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Clip closure reduced bleeding after large lesion resection
Use of clip closure significantly reduced delayed bleeding in patients who underwent resections for large colorectal lesions, based on data from 235 individuals.
Source: American Gastroenterological Association
“Closure of a mucosal defect with clips after resection has long been considered to reduce the risk of bleeding,” but evidence to support this practice is limited, wrote Eduardo Albéniz, MD, of the Public University of Navarra (Spain), and colleagues.
In a study published in Gastroenterology, the researchers identified 235 consecutive patients who had resections of large nonpedunculated colorectal lesions from May 2016 to June 2018. Patients had an average or high risk of delayed bleeding and were randomized to receive scar closure with either 11-mm through-the-scope clips (119 patients) or no clip (116 patients).
Delayed bleeding occurred in 14 control patients (12.1%), compared with 6 clip patients (5%), for a risk reduction of 7%. The clip group included 68 cases (57%) of complete closure and 33 cases (28%) with partial closure, as well as 18 cases of failure to close (15%); only 1 case of delayed bleeding occurred in the clip group after completion of clip closure. On average, six clips were needed for complete closure.
None of the patients who experienced delayed bleeding required surgical or angiographic intervention, although 15 of the 20 patients with bleeding underwent additional endoscopy. Other adverse events included immediate bleeding in 21 clip patients and 18 controls that was managed with snare soft-tip coagulation. No deaths were reported in connection with the study.
Demographics were similar between the two groups, but the subset of patients with complete closure included more individuals aged 75 years and older and more cases with smaller polyps, compared with other subgroups, the researchers noted.
The study findings were limited by several factors, including the difficulty in predicting delayed bleeding, the potential for selection bias given the timing of patient randomization, the lack of information about polyps that were excluded from treatment, and the difficulty in completely closing the mucosal defects, the researchers noted. However, the results suggest that complete clip closure, despite its challenges, “displays a clear trend to reduce delayed bleeding risk,” and is worth an attempt.
The study was supported by the Spanish Society of Digestive Endoscopy. The researchers had no financial conflicts to disclose. MicroTech (Nanjing, China) contributed the clips used in the study.
SOURCE: Albéniz E et al. Gastroenterology. 2019 Jul 27. doi: 10.1053/j.gastro.2019.07.037.
With the advent of routine submucosal lifting prior to endoscopic mucosal resection, perforation now occurs less commonly; however, delayed bleeding following resection remains problematic given the aging population and increasing use of antithrombotic agents. In this study, clip closure resulted in a decrease in post-polypectomy bleeding in patients deemed to be at high risk (at least 8%) for delayed bleeding.
The protective benefit of clip closure was seen almost exclusively in patients who had complete closure of the defect, which was achieved in only 57% of procedures. Clinical efficacy is largely driven by endoscopist skill level and the ability to achieve complete closure. Notably, defects that were successfully clipped were smaller in size, had better accessibility, and were technically easier. Defining such procedural factors a priori is important and may influence whether one should attempt clip closure if complete clip closure is unlikely. Interestingly, the bleeding rate was higher in the control group in lesions proximal to the transverse colon, where clip closure is likely to be most beneficial and cost effective, based on emerging data. It’s worth noting that the clips used in this study were relatively small (11 mm), and not currently available in the United States, although most endoscopic clips function similarly.
Studies such as this provide evidenced-based medicine to endoscopic practice. Hemostatic clips were introduced nearly 20 years ago without evidence for their effectiveness. Future studies are needed, such as those that compare electrocautery-based resection of high-risk polyps with standard clips to over-the-scope clips, and those that compare electrocautery-based resection to cold snare resection.
Todd H. Baron, MD, is a gastroenterologist based at the University of North Carolina, Chapel Hill. He is a speaker and consultant for Olympus, Boston Scientific, and Cook Endoscopy.
With the advent of routine submucosal lifting prior to endoscopic mucosal resection, perforation now occurs less commonly; however, delayed bleeding following resection remains problematic given the aging population and increasing use of antithrombotic agents. In this study, clip closure resulted in a decrease in post-polypectomy bleeding in patients deemed to be at high risk (at least 8%) for delayed bleeding.
The protective benefit of clip closure was seen almost exclusively in patients who had complete closure of the defect, which was achieved in only 57% of procedures. Clinical efficacy is largely driven by endoscopist skill level and the ability to achieve complete closure. Notably, defects that were successfully clipped were smaller in size, had better accessibility, and were technically easier. Defining such procedural factors a priori is important and may influence whether one should attempt clip closure if complete clip closure is unlikely. Interestingly, the bleeding rate was higher in the control group in lesions proximal to the transverse colon, where clip closure is likely to be most beneficial and cost effective, based on emerging data. It’s worth noting that the clips used in this study were relatively small (11 mm), and not currently available in the United States, although most endoscopic clips function similarly.
Studies such as this provide evidenced-based medicine to endoscopic practice. Hemostatic clips were introduced nearly 20 years ago without evidence for their effectiveness. Future studies are needed, such as those that compare electrocautery-based resection of high-risk polyps with standard clips to over-the-scope clips, and those that compare electrocautery-based resection to cold snare resection.
Todd H. Baron, MD, is a gastroenterologist based at the University of North Carolina, Chapel Hill. He is a speaker and consultant for Olympus, Boston Scientific, and Cook Endoscopy.
With the advent of routine submucosal lifting prior to endoscopic mucosal resection, perforation now occurs less commonly; however, delayed bleeding following resection remains problematic given the aging population and increasing use of antithrombotic agents. In this study, clip closure resulted in a decrease in post-polypectomy bleeding in patients deemed to be at high risk (at least 8%) for delayed bleeding.
The protective benefit of clip closure was seen almost exclusively in patients who had complete closure of the defect, which was achieved in only 57% of procedures. Clinical efficacy is largely driven by endoscopist skill level and the ability to achieve complete closure. Notably, defects that were successfully clipped were smaller in size, had better accessibility, and were technically easier. Defining such procedural factors a priori is important and may influence whether one should attempt clip closure if complete clip closure is unlikely. Interestingly, the bleeding rate was higher in the control group in lesions proximal to the transverse colon, where clip closure is likely to be most beneficial and cost effective, based on emerging data. It’s worth noting that the clips used in this study were relatively small (11 mm), and not currently available in the United States, although most endoscopic clips function similarly.
Studies such as this provide evidenced-based medicine to endoscopic practice. Hemostatic clips were introduced nearly 20 years ago without evidence for their effectiveness. Future studies are needed, such as those that compare electrocautery-based resection of high-risk polyps with standard clips to over-the-scope clips, and those that compare electrocautery-based resection to cold snare resection.
Todd H. Baron, MD, is a gastroenterologist based at the University of North Carolina, Chapel Hill. He is a speaker and consultant for Olympus, Boston Scientific, and Cook Endoscopy.
Use of clip closure significantly reduced delayed bleeding in patients who underwent resections for large colorectal lesions, based on data from 235 individuals.
Source: American Gastroenterological Association
“Closure of a mucosal defect with clips after resection has long been considered to reduce the risk of bleeding,” but evidence to support this practice is limited, wrote Eduardo Albéniz, MD, of the Public University of Navarra (Spain), and colleagues.
In a study published in Gastroenterology, the researchers identified 235 consecutive patients who had resections of large nonpedunculated colorectal lesions from May 2016 to June 2018. Patients had an average or high risk of delayed bleeding and were randomized to receive scar closure with either 11-mm through-the-scope clips (119 patients) or no clip (116 patients).
Delayed bleeding occurred in 14 control patients (12.1%), compared with 6 clip patients (5%), for a risk reduction of 7%. The clip group included 68 cases (57%) of complete closure and 33 cases (28%) with partial closure, as well as 18 cases of failure to close (15%); only 1 case of delayed bleeding occurred in the clip group after completion of clip closure. On average, six clips were needed for complete closure.
None of the patients who experienced delayed bleeding required surgical or angiographic intervention, although 15 of the 20 patients with bleeding underwent additional endoscopy. Other adverse events included immediate bleeding in 21 clip patients and 18 controls that was managed with snare soft-tip coagulation. No deaths were reported in connection with the study.
Demographics were similar between the two groups, but the subset of patients with complete closure included more individuals aged 75 years and older and more cases with smaller polyps, compared with other subgroups, the researchers noted.
The study findings were limited by several factors, including the difficulty in predicting delayed bleeding, the potential for selection bias given the timing of patient randomization, the lack of information about polyps that were excluded from treatment, and the difficulty in completely closing the mucosal defects, the researchers noted. However, the results suggest that complete clip closure, despite its challenges, “displays a clear trend to reduce delayed bleeding risk,” and is worth an attempt.
The study was supported by the Spanish Society of Digestive Endoscopy. The researchers had no financial conflicts to disclose. MicroTech (Nanjing, China) contributed the clips used in the study.
SOURCE: Albéniz E et al. Gastroenterology. 2019 Jul 27. doi: 10.1053/j.gastro.2019.07.037.
Use of clip closure significantly reduced delayed bleeding in patients who underwent resections for large colorectal lesions, based on data from 235 individuals.
Source: American Gastroenterological Association
“Closure of a mucosal defect with clips after resection has long been considered to reduce the risk of bleeding,” but evidence to support this practice is limited, wrote Eduardo Albéniz, MD, of the Public University of Navarra (Spain), and colleagues.
In a study published in Gastroenterology, the researchers identified 235 consecutive patients who had resections of large nonpedunculated colorectal lesions from May 2016 to June 2018. Patients had an average or high risk of delayed bleeding and were randomized to receive scar closure with either 11-mm through-the-scope clips (119 patients) or no clip (116 patients).
Delayed bleeding occurred in 14 control patients (12.1%), compared with 6 clip patients (5%), for a risk reduction of 7%. The clip group included 68 cases (57%) of complete closure and 33 cases (28%) with partial closure, as well as 18 cases of failure to close (15%); only 1 case of delayed bleeding occurred in the clip group after completion of clip closure. On average, six clips were needed for complete closure.
None of the patients who experienced delayed bleeding required surgical or angiographic intervention, although 15 of the 20 patients with bleeding underwent additional endoscopy. Other adverse events included immediate bleeding in 21 clip patients and 18 controls that was managed with snare soft-tip coagulation. No deaths were reported in connection with the study.
Demographics were similar between the two groups, but the subset of patients with complete closure included more individuals aged 75 years and older and more cases with smaller polyps, compared with other subgroups, the researchers noted.
The study findings were limited by several factors, including the difficulty in predicting delayed bleeding, the potential for selection bias given the timing of patient randomization, the lack of information about polyps that were excluded from treatment, and the difficulty in completely closing the mucosal defects, the researchers noted. However, the results suggest that complete clip closure, despite its challenges, “displays a clear trend to reduce delayed bleeding risk,” and is worth an attempt.
The study was supported by the Spanish Society of Digestive Endoscopy. The researchers had no financial conflicts to disclose. MicroTech (Nanjing, China) contributed the clips used in the study.
SOURCE: Albéniz E et al. Gastroenterology. 2019 Jul 27. doi: 10.1053/j.gastro.2019.07.037.
FROM GASTROENTEROLOGY
Three distinct scenarios for treating facial redness with lasers and light
SAN DIEGO – In the clinical experience of J. Stuart Nelson, MD, PhD,
“There’s the patient with telangiectasia without diffuse redness, the patient who has telangiectasia with diffuse redness, and the patient who has diffuse redness,” Dr. Nelson said at the annual Masters of Aesthetics Symposium. “Because the vessel sizes are different, your approach to the clinical management of each one of these patients is going to be very different.”
For patients with telangiectasia without the redness, using pulsed dye lasers with a wavelength of 585-600 nm can be effective. “If someone has a single isolated telangiectasia, it’s the simplest thing you’ll do that day in your office,” said Dr. Nelson, professor of surgery and biomedical engineering at the Beckman Laser Institute and Medical Clinic at the University of California, Irvine. “It’s like Tiger Woods putting for a 2-foot birdie. Similarly, with the millisecond green devices, you can focus the laser beam onto the spot and you will see the blood vessels go away in real time.”
Treating patients who have telangiectasia and diffuse redness requires two steps. First, treat the larger telangiectasia with pulse durations of 20 ms, he said, and then treat the global background redness with shorter pulse durations (of 3 ms and 6 ms). “You can do this with pulse dye lasers and with green millisecond devices,” he noted.
For patients who present with diffuse global redness, “you don’t have to worry about the larger blood vessels, so you’re not going to be using the long pulse durations of the laser exposure,” said Dr. Nelson, past president of the American Society for Laser Medicine and Surgery. “You’re going to be using much shorter pulse durations, because you’re targeting blood vessels that are much smaller. You’re trying to tease out that background redness.”
If you’re concerned about how a particular patient will fare, consider performing a test spot. “This allows you to check for any unusual tissue reaction and to gauge the potential success of the laser treatment you’re doing,” he said. “It allows the patient to sort of experience the swelling and healing process they’re going to be going through.”
Dr. Nelson advised against applying a “cookbook” approach to using lasers and light sources in dermatology. “Don’t memorize treatment parameters,” he said. “What you really need to do is look for the clinical endpoints. What is the tissue response you want to see? You also want to exercise caution in patients who are tanned. The epidermal melanin absorption by tanned patients can be significant, even with some of the cooling technologies we have.”
Dr. Nelson reported having intellectual property rights with Syneron/Candela.
SAN DIEGO – In the clinical experience of J. Stuart Nelson, MD, PhD,
“There’s the patient with telangiectasia without diffuse redness, the patient who has telangiectasia with diffuse redness, and the patient who has diffuse redness,” Dr. Nelson said at the annual Masters of Aesthetics Symposium. “Because the vessel sizes are different, your approach to the clinical management of each one of these patients is going to be very different.”
For patients with telangiectasia without the redness, using pulsed dye lasers with a wavelength of 585-600 nm can be effective. “If someone has a single isolated telangiectasia, it’s the simplest thing you’ll do that day in your office,” said Dr. Nelson, professor of surgery and biomedical engineering at the Beckman Laser Institute and Medical Clinic at the University of California, Irvine. “It’s like Tiger Woods putting for a 2-foot birdie. Similarly, with the millisecond green devices, you can focus the laser beam onto the spot and you will see the blood vessels go away in real time.”
Treating patients who have telangiectasia and diffuse redness requires two steps. First, treat the larger telangiectasia with pulse durations of 20 ms, he said, and then treat the global background redness with shorter pulse durations (of 3 ms and 6 ms). “You can do this with pulse dye lasers and with green millisecond devices,” he noted.
For patients who present with diffuse global redness, “you don’t have to worry about the larger blood vessels, so you’re not going to be using the long pulse durations of the laser exposure,” said Dr. Nelson, past president of the American Society for Laser Medicine and Surgery. “You’re going to be using much shorter pulse durations, because you’re targeting blood vessels that are much smaller. You’re trying to tease out that background redness.”
