyurethane inner coating and polypropylene drawstring (Figure 4). The bag comes in four sizes, the largest (size 8 x 10 inch, volume 1,500 mL) of which I used to assist in removing the 18-week size uterus in the accompanying video.

Courtesy Dr. Ceana H. Nezhat
Figure 8: The fundus of the hysterectomy specimen is grasped and placed in the bag. The bag is cinched and opening pulled through the vagina.

The other key piece of equipment for vaginal extraction of large uteri is a transvaginally-placed wound retractor. As I have previously described, the self-retaining retractor provides optimal exposure in a narrow field and minimizes trauma to surrounding tissue (J. Minim. Inv. Gynecol. 2009:16:616-7). Two wound retractors are suitable for this surgical technique: the Alexis Wound Protector/Retractor (Applied Medical) (Figure 5) and the Mobius Elastic Abdominal Retractor (Cooper Surgical) (Figure 6).

After complete laparoscopic detachment of the uterus and cervix (and adnexa), the wound retractor is placed transvaginally. One semirigid ring is pushed superiorly through the vagina and into the peritoneal cavity, where is it placed in the cul-de-sac. In this manner, a uniform, circumferential orifice is created. In narrower vaginal vaults, the ring can be compressed between the thumb and index finger to reduce its diameter and thus be introduced into the peritoneal cavity atraumatically. With the small-size retraction systems, an orifice of 2.5 to 6 cm diameter can be created.

The LapSac is folded and then inserted with ring forceps transvaginally through the wound retractor. (See Figure 7.) The bag is unfolded intraperitoneally using the integral tabs to demarcate the edges of the bag. The bag should be unfolded in the pelvis with the opening of the bag cephalad. The fundus of the hysterectomy specimen is grasped with a tenaculum and placed inside the bag. (See Figure 8.)

 

 

It is an important technical point to grab the fundus or the heaviest point of the specimen to allow weight and gravity to facilitate placing the specimen securely in the bag. If the cervix or a lighter part of the specimen is grasped, placement in the bag is more difficult and the specimen will likely slip out of the bag.

Courtesy Dr. Ceana H. Nezhat
Figure 9: Tenaculum are used to pull the uterus to the vaginal opening where it is hand-morcellated with a scalpel.

Once the entire hysterectomy specimen is in the LapSac, the bag is cinched by grasping the blue drawstrings. The opening of the bag is pulled through the vagina. The opening of the bag is externalized and the edges are attached with Allis clamps to the external edge of the wound retractor. The specimen (typically the cervix first) is grasped with a tenaculum and vaginally morcellated and cored with a scalpel (Figure 9).

Metal vaginal retractors are placed within the bag to protect against sharp injury during morcellation. I prefer to amputate the cervix and adnexa separately and en bloc to preserve as much original architecture as possible so the pathologists can properly orient and examine the tissue. After completion of the morcellation, the wound retractor is removed, the cuff closed, and the procedure completed per surgeon preference.

 

 

Dr. Shibley has been in full-time practice with Ob.Gyn. Specialists, Fairview Health Services in the Minneapolis area (Edina), for 20 years. He reported that he has a financial interest in the artificial pneumoperitoneum device under development, and that he is a consultant for Olympus.

Dr. Taylor is a urogynecologist who is a female pelvic medicine and reconstructive surgeon practicing at the Carolinas Medical Center–Advanced Surgical Specialties for Women in Charlotte, N.C. He reported that he has no disclosures relevant to this Master Class.

Dr. Nezhat is the current president of the AAGL, adjunct professor of obstetrics and gynecology at Emory University and program director of minimally invasive surgery at Northside Hospital, both in Atlanta, and adjunct clinical professor of obstetrics and gynecology at Stanford (Calif.) University. He reported that he is a consultant for Karl Storz Endoscopy.

Videos of these experts' individual techniques of electromechanical power morcellation within the confines of a bag, as well as that of Dr. Douglas Brown, director of the Center for Minimally Invasive Gynecologic Surgery at Massachusetts General Hospital, Boston, can be viewed at the SurgeryU website.

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Clamantis in deserto

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Actually the complete phrase is "vox clamantis in deserto," and it is the motto of my alma mater. We were told as freshmen that it translated as "a voice crying in the wilderness" – which prior to the Internet, cheap long distance rates, and Interstate 89 seemed to be an apt description of my situation. The words resurfaced in my consciousness a few months ago when I met one of the regular readers of this column. A man of my vintage, he observed that over the 40-plus years he had been in practice, parents had grown increasingly less interested in his views on health and child rearing. He asked if I had experienced the same phenomenon.

In other words, he wondered if we both had become just voices crying in the wilderness. As we discussed his observation in more depth, it became clear that he wasn’t talking about the age-old phenomenon in which young people begin to tune out their elders who have persisted in palavering the same old "when-I-was-your-age" bologna. No, his question was more general. Is anyone listening to what pediatricians of any age are saying? Are our opinions less valued than they were 40 years ago? If our audience is less attentive, then why?

I agree that it does feel like, over the last 40 years, parents are less influenced by our opinions and are using increasing amounts of salt when they do listen. One only needs to consider the issue of vaccine refusal to appreciate that our advice often goes unheeded with potentially dangerous consequences.

Is the muting of our voices simply an example of dilution? Fifty years ago, pediatricians didn’t have much competition for the ears of new parents. There were Ben Spock and the always to be reckoned with army of grandmothers. Yes, there were magazines for parents, but they paled in comparison to the profusion of websites, blogs, and chat rooms that offer advice of varying quality just a mouse click away. Now we share the stage with anyone who cares to venture an opinion on health or parenting. No wonder we have trouble having our voices heard over the cacophony.

But, the din from the media is only part of the problem. I’m not sure exactly why, but over the last several decades, science has lost its mojo. Some of it has to do with the ease with which junk science can find an audience. Some of it is fallout from an educational system that is trying to regain its legs. While a good physician is more of an artist than a scientist, we were all trained as scientists. And, the public sees us as scientists, and as such, we are vulnerable to being painted with the same broad brush strokes of the antiscience folks.

To some degree we have been guilty of diluting our own messages. The trend toward health maintenance visits that are scripted by committee has done little to encourage parents to ask the questions about which they are most concerned. If we return to a model in which the patient or the parent is in the driver’s seat, we may start hearing more questions and discover our answers are given more consideration.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including "How to Say No to Your Toddler." E-mail him at [email protected].

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Actually the complete phrase is "vox clamantis in deserto," and it is the motto of my alma mater. We were told as freshmen that it translated as "a voice crying in the wilderness" – which prior to the Internet, cheap long distance rates, and Interstate 89 seemed to be an apt description of my situation. The words resurfaced in my consciousness a few months ago when I met one of the regular readers of this column. A man of my vintage, he observed that over the 40-plus years he had been in practice, parents had grown increasingly less interested in his views on health and child rearing. He asked if I had experienced the same phenomenon.

In other words, he wondered if we both had become just voices crying in the wilderness. As we discussed his observation in more depth, it became clear that he wasn’t talking about the age-old phenomenon in which young people begin to tune out their elders who have persisted in palavering the same old "when-I-was-your-age" bologna. No, his question was more general. Is anyone listening to what pediatricians of any age are saying? Are our opinions less valued than they were 40 years ago? If our audience is less attentive, then why?

I agree that it does feel like, over the last 40 years, parents are less influenced by our opinions and are using increasing amounts of salt when they do listen. One only needs to consider the issue of vaccine refusal to appreciate that our advice often goes unheeded with potentially dangerous consequences.

Is the muting of our voices simply an example of dilution? Fifty years ago, pediatricians didn’t have much competition for the ears of new parents. There were Ben Spock and the always to be reckoned with army of grandmothers. Yes, there were magazines for parents, but they paled in comparison to the profusion of websites, blogs, and chat rooms that offer advice of varying quality just a mouse click away. Now we share the stage with anyone who cares to venture an opinion on health or parenting. No wonder we have trouble having our voices heard over the cacophony.

But, the din from the media is only part of the problem. I’m not sure exactly why, but over the last several decades, science has lost its mojo. Some of it has to do with the ease with which junk science can find an audience. Some of it is fallout from an educational system that is trying to regain its legs. While a good physician is more of an artist than a scientist, we were all trained as scientists. And, the public sees us as scientists, and as such, we are vulnerable to being painted with the same broad brush strokes of the antiscience folks.

To some degree we have been guilty of diluting our own messages. The trend toward health maintenance visits that are scripted by committee has done little to encourage parents to ask the questions about which they are most concerned. If we return to a model in which the patient or the parent is in the driver’s seat, we may start hearing more questions and discover our answers are given more consideration.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including "How to Say No to Your Toddler." E-mail him at [email protected].

Actually the complete phrase is "vox clamantis in deserto," and it is the motto of my alma mater. We were told as freshmen that it translated as "a voice crying in the wilderness" – which prior to the Internet, cheap long distance rates, and Interstate 89 seemed to be an apt description of my situation. The words resurfaced in my consciousness a few months ago when I met one of the regular readers of this column. A man of my vintage, he observed that over the 40-plus years he had been in practice, parents had grown increasingly less interested in his views on health and child rearing. He asked if I had experienced the same phenomenon.

In other words, he wondered if we both had become just voices crying in the wilderness. As we discussed his observation in more depth, it became clear that he wasn’t talking about the age-old phenomenon in which young people begin to tune out their elders who have persisted in palavering the same old "when-I-was-your-age" bologna. No, his question was more general. Is anyone listening to what pediatricians of any age are saying? Are our opinions less valued than they were 40 years ago? If our audience is less attentive, then why?