If you’re concerned about how a particular patient will fare, consider performing a test spot. “This allows you to check for any unusual tissue reaction and to gauge the potential success of the laser treatment you’re doing,” he said. “It allows the patient to sort of experience the swelling and healing process they’re going to be going through.”
Dr. Nelson advised against applying a “cookbook” approach to using lasers and light sources in dermatology. “Don’t memorize treatment parameters,” he said. “What you really need to do is look for the clinical endpoints. What is the tissue response you want to see? You also want to exercise caution in patients who are tanned. The epidermal melanin absorption by tanned patients can be significant, even with some of the cooling technologies we have.”
Dr. Nelson reported having intellectual property rights with Syneron/Candela.
SAN DIEGO – In the clinical experience of J. Stuart Nelson, MD, PhD,
“There’s the patient with telangiectasia without diffuse redness, the patient who has telangiectasia with diffuse redness, and the patient who has diffuse redness,” Dr. Nelson said at the annual Masters of Aesthetics Symposium. “Because the vessel sizes are different, your approach to the clinical management of each one of these patients is going to be very different.”
For patients with telangiectasia without the redness, using pulsed dye lasers with a wavelength of 585-600 nm can be effective. “If someone has a single isolated telangiectasia, it’s the simplest thing you’ll do that day in your office,” said Dr. Nelson, professor of surgery and biomedical engineering at the Beckman Laser Institute and Medical Clinic at the University of California, Irvine. “It’s like Tiger Woods putting for a 2-foot birdie. Similarly, with the millisecond green devices, you can focus the laser beam onto the spot and you will see the blood vessels go away in real time.”
Treating patients who have telangiectasia and diffuse redness requires two steps. First, treat the larger telangiectasia with pulse durations of 20 ms, he said, and then treat the global background redness with shorter pulse durations (of 3 ms and 6 ms). “You can do this with pulse dye lasers and with green millisecond devices,” he noted.
For patients who present with diffuse global redness, “you don’t have to worry about the larger blood vessels, so you’re not going to be using the long pulse durations of the laser exposure,” said Dr. Nelson, past president of the American Society for Laser Medicine and Surgery. “You’re going to be using much shorter pulse durations, because you’re targeting blood vessels that are much smaller. You’re trying to tease out that background redness.”
If you’re concerned about how a particular patient will fare, consider performing a test spot. “This allows you to check for any unusual tissue reaction and to gauge the potential success of the laser treatment you’re doing,” he said. “It allows the patient to sort of experience the swelling and healing process they’re going to be going through.”
Dr. Nelson advised against applying a “cookbook” approach to using lasers and light sources in dermatology. “Don’t memorize treatment parameters,” he said. “What you really need to do is look for the clinical endpoints. What is the tissue response you want to see? You also want to exercise caution in patients who are tanned. The epidermal melanin absorption by tanned patients can be significant, even with some of the cooling technologies we have.”
Dr. Nelson reported having intellectual property rights with Syneron/Candela.
EXPERT ANALYSIS FROM MOA 2019
Medical boards change or consider amending mental health-related licensing questions
Delicia M. Haynes, MD, wants the Florida Board of Medicine to take another look at how its licensing applications query physicians about their mental health history. Her state’s board is one of several nationwide that has, in recent years, mulled whether the phrasing of its questions poses an unintended hurdle for physicians who need help for conditions such as depression.
The Federation of State Medical Boards (FSMB) recommends limiting such queries, if they must be asked, to questions about potential current impairment. But the Florida license application takes a more sweeping approach that may discourage physicians from seeking treatment, Dr. Haynes, founder and CEO of Family First Health Center in Daytona Beach, Fla., said in a video. She describes herself as a direct primary care physician.
In the video, which was posted on YouTube in January, 2019, Dr. Haynes discussed her own experience with having been treated for depression and then needing to report that to the state board. Florida’s license application asks if physicians have been treated within the past 5 years for a mental disorder that has impaired the ability to practice medicine. Those who have had such a condition may need to give the board an explanation providing the names of the physicians, therapists, and counselors they have seen, as well as details and dates for the institutions where they received treatment.
State medical boards play a critical role in protecting people from physicians whose current mental health conditions may risk harming patients, Dr. Haynes said. But they must balance that against the consequences of overly intrusive questioning. Florida’s current application wording may deter physicians from seeking care if they develop conditions such as depression, she said.
“It’s the fear of what’s going to happen if I have to check yes,” Dr. Haynes said in her YouTube video. Physicians will wonder how getting treatment could put their license and their employment at risk, she added.
“It’s really important that [state medical boards] are asking the questions that matter and those questions are questions that talk about impairment, and not just having a history,” Dr. Haynes said.
Members of Florida’s board of medicine last year favorably discussed making such a change during a rules/legislative committee meeting, but have not yet implemented it. The board has postponed further discussion of this topic until its December meeting, said Brad Dalton, a spokesman for the Florida Department of Health.
Dr. Haynes said in an email that she will continue to press for changes in her state’s licensing application.
There’s been a wave of reconsideration of these kinds of questions, spurred by FSMB efforts, which included the board’s offering specific advice to state medical boards about questions on licensing applications as part of a set of recommendations on addressing physician wellness and burnout last year in a report.
Boards have the option of omitting or dropping specific inquiries about mental health. But if they choose to retain this question, FSMB recommends using this phrasing: “Are you currently suffering from any condition for which you are not being appropriately treated that impairs your judgment or that would otherwise adversely affect your ability to practice medicine in a competent, ethical and professional manner? (Yes/No)” the report says.
The staff of the Medical Board of California cited FSMB’s recommendation in a January 2019 report about revising the state’s approach to asking physicians about their mental health. In May 2019, the board voted unanimously to revise its questions on physicians’ mental health, narrowing its inquiry on the licensing application to focus on current impairment.
“There are many doctors who do not seek treatment or find it threatening to seek treatment, because they are concerned that they may lose their license,” Peter Yellowlees, MBBS, MD, chief wellness officer and a professor of psychiatry at University of California, Davis, said in a public comment offered at the meeting. “This is ultimately all about patient safety.”
said Joe Knickrehm, a spokesman for the FSMB. Over the past few years, Kentucky, New Hampshire, New Mexico, North Carolina, North Dakota, Ohio, Vermont and Washington have made changes to their licensing questions, he added.
Still, state boards are not moving quickly enough to remove or revise these questions about mental health, said Katherine J. Gold, MD MSW, associate professor in the department of family medicine at University of Michigan, Ann Arbor. She has studied how these queries can deter physicians from seeking treatment for mental illness. A past treatment for postpartum depression may have no bearing on a physician’s practice, yet members of many state medical boards hesitate to alter their approach, she noted.
Groups including the American Medical Association (AMA) and the American Psychiatric Association also have pushed in recent years for changes in state rules about what a physician has to disclose about mental health, with the FSMB taking a lead in these efforts. In many cases, physicians face questions about their mental health that are beyond the limits of standards set by the Americans With Disabilities Act, according to an article published this year in the FSMB’s Journal of Medical Regulation. As of 2017, a review of questions on initial licensure applications for all 50 states and the District of Columbia showed that 32 licensing boards ask questions beyond the limits of ADA standards, the article said.
Consequences of “reporting stable and easily treatable conditions such as anxiety or depression to a state licensing board can range from a physician simply being required to submit a letter from their primary care provider documenting fitness to practice, to a request to appear before the board, to being required to undergo and pay for an examination by a board-appointed physician,” wrote Catherine M. Welcher, an AMA senior policy analyst, and coauthors of the paper, including Humayun J. Chaudhry, DO, FSMB’s CEO.
Nearly 40% of physicians surveyed about medical licensing questions (2,325 of 5,829) indicated they would be reluctant to seek formal medical care for a mental health condition because of potential repercussions, Liselotte N. Dyrbye, MD, and coauthors reported in 2017 in the Mayo Clinic Proceedings.
“You’re sort of stuck. You recognize you have a problem and you want to seek care so that you can get better, but if you do that, you might have to tell the board,” Dr. Dyrbye said in an interview. “You could be mandated potentially to have an outside psychiatric evaluation, to have your personal medical records reviewed by people other than your personal physician.”
Rising levels of burnout among physicians make it critical to remove obstacles to care, said Arthur S. Hengerer, MD, a former chair of the FSMB who has been a leader in efforts to revise medical licensing questions.
“The only thing that really brings joy to medicine are the relationships you develop with patients, the trust that comes from that, and when you can’t develop relationships because you can’t spend the time, because you are clicking and documenting, it hurts,” said Andrew Lamb, MD, who aided in successful efforts to change North Carolina’s licensing questions.
North Carolina approached this issue in steps. In 2017, it removed a question about mental health from its annual physician license renewal form. In 2018, the North Carolina Medical Board voted to drop questions about mental and physical health from physician license applications.
“It’s hoped that removing this question will encourage clinicians to get the help they need, without fear it will compromise their chances to obtain a professional license,” the board said in an annual report.
Other states are retaining these questions, but allowing physicians to check “no” if they are in an approved program for mental health treatment. The North Dakota Board of Medicine took this approach.
“Because our mission is protection of the public, we didn’t feel that we could eliminate that question,” Bonnie Storbakken, JD, executive secretary of the North Dakota Board of Medicine, said in an interview.
The North Dakota board voted in March 2018 to change its question on mental health after the FSMB spurred a national dialogue on this issue, she said. The North Dakota board opted to allow physicians to check ‘no’ on the question about current mental health and or substance issues if they had voluntarily sought assistance from the North Dakota Professional Health Program or a professional health program in another state. The approach preserves anonymity. The question as previously phrased made some physicians feel they had to report their treatment, she said.
In Alabama, physicians also have the option to check “no” on questions about whether they are undergoing mental health treatment if they are participating in a professional assistance program. Mark Jackson, executive director of the Medical Association of Alabama, said he hopes more states give physicians this option for seeking help not only with mental health issues, but with addiction as well.
“You need to get people in and get them help and not jeopardize their career in the process. Society in general has got that problem going on and physicians are not immune from that,” Mr. Jackson said. “Hopefully other states will see that we need to do something to make sure that the physician population is taken care of.”
Pamela Wible, MD, an advocate for physicians’ mental health, did her own review of state board’s licensing questions. In an assessment posted on her website, Dr. Wible, who practices family medicine, gives 13 states an “A” grade for having no mental health questions or one or two straightforward current questions about impairment that do not mention mental health. “Connecticut, Hawaii, Michigan, and New York are the most physician-friendly of all states with no mental health or impairment questions,” Dr. Wible wrote.
The Texas Medical Board earned a “C” grade in Dr. Wible’s survey. In May 2019, that board’s chairman, Sherif Zaafran, MD, wrote about how his organization had taken a new look at the licensing questions, which were last revised in 2014. While the board has not decided on any immediate changes, it is “maintaining an open dialogue to address future concerns,” Dr. Zaafran wrote in the board’s bulletin.
The Texas Medical Board’s physician licensing form, as posted on its website, includes a broadly phrased question on mental health: “Within the past five (5) years, have you been diagnosed with or treated for any: psychotic disorder, delusional disorder, mood disorder, major depression, personality disorder, or any other mental condition which impaired or does impair your behavior, judgment, or ability to function in school or work?”
Physicians who have had treatment for mental health conditions then must submit another form. They may have to provide details on diagnosis, prognosis, and medications prescribed. Compliance requirements include counseling records, contracts with impairment support groups, and records on file with law enforcement agencies and licensing agencies.
State officials are trying to figure out how best to learn of potential impairments that could pose a risk for patients, without scaring physicians away from getting the care they themselves need said Stephen ‘Brint’ Carlton, JD, executive director of the Texas Medical Board.
Delicia M. Haynes, MD, wants the Florida Board of Medicine to take another look at how its licensing applications query physicians about their mental health history. Her state’s board is one of several nationwide that has, in recent years, mulled whether the phrasing of its questions poses an unintended hurdle for physicians who need help for conditions such as depression.
The Federation of State Medical Boards (FSMB) recommends limiting such queries, if they must be asked, to questions about potential current impairment. But the Florida license application takes a more sweeping approach that may discourage physicians from seeking treatment, Dr. Haynes, founder and CEO of Family First Health Center in Daytona Beach, Fla., said in a video. She describes herself as a direct primary care physician.
In the video, which was posted on YouTube in January, 2019, Dr. Haynes discussed her own experience with having been treated for depression and then needing to report that to the state board. Florida’s license application asks if physicians have been treated within the past 5 years for a mental disorder that has impaired the ability to practice medicine. Those who have had such a condition may need to give the board an explanation providing the names of the physicians, therapists, and counselors they have seen, as well as details and dates for the institutions where they received treatment.
State medical boards play a critical role in protecting people from physicians whose current mental health conditions may risk harming patients, Dr. Haynes said. But they must balance that against the consequences of overly intrusive questioning. Florida’s current application wording may deter physicians from seeking care if they develop conditions such as depression, she said.
“It’s the fear of what’s going to happen if I have to check yes,” Dr. Haynes said in her YouTube video. Physicians will wonder how getting treatment could put their license and their employment at risk, she added.
“It’s really important that [state medical boards] are asking the questions that matter and those questions are questions that talk about impairment, and not just having a history,” Dr. Haynes said.
Members of Florida’s board of medicine last year favorably discussed making such a change during a rules/legislative committee meeting, but have not yet implemented it. The board has postponed further discussion of this topic until its December meeting, said Brad Dalton, a spokesman for the Florida Department of Health.
Dr. Haynes said in an email that she will continue to press for changes in her state’s licensing application.
There’s been a wave of reconsideration of these kinds of questions, spurred by FSMB efforts, which included the board’s offering specific advice to state medical boards about questions on licensing applications as part of a set of recommendations on addressing physician wellness and burnout last year in a report.
Boards have the option of omitting or dropping specific inquiries about mental health. But if they choose to retain this question, FSMB recommends using this phrasing: “Are you currently suffering from any condition for which you are not being appropriately treated that impairs your judgment or that would otherwise adversely affect your ability to practice medicine in a competent, ethical and professional manner? (Yes/No)” the report says.
The staff of the Medical Board of California cited FSMB’s recommendation in a January 2019 report about revising the state’s approach to asking physicians about their mental health. In May 2019, the board voted unanimously to revise its questions on physicians’ mental health, narrowing its inquiry on the licensing application to focus on current impairment.
“There are many doctors who do not seek treatment or find it threatening to seek treatment, because they are concerned that they may lose their license,” Peter Yellowlees, MBBS, MD, chief wellness officer and a professor of psychiatry at University of California, Davis, said in a public comment offered at the meeting. “This is ultimately all about patient safety.”
said Joe Knickrehm, a spokesman for the FSMB. Over the past few years, Kentucky, New Hampshire, New Mexico, North Carolina, North Dakota, Ohio, Vermont and Washington have made changes to their licensing questions, he added.
Still, state boards are not moving quickly enough to remove or revise these questions about mental health, said Katherine J. Gold, MD MSW, associate professor in the department of family medicine at University of Michigan, Ann Arbor. She has studied how these queries can deter physicians from seeking treatment for mental illness. A past treatment for postpartum depression may have no bearing on a physician’s practice, yet members of many state medical boards hesitate to alter their approach, she noted.
Groups including the American Medical Association (AMA) and the American Psychiatric Association also have pushed in recent years for changes in state rules about what a physician has to disclose about mental health, with the FSMB taking a lead in these efforts. In many cases, physicians face questions about their mental health that are beyond the limits of standards set by the Americans With Disabilities Act, according to an article published this year in the FSMB’s Journal of Medical Regulation. As of 2017, a review of questions on initial licensure applications for all 50 states and the District of Columbia showed that 32 licensing boards ask questions beyond the limits of ADA standards, the article said.
Consequences of “reporting stable and easily treatable conditions such as anxiety or depression to a state licensing board can range from a physician simply being required to submit a letter from their primary care provider documenting fitness to practice, to a request to appear before the board, to being required to undergo and pay for an examination by a board-appointed physician,” wrote Catherine M. Welcher, an AMA senior policy analyst, and coauthors of the paper, including Humayun J. Chaudhry, DO, FSMB’s CEO.
Nearly 40% of physicians surveyed about medical licensing questions (2,325 of 5,829) indicated they would be reluctant to seek formal medical care for a mental health condition because of potential repercussions, Liselotte N. Dyrbye, MD, and coauthors reported in 2017 in the Mayo Clinic Proceedings.
“You’re sort of stuck. You recognize you have a problem and you want to seek care so that you can get better, but if you do that, you might have to tell the board,” Dr. Dyrbye said in an interview. “You could be mandated potentially to have an outside psychiatric evaluation, to have your personal medical records reviewed by people other than your personal physician.”
Rising levels of burnout among physicians make it critical to remove obstacles to care, said Arthur S. Hengerer, MD, a former chair of the FSMB who has been a leader in efforts to revise medical licensing questions.
“The only thing that really brings joy to medicine are the relationships you develop with patients, the trust that comes from that, and when you can’t develop relationships because you can’t spend the time, because you are clicking and documenting, it hurts,” said Andrew Lamb, MD, who aided in successful efforts to change North Carolina’s licensing questions.
North Carolina approached this issue in steps. In 2017, it removed a question about mental health from its annual physician license renewal form. In 2018, the North Carolina Medical Board voted to drop questions about mental and physical health from physician license applications.
“It’s hoped that removing this question will encourage clinicians to get the help they need, without fear it will compromise their chances to obtain a professional license,” the board said in an annual report.
Other states are retaining these questions, but allowing physicians to check “no” if they are in an approved program for mental health treatment. The North Dakota Board of Medicine took this approach.
“Because our mission is protection of the public, we didn’t feel that we could eliminate that question,” Bonnie Storbakken, JD, executive secretary of the North Dakota Board of Medicine, said in an interview.
The North Dakota board voted in March 2018 to change its question on mental health after the FSMB spurred a national dialogue on this issue, she said. The North Dakota board opted to allow physicians to check ‘no’ on the question about current mental health and or substance issues if they had voluntarily sought assistance from the North Dakota Professional Health Program or a professional health program in another state. The approach preserves anonymity. The question as previously phrased made some physicians feel they had to report their treatment, she said.
In Alabama, physicians also have the option to check “no” on questions about whether they are undergoing mental health treatment if they are participating in a professional assistance program. Mark Jackson, executive director of the Medical Association of Alabama, said he hopes more states give physicians this option for seeking help not only with mental health issues, but with addiction as well.
“You need to get people in and get them help and not jeopardize their career in the process. Society in general has got that problem going on and physicians are not immune from that,” Mr. Jackson said. “Hopefully other states will see that we need to do something to make sure that the physician population is taken care of.”
Pamela Wible, MD, an advocate for physicians’ mental health, did her own review of state board’s licensing questions. In an assessment posted on her website, Dr. Wible, who practices family medicine, gives 13 states an “A” grade for having no mental health questions or one or two straightforward current questions about impairment that do not mention mental health. “Connecticut, Hawaii, Michigan, and New York are the most physician-friendly of all states with no mental health or impairment questions,” Dr. Wible wrote.
The Texas Medical Board earned a “C” grade in Dr. Wible’s survey. In May 2019, that board’s chairman, Sherif Zaafran, MD, wrote about how his organization had taken a new look at the licensing questions, which were last revised in 2014. While the board has not decided on any immediate changes, it is “maintaining an open dialogue to address future concerns,” Dr. Zaafran wrote in the board’s bulletin.
The Texas Medical Board’s physician licensing form, as posted on its website, includes a broadly phrased question on mental health: “Within the past five (5) years, have you been diagnosed with or treated for any: psychotic disorder, delusional disorder, mood disorder, major depression, personality disorder, or any other mental condition which impaired or does impair your behavior, judgment, or ability to function in school or work?”
Physicians who have had treatment for mental health conditions then must submit another form. They may have to provide details on diagnosis, prognosis, and medications prescribed. Compliance requirements include counseling records, contracts with impairment support groups, and records on file with law enforcement agencies and licensing agencies.
State officials are trying to figure out how best to learn of potential impairments that could pose a risk for patients, without scaring physicians away from getting the care they themselves need said Stephen ‘Brint’ Carlton, JD, executive director of the Texas Medical Board.
Delicia M. Haynes, MD, wants the Florida Board of Medicine to take another look at how its licensing applications query physicians about their mental health history. Her state’s board is one of several nationwide that has, in recent years, mulled whether the phrasing of its questions poses an unintended hurdle for physicians who need help for conditions such as depression.
The Federation of State Medical Boards (FSMB) recommends limiting such queries, if they must be asked, to questions about potential current impairment. But the Florida license application takes a more sweeping approach that may discourage physicians from seeking treatment, Dr. Haynes, founder and CEO of Family First Health Center in Daytona Beach, Fla., said in a video. She describes herself as a direct primary care physician.
In the video, which was posted on YouTube in January, 2019, Dr. Haynes discussed her own experience with having been treated for depression and then needing to report that to the state board. Florida’s license application asks if physicians have been treated within the past 5 years for a mental disorder that has impaired the ability to practice medicine. Those who have had such a condition may need to give the board an explanation providing the names of the physicians, therapists, and counselors they have seen, as well as details and dates for the institutions where they received treatment.
State medical boards play a critical role in protecting people from physicians whose current mental health conditions may risk harming patients, Dr. Haynes said. But they must balance that against the consequences of overly intrusive questioning. Florida’s current application wording may deter physicians from seeking care if they develop conditions such as depression, she said.
“It’s the fear of what’s going to happen if I have to check yes,” Dr. Haynes said in her YouTube video. Physicians will wonder how getting treatment could put their license and their employment at risk, she added.
“It’s really important that [state medical boards] are asking the questions that matter and those questions are questions that talk about impairment, and not just having a history,” Dr. Haynes said.
Members of Florida’s board of medicine last year favorably discussed making such a change during a rules/legislative committee meeting, but have not yet implemented it. The board has postponed further discussion of this topic until its December meeting, said Brad Dalton, a spokesman for the Florida Department of Health.
Dr. Haynes said in an email that she will continue to press for changes in her state’s licensing application.
There’s been a wave of reconsideration of these kinds of questions, spurred by FSMB efforts, which included the board’s offering specific advice to state medical boards about questions on licensing applications as part of a set of recommendations on addressing physician wellness and burnout last year in a report.
Boards have the option of omitting or dropping specific inquiries about mental health. But if they choose to retain this question, FSMB recommends using this phrasing: “Are you currently suffering from any condition for which you are not being appropriately treated that impairs your judgment or that would otherwise adversely affect your ability to practice medicine in a competent, ethical and professional manner? (Yes/No)” the report says.
The staff of the Medical Board of California cited FSMB’s recommendation in a January 2019 report about revising the state’s approach to asking physicians about their mental health. In May 2019, the board voted unanimously to revise its questions on physicians’ mental health, narrowing its inquiry on the licensing application to focus on current impairment.
“There are many doctors who do not seek treatment or find it threatening to seek treatment, because they are concerned that they may lose their license,” Peter Yellowlees, MBBS, MD, chief wellness officer and a professor of psychiatry at University of California, Davis, said in a public comment offered at the meeting. “This is ultimately all about patient safety.”
said Joe Knickrehm, a spokesman for the FSMB. Over the past few years, Kentucky, New Hampshire, New Mexico, North Carolina, North Dakota, Ohio, Vermont and Washington have made changes to their licensing questions, he added.
Still, state boards are not moving quickly enough to remove or revise these questions about mental health, said Katherine J. Gold, MD MSW, associate professor in the department of family medicine at University of Michigan, Ann Arbor. She has studied how these queries can deter physicians from seeking treatment for mental illness. A past treatment for postpartum depression may have no bearing on a physician’s practice, yet members of many state medical boards hesitate to alter their approach, she noted.
Groups including the American Medical Association (AMA) and the American Psychiatric Association also have pushed in recent years for changes in state rules about what a physician has to disclose about mental health, with the FSMB taking a lead in these efforts. In many cases, physicians face questions about their mental health that are beyond the limits of standards set by the Americans With Disabilities Act, according to an article published this year in the FSMB’s Journal of Medical Regulation. As of 2017, a review of questions on initial licensure applications for all 50 states and the District of Columbia showed that 32 licensing boards ask questions beyond the limits of ADA standards, the article said.
Consequences of “reporting stable and easily treatable conditions such as anxiety or depression to a state licensing board can range from a physician simply being required to submit a letter from their primary care provider documenting fitness to practice, to a request to appear before the board, to being required to undergo and pay for an examination by a board-appointed physician,” wrote Catherine M. Welcher, an AMA senior policy analyst, and coauthors of the paper, including Humayun J. Chaudhry, DO, FSMB’s CEO.
Nearly 40% of physicians surveyed about medical licensing questions (2,325 of 5,829) indicated they would be reluctant to seek formal medical care for a mental health condition because of potential repercussions, Liselotte N. Dyrbye, MD, and coauthors reported in 2017 in the Mayo Clinic Proceedings.
“You’re sort of stuck. You recognize you have a problem and you want to seek care so that you can get better, but if you do that, you might have to tell the board,” Dr. Dyrbye said in an interview. “You could be mandated potentially to have an outside psychiatric evaluation, to have your personal medical records reviewed by people other than your personal physician.”
Rising levels of burnout among physicians make it critical to remove obstacles to care, said Arthur S. Hengerer, MD, a former chair of the FSMB who has been a leader in efforts to revise medical licensing questions.
“The only thing that really brings joy to medicine are the relationships you develop with patients, the trust that comes from that, and when you can’t develop relationships because you can’t spend the time, because you are clicking and documenting, it hurts,” said Andrew Lamb, MD, who aided in successful efforts to change North Carolina’s licensing questions.
North Carolina approached this issue in steps. In 2017, it removed a question about mental health from its annual physician license renewal form. In 2018, the North Carolina Medical Board voted to drop questions about mental and physical health from physician license applications.
“It’s hoped that removing this question will encourage clinicians to get the help they need, without fear it will compromise their chances to obtain a professional license,” the board said in an annual report.
Other states are retaining these questions, but allowing physicians to check “no” if they are in an approved program for mental health treatment. The North Dakota Board of Medicine took this approach.
“Because our mission is protection of the public, we didn’t feel that we could eliminate that question,” Bonnie Storbakken, JD, executive secretary of the North Dakota Board of Medicine, said in an interview.
The North Dakota board voted in March 2018 to change its question on mental health after the FSMB spurred a national dialogue on this issue, she said. The North Dakota board opted to allow physicians to check ‘no’ on the question about current mental health and or substance issues if they had voluntarily sought assistance from the North Dakota Professional Health Program or a professional health program in another state. The approach preserves anonymity. The question as previously phrased made some physicians feel they had to report their treatment, she said.
In Alabama, physicians also have the option to check “no” on questions about whether they are undergoing mental health treatment if they are participating in a professional assistance program. Mark Jackson, executive director of the Medical Association of Alabama, said he hopes more states give physicians this option for seeking help not only with mental health issues, but with addiction as well.
“You need to get people in and get them help and not jeopardize their career in the process. Society in general has got that problem going on and physicians are not immune from that,” Mr. Jackson said. “Hopefully other states will see that we need to do something to make sure that the physician population is taken care of.”
Pamela Wible, MD, an advocate for physicians’ mental health, did her own review of state board’s licensing questions. In an assessment posted on her website, Dr. Wible, who practices family medicine, gives 13 states an “A” grade for having no mental health questions or one or two straightforward current questions about impairment that do not mention mental health. “Connecticut, Hawaii, Michigan, and New York are the most physician-friendly of all states with no mental health or impairment questions,” Dr. Wible wrote.
The Texas Medical Board earned a “C” grade in Dr. Wible’s survey. In May 2019, that board’s chairman, Sherif Zaafran, MD, wrote about how his organization had taken a new look at the licensing questions, which were last revised in 2014. While the board has not decided on any immediate changes, it is “maintaining an open dialogue to address future concerns,” Dr. Zaafran wrote in the board’s bulletin.
The Texas Medical Board’s physician licensing form, as posted on its website, includes a broadly phrased question on mental health: “Within the past five (5) years, have you been diagnosed with or treated for any: psychotic disorder, delusional disorder, mood disorder, major depression, personality disorder, or any other mental condition which impaired or does impair your behavior, judgment, or ability to function in school or work?”
Physicians who have had treatment for mental health conditions then must submit another form. They may have to provide details on diagnosis, prognosis, and medications prescribed. Compliance requirements include counseling records, contracts with impairment support groups, and records on file with law enforcement agencies and licensing agencies.
State officials are trying to figure out how best to learn of potential impairments that could pose a risk for patients, without scaring physicians away from getting the care they themselves need said Stephen ‘Brint’ Carlton, JD, executive director of the Texas Medical Board.
TKI preserved lung function in patients with fibrosing interstitial disease
MADRID – according to findings from a phase 3, placebo-controlled trial presented at the annual congress of the European Respiratory Society.
The trial, called INBUILD, enrolled patients who had a progressive lung disease with a fibrosing phenotype, such as interstitial pneumonia with autoimmune features (IPAF) or noninterstitial pneumonia (NSIP), on the premise that these conditions might share a pathology responsive to a common therapy, explained Kevin R. Flaherty, MD, of National Jewish Health, Denver. The INBUILD trial was a randomized, double-blind, placebo-controlled, parallel-group trial conducted at 153 sites in 15 countries. A total of 663 patients underwent randomization and received at least one dose of nintedanib (332) or placebo (331).