I agree that it does feel like, over the last 40 years, parents are less influenced by our opinions and are using increasing amounts of salt when they do listen. One only needs to consider the issue of vaccine refusal to appreciate that our advice often goes unheeded with potentially dangerous consequences.

Is the muting of our voices simply an example of dilution? Fifty years ago, pediatricians didn’t have much competition for the ears of new parents. There were Ben Spock and the always to be reckoned with army of grandmothers. Yes, there were magazines for parents, but they paled in comparison to the profusion of websites, blogs, and chat rooms that offer advice of varying quality just a mouse click away. Now we share the stage with anyone who cares to venture an opinion on health or parenting. No wonder we have trouble having our voices heard over the cacophony.

But, the din from the media is only part of the problem. I’m not sure exactly why, but over the last several decades, science has lost its mojo. Some of it has to do with the ease with which junk science can find an audience. Some of it is fallout from an educational system that is trying to regain its legs. While a good physician is more of an artist than a scientist, we were all trained as scientists. And, the public sees us as scientists, and as such, we are vulnerable to being painted with the same broad brush strokes of the antiscience folks.

To some degree we have been guilty of diluting our own messages. The trend toward health maintenance visits that are scripted by committee has done little to encourage parents to ask the questions about which they are most concerned. If we return to a model in which the patient or the parent is in the driver’s seat, we may start hearing more questions and discover our answers are given more consideration.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including "How to Say No to Your Toddler." E-mail him at [email protected].

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EHR Report: Across the ages

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Eighty percent of physicians are now using electronic health records in their offices. We have been impressed that the younger physicians to whom we have spoken often view their experience with EHRs very differently from older physicians. Is such a difference inevitable, perhaps, not just because change is more difficult for many people as they get older but also because expectations are influenced by experience. Noticing these different thoughts and feelings, we’ve asked two physicians more than 55 years old and two younger physicians to share some thoughts on their experiences with electronic records.

Mathew Clark (family physician)

I’ve been in practice for 31 years and using an EHR system for just under 5. I’m not thrilled with it, but I accept that it’s an unavoidable part of my practice now, and so I don’t waste energy being upset about it. I’ve learned to function efficiently with an EHR, doing the best I can. I remember physicians, before the days of SOAP notes, who would write pithy, useful notes such as "probable strep, Pen VK 500 bid for 10 days" on 3x5 index cards. Such notes lacked detail, and it’s not hard to imagine the problems this lack of detail might create, but they were readable at a glance, and told you what you needed to know. On the other hand, the massively detailed, bloated notes we see with our EHRs, obscured by "copy-forward" text and fictional (in other words, never really asked or examined) information, present very significant practical and legal issues of their own, and take hours of physician time to complete. Given a choice, I’d probably go for the index cards.

Natalie McGann (family physician)

I have been a family physician in practice for 4 years since graduating from residency. The advent of the EHR hasn’t been an overwhelming transition for those of us in the early stages of our careers. Much of our schooling to date has included laptops and other electronic devices that for many prove an easier means of communication. Despite that fact that EHRs require a host of extraneous clicks and check boxes, it is still less cumbersome than documenting encounters on paper. For the generation of young physicians accustomed to having answers at their fingertips, the idea of flipping through paper charts to collate a patient’s medical record seems far more complicated than clicking a few tabs without ever leaving your chair. I, and most colleagues in my peer group to whom I’ve spoken, agree that we would not be likely to a join a practice that doesn’t utilize an EHR or have a current plan to adopt one. Anything less would feel like a step back at this point.

Danielle Carcia (intern, family medicine residency)

Overall, I enjoy using electronic medical records. I feel that it places all pertinent information about the patient in an easy-to-follow and concise manner. The ability to read through past providers and even at times specialists visits with a patient can be very helpful when navigating an appointment with a new patient. As a young physician, electronics have been an extension of myself for my entire adult life, so a computer in front of me during an office visit is comforting. I do not feel it distracts from my interaction with patients, or takes away from their experience at all, just the opposite, it allows me to more confidently care for them with up to date, and organized information at my fingertips.

Dave Depietro (family physician)

I have been a family physician for 25 years and feel that the EHRs have affected my office in a number of ways. It has definitely improved the efficacy of office tasks such as doing prescription refills, interoffice communication, and scheduling. Also before EHRs, the turnaround time for a dictated note was about a week, and now most notes are completed by the end of the day. This makes it easier if I am taking care of one of my partner’s patients or dealing with a patient I recently saw. Also in this day of pay for performance we can now gather data much easier. This would be almost impossible to do if we still had paper charts.

EHRs unfortunately also have their downsides. The main problem I see is that they add a significant amount of time for providers to complete tasks. When I dictated a note, I could have completed a note within 1-2 minutes where now with EHRs, it can take maybe 3-5 minutes/patient. Also to approve labs, x-rays, etc. it just takes longer. I feel that EHRs have added about 1½ hr to my day. I feel most of my colleagues have the same complaint. They routinely take work home at night and spend 1-2 hours at home completing notes. Many of my peers seem stressed and frustrated. Even though EHRs make the office more efficient, I feel that the provider pays the price. My other complaint is the cost of IT support to keep the EHRs running smoothly. The promise of EHRs is that they would save physicians’ money and reduce staffing, however I have not seen that happen.

 

 

I ask myself, at the end of the day, would I go back to paper charts? The answer is no. Despite their downsides, I feel that the positives of EHRs outweigh the negatives. Older doctors just need to adapt to this new way of practicing medicine.

The Bottom Line

Clearly there is a range of opinion about the effect of electronic health records on our practices and our lives, with those opinions at least partly segregated by age. We are interested in your thoughts and plan to publish some of those thoughts in future columns, so please let us know at [email protected]. Thanks.

Dr. Notte is a family physician and clinical informaticist for Abington Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital and professor of family and community medicine at Temple University, Philadelphia. He is editor in chief of Redi-Reference Inc., a software company that creates mobile apps.

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Eighty percent of physicians are now using electronic health records in their offices. We have been impressed that the younger physicians to whom we have spoken often view their experience with EHRs very differently from older physicians. Is such a difference inevitable, perhaps, not just because change is more difficult for many people as they get older but also because expectations are influenced by experience. Noticing these different thoughts and feelings, we’ve asked two physicians more than 55 years old and two younger physicians to share some thoughts on their experiences with electronic records.

Mathew Clark (family physician)

I’ve been in practice for 31 years and using an EHR system for just under 5. I’m not thrilled with it, but I accept that it’s an unavoidable part of my practice now, and so I don’t waste energy being upset about it. I’ve learned to function efficiently with an EHR, doing the best I can. I remember physicians, before the days of SOAP notes, who would write pithy, useful notes such as "probable strep, Pen VK 500 bid for 10 days" on 3x5 index cards. Such notes lacked detail, and it’s not hard to imagine the problems this lack of detail might create, but they were readable at a glance, and told you what you needed to know. On the other hand, the massively detailed, bloated notes we see with our EHRs, obscured by "copy-forward" text and fictional (in other words, never really asked or examined) information, present very significant practical and legal issues of their own, and take hours of physician time to complete. Given a choice, I’d probably go for the index cards.

Natalie McGann (family physician)

I have been a family physician in practice for 4 years since graduating from residency. The advent of the EHR hasn’t been an overwhelming transition for those of us in the early stages of our careers. Much of our schooling to date has included laptops and other electronic devices that for many prove an easier means of communication. Despite that fact that EHRs require a host of extraneous clicks and check boxes, it is still less cumbersome than documenting encounters on paper. For the generation of young physicians accustomed to having answers at their fingertips, the idea of flipping through paper charts to collate a patient’s medical record seems far more complicated than clicking a few tabs without ever leaving your chair. I, and most colleagues in my peer group to whom I’ve spoken, agree that we would not be likely to a join a practice that doesn’t utilize an EHR or have a current plan to adopt one. Anything less would feel like a step back at this point.

Danielle Carcia (intern, family medicine residency)

Overall, I enjoy using electronic medical records. I feel that it places all pertinent information about the patient in an easy-to-follow and concise manner. The ability to read through past providers and even at times specialists visits with a patient can be very helpful when navigating an appointment with a new patient. As a young physician, electronics have been an extension of myself for my entire adult life, so a computer in front of me during an office visit is comforting. I do not feel it distracts from my interaction with patients, or takes away from their experience at all, just the opposite, it allows me to more confidently care for them with up to date, and organized information at my fingertips.

Dave Depietro (family physician)

I have been a family physician for 25 years and feel that the EHRs have affected my office in a number of ways. It has definitely improved the efficacy of office tasks such as doing prescription refills, interoffice communication, and scheduling. Also before EHRs, the turnaround time for a dictated note was about a week, and now most notes are completed by the end of the day. This makes it easier if I am taking care of one of my partner’s patients or dealing with a patient I recently saw. Also in this day of pay for performance we can now gather data much easier. This would be almost impossible to do if we still had paper charts.

EHRs unfortunately also have their downsides. The main problem I see is that they add a significant amount of time for providers to complete tasks. When I dictated a note, I could have completed a note within 1-2 minutes where now with EHRs, it can take maybe 3-5 minutes/patient. Also to approve labs, x-rays, etc. it just takes longer. I feel that EHRs have added about 1½ hr to my day. I feel most of my colleagues have the same complaint. They routinely take work home at night and spend 1-2 hours at home completing notes. Many of my peers seem stressed and frustrated. Even though EHRs make the office more efficient, I feel that the provider pays the price. My other complaint is the cost of IT support to keep the EHRs running smoothly. The promise of EHRs is that they would save physicians’ money and reduce staffing, however I have not seen that happen.

 

 

I ask myself, at the end of the day, would I go back to paper charts? The answer is no. Despite their downsides, I feel that the positives of EHRs outweigh the negatives. Older doctors just need to adapt to this new way of practicing medicine.

The Bottom Line

Clearly there is a range of opinion about the effect of electronic health records on our practices and our lives, with those opinions at least partly segregated by age. We are interested in your thoughts and plan to publish some of those thoughts in future columns, so please let us know at [email protected]. Thanks.

Dr. Notte is a family physician and clinical informaticist for Abington Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital and professor of family and community medicine at Temple University, Philadelphia. He is editor in chief of Redi-Reference Inc., a software company that creates mobile apps.

Eighty percent of physicians are now using electronic health records in their offices. We have been impressed that the younger physicians to whom we have spoken often view their experience with EHRs very differently from older physicians. Is such a difference inevitable, perhaps, not just because change is more difficult for many people as they get older but also because expectations are influenced by experience. Noticing these different thoughts and feelings, we’ve asked two physicians more than 55 years old and two younger physicians to share some thoughts on their experiences with electronic records.

Mathew Clark (family physician)

I’ve been in practice for 31 years and using an EHR system for just under 5. I’m not thrilled with it, but I accept that it’s an unavoidable part of my practice now, and so I don’t waste energy being upset about it. I’ve learned to function efficiently with an EHR, doing the best I can. I remember physicians, before the days of SOAP notes, who would write pithy, useful notes such as "probable strep, Pen VK 500 bid for 10 days" on 3x5 index cards. Such notes lacked detail, and it’s not hard to imagine the problems this lack of detail might create, but they were readable at a glance, and told you what you needed to know. On the other hand, the massively detailed, bloated notes we see with our EHRs, obscured by "copy-forward" text and fictional (in other words, never really asked or examined) information, present very significant practical and legal issues of their own, and take hours of physician time to complete. Given a choice, I’d probably go for the index cards.

Natalie McGann (family physician)

I have been a family physician in practice for 4 years since graduating from residency. The advent of the EHR hasn’t been an overwhelming transition for those of us in the early stages of our careers. Much of our schooling to date has included laptops and other electronic devices that for many prove an easier means of communication. Despite that fact that EHRs require a host of extraneous clicks and check boxes, it is still less cumbersome than documenting encounters on paper. For the generation of young physicians accustomed to having answers at their fingertips, the idea of flipping through paper charts to collate a patient’s medical record seems far more complicated than clicking a few tabs without ever leaving your chair. I, and most colleagues in my peer group to whom I’ve spoken, agree that we would not be likely to a join a practice that doesn’t utilize an EHR or have a current plan to adopt one. Anything less would feel like a step back at this point.

Danielle Carcia (intern, family medicine residency)

Overall, I enjoy using electronic medical records. I feel that it places all pertinent information about the patient in an easy-to-follow and concise manner. The ability to read through past providers and even at times specialists visits with a patient can be very helpful when navigating an appointment with a new patient. As a young physician, electronics have been an extension of myself for my entire adult life, so a computer in front of me during an office visit is comforting. I do not feel it distracts from my interaction with patients, or takes away from their experience at all, just the opposite, it allows me to more confidently care for them with up to date, and organized information at my fingertips.

Dave Depietro (family physician)

I have been a family physician for 25 years and feel that the EHRs have affected my office in a number of ways. It has definitely improved the efficacy of office tasks such as doing prescription refills, interoffice communication, and scheduling. Also before EHRs, the turnaround time for a dictated note was about a week, and now most notes are completed by the end of the day. This makes it easier if I am taking care of one of my partner’s patients or dealing with a patient I recently saw. Also in this day of pay for performance we can now gather data much easier. This would be almost impossible to do if we still had paper charts.

EHRs unfortunately also have their downsides. The main problem I see is that they add a significant amount of time for providers to complete tasks. When I dictated a note, I could have completed a note within 1-2 minutes where now with EHRs, it can take maybe 3-5 minutes/patient. Also to approve labs, x-rays, etc. it just takes longer. I feel that EHRs have added about 1½ hr to my day. I feel most of my colleagues have the same complaint. They routinely take work home at night and spend 1-2 hours at home completing notes. Many of my peers seem stressed and frustrated. Even though EHRs make the office more efficient, I feel that the provider pays the price. My other complaint is the cost of IT support to keep the EHRs running smoothly. The promise of EHRs is that they would save physicians’ money and reduce staffing, however I have not seen that happen.

 

 

I ask myself, at the end of the day, would I go back to paper charts? The answer is no. Despite their downsides, I feel that the positives of EHRs outweigh the negatives. Older doctors just need to adapt to this new way of practicing medicine.

The Bottom Line

Clearly there is a range of opinion about the effect of electronic health records on our practices and our lives, with those opinions at least partly segregated by age. We are interested in your thoughts and plan to publish some of those thoughts in future columns, so please let us know at [email protected]. Thanks.

Dr. Notte is a family physician and clinical informaticist for Abington Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital and professor of family and community medicine at Temple University, Philadelphia. He is editor in chief of Redi-Reference Inc., a software company that creates mobile apps.

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Mild benefits from diabetes apps so far

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Several new mobile applications and platforms for managing diabetes will be announced at the American Diabetes Association annual scientific sessions in San Francisco this month, and the results of a handful of trials of apps will be reported there. As a prelude, it’s helpful to know what’s been reported about diabetes apps previously.

Diabetes management has been one of the most talked-about goals of app development, given the immense costs in patients’ lives and in health care dollars from the disease. Although there are more than 1,000 specific diabetes apps for iOS and Android devices, only 1.2% of people with diabetes who have a smartphone or tablet use these apps, according to the Germany-based market research and consultancy firm research2guidance. The company expects that to grow to 7.8% (24 million people) by 2018. As of now, few diabetes apps incorporate seven standards for quality and functionality, or include them only at the most basic level, according to a recent report for sale on the company’s website.

German investigators analyzed information for 656 currently available diabetes apps and used a representative 65 of them to evaluate their usability for patients aged 50 years or older. Most were for English speakers (85%), and 54% were free, with no clear differences in user ratings between free and paid apps. The majority of apps offered just one function (54%), and only 5% offered an interface to a measurement device such as a glucometer. For older patients, the usability of the 65 tested apps was moderate to good but worsened if the app offered more than one function, especially documentation or analysis functions (J. Med. Internet Res. 2014;16:e101).

A Cochrane meta-analysis of data from 16 randomized controlled trials of Internet-based self-management interventions involving 3,578 adults with type 2 diabetes found 1-12 months of use reduced hemoglobin A1c (HbA1c) levels by 0.2%, compared with HbA1c levels in control groups. Results were somewhat better, however, in the three trials of mobile phone-based interventions, which reduced HbA1c levels by 0.5%, compared with controls. The other interventions studied were on computers or a touch-screen in homes or clinics (Cochrane Database Syst. Rev. 2013 March 28;3[doi:10.1002/14651858.CD008776.pub2]).

An earlier meta-analysis of results from a variety of mobile phone interventions in 15 studies involving a total of 929 children and adults with diabetes suggested overall benefits in managing blood glucose and HbA1c levels, adhering to medical therapy, and maintaining a healthy lifestyle. The 12 trials that measured HbA1c levels showed an average 0.4% reduction after 1-12 months of the intervention, compared with before (J. Mob. Technol. Med. 2012;1:17-24).

Combining usual care with use of the Glucose Buddy smartphone app and weekly text-message feedback from a diabetes educator significantly reduced HbA1c levels, compared with usual care alone, in a randomized controlled trial of 72 Australians with type 1 diabetes. Among 53 patients who completed the 6-month intervention and 3-month follow-up, HbA1c levels decreased from 9% at baseline to 7.8% in the 25 patients in the intervention group and increased from 8.5% at baseline to 8.6% in the control group of 28 patients (J. Med. Internet Res. 2013;15:e235).

A recent pilot study found that 60 adults with diabetes were enthusiastic about using the free SightBook app to monitor visual acuity changes at home but suggested that improvements will be needed to incorporate such apps into existing electronic medical records if they are to facilitate coordination between patients, diabetologists, and ophthalmologists in managing the risk of diabetic retinopathy (J. Diabetes Sci. Technol. 2014 April 14 [doi:10.1177/1932296814529637]).

Several trials have looked at text message–based interventions, including one that found no significant difference in HbA1c levels but found improved medication adherence in 128 adults with poorly controlled diabetes who often relied on emergency departments for care. The effects were larger among Spanish speakers (Ann. Emerg. Med. 2014;63:745-54). A separate randomized controlled trial found that patients receiving text-message reminders when they forgot their diabetes medication took significantly more doses within 1 hour and 4 hours of the appropriate time (Int. J. Med. Inform. 2012;81:594-604).

Health care professionals who want to guide patients seeking to use diabetes apps may want to consider some key factors, a recent article suggested. These may include the age of the patient, the cost of the technology, the fact that most apps work only on Apple operating systems, and whether the app includes features such as blood glucose logging, nutritional databases or tracking, physical activity trackers, data sharing and social support, and text-message reminders. Patients should try using an app for at least a couple of weeks before judging it and be reminded that these are adjuncts, not substitutes for regular visits with their physician, the authors wrote (Diabetes Spectr. 2013;26:211-5).

 

 

[email protected]

On Twitter @sherryboschert

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Several new mobile applications and platforms for managing diabetes will be announced at the American Diabetes Association annual scientific sessions in San Francisco this month, and the results of a handful of trials of apps will be reported there. As a prelude, it’s helpful to know what’s been reported about diabetes apps previously.