Patients with fibrosing lung disease affecting more than 10% of lung volume were randomized to 150 mg twice daily of nintedanib, which inhibits intracellular growth factors implicated in fibrosis and is already indicated for IPF, or matching placebo.
On the primary endpoint of change in forced vital capacity (FVC) at 52 weeks, those in the nintedanib arm lost lung function at a rate that was less than half that of those randomized to placebo (–80.8 vs. –187.8 mL/year; P less than .001).
In a preplanned stratification, the protection from nintedanib against a decline in lung function was found to be at least as good in those with a usual interstitial pneumonia (UIP-like) pattern of fibrosis on baseline imaging (–82.9 vs. –211.1 mL/year), compared with those with other fibrotic patterns (–79.0 vs. –154.2 mL/year). The UIP-like subgroup represented about 60% of those enrolled.
“The relative protection from decline in lung function supports the hypothesis that progressive fibrosing interstitial lung diseases have a similar pathobiologic mechanism,” said Dr. Flaherty. Results from the INBUILD were published simultaneously with his ERS presentation (N Engl J Med. 2019 Sep 29. doi: 10.1056/NEJMoa1908681).
The curves documenting change of lung function in favor of nintedanib relative to placebo separated within 12 weeks of treatment initiation, according to Dr. Flaherty. The ERS-invited discussant, Martin Kolb, MD, PhD, professor of respirology, McMaster University, Hamilton, Ont., called the reductions in loss of lung function “profound” and “very impactful.”
However, despite these reductions, there was no significant difference in quality of life as measured with the King’s Brief Interstitial Lung Disease (KBILD) questionnaire, which was a secondary outcome. The problem was that there was little change in KBILD in either group at 52 weeks, limiting the ability to show differences.
The rates of death were numerically lower at 52 weeks in the nintedanib arm for the study overall (4.8% vs. 5.1%) and for the UIP-like subgroup (5.3% vs. 7.8%), but the differences did not reach statistical significance.
A suggestion of benefit was derived from a design feature of INBUILD that called for patients to remain on blinded therapy until all enrolled patients completed the trial. When the effect of nintedanib was evaluated in this extended analysis, the event curves for the combined endpoint of interstitial lung disease or death separated and approached significance.
In this extended analysis, which suggests that clinical benefit is likely to accrue after longer periods of treatment, “we saw similar trends when we looked at mortality as an independent outcome,” Dr. Flaherty reported.
More patients in the nintedanib group discontinued therapy because of adverse events (19.6% vs. 10.3%), but Dr. Flaherty characterized the rate of serious adverse events as “similar.” He made this statement even though several adverse events, particularly those involving the gastrointestinal tract, such as diarrhea (66.9% vs. 23.9%), nausea (28.9% vs. 9.4%), vomiting (18.4% vs. 5.1%), and abdominal pain (10.2% vs. 2.4%), were higher in the nintedanib arm.
The INBUILD trial demonstrates that nintedanib preserves lung function in fibrosing lung diseases other than IPF. In his review of this paper, Dr. Kolb pointed out that non-IPF etiologies represent about 75% of interstitial lung diseases. For these patients “we have no drugs, so there is a big medical need.”
Dr. Flaherty reports no potential conflicts of interest. The study was funded by Boehringer-Ingelheim, which produces nintedanib.
SOURCE: Flaherty KR et al. N Engl J Med. 2019 Sep 29. doi: 10.1056/NEJMoa1908681.
MADRID – according to findings from a phase 3, placebo-controlled trial presented at the annual congress of the European Respiratory Society.
The trial, called INBUILD, enrolled patients who had a progressive lung disease with a fibrosing phenotype, such as interstitial pneumonia with autoimmune features (IPAF) or noninterstitial pneumonia (NSIP), on the premise that these conditions might share a pathology responsive to a common therapy, explained Kevin R. Flaherty, MD, of National Jewish Health, Denver. The INBUILD trial was a randomized, double-blind, placebo-controlled, parallel-group trial conducted at 153 sites in 15 countries. A total of 663 patients underwent randomization and received at least one dose of nintedanib (332) or placebo (331).
Patients with fibrosing lung disease affecting more than 10% of lung volume were randomized to 150 mg twice daily of nintedanib, which inhibits intracellular growth factors implicated in fibrosis and is already indicated for IPF, or matching placebo.
On the primary endpoint of change in forced vital capacity (FVC) at 52 weeks, those in the nintedanib arm lost lung function at a rate that was less than half that of those randomized to placebo (–80.8 vs. –187.8 mL/year; P less than .001).
In a preplanned stratification, the protection from nintedanib against a decline in lung function was found to be at least as good in those with a usual interstitial pneumonia (UIP-like) pattern of fibrosis on baseline imaging (–82.9 vs. –211.1 mL/year), compared with those with other fibrotic patterns (–79.0 vs. –154.2 mL/year). The UIP-like subgroup represented about 60% of those enrolled.
“The relative protection from decline in lung function supports the hypothesis that progressive fibrosing interstitial lung diseases have a similar pathobiologic mechanism,” said Dr. Flaherty. Results from the INBUILD were published simultaneously with his ERS presentation (N Engl J Med. 2019 Sep 29. doi: 10.1056/NEJMoa1908681).
The curves documenting change of lung function in favor of nintedanib relative to placebo separated within 12 weeks of treatment initiation, according to Dr. Flaherty. The ERS-invited discussant, Martin Kolb, MD, PhD, professor of respirology, McMaster University, Hamilton, Ont., called the reductions in loss of lung function “profound” and “very impactful.”
However, despite these reductions, there was no significant difference in quality of life as measured with the King’s Brief Interstitial Lung Disease (KBILD) questionnaire, which was a secondary outcome. The problem was that there was little change in KBILD in either group at 52 weeks, limiting the ability to show differences.
The rates of death were numerically lower at 52 weeks in the nintedanib arm for the study overall (4.8% vs. 5.1%) and for the UIP-like subgroup (5.3% vs. 7.8%), but the differences did not reach statistical significance.
A suggestion of benefit was derived from a design feature of INBUILD that called for patients to remain on blinded therapy until all enrolled patients completed the trial. When the effect of nintedanib was evaluated in this extended analysis, the event curves for the combined endpoint of interstitial lung disease or death separated and approached significance.
In this extended analysis, which suggests that clinical benefit is likely to accrue after longer periods of treatment, “we saw similar trends when we looked at mortality as an independent outcome,” Dr. Flaherty reported.
More patients in the nintedanib group discontinued therapy because of adverse events (19.6% vs. 10.3%), but Dr. Flaherty characterized the rate of serious adverse events as “similar.” He made this statement even though several adverse events, particularly those involving the gastrointestinal tract, such as diarrhea (66.9% vs. 23.9%), nausea (28.9% vs. 9.4%), vomiting (18.4% vs. 5.1%), and abdominal pain (10.2% vs. 2.4%), were higher in the nintedanib arm.
The INBUILD trial demonstrates that nintedanib preserves lung function in fibrosing lung diseases other than IPF. In his review of this paper, Dr. Kolb pointed out that non-IPF etiologies represent about 75% of interstitial lung diseases. For these patients “we have no drugs, so there is a big medical need.”
Dr. Flaherty reports no potential conflicts of interest. The study was funded by Boehringer-Ingelheim, which produces nintedanib.
SOURCE: Flaherty KR et al. N Engl J Med. 2019 Sep 29. doi: 10.1056/NEJMoa1908681.
MADRID – according to findings from a phase 3, placebo-controlled trial presented at the annual congress of the European Respiratory Society.
The trial, called INBUILD, enrolled patients who had a progressive lung disease with a fibrosing phenotype, such as interstitial pneumonia with autoimmune features (IPAF) or noninterstitial pneumonia (NSIP), on the premise that these conditions might share a pathology responsive to a common therapy, explained Kevin R. Flaherty, MD, of National Jewish Health, Denver. The INBUILD trial was a randomized, double-blind, placebo-controlled, parallel-group trial conducted at 153 sites in 15 countries. A total of 663 patients underwent randomization and received at least one dose of nintedanib (332) or placebo (331).
Patients with fibrosing lung disease affecting more than 10% of lung volume were randomized to 150 mg twice daily of nintedanib, which inhibits intracellular growth factors implicated in fibrosis and is already indicated for IPF, or matching placebo.
On the primary endpoint of change in forced vital capacity (FVC) at 52 weeks, those in the nintedanib arm lost lung function at a rate that was less than half that of those randomized to placebo (–80.8 vs. –187.8 mL/year; P less than .001).
In a preplanned stratification, the protection from nintedanib against a decline in lung function was found to be at least as good in those with a usual interstitial pneumonia (UIP-like) pattern of fibrosis on baseline imaging (–82.9 vs. –211.1 mL/year), compared with those with other fibrotic patterns (–79.0 vs. –154.2 mL/year). The UIP-like subgroup represented about 60% of those enrolled.
“The relative protection from decline in lung function supports the hypothesis that progressive fibrosing interstitial lung diseases have a similar pathobiologic mechanism,” said Dr. Flaherty. Results from the INBUILD were published simultaneously with his ERS presentation (N Engl J Med. 2019 Sep 29. doi: 10.1056/NEJMoa1908681).
The curves documenting change of lung function in favor of nintedanib relative to placebo separated within 12 weeks of treatment initiation, according to Dr. Flaherty. The ERS-invited discussant, Martin Kolb, MD, PhD, professor of respirology, McMaster University, Hamilton, Ont., called the reductions in loss of lung function “profound” and “very impactful.”
However, despite these reductions, there was no significant difference in quality of life as measured with the King’s Brief Interstitial Lung Disease (KBILD) questionnaire, which was a secondary outcome. The problem was that there was little change in KBILD in either group at 52 weeks, limiting the ability to show differences.
The rates of death were numerically lower at 52 weeks in the nintedanib arm for the study overall (4.8% vs. 5.1%) and for the UIP-like subgroup (5.3% vs. 7.8%), but the differences did not reach statistical significance.
A suggestion of benefit was derived from a design feature of INBUILD that called for patients to remain on blinded therapy until all enrolled patients completed the trial. When the effect of nintedanib was evaluated in this extended analysis, the event curves for the combined endpoint of interstitial lung disease or death separated and approached significance.
In this extended analysis, which suggests that clinical benefit is likely to accrue after longer periods of treatment, “we saw similar trends when we looked at mortality as an independent outcome,” Dr. Flaherty reported.
More patients in the nintedanib group discontinued therapy because of adverse events (19.6% vs. 10.3%), but Dr. Flaherty characterized the rate of serious adverse events as “similar.” He made this statement even though several adverse events, particularly those involving the gastrointestinal tract, such as diarrhea (66.9% vs. 23.9%), nausea (28.9% vs. 9.4%), vomiting (18.4% vs. 5.1%), and abdominal pain (10.2% vs. 2.4%), were higher in the nintedanib arm.
The INBUILD trial demonstrates that nintedanib preserves lung function in fibrosing lung diseases other than IPF. In his review of this paper, Dr. Kolb pointed out that non-IPF etiologies represent about 75% of interstitial lung diseases. For these patients “we have no drugs, so there is a big medical need.”
Dr. Flaherty reports no potential conflicts of interest. The study was funded by Boehringer-Ingelheim, which produces nintedanib.
SOURCE: Flaherty KR et al. N Engl J Med. 2019 Sep 29. doi: 10.1056/NEJMoa1908681.
REPORTING FROM ERS 2019
Direct-acting antiviral therapy boosts survival for infected HCC patients
Direct-acting antiviral (DAA) therapy significantly reduced the risk of death in patients with hepatitis C infections and a history of hepatocellular carcinoma, based on data from 797 individuals.
Previous studies have reported a benefit of direct-acting antiviral (DAA) therapy for reducing mortality in patients with hepatocellular carcinoma (HCC), but data on its impact in patients with complete responses to HCC therapy are limited, wrote Amit G. Singal, MD, of the University of Texas, Dallas, and colleagues.
In a study published in Gastroenterology, the researchers identified adult HCC patients who achieved complete treatment response between January 2013 and December 2017. The study included patients from 31 locations in the United States and Canada. Complete response to treatment was defined as “disappearance of arterial enhancement from all HCC lesions on contrast-enhanced cross-sectional imaging.”
A total of 383 (48.1%) of patients were randomized to DAA therapy, and 414 (51.9%) did not receive DAA treatment for their HCV infection after complete response to prior HCC therapy.
A total of 43 deaths occurred among DAA patients over 941 person-years of follow-up, compared with 103 deaths over 527 person-years of follow-up for the untreated controls. Overall, DAA therapy was associated with a significantly reduced risk of death (hazard ratio, 0.54), compared with no therapy. Of note, patients with a sustained virologic response showed a reduced risk of death (HR, 0.29), but those without a sustained virologic response to DAA therapy did not (HR, 1.13).
The findings support those from previous studies suggesting that DAA therapy may reduce mortality in patients with a history of HCC, the researchers said.
The study findings were limited by several factors, including potential confounding if DAA was given to patients with better prognoses, the researchers noted. Other limitations include the use of imaging in routine clinical care rather than centralized review, the loss of approximately 9% of the patients to follow-up, and the lack of data on hepatic decompensation during follow-up, the researchers said. However, the results were strengthened by the multicenter design, large cohort, and inclusion of untreated controls, and support the use of DAA therapies as “likely beneficial in HCV-infected patients with a history of HCC,” they concluded.
The study was funded in part by the National Cancer Institute and AbbVie. Dr. Singal disclosed relationships with companies including AbbVie, Gilead, Bayer, Eisai, Wako Diagnostics, Exact Sciences, Exelixis, Roche, Glycotest, and Bristol-Myers Squibb.
SOURCE: Singal AG et al. Gastroenterology. 2019. doi: 10.1053/j.gastro.2019.07.040.
Direct-acting antiviral (DAA) therapy significantly reduced the risk of death in patients with hepatitis C infections and a history of hepatocellular carcinoma, based on data from 797 individuals.
Previous studies have reported a benefit of direct-acting antiviral (DAA) therapy for reducing mortality in patients with hepatocellular carcinoma (HCC), but data on its impact in patients with complete responses to HCC therapy are limited, wrote Amit G. Singal, MD, of the University of Texas, Dallas, and colleagues.
In a study published in Gastroenterology, the researchers identified adult HCC patients who achieved complete treatment response between January 2013 and December 2017. The study included patients from 31 locations in the United States and Canada. Complete response to treatment was defined as “disappearance of arterial enhancement from all HCC lesions on contrast-enhanced cross-sectional imaging.”