Diabetes management has been one of the most talked-about goals of app development, given the immense costs in patients’ lives and in health care dollars from the disease. Although there are more than 1,000 specific diabetes apps for iOS and Android devices, only 1.2% of people with diabetes who have a smartphone or tablet use these apps, according to the Germany-based market research and consultancy firm research2guidance. The company expects that to grow to 7.8% (24 million people) by 2018. As of now, few diabetes apps incorporate seven standards for quality and functionality, or include them only at the most basic level, according to a recent report for sale on the company’s website.

German investigators analyzed information for 656 currently available diabetes apps and used a representative 65 of them to evaluate their usability for patients aged 50 years or older. Most were for English speakers (85%), and 54% were free, with no clear differences in user ratings between free and paid apps. The majority of apps offered just one function (54%), and only 5% offered an interface to a measurement device such as a glucometer. For older patients, the usability of the 65 tested apps was moderate to good but worsened if the app offered more than one function, especially documentation or analysis functions (J. Med. Internet Res. 2014;16:e101).

A Cochrane meta-analysis of data from 16 randomized controlled trials of Internet-based self-management interventions involving 3,578 adults with type 2 diabetes found 1-12 months of use reduced hemoglobin A1c (HbA1c) levels by 0.2%, compared with HbA1c levels in control groups. Results were somewhat better, however, in the three trials of mobile phone-based interventions, which reduced HbA1c levels by 0.5%, compared with controls. The other interventions studied were on computers or a touch-screen in homes or clinics (Cochrane Database Syst. Rev. 2013 March 28;3[doi:10.1002/14651858.CD008776.pub2]).

An earlier meta-analysis of results from a variety of mobile phone interventions in 15 studies involving a total of 929 children and adults with diabetes suggested overall benefits in managing blood glucose and HbA1c levels, adhering to medical therapy, and maintaining a healthy lifestyle. The 12 trials that measured HbA1c levels showed an average 0.4% reduction after 1-12 months of the intervention, compared with before (J. Mob. Technol. Med. 2012;1:17-24).

Combining usual care with use of the Glucose Buddy smartphone app and weekly text-message feedback from a diabetes educator significantly reduced HbA1c levels, compared with usual care alone, in a randomized controlled trial of 72 Australians with type 1 diabetes. Among 53 patients who completed the 6-month intervention and 3-month follow-up, HbA1c levels decreased from 9% at baseline to 7.8% in the 25 patients in the intervention group and increased from 8.5% at baseline to 8.6% in the control group of 28 patients (J. Med. Internet Res. 2013;15:e235).

A recent pilot study found that 60 adults with diabetes were enthusiastic about using the free SightBook app to monitor visual acuity changes at home but suggested that improvements will be needed to incorporate such apps into existing electronic medical records if they are to facilitate coordination between patients, diabetologists, and ophthalmologists in managing the risk of diabetic retinopathy (J. Diabetes Sci. Technol. 2014 April 14 [doi:10.1177/1932296814529637]).

Several trials have looked at text message–based interventions, including one that found no significant difference in HbA1c levels but found improved medication adherence in 128 adults with poorly controlled diabetes who often relied on emergency departments for care. The effects were larger among Spanish speakers (Ann. Emerg. Med. 2014;63:745-54). A separate randomized controlled trial found that patients receiving text-message reminders when they forgot their diabetes medication took significantly more doses within 1 hour and 4 hours of the appropriate time (Int. J. Med. Inform. 2012;81:594-604).

Health care professionals who want to guide patients seeking to use diabetes apps may want to consider some key factors, a recent article suggested. These may include the age of the patient, the cost of the technology, the fact that most apps work only on Apple operating systems, and whether the app includes features such as blood glucose logging, nutritional databases or tracking, physical activity trackers, data sharing and social support, and text-message reminders. Patients should try using an app for at least a couple of weeks before judging it and be reminded that these are adjuncts, not substitutes for regular visits with their physician, the authors wrote (Diabetes Spectr. 2013;26:211-5).

 

 

[email protected]

On Twitter @sherryboschert

Several new mobile applications and platforms for managing diabetes will be announced at the American Diabetes Association annual scientific sessions in San Francisco this month, and the results of a handful of trials of apps will be reported there. As a prelude, it’s helpful to know what’s been reported about diabetes apps previously.

Diabetes management has been one of the most talked-about goals of app development, given the immense costs in patients’ lives and in health care dollars from the disease. Although there are more than 1,000 specific diabetes apps for iOS and Android devices, only 1.2% of people with diabetes who have a smartphone or tablet use these apps, according to the Germany-based market research and consultancy firm research2guidance. The company expects that to grow to 7.8% (24 million people) by 2018. As of now, few diabetes apps incorporate seven standards for quality and functionality, or include them only at the most basic level, according to a recent report for sale on the company’s website.

German investigators analyzed information for 656 currently available diabetes apps and used a representative 65 of them to evaluate their usability for patients aged 50 years or older. Most were for English speakers (85%), and 54% were free, with no clear differences in user ratings between free and paid apps. The majority of apps offered just one function (54%), and only 5% offered an interface to a measurement device such as a glucometer. For older patients, the usability of the 65 tested apps was moderate to good but worsened if the app offered more than one function, especially documentation or analysis functions (J. Med. Internet Res. 2014;16:e101).

A Cochrane meta-analysis of data from 16 randomized controlled trials of Internet-based self-management interventions involving 3,578 adults with type 2 diabetes found 1-12 months of use reduced hemoglobin A1c (HbA1c) levels by 0.2%, compared with HbA1c levels in control groups. Results were somewhat better, however, in the three trials of mobile phone-based interventions, which reduced HbA1c levels by 0.5%, compared with controls. The other interventions studied were on computers or a touch-screen in homes or clinics (Cochrane Database Syst. Rev. 2013 March 28;3[doi:10.1002/14651858.CD008776.pub2]).

An earlier meta-analysis of results from a variety of mobile phone interventions in 15 studies involving a total of 929 children and adults with diabetes suggested overall benefits in managing blood glucose and HbA1c levels, adhering to medical therapy, and maintaining a healthy lifestyle. The 12 trials that measured HbA1c levels showed an average 0.4% reduction after 1-12 months of the intervention, compared with before (J. Mob. Technol. Med. 2012;1:17-24).

Combining usual care with use of the Glucose Buddy smartphone app and weekly text-message feedback from a diabetes educator significantly reduced HbA1c levels, compared with usual care alone, in a randomized controlled trial of 72 Australians with type 1 diabetes. Among 53 patients who completed the 6-month intervention and 3-month follow-up, HbA1c levels decreased from 9% at baseline to 7.8% in the 25 patients in the intervention group and increased from 8.5% at baseline to 8.6% in the control group of 28 patients (J. Med. Internet Res. 2013;15:e235).

A recent pilot study found that 60 adults with diabetes were enthusiastic about using the free SightBook app to monitor visual acuity changes at home but suggested that improvements will be needed to incorporate such apps into existing electronic medical records if they are to facilitate coordination between patients, diabetologists, and ophthalmologists in managing the risk of diabetic retinopathy (J. Diabetes Sci. Technol. 2014 April 14 [doi:10.1177/1932296814529637]).

Several trials have looked at text message–based interventions, including one that found no significant difference in HbA1c levels but found improved medication adherence in 128 adults with poorly controlled diabetes who often relied on emergency departments for care. The effects were larger among Spanish speakers (Ann. Emerg. Med. 2014;63:745-54). A separate randomized controlled trial found that patients receiving text-message reminders when they forgot their diabetes medication took significantly more doses within 1 hour and 4 hours of the appropriate time (Int. J. Med. Inform. 2012;81:594-604).

Health care professionals who want to guide patients seeking to use diabetes apps may want to consider some key factors, a recent article suggested. These may include the age of the patient, the cost of the technology, the fact that most apps work only on Apple operating systems, and whether the app includes features such as blood glucose logging, nutritional databases or tracking, physical activity trackers, data sharing and social support, and text-message reminders. Patients should try using an app for at least a couple of weeks before judging it and be reminded that these are adjuncts, not substitutes for regular visits with their physician, the authors wrote (Diabetes Spectr. 2013;26:211-5).

 

 

[email protected]

On Twitter @sherryboschert

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About 5 years ago, when I first started speaking to physicians about social media, I’d ask my audience how many of them used Twitter. Typically, one or two hands would go up. Last month I asked my audience of physicians how many were on Twitter, and about 30 people raised their hands.

According to a recent report by London-based FierceHealthcare, only 23 healthcare professionals signed up for Twitter when it launched in 2006. Today, there are over 75,000 healthcare professionals on the site, with the number rising.

Why are they on Twitter? Let’s look at Twitter’s mission statement: "To give everyone the power to create and share ideas and information instantly, without barriers." That’s what we’re hardwired to do: Share ideas and information with each other. Which is why individuals from physicians to celebrities to retired grandparents are on Twitter creating and sharing ideas. Currently, there are over 255 million active Twitter users sending out approximately 500 million tweets a day.

Because Twitter is a real-time social platform, it enables conversations. Topics of conversation are tagged through the use of the # symbol, called a hashtag. If, for example, you’re a dermatologist with an interest in reaching out to teens, you might create the following tweet: "Don’t know what foods are good and bad for #acne? Check out our post on best foods for healthy skin." Then you would include the link to the post on your practice website. Anyone searching for information on diet and acne will easily find your tweet and be able to link through to your website.

Twitter is also unique in that posts, referred to as "tweets," are limited to 140 characters. So, it forces you to be concise and specific and encourages other uses to respond to your tweet or to share it, ("retweeting").

This column isn’t about the nuts and bolts of how to use Twitter; there are numerous tutorials online for that. Simply search "Twitter tutorial," and you’ll get dozens of hits. Instead, I’d like you to see the potential Twitter offers you and your practice.

• Get lots of exposure for minimal investment. I typically spend about 20 minutes a day on Twitter. Since posts are so short, I can scan conversations quickly and easily.

• Reach your target audience quickly and easily with Twitter’s great search ability. For example, a dermatologist might tweet about #skincancer, but a psychiatrist might tweet about #anxiety or #depression, while an oncologist might focus on #ovariancancer or #breastcancer.

• Build and maintain your brand and online reputation. I often tweet about skin care tips and skin cancer facts using the hashtags #dermtip and #skincancer, respectively. Doing so allows me to interact with other healthcare providers, patients, and caregivers. And it lets those people know that I’m a dermatologist who cares about these topics. For example, a recent tweet of mine was retweeted (shared by others) 28 times: "Squamous cell carcinoma has risen 700% in women under 40. There’s no such thing as a safe tan. #skincancer #womenshealth."

• Become a more active member of your medical community. The website www.symplur.com has created The Healthcare Hashtag Project which allows you to discover healthcare conversations taking place on Twitter, including conferences, and who to follow in your specialty. They also list tweet chats that are real-time online chats about specific healthcare topics. Examples include #alzchat (an Alzheimer’s disease and caregiving chat), #rheum (a rheumatoid arthritis chat), and #bcsm (a chat about the intersection of breast cancer and all things social media). Becoming an active participant in chats can help build your online reputation as an expert in the field.

• Improve quality of care by disseminating accurate information. As with any social platform, misinformation abounds about health and healthcare. As a physician you can post vetted information and become a trusted source of knowledge both online and in person. For example, a tweet of mine in April included a link to a newly published study about rising rates of melanoma in adolescents. It read: "Scary truth: #melanoma is rising in kids & teens. 77% aged 15-19 yrs." Then I included the link to the study.

• Engage for an effective networking tool. For example, my interactions on Twitter have led to invitations to speak at conferences as well as media queries. It has also broadened my circle of friends, as I have become real-life friends with people I initially met through Twitter.

• Stay abreast of information from conferences that you can’t attend. Most conferences today use an official hashtag that allows people all over the world to track what is being said at the conference and to engage with conference attendees.

 

 

• Create traffic and potential referrals to your practice website. As mentioned earlier in the column, linking tweets to posts is another way to introduce potential patients to your practice via your website. Satisfied patients may retweet your tweets, too.

Are you on Twitter? If so, do you like using it? Has it been helpful to you? Let us know. And if you follow me on Twitter (I’m @dermdoc), I’ll follow you back.

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Medical Group in San Diego and a volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @dermdoc on Twitter.

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About 5 years ago, when I first started speaking to physicians about social media, I’d ask my audience how many of them used Twitter. Typically, one or two hands would go up. Last month I asked my audience of physicians how many were on Twitter, and about 30 people raised their hands.

According to a recent report by London-based FierceHealthcare, only 23 healthcare professionals signed up for Twitter when it launched in 2006. Today, there are over 75,000 healthcare professionals on the site, with the number rising.

Why are they on Twitter? Let’s look at Twitter’s mission statement: "To give everyone the power to create and share ideas and information instantly, without barriers." That’s what we’re hardwired to do: Share ideas and information with each other. Which is why individuals from physicians to celebrities to retired grandparents are on Twitter creating and sharing ideas. Currently, there are over 255 million active Twitter users sending out approximately 500 million tweets a day.

Because Twitter is a real-time social platform, it enables conversations. Topics of conversation are tagged through the use of the # symbol, called a hashtag. If, for example, you’re a dermatologist with an interest in reaching out to teens, you might create the following tweet: "Don’t know what foods are good and bad for #acne? Check out our post on best foods for healthy skin." Then you would include the link to the post on your practice website. Anyone searching for information on diet and acne will easily find your tweet and be able to link through to your website.

Twitter is also unique in that posts, referred to as "tweets," are limited to 140 characters. So, it forces you to be concise and specific and encourages other uses to respond to your tweet or to share it, ("retweeting").

This column isn’t about the nuts and bolts of how to use Twitter; there are numerous tutorials online for that. Simply search "Twitter tutorial," and you’ll get dozens of hits. Instead, I’d like you to see the potential Twitter offers you and your practice.

• Get lots of exposure for minimal investment. I typically spend about 20 minutes a day on Twitter. Since posts are so short, I can scan conversations quickly and easily.

• Reach your target audience quickly and easily with Twitter’s great search ability. For example, a dermatologist might tweet about #skincancer, but a psychiatrist might tweet about #anxiety or #depression, while an oncologist might focus on #ovariancancer or #breastcancer.

• Build and maintain your brand and online reputation. I often tweet about skin care tips and skin cancer facts using the hashtags #dermtip and #skincancer, respectively. Doing so allows me to interact with other healthcare providers, patients, and caregivers. And it lets those people know that I’m a dermatologist who cares about these topics. For example, a recent tweet of mine was retweeted (shared by others) 28 times: "Squamous cell carcinoma has risen 700% in women under 40. There’s no such thing as a safe tan. #skincancer #womenshealth."

• Become a more active member of your medical community. The website www.symplur.com has created The Healthcare Hashtag Project which allows you to discover healthcare conversations taking place on Twitter, including conferences, and who to follow in your specialty. They also list tweet chats that are real-time online chats about specific healthcare topics. Examples include #alzchat (an Alzheimer’s disease and caregiving chat), #rheum (a rheumatoid arthritis chat), and #bcsm (a chat about the intersection of breast cancer and all things social media). Becoming an active participant in chats can help build your online reputation as an expert in the field.

• Improve quality of care by disseminating accurate information. As with any social platform, misinformation abounds about health and healthcare. As a physician you can post vetted information and become a trusted source of knowledge both online and in person. For example, a tweet of mine in April included a link to a newly published study about rising rates of melanoma in adolescents. It read: "Scary truth: #melanoma is rising in kids & teens. 77% aged 15-19 yrs." Then I included the link to the study.

• Engage for an effective networking tool. For example, my interactions on Twitter have led to invitations to speak at conferences as well as media queries. It has also broadened my circle of friends, as I have become real-life friends with people I initially met through Twitter.

• Stay abreast of information from conferences that you can’t attend. Most conferences today use an official hashtag that allows people all over the world to track what is being said at the conference and to engage with conference attendees.

 

 

• Create traffic and potential referrals to your practice website. As mentioned earlier in the column, linking tweets to posts is another way to introduce potential patients to your practice via your website. Satisfied patients may retweet your tweets, too.

Are you on Twitter? If so, do you like using it? Has it been helpful to you? Let us know. And if you follow me on Twitter (I’m @dermdoc), I’ll follow you back.

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Medical Group in San Diego and a volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @dermdoc on Twitter.

About 5 years ago, when I first started speaking to physicians about social media, I’d ask my audience how many of them used Twitter. Typically, one or two hands would go up. Last month I asked my audience of physicians how many were on Twitter, and about 30 people raised their hands.

According to a recent report by London-based FierceHealthcare, only 23 healthcare professionals signed up for Twitter when it launched in 2006. Today, there are over 75,000 healthcare professionals on the site, with the number rising.

Why are they on Twitter? Let’s look at Twitter’s mission statement: "To give everyone the power to create and share ideas and information instantly, without barriers." That’s what we’re hardwired to do: Share ideas and information with each other. Which is why individuals from physicians to celebrities to retired grandparents are on Twitter creating and sharing ideas. Currently, there are over 255 million active Twitter users sending out approximately 500 million tweets a day.

Because Twitter is a real-time social platform, it enables conversations. Topics of conversation are tagged through the use of the # symbol, called a hashtag. If, for example, you’re a dermatologist with an interest in reaching out to teens, you might create the following tweet: "Don’t know what foods are good and bad for #acne? Check out our post on best foods for healthy skin." Then you would include the link to the post on your practice website. Anyone searching for information on diet and acne will easily find your tweet and be able to link through to your website.

Twitter is also unique in that posts, referred to as "tweets," are limited to 140 characters. So, it forces you to be concise and specific and encourages other uses to respond to your tweet or to share it, ("retweeting").

This column isn’t about the nuts and bolts of how to use Twitter; there are numerous tutorials online for that. Simply search "Twitter tutorial," and you’ll get dozens of hits. Instead, I’d like you to see the potential Twitter offers you and your practice.

• Get lots of exposure for minimal investment. I typically spend about 20 minutes a day on Twitter. Since posts are so short, I can scan conversations quickly and easily.

• Reach your target audience quickly and easily with Twitter’s great search ability. For example, a dermatologist might tweet about #skincancer, but a psychiatrist might tweet about #anxiety or #depression, while an oncologist might focus on #ovariancancer or #breastcancer.

• Build and maintain your brand and online reputation. I often tweet about skin care tips and skin cancer facts using the hashtags #dermtip and #skincancer, respectively. Doing so allows me to interact with other healthcare providers, patients, and caregivers. And it lets those people know that I’m a dermatologist who cares about these topics. For example, a recent tweet of mine was retweeted (shared by others) 28 times: "Squamous cell carcinoma has risen 700% in women under 40. There’s no such thing as a safe tan. #skincancer #womenshealth."

• Become a more active member of your medical community. The website www.symplur.com has created The Healthcare Hashtag Project which allows you to discover healthcare conversations taking place on Twitter, including conferences, and who to follow in your specialty. They also list tweet chats that are real-time online chats about specific healthcare topics. Examples include #alzchat (an Alzheimer’s disease and caregiving chat), #rheum (a rheumatoid arthritis chat), and #bcsm (a chat about the intersection of breast cancer and all things social media). Becoming an active participant in chats can help build your online reputation as an expert in the field.