A total of 383 (48.1%) of patients were randomized to DAA therapy, and 414 (51.9%) did not receive DAA treatment for their HCV infection after complete response to prior HCC therapy.
A total of 43 deaths occurred among DAA patients over 941 person-years of follow-up, compared with 103 deaths over 527 person-years of follow-up for the untreated controls. Overall, DAA therapy was associated with a significantly reduced risk of death (hazard ratio, 0.54), compared with no therapy. Of note, patients with a sustained virologic response showed a reduced risk of death (HR, 0.29), but those without a sustained virologic response to DAA therapy did not (HR, 1.13).
The findings support those from previous studies suggesting that DAA therapy may reduce mortality in patients with a history of HCC, the researchers said.
The study findings were limited by several factors, including potential confounding if DAA was given to patients with better prognoses, the researchers noted. Other limitations include the use of imaging in routine clinical care rather than centralized review, the loss of approximately 9% of the patients to follow-up, and the lack of data on hepatic decompensation during follow-up, the researchers said. However, the results were strengthened by the multicenter design, large cohort, and inclusion of untreated controls, and support the use of DAA therapies as “likely beneficial in HCV-infected patients with a history of HCC,” they concluded.
The study was funded in part by the National Cancer Institute and AbbVie. Dr. Singal disclosed relationships with companies including AbbVie, Gilead, Bayer, Eisai, Wako Diagnostics, Exact Sciences, Exelixis, Roche, Glycotest, and Bristol-Myers Squibb.
SOURCE: Singal AG et al. Gastroenterology. 2019. doi: 10.1053/j.gastro.2019.07.040.
Direct-acting antiviral (DAA) therapy significantly reduced the risk of death in patients with hepatitis C infections and a history of hepatocellular carcinoma, based on data from 797 individuals.
Previous studies have reported a benefit of direct-acting antiviral (DAA) therapy for reducing mortality in patients with hepatocellular carcinoma (HCC), but data on its impact in patients with complete responses to HCC therapy are limited, wrote Amit G. Singal, MD, of the University of Texas, Dallas, and colleagues.
In a study published in Gastroenterology, the researchers identified adult HCC patients who achieved complete treatment response between January 2013 and December 2017. The study included patients from 31 locations in the United States and Canada. Complete response to treatment was defined as “disappearance of arterial enhancement from all HCC lesions on contrast-enhanced cross-sectional imaging.”
A total of 383 (48.1%) of patients were randomized to DAA therapy, and 414 (51.9%) did not receive DAA treatment for their HCV infection after complete response to prior HCC therapy.
A total of 43 deaths occurred among DAA patients over 941 person-years of follow-up, compared with 103 deaths over 527 person-years of follow-up for the untreated controls. Overall, DAA therapy was associated with a significantly reduced risk of death (hazard ratio, 0.54), compared with no therapy. Of note, patients with a sustained virologic response showed a reduced risk of death (HR, 0.29), but those without a sustained virologic response to DAA therapy did not (HR, 1.13).
The findings support those from previous studies suggesting that DAA therapy may reduce mortality in patients with a history of HCC, the researchers said.
The study findings were limited by several factors, including potential confounding if DAA was given to patients with better prognoses, the researchers noted. Other limitations include the use of imaging in routine clinical care rather than centralized review, the loss of approximately 9% of the patients to follow-up, and the lack of data on hepatic decompensation during follow-up, the researchers said. However, the results were strengthened by the multicenter design, large cohort, and inclusion of untreated controls, and support the use of DAA therapies as “likely beneficial in HCV-infected patients with a history of HCC,” they concluded.
The study was funded in part by the National Cancer Institute and AbbVie. Dr. Singal disclosed relationships with companies including AbbVie, Gilead, Bayer, Eisai, Wako Diagnostics, Exact Sciences, Exelixis, Roche, Glycotest, and Bristol-Myers Squibb.
SOURCE: Singal AG et al. Gastroenterology. 2019. doi: 10.1053/j.gastro.2019.07.040.
FROM GASTROENTEROLOGY
NICUs admitting more normal-weight newborns
Almost half of the newborns admitted to U.S. neonatal intensive care units in 2017 were of normal birth weight, according to a new report from the Dartmouth Institute for Health Policy & Clinical Practice.
The proportion of NICU admissions involving normal-weight (2,500-3,999 g) newborns increased from 42% in 2007 to 48% in 2017, investigators said in the Dartmouth Atlas of Neonatal Intensive Care. Over that same period, admissions of very-low-birth-weight (500-1,499 g) babies dropped from 16% to 13% of the total.
Those changes were part of a larger, longer-term trend. “The expansion of NICUs and beds in recent decades has been associated with changes in the newborn population receiving NICU care,” the investigators said in the report.
The number of NICU beds increased by 65% from 1995 to 2013, and the number of neonatologists rose by 75% from 1996 to 2013. “At the same time, ” they said in a written statement.
The increases in NICU and neonatologist supply, however, did not always follow the need for such care. Areas of the country with high rates of newborn prematurity, or of risk factors such as low maternal education levels or high cesarean section rates, do not have higher supplies of NICU beds or neonatologists, the researchers noted.
“We should not spare a dollar in providing the best care for newborns. But spending more doesn’t help infants if they could receive the care they need in a maternity unit or home with their mothers. It is very troubling that such a valuable and expensive health care resource is not distributed where it is needed,” said principal author David C. Goodman, MD, of the Dartmouth Institute for Health Policy & Clinical Practice in Lebanon, N.H.
Almost half of the newborns admitted to U.S. neonatal intensive care units in 2017 were of normal birth weight, according to a new report from the Dartmouth Institute for Health Policy & Clinical Practice.
The proportion of NICU admissions involving normal-weight (2,500-3,999 g) newborns increased from 42% in 2007 to 48% in 2017, investigators said in the Dartmouth Atlas of Neonatal Intensive Care. Over that same period, admissions of very-low-birth-weight (500-1,499 g) babies dropped from 16% to 13% of the total.
Those changes were part of a larger, longer-term trend. “The expansion of NICUs and beds in recent decades has been associated with changes in the newborn population receiving NICU care,” the investigators said in the report.
The number of NICU beds increased by 65% from 1995 to 2013, and the number of neonatologists rose by 75% from 1996 to 2013. “At the same time, ” they said in a written statement.
The increases in NICU and neonatologist supply, however, did not always follow the need for such care. Areas of the country with high rates of newborn prematurity, or of risk factors such as low maternal education levels or high cesarean section rates, do not have higher supplies of NICU beds or neonatologists, the researchers noted.
“We should not spare a dollar in providing the best care for newborns. But spending more doesn’t help infants if they could receive the care they need in a maternity unit or home with their mothers. It is very troubling that such a valuable and expensive health care resource is not distributed where it is needed,” said principal author David C. Goodman, MD, of the Dartmouth Institute for Health Policy & Clinical Practice in Lebanon, N.H.
Almost half of the newborns admitted to U.S. neonatal intensive care units in 2017 were of normal birth weight, according to a new report from the Dartmouth Institute for Health Policy & Clinical Practice.
The proportion of NICU admissions involving normal-weight (2,500-3,999 g) newborns increased from 42% in 2007 to 48% in 2017, investigators said in the Dartmouth Atlas of Neonatal Intensive Care. Over that same period, admissions of very-low-birth-weight (500-1,499 g) babies dropped from 16% to 13% of the total.
Those changes were part of a larger, longer-term trend. “The expansion of NICUs and beds in recent decades has been associated with changes in the newborn population receiving NICU care,” the investigators said in the report.
The number of NICU beds increased by 65% from 1995 to 2013, and the number of neonatologists rose by 75% from 1996 to 2013. “At the same time, ” they said in a written statement.
The increases in NICU and neonatologist supply, however, did not always follow the need for such care. Areas of the country with high rates of newborn prematurity, or of risk factors such as low maternal education levels or high cesarean section rates, do not have higher supplies of NICU beds or neonatologists, the researchers noted.
“We should not spare a dollar in providing the best care for newborns. But spending more doesn’t help infants if they could receive the care they need in a maternity unit or home with their mothers. It is very troubling that such a valuable and expensive health care resource is not distributed where it is needed,” said principal author David C. Goodman, MD, of the Dartmouth Institute for Health Policy & Clinical Practice in Lebanon, N.H.
Caution with IVC filters in elderly
Background: Acute pulmonary embolism is a common cause of morbidity and mortality in older adults, and IVC filters have historically and frequently been used to prevent subsequent PE. Almost one in six elderly Medicare fee-for-service (FFS) beneficiaries with PE currently receives an IVC filter.
Study design: Retrospective, matched cohort study.
Setting: United States inpatients during 2011-2014.
Synopsis: Of 214,579 Medicare FFS patients aged 65 years or older who were hospitalized for acute PE, 13.4% received an IVC filter. Mortality was higher in those receiving an IVC filter (11.6%), compared with those who did not receive an IVC filter (9.3%), with an adjusted odds ratio of 30-day mortality of 1.02 (95% CI, 0.98-1.06). One-year mortality rates were 20.5% in the IVC filter group and 13.4% in the group with no IVC filter, with an adjusted OR of 1.35 (95% CI, 1.31-1.40).
In the 76,198 Medicare FFS patients hospitalized with acute PE in the matched cohort group, 18.2% received an IVC filter. The IVC-filter group had higher odds for 30-day mortality, compared with the no–IVC filter group (OR, 2.19; 95% CI, 2.06-2.33).
Bottom line: In patients aged 65 years or older, use caution when considering IVC filter placement for prevention of subsequent PE. Future studies across patient subgroups are needed to analyze the safety and value of IVC filters.
Citation: Bikdeli B et al. Association of inferior vena cava filter use with mortality rates in older adults with acute pulmonary embolism. JAMA Intern Med. 2019;179(2):263-5.
Dr. Trammell Velasquez is an associate professor of medicine in the division of general and hospital medicine at UT Health San Antonio and a hospitalist at South Texas Veterans Health Care System.
Background: Acute pulmonary embolism is a common cause of morbidity and mortality in older adults, and IVC filters have historically and frequently been used to prevent subsequent PE. Almost one in six elderly Medicare fee-for-service (FFS) beneficiaries with PE currently receives an IVC filter.
Study design: Retrospective, matched cohort study.
Setting: United States inpatients during 2011-2014.
Synopsis: Of 214,579 Medicare FFS patients aged 65 years or older who were hospitalized for acute PE, 13.4% received an IVC filter. Mortality was higher in those receiving an IVC filter (11.6%), compared with those who did not receive an IVC filter (9.3%), with an adjusted odds ratio of 30-day mortality of 1.02 (95% CI, 0.98-1.06). One-year mortality rates were 20.5% in the IVC filter group and 13.4% in the group with no IVC filter, with an adjusted OR of 1.35 (95% CI, 1.31-1.40).
In the 76,198 Medicare FFS patients hospitalized with acute PE in the matched cohort group, 18.2% received an IVC filter. The IVC-filter group had higher odds for 30-day mortality, compared with the no–IVC filter group (OR, 2.19; 95% CI, 2.06-2.33).
Bottom line: In patients aged 65 years or older, use caution when considering IVC filter placement for prevention of subsequent PE. Future studies across patient subgroups are needed to analyze the safety and value of IVC filters.
Citation: Bikdeli B et al. Association of inferior vena cava filter use with mortality rates in older adults with acute pulmonary embolism. JAMA Intern Med. 2019;179(2):263-5.
Dr. Trammell Velasquez is an associate professor of medicine in the division of general and hospital medicine at UT Health San Antonio and a hospitalist at South Texas Veterans Health Care System.
Background: Acute pulmonary embolism is a common cause of morbidity and mortality in older adults, and IVC filters have historically and frequently been used to prevent subsequent PE. Almost one in six elderly Medicare fee-for-service (FFS) beneficiaries with PE currently receives an IVC filter.
Study design: Retrospective, matched cohort study.
Setting: United States inpatients during 2011-2014.
Synopsis: Of 214,579 Medicare FFS patients aged 65 years or older who were hospitalized for acute PE, 13.4% received an IVC filter. Mortality was higher in those receiving an IVC filter (11.6%), compared with those who did not receive an IVC filter (9.3%), with an adjusted odds ratio of 30-day mortality of 1.02 (95% CI, 0.98-1.06). One-year mortality rates were 20.5% in the IVC filter group and 13.4% in the group with no IVC filter, with an adjusted OR of 1.35 (95% CI, 1.31-1.40).
In the 76,198 Medicare FFS patients hospitalized with acute PE in the matched cohort group, 18.2% received an IVC filter. The IVC-filter group had higher odds for 30-day mortality, compared with the no–IVC filter group (OR, 2.19; 95% CI, 2.06-2.33).
Bottom line: In patients aged 65 years or older, use caution when considering IVC filter placement for prevention of subsequent PE. Future studies across patient subgroups are needed to analyze the safety and value of IVC filters.
Citation: Bikdeli B et al. Association of inferior vena cava filter use with mortality rates in older adults with acute pulmonary embolism. JAMA Intern Med. 2019;179(2):263-5.
Dr. Trammell Velasquez is an associate professor of medicine in the division of general and hospital medicine at UT Health San Antonio and a hospitalist at South Texas Veterans Health Care System.
Using reimbursement to drive innovation in tumor biomarker tests
Implementing a tiered, value-based reimbursement policy for tumor biomarker tests could be an important part of improving innovation and the quality of this tests.
“Precision medicine in cancer care depends on on accurate tumor biomarker tests (TBTs) to determine prognosis and guide treatment selection,” wrote Michaela Dinan, PhD, of Duke University, Durham, N.C., and colleagues. Their report is in JCO Precision Oncology.
“The true clinical utility of a TBT is often difficult to determine, initiating a vicious cycle in which TBTs are often undervalued and poorly reimbursed because of a lack of high-level evidence of clinical utility,” they continued. “An inconsistent regulatory and reimbursement environment results in unfavorable return on investment in the research and development (R&D) needed to generate the high levels of evidence (LOEs) necessary to demonstrate the clinical utility of TBTs.”
To that end, the authors have developed a tiered, value-based reimbursement policy to help spur innovation and improve the clinical utility of TBTs.
The tiering involves three categories: Opt-In, Opt-Out, and Opt-Alt, with each of these terms referring to a decision that might be made with the results of the TBT compared with decisions that would be made based on standard of care (SOC) without TBT results.
“Often in oncology, the SOC is to treat all patients in a given context, knowing that all patients will be exposed to potential risks and costs but only a fraction will benefit,” Dr. Dinan and colleagues wrote. “Opt-Out TBTs have value and the potential to be directly cost saving by reducing the use of unnecessary or ineffective yet toxic and costly therapies, either by indicating that the patient does not need additional therapy (prognosis) or that the therapy under consideration is unlikely to work.”