• Improve quality of care by disseminating accurate information. As with any social platform, misinformation abounds about health and healthcare. As a physician you can post vetted information and become a trusted source of knowledge both online and in person. For example, a tweet of mine in April included a link to a newly published study about rising rates of melanoma in adolescents. It read: "Scary truth: #melanoma is rising in kids & teens. 77% aged 15-19 yrs." Then I included the link to the study.

• Engage for an effective networking tool. For example, my interactions on Twitter have led to invitations to speak at conferences as well as media queries. It has also broadened my circle of friends, as I have become real-life friends with people I initially met through Twitter.

• Stay abreast of information from conferences that you can’t attend. Most conferences today use an official hashtag that allows people all over the world to track what is being said at the conference and to engage with conference attendees.

 

 

• Create traffic and potential referrals to your practice website. As mentioned earlier in the column, linking tweets to posts is another way to introduce potential patients to your practice via your website. Satisfied patients may retweet your tweets, too.

Are you on Twitter? If so, do you like using it? Has it been helpful to you? Let us know. And if you follow me on Twitter (I’m @dermdoc), I’ll follow you back.

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Medical Group in San Diego and a volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @dermdoc on Twitter.

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Critical Care Commentary: Brain death – patient, law, and family

Brain death is not 'black and white'
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Critical Care Commentary: Brain death – patient, law, and family

Perhaps no other concept in modern medicine is surrounded by as much misunderstanding and controversy as that of death by neurologic criteria, or brain death.

Legal challenges to brain death have spanned the gamut of continuing life support for a legally dead patient to denying a family’s request to continue support for their dead child.

Dr. David Bowton, FCCP

Two recent, highly publicized cases highlight the poles of these controversies and concerns. In November 2013, Marlise Muñoz was declared brain dead. She was 33 years old and 14 weeks’ pregnant. Concordant with the patient’s wishes, the husband requested that the hospital remove the patient from mechanical ventilatory support. Citing Texas law that precludes the withholding of life-sustaining treatment to a pregnant patient, the hospital refused, despite the logical fallacy of withholding life support from a person declared dead.

In December 2013, 13-year-old Jahi McMath was declared brain dead. Her parents obtained a court order to prevent the hospital from discontinuing ventilatory support. A better understanding of the development of the concept of brain death and the incorporation of recent evidence into its determination may reduce the confusion and misunderstandings surrounding the determination of brain death.

Three reports in 1959 describe death of the nervous system and brain death (coma dépassé) building upon clinical and laboratory data from the 1930s relating the cessation of brain blood flow and EEG activity to ensuing apnea and subsequent cardiac arrest (Machado et al. J Med Ethics. 2007;33[4]:197). With the increasing sophistication of critical care support, especially mechanical ventilation, the loss of central respiratory drive no longer meant imminent death, and patients could be supported for long periods of time without recovery of brain function.

In 1968, an ad hoc committee at Harvard Medical School proposed a definition of irreversible coma and brain death (Beecher et al. JAMA. 1968;205[6]:337). They posited that any organ that no longer functions and has no possibility of functioning again was "for all practical purposes dead." The goals of the committee were (1) to reduce the suffering of patients and families and the care burden of hospitals; and (2) mitigate the controversies that surrounded obtaining organs for transplantation.

The committee then set out their rationale for their proposed characteristics of the permanently nonfunctioning brain. Subsequently, in 1976, The Conference of the Medical Royal Colleges and their Faculties in the United Kingdom required a deeply comatose state, irremediable structural brain damage, and irreversible cessation of brain stem function to ascertain brain death (Spinello. J Intensive Care Med. May 2014, in press).

In 1981, the National Conference of Commissioners on Uniform State Laws approved the Uniform Determination of Death Act (UDDA), codifying the legal concept of brain death. Thirty-six states and the District of Columbia have enacted the UDDA, but legal precedent and statutes in the remaining states are consistent with the UDDA. New York and New Jersey require that a family’s religious or moral views be considered in the process following the determination of brain death (Gostin. JAMA. 2014;311[9]:903); in all other states, clinicians are not required to consult with family prior to withdrawing ventilatory support from the brain dead patient.

‘No reports of clinical recovery’

However, the UDDA does not define brain death but rather states that "a determination of death must be made with accepted medical standards" (Wijdicks et al. Neurology. 2010;74[23]:1911). The American Academy of Neurology (AAN) published a practice parameter in 1995 to guide clinicians in the determination of brain death; this was updated by their Quality Standards Committee in 2010 (Wijdicks et al. Neurology. 2010;74[23]:1911). In the updated guidance document, the committee stated: "There are no reports of clinical recovery in patients after the clinical diagnosis of brain death has been determined using the AAN practice parameter."

It is striking, however, that there appears to be an inconsistent approach and criteria for the determination of brain death across hospitals, and even amongst specialties within a hospital (Powner et al. Crit Care Med. 2004;32[6]:1284). Further, in most states, any physician is permitted to ascertain brain death, though some states have now added requirements for specific qualifications and/or confirmation by a second physician (Spinello IM. J Intensive Care Med. May 2014, in press).

These inconsistencies in criteria, process, and experience may be responsible for reports in the lay press of recovery following pronouncement of brain death. Every hospital should have a validated, well-defined process for the evaluation of brain death guided by the AAN practice parameter.

A single exam

In most states, a single exam is required to determine brain death. The clinical setting and the results of imaging studies should be used to determine the duration of observation needed to exclude the possibility of recovery. Given that the patient should be normothermic, have a normal systolic blood pressure, have both a history and imaging studies supporting an irreversible cause of coma, and that drugs and toxins must be excluded as a cause of coma, this observation period is uncommonly less than several hours.

 

 

Confounded by movement

Movement of the patient with devastating brain injury is often a confounder in the determination of brain death.

This is also a source of confusion and concern for the family. Plantar reflexes have been commonly reported in patients pronounced brain dead. Head turning in response to noxious stimuli, repetitive leg movements, facial myokymia, and other movements have been observed (Wu et al. Crit Care. 2013;17[4]:440; Wijdicks et al. Neurology. 2010;74[23]:1911). When this is observed, knowledge of the potential reflex arcs is needed, and consultation with a neurologist or other physician skilled in brain death determination is usually appropriate.

Movement can sometimes extend to apparent respiratory activity. This can be caused by ventilator autocycling due to variations in circuit pressure (especially in a noncompliant lung or with large tidal volumes) or triggering due to cardiac-induced alterations in transpulmonary pressure. The latter is most common in a hyperdynamic circulatory state.

Apnea is a critical criterion for the determination of brain death and is most reliably assessed when the patient has been removed from the mechanical ventilator. During testing, apnea should be present despite achieving a PaCO2 of greater than or equal to 60 mm Hg, or 20 mm Hg above the baseline to support the diagnosis of brain death.

Some patients, especially those who are hemodynamically unstable or who require high levels of PEEP to support oxygenation, may not tolerate the apnea test without oxygen desaturation or hypotension.

Most commonly, the apnea test is performed with the patient off the ventilator and 6 L/min of oxygen flowing through an insufflation catheter placed near the carina. We prefer to use a modified Mapleson circuit with enough flow to only partially distend the anesthesia bag in the circuit. With this arrangement, one can look not only at the patient’s chest wall and abdomen for signs of respiratory activity but also look for cyclic changes in the level of bag inflation.

In patients with ARDS, trauma involving the chest or other causes of oxygenation failure, CPAP, with or without an antecedent recruitment maneuver may facilitate successful completion of the apnea test (Hocker et al. Neurocrit Care. 2014;20[2]:298).

Controversy over ancillary testing

There are no well-designed prospective studies examining the accuracy of ancillary tests for the determination of brain death using the appropriate control group of patients with coma but who are not brain dead and with blinding of the interpretation of the study results to the clinical setting.

Brain death is not synonymous with complete neuronal death. While cortical areas exhibit moderate to severe histopathologic ischemic changes in the large majority (but not all) of brain dead patients, the basal ganglia and diencephalon inconsistently demonstrate these changes (Wijdicks et al. Neurology. 2008;70[15]:1234). Thus, it may not be surprising that both false-positive (test positive for brain death – clinically not brain dead) and false-negative (test negative for brain death – clinically brain dead) results have been reported for virtually all tests proposed for confirmatory testing, including CT angiography, transcranial Doppler, and nuclear brain scan. Confirmatory testing is most commonly used in patients who cannot complete an apnea test.

It has been forcefully argued that, in adults, confirmatory tests should not be done (Wijdicks. Neurology. 2010;75[1]:77). There will be some patients in whom brain death cannot be definitively determined. When all criteria of the AAN guidelines cannot be fulfilled, clinicians should err on the side of concluding that the patient is not brain dead and turn their efforts toward counseling the family regarding the likelihood of neurologic recovery and assisting the family in ascertaining the desires of the patient under these circumstances.

It is vital that care providers not lose perspective on the plight of the family in these settings. The symbolic power of a beating heart to a parent, spouse, or loved one cannot be underestimated. Family members who observe resuscitation efforts have been shown to have a lower incidence of posttraumatic stress disorder symptoms (Jabre et al. N Engl J Med. 2013;368[11]:1008).

A recent trial demonstrated that family presence during the brain death determination had an increased understanding of brain death without an adverse impact on emotional well being (Tawil et al. Crit Care Med. 2013;42[4]:934). A consistent process for determination of brain death, engagement of the family in the brain death evaluation and helping them understand the meaning of patient movements that can be distressingly misinterpreted, and honesty when a definitive determination of brain death cannot be determined will not remove the misunderstanding or controversy surrounding a diagnosis of brain death but will serve to ensure its accurate and humane application.