And example of Opt-Out TBTs are tests used to determine whether adjuvant chemotherapy should be given to patients with estrogen receptor–positive, human epidermal growth factor receptor 2–negative, and node-negative breast cancer.
For the Opt-In tier, “the SOC is to not treat, and the TBT leads to treatment,” the authors noted. “In this case, the value of the TBT is generated by turning a minimally effective or unacceptable therapy into one that is indicated, and therefore acceptable, because of an altered risk-benefit that justifies or refines treatment. An Opt-In TBT will typically increase costs, but still has value because it may result in improved long-term clinical outcomes.”
An example of an Opt-In TBT is an analysis of germline susceptibility genes, such as BRCA1 or BRCA2, which could show increased odds of developing and dying as a result of breast and/or ovarian cancer, though the risk can be cut with prophylactic mastectomy and salpingo-oophorectomy, respectively.
“In this case, these otherwise unacceptable interventions become appropriate because of the increased chances of long-term survival as a result of the intervention in a high-risk population,” the authors wrote.
The Opt-Alt TBT is a subcategory of Opt-In, where the SOC is treatment A but a positive TBT results in the selection of a different treatment.
In each teir, the minimum reimbursement of the TBT increases with the analytic validity and clinical utility of the test. For example, the highest minimum reimbursement would come with tests that have been validated as a primary endpoint in prospective randomized trials, while the lowest would be TBTs with ad hoc analyses of convenience cohorts. In the middle would be those validated ad secondary endpoints in prospective trials.
“Our tiered approach provides a clear and achievable opportunity for companies to develop high-quality TBTs with a guarantee for a commensurate return on investment,” the authors state. “Although our system does not reward a TBT for having slightly better performance than another for a similar indication, it does so indirectly. We posit that by ensuring a fertile ground for multiple high-quality competing TBTs, market forces will be allowed to then appropriately drive the use of TBTs that perform best, given current and local practices.”
The authors make no economic estimates related to the implementation of this type of system.
SOURCE: Michaela Dinan et al. JCO Precis Oncol. 2019 Sep 18. doi: 10.1200/PO.19.00210.
Implementing a tiered, value-based reimbursement policy for tumor biomarker tests could be an important part of improving innovation and the quality of this tests.
“Precision medicine in cancer care depends on on accurate tumor biomarker tests (TBTs) to determine prognosis and guide treatment selection,” wrote Michaela Dinan, PhD, of Duke University, Durham, N.C., and colleagues. Their report is in JCO Precision Oncology.
“The true clinical utility of a TBT is often difficult to determine, initiating a vicious cycle in which TBTs are often undervalued and poorly reimbursed because of a lack of high-level evidence of clinical utility,” they continued. “An inconsistent regulatory and reimbursement environment results in unfavorable return on investment in the research and development (R&D) needed to generate the high levels of evidence (LOEs) necessary to demonstrate the clinical utility of TBTs.”
To that end, the authors have developed a tiered, value-based reimbursement policy to help spur innovation and improve the clinical utility of TBTs.
The tiering involves three categories: Opt-In, Opt-Out, and Opt-Alt, with each of these terms referring to a decision that might be made with the results of the TBT compared with decisions that would be made based on standard of care (SOC) without TBT results.
“Often in oncology, the SOC is to treat all patients in a given context, knowing that all patients will be exposed to potential risks and costs but only a fraction will benefit,” Dr. Dinan and colleagues wrote. “Opt-Out TBTs have value and the potential to be directly cost saving by reducing the use of unnecessary or ineffective yet toxic and costly therapies, either by indicating that the patient does not need additional therapy (prognosis) or that the therapy under consideration is unlikely to work.”
And example of Opt-Out TBTs are tests used to determine whether adjuvant chemotherapy should be given to patients with estrogen receptor–positive, human epidermal growth factor receptor 2–negative, and node-negative breast cancer.
For the Opt-In tier, “the SOC is to not treat, and the TBT leads to treatment,” the authors noted. “In this case, the value of the TBT is generated by turning a minimally effective or unacceptable therapy into one that is indicated, and therefore acceptable, because of an altered risk-benefit that justifies or refines treatment. An Opt-In TBT will typically increase costs, but still has value because it may result in improved long-term clinical outcomes.”
An example of an Opt-In TBT is an analysis of germline susceptibility genes, such as BRCA1 or BRCA2, which could show increased odds of developing and dying as a result of breast and/or ovarian cancer, though the risk can be cut with prophylactic mastectomy and salpingo-oophorectomy, respectively.
“In this case, these otherwise unacceptable interventions become appropriate because of the increased chances of long-term survival as a result of the intervention in a high-risk population,” the authors wrote.
The Opt-Alt TBT is a subcategory of Opt-In, where the SOC is treatment A but a positive TBT results in the selection of a different treatment.
In each teir, the minimum reimbursement of the TBT increases with the analytic validity and clinical utility of the test. For example, the highest minimum reimbursement would come with tests that have been validated as a primary endpoint in prospective randomized trials, while the lowest would be TBTs with ad hoc analyses of convenience cohorts. In the middle would be those validated ad secondary endpoints in prospective trials.
“Our tiered approach provides a clear and achievable opportunity for companies to develop high-quality TBTs with a guarantee for a commensurate return on investment,” the authors state. “Although our system does not reward a TBT for having slightly better performance than another for a similar indication, it does so indirectly. We posit that by ensuring a fertile ground for multiple high-quality competing TBTs, market forces will be allowed to then appropriately drive the use of TBTs that perform best, given current and local practices.”
The authors make no economic estimates related to the implementation of this type of system.
SOURCE: Michaela Dinan et al. JCO Precis Oncol. 2019 Sep 18. doi: 10.1200/PO.19.00210.
Implementing a tiered, value-based reimbursement policy for tumor biomarker tests could be an important part of improving innovation and the quality of this tests.
“Precision medicine in cancer care depends on on accurate tumor biomarker tests (TBTs) to determine prognosis and guide treatment selection,” wrote Michaela Dinan, PhD, of Duke University, Durham, N.C., and colleagues. Their report is in JCO Precision Oncology.
“The true clinical utility of a TBT is often difficult to determine, initiating a vicious cycle in which TBTs are often undervalued and poorly reimbursed because of a lack of high-level evidence of clinical utility,” they continued. “An inconsistent regulatory and reimbursement environment results in unfavorable return on investment in the research and development (R&D) needed to generate the high levels of evidence (LOEs) necessary to demonstrate the clinical utility of TBTs.”
To that end, the authors have developed a tiered, value-based reimbursement policy to help spur innovation and improve the clinical utility of TBTs.
The tiering involves three categories: Opt-In, Opt-Out, and Opt-Alt, with each of these terms referring to a decision that might be made with the results of the TBT compared with decisions that would be made based on standard of care (SOC) without TBT results.
“Often in oncology, the SOC is to treat all patients in a given context, knowing that all patients will be exposed to potential risks and costs but only a fraction will benefit,” Dr. Dinan and colleagues wrote. “Opt-Out TBTs have value and the potential to be directly cost saving by reducing the use of unnecessary or ineffective yet toxic and costly therapies, either by indicating that the patient does not need additional therapy (prognosis) or that the therapy under consideration is unlikely to work.”
And example of Opt-Out TBTs are tests used to determine whether adjuvant chemotherapy should be given to patients with estrogen receptor–positive, human epidermal growth factor receptor 2–negative, and node-negative breast cancer.
For the Opt-In tier, “the SOC is to not treat, and the TBT leads to treatment,” the authors noted. “In this case, the value of the TBT is generated by turning a minimally effective or unacceptable therapy into one that is indicated, and therefore acceptable, because of an altered risk-benefit that justifies or refines treatment. An Opt-In TBT will typically increase costs, but still has value because it may result in improved long-term clinical outcomes.”
An example of an Opt-In TBT is an analysis of germline susceptibility genes, such as BRCA1 or BRCA2, which could show increased odds of developing and dying as a result of breast and/or ovarian cancer, though the risk can be cut with prophylactic mastectomy and salpingo-oophorectomy, respectively.
“In this case, these otherwise unacceptable interventions become appropriate because of the increased chances of long-term survival as a result of the intervention in a high-risk population,” the authors wrote.
The Opt-Alt TBT is a subcategory of Opt-In, where the SOC is treatment A but a positive TBT results in the selection of a different treatment.
In each teir, the minimum reimbursement of the TBT increases with the analytic validity and clinical utility of the test. For example, the highest minimum reimbursement would come with tests that have been validated as a primary endpoint in prospective randomized trials, while the lowest would be TBTs with ad hoc analyses of convenience cohorts. In the middle would be those validated ad secondary endpoints in prospective trials.
“Our tiered approach provides a clear and achievable opportunity for companies to develop high-quality TBTs with a guarantee for a commensurate return on investment,” the authors state. “Although our system does not reward a TBT for having slightly better performance than another for a similar indication, it does so indirectly. We posit that by ensuring a fertile ground for multiple high-quality competing TBTs, market forces will be allowed to then appropriately drive the use of TBTs that perform best, given current and local practices.”
The authors make no economic estimates related to the implementation of this type of system.
SOURCE: Michaela Dinan et al. JCO Precis Oncol. 2019 Sep 18. doi: 10.1200/PO.19.00210.
FROM JCO PRECISION ONCOLOGY
Transcervical ablation of symptomatic uterine fibroids under US guidance
On Aug. 29, 2019, the first commercial case utilizing the Sonata system to transcervically ablate symptomatic uterine fibroids under ultrasound guidance was performed at Stamford (Conn.) Hospital. This truly minimally invasive new treatment expands our options in the surgical management of uterine fibroids.
Uterine fibroids are the most common benign tumors of the reproductive tract. It has been estimated that nearly half of the 70%-80% of women who develop fibroids during their reproductive years are symptomatic. Given that some patients present with fertility concerns, it also has been estimated that at least one in three women with fibroids have symptoms such as heavy bleeding (menorrhagia) and bulk symptoms, pain (dyspareunia, dysmenorrhea, noncyclic pain), and increased urinary frequency.
Fibroids are the most common cause of hysterectomy in the United States, with 240,000 (40% of 600,000) performed annually, yet research shows that many women are interested in minimally invasive options and in uterine conservation. In a 2013 national survey published in the American Journal of Obstetrics and Gynecology, 79% of women expressed an interest in minimally invasive approaches for fibroid treatment, and over 50% reported a desire for uterine conservation.1
Both myomectomy and uterine artery embolization are uterine-sparing procedures. However, uterine artery embolization should not be performed in a woman interested in pregnancy. Moreover, there are reports of ovarian reserve issues when the procedure is performed in women in their later reproductive years.
Depending on the technique performed, women undergoing hysteroscopic myomectomy are at risk of fluid overload, hyponatremia, gas-related embolism, and postoperative adhesions. The suture requirements of a laparoscopic myomectomy make this approach an often-difficult one to master, even with robotic assistance. It also requires intubation and potentially places the patient at risk for bleeding and infection. Furthermore, long-term risks include adhesions and the need for C-section with pregnancy.
The impact of uterine fibroids on patients’ lives and their desire for uterine conservation has spurred growing interest in the use of radiofrequency (RF) energy to ablate uterine fibroids. In a 2018 systematic review of nonresective treatments for uterine fibroids published in the International Journal of Hyperthermia, investigators found that the pooled fibroid volume reductions at 6 months after RF ablation and uterine artery embolization were 70% and 54%, respectively.2
The first commercially available system utilizing RF frequency to shrink fibrosis – Acessa – involves laparoscopy, and thus requires abdominal incisions. In August 2018, the Sonata system (Gynesonics: Redwood, Calif.) received Food and Drug Administration clearance after having received European CE-Mark approval in 2010 (for the original device, the VizAblate) and in 2014 (for the next-generation device, the Sonata).
The technology
For a complete description of transcervical, intrauterine sonography–guided radiofrequency ablation of uterine fibroids, one can refer to the excellent outline by David Toub, MD, in Current Obstetrics and Gynecology Reports.3 Basically, the Sonata system allows for real-time, image-guided treatment through the use of a reusable intrauterine ultrasound (IUUS) probe, a single-use RF ablation (RFA) handpiece, and graphical guidance software for diagnosis and targeting.
Initially, the IUUS probe enables identification of fibroids from within the uterine cavity, then guides deployment of an introducer and needle electrode into the targeted fibroid(s). The probe image is curvilinear, penetrates more than 9 cm, and provides a 90-degree field of view.
The RFA handpiece contains the introducer and needle electrode array. It snaps together with the IUUS probe to form and integrate into a single treatment device that contains all controls needed to place and size the ablation. Mechanical stops and lockouts within the RFA handpiece further enhance proper localization and sizing of the ablation.
The system’s graphical guidance software, also known as the SMART Guide, is a real-time graphical overlay on the ultrasound display, which enables one to visually select deployment length, width, and position of the ablation guides. In so doing, the mechanical stops for the introducer and needle electrodes are determined prior to their insertion into the targeted fibroid(s). This was validated in more than 4,000 ablations in bovine muscle and human-extirpated uteri, as well as in vivo at time of laparotomy.
By displaying the ellipsoidal region where the ablation will take place (ablation zone) along with a surrounding ellipsoid (thermal safety border) where tissue temperature will be elevated, the SMART Guide provides a safer and more accurate understanding of the ablation than if it showed only the ablation zone.
As with transabdominal or transvaginal sonography, the serosa will appear hyperechoic at the time of intrauterine ultrasound. By using the SMART Guide, the ablation is sized and positioned to encompass as much of the fibroid as possible while maintaining thermal energy within the uterine serosal margin. Once the desired ablation size has been selected, and safe placement of the needle electrodes is confirmed by rotating the IUUS probe in multiple planes, therapeutic RF energy is delivered to the fibroid; the fixed treatment cycle is dependent on ablation size.
The system will modulate power (up to 150W) to keep temperature at the tips of the needle electrode at 105° C. Moreover, the time of energy delivery at the temperature of 105° – 2-7 minutes – is automatically set based on ablation size, which is a continuum up to 4 cm wide and up to 5 cm long. Multiple ablations may be utilized in a particularly large fibroid.
Unlike hysteroscopic myomectomy, only a small amount of hypotonic solution is instilled within the uterine cavity to enhance acoustic coupling. Furthermore, the treatment device (RFA handpiece and IUUS probe) is only 8.3 mm in diameter. This requires Hegar dilatation of the cervix to 9.
The procedure
After administering anesthesia (regional or sedation), dispersive electrode pads are placed on the anterior thighs. After the cervix is dilated to Hegar dilatation of 9, the treatment device is inserted transcervically into the uterine cavity and the fibroid(s) are identified with the ultrasound probe. The physician plans and optimizes the ablation by sizing and aligning the graphical overlay targeting guide (the SMART Guide) over the live image. Once the size and location of the ablation are set, the trocar-tipped introducer is advanced into the fibroid. After ensuring the guide is within the serosal boundary, the needle electrodes are deployed.
A second visual safety check is completed, and the delivery of RF energy is initiated using a footswitch control. The time of energy delivery is determined based on the size of the desired ablation, up to 7 minutes for the largest ablation size (5 cm x 4 cm). The targeting and treatment steps are repeated as required to treat additional fibroids. Once the treatment is completed, the needle electrodes and introducer are retracted, and the treatment device removed.
Study results and the future
The 12-month safety and effectiveness data for ultrasound-guided transcervical ablation of uterine fibroids were reported in January 2019 in Obstetrics & Gynecology.4 Women enrolled in the prospective, multicenter, single-arm, interventional trial had 1-10 fibroids – the International Federation of Gynecology and Obstetrics (FIGO) types 1, 2, 3, 4, and 2-5 (pedunculated fibroids excluded) – with diameters of 1-5 centimeters. Patients also were required to have at least one fibroid indenting or impinging on the endometrial cavity (FIGO type 1, 2, 3, or 2-5).
Upon study entry, the pictorial assessment blood loss was required to be 150-500 cc. The study included 147 patients. Both coprimary endpoints were satisfied at 12 months; that is, 65% of patients experienced a 50% or greater reduction in menstrual bleeding, and 99% were free from surgical intervention at 1 year.
The mean pictorial blood loss decreased by 39%, 48%, and 51% at 3, 6, and 12 months respectively. Moreover, 95% of the study population experienced some reduction in menstrual bleeding at 12 months. There also were mean improvements in symptom severity and health-related quality-of-life parameters. Mean maximal fibroid volume reduction per patient was 62%.
More than half of the patients returned to normal activity within 1 day, 96% of patients reported symptom improvement at 12 months, and 97% expressed satisfaction with the procedure and results at 12 months. There were no device-related adverse events.
I am the lead author for the 2-year follow-up study utilizing transcervical RFA of symptomatic uterine fibroids, which currently is in press. Suffice it to say, the quality-of-life data, symptom improvement, and lower rate of surgical reintervention all are significant and compelling. Ultimately, I believe Sonata will not only be a treatment of choice in the appropriate patient presenting with heavy menstrual flow or bulk symptoms secondary to uterine fibroids, but will prove to be beneficial in women with impinging or deep submucosal fibroids and implantation failure.
Dr. Miller is a clinical associate professor at the University of Illinois in Chicago and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in metropolitan Chicago and the director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill. Dr. Miller disclosed that he is a consultant for Gynesonics and holds a stock option agreement with the company.
References
1. Am J Obstet Gynecol. 2013 Oct;209(4):319.e1-319.e20.
2. Int J Hyperthermia. 2019;36(1):295-301.
3. Curr Obstet Gynecol Rep. 2017; 6(1): 67-73.
4. Obstet Gynecol. 2019 Jan;133(1):13-22.
On Aug. 29, 2019, the first commercial case utilizing the Sonata system to transcervically ablate symptomatic uterine fibroids under ultrasound guidance was performed at Stamford (Conn.) Hospital. This truly minimally invasive new treatment expands our options in the surgical management of uterine fibroids.
Uterine fibroids are the most common benign tumors of the reproductive tract. It has been estimated that nearly half of the 70%-80% of women who develop fibroids during their reproductive years are symptomatic. Given that some patients present with fertility concerns, it also has been estimated that at least one in three women with fibroids have symptoms such as heavy bleeding (menorrhagia) and bulk symptoms, pain (dyspareunia, dysmenorrhea, noncyclic pain), and increased urinary frequency.
Fibroids are the most common cause of hysterectomy in the United States, with 240,000 (40% of 600,000) performed annually, yet research shows that many women are interested in minimally invasive options and in uterine conservation. In a 2013 national survey published in the American Journal of Obstetrics and Gynecology, 79% of women expressed an interest in minimally invasive approaches for fibroid treatment, and over 50% reported a desire for uterine conservation.1
Both myomectomy and uterine artery embolization are uterine-sparing procedures. However, uterine artery embolization should not be performed in a woman interested in pregnancy. Moreover, there are reports of ovarian reserve issues when the procedure is performed in women in their later reproductive years.
Depending on the technique performed, women undergoing hysteroscopic myomectomy are at risk of fluid overload, hyponatremia, gas-related embolism, and postoperative adhesions. The suture requirements of a laparoscopic myomectomy make this approach an often-difficult one to master, even with robotic assistance. It also requires intubation and potentially places the patient at risk for bleeding and infection. Furthermore, long-term risks include adhesions and the need for C-section with pregnancy.
The impact of uterine fibroids on patients’ lives and their desire for uterine conservation has spurred growing interest in the use of radiofrequency (RF) energy to ablate uterine fibroids. In a 2018 systematic review of nonresective treatments for uterine fibroids published in the International Journal of Hyperthermia, investigators found that the pooled fibroid volume reductions at 6 months after RF ablation and uterine artery embolization were 70% and 54%, respectively.2
The first commercially available system utilizing RF frequency to shrink fibrosis – Acessa – involves laparoscopy, and thus requires abdominal incisions. In August 2018, the Sonata system (Gynesonics: Redwood, Calif.) received Food and Drug Administration clearance after having received European CE-Mark approval in 2010 (for the original device, the VizAblate) and in 2014 (for the next-generation device, the Sonata).
The technology
For a complete description of transcervical, intrauterine sonography–guided radiofrequency ablation of uterine fibroids, one can refer to the excellent outline by David Toub, MD, in Current Obstetrics and Gynecology Reports.3 Basically, the Sonata system allows for real-time, image-guided treatment through the use of a reusable intrauterine ultrasound (IUUS) probe, a single-use RF ablation (RFA) handpiece, and graphical guidance software for diagnosis and targeting.
Initially, the IUUS probe enables identification of fibroids from within the uterine cavity, then guides deployment of an introducer and needle electrode into the targeted fibroid(s). The probe image is curvilinear, penetrates more than 9 cm, and provides a 90-degree field of view.
The RFA handpiece contains the introducer and needle electrode array. It snaps together with the IUUS probe to form and integrate into a single treatment device that contains all controls needed to place and size the ablation. Mechanical stops and lockouts within the RFA handpiece further enhance proper localization and sizing of the ablation.
The system’s graphical guidance software, also known as the SMART Guide, is a real-time graphical overlay on the ultrasound display, which enables one to visually select deployment length, width, and position of the ablation guides. In so doing, the mechanical stops for the introducer and needle electrodes are determined prior to their insertion into the targeted fibroid(s). This was validated in more than 4,000 ablations in bovine muscle and human-extirpated uteri, as well as in vivo at time of laparotomy.
By displaying the ellipsoidal region where the ablation will take place (ablation zone) along with a surrounding ellipsoid (thermal safety border) where tissue temperature will be elevated, the SMART Guide provides a safer and more accurate understanding of the ablation than if it showed only the ablation zone.
As with transabdominal or transvaginal sonography, the serosa will appear hyperechoic at the time of intrauterine ultrasound. By using the SMART Guide, the ablation is sized and positioned to encompass as much of the fibroid as possible while maintaining thermal energy within the uterine serosal margin. Once the desired ablation size has been selected, and safe placement of the needle electrodes is confirmed by rotating the IUUS probe in multiple planes, therapeutic RF energy is delivered to the fibroid; the fixed treatment cycle is dependent on ablation size.
The system will modulate power (up to 150W) to keep temperature at the tips of the needle electrode at 105° C. Moreover, the time of energy delivery at the temperature of 105° – 2-7 minutes – is automatically set based on ablation size, which is a continuum up to 4 cm wide and up to 5 cm long. Multiple ablations may be utilized in a particularly large fibroid.
Unlike hysteroscopic myomectomy, only a small amount of hypotonic solution is instilled within the uterine cavity to enhance acoustic coupling. Furthermore, the treatment device (RFA handpiece and IUUS probe) is only 8.3 mm in diameter. This requires Hegar dilatation of the cervix to 9.
The procedure
After administering anesthesia (regional or sedation), dispersive electrode pads are placed on the anterior thighs. After the cervix is dilated to Hegar dilatation of 9, the treatment device is inserted transcervically into the uterine cavity and the fibroid(s) are identified with the ultrasound probe. The physician plans and optimizes the ablation by sizing and aligning the graphical overlay targeting guide (the SMART Guide) over the live image. Once the size and location of the ablation are set, the trocar-tipped introducer is advanced into the fibroid. After ensuring the guide is within the serosal boundary, the needle electrodes are deployed.
A second visual safety check is completed, and the delivery of RF energy is initiated using a footswitch control. The time of energy delivery is determined based on the size of the desired ablation, up to 7 minutes for the largest ablation size (5 cm x 4 cm). The targeting and treatment steps are repeated as required to treat additional fibroids. Once the treatment is completed, the needle electrodes and introducer are retracted, and the treatment device removed.
Study results and the future
The 12-month safety and effectiveness data for ultrasound-guided transcervical ablation of uterine fibroids were reported in January 2019 in Obstetrics & Gynecology.4 Women enrolled in the prospective, multicenter, single-arm, interventional trial had 1-10 fibroids – the International Federation of Gynecology and Obstetrics (FIGO) types 1, 2, 3, 4, and 2-5 (pedunculated fibroids excluded) – with diameters of 1-5 centimeters. Patients also were required to have at least one fibroid indenting or impinging on the endometrial cavity (FIGO type 1, 2, 3, or 2-5).
Upon study entry, the pictorial assessment blood loss was required to be 150-500 cc. The study included 147 patients. Both coprimary endpoints were satisfied at 12 months; that is, 65% of patients experienced a 50% or greater reduction in menstrual bleeding, and 99% were free from surgical intervention at 1 year.
The mean pictorial blood loss decreased by 39%, 48%, and 51% at 3, 6, and 12 months respectively. Moreover, 95% of the study population experienced some reduction in menstrual bleeding at 12 months. There also were mean improvements in symptom severity and health-related quality-of-life parameters. Mean maximal fibroid volume reduction per patient was 62%.
More than half of the patients returned to normal activity within 1 day, 96% of patients reported symptom improvement at 12 months, and 97% expressed satisfaction with the procedure and results at 12 months. There were no device-related adverse events.
I am the lead author for the 2-year follow-up study utilizing transcervical RFA of symptomatic uterine fibroids, which currently is in press. Suffice it to say, the quality-of-life data, symptom improvement, and lower rate of surgical reintervention all are significant and compelling. Ultimately, I believe Sonata will not only be a treatment of choice in the appropriate patient presenting with heavy menstrual flow or bulk symptoms secondary to uterine fibroids, but will prove to be beneficial in women with impinging or deep submucosal fibroids and implantation failure.
Dr. Miller is a clinical associate professor at the University of Illinois in Chicago and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in metropolitan Chicago and the director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill. Dr. Miller disclosed that he is a consultant for Gynesonics and holds a stock option agreement with the company.
References
1. Am J Obstet Gynecol. 2013 Oct;209(4):319.e1-319.e20.
2. Int J Hyperthermia. 2019;36(1):295-301.
3. Curr Obstet Gynecol Rep. 2017; 6(1): 67-73.
4. Obstet Gynecol. 2019 Jan;133(1):13-22.
On Aug. 29, 2019, the first commercial case utilizing the Sonata system to transcervically ablate symptomatic uterine fibroids under ultrasound guidance was performed at Stamford (Conn.) Hospital. This truly minimally invasive new treatment expands our options in the surgical management of uterine fibroids.
Uterine fibroids are the most common benign tumors of the reproductive tract. It has been estimated that nearly half of the 70%-80% of women who develop fibroids during their reproductive years are symptomatic. Given that some patients present with fertility concerns, it also has been estimated that at least one in three women with fibroids have symptoms such as heavy bleeding (menorrhagia) and bulk symptoms, pain (dyspareunia, dysmenorrhea, noncyclic pain), and increased urinary frequency.
Fibroids are the most common cause of hysterectomy in the United States, with 240,000 (40% of 600,000) performed annually, yet research shows that many women are interested in minimally invasive options and in uterine conservation. In a 2013 national survey published in the American Journal of Obstetrics and Gynecology, 79% of women expressed an interest in minimally invasive approaches for fibroid treatment, and over 50% reported a desire for uterine conservation.1
Both myomectomy and uterine artery embolization are uterine-sparing procedures. However, uterine artery embolization should not be performed in a woman interested in pregnancy. Moreover, there are reports of ovarian reserve issues when the procedure is performed in women in their later reproductive years.
Depending on the technique performed, women undergoing hysteroscopic myomectomy are at risk of fluid overload, hyponatremia, gas-related embolism, and postoperative adhesions. The suture requirements of a laparoscopic myomectomy make this approach an often-difficult one to master, even with robotic assistance. It also requires intubation and potentially places the patient at risk for bleeding and infection. Furthermore, long-term risks include adhesions and the need for C-section with pregnancy.
The impact of uterine fibroids on patients’ lives and their desire for uterine conservation has spurred growing interest in the use of radiofrequency (RF) energy to ablate uterine fibroids. In a 2018 systematic review of nonresective treatments for uterine fibroids published in the International Journal of Hyperthermia, investigators found that the pooled fibroid volume reductions at 6 months after RF ablation and uterine artery embolization were 70% and 54%, respectively.2
The first commercially available system utilizing RF frequency to shrink fibrosis – Acessa – involves laparoscopy, and thus requires abdominal incisions. In August 2018, the Sonata system (Gynesonics: Redwood, Calif.) received Food and Drug Administration clearance after having received European CE-Mark approval in 2010 (for the original device, the VizAblate) and in 2014 (for the next-generation device, the Sonata).
The technology
For a complete description of transcervical, intrauterine sonography–guided radiofrequency ablation of uterine fibroids, one can refer to the excellent outline by David Toub, MD, in Current Obstetrics and Gynecology Reports.3 Basically, the Sonata system allows for real-time, image-guided treatment through the use of a reusable intrauterine ultrasound (IUUS) probe, a single-use RF ablation (RFA) handpiece, and graphical guidance software for diagnosis and targeting.
Initially, the IUUS probe enables identification of fibroids from within the uterine cavity, then guides deployment of an introducer and needle electrode into the targeted fibroid(s). The probe image is curvilinear, penetrates more than 9 cm, and provides a 90-degree field of view.
The RFA handpiece contains the introducer and needle electrode array. It snaps together with the IUUS probe to form and integrate into a single treatment device that contains all controls needed to place and size the ablation. Mechanical stops and lockouts within the RFA handpiece further enhance proper localization and sizing of the ablation.