 

 

Dr. Bowton is Professor, Section on Critical Care, Department of Anesthesiology, Wake Forest Baptist Health, Winston-Salem, North Carolina. Read previous Critical Care Commentaries online.

Body


Dr. Peter Spiro, FCCP

In this thorough and somber commentary, Dr. Bowton clearly points out how much gray remains in a world that demands black and white certainty.

Brain death, and its implication, is not an exact diagnosis, which impacts the family, society, and the care-giving team, but most of all, the patient.

As there are times that brain death cannot be truly determined, we must be mindful that our primary goal is always the patient, then the families, society, and others. As a practitioner in New York, where family discussion is the law, I have not found this to be a great impediment; with palliative care and pastoral support, most issues can be resolved. As we progress in our knowledge, a more global unified approach would be welcomed.

Dr. Peter Spiro, FCCP Section Editor

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Dr. Bowton
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Body


Dr. Peter Spiro, FCCP

In this thorough and somber commentary, Dr. Bowton clearly points out how much gray remains in a world that demands black and white certainty.

Brain death, and its implication, is not an exact diagnosis, which impacts the family, society, and the care-giving team, but most of all, the patient.

As there are times that brain death cannot be truly determined, we must be mindful that our primary goal is always the patient, then the families, society, and others. As a practitioner in New York, where family discussion is the law, I have not found this to be a great impediment; with palliative care and pastoral support, most issues can be resolved. As we progress in our knowledge, a more global unified approach would be welcomed.

Dr. Peter Spiro, FCCP Section Editor

Body


Dr. Peter Spiro, FCCP

In this thorough and somber commentary, Dr. Bowton clearly points out how much gray remains in a world that demands black and white certainty.

Brain death, and its implication, is not an exact diagnosis, which impacts the family, society, and the care-giving team, but most of all, the patient.

As there are times that brain death cannot be truly determined, we must be mindful that our primary goal is always the patient, then the families, society, and others. As a practitioner in New York, where family discussion is the law, I have not found this to be a great impediment; with palliative care and pastoral support, most issues can be resolved. As we progress in our knowledge, a more global unified approach would be welcomed.

Dr. Peter Spiro, FCCP Section Editor

Name
Dr. Bowton
Name
Dr. Bowton
Title
Brain death is not 'black and white'
Brain death is not 'black and white'

Perhaps no other concept in modern medicine is surrounded by as much misunderstanding and controversy as that of death by neurologic criteria, or brain death.

Legal challenges to brain death have spanned the gamut of continuing life support for a legally dead patient to denying a family’s request to continue support for their dead child.

Dr. David Bowton, FCCP

Two recent, highly publicized cases highlight the poles of these controversies and concerns. In November 2013, Marlise Muñoz was declared brain dead. She was 33 years old and 14 weeks’ pregnant. Concordant with the patient’s wishes, the husband requested that the hospital remove the patient from mechanical ventilatory support. Citing Texas law that precludes the withholding of life-sustaining treatment to a pregnant patient, the hospital refused, despite the logical fallacy of withholding life support from a person declared dead.

In December 2013, 13-year-old Jahi McMath was declared brain dead. Her parents obtained a court order to prevent the hospital from discontinuing ventilatory support. A better understanding of the development of the concept of brain death and the incorporation of recent evidence into its determination may reduce the confusion and misunderstandings surrounding the determination of brain death.

Three reports in 1959 describe death of the nervous system and brain death (coma dépassé) building upon clinical and laboratory data from the 1930s relating the cessation of brain blood flow and EEG activity to ensuing apnea and subsequent cardiac arrest (Machado et al. J Med Ethics. 2007;33[4]:197). With the increasing sophistication of critical care support, especially mechanical ventilation, the loss of central respiratory drive no longer meant imminent death, and patients could be supported for long periods of time without recovery of brain function.

In 1968, an ad hoc committee at Harvard Medical School proposed a definition of irreversible coma and brain death (Beecher et al. JAMA. 1968;205[6]:337). They posited that any organ that no longer functions and has no possibility of functioning again was "for all practical purposes dead." The goals of the committee were (1) to reduce the suffering of patients and families and the care burden of hospitals; and (2) mitigate the controversies that surrounded obtaining organs for transplantation.

The committee then set out their rationale for their proposed characteristics of the permanently nonfunctioning brain. Subsequently, in 1976, The Conference of the Medical Royal Colleges and their Faculties in the United Kingdom required a deeply comatose state, irremediable structural brain damage, and irreversible cessation of brain stem function to ascertain brain death (Spinello. J Intensive Care Med. May 2014, in press).

In 1981, the National Conference of Commissioners on Uniform State Laws approved the Uniform Determination of Death Act (UDDA), codifying the legal concept of brain death. Thirty-six states and the District of Columbia have enacted the UDDA, but legal precedent and statutes in the remaining states are consistent with the UDDA. New York and New Jersey require that a family’s religious or moral views be considered in the process following the determination of brain death (Gostin. JAMA. 2014;311[9]:903); in all other states, clinicians are not required to consult with family prior to withdrawing ventilatory support from the brain dead patient.

‘No reports of clinical recovery’

However, the UDDA does not define brain death but rather states that "a determination of death must be made with accepted medical standards" (Wijdicks et al. Neurology. 2010;74[23]:1911). The American Academy of Neurology (AAN) published a practice parameter in 1995 to guide clinicians in the determination of brain death; this was updated by their Quality Standards Committee in 2010 (Wijdicks et al. Neurology. 2010;74[23]:1911). In the updated guidance document, the committee stated: "There are no reports of clinical recovery in patients after the clinical diagnosis of brain death has been determined using the AAN practice parameter."

It is striking, however, that there appears to be an inconsistent approach and criteria for the determination of brain death across hospitals, and even amongst specialties within a hospital (Powner et al. Crit Care Med. 2004;32[6]:1284). Further, in most states, any physician is permitted to ascertain brain death, though some states have now added requirements for specific qualifications and/or confirmation by a second physician (Spinello IM. J Intensive Care Med. May 2014, in press).

These inconsistencies in criteria, process, and experience may be responsible for reports in the lay press of recovery following pronouncement of brain death. Every hospital should have a validated, well-defined process for the evaluation of brain death guided by the AAN practice parameter.

A single exam

In most states, a single exam is required to determine brain death. The clinical setting and the results of imaging studies should be used to determine the duration of observation needed to exclude the possibility of recovery. Given that the patient should be normothermic, have a normal systolic blood pressure, have both a history and imaging studies supporting an irreversible cause of coma, and that drugs and toxins must be excluded as a cause of coma, this observation period is uncommonly less than several hours.

 

 

Confounded by movement

Movement of the patient with devastating brain injury is often a confounder in the determination of brain death.

This is also a source of confusion and concern for the family. Plantar reflexes have been commonly reported in patients pronounced brain dead. Head turning in response to noxious stimuli, repetitive leg movements, facial myokymia, and other movements have been observed (Wu et al. Crit Care. 2013;17[4]:440; Wijdicks et al. Neurology. 2010;74[23]:1911). When this is observed, knowledge of the potential reflex arcs is needed, and consultation with a neurologist or other physician skilled in brain death determination is usually appropriate.

Movement can sometimes extend to apparent respiratory activity. This can be caused by ventilator autocycling due to variations in circuit pressure (especially in a noncompliant lung or with large tidal volumes) or triggering due to cardiac-induced alterations in transpulmonary pressure. The latter is most common in a hyperdynamic circulatory state.

Apnea is a critical criterion for the determination of brain death and is most reliably assessed when the patient has been removed from the mechanical ventilator. During testing, apnea should be present despite achieving a PaCO2 of greater than or equal to 60 mm Hg, or 20 mm Hg above the baseline to support the diagnosis of brain death.

Some patients, especially those who are hemodynamically unstable or who require high levels of PEEP to support oxygenation, may not tolerate the apnea test without oxygen desaturation or hypotension.

Most commonly, the apnea test is performed with the patient off the ventilator and 6 L/min of oxygen flowing through an insufflation catheter placed near the carina. We prefer to use a modified Mapleson circuit with enough flow to only partially distend the anesthesia bag in the circuit. With this arrangement, one can look not only at the patient’s chest wall and abdomen for signs of respiratory activity but also look for cyclic changes in the level of bag inflation.

In patients with ARDS, trauma involving the chest or other causes of oxygenation failure, CPAP, with or without an antecedent recruitment maneuver may facilitate successful completion of the apnea test (Hocker et al. Neurocrit Care. 2014;20[2]:298).

Controversy over ancillary testing

There are no well-designed prospective studies examining the accuracy of ancillary tests for the determination of brain death using the appropriate control group of patients with coma but who are not brain dead and with blinding of the interpretation of the study results to the clinical setting.

Brain death is not synonymous with complete neuronal death. While cortical areas exhibit moderate to severe histopathologic ischemic changes in the large majority (but not all) of brain dead patients, the basal ganglia and diencephalon inconsistently demonstrate these changes (Wijdicks et al. Neurology. 2008;70[15]:1234). Thus, it may not be surprising that both false-positive (test positive for brain death – clinically not brain dead) and false-negative (test negative for brain death – clinically brain dead) results have been reported for virtually all tests proposed for confirmatory testing, including CT angiography, transcranial Doppler, and nuclear brain scan. Confirmatory testing is most commonly used in patients who cannot complete an apnea test.

It has been forcefully argued that, in adults, confirmatory tests should not be done (Wijdicks. Neurology. 2010;75[1]:77). There will be some patients in whom brain death cannot be definitively determined. When all criteria of the AAN guidelines cannot be fulfilled, clinicians should err on the side of concluding that the patient is not brain dead and turn their efforts toward counseling the family regarding the likelihood of neurologic recovery and assisting the family in ascertaining the desires of the patient under these circumstances.