The system’s graphical guidance software, also known as the SMART Guide, is a real-time graphical overlay on the ultrasound display, which enables one to visually select deployment length, width, and position of the ablation guides. In so doing, the mechanical stops for the introducer and needle electrodes are determined prior to their insertion into the targeted fibroid(s). This was validated in more than 4,000 ablations in bovine muscle and human-extirpated uteri, as well as in vivo at time of laparotomy.
By displaying the ellipsoidal region where the ablation will take place (ablation zone) along with a surrounding ellipsoid (thermal safety border) where tissue temperature will be elevated, the SMART Guide provides a safer and more accurate understanding of the ablation than if it showed only the ablation zone.
As with transabdominal or transvaginal sonography, the serosa will appear hyperechoic at the time of intrauterine ultrasound. By using the SMART Guide, the ablation is sized and positioned to encompass as much of the fibroid as possible while maintaining thermal energy within the uterine serosal margin. Once the desired ablation size has been selected, and safe placement of the needle electrodes is confirmed by rotating the IUUS probe in multiple planes, therapeutic RF energy is delivered to the fibroid; the fixed treatment cycle is dependent on ablation size.
The system will modulate power (up to 150W) to keep temperature at the tips of the needle electrode at 105° C. Moreover, the time of energy delivery at the temperature of 105° – 2-7 minutes – is automatically set based on ablation size, which is a continuum up to 4 cm wide and up to 5 cm long. Multiple ablations may be utilized in a particularly large fibroid.
Unlike hysteroscopic myomectomy, only a small amount of hypotonic solution is instilled within the uterine cavity to enhance acoustic coupling. Furthermore, the treatment device (RFA handpiece and IUUS probe) is only 8.3 mm in diameter. This requires Hegar dilatation of the cervix to 9.
The procedure
After administering anesthesia (regional or sedation), dispersive electrode pads are placed on the anterior thighs. After the cervix is dilated to Hegar dilatation of 9, the treatment device is inserted transcervically into the uterine cavity and the fibroid(s) are identified with the ultrasound probe. The physician plans and optimizes the ablation by sizing and aligning the graphical overlay targeting guide (the SMART Guide) over the live image. Once the size and location of the ablation are set, the trocar-tipped introducer is advanced into the fibroid. After ensuring the guide is within the serosal boundary, the needle electrodes are deployed.
A second visual safety check is completed, and the delivery of RF energy is initiated using a footswitch control. The time of energy delivery is determined based on the size of the desired ablation, up to 7 minutes for the largest ablation size (5 cm x 4 cm). The targeting and treatment steps are repeated as required to treat additional fibroids. Once the treatment is completed, the needle electrodes and introducer are retracted, and the treatment device removed.
Study results and the future
The 12-month safety and effectiveness data for ultrasound-guided transcervical ablation of uterine fibroids were reported in January 2019 in Obstetrics & Gynecology.4 Women enrolled in the prospective, multicenter, single-arm, interventional trial had 1-10 fibroids – the International Federation of Gynecology and Obstetrics (FIGO) types 1, 2, 3, 4, and 2-5 (pedunculated fibroids excluded) – with diameters of 1-5 centimeters. Patients also were required to have at least one fibroid indenting or impinging on the endometrial cavity (FIGO type 1, 2, 3, or 2-5).
Upon study entry, the pictorial assessment blood loss was required to be 150-500 cc. The study included 147 patients. Both coprimary endpoints were satisfied at 12 months; that is, 65% of patients experienced a 50% or greater reduction in menstrual bleeding, and 99% were free from surgical intervention at 1 year.
The mean pictorial blood loss decreased by 39%, 48%, and 51% at 3, 6, and 12 months respectively. Moreover, 95% of the study population experienced some reduction in menstrual bleeding at 12 months. There also were mean improvements in symptom severity and health-related quality-of-life parameters. Mean maximal fibroid volume reduction per patient was 62%.
More than half of the patients returned to normal activity within 1 day, 96% of patients reported symptom improvement at 12 months, and 97% expressed satisfaction with the procedure and results at 12 months. There were no device-related adverse events.
I am the lead author for the 2-year follow-up study utilizing transcervical RFA of symptomatic uterine fibroids, which currently is in press. Suffice it to say, the quality-of-life data, symptom improvement, and lower rate of surgical reintervention all are significant and compelling. Ultimately, I believe Sonata will not only be a treatment of choice in the appropriate patient presenting with heavy menstrual flow or bulk symptoms secondary to uterine fibroids, but will prove to be beneficial in women with impinging or deep submucosal fibroids and implantation failure.
Dr. Miller is a clinical associate professor at the University of Illinois in Chicago and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in metropolitan Chicago and the director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill. Dr. Miller disclosed that he is a consultant for Gynesonics and holds a stock option agreement with the company.
References
1. Am J Obstet Gynecol. 2013 Oct;209(4):319.e1-319.e20.
2. Int J Hyperthermia. 2019;36(1):295-301.
3. Curr Obstet Gynecol Rep. 2017; 6(1): 67-73.
4. Obstet Gynecol. 2019 Jan;133(1):13-22.
Treating uterine fibroids
Uterine fibroids are the most common benign tumor in women originating from the smooth muscles of the myometrium. While some women are asymptomatic, others experience pelvic pain, pressure, and abnormal uterine bleeding. Uterine fibroids also are associated with gastrointestinal disturbances; urinary problems; infertility; and obstetrical complications including miscarriages, preterm delivery, and cesarean sections.
The first successful abdominal myomectomy was described in 1845 but the procedure quickly fell out of favor because of unacceptably high mortality rates. Myomectomies require special skills and, at times, are associated with bleeding resulting in massive transfusions or sometimes unwanted hysterectomies. In 1922, Victor Bonney developed a uterine artery clamp which significantly decreased bleeding associated with morbidity and mortality.1
The latter part of the 20th century belonged to the minimally invasive surgery (MIS) evolution. Currently, video- or robotic-assisted laparoscopic myomectomies are increasingly employed in fertility-sparing surgery. In 2014, electromechanical morcellators came under scrutiny with concerns about iatrogenic dissemination of both benign and malignant tissues. A media storm ensued, resulting in the 2014 Food and Drug Administration black-box warning, and electromechanical morcellators were pulled from shelves. Data are being collected to quantify and understand these risks more clearly.
While exposing patients to even a small risk of dissemination of an occult uterine malignancy is unwise, MIS should not be abandoned altogether given its advantages to patients.2 Most recently, the American College of Obstetricians and Gynecologists concluded that, although abdominal hysterectomy or myomectomy may reduce the chance of spreading undiagnosed leiomyosarcoma cells, it is associated with increased morbidity, compared with noninvasive approaches, and ob.gyns. should engage in open decision-making processes and explain nonsurgical options with patients.3
The author of this Master Class, Dr. Charles Miller, a world-renowned MIS surgeon, will enlighten readers on the latest development in noninvasive treatment of symptomatic patients. The Sonata system, a promising transcervical (and thus incisionless) treatment modality utilizing intrauterine sonography–guided radiofrequency ablation for uterine fibroids which does not require general anesthesia or hospitalization. He believes that Sonata “will not only be a treatment of choice in the appropriate patient presenting with heavy menstrual flow or bulk symptoms secondary to uterine fibroids, but will prove to be beneficial in women with impinging or deep submucosal fibroids and implantation failure.”
Dr. Miller is on the editorial advisory boards of numerous academic journals and serves as the editor of the award-winning Master Class in Gynecologic Surgery column. For this installment, he has stepped into the role of guest author. Dr. Miller has received numerous awards for his educational contributions and was recently granted the distinct honor of taking the lead in the March 28, 2020 Worldwide EndoMarch–Chicago. It is my pleasure to take part in this introduction.
Dr. Nezhat is director of minimally invasive surgery and robotics as well as the medical director of training and education at Northside Hospital, both in Atlanta. He is fellowship director at Atlanta Center for Special Minimally Invasive Surgery & Reproductive Medicine. Dr. Nezhat also is an adjunct professor of gynecology and obstetrics at Emory University, Atlanta, and is past president of the Society of Reproductive Surgeons and the AAGL. He reported that he has no disclosures relevant to this Master Class. Email him at [email protected].
References
1. BJOG. 2018 Apr;125(5):586.
2. JAMA Oncol. 2015;1(1):78-9.
3. Obstet Gynecol. 2019 Mar;133(3):e238-48.
Uterine fibroids are the most common benign tumor in women originating from the smooth muscles of the myometrium. While some women are asymptomatic, others experience pelvic pain, pressure, and abnormal uterine bleeding. Uterine fibroids also are associated with gastrointestinal disturbances; urinary problems; infertility; and obstetrical complications including miscarriages, preterm delivery, and cesarean sections.
The first successful abdominal myomectomy was described in 1845 but the procedure quickly fell out of favor because of unacceptably high mortality rates. Myomectomies require special skills and, at times, are associated with bleeding resulting in massive transfusions or sometimes unwanted hysterectomies. In 1922, Victor Bonney developed a uterine artery clamp which significantly decreased bleeding associated with morbidity and mortality.1
The latter part of the 20th century belonged to the minimally invasive surgery (MIS) evolution. Currently, video- or robotic-assisted laparoscopic myomectomies are increasingly employed in fertility-sparing surgery. In 2014, electromechanical morcellators came under scrutiny with concerns about iatrogenic dissemination of both benign and malignant tissues. A media storm ensued, resulting in the 2014 Food and Drug Administration black-box warning, and electromechanical morcellators were pulled from shelves. Data are being collected to quantify and understand these risks more clearly.
While exposing patients to even a small risk of dissemination of an occult uterine malignancy is unwise, MIS should not be abandoned altogether given its advantages to patients.2 Most recently, the American College of Obstetricians and Gynecologists concluded that, although abdominal hysterectomy or myomectomy may reduce the chance of spreading undiagnosed leiomyosarcoma cells, it is associated with increased morbidity, compared with noninvasive approaches, and ob.gyns. should engage in open decision-making processes and explain nonsurgical options with patients.3
The author of this Master Class, Dr. Charles Miller, a world-renowned MIS surgeon, will enlighten readers on the latest development in noninvasive treatment of symptomatic patients. The Sonata system, a promising transcervical (and thus incisionless) treatment modality utilizing intrauterine sonography–guided radiofrequency ablation for uterine fibroids which does not require general anesthesia or hospitalization. He believes that Sonata “will not only be a treatment of choice in the appropriate patient presenting with heavy menstrual flow or bulk symptoms secondary to uterine fibroids, but will prove to be beneficial in women with impinging or deep submucosal fibroids and implantation failure.”
Dr. Miller is on the editorial advisory boards of numerous academic journals and serves as the editor of the award-winning Master Class in Gynecologic Surgery column. For this installment, he has stepped into the role of guest author. Dr. Miller has received numerous awards for his educational contributions and was recently granted the distinct honor of taking the lead in the March 28, 2020 Worldwide EndoMarch–Chicago. It is my pleasure to take part in this introduction.
Dr. Nezhat is director of minimally invasive surgery and robotics as well as the medical director of training and education at Northside Hospital, both in Atlanta. He is fellowship director at Atlanta Center for Special Minimally Invasive Surgery & Reproductive Medicine. Dr. Nezhat also is an adjunct professor of gynecology and obstetrics at Emory University, Atlanta, and is past president of the Society of Reproductive Surgeons and the AAGL. He reported that he has no disclosures relevant to this Master Class. Email him at [email protected].
References
1. BJOG. 2018 Apr;125(5):586.
2. JAMA Oncol. 2015;1(1):78-9.
3. Obstet Gynecol. 2019 Mar;133(3):e238-48.
Uterine fibroids are the most common benign tumor in women originating from the smooth muscles of the myometrium. While some women are asymptomatic, others experience pelvic pain, pressure, and abnormal uterine bleeding. Uterine fibroids also are associated with gastrointestinal disturbances; urinary problems; infertility; and obstetrical complications including miscarriages, preterm delivery, and cesarean sections.
The first successful abdominal myomectomy was described in 1845 but the procedure quickly fell out of favor because of unacceptably high mortality rates. Myomectomies require special skills and, at times, are associated with bleeding resulting in massive transfusions or sometimes unwanted hysterectomies. In 1922, Victor Bonney developed a uterine artery clamp which significantly decreased bleeding associated with morbidity and mortality.1
The latter part of the 20th century belonged to the minimally invasive surgery (MIS) evolution. Currently, video- or robotic-assisted laparoscopic myomectomies are increasingly employed in fertility-sparing surgery. In 2014, electromechanical morcellators came under scrutiny with concerns about iatrogenic dissemination of both benign and malignant tissues. A media storm ensued, resulting in the 2014 Food and Drug Administration black-box warning, and electromechanical morcellators were pulled from shelves. Data are being collected to quantify and understand these risks more clearly.
While exposing patients to even a small risk of dissemination of an occult uterine malignancy is unwise, MIS should not be abandoned altogether given its advantages to patients.2 Most recently, the American College of Obstetricians and Gynecologists concluded that, although abdominal hysterectomy or myomectomy may reduce the chance of spreading undiagnosed leiomyosarcoma cells, it is associated with increased morbidity, compared with noninvasive approaches, and ob.gyns. should engage in open decision-making processes and explain nonsurgical options with patients.3
The author of this Master Class, Dr. Charles Miller, a world-renowned MIS surgeon, will enlighten readers on the latest development in noninvasive treatment of symptomatic patients. The Sonata system, a promising transcervical (and thus incisionless) treatment modality utilizing intrauterine sonography–guided radiofrequency ablation for uterine fibroids which does not require general anesthesia or hospitalization. He believes that Sonata “will not only be a treatment of choice in the appropriate patient presenting with heavy menstrual flow or bulk symptoms secondary to uterine fibroids, but will prove to be beneficial in women with impinging or deep submucosal fibroids and implantation failure.”
Dr. Miller is on the editorial advisory boards of numerous academic journals and serves as the editor of the award-winning Master Class in Gynecologic Surgery column. For this installment, he has stepped into the role of guest author. Dr. Miller has received numerous awards for his educational contributions and was recently granted the distinct honor of taking the lead in the March 28, 2020 Worldwide EndoMarch–Chicago. It is my pleasure to take part in this introduction.
Dr. Nezhat is director of minimally invasive surgery and robotics as well as the medical director of training and education at Northside Hospital, both in Atlanta. He is fellowship director at Atlanta Center for Special Minimally Invasive Surgery & Reproductive Medicine. Dr. Nezhat also is an adjunct professor of gynecology and obstetrics at Emory University, Atlanta, and is past president of the Society of Reproductive Surgeons and the AAGL. He reported that he has no disclosures relevant to this Master Class. Email him at [email protected].
References
1. BJOG. 2018 Apr;125(5):586.
2. JAMA Oncol. 2015;1(1):78-9.
3. Obstet Gynecol. 2019 Mar;133(3):e238-48.