It is vital that care providers not lose perspective on the plight of the family in these settings. The symbolic power of a beating heart to a parent, spouse, or loved one cannot be underestimated. Family members who observe resuscitation efforts have been shown to have a lower incidence of posttraumatic stress disorder symptoms (Jabre et al. N Engl J Med. 2013;368[11]:1008).

A recent trial demonstrated that family presence during the brain death determination had an increased understanding of brain death without an adverse impact on emotional well being (Tawil et al. Crit Care Med. 2013;42[4]:934). A consistent process for determination of brain death, engagement of the family in the brain death evaluation and helping them understand the meaning of patient movements that can be distressingly misinterpreted, and honesty when a definitive determination of brain death cannot be determined will not remove the misunderstanding or controversy surrounding a diagnosis of brain death but will serve to ensure its accurate and humane application.

 

 

Dr. Bowton is Professor, Section on Critical Care, Department of Anesthesiology, Wake Forest Baptist Health, Winston-Salem, North Carolina. Read previous Critical Care Commentaries online.

Perhaps no other concept in modern medicine is surrounded by as much misunderstanding and controversy as that of death by neurologic criteria, or brain death.

Legal challenges to brain death have spanned the gamut of continuing life support for a legally dead patient to denying a family’s request to continue support for their dead child.

Dr. David Bowton, FCCP

Two recent, highly publicized cases highlight the poles of these controversies and concerns. In November 2013, Marlise Muñoz was declared brain dead. She was 33 years old and 14 weeks’ pregnant. Concordant with the patient’s wishes, the husband requested that the hospital remove the patient from mechanical ventilatory support. Citing Texas law that precludes the withholding of life-sustaining treatment to a pregnant patient, the hospital refused, despite the logical fallacy of withholding life support from a person declared dead.

In December 2013, 13-year-old Jahi McMath was declared brain dead. Her parents obtained a court order to prevent the hospital from discontinuing ventilatory support. A better understanding of the development of the concept of brain death and the incorporation of recent evidence into its determination may reduce the confusion and misunderstandings surrounding the determination of brain death.

Three reports in 1959 describe death of the nervous system and brain death (coma dépassé) building upon clinical and laboratory data from the 1930s relating the cessation of brain blood flow and EEG activity to ensuing apnea and subsequent cardiac arrest (Machado et al. J Med Ethics. 2007;33[4]:197). With the increasing sophistication of critical care support, especially mechanical ventilation, the loss of central respiratory drive no longer meant imminent death, and patients could be supported for long periods of time without recovery of brain function.

In 1968, an ad hoc committee at Harvard Medical School proposed a definition of irreversible coma and brain death (Beecher et al. JAMA. 1968;205[6]:337). They posited that any organ that no longer functions and has no possibility of functioning again was "for all practical purposes dead." The goals of the committee were (1) to reduce the suffering of patients and families and the care burden of hospitals; and (2) mitigate the controversies that surrounded obtaining organs for transplantation.

The committee then set out their rationale for their proposed characteristics of the permanently nonfunctioning brain. Subsequently, in 1976, The Conference of the Medical Royal Colleges and their Faculties in the United Kingdom required a deeply comatose state, irremediable structural brain damage, and irreversible cessation of brain stem function to ascertain brain death (Spinello. J Intensive Care Med. May 2014, in press).

In 1981, the National Conference of Commissioners on Uniform State Laws approved the Uniform Determination of Death Act (UDDA), codifying the legal concept of brain death. Thirty-six states and the District of Columbia have enacted the UDDA, but legal precedent and statutes in the remaining states are consistent with the UDDA. New York and New Jersey require that a family’s religious or moral views be considered in the process following the determination of brain death (Gostin. JAMA. 2014;311[9]:903); in all other states, clinicians are not required to consult with family prior to withdrawing ventilatory support from the brain dead patient.

‘No reports of clinical recovery’

However, the UDDA does not define brain death but rather states that "a determination of death must be made with accepted medical standards" (Wijdicks et al. Neurology. 2010;74[23]:1911). The American Academy of Neurology (AAN) published a practice parameter in 1995 to guide clinicians in the determination of brain death; this was updated by their Quality Standards Committee in 2010 (Wijdicks et al. Neurology. 2010;74[23]:1911). In the updated guidance document, the committee stated: "There are no reports of clinical recovery in patients after the clinical diagnosis of brain death has been determined using the AAN practice parameter."

It is striking, however, that there appears to be an inconsistent approach and criteria for the determination of brain death across hospitals, and even amongst specialties within a hospital (Powner et al. Crit Care Med. 2004;32[6]:1284). Further, in most states, any physician is permitted to ascertain brain death, though some states have now added requirements for specific qualifications and/or confirmation by a second physician (Spinello IM. J Intensive Care Med. May 2014, in press).

These inconsistencies in criteria, process, and experience may be responsible for reports in the lay press of recovery following pronouncement of brain death. Every hospital should have a validated, well-defined process for the evaluation of brain death guided by the AAN practice parameter.

A single exam

In most states, a single exam is required to determine brain death. The clinical setting and the results of imaging studies should be used to determine the duration of observation needed to exclude the possibility of recovery. Given that the patient should be normothermic, have a normal systolic blood pressure, have both a history and imaging studies supporting an irreversible cause of coma, and that drugs and toxins must be excluded as a cause of coma, this observation period is uncommonly less than several hours.

 

 

Confounded by movement

Movement of the patient with devastating brain injury is often a confounder in the determination of brain death.

This is also a source of confusion and concern for the family. Plantar reflexes have been commonly reported in patients pronounced brain dead. Head turning in response to noxious stimuli, repetitive leg movements, facial myokymia, and other movements have been observed (Wu et al. Crit Care. 2013;17[4]:440; Wijdicks et al. Neurology. 2010;74[23]:1911). When this is observed, knowledge of the potential reflex arcs is needed, and consultation with a neurologist or other physician skilled in brain death determination is usually appropriate.

Movement can sometimes extend to apparent respiratory activity. This can be caused by ventilator autocycling due to variations in circuit pressure (especially in a noncompliant lung or with large tidal volumes) or triggering due to cardiac-induced alterations in transpulmonary pressure. The latter is most common in a hyperdynamic circulatory state.

Apnea is a critical criterion for the determination of brain death and is most reliably assessed when the patient has been removed from the mechanical ventilator. During testing, apnea should be present despite achieving a PaCO2 of greater than or equal to 60 mm Hg, or 20 mm Hg above the baseline to support the diagnosis of brain death.

Some patients, especially those who are hemodynamically unstable or who require high levels of PEEP to support oxygenation, may not tolerate the apnea test without oxygen desaturation or hypotension.

Most commonly, the apnea test is performed with the patient off the ventilator and 6 L/min of oxygen flowing through an insufflation catheter placed near the carina. We prefer to use a modified Mapleson circuit with enough flow to only partially distend the anesthesia bag in the circuit. With this arrangement, one can look not only at the patient’s chest wall and abdomen for signs of respiratory activity but also look for cyclic changes in the level of bag inflation.

In patients with ARDS, trauma involving the chest or other causes of oxygenation failure, CPAP, with or without an antecedent recruitment maneuver may facilitate successful completion of the apnea test (Hocker et al. Neurocrit Care. 2014;20[2]:298).

Controversy over ancillary testing

There are no well-designed prospective studies examining the accuracy of ancillary tests for the determination of brain death using the appropriate control group of patients with coma but who are not brain dead and with blinding of the interpretation of the study results to the clinical setting.

Brain death is not synonymous with complete neuronal death. While cortical areas exhibit moderate to severe histopathologic ischemic changes in the large majority (but not all) of brain dead patients, the basal ganglia and diencephalon inconsistently demonstrate these changes (Wijdicks et al. Neurology. 2008;70[15]:1234). Thus, it may not be surprising that both false-positive (test positive for brain death – clinically not brain dead) and false-negative (test negative for brain death – clinically brain dead) results have been reported for virtually all tests proposed for confirmatory testing, including CT angiography, transcranial Doppler, and nuclear brain scan. Confirmatory testing is most commonly used in patients who cannot complete an apnea test.

It has been forcefully argued that, in adults, confirmatory tests should not be done (Wijdicks. Neurology. 2010;75[1]:77). There will be some patients in whom brain death cannot be definitively determined. When all criteria of the AAN guidelines cannot be fulfilled, clinicians should err on the side of concluding that the patient is not brain dead and turn their efforts toward counseling the family regarding the likelihood of neurologic recovery and assisting the family in ascertaining the desires of the patient under these circumstances.

It is vital that care providers not lose perspective on the plight of the family in these settings. The symbolic power of a beating heart to a parent, spouse, or loved one cannot be underestimated. Family members who observe resuscitation efforts have been shown to have a lower incidence of posttraumatic stress disorder symptoms (Jabre et al. N Engl J Med. 2013;368[11]:1008).

A recent trial demonstrated that family presence during the brain death determination had an increased understanding of brain death without an adverse impact on emotional well being (Tawil et al. Crit Care Med. 2013;42[4]:934). A consistent process for determination of brain death, engagement of the family in the brain death evaluation and helping them understand the meaning of patient movements that can be distressingly misinterpreted, and honesty when a definitive determination of brain death cannot be determined will not remove the misunderstanding or controversy surrounding a diagnosis of brain death but will serve to ensure its accurate and humane application.

 

 

Dr. Bowton is Professor, Section on Critical Care, Department of Anesthesiology, Wake Forest Baptist Health, Winston-Salem, North Carolina. Read previous Critical Care Commentaries online.

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